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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\nBreast Cancer Toxicity\n\n**Clinical Trial Summary:**\n\nThe aims of the cohort will be to quantify impact of cancer treatments toxicities , and to\r generate predictors of chronic toxicity in patients with non-metastatic breast cancer.\r\n\r The project will include four specific aims :\r\n\r 1. To develop a database of chronic treatment related toxicity in a cohort of 13250 women\r with stage I-III breast cancer (= non metastatic), whatever these treatments are\r (surgery; radiation therapy; chemotherapy …)\r\n\r 2. To describe incidence, clinical presentation, and outcome of chronic toxicities over a\r maximum of 8 years.\r\n\r 3. To describe the psychological, the social and the economic impacts of chronic\r toxicities.\r\n\r 4. To generate predictors for chronic toxicities in order to prevent them, based upon\r biological criteria.\r\n\r The expected impact of these toxicities, when identified, will be to improve quality of life\r and to decrease health cost, by the early identification of patients at high risk of\r toxicity. Such early identification could lead to prevent toxic effect by: a. developing\r prevention strategies, b. substituting toxic treatment by a non (less) toxic one.\r\n\r Also, such cohort will offer a quantification of the impact of treatment toxicity, that could\r be further used to quantify medical usefulness of strategies that aim at decreasing treatment\r toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen\r etc…)\n\n**Clinical Trial Detailed Description:**\n\nSPECIFIC AIM I: TO DEVELOP A TOXICITY DATABASE ON A COHORT OF 20,000 WOMEN WITH STAGE I-III\r (NON METASTATIC) BREAST CANCER\r\n\r Selection criteria The cohort will include female patients with non-metastatic breast cancer\r (stage I-III) without any selection based on their characteristics (except stage) or\r treatment. They may be included in other concomitant clinical studies.\r\n\r Patients will have to sign informed consent and will have to benefit from social security.\r\n\r The lack of selection criteria is related to the fact that the cohort aims at investigating\r toxicity in the whole population of breast cancer from a public health perspective.\r\n\r Sample size The cohort plans to include 13250 women in 13 years. A cohort of 13250 patients\r will allow to detect a two fold increased in the risk of a specific toxicity in a homogenous\r subgroup.\r\n\r As illustration, the study present a 90% power to detect whether a variable (age as example)\r observed in 50% of patients is associated with an increased risk of toxicity (heart toxicity)\r in a specific subgroup (Her2+++).\r\n\r Development of the cohort The13250 patients will be recruited in 20 cancer centers, maximum\r in France. The project will start with 14 centers and will further be expanded to 6\r additional centers. These patients will be followed for at least 5 years in the context of\r the cohort. After 5 years, additional specific data will then be captured each year.\r\n\r Patients will be included at the time of diagnosis, before any cancer specific treatment.\r After having signed informed consent, the patient will fill a first questionnaire for\r demographics (adapted from French DREES reference study) and living conditions, and a set of\r validated questionnaires related to QoL (BR 23) and special psychological dimensions. In\r addition, blood samples will be collected at baseline.\r\n\r The toxicities (events) will start to be collected 3 months after the end of \"acute\"\r treatment (surgery/adjuvant/chemotherapy/radiation therapy). Toxicity data will also be\r collected at the time of the last chemotherapy. Toxicities will be collected each 6 months,\r alternatively by a dedicated nurse and by the patient herself. Three sets of toxicities will\r be collected.\r\n\r - First, predefined and previously described toxicities will be collected on dedicated\r items in the case report form.\r\n\r - Second, unknown toxicities will be captured by the use of a patient's notebook where\r each patient will collect events and doctor' visits (general practitioner or organ\r specialist). This will allow capturing events that have not previously been associated\r with cancer treatment toxicities.\r\n\r - Finally, objective measurements by paraclinic exams will be done. This includes yearly\r blood tests and a heart ultrasonography at 1 and 5 years.\r\n\r In addition to the data collection, a baseline blood sample for genetic analyses will be\r done, and serum samples will be collected at baseline and yearly during 5 years (serum).\r\n\r Outcome data will also be collected and will include metastatic relapse (+ site),\r locoregional relapse (+ site) and death.\r\n\r SPECIFIC AIM II: TO DESCRIBE INCIDENCE, CLINICAL PRESENTATION, BIOLOGICAL CHARACTERISTICS AND\r OUTCOME OF CHRONIC TOXIC EVENTS\r\n\r This specific aim will follow three goals :\r\n\r - First, the investigators will describe the incidence of predefined chronic toxicities\r according to the treatment received.\r\n\r - Second, the investigators will aim at identifying new treatment-related toxicities. This\r information will be captured through a dedicated notebook where each patient will report\r all health and social related events.\r\n\r - Finally, the investigators will also assess the outcome of each adverse event, and try\r to develop some hypotheses to be addressed in further clinical trials.\r\n\r SPECIFIC AIM III: TO DESCRIBE THE PSYCHOLOGICAL AND THE SOCIAL IMPACTS OF TOXIC EVENTS This\r specific aim will be split in two parts: a. to describe the psychological and the social\r impact to the patient, b. to describe the impact at the population level.\r\n\r To describe psychological and social impact for the patient\r\n\r Using robust well validated methods, subjective and objective dimensions of wellbeing will be\r investigated, that is: a. Quality of life b. Living conditions c. Psychosocial issues.\r\n\r Quality of life Global perception of quality of life will be assessed through both SF-36,\r QLQ-C30 and BR 23.\r\n\r Social impact Living conditions will be assessed through a questionnaire derived from the\r French DRESS reference study on living conditions. The initial questionnaire was designed by\r DRESS to investigate the social, economical, professional condition two years after the\r diagnosis of cancer: back or abandonment of the initial professional/social activity,\r conversion, income trends, etc.\r\n\r Psychological impact This part will focus on psychological functioning, including\r psychological impact of chronic toxicities and psychological impact of cancer itself.