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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nGait in Adult Patients With Cervical Spondylotic Myelopathy\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the effect of cervical decompression surgery on the\r biomechanics of the lower extremities and spine during balance and gait in patients with\r cervical spondylotic myelopathy (CSM), before and after surgical intervention, and compare\r these parameters to an asymptomatic control group. To test our hypothesis that cervical\r decompression will improve preexisting gait disturbance, a gait analysis using dynamic\r surface EMG, video motion capture, and force plate analysis will be used. Patients 30 to 70\r years old will be eligible for the study. Thirty subjects diagnosed with symptomatic CSM and\r are deemed appropriate surgical candidates, along with 30 healthy subjects with no spine\r pathology, will be enrolled in this study. Exclusion criteria include any history of previous\r lumbar/thoracic surgery or lower extremity surgery, BMI greater than 35, or currently\r pregnant. Each subject from the surgical group will be evaluated on 3 different occasions: 1)\r 1 week before surgery, 2) 3 months postoperative, and 3) 12 months postoperative. Control\r subject will only be evaluated once. Bilateral trunk and lower extremity neuromuscular\r activity will be measured during a full gait cycle using dynamic surface EMG measurements.\r Human video motion capture cameras will collect lumbar spine and lower and upper extremity\r joint angles. Ground reaction forces (GRFs) will be collected from a 5 foot stretch of force\r platforms in order to define a full gait cycle.\n\n**Clinical Trial Detailed Description:**\n\nCervical spondylotic myelopathy (CSM) is a neurologic condition resulting from spinal cord\r compression caused by degenerative narrowing of the cervical spinal canal. CSM is most common\r after the age of 50 years, but the age of onset is variable depending on the degree of\r congenital spinal canal narrowing. Progressive degenerative changes in the cervical spine,\r such as disc bulges or herniations, facet hypertrophy, ligamentum flavum thickening, and\r degenerative vertebral spondylolisthesis, can all contribute to progressive spinal cord\r compression. The end result is chronic compression of the spinal cord and/or nerve roots\r leading to impaired blood flow, which can result in frank damage within the spinal cord\r itself. CSM is characterized by a wide variety of clinical presentations, which can include\r neck pain, numbness or weakness in the extremities, hand clumsiness, and, classically, gait\r disturbances. This typically manifests as difficulty with balance, but patients with more\r advanced myelopathy can also develop a stiff, spastic gait.\r\n\r Surgical treatment of CSM revolves around decompressing the spinal cord, either with or\r without concurrent fusion. Many surgical strategies have been proposed. Anterior surgical\r approaches include anterior cervical discectomy and fusion or anterior corpectomy and fusion.\r Posterior surgical approaches include laminectomy with or without fusion, or laminoplasty.\r The choice of surgical approach is specific to each patient based upon the extent and\r location of the pathology, the presence or absence of deformity or spinal instability, the\r sagittal alignment of the spine, the presence or absence of ossification of the posterior\r longitudinal ligament (OPLL), as well as other patient co-morbidity factors and surgeon\r preference. While there may be some debate as to when patients with radiographic cervical\r stenosis should undergo decompressive surgery, most surgeons would agree on surgery for\r patients with moderate or severe clinical myelopathy.\r\n\r Altered gait is frequently seen with CSM, and has been reported to be improved by surgical\r intervention. A stiff or spastic gait is also characteristic of CSM in its later stages. Many\r clinical studies have determined that patients with CSM have a slower gait speed, prolonged\r double support duration, and reduced cadence compared to healthy controls.Previous studies\r also identified reduced knee flexion during swing in the early stages of the disease, and, in\r more severe cases, decreased ankle plantar flexion at the terminal stance and reduced knee\r flexion during loading response.\r\n\r Upright stance and body stability depends on the vestibular, visual, and somatosensory\r systems.These systems contribute to the maintenance of postural control. The spinal cord,\r particularly the dorsal column, is an integral part of the somatosensory system.The dorsal\r columns relay the position and vibration sensations as well as play an important role in\r maintaining postural stability and conveying sensory information such as deep sensations to\r the lower limbs.When the dorsal column of the spinal cord is compressed, the functions of\r vibration sense, deep sensibility, and joint position sense are lost. CSM patients were found\r to have impaired knee proprioception when using electrogoniometer.22 A damaged spinal cord\r causes impaired body balance because of proprioceptive loss, and patients develop ataxia in\r the lower limbs.\r\n\r Jean Dubousset, first introduced the concept of the cone of economy and balance (COE) in\r 1994. The COE refers to a stable region of standing posture. The fundamental assumption is\r that swaying outside one's individual cone challenges the balance mechanisms and expends\r critical energy. Balance is defined as the ability of the human body to maintain its center\r of mass within the base of support with minimal postural sway. Sway is the movement of the\r COM in the horizontal plane when a person is standing in a static position. Balance\r efficiency is defined as the ability of the patients to maintain their COM within the COE\r with minimal sway and energy expenditure.Maintenance of balance requires coordination between\r the sensorineural and musculoskeletal systems. Very few studies have looked at functional\r balance in CSM patients. These studies used a stabilometer to measure center of gravity.\r During a 30 seconds balance test with closed eyes, CSM patients swayed significantly more and\r had greater postural instability compared to healthy controls. Neither of those studies\r reported on neuromuscular activity during a functional balance test. Haddas et al.was first\r to introduce a method to objectively quantify the COE and neuromuscular energy expenditure\r during a dynamic balance test.\r\n\r There is very little literature investigating the effect of surgical intervention on a CSM\r patient's balance and gait using human motion analysis both before and after surgery. In\r fact, there have not been any studies examining how surgical intervention for CSM can improve\r patients' balance and gait utilizing objective neuromuscular data as well as full body\r kinematic analysis. Additionally, none of the previous studies have been able to validate\r self-reported pain and functional outcome measures utilizing a human motion capture system\r and EMG.\r\n\r This study explores the effect of CSM on human balance and gait and will utilize kinematic\r balance and gait analyses to examine the dynamic range of motion of the spine and lower\r extremities, along with neuromuscular data from surface EMG to precisely define the timing\r and degree of spine and lower extremity muscle activation and peak activity, as well as\r measurements of ground reaction forces throughout the gait cycle. All of this will be\r compared pre- and post-operatively and also with a healthy control group in order to\r determine the extent to which CSM affects the biomechanics of and neuromuscular control\r during balance and gait and how this changes after surgical intervention. We will also be\r able to correlate these objective measures with patient self-reported pain and function based\r on commonly used outcome instruments.\r\n\r In summary, the purpose of this study is to explore the level of functional compromise, both\r objectively and with patient-reported outcome measures, in patients with CSM and to quantify\r the possible benefit of surgical intervention on the biomechanics and neuromuscular control\r of the spine and lower extremities as evaluated by balance and gait analyses using dynamic\r EMG, video motion capture, force plate analysis, and validated patient-reported outcome\r metrics.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age 30 years and older\r\n\r 2. Diagnosis of CSM with correlative imaging studies (MRI or CT-myelogram)\r\n\r 3. Able to ambulate without assistance and stand without assistance with participant eyes\r open for a minimum of 10 seconds\r\n\r 4. Able and willing to attend and perform the activities described in the informed\r consent within the boundaries of the timelines set forth for pre-, and post-operative\r follow-up\r\n\r Exclusion Criteria:\r\n\r 1. History of prior attempt at fusion (successful or not) at the indicated levels,\r (history of one level fusion is not an exclusion)\r\n\r 2. Major lower extremity surgery or previous injury that may affect gait (a successful\r total joint replacement is not an exclusion)\r\n\r 3. BMI higher than 35\r\n\r 4. Neurological disorder (beside cervical spondylotic myelopathy), diabetic neuropathy or\r other disease that impairs the patient's ability to ambulate or stand without\r assistance\r\n\r 5. Usage of blood thinners\r\n\r 6. Pregnant or wishing to become pregnant during the study\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRuxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test how well the drug works, safety and tolerability of an\r investigational drug called Ruxolitinib in gliomas and glioblastomas, when combined with\r standard treatment for brain cancer, temozolomide and radiation.\r\n\r Ruxolitinib is an experimental drug that works by targeting proteins in cells and stops them\r from growing. Ruxolitinib is experimental because it is not approved by the Food and Drug\r Administration (FDA) for the treatment of gliomas or glioblastomas\r\n\r Temozolomide works by damaging the DNA of tumor cells so that they cannot divide properly.\r Some tumor cells can repair that damage and therefore be resistant to temozolomide.\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objective\r\n\r Arm 1:\r\n\r To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) in\r patients with unmethylated MGMT high-grade glioma (HGG)\r\n\r Arm 2:\r\n\r To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) and daily\r temozolomide at 75 mg/m2 in patients with methylated MGMT high-grade glioma (HGG)\r\n\r Secondary Objective(s)\r\n\r Arm 1:\r\n\r - Safety of combination of ruxolitinib with radiation\r\n\r - Progression free survival (PFS)\r\n\r - Overall survival (OS)\r\n\r Arm 2:\r\n\r - Safety of combination of ruxolitinib with radiation and temozolomide\r\n\r - Progression free survival (PFS)\r\n\r - Overall survival (OS)\r\n\r STUDY DESIGN\r\n\r A phase 1 design will be used with cohorts of 3 patients treated at each dose level in both\r arms 1 and 2 and monitored for treatment-related toxicities. Escalation to the next dose will\r proceed in the absence of dose-limiting toxicities (DLTs).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Arm 1:\r\n\r - Patients must have unmethylated MGMT supratentorial high-grade glioma (anaplastic\r astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or\r glioblastoma).\r\n\r Arm 2:\r\n\r - Patients must have supratentorial methylated MGMT high-grade glioma (anaplastic\r astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or\r glioblastoma).\r\n\r Both:\r\n\r - Patients must have MRI or CT with contrast within 28 days prior to starting treatment.\r\n\r - Patients must have a Karnofsky performance status ≥ 70% (i.e. the patient must be able\r to care for himself/herself with occasional help from others).\r\n\r - Patients must have adequate blood, kidney and liver function\r\n\r - Patients must be able to provide written informed consent.\r\n\r - Patients and their sexual partners must agree to avoid conception while on the study\r due to possible risks from experimental drugs. Women will need a negative pregnancy\r test to be on the study\r\n\r - Patients may not have any other cancers except skin cancer and localized bladder,\r prostate, cervical, or breast cancer which were cured more than 3 years ago\r\n\r Exclusion Criteria:\r\n\r - Patients with other serious diseases\r\n\r - Pregnant women\r\n\r - Patients getting other cancer treatments\r\n\r - Patients with other cancers except for localized skin cancer and localized bladder,\r prostate, cervical, or breast cancer which were cured more than 3 years ago\r\n\r - Patients who have had repeat craniotomy for tumor therapy after receiving radiation\r therapy and temozolomide treatment.\r\n\r - Patients who have previously received other treatments for their cancers\r\n\r - Patient has previously taken ruxolitinib or is allergic to components of the study\r drug\r\n\r - Use of blood thinners\r\n\r - Human immunodeficiency virus (HIV) infection\r\n\r - Active hepatitis B or C infection\r\n\r - Heart diseases including abnormal electrocardiogram (EKG)\r\n\r - Patients unwilling or unable to follow this protocol\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCB-839 With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nThis phase 1b trial studies the side effects and best dose of glutaminase inhibitor CB-839\r hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating\r patients with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of\r tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses\r high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as\r temozolomide, work in different ways to stop the growth of tumor cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 with\r radiation therapy and temozolomide may work better than surgery, radiation therapy, and\r temozolomide in treating patients with IDH-mutated diffuse astrocytoma or anaplastic\r astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. Determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of\r CB-839 hydrochloride (HCl) (telaglenastat) when combined with radiation therapy (RT) and\r temozolomide (TMZ) in patients with newly diagnosed IDH-mutated diffuse astrocytoma (DA) and\r anaplastic astrocytoma (AA).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To observe and record anti-tumor activity. II. Determine the safety and tolerability of\r RT/TMZ/CB-839 HCl (telaglenastat) in patients based on physician reported adverse event (AE)\r data.\r\n\r III. Estimate the 2-year progression-free survival (PFS2) of RT/TMZ/CB-839 HCl\r (telaglenastat) in patients with IDH-mutated glioma based on the Response Assessment in\r Neuro-Oncology (RANO) criteria.\r\n\r IV. Estimate the 2-year overall survival (OS2) of RT/TMZ/CB-839 HCl (telaglenastat) in\r patients with IDH-mutated glioma based on RANO criteria.\r\n\r CORRELATIVE OBJECTIVES:\r\n\r I. Determine the minor response rate (MRR) and clinical benefit rate (CBR) for the\r combination of CB-839 HCl (telaglenastat) and RT/TMZ in IDH-mutated glioma based on RANO\r criteria.\r\n\r II. Determine the patient-reported tolerability of RT/TMZ/CB-839 HCl (telaglenastat) using\r the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) instrument to measure self-reported\r symptom severity and interference with daily activities.\r\n\r II. Determine the neurocognitive impact of CB-839 HCl (telaglenastat) when used in\r combination with RT/TMZ.\r\n\r III. Determine the effect of CB-839 HCl (telaglenastat)/RT/TMZ on plasma oncometabolite\r levels of glutamine, glutamate, aspartate, asparagine, and 2-hydroxyglutarate (2-HG) in\r patients with IDH-mutated glioma and associate the changes with disease response.\r\n\r IV. Determine the effect of CB-839 HCl (telaglenastat)/RT/TMZ on tumor glutamine and\r glutamate MRS signals in patients with IDH-mutated glioma and associate the signal with\r disease response.\r\n\r V. Determine the pharmacokinetics (PK) of CB-839 HCl (telaglenastat) when used alone and in\r combination with TMZ.\r\n\r VI. To perform molecular profiling assays on archived tumor tissue and peripheral blood,\r including, but not limited to, low-pass whole genome sequencing (WGS), whole exome sequencing\r (WES), and messenger RNA sequencing (RNA-Seq) in order to VIa. Identify potential predictive\r and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned.\r\n\r VIb. Identify resistance mechanisms using genomic deoxyribonucleic acid (DNA)- and\r ribonucleic acid (RNA)-based assessment platforms.\r\n\r VII. To contribute genetic analysis data from de-identified biospecimens to Genomic Data\r Commons (GDC), a well annotated cancer molecular and clinical data repository, for current\r and future research; specimens will be annotated with key clinical data, including\r presentation, diagnosis, staging, summary treatment, and if possible, outcome.\r\n\r VIII. To bank formalin-fixed, paraffin-embedded (FFPE) tissue, blood (for cell-free DNA\r analysis), and nucleic acids obtained from patients at the Experimental Therapeutics Clinical\r Trials Network (ETCTN) Biorepository at Nationwide Children's Hospital.\r\n\r OUTLINE: This is a dose escalation study of CB-839.\r\n\r Patients receive CB-839 orally (PO) twice daily (BID) 7 days a week, temozolomide PO once\r daily (QD) 7 days a week, and undergo RT 5 days a week for up to 5.5 weeks (diffuse\r astrocytoma) or 6.5 weeks (anaplastic astrocytoma) in the absence of disease progression or\r unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up every 3 months for up to 2\r years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histopathologic or molecular confirmation of either IDH-mutant DA\r or IDH-mutant AA. Acceptable IDH mutations for study eligibility include any IDH1\r mutation at codon 132 or any IDH2 mutation at codon 172.\r\n\r - Age >= 16 years. The intended neurocognitive tests have not been validated in children\r below the age of 16.\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%).\r\n\r - Hemoglobin > 9.0 g/dL\r\n\r - Leukocytes >= 3.0 x 10^9/L\r\n\r - Absolute neutrophil count >= 1.5 x 10^9/L\r\n\r - Platelets >= 100 x 10^9/L\r\n\r - International normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)\r\n\r - Partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) =<\r 1.5 x ULN\r\n\r - Patients on a stable dose of anti-coagulation therapy will be allowed to participate\r if they have no signs of bleeding or clotting and the INR/PT and PTT/aPTT results are\r compatible with an acceptable risk-benefit ratio as per the investigator's discretion.\r\n\r - Total bilirubin =< 1.5 x institutional ULN and < 3 mg/dL for patients with Gilbert's\r disease\r\n\r - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) &\r alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x\r institutional ULN\r\n\r - Creatinine =< 1.5 x institutional ULN or creatinine clearance >= 60 mL/minute\r\n\r - If there is history of human immunodeficiency virus (HIV) infection, patients must be\r on effective antiretroviral therapy and HIV viral load must be undetectable within 6\r months of study enrollment.\r\n\r - If there is history of chronic hepatitis B virus (HBV) infection, patients must have\r either been treated or are on suppressive therapy (as indicated), and HBV viral load\r must be undetectable.\r\n\r - If there is history of hepatitis C virus (HCV) infection, patients must have been\r treated and HCV viral load must be undetectable.\r\n\r - Patient must have measurable disease by RANO criteria (dose expansion cohort only).\r\n\r - Patient must be at least 7 days beyond stereotactic biopsy and/or at least 14 days\r beyond open craniotomy at the time of registration.\r\n\r - Patients must have been on a stable or decreasing dose of corticosteroids over the\r last 7 days at the time of registration.\r\n\r - Patients must have been on a stable or decreasing dose of antiepileptic therapy over\r the last 14 days at the time of registration.\r\n\r - Females of childbearing potential must have a negative pregnancy test (=< 14 days)\r prior to start of trial treatment. The effects of CB-839 HCl on the developing human\r fetus are unknown. For this reason and because alkylating agents as well as TMZ are\r known to be teratogenic, women of child-bearing potential and men must agree to use\r adequate contraception (hormonal or barrier method of birth control; abstinence) prior\r to study entry and for the duration of study participation. Should a woman become\r pregnant or suspect she is pregnant while she or her partner is participating in this\r study, she should inform her treating physician immediately. Men treated or enrolled\r on this protocol must also agree to use adequate contraception prior to the study, for\r the duration of study participation, and 4 months after completion of CB-839 HCl\r (telaglenastat) administration.\r\n\r - Ability to understand and the willingness to sign a written informed consent document.\r\n\r - Patients with a prior or concurrent malignancy whose natural history or treatment does\r not have the potential to interfere with the safety or efficacy assessment of the\r investigational regimen are eligible for this trial.\r\n\r - Patients with known history or current symptoms of cardiac disease, or history of\r treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac\r function using the New York Heart Association functional classification. To be\r eligible for this trial, patients should be class 2B or better.\r\n\r - Availability of archival FFPE tumor tissue collected within 12 months prior to\r registration.\r\n\r Exclusion Criteria:\r\n\r - Patients must not have received prior chemotherapy to treat the glioma.\r\n\r - Patients who are receiving any other investigational agents.\r\n\r - History of allergic reactions attributed to compounds of similar chemical or biologic\r composition to CB-839 HCl (telaglenastat) or TMZ.\r\n\r - Patient must not have received prior radiation therapy to the brain. Prior radiation\r therapy to the head and neck is also excluded if radiation fields overlap.\r\n\r - No prior use of Gliadel wafers.\r\n\r - Patient must have no evidence of either infratentorial or spinal involvement with\r tumor.\r\n\r - Patients who are unable to swallow tablets.\r\n\r - Patients who are at risk for impaired absorption of oral medication including, but not\r limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal\r resection.\r\n\r - Patients with uncontrolled intercurrent illness.\r\n\r - Patients with a \"currently active\" second malignancy other than non-melanoma skin\r cancers. Patients are not considered to have a \"currently active\" malignancy if they\r have completed therapy and are free of disease for more than 3 years.\r\n\r - Pregnant women are excluded from this study because CB-839 HCl (telaglenastat) is an\r agent with the potential for teratogenic or abortifacient effects. Because there is an\r unknown but potential risk for AEs in nursing infants secondary to treatment of the\r mother with CB-839 HCl (telaglenastat), breastfeeding should be discontinued if the\r mother is treated with CB-839 HCl (telaglenastat). These potential risks may also\r apply to TMZ.\r\n\r - Adolescent patients who require sedation for magnetic resonance imaging (MRI) or\r magnetic resonance spectroscopy (MRS).\r\n\r - Patients with psychiatric illness/social situations that would limit compliance with\r study requirements.\r\n\r - The primary language of communication for the patient must be English (dose expansion\r cohort only). The intended neurocognitive tests have not been validated in patients\r who do not primarily speak English.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression\n\n**Clinical Trial Summary:**\n\nSpinal cord compression (SCC) is a devastating complication of advanced malignancy, and can\r cause significant deterioration in function and quality of life (QoL). The goal of treatment\r is to improve functional status and symptoms, but the optimal treatment regimen for these\r patients has not been thoroughly established. Many patients with SCC present with\r uncontrolled systemic disease and poor performance status, and are not eligible for standard\r surgical resection. They are generally treated with 3D conformal palliative RT (3DCRT) alone,\r however recent trials suggest that less than 70% of patients are ambulatory, that the\r re-establishment of ambulation in non-ambulatory patients is poor, and the duration of\r improvement is guarded with radiotherapy alone.\r\n\r Recently, stereotactic body radiotherapy (SBRT) used alone or after previous radiotherapy to\r treat spinal metastasis has demonstrated superior results in pain control, tumour response\r and durability. SBRT requires time for careful planning, and many patients with neurologic\r symptoms must be treated immediately to prevent progression. Therefore the role of SBRT is\r still unclear in this patient population, although it seems to be a potential alternative to\r surgical decompression in patient not suitable for surgery. The investigators propose a\r feasibility study to investigate the potential benefits of dose escalation with a sequential\r SBRT boost to urgent 3D CRT in the setting of SCC. This regimen will allow inoperable\r patients to receive urgent 3DCRT while simultaneously creating the opportunity for superior\r outcomes with SBRT. The investigators also aim to characterize the effect on motor function\r and ambulation, pain and QoL. This study could stimulate further multi-center randomized\r trials in this area, improve motor function and patient-reported QoL, and contribute to\r improving oncology care in Canada in a meaningful way.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Diagnosis of metastatic malignancy (radiologic or pathologic)\r\n\r 2. Evidence of disease in vertebral body with epidural component such that Bilsky\r radiologic score is 1c-2 on MRI (abuts spinal cord without cord compression (1c), or\r spinal cord compression but with visible CSF (2)\r\n\r 3. Motor function (MF) of 3 or greater\r\n\r Exclusion Criteria:\r\n\r 1. Surgical candidate\r\n\r 2. Instability of vertebral bodies with or without bony retropulsion requiring surgical\r intervention or hardware placement\r\n\r 3. Previous radiotherapy course to same region of spine with overlapping fields (prior to\r phase I course) at discretion of treating radiation oncologist\r\n\r 4. No CT or MRI within previous 3 months\r\n\r 5. Life expectancy estimated <3 months\r\n\r 6. Performance status KPS<40\r\n\r 7. On active chemotherapy or targeted therapy or immunotherapy (must be stopped for at\r least one week prior to and following)\r\n\r 8. Pregnant or lactating\r\n\r 9. Contraindications to radiotherapy (eg. active autoimmune disease requiring medication)\r\n\r 10. Inability to lie flat comfortably for at least 20 minutes\r\n\r 11. Age < 18\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nHigh Dose Radiotherapy for the Treatment of Rectal Cancer\n\n**Clinical Trial Summary:**\n\nWhile surgery remains the standard treatment for rectal cancer, some patients still firmly\r refuse surgery for various reasons. Here, we conducted this retrospective observation study\r to discuss the feasibility of high-dose radiotherapy combined with chemotherapy in treating\r rectal cancer We retrospectively collect data of rectal cancer patients who were treated with\r high-dose radiotherapy plus chemotherapy in Sun Yat-sen University Cancer Center from April\r 1st, 2006 to July 30th, 2017. Patients gave up surgery before any treatment would have\r received one course of high dose radiotherapy (GTV60-70Gy/30-35f). Patients with tumor\r residual after neoadjuvant chemoradiotherapy but insisted non-operative treatment would have\r received 2 courses of radiotherapy (1st: GTV 45-50Gy/25f, 2nd: GTV 30/15f). The chemotherapy\r regimens included Capox, FOLFOX, or capecitabine at the discretion of the treating physician.\r\n\r After treatment, patients were followed every 3 months for the first two years, at least\r every 6 months in the year thereafter. Recurrence, early and late toxicity were recorded.\r\n\r Analyses were performed using SPSS software, version 19.0 (SPSS, Chicago, IL). Local\r recurrence and distant metastasis rate, progression free survival, and overall survival were\r calculated using the Kaplan Meier Method and were compared by log-rank test.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. pathologically confirmed diagnosis of rectal adenocarcinoma located within 15cm from\r the anal verge;\r\n\r 2. pelvic radiation with a total dose ≥60Gy for the treatment of rectal cancer;\r\n\r 3. refused surgery as the initial treatment;\r\n\r 4. a complete set of clinical information and follow-up data.\r\n\r Exclusion Criteria:\r\n\r 1. patients with terminal cancer who received palliative treatment;\r\n\r 2. patients received any treatment before admission to Sun Yat-sen University Cancer\r Center;\r\n\r 3. patients with second primary cancer.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nQuality of Life of Patients Who Have Rocket Indwelling Pleural Catheter Drainage or Repeated Large Volume Paracentesis\n\n**Clinical Trial Summary:**\n\nAscites (accumulation of fluid in the abdominal cavity) is a common problem which can lead to\r distressing symptoms. When caused by cancer, management options are chemotherapy, diuretics\r and ascitic drainage. Ascitic drainage is performed by inserting a plastic tube into the\r abdomen and draining off the fluid under local anaesthetic, removing the drain afterwards.\r For some, the fluid will return and the procedure needs repeating. A relatively new treatment\r involves inserting a semi-permanent drain - a small plastic tube under the skin which is left\r in place so that the fluid can be drained if it builds up again. The potential benefit to\r patients is that afterwards they can have fluid removed at home. This might reduce the number\r of hospital admissions, outpatient visits and the number of procedures they need to have in\r the last few months of life. In Gloucestershire, the Rocket Indwelling Pleural Catheter (IPC)\r is the semi-permanent drain of choice.\r\n\r Our research group has a particular interest in the management of ascites and we recently\r completed the first qualitative interview study with patients with this condition - patients\r with ascites secondary to cancer. Patients were pleased to have semi-permanent drains in\r place as it meant that repeated admissions to hospital were avoided. They did not have to\r wait for a build-up of fluid before more could be drained off; and symptoms never had to\r build up as badly as when they were having repeated ascitic drainage.\r\n\r We plan a feasibility study to ascertain whether a definitive non-randomised study to detect\r differences in quality of life between Rocket IPC and repeat ascitic drainage is possible and\r how many patients would be needed for such a study.\n\n**Clinical Trial Detailed Description:**\n\nStudy Objective This feasibility study aims to establish how best to conduct a definitive\r prospective non-randomised QOL study for patients with malignant ascites who either have\r placement of a Rocket IPC or repeated LVP\r\n\r Study Design This is an open label, non-randomised observational study. Each patient will\r receive verbal and written information followed by signing of an Informed Consent Form prior\r to participation. They will be asked to capture data about their QOL by completing paper\r diaries.\r\n\r If the patient has a relative / next of kin we will ask permission from the patient to\r approach them to see if they would be happy to consent to helping with data collection for\r the study.\r\n\r Study Procedures\r\n\r When patients are booked for ascitic drainage in hospitals or hospice a member of the\r patient's clinical team will discuss the study with the patient (either in person or via\r telephone). If in agreement, the doctor / nurse will pass on their contact details to a\r member of the research team who will then telephone the patient and:\r\n\r - Ask the patient if they would be happy to receive a patient information leaflet by post\r or email\r\n\r - Ask the patient if they would be happy for their relative / next of kin to be contacted\r about this study. The relative / next of kin will then be contacted and, if they are\r happy to receive it, a participant information leaflet will be posted or emailed to\r them.\r\n\r [If the patient is having an IPC fitted the relative may fit the inclusion criteria for the\r related study, Rocket Project 2, so that this study may be discussed at this point and a\r participant information leaflet provided too.]\r\n\r At the time of admission for the procedure informed consent will be obtained from the patient\r and the following information will be obtained and recorded on a case report form:\r\n\r - Patient's age, gender, diagnosis\r\n\r - Performance status\r\n\r - How many LVPs the patient has had up until the current procedure\r\n\r - Patient's understanding of treatment options for ascites management, in particular\r whether Rocket IPC has been mentioned\r\n\r - Why was this option chosen?\r\n\r - Opinion about participation in a randomised trial if one was being conducted The\r research nurse will ensure that baseline blood tests to include renal function and\r albumin have been performed prior to the procedure.\r\n\r Rarely, a patient could be referred for the procedure and have it performed later that day.\r In that scenario we would like to have permission for a cooling off period to be waived by\r the participants - we would argue that this is not a particularly burdensome study.\r\n\r Informed consent will also be sought from the relative / next of kin. It will usually be\r possible to do obtain this when the patient attends for the procedure but a separate\r appointment to obtain informed consent may be needed at the relative / next of kin's home or\r care setting.\r\n\r A patient can be recruited to the study if their relative / next of kin does not consent OR\r they have no relative / next of kin.\r\n\r A four week diary will be given to the patient to capture the following information:\r\n\r 1. Number of LVPs / Rocket IPC drainage episodes performed*\r\n\r 2. Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC\r drainage*\r\n\r 3. Any complications - catheter blockage, infections, hospital admissions*\r\n\r 4. The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY\r\n\r 5. The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY\r\n\r 6. The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL\r Questionnaire (QLQ-C30) WEEKLY\r\n\r 7. Anti-cancer treatment received by the patient*\r\n\r 8. Diuretics received by the patient*\r\n\r If a relative / next of kin has consented they can help the patient to complete their diary.\r They will not be able to give a proxy measure for any of the quality of life scores but will\r be able to assist the patient with completion of these and also with objective measures (e.g.\r those marked * above) The research nurse will contact the patient frequently by phone, to\r provide support with data collection, if required.\r\n\r When the patient is close to completing 4 weeks in the study they will be offered the\r opportunity to complete another 4 week diary. It will be explained to them that this is not\r essential but will provide useful information.\r\n\r When close to completing the 2nd 4 week diary (i.e. after 8 weeks) they will, once again, be\r offered a further diary. Patients will complete a maximum of three diaries.\r\n\r Patients will not be expected to complete questionnaires if they do not feel well enough or\r lose capacity. Patients' clinical course can fluctuate and there may be a time when they feel\r well enough to complete questionnaires again. Data about fluid volumes removed may still be\r collected after a patient loses capacity by healthcare staff, as is routine practice, or\r consenting relatives / next of kin.\r\n\r Only patients with capacity will be approached for participation in the study.\r\n\r Blood Tests Renal function and albumin will be measured at baseline, 6 weeks and 12 weeks\r (the latter 2 time points only if the patient remains in the study after 4 weeks and 8 weeks)\r - if necessary performed by the research nurse at patient's home.\r\n\r Blood tests will not be performed on patients who have lost capacity for the purposes of this\r study. If patients without capacity have blood tests taken for other reasons the results will\r be used as part of data analysis.\r\n\r Only a very small percentage of people living in Gloucestershire are not English speaking. It\r has been decided that it is not cost effective to fund translation for this feasibility\r study. The information on the numbers of patients / carers who may have been excluded and the\r languages that might have been needed will be collected and this will be taken into account\r when planning a larger study.\r\n\r Outcome measures\r\n\r There have been recommendations about suitable QOL measures for use with patients with\r ascites. We discussed these with service users and carers and have agreed on using for this\r study:\r\n\r 1. The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM)\r\n\r 2. The EuroQol questionnaire (EQ-5D) as a generic QOL measure\r\n\r 3. The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL\r Questionnaire (QLQ-C30)\r\n\r In addition we will ask healthcare professionals, patients or consenting carers (depending on\r who manages the drain) to record volumes of fluid removed at each paracentesis and episode of\r semi-permanent drainage.\r\n\r We will ask patients and carers about:\r\n\r Drainage complications and hospital admissions. Chemotherapy use Diuretic use\r\n\r Withdrawal of subjects from the study\r\n\r Patients will cease participation in the study when one of the following criteria is met:\r\n\r They choose to withdraw They choose not to complete a further QOL diary They complete their\r third monthly QOL diary They lose capacity and it is thought that this will be permanent\r\n\r Carers will cease participation in the study when one of the following criteria is met:\r\n\r They choose to withdraw The patient dies\r\n\r A patient may remain in the study although a carer / next of kin has withdrawn and vice\r versa.\r\n\r Statistical Analysis Percentage presence and percentage completeness of the three QOL\r measures will be evaluated. These results will allow an estimation of the number of patients,\r resources and time needed to perform a definitive prospective non-randomised QOL study for\r patients with malignant ascites who either have placement of a Rocket IPC or repeated LVP.\r\n\r The following analysis will also be conducted:\r\n\r - QLQ-C30 and EQ-5D averaged for each participant for the duration of their participation,\r using the area under the curve method.\r\n\r - ESAS:AM analysed by estimating the prevalence of individual symptoms at each time point,\r as well as the time-weighted average burden of symptoms for each participant.\r\n\r It is hoped that data from the feasibility study can be used in the definitive study if the\r methodology of the two studies remains the same.\r\n\r We estimate over a 6-month period approximately 60 patients with ascites secondary to cancer\r will have a paracentesis. We plan to recruit 20 patients having a drainage procedure (LVP or\r Rocket IPC) within 6 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nPatient Inclusion Criteria:\r\n\r 1. Male or female adult patients\r\n\r 2. Have ascites due to cancer undergoing treatment at Gloucestershire Hospitals NHS\r Foundation Trust\r\n\r 3. Planned to have an ascitic tap within a week\r\n\r 4. Thought to have an estimated prognosis of 12 weeks or more\r\n\r 5. Willing and able to provide signed written informed consent\r\n\r Patient Exclusion Criteria\r\n\r 1. Patients who, in the opinion of the clinical team, would be too distressed by the idea\r of participation.\r\n\r 2. Patients who might not adequately understand verbal explanations or written\r information given in English.\r\n\r Relative Inclusion Criteria:\r\n\r 1. Adult supporting patient participant in Rocket Project 1\r\n\r 2. Happy to support patient with completion of patient diaries\r\n\r Relative Exclusion Criteria\r\n\r 1. Relatives who, in the opinion of the clinical team, would be too distressed by the\r idea of participation.\r\n\r 2. Relatives who might not adequately understand verbal explanations or written\r information given in English.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\n3D Prediction of Patient-Specific Response\n\n**Clinical Trial Summary:**\n\nThis is a prospective, non-randomized, observational registry study evaluating a\r patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or\r resected tumor tissue for assessing tissue response to therapy in patients with advanced\r cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors.\n\n**Clinical Trial Detailed Description:**\n\nThis protocol defines a prospective, open-label, multi-institutional, non-interventional\r study for the purpose of examining the Assay's clinical use and potential to impact patient\r outcomes. This Study will establish a registry of clinical parameters, including clinical\r response, clinical outcomes, Assay performance and potential utilization across multiple\r types of advanced cancers in consenting patients who have their tumor tissue tested by the\r Assay. Physicians may have access to Assay results which which predict therapeutic response\r to cancer drugs most often prescribed to treat the specified indications. For cancers with\r standard of care (SOC) cancer drug treatments, the Assay panel tests SOC systemic agents per\r NCCN guidelines, some of which may include both FDA approved and off-label FDA approved\r therapies. The Assay currently assesses the most common cancer drugs across multiple tumor\r types. It requires freshly obtained tumor specimen that has not been previously preserved for\r traditional histologic analysis. The Registry will focus initially on tumor types and agents\r which have been analytically validated with the Assay and determined to meet strict\r laboratory qualifications and standards. The Registry will collect data on a limited number\r of cancer types to include epithelial ovarian cancer (EOC), high-grade gliomas (HGG) limited\r to anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM), and high-grade rare tumors\r (RT).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18 years and older\r\n\r - Diagnosis of or suspected diagnosis of EOC, HGG, high-grade RT\r\n\r - Individual must undergo elective surgery or biopsy to remove tumor tissue\r\n\r - Consideration as a candidate for systemic therapy with cytotoxic chemotherapy,\r targeted small molecule inhibitors or immunotherapy\r\n\r - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3\r\n\r - Written informed consent in accordance with institutional standards must be obtained\r from the patient or legal guardian\r\n\r Exclusion Criteria:\r\n\r - Inability or refusal of the patient or legal guardian to sign a written informed\r consent\r\n\r - Failure to have surgery or a biopsy as part of routine clinical practice\r\n\r - Refusal to have the Assay performed on their tissue\r\n\r - Known active cancer metastatic to the brain except for patients with brain metastases\r that have been treated and are considered stable.\r\n\r - Inability or unwillingness to receive chemotherapy treatment beyond surgery\r\n\r - Any coincidental medical condition that, in the Investigator's opinion, would preclude\r participation in the study or compromise the patient's ability to give informed\r consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVeliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies how well veliparib, radiation therapy, and temozolomide work in\r treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600\r mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help\r repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so\r tumor cells can't repair themselves, and they may stop growing. Radiation therapy uses high\r energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as\r temozolomide, work in different ways to stop the growth of tumor cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib,\r radiation therapy, and temozolomide may work better in treating patients with newly diagnosed\r malignant glioma without H3 K27M or BRAFV600 mutations compared to radiation therapy and\r temozolomide alone.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine whether veliparib (ABT-888), when added to radiotherapy (RT) and\r temozolomide, is efficacious for the treatment of patients with newly-diagnosed high-grade\r glioma (HGG) whose tumors' molecular profile are wild-type for H3 K27M, BRAF, and IDH1/2.\r\n\r II. To determine whether veliparib (ABT-888), when added to RT and temozolomide, is\r efficacious for the treatment of patients with newly-diagnosed HGG whose tumors' molecular\r profile are wild-type for H3 K27M and BRAF and harbor an IDH1/2 mutation.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To explore associations of genomic, transcriptomic, and/or epigenetic alterations of the\r tumors with treatment response and outcome.\r\n\r II. To explore the extent to which patients with BRCA1/2 gene alterations and other\r deoxyribonucleic acid (DNA) damaged genes display tumor genomic features consistent with\r homologous repair deficiency (HRD), including large scale state transitions (LSTs),\r mutational signature 3, and an enrichment for deletions flanked by sequences of (micro)\r homology.\r\n\r III. To explore the burden of high, moderate, and low penetrant germline alterations in HRD\r genes (such as BRCA1, BRCA2, PALB2, Fanconi complex genes, ATM, CHEK2, RAD51B/C/D), mis-match\r repair genes (such as MLH1, MSH2, MSH6, PMS2, EPCAM), and energy metabolism genes (such as\r SDHA, SDHB, SDHC, SDHAF2, SDHD, IDH1, IDH2, and FH).\r\n\r IV. To explore constitutional imprinting abnormalities associated with EP300 and IGF2 in\r peripheral blood from patients with HGGs.\r\n\r OUTLINE:\r\n\r CHEMORADIOTHERAPY PHASE: Patients receive veliparib orally (PO) twice daily (BID) and undergo\r 30 daily fractions of radiation therapy 5 days per week for 6-7 weeks in the absence of\r disease progression or unacceptable toxicity.\r\n\r MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after chemoradiotherapy phase, patients receive\r veliparib PO BID and temozolomide PO once daily (QD) on days 1-5. Treatment repeats every 28\r days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up every 3 months for year 1,\r every 4 months for year 2, every 6 months for year 3, and then once yearly for years 4-10.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Stratum 1 (IDH wild-type): Patients must be >= 3 years of age and =< 21 years of age\r at the time of enrollment\r\n\r - Stratum 2 (IDH mutant): Patients must be >= 3 years of age and =< 25 years of age at\r the time of enrollment\r\n\r - Patients must have eligibility confirmed by rapid central pathology and central\r molecular screening reviews performed on APEC14B1:\r\n\r - Newly-diagnosed high-grade glioma such as anaplastic astrocytoma or glioblastoma\r\n\r - Negative results for H3 K27M by immunohistochemistry (IHC)\r\n\r - Negative results for BRAFV600 mutation by next-generation sequencing (NGS)\r\n\r - Patients must have histological verification of diagnosis. Patients with M+ disease\r (defined as evidence of neuraxis dissemination) are not eligible. Cerebrospinal fluid\r (CSF) cytology is not required but may be obtained if clinically indicated prior to\r study enrollment. If cytology is positive, the patient would be considered to have\r metastatic disease and would, therefore, be ineligible\r\n\r - Pre-operative and post-operative brain magnetic resonance imaging (MRI) with and\r without contrast must be obtained. The requirement for a post-operative MRI is waived\r for patients who undergo biopsy only. A spine MRI is not required, but may be obtained\r if clinically indicated. If the spine MRI is positive, the patient would be considered\r to have M+ disease (defined as neuraxis dissemination) and would be ineligible\r\n\r - Patients must have a performance status corresponding to Eastern Cooperative Oncology\r Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and\r Lansky for patients =< 16 years of age\r\n\r - Peripheral absolute neutrophil count (ANC) >= 1,000/uL (within 7 days prior to\r enrollment)\r\n\r - Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to\r enrollment)\r\n\r - Hemoglobin >= 8.0 gm/dL (can be transfused) (within 7 days prior to enrollment)\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70\r mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows (within 7 days\r prior to enrollment):\r\n\r - 3 to < 6 years: 0.8 (male and female) maximum serum creatinine (mg/dL)\r\n\r - 6 to < 10 years: 1 (male and female) maximum serum creatinine (mg/dL)\r\n\r - 10 to < 13 years: 1.2 (male and female) maximum serum creatinine (mg/dL)\r\n\r - 13 to < 16 years: 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL)\r\n\r - >= 16 years: 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)\r\n\r - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to\r enrollment)\r\n\r - Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or\r serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x\r upper limit of normal (ULN) for age (within 7 days prior to enrollment)\r\n\r - Patients with seizure disorder may be enrolled if seizures are well-controlled (i.e.,\r patients must not have required rescue medications for uncontrolled seizures within 14\r days prior to enrollment)\r\n\r - Patients must be enrolled and protocol therapy must be projected to begin no later\r than 31 days after definitive diagnostic surgery (Day 0)\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met\r\n\r Exclusion Criteria:\r\n\r - Patients with the following histologies:\r\n\r - Diffuse astrocytoma (grade 2)\r\n\r - Oligodendrogliomas (any grade)\r\n\r - Pleomorphic xanthoastrocytoma (PXA, any grade)\r\n\r - Patients with primary tumor location of brainstem or spinal cord\r\n\r - Patients with M+ disease (defined as neuraxis dissemination either by imaging or by\r cytology)\r\n\r - Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic\r syndrome (MDS) or with features suggestive of AML/MDS\r\n\r - Prior allogenic bone marrow transplant or double umbilical cord blood transplantation\r\n\r - Patients must not have received any prior tumor-directed therapy including radiation\r therapy, chemotherapy (tumor-directed therapy), molecularly targeted agents, or\r immunotherapy for the treatment of HGG other than surgical intervention and/or\r corticosteroids\r\n\r - Lumbar CSF cytology is not required, but may be performed if clinically indicated\r prior to study enrollment. If lumbar CSF cytology is positive, the patient is\r considered to have M+ disease and is ineligible\r\n\r - Note: False positive cytology can occur within 10 days of surgery\r\n\r - Patients with gliomatosis cerebri type 1 or 2\r\n\r - Patients who are not able to receive protocol specified radiation therapy\r\n\r - Patients must not be currently receiving other anti-cancer agents\r\n\r - Patients with known constitutional mismatch repair deficiency syndrome\r (CMMR-D)/biallelic mismatch repair deficiency (bMMRD)\r\n\r - Female patients who are pregnant are ineligible due to risks of fetal and teratogenic\r adverse events as seen in animal/human studies\r\n\r - Lactating females are not eligible unless they have agreed not to breastfeed their\r infants\r\n\r - Female patients of childbearing potential are not eligible unless a negative pregnancy\r test result has been obtained\r\n\r - Sexually active patients of reproductive potential are not eligible unless they have\r agreed to use an effective contraceptive method for the duration of their study\r participation and for 6 months after the last dose of protocol-specified chemotherapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nRole of Virtual Reality in Improving Balance in Patients With Myelopathy\n\n**Clinical Trial Summary:**\n\nBalance of the body is achieved by the coordination of three major systems, visual,\r vestibular and proprioceptive sensation and by the reflexive control of the limbs. In\r myelopathy, factors like balance and posture, range of motion, muscle strength, coordinated\r motor control, muscle tone and proprioception are affected. Balance and gait rehabilitation\r is an important goal in myelopathy. Virtual reality (VR) is a computer based technology that\r is used for task oriented biofeedback therapy in rehabilitation. This study was envisioned to\r observe the utility of VR in rehabilitation for improving balance in patients of myelopathy.\n\n**Clinical Trial Detailed Description:**\n\nBalance of the body is achieved by the coordination of three major systems, visual,\r vestibular and proprioceptive sensation and by the reflexive control of the limbs. Static\r balance which determines the ability to maintain postural stability during sitting or\r standing is important to perform daily functional activities. Dynamic balance on the other\r hand is the ability to respond and adjust to a moving floor or any external stimuli or\r perturbation and is a requirement for successful gait performance.\r\n\r In myelopathy, factors like balance and posture, range of motion, muscle strength,\r coordinated motor control, muscle tone and proprioception are affected. Lack of normal\r postural synergy and sensory motor integration of lower limbs and trunks and spatial\r information that regulate upright position and sitting balance leads to balance dysfunction\r in the population. Hence patient develops compensatory strategies. But ambulation involves\r the intricate coordination of leg movements, regulating upright posture and balance and\r adaptation to environmental changes. Hence balance and gait rehabilitation is an important\r goal in myelopathy.\r\n\r Virtual reality (VR) is a computer based technology that is used for task oriented\r biofeedback therapy in rehabilitation. It constructs a virtual environment resembling a\r situation in the real world and provides multimodal sensory cues. VR ranges from non\r immersive to semi immersive to fully immersive, depending on the degree to which the user is\r isolated from the physical surroundings when interacting with the virtual environment.\r\n\r In virtual reality training, participants perform functional stretching of their extremities,\r learn postural control of the trunk and practice weight shifting. As the level of difficulty\r and speed are increased for various tasks, the movement of the body's center of gravity\r beyond the base of support increases thus increasing the proprioceptive sensations to the\r joints and improves the subject's ability to adjust balance. Hence it encourages dynamic\r motions and functional mobility. The VR environment can be controlled and manipulated in\r advance to fine tune the exercises and meet individual needs. It is interactive as well as\r enjoyable.\r\n\r Studies indicate that spinal reflex circuitry exhibits activity dependent plasticity (the\r capacity of the nervous system to modify its organization). Intensive task specific training\r is one of the most effective ways to promote neuroplasticity and develop more normalized\r movement patterns. VR uses this principle of neuroplasticity to promote motor relearning.\r Literature supports the use of VR as an effective rehabilitative tool in individuals with\r stroke, spinal cord injury, cerebral palsy, multiple sclerosis and other neurological\r disorders.\r\n\r There are few studies on balance rehabilitation in myelopathy from this part of the world.\r Due to absence of any guidelines, identifying the most suitable type of VR system, defining\r the most appropriate treatment dosing, timing and intensity of training for the therapeutic\r application is a challenge. This study was envisioned to observe the utility of VR in\r rehabilitation for improving balance in patients of myelopathy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with myelopathy with neurological level of injury below C4.\r\n\r 2. Both traumatic and non-traumatic myelopathy.\r\n\r 3. Duration of illness less than 6 months.\r\n\r Exclusion Criteria:\r\n\r 1. Severe orthopedic or medical impairment that interfered with sitting.\r\n\r 2. Upper limb muscle power <3/5.\r\n\r 3. Cognitive or visual impairment.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nImpact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients\n\n**Clinical Trial Summary:**\n\nThe LEAP protocol is a prospective cohort study of dysvascular patients designed to determine\r whether implementation of a multi-disciplinary lower extremity amputation protocol in the\r peri-operative period can shorten post-operative length of stay in patients undergoing\r trans-tibial or trans-femoral amputations. A consecutive sample of patients diagnosed with\r peripheral vascular disease and/or diabetes requiring major lower extremity amputation will\r be enrolled in the study and compared to retrospective controls.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients >18 years of age diagnosed with peripheral vascular disease and/or diabetes\r mellitus\r\n\r - Patients undergoing trans-tibial or trans-femoral amputations\r\n\r Exclusion Criteria:\r\n\r - Patients undergoing amputation for trauma, malignancy, or necrotizing fasciitis with\r no dysvascular diagnosis\r\n\r - Patients who have previously undergone an amputation\r\n\r - Patients who were unable to function independently prior to admission\r\n\r - Patients admitted to the ICU prior to surgery\r\n\r - Attending surgeon does not approve of the patient being enrolled\r\n\r - Prisoners\r\n\r - Pregnant women\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nA Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas\n\n**Clinical Trial Summary:**\n\nThis is a surgical biospecimen collection study. The purpose of this study is to understand\r how much of two drugs (dabrafenib and trametinib) are able to penetrate brain tumors and turn\r off the RAF signaling pathway. This is important because these drugs are currently FDA\r approved for other tumors and may have efficacy in brain tumors with the BRAF V600E mutation.\n\n**Clinical Trial Detailed Description:**\n\nThe primary goal of this study is to establish concentrations of dabrafenib and trametinib in\r enhancing brain tissue and cerebrospinal fluid from people with BRAF-V600E mutant recurrent\r gliomas who undergo tumor resection. The exploratory goals are to measure the amount of ERK\r signaling pathway activity, to identify mechanisms of resistance to these drugs, and evaluate\r feasibility of measuring tumor DNA in cerebrospinal fluid.\r\n\r People (adults or children) with brain tumors who are already taking dabrafenib and / or\r trametinib and are in need of a surgical resection are potentially eligible. On the day of\r surgery, blood, cerebrospinal fluid, and tumor tissue will be collected for research\r purposes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects must have a history of primary brain tumor (including but not limited to\r glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and\r anaplastic pleomorphic xanthoastrocytoma (PXA)).\r\n\r - Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be\r IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.\r\n\r - Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults\r only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7\r days prior to surgery as prescribed by their treating physician. Note: Pediatric\r patients may be taking any dose of dabrafenib and / or trametinib as prescribed by\r their treating physician for at least 7 days prior to surgery.\r\n\r - Subjects must be undergoing surgery for clinical purposes.\r\n\r - Written informed consent - a signed informed consent and/or assent (as age\r appropriate) for study participation will be obtained according to institutional\r guidelines.\r\n\r Exclusion Criteria:\r\n\r - Subjects who are receiving any other investigational agents or chemotherapeutic\r agents.\r\n\r - Subjects for whom collection of blood, spinal fluid, or tissue samples is unsafe or\r clinically inadvisable.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis\n\n**Clinical Trial Summary:**\n\nMuscle weakness, which is one of the most common symptoms in patients with MS, limits the\r activities of daily life activities of patients by causing balance and gait disturbance.\r Lower extremity muscle strengths of MS patients are reported to be weaker than healthy\r individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor\r muscles in patients with MS caused a decrease in walking distance and they are important\r determinants of walking capacity.\r\n\r The effects of the endurance and strength of core muscles, as well as the extremity muscles,\r are important on physical performance. The weakness of the extremities and core muscles in MS\r patients also affects the sit-to-stand performance negatively as well as a decrease in\r walking speed and capacity.\r\n\r In this study, it was aimed to investigate the effects of extremity and core muscle strength\r on walking and sitting-up performance of MS patients.\n\n**Clinical Trial Detailed Description:**\n\nPatients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)\r and healthy individuals of similar age and sex to patients will be included in the study. The\r strength of the extremity and core muscles, walking capacity, and sit-to-stand performance\r will be evaluated once.\r\n\r Investigators will use descriptive statistics and t-tests to compare variables between\r groups. Investigators will examine the correlations between variables using Pearson bivariate\r correlations. The significance level is set at p<0,05\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants who 18-65 years of age\r\n\r - MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a\r stable phase of the disease, without relapses in the last 3 month.\r\n\r Exclusion Criteria:\r\n\r - Participants who have orthopedic, vision, hearing, or perception problems\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAtezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies how well atezolizumab and cobimetinib work in treating patients\r with non-small cell lung cancer that has spread to other places in the body (metastatic), has\r come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with\r monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the\r cancer, and may interfere with the ability of tumor cells to grow and spread. Cobimetinib may\r stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving\r atezolizumab and cobimetinib may work better in treating patients with non-small cell lung\r cancer.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To evaluate durable overall response rate with atezolizumab plus cobimetinib in patients\r with metastatic non-small cell lung cancer (NSCLC) resistant or refractory to prior PD-1 or\r PD-L1 therapy.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the overall response rate of atezolizumab plus cobimetinib in patients with\r metastatic NSCLC resistant or refractory to prior PD-1 or PD-L1 therapy.\r\n\r II. To evaluate the progression-free survival (PFS) of atezolizumab plus cobimetinib in\r patients with metastatic NSCLC resistant or refractory to prior PD-1 or PD-L1 therapy.\r\n\r III. To evaluate the overall survival (OS) of atezolizumab plus cobimetinib in patients with\r metastatic NSCLC resistant or refractory to prior PD-1 or PD-L1 therapy.\r\n\r IV. To evaluate the duration of response (DOR) of atezolizumab plus cobimetinib in patients\r with metastatic NSCLC resistant or refractory to prior PD-1 or PD-L1 therapy.\r\n\r V. To evaluate the grade 3 and 4 toxicity rate in patients with metastatic NSCLC resistant or\r refractory to prior PD-1 or PD-L1 therapy when treated with atezolizumab plus cobimetinib.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To evaluate the consequences of treatment with atezolizumab plus cobimetinib on the tumor\r microenvironment in patients with metastatic NSCLC resistant or refractory to prior PD-1 or\r PD-L1 therapy.\r\n\r II. To correlate genomic characteristics including tumor mutation burden to response to\r therapy with atezolizumab plus cobimetinib in patients with metastatic NSCLC resistant or\r refractory to prior PD-1 or PD-L1 therapy.\r\n\r OUTLINE:\r\n\r Patients receive atezolizumab intravenously (IV) over 30-60 minutes on days 1, and\r cobimetinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the\r absence of disease progression or unaccepted toxicity.\r\n\r After completion of study treatment, patients are followed up for 90 days.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histologically or cytologically confirmed metastatic or recurrent\r non-small cell lung cancer; presence of a mutation in KRAS as detected by a Clinical\r Laboratory Improvement Act (CLIA)-approved assay is required for patients enrolled in\r cohort 1; central validation is not required for enrollment\r\n\r - If, and only if, cohort 1 is positive (at least 1 out of up to 24 patients\r experience a confirmed durable response, lasting at least 6 months), then cohort\r 2 will open; this can occur prior to full enrollment to 24 patients; absence of a\r mutation in KRAS (KRAS wild type) is required for patients enrolled in cohort 2;\r central validation is not required for enrollment\r\n\r - Patients must have primary resistance to anti-PD-1 or anti-PD-L1 therapy, given as\r monotherapy or in combination with other agents; patients must experienced progressive\r disease within 6 months (180 days) of initiating treatment with a PD-1/PD-L1 inhibitor\r\n\r - Patients with a sensitizing alteration in EGFR, ALK or ROS1 are eligible provided they\r have experienced disease progression or intolerance to treatment with an approved\r EGFR, ALK or ROS1 inhibitor, respectively; patients who have received investigational\r inhibitors may be eligible following discussion with the study principal investigator\r (PI)\r\n\r - Patients must have disease amenable to core biopsy and be willing to undergo the\r required research biopsies\r\n\r - Patients must have measurable disease, defined as at least one lesion that can be\r accurately measured in at least one dimension (longest diameter to be recorded for\r non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest\r x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance\r imaging (MRI), or calipers by clinical exam\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\r\n\r - Leukocytes >= 2,500/mcL\r\n\r - Absolute neutrophil count >= 1,000/mcL\r\n\r - Platelets >= 100,000/mcL\r\n\r - Hemoglobin >= 8 g/dL\r\n\r - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients\r with known Gilbert disease who have serum bilirubin level =< 3 x upper limit of normal\r [ULN] may be enrolled)\r\n\r - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase\r [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r =< 3 x ULN (AST and/or ALT =< 5 x ULN for patients with liver involvement)\r\n\r - Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver\r involvement or bone metastases)\r\n\r - Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault\r\n\r - Institutional normalized ratio (INR) and partial thromboplastin time (aPTT) =< 1.5 x\r ULN; (this applies only to patients who do not receive therapeutic anticoagulation;\r patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin\r or warfarin, should be on a stable dose)\r\n\r - Administration of atezolizumab or cobimetinib may have an adverse effect on pregnancy\r and poses a risk to the human fetus, including embryo-lethality; women of\r child-bearing potential and men must agree to use adequate contraception (hormonal or\r barrier method of birth control; abstinence) prior to study entry, for the duration of\r study participation, and for 5 months (150 days) after the last dose of study agent;\r should a woman become pregnant or suspect she is pregnant while she or her partner is\r participating in this study, she should inform her treating physician immediately\r\n\r - Ability to understand and the willingness to sign a written informed consent document\r\n\r - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral\r therapy with undetectable viral load within 6 months are eligible for this trial\r\n\r Exclusion Criteria:\r\n\r - Patients who have not recovered from clinically significant adverse events (other than\r alopecia) due to prior anti-cancer therapy\r\n\r - Treatment with any investigational agent within 4 weeks prior to cycle 1, day 1\r\n\r - Treatment with systemic immunosuppressive medications (including, but not limited to,\r prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor\r necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1\r\n\r - Patients who have received acute, low dose, systemic immunosuppressant\r medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled\r\n\r - The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone)\r for patients with orthostatic hypotension or adrenocortical insufficiency is\r allowed\r\n\r - Patients with symptomatic central nervous system (CNS) metastases are excluded\r\n\r - Patients with asymptomatic untreated CNS disease may be enrolled, provided all of\r the following criteria are met:\r\n\r - Evaluable or measurable disease outside the CNS\r\n\r - No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within\r 10 mm of the optic apparatus (optic nerves and chiasm)\r\n\r - No history of intracranial hemorrhage or spinal cord hemorrhage\r\n\r - No ongoing requirement for dexamethasone for CNS disease; patients on a\r stable dose of anticonvulsants are permitted\r\n\r - No neurosurgical resection or brain biopsy within 28 days prior to cycle 1,\r day 1\r\n\r - Patients with asymptomatic treated CNS metastases may be enrolled, provided all\r the criteria listed above are met as well as the following:\r\n\r - Radiographic demonstration of improvement upon the completion of CNS\r directed therapy and no evidence of interim progression between the\r completion of CNS directed therapy and the screening radiographic study\r\n\r - No stereotactic radiation or whole-brain radiation within 28 days prior to\r cycle 1, day 1\r\n\r - Screening CNS radiographic study >= 4 weeks from completion of radiotherapy\r and >= 2 weeks from discontinuation of corticosteroids\r\n\r - Has a known concurrent malignancy that is expected to require active treatment within\r two years, or may interfere with the interpretation of the efficacy and safety\r outcomes of this study in the opinion of the treating investigator; superficial\r bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring\r therapy should not exclude participation in this trial\r\n\r - Known hypersensitivity to Chinese hamster ovary cell products or other recombinant\r human antibodies\r\n\r - History of allergic reactions attributed to compounds of similar chemical or biologic\r composition to atezolizumab or cobimetinib\r\n\r - History of congenital long QT syndrome or corrected QT interval (QTc) > 450 msec\r within 28 days of cycle 1, day 1\r\n\r - Cardiac ejection fraction below institutional lower limit of normal (LLN) or below\r 50%, whichever is lower, as determined by echocardiogram or multigated acquisition\r (MUGA) scan within 4 weeks of cycle 1, day 1\r\n\r - History of or evidence of retinal pathology on ophthalmologic examination that is\r considered a risk factor for neurosensory retinal detachment, central serous\r chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration\r\n\r - Any grade 3 or above hemorrhage or bleeding event within 4 weeks prior to initiation\r of study treatment\r\n\r - History of stroke, reversible ischemic neurological defect, or transient ischemic\r attack within 6 months prior to initiation of study treatment\r\n\r - Patients receiving any medications or substances that are strong or moderate\r inhibitors or inducers of CYP3A4 enzymes are ineligible; these include St. John's wort\r or hyperforin (potent CYP3A4 enzyme inducer) and grapefruit juice (potent cytochrome\r P450 CYP3A4 enzyme inhibitor); because the lists of these agents are constantly\r changing, it is important to regularly consult medical reference texts such as the\r Physicians' Desk Reference may also provide this information; as part of the\r enrollment/informed consent procedures, the patient will be counseled on the risk of\r interactions with other agents, and what to do if new medications need to be\r prescribed or if the patient is considering a new over-the-counter medicine or herbal\r product\r\n\r - Known clinically significant liver disease, including active viral, alcoholic, or\r other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n\r - Patients with past or resolved hepatitis B infection (defined as having a\r negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc\r [antibody to hepatitis B core antigen] antibody test) are eligible\r\n\r - Patients positive for hepatitis C virus (HCV) antibody are eligible only if\r polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\r\n\r - History or risk of autoimmune disease, including, but not limited to, systemic lupus\r erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis\r associated with antiphospholipid syndrome, autoimmune hemolytic anemia, Wegener's\r granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple\r sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n\r - Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid\r replacement hormone may be eligible\r\n\r - Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may\r be eligible\r\n\r - Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with\r dermatologic manifestations only (e.g., patients with psoriatic arthritis would\r be excluded) are permitted provided that they meet the following conditions:\r\n\r - Patients with psoriasis must have a baseline ophthalmologic exam to rule out\r ocular manifestations\r\n\r - Rash must cover less than 10% of body surface area (BSA)\r\n\r - Disease is well controlled at baseline and only requiring low potency\r topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%,\r flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n\r - No acute exacerbations of underlying condition within the last 12 months\r (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate,\r retinoids, biologic agents, oral calcineurin inhibitors; high potency or\r oral steroids)\r\n\r - History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),\r organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing\r pneumonia, etc.), or evidence of active pneumonitis on screening chest computed\r tomography (CT) scan; history of radiation pneumonitis in the radiation field\r (fibrosis) is permitted\r\n\r - Any significant active infection requiring treatment within 14 days prior to cycle 1,\r day 1\r\n\r - Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of\r need for a major surgical procedure during the course of the study\r\n\r - Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or\r anticipation that such a live, attenuated vaccine will be required during the study\r and up to 5 months after the last dose of atezolizumab\r\n\r - Influenza vaccination should be given during influenza season only (approximately\r October to March); patients must not receive live, attenuated influenza vaccine\r within 4 weeks prior to cycle 1, day 1 or at any time during the study\r\n\r - Uncontrolled pleural or pericardial effusion or ascites requiring recurrent drainage\r procedures\r\n\r - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r infection, active tuberculosis (TB), symptomatic congestive heart failure, unstable\r angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that\r would limit compliance with study requirements\r\n\r - Pregnant women are excluded from this study because both atezolizumab and cobimetinib\r are expected to cause fetal harm if used during pregnancy; because there is an unknown\r but potential risk for adverse events in nursing infants secondary to treatment of the\r mother with cobimetinib or atezolizumab, breastfeeding should be discontinued if the\r mother is treated with either therapy; these potential risks may also apply to other\r agents used in this study\r\n\r - Inability or unwillingness to swallow pills\r\n\r - History of malabsorption syndrome or other condition that would interfere with enteral\r absorption\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nHSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM\n\n**Clinical Trial Summary:**\n\nStudy to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy\r and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma\r (AA).\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, phase I-II study to assess the efficacy and toxicity of HSV-tk +\r valacyclovir gene therapy in combination with radiotherapy and standard of care chemotherapy\r for anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). This study is comprised of\r newly diagnosed patients with AA or GBM.\r\n\r Clinical response will be evaluated by neurological evaluation, neuropsychological testing,\r and imaging studies as well as by histological examination. Blood samples will be taken for\r systemic immunological response, blood counts, and liver functions tests. Genetic testing of\r tumor tissue will be performed, including genetic analysis and cell cultures. Toxicity will\r be graded by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and Radiation\r Therapy Oncology Group (RTOG) neuro-toxicity scores (see Appendices). Patients will also be\r followed to assess median time to progression and median survival.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients must have frozen section biopsy proven anaplastic astrocytoma or\r glioblastoma multiforme without evidence of multifocal tumor or leptomeningeal\r metastatic disease or brainstem involvement as well as radiographic evidence\r consistent with these diagnoses.\r\n\r - Life expectancy ≥ 12 weeks.\r\n\r - Patient can receive second treatment of HSV-tk after 6 months\r\n\r - Patients should have the following characteristics: newly diagnosed anaplastic\r astrocytoma or glioblastoma demonstrated by frozen section biopsy, ECOG performance\r status of 0-1. No evidence of other active malignancy (except squamous or basal cell\r skin cancers).\r\n\r - Signed informed consent to participate in the study must be obtained from patients\r after they have been fully informed of the nature and potential risks of the study by\r the investigator (or his/her designee) with the aid of written information.\r\n\r - Willing to provide biopsies as required by the study.\r\n\r - WOCBP must have a negative serum pregnancy test within 7 days prior to the\r administration of the first study treatment. Women must not be lactating.\r\n\r - WOCBP and men must practice an effective method of birth control\r\n\r - Patients must have adequate baseline organ function as assessed by the following\r laboratory values before initiating the protocol:\r\n\r - serum creatinine < 1.5 mg/dL\r\n\r - T. bilirubin < 2.5 mg/dL, ALT, AST, GGT and Alk Phos < 2 x normal\r\n\r - Platelet count > 100,000/ml , ANC> 1500/ml , Hgb> 10 gm/dL\r\n\r - Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)\r\n\r Exclusion Criteria:\r\n\r - Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector\r therapy in the past 3 months.\r\n\r - Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3\r weeks of study treatment start.\r\n\r - Evidence of multifocal disease, brainstem involvement, or leptomeningeal metastasis,\r Discrete areas of contrast enhancement connected by abnormal T2 FLAIR signal on MRI\r scan are not considered multifocal disease, as this represents a single tumor.\r\n\r - Patients on immunosuppressive drugs (other than steroids for brain edema).\r\n\r - Liver disease, such as cirrhosis or active/chronic hepatitis B or C.\r\n\r - History of or current alcohol misuse/abuse within the past 12 months.\r\n\r - Known or suspected allergy or hypersensitivity to any component of the proposed\r regimen (gene vector/Valacyclovir).\r\n\r - Inability to swallow food or any condition of the upper gastrointestinal tract that\r precludes administration of oral medications (Valacyclovir).\r\n\r - No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or\r treated cancer from which the patient has been continuously disease free for more than\r 3 years.\r\n\r - The presence of active CNS toxoplasmosis infection or Progressive Multifocal\r Leukoencephalopathy demonstrated on CT or MRI imaging\r\n\r - The presence of active untreated cellulitis or untreated wound infections. Treated and\r resolving cellulitis and infections are not an exclusion criteria.\r\n\r - Active IV drug abuse or severe opioid abuse\r\n\r - Pregnant or breastfeeding women or women/men able to conceive and unwilling to\r practice an effective method of birth control. WOCBP must have a negative serum\r pregnancy test within 7 days prior to the administration of the first study treatment.\r\n\r - Presence of active or suspected acute or chronic uncontrolled infection or history of\r immunocompromise, including a positive HIV test result.\r\n\r - Patients < 18 years of age\r\n\r - Unwilling or unable to comply with the study protocol.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nSystemic, Pancoronary and Local Coronary Vulnerability\n\n**Clinical Trial Summary:**\n\n• The aim of the VIP study is to investigate the impact of vulnerability markers\r (inflammatory serum biomarkers for systemic vulnerability, coronary shear stress and\r vulnerability mapping for pancoronary vulnerability, and imaging-based plaque features for\r systemic vulnerability) on the rate of major adverse cardiovascular events caused by\r progression of the non-culprit lesion in patients with acute ST or non-ST segment elevation\r myocardial infarction who undergo revascularization of the culprit lesion during the acute\r event. Furthermore, the study will evaluate the rate of progression of non-culprit lesions\r towards a higher degree of vulnerability, based on coronary computed tomography angiographic\r assessment at 1 year after enrollment.\n\n**Clinical Trial Detailed Description:**\n\nThe project is a prospective, cohort, mono-centric study which will be carried out in the\r Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed.\r\n\r The project will include 100 subjects who present ST and non-ST segment elevation myocardial\r infarction at 30 days prior to study enrollment, who underwent emergency revascularization of\r the culprit lesion. Samples for systemic serum biomarkers for myocardial injury, myocardial\r strain and enhanced systemic inflammation will be collected at the moment of the acute event.\r All patients will undergo coronary CT angiography, cardiac perfusion CT and intracoronary\r imaging procedures (Intravascular ultrasound - IVUS; Optical Coherence Tomography - OCT) at\r the moment of enrollment in the study, for complex assessment of non-culprit coronary\r lesions. The endothelial coronary shear stress will be calculated with imaging\r post-processing techniques on the CT data acquired at baseline, by using computational fluid\r dynamics.\r\n\r The study will be conducted over a period of 3 years, in which patients will be examined at\r baseline, and during several follow-up visits. At the one-year follow-up, the study subjects\r will undergo CT coronary angiography for re-evaluation of the non-culprit lesions, in the\r prospects of analyzing the rate of plaque progression towards a higher degree of\r vulnerability. At the end of the 3-year period, patients will be assessed about the\r occurrence of major adverse cardiovascular events and the rate or revascularization for\r non-culprit lesions.\r\n\r Study objectives:\r\n\r Primary: to investigate the association between systemic, pancoronary and local vulnerability\r features of coronary plaques and the risk for major adverse cardiac events - MACE (all-cause\r mortality, cardiovascular death, myocardial infarction, repeated revascularization, repeated\r hospitalizations for cardiovascular related incidents, cerebrovascular events) during a\r 3-year follow-up.\r\n\r Secondary: to assess the rate of progression for the non-culprit lesions towards a higher\r degree of vulnerability, as evaluated via coronary CT angiography at 1 year after enrollment,\r in relation to systemic, pancoronary and local vulnerability features at baseline.\r\n\r To identify the type of vulnerability (systemic, pancoronary or local) with the highest\r impact on plaque progression and future MACE\r\n\r Study Timeline:\r\n\r Baseline (day 0)\r\n\r - Obtain and document consent from participant on study consent form.\r\n\r - Verify inclusion/exclusion criteria.\r\n\r - Obtain demographic information, medical history, medication history, alcohol and tobacco\r use history.\r\n\r - Record results of physical examinations and 12-lead ECG.\r\n\r - Collect blood specimens.\r\n\r - Imaging procedures: transthoracic 2-D echocardiography, 128-multisclice CT angiography,\r cardiac perfusion CT, IVUS, OCT\r\n\r Visit 1 (month 1)\r\n\r - Record results of physical examinations, 12-lead ECG and medical history.\r\n\r - Imaging procedures: transthoracic 2-D echocardiography\r\n\r Visit 2 (month 3)\r\n\r • Telephone follow-up\r\n\r Visit 3 (month 6)\r\n\r - Record results of physical examinations, 12-lead ECG and medical history.\r\n\r - Imaging procedures: transthoracic 2-D echocardiography\r\n\r Visit 4 (month 12)\r\n\r - Record results of physical examinations, 12-lead ECG and medical history.\r\n\r - Imaging procedures: transthoracic 2-D echocardiography, 128-multislice CT coronary\r angiography for evaluation of non-culprit lesion\r\n\r - End-point evaluation\r\n\r Visit 5 (month 15)\r\n\r • Telephone follow-up\r\n\r Visit 6 (month 18)\r\n\r • Telephone follow-up\r\n\r Visit 7 (month 24)\r\n\r - Record results of physical examinations, 12-lead ECG and medical history.\r\n\r - Imaging procedures: transthoracic 2-D echocardiography.\r\n\r - End-point evaluation\r\n\r Visit 8 (month 30)\r\n\r • Telephone follow-up\r\n\r Final study visit (month 36)\r\n\r - Record results of physical examinations, 12-lead ECG and medical history.\r\n\r - Imaging procedures: transthoracic 2-D echocardiography\r\n\r - End-point evaluation.\r\n\r Study procedures:\r\n\r - Clinical examination, medical history\r\n\r - 12-lead ECG\r\n\r - 2D transthoracic echocardiography with measurement of: cardiac diameters, volumes,\r valvular function and regurgitation, pressure gradients, pericardial fat thickness,\r pericardial effusion, left ventricular global and regional function and ejection\r fraction.\r\n\r - 128-multislice CT coronary angiography with the evaluation of: epicardial fat volume,\r plaque burden, total and local calcium score, markers for lesion severity (degree of\r stenosis, lesion length, lumen area and diameter, minimum and maximum plaque thickness);\r morphological plaque characteristics (plaque related volumes, plaque burden, vascular\r indexes - remodeling and eccentricity index); plaque components evaluated via volumetric\r and planimetric units (necrotic core, fibrofatty tissue, fibrotic tissue, dense\r calcium); markers of plaque vulnerability (necrotic core, low attenuation plaque, spotty\r calcification, napkin ring sign, positive remodeling).\r\n\r - Shear stress evaluation of CT acquired images and computational fluid dynamics\r\n\r - Intracoronary imaging techniques: IVUS and OCT with evaluation of plaque\r characteristics.\r\n\r - Venous blood sample collection during the acute coronary event for evaluation of serum\r levels of hsCRP, IL-6, matrixmetalloproteases MMP9, Adhesion molecules (VCAM, ICAM),\r alfa tumour necrosis factor, hs-cTnI, NTproBNP\r\n\r Data collection: In a dedicated database that includes all patient information, demographics,\r medical history, medication, therapeutic procedures, information derived from imaging\r techniques (echocardiography, CT angiography, CT imaging post-processing and shear stress\r evaluation).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients aged over 18 years old that have signed the written informed consent;\r\n\r - Patients with ST and non-ST segment elevation myocardial infarction (as stated in the\r Third Universal Definition of Myocardial Infarction) at 30 days prior to\r randomization;\r\n\r Exclusion Criteria:\r\n\r - unwillingness or incapacity to provide informed consent (and if consent of legal\r guardian or family is not available);\r\n\r - acute myocardial infarction at the moment of randomization (as these patients are\r referred to the hospital for emergency invasive coronary angiography and\r revascularization)\r\n\r - conditions that present an estimated life expectancy of under 5 years;\r\n\r - acute renal failure or terminal stage chronic kidney disease;\r\n\r - pregnancy or lactation and women of reproductive age who are not using any\r contraceptive method;\r\n\r - allergy and history of allergic reactions to iodine contrast media;\r\n\r - active malignancy or malignancy within the last 1 year prior to enrollment;\r\n\r - patients who, in the opinion of the investigators are not compliant and will not\r present for study visits.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nFallSensing, a Multifactorial Screening Tool for Fall-risk in Community-dwelling Adults Aged 50 Years or Over\n\n**Clinical Trial Summary:**\n\nFallSensing screening tool is a technological solution for fall risk screening, including a\r software, a pressure platform and two inertial sensors. The screening includes questions\r about demographic and anthropometric data, health and lifestyle behaviors, a detailed\r explanation about procedures to accomplish six functional tests (Grip Strength, Timed Up and\r Go, 30 seconds Sit-to-Stand, Step test, 4 Stage Balance test \"modified\" and 10 meters Walking\r Speed) and three questionnaires concerning environmental home hazards, activities and\r participation profile related to mobility and self-efficacy for exercise.\n\n**Clinical Trial Detailed Description:**\n\nVariable: History of Fall (HoF) A fall can be defined as \"an unexpected event in which the\r participant comes to rest on the ground, floor, or lower level\" and \"excludes coming to rest\r against furniture, wall, or other structure\" .\r\n\r The HoF within the previous 12 months will be determined by self-report, answering the\r question \"Did you fall in the past 12 months? Yes-No\". If the participant has fallen, it will\r be asked if the fall was outdoor or indoor, the reason of the fall (slip, stumble, loss of\r consciousness, dizziness, lower extremities weakness, no special reason and other), need of\r health services assistance, which health service (hospital, primary health care centre),\r hospitalization (how many days), activities limitation and restrictions on participation (how\r many days) and fractures occurrence (wrist or hand, hip, skull or spine, others).\r\n\r Variable: History of falls after 12 months Participants will be prospectively followed for a\r 12-month period, via monthly phone calls, in order to record the falls occurrence. The rate\r of falls will be recorded from the day of inclusion until voluntary dropout, loss of phone\r contact or the end of the follow-up period (365 days later).\r\n\r Variable: Fear of Falling (FoF) FoF is defined as \"a lasting concern about falling that leads\r to an individual avoiding activities that he/she remains capable of performing\".\r\n\r Considering the negative influence of FoF, its existence will be assessed by self-report\r through the question \"Are you afraid of falling? Yes - No\".\r\n\r Variable: Health Conditions There are certain conditions that can have a significant effect\r on fall rates among older adults, such as bladder incontinence, osteoarthritis, Parkinson's\r disease, cardiovascular accidents and conditions associated with cardiovascular disease, like\r hypertension.\r\n\r The question \"Do you have trouble seeing well or it has been past more than 2 years since\r your eyes have been tested?\", once changes in visual acuity, development of cataracts,\r macular degeneration, glaucoma, and other conditions related to the aging process contribute\r to risk of falling.\r\n\r Variable: Medication Older adults taking more than three or four medicines were found to be\r at increased risk of recurrent falls.\r\n\r The number of medicines taken by each person was assessed by self-report through the question\r \"Do you take 4 or more different medicines per day? Yes-No\". The name of the medicines was\r also registered and they were identified according to their pharmaceutical group\r (benzodiazepines, antidepressants, antipsychotics, anti-inflammatory drugs, antihypertensive\r drugs and others drugs).\r\n\r Variable: Sedentary Behavior In order to understand the community-dwelling adults' sedentary\r behavior by using a self-reported question, it was adopted the estimate measure of\r sedentariness calculated by Heseltine et al. (2015): \"Do you spend over 4 hours seated, 5\r days or more per week?\".\r\n\r Variable: Upper Extremities Assistance to Stand from a Chair The upper extremities assistance\r to stand from a chair was assessed through the question \"Do you need assistance from the\r upper extremities to stand up from a chair? Yes-No\", once it is assumed that is a sign of\r weak lower extremities muscles, a major reason for falling.\r\n\r Variable: Living settings Since FoF is more frequent among older adults living alone, this\r protocol intends to assess the living settings through the question \"Do you live alone?\r Yes-No\".\r\n\r Variable: Alcohol habits Regular alcohol consumption among older adults has been linked to\r impaired balance and postural hypotension, which has been associated with frequent falls.\r\n\r The participants will be asked about their daily alcohol habits, \"Do you drink alcohol every\r day? Yes-No\".\r\n\r Variable: Self-Perceived Health The self-perceived health (SPH) is considered a valid and\r reliable indicator of overall health status, a predictor of mortality and health services\r use.\r\n\r SPH will be assessed by self-report through the question \"In general, do you perceived your\r health as excellent, very good, good, sufficient or poor?\"\r\n\r Variable: Unintentional or involuntary weight loss The involuntary weight loss is one of the\r features that, simultaneously with others, can help to define a frailty phenotype.\r\n\r The literature reveals an association between the frailty phenotype and the number of\r previous falls in older people. The participants will be asked if they had experienced a\r weight loss higher than ≥4,5kg or ≥5% of body weight during the previous 12 months.\r\n\r Variable: Grip Strength The hand grip strength is significantly correlated with lower limb\r muscular strength, being a powerful predictor of disability, morbidity and mortality.\r\n\r This test will be performed with the person seated on a standard chair without armrests,\r shoulder adducted and neutrally rotated, elbow flexed at 90 degrees, forearm neutral, wrist\r held between 0-15 degrees of ulnar deviation and with the arm not supported. A Jamar™\r Hydraulic Hand Dynamometer will be settled at the second handle position, held with the\r dominant hand, and during the performance of the test will be presented vertically in line\r with the forearm. The test is performed only one time and the person is encouraged to exert\r her/his maximal grip strength for 5 seconds. The final score is measured in kilograms force\r (kgf). Normative data for this test are commonly analysed by gender, with males showing\r higher grip strength at all ages. A score below 15 kgf, for women, and 21 kgf, for men,\r identify those with higher risk of falling.\r\n\r Variable:Timed Up and Go Timed Up and Go test (TUG) is used to assess dynamic balance during\r gait and transfers tasks, mobility and lower body strength. To perform this test, the person,\r wearing his/her regular footwear, is instructed to sit on a standard chair (chair height\r between 44 and 47 cm) with his/her back against the chair back, to stand up and walk straight\r for 3 meters as fast as possible, turn around, walk back and sit down. The person must stand\r up without help (cannot use the upper extremities for support), however if a walking aid is\r needed it should be placed next to the chair and can be used to perform the gait component of\r the test. The test is performed only one time, the timing begins at the instruction \"go\" and\r stops when the patient seats on the chair. A score higher than 10 seconds will indicate which\r community-dwelling older adults are more likely to be fallers.\r\n\r Variable: 30 seconds Sit-to-Stand Lower body strength is a significant element to maintaining\r functional capacity in older adults, therefore its evaluation is critical. 30 seconds\r Sit-to-Stand (STS), being a simple and effective instrument for assessing lower body strength\r and identifying muscle weakness in community-dwelling older adults, is one of the most\r important functional evaluation clinical tests. The person is instructed to perform cycles of\r sits and stands up from a chair, as many times as possible over 30 seconds.\r\n\r The person starts the test seated in the middle of the chair (chair height between 40 and\r 43,3cm), feet approximately shoulder-width apart and placed on the floor, and arms crossed by\r the wrists placed against the chest. The vocal instruction \"go\" sets the test´s beginning and\r if the participant completes more than halfway up at the end of 30 seconds it is counted as a\r full stand. Final score involves recording the number of stands a person can complete in 30\r seconds. The normative levels for number of stands depends on age and gender.\r\n\r Variable: Step Test The step test, was designed to assess the dynamic standing balance and\r reproduces lower-extremity motor control and coordination.\r\n\r In order to perform the test, the person is asked to step on and off a block (7,5 cm height,\r 55 cm width, 35cm depth), placed against a wall, as many times as possible during 15 seconds.\r The whole foot is required to step onto the block and then return it fully to the ground. The\r total number of completed steps in 15 seconds is recorded. The patient is unsupported and\r should look straight forward, although investigator must stand close by for safety. In the\r case of patient overbalanced or need stabilization during the test, counting of steps stops\r and it is recorded the complete number of steps prior to overbalancing. This test is\r performed only for the dominant side, indicated by the person. A performance lower than 10\r steps indicates higher risk of falling.\r\n\r 4 Stage Balance Test \"Modified\" Deficits in balance can lead to falls and fall related\r injuries, representing one of the most important intrinsic fall risk factors among older\r adults, being commonly assessed in this population.\r\n\r The 4 Stage Balance Test \"modified\" is one of the tests available to evaluate balance. In\r order to complete this test, the person needs to progressively accomplish four different feet\r positions: side by side stance, semi-tandem stance (preferred foot forward with the instep of\r one foot touching the big toe of the other foot), tandem stance (one foot in front of the\r other, heel touching toe) and one legged stance (preferred leg for support).\r\n\r The person is instructed to stand quietly on the pressure platform, arms along the body,\r neither with shoes or assistive devices. The positions must be held by 10 seconds each,\r without moving the feet, needing support, losing balance or touching the leg of support with\r the other leg, and must be performed with eyes open and then closed (excluding one legged\r stance position). The sequence will be side by side stance eyes open, side by side stance\r eyes closed, semi-tandem stance eyes open, semi-tandem stance eyes closed, tandem stance eyes\r open, tandem stance eyes closed and one leg stand eyes open. If the person failed to\r accomplish one of the test positions, the test finishes. The final score will be the number\r of positions successfully completed. The inability to complete 10 seconds in the tandem\r stance position, with eyes open, has been associated with higher risk of falling and mobility\r dysfunction.\r\n\r 10 meters Walking Speed Walking speed is the result of a complex interaction of multiple body\r structures and functions, such as lower extremity strength, proactive and reactive postural\r control, motor control or musculoskeletal condition. Accessing the gait speed (GS) as a\r screening tool can be useful to identify those at risk or in need of intervention, since the\r gait speed results are related to various health outcomes, like functional decline or fear of\r falling, besides GS can be a predictor of falls.\r\n\r The performance of this test requires a 20 meters straight path, with 5 meters for\r acceleration, 10 meters for steady-state walking and 5 meters for deceleration. Markers are\r placed at the 0, 5, 15 and 20 meters positions of the path and the time to walk along the 5\r and 15 meters is registered. The person is instructed to walk at his/her faster walking\r speed, without running, along the 20 meters path; an assistive device can be used if needed\r and the person should wear his/her regular footwear.\r\n\r The range of normal walking speed is between 1,2 and 1,4 m/s, since it varies by age, gender\r and anthropometrics A value lower than 0,4m/s indicates a probability of needing an assistive\r device at home; 0,4 to 0,8 m/s is correlated with limited mobility; 0,8 to 1,25 m/s\r ambulation in the community with some risks; ≤ 1m/s subjects should start a program to reduce\r the risk of falling; ≥ 1,42 m/s is the safe streets crossing speed.\r\n\r Questionnaires Self-efficacy for exercise The self-efficacy reflects the confidence that a\r person has to perform a certain behavior.\r\n\r The self-efficacy for exercise is a 5-items scale intended to analyse the confidence that a\r person has to perform exercise according to five different emotional states, like feeling\r worried/having problems, feeling depressed, feeling tired, feeling tense and being busy.\r\n\r Ratings are done using a 5-points Likert scale from 1 \"not at all true\" to 4 \"completely\r true\"; in between, 2 \"slightly true\" and 3 \"moderately true\".\r\n\r Activities and Participation Profile related to Mobility (PAPM) The PAPM is an 18-items scale\r intended to improve understanding of the difficulties an individual experiences in performing\r certain daily activities in their natural environment. These activities can be conditioned by\r mobility and are related to the interactions and social relations, education, employment,\r money management, social and community life, influencing the active participation of any\r person as a full member of the society.\r\n\r Ratings are done using a 5-points Likert scale from 0 \"no limitation/restriction\" to 4\r \"complete limitation/restriction\". In between, 1 \"mild limitation/restriction\", 2 \"moderate\r limitation/restriction\" and 3 \"severe limitation/restriction\". Since some activities may not\r apply, not all activities may be rated. As a result, an individual's participation profile\r will be produced.\r\n\r Home Safety Checklist for Fall Prevention The Home Safety Checklist for Fall Prevention is a\r 38-items scale intended to identify home hazards in each room of a person's home, namely hall\r and hallways, stairs, living/dining room, kitchen, bathroom, bedroom and outdoors.\r\n\r Ratings are done using a 3 points scale from 0 \"no risk\", 1 \"risk\" to 99 \"do not apply\". A\r risk score is produced both to each room and for the home in general.\r\n\r Statistical Analysis Statistical analysis will be performed using International Business\r Machines Statistical Package for the Social Sciences (IBM SPSS) (v.24) software. The sample\r size was calculated for infinite population for a 95% confidence interval and 5% margin of\r error, in order to assess the number of participants needed to consider a representative\r sample of Portuguese population (minimum of participants 385).\r\n\r To perform the data analysis, the participants will be categorized as \"fallers\" (with one or\r more falls) and \"non-fallers\", according to the occurrence of falls during the 12 months\r follow-up period.\r\n\r The statistical approach will be different according to the level of measurement for the\r variables. The descriptive analysis will determine mean and standard deviation for the\r quantitative variables and frequencies for the qualitative ones. Differences in the data\r between \"fallers\" and \"non-fallers\" will be analysed by Student t test for independent\r samples or Chi-square test. Binary logistic regression analysis will be performed to\r determine a model that allows the prediction of falls from the functional tests and other\r variables. Receiver-Operating Characteristic curves (ROC curve) analysis will be used to\r identify the best cut-off score that distinguishes \"fallers\" from \"non-fallers\". Sensitivity\r (percentage of \"fallers\" who were correctly identified), specificity (percentage of\r \"non-fallers\" that were correctly identified) and area under the receiver characteristic\r curve (AUC) of the model will be calculated for prediction of falls. A significance of 0.05\r will be considered for all comparisons, except for the quality of adjustment of the\r regression models, obtained with the Hosmer and Lemeshow test, whose significance is\r considered for p≥0.05.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - adults aged 50 years or over,\r\n\r - Community-dweller\r\n\r - independent to be standing and walking, with or without walking aids\r\n\r - interest to participate in the study.\r\n\r Exclusion Criteria:\r\n\r - severe sensorial impairments (deafness or blindness)\r\n\r - cognitive impairments which precludes the ability to comprehend the questionnaires and\r functional tests included in the screening protocol\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nConnected Catheter (C2P) Study for Bladder Management\n\n**Clinical Trial Summary:**\n\nThe objective of this study is to evaluate the safety and essential performance of the C2P\r System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute\r clinical setting and an extended period of home use.\n\n**Clinical Trial Detailed Description:**\n\nSpinal Singularity had developed C2P system to address several drawbacks of current\r standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary\r prosthesis designed for improved bladder management in males with urinary retention disorders\r requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device\r that resides fully internally to the male lower urinary tract for an intended service life of\r up to 29 days per catheter\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction\r (NLUTD)\r\n\r 2. Must be clinically suitable and capable of safely managing bladder using an\r intermittent voiding or indwelling strategy\r\n\r - Must have stable urinary management history: no significant changes in bladder\r management regimen within past 12 months\r\n\r OR:\r\n\r - Must have urodynamic profile suitable for C2P, as assessed via urodynamics study\r within past 12 months (including bladder capacity > 200mL without uninhibited\r bladder contractions)\r\n\r 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the\r C2P device, as specified in the investigational device instructions for use (IFU).\r\n\r Exclusion Criteria:\r\n\r 1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may\r receive the device after Urinary Tract Infection (UTI) has been treated)\r\n\r 2. Significant risk profile or recent history of urethral stricture (e.g. stricture\r within past 90 days)\r\n\r 3. Significant risk profile or recent history of clinically significant autonomic\r dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)\r\n\r 4. Significant intermittent urinary incontinence (between catheterizations)\r\n\r 5. Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably\r controlled with medication or alternate therapy (e.g. Botox injections)\r\n\r 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower\r urinary tract or bladder (assessed during in-depth medical screening, including\r cystoscopy and urine analysis)\r\n\r 7. Urinary tract inflammation or neoplasm\r\n\r 8. Urinary fistula\r\n\r 9. Bladder diverticulum (outpouching) > 5cm in size\r\n\r 10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6\r months)\r\n\r 11. Impaired kidney function or renal failure\r\n\r 12. Active gross hematuria\r\n\r 13. Active urethritis\r\n\r 14. Bladder stones\r\n\r 15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted\r drug pump) or external device\r\n\r 16. Any unsuitable comorbidities as determined by the investigator or complications\r related to use of certain medications\r\n\r 17. Any physical or cognitive impairments that diminish the subject's ability to follow\r directions or otherwise safely use the C2P System\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma\n\n**Clinical Trial Summary:**\n\nThis is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted\r on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma\r referring to the oncology clinics during March 2018 and March 2019. The patients will be\r randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization\r method (1:1).\n\n**Clinical Trial Detailed Description:**\n\nThis study aimed to compare the overall survival and progression free survival between 6\r cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and\r anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with\r glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic\r evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure.\r The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients\r will receive chemoradiation. After completion of chemoradiation, the cases will receive 12\r cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body\r surface per day for the first 5 days of every 28 days). In the control group, the patients\r will receive 6 cycles of adjuvant Temozolomide (in the same dosage). This is a phase III,\r non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed\r patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the\r oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle\r and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). This study\r will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad.\r Blinding is not observed in this study. The primary endpoints of study are overall survival\r and progression free survival.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Newly diagnosed glioblastoma and anaplastic astrocytoma\r\n\r - age between 18 and 70 years\r\n\r - Karnofsky Performance Scale Index equal or more than 60 percent\r\n\r - signed informed consent\r\n\r Exclusion Criteria:\r\n\r - chronic hepatic\r\n\r - renal failure\r\n\r - cardiac failure\r\n\r - history of hematologic malignancies\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAcute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to try to understand and explain why HIV-infected and uninfected\r women who use cannabis (marijuana) currently, or have used cannabis in the past, have higher\r risk of having experienced a fall in our earlier analyses in WIHS. This study will compare\r what happens when women are given cannabis compared with placebo, on measures of mobility,\r including walking speed under walking conditions that vary in terms of difficulty; for\r example normal walking and walking while reciting alternate letters of the alphabet, as well\r as measures of balance and cognition (for example attention, memory).\n\n**Clinical Trial Detailed Description:**\n\nCannabis is the most prevalent drug used by adults aged 50 and older in the U.S., after\r alcohol and tobacco. Recent trends show dramatic increases in cannabis use among older U.S.\r adults, and rising cannabis tetrahydrocannabinol (THC) content. Cannabis intoxication acutely\r alters short-term memory, attention span, verbal fluency, reaction time, and psychomotor\r control. Heavy long term cannabis use has been associated with lasting impairments in verbal\r learning, memory, and attention that correlate with duration of use; however, other studies\r have found that cognitive deficits from cannabis are reversible and related to recent\r exposure. But studies on cannabis exposure and cognition are age limited by including only\r adolescents through middle-aged adults; effects of acute and long-term cannabis use on\r cognition among older adults are virtually unknown. Given the rising potency and increasing\r frequency of cannabis use among older adults, studies systematically examining the risks and\r benefits of cannabis use in older adults are urgently needed.\r\n\r Cannabis use is particularly common in people living with HIV (PLWH), with 12- 56% prevalence\r rates compared to 9.5% in the general U.S. population. HIV has detrimental effects on both\r mobility and cognition, and similar to normal aging, mobility in patients with HIV may be\r influenced by cognitive function. Mild-to-moderate neurocognitive impairments (NCI), notably\r in attention and executive functions, remain highly prevalent and persist despite suppressive\r antiretroviral therapy, affecting almost half of PLWH. Little is known about the combined\r effects of cannabis use and HIV infection on cognition and mobility, particularly among older\r individuals. As the population of older PLWH continues to grow, co-occurring aging and HIV\r related declines in cognition and mobility will coincide; the effects of continued cannabis\r use In the Women's Interagency HIV Study (WIHS), it was found that current cannabis use was\r associated with over double the odds of single fall, and over 2.5 times the odds of multiple\r falls in 6 months; past cannabis use was associated with over 1.5 greater odds of single fall\r and multiple falls. Preliminary data shows that 40% of WIHS women (mean age 48) reported at\r least one fall over 2 years; current cannabis users had 1.7 times greater fall risk among\r HIV+ but not HIV-women. The hypothesis is that falls are related to acute effects of cannabis\r on attention and mobility, and that given subtle, pre-existing deficits associated with HIV\r infection, these acute cannabis effects may be more pronounced in HIV+ women, placing them at\r increased risks of falls. Whether this observed fall risk associated with cannabis use\r represents acute effects, or persistent effects of past cannabis use on cognition, balance,\r or mobility, or whether adverse effects of cannabis differ by HIV status merits further study\r in this aging population.\r\n\r The \"Walking While Talking\" (WWT) test requires individuals to walk while performing a\r secondary attention-demanding task (dual task), has been used to assess the interactions\r between cognition and gait, and provides a framework for evaluating the effect of divided\r attention, a facet of executive functions, on mobility. Increased dual task costs measured\r using WWT may help unmask subtle and latent cognitive abnormalities before they become\r clinically apparent by increasing the complexity of the walking condition, and predict falls,\r frailty, disability, and mortality among older community-residing adults. Because both\r cannabis use and HIV have been implicated in impairments in attention and executive\r functions, the WWT may be a quick and simple mobility stress test to identify subtle\r cognitive and motor effects of acute cannabis administration as a function of HIV status.\r\n\r The objective is to explore the mechanisms that underlie the increased fall risk associated\r with cannabis use. The effects of controlled administration of active (7.0% THC) and inactive\r (0.0%) cannabis in aging HIV+ women on stable HAART and HIV- controls enrolled on the WIHS\r will be compared. Endpoints will be balance, mobility, and cognition, including a\r cognitive-motor divided attention task (WWT). Specific aims and hypotheses are:\r\n\r 1. To determine the acute effects of cannabis on balance and mobility among older HIV+ and\r HIV- women. These test will be performed within subject comparisons of performance on\r balance and mobility tests at two supervised visits, with administration of placebo vs.\r active cannabis in counter-balanced order. The hypothesis is that HIV+ women will have\r greater impairment on balance and mobility, especially on complex walking conditions\r that demand attention, with administration of active cannabis than HIV- women\r\n\r 2. To determine the acute effects of cannabis on cognition among older HIV+ and HIV-\r women.HIV+ women will have greater impairment on cognitive testing, especially in\r attention, with administration of active cannabis than HIV- women.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. current cannabis use (within 6 months) based on self-report\r\n\r 2. able to perform study procedures, including ability to ambulate independently\r\n\r 3. adequate hearing and vision\r\n\r 4. for HIV+ women use of stable HAART for at least 6 months.\r\n\r Exclusion Criteria:\r\n\r 1. pregnancy\r\n\r 2. current illicit drug use other than cannabis\r\n\r 3. request for substance use treatment\r\n\r 4. current parole or probation\r\n\r 5. recent history of significant violent behavior (within 12 months)\r\n\r 6. major current Axis I psychopathology (e.g.,bipolar disorder, suicide risk,\r schizophrenia)\r\n\r 7. current use of psychiatric medication known to influence cognition\r\n\r 8. significant uncontrolled medical illness (such as uncontrolled diabetes or\r hypertension, clinically significant laboratory abnormalities, liver function tests\r (LFTs)>3x upper limit of normal)\r\n\r 9. history of active heart disease within 12 months\r\n\r 10. history of dementia\r\n\r 11. severe hand tremor\r\n\r 12. history of Central Nervous System (CNS) diseases or injury\r\n\r 13. poor English fluency.\r\n\r All participants will be consented and compensated for their effort as approved by the\r Institutional Review Boards (IRBs) of each participating institution (see human subjects).\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nElectroacupuncture for Patients With Chronic Urinary Retention Secondary to Lower Motor Neuron Lesion\n\n**Clinical Trial Summary:**\n\nChronic Urinary Retention (CUR) is defined as a non-painful bladder which remains palpable or\r percussible after the patient has passed urine by International Continence Society. Postvoid\r residual urine volume ≥300 mL seems to be widely accepted.\r\n\r CUR may be caused by a variety of diseases and events including injury of sacral plexus,\r cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and\r peripheral neuropathy due to diabetes, etc.. Aforementioned injuries generally affect lower\r motor neuron causing detrusor underactivity, acontractile detrusor or detrusor areflexia. The\r prevalence varies by different causes of lower motor neuron lesion. The symptoms of patients\r are voiding difficulty, bladder distention, bladder without sensation and overflow\r incontinence.\r\n\r A multi-center randomized sham-controlled trial will be conducted. The aim of this study is\r to assess the efficacy and safety of electroacupuncture for urinary function of patients with\r CUR caused by lower motor neuron lesion.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Have chronic urinary retention caused by lower motor neuron damage.\r\n\r - Age 18 to 75 years.\r\n\r - Have chronic urinary retention caused by injury of sacral plexus, cauda equina and\r sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral\r neuropathy due to diabetes.\r\n\r - Have postvoid residual urine volume 300 mL or more and sensation of bladder.\r\n\r - Bladder contractile index is more than 100 or more.\r\n\r - Duration of disease is more than 3 months.\r\n\r - Intermittent clean catheterization or indwelling catheterization.\r\n\r - Sign informed consent and participate in the study voluntarily.\r\n\r - Exclusion Criteria:\r\n\r - Have urinary retention due to bladder outlet obstruction (bladder neck contracture,\r urethral stricture, prostate cancer, prostatic hyperplasia, etc.)\r\n\r - Have urinary system tumors or stones.\r\n\r - Have detrusor underactivity due to other non-lower motor neurogenic disease.\r\n\r - Have bowel and urinary disorder due to lesions or injuries of thoracic spinal cord,\r cervical spinal cord and brain.\r\n\r - After suprapubic cystostomy.\r\n\r - Have heart, liver, kidney, mental disorders or coagulation disorders.\r\n\r - Have been implanted a cardiac pacemaker, sacral nerve stimulation electrode, pudendal\r nerve stimulation electrode, or bladder stimulation electrode.\r\n\r - During pregnancy or in lactation.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nClinical Research of H3F3AK27M in Spinal Glioma and Its Impact on TMZ Chemoradiotherapy\n\n**Clinical Trial Summary:**\n\nH3F3AK27M may be a feature of primary spinal cord glioma and affect the outcome and prognosis\r of TMZ chemoradiotherapy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Surgical treatment and pathological confirmation of spinal glioma in our department\r and is the first case without any treatment before operation.\r\n\r Exclusion Criteria:\r\n\r - The tumor is recurrent or has been treated before operation.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nPerineal Local Infiltration Study\n\n**Clinical Trial Summary:**\n\nThe prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The\r repair of such lacerations is usually done using a pre-existing epidural analgesia. Once the\r analgesic effect of the epidural analgesia fades, the laceration may cause intolerable pain,\r and result in emotional stress, difficulties in ambulation and breastfeeding, and more.\r\n\r The research team hypothesis is that adding a locally injected analgesic, which will take\r effect once the epidural analgesia fades, may alleviate perineal pain, prevent such\r difficulties, and improve women's overall well-being and satisfaction.\r\n\r The proposed trial is a two-arm, single-masked, randomized trial. Women with a working\r epidural analgesia, and a laceration will be invited to participate. Women in the local\r anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will\r get no injection. The differences in perineal pain between the groups will be evaluated at 6\r hours after last epidural dose.\n\n**Clinical Trial Detailed Description:**\n\n1. The Need for the Trial\r\n\r 1.1. Background\r\n\r Perineal trauma during delivery may be iatrogenic (episiotomy) or spontaneous (perineal\r tear). First-degree injury involves the perineal skin only, while a 2nd-degree perineal\r tear (2PT) involves perineal muscles as well1,2. A 3rd-degree tear involves the anal\r sphincter, and a 4th-degree tear involves the entire anal sphincter complex (external\r and internal anal sphincters) and the anal epithelium1,2. An episiotomy (Epi) is usually\r performed in a mediolateral or lateral manner, and is considered a 2nd degree laceration\r by definition. The morbidity associated with obstetrical anal sphincter injury (3rd or\r 4th degree perineal tear) is considerably higher than in 1st or 2nd degree tear1,2.\r\n\r The repair of a perineal tear may be done using the epidural anesthesia that was used\r during delivery, with no additional analgesia. If the patient is delivered without an\r epidural anesthesia, a short-acting local anesthetic agent, such as lidocaine, may be\r infiltrated to the edges of the wound prior to suturing.\r\n\r Scope of the problem The annual number of deliveries in Canada approaches 390,000, of\r which more than 145,000 are anticipated to take place in Ontario3. It has been reported\r that approximately 70% of deliveries in Ontario are vaginal deliveries4. Episiotomies\r occur in approximately 20% of vaginal deliveries, with 50% a 1st or 2nd degree perineal\r tear occur, and 3.2% of vaginal deliveries are complicated by a 3rd or 4th degree\r perineal tear4,5.\r\n\r Pain and morbidity associated with perineal lacerations Numerous studies have addressed\r the short- and long-term pain and morbidity associated with perineal lacerations. While\r numbers vary according to local practices and cultural and ethnical differences, most\r agree that perineal trauma is a major source of pain and morbidity6-12. Most studies\r reported Numeric Rating Scale (NRS) or Visual Analog Scale (VAS) scores in which pain is\r ranked by the patient verbally (from 0 to 10) or on a 10-cm ruler13, respectively. Some\r of the studies have reported VAS scores associated with 2PT/Epi of more than 5, and up\r to 8.5, in the first postpartum day7,9,12. Moreover, it has been shown that perineal\r lacerations, iatrogenic or spontaneous, are associated with interference with daily\r activities such as sitting, ambulation, urination and bowel movements14-19. Some have\r reported that more than 55% of women with 2PT/Epi experienced interference with at least\r one daily activity that was attributed to perineal pain7, and others have shown that\r between 45-75% of women with 2PT/Epi complained of at least moderate pain while sitting\r or moving10. Perineal pain associated with 2PT/Epi was also found to interfere with\r breastfeeding, and proper analgesia was found to have a beneficial effect on this\r matter14-16. Furthermore, acute pain during the immediate postpartum period was found to\r be associated with a higher risk of persistent pain 8 weeks postpartum, as well as with\r the development of postpartum depression7. The authors hypothesized that the severity of\r acute pain is not just a marker for the development of persistent pain, but also plays a\r role in the plasticity pathophysiology of acute-to-chronic pain transition.\r\n\r Pain relief - current practice\r\n\r As stated, perineal tear is usually repaired and sutured using the pre-existing epidural\r anesthesia that was used for delivery. Once the epidural anesthesia fades, the women\r will likely experience some perineal pain, mainly during the first 24 hours postpartum.\r Several studies have examined the benefits of different analgesic regimens, including\r oral or rectal analgesics, non-pharmacological methods, and topical anesthetics20-25. In\r most institutions, oral analgesics are provided, whether in a pre-scheduled analgesic\r plan or as per patient request.\r\n\r Despite efforts to alleviate perineal pain, current acceptable pain management protocols\r have several limitations. First, the use of systematic medications in order to treat\r local pain may induce side effects, and fail to target the specific pain on the other.\r Second, many women have concerns regarding the use of systemic medications along with\r breastfeeding, despite reassurance from medical staff. Topically applied anesthetics\r were not proven to alleviate postpartum perineal tear, and rectal analgesia was only\r studied as a single agent compared to placebo, and not as an adjunct to commonly used\r pain management protocols, thus no superiority was shown.\r\n\r At Sunnybrook Health Sciences Centre), a per-patient-request protocol is instituted,\r which includes acetaminophen (oral, 1000mg every 6 hours, PRN) and naproxen (oral, 400mg\r every 6 hours, PRN). Additionally, patients may ask for topical lidocaine 4% solution\r and oral oxycodone 5-10 mg every 4 hours (up to 40 mg/day in breastfeeding mothers).\r\n\r 1.2. Hypothesis\r\n\r Injecting a long-acting local anesthetic into the edges of 2PT/Epi, before suturing, in\r women who had a vaginal delivery with an epidural anesthesia, will provide longer and\r more efficient pain relief compared with the common practice of not using local\r anesthetics.\r\n\r 1.3. Research questions\r\n\r 1.3.1. Primary research question\r\n\r Using the PICOT technique, the primary research question addresses five main aspects of\r the trial: population, intervention, comparison, outcome, and time.\r\n\r P: In women who have had a vaginal delivery under an epidural anesthesia and have\r experienced an episiotomy or a 2nd degree perineal tear, I: Does the local injection of\r bupivacaine to the edges of 2PT/Epi C: compared to a current practice of no analgesic O:\r increase or decrease perineal pain T: 6 hours after last epidural bolus?\r\n\r 1.3.2. Other research questions\r\n\r In women who have had a vaginal delivery under an epidural anesthesia and have\r experienced an episiotomy or a 2nd degree tear, does the local injection of bupivacaine\r to the edges of 2PT/Epi compared to no analgesic increase or decrease -\r\n\r - Time to first ambulation (getting out of bed for any activity).\r\n\r - Time to first analgesic administration.\r\n\r - Number of analgesics administrations during the 24 hours after last epidural bolus.\r\n\r - Perineal pain at 12 and 24 hours (±30 minutes) after last epidural bolus.\r\n\r - Most severe perineal pain in rest during the first 12 and 24 hours after last\r epidural bolus.\r\n\r - Most severe perineal pain while sitting during the first 12 and 24 hours after last\r epidural bolus.\r\n\r - Most severe perineal pain during walking and breastfeeding during the first 12 and\r 24 hours after last epidural bolus.\r\n\r - Most severe perineal pain during breastfeeding during the first 12 and 24 hours\r after last epidural bolus.\r\n\r - Most severe perineal pain in rest, sitting, walking and breastfeeding during the\r first 12 and 24 hours after last epidural bolus.\r\n\r 1.4. Supporting evidence for the hypothesis\r\n\r Potential intervention - local infiltration of surgical wound with local anesthetics\r\n\r Local anesthetics have been used in multimodal anesthesia regimens in order to reduce\r the need for post-operative analgesia, mainly opioids26. Several reports have\r demonstrated the efficacy of local infiltration of anesthetics in surgical wounds. Some\r have found reductions in both post-operative analgesia use and VAS scores, while some\r reported more modest outcomes27-33.\r\n\r Local infiltration of perineal lacerations with local anesthesia agent or saline\r\n\r Two studies have examined infiltration of perineal laceration as a preventative measure\r to provide longer-acting pain relief once the epidural anesthesia fades.\r\n\r The first, by Khan and Lilford, dates back to 198734. In their study, they compared\r three groups of women with episiotomies (50 women in each group): group 1 had an\r epidural anesthesia, group 2 had an epidural anesthesia and local infiltration of\r saline, and group 3 did not have epidural anesthesia, and received lignocaine prior to\r suture of the episiotomy. They excluded women with large perineal tears, extended\r episiotomies or third degree perineal tears. They have found that both group 2 and 3 had\r lower pain scores on day 1 postpartum, and that group 2 (epidural + saline) had the\r lowest pain scores. They concluded that the artificial swelling induced by the\r infiltrated agents (regardless of which agent) accommodates the inflammatory edematous\r response, thus preventing the compression of the tissue by the sutures, and preventing\r the pain resulting from it. This study had some limitations in that it was not blinded,\r it excluded perineal tears, was performed three decades ago when practices were\r different, and did not control for different confounders.\r\n\r The second report is more recent, yet only patients with episiotomies were included35.\r In this double-blind randomized prospective study, infiltration with 15 mL of 0.75%\r ropivacaine, 1% lidocaine, or saline was performed immediately before initiating the\r perineal repair. A total of 154 patients were included. The authors did not find any\r differences between time to first oral analgesic request or pain scores during the first\r 24 hours postpartum. Yet, while this study employed a more adequate methodology, it did\r not compare patients to common practice (which is to infiltrate no agent), it included\r only women with episiotomies and excluded women with operative vaginal deliveries, and\r did not report the power of the study.\r\n\r Bupivacaine\r\n\r Bupivacaine Hydrochloride is 2-Piperidinecarboxamide,\r 1-butyl-N-(2,6-dimethylphenyl)-monohydrochloride, monohydrate, a white crystalline\r powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly\r soluble in chloroform or acetone. It is available in sterile isotonic solutions with and\r without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration,\r peripheral nerve block, and caudal and lumbar epidural blocks. It is related chemically\r and pharmacologically to the aminoacyl local anesthetics, and is chemically related to\r lidocaine.\r\n\r The onset of action with Bupivacaine Hydrochloride is rapid and anesthesia is long\r lasting. The duration of anesthesia is significantly longer with Bupivacaine\r Hydrochloride than with any other commonly used local anesthetic. It has also been noted\r that there is a period of analgesia that persists after the return of sensation, during\r which time the need for strong analgesics is reduced. The half-life of Bupivacaine\r Hydrochloride in adults is 2.7 hours36. Bupivacaine was chosen for the purpose of this\r study since it is long-acting37 and likely to provide pain relief once the epidural\r analgesia has subsided.\r\n\r How will the information from the study be used? If the proposed hypothesis will be\r proven, better pain management could be offerred to women, and improve the quality of\r postpartum care. In addition, alleviation of postpartum perineal pain will enable women\r to take better care of their offspring.\r\n\r 2. The Proposed Trial\r\n\r 2.1. Proposed Trial design\r\n\r The proposed trial will be a two-armed, randomized, single-masked, controlled trial\r\n\r 2.2. Planned interventions\r\n\r 2.2.1. Randomization\r\n\r Once a woman has consented to be considered for the trial, eligibility must be\r confirmed. Once eligibility has been confirmed, the women will be randomized into the\r study using computer-generated sequence and sealed envelopes to one of three study arms:\r Bupivacaine injection or sham injection to reflect current care.\r\n\r 2.2.2. All study participants\r\n\r Prior to injection of the intervention drug, the patient will be asked to press the\r bolus button of the epidural analgesia; the time of this occurs will be recorded. The\r length of the 2PT/Epi will be measured in centimeters and documented. The laceration\r will be sutured using 2-0 Caprosyn suture. Subcuticular sutures will be used for skin\r closure.\r\n\r 2.2.3. Bupivacaine arm\r\n\r The edges of the 2PT/Epi will be infiltrated with 10ml of Bupivacaine 0.5%+Epinephrine\r 50mcg prior to suture placement.\r\n\r 2.2.4. Control arm\r\n\r Sham injection will be done using a syringe filled with 10ml of NaCl 0.9%, but the fluid\r will not be injected to the edges of the laceration but discarded. The sham injection\r will last no less than 10 seconds.\r\n\r 2.3. Methods of protecting against bias\r\n\r The randomization will be done using a computer software. The patients and their\r companions will be asked not to observe the injection process. The physician performing\r the perineal repair will prepare the injection outside the patient's room. The nursing\r staff who will be directly involved with the care of the patients will be masked to the\r assigned arm.\r\n\r 2.4. Planned inclusion/exclusion criteria\r\n\r 2.4.1. Inclusion criteria\r\n\r - Maternal age > 18 years of age\r\n\r - Gestational age≥34 weeks of gestation\r\n\r - Vaginal delivery\r\n\r - Perineal laceration (2PT/Epi)\r\n\r - Effective epidural anesthesia\r\n\r - No known hypersensitivity to bupivacaine or amino-amide anesthetics\r\n\r 2.4.2. Exclusion criteria\r\n\r - Medical history of a chronic pain syndrome\r\n\r - Intrapartum morphine use\r\n\r 2.5. Duration of treatment period The treatment will be given as a single dose.\r Follow-up will take place for 24 hours after the last bolus dose.\r\n\r 2.6. Primary outcome and other outcomes\r\n\r 2.6.1. Primary outcome\r\n\r The primary outcome will be the proportion of women in the bupivacaine arm and the no\r analgesic arm who have a Numeric Rating Scale (NRS) score≤4 at 6-hours (±30 minutes)\r after last epidural bolus.\r\n\r Numeric Rating Scale (NRS)\r\n\r The NRS for pain is a unidimensional measure of pain intensity in adults. It is a\r segmented numeric version of the visual analog scale (VAS) in which a respondent selects\r a whole number (0-10 integers) that best reflects the intensity of their pain. The NRS\r is anchored by terms describing pain severity extremes, with 0 representing one pain\r extreme (e.g., \"no pain\") and 10 representing the other pain extreme (e.g., \"pain as bad\r as you can imagine\" and \"worst pain imaginable\"). The number that the respondent\r indicates on the scale to rate their pain intensity is recorded. Scores range from 0\r -1013.\r\n\r Visual Analog Scale (VAS)\r\n\r The pain VAS is a continuous scale comprised of a horizontal or vertical line, usually\r 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each\r symptom extreme. The respondent is asked to place a line perpendicular to the VAS line\r at the point that represents their pain intensity. The score is determined by measuring\r the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient's mark,\r providing a range of scores from 0-100 (mm) or 0-10 (cm). A higher score indicates\r greater pain intensity. Based on the distribution of pain VAS scores in postsurgical\r patients, the following cut points on the pain VAS have been recommended: no pain (0-4\r mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). No\r training is required other than the ability to use a ruler to measure distance to\r determine a score13.\r\n\r 2.6.3. Other outcomes\r\n\r The following are the other outcomes which will be compared among the three intervention\r arms:\r\n\r - Time to first ambulation (getting out of bed).\r\n\r - Time to first analgesic administration.\r\n\r - Number of administration of additional analgesics in the first 24 hours after last\r epidural bolus.\r\n\r - NRS at 12 and 24 hours (±30 minutes) after last epidural bolus.\r\n\r - Highest NRS while in rest during the first 12 and 24 hours after last epidural\r bolus.\r\n\r - Highest NRS while sitting during the first 12 and 24 hours after last epidural\r bolus.\r\n\r - Highest NRS while walking during the first 12 and 24 hours after last epidural\r bolus.\r\n\r - Highest NRS while breastfeeding during the first 12 and 24 hours after last\r epidural bolus.\r\n\r 2.7. Sample size and planned Recruitment Rate\r\n\r Group sample sizes of 323 in group one and 323 in group two achieve 80% power to detect\r a difference between the group proportions of -0.0990 (30% reduction). The proportion in\r group one (the treatment group) is assumed to be 0.3300 under the null hypothesis and\r 0.2310 under the alternative hypothesis. The proportion in group two (the control group)\r is 0.3300. The test statistic used is the two-sided Z test with pooled variance. The\r significance level of the test was targeted at 0.0500.\r\n\r To account for 10% loss to follow-up the sample size will be inflated to 355 per group.\r This will result in a total sample size of 710 for the 2 arms. The calculation was\r carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC. Kaysville, Utah.).\r\n\r 2.8. Analysis plan\r\n\r 2.8.1. Interim Analysis\r\n\r An interim analysis of efficacy (the primary outcome) is planned when 50% of the total\r subjects have outcome data available. The group sequential method of Lan and DeMets will\r be used to characterize the rate at which the type I error is spent where the spending\r function is the O'Brien-Fleming boundary. The nominal alpha level at the interim\r analysis (50% of participants) is 0.0031 and at the final analysis (100%) is 0.049. In\r addition, a futility analysis will be conducted whereby the probability of finding a\r significant result at the end of the study will be calculated based on the current trend\r in the data, the null and alternative hypotheses.\r\n\r 2.8.2. Final Analysis\r\n\r Descriptive statistics will be calculated for all variables of interest. Continuous\r measures such as age will be summarized using means and standard deviations whereas\r categorical measures will be summarized using counts and percentages.\r\n\r The primary outcome, proportion of women with NRS≥4 , will be compared between arms\r using tests of proportions.\r\n\r The secondary outcome, will be compared between arms using chi-square tests (or Fisher's\r exact tests in the case of low expected cell counts).\r\n\r The remaining outcome measures, such as Time to first ambulation, are continuous or\r interval measures. These will be assessed using t-tests or Wilcoxon rank sum tests in\r the case of non-normally distributed data.\r\n\r All analyses will be carried out using SAS Version 9.4 (SAS Institute, Cary, NC, USA).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Maternal age > 18 years of age\r\n\r - Gestational age≥34 weeks of gestation\r\n\r - Vaginal delivery\r\n\r - Perineal laceration (2PT/Epi)\r\n\r - Effective epidural anesthesia\r\n\r - No known hypersensitivity to bupivacaine or amino-amide anesthetics\r\n\r Exclusion Criteria:\r\n\r - Medical history of a chronic pain syndrome\r\n\r - Intrapartum morphine use\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nPrognostic Value of DTI and fMRI of Cervical Myelopathy\n\n**Clinical Trial Summary:**\n\nCervical myelopathy (CM) is one of the most common degenerative spinal cord disorders\r affecting older people. The progression of CM is insidious and the neurological decline can\r vary between patients. Surgical decompression is considered the most effective way to treat\r CM, however, it is not free from risk and the surgical outcome is not always satisfactory.\r The expected outcome of surgical intervention for CM remains a difficulty. There is a\r pressing need for a reliable and quantitative approach to predict surgical outcomes of CM and\r the precise prognosis. Previous studies have suggested a number of prognostic factors, such\r as age, duration of symptoms, pre-operative neurological status and abnormal MRI, but their\r prognostic value remains controversial. Recently, diffusion tensor imaging (DTI) and fMRI\r have been proposed as a promising tool for predicting the surgical prognosis of CM. In\r previous study, the protocol was successfully established for DTI microstructural\r characterization and resting state fMRI of the cervical spinal cord. This study is to\r evaluate the value of DTI and fMRI in predicting the outcome of surgical treatment. The\r ultimate goal is to establish a clinical protocol for quantitative DTI and fMRI analysis that\r could give accurate prognosis for surgical intervention to CM.\n\n**Clinical Trial Detailed Description:**\n\nCervical myelopathy (CM) is the most common cause of spinal cord dysfunction in the elderly.\r Symptoms often develop insidiously and are characterized by neck stiffness, arm pain,\r numbness in the hands, and weakness of the hands and legs. The causes of this myelopathy are\r many, such as spinal canal narrowing, osteophytes, herniated discs and hypertrophy of the\r ligamentum flavum. Although the clinical signs and symptoms of CM are well documented in the\r literature, a precise localization of the maximum level of compression is sometimes difficult\r in the elderly patients where multiple levels of the cervical spine are degenerated. Also the\r lack of understanding of the pathophysiology and pathomechanism of CM has significantly\r hampered the development of a rational approach to the surgical treatment of such condition.\r\n\r The diagnosis is made based on clinical signs and symptoms with the help of conventional MRI\r imaging which demonstrates the levels of anatomical stenosis. Surgical decompression of the\r cervical spine is the most common form of treatment. Magnetic resonance imaging (MRI) has\r been used widely in the evaluation of patients with CM. The commonly applied MR techniques\r include spin echo sequence, both conventional spin echo and fast/turbo spin echo for T1 and\r T2 information; gradient echo sequences, which generate T2 images; STIR (short tau inversion\r recovery) images; fat suppressed T1 images; gadolinium enhanced images applied to either\r routine T1WIs or fat suppressed T1WIs; MR spinal angiography; and cerebrospinal fluid flow\r (CSF) studies (either magnitude or phase contrast). However, conventional MRI mainly concerns\r anatomical information about CM, with less pathophysiological information. BOLD-fMRI is able\r to present the activated neuronal volume decreased in CM patients along with an increase in\r neuronal activities. diffusion tensor imaging (DTI) permits the detection of tissue-water\r molecular diffusion at microscopic dimensions. Previous studies have demonstrated the\r feasibility of DTI in evaluating microstructural changes in the myelopathic cervical cord.\r The prognostic values of spinal cord DTI in CM have been addressed in several previous\r studies. In recent years, combination of DTI and fMRI has been proposed to be an accurate\r prognostic tool for surgical management of CM.\r\n\r Cervical myelopathy (CM) is caused by degenerative stenosis of the cervical spine with\r progressive compression on the spinal cord resulting in loss of sensory and motor functions\r in the upper and lower limbs. Surgical decompression of the cervical spine is the most common\r form of treatment.\r\n\r The objective of this project is to evaluate the value of DTI and fMRI in predicting the\r outcome of surgical treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The inclusion criteria are a clinical diagnosis of CM including the signs of\r corticospinal lesions together with the appropriate radiographic findings.\r\n\r Exclusion Criteria:\r\n\r - Patients with acute spinal cord injuries, prior spinal intervention, with shrapnel or\r other metal or electronic implants in their bodies (such as pacemakers, aneurysm\r clips, surgical devices, metallic tattoos on the head, etc.), with claustrophobia and\r pregnant women will be excluded.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nEffects of End-effector Type Robot Assisted Gait Therapy on Gait Pattern and Energy Consumption in Chronic Post-stroke Hemiplegic Patients\n\n**Clinical Trial Summary:**\n\nRestoration of gait independence in stroke patients is one of the most important goals of\r rehabilitation therapy, and gait rehabilitation is one of the most important treatments in\r the treatment of stroke because it is a major factor affecting rehabilitation after stroke.\r In the rehabilitation of patients with post - stroke walking disorders, previous physical\r therapy was mainly manual therapy using therapist 's physical effort and walking training\r with walking aids. In recent years, however, emphasis has been placed on therapies based on\r motor learning concepts, which allow the patient to intensively train the exercise as closely\r as possible to the ultimate goal.\r\n\r The robot used for walking rehabilitation includes exoskeleton walking robot such as Lokomat®\r (Hocoma AG, Switzerland), Walkbot-G® (P & S Mechanics, Korea), MorningWalk® (Curexo, Korea)\r According to the Systematic Review, which compares two types of robot-assisted gait treatment\r divided into end-effector type, which is not an exoskeletal type such as System® (Rehatech,\r Switzerland) It has been reported that the percentage of patients who were able to walk\r independently when treated with a robot was higher than that of an exoskeleton-type robot.\r\n\r In this regard, in terms of acquisition of independent gait, studies on the therapeutic\r effect of the exoskeleton-type robot and the end-effector-type robot before and after the\r gait therapy were continuously performed, but 80% of the patients obtained independent gait,\r Despite the fact that many of these patients have abnormal walking, research has not yet been\r conducted. In previous studies, there was a statistically significant improvement in\r parameters of Gait speed, Cadence, and step length when compared with spatiotemporal\r parameters in training using exoskeleton robots for stroke patients. In another study, Gait\r speed and Cadence did not show a statistically significant improvement, and the effect on\r Gait speed and Cadence is still unknown. However, unlike exoskeletal robots, end-effector\r robotic gait training has been reported to improve Gait speed in most studies compared to\r conventional gait training. In addition, Cadence, Temporal symmetry ratio, Single, an\r improved side stride length, an improvement in the symmetry index of stance phase, and an\r improvement in Gait endurance.\r\n\r In this way, the end effector type robot walking training is more likely to improve walking\r quality than the exoskeleton type robot. The end-effector type robot, which is different from\r the exoskeleton type, reproduces the gait using the ankle joint to induce the movement of the\r knee joint and the hip joint. Therefore, it is possible to control the ankle joint, which is\r essential for improving the gait pattern. It is considered that the end effector type robot\r which can control the ankle joint is more likely to induce the improvement of the gait\r pattern than the existing exoskeleton type robot because it shows limitations in reproducing\r the ankle rocker motion.\n\n**Clinical Trial Detailed Description:**\n\nThere are few studies on kinematic, kinematic, and energy consumption after robot training,\r so it is urgent to study this part. In a small retrospective open-label study, the results of\r spatiotemporal parameters and kinetic and kinematic analyzes of patients with chronic stroke\r in patients who underwent gait using an end-effector robot were compared with those of Gait\r speed, Cadence , Stride time, and stride speed, improvement of hip extension in kinematic\r analysis as a whole, and reduction of anterior tilting in pelvis. This suggests that\r robot-assisted gait training may improve the kinematic index Randomized Controlled Trial\r design is a systematic study.\r\n\r In addition, it is important to evaluate the energy expenditure and cardiorespiratory load of\r robot-assisted walking therapy for the rehabilitation of patients at risk of cardiovascular\r disease and stroke patients with impaired cardiopulmonary function. The purpose of gait\r therapy in stroke patients is to improve the efficiency of energy consumption by calibrating\r patterns of gait and asymmetry of gait movements. This is also an important issue for gait\r researchers.\r\n\r The authors reported that when using an end-effector type robot, the oxygen consumption was\r statistically significantly lower during the robot-assisted walking compared to when the\r robot was not assisted by the robot. During the walking with the exoskeleton type robot, and\r when compared to OTW (Overground treadmill walking) during ATW, there was a statistically\r significant decrease in mean oxygen consumption There was a report. However, previous\r researches did not compare the pre - treatment and post - treatment, but there is no report\r on the possibility of improvement of oxygen consumption after robot - assisted gait training.\r\n\r In this study, we divided the patients into two groups. One group was treated with 6-week\r gait training using an end-effector type robot-assisted walking device and the other group\r was treated with gait therapy for the same period of time. Six weeks after the end of the\r treatment, three-dimensional motion analysis, foot pressure analysis and energy consumption\r analysis were performed to obtain robot assisted training in terms of space time index,\r kinematics, kinematic index, dynamic EMG activation pattern, The purpose of this study was to\r investigate whether the improvement in walking performance and the energy consumption\r efficiency of walkers are more effective than the conventional walking training group.\r\n\r the three most natural walking cycles Calculate kinematical index and spatio-temporal index\r according to each gait cycle\r\n\r Dynamic EMG analysis Dynamic EMG was performed by attaching surface EMG to the skin using\r Medial GCM, Tibialis Anterior, Vastus Medialis, Rectus Femoris, Medial Hamstring, and Gluteus\r Maximus of both lower limbs using a wireless Delsys Trigno Sensor System (Delsys Inc, USA)\r Measure the signal and convert it to Root mean square (RMS). (Figure 5) EMG signal sampling\r rate: 2000 samples / sec Filter: EMG signal bandwidth 20- 450 Hz Surface electrode: Parallel\r bar electrode\r\n\r The measured EMG signals are obtained by measuring the duration and the period of activity\r according to the walking cycle and analyzing the degree of activation.\r\n\r 1. Medial GCM, Tibialis Anterior, Vastus Medialis, Rectus Femoris, Medial Hamstring, and\r Gluteus Maximus\r\n\r 2. Starting and ending points of muscle activation cycle\r\n\r 3. Muscle activation duration and RMS integral and peak value\r\n\r 4. The root mean square (RMS) value divided by 16 sections divided by time\r\n\r 5. Comparison between the right side and the left side\r\n\r 2-2. Energy consumption analysis Use K4b2 (COSMED, Italy) as a wearable metabolic system\r (Fig. 6) Measure O2 cost [ml / (m / kg)] and O2 rate (ml / min / kg) The walking distance was\r measured by walking with the self-selected gait velocity while wearing K4b2 (COSMED, Italy)\r for 5 minutes in total. The walking distance was measured for 3 minutes except the first 1\r minute and the last 1 minute of oxygen consumption data for 5 minutes Using O2 rate and O2\r cost\r\n\r 2-3. Foot pressure analysis The foot pressure was measured using a F-Scan system (Tekscan,\r USA) with a 0.16-mm thick, 980 force-sensing resistors (3.88 sensors per centimeter square)\r After inserting the pressure insoles, calibrate them according to the Tekscan user manual\r (Tekscan Research Software User Manual version 6.7 Rev. D, 2003) and measure them and analyze\r them as follows.\r\n\r 2-4. Fugl-Meyer Assessment(FMA) for Lower extremities 2-5. 10m walking test 2-6. Berg balance\r scale(BBS) 2-7. Timed up and go test(TUG) 2-8. Functional Ambulation Category(FAC) 2-9.\r Modified Ashworth Scale(MAS) 2-10. Rivermead Mobility Index(RMI) 2-11. Functional\r independence measure(FIM)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Stroke patient visited Shinchon Severance Hospital Rehabilitation Department\r\n\r - Adults over 19 years\r\n\r - Ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging or\r computed tomography\r\n\r - Patients who have had a stroke for more than 3 months\r\n\r - Those who have hemiplegia after a stroke\r\n\r - If the walking pattern is abnormal and the walking speed is less than 0.8m / sec\r\n\r - Those who have a score of K-MMSE score of 24 or higher in the Korean version\r\n\r - A person who can walk independently with 3 or more points in the Functional Ambulation\r Category (FAC) classified as 0 ~ 5 according to the degree of need for assistance in\r walking\r\n\r - The patients who understand the research and have voluntary participation\r\n\r Exclusion Criteria:\r\n\r - Those who have difficulty walking before stroke\r\n\r - Modified Ashworth scale of the lower extremity muscle is 3 or more\r\n\r - Patients with ataxia\r\n\r - Severe lower extremity joints, osteoporosis, and untreated fractures.\r\n\r - Patients who weigh more than 135kg\r\n\r - Damage of the skin in contact with the machine during robot walking\r\n\r - Patients who underwent orthopedic or neurosurgical surgery within 6 months of the\r start of the study\r\n\r - uncontrolled hypertension or orthostatic hypotension\r\n\r - Patients who are likely to spread pathogenic microorganisms due to contact\r\n\r - Not cutting\r\n\r - Cardiovascular disease, venous thrombosis or heart failure, respiratory disease\r\n\r - Malignant neoplasm\r\n\r - Other basic diseases that can not tolerate robot assisted walking\r\n\r - If the tester is judged as not suitable for this study\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBlood Flow Restriction Therapy in Patellofemoral Pain Syndrome\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the efficacy of blood restriction therapy by\r comparing increase in muscle mass and strength in patients that receive blood restriction\r therapy to patients who receive a placebo.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - ASA class I-II\r\n\r - Diagnosed with patellofemoral pain syndrome\r\n\r Exclusion Criteria:\r\n\r - Patients with confirmed radiographic evidence explaining knee pain\r\n\r - Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia,\r etc.)\r\n\r - Younger than 18 years of age or older than 65\r\n\r - Any patient considered a vulnerable subject\r\n\r - Patients with impaired circulation, peripheral vascular compromise, Previous\r revascularization of the extremity, or severe hypertension\r\n\r - Patients with Sickle cell anemia or venous thromboembolism\r\n\r - Patients with Sickle cell anemia or venous thromboembolism\r\n\r - Patients with cancer or Lymphectomies\r\n\r - Patients with increased intracranial pressure\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMarizomib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial, and Spinal Cord Ependymoma\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r Ependymomas are rare tumors that arise from the ependyma. That is a tissue of the central\r nervous system. They can develop in the brain or the spine. They are usually treated with\r surgery, radiation, and/or chemotherapy. Researchers want to see if the new drug marizomib\r can help people with a certain kind of ependymoma.\r\n\r Objective:\r\n\r To see if marizomib stops tumor growth and prlongs the time that the tumor is controlled.\r\n\r Eligibility:\r\n\r Adults age 18 and older who have been diagnosed with ependymomas and have already been\r treated with standard therapies\r\n\r Design:\r\n\r Participants will be screened with the following tests or recent results from similar tests:\r\n\r - Medical history\r\n\r - Physical exam\r\n\r - Neurological assessment\r\n\r - Electrocardiogram (EKG) to evaluate the heart\r\n\r - Review of symptoms and ability to perform normal activities\r\n\r - Computed tomographic scan (CT) or magnetic resonance imaging (MRI) to produce an image\r of the brain or spine.\r\n\r - Blood and urine tests\r\n\r - Tests of tumor samples. Participants may have to have new tumor samples taken.\r\n\r Participants will get the study drug in cycles. Each cycle is 4 weeks. Participants will have\r up to 24 cycles.\r\n\r Participants will get the study drug through a small plastic tube in a vein on days 1, 8, and\r 15 of each cycle.\r\n\r During each cycle, some screening tests will be repeated.\r\n\r Participants will answer questions about their general well-being and functioning.\r\n\r About 4 5 weeks after finishing the study drug, participants will have a follow-up visit.\r They will answer questions about their health, get a physical and a neurological exam, and\r have blood tests. They may have an MRI or CT scan.\r\n\r ...\n\n**Clinical Trial Detailed Description:**\n\nBackground:\r\n\r - Ependymomas are rare primary brain tumors arising from radial glial stem cells. They\r comprise 5.2% of all pediatric primary brain tumors and 1.9% of all adult primary brain\r tumors.\r\n\r - The standard therapy for newly diagnosed ependymoma is gross total resection followed by\r radiation therapy. For anaplastic ependymoma, recurrence rate is high with a median\r progression free survival (PFS) of 2.3 years.\r\n\r - There are limited chemotherapy options for recurrent ependymomas, which have already\r been irradiated. Therefore, there is an unmet need to target novel pathways for\r treatment of ependymomas.\r\n\r - About 70% of supratentorial ependymomas have a characteristic signature C11orf95-RELA\r fusion which drives tumorigenesis in ependymomas by activating the NF-KB transcription\r pathway.\r\n\r - Marizomib is a second-generation irreversible proteasome inhibitor which penetrates\r across the blood-brain-barrier (BBB). It inhibits the activity of 20S proteasome in\r glioma cells, activates caspases, builds up reactive oxygen species and thus induces\r apoptosis. Marizomib blocks the NF-pathway by proteasome inhibition. Thus, it may have\r an additional targeted therapeutic effect in the RELA-fusion molecular subgroup of\r ependymomas.\r\n\r Objective:\r\n\r -To evaluate the efficacy of treatment with marizomib in RELA-fusion recurrent ependymoma and\r non RELA-fusion recurrent ependymoma as measured by progression-free survival at 6 months\r (PFS6).\r\n\r Eligibility:\r\n\r - Histologically proven intra-cranial or spinal ependymoma.\r\n\r - Radiographic evidence of tumor progression\r\n\r - Patients must be greater than or equal to 18 years old.\r\n\r Patients must have had prior radiotherapy.\r\n\r Design:\r\n\r - This is a phase II study to determine the efficacy of marizomib in recurrent ependymoma.\r\n\r - A novel 2-stage sequential design will be employed to conduct the trial for recurrent\r ependymoma.\r\n\r - In the first stage, we will enroll 18 patients with RELA-fusion ependymoma and if 4 or\r more patients in Cohort 1 are progression free at 6 months, we will proceed to stage 2;\r otherwise we will terminate the trial and conclude that marizomib is not effective.\r\n\r - In the second stage, we will enroll 32 patients with non RELA-fusion ependymoma.\r\n\r - Patients will be treated with marizomib in cycles consistent of 28 days until disease\r progression or a maximum of 24 cycles.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r - Stage 1 Eligibility (Cohort 1 and 2)\r\n\r Cohort 1\r\n\r - Histologically confirmed by NCI Laboratory of Pathology intra-cranial or spinal RELA-\r fusion ependymoma of grade I, II or III.\r\n\r - Has received two or fewer prior chemotherapy regimens\r\n\r Cohort 2\r\n\r - Histologically confirmed by NCI Laboratory of Pathology intra-cranial or spinal\r RELA-fusion ependymoma of grade I, II or III.\r\n\r - Has received more than two prior chemotherapy regimens\r\n\r - Stage 2 Eligibility (Cohorts 3 and 4)\r\n\r Cohort 3\r\n\r - Histologically confirmed by NCI Laboratory of Pathology intra-cranial or spinal non\r RELA-fusion ependymoma of grade I, II or III.\r\n\r - Has received two or fewer prior chemotherapy regimens\r\n\r Cohort 4\r\n\r - Histologically confirmed by NCI Laboratory of Pathology intra-cranial or spinal non\r RELA-fusion ependymoma of grade I, II or III.\r\n\r - Has received more than two prior chemotherapy regimens .\r\n\r - Patients must have an evidence of tumor progression.\r\n\r - Patients must have had prior radiation therapy.\r\n\r - Patients must be greater than or equal to 18 years old. Currently, no dosing or\r adverse event data is available on the use of marizomib in patients < 18 years of\r age; therefore, only adults are included in this study. Patients < 18 years of\r age will be eligible for future pediatric trials.\r\n\r - Patients must have a Karnofsky performance status of greater than or equal to 60.\r\n\r - Patients must have adequate organ and marrow function as defined below:\r\n\r - leukocytes: greater than or equal to 3,000/microliters\r\n\r - absolute neutrophil count: greater than or equal to 1,500/microliters\r\n\r - platelets: greater than or equal to 100,000/microliters\r\n\r - hemoglobin: greater than or equal to 10 gm/dL (can be achieved by transfusion)\r\n\r - AST(SGOT)/ALT(SGPT): less than or equal to 2.5 X institutional upper limit of\r normal\r\n\r - Bilirubin: <1.5 mg/dL\r\n\r - Creatinine up to 1.5-times upper institutional limits OR eGFR within normal as\r predicted by the CKD-EPI equation (greater than or equal to 60 mL/min/1.73m(2).\r\n\r - Negative urine protein or urine protein concentration less than or equal to 60\r mg/dL\r\n\r - The effects of marizomib on the developing human fetus are unknown. For this\r reason, women of child-bearing potential and men must agree to use adequate\r contraception (hormonal or barrier method of birth control; abstinence) prior to\r study entry and for the duration of study participation and up to 30 days after\r the last dose of the drug. Should a woman become pregnant or suspect she is\r pregnant while she or her partner is participating in this study, she should\r inform her treating physician immediately.\r\n\r - Ability of subject to understand and the willingness to sign a written informed\r consent document.\r\n\r EXCLUSION CRITERIA:\r\n\r - Anticancer treatment within designated period of time before enrollment including:\r\n\r - surgery within 14 days\r\n\r - needle or core biopsy within 7 days\r\n\r - prior cytotoxic therapy within 28 days,\r\n\r - vincristine within 14 days\r\n\r - nitrosoureas within 42 days,\r\n\r - procarbazine administration within 21 days\r\n\r - non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid\r (radiosensitizer does not count) within 7 days; Avastin within 21 days. Any\r questions related to the definition of non-cytotoxic agents should be directed to\r the NCI Principal Investigator.\r\n\r - Treatment with any investigational agent within 28 days before enrollment.\r\n\r - History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of\r the cervix), unless patient is in complete remission and off all therapy for that\r disease for a minimum of 3 years.\r\n\r - History of allergic reactions attributed to compounds of similar chemical or biologic\r composition to marizomib.\r\n\r - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r arrhythmia, or psychiatric illness/social situations that would limit compliance with\r study requirements.\r\n\r - Inadequately controlled hypertension (defined as systolic blood pressure > 140 mmHg\r and/or diastolic blood pressure > 90 mmHg).\r\n\r - Current active hepatic or biliary disease (with exception of patients with Gilbert s\r syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator\r assessment).\r\n\r - New York Heart Association (NYHA) Grade II heart failure or greater or history of\r hospitalization for congestive heart failure diagnosis within 12 months prior to\r enrollment.\r\n\r - History of myocardial infarction or unstable angina within 3 months prior to\r enrollment.\r\n\r - A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a\r QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Frederica s QT correction\r\n\r formula.\r\n\r - A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family\r history of Long QT Syndrome).\r\n\r - Current use of concomitant medications that prolong the QT/QTc interval\r\n\r - History of stroke or transient ischemic attack within 3 months prior to enrollment.