\r Psychological impact is mainly expected on emotional issues, cognitive disorders, body image\r and sexual disorders.\r\n\r To describe the impact on the society This sub-aim will mainly focus on medico-economics and\r will assess the global impact of treatment toxicity on health economy. The quantification of\r costs related to toxicities is a major challenge since it could allow to identify avoidable\r major source of expenses and could allow better tailoring treatment accordingly. Specific\r partnerships are being developed with the French social security and other public/private\r partners in order to accurately quantify toxicity-related cost.\r\n\r SPECIFIC AIM IV TO DEVELOP PREDICTORS FOR CHRONIC TOXICITIES In the present specific aim, the\r goal will be to develop molecular/biologic predictors for toxic events. In as many cases as\r possible, the investigators will split the cohort into a discovery set and a test set, or\r will identify a cross-validating series before doing analyses.\r\n\r Ultimately, the goal is to develop multiparametric scores to predict the occurrence of\r toxicity.\r\n\r Regarding molecular predictors, it is planned that 20 ml blood will be collected yearly. One\r sample at baseline will be dedicated to single nucleotide polymorphism (SNP) arrays and\r validation of candidate genetic variants.\r\n\r A number of tests are already planned. First, we will investigate conventional biological\r parameters including endocrine tests (cortisolemia, TSH, estradiol levels, mullerian\r hormone…), metabolic test (including lipidemia), hematologic tests, liver function, immune\r function (assessed by lymphocyte counts). Second, more recent and under investigation tests\r will be added including troponin (heart failure), mullerian hormone, bone resorption markers\r (bone loss), RANK / RANKL, osteoprotegerin (bone loss).\r\n\r Finally, it is planned to use the baseline sample for the discovery of genetic tests and to\r use the serum for the discovery of biochemical predictors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Women,\r\n\r - Aged 18 years and over,\r\n\r - With an invasive breast cancer diagnosed by cytology or histology,\r\n\r - Tumors cT0 to cT3, CN0-3,\r\n\r - No clinical evidence of metastasis at the time of inclusion,\r\n\r - Untreated including scored for breast cancer surgery in progress,\r\n\r - Patient receiving a social security system,\r\n\r - Patient mastering the French language,\r\n\r - Free and informed consent for additional biological samples, different questionnaires\r and collecting information on resource usage.\r\n\r Exclusion Criteria:\r\n\r - Metastatic breast cancer,\r\n\r - Local recurrence of breast cancer,\r\n\r - History of cancer within 5 years prior to entry into the trial other than basal cell\r skin or carcinoma in situ of the cervix,\r\n\r - Already received treatment for breast cancer ongoing,\r\n\r - Blood transfusion performed for less than six months,\r\n\r - Persons deprived of liberty or under supervision (including guardianship).\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\nDeveloping and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients\n\n**Clinical Trial Summary:**\n\nWhile thyroid cancer is generally associated with a favourable prognosis, there is a\r discrepancy with how important if not traumatic its impact can be on patients. Quality of\r life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an\r optimal period for a preventive intervention. The goal of this study is to evaluate the\r impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid\r cancer patients, including a dedicated nurse who will provide important psychoeducational\r elements identified in previous focus group studies of thyroid cancer patients, i.e.,\r information on: the physical illness; the emotional impact of being newly diagnosed with\r thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine\r treatments and its associated safety precautions, nutrition and dietary considerations; and\r how the cancer diagnosis can be an opportunity to make important lifestyle changes and\r establish new life-priorities.\n\n**Clinical Trial Detailed Description:**\n\nThe investigators will conduct a 2-arm Randomized Controlled Trial comparing an\r Interdisciplinary Team-Based Care Approach to usual care.\r\n\r The primary research question will be: Does adding the Interdisciplinary Team-Based Care\r Approach (ITCA-ThyCa) to usual care (EG) increase levels of overall QoL among newly diagnosed\r thyroid cancer patients, compared with those receiving usual care (UC), at 9 months\r post-randomization (i.e., after all of the dedicated-nurse meetings are administered) as\r judged by scores on the Functional Assessment of Chronic Illness Therapy-General (FACT-G)?\r Primary hypothesis: The EG will report higher scores of overall QoL on the FACT-G than the UC\r at 9 months post-randomization.\r\n\r Secondary research questions: The investigators plan to evaluate ITCA-ThyCa effects on\r secondary outcomes such as level of: physical health (SF-36 Physical Health subscale), mental\r health (SF-36 Mental Health subscale), fatigue (Functional Assessment of Chronic Illness\r Therapy-Fatigue; FACIT-F), anxiety and depression (Hospital Anxiety and Depression Scale;\r HADS), and negative illness perception (Illness Perception Questionnaire - Revised (IPQ-R).\r The investigators also plan to explore ITCA-ThyCa effects on satisfaction with care (16\r questions of the NRC Picker satisfaction survey measuring patient satisfaction with care) and\r healthcare service use (types of professionals consulted, frequency of visits, and time\r elapsed between referral and first consultation). Hypotheses: The EG will report a higher\r level of physical and mental health on the SF-Physical and Mental Health subscales,\r respectively; and a lower level of fatigue on the FACIT-F, anxiety and depression on the\r HADS, and negative illness perception on the IPQ-R; compared with the UC at 9 months\r post-randomization.\r\n\r All of the abovementioned changes will be present throughout the treatment, namely at 7-10\r days and 5 months post-randomization (i.e., immediately after each of the meetings planned\r with the dedicated nurse).\r\n\r All of the abovementioned changes will persist at 12 months post-randomization (i.e.,\r corresponding to 6 months after all anti-cancer treatments are completed and 3 months after\r all dedicated-nurse meetings have been administered).