\r\n\r - Pregnant women are excluded from this study because marizomib s potential\r forteratogenic or abortifacient effects is unknown. Because there is an unknown but\r potential risk for adverse events in nursing infants secondary to treatment of the\r mother with marizomib, breastfeeding should be discontinued if the mother is treated\r with marizomib.\r\n\r - Patients receiving combination antiretroviral therapy for treatment of Human\r Immunodeficiency Virus (HIV) or active anti-viral treatment for Hepatitis A, B or C\r infection. Anti-viral therapy, when combined with marizomib, poses a potential for\r pharmacokinetic interactions. Marizomib also increases immunosuppression, placing\r patients at an increased risk of acquiring lethal infections. Appropriate studies will\r be undertaken in patients receiving combination antiretroviral therapy when indicated.\r\n\r - Inclusion Criteria for Pregnancy Cohort (P)\r\n\r Because the drug manufacturer would like to study the effect of the study therapy on\r pregnancy, and because the required information cannot be collected unless a subject is\r enrolled per ruling of the OGC, the following additional groups of subjects may be enrolled\r if necessary.\r\n\r -A child whose parent (male or female) is/was an active participant in the study at any\r time during the child s gestation. Active participant is defined as having received at\r least one dose of study therapy through 6 months after the last dose of study therapy.\r\n\r OR\r\n\r - An expectant mother of child whose father is/was an active participant in the study at\r any time during the child s gestation. The father must have received at least one dose\r of study therapy. Active participant is defined as having received at least one dose\r of study therapy through 6 months after the last dose of study therapy.\r\n\r - The expectant mother must be age 18 or older and must have the capacity to provide\r informed consent.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"content": "**Clinical Trial Title:**\n\nRACIN in Patients With Advanced TIL-negative Solid Tumors\n\n**Clinical Trial Summary:**\n\nSubjects with locally advanced or metastatic incurable Tumor Infiltrating Lymphocytes\r (TIL)-negative solid tumors who are not eligible for, declined or failed standard therapy\r will be treated with a combination nivolumab, low-dose ionizing radiation (RT) (0.5-2 Gy),\r aspirin (ASA)(cohorts 1 and 2)/celecoxib (cohorts 3, 4 and Phase Ib), and either ipilimumab\r or low-dose cyclophosphamide. The study comprises 2 phases: The aim of Phase Ia, is to\r determine safety and tolerability of a given combination therapy, as well as the maximum\r tolerated dose (MTD) or recommended phase Ib dose (RP1bD) of radiotherapy. Phase Ib aims to\r further explore safety and tolerability of this treatment in an expansion cohort.\r\n\r In Phase Ia, 4 distinct cohorts will receive the following combination therapy:\r\n\r Cohort1: combination therapy for 5 cycles (C0-C4) which includes: RT 0.5 Gy every 2 weeks\r (Q2W), Cy (200 mg/m2) Q2W (cycles C0 to C4); ASA (300 mg) daily, with nivolumab 240 mg flat\r dose Q2W and ipilimumab 1 mg/kg every 6 weeks (Q6W) will be administered (cycles C1 to C4).\r\n\r Cohort2: combination therapy for 5 cycles (C0-C4) which includes: RT 1 Gy every 2 weeks\r (Q2W), Cy (200 mg/m2) Q2W (cycles C0 to C4); ASA (300 mg) daily, with nivolumab 240 mg flat\r dose Q2W and ipilimumab 1 mg/kg (Q6W) will be administered (cycles C1 to C4).\r\n\r Cohorts 3a and 4a: Patients will receive Cy (200 mg/m2) Q2W, celecoxib (2x200mg daily),\r nivolumab (240 mg flat dose) Q2W, and low-dose radiation. Cohort 3a will receive 1 Gy of\r low-radiation dose and cohort 4a will receive 2 Gy.\r\n\r Cohorts 3b and 4b: Patients will receive nivolumab (240 mg flat dose) Q2W, ipilimumab 1 mg/kg\r (Q6W), celecoxib (2x200mg daily) and low-dose radiation. Cohort 3b will receive 1 Gy of\r low-radiation dose and cohort 4b will receive 2 Gy.\r\n\r In Phase Ia, the safety of combination (nivolumab, celecoxib, low-dose irradiation and\r cyclophosphamide) or (nivolumab, celecoxib, low-dose irradiation and ipilimumab) will be\r evaluated , and MTD or RP1bD will be defined. RP1bD will be the MTD or, in the absence of\r dose limiting toxicities (DLTs), the biologically best RT dose based on pharmacodynamics\r parameters.\r\n\r In Phase Ib, patients will be treated with the MTD or RP1bD dose of RT and will follow the\r selected schema of treatment used in the Phase Ia cohort 3 or 4. At the end of the 5th cycle,\r patients eligible for nivolumab maintenance, will be treated with nivolumab at 240 mg Q2W\r until progression or excessive toxicity; celecoxib will be maintained according to\r tolerability.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nPre-screening registration\r\n\r Inclusion Criteria:\r\n\r 1. Signed pre-screening Informed Consent Form\r\n\r 2. Patients with recurrent or metastatic solid tumor (any histology), who progress after\r at least one standard therapy for advanced disease\r\n\r 3. Patient willingness and acceptance to participate in the immunology research is\r mandatory\r\n\r 4. At least one lesion accessible to biopsy without putting patient at risk\r\n\r 5. Biopsies obtained previously (within a maximum of 12 weeks before pre-screening\r visit), outside this protocol, for TIL assessment can be also considered for patient\r selection. Fresh tumor biopsies for subsequent translational studies will be used as\r baseline and collected at pre-screening (when biopsy will be performed for TIL status)\r or at screening (when archival biopsy will be used for TIL status). Biopsy from\r metastatic lymph nodes is accepted.\r\n\r 6. Eastern Cooperative Oncology Group (ECOG) clinical performance status: 0-1 for all\r patients, independently of the number of previous lines of therapy.\r\n\r 7. Life expectancy of ≥ 12 weeks\r\n\r 8. Patients with Glycose-6-Phosphate Dehydrogenase (G6PD) deficiency or any other\r hereditary coagulation disorder are excluded, as well as patients with clinical\r history of Reye syndrome\r\n\r 9. Adequate serology defined by the following laboratory results obtained during\r pre-screening period (day-28 to day-14).\r\n\r 1. Seronegative for HIV infection (anti-HIV-1/-2)\r\n\r 2. Seronegative for hepatitis B infection (HBs Ag, total anti-hemoglobin C (HBc),\r anti-HBs). Patients with past or resolved hepatitis B infection (defined as\r having a negative hepatitis B surface antigen HBsAg test and a positive anti-HBc\r antibody test) are eligible, if hepatitis B virus (HBV) DNA test is negative.\r\n\r 3. Seronegative for hepatitis C infection (anti-HCV): if a patient has positive\r anti-HCV antibody, a negative hepatitis C virus (HCV) RNA need to be obtain to\r register the patient.\r\n\r Study registration\r\n\r Inclusion Criteria\r\n\r 1. Signed main study Informed Consent Form\r\n\r 2. Absence of tumor-infiltrating intraepithelial Cluster of differentiation-8 positive T\r cells (CD8+ T cells) by immunohistochemistry (IHC) on baseline biopsy defined as <5\r CD8+ cells per high power field of tumor\r\n\r 3. At least one lesion accessible to biopsy without putting patient at risk\r\n\r 4. Number of metastatic lesions viewed on Positron emission tomography-computed\r tomography (PET/CT) scan: for both Phase Ia and Phase Ib, the patient may have any\r number of metastatic lesions. A maximum of 10 metastatic lesions visible by PET/CT\r scan will be irradiated at the investigator's discretion. It is at the discretion of\r the investigator to exclude a metastatic site from the radiation field that, due to\r the radiotherapy volume, dose or location too close to a healthy organ, may put the\r patient at risk of suffering from radiation induced toxicity. If this would be the\r only metastatic site to be irradiated, the concerned patient will be excluded from the\r study.\r\n\r 5. Absence of any psychological, familial, sociological or geographical condition\r potentially hampering compliance with the study protocol\r\n\r 6. Adequate hematologic and end-organ function, defined by the following laboratory\r results obtained within 14 days prior to the first study treatment:\r\n\r 1. Absolute neutrophil count ≥ 1.5 g/L (without granulocyte colony-stimulating\r factor support within 2 weeks prior registration)\r\n\r 2. White Blood Cell (WBC) counts > 2.5 g/L and < 15 g/L\r\n\r 3. Lymphocyte count ≥ 0.5 g/L\r\n\r 4. Platelet count ≥ 100 g/L (without transfusion within 1 week prior registration)\r\n\r 5. Hemoglobin ≥ 90 g/L (Patients may be transfused to meet this criterion but it\r should not be done within 1 week prior registration)\r\n\r 6. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and\r alkaline phosphatase ≤ 2.5 x ULN (with the exception for patients with documented\r liver metastases: AST, ALT and alkaline phosphatase ≤ 5 x ULN)\r\n\r 7. Serum bilirubin ≤ 1.5 x ULN (with the exception for: patients with known or\r suspicion of Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be\r enrolled)\r\n\r 8. Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5\r X ULN unless subject is receiving anticoagulant therapy as long as PT or Partial\r Thromboplastin Time (PTT) is within therapeutic range of intended use of\r anticoagulants; Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless\r subject is receiving anticoagulant therapy as long as PT or PTT is within\r therapeutic range of intended use of anticoagulants.\r\n\r 9. Serum albumin > 25 g/L\r\n\r 10. Serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 40 ml/min on the basis of\r Cockcroft-Gault Formula\r\n\r 7. No prior radiation therapy in areas of desired radiation\r\n\r 8. Patients may have had prior therapy provided a washout period of 4 weeks prior to\r registration is allowed. Exception: hormone therapy for breast and prostate cancer is\r allowed to be continued during the study.\r\n\r 9. Recovery from any toxic effects of prior therapy before registration to ≤ Grade 1 per\r the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI\r CTCAE v4.03) except for toxicities described below, as they do not put at risk the\r patient's condition and do not require systemic immunosuppressive steroids at any\r dose, including but not limited to: fatigue, alopecia, skin disorders, stable\r neuropathy, endocrinopathies requiring replacement treament.\r\n\r Note: for other medical conditions, or for any other toxicity with a higher grade but\r controlled by adequate treatment, prior discussion and agreement with the trial chair\r is mandatory.\r\n\r Note: Patients may have undergone surgical procedures within the past 3 weeks, as long\r as all toxicities have recovered to grade 1 or less.\r\n\r 10. For women of childbearing potential (WOCBP: sexually mature women who have not\r undergone a hysterectomy, have not been naturally post-menopausal for at least 12\r consecutive months or have a serum follicle-stimulating hormone (FSH) < 40 Millions\r International Units (mIU)/ml):\r\n\r 1. Agreement to use 2 acceptable methods of contraception during participation in\r the trial and for 6 months after last study combined treatment and after 5 months\r of maintenance treatment\r\n\r 2. Women must have a negative urine pregnancy test within 7 days before\r registration. A positive urine test must be confirmed by a serum pregnancy test,\r or menopausal as per National Comprehensive Cancer Network (NCCN) guidelines.\r\n\r 11. For men: agreement to use 2 acceptable methods of effective contraception during\r participation in the trial and for 7 months after last study treatment (combined or\r maintenance treatment). Female partners of men who take part in this trial must also\r use at least one method of effective contraception during the trial and 7 months after\r last study treatment (combined or maintenance).\r\n\r Exclusion Criteria:\r\n\r 1. Patients with soft tissue sarcoma, glioblastoma, or lymphoma are excluded.\r\n\r 2. Pregnant or breast-feeding women.\r\n\r 3. Symptomatic brain or leptomeningeal disease; any brain metastases must be stable for\r at least 6 months\r\n\r 4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent\r drainage procedures (once monthly or more frequently)\r\n\r 5. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected\r serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of\r bisphosphonate therapy or denosumab\r\n\r a) Patients who are receiving bisphosphonate therapy or denosumab specifically to\r prevent skeletal events and who do not have a history of clinically significant\r hypercalcemia are eligible.\r\n\r 6. Life expectancy of < 12 weeks\r\n\r 7. Current, recent (within 4 weeks prior to registration), or planned participation in an\r experimental drug study\r\n\r 8. New York Heart Association Class II or greater congestive heart failure\r\n\r 9. History of myocardial infarction or unstable angina within 6 months prior registration\r\n\r 10. History of stroke or transient ischemic attack within 6 months prior registration\r\n\r 11. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or\r recent peripheral arterial thrombosis) within 6 months prior registration)\r\n\r 12. Evidence of bleeding diathesis or significant coagulopathy (in the absence of\r therapeutic anticoagulation)\r\n\r 13. Patients with active peptic or duodenal ulceration (within 4 weeks prior to\r registration)\r\n\r 14. Current or recent (within 14 days prior registration) treatment use of dipyramidole,\r ticlopidine, clopidogrel, cilostazol, prasugrel, or ticagrelor\r\n\r 15. Current or recent (within 14 days prior registration) use of full-dose oral or\r parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to\r prophylactic) purpose\r\n\r 1. Prophylactic anticoagulation for the patency of venous access devices is allowed,\r provided the activity of the agent results in an International Normalized Ratio\r (INR) < 1.5 x ULN and aPTT is within normal limits within 2 weeks prior\r registration.\r\n\r 2. Prophylactic use of low molecular-weight heparin (e.g., enoxaparin) is allowed.\r\n\r 16. History of severe allergic, anaphylactic, or other hypersensitivity reactions to\r chimeric or humanized antibodies or fusion proteins or allergy to biopharmaceuticals\r produced in Chinese hamster ovary cells\r\n\r 17. Known hypersensitivity to any component of the Investigational Medicinal Products\r (IMPs)\r\n\r 18. History of autoimmune disease, including but not limited to myasthenia gravis,\r myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,\r inflammatory bowel disease, vascular thrombosis associated with antiphospholipid\r syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome,\r multiple sclerosis, vasculitis, or glomerulonephritis. The following exceptions are\r considered:\r\n\r 1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of\r thyroid replacement hormone are eligible for this study.\r\n\r 2. Patients with controlled Type I diabetes mellitus on a stable insulin regimen are\r eligible\r\n\r 19. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis\r obliterans), druginduced pneumonitis, idiopathic pneumonitis, or evidence of active\r pneumonitis on screening chest Computerized Tomography (CT) scan. Exception: history\r of radiation pneumonitis in previous radiation field (fibrosis) is permitted provided\r that this area does not undergo current low dose irradiation as part of this protocol.\r\n\r 20. Severe infections within 4 weeks prior registration including but not limited to\r hospitalization for complications of infection, bacteremia, or severe pneumonia\r\n\r 21. Signs or symptoms of infection within 2 weeks prior registration\r\n\r 22. Received therapeutic oral or IV antibiotics within 2 weeks prior registration.\r Exception: patients receiving routine antibiotic prophylaxis (e.g., to prevent chronic\r obstructive pulmonary disease exacerbation or for dental extraction) are eligible.\r\n\r 23. Prior allogeneic stem cell or solid organ transplant\r\n\r 24. Administration of a live, attenuated vaccine within 4 weeks before registration.\r Exception: influenza vaccination should be given during influenza season only\r (approximately October to March). Patients must not receive live, attenuated influenza\r vaccine within 4 weeks prior registration or at any time during the study.\r\n\r 25. Any other diseases, metabolic dysfunction, physical examination finding, or clinical\r laboratory finding giving reasonable suspicion of a disease or condition that\r contraindicates the use of an investigational drug or that may affect the\r interpretation of the results or render the patient at high risk from treatment\r complications\r\n\r 26. Patients who have received prior treatment with anti-Programmed Cell Death-1 (PD1),\r anti-Programmed Cell Death Ligand-1 (PD-L1) or anti-Cytotoxic T-lymphocyte Associated\r 4 (CTLA-4) may be enrolled, provided at least 5 half-lives (approximately 75 days)\r have elapsed from the last dose to the registration and there was no history of severe\r immune-mediated adverse effects from such therapy (NCI CTCAE Grade 3 and 4).\r\n\r 27. Treatment with systemic immunostimulatory agents (including but not limited to\r interferon-alpha (IFN-a), interleukin-2 (IL-2)) for any reason within 6 weeks or five\r half-lives of the drug, whichever is shorter, prior registration\r\n\r 28. Treatment with systemic immunosuppressive medications (including but not limited to\r prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide,\r and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior registration\r\n\r 1. Patients who have received acute, low-dose, systemic immunosuppressant\r medications (e.g., a one-time dose of dexamethasone for nausea) or physiologic\r replacement doses (i.e., prednisone 5-7.5 mg/day) for adrenal insufficiency may\r be enrolled in the study.\r\n\r 2. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone)\r is allowed.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nUtilization of High Frequency Ultrasound to Diagnose Chronic Exertional Compartment Syndrome\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to investigate high frequency ultrasound as a future modality\r for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the\r ultrasound will help determine if there are any significant radiologic findings or patterns\r seen in patients with CECS.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to investigate high frequency ultrasound as a future modality\r for the diagnosis of chronic exertional compartment syndrome (CECS). The results of the\r ultrasound will help determine if there are any significant radiologic findings or patterns\r seen in patients with CECS. Evaluation of ultrasonographic findings will be dependent on\r tissue density as measured by hypoechoic versus hyperechoic signal as well as muscle\r compartment thickness at its largest dimension. A specific aim for this study would be to\r facilitate future research in order to eliminate the need for painful and invasive diagnostic\r techniques for CECS.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female ages 13 and over\r\n\r - Patients with any combination of the following symptoms who would otherwise be\r evaluated for CECS:\r\n\r - Symptoms of leg pain worsened with activity and relieved by rest\r\n\r - Pain that is generalized in the anterior or lateral compartments of lower leg\r\n\r - Numbness or tingling in the distribution of the superficial peroneal nerve\r\n\r - Sensation of \"slap foot\" or anterior/lateral compartment weakness\r\n\r - Able to exercise for CPT testing: Patients will be asked to go through a standardized\r warm up on a treadmill with increasing speed and incline settings until symptoms are\r achieved. They will maintain exercise for a minimum of five minutes or to patient\r tolerance.\r\n\r Exclusion Criteria:\r\n\r - Known vascular disease\r\n\r - Neurogenic or radicular symptoms\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effect of Spinal Stabilization Exercises in Patients With Myasthenia Gravis\n\n**Clinical Trial Summary:**\n\nMyasthenia Gravis (MG) is an autoimmune disease characterized by increased exercise-induced\r fatigue and muscle weakness. MG is a disease caused by impaired receptor function due to\r antibodies to nicotinic acetylcholine receptors in postsynaptic region in voluntary skeletal\r muscles.Spinal stabilization exercises, which use the basic principles of motor learning,\r aiming to improve the coordination, contraction rate and endurance of the body muscles by\r increasing kinesthetic awareness, can be used to strengthen body stability.\r\n\r The aim of this study was to investigate the effects of spinal stabilization exercises on\r fatigue, muscle strength, pulmonary functions and functional capacity in patients with MG.\n\n**Clinical Trial Detailed Description:**\n\nMyasthenia Gravis (MG) is an autoimmune disease characterized by increased exercise-induced\r fatigue and muscle weakness. MG is a disease caused by impaired receptor function due to\r antibodies to nicotinic acetylcholine receptors in postsynaptic region in voluntary skeletal\r muscles. The disease usually begins with ptosis from ocular symptoms. With the progression of\r the disease, symptoms of bulbar muscles and extremity muscles are added to the ocular\r symptoms. Bulbar symptoms occur when speaking, swallowing, chewing difficulties and\r difficulty breathing, while the symptoms in the extremity muscles arise as the difficulty of\r raising the arms uphill and the strain of climbing stairs.\r\n\r The weakness of the limb muscles is proximal and distal in the arms and more proximal muscles\r in the legs. As the disease progresses, weakness occurs in most striated muscles. This causes\r weakness in the trunk muscles.\r\n\r In the literature, the physiotherapy methods used in MG patients include breathing exercises,\r aerobic exercises and resistant exercises.Spinal stabilization exercises enable activation of\r the trunk muscles.\r\n\r Spinal stabilization exercises, which use the basic principles of motor learning, aiming to\r improve the coordination, contraction rate and endurance of the body muscles by increasing\r kinesthetic awareness, can be used to strengthen body stability. Spinal stabilization\r exercises are a type of exercise that aims more smooth limb movements with a strong spine,\r ensuring smoothness and stability of the spine. In the literature, there is no study using\r spinal stabilization exercises in MG patients. The aim of this study was to investigate the\r effects of spinal stabilization exercises on fatigue, muscle strength, pulmonary functions\r and functional capacity in patients with MG.\r\n\r Method The study was planned as randomized, single-blind and cross-over. Randomization will\r be done with closed envelope system. Group 1 will be written on five sheets and group 2 will\r be written on another five sheets.\r\n\r Then, these papers will be placed on the envelopes, these envelopes will be mixed in a box\r and patients will be asked to withdraw from these envelopes.\r\n\r Thus, patients will be divided into 2 groups. Assessments will be made by Yeliz Salcı and\r Ebru Kütük Çalıkçı. The assessors will not know who is in the which group. Treatment\r intervention will be done by Ali Naim Ceren. The assessors will evaluate patients without\r knowing the patients' groups. So the work will be single blind. Group 1, 3 days per week for\r 6 weeks so that it will be taken to the physiotherapy program consisting of spinal\r stabilization exercises. Also the treatment will be supported by home program exercises. The\r patients will be rested for 4 weeks to eliminate the effects of the spinal stabilization\r program. After this period, only the home program will be given for 6 weeks. In Group 2;\r treatment will start with a 6-week home program, followed by a 4-week break.\r\n\r At the end of this period to be 3 days a week for 6 weeks spinal stabilization exercise\r program will be implemented. In addition to this exercise program, patients will be given a\r home program. The home program will include breathing exercises tailored to the patient's\r needs, calisthenic exercises, and MAT activities.\r\n\r Assessments will be made at the beginning of the treatment, after 6 weeks of treatment, at\r the end of 4 weeks of rest and at the end of 6 weeks of treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Being diagnosed with MG by a neurologist,\r\n\r - Aged between18-65 years,\r\n\r - To be in Stage II or III according to the Clinical Classification of the Medialia\r Gravis Functional Assessment (MGFA),\r\n\r - The Mini Mental Test score should be over 24 in order to be cooperative to the\r physiotherapist's instructions,\r\n\r - To volunteer to participate in the study.\r\n\r Exclusion Criteria:\r\n\r - Having a cognitive problem and having a Mini Mental Test score below 24\r\n\r - To have had myasthenic crisis in the last month,\r\n\r - Modification of medical treatment and dose in the last month,\r\n\r - Systemic, orthopedic and neurological disease in addition to the disease\r\n\r - Participation in physiotherapy program in the last six months.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSensory Potentials and Ultrasonography in Common Peroneal Mononeuropathy\n\n**Clinical Trial Summary:**\n\nCommon peroneal mononeuropathy at the fibular neck (CPN) is one of the most frequent\r mononeuropathies of the lower extremities.\r\n\r The common peroneal nerve sub serves sensation to the dorsum of the foot and toes. In CPN\r motor fibers of the deep peroneal nerve are more frequently affected than those of the\r superficial peroneal nerve. Fascicles of the deep branch of the common peroneal nerve are\r more anteriorly located and more vulnerable to injury than those of the superficial peroneal\r branch. The clinical and electrodiagnostic findings in CPN resemble the anatomical structure\r of the common peroneal nerve, indeed fibers for the deep peroneal nerve and the superficial\r peroneal nerve are bounded in separate fascicles along the course of the nerve.\r\n\r Superficial peroneal nerve sensory potential (SPSP) should be performed to localize the site\r of injury.\r\n\r Electrodiagnostic testing is used widely to evaluate the function of the common peroneal\r nerve. SPSP have been examined in CPN with conflicting results. A loss in amplitude of this\r response implies some axonal loss affecting either the common peroneal nerve or its\r superficial branch. Prominent axonal loss is the hallmark of most CPN lesions and suggested\r that abnormalities in sensory nerves mirror those in motor nerves.\r\n\r Moreover, assessment of the structure of the common peroneal nerve is likely to improve the\r diagnostic yield\" by using high-resolution ultrasonography. Ultrasound imaging is painless,\r does not expose the patient to radiation, and has several advantages compared with magnetic\r resonance imaging in the laboratory setting, including reduced cost, accessibility, ability\r to image the entire length of the nerve in a single study, and the ability to image both\r statically and dynamically.\r\n\r This study was conducted to evaluate the superficial peroneal sensory potential and\r high-resolution ultrasonography role in confirmation of common peroneal mononeuropathy at the\r fibular neck.\n\n**Clinical Trial Detailed Description:**\n\nThe current study is a case control study that was done in the period from January 2015 to\r January 2016. The study included 70 participants presented with clinical and\r electrophysiological evidence of common peroneal neuropathy at the fibular neck (CPN)\r attending to Zagazig University Hospitals (Neurology, Rheumatology& Rehabilitation, and\r Orthopedic departments) and insurance hospitals of Sharkia governorate (47 male and 23\r female). Their age (mean ± SD/years) was 40.4± 12.9, the duration between the onset of\r symptom and enrollment in the study ranged between 21 days to 6 months. Seventy (45 males and\r 25 females) apparently healthy volunteers were included as controls, and their age (mean ±\r SD/ years) was 41.3 ± 11.8. They were selected from the persons attending to blood bank for\r blood donation.\r\n\r All participants included in the present study are subjected to:\r\n\r 1. Full history taking.\r\n\r 2. Thorough clinical and neurological examination.\r\n\r 3. Routine laboratories tests for exclusion of other systemic affection like diabetes\r mellitus, renal or hepatic failure.\r\n\r 4. Electrodiagnostic studies\r\n\r All tests were done in the same room, at the time of clinical diagnosis using a Nicolet\r Viking Quest cart electrodiagnostic system. Lower extremity temperature was maintained\r at or above 30º C at time of examination. The electrophysiological studies included the\r following:\r\n\r A-Motor nerve conduction studies:\r\n\r Motor conduction study of the common peroneal nerve (ankle-fibular neck -popliteal\r fossa), tibial motor nerve conduction study were performed with surface disc recording\r electrodes for the affected limb and the contralateral limb in all subjects. Evaluations\r of both upper limbs were added to exclude more wide lesions if suspected.\r\n\r Common peroneal CMAPs were recorded over extensor digitorum brevis and tibialis\r anterior.\r\n\r Investigators considered that the lesion is axonal via axonal loss estimation:\r\n\r Axonal loss of the motor branch of the common peroneal nerve was estimated by comparing\r the CMAP amplitude recorded from the extensor digitorum brevis on the affected and\r contralateral sides.\r\n\r An estimate of EDB axonal loss was obtained from the formula (U -A)/U ×100 U : (extensor\r digitorum brevis response amplitude from the unaffected side).\r\n\r A : (extensor digitorum brevis response amplitude from the affected side).\r\n\r Categorization based on the motor estimated axonal loss as follow:\r\n\r No loss: (<50%). Mild to moderate loss: (50-75%). Severe loss: (>75%).\r\n\r B- Sensory nerve conduction studies:\r\n\r Antidromic evaluation of the superficial peroneal nerve sensory potential (SPSP) at the\r ankle was studied with surface stimulating and recording electrodes on the affected limb\r and the contralateral limb in all subjects. The site of stimulation was just anterior to\r the edge of the shaft of the fibula and 14 cm proximal to the active ankle electrode.\r The active recording electrode was placed midway between the edge of the tibia and the\r tip of the lateral malleolus or 3 cm proximal to the bimalleolar line. The reference\r recording electrode was placed 3 cm distal to the active electrode.\r\n\r SPSP was considered affected when any one of the following is detected :\r\n\r - No constant wave forms could be detected.\r\n\r - SPSP amplitudes < 5 μv or < 50% of the contra lateral side.\r\n\r - Increased peak latency ≥ 4.4 ms (based on standard distance of 14 cm).\r\n\r C-Electromyographic study (EMG) was carried out using concentric needle in the following\r muscles: extensor digitorum brevis (EDB), tibialis anterior, peroneus longus, tibialis\r posterior, extensor halucis longus, short head of biceps femoris, vastus lateralis,\r medial head of gastrocnemius, iliacus, gluteus medius, tensor fascia lata and Paraspinal\r muscles. Concentric needle EMG was performed in all patients. Spontaneous and voluntary\r motor unit activity was assessed.\r\n\r 5. Radiological examination:\r\n\r A) Ultrasonographic assessment of participants:\r\n\r Ultrasonographic examination by radiologist was conducted with a General Electric Logiq 7 Pro\r machine (GE Healthcare, Chalfont St Giles, England), using a 5- to 12-MHz linear array\r transducer. The cross sectional area (CSA) of the common peroneal nerve was determined within\r the echogenic rim surrounding the nerve at the level of the fibular neck with the probe\r perpendicular to the main nerve course in the transverse and longitudinal plane. The\r sonographic measurements were done on the same day or within 1 week after the\r electrodiagnostic studies.\r\n\r The radiologist was blinded to the participants' electrophysiological study data. However,\r the radiologist was aware of the clinical and electrophysiological suspicion for common\r peroneal neuropathy.\r\n\r Authors of the present study considered that common peroneal nerve is affected by the\r sonographic measurements if the value of CSA of the common peroneal nerve at the fibular neck\r was >11 mm2 according to the study control group.\r\n\r B) Plain radiographs were done to detect the underlying traumatic injuries, such as a\r proximal fibular head fracture or osseous tumors, or in assessing the severity of angular\r deformities about the knee. Lumbosacral plain X ray or MRI were done only if needed to rule\r lumbosacral affection.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants were eligible for inclusion in the study if they had clinical and motor\r electrophysiological evidence suggesting common peroneal mononeuropathy at the fibular\r neck\r\n\r Clinical evidence of common peroneal mononeuropathy at the fibular neck:\r\n\r - Numbness of the antero lateral aspect of the lower limb from about midway between the\r knee and the ankle, most of the dorsal aspect of the foot and toes and the web space\r between the first and second toes.\r\n\r - Weakness of the leg muscles innervated by the peroneal nerve. The strength of the\r tibialis anterior (TA), extensor hallucislongus (EHL), and peroneius longus muscles\r was tested using the Medical Research Council (MRC) rating scale.\r\n\r Electrophysiological Motor localizing evidence of common peroneal mononeuropathy at the\r fibular neck:\r\n\r Peroneal motor nerve conduction velocity decrement ≥10 m/s across the fibular neck segment;\r or focal conduction block, defined as compound motor action potential (CMAP) amplitude and\r area reduction ≥ 50% across the fibular neck segment.\r\n\r Exclusion Criteria:\r\n\r - Participants were excluded if any of the following was detected:\r\n\r - Historical or clinical signs suggesting coexisting neurological conditions (e.g.\r polyneuropathy and motor neuropathy).\r\n\r - Foot drop with symptoms, signs or radiological findings of L5 radiculopathy in\r association with CPN.\r\n\r - Symptoms or signs suggesting systemic clinical illness like diabetes mellitus,\r renal failure, and hepatic failure.\r\n\r - Previous surgery for peroneal nerve.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy of Acupuncture for Lumbar Spinal Stenosis\n\n**Clinical Trial Summary:**\n\nDegenerative lumbar spinal stenosis (DLSS) is a condition which there is narrowing space of\r sagittal diameter of spinal canal or nerve root canal for spinal nerve or cauda equina\r secondary to degenerative changes. DLSS is a common cause of gluteal or lower extremity pain,\r women and elderly people aged 60-70 are more likely to have DLSS. The early symptoms of this\r disease are soreness and pain in the low back, gluteal region and posterior region of thighs\r which can be relieved after resting or changing posture. Being accompanied with gradually\r aggravated symptoms, patients with DLSS may have neurogenic claudication with hypoesthesia\r and numbness in lateral lower legs and feet, additionally, few patients may have bowel and\r bladder disturbances. In accordance of the guidelines of North American Spine Society (NASS),\r treatment options comprise surgical therapy, epidural steroid injections and physical therapy\r and transcutaneous electrical stimulation, however, the long-term efficacy of surgery is not\r superior to that of non-surgical therapy. Moreover, the short-term efficacy of non-surgical\r therapy is with insufficient evidence. According to a systematic review and recent studies,\r acupuncture may improve the symptoms of patients and their quality of life, however, there is\r a lack of placebo-controlled and large sample sized study.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Meet the requirements for a clinical diagnosis of DLSS combined with a MRI- or\r computed tomography (CT)-based radiological diagnosis of central sagittal diameter\r stenosis of the lumbar spinal canal;\r\n\r - Have neurogenic intermittent claudication (IC) characterized by progressive pain,\r numbness, weakness, and tingling of the buttocks and/or legs when standing or walking\r or with extension of the back, which are relieved upon sitting, lying down, or bending\r forward [22]; they must always walk in flexion or hunchback posture;\r\n\r - Have pain of an intensity ≥4 in the buttocks and/or legs when walking, standing, or\r extending the back, as measured using the Numerical Rating Scale (NRS);\r\n\r - Have pain in the buttock and/or leg that is more severe than their pain in the lower\r back;\r\n\r - Have a Roland-Morris score of at least 7;\r\n\r - Have received a MRI or CT scan within 1 year that showed the anterior posterior\r diameter of the canal was ≤12 mm;\r\n\r - Are aged 50-80 years;\r\n\r - Have provided signed consent and exhibit willingness to participate in the trial.\r\n\r Exclusion Criteria:\r\n\r - Congenital stenosis of the vertebral canal, indications of surgery for DLSS (e.g.,\r segmental muscular atrophy, bowel and bladder disturbances), spinal instability\r requiring surgery, lumbar tuberculosis, lumbar metastatic carcinoma, or vertebral\r body/vertebral stenosis segment compression fracture;\r\n\r - Severe vascular, pulmonary, or coronary artery disease with limited lower extremities\r motility;\r\n\r - Clinical comorbidities that could interfere with the collection of data related to\r pain and walking function such as fibromyalgia, chronic widespread pain, amputation,\r stroke, Parkinson's disease, spinal cord injury, and dementia;\r\n\r - Cognitive impairment, such that they are unable to understand the content of the\r assessment scales or provide accurate data;\r\n\r - A history of lumbar surgery;\r\n\r - Plans to become pregnant within 12 months or are already pregnant;\r\n\r - Received acupuncture treatments for DLSS within the previous 30 days;\r\n\r - Neurogenic IC mainly manifesting as numbness, weakness, or paraesthesia of the lower\r extremities instead of pain.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSafety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome\n\n**Clinical Trial Summary:**\n\nInterventional study to evaluate efficacy and safety of an active splint.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female patients, above 40 years of age.\r\n\r - Able to understand and sign informed consent\r\n\r - Pain associated with mild to moderate carpal tunnel syndrome in a single wrist\r\n\r - Numbness and tingling in the median nerve distribution\r\n\r - Nocturnal Numbness\r\n\r - Weakness and/or atrophy of the thenar musculature\r\n\r - Demonstrate positive Phalen's Test of the affected extremity\r\n\r - Demonstrate positive Tinel's Test of the affected extremity\r\n\r - Sensory impairment defined as a loss of 2-point discrimination\r\n\r - Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome\r\n\r Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome\r\n\r - History of surgical carpal tunnel release\r\n\r - Pregnancy\r\n\r - Diabetes not controlled by medication\r\n\r - Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy\r\n\r - Thoracic outlet syndrome\r\n\r - Compromised skin integrity\r\n\r - Past history of traumatic event, surgery, or congenital impairment of the forearm,\r wrist, or hand\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nConnected Catheter- Safety and Effectiveness Study\n\n**Clinical Trial Summary:**\n\nThe Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed\r for improved bladder management in males with urinary retention disorders requiring\r catheterization. It is a sterile, extended-use device that resides fully internally to the\r male lower urinary tract for an intended use life of up to 7 days per catheter.\n\n**Clinical Trial Detailed Description:**\n\nSpinal Singularity has developed the Connected Catheter System to address several drawbacks\r of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis\r designed for improved bladder management in males with urinary retention disorders requiring\r catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This\r includes five device exchange appointments. The appointments are spaced 7 days apart and at\r each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up\r will occur for 14 days following the final appointment after the subject discontinues use of\r study device and reverts to his original catheter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Males age ≥ 18 with clinical diagnosis of significant urinary retention\r\n\r 2. Must be clinically suitable and capable of safely managing bladder using an\r intermittent voiding or indwelling strategy\r\n\r Must have stable urinary management history as determined by the Investigator\r\n\r OR:\r\n\r Must have urodynamic profile suitable for the Gen 2 Connected Catheter (including\r bladder capacity > 200mL without uninhibited bladder contractions)\r\n\r 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the\r Gen 2 Connected Catheter device, as specified in the Investigational Device\r Instructions for use (IFU)\r\n\r Exclusion Criteria:\r\n\r 1. Active symptomatic urinary tract infection (UTI), as defined in this protocol\r (subjects may receive the device after UTI has been treated)\r\n\r 2. Significant risk profile or recent history of urethral stricture (e.g. stricture\r within past 90 days)\r\n\r 3. Significant risk profile or recent history of clinically significant (uncontrolled)\r autonomic dysreflexia (AD)\r\n\r 4. Significant intermittent urinary incontinence (between catheterizations)\r\n\r 5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably\r controlled with medication or alternate therapy (e.g. Botox injections)\r\n\r 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower\r urinary tract or bladder (assessed during in-depth medical screening, including\r cystoscopy and urine analysis)\r\n\r 1. Urinary tract inflammation or neoplasm\r\n\r 2. Urinary fistula\r\n\r 3. Bladder diverticulum (outpouching) > 5cm in size\r\n\r 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past\r 6 months)\r\n\r 5. Impaired kidney function or renal failure\r\n\r 6. Active gross hematuria\r\n\r 7. Active urethritis\r\n\r 8. Bladder stones\r\n\r 7. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted\r drug pump) or external device\r\n\r 8. Any unsuitable comorbidities as determined by the investigator or complications\r related to use of certain medications\r\n\r 9. Any physical or cognitive impairments that diminish the subject's ability to follow\r directions or otherwise safely use the Connected Catheter System\r\n\r 10. Catheter Assessment Tool screening yields unacceptable results\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPilot Study Using Amide Proton Transfer Magnetic Resonance Imaging Distinguishing Glioma\n\n**Clinical Trial Summary:**\n\nThis research is being done to study the pattern of changes in various parts of the magnetic\r resonance imaging (MRI) studies that patients have done to help plan their radiation therapy\r and to evaluate the effects of therapy.\r\n\r The MRI of the brain is one of the major ways a participant's doctors determine how to treat\r a participant's tumor and if the participant's tumor is growing or not. In this study the\r investigators want to learn if new sequences added to the MRI that the investigators are\r already getting to guide partipants' radiation treatment can be analyzed to help make better\r treatment decisions. MRI sequences that examine the composition and structure of the tissues\r in the brain in a different way will be obtained. These are called called Amide Proton\r Transfer (APT) and Diffusion Weighted MRI.\r\n\r These scans will first be performed at the time of participants' radiation plannings scan\r done before treatment and near the end of the course of radiation treatments. This will allow\r the study team to investigate if there are changes in these sequences before radiation\r treatment and to see if using these MRI studies will allow us to better plan radiation\r treatments for patients in the future. This pre-treatment scan will be done at the same time\r as participants' standard radiation planning MRI, but will cause the scan to take longer.\r Participants will also have an extra MRI during one of the last 5 days of the planned 28-33\r radiation treatments that are standardly used. This additional scan will not include\r administration of injected contrast agents, and would occur on a day when participants are\r also coming in for radiation. This scan will be compared with the first scan. The\r investigators will determine whether these changes may predict later long term outcome of\r treatment for patients. Patients who enroll in this study will get all of the standard\r therapy they would get for their tumor whether or not they participate in this study. There\r is no extra or different therapy given.\r\n\r The investigators anticipate that the radiation treatment volumes created using APT will\r largely overlap with the conventional plan but will be distinct at the margins. Disease\r failure is more likely to occur in areas with APT abnormalities suggestive of active tumor.\r In patients that have failure outside the contrast enhancing area, the region of failure will\r be predicted by regions of increased APT activity. Current MRI sequences do not allow for\r prediction of regions of recurrence or progression, or distinguish between tumor, pressure,\r or surgical injury as the cause of FLAIR/T2 abnormalities. Disease failure is more likely to\r occur in areas with APT abnormalities suggestive of active tumor. In patients that have\r failure outside the contrast enhancing area, the region of failure will be predicted by\r regions of increased APT activity. Current MRI sequences do not allow for prediction of\r regions of recurrence or progression, or distinguish between tumor, pressure, or surgical\r injury as the cause of FLAIR/T2 abnormalities. Volume containing elevated APT signal may be\r associated with outcome (survival). In an exploratory analysis, the investigators will\r evaluate whether there are characteristic patterns that should be prospectively studied in a\r larger trial.\n\n**Clinical Trial Detailed Description:**\n\nCurrently, all brain tumors are routinely evaluated using gadolinium contrast-enhanced\r (Gd-CE) MRI, in combination with T2-weighted or fluid-attenuated inversion recovery (FLAIR)\r MRI, which are used to determine the extent of tumor involvement to guide treatments, and to\r assess therapeutic response. However, Gd-CE only depicts disruption of the blood brain\r barrier and is not specific for tumor activity. Therefore, standard MRI may not be optimal in\r defining the true extent of tumor, defining as abnormal areas that may contain only edema\r related to mass effect or surgery and miss tumor extensions that do not sufficiently disrupt\r the blood-brain-barrier. In addition, in the setting of radiation therapy which also disrupts\r the blood brain barrier, it does not serve as an early marker of tumor response.\r\n\r The primary goal of the current observational study is to explore whether Amide Proton\r Transfer (APT) imaging can better determine the extent of tumor involvement. APT signal is\r created by mobile cytoplasmic proteins, which are increased in malignant brain tumors and\r have been found in preclinical and clinical studies to be associated with a high APT weighted\r signal in glioma. Such imaging may provide information that may improve the ability of MR\r imaging to guide targeting of radiotherapy. In particular, it may (1) detect tumor bearing\r brain that is not contrast enhancing on the standard brain MRI scan for patients with high\r grade glioma and/or (2) fail to confirm tumor in areas of brain identified as abnormal on\r standard MRI. The investigators will also explore patterns of disease failure in patients\r with malignant gliomas to validate the observations, and whether such imaging may predict\r outcome.\r\n\r Similar questions may be important in the therapy of low grade glioma, and an exploratory\r informational cohort of patients with this less common diagnosis will be accrued during the\r study period to inform decisions about whether further study is desirable.\r\n\r A second APT image will be obtained during the final week of treatment for enrolled patients\r to determine whether changes in APT signal occur, and whether there is evidence that this may\r be prognostic for treatment success or failure when correlated with progression free survival\r and survival outcome. Currently, there is no imaging method to assess tumor response and\r predict outcome within the first several months as a result of the confounding effect of\r radiation on both the tumor and surrounding brain. In addition, standard brief apparent\r diffusion coefficient (ADC) MRI sequences will be performed as part of the pretreatment\r imaging and the end of treatment scan as an additional potential early imaging biomarker that\r may be a part of multiparametric assessment of response to radiotherapy as identified in\r preclinical studies performed at Johns Hopkins.\r\n\r These first steps may form the basis for possible future studies to assess new approaches to\r radiation planning for patients with brain cancer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Pathologically Confirmed Glioma after completion of planned biopsy or resection.\r\n\r High grade glioma histologies:\r\n\r - Glioblastoma\r\n\r - High Grade or Malignant Glioma\r\n\r - Anaplastic Astrocytoma\r\n\r - Anaplastic Oligodendroglioma\r\n\r - Gliosarcoma\r\n\r - Mixture of any of the above histologies Low Grade Histologies\r\n\r - Astrocytoma\r\n\r - Grade II or low grade glioma\r\n\r - Oligodendroglioma\r\n\r - Mixtures of the above histologies\r\n\r 2. Plan to undergo external radiation treatment as part of therapy\r\n\r 3. No prior therapeutic cranial radiotherapy\r\n\r 4. Can safely perform clinically indicated MRI (no contraindications to MRI with\r Gadolinium) as determined by the standard Johns Hopkins Radiation Oncology screening\r procedures,\r\n\r Exclusion Criteria:\r\n\r 1. Patients who cannot undergo MRIs.\r\n\r 2. Patients who are allergic to gadolinium based contrast agent\r\n\r 3. Patients who have cardiac pacemaker or other electronic or metal implant\r\n\r 4. Patients who have chronic kidney disease judged sufficient to exclude them from the\r clinically indicated contrast enhanced MRI.\r\n\r 5. Female patients who is pregnant\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nImpact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention (POUR)\n\n**Clinical Trial Summary:**\n\nA prospective randomized control trial will be conducted at Good Samaritan Hospital and\r TriHealth Evendale Hospital. Subjects will receive total hip or knee surgery and follow-up\r via standard care at the discretion of the treating physician or the experimental study arm\r in which all patients will undergo the integrated care pathway.\n\n**Clinical Trial Detailed Description:**\n\nPatients will be randomized to the control group or the experimental group. Patients in the\r control group will receive the treating physician's standard of care, and undergo bladder\r scans in the post anesthesia care unit (PACU), upon admission to the unit, and prior to\r discharge from the hospital. Patients in the experimental group will undergo a multimodal\r pain control care pathway that minimizes opioid consumption.\r\n\r The primary endpoint will be the presence of or absence of post-operative urinary retention\r (POUR) between discharge from the PACU and prior to discharge from the hospital. POUR will be\r defined as bladder volume of greater than 500cc and the inability to void for at least 2\r hours within the first 24 hours. POUR, once identified will be treated with intermittent\r straight catheterization (ISC). Secondary endpoints will include opioid consumption (in\r morphine milligram equivalents; MME), genito-urinary consultation, type (knee or hip) and\r duration of surgery, type of anesthesia, duration of anesthesia, total amount of IV fluids,\r blood loss, length of hospital stay (LOS), discharge status (home with early outpatient\r physical therapy, etc.), time of first spontaneous voiding, and the number of ISCs and any\r necessary indwelling catheterization and adverse events of interest including POUR,\r post-operative nausea and vomiting (PONV), severe pain of 7 or greater on the numeric rating\r scale(NRS), blood loss requiring transfusion, and lower urinary tract symptoms (LUTS).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - ASA grade I- III\r\n\r - BMI under 36 kg/m^2\r\n\r - Scheduled surgery for primary total hip or knee replacement\r\n\r - Age 18+ years\r\n\r Exclusion Criteria:\r\n\r - Contraindications or failure of neuraxial anesthesia\r\n\r - Patients must not be outpatient total hip or knee procedure\r\n\r - Known intercurrent UTI, incontinence, or urinary retention not addressed by\r pre-operative urologic consultation and correction\r\n\r - Pregnancy\r\n\r - Current nicotine, alcohol or drug abusers\r\n\r - Pre-operative narcotic use (any narcotic consumption within 3 days prior to surgery)\r\n\r - Post- operative parenteral narcotic administration\r\n\r - Allergy or intolerance to liposomal bupivacaine, bupivacaine, celecoxib, dexamethasone\r and/or pregabalin\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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335
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Neurofeedback Treatment for Chronic Musculoskeletal Pain\n\n**Clinical Trial Summary:**\n\nThis study evaluates the effects of a novel neurofeedback treatment on pain specific\r brainwaves in adults.\r\n\r Chronic pain patients enrolled in this study will be randomized into a treatment group and a\r sham group.\n\n**Clinical Trial Detailed Description:**\n\nRecent research has underlined that central nervous system structures play a key role in the\r development of pain with significant maladaptive plasticity occurring in several brain areas.\r Non-pharmacological treatments, such as neurofeedback, are designed to restore normal brain\r function alongside with relieving pain symptoms. With a neurofeedback approach, the patient\r is provided with a feedback on specific brain waves recorded using non-invasive recording\r techniques (electroencephalography - EEG) and visualized on a screen.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients suffering from chronic pain due to tennis elbow for at least 3 months\r\n\r - A clinical diagnosis of chronic lateral epicondylalgia,\r\n\r - Pain associated with functional activities such as gripping and pain with resisted\r contraction of the wrist extensors or extensor carpi radialis brevis, or with passive\r stretching of the wrist extensors.\r\n\r Exclusion Criteria:\r\n\r - Clinical diagnosis of chronic lateral epicondylalgia on both sides, cervicothoracic\r spinal pathology, other upper limb musculoskeletal disorders or neurological disorders\r\n\r - Pregnancy\r\n\r - Drug addiction defined as the use of cannabis, opioids or other drugs\r\n\r - Previous or current neurologic, musculoskeletal or mental illnesses defined as an\r on-going systemic condition\r\n\r - Lack of ability to cooperate\r\n\r - Current use of medications that may affect the trial e.g. analgesics, anti-\r inflammatory drugs\r\n\r - Consumption of alcohol, caffeine, nicotine or painkillers throughout the study period\r\n\r - Past history of chronic pain, neurological or psychiatric conditions\r\n\r - Participation in other pain trials throughout the study period and one month prior to\r participation\r\n\r - Participation in more than two sessions of muscle training exercises per week\r involving the upper limb and/or lower back\r\n\r - Evidence of other sources of elbow pain such as exacerbation of pain with neck\r movement or manual examination\r\n\r - Sensory disturbances\r\n\r - History of fractures\r\n\r - Elbow surgery\r\n\r - Contraindications to the use of TMS\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBlood Pressure-Improving Control Among Alaska Native People\" (BP-ICAN)\n\n**Clinical Trial Summary:**\n\nThe investigators have designed a group randomized, multi-level, sustainable stroke and\r cardiovascular disease (CVD) prevention trial - \"Blood Pressure: Improving Control among\r Alaska Native People\" (BP-ICAN) - that targets blood pressure control among Alaska Native and\r American Indian people diagnosed with hypertension. Washington State University will assist\r with design, provides general scientific and clinical consulting, and will help guide\r implementation and conduct statistical analyses. The purpose of the study is to see if\r monitoring blood pressure at home improves the management of hypertension.\r\n\r Participants will include adults who have a diagnosis of hypertension and have not achieved\r blood pressure control. This study will include both a control arm (treatment as usual) and\r an intervention arm. Primary Care Center (PCC) provider teams and associated panels of Alaska\r Native or American Indian (ANAI) adults will be randomized into the control or intervention\r arm. The investigators will recruit up to 10 ANAI adults per PCC provider for a total of 324\r participants.\r\n\r Intervention participants will receive a home blood pressure monitor (HBPM), upload personal\r home blood pressure values into a data mall, and be encouraged to communicate with providers\r and pharmacists about HBPM results using an online electronic health record application,\r telephone, or other existing clinical processes. HBPM measurements for each intervention arm\r participant will be provided to provider teams and integrated pharmacists. Control\r participants will receive care as usual.\r\n\r The investigators will collect data from study participants in both the intervention and\r control arms over a 12 month period. Participants will meet with investigators at time of\r consent (baseline), and 3, 6, and 12 months after baseline. At each visit, participants will\r have blood pressure measured using 3 methods (aneroid sphygmomanometer, automated Omron upper\r arm cuff device, and automated Omron wrist cuff device), complete surveys, and have height,\r weight, and arm circumference measured. Clinical and service utilization information will be\r electronically queried with participant consent.\r\n\r The investigators will examine whether participants in the intervention arm have better blood\r pressure control at the end of the 12 month period than participants in the control arm.\n\n**Clinical Trial Detailed Description:**\n\nBackground:\r\n\r Cardiovascular disease (CVD) and stroke have become leading causes of mortality among ANAI\r people, who experience CVD disparities in incidence, risk factors, and mortality, especially\r for stroke, compared to the general population. From 1994-2003 stroke mortality in ANAIs was\r at least 25% higher than for Whites in Alaska. Over the same period, stroke mortality for\r ANAIs under age 45 increased 400%, but declined in Whites. In addition, the decline in\r age-adjusted CVD mortality observed in recent decades within the general population does not\r extend to ANAIs. Controlling hypertension is a pillar of prevention for CVD and stroke.\r\n\r Although ANAIs were formerly thought to have a very low prevalence of stroke and CVD, more\r reliable newer data indicate high levels of hypertension and associated mortality. A recent\r systematic review of 141 publications on hypertension in ANAI people documented a significant\r increase in recorded prevalence over the past 3 decades, as well as a significantly higher\r prevalence in ANAI adults than in reference populations, usually White. Aggregated data from\r the Behavioral Risk Factor Surveillance System (BRFSS) also show a higher prevalence of\r self-reported hypertension in ANAIs than in non-Hispanic Whites (27% vs. 22%). The National\r Health Interview Survey found a similar disparity of 35% vs 26% in ANAIs vs. Whites. As in\r non-Hispanic Whites, 61% of ANAIs with hypertension were taking anti-hypertensive medication.\r In a previous study, an investigator on the present proposal examined the health records of\r 524 ANAI elders, finding that 23% had undiagnosed hypertension, and 38% had diagnosed\r hypertension. Of those with diagnoses, 81% were taking medication, 37% had well-controlled\r blood pressure (BP), and lifestyle counseling was rare.\r\n\r Ongoing management of high BP often requires healthcare providers to initiate or intensify\r therapy in response to uncontrolled high BP. A recent review concluded that the\r patient/provider relationship, patient/provider communication, and patient-centered decision\r making were essential to appropriate decisions on medication change. Another study using\r electronic health record (EHR) data on military veterans found that ~60% of patients with\r hypertension had poorly controlled systolic BP, yet less than half of clinicians made\r medication changes after a computer-generated notification.\r\n\r Improving BP control requires the involvement not only of individuals but of healthcare\r systems and social environments. Communications must extend care to patients \"where patients\r are\" outside the clinic; facilitate BP self-management; and minimize barriers to care AN/AIs\r face in healthcare access. Across Alaska, 60% of residents are medically underserved, and in\r 75% of Alaskan communities, regardless of residents' race, comprehensive healthcare services\r are accessible only by air or water. Even in urban areas, health disparities among AN/AIs\r persist, and access to care is affected by factors such as lack of transportation.\r\n\r CVD morbidity, mortality, and organ damage are more accurately predicted by home blood\r pressure monitoring (HBPM) than by in-office measurements. HBPM avoids over-treating sporadic\r high BP readings and \"white coat\" hypertension while facilitating control of both resistant\r and \"masked\" hypertension (high at home and normal in the clinic), which are associated with\r stroke. Compared to usual care or HBPM alone, HBPM combined with self-titration of\r medications or with physician, pharmacist, or nurse management leads to better use of\r medications and BP control. Research shows the value of using HBPM values to trigger\r modifications in anti-hypertensive regimens, and the addition of provider feedback, patient\r and provider education, and decision-making support to encourage treatment adjustments\r improves control even more. HBPM can support patient decision making, provide data to\r providers, facilitate patient/provider communication, and engage, educate, and empower\r patients. HBPM devices are widely accepted by patients, who prefer them to clinic-based\r measurements. HBPM interventions appear to be most effective in patients with less\r well-controlled BP at baseline. Therefore, tailored HBPM interventions have been developed\r for minorities, who may receive more benefit from HBPM than Whites.\r\n\r Significance:\r\n\r BP-ICAN is innovative in many ways. First, it will be the only rigorous, population-based\r study about BP control for prevention of CVD and stroke in ANs, and one of very few\r multilevel interventions in any minority population. Second, the South Central Foundation\r (SCF) service area includes rural, suburban, and urban locations. Third, the intervention\r design addresses therapeutic inertia, a well-recognized barrier to hypertension control that\r is often neglected in clinical trials, so the approach to improve self-efficacy and ownership\r should lead to more timely communication with providers and titration of medications.\r\n\r The investigators will conduct a group-randomized trial for improving BP control among ANAI\r adults with diagnosed hypertension (Figure 2). Study group assignment will occur by\r randomizing all SCF primary care panels to the BP-ICAN or usual care control arms; adults\r with uncontrolled hypertension will be nested within groups defined by panel, which\r corresponds to one provider. For each panel, investigators will recruit up to 10 ANAI adults\r (expecting average of 8-9 per provider, for a total n = 324) who have had systolic BP ≥ 130\r mmHg measured at one or more clinic visits in the past 18 months OR who have previously\r diagnosed hypertension and systolic BP ≥ 130 mmHg measured at the study screening visit. The\r study period for all participants will last 12 months.\r\n\r Participants who are randomized to the BP-ICAN arm will receive education about BP control,\r CVD and stroke and the importance of hypertension management for prevention, other lifestyle\r changes that can prevent or reduce morbidity from hypertension, and educational materials\r about the importance of timely response to uncontrolled hypertension. BP-ICAN arm\r participants will also receive HBPM equipment (Omron device) and training in its use,\r interpretation of results, and assistance with communicating high BP values to healthcare\r providers. Lastly, participants will receive culturally tailored text messages to reinforce\r the educational material and motivate adherence to HBPM and provider communication\r strategies. Participants whose providers have been randomized to the control condition will\r continue to receive care as usual.\r\n\r Patient-initiated communication about uncontrolled BP will serve as one component of the\r provider-level intervention. Participants will be trained to sync HBPM and smart phone to\r automatically upload BP measurements into a data repository using Omron's free wellness\r application. This will update the participant's data on Omron's Wellness Application website.\r Investigators plan to use a cloud-based technology platform to serve as a data repository and\r are working with tribal leadership, institutional privacy officers, compliance officers, and\r providers on how data will displayed and stored within the health care system. The goal is to\r make aggregate BP measure data available to providers in either a personal health record\r (PHR) and/or health information exchange (HIE) that allows for transmission of select\r measures into the electronic health and or population health record. Note that this protocol\r was developed based on extensive collaboration with SCF providers.\r\n\r At the individual level, the primary outcome is within-person change in systolic BP.\r Secondary outcomes are diastolic BP, anti-hypertensive medication use and adherence, physical\r activity, weight, and tobacco use. Individual-level outcomes will be measured at baseline, 3\r months, 6 months, and 1 year post-baseline. At the provider level, the primary outcome is\r change in prescribing behavior for medication and other relevant lifestyle changes. At the\r systems level, the primary outcome is change in systolic BP for all adults with hypertension\r whose providers are randomized to the BP-ICAN arm vs. the care as usual arm, regardless of\r whether the adults were directly enrolled into the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. At least one visit to SCF providers or Community Health Aides within the previous year\r\n\r 2. Alaska Native or American Indian\r\n\r 3. At least 18 years old\r\n\r 4. Hypertension diagnosis based on International Classification of Disease (ICD) version\r 9 and/or ICD version10 codes\r\n\r 5. Systolic BP ≥ 130 mmHg recorded at 1 or more clinic visits in the past 18 months, OR\r systolic BP ≥ 130 mmHg at the study screening visit\r\n\r 6. Ability to provide informed consent\r\n\r 7. Willingness and ability to use a HBPM\r\n\r 8. Willingness to complete the necessary data collection procedures, including\r transmission of BP measurements and permission for study staff to access EHR and/or\r PHR data.\r\n\r Exclusion Criteria:\r\n\r 1. Currently pregnant\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nVirtual Environment Rehabilitation for Patients With Motor Neglect Trial\n\n**Clinical Trial Summary:**\n\nMotor neglect describes a loss of function without a loss of strength, reflexes or sensation.\r Motor neglect has been described in patients with traumatic brain injury, stroke and chronic\r pain conditions, e.g. complex regional pain syndrome. These conditions affect hundreds of\r thousands of patients in the UK each year and motor neglect is a significant obstacle in\r their rehabilitation towards a good outcome. By focussing on improving motor neglect,\r outcomes including function and quality of life for these groups of patients may\r significantly improve.\r\n\r Motor neglect is potentially reversible. Rehabilitation using repetition, feedback and\r motivation are beneficial for optimal outcome. Current protocols use face-to-face physical\r therapies which can not optimise intensity due to a lack of resources. Furthermore,\r engagement with exercise is recognised to be poor, in part, due to a lack of attention.\r Innovative technologies may well improve engagement. Furthermore, telemedicine, or remote\r delivery of healthcare, offer opportunities in resource management, which can be delivered\r through the use of such innovative technologies.\r\n\r Virtual reality systems have been designed and utilised in rehabilitation in various\r conditions, e.g post-stroke, cerebral palsy and Parkinson's disease. Studies demonstrate\r improved function in both upper and lower limbs. Potentially more effective treatments for\r motor neglect utilising such technology are therefore available but need more formal\r evaluation.\r\n\r This protocol describes a Phase II randomised controlled trial for both in-patients and\r out-patients requiring rehabilitation with motor neglect from neurological causes (stroke,\r traumatic brain injury) and chronic pain conditions (Complex Regional Pain Syndromes, chronic\r low back pain and referred leg pain (sciatica)). The intervention will be a novel interactive\r virtual reality system using established technology and tailored software used in conjunction\r with a treadmill. The control group will be the same screen showing random static images\r whilst on the treadmill. Rehabilitation for each group will be offered in 3-4 sessions per\r week for 2 weeks. Each session will last about 30 minutes supervised by a physiotherapist.\r Follow-up will be by questionnaire at weeks 2, 6 and 12 and by face-to-face consultation at\r weeks 2 and 12.\n\n**Clinical Trial Detailed Description:**\n\nTo investigate whether a virtual reality biofeedback system in conjunction with a treadmill\r is safe and feasible for the rehabilitation of patients with motor neglect due to chronic\r pain conditions, traumatic brain injury and stroke compared to a control group of patients\r with these conditions whose rehabilitation consists of a non-virtual reality screen and\r treadmill.\r\n\r To investigate whether a virtual reality biofeedback system in conjunction with a treadmill\r can improve outcome such as distance walked, pain, function, emotional well being and\r activity.\r\n\r Study Design Randomised single-blind controlled trial\r\n\r Setting The study will take place as part of the normal rehabilitation programmes at the\r single centre of Addenbrookes's Hospital, Cambridge University Hospitals NHS Foundation\r Trust. The treadmill gait task will be undertaken in the Clinical Movement Laboratory in\r Clinic 9 (Orthotics and Prosthetics Department).\r\n\r Study population Subjects will be recruited from patients attending in-patient and\r out-patient rehabilitation programmes for chronic pain conditions or neurological conditions.\r Suitable candidates will be identified by the consultants or therapists involved in the\r programme. With consent, potential subjects will be referred to the researchers for\r screening.\r\n\r Inclusion criteria\r\n\r - Patients with a diagnosis of stroke (of any cause), traumatic brain injury or a chronic\r pain condition of more than 3 months duration (e.g. back and referred leg pain; complex\r regional pain syndrome; fibromyalgia) who are undergoing an inpatient or out-patient\r rehabilitation programme\r\n\r - Motor neglect as assessed by standard clinical examination by a physiotherapist trained\r to detect such motor neglect. This is defined as weakness and functional impairment\r without a loss of strength, reflexes or sensation.\r\n\r Exclusion criteria\r\n\r - Patients with active serious medical problems that might affect their ability to\r participate in the exercise protocol (e.g. ongoing sepsis; recent myocardial infarction)\r\n\r - Patients who are unable to use treadmill safely as judged by the screening\r physiotherapist.\r\n\r - Patients who are unable to give informed consent, either through issues relating to\r competency or to language.\r\n\r - Patients with significant previous experience of virtual reality rehabilitation.\r\n\r Sample size This will be calculated using standard models. It is unknown what the effect size\r will be. Alpha will be 0.05, Beta will be 0.2. It is likely that at least 20 patients will\r need to be recruited in each arm (40 in total). Estimating the likely recruitment target from\r the numbers of patients requiring inpatients rehabilitation at Addenbrooke's (n=400 per annum\r for stroke, traumatic brain injury, back pain and Complex Regional Pain Syndrome), this would\r require a 12-month window of recruitment, assuming approximately 10% successful enrolment\r (n=40).\r\n\r Withdrawal criteria Patients who wish to withdraw will be allowed to do so with out this\r affecting their rehabilitation.\r\n\r Randomisation Subjects will be randomised to either the study or control group using a\r concealed blind allocation. This will be performed by a group independent from the trial.\r\n\r Subjects will be allocated to the study:control groups on a 1:1 ratio using a random number\r generator (e.g. www.mathgoodies.com/calculators/random_no_custom.html) to determine the order\r of the couplets.\r\n\r The exception will be applied to the groups who are successfully screened (e.g. Back Pain\r Programme). For this purpose, the entire group will be randomised to either receiving control\r or intervention due to cross-contamination of the treatment effect within a single group\r receiving otherwise identical rehabilitation.\r\n\r Blinding Patients and therapists can not be blinded due to the nature of the research. Data\r analysis will be conducted by members of the trial research group who are blinded to whether\r an individual patient received the experimental or control arm. This will be achieved by the\r use of data stripped of any patient identifiable content and divided into the two groups.\r This task will be performed by the senior physiotherapist supervising the project. There\r should be no necessity to 'unblind' subjects from the study due to the lack of any clear\r serious side effects associated with the intervention.\r\n\r Intervention Patients will be randomly assigned to one of two groups: intervention or\r control.\r\n\r Both groups will walk on a treadmill as part of the task. Walking on the treadmill will be\r explained and demonstrated, and the subjects will have time to practice this task before this\r study commences. For extra safety, the subjects will be allowed to use the handlebars of the\r treadmill for extra support if they wish. The therapy assistant will stand next to the\r Emergency stop button and is fully trained in the use of the treadmill and Virtual\r Environment device.\r\n\r In both groups the walking cycles will be determined by their functional ability as assessed\r by the screening physiotherapist but the treadmill walking will not be longer than 5 minutes\r at each cycle. Every 30 seconds, the therapy assistant will ask whether the subject would\r like to change the speed of the treadmill and will make a decision based on his experience as\r to whether to increase the treadmill by 0.1 km/h or reduce / stop the treadmill as necessary.\r The next cycle will start at the speed at which the previous cycle finished. The next day's\r session will commence at baseline speed and increase or decrease as above. The subject will\r be required to complete five walking cycles and will have up to a 3 minute break between each\r cycle. The primary outcome will be the distance walked in the final 5-minute cycle of the\r session at Baseline, week 2 and at 24 weeks. This task will be performed 3 to 4 times per\r week for two weeks. The speed of each cycle will be set back to baseline for each day.\r\n\r Intervention group:\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with a diagnosis of stroke (of any cause), traumatic brain injury or chronic\r pain condition of more than 3 months duration (e.g. back and referred leg pain;\r complex regional pain syndrome; fibromyalgia) who are undergoing an inpatient or\r out-patient rehabilitation programme\r\n\r - Motor neglect as assessed by standard clinical examination by a physiotherapist\r trained to detect such motor neglect (EV). This is defined as weakness and functional\r impairment without a loss of strength, reflexes or sensation.\r\n\r Exclusion Criteria:\r\n\r - Patients with active serious medical problems that might affect their ability to\r participate in the exercise protocol (e.g. ongoing sepsis; recent myocardial\r infarction)\r\n\r - Patients who are unable to use treadmill safely as judged by the screening\r physiotherapist (EV).\r\n\r - Patients who are unable to give informed consent, either through issues relating to\r competency or to language.\r\n\r - Patients with significant previous experience of virtual reality rehabilitation.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nSafety Assessment of Angioplasty Procedures\n\n**Clinical Trial Summary:**\n\nIschemic heart disease, or coronary heart disease, covers a set of pathologies due to\r insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one\r or more coronary arteries. To evaluate the safety of angioplasty performed in patients\r operated on at La Rochelle Hospital, the rate of major adverse cardiac events (MACE) will be\r determined and compared with data from the literature.\n\n**Clinical Trial Detailed Description:**\n\nThe use of active stents for the treatment of coronary stenosis is currently the standard\r treatment in almost all types of coronary lesions. In percutaneous transluminal treatment of\r coronary lesions, balloon angioplasty and bare stents have not shown satisfactory results in\r the past. The so-called active drug-eluting balloon could represent a new therapeutic option\r for the treatment of de novo lesions.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Interventional revascularization of a coronary lesion,\r\n\r - Member or beneficiary of a social security system,\r\n\r - Informed of the study.\r\n\r Exclusion Criteria:\r\n\r - Language barrier,\r\n\r - Minor,\r\n\r - Pregnant woman,\r\n\r - Person under guardianship,\r\n\r - Person deprived of his/her liberty,\r\n\r - Refusal to participate.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nOncolytic Adenovirus DNX-2401 in Treating Patients With Recurrent High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nThis phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in\r treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus\r DNX-2401 is made from the common cold virus that has been changed in the laboratory to make\r it less likely to cause an infection (such as a cold). The virus is also changed to target\r brain cancer cells and attack them.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine the maximal tolerated dose (MTD) of allogeneic bone marrow-derived human\r mesenchymal stem cells (BM-hMSCs) loaded with the oncolytic adenovirus DNX-2401\r (BM-hMSCs-DNX2401) administered by intra-arterial injection (i.e., transfemoral\r super-selective endovascular intracranial injection) in patients with recurrent glioblastoma\r (GBM), gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.\r\n\r II. To determine the local and systemic toxicity of allogeneic BM-hMSCs-DNX2401 administered\r by intra-arterial injection (i.e., transfemoral super-selective endovascular intracranial\r injection) in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic\r astrocytoma.\r\n\r III. To determine at the molecular and cellular level the capacity of allogeneic\r BM-hMSCs-DNX2401 administered intra-arterially to home to and deliver DNX-2401 to recurrent\r GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma by analyzing post-treatment\r surgical brain tumor specimens for the expression and distribution of adenoviral proteins.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To assess shedding of adenovirus into the blood, sputum, and nasopharynx after\r intra-arterial administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma\r or wild-type IDH-1 anaplastic astrocytoma.\r\n\r II. To assess the development of anti-adenovirus antibodies after intra-arterial\r administration of BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type\r IDH-1 anaplastic astrocytoma.\r\n\r III. To evaluate immune-mediated cytokine responses after intra-arterial administration of\r BM-hMSCs-DNX2401 in patients with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic\r astrocytoma.\r\n\r IV. To assess anti-tumoral activity and to determine progression-free survival (PFS) and\r overall survival (OS) after intra-arterial administration of BM-hMSCs-DNX2401 in patients\r with recurrent GBM, gliosarcoma or wild-type IDH-1 anaplastic astrocytoma.\r\n\r OUTLINE: This is a dose-escalation study.\r\n\r PART I: Patients receive oncolytic adenovirus Ad5-DNX-2401 intra-arterially (IA) over 20-30\r minutes on day 0.\r\n\r PART II: Patients receive oncolytic adenovirus Ad5-DNX-2401 as in part I. After 2 weeks,\r patients undergo surgery, then receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30\r minutes.\r\n\r After completion of study treatment, patients in part I are followed up on days 1, 4, 7, and\r 14 of month 1, months 1.5, 3, and 4.5, every 2 months up to month 26, month 30, then every 6\r months thereafter. Patients in part II will be followed up on the day after surgery, weeks 1,\r 2 and 4, months 2, 2.5, 4, 5.5 and 7, every 2 months until month 19, every 4 months until\r month 32, then every 6 months thereafter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects must be willing and able to provide informed consent, undergo and comply with\r all study assessments and adhere to the protocol schedule\r\n\r - Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with\r recurrent anaplastic astrocytoma with wild-type IDH-1 gene will also be eligible if\r there is a significant enhancing mass on magnetic resonance imaging (MRI) because\r their prognosis/behavior is similar to GBM. A pathology report constitutes adequate\r documentation of histology for study inclusion. Subjects with an initial diagnosis of\r a lower grade glioma are eligible if a subsequent biopsy is determined to be GBM and\r there is a significant enhancing mass on MRI\r\n\r - Patients must show unequivocal evidence for tumor recurrence or progression by MRI\r scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A\r baseline MRI must be performed within 24 days prior to registration. Biopsy is\r encouraged at the time of recurrence if it is unclear that there is recurrent tumor.