\r\n\r Feasibility and acceptability (9 first months of the trial):\r\n\r The investigators plan on testing the feasibility and acceptability of the 2-arm RCT of\r ITCA-ThyCa during the first 9 months of the trial (once the investigators start recruiting,\r after the first 3-6 months dedicated to hiring our personnel and developing the manual of our\r approach). During this phase, the investigators will aim to address the following research\r questions:\r\n\r 1. Can the investigators recruit a sufficient number of patients (i.e., a minimum of 60\r patients over 6 months or 10/month) and retain a sufficient proportion of thyroid cancer\r patients (i.e., at least 80% at 7-10 days, 5 months or 9 months post-randomization) in\r both trial arms?\r\n\r 2. Is ITCA-ThyCa acceptable to at least 80% of EG thyroid cancer patients? Secondary pilot\r study questions\r\n\r 3. Which evaluation time should be primary post-randomization, based on an acceptable\r retention rate of 80%?\r\n\r 4. What variance estimates can be used to inform calculation of sample size for the full\r study?\r\n\r If the design remains the same following this pilot, the investigators aim to roll in the\r pilot data in the full trial.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis\r (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary\r type; TNM classification system);\r\n\r - Willing to participate in the EG meetings;\r\n\r - >18 years;\r\n\r - Alert and capable of giving free and informed consent;\r\n\r - Able to speak and read English or French.\r\n\r Exclusion Criteria:\r\n\r - Anaplastic thyroid cancer;\r\n\r - Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC)\r or referring physician) or expected survival <6 months according to clinical judgment.\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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"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\nPain in Women With Chronic Pelvic Pain\n\n**Clinical Trial Summary:**\n\nChronic pelvis pain is very common between adult women. Significant progress is made in\r clarifying the multifactorial model of chronic pain pathogenesis, but a more complete\r assessment is important in order to improve the therapeutic approach. The purpose of this\r study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.\n\n**Clinical Trial Detailed Description:**\n\nChronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at\r least 6 months. This pain interfere with habitual activities and requires clinical or\r surgical treatment. It is a complex interaction between the gastrointestinal, urinary,\r gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological\r factors. Its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14\r to 24% among women of reproductive age. It is very important a multidimensional approach in\r order to stablish a more specific profile.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Women.\r\n\r - Clinical diagnosis of chronic pelvic pain.\r\n\r - More than eighteen years.\r\n\r - Non-menstrual or noncyclic pelvic pain.\r\n\r - Duration of pain of at least 6 months.\r\n\r Exclusion Criteria:\r\n\r - Duration of pain less than 6 months.\r\n\r - Women who were pregnant in the last 12 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\"."
}
] |
[
{
"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\nAngiography Study of BioNIR Drug Eluting Stent System (NIREUS)\n\n**Clinical Trial Summary:**\n\nThe NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR\r Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison\r to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute).\r\n\r The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary\r endpoint of angiographic in-stent late loss at 6 months.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, multi-center, single-blind, two-arm, 2:1 randomized clinical trial.\r\n\r Randomization will be stratified by the presence of medically treated diabetes vs. no\r medically treated diabetes and by site. Lesions planned to be treated must be declared and\r recorded at time of randomization.\r\n\r Angiographic follow-up will be performed at 6 months. Clinical follow-up will be performed at\r 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization.\r\n\r The Primary Endpoint is in-stent late loss at 6 months as measured by the angiographic core\r laboratory.\r\n\r Angiographic Secondary Endpoints to be evaluated at 6 months are:\r\n\r - In-segment late loss\r\n\r - Follow-up percent diameter stenosis (in-stent and in-segment)\r\n\r - Binary restenosis (in-stent and in-segment)\r\n\r - Length and patterns of angiographic restenosis (Mehran classification)\r\n\r Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5\r years, except as noted, are:\r\n\r - Device, Lesion, and Procedure Success at time of baseline procedure\r\n\r - Target lesion failure (TLF; the composite of cardiac death, target vessel-related MI, or\r ischemia-driven TLR)\r\n\r - Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or\r ischemia-driven TLR)\r\n\r - Target vessel failure (TVF; the composite rate of death, target vessel-related MI, or\r ischemia-driven TVR)\r\n\r - Overall Mortality\r\n\r - Cardiac Death\r\n\r - Myocardial Infarction\r\n\r - Target Vessel Related MI\r\n\r - Ischemia-driven TLR\r\n\r - Ischemia-driven TVR\r\n\r - Stent Thrombosis (ARC definite and probable)\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 18 years\r\n\r - Patient with an indication for PCI including angina (stable or unstable), silent\r ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis\r of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI,\r or recent STEMI. For STEMI the time of presentation to the first treating hospital,\r whether a transfer facility or the study hospital, must be >24 hours prior to\r randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both\r enzyme levels have peaked.\r\n\r - Non-target vessel PCI are allowed prior to randomization depending on the time\r interval and conditions as follows:\r\n\r a. During Baseline Procedure: i. PCI of non-target vessels performed during the\r baseline procedure itself immediately prior to randomization if successful and\r uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI\r Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment\r changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.\r\n\r b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see exclusion\r criteria #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target\r vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as\r defined above.\r\n\r ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the\r baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12\r hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above\r the local laboratory upper limit of normal, serial measurements must demonstrate that the\r biomarkers are falling.\r\n\r d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed\r greater than 30 days prior to procedure whether or not successful and uncomplicated.\r\n\r - Patient or legal guardian is willing and able to provide informed written consent and\r comply with follow-up visits and testing schedule.\r\n\r Angiographic inclusion criteria (visual estimate):\r\n\r - Treatment of up to three de novo target lesions, maximum of one de novo target lesion\r per vessel\r\n\r - Target lesion(s) must be located in a native coronary artery with visually estimated\r diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100%.\r\n\r - Lesion must be ≤28 mm long and can be covered by a single study stent with maximum\r length of 33 mm (note: multiple focal stenoses may be considered as a single lesion\r and be enrolled if they can be completely covered with one stent).\r\n\r - TIMI flow 2 or 3\r\n\r - If more than one target lesion will be treated, the RVD and lesion length of each must\r meet the above criteria.\r\n\r Exclusion Criteria:\r\n\r - Planned procedures after the baseline procedure in either the target or non-target\r vessels.\r\n\r - STEMI within 24 hours of initial time of presentation to the first treating hospital,\r whether at a transfer facility or the study hospital or in whom enzyme levels (either\r CK-MB or Troponin)have not peaked.\r\n\r - PCI within the 24 hours preceding the baseline procedure and randomization.\r\n\r - Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.\r\n\r - History of stent thrombosis.\r\n\r - Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90\r mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support,\r including IABP.\r\n\r - Known LVEF <30%.\r\n\r - Subject is intubated.\r\n\r - Relative or absolute contraindication to DAPT for 12 months (including planned\r surgeries that cannot be delayed, or subject is indicated for chronic oral\r anticoagulant treatment).\r\n\r - Hemoglobin <10 g/dL.\r\n\r - Platelet count <100,000 cells/mm3 or >700,000 cells/mm3.\r\n\r - White blood cell (WBC) count <3,000 cells/mm3.\r\n\r - Clinically significant liver disease.\r\n\r - Renal disease as defined by an estimated creatinine clearance <40 mL/min using\r Cockcroft-Gault equation.\r\n\r - Active peptic ulcer or active bleeding from any site.\r\n\r - Bleeding from any site within the prior 8 weeks requiring active medical or surgical\r attention.\r\n\r - History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions.\r\n\r - If femoral access is planned, significant peripheral arterial disease which precludes\r safe insertion of a 6F sheath.\r\n\r - Cerebrovascular accident or transient ischemic attack within the past 6 months, or any\r permanent neurologic defect attributed to CVA.\r\n\r - Known allergy to the study stent components, whether in the BioNIR or Resolute, e.g.\r cobalt, nickel, chromium, molybdenum, Carbosil®, PBMA, Biolinx polymer, or limus drugs\r (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or\r any other analogue or derivative or similar compounds).\r\n\r - Known allergy to protocol-required concomitant medications such as aspirin, or DAPT\r (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated\r contrast that cannot be adequately pre-medicated.\r\n\r - Any co-morbid condition that may cause non-compliance with the protocol (e.g.\r dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g.\r cancer, severe heart failure, severe lung disease).\r\n\r - Patient is participating in or plans to participate in any other investigational drug\r or device clinical trial that has not reached its primary endpoint.\r\n\r - Women who are pregnant or breastfeeding (women of child-bearing potential must have a\r negative pregnancy test within one week before treatment).\r\n\r - Women who intend to become pregnant within 12 months after the baseline procedure\r (women of child-bearing potential who are sexually active must agree to use a reliable\r method of contraception from the time of screening through 12 months after the\r baseline procedure).\r\n\r - Patient has received an organ transplant or is on a waiting list for an organ\r transplant.\r\n\r - Patient is receiving or scheduled to receive chemotherapy within 30 days before or any\r time after the baseline procedure.\r\n\r - Patient is receiving oral or intravenous immunosuppressive therapy or has known\r life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are\r allowed.\r\n\r Angiographic Exclusion Criteria (visual estimate):\r\n\r - Unprotected left main lesions ≥30%, or planned left main intervention.\r\n\r - Stenting of ostial LAD or LCX lesions (stenting of any diseased segment within 5 mm of\r the unprotected left main coronary artery).\r\n\r - Lesions located within an arterial or saphenous vein graft or distal to a diseased\r arterial or saphenous vein graft.\r\n\r - Moderately or heavily calcified lesions.\r\n\r - Moderately or heavily tortuous or angulated lesions or vessels.\r\n\r - Bifurcation lesions in the presence of a side branch ≥2.0 mm in diameter.\r\n\r - Lesions containing thrombus.\r\n\r - Total occlusions.\r\n\r - In-stent restenotic lesions or lesions present within 10 mm of a previously implanted\r stent.\r\n\r - Lesions requiring pre-dilatation with any device other than simple balloon angioplasty\r (e.g. atherectomy or cutting/scoring balloons).\r\n\r - Another lesion in the target vessel is present that requires or has a high probability\r of requiring PCI during the baseline procedure or within 6 months after the baseline\r procedure.\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\n3T MRI Biomarkers of Glioma Treatment Response\n\n**Clinical Trial Summary:**\n\nThis pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in\r measuring treatment response in patients with high-grade glioma. New diagnostic procedures,\r such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in\r measuring treatment response in patients receiving treatment for high-grade gliomas.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To correlate treatment-induced changes in quantitative MRI-based biomarkers-specifically,\r those sensitive to tumor protein content (amide proton transfer asymmetry [APTasym] from\r chemical exchange saturation transfer [CEST]), cellularity (apparent diffusion coefficient\r [ADC] from diffusion-weighted imaging [DWI]), and blood flow (volume transfer constant\r [K^trans] from dynamic contrast-enhanced [DCE]; cerebral blood flow [CBF] from dynamic\r susceptibility contrast [DSC])-with treatment-induced changes in tumor size, measured via\r standard anatomic MRI.\r\n\r II. To correlate treatment-induced changes in the above quantitative MRI endpoints with\r patient progression-free survival (PFS).