\r However, biopsy is not required if the practicing physician thinks that there is\r adequate radiographic and clinical evidence for recurrence\r\n\r - Patients must be able to undergo endovascular treatment based on Doppler studies\r showing internal carotid artery (ICA) that is less than 50% occluded\r\n\r - For patients undergoing resection for biological endpoints, tumors must be surgically\r resectable at the time of baseline evaluation and craniotomy for tumor resection would\r be part of their standard medical care\r\n\r - Tumors must be > 1.0 cm in diameter with upper limit of 5 cm maximal diameter\r\n\r - Patients must have a Karnofsky performance score >= 70\r\n\r - Patients must have a life expectancy of at least 16 weeks\r\n\r - Absolute granulocyte count >= 1,500 prior to starting therapy\r\n\r - Platelet count of >= 75,000 prior to starting therapy\r\n\r - Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic\r transaminase (SGOT) < 2 times institutional normal ranges prior to starting therapy\r\n\r - Bilirubin < 2 times institutional normal ranges prior to starting therapy\r\n\r - Creatinine < 2.0 times institutional normal prior to starting therapy\r\n\r - Prothrombin time (PT), partial thromboplastin time (PTT), and thrombin time within\r institutional normal limits after correction of nutritional deficiencies that may\r contribute to prolonged PT/PTT\r\n\r - Subjects who have received the following chemotherapies must have completed them\r within the following time periods prior to baseline/day 0 of hMSC-DNX2401 delivery\r with recovery from any drug-related toxic effects to grade 1, or less, severity: 4\r weeks from cytotoxic agents (3 weeks from procarbazine or temozolomide, 2 weeks from\r vincristine), 6 weeks from nitrosoureas (lomustine [CCNU], carmustine [BCNU]), 4 weeks\r from any investigational agent, 1 week from non-cytotoxic agents\r\n\r - Patients must be 8 weeks from radiotherapy to minimize the potential for MRI changes\r related to radiation necrosis that might be misdiagnosed as progression of disease, or\r 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside\r the primary radiation field (beyond 80% isodose line). However, if a biopsy is\r undertaken prior to these times and this biopsy documents histological evidence for\r recurrent disease, then patients will be eligible regardless of the time after\r radiation\r\n\r - Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation\r therapy against the tumor while enrolled in the study\r\n\r - Women of childbearing potential must have a negative urine pregnancy test documented\r within 7 days prior to study initiation\r\n\r - Subjects and their partners must be willing to use effective birth control during the\r study and for up to 6 months following administration of hMSC-DNX2401. Birth control\r that is acceptable to use in this study:\r\n\r - Using twice the normal protection of birth control (i.e., double-barrier) by\r using a condom AND spermicidal jelly or foam, or a diaphragm AND spermicidal\r jelly or foam. A spermicidal jelly or foam must be used in addition to a barrier\r method (e.g., condom or diaphragm)\r\n\r - Birth control pills (\"The Pill\")\r\n\r - Depot or injectable birth control\r\n\r - IUD (intrauterine device)\r\n\r - Birth control patch (e.g., Ortho Evra)\r\n\r - NuvaRing\r\n\r - Surgical sterilization (i.e., tubal ligation or hysterectomy for women or\r vasectomy for men)\r\n\r Exclusion Criteria:\r\n\r - Histology other than astrocytoma grade IV (GBM or gliosarcoma), although astrocytoma\r grade III that is IDH-1 wild-type will be included\r\n\r - Tumor foci detected below the tentorium or beyond the cranial vault\r\n\r - Tumor within the posterior fossa\r\n\r - Tumor with leptomeningeal spread\r\n\r - Difficulty in obtaining vascular access for percutaneous procedure\r\n\r - Ipsilateral carotid stenosis (> 50%, by Doppler studies)\r\n\r - Thrombophilias or primary hematological diseases\r\n\r - Transfusions or medications (G-CSF) to treat pancytopenia or other hematological\r conditions < 28 days prior to baseline/day 0/hMSC-DNX2401 administration\r\n\r - Biologic/immunotherapy within 2 weeks of baseline\r\n\r - Clinical or laboratory evidence of inflammatory and/or autoimmune disorders\r\n\r - Any contraindication for undergoing MRI such as: individuals with pacemakers,\r epicardial pacer wires, infusion pumps, surgical and/or aneurysm clips, shrapnel,\r metal prosthesis, implants with potential magnetic properties, metallic bodies in the\r eyes, etc. In addition, subjects must present with tumor that is evaluable by MRI\r\n\r - Pregnant or nursing females\r\n\r - Evidence of active uncontrolled infection or unstable or severe intercurrent medical\r conditions. All subjects must be afebrile at baseline (i.e., < 38.0 degrees Celsius\r [C])\r\n\r - Any medical condition that precludes surgery or endovascular treatment\r\n\r - Alcoholism (dependency), alcohol or substance abuse within twelve (12) months prior to\r screening that has caused health consequences\r\n\r - Immunocompromised subjects or those with autoimmune conditions, active hepatitis\r (liver function tests > 2x normal) or human immunodeficiency virus (HIV)\r seropositivity\r\n\r - Evidence of bleeding diathesis or use of anticoagulant medication or any medication\r that may increase the risk of bleeding that cannot be stopped prior to surgery. If the\r medication can be discontinued prior to DNX-2401 injection then the subject may be\r eligible following consultation with the study chair. Low weight heparin and Lovenox\r (enoxaparin) administered on a temporary limited basis for post procedure deep venous\r thrombosis (DVT) prophylaxis is permitted\r\n\r - History or current diagnosis of any medical or psychological condition that in the\r investigator's opinion, might interfere with the subject's ability to participate or\r inability to obtain informed consent because of psychiatric or complicating medical\r problems\r\n\r - Encephalitis, multiple sclerosis or other central nervous system (CNS) infection or\r primary CNS disease that would interfere with subject evaluation\r\n\r - Subjects with known Li-Fraumeni syndrome or with a known germ line deficit in the\r retinoblastoma gene or its related pathways\r\n\r - Subjects with significant systemic or major illnesses including but not limited to:\r congestive heart failure, ischemic heart disease, cerebrovascular disease (history of\r strokes or transient ischemic attacks [TIAs] in large vessel or small vessel\r distribution), kidney disease or renal failure, active liver disease, organ\r transplantation, or significant psychiatric disorder\r\n\r - Enrollment in a concomitant therapeutic clinical study\r\n\r - Any condition that prevents compliance with the protocol or adherence to therapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nFORWARD Optune and Adjuvant TMZ in Grade II/III Astrocytoma\n\n**Clinical Trial Summary:**\n\nThis is a phase 2, multi-institutional, historically-controlled, study of 100 patients with\r newly diagnosed Grade II and III astrocytoma comparing the combination of TTFields with\r adjuvant temozolomide versus temozolomide alone in historical controls after the completion\r of definitive chemoradiotherapy. Study treatment may continue past first tumor recurrence.\r The primary endpoint will be overall survival.\n\n**Clinical Trial Detailed Description:**\n\nPatients with newly diagnosed high-risk Grade II or III astrocytoma must undergo maximal safe\r resection (biopsy alone may be eligible) and chemoradiotherapy: concomitant 75mg/m2 daily\r temozolomide with 80% prescribed dose completed and RT with minimal RT dose of 40 Gy\r delivered.\r\n\r Within three weeks prior to beginning adjuvant temozolomide, all patients will undergo a\r Baseline contrast-enhanced MRI of the brain. Within two weeks prior to beginning adjuvant\r temozolomide, all patients will undergo baseline assessments. Patients will begin study\r treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no\r later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the\r latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will\r be given. Patients will be seen and examined before each cycle of temozolomide. After a\r maximum of 12 cycles of adjuvant temozolomide, patients will be seen every 8 weeks. Brain MRI\r and QoL assessments will be performed every 8 weeks following the baseline MRI for the first\r 2 years then every 3 months thereafter until second progression (when TTFields treatment will\r be terminated).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Willing and able to provide written informed consent\r\n\r - Stated willingness to comply with all study procedures and availability for the\r duration of the study\r\n\r - Life expectancy of at least 3 months\r\n\r - Histologic confirmation of WHO Grade II or III astrocytoma---mixed oligoastrocytomas\r are permitted\r\n\r - 1p/19q intact per FISH and/or ATRX mutation(s) per immunohistochemistry or\r next-generation sequencing (e.g. Foundation Medicine, TEMPUS, Caris, or similar\r CLIA-certified sequencing service)\r\n\r - Mutational identity determined by CLIA-certified sequencing including:\r\n\r 1. IDH1/2 wildtype (i.e. lack of detectable mutations on the sequencing report) and\r\n\r 2. TERT promoter mutation\r\n\r - Karnofsky performance status ≥70%\r\n\r - Maximal safe resection---biopsy alone is allowed\r\n\r - Completed standard chemoradiation with total RT dose of at least 40 Gy and concurrent\r temozolomide (75mg/m2 daily dose with 80% prescribed dose completed)\r\n\r - Patients with a tumor that was biopsied or resected in the past followed by\r observation only without definitive chemoradiation and/or chemotherapy given will be\r eligible, as long as: repeat maximal surgical resection (biopsy only allowed) has been\r performed, definitive temozolomide/RT treatment meets the criteria above, and adjuvant\r temozolomide treatment is planned\r\n\r - Candidate for adjuvant high dose temozolomide per investigator's clinical judgement\r\n\r - Adjuvant Temozolomide start date at least 4 weeks, but not more than 6 weeks, from the\r later of last dose of concomitant temozolomide or radiotherapy\r\n\r - No evidence of early disease progression per RANO criteria at the time of enrollment\r\n\r - Women of childbearing potential (WOCBP) must be using a highly effective method of\r contraception to avoid pregnancy throughout the study and for at least 24 weeks after\r the last dose of study drug to minimize the risk of pregnancy.\r\n\r 1. Prior to study enrollment, women of childbearing potential must be advised of the\r importance of avoiding pregnancy during trial participation and the potential\r risk factors for an unintentional pregnancy.\r\n\r 2. Refer to section 10.2.1 for guidance on highly effective contraceptive methods\r acceptable in this study.\r\n\r 3. WOCBP include any woman who has experienced menarche and who has not undergone\r successful surgical sterilization (hysterectomy, bilateral tubal ligation, or\r bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined\r as: Amenorrhea that has lasted for ≥ 12 consecutive months without another cause,\r or For women with irregular menstrual periods who are taking hormone replacement\r therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of\r greater than 35 mIU/mL.\r\n\r - Males with female partners of child-bearing potential must agree to use\r physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy)\r throughout the study and should avoid conceiving children for 24 weeks following the\r last dose of study drug.\r\n\r Exclusion Criteria:\r\n\r - Prior treatment with anti-angiogenic agents including bevacizumab.\r\n\r - Prior treatment with TTFields.\r\n\r - Progressive disease (according to RANO criteria) after temozolomide/RT.\r\n\r - Actively participating in another clinical treatment trial intended to treat the\r underlying astrocytoma.\r\n\r - Females who are pregnant or breastfeeding.\r\n\r - Significant co-morbidities at baseline (within 2 weeks prior to adjuvant temozolomide\r start) which would prevent adjuvant temozolomide treatment:\r\n\r 1. Thrombocytopenia (platelet count < 100 x 103/μL)\r\n\r 2. Neutropenia (absolute neutrophil count < 1.5 x 103/μL)\r\n\r 3. CTC grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting)\r\n\r 4. Significant liver function impairment - AST or ALT > 5 times the upper limit of\r normal\r\n\r 5. Total bilirubin > 2 times upper limit of normal\r\n\r 6. Significant renal impairment (GFR ≤ 30 ml/min)\r\n\r - Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other\r implanted electronic devices in the brain, or documented clinically significant\r arrhythmias.\r\n\r - A skull defect such as missing bone with no replacement\r\n\r - Bullet fragments embedded the skull\r\n\r - Tumors located in the brain stem and/or the cerebellum\r\n\r - History of hypersensitivity reaction to temozolomide, Dacarbazine (DTIC) or hydrogel.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nBeach Tennis And Hypertension Study 2\n\n**Clinical Trial Summary:**\n\nNo studies have investigated the chronic effects of team sports on 24 h ambulatory blood\r pressure and have assessed the effects of a beach tennis intervention in cardiovascular\r profile and physical fitness. Based on that, the investigators designed this parallel\r randomized controlled trial to evaluate the effect of beach tennis training on 24 h\r ambulatory blood pressure and different physical fitness parameters in individuals with\r hypertension. The difference between the intervention arms in mean change from baseline in 24\r h, daytime and nighttime systolic and diastolic ambulatory blood pressure at 12-weeks is the\r primary outcome; secondary outcomes are the difference between mean change in office blood\r pressure as well as cardiorespiratory fitness, muscular strength and power. The investigators\r anticipate that 12 weeks of beach tennis training will reduce blood pressure when compared to\r a non-exercising control group. Additionally, our recreational beach tennis intervention will\r improve all physical fitness components in comparison to the baseline values.\n\n**Clinical Trial Detailed Description:**\n\nThis is a single-center, two-arms, parallel randomized controlled trial with concealed\r allocation, blinded measurers, with 12 weeks of follow-up analyzed using an\r intention-to-treat approach.\r\n\r Participants will be randomly allocated to the beach tennis training intervention (BTT) or to\r the control group (Con), which will not be submitted to intervention and will be instructed\r not to engage in any kind of structured physical exercise training and to keep the life\r activities identified at baseline. The International Physical Activity Questionnaire (IPAQ)\r will be applied before and after the intervention in order to assess the level of physical\r activity.\r\n\r In BTT, supervised beach tennis sessions will be performed two times per week. Each session\r will be composed of an initial period of 10 min of warm up and technical exercises (i.e.,\r serve, volley, forehand and backhand). After that, 3 games of 10-15 min each (weeks 1-4: 3 ×\r 10 min; weeks 5-8: 3 × 12 min; and weeks 9-12: 3 × 15 min) with an interval of 2 min between\r each game will be played in pairs (i.e., 2 versus 2). In case of less than 4 participants are\r able to play at the same time, the games can also be played individually (i.e., 1 versus1).\r In Con, participants will be advised to not change their daily usual activities and to not\r participate in any structured physical exercise program during this period.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood\r pressure, respectively;\r\n\r - Non-engaged in structured exercise programs in the last 3 months before the beginning\r of this study;\r\n\r - Able to perform the proposed exercises.\r\n\r Exclusion Criteria:\r\n\r - Underlying cardiovascular disease in the last 24 months such as acute myocardial\r infarction, angina, stroke or heart failure;\r\n\r - Diseases that reduce life expectancy;\r\n\r - Smokers;\r\n\r - BMI >39.9 kg/m²;\r\n\r - Diabetic proliferative retinopathy.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia\n\n**Clinical Trial Summary:**\n\nThis phase III trial studies how well blinatumomab works in combination with chemotherapy in\r treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or\r B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as\r blinatumomab, may induce changes in the body's immune system and may interfere with the\r ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine,\r dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine,\r mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to\r stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,\r or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate.\r Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving\r blinatumomab and combination chemotherapy may work better than combination chemotherapy alone\r in treating patients with B-ALL. This trial also assigns patients into different chemotherapy\r treatment regimens based on risk (the chance of cancer returning after treatment). Treating\r patients with chemotherapy based on risk may help doctors decide which patients can best\r benefit from which chemotherapy treatment regimens.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine in a randomized manner if the addition of 2 cycles of blinatumomab to\r standard therapy improves disease-free survival (DFS) in patients with standard risk (SR)\r B-ALL and higher risk features (SR-High), and patients with standard-risk average (SR-Avg)\r B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have\r detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of\r induction (EOI).\r\n\r II. To confirm that boys in the standard-risk favorable (SR-Fav) subset of B-ALL, with or\r without Down syndrome (DS), will maintain a 5-year DFS of greater than 93% when treated with\r a standard chemotherapy regimen with a treatment duration of 2 years from the start of\r interim maintenance I (IM1).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To describe the DFS for patients with SR-Avg B-ALL who are negative for MRD measured by\r flow cytometry and HTS at EOI when treated with standard chemotherapy with a treatment\r duration of 2 years from the start of IM1, regardless of sex.\r\n\r II. To describe the DFS for patients with standard-risk favorable (SR-Fav) B-ALL when treated\r with a standard chemotherapy regimen.\r\n\r III. To determine if patients with DS-High achieve a reduction of treatment-related mortality\r (TRM) after replacement of intensive elements of standard chemotherapy (omission of\r anthracyclines in induction, omission of the second month of delayed intensification [DI])\r with 3 cycles of blinatumomab.\r\n\r IV. To describe the DFS characterized by the replacement of intensive elements of standard\r chemotherapy with 3 cycles of blinatumomab in patients with DS-High B ALL.\r\n\r V. To describe the DFS for patients with localized (Murphy stage I and II) B lymphoblastic\r lymphoma (B-LLy) receiving standard risk B-ALL therapy.\r\n\r VI. To compare the change in neurocognitive functioning, as measured by the CogState\r Cognitive Composite, from baseline to end-of-therapy among patients with ALL ages 4- < 10\r years at the time of diagnosis between children from poor families (defined as presence of\r household material hardship [HMH], including either food, housing or energy insecurity) and\r non-poor families (absence of HMH).\r\n\r VII. To describe the impact of blinatumomab on caregiver burden and patient/proxy-reported\r symptoms among a subset of children enrolled in the HMH and neurocognitive outcome study.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To explore adaptive and innate immune functions and host genetic factors associated with\r severe infectious complications in children with DS B-ALL.\r\n\r II. To explore the impact of acute lymphoblastic leukemia (ALL) and its therapy on\r neurocognitive, functional, and quality of life outcomes in patients with DS and ALL, as\r measured by caregiver (parent/legal guardian) questionnaires.\r\n\r III. To define the prevalence of minimal marrow disease (MMD) in B-LLy and to correlate MMD\r at diagnosis with outcome in patients with B-LLy.\r\n\r OUTLINE: All patients are assigned to, and complete an INDUCTION treatment regimen. Patients\r are then assigned to a CONSOLIDATION treatment regimen. Finally, following CONSOLIDATION,\r patients are either assigned or randomized to 1 of 7 arms.\r\n\r NON-DS SR B-ALL INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1,\r vincristine intravenous (IV) push over 1 minute on days 1, 8, 15, and 22, dexamethasone\r orally (PO) or IV twice daily (BID) on days 1-28, pegaspargase IV over 1-2 hours or\r intramuscularly (IM) on day 4, and methotrexate IT on days 8 and 29. CNS2 patients also\r receive cytarabine IT twice weekly except during weeks when days 8 and 29 methotrexate is\r administered. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r * After Non-DS SR B-ALL INDUCTION, SR-Fav and SR-Avg patients complete SR CONSOLIDATION,\r while patients with SR-High complete high-risk (HR) CONSOLIDATION.\r\n\r DS B-ALL INDUCTION: Patients receive cytarabine IT on day 1, vincristine IV push over 1\r minute on days 1, 8, 15, and 22, pegaspargase IV over 1-2 hours or IM on day 4, methotrexate\r IT on days 8 and 29, and leucovorin PO or IV every 6 hours for 2 doses on days 9 and 30.\r Additionally, patients under 10 years of age receive dexamethasone PO or IV BID on days 1-28,\r and patients 10 years of age or older receive prednisone or prednisolone PO or IV BID on days\r 1-28. CNS2 patients also receive cytarabine IT twice weekly except during weeks when days 8\r and 29 IT methotrexate is administered. CNS3 patients also receive methotrexate IT on days 15\r and 22, and leucovorin PO or IV every 6 hours for 2 doses on days 16 and 23. Treatment\r continues for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r * After DS B-ALL INDUCTION, patients without high risk features and MRD < 0.01 % complete SR\r CONSOLIDATION. Patients without high risk features and MRD >= 0.01%, OR with high risk\r features and any MRD complete HR CONSOLIDATION.\r\n\r NON-DS B-LLy INDUCTION: Patients receive cytarabine IT on day 1 and twice weekly if CNS2,\r vincristine IV push over 1 minute on days 1, 8, 15, and 22, dexamethasone PO or IV BID on\r days 1-28, pegaspargase IV over 1-2 hours or IM on day 4, and methotrexate IT on days 8 and\r 29. Treatment continues for 35 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r * After NON-DS B-LLy INDUCTION, all B-LLy patients then complete SR CONSOLIDATION.\r\n\r DS B-LLY INDUCTION: Patients receive cytarabine IT on day 1, vincristine IV push over 1\r minute on days 1, 8, 15, and 22, pegaspargase IV over 1-2 hours or IM on day 4, methotrexate\r IT on days 8 and 29, and leucovorin PO or IV every 6 hours for 2 doses on days 9 and 30.\r Additionally, patients under 10 years of age receive dexamethasone PO or IV BID on days 1-28,\r and patients 10 years of age or older receive PO or IV prednisone or methylprednisolone on\r days 1-28. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r * After DS B-LLy INDUCTION, patients then complete SR CONSOLIDATION.\r\n\r SR CONSOLIDATION: Patients receive vincristine IV push over 1 minute on day 1, mercaptopurine\r PO on days 1-28, and methotrexate IT on days 1, 8, and 15. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on days 2, 9, and 16. Treatment continues for\r 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r * After SR CONSOLIDATION, patients with MRD undetectable are assigned to ARM A, and patients\r with MRD detectable/indeterminate/unavailable are randomized to ARM A or B. Patients with\r SR-Fav and all B-LLy patients are assigned to treatments identical to that in ARM A.\r\n\r HR CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, vincristine IV\r push over 1 minute on days 15, 22, 43, and 50, mercaptopurine PO on days 1-14 and 29-42,\r methotrexate IT on days 1, 8, 15, and 22 , and pegaspargase IV over 1-2 hours or IM on days\r 15 and 43. DS patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2,\r 9, 16, and 23 (on days 2 and 9 only for DS CNS3 patients). Treatment continues for 56 days in\r the absence of disease progression or unacceptable toxicity. Patients with continued clinical\r evidence of DS or testicular leukemia (from diagnosis through the end of Induction) undergo\r testicular radiation therapy over 12 fractions once daily (QD).\r\n\r * After HR CONSOLIDATION, patients are randomized to ARM C or D. DS B-ALL patients with MRD <\r 1% are assigned to an arm including three blocks of blinatumomab.\r\n\r ARM A:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted)\r on days 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1 and 29, dexamethasone\r PO BID or IV on days 1-7 and 15-21, vincristine IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV push/infusion over 1-15 minutes on days 1, 8, and 15, pegaspargase IV\r over 1-2 hours or IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29,\r thioguanine PO on days 29-42, and cytarabine IV over 1-30 minutes or subcutaneously (SC)\r on days 29-32 and 36-39. DS patients receive leucovorin PO or IV every 6 hours for 2\r doses on days 2 and 30. Treatment continues for 56 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes undiluted or 10-15 minutes diluted\r on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS patients receive\r leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32. Treatment continues for\r 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Non-DS patients receive methotrexate IT on day 1, vincristine IV push over\r 1 minute on day 1, dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84, and\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. DS patients\r receive vincristine IV push over 1 minute on day 1, methotrexate IT on day 1,\r dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84, and methotrexate PO on\r days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78, and leucovorin IV or PO on day 2 if\r DS. Treatment repeats every 84 days until a total duration of therapy of 2 years from\r start of INTERIM MAINTENANCE I is reached in the absence of disease progression or\r unacceptable toxicity.\r\n\r ARM B:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone IV or PO on day 1, methotrexate IT\r on day 1, and blinatumomab IV continuously on days 1-28. DS patients also receive\r leucovorin IV or PO every 6 hours for 2 doses on day 2. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted)\r on days 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive methotrexate IT on day 1, and blinatumomab IV\r continuously on days 1-28. DS patients also receive leucovorin PO or IV every 6 hours\r for 2 doses on day 2. Treatment continues for 35 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1 and 29, dexamethasone\r PO or IV on days 1-7 and 15-21, vincristine IV push over 1 minute on days 1, 8, and 15,\r doxorubicin IV push/infusion over 1-15 minutes on days 1, 8, and 15, pegaspargase IV\r over 1-2 hours or IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29,\r thioguanine PO on days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32\r and 36-39. DS patients receive leucovorin PO or IV every 6 hours for 2 doses on days 2\r and 30. Treatment continues for 56 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes\r (diluted) on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS\r patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - MAINTENANCE: Non-DS patients receive methotrexate IT on day 1 (omit on final 2 cycles),\r vincristine IV push over 1 minute on day 1, dexamethasone PO on days 1-5, mercaptopurine\r PO on days 1-84, and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71,\r and 78 (omit day 1 on final 2 cycles). DS patients receive methotrexate IT on day 1\r (omit on final 2 cycles), dexamethasone PO on days 1-5, mercaptopurine PO on days 1-84,\r and methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (omit day 1\r except for final 2 cycles), for DS patients and leucovorin IV or PO every 6 hours for 2\r doses on day 2 (omit on final 2 cycles). Treatment repeats every 84 days until a total\r duration of therapy of 2 years from start of INTERIM MAINTENANCE I is reached in the\r absence of disease progression or unacceptable toxicity.\r\n\r ARM C:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 15,\r 29, and 43, high dose methotrexate IV on days 1, 15, 29, and 43, mercaptopurine PO on\r days 1-14, 15-28, 29-42, and 43-56, methotrexate IT on day 1 and 29, and leucovorin PO\r or IV on days 3-4, 17-18, 31-32, and 45-46. Treatment continues for 56 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1, dexamethasone PO BID\r or IV on days 1-7 and 15-21, vincristine IV over 1 minute on days 1, 8, 15, 43, and 50,\r doxorubicin IV over 1-15 minutes on days 1, 8, and 15, pegaspargase IV over 1-2 hours or\r IM on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on\r days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV over 1 minute on days 1, 11, 21,\r 31, and 41, Capizzi style methotrexate IV over 2-5 minutes (undiluted) or over 10-15\r minutes (diluted) on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and\r pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV over 1 minute on day 1, prednisone or\r prednisolone or methylprednisolone PO or IV on days 1-5, mercaptopurine PO on days 1-84,\r methotrexate IT on days 1 and 29 of cycles 1-2 and on day 1 of subsequent cycles,\r methotrexate PO on days 8, 15, 22, 29 (for cycle 3 and later only), 36, 43, 50, 57, 64,\r 71, and 78. Treatment repeats every 84 days until a total duration of therapy of 2 years\r from start of interim maintenance I is reached in the absence of disease progression or\r unacceptable toxicity.\r\n\r ARM D:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, methotrexate IT\r on day 1, and blinatumomab IV continuously on days 1-28. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV over 1 minute on days 1, 15, 29,\r and 43, high dose methotrexate IV on days 1, 15, 29, and 43, mercaptopurine PO on days\r 1-14, 15-28, 29-42, and 43-56, methotrexate IT on days 1 and 29, and leucovorin PO or IV\r on days 3-4, 17-18, 31-32, and 45-46. Treatment continues for 56 days in the absence of\r disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive blinatumomab IV on days 1-28 and methotrexate IT\r on day 1. Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive methotrexate IT on day 1, dexamethasone PO or\r IV on days 1-7 and 15-21, vincristine IV over 1 minute on days 1, 8, 15, 43, and 50,\r doxorubicin IV over 1-15 minutes on days 1, 8, and 15, pegaspargase IV over 1-2 hours or\r IM on days 4 and 43, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on\r days 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV over 1 minute on days 1, 11, 21,\r 31, and 41, Capizzi style methotrexate IV over 2-5 minutes (undiluted) or over 10-15\r minutes (diluted) on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and\r pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive methotrexate IT on day 1, vincristine IV over 1 minute on\r day 1, prednisone, prednisolone or methylprednisolone PO or IV on days 1-5,\r mercaptopurine PO on days 1-84, and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50,\r 57, 64, 71, and 78. Treatment repeats every 84 days until a total duration of therapy of\r 2 years from start of interim maintenance I is reached in the absence of disease\r progression or unacceptable toxicity.\r\n\r DS-HIGH B-ALL:\r\n\r - BLINATUMOMAB BLOCK I: Patients receive dexamethasone PO or IV on day 1, blinatumomab IV\r continuously on days 1-28, methotrexate IT on day 1 (or on day 56 of Consolidation), and\r leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment continues for 35 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - INTERIM MAINTENANCE: Patients receive vincristine IV push over 1 minute on days 1, 15,\r 29, and 43, intermediate dose methotrexate IV over 24 hours on days 1, 15, 29, and 43,\r mercaptopurine PO on days 1-14, 15-28, 29-42, and 43-46, methotrexate IT on days 1 and\r 29, and leucovorin PO or IV every 6 hours for 2 doses on days 2-4, 16-18, 30-32, and\r 44-46. Treatment continues for 63 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK II: Patients receive blinatumomab IV on days 1-28, methotrexate IT on\r day 1, and leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment continues\r for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive vincristine IV over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes on days 1, 8, and 15, dexamethasone PO or IV on\r days 1-7 and 15-21, methotrexate IT on day 1, leucovorin PO or IV every 6 hours for 2\r doses on day 2, and pegaspargase IV over 1-2 hours or IM on day 4. Treatment continues\r for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r - BLINATUMOMAB BLOCK III: Patients receive blinatumomab IV on days 1-28, methotrexate IT\r on day 1, and leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment\r continues for 35 days in the absence of disease progression or unacceptable toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV push over 1 minute on day 1, prednisone,\r prednisolone or methylprednisolone PO or IV BID on days 1-5, mercaptopurine PO on days\r 1-84, methotrexate IT on day 1, methotrexate PO on days 8, 15, 22, 29 (omit day 29 for\r first 3 cycles for patients who do not receive cranial radiotherapy), 36, 43, 50, 57,\r 64, 71, and 78, and leucovorin PO on days 2 and 30 (day 30 dose is for cycles 1-3 and\r for patients who do not receive cranial radiotherapy). CNS3 patients receive cranial\r radiotherapy during first 4 weeks of cycle 1. Treatment repeats every 84 days until a\r total duration of therapy of 2 years from start of interim maintenance I is reached in\r the absence of disease progression or unacceptable toxicity.\r\n\r All B-LLy patients:\r\n\r - INTERIM MAINTENANCE I: Patients receive vincristine IV push over 1 minute on days 1, 11,\r 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 (diluted) on days\r 1, 11, 21, 31, and 41, and methotrexate IT on day 31. DS patients also receive\r leucovorin PO or IV every 6 hours for 2 doses on day 32. Treatment continues for 56 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r - DELAYED INTENSIFICATION: Patients receive vincristine IV push over 1 minute on days 1, 8\r and 15, doxorubicin IV over 1-15 minutes on days 1, 8, and 15, dexamethasone PO or IV on\r days 1-7 and 15-21, methotrexate IT on days 1 and 29, pegaspargase IV over 1-2 hours or\r IM on day 4, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days\r 29-42, and cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39. DS patients\r additionally receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 30.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - INTERIM MAINTENANCE II: Patients receive vincristine IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes\r (diluted) on days 1, 11, 21, 31, and 41, and methotrexate IT on days 1 and 31. DS\r patients also receive leucovorin PO or IV every 6 hours for 2 doses on days 2 and 32.\r Treatment continues for 56 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r - MAINTENANCE: Patients receive vincristine IV push over 1 minute on day 1, dexamethasone\r PO on days 1-5, mercaptopurine PO on days 1-84, methotrexate IT on day 1, and\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. DS patients also\r receive leucovorin PO or IV every 6 hours for 2 doses on day 2. Treatment repeats every\r 84 days until a total duration of therapy of 2 years from start of interim maintenance I\r is reached in the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up every 4 weeks until complete\r blood count(CBC)/differential/platelet count recovery, then every 3 months for the first 2\r years, then every 4-6 months for the 3rd year, and every 6-12 months for the 4th and 5th\r years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening\r (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement\r for B-LLy patients. B-LLy patients may directly enroll on AALL1731.\r\n\r - Age at diagnosis:\r\n\r - Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS).\r\n\r - Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS).\r\n\r - Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or\r without DS).\r\n\r - B-ALL patients without DS must have an initial white blood cell count < 50,000/uL\r (performed within 7 days prior to enrollment).\r\n\r - B-ALL patients with DS are eligible regardless of the presenting white blood cell\r count (WBC) (performed within 7 days prior to enrollment).\r\n\r - Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on\r a bone marrow (BM) aspirate;\r\n\r - OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis\r can be established by a pathologic diagnosis of B-ALL on a BM biopsy;\r\n\r - OR a complete blood count (CBC) documenting the presence of at least 1,000/uL\r circulating leukemic cells;\r\n\r - OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without\r Down syndrome.\r\n\r - Note: For B-LLy patients with tissue available for flow cytometry, the criterion\r for diagnosis should be analogous to B-ALL. For tissue processed by other means\r (i.e., paraffin blocks), the methodology and criteria for immunophenotypic\r analysis to establish the diagnosis of B-LLy defined by the submitting\r institution will be accepted (diagnostic biopsy for B-LLy must be performed\r within 14 days prior to enrollment).\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent.\r\n\r Exclusion Criteria:\r\n\r - Patient must not have secondary ALL that developed after treatment of a prior\r malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior\r history of transient myeloproliferative disease (TMD) are not considered to have had a\r prior malignancy. They would therefore be eligible whether or not the TMD was treated\r with cytarabine.\r\n\r - With the exception of steroid pretreatment or the administration of intrathecal\r cytarabine, patients must not have received any prior cytotoxic chemotherapy for\r either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to\r initiation of protocol therapy on AALL1731.\r\n\r - For patients receiving steroid pretreatment, the following additional exclusion\r criteria apply:\r\n\r - Non-DS B-ALL patients must not have received steroids for more than 24 hours in\r the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to\r initiation of the steroids.\r\n\r - DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV\r steroids within 4 weeks of diagnosis.\r\n\r - Patients who have received > 72 hours of hydroxyurea.\r\n\r - B-ALL patients who do not have sufficient diagnostic bone marrow submitted for\r APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted\r containing > 1,000/uL circulating leukemia cells.\r\n\r - Patient must not have acute undifferentiated leukemia (AUL).\r\n\r - Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be\r known prior to enrollment).\r\n\r - Note: DS patients with CNS3 disease are eligible but will be assigned to the\r DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior\r to administration of any systemic or intrathecal chemotherapy, except for steroid\r pretreatment.\r\n\r - Non-DS B-ALL patients with testicular leukemia. (Note: DS patients with testicular\r disease are eligible but will be assigned to the DS-High B-ALL arm).\r\n\r - For LLy patients, the following additional exclusion criteria apply:\r\n\r - T-Lymphoblastic Lymphoma.\r\n\r - Morphologically unclassifiable lymphoma.\r\n\r - Absence of both B-cell and T-cell phenotype markers in a case submitted as\r lymphoblastic lymphoma.\r\n\r - CNS positive disease or testicular involvement.\r\n\r - M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow.\r\n\r - Patients with known Charcot-Marie-Tooth disease.\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype.\r\n\r - Patients requiring radiation at diagnosis.\r\n\r - Female patients who are pregnant since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential.\r\n\r - Lactating females who plan to breastfeed their infants.\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of their study participation.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nComparison of Complete Decongestive Therapy With Intermittent Pneumatic Compression for Treatment of Lipedema\n\n**Clinical Trial Summary:**\n\nLipedema is a chronic, progressive and hereditary adipose tissue disorder characterized by an\r abnormal increase of subcutaneous adipose tissue, especially in the lower extremities. In\r contrast to obesity, lipoedema may not improve with weight loss and does not include the risk\r of metabolic syndrome such as diabetes, hypertension and dyslipidemia. However, if not\r treated for lipedema, medical complications such as hypermobility, joint problems, walking\r difficulties, and psychological complications such as anxiety and depression may develop.The\r aim of this study was to compare the effects of combined decongestive treatment and\r intermittent pneumatic compression treatment combined with aerobic exercise on pain, quality\r of life and fatigue in patients with lipedema.\n\n**Clinical Trial Detailed Description:**\n\nLipedema is a chronic, progressive and hereditary adipose tissue disorder characterized by an\r abnormal increase of subcutaneous adipose tissue, especially in the lower extremities. It is\r often seen in female sex. The main determinants of lipedema are bilateral symmetric swelling\r of the hypodermis of the legs which are painful with palpation or spontaneous and easy\r ecchymosis and hematoma with minor trauma.\r\n\r Lipedema usually begins in the period of hormonal change in adolescence or after a few years\r and can progress in women during hormone changes such as pregnancy, gynecologic surgery or\r menopause.\r\n\r Lipedema is a different diagnosis from obesity, but it can be misdiagnosed as primary obesity\r due to clinical overlap. In contrast to obesity, lipoedema may not improve with weight loss\r and does not include the risk of metabolic syndrome such as diabetes, hypertension and\r dyslipidemia. However, if not treated for lipedema, medical complications such as\r hypermobility, joint problems, walking difficulties, and psychological complications such as\r anxiety and depression may develop.\r\n\r However, if not treated for lipedema, medical complications such as hypermobility, joint\r problems, walking difficulties and psychological complications such as anxiety and depression\r may develop.\r\n\r Treatment for lipedema includes conservative and surgical options. In conservative treatment\r to control edema, combined decongestive treatment which consists of manual lymphatic drainage\r and compression bandaging, intermittent pneumatic compression and exercise options are\r included.\r\n\r The aim of this study was to compare the effects of combined decongestive treatment and\r intermittent pneumatic compression treatment combined with aerobic exercise on pain, quality\r of life and fatigue in patients with lipedema.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject diagnosed with lipedema according to the criteria of revised Wold.\r\n\r - Subject did not participate in any exercise program within the last three months.\r\n\r - No pregnancy / breastfeeding\r\n\r Exclusion Criteria:\r\n\r - History of acute infection, cancer, inflammatory rheumatic / connective tissue\r diseases\r\n\r - History of cardiovascular or musculoskeletal problems that may prevent them from\r participating in the exercise program\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to describe patterns of treatment used for cHL and sALCL in real\r world setting.\n\n**Clinical Trial Detailed Description:**\n\nThis is a non-interventional, prospective and retrospective study of participants with cHL\r and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in\r real-life clinical practice.\r\n\r The study will enroll approximately 2000 participants. Based on the diagnosis of the disease,\r participants will be assigned to one of the following groups:\r\n\r - Newly Diagnosed and RR cHL Participants\r\n\r - Newly Diagnosed and RR sALCL Participants\r\n\r This multi-center trial will be conducted in Russia. The retrospective data will be collected\r for the participants with RR cHL or RR sALCL at the time of enrollment and for participants\r with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline).\r The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to\r Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and\r participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL\r or RR sALCL within 3 years prior to inclusion in the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male and female participants 18 years or older by the time of enrollment.\r\n\r 2. Histologically confirmed diagnosis of cHL or sALCL.\r\n\r 3. Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of\r enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion\r in the Study.\r\n\r Exclusion Criteria:\r\n\r 1. Unconfirmed diagnosis of cHL or sALCL.\r\n\r 2. Current, previous (within the last 3 years) or planned (for the next 2 years)\r participation in interventional clinical trials.\r\n\r 3. Participation in the non-interventional study CHL-5001 \"An international,\r multi-centre, non-interventional retrospective study to describe treatment pathways,\r outcomes, and resource use in participants with classical Hodgkin lymphoma\r (B-HOLISTIC)\" (Sponsor is Takeda Pharmaceuticals International AG).\r\n\r 4. Participants for whom the minimum study dataset was not available from their hospital\r medical records.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\n3 Local Anesthetics for Spinal Anesthesia in Primary Total Hip Arthroplasty\n\n**Clinical Trial Summary:**\n\nSpinal anesthesia is commonly utilized for hip replacement surgery. Different medications\r used for spinal anesthesia work for different lengths of time. This study will compare three\r different spinal anesthesia medications in patients having hip replacement surgery to see if\r patients are able to get out of bed and walk earlier after surgery with one medication versus\r the others.\n\n**Clinical Trial Detailed Description:**\n\nTotal hip replacement is often performed under spinal anesthesia, which is the standard at\r Thomas Jefferson University Hospital (TJUH) and Rothman Orthopedic Specialty Hospital (ROSH)\r for patients without contraindications. Spinal anesthesia involves injecting a numbing\r medicine (local anesthetic) into the cerebrospinal fluid that bathes the spinal cord through\r a space between two bones in the back. This causes temporary numbness of the legs and hips\r and allows surgery to take place without patients feeling pain during surgery. Different\r local anesthetics can be used for spinal anesthesia and each works for a different duration\r of time. Another factor that affects how spinal anesthesia medications work is the baricity\r of the medication, which refers to how dense it is compared to cerebrospinal fluid (CSF).\r Medications that are less dense than CSF are hypobaric, those with same density are isobaric,\r and those with greater density are hyperbaric. For clinical purposes, this really only comes\r into play when positioning the patient immediately after spinal placement as patient position\r has different effects on the dermatomal level attained depending on baricity of the local\r anesthetic. Bupivacaine is a long-acting local anesthetic that has been used for several\r decades for total hip replacement. It is available in both hyperbaric form (with dextrose\r added) and isobaric form (with no dextrose added). Mepivacaine is another local anesthetic\r that has a shorter duration of action and is also used for spinal anesthesia in total hip\r replacement at many centers. All three drugs are used routinely at different centers in the\r United States. Despite the differences in duration that have been described from\r pharmacokinetic studies, a randomized, controlled study comparing the three drugs in terms of\r important outcomes, such as the ability to walk after surgery, has not been published yet.\r Therefore, the investigators want to compare the three local anesthetics in a randomized,\r controlled fashion to see if more patients are able to walk sooner after receiving\r mepivacaine spinal anesthesia than either form of bupivacaine spinal anesthesia.\r\n\r Patients who are eligible will be called the night prior to surgery and the study will be\r explained over the phone. Patients who express interest will be recruited on the day of their\r scheduled surgery in the short-procedure unit. Patients will be given consent forms and time\r to read them and ask questions.\r\n\r Preoperative Management All patients without contraindications or allergies will receive oral\r gabapentin and acetaminophen in the short procedure unit prior to surgery per routine\r practice.\r\n\r Intraoperative Management The targeted spinal dermatome level to achieve will be T10\r (umbilicus). For isobaric drugs, patients will sit after spinal placement for 3-5 minutes to\r achieve this level. For hyperbaric bupivacaine, patients will be immediately placed supine\r and in Trendelenberg position for 3-5 minutes to achieve adequate level and confirmed with\r sensory pinprick testing, which will be performed every 2 minutes beginning at spinal\r placement time. After spinal is placed, sedation will be titrated at the discretion of the\r anesthesia team to achieve the American Society of Anesthesiology's definition of moderate\r sedation (purposeful response to verbal or tactile stimulation, spontaneous ventilation, and\r no airway intervention needed) using propofol. All patients will receive tranexamic acid\r unless contraindicated (10 mg/kg bolus), as well as multimodal analgesia with a non-steroidal\r anti-inflammatory drug (NSAID) and dexamethasone 4 mg IV per routine practice.\r\n\r Postoperative Management\r\n\r Sensory and motor assessments will take place every 30 minutes from PACU arrival time until\r motor strength is 5/5 in both lower extremities in hip flexion, knee extension, and toe\r dorsiflexion or the patient's motor function returns to baseline. The time of return of motor\r function will be documented. Physical therapists will visit the patient between 3 and 3.5\r hours after spinal placement to assess for ability to ambulate and perform Tinnetti test,\r which assesses ambulation and gait and gives a score of 0 through 28 (see attached). Urinary\r retention will be assessed through asking the following on postoperative day 1:\r\n\r 1. At what time did the participant first urinate?\r\n\r 2. Did participant require a Foley catheter or straight catheter to drain urine from his or\r her bladder?\r\n\r These questions will be asked along with the following about TNS (transient neurological\r symptoms):\r\n\r 1. Does the participant have any pain in his or her lower back that goes into his or her\r buttocks and/or down his or her thigh that was not there before surgery?\r\n\r 2. If yes, how would the participant rate that specific pain from 0 (no pain) to 10 (worst\r pain imaginable).\r\n\r 3. How would the participant rate his/her overall pain (0 to 10 scale)?\r\n\r 4. How satisfied is the participant with his/her anesthesia experience (0 to 10 scale where\r 0 is very dissatisfied and 10 is very satisfied)?\r\n\r TNS will be defined as the new onset (within 24 hours of surgery) of back pain that radiates\r into the buttocks, thighs, hips, or distally. Localized back pain will not be included.\r\n\r Urinary retention will be defined by inability to urinate within 8 hours, a report of\r distended or painful bladder occurring on postoperative days 0 or 1, either by patient report\r or on assessment by nursing, or the use of a Foley catheter or straight catheter.\r\n\r Post-discharge phone calls\r\n\r The following will be asked to patients via phone calls after discharge at 24 and 48 hours\r after surgery if not still in the hospital (will be asked in-person otherwise):\r\n\r 1. Does the participant have any back pain that was not present before surgery that goes\r into his/her buttocks, thighs, hips, or lower leg?\r\n\r 2. If yes, how would the participant rate that specific pain from 0 (no pain) to 10 (worst\r pain imaginable).\r\n\r 3. How would the participant rate his/her overall pain (0 to 10 scale)?\r\n\r 4. How satisfied is the participant with his/her anesthesia experience (0 to 10 scale where\r 0 is very dissatisfied and 10 is very satisfied)?\r\n\r Post-discharge data collection Readmissions within 90 days will be recorded for all patients\r including the reason for readmission.\r\n\r General Operating Procedures Patients who agree to participate will then be randomized by a\r computer-generated sequence to one of the three study groups. The anesthesiologist and\r certified registered nurse anesthetist or resident performing the spinal will be aware of\r group allocation and will perform spinal anesthesia according to standard operating\r procedures with the assigned local anesthetic. Intraoperative sedation will be with propofol\r or dexmedetomidine, at the discretion of the anesthesia team. Patients will remain blinded\r and surgeons and those performing postoperative assessments will remain blinded as well. As\r all study drugs are standard spinal anesthesia drugs and readily available, the anesthesia\r team caring for the patient will be informed of group allocation and the appropriate drug\r will be selected. These doses of hyperbaric and isobaric bupivacaine are considered \"low\r dose\" and are lower than those routinely used at TJUH and ROSH. However, existing evidence\r shows that low-dose bupivacaine for spinal anesthesia provides adequate anesthesia time for a\r total joint replacement. Dosing will be as follows: isobaric bupivacaine 12.5 mg (2.5 cc of\r 0.5%) for < 74\" height and 15 mg (3 cc) for > or = 74\" height; hyperbaric bupivacaine 10.25\r mg (1.5 cc 0.75%) for < 74\" height and 13.125 mg (1.75 cc) for > or = 74\" height; and\r isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for < 74\" height and 60 mg (4 cc) for > or =\r 74\" height. Patients with BMI of 35 or greater will also be given the higher dose of each of\r the 3 medications listed above.\r\n\r Intraoperative variables that will be measured include: hypotension (defined as a decrease in\r baseline blood pressure of 20% or greater), surgeon rating of intraoperative muscle tension\r (0, 1, 2, or 3 where 0 is the most relaxed and 3 is the tightest), and conversion to general\r anesthesia.\r\n\r Postoperative variables that will be measured include: ambulation at 3-3.5 hours (primary\r endpoint), time to ambulation, attempts needed to ambulate, episodes of orthostatic\r hypotension while trying to ambulate, urinary retention, opioid consumption, pain, incidence\r of transient neurological symptoms up to 48 hours postoperatively, discharge readiness, and\r length of stay.\r\n\r Post-discharge phone calls\r\n\r The following will be asked to patients via phone calls after discharge on postoperative days\r 1 and 2 after surgery if not still in the hospital (will be asked in-person otherwise):\r\n\r 1. Does the participant have any pain in his/her lower back that goes into his/her buttocks\r and/or down his/her thigh that was not there before surgery?\r\n\r 2. If yes, how would the participant rate that specific pain from 0 (no pain) to 10 (worst\r pain imaginable).\r\n\r 3. How would the participant rate his/her overall pain (0 to 10 scale)?\r\n\r 4. How satisfied is the participant with his/her anesthesia experience (0 to 10 scale where\r 0 is very dissatisfied and 10 is very satisfied)?\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - undergoing elective primary hip replacement surgery\r\n\r - American Society of Anesthesiologists physical status 1-3\r\n\r Exclusion Criteria:\r\n\r - hip fracture\r\n\r - contraindication to spinal anesthesia (refusal, coagulopathy or recent use of\r anticoagulant medication that prevents spinal anesthesia, local or systemic infection)\r\n\r - any other reason deemed significant by attending anesthesiologist\r\n\r - any patient requiring a wheelchair for ambulation or who cannot walk 25 feet with or\r without an assist device at time of surgery\r\n\r - presence of neuropathy in posterior thighs or buttocks\r\n\r - use of greater than the equivalent of morphine 25 mg IV (oxycodone 30 mg PO) daily\r\n\r - any patient deemed a poor candidate for spinal anesthesia as determined by the\r attending anesthesiologist\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBenign Prostatic Hyperplasia and Glycosaminoglycan\n\n**Clinical Trial Summary:**\n\nLower urinary tract symptoms (LUTS) are one of the most common conditions in the urology\r clinic, affecting at least one in four men after 40 years of age. Benign prostatic\r hyperplasia is the most common cause of LUTS. Bladder dysfunction (hypersensitivity or\r detrusor overactivity) and bladder outlet obstruction are two main pathologies involved in\r the etiology of LUTS. In men aged 40-49, moderate and severe LUTS are reported as 26%, while\r this ratio is doubled in the age group of 70 years and older. Clinically, BPH is defined as\r an international symptom score of more than 8, a prostate volume of more than 30 ml, and a\r maximum flow rate of less than 15 ml / sec. Alpha blockers are recommended as the first-line\r medical treatment according to European Urology Guidelines (EAU Guidelines 2018) for patients\r diagnosed with BPH clinically. In recent years, many studies have been published on the\r relationship of urinary biomarkers with LUTS. Nerve growth factor and brain derived\r neurotrophic factor have been shown to be closely related to neurogenic or non-neurogenic\r detrusor overactivity and significant improvements were observed after treatment.The\r relationship between urinary glycosaminoglycan and overactive bladder has been shown and it\r has been reported that the values have decreased after treatment.Male patients with LUTS\r caused by BPH often have symptoms of overactive bladder. However, as far as we know, there is\r no study in the literature about the meaning of urinary GAG levels in this patient group. The\r aim of this study was to investigate the relationship between urinary glycosaminoglycan\r levels and patients who had benign prostatic hyperplasia with and without overactive bladder\r symptoms.\n\n**Clinical Trial Detailed Description:**\n\n35 patients and 10 controls were planned to be included in the study. Urine will be collected\r from patients before and after one month of medical treatment (alpha-blocker). After being\r centrifuged at 5000 g for 10 minutes, urine will be stored at -80 ° C. At the end of the\r study, urinary glycosaminoglycan levels will be studied by spectrophotometric method. Urine\r GAG levels and pre and post treatment uroflowmetry, IPSS, overactive bladder symptom score,\r bladder frequency volume chart, post void residual urine volume will be compared.\n\n**Clinical Trial Eligibility Criteria:**\n\nEligibility Criteria\r\n\r 1. Male patients presenting with lower urinary tract symptoms to urology outpatient\r clinic\r\n\r 2. According to the European Association of Urology Guidelines:\r\n\r 1. International prostate symptom score> 8\r\n\r 2. Prostate volume> 40 ml\r\n\r 3. Q max <15 ml /sn\r\n\r 3. Patients who did not receive any treatment for lower urinary tract symptoms and\r applied for the first time\r\n\r 4. Patients who have not undergone lower urinary tract surgery\r\n\r Exclusion Criteria\r\n\r 1. Patients who had undergone medical and surgical treatment for lower urinary tract\r symptoms\r\n\r 2. Patients with accompanying urethral stricture\r\n\r 3. Patients with neurological diseases (Parkinson's, Multiple Sclerosis etc ...)\r\n\r 4. Patients with spinal cord trauma\r\n\r 5. Patients with indication for surgical treatment at the time of initial admission\r (Macroscopic hematuria, bladder stone, urinary retention, upper urinary tract\r dilatation)\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nInotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy\n\n**Clinical Trial Summary:**\n\nThis phase III trial studies whether inotuzumab ozogamicin added to post-induction\r chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves\r outcomes. This trial also studies the outcomes of patients with mixed phenotype acute\r leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without\r inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab,\r linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in\r a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy\r regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin,\r methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and\r pegaspargase work in different ways to stop the growth of cancer cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. This trial will\r also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and\r disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.\r\n\r The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard\r of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic\r Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy:\r Induction and Consolidation. This part will collect information on the leukemia, as well as\r the effects of the initial treatment, in order to classify patients into post-consolidation\r treatment groups. On the second part of this study, patients will receive the remainder of\r the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance\r II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this\r study include investigating whether treating both males and females with the same duration of\r chemotherapy maintains outcomes for males who have previously been treated for an additional\r year compared to girls, as well as to evaluate the best ways to help patients adhere to oral\r chemotherapy regimens. Finally, this study will be the first to track the outcomes of\r subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute\r Leukemia (MPAL) when treated with B-ALL chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To determine in a randomized manner if the addition of 2 blocks of inotuzumab ozogamicin\r to modified Berlin-Frankfurt-Munster (mBFM) chemotherapy will improve 5-year disease-free\r survival (DFS) in children and young adults with high-risk B-cell acute lymphoblastic\r leukemia (HR B-ALL).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To describe the 5-year DFS for a favorable risk subset of National Cancer Institute (NCI)\r HR B-ALL (HR-Fav) when treated with mBFM chemotherapy with a single high-dose methotrexate\r (HD-MTX) interim maintenance (IM) phase and treatment duration of 2 years from the start of\r IM regardless of sex.\r\n\r II. To determine the toxicity and tolerability of inotuzumab ozogamicin integrated into the\r mBFM chemotherapy backbone in HR B-ALL.\r\n\r III. To describe the 5-year event-free survival (EFS) for patients with mixed phenotype acute\r leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi\r escalating intravenous (IV) methotrexate (MTX) without leucovorin rescue plus pegaspargase\r (C-MTX).\r\n\r IV. To describe the 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell\r lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM\r phase with C-MTX.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To describe the therapy administered, disease response, and survival outcomes of patients\r with MPAL who come off protocol therapy due to poor disease response to ALL therapy either\r during Induction, at end of induction (EOI), or at end of consolidation (EOC).\r\n\r II. To define the prevalence and significance of minimal marrow disease (MMD) at diagnosis\r and bone marrow minimal residual disease (MRD) at EOI in disseminated B-LLy.\r\n\r III. To determine the impact of proposed adherence-enhancing interventions on adherence to\r oral 6-mercaptopurine in patients with ALL.\r\n\r OUTLINE: All patients receive the same Induction and Consolidation chemotherapy. Patients\r with HR-Fav B-ALL are assigned to Arm I. Patients with HR B-ALL are randomized to Arm II or\r III. Patients with MPAL are assigned to Arm IV, and patients with B-LLy are assigned to Arm\r V.\r\n\r All patients with B-ALL receive Induction and Consolidation therapy:\r\n\r INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1 and central nervous system\r (CNS)2 patients also receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also\r receive vincristine intravenously (IV) or IV push over 1 minute on days 1, 8, 15, and 22,\r daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargase intramuscularly (IM) or\r IV over 1-2 hours on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for\r CNS3 patients). Patients < 10 years old receive dexamethasone orally (PO) twice daily (BID)\r or IV on days 1-14; patients >= 10 years old receive prednis(ol)one PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39,\r mercaptopurine PO once daily (QD) on days 1-14 and 29-42, and methotrexate IT on days 1, 8,\r 15, and 22 (CNS3 patients receive methotrexate IT on days 1 and 8). Patients also receive\r vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and pegaspargase IV over\r 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in the absence of disease\r progression or unacceptable toxicity. Additionally, patients with testicular disease at\r diagnosis that does not resolve by the end of induction will undergo radiation therapy over\r 12 once daily fractions.\r\n\r POST-CONSOLIDATION THERAPY: After Consolidation, based on clinical features and response,\r patients with B-ALL are designated as HR-Fav or HR B-ALL. Patients with HR-Fav B-ALL are\r assigned to Arm I. Patients with HR B-ALL are randomized to Arm II or III. Patients with MPAL\r and B-LLy are assigned to therapy arms (Arms IV and V) that are identical to Arm II. Patients\r that are < 10 years, have CNS1, no testicular leukemia, with favorable cytogenetics (ETV6\r RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours of steroids in the two weeks prior\r to diagnosis, and EOI MRD < 0.01% are assigned to Arm I. Patients with HR B-ALL who are\r surface CD22 positive at diagnosis and have MRD < 0.01% by the end of Consolidation, are\r randomized to either Arm II or III.\r\n\r ARM I: HR-FAV B-ALL (Patients that are < 10 years, have CNS1 status, no testicular leukemia,\r with favorable cytogenetics (ETV6 RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours\r of steroids in the two weeks prior to diagnosis, and EOI MRD < 0.01%)\r\n\r INTERIM MAINTENANCE: Patients receive vincristine IV or IV push over 1 minute on days 1, 15,\r 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO\r or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO QD on days 1-14, 15-28, 29-42,\r and 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the\r absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINTENANCE: Patients receive methotrexate IT on days 1 and 29 for cycles 1-4, and day 1 for\r subsequent cycles. Patients also receive vincristine IV or IV push over 1 minute on day 1,\r prednisolone PO BID or IV on days 1-5, mercaptopurine PO QD on days 1-84, and methotrexate PO\r on days 8, 15, 22, (29 excluded in cycles 1-4), 36, 43, 50, 57, 64, 71, and 78. Cycles repeat\r every 12 weeks for up to 2 years in the absence of disease progression or unacceptable\r toxicity.\r\n\r Patients with HR B-ALL who have MRD < 0.01% by the end of Consolidation, and leukemic blasts\r positive for surface CD22 at diagnosis are randomized to Arm II or Arm III.\r\n\r ARM II: HR B-ALL (CONTROL) INTERIM MAINTENANCE I: Patients receive vincristine IV or IV push\r over 1 minute on days 1, 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1,\r 15, 29 and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, 45-46, mercaptopurine PO QD on\r days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29. Treatment continues\r for 9 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31 and 41, methotrexate IV over 2-15 minutes or 10-15 minutes on days 1, 11, 21, 31,\r and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2 hours or IM on days 2\r and 22. Treatment continues for 8 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r ARM III: HR B-ALL (EXPERIMENTAL) INOTUZUMAB OZOGAMICIN (InO) BLOCK 1: Patients receive\r inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 and methotrexate IT on day 1.\r Treatment continues for 4 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r INTERIM MAINTENANCE I: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin\r PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-14, 15-28, 29-42,\r and 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the\r absence of disease progression or unacceptable toxicity.\r\n\r InO BLOCK 2: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15.\r Treatment continues for 4 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV on days 1, 11, 21, 31, and 41, methotrexate IT on days 1\r and 31, and pegaspargase IV over 1-2 hours or IM on days 2 and 22. Treatment continues for 8\r weeks in the absence of disease progression or unacceptable toxicity.\r\n\r ARMS II AND III: HR B-ALL MAINTENANCE: Patients receive vincristine IV or IV push over 1\r minute on day 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO on days 1-84,\r methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71\r and 78, and methotrexate IT on days 1 (and 29 of cycles 1-2 for patients who do not receive\r cranial radiation). Cycles repeat every 12 weeks for up to 2 years in the absence of disease\r progression or unacceptable toxicity. Patients with CNS3 disease undergo cranial radiation\r therapy over 10 fractions during the first 4 weeks.\r\n\r ARM IV: MPAL INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also\r receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV or\r IV push over 1 minute on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8,\r 15, and 22, pegaspargase IM or IV over 1-2 hours on day 4, and methotrexate IT on days 8 and\r 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone\r PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO\r on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22\r for CNS3 patients), vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and\r pegaspargase IV over 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in\r the absence of disease progression or unacceptable toxicity. Patients with testicular disease\r at diagnosis that does not resolve by the end of induction will and continued evidence of\r testicular disease at end of induction undergo testicular radiation over 12 once-daily\r fractions.\r\n\r ARM V: B-LLY INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also\r receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV or\r IV push over 1 minute on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8,\r 15, and 22, pegaspargase IM or IV over 1-2 hours on day 4, and methotrexate IT on days 8 and\r 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone\r PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days\r 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable\r toxicity.\r\n\r CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,\r cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO\r on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22\r CNS3 patients), vincristine IV or IV push over 1 minute on days 15, 22, 43, and 50, and\r pegaspargase IV over 1-2 hours or IM on days 15 and 43. Treatment continues for 8 weeks in\r the absence of disease progression or unacceptable toxicity. Patients with testicular disease\r at diagnosis that does not resolve by the end of induction will and continued evidence of\r testicular disease at end of induction undergo testicular radiation therapy over 12\r once-daily fractions.\r\n\r ARM IV AND V: MPAL AND B-LLY (Post-Consolidation Therapy) INTERIM MAINTENANCE I: Patients\r receive vincristine IV or IV push over 1 minute on days 1, 15, 29, and 43, high dose\r methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4,\r 17-18, 31-32, and 45-46, methotrexate IT on days 1 and 29 and mercaptopurine PO QD on days\r 1-14, 15-28, 29-42, and 43-56. Treatment continues for 9 weeks in the absence of disease\r progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO\r BID or IV on days 1-7 and 15-21, vincristine IV or IV push over 1 minute on days 1, 8, and\r 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase\r IV over 1-2 hours or IM on day 4. Treatment (Parts I and II of Delayed Intensification)\r continues for 8 weeks in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on\r day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and\r 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43\r and 50, and pegaspargase IV over 1-2 hours or IM on day 43. Treatment (Parts I and II of\r Delayed Intensification) continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r INTERIM MAINTENANCE II: Patients receive vincristine IV or IV push over 1 minute on days 1,\r 11, 21, 31, and 41, methotrexate IV or infusion over 2-15 minutes or 10-15 minutes on days 1,\r 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2 hours or\r IM on days 2 and 22. Treatment continues for 8 weeks in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINTENANCE: Patients receive vincristine IV or IV push over 1 minute on days 1, prednisolone\r PO BID or IV on days 1-5, mercaptopurine PO on days 1-84, methotrexate PO on days 8, 15, 22,\r 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71, and 78, and methotrexate IT on days\r 1 (and 29 of cycles 1-2 for patients who do not receive cranial radiation). Cycles repeat\r every 12 weeks for up to 2 years in the absence of disease progression or unacceptable\r toxicity. Patients with CNS3 disease at diagnosis undergo cranial radiation therapy for 10\r fractions over 4 weeks.\r\n\r After completion of study treatment, patients are followed up at 4 weeks, then every 3 months\r for 2 years, every 4-6 months for the third year, then every 6-12 months for years 4-5.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility\r studies (Part A) prior to treatment and enrollment on AALL1732. Note that central\r confirmation of MPAL diagnosis must occur within 7 business days after enrollment for\r MPAL patients. If not performed within this time frame, patients will be taken off\r protocol.\r\n\r - APEC14B1 is not a requirement for B-LLy patients but for institutional compliance\r every patient should be offered participation in APEC14B1. B-LLy patients may directly\r enroll on AALL1732.\r\n\r - White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to\r the start of protocol-directed systemic therapy):\r\n\r - Age 1-9.99 years: WBC >= 50,000/uL\r\n\r - Age 10-24.99 years: Any WBC\r\n\r - Age 1-9.99 years: WBC < 50,000/uL with:\r\n\r - Testicular leukemia\r\n\r - CNS leukemia (CNS3)\r\n\r - Steroid pretreatment.\r\n\r - White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to\r the start of protocol-directed systemic therapy):\r\n\r - Age 1-24.99 years: any WBC.\r\n\r - Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016\r criteria) with > 25% blasts on a bone marrow (BM) aspirate;\r\n\r - OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the\r diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM\r biopsy;\r\n\r - OR A complete blood count (CBC) documenting the presence of at least 1,000/uL\r circulating leukemic cells if a bone marrow aspirate or biopsy cannot be\r performed.\r\n\r - Patient has newly diagnosed B-LLy Murphy stages III or IV.\r\n\r - Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\r\n\r - Note: For B-LLy patients with tissue available for flow cytometry, the criterion for\r diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e.,\r paraffin blocks), the methodology and criteria for immunophenotypic analysis to\r establish the diagnosis of B-LLy defined by the submitting institution will be\r accepted.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent.\r\n\r - All institutional, Food and Drug Administration (FDA), and NCI requirements for human\r studies must be met.\r\n\r Exclusion Criteria:\r\n\r - Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL\r are eligible for AALL1731, regardless of NCI risk group).\r\n\r - With the exception of steroid pretreatment or the administration of intrathecal\r cytarabine, patients must not have received any prior cytotoxic chemotherapy for the\r current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to\r initiation of protocol therapy on AALL1732.\r\n\r - Patients who have received > 72 hours of hydroxyurea within one week prior to start of\r systemic protocol therapy.\r\n\r - Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow\r submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted\r containing > 1,000/uL circulating leukemia cells.\r\n\r - Patients with acute undifferentiated leukemia (AUL) are not eligible.\r\n\r - For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid\r pretreatment, the following additional exclusion criteria apply:\r\n\r - T-lymphoblastic lymphoma.\r\n\r - Morphologically unclassifiable lymphoma.\r\n\r - Absence of both B-cell and T-cell phenotype markers in a case submitted as\r lymphoblastic lymphoma.\r\n\r - Patients with known Charcot-Marie-Tooth disease.\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype.\r\n\r - Patients requiring radiation at diagnosis.\r\n\r - Female patients who are pregnant, since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential.\r\n\r - Lactating women who plan to breastfeed their infants while on study and for 2 months\r after the last dose of inotuzumab ozogamicin.\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of study participation. For those\r patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the\r last dose of inotuzumab ozogamicin for females and 5 months after the last dose of\r inotuzumab ozogamicin for males.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"content": "**Clinical Trial Title:**\n\nDataBase of pulmoNary hyPertesion in PoLish Population - BNP-PL\n\n**Clinical Trial Summary:**\n\nThe BNP-PL is a multicenter, observational study in which patients are prospectively followed\r in order to investigate clinical course and management of pulmonary hypertension in Poland.\r\n\r All patients diagnosed with pulmonary arterial hypertension and chronic thromboembolic\r pulmonary hypertension confirmed in right heart catheterization, will be eligible to\r participate in the study.\n\n**Clinical Trial Detailed Description:**\n\nThe BNP-PL Registry is an initiative of the Polish Cardiac Society Task Force for Pulmonary\r Vascular Diseases This study is conducted by the Polish Cardiac Society. All centers of\r pulmonary hypertension in Poland which are accredited by the National Health Fund have been\r invited to join the study. The data is administrated by the Jagiellonian University Medical\r College on the basis of an agreement between the Polish Cardiac Society, Jagiellonian\r University Medical College and pulmonary hypertension centres.\r\n\r The goal is to describe current practice and outcomes in patients with pulmonary arterial\r hypertension and chronic thromboembolic pulmonary hypertension.\r\n\r The data collection will have no impact on the way the patient is diagnosed and treated.\r\n\r Collection of data on patients with pulmonary hypertension is carried out via the electronic\r platform.\r\n\r No personal data is entered into the project database.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary\r hypertension diagnosed after 1st March 2018 (incident cases) who:\r\n\r - are aged > 3 months at the time of enrollment\r\n\r - fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mPAP) of\r 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular\r end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance\r (PVR) of 3 Woods.\r\n\r Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary\r hypertension diagnosed before 1st March 2018 (prevalent cases) who:\r\n\r - are aged > 3 months at the time of enrollment\r\n\r - fulfill the following hemodinamic criteria: mean pulmonary arterial pressure (mPAP) of\r 25 mm Hg or more, mean pulmonary arterial wedge pressure (PAWP) or left ventricular\r end-diastolic pressure (PVEDP) of 15 mm Hg or less, pulmonary vascular resistance\r (PVR) of 3 Woods\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nStudy of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG\n\n**Clinical Trial Summary:**\n\nThe goal of this study is to estimate the efficacy of encorafenib and binimetinib as measured\r by radiographic response in recurrent high-grade primary brain tumors.\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objective Estimate the efficacy of combination treatment with encorafenib and\r binimetinib, as measured by response rate (RANO criteria), in patients with recurrent BRAF\r V600E/K-mutated malignant glioma (MG) and anaplastic pleomorphic xanthoastrocytoma (PXAs).\r\n\r Secondary Objectives\r\n\r 1. Estimate efficacy as measured by progression-free survival in subjects with recurrent\r malignant glioma or anaplastic PXA containing a BRAF-V600E/K mutation who receive drug.\r\n\r 2. Evaluate duration of response in subjects who have a partial or complete response.\r\n\r 3. Quantify the time-to-response among subjects who have a radiologic response.\r\n\r 4. Estimate efficacy as measured by overall survival in subjects with recurrent malignant\r glioma or anaplastic PXA containing a BRAF-V600E/K mutation who receive drug.\r\n\r 5. Characterize the toxicity profile of the combination of encorafenib and binimetinib in\r this patient population.\r\n\r There are two arms: medical and surgical. Subjects on the surgical arm must have a high-grade\r glioma or a known BRAF-mutated low-grade glioma with high clinical suspicion for progression\r to high-grade.\r\n\r Medical: Following enrollment, patients will receive encorafenib and binimetinib at the\r FDA-approved dose of 450 mg of encorafenib once daily and the FDA-approved dose of 45 mg of\r binimetinib twice daily separated by 12 hours, continuously in 28-day cycles until\r progression or unacceptable toxicity. Patients will be followed by routine blood work, and\r general and neurological examination. A brain MRI will be performed prior to every\r odd-numbered cycle (every 8 weeks). Response will be assessed by RANO criteria. Patients may\r remain on study and receive treatment until progression or other reason.\r\n\r Surgical: These subjects will take encorafenib and binimetinib in combination at their\r FDA-approved doses for 10-14 days prior to surgery. The last dose of both drugs will be\r administered two hours prior to surgery. Specimens will be collected during surgery. After\r surgery, the subjects will not take further encorafenib or binimetinib until a study visit to\r assess their neurological exam, physical exam, and performance status, at 2-6 weeks\r post-operatively. At time of restarting combination treatment, subjects will follow the\r schedule for the medical cohort, and will continue treatment until progression.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients receiving any other standard or investigational agents are ineligible.\r\n\r 2. Patients with history or current evidence of the following conditions are excluded:\r neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies,\r muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy),\r pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception\r will be made for (HIV)-infected patients on effective anti-retroviral therapy with\r undetectable viral load within 6 months and for subjects with cleared HBV and HCV\r infections, who may enroll in the study.\r\n\r 3. Patients must have measurable (defined by at least 1 cm x 1 cm) contrast-enhancing\r disease by MRI imaging within 30 days of starting treatment.\r\n\r 4. The following intervals from previous treatments are required to be eligible:\r\n\r - 12 weeks from the completion of radiation.\r\n\r - 16 weeks from an anti-VEGF therapy\r\n\r - 4 weeks from a nitrosourea chemotherapy\r\n\r - 3 weeks from a non-nitrosourea chemotherapy\r\n\r - 2 weeks or 5 half-lives from any investigational (not FDA-approved) agents\r\n\r - 2 weeks from administration of a non-cytotoxic, FDA-approved agent (e.g.,\r erlotinib, hydroxychloroquine, etc.)\r\n\r 5. Patients must be 18 years of age or older.\r\n\r 6. Patients must have a Karnofsky Performance (KPS) Status ≥ 60%\r\n\r 7. Patients must have adequate organ and marrow function within 30 days of starting\r treatment.\r\n\r 8. Patients must be able to provide written informed consent.\r\n\r 9. Women of childbearing potential must have a negative serum pregnancy test prior to\r study start. Women of childbearing potential must agree to use adequate contraception\r (intrauterine device, barrier, or other non-hormonal method of birth control; or\r abstinence) and not to donate ova from screening through 30 days after the last dose\r of study drug. Male participants must also agree to use adequate contraception and not\r to donate sperm from screening until 90 days after the last dose of study drug.\r\n\r 10. Patients must be maintained on a stable or decreasing dose of systemic corticosteroid\r regimen (no increase for 5 days) prior to baseline MRI. Topical and inhaled steroid\r treatment is allowed.\r\n\r 11. Patients must have no concurrent malignancy except curatively treated basal or\r squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or\r bladder. Patients with other malignancies must be disease-free for ≥ 2 years.\r\n\r 12. Patients must be able to swallow tablets and capsules.\r\n\r 13. Patients must have a tumor tissue form completed and signed by a pathologist (see\r Section 9.6.4). The tumor tissue form must indicate availability of archived tissue.\r The archived tissue should be from the most recent tumor resection, demonstrating\r active tumor when sufficient tissue is available. If sufficient tissue is not\r available from the most recent surgery, then tissue from an earlier surgery is\r acceptable, if available, including from the initial resection at diagnosis.\r\n\r Exclusion Criteria:\r\n\r 1. Patients receiving any other standard or investigational agents are ineligible.\r\n\r 2. Patients with history or current evidence of the following conditions are excluded:\r neuromuscular disorder with associated elevated CK (e.g. inflammatory myopathies,\r muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy),\r pancreatitis, retinal vein occlusion, uncontrolled HIV, or Hepatitis B/C. An exception\r will be made for (HIV)-infected patients on effective anti-retroviral therapy with\r undetectable viral load within 6 months and for subjects with cleared HBV and HCV\r infections, who may enroll in the study.\r\n\r 3. Known hypersensitivity or contraindication to any component of binimetinib or\r encorafenib or their excipients\r\n\r 4. Current use of a prohibited medication (including herbal medications, supplements, or\r foods), or use of a prohibited medication ≤ 7 days prior to the start of study\r treatment.\r\n\r 5. Patient has not recovered to ≤ Grade 1 non-hematologic toxic effects of prior therapy\r before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are\r not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related\r endocrinopathies) are exceptions and may enroll.\r\n\r 6. Impaired cardiovascular function or clinically significant cardiovascular disease\r including, but not limited to, any of the following:\r\n\r - History of acute coronary syndromes (including myocardial infarction, unstable\r angina, coronary artery bypass grafting, coronary angioplasty or stenting) ≤ 180\r days prior to start date;\r\n\r - Congestive heart failure requiring treatment (New York Heart Association Grade ≥\r 2);\r\n\r - Left ventricular ejection fraction (LVEF) < 50% as determined by MUGA or ECHO;\r\n\r - Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150\r mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;\r\n\r - History or presence of clinically significant cardiac arrhythmias (including\r resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal\r supraventricular tachycardia);\r\n\r - Triplicate average baseline QTc interval ≥ 480 ms.\r\n\r 7. Impairment of gastrointestinal function or disease which may significantly alter the\r absorption of study drug (e.g., active ulcerative disease, uncontrolled vomiting or\r diarrhea, malabsorption syndrome, small bowel resection with decreased intestinal\r absorption), or recent (≤ 90 days) history of a partial or complete bowel obstruction,\r or other conditions that will interfere significantly with the absorption of oral\r drugs.\r\n\r 8. History of recent (≤ 90 days) thromboembolic or cerebrovascular event such as\r transient ischemic attack, cerebrovascular accident, or hemodynamically significant\r (massive or sub-massive) deep vein thrombosis or pulmonary emboli (DVT/PE). Note:\r Patients with DVT/PE that does not result in hemodynamic instability may enroll as\r long as they are anticoagulated for at least 4 weeks. Note: Patients with DVT/PE\r related to indwelling catheters or other procedures may enroll.\r\n\r 9. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing\r or active infection or psychiatric illness/social situations that would limit\r compliance with study requirements, are ineligible.\r\n\r 10. Pregnant women are excluded from this study because the effects of encorafenib and/or\r binimetinib on a fetus are unknown. Because there is an unknown but potential risk for\r adverse events in nursing infants secondary to treatment of the mother with\r encorafenib or binimetinib, breastfeeding should be discontinued if the mother is\r treated with encorafenib and/or binimetinib.\r\n\r 11. Patients who previously received BRAF or MEK inhibitors are excluded (including but\r not limited to dabrafenib, vemurafenib, encorafenib, sorafenib, trametinib,\r binimetinib, cobimetinib, or selumetinib).\r\n\r 12. Patients will be excluded if their tumor harbors a known RAS activating mutation. This\r does not need to be specifically tested for eligibility.\r\n\r 3.4 Additional Inclusion Criteria for Surgical Arm\r\n\r Patients must meet the above inclusion / exclusion criteria for consideration with one\r exception. Patients with a BRAF-V600 E or K mutated low-grade glioma for whom there is a\r strong clinical suspicion of progression to high-grade would also be eligible for this arm.\r Additionally:\r\n\r 1. Patients must have a clinical indication for a tumor surgery.\r\n\r 2. No a priori contraindication to biospecimen collection (blood, tumor, CSF).\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEffects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke\n\n**Clinical Trial Summary:**\n\nThe goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted\r gait training on rehabilitation functional outcomes in patients with stroke undergoing\r therapy in an in-patient rehabilitation facility.\n\n**Clinical Trial Detailed Description:**\n\nAbstract\r\n\r Objective: The goal of this study is to determine the efficacy of electromechanical\r exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with\r stroke undergoing therapy in an in-patient rehabilitation facility.\r\n\r Background:\r\n\r Method: The investigators will study 50 patients with stroke consecutively admitted to a\r designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients\r will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or\r over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either\r the experimental (exoskeleton) or the control (over-ground) groups by computer-generated\r randomization. This is an open-label pragmatic trial, where neither the patients nor the\r clinicians could be masked to the intervention. Institution review board (IRB) approval will\r be obtained for the protocol. The demographic data to be collected includes: age, gender,\r race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke\r severity (on the National Institute of Health Stroke Severity [NIHSS] scale. Admission and\r discharge total Functional Independence Measure (FIM), spasticity and depression scores,\r ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The\r intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM,\r depression and spasticity scores. The secondary outcome measure was discharge disposition.\r Continuous variables were analyzed using Students t-test, ordinal variables were analyzed\r using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. All patients with acute hemorrhagic or ischemic stroke documented clinically and by\r neuroimaging.\r\n\r 2. Medically stable from a cardio-respiratory stand point so that they can participate in\r daily therapies.\r\n\r 3. Depressed patients will be included in the study\r\n\r 4. Patients able to stand alone\r\n\r 5. Patients able to provide a written informed consent, from cognitively intact patients\r (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21).\r\n\r Exclusion Criteria:\r\n\r 1. Aphasic patients unable to communicate\r\n\r 2. Confused patients\r\n\r 3. Patients medically unstable\r\n\r 4. Patients unable to stand alone\r\n\r 5. Refusal to provide written informed consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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351