\r\n\r OUTLINE:\r\n\r Patients undergo measurement of tumor protein content using CEST-MRI, cellularity using\r DWI-MRI, and blood flow using DCE-MRI and DSC-MRI within 2 weeks of treatment and at 2 and 4\r weeks after initiation of treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must sign an institutional review board (IRB)-approved informed consent\r document\r\n\r - Patients must have been diagnosed with high-grade glioma:\r\n\r - World Health Organization (WHO) grade III: anaplastic astrocytoma,\r oligodendroglioma, ependymoma, or oligoastrocytoma; OR\r\n\r - WHO grade IV: glioblastoma multiforme; or neuroepithelial tumors of uncertain\r origin (polar spongioblastoma, astroblastoma, or gliomatosis cerebri)\r\n\r - As measured by conventional high spatial resolution MRI, the minimum diameter of the\r primary lesion (short axis) should be at least 5 mm\r\n\r - Patients must be scheduled to receive: 1) standard chemotherapy with/without radiation\r therapy; OR 2) single-agent bevacizumab (Avastin)\r\n\r Exclusion Criteria:\r\n\r - Patients with low-grade (WHO grade I or II) glioma\r\n\r - Patients with metastatic disease\r\n\r - Patients who have any type of bioimplant activated by mechanical, electronic, or\r magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators,\r electronic infusion pumps, etc), because such devices may be displaced or malfunction\r\n\r - Patients who have any type of ferromagnetic bioimplant that could potentially be\r displaced\r\n\r - Patients who have cerebral aneurysm clips\r\n\r - Patients who may have shrapnel imbedded in their bodies (such as from war wounds),\r metal workers and machinists (potential for metallic fragments in or near the eyes)\r\n\r - Patients with inadequate renal function (creatinine >= 1.5 times upper limit of\r normal) or acute or chronic renal insufficiency (glomerular filtration rate < 20\r ml/min)\r\n\r - Patients who are pregnant or breast feeding; urine pregnancy test will be performed on\r women of child bearing potential\r\n\r - Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe\r vertigo when they are moved into the magnet bore\r\n\r - Patients incapable of giving informed written consent, for the following reasons:\r\n\r - Inability to adhere to the experimental protocols for any reason\r\n\r - Inability to communicate with the research team\r\n\r - Limited ability to give informed consent due to mental disability, altered mental\r status, confusion, cognitive impairment, or psychiatric disorders\r\n\r - Patients scoring 14.5 or lower on the University of California at San Diego\r (UCSD) Brief Assessment of Consent Capacity (UBACC) Capacity to Consent\r Questionnaire will be excluded\r\n\r - Prisoners or other individuals deemed to be susceptible to coercion\r\n\r - For patients who have undergone surgical resection prior to joining the study, in whom\r baseline magnetic resonance (MR) images exhibit enough signal degradation (due to\r susceptibility artifact in the region of the surgical bed) such that the data are\r uninterpretable 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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"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."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nEvaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors\n\n**Clinical Trial Summary:**\n\nTo determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.\n\n**Clinical Trial Detailed Description:**\n\nEvaluate the feasibility of using FDOPA-PET/MRI pediatric patients with CNS tumors. Positive\r results in this small study would provide the data needed to expand the study to validate the\r use in a larger population of pediatric patients. Validating the use of FDOPA-PET imaging as\r an early predictor for response to anti-angiogenic therapy could greatly impact the standard\r of care for treating and evaluating pediatric brain tumors and provide a useful biomarker for\r assessing experimental therapeutics.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient must have histological verification of one of the eligible diagnosis listed\r below. Biopsy is required at time of diagnosis, with the exception of optic pathway\r tumors. Patients with spinal cord disease are eligible if they have a lesion >1 cm in\r 2 dimensions. The following histologies are eligible:\r\n\r - Astrocytoma variants: fibrillary, protoplasmic, mixed\r\n\r - Pilocytic astrocytoma, including pilomyxoid variants\r\n\r - Pleomorphic xanthoastrocytoma\r\n\r - Infantile desmoplastic astrocytoma\r\n\r - Ganglioneuroma\r\n\r - Oligodendroglial tumor\r\n\r - Mixed glioma (including oligoastrocytoma)\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic ganglioglioma\r\n\r - Glioblastoma multiforme (including giant cell and gliosarcoma types)\r\n\r - Medulloblastoma\r\n\r - Ependymoma\r\n\r - Other rare malignant CNS tumors (i.e., pineal blastoma, small cell astrocytoma,\r etc.)\r\n\r - Patient must be ≤ 21 years of age at time of study enrollment.\r\n\r - Patient must have measurable residual disease, defined as tumor that is measurable in\r two perpendicular diameters on MRI. Diffuse leptomeningeal disease is not considered\r measurable.\r\n\r - Patient must have a Lansky or Karnofsky performance of >40% corresponding to ECOG\r categories 0, 1, or 2. Karnofsky will be used for patients >16 years of age and Lansky\r for patients <16 years of age. Patients who are unable to walk because of paralysis,\r but who are up in a wheelchair, will be considered ambulatory for the purpose of\r assessing the performance score.\r\n\r - Patient must have a life expectancy of >8 weeks.\r\n\r - Patient must have fully recovered from the acute toxic effects of all prior\r chemotherapy or radiation prior to entering this study.\r\n\r - Patient must have recovered from any surgical procedure before enrolling on this\r study.\r\n\r - Hypertensive patients are eligible provided the hypertension is well controlled (95th\r percentile for age and height if patient ≤17 years) on stable doses of medication.\r (See Appendices I and II for tables of blood pressure based on age and gender).\r\n\r - Patients receiving corticosteroids are eligible provided the dose is stable or\r decreasing for at least 7 days.\r\n\r - Patient must have adequate bone marrow function (including status post-SCT) defined\r as:\r\n\r 1. Peripheral absolute neutrophil count (ANC) ≥1000/uL (must not have received G-CSF\r within the prior 7 days)\r\n\r 2. Platelet count ≥ 100,000/uL (transfusion independent)\r\n\r 3. Hemoglobin ≥ 8.0 gm/dL (may receive pRBC transfusions)\r\n\r - Patient must have adequate renal function defined as:\r\n\r 1. Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or\r\n\r 2. A serum creatinine based on age/gender as follows:\r\n\r - 1 month to < 6 months, male max 0.4, female max 0.4\r\n\r - 6 months to < 1 year, male max 0.5, female max 0.5\r\n\r - 1 to <2 years, male max 0.6, female max 0.6\r\n\r - 2 to < 6 years, male max 0.8, female max 0.8\r\n\r - 6 to <10 years, male max 1.0, female max 1.0\r\n\r - 10 to <13 years, male max 1.2, female max 1.2\r\n\r - 13 to <16 years, male max 1.5, female max 1.4\r\n\r - 16 years, male max 1.7, female max 1.4\r\n\r - Urine protein should be screened by dipstick analysis. If protein ≥ 2+ on dipstick,\r then Urine Protein Creatinine (UPC) ratio should be calculated. If UPC ratio >1,\r 24-hour urine protein should be obtained and the level should be <1000 mg/24 hours for\r patient enrollment.\r\n\r Note: UPC ratio of spot urine is an estimation of the 24 hour urine protein excretion- a\r UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is\r calculated using of the following formulae:\r\n\r [urine protein]/[urine creatinine] - if both protein and creatinine are reported in mg/dL\r [(urine protein x 0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L\r\n\r - Patient must have adequate liver function defined as:\r\n\r 1. Total bilirubin ≤1.5x upper limit of normal for age (ULN)\r\n\r 2. SGPT (ALT) ≤ 2.5 x the upper limit of normal (ULN) for age\r\n\r - Patients with a seizure disorder are eligible if well-controlled on anticonvulsants.\r If on a non-enzyme inducing anticonvulsant, the irinotecan dose will be adjusted as\r outline in treatment plan.\r\n\r - Sexually active patients of childbearing potential must agree to use an effective\r method of contraception during the study and for at least 6 months after the\r completion of bevacizumab therapy.\r\n\r - Patient or legally authorized representative must be able to understand and willing to\r sign a written informed consent document.\r\n\r Exclusion Criteria:\r\n\r - Patient must not have had myelosuppressive chemotherapy ≤ 3 weeks prior to entry onto\r this study (or 6 weeks if prior nitrosourea).\r\n\r - Patient must not have had any anti-neoplastic biologic agent ≤7 days prior to entry\r onto this study (or at least 3 half-lives for biologic agents with a long half-life).\r\n\r - Patient must not have received craniospinal radiotherapy or involved field\r radiotherapy to the local tumor (and/or tumor designated as \"measurable\" for protocol\r purposes) ≤ 24 weeks prior to study entry; focal radiation to areas of symptomatic\r metastatic disease must not be given within 14 days of study entry.\r\n\r - Patient must not have received bevacizumab, or other anti-VEGF inhibitor in the last 3\r months.\r\n\r - Patient must not require a major surgical procedure ≤ 21 days prior to beginning\r therapy.\r\n\r - Patient must not require an intermediate surgical procedure ≤14 days prior to\r beginning therapy.\r\n\r - Patient must not require a minor surgical procedure (i.e., Broviac line or infusaport\r placement) ≤ 7 days prior to beginning therapy, and the wound must be healed prior to\r initiation of therapy.\r\n\r - There should be no anticipation of need for major surgical procedures during the\r course of the study.\r\n\r - Patient must not have received any growth factors ≤7 days of entry onto this study.\r\n\r - Patient must not be taking NSAIDS, clopidogrel, dipyridamole, or aspirin therapy >81\r mg/day.\r\n\r - Patient must not have a serious or non-healing wound, ulcer, or bone fracture.\r\n\r - Patient must not require sedation for imaging purposes.\r\n\r - Patient must not be receiving an investigational drug.\r\n\r - Patient must not be receiving any other anti-cancer agent.\r\n\r - Patient must not have an uncontrolled infection.\r\n\r - Patient must not have a history of abdominal fistula, gastrointestinal perforation or\r intra-abdominal abscess ≤ 6 months prior to study entry.\r\n\r - Patient must not have a known bleeding diathesis or coagulopathy.\r\n\r - Patient must not have had significant vascular disease (e.g., Moya-Moya, aortic\r aneurysm requiring surgical repair, deep venous or arterial thrombosis) ≤ 6 months\r prior to study entry.\r\n\r - Patient must not have a known thrombophilic condition (i.e. protein S, protein C or\r antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation,\r homocysteinemia, or antiphospholipid antibody syndrome). Testing is not required in\r patients without a thrombophilic history.\r\n\r - Patient must not have evidence of a new CNS hemorrhage greater than 0.5cm on baseline\r MRI obtained ≤ 14 days prior to study enrollment.\r\n\r - Patient must not have a history of stroke, myocardial infarction, transient ischemic\r attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or\r greater congestive heart failure ≤ 6 months prior to study entry.\r\n\r - Patient must not have serious and inadequately controlled cardiac arrhythmia\r\n\r - Patient must not be pregnant or breastfeeding.\r\n\r - Patient must not have a known hypersensitivity to Chinese hamster ovary cell products\r or other recombinant human antibodies.\r\n\r - Patient must not be known to be HIV-positive on combination antiretroviral therapy\r because of the potential for pharmacokinetic interactions with study therapy. In\r addition, these patients are at increased risk of lethal infections when treated with\r marrow-suppressive therapy.\r\n\r - Patient must not have any contraindications to MRI imaging including implanted medical\r devices and metal objects which may be adversely affected by MRI imaging. All subjects\r will be required to complete a standard MRI screening form prior to imaging.\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\nImmunophenotyping From Blood of Patients With Malignant Gliomas\n\n**Clinical Trial Summary:**\n\nIn this explorative study immunological changes during tumor therapy will be analyzed in\r patients with malignant glioma. Immunophenotyping before and during therapy is used as\r analysis method. Thereby immune cells are quantitatively and qualitatively detected from\r patient's blood at continuous time points. Additionally relevant mediators like cytokines,\r danger signals and chemokines are analyzed by other methods. Obtained results may give\r information about the effects of therapy on immunological processes and immune cells and may\r help to find immunological based predictive or prognostic tumor markers and to define time\r points for including additional immune therapy in the future.