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nAcupuncture on GB26 to Treat Chronic Low Back Pain\n\n**Clinical Trial Summary:**\n\nThis study evaluates the effecacy of acupoint GB26 based acupuncture treatment in patients\r with chronic low back pain. Half of the participants will partake in a 2-week acupuncture\r intervention, while the other half will receive a placebo treatment. The investigators\r hypothesize that acupuncture on GB26 reduces disability and pain more than the control\r intervention.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adults (both male and female) with non-specific low back pain for more than three\r months.\r\n\r - Age range: between 20 and 60 years.\r\n\r - Willingness of the patient to participate in the study, and written informed consent\r signed and personally dated by the patient.\r\n\r - Chronic non-specific low back pain clinically diagnosed as repeated lumbar sourness\r and swelling pain or a chronic progressive process, accompanied by (i) X-ray\r examination to exclude lumbar vertebrate fractures, spondylolysis, spondylolisthesis\r and severe osteoporosis, and/or (ii) MRI with normal signal or low nucleus pulposus\r signal.\r\n\r Exclusion Criteria:\r\n\r - Age less than 20 or greater than 60 years\r\n\r - Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections)\r\n\r - Complicated back problems (e.g., prior back surgery, medico-legal issues)\r\n\r - Possible contraindications for acupuncture (e.g., coagulation disorders, cardiac\r pacemakers, pregnancy, seizure disorder), and conditions that might confound treatment\r effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis)\r\n\r - Conditions making treatment difficult (e.g., paralysis, psychoses, or other severe\r psychiatric problems based on the judgment of a physician investigator and/or a T\r score >60 on the psychological assessments performed during Session 1)\r\n\r - Prior acupuncture treatment for back pain; 1 year minimum for any other condition.\r\n\r - The intent to undergo surgery during the time of involvement in the study.\r\n\r - History of cardiac, respiratory, or nervous system disease that, in the judgment of a\r physician investigator, precludes participation in the study because of a heightened\r potential for adverse outcome (e.g., asthma, claustrophobia)\r\n\r - Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal\r implants, fear of closed spaces, pregnancy)\r\n\r - Active substance abuse disorders within the last 24 months, based on subject\r self-report\r\n\r - Radicular knee pain extending below the knee\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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352
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nReminiscence Technology Balance and Mobility\n\n**Clinical Trial Summary:**\n\nThis study evaluates the feasibility of a larger randomized controlled trial to examine the\r effect of reminiscence aided physical activity on the balance and mobility of older adults\r living in long term care. The study uses the jDome BikeAround system, which is a stationary\r bicycle with a projector screen that runs google earth, as the user bicycles, the map\r progresses giving the appearance that the user is bicycling through the environment chosen.\r Half of the participants will use the system during the first 6 week campaign, there will\r then be a 6 week washout period. Following the washout period, there will be a second 6 week\r campaign when the other half of the participants will use the jDome BikeAround system.\n\n**Clinical Trial Detailed Description:**\n\nPhysical activity has been shown to have numerous benefits for physical well-being and\r function. Stationary cycling is one example of physical activity that can provide\r opportunities for residents who are inactive, living in long term care and are at high risk\r for falls.\r\n\r The use of jDome BikeAround provides older adults in long term care an opportunity to engage\r in a motivating reminiscence activity that is coupled with physical activity. Participants\r will be divided into two groups, one group will take part in jDome BikeAround sessions 3x per\r week for 6 weeks in addition to The Glebe Centre's Fall Prevention program, while the second\r group will just participant in Fall Prevention program. There will be a 6 week wash out, then\r the second cohort will participant in the jDome Bike Around sessions 3x a week in addition to\r the Fall Prevention program while the first cohort will just participate in the Fall\r Prevention Program.\r\n\r Participants will have their balance, mobility, leg strength, endurance tested as well as a\r tracking of fall risks at the beginning and end of each of the jDome BikeAround sessions (4\r measurement points). Feasibility will be determined by the ability to enroll an adequate\r number of participants, protocol completion by participants, and the number of adverse\r events.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Scott fall risk of 2-17 (this is the current range used by the Glebe Centre, there\r have been 0 falls during transportation to the equipment and during each session of\r the BikeAround system)\r\n\r - Sufficient visual abilities to observe images on the domed screen\r\n\r - Able to comprehend and communicate in English.\r\n\r - Adequate attentional capacity to remain focused on the pedalling task.\r\n\r - Minimum height requirement of 5'2\" or 157cm in order to successfully fit the\r BikeAround system's stationary bike.\r\n\r Exclusion Criteria:\r\n\r - Physical limitations (as determined by the Glebe Centre healthcare/physiotherapy team)\r that prevent use of the jDome bike.\r\n\r - Cognitive impairment (as determined by the Glebe Centre healthcare/physiotherapy team)\r Inability to sustain attention Inability to follow one-step commands.\r\n\r - Known behavioural abnormalities (e.g. overly aggressive behavior) that in the opinion\r of the clinical care team might impede any meaningful participation in the project\r\n\r - Those who are in the opinion of attending physician or clinical team too unwell to\r participate in the project\r\n\r - Fully unable to complete outcome measures indicated (Section 7, Outcomes)\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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353
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee\n\n**Clinical Trial Summary:**\n\nThis study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin\r in patients with moderate to severe knee pain due to osteoarthritis.\n\n**Clinical Trial Detailed Description:**\n\nThis study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered\r intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).\n\n**Clinical Trial Eligibility Criteria:**\n\nKey Inclusion Criteria:\r\n\r - Male or female 35 to 85 years of age (inclusive).\r\n\r - Diagnosis of moderate to severe pain in the index knee due to OA.\r\n\r - Pain in the non-index knee is less than pain in the index knee.\r\n\r - Body mass index ≤40 kg/m².\r\n\r - Experienced treatment failure with at least 2 prior categories of therapies.\r\n\r - Able to understand and complete study-related forms and communicate with the\r Investigator and/or site staff.\r\n\r Key Exclusion Criteria:\r\n\r - Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited\r bleeding disorders or thrombocytopenia.\r\n\r - History of or current condition of poorly controlled hypertension, QTc prolongation,\r history of risk factors for Torsades de Pointes, or family history of long QT\r syndrome; or is using concomitant medications that prolong the QT interval.\r\n\r - Received index knee injections with corticosteroids within 30 days, or hyaluronic acid\r within 3 months, or platelet-rich plasma within 6 months prior to the injection day.\r\n\r - Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone\r OA, or knee pain attributable to disease other than OA.\r\n\r - Instability or misalignment in the index knee.\r\n\r - Concurrent use of opioids or indications other than knee pain.\r\n\r - History within the past 2 years of substance abuse, including alcohol.\r\n\r - Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin,\r acetaminophen, tramadol, or radiographic contrast agents.\r\n\r - Female participants who are pregnant, planning on becoming pregnant, or currently\r breastfeeding.\r\n\r - Any medical condition or comorbidities that, in the Investigator's opinion, could\r adversely impact study participation or safety, conduct of the study, or interfere\r with pain assessments.\r\n\r - Sensory peripheral neuropathy that is of moderate severity or higher.\r\n\r - Arterial or venous thrombi (including stroke), myocardial infarction, hospital\r admission for unstable angina, cardiac angioplasty, or stenting within the past 12\r months.\r\n\r - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related\r illness, acute or history of chronic hepatitis B or hepatitis C. Participants with\r these viral infections who are receiving or have received antiviral treatment and have\r a viral load that is undetectable are eligible.\r\n\r - Concurrent medical or arthritic conditions that could interfere with the evaluation of\r the index knee joint including chondromalacia patellae, metabolic diseases,\r gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or\r other inflammatory arthropathies affecting the knee joint.\r\n\r - Undergone arthroscopic surgery of the index knee within 6 months of the injection day,\r or open surgery to the index knee within 24 months of the injection day.\r\n\r - Undergone replacement surgery of the index knee.\r\n\r - Presence of surgical hardware or other foreign bodies in the index knee.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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354
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma\n\n**Clinical Trial Summary:**\n\nCC-90010-GBM-001 is a multi-center, open-label study to assess the pharmacokinetics (PK),\r pharmacodynamics (PD) and CNS penetration of CC-90010 following short-term interval therapy\r (4 daily doses ) prior to surgery, in subjects with progressive or recurrent WHO Grade II\r Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and recurrent Glioblastoma who have\r failed radiation and chemotherapy, and who are candidates for surgical tumor resection as\r part of their salvage regimen (planned salvage resection).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Subjects must satisfy the following criteria to be enrolled in the study:\r\n\r 1. Men and women ≥ 18 years of age,) with recurrent or progressive WHO Grade II Diffuse\r Astrocytoma, Grade III Anaplastic Astrocytoma or recurrent WHO Grade IV Glioblastoma .\r\n\r 2. Subjects must have previously completed standard or a hypofractionated course of\r radiation therapy and have been exposed to procarbazine, lomustine and vincristine\r (for Grade II Astrocytoma), including those who have progressed on (or not been able\r to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer\r therapy, with radiation completed > 12 weeks prior to the first CC-90010 dose (Day 1).\r\n\r 3. Subject must be in first or second recurrence.\r\n\r 4. Subject must have archival tumor tissue suitable for genetic testing and must give\r permission to access and test the tissue.\r\n\r 5. Subject is considered an appropriate candidate for surgical resection of the recurrent\r tumor tissue (salvage resection).\r\n\r 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\r\n\r 7. Subject must meet laboratory values at screening:\r\n\r - Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without growth factor support for\r 7 days (14 days if subject received pegfilgrastim).\r\n\r - Hemoglobin (Hgb) ≥10 g/dL\r\n\r - Platelet count (plt) ≥100 x 10^9/L\r\n\r - Serum potassium concentration within normal range, or correctable with\r supplements\r\n\r - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x Upper\r Limit of Normal (ULN).\r\n\r - Serum total bilirubin ≤ 1.5 x ULN.\r\n\r - Serum creatinine ≤ 1.5 x ULN or measured glomerular filtration rate (GFR) ≥ 50\r mL/min/1.73 m2 using an exogenous filtration marker such as iohexol, inulin, 51Cr\r EDTA or 1 iothalamate, or creatinine clearance of ≥ 50 mL/min using\r Cockroft-Gault equation.\r\n\r - Serum albumin > 3.5 g/dL\r\n\r - PT (or INR) and APTT ≤ normal range\r\n\r 8. Females and males must agree to contraceptive methods and avoid conceiving throughout\r study and up to 46 days (females) and 106 days (males) following last dose of\r CC-90010.\r\n\r Exclusion Criteria:\r\n\r The presence of any of the following will exclude a subject from enrollment:\r\n\r 1. Subject has received anti-cancer therapy (either approved or investigational) within ≤\r 4 weeks (6 weeks for nitrosoureas) or 5 half-lives, whichever is shorter, prior to\r starting CC-90010. If subject received prior immunotherapy (immune checkpoint\r inhibitor, vaccine, etc.), a 2 week wash-out is required. For a subject treated with\r the Optune-TTF device, a 2 day period without use is required.\r\n\r 2. Toxicities resulting from prior chemotherapy, surgery, or radiotherapy must have\r resolved to ≤ NCI CTCAE (version 5.0) Grade 1 prior to starting CC-90010 treatment\r (with the exception of Grade 3 alopecia).\r\n\r 3. Subject has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to\r starting CC-90010 or subject who has not recovered from surgery.\r\n\r 4. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue\r or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management, or any\r other significant GI disorder that could affect the absorption of CC-90010.\r\n\r 5. Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly\r those with a history of and/or risk of perforation and GI tract hemorrhages.\r\n\r 6. Evidence of CNS hemorrhage on baseline MRI or CT scan (except for post-surgical,\r asymptomatic Grade 1 hemorrhage that has been stable for at least 4 weeks).\r\n\r 7. Subject who requires increasing doses of corticosteroids to treat symptomatic cerebral\r edema within 7 days of study therapy.\r\n\r 8. Known symptomatic acute or chronic pancreatitis.\r\n\r 9. Impaired cardiac function or clinically significant cardiac diseases, including any of\r the following:\r\n\r - LVEF < 45% as determined by multiple gated acquisition scan (MUGA) or\r echocardiogram (ECHO).\r\n\r - Complete left bundle branch or bifascicular block.\r\n\r - Congenital long QT syndrome.\r\n\r - Persistent or clinically meaningful ventricular arrhythmias or atrial\r fibrillation.\r\n\r - QTcF ≥ 480 msec on Screening ECG (mean of triplicate recordings); a marked\r baseline prolongation of QT/QTc interval, using Fridericia´s QT correction\r formula.\r\n\r - History of additional risk factors for Torsade de Pointes (TdP) (e.g. heart\r failure, hypokalemia, family history of Long QT syndrome.\r\n\r - Use of concomitant medications that prolong the QT/QTc interval.\r\n\r - Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting\r CC-90010.\r\n\r - Other clinically significant heart disease such as congestive heart failure\r requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg).\r\n\r 10. Pregnant or nursing females.\r\n\r 11. Known HIV infection.\r\n\r 12. Known chronic active hepatitis B or C virus (HBV, HCV) infection.\r\n\r 13. Subject with a requirement for ongoing treatment with therapeutic dosing of\r anticoagulants or for ongoing prophylactic anticoagulation. Low dose low molecular\r weight heparin for catheter maintenance is allowed.\r\n\r 14. History of concurrent second cancers requiring active, ongoing systemic treatment.\r\n\r 15. Evidence of history of bleeding diathesis.\r\n\r 16. Subject with known prior episodes of non-arteritic anterior ischemic optic neuropathy\r (NAION) should be excluded from the study. CC-90010 should be used with caution in\r subjects with retinitis pigmentosa.\r\n\r 17. Subject has any significant medical condition (e.g., active or uncontrolled infection\r or renal disease), laboratory abnormality, or psychiatric illness that would prevent\r the subject from participating (or compromise compliance) in the study or would place\r the subject at unacceptable risk if he/she were to participate in the study.\r\n\r 18. Subject has any condition that confounds the ability to interpret data from the study.\r\n\r 19. Subject with poor bone marrow reserve as assessed by Investigator such as in the\r following condition:\r\n\r • Requiring regular hematopoietic support (blood or platelet transfusions,\r erythropoietin, granulocyte colony stimulating factor [GCSF] or other hematopoietic\r growth factors)\r\n\r 20. Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20\r days for severe/critical illness prior to starting study drug.\r\n\r • Acute symptoms must have resolved and based on investigator assessment in\r consultation with the medical monitor, there are no sequelae that would place the\r participant at a higher risk of receiving study treatment.\r\n\r 21. Previous SARS-CoV-2 vaccine within 14 days of starting drug study.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nValidation of a Treadmill Walking Test to Discriminate Neurogenic Claudication From Vascular Claudication\n\n**Clinical Trial Summary:**\n\nThe first aim of this study was to elaborate and validate a treadmill walking test that would\r help discriminate between neurogenic claudication from vascular claudication. The second\r objective of this study is to determine if the treadmill walking test can discriminate spinal\r stenosis from low back pain with radiating pain in lower limb.\n\n**Clinical Trial Detailed Description:**\n\nTo date, an important challenge that clinicians hare facing in the assessment and diagnosis\r of intermittent claudication is that pathologies associated with vascular or neurogenic\r claudication can coexist in the same patient. Differentiation between both origins can be\r difficult due to variable signs and symptoms which can be atypical.\r\n\r The first aim of this study was to elaborate and validate a treadmill walking test that would\r help discriminate between neurogenic claudication from vascular claudication. The second\r objective of this study is to determine if the treadmill walking test can discriminate spinal\r stenosis from low back pain with radiating pain in lower limb. 60 participants (20 with\r spinal stenosis, 20 with peripheral artery disease and 20 with non-specific low back pain)\r will be recruited. Participants will be invited to walk on a treadmill at a speed of 1,2 mph\r for a maximum of five minutes for both tasks (straight walking posture and inclined walking\r posture). Each walking task will be followed by a rest time of five minutes in sitting\r position. It is hypothesized that walking time difference for the occurrence of pain and for\r pain relief will be sensitive and specific to pathologies and help to discriminate lumbar\r spinal stenosis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Lumbar spinal stenosis (LSS) group :\r\n\r - Central stenosis\r\n\r - Pain in at least one leg\r\n\r - Neurological signs in the lower limbs (numbness or tingling)\r\n\r - Weaknesses in the lower limb\r\n\r - Pain relieved by sitting or bending the trunk\r\n\r Peripheral artery disease (PAD) group :\r\n\r - Claudication while walking\r\n\r - Ankle-brachial index < 0.9\r\n\r - Pain relieved by rest\r\n\r Low back pain (LBP) :\r\n\r - Pain radiating in the lower limb\r\n\r - Weaknesses\r\n\r - Pain relieved by sitting\r\n\r Exclusion Criteria:\r\n\r - Foraminal stenosis\r\n\r - Spinal stenosis with predominant back pain\r\n\r - Symptomatic disc herniation\r\n\r - Previous lumbar surgery\r\n\r - Previous vascular surgery\r\n\r - Type 1 diabetes\r\n\r - Knee or hip osteoarthritis\r\n\r - Hip or knee arthroplasty\r\n\r - Inability to provide free and informed consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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356
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[
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention\n\n**Clinical Trial Summary:**\n\nThe Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed\r for improved bladder management in males with urinary retention disorders requiring\r catheterization. It is a sterile, extended-use device that resides fully internally to the\r male lower urinary tract for an intended use life of up to 7 days per catheter.\n\n**Clinical Trial Detailed Description:**\n\nSpinal Singularity has developed the Connected Catheter System to address several drawbacks\r of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis\r designed for improved bladder management in males with urinary retention disorders requiring\r catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This\r includes five device exchange appointments. The appointments are spaced 7 days apart and at\r each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up\r will occur for 14 days following the final appointment after the subject discontinues use of\r study device and reverts to his original catheter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Males age ≥ 18 with clinical diagnosis of significant urinary retention\r\n\r 2. Must be clinically suitable and capable of safely managing bladder using an\r intermittent voiding or indwelling strategy\r\n\r 1. Must have stable urinary management history as determined by the investigator OR:\r\n\r 2. Must have urodynamic profile suitable for Gen 2 Connected Catheter (including\r bladder capacity > 200mL without uninhibited bladder contractions)\r\n\r 3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the\r Gen 2 Connected Catheter device, as specified in the Investigational Device\r Instructions for Use (IFU).\r\n\r Exclusion Criteria:\r\n\r 1. Active symptomatic urinary tract infection, as defined in this clinical investigation\r protocol (subjects may receive the device after UTI has been treated)\r\n\r 2. Significant risk profile or recent history of urethral stricture (e.g. stricture\r within past 90 days)\r\n\r 3. Significant risk profile or recent history of clinically significant (uncontrolled)\r autonomic dysreflexia\r\n\r 4. Significant intermittent urinary incontinence (between catheterizations)\r\n\r 5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably\r controlled with medication or alternate therapy (e.g. Botox injection)\r\n\r 6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower\r urinary tract or bladder (assessed during in-depth medical screening, including\r cystoscopy and urine analysis)\r\n\r 1. Urinary tract inflammation or neoplasm\r\n\r 2. Urinary fistula\r\n\r 3. Bladder diverticulum (outpouching) > 5cm in size\r\n\r 4. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past\r 6 months)\r\n\r 5. Impaired kidney function or renal failure\r\n\r 6. Active gross hematuria\r\n\r 7. Active urethritis\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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357
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIndividual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Chronic Spinal Cord Injury\n\n**Clinical Trial Summary:**\n\nThis protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request\r submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about\r 4:30pm, slipped off a boat head-first while in the Florida Keys for a family wedding, and was\r immediately unable to move his legs. He was emergently transferred to Miami, FL for\r stabilization and treatment, where he was diagnosed with a C5 -C6 Grade 2 anterolisthesis of\r C5 on C6: 7mm, with flexion teardrop fracture of the anterior aspect of C6, as well as jumped\r facet on the right and perched facet on the left at C5-C6 with spinal canal stenosis with\r cord compression, as well as with aspiration and near drowning. He underwent ACDF (anterior\r cervical discectomy and fusion) of C5-C6 and reduction of jumped facets and was immediately\r started on a hypothermia protocol to reduce spinal cord edema. His hospital course was\r complicated by aspiration pneumonia. He discharged to Texas via air ambulance for physical\r rehabilitation on August 23, 2017 with a diagnosis of ASIA B (American Spinal Injury\r Association) C-5 SCI (spinal cord injury).\n\n**Clinical Trial Detailed Description:**\n\nOnce the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline\r visit, the subject will receive the first infusion. Subsequent treatments will occur every\r other week in the subject's home, administered by a nurse.\r\n\r On each of these visits, the subject will receive one autologous HB-adMSC infusion of 200\r million (2 x 10^8 cells) total cells. Every infusion visit will include the following\r procedures:\r\n\r 1. Interval H&P and concomitant medications update utilizing the secure VirTrial platform.\r\n\r 2. QOL and Disability (SCIM self eval) surveys will be completed by the subject with the\r assistance of the primary caregiver.\r\n\r 3. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),\r\n\r 4. A peripheral IV line will be inserted,\r\n\r 5. A blood sample for clinical labs (CBC with Platelets, CMP, PT, PTT, TNFa, IL6, CRP) will\r be drawn monthly during the infusion period.\r\n\r 6. A \"time out\" verification of patient/consent/procedure/cell product will be performed,\r\n\r 7. The HB-adMSC infusion will be given by through the peripheral IV, infused over 1 hour at\r a rate of 250ml/hr (83gtts/minute) by a registered nurse.\r\n\r 8. Assessment for Infusion Related AE/SAEs\r\n\r 9. The subject will be monitored for a minimum of 2 hours\r\n\r In-Person Visits The subject will return to the Clinical Trial Network CTN site for In-Person\r visits to occur at Screening, Baseline and Week twelve (12), twenty-six (26) and at Week\r fifty-two (52). Week 52 visit will serve as the End of Study visit. The end of study (EOS)\r visit will include an MRI of the c-spine as well as all of the study procedures for Follow-up\r Visits without Infusion. A written summary of the results of the treatment, including adverse\r events will be submitted to the FDA after completion of the last follow-up visit.\r\n\r Visits without infusion will include:\r\n\r 1. Interval H&P and concomitant medications update.\r\n\r 2. QOL and Disability (SCIM self eval) surveys will be completed by the subject with the\r assistance of the primary caregiver.\r\n\r 3. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),\r\n\r 4. A Physical and Neuro Exam (Asia Impairment Scale) will be completed\r\n\r 5. A blood sample for clinical labs (CBC with Platelets, CMP, PT, PTT, TNFa, IL6, CRP) will\r be drawn.\r\n\r 6. Video documentation of patient condition.\r\n\r 7. Assessment for infusion related AEs/SAEs\r\n\r 8. Weight\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Adult individual 18 yr. of age or older.\r\n\r 2. Cognitively intact and capable of giving informed consent.\r\n\r 3. Clinical diagnosis of a non-penetrating traumatic SCI to the cervical spine\r\n\r 4. Patient and Caregiver agree to use Care Connect app or web version of VirTrial\r platform for virtual visits.\r\n\r Exclusion Criteria:\r\n\r 1. Prior history of:\r\n\r 1. Recent or ongoing infection,\r\n\r 2. Clinically significant cardiovascular, lung, renal, hepatic, or endocrine\r disease,\r\n\r 3. Neurodegenerative disorders,\r\n\r 4. Cancer,\r\n\r 5. Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening,\r\n\r 6. Chemical or ETOH dependency,\r\n\r 2. Having a contraindication to MRI scans\r\n\r 3. Other acute or chronic medical conditions that, in the opinion of the investigator,\r may increase the risks associated with study participation or HB-adMSC administration\r\n\r 4. Participation in other interventional research studies.\r\n\r 5. Unwillingness to return for follow-up visits\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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358
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nWhole-body Vibration in Spastic Hemiplegic Cerebral Palsy\n\n**Clinical Trial Summary:**\n\nTo target spasticity, balance and mobility whole body vibration exercises along with selected\r physical therapy is given to experimental group. Control group will receive only selected\r physical therapy that includes sstretching exercises, gait training, ffacilitation of\r postural reactions, ffacilitation of standing and weight shift and facilitation of standing\r balance by using a balance board.\n\n**Clinical Trial Detailed Description:**\n\nCerebral palsy is the most common childhood disabilities affecting individual's posture and\r movement. Cerebral palsy is a disorder that causes activity limitations attributed to\r non-progressive disturbances of the foetal or infant brain that may also affect sensation,\r perception, cognition, communication, and behavior. Cerebral palsy (CP) results from damage\r to the developing central nervous system while in utero, during delivery, or during the first\r two years of life.\r\n\r The most common movement disorder in Cerebral palsy is a spastic paresis, defined as a\r posture and movement-dependent tone regulation disorder.The most common signs of the disorder\r are spasticity, rigidity, muscle weakness, ataxia, balance and movement disorders. Compared\r to the typically developed children, these children have impaired sensation and increased\r muscle tone therefore they have trouble voluntarily controlling their muscles. Cerebral Palsy\r can be grouped based on the motor effects it has on the individual, these can include spastic\r Cerebral palsy or non-spastic Cerebral palsy. Spastic Cerebral Palsy is the most common type\r and is associated with tight or contracted muscles.\r\n\r Cerebral Palsy is more prevalent in more deprived socio-economic populations. Cerebral palsy\r is a disease that globally has a prevalence of 2 to 3 cases per 1,000 live born neonates. An\r increase in the prevalence of CP was also seen in low birth weight survivors from the Mersey\r region of the United Kingdom for the same period. Pilot studies of severe mental retardation\r conducted in selected populations in Pakistan and India have reported extraordinarily high\r prevalence estimates in the range of 12-24 /1,000 Spasticity may be defined as a motor\r disorder characterised by a velocity-dependent exaggeration of stretch reflexes resulting\r from abnormal intraspinal processing of primary afferent input. The impaired sensation and\r increase in tone leads to wide range in movement dysfunction. About seventy to eighty percent\r of children with Cerebral Palsy demonstrate spastic clinical features. Many children with\r cerebral palsy (CP) have poor walking abilities and manipulation skills. One contributing\r factor to their problems with gait and reaching movement is poor balance control. Balance\r control is important as it helps a child to recover from unexpected balance\r disturbances.Currently, there are many options for the management of spasticity, balance\r disturbances and risk of fall that includes physical modalities, oral pharmacologic agents,\r peripheral injectables, intrathecal agents, and surgical interventions, however mostly\r physical therapy is commonly preferable treatment that includes stretching, NDT,\r Proprioceptive neuromuscular facilitations,strength training and gait training.\r\n\r Dynamic mechanical loading of the skeleton is an arduous task and troublesome to induce in\r children who suffer from severe cerebral palsy. The lack of dynamic weight bearing in this\r population predisposes them to reduced bone mineral density (BMD) and pre-mature\r osteoporosis. These children are also more prone to muscle weakness, which contributes to\r pain, deformity and functional loss. Whole-body vibration training was proposed as a new\r therapeutic modality for the treatment of the gross motor function, balance and functional\r performance Whole body vibration (WBV), for which the participant stands on a vibrating\r platform, delivers low-frequency, low-amplitude mechanical stimuli that enter the human body\r via the feet. The vibrations stimulate the muscle spindles and alpha motor neuron sending\r nerve impulses to initiate muscle contractions according to the tonic vibration reflex.\r Compared to the repetitive passive movement, this WBV protocol adds a muscle strengthening\r component to the anti-spastic effects. Activity restrictions in spastic cerebral palsy are\r mainly due to poor postural control. Many interventions like resisting exercises, therapeutic\r horseback riding, electrical stimulations leads to short term posture and balance\r improvement. Training using vibration platforms adjunct to exercise has shown to be effective\r in increasing strength resulting in improved balance and coordination. Whole body vibration\r has shown to be effective in reducing lower limb spasticity after first application of WBV\r with a vibration frequency of 12 Hz to 18 Hz ( 2-3 m of amplitude ) for 9 minutes and a\r significant decrease in tone is observed and even the functional mobility and balance is\r improved.. During all of the vibration-training sessions, the children will wear the\r gymnastic shoes to standardize the damping of the vibration due to footwear.\r\n\r There is paucity in the literature regarding evidence for the safe and effective use of\r vibration intervention in children with or without pathology and has great effects in\r spasticity, mobility and improving balance.Chia-Ling Chen concluded that the WBV is an\r effective intervention for controlling spasticity and improving ambulation. Villarreal et\r al.showed that 20-week WBV therapy had positive effects on the balance of DS adolescents,\r although only under specific conditions, with vision and somatosensory input altered.\r\n\r In previous studies high dosage of whole body vibration has both positive and negative\r effects. Because this type of treatment seems to improve bone health, The purpose of this\r intervention is to ensure functional independence in cerebral palsy patients. Whole Body\r Vibration Therapy has proven to be effective in improving balance by reducing spasticity and\r improving muscle strength. It is essential to explore new interventions for patients\r specially for cerebral palsy in whom functional independence is impaired thus their mobility\r is restricted leading to secondary complications. In my study my goal is to use combination\r of conventional physical therapy with whole body vibration which can control spasticity and\r enhance ambulatory performance.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Ashworth scale score +1-3\r\n\r - age between 6 and 13 years,\r\n\r - able to accept and follow verbal instructions,\r\n\r - Gross Motor Function Classification System [GMFCS] levels I-III),\r\n\r Exclusion Criteria:\r\n\r - unstable seizures, any treatment for spasticity or surgical procedures from 3 months\r (for botulinum toxin type A injections)\r\n\r - Suffering from any other condition that interfered with physical activity.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nTesting the Addition of an Anti-cancer Viral Gene Therapy, Toca 511/Toca FC, to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed Glioblastoma\n\n**Clinical Trial Summary:**\n\nThis phase II/III trial studies how well vocimagene amiretrorepvec (Toca 511) and extended\r release flucytosine (Toca FC) work when added to the usual treatment (temozolomide and\r radiation therapy) in treating patients with newly diagnosed glioblastoma. Toca 511 is a live\r virus that has been built to carry a gene into tumor cells. This gene carries instructions\r that cause the tumor cells to turn Toca FC, typically used to treat fungal infections, into a\r drug that may kill the tumor cells. Drugs used in chemotherapy, such as temozolomide, work in\r different ways to stop the growth of tumor cells, either by killing the cells, by stopping\r them from dividing, or by stopping them from spreading. Radiation therapy uses high energy\r x-rays to kill tumor cells and shrink tumors. Giving Toca 511 and Toca FC in addition to the\r usual treatment (temozolomide and radiation therapy) may help shrink or stabilize cancer or\r extend the life of patients with newly diagnosed glioblastoma.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To compare the progression-free survival (PFS) of patients with newly diagnosed\r glioblastoma treated with Toca 511 at the time of tumor resection followed by Toca FC in\r combination with standard of care (SOC) treatment to patients with newly diagnosed\r glioblastoma treated with SOC after tumor resection. (Phase II) II. To compare the overall\r survival (OS) from time of randomization of all patients with newly diagnosed glioblastoma\r treated with Toca 511 at the time of tumor resection followed by Toca FC in combination with\r SOC treatment to patients with newly diagnosed glioblastoma treated with SOC after tumor\r resection. (Phase III)\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the safety of each arm as administered in this study. II. To compare the OS\r between arms (only for phase II part of the study). III. To compare the PFS between arms\r using Response Assessment in Neuro-Oncology (RANO) (only for phase III part of the study).\r\n\r IV. To evaluate the objective response rate (ORR) in patients with measurable disease at the\r post-surgical scan.\r\n\r V. To evaluate the effect of IDH mutation status on survival outcomes between arms.\r\n\r VI. To evaluate the PFS and OS by extent of resection. VII. To evaluate the effect of MGMT\r methylation status on survival outcomes between arms.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To evaluate the duration of response (DoR) in patients with measurable disease at the\r post-surgical scan using mRANO.\r\n\r II. To evaluate the effect of corticosteroids administration on efficacy of Toca 511 and Toca\r FC.\r\n\r III. To optimize quality assurance methodologies and processes for radiotherapy and imaging.\r\n\r IV. To determine if there is a tumor-microenvironment signature based on ribonucleic acid\r (RNA) sequencing that is associated with a selective increase in benefit from the addition of\r Toca 511 and Toca FC.\r\n\r V. To compare regional genomic heterogeneity and molecular profiles, as measured by RNA\r sequencing and methylation analyses between arms.\r\n\r VI. To compare quality of life (QOL), as measured by the European Organization for Research\r and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and Brain\r Cancer Module (BN20), between arms.\r\n\r VII. To compare health utilities, as measured by the EuroQoL 5-Dimension 5-Level (EQ-5D-5L),\r between arms.\r\n\r OUTLINE: Patients are randomized to 1 of 2 arms.\r\n\r ARM I: Beginning on week 5 following standard of care surgery, patients undergo radiation\r therapy over 30 fractions 5 days per week for up to 6 weeks, and receive temozolomide orally\r (PO) once daily (QD) for up to 49 days. At the discretion of treating physician, patients may\r also receive novoTTF-100A (Optune) device 0-7 weeks following radiation and temozolomide\r treatment. One month following completion of radiation therapy, patients continue to receive\r temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the\r absence of disease progression or unacceptable toxicity.\r\n\r ARM II: Patients receive vocimagene amiretrorepvec via intracranial injection during surgery\r on day 1. Beginning on week 5 following surgery, patients receive extended release\r flucytosine PO three times daily (TID) for 7 consecutive days every 7 weeks. Patients also\r undergo radiation therapy and receive temozolomide as in arm I. After completion of radiation\r therapy and at the discretion of the treating physician, patients may continue to receive\r extended release flucytosine PO TID for 7 consecutive days every 8 weeks in the absence of\r disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up until progression then, every 3\r months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Presumptive diagnosis of glioblastoma based on magnetic resonance imaging (MRI)\r imaging within 14 days prior to registration.\r\n\r - NOTE: Patients who undergo treatment with Toca 511 whose final pathology shows\r diagnosis other than glioblastoma (e.g. anaplastic astrocytoma or\r oligodendroglioma or any other histology) will be treated with Toca FC and\r chemoradiation; however they will not be analyzed in the primary endpoint. The\r outcomes of these patients will be reported descriptively. Similarly the patients\r with anaplastic astrocytoma or oligodendroglioma or any other histology treated\r on the standard-of-care arm will be reported separately and they are allowed to\r receive the treatment per choice of the treating physician/ investigator (for\r e.g. radiation therapy [RT] plus temozolomide or RT plus\r procarbazine-lomustine-vincristine [PCV])\r\n\r - In addition, patients who have undergone biopsy with diagnosis of glioblastoma and who\r have never received any chemotherapy and/or radiation and are candidates for >= 80%\r resection of enhancing region are eligible\r\n\r - The tumor must be unifocal, confined to the supratentorial compartment and based on\r the pre-operative evaluation, the patient is a candidate for >= 80% resection of\r enhancing region\r\n\r - Measurable disease preoperatively, defined as at least 1 contrast enhancing lesion,\r with 2 perpendicular measurements of at least 1 cm, as per Response Assessment in\r Neuro-Oncology (RANO) criteria\r\n\r - The hematoxylin and eosin (H&E) slide and formalin-fixed paraffin-embedded (FFPE)\r tumor tissue block must be available to be sent for mandatory central pathology review\r after registration\r\n\r - Patients must be able to undergo an evaluation by MRI within 96 hours post surgery to\r assess extent of resection\r\n\r - Karnofsky performance status >= 70 within 14 days prior to registration\r\n\r - History/physical examination within 14 days prior to registration\r\n\r - Platelet count >= 100,000/mm^3 (within 14 days prior to registration)\r\n\r - Hemoglobin (Hgb) >= 10 g/dL (within 14 days prior to registration)\r\n\r - Absolute neutrophil count (ANC) >= 1,500/mm^3 (within 14 days prior to registration)\r\n\r - Absolute lymphocyte count (ALC) >= 1000/mm^3 (within 14 days prior to registration)\r\n\r - Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless has Gilbert?s syndrome)\r (within 14 days prior to registration)\r\n\r - Alanine aminotransferase (ALT) =< 2.5 x ULN (within 14 days prior to registration)\r\n\r - Estimated glomerular filtration rate of at least 50 mL/min by the Cockcroft Gault\r formula (within 14 days prior to registration)\r\n\r - Women of childbearing potential (women who have not had >=12 months of non therapy\r induced amenorrhea or are not surgically sterile) must have had a negative serum\r pregnancy test within 14 days prior to registration and must agree to use a birth\r control method in addition to barrier methods (condoms or diaphragm) during treatment\r with temozolomide\r\n\r - If the patient is randomized to arm 2, the patient or patient?s partner must be\r willing to use barrier method of contraception for 12 months after receiving Toca 511\r and 1 month after stopping Toca FC or until there is no evidence of the virus in the\r patient?s blood, whichever is longer\r\n\r - The patient or a legally authorized representative must provide study-specific\r informed consent prior to registration\r\n\r Exclusion Criteria:\r\n\r - History of prior invasive malignancy (except non-melanomatous skin cancer) unless\r disease free for a minimum of 3 years\r\n\r - A contrast enhancing brain tumor on MRI that is any of the following:\r\n\r - Multi focal (defined as 2 separate areas of contrast enhancement measuring at\r least 10 mm in 2 planes that are not contiguous on either fluid attenuated\r inversion recovery [FLAIR] or T2 hyperintensity);\r\n\r - Associated with either diffuse subependymal or leptomeningeal dissemination; or\r\n\r - > 50 mm in any dimension\r\n\r - Active infection (excluding skin or toenail infections) requiring systemic antibiotic,\r antifungal or antiviral therapy within 28 days prior to registration\r\n\r - Bleeding diathesis, or must take anticoagulants, or antiplatelet agents, including\r nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the scheduled resection\r that cannot be stopped for surgery\r\n\r - Known human immunodeficiency virus (HIV) positive status\r\n\r - History of allergy or intolerance to flucytosine\r\n\r - Swallowing difficulty that would prevent patient from being able to swallow either\r temozolomide or Toca FC or severe active mal-absorption\r\n\r - Patients who are breast feeding or lactating\r\n\r - Intent to undergo treatment with the Gliadel wafer at the time of this surgery or has\r received the Gliadel\r\n\r - Prior to registration, steroid treatment beyond a maximum of 8 mg/day of dexamethasone\r (or equivalent) or a total of 8 weeks (56 days) is excluded\r\n\r - Severe pulmonary, cardiac or other systemic disease, specifically:\r\n\r - New York Heart Association > =Class II congestive heart failure within 6 months\r (180 days) prior to registration, unless asymptomatic and well controlled with\r medication\r\n\r - Uncontrolled or significant cardiovascular disease, clinically significant\r ventricular arrhythmia (such as ventricular tachycardia, ventricular\r fibrillation, or Torsades de pointes), clinically significant pulmonary disease\r (such as >= grade 2 dyspnea)\r\n\r - Any other disease that as per investigator assessment may affect the patient?s\r compliance or place the patient at higher risk of potential treatment\r complications\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nCognitive Function After Radiation Therapy for Brain Tumours\n\n**Clinical Trial Summary:**\n\nThis study will assess cognitive function in adult patients with a primary brain tumour\r treated with surgical resection with or without radiation therapy (RT). All types of brain\r tumours apart from glioblastoma will be included\n\n**Clinical Trial Detailed Description:**\n\nRT to brain tumours causes cognitive dysfunction. The extent of RT induced changes in\r cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of\r photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive\r dysfunction. There is modest knowledge on which parts of the brain the investigators need to\r spare, to prevent cognitive dysfunction.\r\n\r The study is a cross sectional study assessing cognitive function in patients with brain\r tumours previously treated with RT compared to a similar non irradiated group. 104 patients\r with specified brain tumours from Aarhus University Hospital treated in the period 2006-2016\r will be included. The patients will do patient reported outcome (PRO) and undergo\r neuropsychological assessment with standardized tests: They will do this prior to RT\r treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on quality of life,\r fatigue, sleep, depression, anxiety, and socio demografica. The standardized tests are: Trail\r making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test\r (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV; Paced Auditory Serial Addition\r Test (PASAT). The correlation between cognitive scores and RT dose-volume parameters to\r specific areas in the brain will be tested.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The participant must be 18 years or older and Danish speaking.\r\n\r - Performance status 0-2\r\n\r - Capable of cooperating on testing\r\n\r - Diagnosed with one of the following diagnoses according to WHO 2016 classification 16\r and been treated between 2006 and 2016\r\n\r 1. ZM93803 glioma (exclusive glioblastoma)\r\n\r 2. ZM9401/3 anaplastic astrocytoma, IDH mutant\r\n\r 3. ZM9400/3 diffuse astrocytoma, IDH-mutant\r\n\r 4. ZM9411/3 gemistocytisk astrocytoma, IDH mutant\r\n\r 5. ZM9400/3 diffuse astrocytoma, NOS\r\n\r 6. ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted\r\n\r 7. ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted\r\n\r 8. ZM9450/3 oligodendroglioma, NOS\r\n\r 9. ZM9451/3 anaplastic oligodendroglioma, NOS\r\n\r 10. ZM9530/0 meningioma\r\n\r 11. ZM9470/3 medulloblastoma, NOS\r\n\r 12. DD352A pituitary adenoma\r\n\r 13. Other rare brain tumours including skull base sarcomas\r\n\r -\r\n\r Exclusion Criteria:\r\n\r Performance status 3-4 Progression after radiation therapy\r\n\r -\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPiloting Diet and Exercise Interventions in Older Hispanics With Diabetes\n\n**Clinical Trial Summary:**\n\nType 2 diabetes affects 9.3% of the U.S. population and health disparities are evident.\r Compared to non-Hispanic Whites, twice as many Hispanics have type 2 diabetes. The estimated\r cost of diabetes was $327 billion in 2017. Older adults with type 2 diabetes often have\r increased risk of falls. Type 2 diabetes standard of care includes one annual self-management\r session, which rarely include assessments of mobility impairments and falls, and diabetes\r education programs are less likely to be offered and more likely to be discontinued in\r economically disadvantaged communities. Consequently, diabetes-related hospitalizations have\r doubled in the past 20 years. The objective of this study is to pilot test nutrition and\r exercise interventions to improve diabetes management (e.g. glycemic control and diet\r quality) and physical function, reduce falls and related healthcare use by disadvantaged\r older Hispanics with type 2 diabetes. The interventions will be tested separately and in\r combination to assess their individual and combined effects. We will recruit 60 older\r Hispanics with type 2 diabetes from 4 senior centers. The exercise intervention was adapted\r from the evidence-based Otago Exercise Program for falls prevention in older adults. The\r nutrition intervention aims to improve glycemic control and diet quality. We will\r cluster-randomize the participants into the following arms (n=15/arm) based on the congregate\r meal sites they attend: 1) Control (no intervention); 2) Exercise only; 3) Nutrition only,\r and 4) Exercise+Nutrition. The project will last 15 months; the duration of the interventions\r will be 6 months, and assessments will be completed at baseline, 3, 6, 9, and 12 months. The\r impact of the interventions will be assessed based on hemoglobin A1C levels (glycemic\r control), diet quality (Healthy Eating Index), blood pressure, physical function (balance,\r gait, strength, body composition, and fear of falls), and self-reported falls and healthcare\r use.\n\n**Clinical Trial Detailed Description:**\n\nThe pilot study will show the potential individual and combined effects of nutrition and\r exercise programs for disadvantaged older Hispanics with type 2 diabetes. The benefits to the\r participants include: 1) enhanced type 2 diabetes management; 2) improved diet quality and\r nutritional status; 3) improved physical function; 4) reduced rates of falls; and, 5) reduced\r rates of diabetes and fall-related emergency room visits and hospitalizations. The expected\r product is an effective type 2 diabetes management and falls prevention program for\r underserved Hispanic older adults with type 2 diabetes. If effective, the program may be\r expanded to additional congregate meal sites and communities serving older Hispanics.\r\n\r The proposed study is a pilot cluster-randomized pilot trial for socioeconomically\r disadvantaged older Hispanics with type 2 diabetes. The participants will be\r cluster-randomized to one of the following four groups (n=10/group) based on the facilities\r they go for congregate meals: 1) Control (no intervention); 2) Exercise program only; 3)\r Nutrition program only; 4) Exercise and nutrition program. The interventions groups (2-4)\r will also receive basic diabetes education. The interventions will be randomized to sites to\r avoid cross-contamination. The interventions will last 6 months and assessments will be\r completed at baseline, 3, 6, 9, and 12 months.\r\n\r The proposed pilot study is innovative because there are no exercise and nutrition programs\r for older Hispanics with type 2 diabetes; because it targets understudied socioeconomically\r disadvantaged older Hispanics with type 2 diabetes; it tests the separate and combined\r effects of nutrition and exercise interventions, and because we will assesses the outcomes as\r well as the mechanisms of falls reduction and improved type 2 diabetes management based on\r hemoglobin A1C levels, Healthy Eating Index scores, blood pressure, balance, gait, strength,\r and health care use.\r\n\r We will assess the effects of the programs when delivered in isolation and in combination in\r relation to a control group. The client-centered programs will be delivered in the congregate\r meal sites and the participants will track their exercise, diet and medication adherence\r behaviors. We will evaluate the effects of the programs in physical function (gait, strength\r and balance), diet quality, nutritional status, falls rates and associated emergency room\r visits and hospitalizations. Glycemic control, physical function and falls in older people\r with type 2 diabetes can be addressed with exercise and adequate nutrition, but the uptake\r and implementation of these evidence-based interventions in the community is limited,\r especially among socioeconomically disadvantaged minority groups.\r\n\r The interventions will be tailored culturally and to needs of older Hispanics with type 2\r diabetes by respecting the participants' language choice, physical abilities and impairments,\r and food preferences. The nutritional intervention will consider the participants eating\r habits, preferences, food availability and costs, and the participants own goals. The\r exercise sessions will consider the participants limitations and health conditions.\r\n\r Exercise and nutritional programs are rarely offered in congregate meal sites like the ones\r we will recruit our participants from. Each congregate meal site will host only one arm of\r the trial, but up to three groups of participants may be recruited from each site. The\r anticipated Mechanism of Action of the diet and exercise interventions involves improved diet\r quality, increasing protein, vitamin D and calcium intake, increased antioxidants from fruits\r and vegetables, reduced hemoglobin A1C and hospitalizations, increased energy for physical\r activity, increased muscle mass, and less falls. Increased exercise, will increase muscle\r mass, reduce A1C, improve physiological function, and reduce falls.\r\n\r METHODS\r\n\r Participants Older (≥ 65 years) Hispanics with type 2 diabetes will be recruited at\r congregate meal sites. We anticipate that approximately 65% of all participants will be women\r based on the sex distribution provided by our community partners.\r\n\r Recruitment and intervention sites 60 eligible participants will be cluster-randomized based\r on the facilities they attend for one of the four trial arms (n=15/group to account for\r attrition). It is anticipated that recruitment will take up to 4 months. Eligible\r participants will be cluster-randomized by participating site into one of the four arms: 1)\r Control (no intervention); 2) Exercise program only; 3) Nutrition program only, or 4)\r Exercise and nutrition program.\r\n\r Assessments will be carried out at baseline, 3, 6, 9 and 12 months at the sites during the\r morning in a private room. The participants will complete questionnaires regarding their\r medical health, falls history, fear of falls - Falls Efficacy Scale, socio-demographics,\r diabetes self-management, nutritional status - Mini Nutritional Assessment, food consumption\r (the Willett food-frequency questionnaire will be used to calculate the Healthy Eating\r Index), and health care use (emergency room visits and hospitalizations). In addition, the\r participants' gait, balance and strength will be measured. Gait will be assessed using an\r instrumented mat (GaitRite) to collect data on gait parameters during preferred walking speed\r and during fast walking conditions. A familiarization trial will be completed, followed by\r three recording trials under each condition in random order. Participants will be free to\r stop participating at any time. Balance will be assessed using force plates, and lower limb\r strength will be assessed based on the number of chair raises completed in 30 seconds. We\r will track any changes in food intake and/or exercise levels during the study period to\r control for potential confounders.\r\n\r Interventions The interventions will be delivered at the congregate meal sites 2x/week in the\r afternoons, and attendance will be recorded. Participants in the 3 intervention groups (2-4)\r will participate in an 1 hour long diabetes education session as part of orientation at the\r beginning of the program. Primarily Hispanic undergraduate and graduate students will be\r trained and help deliver the exercise (physical therapy students) and nutrition (dietetics\r and nutrition students) interventions under supervision. Participants in all 4 groups\r (including those in the control group) will receive a physical activity log to record the\r days they exercise in group sessions and individually, and the days and duration of walks.\r Participants will track exercise using logs and we will assess medication history, medication\r changes, and medication adherence for all trial arms. The control arm will not receive any\r intervention other than possibly the standard of care provided by their physician.\r Information regarding the participation in diabetes self-management and other activities will\r be collected during the assessments. Adjustments will be made for duration of diabetes.\r Participants in all arms will track their exercise and medication adherence will be assessed.\r\n\r Trial Arms: Duration, Frequency and Details.\r\n\r Arms Interventions\r\n\r 1. Control It will complete all assessments, but will not receive any intervention.\r\n\r 2. Exercise 2x/week, 30 min. group exercise, and 30 min. of walking.\r\n\r 3. Nutrition 2x/week, 30 min. group sessions.\r\n\r 4. Exercise & Nutrition 2x/week, 30 min. group exercise, 30 min of walking, & 2x/week, 30\r min. group nutrition sessions.\r\n\r The Exercise Intervention will be tailored for needs and capabilities of the participants and\r will involve short conversations (~5 min) about physical function, falls risks and\r prevention, exercise effects on diabetes and other exercise-related topics, followed by\r 30-minute exercise sessions. The intervention was developed based on the Otago Exercise\r Program, which is effective in reducing falls in community-dwelling older adults. It was\r piloted and well accepted by older Caribbeans, but it has not been tested in older Hispanics,\r nor in people with type 2 diabetes. The exercises involve lower and upper limb strengthening,\r balance training and a walking plan. Based on the baseline assessment, the participants will\r receive individualized exercise parameters and instructions on the weights to use, walking\r time (up to 30 minutes 2x/week) and safety instructions. The participants will receive\r illustrations of the exercises to do. Each participant will exercise for 30 minutes, 2x/week\r during supervised sessions in the facilities and be encouraged to do the exercises by\r themselves on days the group sessions are not offered. At the end of the sessions, we will\r have discussions of safe places to walk, proper footwear, adequate lighting (avoid down, dusk\r and evening walks), and safe environments (sidewalks in good conditions or walk in maintained\r trails in a park). We will also teach self-monitoring for signs of low-blood glucose to\r ensure safety. Bilingual research team members will be present to ensure that participants\r that only speak Spanish can understand the instructions. Progression will be done every two\r weeks during the first 2 months, once at month 3, and once at month 6 by increasing intensity\r and/or difficulty and the walks by increasing continuous walking time and walking speed\r without compromising safety. Assessments will be completed at baseline, 3, 6, 9, and 12\r months.\r\n\r The Nutrition Intervention will be tailored for the participants and based on Dietary\r Guidelines for Older Americans and Diabetes.org's food and Nutrition Recommendations, and\r will consider the participants' food preferences and concerns for managing glycemic control\r and maintaining muscle-mass. Each topic will be presented interactively and the participants\r will be encouraged to attend 2 times/week (attendance will be logged). The topics will be\r presented as a combination of evidenced-based materials for older adults with type 2\r diabetes. We anticipate 3 sessions/topic during the 6-month intervention and will modify the\r topics and time to fit the needs of our audience. The lessons and materials will be offered\r in English and Spanish. The food quality change will be measured using a Food Frequency\r Questionnaire validated in Hispanic populations. The goals are to increase the participants'\r self-efficacy (belief and self-confidence) that they have the tools necessary to manage\r diabetes and reduce mobility impairments.\r\n\r DATA ANALYSIS All primary analyses will be done on an \"intent to treat\" basis, and\r adjustments will be made for duration of diabetes. We will perform descriptive analysis on\r the demographic variables to describe the sample. Additional analysis will be conducted to\r assess differences between completers and dropouts. We will examine the potential cluster\r effect among the sites using the intraclass correlation (ICC), and will adjust the cluster\r effect in the analyses below if the ICC is significant. The effects of age and sex will be\r assessed during the analysis. The regression model for Aim 1 and 2 will include\r sociodemographic and biometric factors (age, sex, medication adherence, years with diabetes,\r insurance coverage, income, living alone, smoking, depressive symptoms, diabetes education,\r waist circumference or percent body fat as covariates for adjustment. All statistical\r analyses will be performed using SPSS v. 21 (SPSS Inc., USA).\r\n\r Specific Aim 1: We will use linear mixed model to examine the change of hemoglobin A1C and\r HEI-2015 score from baseline to 3, 6, 9, and 12 months respectively by treating time as\r categorical variable. We are expecting there will be significant improvement from baseline to\r 3 and 6 months, a subsequent slight decline from 6 to 9 month, and then a sustained plateau\r at an improved level at the 12-month follow-up compared to baseline. We will compare the\r change of A1C and HEI-2015 score for the nutrition + exercise group with the other three\r groups by testing the interaction effect between time and treatment arms in the linear mixed\r model with Bonferroni correction as the multiple testing adjustment.\r\n\r Specific Aim 2: We will compare the percentage of falls within each treatment arm between\r baseline and 3, 6, 9, and 12 months respectively using a McNemar test. And we will employ a\r repeated measures logistic regression to compare the change of risk of falls for nutrition +\r exercise group with the other three groups by the testing the interaction effect between time\r and treatment arms with Bonferroni correction as the multiple testing adjustment.\r\n\r Ancillary Measures: We will use the same statistical models in Aim 1 and 2 for the secondary\r outcomes based on the type of the outcome variables. We will also perform a mediation\r analysis to test whether the gains in physical function, including gait characteristics,\r lower limb and grip strength, muscle mass, balance, and reduce fatigability and fear of\r falls, mediate the effect of the intervention on the percent of falls.\r\n\r IMPLEMENTATION\r\n\r Assessments will be carried out at baseline, 3, 6, 9 and 12 months at the sites during the\r morning in a private room. The participants will complete questionnaires regarding their\r medical health, falls history, fear of falls, socio-demographics, diabetes self-management,\r nutritional status, food consumption, and health care use (emergency room visits and\r hospitalizations). In addition, the participants gait, balance and strength will be tested.\r Gait will be assessed using an instrumented mat (GaitRite) to collect data on gait parameters\r during preferred walking speed and during fast walking conditions. A familiarization trial\r will be completed, followed by three recording trials under each condition in random order.\r Participants will be free to stop participating at any time. Balance will be assessed using\r force plates, and lower limb strength will be assessed based on the number of chair raises\r completed in 30 seconds. We will track any changes in food intake and/or exercise levels\r during the study period to control for potential confounders.\r\n\r Interventions The interventions will be delivered at the congregate meal sites 2x/week in the\r afternoons, and attendance will be recorded. Primarily Hispanic undergraduate and graduate\r students will be trained and help deliver information on diabetes self-management (nursing\r students; i.e. what is diabetes, importance of lifestyle management and handouts), the\r exercise (physical therapy students) and nutrition (dietetics and nutrition students)\r interventions under supervision. Participants in all 4 groups (including those in the control\r group) will receive a physical activity log to record the days they exercise in group\r sessions and individually, and the days and duration of walks. Participants will track\r exercise using logs and we will assess medication history, medication changes, and medication\r adherence for all trial arms. The control arm will not receive any intervention other than\r possibly the standard of care provided by their physician. Information regarding the\r participation in diabetes self-management and other activities will be collected during the\r assessments.\r\n\r Attrition Management The following will be done to minimize attrition: 1) we will have\r sessions on the health benefits of completing the study; 2) we will tailor the interventions\r to the needs and preferences of the participants; 3) the participants will be compensated for\r their time ($50: $10 per assessment), and 4) the participants will receive reports after each\r assessment including information on their physical performance and the lab results for A1C,\r lipid panel, albumin and hemoglobin, and body composition (Bioelectric Impedance Analysis),\r and the results will be explained to them.\r\n\r Data analysis: Potential problems include non-linear data. The first approach would be to\r transform the data to achieve linearity and normality. If this is not achieved,\r non-parametric tests such as non-linear regression and a suitable alternative to path\r analysis will be conducted.\r\n\r Missing Data: To reduce sample bias, we will use \"intent to treat' analysis and will\r carry-over values for participants who dropped out and who have missing data points. For the\r data missing at random, we will use maximum likelihood imputation algorithms (SAS PROC MI),\r which are applicable to both missing outcomes and missing covariates. While, for data not at\r random missing, we will use complex modeling for missing values estimation.\r\n\r Self-reported questionnaires: Since there may be bias, we will include objective measures of\r diabetes management and physical function. The Willett's food frequency questionnaire is a\r validated tool and calculation of HEI-2015 is a validated method; however, social\r desirability bias may impact the results. We will compare changes in A1C with diet quality.\r\n\r General Measures:\r\n\r Socio-demographic data will be collected by trained bilingual interviewers (English/Spanish).\r Subjects will be asked to complete a socio-demographic questionnaire constructed by the PI\r and used in previous studies, which will include questions related to gender, age, education,\r income, employment status, health insurance, smoking, and medications. The effects of the\r interventions will be assessed by age group (decade of life) and sex.\r\n\r Anthropometric Measures: Height and weight will be measured using a SECA balance scale with\r stadiometer (Seca Corp, Columbia, MD). Body Mass Index will be calculated as weight in\r kg/height in m2. To attain the waist-to-hip ratio, the subject will stand erect with the\r weight evenly distributed. Waist circumference will be measured at the narrowest part between\r the lowest rib and iliac crest; the hip circumference will be taken around the widest portion\r of the buttocks. The ratio will be calculated by dividing waist circumference by hip\r circumference. Each measurement will be taken twice and averaged. Estimation of body fat mass\r and percent muscle will be made using Bioelectric Impedance Analysis with the InBody\r (Biospace, Inc. Los Angeles, CA, U.S.) model 529.\r\n\r All participants will complete a questionnaire including information on health status,\r hospitalizations, doctors' and emergency room visits, falls history and fear of falls. The\r 1-1:30-hour long assessments will be conducted at baseline, 3, 6, 9 and 12 months and will\r also include the evaluation of physical activity level, grip, and lower limb functional\r strength, gait and balance.\r\n\r Falls history: will be assessed based on self-reporting using the following questions: How\r many times have you fallen in the last 3, 6, and 12 months? Approximately when did you fall\r each of these times reported (e.g. complete date or just the month and year)? Did you get\r injured in any fall (please state the injury type)? Did it result in ER visits or\r hospitalization?\r\n\r Fear of falls: will be based on the Falls Efficacy Scale. Falls self-efficacy (an indication\r of fear of falls) is associated with increased risk of subsequent falls. Falls can trigger a\r cycle of fear of falls, reduced physical activity, deconditioning, functional decline, social\r isolation, reduced quality of life, depression, and increased risk of subsequent falls.\r\n\r Grip Strength: will be assessed using a Jamar dynamometer allowing adaptable grip lengths.\r The isometric hand grip strength measure using a Jamar dynamometer was chosen not only\r because it is strongly related to lower extremity muscle power, knee extension torque and\r calf cross-sectional muscle area, but also because decreased grip strength is a clinical\r marker of poor mobility. The participants will complete one five-second familiarization trial\r followed by two testing trials. The grip strength measures will be used to classify the\r frailty status and will also be classified as normal, intermediate or week based on the\r following criteria for men (>32, 26-32, <26 kg) and women (>20, 16-20, <16 kg).\r\n\r Lower Limb Functional Strength: will be assessed based on the number of chair-stands\r completed in 30 seconds without hand assistance from a strait back chair without armrest,\r with seat height of 17 inches. Completing less than 8 repetitions in 30 seconds is a frailty\r functional marker.\r\n\r Gait: will be assessed during preferred speed and fast walking conditions using a GAITRite®\r system (SN: Q209, CIR Systems Inc). In general, the reliability of the GAITRite® system\r measures of temporo-spacial parameters of gait has been found to be excellent for both young\r and older adults. The participants will complete one familiarization walking trial followed\r by two testing trials. The following gait parameters will be assessed:\r\n\r - Velocity - walking speed in cm/s calculated as distance covered divided by the\r ambulation time.\r\n\r - Cadence - number of steps per minute.\r\n\r - Step length - distance between the heel center of 1 foot to the heel center of other\r foot during heel strike.\r\n\r - Step width - the distances between a line linking the center of 1 foot during 2\r subsequent steps and the center of the opposite foot during mid stance.\r\n\r - Swing and stance time - time from toe off to heel strike and time from heel strike to\r toe off.\r\n\r - Single and double support time - time that one or both feet are on the floor\r simultaneously.\r\n\r Balance: will be assessed based on postural sway frequency, velocity and area during bipedal\r and single-leg stance for 30 seconds with eyes open and closed on a force plate. The\r participants will complete one familiarization trial followed by two testing trials.\r\n\r Emergency Department Visits and Hospital Admissions: Self-reported measures of recent health\r care utilization agrees with actual records in more than 90% of the times and therefore are\r adequate for use in clinical and epidemiological studies.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 65 years\r\n\r - Type 2 diabetes\r\n\r - Hispanic ethnicity\r\n\r - >3/5 points in the Mini Cog test\r\n\r - Score >17 on the Mini Nutritional Assessment\r\n\r Exclusion Criteria:\r\n\r - Not willing or not able to exercise due to medical issues or physical limitations\r\n\r - Malnutrition: Score <17 on the Mini Nutritional Assessment\r\n\r - On dialysis\r\n\r - Liver disease,\r\n\r - Cancer\r\n\r - HIV/AIDS\r\n\r - Other physical/psychological condition preventing participation\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nPrognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease\n\n**Clinical Trial Summary:**\n\nLate stage lower extremity arterial disease (LEAD) is known to be associated with hemodynamic\r and metabolic abnormalities and very poor long-term prognosis. The prognostic value of\r hemodynamic and metabolic profiling, however, is yet to be determined in this patient group.\r\n\r Current study aims to identify novel prognostic biomarkers for better risk stratification of\r late stage LEAD patients. It also allows to determine associations between\r hemodynamic/arterial stiffness indices, low-molecular weight metabolites and other substances\r (e.g. mediators of inflammation and bone-mineral metabolism, cardiac and kidney injury\r biomarkers, microRNAs) thus providing potentially valuable insight into the pathogenic\r mechanisms of this disease.