\n\n**Clinical Trial Detailed Description:**\n\nPatients with malignant glioma generally have a bad prognosis. To improve patients' situation\r new therapy options as well as new possibilities to determine prognosis and prediction more\r precisely are needed. One approach is the targeted activation of the immune system to\r recognize and eliminate tumor cells. Due to cerebral tumors the brain is no immune privileged\r organ anymore, so that immune cells may pass the haemato-encephalic barrier to attack tumor\r cells. This study aims to offer valuable clues about how the immune system is influenced by\r standard therapies (radiotherapy and chemotherapy). Just with the background knowledge of\r immune mechanisms and influencing factors by tumor therapy, an effective anti-tumor response\r can systematically be induced by modulating immune therapy. To analyze immunological changes,\r immunophenotyping by flow cytometry is performed with blood from patients with malignant\r gliomas during their therapy concluding chemoradiation and chemotherapy alone. Count, class\r and activation status of immune cells are detected by flow cytometry. Together with\r additional analysis methods, information about immunological mediators like cytokines,\r chemokines and danger signals can be received. For these purposes serum and plasma are\r generated from blood samples and stored for prospective questions. The explorative determined\r results may also help to discover new, immunological based, prognostic or predictive tumor\r markers.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients with glioblastoma or anaplastic astrocytoma\r\n\r - legal age\r\n\r - planned chemoradiation and adjuvant chemotherapy (according to Stupp et. al.)\r\n\r Exclusion Criteria:\r\n\r - Fertile patients who refuse effective contraception during study treatment\r\n\r - persistent drug and/or alcohol abuse\r\n\r - patients not able or willing to behave according to study protocol\r\n\r - patients in care\r\n\r - patients that are not able to speak German\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."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nStudy of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma\n\n**Clinical Trial Summary:**\n\nThis is a dose-toleration study designed to investigate and determine the maximum tolerated\r dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered\r directly into the tumor using a process called convection-enhanced delivery. (CED)\n\n**Clinical Trial Detailed Description:**\n\nHigh grade gliomas (HGG) are the most common brain tumor in adults, with 15,000 new\r cases/year in the USA. Despite progress made using combination therapies including surgery,\r radiation and/or chemotherapy, the treatment of HGG remains challenging with a typical median\r survival of 6-12 months for patients with newly diagnosed glioblastoma multiforme (GB) and\r 24-36 months for patients with anaplastic astrocytoma. The time to tumor progression of\r patients with recurrent GBM is nine weeks and the median survival is 25 weeks, while for\r recurrent anaplastic astrocytomas (AA), the time to tumor progression is 13 weeks and the\r median survival is 47 weeks. More recently, single-agent Avastin has been seen to improve\r 6-month progression-free survival (PFS-6) to 42.6% as well as increase Median Overall\r Survival to 9.3 months in patients with recurrent GBM. However, chemotherapy treatment for\r malignant gliomas has limitations given the low activity of available antineoplastic agents,\r the emergence or de-novo presence of resistance to such agents, the sensitivity of the brain\r to irreversible damage from a therapeutic modality, and the compromised delivery of these\r agents to partially privileged intracranial sites. Effective agents with novel mechanisms of\r action need to be evaluated in HGG which account for these limitations.\r\n\r With these limitations in mind, this study directs attention to two particularly appealing\r delivery modalities which may improve the efficacy of neuro-oncologic chemotherapeutic\r agents: liposomes (liposomal irinotecan) and convection enhanced delivery (CED). Liposomes\r are typically composed of double chain phospholipid amphiphiles (chemical compounds with\r combined hydrophilic and lipophilic properties) in combination with cholesterol, forming\r spheroidal bilayer membrane structures that encompass an aqueous internal domain. Based on\r structural/pharmacologic features, distinct liposome classes have been developed to package\r various therapeutic agents for the treatment of cancer. From the circulating bloodstream,\r liposomes are able to diffuse across the blood brain barrier (BBB) due to their lipophilic\r characteristics. An example is liposomal irinotecan which may reduce the toxicity of\r irinotecan to healthy tissues while maintaining or increasing its anti-tumor potency.\r\n\r CED improves chemotherapeutic delivery to brain tumors intraparenchymally by utilizing bulk\r flow, or fluid convection, established as a result of a pressure gradient, rather than a\r concentration gradient. As such, CED offers markedly improved distribution of infused\r therapeutics within the central nervous system (CNS) compared to direct injection or via drug\r eluting polymers, both of which depend on diffusion for parenchymal distribution.\r Additionally, CED obviates the challenges of systemic agents crossing the blood brain barrier\r while minimizing systemic exposure and toxicity. Through the maintenance of a pressure\r gradient from the delivery cannula tip to the surrounding tissues, CED is able to distribute\r small and large molecules, including high molecular weight proteins, to clinically\r significant target volumes centimeters rather than millimeters in diameter. Although\r developed independently, work combining the two delivery options, liposomes and CED, is\r presently underway in an effort to improve treatment efficacy in the treatment of CNS\r malignancies. This clinical trial is a step in this direction with a prospective, single-arm,\r open-label trial that delivers liposomal-irinotecan and gadolinium (which provided real time\r imaging of delivery) by CED in patients with recurrent malignant glioma.\r\n\r Added to this logic is support from a recent preclinical study at the University of\r California, San Francisco (UCSF) which compared routes of delivery for liposomal irinotecan\r (CED versus IV) and showed superior anti-tumor activity of CED administration in treating\r mice with intracranial glioblastoma xenografts. In total, such results indicate that\r liposomal formulation plus direct intratumoral administration of therapeutic are important\r for maximizing the anti-tumor effects of irinotecan and support the current clinical trial\r evaluation of this therapeutic plus CED route of administration combination.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with radiographically proven recurrent, intracranial high grade glioma will\r be eligible for this protocol. Patients must have evidence of tumor progression as\r determined by the Revised Assessment in Neuro-Oncology RANO criteria following\r standard therapy.