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nExclusion Criteria:\r\n\r - Fontaine stage I-IIa;\r\n\r - acute limb ischemia;\r\n\r - age <35 or >85 years;\r\n\r - fasting < 6 hours;\r\n\r - time since the last use of tobacco products < 4 hours;\r\n\r - body mass index ≥ 40 kg/m2\r\n\r - blood pressure ≥ 180/120mmHg;\r\n\r - unstable angina;\r\n\r - atrial fibrillation at the time of presentation;\r\n\r - myocardial infarction, stroke or TIA during the preceding 3 months;\r\n\r - any revascularization during the preceding 1 month;\r\n\r - severe heart failure (NYHA IV);\r\n\r - clinically significant heart valve disease;\r\n\r - severe physical disability (other than limb ischemia);\r\n\r - acute infectious disease;\r\n\r - active malignancy or chemotherapy or disease-free < 5 years;\r\n\r - type 1 diabetes;\r\n\r - uncompensated thyrotoxicosis/hypothyroidism or other clinically significant endocrine\r disorders;\r\n\r - moderate to severe asthma (GINA 2016);\r\n\r - severe chronic obstructive pulmonary disease (mMRC grade 3-4)\r\n\r - acute (KDIGO 2012) or chronic renal disease (eGFR-EPI <30mL/min/1.73 m2);\r\n\r - clinically significant acute or chronic liver disease;\r\n\r - severe anemia (<80 g/L);\r\n\r - clinically significant neuroinflammatory or neurodegenerative disease;\r\n\r - active rheumatism;\r\n\r - clinically significant connective tissue disease;\r\n\r - alcoholism or drug abuse;\r\n\r - psychotic disorders\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nFactors Influencing Postural Balance and Movement in Individuals With Stroke\n\n**Clinical Trial Summary:**\n\nThere are several factors influencing on balance and movement in individuals with stroke,\r such as previous stroke, age, bowel incontinence, visuospatial problem. However, those\r factors involving in postural control and voluntary movement were studied in subacute and\r chronic phase of stroke, but not in the acute period. The aim of the study is to determine\r factors for postural control and voluntary movement in individuals with acute stroke and then\r follow at the first, third, and sixth month.\n\n**Clinical Trial Detailed Description:**\n\nBackground\r\n\r Postural control is an important component of movement. Prior to movement initiation, it is\r necessary to control posture such as gait initiation. Individuals with stroke often show\r impairment in both postural control and voluntary movement. The deficiencies restrict\r individuals with stroke to perform activities daily living and reduce quality of life leading\r to a great burden on family members and healthcare system. Additionally, there are positive\r association between postural control and movement. Therefore, postural control influences\r movement in individuals with stroke that may be in long term.\r\n\r Factors influencing on postural control and voluntary movement are shown in subacute and\r chronic phase of stroke. Previous stroke, age, bowel incontinence, visuospatial problem,\r initial severe hemiplegia, lesion edema, and intraparenchymal bleeding can predict postural\r control. Static and dynamic postural balance can predict functional outcome and discharge\r destination, as well as independent ambulation in individuals with stroke. Level of paresis,\r motor-evoked potentials, and size of lesion can predict voluntary movement. Furthermore,\r baseline upper extremity (UE) voluntary movement, hemorrhagic stroke, baseline National\r Institutes of Health Stroke Scale (NIHSS), and cortical lesion excluding primary motor cortex\r can predict outcome of UE movement in subacute stroke. Admission lower extremity (LE)\r voluntary movement score and volume and edema of lesion are predictors for motor recovery of\r LE at discharge from rehabilitation ward. Age, severity of LE weakness, visual problems, size\r of lesion, and type of stroke are predictors for walking ability within 30 days after stroke.\r\n\r Those factors associating with postural control and voluntary movement were studied in\r subacute and chronic phase of stroke, but not in the acute period. The findings may limit to\r apply to the earlier period of stroke since different mechanisms of recovery occurring in\r different timing after brain injury. Additionally, in clinical practice, one of the common\r questions that clinicians are often asked by individuals with stroke and family members is\r whether he/she can sit, stand, and walk. To provide an assurance response, the factors\r associated with postural control and voluntary movement in the acute phase of stroke is\r required.\r\n\r Furthermore, previous studies investigating predictors of postural control and voluntary\r movement used diverse outcome measures. Posture control were examined by different measures,\r for example Barthel Index, Mini-Mental State Examination, Frenchay Activity Index and Rankin\r Scale. Similarly, motor function recovery was assessed by various outcomes such as\r Scandinavian Stroke Scale, Medical Research Council scale, Motricity index, and exclusive of\r own scale. These measurements indirectly assessed postural control and voluntary movement.\r However, there is a measure directly examining postural control and voluntary movement for\r individuals with stroke that is Postural Assessment Scale for Stroke (PASS) and Stroke\r Rehabilitation Assessment of Movement (STREAM). These two measurements have excellent\r reliability and show no floor or ceiling effect in acute stroke. In addition, the PASS is an\r outcome measure recommended for acute stroke care. It would be, therefore, better using PASS\r and STREAM to record and for communication.\r\n\r The aim of the study is to determine factors for postural control and voluntary movement in\r individuals with acute stroke and then follow at the first, third, and sixth month.\r\n\r Methods\r\n\r The study is observation clinical research. Participants are individuals with stroke admitted\r to acute stroke unit, Siriraj hospital. They are included if they are first stroke and aged\r 18 years and over. They are excluded if they recurrent stroke, have other neurological\r diseases such as brain tumor, Parkinson's Disease, systolic blood pressure greater than 160\r mmHg and/or diastolic blood pressure greater than 100 mmHg, heart failure recorded in\r patient's file, joint limitation in functional range, and difficulty in communication (i.e.\r sensory aphasia, severe hearing loss). The sample size is calculated with 15% dropout and\r requires 103 participants.\r\n\r A researcher will contact physical therapist who is on duty to ask for patients who are in\r the inclusion criteria. Then, a researcher contacts patients or family members taking\r responsibility for patients via face to face to inform the study and ask he/she to sign\r written inform consent if he/she would like to participate in the study. Within 3 days of\r admission, a researcher will extract the information from patients' file. The information is\r age, gender, body mass index, Glasgow coma score, onset to admission interval (OAI),\r hemisphere lesion, affected side, initial National Institute Health Stroke Scale (NIHSS-IN),\r history of receiving recombinant tissue plasminogen activator (rtPA), thrombectomy,\r craniotomy, craniectomy, receiving transcranial direct current stimulation (tDCS), days\r staying in acute stroke unit (DOS), days from admission to first physical therapy (DA-PT),\r days receiving physical therapy (DPT), days from baseline to final assessment (D-B-FA).\r Furthermore, progressive stroke and physical therapy treatments are noted. Additionally, the\r researcher will assess postural control by PASS and voluntary movement by STREAM that will be\r baseline PASS (PASS-B) and baseline STREAM (STREAM-B). The researcher will take NIHSS score\r of that day from patient's file (NIHSS-B). The PASS-B includes baseline score of ability to\r maintain posture (PASS-B_M) and baseline score of ability to control balance changing\r position (PASS-B_C). The STREAM-B consists of score of upper extremity movement\r (STREAM-B_UE), baseline score of lower extremity movement (STREAM-B_LE), and baseline score\r of basic mobility (STREAM-B_Mo).\r\n\r Before 2 days of discharge or on the day of discharge from the ward the same researcher will\r assess postural control and voluntary movement again. Hence, the data will be PASS at\r discharge (PASS-DC) and its subitems (PASS-DC_M; PASS-DC_C), STREAM at discharge (STREAM-DC)\r and its subitems (STREAM-DC_UE; STREAM-DC_LE; STREAM-DC_Mo).\r\n\r After discharge at 1st, 3rd, and 6th month participants will assess postural control (PASS-1,\r PASS-3, PASS-6) and its subitems (PASS-1_M, PASS-1_C, PASS-3_M; PASS-3_C, PASS-6_M; PASS-6_C)\r voluntary movement (STREAM-1, STREAM-3, STREAM-6) and its subitems (STREAM-1_UE; STREAM-1_LE;\r STREAM-1_Mo, STREAM-3_UE; STREAM-3_LE; STREAM-3_Mo, STREAM-6_UE; STREAM-6_LE; STREAM-6_Mo).\r Participants will be contacted via phone to make an appointment for the assessment at Siriraj\r hospital or home depending on convenience of participants.\r\n\r Descriptive analysis is performed for subject characteristics with frequency or mean and SD,\r as appropriate. Association between any of continuous or categorical variables and NIHSS-DC,\r PASS-DC, STREAM-DC, PASS-1, STREAM-1, PASS-3, STREAM-3, PASS-6, or STREAM-6 is conducted by\r Pearson correlation or Spearman correlation test, as appropriate. To identify the potential\r factors for postural control and voluntary movement, univariate analysis is conducted for all\r variables, then followed by the regression analysis. If the association shows significance\r with p-value < 0.05, the candidate variable can be assumed as potential factor. Finally, a\r multiple linear regression analysis was performed to determine the last predictors for PASS\r and STREAM at discharge. Multicollinearity among independent factors is tested by variance\r inflation factor (VIF) and admitted if VIF > 10.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. 18 years old and over\r\n\r 2. First stroke\r\n\r Exclusion Criteria:\r\n\r 1. Recurrent stroke\r\n\r 2. Having other neurological diseases such as brain tumor, Parkinson's Disease\r\n\r 3. Systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater\r than 100 mmHg\r\n\r 4. Having heart failure recorded in patient's file\r\n\r 5. Having joint limitation in functional range\r\n\r 6. Difficulty in communication (i.e. sensory aphasia, severe hearing loss)\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"content": "**Clinical Trial Title:**\n\nIntermittent Fasting as a Means to Lose Fluid Overload and Weight in Complicated Obesity\n\n**Clinical Trial Summary:**\n\nTo examine the feasibility of intermittent fasting (36h, twice a week, unlimited salt and\r calorie-free fluid consumption), over three months, on body weight and composition in\r complicated obesity in whom age and medical complexity exclude the possibility of bariatric\r surgery.\n\n**Clinical Trial Detailed Description:**\n\nRationale:\r\n\r Complicated obesity: In weight loss-targeted treatment of obesity, current therapeutic\r choices include lifestyle modification, drug therapy, and bariatric surgery. For\r uncomplicated obesity, all the above comprise legitimate means. Attempted weight loss is\r traditionally initiated by targeting lifestyle, but unfortunately, the long term effect of\r this approach is limited as regards success rate, the extent of the achieved weight loss and\r the ability to sustain the achieved weight loss. The use of drugs is mostly reserved for\r cases where a limited weight loss of 5-10% is considered satisfactory. The safety of\r drug-assisted weight loss in older obese subjects with co-morbidities such as fluid\r retention, nephropathy, and heart failure remains insufficiently studied. Even for older\r subjects without such dominant conditions, data is scarce. For example, two trials (using\r phentermine/topiramate and liraglutide) have documented efficacy analyses between older\r adults and their younger, but enrolled only 7% (n= 5254) and 6.9% (n= 5232) older adults,\r respectively, among their study subjects. It is now well established that in non-elderly\r subjects, bariatric surgery is followed by substantial weight loss and leads to the cure of\r obesity and at least to a temporary amelioration/delay/cure of its sequels, including\r diabetes and hypertension.\r\n\r However, weight loss is often most critically needed in subjects with complicated obesity, in\r whom an overall poor health state precludes bariatric surgery altogether. Individuals with\r long-standing obesity complicated by previous cardiovascular events, diabetes, renal\r impairment, fluid retention due to renal disease, the use of vasodilator drugs needed to\r control hypertension (alpha-blockers, calcium channel blocker), left ventricular diastolic\r dysfunction, respiratory dysfunction including obstructive sleep apnea, pulmonary\r hypertension, and restrictive lung disease. Such patients are generally too sick to be\r considered for bariatric surgery. In such patients concomitant weight loss from two body\r compartments could be extremely beneficial: reduction in fat mass and, often more critical in\r immediate terms, rapid loss of excess body fluids. In obesity complicated by clinically\r significant fluid retention, most of the excessive fluid volume is extra-vascular, residing\r in the extracellular tissue compartment, with only a small, though critical excess, occupying\r the intracellular compartment. Diuretics are the key tool to reduce volume overload, but they\r acutely lower the volume of the intravascular fluid compartment, which leads to impairment in\r renal, myocardial and general tissue arterial perfusion, thus often exacerbating renal\r failure and overall tissue hypoperfusion, including cerebral, myocardial and hepatic blood\r supply.\r\n\r Most older and significantly obese subjects have had sustained obesity for several decades,\r which has allowed the cumulative evolution of at least some additional comorbidities such as\r the metabolic syndrome, diabetes, hyperlipidemia coronary heart disease, carotid artery\r stenosis and/or uncontrolled hypertension, congestive heart failure and renal disease.\r Paradoxically, then, those older subjects with a complex disease profile, who obviously\r comprise poor candidates for bariatric surgery, are also the group with the greatest\r immediate need to lose weight. It is therefore noteworthy that in Israel, individuals over\r the age of 65 cannot undergo bariatric surgery on the basis of obesity per se, unless\r approved by a special committee. Although European guidelines for the treatment of obesity in\r the elderly have concluded that the elderly should not be denied bariatric surgery solely on\r age grounds, long-term evidence in support of this statement is lacking such that both\r patients and physicians often consider bariatric surgery at this stage as too risky. Thus,\r current standard medical practice has little to offer to the complicated older obese patient\r who, on one hand is burdened with incapacitating obesity and its complications, and, on the\r other hand, is beyond the reach of the only tool to permanently alleviate obesity, i.e.,\r bariatric surgery.\r\n\r Intermittent and or short term fasting in humans: There is truly a lack of solid work on the\r safety and efficacy of fasting as a tool to lose weight in humans. The largest medical\r database on fasting has been collected on subjects practicing religious fast, such as the\r Ramadan. However, these forms of fasting are almost uniformly compensated for by excessive\r feeding either in the beginning or the end of the fast, or both. Insights on the effects of\r true fasting, longer than 24h, under medical supervision in humans is hard to find in\r published reports. In one study where caloric restriction for most of the week was combined\r with one day/week of nearly complete fasting (125Kcal), the intervention was deemed effective\r and unassociated with untoward effects in 54 obese women over a period of 24 weeks. A recent\r review included 16 studies of intermittent fasting in humans, of which 11 were carried out in\r overweight or obese subjects. Duration of the trials varied from 24h to 6 months. In two\r studies, fasting was daily and lasted from 11 and 16 hours within each day. There were 7\r studies lasting 8-12 weeks, with alternate-day fasting, in which fasting was defined as\r consuming 20-30% of the required caloric intake on the fasting day. In two studies, caloric\r restriction was defined as consuming 25% less calories on the fasting day. As compared to a\r variety of more standard dietary measures, intermittent fasting appears to result in some\r modestly larger weight reduction. Among 16 intervention trials included in review, 11\r reported statistically significant weight loss. However, in most of the reviewed intervention\r trials, complete fasting was either not attempted or restricted to 16 hours only, or less.\r\n\r Complete intermittent fasting (excluding water) in humans: Despite the lack of data on the\r effects of complete intermittent fasting, however, a day of fasting is semi/non-intentionally\r practiced in many subjects undergoing investigative diagnostic procedures such as combined\r endoscopy and colonoscopy conducted in the afternoon or surgery unexpectedly postponed to the\r evening hours and many other medical conditions. Unfortunately, this unwanted form of fasting\r was never studied in depth. However, as early as the late 50s and early 60s of the previous\r century, it was noted that 5-7 days of complete fasting was associated with diuresis,\r natriuresis, and weight loss and appeared an effective mode of treatment of the failing\r heart, in otherwise treatment-refractory subjects who were, at that time, already \"fully\r digitalized\". An unexpected finding was the observation that water and salt excretion was\r enhanced during fasting: one of the fasting patients with heart failure lost 7.3 kg in 5\r days, and the average daily weight loss of his 10 original subjects 0.85 kg to 1.5 kg per\r day, way above what might have been expected by the effect of negative caloric balance on fat\r and lean tissue loss alone.\r\n\r Fasting diuresis and fasting as an ancillary tool to lower fluid overload Although it is well\r known that fasting in obese subjects is associated with natriuresis and development of\r cumulative negative sodium balance, the mechanism of increased urinary sodium excretion\r remains largely obscure. The leading hypothesis in recent decades was that reduction in\r insulin ameliorated increased insulin-driven re-absorption of sodium in the kidney, but\r overall, following the initial discovery of this phenomenon, it has attracted little\r research. It is also well established that the obese state, even uncomplicated by renal\r disease or congestive heart failure, is accompanied by a diminished ability to excrete salt.\r\n\r During starvation, there appears to be an obligatory sodium loss in linkage to the\r metabolically generated organic anions, which further enhances fasting related natriuresis.\r Notably, unlike the action of diuretics and the tubular inhibition of sodium reabsorption,\r which lowers intravascular volume, the formation of organic anions during starvation takes\r place in the extravascular compartment, particularly in fat tissue, and would therefore allow\r the recruitment of tissue sodium (coupled to organic anions formed during lipolysis, and\r water), followed by the shift of sodium and water from the extravascular compartment to the\r intravascular compartment, and only then, excretion via the kidney. The latter process,\r therefore, does not lower intravascular fluid volume and should not impair renal perfusion\r and function. In support of this concept is the apparent dissociation between sodium and\r chloride excretion that has been reported with a relatively minimal increase in chloride\r excretion during the first week of fasting when sodium excretion is rapidly increasing. In\r fact, during the initial 3 days of fast in obese humans, natriuresis was proportional to\r urinary 3beta hydroxybutyrate excretion while urinary ammonium had not yet increased, thus\r indicating that the organic acids generated during lipolysis are the driving force in the\r shift of sodium from the body, outwards through the kidneys.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria 1)\r\n\r 1. Subjects with complicated obesity grade 2 or higher (Body Mass Index [BMI]>35kg/m2),\r i.e., obesity associated with renal failure with eGFR<60cc/min or heart failure with\r preserved ejection fraction (EF) (≥50%) and clinical evidence of fluid retention\r evidenced by the use of loop diuretic, or the presence of peripheral edema; or\r treatment in congestive heart failure clinics or history of admission to the hospital\r for heart failure during the past 3 years; OR • b. Subjects with complicated obesity,\r grade 2 or higher (BMI>35 kg/m2) [with renal failure as defined above-delete this\r requirement] and at least one of the following comorbidities: 1) Uncontrolled\r hypertension despite the use of at least 3 drugs administered at their maximal or\r close to maximal dose 2) Severe sleep apnea (based on a sleep lab report) 3) Pulmonary\r hypertension 4) Coronary heart disease 5) Type 2 diabetes mellitus 6) History of\r stroke (> 3 months prior to the recruitment to the trial) 2) Subjects who failed to\r lose weight on standard treatment, refuse standard medical treatment or are judged as\r unable to tolerate/unsuitable to receive standard medical treatment to lower body\r weight and in whom bariatric surgery is deemed unacceptable due to excessive surgical\r risk by the referring physician and/ or the PI and / or the patient and fulfill the\r following criteria\r\n\r 1. Wish to fast 36 hours, twice a week, over three months\r\n\r 2. Committed to attend the clinic at least once a week and perform blood tests every\r 2-14 days, as detailed in the protocol.\r\n\r 3. Are well trained in-home glucose monitoring and are willing to monitor glucose\r levels during the fasting days.\r\n\r 4. Are well trained in-home monitoring of blood pressure and are willing to measure\r blood pressure twice a day during the fasting days.\r\n\r 5. Own and control a dependable means of 24/7 communication device, eg, cell phone,\r and are committed to avail this route of communication to the study staff.\r\n\r Exclusion criteria:\r\n\r 1. Severe renal failure (eGFR<20cc/min)\r\n\r 2. Liver disease other than non-alcoholic fatty liver disease or cardiac cirrhosis or any\r liver disease with aspartate aminotransferase (AST), alanine aminotransferase (ALT) or\r alkaline phosphatase levels>3 times of the upper limit of the normal range, albumin<\r 3.5 gr% or direct bilirubin>1.2 mg%.\r\n\r 3. Cognitive impairment assessed by a Mini-Mental State Exam (MMSE) score < 24\r\n\r 4. Living in a single household (caretaker is allowed)\r\n\r 5. Age less than 18 or >85 years\r\n\r 6. Pregnancy or intention to conceive or female at the reproductive age not using birth\r control means.\r\n\r 7. History of documented hypoglycemia during the past year despite attempted adjustment\r of treatment.\r\n\r 8. Unintended weight loss > 2kg over the past 2 months.\r\n\r 9. The initiation, within the study period of any one of the following medications,\r including topiramate, lyxumia, byetta, bydureon, belviq, Xenical, victoza, saxenda,\r trulicity, semaglutide or any other glucagon-like peptide-1 (GLP-1) analog. However,\r subjects already treated with these agents before the initiation of the trial may be\r included provided that the medication has been started at least 4 months prior to the\r beginning of the study and that weight loss during the 2 months preceding the trial\r did not exceed 2 kgs.\r\n\r 10. A subject who must use drugs whose use is not recommended on an empty stomach and in\r whom this qualification appears, in the investigator's opinion more critical than the\r potential chance to lose weight and excrete excess bodily fluids.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nWSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases\n\n**Clinical Trial Summary:**\n\nThis phase I trial studies the side effects and best dose of WSD0922-FU for the treatment of\r glioblastoma, anaplastic astrocytoma, or non-small cell lung cancer that has spread to the\r central nervous system (central nervous system metastases). WSD0922-FU is a targeted\r treatment which blocks the EGFR protein - a strategy that has led to a lot of benefit in\r patients with many different cancers. WSD0922-FU may also be able to get into cancers in the\r brain and spinal cord and help patients with brain and spinal cord cancers.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D)\r of EGFR/EGFRvIII inhibitor WSD0922-FU (WSD0922-FU) in subjects with recurrent glioblastoma,\r IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and central nervous system\r (CNS) metastases of non-small cell lung cancer (NSCLC).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the incidence of treatment-emergent adverse events (TEAEs) related to\r WSD0922-FU.\r\n\r II. To assess anti-tumor activity: intracranial and extracranial overall response rate (ORR),\r and change in tumor size compared with baseline according to Response Assessment in\r Neuro-Oncology (RANO) criteria for GBM/AA and Response Evaluation Criteria in Solid Tumors\r (RECIST) 1.1 for NSCLC.\r\n\r III. To assess anti-tumor activity: intracranial and extracranial disease control rate (DCR)\r and change in tumor size compared with baseline according to RANO criteria for GBM/AA and\r RECIST 1.1 for NSCLC.\r\n\r IV. To assess anti-tumor activity: intracranial and extracranial duration of response (DOR)\r and change in tumor size compared with baseline according to RANO criteria for GBM/AA and\r RECIST 1.1 for NSCLC.\r\n\r V. To assess anti-tumor activity: intracranial and extracranial progression-free survival\r (PFS) and change in tumor size compared with baseline according to RANO criteria for GBM/AA\r and RECIST 1.1 for NSCLC.\r\n\r EXPLORATORY/CORRELATIVE RESEARCH OBJECTIVES:\r\n\r I. To investigate the presence and/or identity of the drug metabolites of WSD0922-FU, and the\r concentrations of these in the plasma, cerebrospinal fluid (CSF), and tumor.\r\n\r II. To assess plasma concentration of WSD0922-FU and metabolite SN16110801P1 and\r pharmacokinetics (PK) parameters after single and multiple doses of WSD0922-FU.\r\n\r III. To assess the brain tumor pharmacokinetics of WSD0922-FU and SN16110801P1 after a single\r dose of WSD0922-FU (Dose Expansion - Brain tumor penetration [BTP] cohort only).\r\n\r IV. To assess cerebrospinal fluid (CSF) concentration of WSD0922-FU and SN16110801P1 after\r multiple doses of WSD0922-FU (Dose Expansion - NSCLC leptomeningeal metastases [NSCLC LM]\r cohort only).\r\n\r V. To explore the impact of tumor markers (e.g. MGMT promoter methylation, EGFR mutation\r [including EGFR vIII], PTEN deletion, TP53 mutation, etc.) on clinical parameters associated\r with WSD0922-FU treatment.\r\n\r VI. To evaluate and measure pharmacodynamic biomarkers of inhibition of EGFR and downstream\r signals in tumor samples after a single dose of WSD0922-FU (Dose Expansion Cohort - BTP\r cohort only).\r\n\r VII. To evaluate the effect of food on the pharmacokinetics of single dose of WSD0922-FU in\r plasma (Dose Expansion - NSCLC LM cohort only).\r\n\r OUTLINE: This is a dose-escalation study.\r\n\r DOSE ESCALATION: Patients receive WSD0922-FU orally (PO) once daily (QD) or twice daily (BID)\r on days 1-28. Cycles repeat every 28 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r DOSE EXPANSION: Patients are assigned to 1 of 3 cohorts.\r\n\r COHORT I: Patients with GBM/AA receive WSD0922-FU PO BID on days 1-28. Cycles repeat every 28\r days in the absence of disease progression or unacceptable toxicity.\r\n\r COHORT II: Patients with BTP receive a single dose of WSD0922-FU prior to surgery. Patients\r then undergo surgical resection of brain tumor. After surgery, patients receive WSD0922-FU PO\r BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r COHORT III: Patients with NSCLC LM receive WSD0922-FU PO on days 1 and 4 of cycle 0. Patients\r then receive WSD0922-FU PO BID on days 1-28 of subsequent cycles. Cycles repeat every 28 days\r in the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up at 4-6 weeks, then every 2\r months until progressive disease, at progressive disease, and then every 3 months after\r progressive disease for up to 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Pre-Registration - Inclusion Criteria Specific to Dose Escalation Cohort\r\n\r - Histological confirmation of either glioblastoma, IDH wildtype (GBM), anaplastic\r astrocytoma, IDH wildtype (AA) or non-small cell lung cancer (NSCLC)\r\n\r - EGFR Status:\r\n\r - GBM/AA must have EGFR amplification and/or EGFRvIII mutation\r\n\r - NSCLC must have confirmed activating EGFR mutation (including Del19, L858R,\r EGFRvIII, G719A, L861Q)\r\n\r - Pre-Registration - Inclusion Criteria Specific to Dose Expansion Cohorts\r\n\r - Glioblastoma, IDH wildtype/Anaplastic astrocytoma, IDH wildtype (GBM/AA) Cohort:\r\n\r - Diagnosis: Histological confirmation of either glioblastoma, IDH wildtype (GBM)\r or anaplastic astrocytoma, IDH wildtype (AA)\r\n\r - EGFR status: GBM/AA must have EGFR amplification and/or EGFRvIII mutation\r\n\r - Brain Tumor Penetration (BTP) Cohort:\r\n\r - Diagnosis: Histological confirmation of either glioblastoma, IDH wildtype (GBM)\r or anaplastic astrocytoma, IDH wildtype (AA)\r\n\r - EGFR status: GBM/AA must have been previously demonstrated to have EGFR\r amplification and/or EGFRvIII mutation based on any prior resection\r\n\r - Non-Small Cell Lung Cancer Leptomeningeal Metastases (NSCLC LM) cohort:\r\n\r - Diagnosis: Histological confirmation of non-small cell lung cancer (NSCLC)\r\n\r - EGFR status: NSCLC must have confirmed activating EGFR mutation (including Del19,\r L858R, EGFRvIII, G719A, L861Q)\r\n\r - Registration -Inclusion Criteria Specific to Dose Escalation Cohort\r\n\r - Previous treatments:\r\n\r - Patients with GBM/AA must have been previously treated with radiation and\r temozolomide\r\n\r - Patients with NSCLC must have been previously treated with at least one line of\r single-agent therapy with an EGFR TKI e.g. gefitinib, erlotinib, afatinib, or\r osimertinib) and at least one line of chemotherapy (doublet chemotherapy such as\r carboplatin/paclitaxel, carboplatin/gemcitabine, cisplatin/paclitaxel,\r cisplatin/gemcitabine; single agent such as pemetrexed, gemcitabine, taxanes, or\r other regimens listed in the National Comprehensive Cancer Network [NCCN]\r guidelines)\r\n\r - Radiographic progression:\r\n\r - Patients with GBM/AA must have radiographic progression based on RANO criteria\r\n\r - Patients with NSCLC must have new or radiographic progression in the central\r nervous system (brain metastases and/or leptomeningeal metastases). Positive\r confirmation of CSF cytology is both necessary and sufficient to define the\r presence of leptomeningeal metastases for patients in this study. Patients with\r positive CSF cytology and brain metastases will be categorized as \"leptomeningeal\r metastases.\"\r\n\r - Measurable disease\r\n\r - Eastern Cooperative Oncology Group (ECOG) 0 or 1. For patients with NSCLC with\r leptomeningeal metastases, ECOG 2 is also acceptable\r\n\r - Registration - Inclusion Criteria Specific to Dose Expansion Cohorts\r\n\r - Glioblastoma, IDH wildtype/Anaplastic astrocytoma, IDH wildtype (GBM/AA) Cohort:\r\n\r - Previous treatments: Patients must have been previously treated with radiation\r and temozolomide\r\n\r - Radiographic progression: Patients with GBM/AA must have radiographic progression\r based on RANO criteria\r\n\r - Measurable disease\r\n\r - Performance status: ECOG 0 or 1 for patients with GBM/AA\r\n\r - Brain Tumor Penetration (BTP) Cohort:\r\n\r - Previous treatments: Patients must have been previously treated with radiation\r and temozolomide\r\n\r - Radiographic progression: Patients with GBM/AA must have radiographic progression\r based on RANO criteria\r\n\r - Therapeutic surgical resection of GBM/AA required as part of routine clinical\r care\r\n\r - Performance status: ECOG 0 or 1\r\n\r - Non-Small Cell Lung Cancer Leptomeningeal Metastases (NSCLC LM) cohort:\r\n\r - Previous treatments: Patients must have had either:\r\n\r - No prior treatment with an EGFR TKI, or\r\n\r - Previous EGFR TKI treatment (e.g. gefitinib, erlotinib, afatinib, or\r osimertinib) followed by central nervous system (CNS) disease progression\r without extra-CNS progression\r\n\r - Radiographic progression: Patients must have new or radiographic progression of\r leptomeningeal metastases. Positive confirmation of CSF cytology is both\r necessary and sufficient to define the presence of leptomeningeal metastases for\r patients in this study\r\n\r - For the NSCLC LM expansion cohort, patients must have both positive confirmation\r of CSF cytology and at least one site of leptomeningeal disease that can be\r assessed by magnetic resonance imaging (MRI) and which is suitable for repeat\r assessments as per the investigator's discretion\r\n\r - Performance Status: ECOG 0, 1, or 2\r\n\r - Registration - Inclusion Criteria Common to Dose Escalation and Dose Expansion\r Cohorts:\r\n\r - Ability to understand and the willingness to sign a written informed consent document\r\n\r - Hemoglobin >= 9.0 g/dL (obtained =< 14 days prior to registration)\r\n\r - Leukocytes >= 3.0 x 10^9/L (obtained =< 14 days prior to registration)\r\n\r - Absolute neutrophil count >= 1.5 x 10^9/L (obtained =< 14 days prior to registration)\r\n\r - Platelets >= 100 x 10^9/L (obtained =< 14 days prior to registration)\r\n\r - International normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) (obtained =<\r 14 days prior to registration)\r\n\r - Patients on a stable dose of anti-coagulation therapy will be allowed to\r participate if they have no signs of bleeding or clotting and the INR/prothrombin\r time (PT) and partial thromboplastin time (PTT)/activated (a)PTT results are\r compatible with an acceptable risk-benefit ratio as per the investigator's\r discretion\r\n\r - aPTT =< 1.5 x ULN (obtained =< 14 days prior to registration)\r\n\r - Patients on a stable dose of anti-coagulation therapy will be allowed to\r participate if they have no signs of bleeding or clotting and the INR/PT and\r PTT/aPTT results are compatible with an acceptable risk-benefit ratio as per the\r investigator's discretion\r\n\r - Total bilirubin =< 1.5 x ULN and < 3 mg/dL for patients with Gilbert's disease\r (obtained =< 14 days prior to registration)\r\n\r - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and\r alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x\r ULN or =< 5 x ULN if due to liver involvement by tumor (obtained =< 14 days prior to\r registration)\r\n\r - Creatinine =< 1.5 x ULN or estimated glomerular filtration rate (estimated glomerular\r filtration rate [eGFR]) >= 60 mL/minute (obtained =< 14 days prior to registration)\r\n\r - Negative pregnancy test done =< 7 days prior to registration, for persons of\r childbearing potential only\r\n\r - Provision of signed and dated written informed consent prior to any study specific\r procedures, sampling, and analyses\r\n\r - Willingness to provide mandatory blood specimens and mandatory tissue specimens for\r correlative research\r\n\r - Willingness to return to enrolling institution for follow-up (during the active\r monitoring phase of the study i.e., active treatment and clinical follow-up)\r\n\r - Male and female patients of child bearing potential must be willing to use\r contraception, (i.e., condoms, birth control) while on study and until 3 months after\r the last dose of study drug is taken\r\n\r - Must be willing to take light-protective measures during the study and for 2 weeks\r after their last dose of WSD0922-FU\r\n\r - Must have a minimum life expectancy of >= 3 months\r\n\r - Must be stable on no more than 2 mg of dexamethasone (or equivalent steroids) per day.\r Steroid dose should not be adjusted during cycle 1 of therapy\r\n\r - Must not take enzyme-inducing anticonvulsants treatment for at least 2 weeks prior to\r enrollment. Patients on enzyme-inducing anticonvulsants will be changed to non-enzyme\r inducing anticonvulsants. Drug-drug interactions (DDI) with proton pump inhibitor\r (PPI), H2 blockers or antacids have not been assessed; therefore it is suggested to\r avoid taking those drugs together with WSD0922-FU\r\n\r - Strong inducers and strong inhibitors of CYP3A should be discontinued at least 14 days\r prior to registration\r\n\r Exclusion Criteria:\r\n\r - Registration - Exclusion Criteria for Dose Escalation and Dose Expansion\r\n\r - Any of the following because this study involves an investigational agent whose\r genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are\r unknown:\r\n\r - Pregnant persons\r\n\r - Nursing persons\r\n\r - Persons of childbearing potential who are unwilling to employ adequate\r contraception\r\n\r - Any of the following prior therapies:\r\n\r - Any cytotoxic chemotherapy or other anticancer drugs for the treatment of\r advanced NSCLC from a previous treatment regimen =< 14 days prior to registration\r\n\r - In patients with NSCLC, treatment with an EGFR TKI (e.g., erlotinib, gefitinib,\r afatinib or osimertinib) within 8 days or approximately 5 x half-life, whichever\r is the longer, prior to registration (if sufficient wash-out time has not\r occurred due to schedule or PK properties, an alternative appropriate wash-out\r time based on known duration and time to reversibility of drug related adverse\r events could be agreed upon by the Investigator and Wayshine)\r\n\r - Radiation therapy to the brain =< 12 weeks prior to registration\r\n\r - Patients with GBM/AA must not have received prior anti-EGFR or EGFRvIII therapies\r (erlotinib, gefitinib, afatinib, osimertinib, ABT-414, ABBV-221, AMG-595, AMG-596\r etc.) or prior treatment with bevacizumab\r\n\r - Received prior systemic biologic therapy (CAR-T, anti-PD-1 / anti-PD-L1,\r anti-CTLA-4, etc.) within 28 days prior to registration.\r\n\r - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment\r of the investigator, would make the patient inappropriate for entry into this study or\r interfere significantly with the proper assessment of safety and toxicity of the\r prescribed regimens including uncontrolled hypertension and active bleeding diatheses,\r which in the investigator's opinion makes it undesirable for the patient to\r participate in the trial or which would jeopardize compliance with the protocol.\r Screening for chronic conditions is not required\r\n\r - Subjects who are human immunodeficiency virus (HIV), hepatitis virus B (HBV), and/or\r hepatitis virus C (HCV) positive\r\n\r - Uncontrolled inter-current illness including, but not limited to:\r\n\r - Symptomatic CNS complications that require urgent neurosurgical or medical (e.g.\r mannitol) intervention\r\n\r - Seizures requiring a change in anti-epileptic medications (addition of new\r anti-epileptic or increase in dose) =< 2 weeks of registration\r\n\r - Known intracranial hemorrhage which is unrelated to tumor\r\n\r - Significant medical or psychiatric illness that would interfere with compliance\r and ability to tolerate treatment as outlined in the protocol\r\n\r - Illness/social situations that would limit compliance with study requirements\r\n\r - Receiving any other investigational agent which would be considered as a treatment for\r the primary neoplasm\r\n\r - Patients with a \"currently active\" second malignancy other than non-melanoma skin\r cancers and carcinoma-in-situ of the cervix. Patients are not considered to have a\r \"currently active\" malignancy if they have completed therapy and are free of disease\r for more than three years prior to registration\r\n\r - Any of the following cardiac criteria:\r\n\r - A marked baseline prolongation of QT/corrected QT (QTc) interval\r\n\r - (e.g., repeated demonstration of a QTc interval > 480 milliseconds (ms) (Common\r Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fridericia's QT\r correction formula\r\n\r - A history of additional risk factors for torsade de pointes (TdP) (e.g., heart\r failure, hypokalemia, family history of long QT syndrome)\r\n\r - The use of concomitant medications that prolong the QT/QTc interval\r\n\r - Patients confirmed to have a cis double mutation (Del19/T790M or L858R/T790M) or cis\r triple mutation (Del19/T790m/C797S or L858R/T790M/C797S)\r\n\r - Past medical history of interstitial lung disease, drug-induced interstitial lung\r disease, radiation pneumonitis which required steroid treatment, or any evidence of\r clinically active interstitial lung disease. History of hypersensitivity to active or\r inactive excipients of WSD0922-FU or drugs with a similar chemical structure or class\r to WSD0922-FU\r\n\r - Refractory nausea and vomiting if not controlled by supportive therapy, chronic\r gastrointestinal diseases, inability to swallow the formulated product or previous\r significant bowel resection that would preclude adequate absorption of WSD0922-FU\r\n\r - Inadequate bone marrow reserve or organ function\r\n\r - Patients with NSCLC LM who are unable to undergo collection of CSF\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
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possibly relevant
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366
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSurgery Plus Intraoperative Radiotherapy as Treatment for Squamous Cell Carcinoma Over Pilonidal Disease.\n\n**Clinical Trial Summary:**\n\nBackground: Pilonidal sinus is a very common disease. Malignant transformation occurs in 0,1%\r of patients. The investigators present a case of squamous cell carcinoma arised from\r recurrent pilonidal disease, managed by multimodal treatment.\r\n\r Case presentation: The investigators present a 70-year-old man with chronic pilonidal sinus.\r Inflammation had worsened in previous months and exploration revealed a large ulcerative mass\r which biopsy showed a squamous cell carcinoma. CT scan and MRI imaging showed tumoral\r invasion of the coccyx and both gluteus major muscles. Neoadjuvant radiotherapy, chemotherapy\r as radiosensitizer and surgery with intraoperative radiotherapy was decided in the\r multidisciplinary tumor committee. Post neoadjuvant therapy MRI showed partial response with\r a decrease of the mass but persistence of the coccyx infiltration.\r\n\r Surgery consisted in en-bloc resection of the tumor with presacral tissues, coccyx and\r partial gluteal resection. Intraoperative radiotherapy was administered over the sacrum and\r in the bed of the coccyx resection. One week later, reconstructive surgery was practiced\r using a latissimus dorsi free flap, advancement of gluteal flaps and skin graft. Histological\r examination showed no residual tumor. The patient is currently asymptomatic and he has a\r satisfactory quality of life.\r\n\r Conclusions: Although squamous cell carcinoma is rare, it must be suspected in patients with\r recurrent pilonidal disease. Diagnosis is done by histological examination of biopsies. This\r type of tumors have a high local recurrence rate. The investigators propose a multimodal\r treatment that includes neoadjuvant radiotherapy and chemotherapy as radiosensitizer and\r surgery plus intraoperative radiotherapy with the aim to decrease local recurrence rate.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Squamous cell carcinoma over pilonidal disease\r\n\r Exclusion Criteria:\r\n\r - Distant Metastases\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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367
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nGenomic Landscape of Intramedullary Astrocytoma\n\n**Clinical Trial Summary:**\n\nintramedullary astrocytoma is a rare and devastating spinal cord glioma. while the management\r of intracranial astrocytoma includes gross total resection, radiotherapy and chemotherapy,\r spinal cord astrocytoma is very difficult to be totally removed due to its infiltrative\r nature and unclear plane of dissection; Moreover, the use radiotherapy and chemotherapy for\r spinal cord astrocytoma is controversial. Therefore, the treatment for spinal cord\r astrocytoma is very limited as compared to its intracranial counterpart. Inadequate\r understanding of spinal cord astrocytoma mainly contribute to limited treatment, while the\r molecular profiling of intracranial astrocytoma is relatively well understood. Hence, we\r performed whole-exome sequencing of intramedullary astrocytoma aiming to identify the\r pathophysiological mechanisms underlying spinal cord astrocytoma\n\n**Clinical Trial Detailed Description:**\n\nIntramedullary tumor only account for 2-4% of central nervous tumor. Of which, ependymoma and\r astrocytoma represent the most common intramedullary tumor. Although intramedullary\r astrocytoma is rare, it can cause significant mortality and morbidity. Different from its\r intracranial counterpart which can receive gross total resection and standard adjuvant\r treatment, intramedullary astrocytoma always cannot be removed completed due to its\r infiltrative nature and, additionally, radiotherapy and chemotherapy is controversial.\r Therefore, the treatment for this tumor is very limited. While the genetic profiling of\r intracranial astrocytoma is relatively well understood and standard treatment strategy has\r been developed, genetic alteration of intramedullary astrocytoma is less well understood.\r Identification of the molecular profiling can lead to well understanding of the\r pathophysiological mechanisms underlying intramedullary astrocytoma and more effective\r therapeutic strategy in future. Hence, we performed this study aiming to investigate the\r genetic profiling of intramedullary. All patients with intramedullary astrocytoma underwent\r surgery in our institution will be enrolled. Tumor tissue and matching blood will be obtained\r after the surgery. Whole-exome sequencing was performed on DNA extracted from these\r specimens. Moreover, demographic information, progress-free survival and overall survival\r will be evaluated in 3 year of follow-up after the initial diagnosis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients that histologically diagnosed as primary spinal cord astrocytoma\r\n\r Exclusion Criteria:\r\n\r - patients with spinal cord tumors rather than astrocytoma\r\n\r - metastatic astrocytoma\r\n\r - tumor sample can not be obtained\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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368
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSafety and Efficacy of Bipolar vs Monopolar Transurethral Resection of Bladder Tumor-A Randomized Controlled Trial\n\n**Clinical Trial Summary:**\n\nStudy design:\r\n\r This was a single center, parallel arm, randomized, controlled trial done at Tribhuvan\r University Teaching Hospital,Institute Of Medicine from May 2017 to April 2018. The\r allocation ratio was 1:1.\r\n\r Inclusion criteria: All patients undergoing Transurethral Resection of Bladder Tumor for\r suspected bladder tumors.\r\n\r Exclusion criteria were: Consent withdrawal, bladder tumour other than in the lateral wall,\r unfit for spinal anesthesia and need of general anesthesia or obturator nerve block.\r\n\r Methodology:\r\n\r All patients suspected to have bladder cancer were subjected to imaging or cystoscopy and\r with confirmation of the diagnosis; they were randomized into two arms of TURBT. Spinal\r anesthesia was used in all cases. To overcome the potential confounding effect on our primary\r end point, obturator jerk, nerve block was not used.\r\n\r Cystoscopy was done first and the findings were noted before proceeding to TURBT.\r\n\r Tumors were resected in block from periphery to center with the stalk resected last. An\r additional sample of deep muscle was obtained from the tumor base and sent for\r histopathological examination in different containers.\r\n\r All study variables were recorded in Per forma during the operation and in post operative\r period. Hemoglobin and sodium level was determined in immediate post operative period.\r\n\r Postoperative irrigation was done with normal saline in both the resection groups and\r continued till the urine was clear. The catheter was removed after 48 hours in uncomplicated\r cases and patients were discharged. Patients were followed up in OPD at 2 weeks with the\n\n**Clinical Trial Detailed Description:**\n\nAll patients suspected to have bladder cancer were subjected to imaging or cystoscopy and\r with confirmation of the diagnosis; they were randomized into two arms of TURBT. Spinal\r anesthesia was used in all cases.\r\n\r To overcome the potential confounding effect on our primary end point, obturator jerk, nerve\r block was not used.\r\n\r Cystoscopy was done first and the findings were noted before proceeding to TURBT.\r\n\r Monopolar resection was done using 1.5% Glycine solution at 110 watt cutting, and 70 watt\r coagulation power (Covidien Valley-lab Force Fx TM) with Karl Storz 26f resectoscope and loop\r (8mm width and 5mm depth) with 300 telescope. Bipolar resection was done with 0.9% Normal\r Saline with digital impedence dependent cutting (power range 150-250 watt) and 80 watt\r coagulation power (Bowa Arc 400) with Karl Storz 26f resectoscope and loop (6mm width and 5mm\r depth) with 300 telescope.\r\n\r Tumors were resected in block from periphery to center with the stalk resected last. An\r additional sample of deep muscle was obtained from the tumor base and sent for\r histopathological examination in different containers. All study variables were recorded in\r Per forma during the operation and in post operative period. Hemoglobin and sodium level was\r determined in immediate post operative period.\r\n\r Postoperative irrigation was done with normal saline in both the resection groups and\r continued till the urine was clear. The catheter was removed after 48 hours in uncomplicated\r cases and patients were discharged. Patients were followed up in Out Patient Department at 2\r weeks with the histopathological report for or when necessary.\r\n\r Study outcome:\r\n\r The incidence of obturator jerk, bladder perforation, resection time, decrease in hemoglobin\r and serum sodium, clot retention, need for blood transfusion, need for recoagulation and TUR\r syndrome were recorded for the cases in both arms. All resected specimen were evaluated by\r pathologist for quality by determining the presence of deep muscle in the sample and\r comparing the degree of cautery artifact. Severe artifact was defined as more than 50%\r cautery artifact in most chips.\r\n\r Statistical Analysis:\r\n\r Sample size (n) was calculated using 80% power and a 95% significance level for obturator\r jerk, assuming a 30% incidence for the monopolar system and a 5% incidence for the bipolar\r system. These values were arrived at after a comprehensive literature review. The sample size\r was determined with the formula n= K {P1(1-P1) x P2(1-P2)}/ )P1-P2)2, Where:\r\n\r N= sample size P1= prevalence of obturator jerk in Monopolar TURBT P2= prevalence of\r obturator jerk in Bipolar TURBT K= constant (7.9 for 80% power of study and 0.05 level of\r significance)\r\n\r A sample size of 33 in each arm was calculated using above formula. Estimating a drop out of\r 10%, we decided to include at least 37 patients in each arm. A computer generated random\r number was used to allocate eligible patients in to monopolar or bipolar resection arm. Data\r analysis was done using Statistical Package for Social Sciences (SPSS) version 21.\r Significance was determined using the independent sample t-test for quantitative variables\r and the chi-square test for qualitative data. P value of <0.05 was considered statistically\r significant.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients undergoing TURBT for suspected bladder tumors.\r\n\r Exclusion Criteria:\r\n\r - Consent withdrawal, bladder tumour other than in the lateral wall, unfit for spinal\r anesthesia and need of general anesthesia or obturator nerve block.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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369
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention\n\n**Clinical Trial Summary:**\n\nThis study is to map the pudendal nerve. In this study the researchers will examine subjects\r who are already receiving an implanted stimulator at their pudendal nerve as part of their\r normal clinical care.\n\n**Clinical Trial Detailed Description:**\n\nThe pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical\r stimulation of this nerve can help with bladder problems and pelvic pain. Researchers do not\r understand how the nerve anatomy is different between people. Successfully mapping the\r pudendal nerve may help improve the medical care for future patients with bladder problems,\r pelvic pain, bowel problems, and sexual problems.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinically referred as having bladder problems that have not responded to conservative\r treatment. Normal clinical care includes referral to implant of Medtronic Interstim\r neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant.\r\n\r - Adult (18 or older), capable of providing own informed consent and communicating\r clearly with research team\r\n\r - Capable of speaking, reading, and understanding English, as all study questionnaires\r are standardized assessments only available in English\r\n\r - Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2:\r stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test)\r\n\r Exclusion\r\n\r - Implanted materials that prohibit magnetic imaging\r\n\r - Any medical problems that prevent an individual from laying flat in an MRI or CT\r scanner, are are claustrophobic.\r\n\r - Areflexive or atonic bladder\r\n\r - Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes\r to participate in this study, they will be pre-screened with a test to detect\r pregnancy.\r\n\r - Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other\r conditions that would affect the neural circuits involved in micturition.\r\n\r - Unwilling to allow de-identified data to be stored for future use or shared with other\r researchers.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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370
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIntra-tumoral Injection of Natural Killer Cells in High-Grade Gliomas\n\n**Clinical Trial Summary:**\n\nPatients will receive 3 cycles of NK cell infusions over 12 weeks. Each cycle will consist of\r 1 infusion per week for 3 weeks, followed by a rest week (week 4). Dose will be escalated in\r an inter-patient stepwise fashion consisting of 4 dose levels.\n\n**Clinical Trial Detailed Description:**\n\nPatient enrollment will follow a 3+3 design. Patients will receive 3 cycles of NK cell\r infusions over 12 weeks. Each cycle will consist of 1 infusion per week for 3 weeks, followed\r by a rest week (week 4). Dose will be escalated in an inter-patient stepwise fashion\r consisting of 4 dose levels until dose limiting toxicities are observed or the recommended\r phase II dose is determined.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients must have a histologically-confirmed recurrent non-metastatic supratentorial\r WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma,\r anaplastic oligodendroglioma, and anaplastic pleomorphic xanthoastrocytoma) or WHO\r Grade IV malignant glioma (glioblastoma multiforme, gliosarcoma, malignant glioma NOS)\r\n\r 2. Patients should be candidates for resection/open biopsy of the recurrent tumor and be\r deemed candidate for placement of an Ommaya reservoir placed intra-cavitary/\r intra-tumoral; measurable residual tumor after surgery is not required for study entry\r\n\r 3. Given the lack of a standard of care treatment for children with recurrent grade\r III/IV gliomas, patients must have completed first-line treatment with 54 Gy of\r radiation prior to participating in this trial\r\n\r 4. All patients must be ≥ 3 years of age and <18 years of age at the time of study entry\r into the study\r\n\r 5. Lansky score of 50 or greater if ≤ 16 years of age or a Karnofsky score of 50 or\r greater if >16 years of age\r\n\r 6. Adequate bone marrow function, without transfusion or growth factors within 21 days of\r NK cell administration, defined as a white blood cell ≥ 2.5 x 103/microliter,\r hemoglobin ≥ 9 gm/dL, absolute neutrophil count ≥ 1,000 cells/microliter and platelet\r count of ≥ 75,000 cells/microliter\r\n\r 7. Patients must be off systemic steroids (except replacement therapy) for at least 3\r days prior to NK cell infusion\r\n\r 8. Adequate liver function (ALT, AST and alkaline phosphatase < 2 times ULN, bilirubin <\r 1.5 times ULN), and adequate renal function (BUN or creatinine < 1.5 times ULN) prior\r to NK cell\r\n\r 9. Must have recovered from the toxic effects of prior therapy (i.e., NCI-CTCEA version 5\r grade 1 or less) 9a. An interval of at least 12 weeks must have elapsed since the\r completion of initial radiation therapy 9b. At least 6 weeks since the completion of\r any cytotoxic chemotherapy regimen 9c. For targeted agents only, patient should have\r recovered from any toxicity of the agent and have a minimum of 2 weeks since the last\r dose 9d. For patients who have received prior bevacizumab, at least 6 weeks is\r required before starting study treatment\r\n\r 10. Patients of child-bearing potential must agree to use adequate contraception (hormonal\r or barrier method of birth control or abstinence) prior to study entry and for six\r months following duration of study participation\r\n\r Exclusion Criteria:\r\n\r 1. Patients with intra- or extra-CNS metastasis\r\n\r 2. Tumor involvement that would require ventricular, brainstem or posterior fossa\r injection or access through a ventricle or risk of ventricular penetration in order to\r deliver the NK cells\r\n\r 3. Tumors involving both hemispheres or those involving the subependyma or suspected CSF\r dissemination\r\n\r 4. Patients undergoing needle biopsies (Open biopsies are the minimum requirement for\r enrollment)\r\n\r 5. Pregnant or lactating patients\r\n\r 6. Patients on chronic corticosteroid therapy (except for replacement therapy)\r\n\r 7. Evidence of active uncontrolled infection or unstable or severe intercurrent medical\r conditions. All subjects must be afebrile at baseline (i.e., < 38.0 Celsius [C])\r\n\r 8. Any medical condition that precludes surgery\r\n\r 9. Prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin\r time (PTT) > 1.5 x ULN\r\n\r 10. Patients with a known disorder that affects their immune system, such as human\r immunodeficiency virus (HIV), or an auto- immune disorder requiring systemic cytotoxic\r or immunosuppressive therapy are not eligible\r\n\r 11. Evidence of bleeding diathesis or use of anticoagulant medication or any medication\r which may increase the risk of bleeding. If the medication can be discontinued >1 week\r prior to NK cell infusion then the subject may be eligible following consultation with\r the principal investigator (PI)\r\n\r 12. Subjects with significant systemic or major illnesses including but not limited to:\r congestive heart failure, ischemic heart disease, kidney disease or renal failure,\r organ transplantation, or significant psychiatric disorder\r\n\r 13. History or current diagnosis of any medical or psychological condition that in the\r Investigator's opinion, might interfere with the subject's ability to participate or\r inability to obtain informed consent because of psychiatric or complicating medical\r problems\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nEffects of Osteopathic Treatment With Cognitive Training on Low Back Pain\n\n**Clinical Trial Summary:**\n\nThe objective of this study is to verify whether the combined approach (osteopathic\r manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term\r than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating\r the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ)\r questionnaire\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - aged between 30 and 65 y\r\n\r - diagnosis of aspecific chronic low back pain\r\n\r - minimum of 3 on the NRS score\r\n\r Exclusion Criteria:\r\n\r - Neuropathic pain or chronic widespread pain\r\n\r - Low back spinal surgery in the last three years\r\n\r - Low back spinal surgery to osteoporosis and/or traumatic fractures\r\n\r - Rheumatic disease\r\n\r - Pregnancy or having a baby in the last 12 months\r\n\r - Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis,\r moderate arthrosis, severe, algodystrophy etc.).\r\n\r - The subjects have not to be treated with physical or manual therapies or psychotherapy\r in the last 6 months\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nCerebral Morbidity After Radiation Therapy for Brain Tumors\n\n**Clinical Trial Summary:**\n\nThis study will assess cognitive function in patients with a primary brain tumour treated\r with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for\r the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma\r will be included.\n\n**Clinical Trial Detailed Description:**\n\nRT to brain tumours causes cognitive dysfunction. The extent of RT induced changes in\r cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of\r photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive\r dysfunction. There is modest knowledge on which parts of the brain we need to spare, to\r prevent cognitive dysfunction.\r\n\r The study is a prospective nationwide study including approximately 60 brain tumour patients\r from the four neuro oncology centres in Denmark. The patients will do patient reported\r outcome (PRO) and undergo neuropsychological assessment with standardized tests: They will do\r this prior to RT treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on\r quality of life, fatigue, sleep, depression, anxiety, and socio demografica. The standardized\r tests are: Trail making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word\r Association Test (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV; Paced Auditory\r Serial Addition Test (PASAT). The correlation between cognitive scores and RT dose-volume\r parameters to specific areas in the brain will be tested.\r\n\r This study will elucidate the dose-response relationship in radiation-induced damage to\r substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that\r will allow the clinician to prioritize these structures in planning of proton radiotherapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 18 years or older and Danish speaking.\r\n\r - Performance status WHO 0-2\r\n\r - Capable of cooperating on testing\r\n\r - Tumor histology (WHO 2016 classification) of the following types: anaplastic\r astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma\r (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma,\r medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base\r sarcomas\r\n\r Exclusion Criteria:\r\n\r - Glioblastoma\r\n\r - Performance status 3-4\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations\n\n**Clinical Trial Summary:**\n\nThis phase III trial compares standard chemotherapy to therapy with CPX-351 and/or\r gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3\r mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab\r ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the\r cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up\r of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone\r marrow longer and could be less likely to cause heart problems than traditional anthracycline\r drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an\r abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that\r carry instructions for development, functioning, growth and reproduction) inside each cell\r that tell the cell what to do and when to grow and divide. FLT3 plays an important role in\r the normal making of blood cells. This gene can have permanent changes that cause it to\r function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function\r of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to\r compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people\r with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or\r bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or\r other FLT3 mutations and 3) to study changes in heart function during and after treatment for\r AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in\r treating patients with acute myeloid leukemia compared to standard chemotherapy alone.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To compare event-free survival (EFS) in children with de novo acute myeloid leukemia (AML)\r without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A with\r daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) (DA-GO) versus Arm B with\r liposome-encapsulated daunorubicin-cytarabine (CPX-351) and GO.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To compare overall survival (OS) and rates of end of Induction 1 (EOI1) minimal residual\r disease (MRD) in children with de novo AML without FLT3 mutations who are randomly assigned\r to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).\r\n\r II. To estimate the EFS and rate of EOI1 MRD in FLT3 internal tandem duplication mutation\r positive patients (FLT3/ITD+; as defined by allelic ratio > 0.1) without favorable\r cytomolecular characteristics (NPM1 and/or CEBPA) receiving gilteritinib fumarate\r (gilteritinib) in combination with DA-GO (Arm AC).\r\n\r III. To estimate the EFS and rate of EOI1 MRD in patients with non-ITD FLT3 activating\r mutations who receive backbone therapy (DA-GO or CPX-351 and GO) with gilteritinib (Arms AD\r and BD).\r\n\r IV. To determine the feasibility of combining gilteritinib and DA-GO or CPX-351 and GO in\r patients with FLT3/ITD mutations (Arm AC/Arm BC/Arm AD/Arm BD).\r\n\r V. To compare EOI1 MRD and EFS in patients with FLT3/ITD AML+ (allelic ratio [AR] > 0.1)\r without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib\r versus (vs) CPX-GO-gilteritinib (Arm AC vs Arm BC).\r\n\r VI. To compare the incidence of significant left ventricular systolic dysfunction (LVSD) in\r children with de novo AML without FLT3 mutations who are randomly assigned to standard\r induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).\r\n\r VII. To compare the changes in echocardiography-derived measures of cardiac function,\r including left ventricular ejection fraction (EF) and global longitudinal strain (GLS),\r throughout AML therapy in patients with low and high risk AML without FLT3 mutations\r receiving Arm A vs Arm B.\r\n\r VIII. Determine if early changes in sensitive echocardiographic measures of cardiac function\r (i.e., post-Induction 1 decline in GLS) and elevations in circulating cardiac biomarkers\r (i.e., cardiac troponin T and N-terminal pro b-type natriuretic peptide) are associated with\r subsequent declines in left ventricular ejection fraction in patients with non-FLT3 mutant\r AML receiving therapy on Arms A or B.\r\n\r IX. To compare longitudinal acute changes in neuropsychological functioning and\r neurocognitive late effects between those with central nervous system (CNS) disease and those\r without CNS disease and between those treated with hematopoietic stem cell transplant (HSCT)\r and those treated with chemotherapy only for patients on Arms A and B.\r\n\r X. To compare cardiotoxicity measures (EF, GLS, and cardiac biomarkers) in patients receiving\r standard induction with dexrazoxane hydrochloride (dexrazoxane) vs. CPX-351 in the context of\r gilteritinib therapy and explore whether the differential cardiotoxicity across arms varies\r from that observed in non-FLT3 mutant AML without gilteritinib exposure.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. To estimate the EFS and rate of EOI1 MRD in patients with high allelic ratio (HAR)\r FLT3/ITD+ patients, as historically defined by an AR > 0.4, receiving gilteritinib in\r combination with DA-GO (Arm AC with AR > 0.4).\r\n\r II. To estimate the EFS and rate of EOI1 MRD in FLT3/ITD+ patients (as defined by allelic\r ratio > 0.1) with NPM1 and/or bZIP CEBPA mutations receiving gilteritinib in combination with\r DA-GO (Arm AC).\r\n\r III. Compare the changes in high sensitivity troponin and natriuretic peptide elevations\r throughout AML therapy, as measured at the end of each chemotherapy course, in patients with\r low and high risk AML without FLT3 mutations receiving Arm A vs Arm B.\r\n\r IV. Quantify the association of host factors (age, sex, body mass index [BMI], race),\r treatment exposures (cumulative anthracycline dose, anthracycline arm, hematopoietic stem\r cell transplant vs. chemotherapy alone), early declines in GLS, and elevations in cardiac\r biomarkers (cTnT and NT-proBNP) with subsequent LVSD.\r\n\r V. Develop a multi-marker risk prediction model incorporating significant host factors,\r treatment exposures, and echocardiographic predictors for the development of LVSD within 1\r year of completing therapy.\r\n\r VI. To describe the rates of CNS disease utilizing an updated strategy for diagnosing and\r defining CNS disease in pediatric AML.\r\n\r VII. To describe the rates of CNS relapse (both isolated CNS and combined bone marrow/CNS)\r when utilizing this updated strategy as well as changing CNS prophylaxis and treatment to\r include triple intrathecal chemotherapy.\r\n\r VIII. To describe disease-free survival (DFS) and overall survival (OS) in high risk patients\r based on multi-dimensional flow cytometry detection of measurable residual disease prior to\r hematopoietic stem cell transplant (HSCT).\r\n\r IX. To describe plasma metabolomics that may impact efficacy, toxicity, and/or\r pharmacokinetics of allogeneic HSCT.\r\n\r X. To estimate the prevalence of non-risk stratifying cytogenetic/molecular variants and\r assess their impact on outcome in childhood AML.\r\n\r OUTLINE: Patients are randomized to either Arm A or B and assigned to Arm C or D based on\r FLT3 testing results.\r\n\r TREATMENT FOR PATIENTS WITHOUT FLT3 MUTATIONS:\r\n\r ARM A LOW RISK GROUP 1:\r\n\r INDUCTION 1: Patients receive cytarabine intravenously (IV) over 1-30 minutes every 12 hours\r (Q12H) on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes\r on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1\r receive methotrexate intrathecally (IT), therapeutic hydrocortisone (hydrocortisone) IT, and\r cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT once weekly (QW) starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the cerebral spinal fluid (CSF) is clear of blasts (CNS1\r status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 1 for 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi intramuscularly (IM) or IV\r over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM B LOW RISK GROUP 1:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM A LOW RISK GROUP 2:\r\n\r INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane\r IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and\r gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and\r dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15\r minutes on days 3-6.\r\n\r INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM B LOW RISK GROUP 2:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and\r dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15\r minutes on days 3-6.\r\n\r INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2,\r 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9.\r\n\r ARM A HIGH RISK GROUP:\r\n\r INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane\r IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and\r gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30\r minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r ARM B HIGH RISK GROUP:\r\n\r INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab\r ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW\r starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90\r minutes on days 1, 3, and 5.\r\n\r INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on\r day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV\r over 90-120 minutes on days 1-5.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r TREATMENT FOR PATIENTS WITH FLT3/ITD MUTATIONS (ITD AR > 0.1):\r\n\r ARM AC LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via\r nasogastric (NG) or gastronomy (G) tube daily on days 1-365.\r\n\r ARM BC LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM AC HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r ARM BC HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r TREATMENT FOR NON-ITD FLT3 ACTIVATING MUTATIONS:\r\n\r ARM AD LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM BD LOW RISK GROUP 2:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days\r 3-6, and gilteritinib PO QD on days 7-34.\r\n\r INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours\r Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-37.\r\n\r POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or\r G tube daily on days 1-365.\r\n\r ARM AD HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes\r Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally\r (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive\r methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may\r continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with\r CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for\r 6 weeks (may continue into Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes\r and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days\r 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r ARM BD HIGH RISK GROUP:\r\n\r CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on\r days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on\r days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT\r on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until\r the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT,\r hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into\r Induction 2).\r\n\r INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone\r IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also\r receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-38.\r\n\r INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT,\r and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H\r and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-33.\r\n\r HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen,\r patients undergo allogeneic HSCT.\r\n\r POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients\r receive gilteritinib PO QD or via NG or G tube daily on days 1-365.\r\n\r NOTE: During Induction 2 or Intensification 2, patients in Arms A and B with left ventricular\r systolic dysfunction receive a replacement course of high-dose cytarabine IV over 3 hours on\r days 1, 2, 8, and 9, and asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and\r asparaginase IM or IV over 30 minutes on days 2 and 9. Patients in Arms AC, BC, AD, and BD\r receive treatment as in Arms A and B and also receive gilteritinib PO QD on days 10-37\r (Induction 2) or days 10-37 (Intensification 2).\r\n\r All treatment continues in the absence of disease progression or unacceptable toxicity.\r\n\r OPTIONAL NEUROCOGNITIVE STUDY:\r\n\r Patients may complete the Cogstate assessment battery at the end of Induction 1, at the end\r of therapy, and at 9 and 60 months post-enrollment.\r\n\r After completion of study treatment, patients are followed up monthly for 6 months and then\r every other month for 6 months (year 1), every 4 months during year 2, every 6 months during\r year 3, then yearly for years 4-10. Patients who undergo HSCT are also followed up at 30,\r 100, and 180 days, 9 months, and 1 year post-HSCT.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part\r A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens\r must be done according to the Manual of Procedures). Risk stratification will not be\r possible without the submission of viable samples. Given there are multiple required\r samples, bone marrow acquisition techniques such as frequent repositioning or\r performing bilateral bone marrow testing should be considered to avoid insufficient\r material for required studies. Consider a repeat marrow prior to starting treatment if\r there is insufficient diagnostic material for the required studies\r\n\r - Patients must be less than 22 years of age at the time of study enrollment\r\n\r - Patient must be newly diagnosed with de novo AML according to the 2016 World Health\r Organization (WHO) classification with or without extramedullary disease\r\n\r - Patient must have 1 of the following:\r\n\r - >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)\r\n\r - In cases where extensive fibrosis may result in a dry tap, blast count\r can be obtained from touch imprints or estimated from an adequate bone\r marrow core biopsy\r\n\r - < 20% bone marrow blasts with one or more of the genetic abnormalities\r (sample obtained within 14 days prior to enrollment)\r\n\r - A complete blood count (CBC) documenting the presence of at least 1,000/uL\r (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a\r WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells\r (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed\r within 7 days prior to enrollment)\r\n\r - ARM C: Patient must be >= 2 years of age at the time of Late Callback\r\n\r - ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular\r Oncology\r\n\r - ARM C: Patient does not have any congenital long QT syndrome or congenital heart block\r\n\r - ARM C: Females of reproductive potential must agree to use effective contraception\r during treatment and for at least 6 months after the last dose of gilteritinib\r\n\r - ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib\r and for 2 months after the last dose of gilteritinib\r\n\r - ARM C: Males of reproductive potential must agree to use effective contraception\r during treatment and for at least 4 months after the last dose of gilteritinib\r\n\r - ARM D: Patient must be >= 2 years of age at the time of Late Callback\r\n\r - ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating\r mutations as reported by Foundation Medicine\r\n\r - ARM D: Females of reproductive potential must agree to use effective contraception\r during treatment and for at least 6 months after the last dose of gilteritinib\r\n\r - ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib\r and for 2 months after the last dose of gilteritinib\r\n\r - ARM D: Males of reproductive potential must agree to use effective contraception\r during treatment and for at least 4 months after the last dose of gilteritinib\r\n\r - NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who\r transfer to Arm C or Arm D are not eligible\r\n\r - NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment\r\n\r - NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking\r\n\r - NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to\r diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental\r retardation)\r\n\r - NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would\r prevent computer use or recognition of visual test stimuli\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met.\r\n\r Exclusion Criteria:\r\n\r - Patients with myeloid neoplasms with germline predisposition are not eligible\r\n\r - Fanconi anemia\r\n\r - Shwachman Diamond syndrome\r\n\r - Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21\r\n\r - Any other known bone marrow failure syndrome\r\n\r - Any concurrent malignancy\r\n\r - Juvenile myelomonocytic leukemia (JMML)\r\n\r - Philadelphia chromosome positive AML\r\n\r - Mixed phenotype acute leukemia\r\n\r - Acute promyelocytic leukemia\r\n\r - Acute myeloid leukemia arising from myelodysplasia\r\n\r - Therapy-related myeloid neoplasms\r\n\r - Administration of prior anti-cancer therapy except as outlined below:\r\n\r - Hydroxyurea\r\n\r - All-trans retinoic acid (ATRA)\r\n\r - Corticosteroids (any route)\r\n\r - Intrathecal therapy given at diagnosis\r\n\r - In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be\r avoided from the time of enrollment until it is determined whether the patient\r will receive gilteritinib. Patients receiving gilteritinib will be required to\r avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the\r study treatment\r\n\r - Female patients who are pregnant since fetal toxicities and teratogenic effects have\r been noted for several of the study drugs. A pregnancy test is required for female\r patients of childbearing potential\r\n\r - Lactating females who plan to breastfeed their infants\r\n\r - Sexually active patients of reproductive potential who have not agreed to use an\r effective contraceptive method for the duration of their study participation\r\n\r - ARM D: Patients with congenital long QT syndrome or congenital heart block are not\r eligible for this treatment arm\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®\n\n**Clinical Trial Summary:**\n\nThis pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of\r patients suffering of knee osteoarthritis as revealed by using scientifically sound,\r objective measurements of biological and MRI-based imaging markers.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a post-marketing, open-label, prospective and multicentric pilot study in 50\r patients suffering from knee OA. Investigators will be rheumatologists or articular disease\r specialists from public or academic hospitals located in Belgium and France. In each\r investigating center, the same injector will perform all the VS.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female between the age of 40 and 80 with BMI ≤ 40\r\n\r - Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee\r OA associated or not with femoropatellar knee OA\r\n\r - Responding to clinical and radiological criteria of the American College of\r Rheumatology (ACR) (Appendix 1)\r\n\r - Symptomatic for more than 6 months in the most painful knee\r\n\r - Radiological Kellgren & Lawrence (K&L) II or III in radiographs from less than 12\r months (Appendix 2)\r\n\r - Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40\r (Appendix 3) with a washout period for Paracetamol and oral NSAIDs depending on the\r half-life of the drug (Appendix 4). The most painful knee is considered.\r\n\r - Able to follow the instructions of the study\r\n\r - Having signed an ICF\r\n\r Exclusion Criteria:\r\n\r Related to the OA pathology\r\n\r - Bilateral (except asymptomatic and grade I) OA of the knee\r\n\r - Radiological K&L grade I or IV (Appendix 2)\r\n\r - Chondromatosis or villonodular synovitis of the knee\r\n\r - Recent trauma (< 1 month) of the knee responsible of the symptomatic knee\r\n\r - Acute inflammatory OA (KOFUS (Knee Osteoarthritis Flare Up Scale) score ≥ 7, Appendix\r 5)\r\n\r - Articular disease resulting from articular dysplasia, aseptic osteonecrosis,\r acromegaly, Paget's disease, hemophilia, hemochromatosis….\r\n\r - Inflammatory disease i.e. rheumatoid arthritis, gout, infectious arthritis, acute\r calcium pyrophosphate arthritis\r\n\r - Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs,\r arteritis…..)\r\n\r - Presence of another joint (other than the target knee) affected by OA (confirmed in\r radiographs and symptomatic)\r\n\r Related to treatments\r\n\r - Corticosteroids injection in the target knee in the last month before first injection\r\n\r - Hyaluronan injection in the target knee in the last 6 months before first injection\r\n\r - Arthroscopy and surgery in the target knee in the last 6 months before first injection\r\n\r - Oral corticotherapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before\r first injection\r\n\r - OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before\r first injection\r\n\r - Change in the dosage of SYSAD i.e. chondroitin, glucosamine, diacerein or avocado-soy\r unsaponifiables in the last 3 months before first injection\r\n\r - Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period\r depending on the half-life of the drug, Appendix 4).\r\n\r - Osteoporosis-related treatments based on strontium ranelate, selective\r estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before\r first injection\r\n\r - An anticipated need for any forbidden OA treatments during the trial\r\n\r - Contraindications to HYMOVIS®: hypersensitivity to the product components and\r infections or skin diseases in the area of the injection site.\r\n\r - Non-pharmacologic therapy (including physical therapy) for the lower extremities\r initiated in the month before first injection\r\n\r - Anticoagulant (coumarinic compound) and heparin\r\n\r Related to associated diseases\r\n\r - Severe diseases (liver or renal failure, lung/heart disease, tumor, HIV….)\r\n\r - Allergy or contra-indication to hyaluronan\r\n\r - Severe alteration of mobility enabling functional evaluation\r\n\r - High risk of hemorrhage and risk of infection at the site of injection\r\n\r - Anticipated need for any surgical or other invasive procedure during the trial\r including prosthesis in the target knee\r\n\r Related to patients\r\n\r - Participation to a therapeutic clinical trial in the last 3 months before first\r injection\r\n\r - Under guardianship or judicial protection\r\n\r - Pregnancy, breastfeeding, planned conception, premenopausal women without\r contraception, tubal ligation or hysterectomy\r\n\r Related to MRI counter-indication\r\n\r - Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a\r neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump\r\n\r - Patient with a ferromagnetic splinter in the body, or having wire sutures\r\n\r - Serious mobility problem (Parkinson, tremors),\r\n\r - Claustrophobia\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nMIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the effectiveness of two minimal invasive spine\r surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal\r decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in\r terms of clinical outcomes, complications, reoperations, and other perioperative data.\n\n**Clinical Trial Detailed Description:**\n\nLumbar spinal stenosis (LSS) is one of the most common degenerative spine diseases in older\r people and is associated with mechanical low back pain, radiculopathy and/or neurological\r claudication. The results of The Spine Patient Outcomes Research Trial (SPORT) reported that,\r surgical treatment in these patients led to significantly greater improvement in pain and\r function than nonsurgical treatment. Nowadays, decompression with instrumented or\r non-instrumented fusion is commonly practiced which is regarded as the \"gold standard\"\r surgery for LSS.\r\n\r Over the last two decades, several retrospective studies comparing the surgical outcomes of\r decompression alone and decompression plus fusion for LSS have been published. Most of the\r studies concluded that decompression plus fusion had better clinical outcomes compared with\r decompression alone. However, in 2016, two randomized control trials (RCT) about LSS were\r published in the New England Journal of Medicine (NEJM) and raised some serious questions.\r The results of both studies showed that fusion did not have much additional value for\r patients with stable LSS, and moreover, it might be regard as an overcautious and unnecessary\r treatment, which were contradictory to most of the previous studies.\r\n\r Over the past few years, minimally invasive spine surgery (MISS) has been improving rapidly\r due to the development of related instruments, more experienced surgeons, and patients'\r demands. Compared with open spine surgery, MISS has already proved to be associated with less\r surgical trauma and rapid recovery with similar clinical outcomes. Minimally invasive spinal\r decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) have\r been performed widely for the treatment of LSS. However, there is no previous study comparing\r MIS-D to MIS-TLIF in terms of clinical outcomes, complications, reoperations, and other\r perioperative data. Therefore, a randomized controlled trial comparing these 2 common MISS\r techniques is warranted.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Intermittent claudication with pain or numbness or weakness of lower limb(s) with or\r without low back pain\r\n\r - An imaging study (MRI or CT) showing single level lumbar spinal stenosis\r\n\r Exclusion Criteria:\r\n\r - Insufficient conservative treatment (6 weeks)\r\n\r - Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical\r intervention\r\n\r - Previous spinal surgery\r\n\r - Other comorbid conditions that contraindicating surgery\r\n\r - Possible pregnancy that contraindicating radiological examination\r\n\r - Age less than 18 years old\r\n\r - Combination with 2°spondylolisthesis or segmental instability (slip distance >4mm or\r angle change >10° in dynamic plain film)\r\n\r - Combination with other spinal disorder requiring advanced surgery (such as lumbar\r stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)\r\n\r - Equal to or more than two responsible level\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPercutaneous Microelectrolysis in Agility, Joint Range and Strength\n\n**Clinical Trial Summary:**\n\nElectrical stimulation has a wide range of clinical applications in rehabilitation, being\r used for activities such as strengthening, pain control, management of edema, or control of\r inflammation after injury or surgery. One of the most classic forms of electrotherapy is\r direct current (DC), which stands out for its particular effects and which are not achieved\r with other forms of electrical stimulation.\r\n\r A new therapeutic alternative through DC is Percutaneous Microelectrolysis (MEP), which began\r to have a significant boom in Latin America a couple of years ago. MEP is a minimally\r invasive procedure in which a low intensity DC is used. MEP has been proposed as a\r therapeutic resource to reduce muscle contractions and shortenings, thus favoring\r flexibility, although research to support this effect is lacking.\r\n\r Muscle flexibility is an important component in rehabilitation and training programs. In\r lower limbs, tightness hamstring muscles is a common condition that limits flexibility and\r affects sedentary and athletic people. Loss of flexibility of hamstrings has been reported\r for different sports disciplines, showing a decrease in a high percentage with the exception\r of sports such as rhythmic gymnastics and dance where flexibility is essential for good\r performance. Loss of hamstring extensibility has been associated with a higher incidence of\r muscle tears, patellar tendinopathy, low back pain and alterations in lumbopelvic rhythm\r associated with compensatory biomechanical changes such as limb shortening, pelvic\r retroversion, and increased thoracic kyphosis, among others.\r\n\r It is interesting to investigate the effectiveness of MEP in hamstring tightness. A increase\r in hamstring flexibility can contribute to increased joint range, muscle strength, and lower\r limb agility.\n\n**Clinical Trial Detailed Description:**\n\n1. INTRODUCTION\r\n\r Electrotherapy is a valuable therapeutic resource used by physiotherapists for different\r purposes, among which are the reduction of pain, control of edema, muscle strengthening,\r control of the inflammatory process and promotion of tissue repair processes.[1,2]\r Within the The most widely used electrotherapy modalities are Sensory Transcutaneous\r Electrical Stimulation (TENS) and Burst Modulated Medium Frequency Alternating Currents\r (BMAC) commonly applied for analgesic purposes or for neuromuscular electrical\r stimulation (NMES).[2,3,4] Electromedicine also offers a variety of unidirectional\r currents such as direct (DC) or galvanic current and other low-frequency variants with a\r galvanic component such as diadynamic currents, 2-5 (Träbert), or faradic applications.\r [2,5 ] Direct current, described by Alexander Volta at the end of the 18th century,\r constitutes one of the first therapeutic currents, and has gained popularity in the last\r decade due to its use in percutaneous electrical applications that seek to promote\r tissue repair and decrease pain in musculoskeletal conditions. [5-10] DC is\r characterized by a unidirectional charge flow, of low voltage (60 to 80 volts) and\r constant intensity, and is produced from batteries or the rectification of alternating\r current from the electrical network. DC has particular physiological effects that are\r not achieved with other types of currents due to their physical characteristics. Its\r effects are based on the electrolysis process, a chemical decomposition phenomenon of\r some substances in solution subjected to a direct current and which results in\r electrophoresis (ion migration) and the formation of acidic or basic substances.\r [1,11-14] DC favors the accumulation of ions and charged molecules in the biological\r tissues that underlie the electrodes where it is applied. The deposition of charges\r occurs as a result of the electric forces of attraction and repulsion that are triggered\r by molecular dissociation, ionic migration, and accumulation of positive or negative\r charge depending on the electrode. All unidirectional currents are capable of greater or\r Less measure of producing electrophoresis and electrolysis under its poles (anode and\r cathode), triggering a series of physiological effects under the electrodes known as\r polar effects. These effects occur due to the modification of the local tissue pH and\r are directly related to the intensity of the current (mA) and its application time\r (minutes). Acidification of the medium by the production of substances such as\r hydrochloric acid (HCl) or carbonic acid (H2CO3), in addition to arteriolar\r vasoconstriction, hyperpolarization of neurons and coagulation, while alkalinization,\r caustic reactions due to the production of sodium hydroxide (NaOH), vasodilation,\r facilitation, depolarization and blood liquefaction occur at the cathode. [5,11-15] Due\r to its electrolytic effects, DC can cause chemical burns if its dosage is inadequate.\r This is how DC applications use intensities of the order of 0.05 µA/cm2 at 1mA/cm2, and\r treatment times between 12 to 15 minutes, although for iontophoresis applications,\r application of drugs loaded with tr Ascutaneous by means of DC, times of up to 30 or 40\r minutes can be reached, although with maximum current intensities between 2 to 4mA. This\r dosage follows the recommendations of the literature to avoid potential adverse effects\r such as acid or alkaline burns. [5,12,15,19] The stratum corneum of human skin, on the\r other hand, constitutes an important barrier for bidirectional electric currents,\r offering a high impedance. although this response is dependent on intensity and time. It\r is the changes in skin impedance that ensure a depth of 4 to 5 cm for CD, a phenomenon\r that supports iontophoresis applications or electroporation treatments for drug\r delivery.[16,20,21]\r\n\r Percutaneous Microelectrolysis (MEP) In the last decade, different percutaneous\r procedures have emerged through DC that seek to induce electrolysis in deep\r musculoskeletal tissues.[6-9,24-26] An example of these percutaneous modalities is\r percutaneous microelectrolysis (MEP), which consists of the application of a\r microgalvanic current through acupuncture needles and where high current densities are\r achieved in the tissues due to the smaller surface area of the needle (2.5 to 3.8\r mA/cm2). Unlike other electrolysis treatments, MEP has reported less discomfort in\r patients because microgalvanic currents (intensities less than 1 mA) are used in it. MEP\r uses the acupuncture needle (active electrode) as a cathode to induce in the tissues the\r synthesis of caustic substances such as sodium hydroxide (NaOH) or potassium hydroxide\r (KOH) resulting from the interaction of sodium (Na+2) and potassium (K+) ions with water\r (H2O) molecules. This promotes a controlled acute inflammatory response coupled with the\r release of molecular hydrogen or dihydrogen (H2) that inhibits free radicals that are\r concentrated in damaged musculoskeletal tissues. The analgesic effects of MEP are\r explained by the destruction of local free nerve endings as a consequence of the caustic\r response of the cathode. On the other hand, the needle's own mechanical stimulation\r promotes tissue micro-rupture that enhances the proinflammatory physiological effects of\r galvanism. Controlled inflammation induced by MEP promotes collagen genesis and\r increased circulation, initiating a new repair process Tissue. MEP is currently used as\r a treatment for acute and chronic tendon injuries, muscle injuries, and in the\r dermatofunctional area for the management of wrinkles, stretch marks, fibrosis and\r neuropathic scars. MEP has been proposed as a resource Therapeutic to reduce muscle\r contractions and shortenings, thus favoring flexibility, although there is a lack of\r research to support this effect.[24-30]\r\n\r Muscle flexibility Muscle flexibility is an important component in rehabilitation and\r training programs. In the lower limb, hamstring muscle shortening is a recurrent\r condition, a common condition that limits flexibility and affects sedentary, physically\r active, and athletic people. Hamstring flexibility is frequently evaluated in clinical\r tests and sports training, and is considered a component Basic physical abilities. Loss\r of flexibility of the hamstrings is associated with short-run sports and those in which\r knee flexion is favored, such as skiing, soccer, rugby, basketball, tennis, judo and\r volleyball.[31,32,33] Loss of hamstring flexibility has been reported for different\r sports disciplines, showing a decrease in a high percentage except for sports such as\r rhythmic gymnastics and dance where flexibility is essential for good performance.\r\n\r Hamstring tightness is characterized by a length-tension alteration compromising the\r articular range of hip flexion and knee extension, also associated with imbalances of\r muscular strength of the quadriceps-hamstring complex, which has been reported in soccer\r players. [31-35] Loss hamstring extensibility has been associated with a higher\r incidence of muscle tears, patellar tendinopathy, low back pain, and alterations in the\r lumbar-pelvic rhythm associated with compensatory biomechanical changes such as limb\r shortening, pelvic retroversion, and increased thoracic kyphosis. In addition, studies\r in soccer players have documented that a limitation in hamstring flexibility can\r compromise vertical jump, kick speed, short stroke and agility.\r\n\r Among the clinical tests used to evaluate hamstring tightness, the tests of straight leg\r elevation (Straight Leg Raising or SLR) and active knee extension (Active Knee Extension\r or AKE) stand out, the former demonstrating an intraclass reliability of 0.94 and the\r second an inter-examiner reliability of 0.99 (r). SLR is also used as a neurodynamic\r maneuver and as a test for clinical diagnosis of lumbar radiculopathy, lumbar hernia or\r sciatica, demonstrating a sensitivity of 0.67 and a specificity of 0.26. [31,34,40,41]\r Loss of hamstring extensibility is considered a modifiable risk variable and can be\r treated to prevent muscle injuries, especially if hamstring tear is considered to be one\r of the most frequent injuries in the athlete population and physically active people. In\r this sense, physical therapy has different intervention strategies to recover or improve\r flexibility, highlighting stretching exercises, soft tissue mobilization techniques,\r muscle energy techniques (PNF), neurodynamic sliding, electrical muscle elongation, dry\r puncture or thermotherapy modalities, although most of them have a short-lasting effect\r if they are not maintained over time. However, the static stretching strategy is the\r most used by physical therapists, sports trainers and physical educators, demonstrated\r good results in short and long or term.[31,49,50-52]\r\n\r 2. OBJECTIVES\r\n\r 2.1. General purpose\r\n\r To assess the effectiveness of the Percutaneous Microelectrolysis (MEP) technique and\r stretching exercises in increasing agility, hamstring and quadriceps strength, and knee\r extension range in athletes with hamstring tightness.\r\n\r 2.2. Specific objectives.\r\n\r - To assess differences in agility, hamstring and quadriceps strength, and knee\r extension joint range in the group exposed to muscle microelectrolysis between\r sessions.\r\n\r - To assess differences in agility, hamstring and quadriceps strength, and knee\r extension joint range in the group exposed to tendon microelectrolysis between\r sessions.\r\n\r - Compare the differences in agility, hamstring and quadriceps strength, and knee\r extension joint range between the groups exposed to microelectrolysis and the group\r treated with a stretching exercise plan for the intervention sessions.\r\n\r 2.3. Investigation hypothesis\r\n\r Groups undergoing Percutaneous Microelectrolysis (MEP) at the level of the muscular and\r tendon belly will exhibit greater agility, hamstring and quadriceps strength, and\r increased knee extension joint range compared to the group treated with a stretching\r exercise plan.\r\n\r 2.4. Hypothesis\r\n\r - H0: There will be no difference in agility, hamstring and quadriceps strength, and\r increased knee extension joint range between the group operated on with\r Percutaneous Microelectrolysis (MEP) and the group treated with a stretching\r exercise plan.\r\n\r - H1: Groups operated on with Percutaneous Microelectrolysis (MEP) will exhibit\r greater agility, hamstring and quadriceps strength, and increased knee extension\r joint range compared to the group treated with a stretching exercise plan.\r\n\r 3. METHODOLOGICAL DESIGN\r\n\r 3.1. Type of study\r\n\r Experimental study, randomized clinical trial (RCT). Participants will be divided\r through a simple randomization process into three study groups; group 1 (application of\r microelectrolysis in the muscular belly), group 2 (application of microelectrolysis at\r the tendon level in the hamstrings) and group 3 (control).\r\n\r 3.2. Ethical considerations of research\r\n\r The study will be presented to the Ethics Committee of the Eastern Metropolitan Health\r Service (SSMO) following the protocol of the principles of the Declaration of Helsinki.\r An informed consent will be applied to the participants in which the protocol and all\r the procedures of intervention. It will be made explicit in writing and verbally that\r the confidentiality of the data will be kept absolute, that participation will be\r voluntary and that the participants are free to leave the study at any time.\r\n\r 3.3. Variables\r\n\r 3.3.1 Conceptual definition of the variables.\r\n\r - Agility: Precise acceleration and deceleration movements and direction changes in\r the shortest possible time in seconds (sec) for the Agility T-Test. The test will\r consist of two attempts recording the shortest of the times obtained as the final\r value.\r\n\r - Muscular strength: Maximum isometric strength (FIMáx) of shortened hamstrings and\r ipsilateral femoral quadriceps developed over 4 to 6 seconds, obtained from the\r best of three attempts in a voluntary maximum contraction. Hamstring and quadriceps\r strength will be assessed with electromechanical dynamometry on a quadriceps table\r with the participant seated keeping his knee flexed 90° and anchoring the\r dynamometer pulley at the distal end of the leg.\r\n\r - Knee joint range: Maximum active range of knee extension performed with the limb\r shortened in the supine position from a 90° hip flexion and 90° knee flexion.\r\n\r - Percutaneous microelectrolysis (MEP): Direct current application percutaneously\r using an acupuncture needle with intensities in microamps (µA) at the level of the\r muscular belly or hamstring tendon. The acupuncture needle will correspond to the\r negative electrode or cathode.\r\n\r - Stretching exercise: Passive assisted stretching performed by a physical therapist\r on the shortened hamstrings. The stretch will be performed with the participant in\r the supine position through the straight leg extension test (SLR), perceiving the\r point of maximum hamstring tension and keeping the limb at that point for 30\r seconds.\r\n\r 3.3.2. Operational definition of variables.\r\n\r - Agility: Agility will be quantified as the minimum time in seconds (sec) that the\r participant takes to complete the circuit for the Agility T-Test.\r\n\r - Muscular strength: The strength of the hamstrings and femoral quads will be\r evaluated with the Dynasystem functional electromechanical dynamometer (DEMF) from\r the company Symotech (Madrid, Spain). The maximum isometric force shall be recorded\r in newtons (N).\r\n\r - Knee joint range: The active range of knee extension will be evaluated in degrees\r of extension using the Active Knee Extension Test (AKE) with a manual goniometer\r (APPENDIX 7). The lateral condyle of the femur will be taken as a fixed point, the\r fixed arm will remain parallel to the axis of the thigh and the mobile arm will\r project to the ipsilateral lateral malleolus.\r\n\r - Percutaneous microelectrolysis (MEP): CD will be applied with the SVELTIA® electro\r stimulator. The current dose (mA * min) applied to each participant will be\r recorded based on the current intensity (mA) and total therapeutic time (minutes).\r The protocol will include three 600 µA direct current applications interrupted by\r 30 second intervals between applications.\r\n\r - Stretching exercise: 5 sets of passive static hamstring stretches will be performed\r using the straight leg extension test (SLR) for a time of 30 seconds and an\r interval of 30 seconds for each series.\r\n\r 3.3.3. Variable type definition.\r\n\r - Agility: Dependent, quantitative, ratio variable.\r\n\r - Muscular strength: Dependent, quantitative, ratio variable.\r\n\r - Knee joint range: Dependent, quantitative, interval variable.\r\n\r - Percutaneous microelectrolysis (MEP): Independent, quantitative, interval variable.\r\n\r - Stretching exercise: Independent variable, quantitative, ratio variable.\r\n\r 4. MATERIALS AND METHOD\r\n\r 4.1. Participants\r\n\r For the study, the athletes from the Andrés Bello University belonging to the rugby,\r soccer, basketball or tennis teams will be considered as participants. An invitation\r will be made to all athletes through the institution's National Director of Sports,\r making it clear that participation is completely voluntary. Those interested will be\r contacted via email or telephone and will be summoned in person to explain the\r characteristics and objectives of the study. Subsequently, they will be asked to sign a\r consent, making explicit the voluntary participation and the withdrawal to continue at\r the time they determine.\r\n\r 4.2 Aletorization and sample size.\r\n\r The participants will be evaluated according to the selection criteria (inclusion and\r exclusion) through a survey with closed questions and a clinical examination in which\r the presence or absence of hamstring shortening will be determined, as well as its\r laterality. . Participants will be divided through a simple randomization process (table\r of random numbers) into three study groups; group 1 (application of microelectrolysis in\r the muscular belly), group 2 (application of microelectrolysis at the tendon level in\r the hamstrings) and group 3 (control). All groups will be called twice a week to carry\r out the assigned treatment. All groups will receive as a basic treatment a therapeutic\r exercise plan for static hamstring stretching of 5 series for 30 seconds twice a week,\r and groups 1 and 2 will receive in addition to the exercise plan an intervention of\r differentiated microelectrolysis (in the muscle belly or tendon).\r\n\r The sample size was determined from the effect size obtained by evidence reported for\r static stretching. Therefore the sample size is calculated as 10 subjects per group.\r\n\r 4.3. Process\r\n\r Joint range of knee extension, maximum isometric muscle strength of quadriceps and\r hamstrings, and agility will be evaluated in all groups once a week. The study will last\r 4 weeks, so all groups will complete a total of 8 treatment sessions and 4 evaluation\r sessions. Joint range differences (ΔROM), maximum isometric muscle strength difference\r (ΔFImax) and agility difference (ΔAg) between the 4 sessions will be considered as main\r variables.\r\n\r 4.4. Phases of the study\r\n\r Three phases have been designated for the investigation; 1. Sampling phase, 2.\r Evaluation phase and 3. Intervention phase. The sampling phase will consist of applying\r the selection survey to all athletes interested in participating in the study. The\r survey will be applied to those selected for rugby, soccer, basketball and tennis at\r Andrés Bello University through the Google Drive® system. All those who meet the survey\r selection criteria will be invited to participate in the research. This stage will last\r two weeks.\r\n\r The evaluation phase will last two weeks and will determine a second filter of the\r population. The athletes selected by the survey and who gave their written consent will\r participate in it. At this stage, a clinical examination will be performed to determine\r the presence of hypermobility using the Beighton hypermobility test and the presence of\r hamstring shortening through the Straight Leg Raising (SLR) test. An examiner will\r assess the presence of hypermobility in athletes to later assess the presence or absence\r of hamstring shortening. In relation to the Beighton test, a score greater than 5 will\r indicate the presence of hypermobility and will exclude the study participant. The SLR\r test will be performed using an inclinometer and will be considered a positive test when\r the participant reports tightness or tension in the back of the thigh when raising the\r limb with an angle less than 80° of hip flexion.If Both extremities have an elevation of\r less than 80°. The one with the lowest value will be considered short. Participants with\r a negative physical examination (-), that is, without the presence of hamstring\r shortening according to the protocol, will be excluded, while those with a positive\r physical examination (+) will become the definitive sample. The evaluator will record\r the laterality of the limb with the shortening in a Microsoft Excel® spreadsheet.\r\n\r The intervention phase will take place over a period of 10 weeks. The sample will be\r randomized into three working groups; group 1 (application of microelectrolysis in the\r muscular belly), group 2 (application of microelectrolysis at the tendon level in the\r hamstrings) and group 3 (control). The randomization of the sample will be performed by\r the study director using the simple random sampling process through a table of random\r numbers taken from the tables proposed by the RAND Corporation®. The study director will\r be the only one with access to the randomization table. Demographic variables (secondary\r variables) for each group, including age, sex and body mass index (BMI) will be\r tabulated in a Microsoft Excel® program spreadsheet.\r\n\r Participants in each group will be evaluated by three evaluators to determine knee\r extension basal joint range (ROMEXT), maximum isometric muscle strength for hamstrings\r and ipsilateral femoral quadriceps (FIImax and FICmax), and agility in (Ag). The range\r will be measured through goniometry, muscle strength will be evaluated by\r electromechanical dynamometry and agility will be determined through the T agility test.\r\n\r ROMEXT, FImax and Ag values will be evaluated in degrees (°), Newtons (N) and seconds\r (sec) respectively, and will be considered as primary variables of the study. ROMEXT,\r FImax and Ag will be tabulated in an Excel® spreadsheet for each evaluator. The\r evaluations will last 4 weeks, with one evaluation per week. Said evaluation will be\r carried out before and after the intervention assigned to each group. Participants will\r be called twice a week to carry out their corresponding treatments, making one of these\r visits coincide with the corresponding evaluation session for the current week.\r\n\r 4.5. Statistical analysis\r\n\r The descriptive statistics for the primary variables ROMEXT, FImax and Ag will use as\r analysis measures, means and standard deviation (x, DS), or median and interquartile\r range (med, RIC). For secondary variables such as sex, body mass index (BMI),\r frequencies and averages or medians, respectively, will be used.\r\n\r Regarding inferential statistics, the SHAPIRO WILK (S-WILK) normality test will be used\r to determine if the distribution of data obtained for the primary and secondary\r variables is normal or not, and according to this, the statistical test atingente, test\r ANOVA if the data distributes normally or Kruskal Wallis test if the data does not\r distribute normal. The SPSS v.24.0 program will be used for the statistical calculation.\r Once the analysis is done, a month will be considered for the analysis of the results\r obtained, discussion approach and conclusion.\r\n\r 5. EVALUATION PROTOCOLS\r\n\r 5.1. Hypermobility Assessment - Beighton Hypermobility Test.\r\n\r The Beighton test is a clinical test for the detection of ligament hypermobility or excessive\r joint range (joint hypermobility). The test requires having a score equal to 5 or higher of a\r total of 9 to be considered positive (+). Participants are evaluated on a 9-point scale,\r considering 1 point for each hypermobile site, performed bilaterally. The test includes the\r following points;\r\n\r - Hyperextension of the elbows (greater than 10°), with the subject sitting on a stool and\r with the arm explored by the extension examiner (bilateral evaluation, 2 points).\r\n\r - Passively touch the forearm with the thumb, holding the wrist in flexion, with the\r individual in the same position as the previous point (bilateral evaluation, 2 points).\r\n\r - Passive extension of the index finger to more than 90°, with the participant sitting and\r with the palm of the hand fully resting on the table (bilateral evaluation, 2 points).\r\n\r - Hyperextension of the knees (more than 100°), with the participant in supine position\r (bilateral evaluation, 2 points).\r\n\r - Forward trunk flexion touching the ground with the palms of the hands when bending over\r without bending the knees (1 point).\r\n\r Participants who give a positive Beighton test (+) will be excluded from the study this\r because joint hypermobility can generate false negative short hamstrings for evaluation.\r\n\r 5.2. Hamstring Shortening Assessment - Straight Leg Hip Flexion Test (SLR).\r\n\r The evaluation will be performed using the straight leg hip flexion test (SLR). The straight\r leg lift is a passive test testing each limb individually. The participant will lie supine\r without a pillow under his head, while the examiner will stand on the side of the table. The\r evaluator will take the ankle and passively flex one of the hips keeping the knee in\r extension while the point of tension is perceived, accompanied by a sensation of tightness\r reported by the user. The angle formed between the surface of the stretcher and the axis of\r the lower limb will be measured. It will be considered as a positive test (+) if the degree\r of tension referred to with the test is less than 80°, while if the tension appears above 80°\r the negative test (-) will be considered. The test is compared with the contralateral side to\r determine the predominance of hamstring shortening. Possible findings when performing the\r test may include;\r\n\r 1. Neither limb has short hamstrings; SLR negative (-) bilaterally. The participant will be\r excluded by not completing the selection criteria.\r\n\r 2. One of the extremities has short hamstrings; Positive SLR (+) for one of the two\r extremities. The participant will be included in the research.\r\n\r 3. Both limbs drop short hamstrings; SLR positive bilaterally. The participant will be\r included in the research and the limb with the least degrees of elevation will be\r considered as the side with short hamstrings.\r\n\r 5.3. Joint Knee Range Assessment - Active Knee Extension Test (AKE).\r\n\r The Active Knee Extension Test (AKE) is used to assess the length of the hamstrings and the\r range of active knee extension in the 90 ° hip flexion position. The participant will be\r placed in a supine position on a stretcher while maintaining one hip in 90° flexion and the\r knee in 90 ° flexion while the contralateral lower extremity is fully supported. The\r participant is instructed to perform an active maximum knee extension. The evaluator will\r measure the angle of extension from the knee flexion position of 90°, which will be\r considered as the 0 ° articular position from which the measurement will be recorded. The\r degrees of knee extension will be recorded using a manual goniometer.\r\n\r 5.4. Evaluation of muscular strength of hamstrings and femoral quadriceps.\r\n\r Maximum voluntary isometric contraction of the knee flexor and extensor muscles will be\r assessed. Strength will be assessed through a functional electromechanical dynamometer (DEMF)\r on the side that was recorded with short hamstrings. For the evaluation, the participant will\r be placed on a quadriceps table keeping the knee in 90° flexion while fixing the thigh in its\r anterior distal part with a belt to avoid lifting the thigh during the test. The participant\r must keep his back supported during the test. For the record, the pulley will be anchored to\r the distal end of the leg, maintaining a 90° angle between the pulley and the leg. To record\r the hamstring strength, the pulley will be placed in front of the leg so that the participant\r flexes the knee and the rope perceives the degree of tension generated. To record the\r quadriceps force, the pulley will be anchored behind the leg so that when performing the knee\r extension the rope perceives the tension generated. Before the test, each subject will\r perform an adequate warm-up, consisting of 2 to 3 submaximal contractions to become familiar\r with the test procedure. Each subject will perform a maximum voluntary isometric contraction\r for hamstrings and femoral quads for 4 to 6 seconds in three series. 1 minute rest between\r attempts will be considered to avoid the effects of fatigue. During the test the subject will\r be instructed to exert as much force as possible.\r\n\r 5.5. Agility assessment - T Agility test (T Agility test).\r\n\r The Agility T-Test is reliable and valid to measure the ability to quickly change directions\r and speed based on stops and agility. The test consists of various multidirectional\r displacements, running forward, laterally to the right and left. For the test, 4 cones (a, b,\r c and d) are used simulating the letter t. Three of them are placed at a lateral distance of\r 5 meters and another is placed 10 meters from the central cone. The participant will be\r instructed to run as fast as possible from the first cone (cone a) forward (cone b), then\r move laterally to the right (cone c), then laterally to the left (cone d), to return\r laterally to the cone b and run to the starting cone (cone a). Agility will be quantified as\r the minimum time in seconds (sec) that the participant takes to complete the circuit for the\r test. The test will be carried out in two attempts taking, registering the least of the times\r as the final value. A 2-minute break will be considered between attempts to avoid the effects\r of fatigue.\r\n\r Before performing the agility test, a five-minute pre-heating will be carried out on a cycle\r ergometer (MONARK 915E®) at a power of 80 watts.\r\n\r 6. TREATMENT PROTOCOLS\r\n\r 6.1. Application of electrotherapy Percutaneous Microelectrolysis (MEP)\r\n\r For the application of microelectrolysis, the SVELTIA® Direct Current equipment will be used.\r Acupuncture needles 0.3 millimeters thick and 25 millimeters long will be used.\r\n\r The procedure will be performed with latex gloves to avoid any contact with the skin. The\r acupuncture needle will be inserted into the point of the muscular belly or hamstring tendon.\r It will work with an intensity of 0.6 milliamps (mA). It will be entered perpendicularly with\r the acupuncture needle mounted on the device's pointer with an emission of 100 microamps\r (µA). When it has been entered, the intensity will be increased to 600 µA and the participant\r will be told that when burning, pain or oppression appears, and that these discomforts become\r uncomfortable, notify the provider. The time of emission until the appearance of symptoms\r will be designated as T1. At that time the broadcast will be paused for 30 seconds. A second\r emission will be carried out maintaining the 600 µA until the participant again manifests a\r burning sensation or discomfort. The current application time will be recorded as T2. The 30\r second pause will repeat. The third emission or T3 will be performed at the same time as the\r emission registered for T2 or until the person reports discomfort by withdrawing the needle\r to later finish the procedure.\r\n\r After MEP, a reevaluation of the knee extension range (AKE test), hamstring and femoral\r quadriceps (functional electromechanical dynamometry) and agility test (T-Test) will be\r performed.\r\n\r 6.2 Passive static stretching application (group 1, 2 and 3).\r\n\r The three groups will receive as a base treatment a hamstring stretching protocol for the\r limb evaluated with shortening. The stretch will be performed using the straight leg hip\r flexion test (SLR). The handler will raise the shortened lower limb to the point of maximum\r tension reported by the participant to keep it in that position. The stretches will consist\r of 5 sets of 30 seconds with a break between sets of 30 seconds, thus completing a 1-minute\r work cycle (stretching and resting). The time will begin to count after locating the stress\r angle.\r\n\r After the intervention with stretching exercises for group 3 (control group), a reevaluation\r of the knee extension range (AKE test), hamstring and femoral quadriceps (functional\r electromechanical dynamometry) and agility test (T-Test) will be performed). On the other\r hand, once the stretching exercises for group 1 and 2 (muscular and tendon microelectrolysis)\r have been completed, a reevaluation of the knee extension range (AKE test), hamstring muscle\r strength and femoral quadriceps (functional electromechanical dynamometry) and agility test\r will be performed. (T-Test).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants over 18 years of age.\r\n\r - Athletes from the university teams in the branches of rugby, soccer, basketball or\r tennis.\r\n\r - Presence of hamstring shortening in one of the two extremities (positive straight leg\r elevation test or Straight Leg Raising). It will be considered as a positive test when\r the participant, in the supine position, shows tension or discomfort in the posterior\r region of the thigh when passively raising the lower limb for any angle less than 80 °\r of hip flexion with extended knee. In the event that the participant presents a\r bilateral shortening, the limb with the lower elevation will be taken as shortened\r hamstrings.\r\n\r Exclusion criteria.\r\n\r - Pain when performing hip or knee movements.\r\n\r - Musculoskeletal injuries such as fractures, sprains, tears, dislocations, contusions,\r or joint problems of the lower extremities in the past 3 months.\r\n\r - Skin disorders such as scars, burns, psoriasis or wounds in the posterior region of\r the thighs.\r\n\r - Neurological signs or symptoms such as tingling, loss of sensation in the lower\r extremities (partial or complete), weakness, changes in color or temperature in the\r thigh, legs or foot.\r\n\r - Background or circulatory abnormalities in the lower extremities such as arterial\r ischemia, venous insufficiency, embolism, post-phlebitic syndrome, lymphedema or deep\r vein thrombosis.\r\n\r - Joint hypermobility (positive Beighton hypermobility test).\r\n\r - Intake of medications or anti-inflammatory drug treatment at the time of recruitment\r (includes non-steroidal or steroidal anti-inflammatory drugs).\r\n\r - Allergy to metals.\r\n\r - Apprehension or fear of the application of electric current.\r\n\r - Belonephobia (extreme and uncontrollable fear of needles and other objects that can\r cause bloody wounds such as pins, knives, pocket knives, syringes, etc.).\r\n\r Elimination criteria.\r\n\r - Discomfort during the intervention with electrotherapy that requires stopping\r treatment.\r\n\r - Failure to complete the evaluation protocol (attendance at all scheduled evaluation\r sessions).\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"content": "**Clinical Trial Title:**\n\nIs the Severity of Urinary Disorders Related to Falls in People With Multiple Sclerosis\n\n**Clinical Trial Summary:**\n\nFalls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe\r consequences (trauma, fear of falling, reduction of social activities). Prevention of falls\r is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can\r result of different factors (motor impairment, ataxia, sensitive disorders, fatigability…).\r Urinary incontinence has been evoked as predictive of falls. But lower urinary tract symptoms\r (LUTSs) are frequent in PwMS, the prevalence of LUTSs is high (32-96.8%) and increases with\r MS duration and severity of neurological deficiencies and disabilities. Overactive bladder\r (OAB) is the most common symptom. Despite its high prevalence and impact on quality of life,\r the severity of LUTSs has never been studied as specific risk factor of falling. However,\r urinary urgency and urinary incontinence could lead to precipitation and thus could increase\r the risk of falling in these patients.\r\n\r The aim of the study was to assess the relationship between severity of LUTSs and risk of\r falling in PwMS.\r\n\r Patients were asked about the number of falls in the past three months and in the past year,\r and the circumstances in which they occurred (frequency, home, outdoors, going to void,\r during urinary urgency, nocturia). Severity of LUTSs were assessed by the Urinary Symptoms\r Profile (USP) Score and patient were classified as with or without urinary incontinence.\r Number of micturition by night were specifically asked. To take into account motor\r difficulties and fear of falling, other clinical evaluations were done. The impact of MS on\r walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire,\r the Expanded Disability Status Scale score, and by clinical test with the Time to be Ready to\r Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy\r Scale-International (FES-I) Questionnaire.\r\n\r The primary aim was to assess the relationship between severity of LUTSs and occurrence of\r falls during the past 3 months. The primary outcome was the importance of overactive bladder\r (OAB) symptoms with OAB USP score. The secondary outcomes were the existence of urinary\r incontinence, the warning time (defined as the time from the first sensation of urgency to\r voiding or incontinence), the importance of nocturia and the other scores of USP\r questionnaire (low stream and stress urinary incontinence).\r\n\r The secondary aims were to look for the relationship between severity of LUTSs and occurrence\r of falls during the past year, and to assess the relationship between falls and the classical\r risk factors of falls.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - age ≥ 18 years\r\n\r - Multiple sclerosis (MS) diagnosis\r\n\r - Lower urinary tract symptoms with or without treatment,\r\n\r - Expanded Disability Status Scale score between 1 and 6.5\r\n\r Exclusion Criteria:\r\n\r - relapse of MS in the past month\r\n\r - urinary tract infection the day of inclusion\r\n\r - impossibility to complete the symptoms' questionnaires\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals\n\n**Clinical Trial Summary:**\n\nIn amputee, dual task has been found to cause a decrease in walking speed. However, there is\r no study of how gait characteristics are affected when the speed does not change. The aim of\r this study is to compare the time-distance characteristics of walking with single task,\r cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.\n\n**Clinical Trial Detailed Description:**\n\nWalking is a complex task in which sensory and cognitive systems must be involved. The lower\r extremity amputee may need to use cognitive resources to focus on walking, monitor and\r control the prosthetic movements. The need to use cognitive resources may be higher in those\r with more proximal level amputation, such as above-knee level. The role of cognition and\r concentration is revealed by a cognitive task performed with posture and gait control using\r the dual task method. The dual task paradigm provides information about the automation of the\r default processes that underpin good performance disclosure. This approach involves\r performing two tasks at the same time. Dual task is divided into primary task and secondary\r task. The performance of the primary task while performing a single task is recorded. If\r there is a drop in performance when the secondary task is added, this indicates that the\r primary task needs high attention.\r\n\r In proximal amputations, with the lost of movement system structures, functional impairment\r increases. Amputation from the proximal level affects daily life activities and walking\r ability more. Above-knee amputees reported more functional difficulties in ambulatory\r ambulation than transtibial amputee.\r\n\r The aim of this study is to compare the time-distance characteristics of walking with single\r task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy\r people.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Using a transtibial or transfemoral prosthesis for at least 1 year,\r\n\r - Between the ages of 18-65,\r\n\r Exclusion Criteria:\r\n\r - To be diagnosed as a neurological, orthopedic, cognitive disorder,\r\n\r - Having a condition other than amputation that may affect gait.\r\n\r - Having different permanent disabilities other than amputation,\r\n\r - Using walking aid,\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness\n\n**Clinical Trial Summary:**\n\nAfter a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually\r have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to\r treatments which had to be used. This disease is expected to be similar or even higher in\r patients suffering from COVID-19 and hospitalized in ICU due to the average length of\r hospitalization of several weeks in this population. This condition will delay the\r return-to-walk of these patients, their discharge from hospitalization and may deteriorate\r their autonomy in daily life activities.\r\n\r Virtual Reality (VR) environments are already used and have proven their worth for the\r assessment and rehabilitation of patients with neurological diseases. It therefore seems\r appropriate to offer the use of virtual environments for this type of population. VR\r represents a unique opportunity for the rehabilitation care of these patients, and in\r particular those who have been reached by COVID-19, due to the possible mismatch between the\r amount of motor rehabilitation to be provided and the fatigability and breathlessness at the\r slightest effort which seem particularly intense in this population.\r\n\r The main objective of our project is to improve and to accelerate gait recovery in patients\r hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or\r Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness\r secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual\r Reality tools. The VR tool will consist of virtual environments presented using a Virtual\r Reality headset where an avatar (double) of the patient hospitalized in Physical and\r Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks\r involving their lower limbs (ex: walking, or kicking a ball) in several different virtual\r environments (settings). The patient will be asked to observe actions, then to imagine\r carrying out their actions which will be performed by the avatar in the virtual environment,\r then they will be able to control the actions of the avatar using their legs thanks to\r sensors, then feel walking sensations through the use of haptic devices.\n\n**Clinical Trial Detailed Description:**\n\nStep 1: The objective is to evaluate the effectiveness of the Observation of Virtual Actions\r on gait recovery in patients hospitalized in Physical and Rehabilitation Medicine (MPR) and\r presenting ICU-weakness, in particular following a COVID-19 infection. If the patient is\r included in the Virtual Reality group, they will be asked to observe once a day for 9 days\r for 5 minutes Virtual Motor Actions (avatar moving in a virtual environment) using a headset.\r Virtual Reality, followed by 5 minutes of relaxation performed using soothing music played\r through headphones. If the patient is included in the Relaxation group, they will be offered\r 10 minutes of relaxation performed using soothing music played in headphones once a day for 9\r days. We will assess gait, motive power, balance, confidence in the future and patient\r autonomy before the start of the first session, the day after the last session and one month\r after inclusion. At the end of each session, we will ask the patient questions about fatigue\r (VAS) and the occurrence of side effects (open question) after wearing the Virtual Reality\r headset or headset. At the end of the 9 sessions, we will ask to patients in the Virtual\r Reality group to complete a questionnaire concerning the acceptance of the proposed device.\r We want to include 20 patients in the Virtual Reality group and 20 patients in the Relaxation\r group.\r\n\r Step 2: The objective is to assess the acceptability (a priori) of the Virtual Reality tool\r created in ICU by the nursing staff and by the patients who are hospitalized there. It will\r be offered to caregivers of the ICU of the Rennes University Hospital and to patients\r hospitalized in these 2 services and presenting ICU- weakness, especially in the aftermath of\r COVID infection. We will be asked to complete an acceptability questionnaire (a priori)\r concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The\r duration of filling in this questionnaire is estimated at 30 minutes. Caregivers will be\r invited to participate in an information meeting (4 will be carried out) at least 1 week\r before their possible participation (which they will be informed by internal mail, and which\r will be led by investigators). We believe that approximately 300 caregivers and 50 patients\r will participate in this acceptability survey.\r\n\r Step 3: The objective is to evaluate the effectiveness of the Observation of Virtual Actions\r on gait recovery in patients hospitalized in ICU and with ICU-weakness. If the acceptability\r questionnaire is in favor of a good future acceptance of the tool designed and after possible\r adaptations of the Virtual Reality device based on the responses of caregivers and patients\r to the acceptability questionnaire proposed during the step 2, we will suggest to patients\r hospitalized in ICU with ICU-weakness to carry out a protocol similar to that carried out\r with Physical and Rehabilitation Medicine patients in step 1. If the patient is included in\r the Virtual Reality group, they will be asked to observe once a day for 9 days for 5 minutes\r Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality\r headset, followed by 5 minutes of relaxation performed using soothing music played through\r headphones. If the patient is included in the Relaxation group, they will be offered 10\r minutes of relaxation performed using soothing music played in headphones once a day for 9\r days. We will assess gait, motive power, balance, confidence in the future and patient\r autonomy before the start of the first session, the day after the last session and 1 month\r after inclusion. At the end of each session, we will ask the patient questions about fatigue\r (VAS) and the occurrence of side effects (open question) after wearing the Virtual Reality\r headset. At the end of the 9 sessions, we will suggest to patients in the Virtual Reality\r group that they complete a questionnaire concerning the acceptance of the proposed device. We\r want to include 20 patients in the Virtual Reality group and 20 patients in the Relaxation\r group.\r\n\r Step 4: The objective is to assess the effectiveness of the realization of virtual actions\r compared to the observation of virtual actions on gait recovery in patients hospitalized in\r ICU or in Physical and Rehabilitation Medicine and presenting ICU-weakness. If the patient is\r included in the group Performing Virtual Actions, they will be asked to perform Virtual\r Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to\r move around in a virtual environment for 10 minutes per day, once a day for 9 days. If the\r patient is included in the Observation of Virtual Actions group, they will be asked to\r observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a\r virtual environment) using a Virtual Reality headset. We will assess gait, motive power,\r balance, confidence in the future and patient autonomy before the start of the first session,\r the day after the last session and 1 month after inclusion. At the end of each session, we\r will ask the patient questions about fatigue (VAS) and the occurrence of side effects (open\r question) after wearing the Virtual Reality headset. At the end of the 9 sessions, we will\r offer patients to fill out a questionnaire concerning the acceptance of the proposed device.\r We want to include 20 patients in the Virtual Actions group and 20 patients in the Virtual\r Actions Observation group.\r\n\r Step 5: The objective is to evaluate the effectiveness of adding a sensation of walking using\r haptic stimuli during the Observation or Realization of Virtual Actions on the recovery of\r walking in patients hospitalized in ICU or in Physical and Rehabilitation Medicine and with\r ICU-weakness. Depending on the superiority or not of the Realization of Virtual Actions or\r the Observation of Virtual Actions, we will test the most effective condition of step 4 in\r combination with: either haptic stimulation (sensory feedback through vibrators positioned on\r the lower limbs to give a feeling of walking), either without haptic stimulation, once a day\r for 10 minutes for 9 days. We will assess gait, motive power, balance, confidence in the\r future and patient autonomy before the start of the first session, the day after the last\r session and 1 month after inclusion. At the end of each session, we will ask the patient\r questions about fatigue (VAS) and the occurrence of side effects (open question) in the\r aftermath of wearing a Virtual Reality headset. At the end of the 9 sessions, we will offer\r patients to fill out a questionnaire concerning the acceptance of the proposed device. We\r want to include 20 patients in the group with haptic stimulation and 20 patients in the group\r without haptic stimulation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r For patients:\r\n\r - Step 1: Patient hospitalized in the Physical Medicine and Rehabilitation department of\r the Rennes University Hospital following a stay in intensive care or in a Continuing\r Care Unit, in particular following a COVID-19 infection, and with muscle weakness of\r the lower limbs with an MRC motor testing on the main muscle segments giving a score\r less than or equal to 48/60 (diagnostic criterion of ICU Weakness)\r\n\r - Steps 2 and 3: Patient hospitalized in one of the ICU of the Rennes University\r Hospital and presenting post-resuscitation muscle weakness in the lower limbs with MRC\r motor testing on the main muscle segments giving a score less than or equal to 48/60\r (diagnostic criterion of ICU Weakness)\r\n\r - Steps 4 and 5: Patient hospitalized in one of the ICU or in the Physical Medicine and\r Rehabilitation service of the Rennes University Hospital and presenting\r post-resuscitation muscle weakness in the lower limbs with an MRC motor testing on the\r main muscle segments giving a score less than or equal to 48/60 (diagnostic criterion\r of ICU-Weakness)\r\n\r For nursing staff:\r\n\r Step 2: Person with one of the following professions: nursing assistant, nurse, doctor,\r physiotherapist, and practicing for more than a month in one of the ICU of the Rennes\r University Hospital .\r\n\r For everyone :\r\n\r - Person of full age;\r\n\r - Affiliation to a social security insurance;\r\n\r - Free, informed and written consent signed.\r\n\r Exclusion Criteria:\r\n\r For patients:\r\n\r - History of central neurological event with clinical repercussions;\r\n\r - Gait disturbances preexisting in ICU hospitalization and limiting the gait perimeter\r (declaration by the patient) or requiring the use of technical assistance;\r\n\r - Uncontrolled epilepsy (last crisis occurring less than 6 months old);\r\n\r - Persons of full age subject to legal protection (safeguard of justice, curators,\r guardians), persons deprived of their liberty;\r\n\r - Pregnant or lactating woman.\r\n\r For caregivers:\r\n\r - Non-French fluent people;\r\n\r - Adults over the age of legal protection (safeguard of justice, curators, guardians),\r persons deprived of their liberty.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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380
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEffect of Lumbar Stabilization on Knee OA\n\n**Clinical Trial Summary:**\n\nThis study will be conducted to investigate the role of lumbar core strengthening in reducing\r knee pain and disability, and improving knee proprioception and Quadriceps strength in\r patients with knee OA.\n\n**Clinical Trial Detailed Description:**\n\nOsteoarthritis (OA) is a highly prevalent degenerative joint disease that impacts quality of\r life and puts a burden on health care costs. Idiopathic knee OA is an age-related disease,\r with prevalence ranging from 19-28%. Aetiology of OA (whether systemic or mechanical) remains\r unclear.\r\n\r Lumbar spine has been reported to be associated with knee joint because of the biomechanical\r interrelationship. Decreased lumbar lordosis (that may indicate weak back extensors) and\r range of motion (that may indicate weak core stabilizers) had significant correlations with\r an increased spinal inclination angle, which was an independent factor related to knee OA (by\r increasing knee flexion angle). Knee OA may radiate pain to the back that together lead to\r more limited hip motion causing overloaded knees. Convergence presents between nerve roots\r supplying mid-lumbar muscles and joints, and that supply femoral nerve and quadriceps.\r Progression of knee OA is associated with progression of lumbar spine osteoarthritis. Altered\r trunk kinematics may cause altered tibiofemoral kinematics.\r\n\r Strengthening of trunk extensors may be very important for knee OA as fatiguing back\r extensors led to 1) increased quadriceps inhibition (QI) that may lead to poor attenuation of\r ground reaction forces and excessive forces on the knees, 2) altered standing postural\r control, 3) a forward-leaned posture that increases the external knee moments, 4) a reduction\r in trunk proprioception.\r\n\r Core stabilization exercises combined with knee-focused exercise or combined with hip\r strengthening resulted in less pain and better function. Interestingly, these studies\r included only patellofemoral pain and OA patients. This program may benefit knee OA patients\r as well. Strength, neuromuscular training and lumbopelvic stabilization reduced muscle\r weakness (of quadriceps and hip abductors), pain, and disability in men with mild knee OA.\r However, specific role of lumbar core muscles on knee OA, their effect on wider population\r (including females) and their effect on higher severity knee OA are lacking.\r\n\r Strengthening of trunk core muscles may help pelvic stability which found to be beneficial in\r improving the trunk and lower extremity movement control, hip muscles strength, gait speed\r and daily activities. However, this done in stroke patients, it is hypothesized to benefit\r knee OA patients as well. Assessment and treatment of the trunk musculature should be\r considered in the rehabilitation of patients who demonstrate abnormal lower-extremity\r kinematics as found in knee OA.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Knee pain for most days of previous month\r\n\r 2. Age 40- 65 years Knee OA grade 2-3 on kellgren- Lawrence grading scale. Unilateral or\r bilateral (provided that they radiologically have one knee ≤ grade 1 on KL score, and\r clinically pain ≤2 in VAS. The more severally affected knee will be included in\r evaluation and treatment) BMI= 25-32 kg/m2.\r\n\r Exclusion Criteria:\r\n\r - Symptomatic hip OA Hip or pelvis trauma Knee or hip infection Congenital or\r developmental disorder of lower limbs Intra-articular corticosteroid or hyaluronic\r acid injection into the knee within the last 3 months.\r\n\r Previous surgery of the affected knee or spine. Significant injury to the knee within the\r past 6 months. Any disease or medication worsens physical function or hampers with knee\r evaluation (e.g. rheumatoid arthritis, canal stenosis..).\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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381
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults\n\n**Clinical Trial Summary:**\n\nMaximal oxygen consumption, VO2max, is the gold standard to evaluate human aerobic fitness,\r which stands for the maximal capacity of cardiorespiratory system and musculoskeletal system\r to transport and utilize oxygen. Previous study showed that there is significant correlation\r between maximal oxygen consumption from cardiopulmonary exercise test and strength and\r endurance of lower extremities. In people with sedentary lifestyle, they often limited by the\r lower limb muscle performance during cardiopulmonary exercise test. Their breathing patterns\r are more irregular than athletes during cardiopulmonary exercise test. However, there is no\r study comparing the activation pattern of respiratory muscles between these two groups.\r Whether the breathing pattern in people with lower exercise capacity is less efficient under\r exertional activities still unknown. The purpose of this study is to investigate the\r relationship between maximal oxygen consumption and inspiratory muscle activation pattern in\r healthy adults.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Healthy adults (age > 20 years old)\r\n\r - Be able to cooperate with the measurements of this study\r\n\r Exclusion Criteria:\r\n\r - any clinical diagnosis that will influence the measurement, including any history of\r neuromyopathy\r\n\r - angina, acute myocardial infarction in the previous one month\r\n\r - pregnancy\r\n\r - history of syncope during exercise\r\n\r - any musculoskeletal system disorder that unable to perform cardiopulmonary exercise\r test\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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382
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRenal Biomarkers in AKI and COVID-19\n\n**Clinical Trial Summary:**\n\nSevere pneumoniae related to Coronavirus Disease (COVID-19), had a high in-hospital\r mortality; this condition are worst in subjects with acute kidney disease (AKI); conditioning\r increased mortality, days of assisted mechanical ventilation (AMV), increased nosocomial\r infections and high costs. We need many studies for determinated the risk factors for AKI in\r subjects with COVID-19.\r\n\r This study pretends identify the incidence of AKI in subjects with severe pneumoniae by\r COVID-19, describe the role of some biomarkers in the physiopathology of AKI-COVID-19; and\r determine the evolution of urinary biomarkers during hospitalization, like neutrophil\r gelatinase-associated lipocalin (NGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2),\r insulin-like growth factor binding protein-7 (IGFBP7), and interleukin-6 (IL-6) and the\r progression of viruria of Severe Acute Respiratory Syndrome (SARS) related to CoronaVirus 2\r (CoV2) in subjects with or without AKI.\n\n**Clinical Trial Detailed Description:**\n\nThe usefulness of urinary NGAL levels and the platelet / lymphocyte index as predictive\r markers of AKI in the context of COVID-19 will be studied. These results will allow to\r propose more appropriate strategies for the prevention, diagnosis and timely management of\r patients with severe pneumonia due to COVID-19 and AKI. Knowing the viral load in urine and\r its evolution in patients with and without AKI will allow us to explore associations between\r the presence of the virus at the local level and the presence of kidney damage. Likewise, the\r presence of viral load in urine and its possible relationship with the local activation of\r the complement system, together with the detection of biomarkers of kidney damage, like NGAL,\r TIMP-2, IGFBP7, and IL-6, will allow us to better understand the pathophysiology of these\r alterations in the context of COVID-19; additionally, some patients received tocilizumab, an\r IL-6 inhibitor as a compassionate measure, which may reduce urinary levels of interleukins\r and other inflammatory markers.\r\n\r Finally, the study of possible differences in the metabolome in urine in patients with and\r without acute kidney injury could favor the discovery of new markers to identify patients\r with SARS-CoV-2 infection susceptible to the development of AKI.\r\n\r Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic basal, and\r the days 3 , 5 and 7 after recruitment\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects over 18 years of age.\r\n\r - Subjects admitted with a diagnosis of probable SARS-CoV-2 pneumonia.\r\n\r - Subjects with a diagnosis of SARS-CoV-2 pneumonia confirmed by Real-time\r quantitative-Polymerase Chain Reaction (qRT-PCR).\r\n\r - Subjects with qRT-PCR negative for SARS-CoV-2, but who meet clinical and radiological\r criteria for COVID-19, and no other causes have been identified.\r\n\r Exclusion Criteria:\r\n\r - Pregnant women\r\n\r - Incomplete medical records.\r\n\r Elimination criteria:\r\n\r - Patients who die within the first 24 hours of entering the institute.\r\n\r - Patients discharged for any reason not considered death within the first 48 hours,\r such as voluntary discharge or transfer to other health institutions.\r\n\r - Patients who during their hospitalization report a positive PCR for other\r non-respiratory viruses without identifying SARS-CoV-2\r\n\r - Patients who withdraw their consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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383
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nEffect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r Hemorrhoid is one of the most common chronic anorectal diseases. The prevalence rate is about\r 44%. It occurs in adults aged 45-65 years. Hemorrhoidetomy resection is still the standard\r treatment for grade III and IV hemorrhoid. Urinary retention is one of the most common\r complications after hemorrhoid surgery, and the complications occur within 24 hours after\r surgery. The warm water sitz bath is a routine nursing care after hemorrhoid surgery in the\r clinic. The purpose is to provide moist heat of the perineum and anus to clean, promote\r healing and drainage, relieve pain, stimulate urination and promote relaxation. In contrast,\r all current studies, warm water sitz bath intervention time is the first day after surgery,\r the complications within 24 hours after surgery are not alleviated.\r\n\r Objective:\r\n\r The main purpose was to use experimental research methods to verify the effect of early warm\r water sitz bath on urinary retention after hemorrhoidectomy. The secondary objective was the\r effect of early warm water sitz bath on wound pain after hemorrhoidectomy.\r\n\r Methods:\r\n\r This study was a single-blind randomized trial in which subjects were randomly assigned to an\r experimental or control group with symptomatic stage III or IV end hemorrhoid who were\r admitted to the hospital for hemorrhoidectomy. The experimental group started the warm water\r bath 6 hours after the end of the operation, while the control group started the warm water\r sitz bath on the first day after the operation. The investigator assessed the amount of\r residual urine and wound pain index before and after each operation of the warm water sitz\r bath after surgery, and each subject was evaluated 8 times until 24 hours after surgery.\n\n**Clinical Trial Detailed Description:**\n\nIn order to ensure that the results of the study are not distorted by humans, this study is a\r single-blind randomized trial study. The subjects were randomly assigned to the experimental\r group or the control group with a permuted block randomization. For the sample number\r calculation, refer to Hedeker, Gibbons & Waternaux (1999) Comparing the time-dependent\r comparison of the longitudinal design sample size estimates between the two groups, and\r considering the 20% sample loss rate, the total number of samples is estimated to be 64 (32\r in the control group and 32 in the experimental group).\r\n\r The two groups of patients also received the same conventional treatment, anesthesia and\r surgery on the night before and on the day of the operation, and the warm water sitz bath was\r performed at different times after the operation. The warm water sitz bath temperature of the\r two groups was also 41-43°C daily 3 times (9:00, 13:00, 17:00), 5 minutes each time, and\r regularly take the same painkillers, stool softeners, and antibiotics. The researchers\r evaluated the wound pain index on the Numerical Rating Scale (NRS) 6 hours after the\r operation, 7 hours after the operation, and before and after each warm water sitz bath; After\r urine, the residual urine volume of the subject was evaluated with a Bladder Scan until the\r first day after the operation. A total of 8 evaluations were performed: 6 hours after the\r operation, 7 hours after the operation, and the first day after the operation 8:30, 9:30,\r 12:30, 13:30, 16:30, 17:30.\r\n\r During the test, the number of subjects with adverse reactions (vertigo, weakness, sustained\r wound bleeding greater than 100ml) was greater than 3% of the total number of cases (2\r persons). The trial was terminated immediately.\r\n\r Acceptance conditions:\r\n\r 1. Age over 20 years old, easy to move, can get out of bed and take a bath.\r\n\r 2. Symptomatic grade III or IV hemorrhoids diagnosed by the surgeon.\r\n\r 3. Accept epidural anesthesia.\r\n\r 4. Perform hemorrhoidectomy.\r\n\r 5. Those who have clear awareness and are willing to participate in and fill out the\r research consent form.\r\n\r Exclusion conditions:\r\n\r 1. Diseases around the anus (fistula, abscess).\r\n\r 2. Urinary tract problems (prostate hypertrophy in the past medical history; urinary tract\r infections on admission routine urine tests, urinary retention as assessed by Bladder\r Scan).\r\n\r 3. Take painkillers before surgery.\r\n\r Statistical methods\r\n\r 1. Descriptive statistical analysis: Adopt the mean, standard deviation, frequency\r distribution and percentage to present the basic attributes of the subjects.\r\n\r 2. Inferential statistics: Chi-square test was used to analyze the categorical variables,\r and independent sample t-test was used to analyze the continuous variables.\r\n\r 3. Use the independent sample t test to compare the differences in the average degree of\r urinary retention and pain between the groups. If the data are not normally distributed,\r switch to the Mann-Whitney U test without parental analysis to compare the experimental\r group and the control group before and after bathing Whether there is a difference, p\r value <0.05 is considered statistically significant.\r\n\r 4. Use GEE (Generalized Estimating Equation) to check whether there is any difference in\r the degree of urinary retention and pain in each group.\r\n\r The use of k-Nearest Neighbours to fill in the missing values is mainly to see that the\r relevant data measured by the subject in the same group is similar to those of other\r subjects, and then average the data measured by these similar subjects at the same time Value\r to fill.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. The age is more than 20 years old, the action is convenient, you can get out of bed\r and take a bath.\r\n\r 2. Diagnosed as symptomatic grade III or IV hemorrhoid by a surgeon.\r\n\r 3. Accept epidural anesthesia.\r\n\r 4. Perform an open hemorrhoidectomy.\r\n\r 5. After the researcher explains the purpose of the study, the person with a clear\r consciousness and willing to participate and fill out the study consent form.\r\n\r Exclusion Criteria:\r\n\r 1. Disease around the anus (fistula, abscess).\r\n\r 2. Urinary tract problems (in the past, there was a hypertrophy of the prostate; the\r routine urine test for admission had a urinary tract infection, and the bladder volume\r tester evaluated urinary retention).\r\n\r 3. Take analgesics before surgery.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nPhase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms\n\n**Clinical Trial Summary:**\n\nThe primary objective of this phase 1 trial is to determine the maximum tolerated dose (MTD),\r food effect, safety and tolerability of oral ONC206 in patients with recurrent, primary CNS\r neoplasms.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 18 years with a recurrent, primary CNS neoplasm. Primary CNS neoplasms included\r in this study: glioblastoma and glioblastoma histologic subtypes, gliosarcoma, primary\r CNS sarcomas, anaplastic glial neoplasms including anaplastic astrocytoma, anaplastic\r oligodendroglioma, anaplastic mixed neuronal-glial tumors, and pilocytic astrocytoma\r with anaplastic features, diffuse astrocytoma, oligodendroglioma, gliomatosis cerebri,\r pleomorphic xanthoastrocytoma, anaplastic pleomorphic xanthoastrocytoma, diffuse\r midline gliomas and histone mutated gliomas, ependymoma, anaplastic ependymoma, and\r all ependymoma subtypes, medulloblastoma and all medulloblastoma subtypes, ATRT,\r primary CNS embryonal/primitive neuroectodermal tumors, atypical and anaplastic\r meningiomas, choroid plexus tumors, and pineal region tumors.\r\n\r - Advanced disease after having received established standard of care treatment for\r their disease and have no standard treatment options available\r\n\r - Karnofsky Performance Score (KPS) of greater than or equal to 70.\r\n\r - Measurable or evaluable disease defined by RANO criteria. The exception will be\r patients who have had surgery in the past 4 weeks, patients who are post-operative\r after a maximal resection will be allowed to enroll after 4 weeks from surgical\r resection.\r\n\r - Washout for prior investigational or approved cytotoxic chemotherapy is 28 days prior\r to the first dose of ONC206; 42 days in the case of nitrosoureas; 28 days or 5\r half-lives (whichever is less; but not less than 14 days) in case of investigational\r or approved molecularly targeted agent; 14 days in the case of radiotherapy.\r\n\r - Patients will be required to enroll on the NCI Neuro-Oncology Branch natural history\r study (16-C-0151).\r\n\r - No major surgery in the prior 4 weeks\r\n\r - Patients must have normal organ and marrow function as defined below:\r\n\r - An available tumor specimen (paraffin-embedded block and/or frozen tissue) from prior\r resection or biopsy, ≥15 unstained slides for IHC analysis.\r\n\r - Ability to swallow oral capsules.\r\n\r - Ability to tolerate an MRI study with intravenous gadolinium contrast.\r\n\r - Men and women must use double barrier contraceptives\r\n\r Exclusion Criteria:\r\n\r - Prior bevacizumab for treatment of high-grade glioma\r\n\r - Known HIV-positive test on combination antiretroviral therapy\r\n\r - Active cardiac disease\r\n\r - Ischemic or hemorrhagic stroke in last 3 months\r\n\r - Refractory epilepsy and patients with primary or secondarily generalized seizures in\r the 28 days before enrollment are excluded. Peri-operative seizures occurring within 7\r days of surgery with resolution by day 8 after surgery are allowable. Patients must be\r on stable doses of one or two seizure medications for 14 days prior to study\r enrollment.\r\n\r - Impairment of gastrointestinal (GI) function\r\n\r - Concurrent use of warfarin sodium or other Coumadin-derivative anti-coagulants\r\n\r - Concurrent use of strong inhibitors or inducers of CYP3A4, 2D6, 1A2, 2C9 and 2C19 are\r excluded at least 14 days prior to and throughout the study.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies the effect of nivolumab in combination with blinatumomab compared\r to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL)\r that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in\r this study. Blinatumomab is an antibody, which is a protein that identifies and targets\r specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer\r cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a\r medicine that may boost a patient's immune system. Giving nivolumab in combination with\r blinatumomab may cause the cancer to stop growing for a period of time, and for some\r patients, it may lessen the symptoms, such as pain, that are caused by the cancer.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To compare rate of minimal residual disease (MRD) negative second remission (Rem-2) after\r up to two cycles of reinduction with blinatumomab versus (vs.) blinatumomab/nivolumab in\r Group 1 patients aged >= 1 to < 31 years old with first relapse of CD19+ B-ALL.\r\n\r II. To compare event-free survival (EFS) PI (EFS post-induction) between consolidation with\r blinatumomab vs. blinatumomab/nivolumab in Group 3 patients aged >= 1 to <31 years old with\r first relapse of CD19+ B ALL.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the safety and tolerability of blinatumomab/nivolumab in patients aged >= 1 to\r < 31 years old with first relapse of CD19+ B ALL.\r\n\r II. To compare EFS post-induction between blinatumomab vs. blinatumomab/nivolumab in Group 2\r patients aged >= 1 to < 31 years old with first relapse of CD19+ B ALL.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. In Group 1 patients, compare EFS between blinatumomab monotherapy and\r blinatumomab/nivolumab arms as compared to similar patients treated on the predecessor trial\r AALL1331.\r\n\r II. In Group 1 patients, compare toxicity as defined by grade 3 or greater adverse events\r during the first cycle of blinatumomab or blinatumomab/nivolumab to similar patients treated\r with block 1 of cytotoxic chemotherapy on the predecessor trial AALL1331.\r\n\r III. In Group 2 patients with MRD >= 0.1% after vincristine sulfate, dexamethasone, pegylated\r asparaginase, and doxorubicin hydrochloride (VXLD), compare MRD negative second remission\r (Rem-2) rate after the first cycle of immunotherapy between blinatumomab monotherapy and\r blinatumomab/nivolumab arms.\r\n\r IV. In patients with Down syndrome (DS) with first relapse of B-ALL, describe the safety,\r tolerability and efficacy (as defined by MRD negative second remission, Rem-2) after up to\r two cycles of blinatumomab/nivolumab.\r\n\r OUTLINE: Patients >= 18 years old with marrow +/- extramedullary (EM) relapse of any duration\r after initial diagnosis, or patients < 18 years old with marrow +/- EM relapse < 24 months\r after initial diagnosis are assigned to Group 1. Patients < 18 years old with marrow +/- EM\r relapse >= 24 months from initial diagnosis, or all isolated extramedullary (IEM) relapses >=\r 1 to < 31 years old are assigned to Groups 2-3 re-induction. Patients with DS are assigned to\r Arm G. NOTE: Patients in Group 1 and DS patients with white blood cells (WBC) >= 30,000/uL,\r CNS 2/3 disease, or testicular disease must first receive 1 of 3 pre-immunotherapy\r treatments.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR PATIENTS WITH WBC >= 30,000/uL: Patients receive methotrexate\r (MTX) intrathecally (IT) or cytarabine IT or intrathecal triple therapy (ITT) consisting of\r MTX, hydrocortisone sodium succinate, and cytarabine IT at the time of diagnostic lumbar\r puncture (LP) or on day 1 (if intrathecal therapy is given with relapse diagnostic LP < 7\r days prior to the start of protocol therapy). Patients also receive dexamethasone\r intravenously (IV) or orally (PO) twice daily (BID) on days 1-5, vincristine sulfate IV push\r over 1 minute or via infusion on day 1. Patients with DS also receive leucovorin calcium PO\r or IV every 6 hours (q6h) for 2 doses on day 2 or at 24 and 30 hours after each MTX or ITT\r dose. Patients should proceed to the next cycle when CNS 1 and no testicular disease is\r present, no sooner than Day 8 and no later than Day 15.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR CNS 2/3 DISEASE: Patients receive MTX IT or cytarabine IT\r twice weekly (Q2W) for 5-7 doses or Intrathecal Triple Therapy (ITT) IT Q2W for 3-4 doses\r until patient is CNS 1. Patients with DS also receive leucovorin calcium PO or IV q6h for 2\r doses at 24 and 30 hours after each MTX or ITT dose. Patients should proceed to the next\r cycle when CNS 1 and no testicular disease is present, no sooner than Day 15 and no later\r than Day 24.\r\n\r PRE-IMMUNOTHERAPY TREATMENT FOR TESTICULAR DISEASE: Patients receive MTX IT, cytarabine IT,\r or ITT IT on days 1 and 15 (day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy). Patients with DS also receive\r leucovorin calcium PO or IV q6h for 2 doses on days 2 and 16 or at 24 and 30 hours after each\r IT MTX or ITT dose. Males with testicular disease at relapse undergo radiation once daily\r (QD) for a total of 12 fractions over 12 days. Patients should proceed to the next cycle when\r CNS 1 and no testicular disease is present, no sooner than Day 15 and no later than Day 22.\r\n\r GROUP 1: Patients are randomized to Arm A or Arm B.\r\n\r ARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via\r continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1\r and 15 of cycle 1 (MTX on day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy), and MTX IT on days 1 and 15\r of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r ARM B: Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A.\r Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1\r and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r GROUPS 2-3 REINDUCTION: Patients receive vincristine sulfate IV push over 1 minute or via\r infusion on days 1, 8, 15, and 22, dexamethasone PO or IV on days 1-14, doxorubicin\r hydrochloride IV over 1-15 minutes on day 1, MTX IT on days 1, 8, and 29 (day 1 may be\r omitted if intrathecal therapy is given with relapse diagnostic LP < 7 days prior to the\r start of protocol therapy) (days 8 and 29 for CNS 1/2 patients at relapse only), pegaspargase\r intramuscularly (IM) or IV over 1-2 hours on days 2 and 16, cytarabine IT on days 4 and 11\r (CNS 2 patients at relapse only), then Q2W until 3 consecutive samples are clear of blasts,\r and ITT IT on days 8, 15, 22, and 29 (CNS 3 patients at relapse only). Treatment continues in\r the absence of disease progression or unacceptable toxicity.\r\n\r GROUP 2: The following patients are randomized to Arm C or Arm D: 1) >= 1 to < 31 years old,\r IEM relapse < 18 months from diagnosis, regardless of MRD after Re-Induction. 2) < 18 years\r old with marrow relapse >= 24 to < 36 months from diagnosis regardless of MRD after\r Re-Induction, 3) >= 1 to < 31 years old, IEM relapse >= 18 months, and MRD >= 0.1% after\r Re-Induction, 4) < 18 years old with marrow relapse >= 36 months, and MRD >= 0.1% after\r Re-Induction.\r\n\r ARM C: Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via\r continuous IV infusion on days 1-28 of cycles 1 and 2, and MTX IT on days 1 and 15 of cycles\r 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal MTX is given < 7 days prior to the\r start of cycle 1 ). Treatment repeats every 36 days for 2 cycles in the absence of disease\r progression or unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop\r study treatment or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle\r 1 proceed to cycle 2.\r\n\r ARM D: Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also\r receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle\r 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or\r unacceptable toxicity. NOTE: Patients with MRD < 0.01% after cycle 1 may stop study treatment\r or may choose to continue to cycle 2. Patients with MRD >= 0.01% after cycle 1 proceed to\r cycle 2.\r\n\r GROUP 3: The following patients are randomized to Arm E or Arm F: 1) >= 1 to < 31 years old\r with IEM relapse >= 18 months from diagnosis and MRD < 0.1% after Re-Induction, 2) < 18 years\r old with marrow relapse >= 36 months from diagnosis and MRD < 0.1% after Re-Induction.\r\n\r ARM E:\r\n\r IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, and MTX IT on days 1 and 15 (day 1 may\r be omitted from cycle 1 if intrathecal therapy is given < 7 days prior to the start of this\r cycle).Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2.\r\n\r CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate\r IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on\r days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide\r IV over 90-120 minutes on days 43 and 50, thioguanine PO once daily (QD) on days 43-49, and\r cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 44-47 and 51-54. CNS 1/2\r patients at relapse also receive MTX IT on days 1 and 43 and PO q6h for 4 doses on day 22,\r and leucovorin calcium PO q6h for 2 doses on day 24. CNS 3 patients at relapse also receive\r ITT IT on days 1 and 43, intermediate dose MTX IV over 36 hours on day 22, and leucovorin\r calcium IV or PO q6h on days 24 and 25. Treatment repeats every 8 weeks for 2 cycles in the\r absence of disease progression or unacceptable toxicity.\r\n\r IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28,\r and MTX IT on days 1 and 15.\r\n\r MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine\r sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on\r days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3\r patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.\r Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the\r absence of disease progression or unacceptable toxicity.\r\n\r MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS ONLY): Beginning between the first and second\r cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21,\r vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and\r pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse\r undergo cranial radiation in the form of 3-dimensional (D)-conformal radiation therapy (CRT)\r over 5 days per week for a total of 10 treatments.\r\n\r ARM F:\r\n\r IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days\r 11-25 of cycle 1 and on days 1 and 15 of cycles 2 and 3, and MTX IT on days 1 and 15 (day 1\r may be omitted from cycle 1 if intrathecal therapy is given with < 7 days prior to the start\r of this cycle). Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2.\r\n\r CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate\r IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on\r days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide\r IV over 90-120 minutes on days 43 and 50, thioguanine PO QD on days 43-49, and cytarabine IV\r over 1-30 minutes or SC on days 44-47 and 51-54. CNS 1/2 patients at relapse also receive MTX\r IT on days 1 and 43 and PO q6h for 4 doses on day 22, and leucovorin calcium PO q6h for 2\r doses on day 24. CNS 3 patients at relapse also receive ITT IT on days 1 and 43, intermediate\r dose MTX IV over 36 hours on day 22, and leucovorin calcium IV or PO q6h on days 24 and 25.\r\n\r IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28,\r nivolumab IV over 30 minutes on days 1 and 15 and MTX IT on days 1 and 15.\r\n\r MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine\r sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on\r days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3\r patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78.\r Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the\r absence of disease progression or unacceptable toxicity.\r\n\r MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS): Beginning between the first and second\r cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21,\r vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and\r pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse\r undergo cranial radiation in the form of 3D-CRT over 5 days per week for a total of 10\r treatments in the absence of disease progression or unacceptable toxicity.\r\n\r ARM G (DS PATIENTS): Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only,\r blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11\r and 25 of cycle 1 and days 1 and 15 of cycle 2, and MTX IT, cytarabine IT, or ITT IT on days\r 1 and 15 of cycle 1 (MTX on day 1 may be omitted if intrathecal therapy is given with relapse\r diagnostic LP < 7 days prior to the start of protocol therapy), MTX IT on days 1 and 15 of\r cycle 2, and leucovorin calcium IV or PO q6h for 2 doses on days 2 and 16.\r\n\r Patients with MRD < 0.01% are eligible to come off protocol therapy to receive Consolidation\r therapy at the end of Cycle 1, or may choose to proceed to Arm G, Cycle 2.\r\n\r After completion of study treatment, patients are followed up every 3 months for 1 year.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must be >= 1 and < 31 years at time of enrollment\r\n\r - Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in\r one of the following categories:\r\n\r - Isolated bone marrow relapse\r\n\r - Isolated central nervous system (CNS) (excluding known optic nerve/retinal and\r CNS chloromas) and/or testicular relapse\r\n\r - Combined bone marrow with extramedullary relapse in the CNS (excluding known\r optic nerve/retinal and CNS chloromas) and/or testes\r\n\r - Patients with Down syndrome (DS) are eligible in the following categories:\r\n\r - Isolated bone marrow relapse\r\n\r - Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS\r chloromas) and/or testicular relapse\r\n\r - Patients must have a performance status corresponding to Eastern Cooperative Oncology\r Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and\r Lansky for patients =< 16 years of age\r\n\r - Patients must have fully recovered from the acute toxic effects of all prior\r chemotherapy, immunotherapy, or radiotherapy prior to entering this study\r\n\r - Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in\r the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19\r expression\r\n\r - Radiation therapy (RT): >= 3 months must have elapsed if prior RT. This includes\r any patient requiring urgent radiation to any sites of extramedullary disease\r prior to enrollment (e.g. retinal/optic nerve involvement)\r\n\r - Hematopoietic stem cell transplant (HSCT): Patients must not have had a prior\r hematopoietic stem cell transplant\r\n\r - A single intrathecal chemotherapy at the time of relapse will be allowed. If < 7\r days have elapsed between this intrathecal therapy (IT) and the start of protocol\r therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine,\r or triple intrathecal) may be omitted\r\n\r - In the 28 days prior to enrollment, up to five days of post-relapse,\r pre-enrollment therapy (steroid and/or hydroxyurea only) is permissible\r\n\r - Group 1 and Down syndrome patients who received pre-enrollment therapy and\r have a white blood count (WBC) >= 30,000/ul at the time of enrollment must\r receive protocol specified cytoreductive therapy with vincristine and\r dexamethasone, and no \"washout\" is required\r\n\r - Group 1 and Down syndrome patients who received pre-enrollment therapy and\r have a WBC < 30,000/ul at the time of enrollment must be given a 24 hour\r \"washout\" before starting immunotherapy\r\n\r - Note: There is no waiting period or \"washout\" for patients who relapse while\r receiving upfront therapy\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70\r mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows (within 5\r calendar days prior to enrollment):\r\n\r - Age: Maximum serum creatinine (mg/dL)\r\n\r - 1 to < 2 years: 0.6 (male), 0.6 (female)\r\n\r - 2 to < 6 years: 0.8 (male), 0.8 (female)\r\n\r - 6 to < 10 years: 1 (male), 1 (female)\r\n\r - 10 to < 13 years: 1.2 (male), 1.2 (female)\r\n\r - 13 to < 16 years: 1.5 (male), 1.4 (female)\r\n\r - >= 16 years: 1.7 (male), 1.4 (female)\r\n\r - Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by\r echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram\r\n\r - No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if\r there is clinical indication for determination.\r\n\r - All patients and/or their parents or legal guardians must sign a written informed\r consent\r\n\r - All institutional, Food and Drug Administration (FDA), and National Cancer Institute\r (NCI) requirements for human studies must be met\r\n\r Exclusion Criteria:\r\n\r - Patients with B-lymphoblastic lymphoma (B-LLy)\r\n\r - Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia\r\n\r - Patients with Philadelphia chromosome positive (Ph+) B-ALL\r\n\r - Patients with mixed phenotype acute leukemia (MPAL)\r\n\r - Patients with known Charcot-Marie-Tooth disease\r\n\r - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,\r regardless of blast immunophenotype\r\n\r - Patients with active, uncontrolled infection defined as:\r\n\r - Positive bacterial blood culture within 48 hours of study enrollment\r\n\r - Receiving IV or PO antibiotics for an infection with continued signs or symptoms.\r Note: Patients may be receiving IV or oral antibiotics to complete a course of\r therapy for a prior documented infection as long as cultures have been negative\r for at least 48 hours and signs or symptoms of active infection have resolved.\r For patients with clostridium (C.) difficile diarrhea, at least 72 hours of\r antibacterial therapy must have elapsed and stools must have normalized to\r baseline.\r\n\r - Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with\r clinical signs of infection. Fever without clinical signs of infection that is\r attributed to tumor burden is allowed as long as blood cultures are negative for\r > 48 hours\r\n\r - A positive fungal culture within 30 days of study enrollment or active therapy\r for presumed invasive fungal infection\r\n\r - Active viral or protozoal infection requiring IV treatment\r\n\r - Patients known to have one of the following concomitant genetic syndromes: Bloom\r syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome\r or any other known bone marrow failure syndrome are not eligible. Of note, patients\r with known human immunodeficiency virus (HIV) infection on effective anti-retroviral\r therapy with undetectable viral load for at least the last 6 months prior to\r enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who\r have been treated and have no viral detectable burden are also eligible\r\n\r - Patients with significant central nervous system pathology that would preclude\r treatment with blinatumomab, including history of severe neurologic disorder or\r autoimmune disease with CNS involvement\r\n\r - Note: Patients with a history of seizures that are well controlled on stable\r doses of anti-epileptic drugs are eligible Patients with a history of\r cerebrovascular ischemia/hemorrhage with residual deficits are not eligible.\r Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible\r provided all neurologic deficits have resolved\r\n\r - Patients with an active known/suspected autoimmune disease are not eligible. However,\r patients with type I diabetes mellitus, hypothyroidism only requiring hormone\r replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring\r systemic treatment, or conditions not expected to recur in the absence of an external\r trigger are permitted to enroll\r\n\r - Group 1 and DS patients with known non-hematopoietic, non-CNS/testicular\r extramedullary disease (i.e., chloromatous disease) are not eligible\r\n\r - Note: Group 2 and 3 patients with known non-hematopoietic, non-CNS/testicular\r extramedullary disease (i.e., chloromatous disease) are eligible provided that\r this is NOT the only site of relapsed disease\r\n\r - Female patients of childbearing potential are not eligible unless a negative pregnancy\r test result has been obtained within 7 days prior to enrollment. Patients who are\r sexually active and of reproductive potential are not eligible unless they agree to\r use an effective contraceptive method for the duration of this study. Men with female\r partners of childbearing potential should use effective contraception during the\r duration of their treatment. The effect of blinatumomab on fertility has not been\r evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing\r potential (WOCBP) not using contraception. Females of reproductive potential must use\r effective contraception during treatment and for at least 48 hours after the last dose\r of blinatumomab. Studies in animal models have shown that nivolumab can adversely\r impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy.\r WOCBP receiving nivolumab must continue contraception for a period of at least 5\r months after the last dose of nivolumab. It is unknown whether nivolumab is present in\r breast milk, thus breastfeeding should be discontinued while a patient is receiving\r nivolumab. Men receiving nivolumab and who are sexually active with WOCBP must\r continue contraception for 7 months after the last dose of nivolumab\r\n\r - Lactating females are not eligible unless they agree not to breastfeed their infants.\r It is unknown whether blinatumomab or its metabolites are excreted in human breast\r milk. Women are not permitted to breastfeed while receiving blinatumomab and for the\r last 48 hours after the last blinatumomab dose. Due to the potential for serious\r adverse reactions in the breastfed infant, women are not permitted to breastfeed\r during treatment and for 5 months after the last nivolumab dose\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nImproving Acute Hypertension Management Through Emergency Department Checklist\n\n**Clinical Trial Summary:**\n\nThe investigators hypothesize that the implementation of a checklist in acute severe\r hypertension would result in improving short and long-term outcomes of patients with acute\r severe hypertension treated in the emergency department (ED). The investigators hypothesize\r that in the short-term, a checklist would improve the diagnosis and management of end-organ\r damage as well as reduce the length of stay of acute severe hypertensive patients in the ED.\r The investigators hypothesize that the checklist will result in better compliance with\r anti-hypertensive medications than without the checklist at six-month post-discharge.\n\n**Clinical Trial Detailed Description:**\n\nHypertension is a global public health issue and results in over 10 million deaths every\r year. The disease affects one-third of people living in low- and middle-income countries\r (LMICs) and contributes to half of all productivity losses in LMICs due to non-communicable\r diseases. Though hypertension often presents as a chronic asymptomatic illness,\r hypertension-related emergencies represent a significant burden to the health care system.\r Acute severe hypertension [i.e., systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood\r pressure (DBP) ≥ 110 mmHg] make up to 5% of all emergency admission. One-third of these\r patients present with end-organ damage; a condition called a hypertensive crisis. More\r worrisome is the fact that a number of ED visits, as a result, severe acute hypertension and\r hypertensive crises have almost tripled between 2006 and 2013 in the US. Treatment approaches\r to managing acute severe hypertension (~5% of ED patients) are largely unclear and only 6% of\r ED patients with acute severe hypertension receive appropriate work-up for the end-organ\r damage, indicating a huge care gap. One approach, which has been used successfully in\r managing other complex and critical conditions, is the use of checklists. Checklists are a\r listing of actions to be performed in a given clinical setting with the aim of improving\r adherence to standards, reducing errors and thus improving patient outcomes. The\r investigators hypothesize that the use of a Checklist, if appropriately implemented, can lead\r to an improvement in the care of patients presenting with hypertensive crisis. During this\r study, the investigators will measure the prevalence of acute severe hypertension and assess\r the current quality of care for these patients. This will be followed by the development of a\r checklist for the management of the hypertensive crises in the ED. The investigators will\r follow these patients to see the impact of the checklist on the quality of care and long-term\r outcomes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adults who visit the Aga Khan University Hospital Emergency Department with acute\r severe hypertension\r\n\r - able to provide consent to participate\r\n\r - Age >25 years of age\r\n\r - Meeting the criteria of acute severe hypertension (SBP>180 and DBP>110).\r\n\r Exclusion Criteria:\r\n\r - Patients not providing consent or are unconscious are excluded from participation.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nPhase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.\n\n**Clinical Trial Summary:**\n\nTo compare the effect of Phase 1 cardiac rehabilitation with lower limb paddling, with phase\r 1 cardiac rehabilitation without lower limb paddling Effects in Post Coronary artery bypass\r graft (CABG) Patients.\n\n**Clinical Trial Detailed Description:**\n\nCoronary artery disease (CAD) is the most common type of heart disease. CAD happens when the\r arteries that supply blood to heart muscle become hardened and narrowed. This is due to the\r buildup of cholesterol and other material, called plaque, on their inner walls. This buildup\r is called atherosclerosis. As it grows, less blood can flow through the arteries. As a\r result, the heart muscle can't get the blood or oxygen it needs. This can lead to chest pain\r (angina) or a heart attack. Most heart attacks happen when a blood clot suddenly cuts off the\r hearts' blood supply, causing permanent heart damage.\r\n\r Previous studies reported positive effects of early exercise in the ICU on these measures .\r In a meta-analysis published earlier, early mobilization increased the number of\r ventilator-free days during hospitalization, but not the duration of Minute ventilation (MV).\r A possible explanation is that many patients without MV were included . As a result, these\r results should be interpreted with caution. The mortality rate is a traditional measure of\r the health status of critically ill patients. Muscle weakness is associated with increased\r mortality. Physical therapy in the intensive care unit (ICU) had no effect on mortality in\r many previous systematic reviews and meta-analyses. Similar to previous studies, early\r mobilization did not improve ICU mortality, hospital mortality, or 28-day mortality rates in\r the previously published meta-analysis. The discharged-to-home rate is an important\r prognostic indicator for critically ill patients, first showed that early mobilization\r increased the discharged-to-home rate compared to the control group.\r\n\r In previous study it was concluded that, after the performance of the mobilization protocol,\r the patients in the Immunoglobulins (IG) improved the distance walked in the 6 min walk test\r (6MWT), which was assessed during 7 postoperative days and 60 days after hospital discharge,\r and it was less time in ICU and lower prevalence of pulmonary complications, when compared to\r the control group (CG). It was also concluded that with the results obtained from their\r study, it was possible to introduce an early mobilization protocol in the ICU routinely unit\r and sensitize the medical board about the importance of proper physiotherapy conduct.\r\n\r Another previously conducted study states that regardless of the different techniques and\r periods of mobilization applied, early mobilization may be initiated safely in the ICU\r setting and appears to decrease the incidence of Intensive care unit-acquired weakness\r (ICU-AW), improve the functional capacity, and increase the number of patients who are able\r to stand, number of ventilator-free days and discharged-to-home rate without increasing the\r rate of adverse events. However, due to the substantial heterogeneity among the included\r studies, the evidence has a low quality.\r\n\r Previous study states the importance of this approach; this has been emphasized in previous\r studies on experienced paddlers, rowers, cross-country skiers, cyclists and runners. However,\r some studies in sports that depend upon a high lower extremity documented a dependence of\r results from a specific Paddler on the season when the test was undertaken. During paddling,\r ventilatory functions are also very important. Values for the maximal minute ventilation\r (Vmax) and tidal volume obtained in the cycle ergometer were higher than in paddling in\r previous studies. During endurance performance the tidal volume depends on age, sex and\r constitutional factors and, in athletes, mainly on the nature and duration.The Max oxygen\r consumption (VO2) differences between maximal cycling and paddling were non-significant in\r previous studies. The ventilation equivalent affords insight into the economy of respiration.\r The magnitude is dependent on constitutional factors, especially on morphological conditions\r of the respiratory system, and partly on sex, age and, especially in athletes, on the economy\r of ventilation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Body mass index (BMI) between 20 and 30 kg/m2\r\n\r - Hemodynamic stability with or without use of positive inotropic drugs\r\n\r - Absence of arrhythmias and angina\r\n\r - Mean blood pressure (MBP) 60 ⩽ MBP ⩽ 100 mmHg\r\n\r - Heart rate (HR) 60 ⩽ HR ⩽ 100 bpm without respiratory distress\r\n\r - Respiratory rate (RR) ⩽ 20 without signs of infection\r\n\r Exclusion Criteria:\r\n\r - Previous pulmonary disease and acute lung disease\r\n\r - Mechanical ventilation >24 h\r\n\r - Left ventricular ejection fraction (LVEF) <35% or >54%\r\n\r - Surgical reintervention\r\n\r - Intraoperative death or any contraindications for the proposed measurements and/or\r treatment\r\n\r - Contraindications for the 6MWT or any proposed protocol\r\n\r - Orthopedic impairments\r\n\r - Unstable angina\r\n\r - HR >120 bpm at rest, and systolic blood pressure >180 mmHg or diastolic >100 mmHg.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPost-operative Analgesic Effect of Oral Nefopam: a Randomized Controlled Trial\n\n**Clinical Trial Summary:**\n\nHigh tibial osteotomy is a common procedure in orthopedic surgery; it is highly standardized\r (incision location and size, the volume of periosteal lesion, implanted material). It is\r associated with short recovery period but intense postoperative pain during first 24 hours.\r The surgical wound has a comprehensive innervation by saphenous and a terminal muscular\r branches of tibial nerve. These conditions allow reproducible measurements of analgesic drugs\r effects in postoperative period.\r\n\r Nefopam is a non-opioid centrally acting analgesic drug used as a part of multimodal\r analgesia. The opioid-sparing effect of nefopam is still controversial across various\r surgical procedures. In France nefopam is only available as a parenteral formulation; however\r it is often administered orally. There is currently no study addressing the efficacy of oral\r nefopam for the postoperative pain management including pain prevention.\r\n\r We conduct a prospective, double-blinded randomized controlled study with the main objective\r to examine the effect of perioperative orally administered nefopam on postoperative pain\r after a high tibial osteotomy. Secondary objectives include the quantification of wound\r allodynia, analysis of adverse events, clinical outcomes, and a pharmacokinetic study of\r orally given nefopam (plasma and cerebrospinal fluid dosage).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - adult patients scheduled for a high tibial osteotomy under spinal anesthesia at the\r Hopital de la Croix Rousse, Hospice Civils de Lyon, France.\r\n\r - ASA (American Society of Anesthesiology) class between 1 et 3.\r\n\r - written informed consent\r\n\r Exclusion Criteria:\r\n\r - any contraindication for nefopam (known hypersensitivity, past medical history of\r seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic\r cardiomyopathy waiting for revascularization, atrial fibrillation)\r\n\r - medical conditions known to influence the pharmacokinetics of nefopam (chronic kidney\r failure with Glomerular Filtration Rate (GFR) <30mL/min/1,73m2, liver failure, current\r treatment with rifampicin, carbamazepine, azoles fungicides, macrolides)\r\n\r - current treatment with benzodiazepines, anxiolytics, antidepressants, histamine H1\r antagonists, neuroleptics, baclofen, thalidomide, barbiturates\r\n\r - medical history of gastric or esophageal surgery.\r\n\r - phenylketonuria\r\n\r - pregnancy or breastfeeding\r\n\r - past use of oral nefopam\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIleal Conduit Versus Cutaneous Ureterostomy After Radical Cystectomy\n\n**Clinical Trial Summary:**\n\nBladder cancer is the most common malignancy of the urinary tract and accounts for about 3.2%\r of all cancer worldwide where it remains the seventh most commonly diagnosed malignancy in\r the male population. Causative risk factors can be broadly divided into inherited and\r acquired due to environmental exposure ,Tobacco smoking is the most important environmental\r risk factor for bladder cancer(1).\r\n\r Histologically, over 90% of bladder tumors are transitional cell carcinomas. The other\r subtypes, such as squamous cell and adenocarcinoma, are uncommon and account for 5 and <2%,\r respectively(2).\r\n\r Radical cystectomy with pelvic lymph node dissection with appropriate urinary diversion\r remains the mainstay of surgical treatment for muscle invasive bladder cancer and for high\r risk non muscle invasive disease. Select group of patients or those unfit or unwilling for\r surgery are managed by trimodal therapy utilizing transurethral resection and\r chemoradiotherapy.(3) The ideal urinary diversion should successfully preserve renal function\r while managing urinary outflow and minimizing morbidity to the patient(4).Several types of\r urinary diversion are present, continent and incontinent. Our study will focus on ileal\r conduit and cutaneous ureterostomy.\r\n\r Although ileal conduit considered the standard method for incontinent urinary diversion, it\r is associated with early bowel related complications, i.e., bowel obstruction, prolonged\r ileus, and anastomotic leak which are mainly associated with bowel resection and anastomosis\r and late complications comprise ureteroenteric stricture, urinary fistula and stomal site\r complications in 25-60% of patients, including stomal stenosis, retraction, prolapsed, and\r parastomal herniation. Cutaneous ureterostomy may represent a method of choice for elderly\r and otherwise morbid patients due to its relative short duration and less bowel and metabolic\r complications but it has a high rate of stomal stenosis making perminant stenting is\r mandatory(5).\r\n\r Cutaneous ureterostomy with separate stomas offers easy exchange of stents not need tertiary\r center with fluoroscopy or endescopy guidance compared to cutaneous ureterostomy with single\r stoma and this is preferable in our community.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients with bladder cancer eligible for surgery\r\n\r Exclusion Criteria:\r\n\r - Patients who refuse to contribute in this study.\r\n\r - patients who are unfit for surgery.\r\n\r - patients refusing cystectomy.\r\n\r - patients with metastatic or inoperable cancer bladder\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMisoprostol for Spinal Stenosis\n\n**Clinical Trial Summary:**\n\nThis single-group cross-sectional cohort study will enroll approximately 25 patients at the\r North Texas VA Health Care System (VANTHCS) who have previously received off-label\r prescriptions of misoprostol for lumbar spinal stenosis for any duration and who are willing\r to provide verbal and informed consent. Patients will answer a questionnaire regarding pain\r and functional improvement especially in reference to misoprostol treatment. Patients will\r also be selected to have their walking tolerance (claudication distance) measured in an\r outpatient clinic setting to determine the severity of their lumbar spinal stenosis symptoms\r after having received misoprostol.\n\n**Clinical Trial Detailed Description:**\n\nLumbar spinal stenosis (LSS) is clinically described as a neurogenic claudication that is\r associated with increased mechanical compression on the spinal nerve roots as well as\r potential compromise of the vascular supply of the spinal nerve roots. This compression\r typically leads to symptoms of lumbar pseudoclaudication, which include pain, paresthesias,\r and discomfort in the lower extremities, commonly exacerbated by walking. Broadly speaking,\r this compression can be the result of a degenerative narrowing of the spinal or nerve root\r canals. While spinal stenosis is typically considered idiopathic, causes can also include\r malignancy, injury, and chronic inflammation. It is often debilitating to patients and can\r lead to a wide variety of negative health outcomes (pre-operative lower levels of function,\r psychological distress, high self-reported disability scores and operative risks of surgical\r correction) related to attempted surgical correction of lumbar spinal stenosis. Spinal\r stenosis continues to be a leading indication for spine surgery in adults older than 65 years\r old. Furthermore, estimated total Medicare costs for surgeries treating lumbar spinal\r stenosis amounted to over $1.65 billion for 37,598 individual operations.\r\n\r Physiologically, the venous blood flow in the lumbar spinal region is disproportionately\r affected by pressure gradients generated secondary to normal movement and pathologic\r constriction. Studies have found that patients diagnosed with lumbar spinal stenosis with\r intermittent claudication, while walking on a treadmill, experienced larger amounts of\r vascular congestion which resolved with sitting. This was measured with a myeloscope in the\r intrathecal space.\r\n\r The current vascular pathologic mechanism of the symptomatic effects of lumbar spinal\r stenosis is thought to be a consequence of constriction leading to increasing vascular\r congestion and inflammation. Authors first described the effect of constriction on vascular\r flow through a post mortem study of a patient with chronic lumbar spinal stenosis at L4-L5.\r Most significantly, they found that venous supply proximal to constriction in fact showed\r reduced and collapsed veins with gross congestion proximal to the lesion. Further\r investigation found that venous congestion led to increased inflammatory markers in nerves\r with atrophy, Wallerian degeneration, and perineural fibrosis in more severe patients. Most\r importantly, these pathologic changes were associated with vascular changes in the absence of\r direct nerve root compression at these sites. This venous congestion is a potential target\r for therapy.\r\n\r There has been previous work done with medications that are PGE1 analogs such as limaprost\r and lipo-PGE1. PGE1 analogs hypothetically treat the above lumbar spinal stenosis pathology\r by improving blood flow to nerve roots through vasodilatory and antiplatelet aggregation\r effects. However, misoprostol (PGE1 analog) has not been thoroughly evaluated as a possible\r treatment for symptoms of lumbar spinal stenosis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adults aged 18 years or older.\r\n\r - Previous diagnosis of lumbar spinal stenosis, mild-severe lumbar central canal\r stenosis identified by MRI or CT scan.\r\n\r - Symptoms:\r\n\r - Lower extremity symptoms consistent with neurogenic claudication.\r\n\r - Pain, weakness &/or numbness triggered by standing or walking, and relieved by\r sitting.\r\n\r - Must be able to read English and complete questionnaire.\r\n\r - Was prescribed Misoprostol specifically for lumbar spinal stenosis.\r\n\r Exclusion Criteria:\r\n\r - Cognitive impairment that renders the patient unable to give informed consent or\r provide accurate data\r\n\r - Clinical co-morbidities that could interfere with the collection of data concerning\r pain and function\r\n\r - Severe vascular, pulmonary, or coronary artery disease that limits ambulation\r including recent myocardial infarction (within 6 months)\r\n\r - Spinal instability requiring surgical fusion\r\n\r - Severe osteoporosis as defined by multiple compression fractures or a fracture at the\r same level as the stenosis\r\n\r - Metastatic cancer\r\n\r - Excessive alcohol consumption or evidence of non-prescribed or illegal drug use\r\n\r - Pregnancy\r\n\r - Concordant pain with internal rotation of the hip (or known hip joint pathology)\r\n\r - Active local or systemic infection\r\n\r - Previous lumbar spine surgery\r\n\r - Prisoners\r\n\r - Use of misoprostol for any other indication then lumbar spinal stenosis\r\n\r - Rheumatological disorders such as rheumatoid arthritis, psoriatic arthritis, systemic\r lupus erythematosis.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nMagnesium Oral Supplementation for Acute Non-specific Low Back Pain\n\n**Clinical Trial Summary:**\n\nAcute non-specific low back pain (LBP) is one of the most common complaints at the emergency\r department. It is more prevalent in countries with high-income economies, where 60-80% of the\r population report back pain at some point in their life. Numerous medication options are\r available for acute LBP relief such as non-steroid anti-inflammatory drugs (NSAIDs),\r myorelaxant drugs, opioids, and benzodiazepines. Magnesium is a physiological\r voltage-dependent blocker of N-methyl-D-aspartate NMDA)-coupled channels that can influence\r inflammatory pain and neuropathic pain through several different mechanisms. In this study\r the investigators aimed to investigate the effect of magnesium oral supplementation for acute\r low back pain.\n\n**Clinical Trial Detailed Description:**\n\nThis study was conducted at our emergency department between June 2018 and March 2020 after\r receiving approval from our institutions' ethics committee (2018/1330). This study was\r registered as a randomized controlled trial with the US National Institute of Health\r (clinical trials.gov). We conducted a three-arm, prospective randomized open label clinical\r trial to compare isolated NSAID group, NSAID with paracetamol group and NSAID with oral\r magnesium supplementation group (described below) for treatment of acute LBP. Patients were\r included after providing informed consent predicated on their understanding of expected\r complications and treatment outcomes. Consolidate Standards of Reporting Trials (CONSORT)\r guidelines were followed reporting the results of the study Patients from a single university\r hospital were recruited for this study between June 2018 and March 2020. Inclusion criteria\r were defined as (1) age>18 years old, (2) duration of symptoms <2 weeks and (3) functionally\r impairing LBP which we defined as a score of > 5 on Roland-Morris Disability Questionnaire\r (RMDQ).\r\n\r Exclusion criteria included (1) age>65 years old, (2) history of trauma, (3) presence of\r radicular pain physical examination which was defined as pain radiating below the gluteal\r folds, (4) history of primary vertebral tumor or metastasis, (4) patients who were pregnant\r or lactating, (5) presence of any contraindication or allergy to investigational medications,\r (6) history of chronic analgesic use, (7) history of autoimmune diseases or inflammatory\r rheumatic disorders, (8) history of cardiopulmonary restrictions, severe kidney or liver\r function disorders and (9) history of prior surgery of lumbar spine.\r\n\r We based our sample size calculation assumptions on a recently published clinical trial [11]\r and widely accepted minimum clinically important improvement of 5 points on the RMDQ.(14)\r With alpha and beta values were set at 0.05 and 0.20 respectively, sample size calculation\r revealed that 50 patients were needed in each study group. To account for protocol\r violations, lost-to-follow-up and to ensure sufficient power for the intention to treat\r analysis (in previous work, up to 1/3 of enrolled patients did not use the investigational\r medication), we enrolled 80 patients for each group.\r\n\r A computer generated random list was established with an online sequencer\r (www.random.org/sequences) according to which participants were randomly assigned to one of\r three study groups with 1:1:1 allocation ratio. Group A included isolated NSAID treatment and\r received 400 mg etodolac twice a day. Group B included NSAID and magnesium treatment and\r received a combination of 400 mg etodolac twice a day with 365 mg oral magnesium\r supplementation once a day. Group C included NSAID and paracetamol treatment and combination\r of 400 mg etodolac twice a day with 500 mg paracetamol twice a day was administered to the\r participants of this group (Figure-1). We effort to prevent the placebo effect by comparing\r the NSAID + magnesium therapy with both a NSAID plus paracetamol therapy and an isolated\r NSAID therapy. Treatment was performed by two authors (S.B and K.Ş) and patients were\r followed-up by same authors throughout the study. External medication was not allowed with\r the exception of topical analgesics. Patients who received any intravenous or intramuscular\r analgesia during the treatment period were excluded from study. Co-medications for any\r accompanying chronic condition (diabetes, hypertension etc.) were unchanged.\r\n\r Clinical evaluation of participants was performed at first admission to emergency department,\r at 4th and 10th days after the initiation of designated treatment. Outcome measures included\r pain, mobility of lumbar spine and functional outcome. Pain intensity was assessed using a\r visual analogue scale (VAS). Lumbar spine mobility was assessed using the \"finger to floor\"\r test. Participants were asked to stand on erect posture with knees extended and then to bend\r forward in an attempt to reach for the floor with their fingertips without losing knee\r extension. Distance between patient's fingertips and the floor was then measured with a\r measuring tape. Functional outcome was evaluated with Roland-Morris Disability Questionnaire\r (RMDQ) score. RMDQ is a 24-item LBP functional scale and is recommended for research\r purposes. Higher scores signify greater low back-related functional impairment. An\r improvement of 5 points was considered clinically significant.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients aged>18 years old,\r\n\r - initiation of acute low back pain in the 10 days prior to study entry and functionally\r impairing low back pain, which we defined as a score of > 5 on the Roland-Morris\r Disability Questionnaire (RMDQ).\r\n\r Exclusion Criteria:\r\n\r - aged>65 years old,\r\n\r - history of trauma,\r\n\r - radicular pain, which we defined as pain radiating below the gluteal folds,\r\n\r - history of vertebral tumor or metastasis,\r\n\r - patients who were pregnant or lactating,\r\n\r - unavailable for follow-up,\r\n\r - with allergy or contraindication to the investigational medications,\r\n\r - chronic analgesic use,\r\n\r - autoimmune diseases or inflammatory rheumatic disorders,\r\n\r - cardiopulmonary restrictions,\r\n\r - severe kidney or liver function disorders and prior surgery on the lumbar spine.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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392
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nE-health for Self-Management of Chronic Pain\n\n**Clinical Trial Summary:**\n\nThe investigators aim to validate if a digital tool for increased self-management of chronic\r pain can improve the quality of life for patients with chronic pain. The validation is based\r on the change in pain interference (Quality of life), pain intensity, physical functioning,\r depression, and anxiety based on self-reported information from baseline to study end.\n\n**Clinical Trial Detailed Description:**\n\nChronic pain is today an increasing health problem in both Europe and US, with an estimation\r of about 90 million people affected in Europe (Breivik, H. et al., 2006) and 100 million\r people in US (Relieving Pain in America, IOM Report 2011), or 20-30% of the adult population\r around the world. Chronic pain is defined as a condition that lasts for at least three to six\r months, after the normal healing period of an injury. Medical interventions offered in\r clinics around the globe are unfortunately not giving the results needed to give back the\r quality of life the patients had prior to the onset of the pain. The treatments offered today\r do sometimes reduce pain, but the effect is minor, and new treatment regimens are needed\r (Relieving Pain in America, 2011). Recent quality assurance registry measurements in Sweden\r has shown that patient taken part of multi modal treatment regimens, such as the acceptance\r and commitment therapy, (ACT) show that less then 40% of the patients have a decline in the\r pain level of 1 level on the VAS scale, 55% has no effect and 9 % has an increased level of\r pain after going through the program (Nationel Register for Pain Rehabilitation, Sweden 2017)\r\n\r The study objective is to evaluate how the use of a digital pain coach, based on artificial\r intelligence that improves the self-management of pain will decrease the pain interference\r and thereby increase QoL among chronic pain patients, as measured by PROMIS pain interference\r 6a. We will here compare the improvement of quality of life by a decrease in pain\r interference, measured by PROMIS, in patients who follow their traditional treatment plan\r provided by the Pain Clinic with the addition of using a web application for increased self\r management of pain. The theory behind the study and the development of the device is\r supported by previously known data, showing that self-management has an effect and is\r important to the treatment by helping patients to believe in their own capacity to control\r their pain.\r\n\r The present investigation aims at exploring the effect of including a digital tool as an add\r on to standard treatment and rehabilitation and will measure the effect it has on:\r\n\r 1. Decreased pain interference\r\n\r 2. Improved management of long-term pain and its consequences. Hence self-management of\r pain\r\n\r 3. Increased function in daily life with the best possible activity and participation level\r\n\r 4. Improved experience of health-related quality of life\r\n\r 5. Decreased pain experience\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Have a complex, prolonged axial neck pain or lower back pain\r\n\r - Have been followed by a pain management specialist for at least 3 months or have a\r history of chronic pain for at least 3 months as recorded by physician\r\n\r - Be >18 years of age\r\n\r - Have a goal and motivation that is adequate in relation to the program offered\r\n\r - Be medically prepared\r\n\r - Have no major change in interventional treatment or be a surgical candidate\r\n\r - Own a smart phone, tablet or computer or have the knowledge to use one\r\n\r Exclusion Criteria:\r\n\r - Chronic pain requiring imminent surgical intervention\r\n\r - Reported severe or acute psychiatric illness, severe anxiety or depression\r\n\r - Current history of substance abuse\r\n\r - Serious health risks or scheduled major health interventions for other medical reasons\r\n\r - Pain related to malignancy\r\n\r - Pain duration <3 months\r\n\r - Other areas of pain exceeding the amount of back or neck pain\r\n\r - Not currently involved in lawsuit or pending litigation\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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393
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComparing Local Anesthesia With and Without iPACK Block\n\n**Clinical Trial Summary:**\n\nTotal knee arthroplasty is an effective surgical intervention for patients with chronic\r osteoarthritis commonly performed worldwide. Postoperative pain management has been a key\r focus in patient care for this procedure. Poorly controlled pain following total knee\r arthroplasty is associated with decreased ambulation, increased length of hospital stay,\r increased complications (particularly related to significant opioid use), and overall\r suboptimal patient recovery. Appropriate postoperative pain management utilizing motor\r sparing peripheral nerve blocks and periarticular injections has been shown to provide\r faster, more optimized patient recovery and reduced hospital length of stay in patients\r undergoing total knee arthroplasty.\r\n\r Adductor canal block (ACB) is a well-studied peripheral nerve block performed for analgesia\r following total knee arthroplasty. ACB is an effective component of multimodal analgesia\r providing improved pain control to the peripatellar and intra-articular aspect of the knee\r joint while largely preserving the strength of the quadriceps muscles1. In addition,\r perioperative local infiltration analgesia (LIA) performed by the orthopaedic surgical team\r is a common practice that has been shown to improve short-term postoperative pain relief and\r reduce total systemic opioid consumption during hospital stay2 for total knee arthroplasty.\r\n\r The Infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block is a\r newly described regional anesthesia technique for postoperative analgesia in total knee\r arthroplasty, performed under ultrasound guidance. It targets the articular branches of the\r tibial, common peroneal, and obturator nerves in the popliteal region, and aims to provide\r analgesia to the posterior aspect of the knee joint without compromising lower extremity\r motor function following total knee arthroplasty.\r\n\r This study aims to determine whether the IPACK block provides additional analgesia (in\r combination with ACB + LIA) for total knee arthroplasty surgeries. The study will examine how\r much additional analgesia IPACK provides in the context of an already-optimized regional\r anesthesia pathway for total knee arthroplasty, which uses ACB + LIA, both modalities that\r have reasonable existing evidence.\n\n**Clinical Trial Detailed Description:**\n\nCurrently, limited studies exist in the literature regarding the use of iPACK for analgesia\r in total knee arthroplasty. Specific studies on the addition of iPACK to ACB or LIA\r demonstrate clinically significant reductions in pain scores for patients undergoing total\r knee arthroplasty. However, no studies currently examine the use of iPACK in the setting of\r patients receiving both ACB and LIA, as a fully optimized regional anesthesia \"bundle\" for\r postoperative analgesia in total knee arthroplasty. As such, this study aims to determine\r whether the addition of the iPACK block, in combination with ACB and LIA, will improve\r analgesia compared to what is provided by ACB and LIA alone.\r\n\r Rationale for study:\r\n\r The IPACK block, based on limited existing literature, seems to provide superior analgesia\r with minimal complications following total knee arthroplasty.\r\n\r This study aims to determine whether the IPACK block provides additional analgesia (in\r combination with ACB + LIA) for total knee arthroplasty surgeries. The study will examine how\r much additional analgesia IPACK provides in the context of an already-optimized regional\r anesthesia pathway for total knee arthroplasty, which uses ACB + LIA, both modalities that\r have reasonable existing evidence.\r\n\r Determining the effectiveness of IPACK in addition to the already validated multimodal\r analgesia including ACB and LIA for improving postoperative pain may further improve clinical\r outcomes in patients undergoing total knee arthroplasty. This may reduce postoperative opioid\r requirements and its side effects, increase patient satisfaction, and decrease morbidity and\r mortality associated with a prolonged hospital stay.\r\n\r The demand for total knee arthroplasty is predicted to increase in the upcoming years owing\r to an aging population and increased prevalence of osteoarthritis worldwide. The growing\r number generates multiple issues to the healthcare system, mainly the additional pressure to\r decrease the already unsustainable high healthcare costs. The role of iPACK as an additional\r component of pain management may be the key to providing a safe and cost-effective healthcare\r service to patients undergoing total knee arthroplasty.\r\n\r Study Question Does the addition of the iPACK block, in combination with ACB and LIA, improve\r postoperative analgesia and clinical outcomes compared to ACB and LIA alone in patients\r undergoing total knee arthroplasty?\r\n\r Hypothesis:\r\n\r Investigators hypothesize that the addition of this newly described, motor-sparing iPACK\r block will significantly improve analgesia and clinical outcomes in patients undergoing total\r knee arthroplasty.\r\n\r Study Design :\r\n\r To determine the effectiveness of the iPACK block as a component of multimodal analgesia for\r patients undergoing total knee arthroplasty, this study will be a prospective double blinded\r randomized controlled trial where the patients will be randomized to 2 groups:\r\n\r Group A will receive perioperative ACB, LIA, and sham IPACK block. Group B will receive\r perioperative ACB, LIA, and real IPACK block.\r\n\r In addition, all patients will receive a standard spinal anesthetic as per our institutional\r protocol, along with procedural IV sedation at the discretion of the attending\r anesthesiologist. Local infiltration analgesia will be administered by the orthopaedic\r surgeon as per standard practice. ACB and iPACK block will be performed by the\r anesthesiologist immediately preoperatively under ultrasound guidance as follows:\r\n\r All patients in the study will receive ACB, performed by an experienced anesthesiologist, as\r conventionally described, using full aseptic technique, in-plane ultrasound guidance,\r identification of the superficial femoral artery, sartorius muscle and adductor canal. Local\r anesthetic (0.25% bupivacaine + 2.5mcg/mL epinephrine + 50mcg/mL preservative-free\r dexamethasone x 15mL) will be infiltrated with real-time ultrasound visualization, needle\r approach lateral to medial, with incremental injection, intermittent aspiration, and\r confirmation of adequate local anesthetic spread.\r\n\r Patients in group A will receive a sham iPACK block while those in group B will receive a\r real iPACK block. Both sham and real iPACK blocks will be performed by an experienced\r anesthesiologist, blinded to the intervention. Real and sham iPACK blocks will be performed\r as conventionally described with ultrasound guidance (initial approach 1 finger breadth above\r the patella, if this approach fails, subsequent attempt at level of femoral\r condyles/bicondylar approach). All sham and real iPACK blocks will be done with full aseptic\r technique, in-plane ultrasound guidance, identification of popliteal artery/vessels, femur,\r and sciatic nerve. Normal saline x 20mL (Group A), or local anesthetic x 20mL (Group B -\r 0.25% bupivacaine + 2.5mcg/mL epinephrine + 50mcg/mL preservative-free dexamethasone), will\r be infiltrated with real-time ultrasound visualization, needle approach medial to lateral,\r with incremental injection, intermittent aspiration, and confirmation of adequate local\r anesthetic spread.\r\n\r The study personnel, including research team, anesthesiologists, surgeons, physiotherapists,\r recovery room and ward nurses, as well as patients will be blinded to the group allocation.\r Anesthesia assistants not involved in study data collection or patient care will prepare the\r sham or real local anesthetic injectate solution for iPACK block. Syringes will be prepared\r immediately after randomization and before block placement and provided to the blinded\r anesthesiologist. Pain scores and opioid consumption, length of stay, and other data will be\r collected and assessed in person by a member of the research team or patient care team who is\r blinded to study interventions.\r\n\r Study procedure:\r\n\r Participating orthopaedic surgeons will identify eligible patients and introduce them to the\r study and research team at Alberta Hip and Knee Clinic (AHKC). Research staff will follow\r recruitment procedure and seek informed consent from patients at AHKC. Participation in this\r study will remain completely voluntary without any pressure from investigators. Patients'\r questions will be answered at recruitment session. Upon recruitment, patients will be asked\r to complete Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Knee\r Society Scoring (KSS).\r\n\r Study participants will be assigned study identification and get randomized in to two\r treatment arms.\r\n\r The statistician who run randomization would only know study identifications and stay blinded\r to patients' treatment arms. Hospital data will be used to know Length of Stay (LOS) and\r opioid consumption at hospital. A physiotherapist will perform Timed Up and Go test and Range\r of Motion (ROM) Pre and post-operatively at Peter Lougheed Hospital. Pain score will be\r recorded using Visual analogue scale 4 hours postoperatively and at discharge. Emergency room\r visit or 30-day readmission will be accessed through Alberta Bone and Joint Health Institute\r (ABJHI) data repository. \"Unanticipated complications of iPACK block\" and \"technical\r difficulties with performing the iPACK block\" will be recorded by the study anesthesiologist.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients scheduled for elective unilateral TKA\r\n\r - Planned for regional anesthesia for the procedure\r\n\r - Age >=18\r\n\r Exclusion criteria:\r\n\r - Contraindications to regional anesthesia or peripheral nerve blocks\r\n\r - Allergy to local anesthetics or any of the study medications\r\n\r - Severe hepatic or renal insufficiency\r\n\r - Chronic opioid consumption\r\n\r - Patient with difficulty comprehending visual analogue scale pain scores\r\n\r - Pre-existing lower extremity neurologic abnormalities\r\n\r - Patients classified as American Society of Anesthesiologists score 3 or 4\r\n\r - Language/communication barrier\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nNeoTIL in Advanced Solid Tumors\n\n**Clinical Trial Summary:**\n\nSingle center, single arm pilot trial to test the feasibility, safety and efficacy of\r NeoTIL-ACT combined with low-dose irradiation (LDI) in patients with advanced, recurrent or\r metastatic solid tumors.\r\n\r The trial is based on lymphodepleting chemotherapy followed by LDI, and then ACT utilizing ex\r vivo expanded TIL, enriched for tumor antigen specificity (NeoTIL), in combination with high\r dose Interleukin-2 (IL-2) (optional, depending on patient's tolerance).\r\n\r LDI will be administered once to metastatic lesions using tomotherapy.\n\n**Clinical Trial Detailed Description:**\n\nThe objective of the trial is to define the feasibility, safety, and efficacy of NeoTIL-ACT\r in combination with LDI in patients with advanced, recurrent or metastatic solid tumors, as\r categorized in two molecularly defined cohorts.\r\n\r Study treatment will begin with intravenous (IV) non-myeloablative (NMA) lymphodepleting\r chemotherapy composed by fludarabine and cyclophosphamide. Both treatments will be started on\r the same day. Fludarabine will be administered from for five days, and cyclophosphamide ffor\r two days. Low-dose irradiation (LDI) will be administered once, to tumor lesions using\r tomotherapy.\r\n\r Patients will receive NeoTIL infusion intravenously followed by high dose IL-2 administration\r every eight hours, for a maximum of eight doses. Supportive care will be given as needed\r during the whole treatment period.\r\n\r Patients achieving a stable disease, partial response or complete response after NeoTIL-ACT\r treatment will then enter a clinical follow-up period for 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with advanced (not radically treatable), recurrent or metastatic solid tumors\r of any histology with the exception of primary central nervous system tumors, who have\r received, and then progressed or been intolerant to at least one standard therapy\r regimen in the advanced or metastatic setting if such a therapy exists, and have been\r considered for all other potentially efficacious therapies prior to enrollment. If the\r participant refuses, or is not eligible for these regimens in the opinion of the\r investigator, the reason must be documented in the medical record.\r\n\r 2. Patients who have previously undergone tumor resection or biopsy and for whom\r pre-Rapid Expansion Protocol (REP) NeoTIL cultures are ongoing or completed.\r\n\r 3. At least one lesion accessible to biopsy for translational research (TR) at baseline\r and D30, without putting the patient at unusual risk.\r\n\r 4. Male or female age ≥ 18 to ≤ 70 years at the time of informed consent. Patients aged\r >70 will be evaluated by the investigator, and decision will be made according to\r patient's status, upon agreement with the PI.\r\n\r 5. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) of 0 to 2.\r\n\r 6. Life expectancy of greater than 12 weeks.\r\n\r 7. Radiologically measurable disease (as per Response Evaluation Criteria in Solid\r Tumours [RECIST] v1.1).\r\n\r 1. Modified RECIST should be used for mesothelioma\r\n\r 2. Prostate Cancer Working Group 3 (PCWG3) criteria should be used for prostate\r cancer\r\n\r 8. Adequate serology defined by the following laboratory results:\r\n\r 1. Negative test for Human Immunodeficiency Virus (HIV)\r\n\r 2. Patients with active or chronic hepatitis B (defined as having a positive\r hepatitis B surface antigen [HBsAg] test at pre-screening) are not eligible.\r\n\r - Patients with past/resolved Hepatitis B virus (HBV) infection (defined as\r having a negative HBsAg test and a positive antibody to hepatitis B core\r antigen (anti-HBc) antibody test) are eligible, if HBV deoxyribonucleic acid\r (DNA) test is negative.\r\n\r - HBV DNA must be obtained in patients with positive hepatitis B core antibody\r prior start of study treatment.\r\n\r 3. Patients with active hepatitis C are not eligible. Patients positive for\r Hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction\r (PCR) is negative for HCV ribonucleic acid (RNA).\r\n\r 9. Hematology\r\n\r 1. Absolute neutrophil count ≥ 1.0 x 109 cell/L without the support of granulocyte\r colony stimulating factor (G-CSF).\r\n\r 2. Platelet count ≥ 100 x109 cell/L\r\n\r 3. Hemoglobin ≥ 80 g/L. Subjects may be transfused to reach this cut-off.\r\n\r 10. Coagulation\r\n\r a. International normalization ratio (INR) ≤1.5 times the upper limit of normal (x\r ULN) unless the subject is receiving anticoagulant.\r\n\r i) Exception: for patients with hepatocellular carcinoma (HCC), the INR may be up to\r 2.2, as long as the Child-Pugh score is A6 maximum.\r\n\r b. Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤\r 1.5 x ULN unless the subject is receiving anticoagulant therapy.\r\n\r 11. Chemistry:\r\n\r 1. Serum alanine transaminase (ALT) / aspartate aminotransferase (AST) ≤ to 3 x ULN\r i) Exception: ALT/AST considered related to liver metastasis ≤ to 5 x ULN ii)\r Exception: for patients with HCC serum ALT/AST ≤ to 5 x ULN\r\n\r 2. Total bilirubin ≤1.5 x ULN i) Exception: in patients with Gilbert's syndrome who\r must have a total bilirubin ≤2.5 x ULN ii) Exception: total bilirubin considered\r related to liver metastasis ≤3 x ULN iii) Exception: for patients with HCC total\r bilirubin ≤2.3 x ULN, as long as the Child-Pugh score is A6 maximum\r\n\r 3. Creatinine clearance by Cockcroft-Gault formula ≥ 40 ml/min\r\n\r 12. Adequate cardiovascular function, with documented left ventricular ejection fraction\r (LVEF) ≥ 45%. This parameter must be documented within 12 weeks before registration\r\n\r 13. Adequate respiratory function with forced expiratory volume in 1 second (FEV1) ≥ 50%\r predicted, forced vital capacity (FVC) ≥ than 50% predicted and diffusing capacity for\r carbon monoxide (DLCO) ≥ than 50% predicted corrected. Patients with lung cancer or\r mesothelioma and values slightly under these limits (but >30% of predicted) can be\r enrolled after discussion and approval by the PI. These parameters must be documented\r within 12 weeks before registration\r\n\r 14. At the time the patient receives the NMA chemotherapy regimen (D-7):\r\n\r 1. ≥14 days or 5 half-lives must have elapsed from any chemotherapeutic cytotoxic\r drug, whichever is shorter.\r\n\r 2. ≥28 days must have elapsed from bevacizumab, aflibercept and other\r anti-angiogenic antibodies\r\n\r 3. ≥28 days or 5 half-lives (whichever is shorter) must have elapsed from a\r non-cytotoxic drug including but not limited to trastuzumab, pertuzumab, and\r other molecular targeted therapy (such as tyrosine kinase inhibitors, etc…) i)\r Note: In case of probable tumor flare upon stopping of the non-cytotoxic drug,\r the investigator may decide to shorten this delay, upon agreement of the\r Principal Investigator (PI), in a case-by-case approach.\r\n\r 4. ≥21 days must have elapsed from the last antibody therapy that could affect an\r anti-cancer immune response, including but not limited to anti-Cytotoxic\r T-lymphocyte-associated protein 4 (CTLA4), anti-Programmed cell death protein 1\r (PD-1), anti-Programmed death-ligand 1 (PD-L1), anti-Tumor Necrosis Factor\r Receptor Superfamily, member 4 (OX-40), or anti-Lymphocyte-activation gene 3\r (LAG3) antibody therapy or their combination\r\n\r 5. Exceptions: denosumab and biphosphonates are permitted (and will be administered\r as standard of care [SOC]).\r\n\r 6. Exceptions: androgen-deprivation therapy (ADT) for prostate cancer and hormonal\r therapy for breast cancer are permitted (and will be administered as SOC).\r\n\r 15. Patients' toxicities from previous therapies must have recovered to at least grade 1\r according to National Cancer Institute Common Terminology Criteria for Adverse v5.0\r (NCI CTCAE v5.0), except for toxicities described below, as long as they do not put at\r risk the patient's condition and do not require systemic immunosuppressive steroids at\r immunosuppressive doses, including but not limited to:\r\n\r - Fatigue\r\n\r - Alopecia\r\n\r - Skin disorders\r\n\r - Stable neuropathy\r\n\r - Endocrinopathies requiring replacement treatment Note: For other medical\r conditions, or for any other toxicity with a higher grade but controlled by\r adequate treatment, prior discussion and agreement with the PI is mandatory.\r\n\r Note: Patients may have undergone surgical procedures within the past 3 weeks, as long\r as all toxicities have recovered to grade 1 or less.\r\n\r 16. For women of childbearing potential (WOCBP: sexually mature women who have not\r undergone a hysterectomy and/or bilateral oophorectomy, have not been naturally\r post-menopausal for at least 12 consecutive months or have a serum\r follicle-stimulating hormone (FSH) < 40 milli-International Unit [mIU]/ml):\r\n\r 1. Agreement to follow instructions for method(s) of contraception for the couple,\r from screening until month 6 post start of NMA chemotherapy of the study.\r\n\r 2. Negative pregnancy test (urine or serum) during screening\r\n\r 17. For men participating in the trial and their female partners: agreement to follow\r instructions for method(s) of contraception for the couple from screening until month\r 6 post start of NMA chemotherapy of the study.\r\n\r Exclusion Criteria:\r\n\r 1. Patients with an active second malignancy, except for\r\n\r 1. non-melanoma skin cancer that has been apparently cured or successfully resected\r\n\r 2. carcinoma in situ as long as they have been adequately treated\r\n\r 3. Any malignancy that can be adequately managed expectantly without compromising\r prognosis, and after PI agreement.\r\n\r Patients who have a history of malignancy are not considered to have an active\r malignancy if they have completed therapy since at least 2 years and are considered by\r their treating investigator to be at ≤ 30% risk for relapse.\r\n\r 2. Patients with symptomatic and/or untreated brain metastases. Patients with\r definitively-treated brain metastases will be considered for enrollment after\r agreement with PI, as long as lesions are stable for ≥ 14 days prior to beginning the\r chemotherapy, there are no new brain lesions, and the patient does not require ongoing\r corticosteroid treatment.\r\n\r 3. Patients with known peritoneal metastases who have a recent history of intermittent\r bowel obstruction (even partial), unless such obstruction has been resolved. Agreement\r with the PI is mandatory.\r\n\r 4. Patients with leptomeningeal carcinomatosis\r\n\r 5. History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any\r origin)\r\n\r 6. History of recent myocardial infarction or unstable angina, either within six months\r of enrolment\r\n\r 7. Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known\r underlying liver dysfunction\r\n\r 8. Active severe systemic infections within four weeks prior to beginning of NMA\r chemotherapy.\r\n\r 9. Patient requiring regular systemic immunosuppressive therapy (for example for organ\r transplantation, chronic rheumatologic disease); all immunosuppressive medications\r including but not limited to steroids, mycophenolate mofetil, azathioprine,\r methotrexate, thalidomide, and anti-tumor necrosis factor-alpha (TNF-alpha) agents\r must have been discontinued within the last two weeks prior to starting NMA\r chemotherapy.\r\n\r 1. Note: Use of inhaled or topical steroids or corticosteroid use for radiographic\r procedures is permitted\r\n\r 2. Note: The use of physiologic corticosteroid replacement therapy is permitted.\r\n\r 10. History of severe immediate hypersensitivity reaction to any of the agents used in\r this study.\r\n\r 11. Women who are pregnant or breastfeeding because of the potentially dangerous effects\r of the treatment on the fetus or infant.\r\n\r 12. Subjects for whom there are concerns that they will not reliably comply with the\r requirements for contraception should not be enrolled into the study.\r\n\r 13. Any serious underlying medical condition that could interfere with study medication\r and potential adverse events.\r\n\r 14. Any mental or other impairment that may compromise compliance with the requirements of\r the study.\r\n\r 15. Patient participation in any other study currently receiving treatment. If the patient\r is in the follow-up period, he/she may be enrolled, as far as the elapsed time since\r the last previous treatment administration and the preparative regimen (NMA\r chemotherapy) is respected according to Inclusion Criteria n°14.\r\n\r 16. Participation in a research project using radiation sources exceeding an effective\r dose of 5 millisievert (mSv) with no direct benefit within the 12 last months.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEffect of Catheter on Postoperative Urinary Retention\n\n**Clinical Trial Summary:**\n\nTo determine if indwelling Foley placement at the onset of the procedure, straight\r catherization at the conclusion of the procedure, or no catheterization produces the lowest\r rates of postoperative urinary retention after transforaminal lumbar interbody fusions\r (TLIFs).\n\n**Clinical Trial Detailed Description:**\n\nPost-operative urinary retention (POUR) is one the most common post-operative complications\r after elective spine surgeries. Common causes of postoperative urinary retention (POUR)\r include bladder stenosis, distension, trauma due to catheterizations, age, and prostate\r hyperplasia. The incidence of POUR increases with age, gender, types of surgery conducted,\r any comorbidities such as cerebral palsy or multiple sclerosis, use of drugs such as\r anticholinergic agents, beta blockers, or sympathomimetics, and use of IV fluids.\r\n\r This condition has been associated with the development of UTIs and sepsis, increased\r post-operative length of stay (LOS), and 90-day readmission after surgery. In the field of\r spine surgery, the reported incidence of POUR is highly variable, and there is no consensus\r on effective methods of prevention. We set out to assess POUR from patients catheterized\r compared to non-catheterized following a transforaminal lumbar interbody fusion.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients undergoing a primary single-level MIS TLIF (Diagnosis: radiculopathy,\r stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis,\r osteophytic complexes, spondylolysis, spondylolisthesis)\r\n\r - Patients able to provide informed consent\r\n\r Exclusion Criteria:\r\n\r - Patients with baseline urinary dysfunction requiring manual bladder emptying via\r intermittent straight catheterization, suprapubic catheters, or other indwelling\r catheters. -Allergies or other contraindications to medicines in the post- operative\r urinary retention protocol\r\n\r - Lack of consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nInvestigation of the Effect of Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity\n\n**Clinical Trial Summary:**\n\nThe aim of this study is; To investigate the Effect of the Exercise Protocol Determined\r According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and\r Functional Capacity, and to create an exercise protocol that can guide researchers working in\r burn patients and physiotherapists working in burn centers at national and international\r level.\r\n\r The study, which is planned to be carried out in Hasan Kalyoncu University Faculty of Health\r Sciences Department of Physiotherapy and Rehabilitation, will be included in the burn\r patients in the 25 Aralık State Hospital Burn Center, service and intensive care unit.\n\n**Clinical Trial Detailed Description:**\n\nBurn injury is one of the longest traumas, causing serious mortality and morbidity, and the\r length of hospital stay and rehabilitation period.\r\n\r For optimal treatment after burns, all pathophysiological changes that may occur locally and\r systemically after injury should be well known.\r\n\r Along with surgical and medical treatments, the role of early exercise in burn treatment is\r becoming more and more important.\r\n\r Burn patients need a long rehabilitation period, including the acute period and the\r post-discharge period.\r\n\r Early exercise is very important, especially in burn intensive care units, for healing of\r burns and minimizing the effects of hypermetabolism. Exercises should be started from the\r first day the patient is hospitalized.\r\n\r In a study on physiotherapists working in 6 major burn centers in the United States, stated\r that all physiotherapists applied various exercises in the early period in burn patients, but\r these exercises varied in all centers in terms of characteristics such as type and frequency.\r In the same study, it was emphasized that exercise programs, which are the biggest help in\r reducing intensive care periods in burn patients, should be more consistent and there is a\r need for studies investigating the components of the exercises.\r\n\r Stated in another study that the exercise program applied in the early period in burns does\r not have an internationally accepted standard and studies should be done to create an\r exercise prescription.\r\n\r In recent years, it has been emphasized that exercise protocols differ between\r physiotherapists and that there is no international standardization in questionnaire studies\r on exercise protocols applied to burn patients.\r\n\r In addition, it has been emphasized that studies investigating exercise components will\r contribute more to the burn literature.\r\n\r The aim of this study is; To investigate the Effect of the Exercise Protocol Determined\r According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and\r Functional Capacity, and to create an exercise protocol that can guide researchers working in\r burn patients and physiotherapists working in burn centers at national and international\r level.\r\n\r The study, which is planned to be carried out in Hasan Kalyoncu University Faculty of Health\r Sciences Department of Physiotherapy and Rehabilitation, will be included in the burn\r patients in the 25 Aralık State Hospital Burn Center, service and intensive care unit.\r\n\r Inclusion criteria\r\n\r - Conscious patients\r\n\r - Enterally fed\r\n\r - >18 years old Exclusion criteria\r\n\r - With inhalation burn\r\n\r - In addition to existing burn trauma, those with other trauma (fracture, loss of limb,\r etc.)\r\n\r - Organ dysfunctions or multiple organ failure\r\n\r - History of chronic diseases such as diabetes, cholesterol and blood pressure\r\n\r - prothrombin time> 14.6 sec A total of 30 patients, 10 patients for each group, were\r planned to be included in the study.\r\n\r The individuals participating in the study will be divided into 3 groups: Standard therapy\r (1st Group), Standard therapy + bicycle ergometer (2nd Group) and Standard therapy + exercise\r protocol to be developed (3rd Group)\r\n\r Assessment of Coagulation and Fibrinolytic Activity\r\n\r Prothrombin time Platelet D-dimer, Fibrinogen\r\n\r These parameters will be monitored 3 days a week for 6 weeks (These parameters will be\r monitored 3 days a week for 6 weeks (These biochemistry parameters are routinely checked in\r every patient at the 25 December State Hospital Burn Center)\r\n\r Evaluation of Functional Capacity 6 min walking test Physiological consumption index MRC\r scale (general muscle strength measurement scale used in intensive care patients)\r\n\r These parameters will be monitored weekly (once a week) for 6 weeks.\r\n\r Evaluation of Basal Metabolism\r\n\r For basal metabolism, \"hand held device\" indirect calorimeter will be used and individuals in\r each group will be evaluated and monitored daily.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Conscious patients Enterally fed >18 years old\r\n\r Exclusion Criteria:\r\n\r - With inhalation burn\r\n\r - In addition to existing burn trauma, those with other trauma (fracture, loss of limb,\r etc.)\r\n\r - Organ dysfunctions or multiple organ failure\r\n\r - History of chronic diseases such as diabetes, cholesterol and blood pressure\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
397
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTake the Pressure Off, NYC!\n\n**Clinical Trial Summary:**\n\nBriefly, a trained barbershop navigator will work with each barbershop to measure blood\r pressure on each adult customer who agrees, and to provide culturally-targeted education\r about high blood pressure and its consequences, and motivational interviewing-informed\r counseling about therapeutic lifestyle changes. For customers found to have high blood\r pressure, the navigator will also provide referral and navigation to a medical provider and,\r as appropriate, a local pharmacy.\n\n**Clinical Trial Detailed Description:**\n\nThis program will be patterned after barbershop-based blood pressure programs that have\r demonstrated efficacy in achieving lower blood pressure and improved hypertension control\r rates among Black men with high blood pressure. This program will reach 10-12 barbershops per\r year, working with 2-3 barbershops each quarter. Briefly, a trained barbershop navigator will\r work with each barbershop t o measure blood pressure on each adult customer who agrees, and\r to provide culturally-targeted education about high blood pressure and its consequences, and\r motivational interviewing-informed counseling about therapeutic lifestyle changes. For\r customers found to have high blood pressure, the navigator will also provide referral and\r navigation to a medical provider and, as appropriate, a local pharmacy. At all recruitment\r events, all study team members and potential participants must wear masks and practice social\r distancing when appropriate. Participants who do not have face masks should be offered masks\r for continued outreach participation. Study team members will also wear gloves and have hand\r sanitizer visible. When available, staff should wash hands frequently with soap and water. If\r this option is not available, staff should frequently use hand sanitizer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants must be age 18 years or older\r\n\r - Self-identified as a black or African American male\r\n\r - Have uncontrolled hypertension defined as SBP>135 mmHg or DBP>85 mmHg and SBP >130\r mmHg or DBP >80 mmHg (in those with diabetes) at the screening\r\n\r Exclusion Criteria:\r\n\r - Under the age of 18\r\n\r - Does not consent to participate\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
398
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nComparison of PENG Block and FICB in Hip Fracture Patients\n\n**Clinical Trial Summary:**\n\nFascia iliaca compartment block (FICB) has been considered the block of choice for patients\r with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively\r newly-developed blocks, could be also used for analgesia in patients with hip fracture. Since\r PENG block could block the accessory obturator nerve, PENG block might have greater analgesic\r effects compared to FICB theoretically. However, the comparison of these two blocks in\r patients with hip fracture has not performed in clinical setting. Thus, we aimed to compare\r the analgesic effect of PENG block and FICB.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - ASA PS 1-4\r\n\r - age: ≥19\r\n\r - baseline pain score (associated with hip fracture): ≥4\r\n\r Exclusion Criteria:\r\n\r - patients who do not agree to participate in this study\r\n\r - patients with uncontrolled hypertension, hyperthyroidism, severe dementia\r\n\r - allergic to ropivacaine\r\n\r - contraindicated to spinal anesthesia due to coagulopathy, severe aortic\r stenosis/mitral stenosis, or active infection on lumbar region\r\n\r - patients who are considered ineligible with any other reason by investigators\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
399
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nElectrical Stimulation for Critically Ill Covid-19 Patients\n\n**Clinical Trial Summary:**\n\nUnfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized\r patients, who often require prolonged bed-rest or paralytics for an extended period of time\r in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss\r of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment\r and complications post-hospital discharge. Physical therapy and in-hospital mobility program\r may reduce the incident of hospital-acquired weakness, but they are often impractical for\r COVID-19 patients. In particular, conventional mobility programs are challenging for those\r who are being treated in an intensive Care Unit. The purpose of this study is to test\r feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical\r stimulation (EE) therapy, as a practical solution to retain lower extremity muscle mass, to\r address chronic morbid consequences of COVID-19 including hospital-acquired weakness.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to test feasibility and proof-of-concept effectiveness of lower\r extremity electrical stimulation (EE) therapy to address chronic morbid consequences of\r COVID-19 including hospital-acquired weakness and neuropathy. This is a proof of concept\r randomized control trial (RCT) study. Eligible participants (n=20 anticipated) will be\r recruited from the Baylor St. Luke's' Medical Center (Houston, Texas). To be eligible\r participants should be hospitalized because of COVID-19 infection and suspected to be at risk\r for hospital acquired-weakness based on judgment of clinical intensivist investigators.\r Participants will be excluded if they are paralyzed. Other exclusion criteria include blow\r the knee amputation, those who have a demand-type cardiac pacemaker, implanted defibrillator\r or other implanted electronic device; those with wound infection, and other conditions that\r may interfere with outcomes or increase the risk of the use EE based on judgement of\r clinicians.\r\n\r The Investigators hypothesize that implementation of EE as means of regular activation of\r lower extremity muscle is feasible and acceptable for the target population and would help to\r retain lower extremity muscle mass, lower extremity tissue oxygen saturation and perfusion,\r and thus reducing the severity of hospital acquired weakness and potentially improve outcomes\r of treatment among COVID-19 patients.\r\n\r Participants will be randomized to intervention (IG) or control group (CG)). The entire\r cohort will receive daily EE in lower extremity (e.g. Gastronemius, tibial anterior muscle)\r up to 1 hour. EE therapy will be provided using a bio-electric stimulation technology (BEST)\r platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG\r and non-functional for CG. The primary outcomes include between group difference and change\r from the baseline in muscle function, muscle strength, lower extremity tissue oxygen\r saturation, neuropathy, and muscle atrophy. Outcomes will be assessed at baseline, time of\r discharge or 4 weeks, whichever came first.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - COVID-19 test positive critically ill non-paralized patients in need of mechanical\r ventilation requiring care in the intensive care unit\r\n\r Exclusion Criteria:\r\n\r - Subject has a demand-type cardiac pacemaker, implanted defibrillator or other\r implanted electronic device.\r\n\r - Active wound infection\r\n\r - Below the knee amputations\r\n\r - Based on the clinicians decision whether the patient is eligible for the study\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
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