\r\n\r - High grade glioma includes glioblastoma multiforme (GBM), Gliosarcoma (GS), anaplastic\r astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma\r (AMO), or malignant astrocytoma not otherwise specified. (NOS)\r\n\r - Magnetic resonance imaging (MRI) must be performed within 21 days prior to enrollment,\r and patients who are receiving steroids must be stable or decreasing for at least 5\r days prior to imaging. If the steroid dose is increased between the date of imaging\r and enrollment, a new baseline MRI is required.\r\n\r - Patients must have completed only 1 prior course of radiation therapy and must have\r experienced an interval of greater than 12 weeks from the completion of radiation\r therapy to study entry.\r\n\r - Patients will be eligible if the original histology was low-grade glioma and a\r subsequent histological diagnosis of a high grade glioma is made.\r\n\r - There is no limit as to the number of prior treatments but patients must have\r radiographic evidence of progressive disease\r\n\r - Recurrent tumor must be a solid, single, supratentorial, contrast-enhancing HGG which\r have a tumor diameter no larger than 4cm or volume of 34cm3\r\n\r - All patients must sign an informed consent indicating that they are aware of the\r investigational nature of this study. Patients must be registered prior to treatment\r with study drug.\r\n\r - Patients must be> 18 years old, and with a life expectancy > 8 weeks\r\n\r - Patients with Karnofsky performance status of > 70.\r\n\r - At the time of registration: Patients must have recovered from the toxic effects of\r prior therapy: > 10 days from any noncytotoxic investigational agent, >28 days from\r prior cytotoxic therapy or Avastin, >14 days from vincristine, >42 days from\r nitrosoureas, >21 days from procarbazine administration, and >7 days for non-cytotoxic\r agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.\r (radiosensitizer does not count). Any questions related to the definition of\r non-cytotoxic agents should be directed to the Study Chair.\r\n\r - requirements for organ and marrow function as follows:\r\n\r - Adequate bone marrow function:\r\n\r - leukocytes > 3,000/microliter (mcL)\r\n\r - absolute neutrophil count > 1,500/mcL\r\n\r - platelets > 100,000/mcL\r\n\r - Adequate hepatic function:\r\n\r - total bilirubin within normal institutional limits\r\n\r - aspartate aminotransferase (AST) < 2.5 X institutional upper limit of normal\r\n\r - alanine aminotransferase (ALT) < 2.5 X institutional upper limit of normal\r\n\r - Adequate renal function:\r\n\r - creatinine within normal institutional limits OR\r\n\r - creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above\r institutional normal\r\n\r - The effects of nano liposomal irinotecan on the developing human fetus are unknown.\r For this reason, women of child-bearing potential and men must agree to use adequate\r contraception: hormonal or barrier method of birth control; abstinence, etc. prior to\r study entry, for the duration of study participation, and for 6 months post drug\r administration. Should a woman become pregnant or suspect she is pregnant while she or\r her partner is participating in this study, she should inform her treating physician\r immediately\r\n\r - Women of childbearing potential must have a negative beta-human chorionic gonadotropin\r (beta-HCG) pregnancy test documented within 14 days prior to treatment.\r\n\r - Patients with prior therapy that included interstitial brachytherapy, or Gliadel\r wafers must have confirmation of true progressive disease rather than radiation\r necrosis based upon either Positron Emission Tomography (PET) or Thallium scanning, MR\r spectroscopy or surgical documentation of disease\r\n\r - Patients must be able to have MRI brain imaging.\r\n\r - Patients must not have any significant medical illnesses that in the investigator's\r opinion cannot be adequately controlled with appropriate therapy or would compromise\r the patient's ability to tolerate this therapy\r\n\r - Patients with a history of any other cancer (except non-melanoma skin cancer or\r carcinoma in-situ of the cervix), unless in complete remission and off of all therapy\r for that disease for a minimum of 3 years are ineligible.\r\n\r - Patients must not have an active infection or serious intercurrent medical illness.\r\n\r - Patients must not be pregnant/breast feeding and must agree to practice adequate\r contraception.\r\n\r - HIV-positive patients on combination antiretroviral therapy are ineligible\r\n\r - Contrast-enhancing tumor which crosses the midline.\r\n\r - Multi-focal disease\r\n\r - Nonparenchymal tumor dissemination (e.g., subependymal or leptomeningeal)\r\n\r - History of hypersensitivity reactions to products containing irinotecan (irinotecan),\r topotecan or other topoisomerase inhibitors, gadolinium contrast agents or lipid\r products\r\n\r - Ongoing treatment with cytotoxic therapy\r\n\r - Patients may not be on an enzyme-inducing anti-epileptic drug (EIAED). If previously\r on an EIAED, patient must be off for at least 10 days prior to CED infusion.\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\nUrodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients\n\n**Clinical Trial Summary:**\n\nThe proposed study is a randomized, double blind placebo controlled multicenter study to\r determine the effectiveness of mirabegron in the treatment of neurogenic bladder dysfunction.\r Patients will be randomized into one of two trial arms: mirabegron 25mg for two weeks, with\r escalation to 50mg for the remaining 8 weeks, or matched placebo capsule for two weeks, with\r placebo escalation for the remaining 8 weeks. Each of these trial arms will be stratified\r based on whether the patient is already taking an anticholinergic medication or not. The\r study will treat a total of 144 patients (72 with placebo, 72 with mirabegron). The study\r hypothesis is that mirabegron will result in a statistically superior (increased) urodynamic\r bladder capacity.\r\n\r The study duration is 12 weeks, with a 1-4 week run in period where no active or placebo\r treatment will be administered. The primary outcome measure will be based on an increase in\r urodynamic bladder capacity. Secondary outcome measures will be additional urodynamic\r parameters, urinary symptom scales, urinary quality of life indices, and voiding diary\r results.\r\n\r Patients who are over 18 years of age with a diagnosis of multiple sclerosis (MS) or spinal\r cord injury (SCI) will be eligible to participate. All eligible patients will have urodynamic\r studies performed within 4 weeks of trial enrollment, and at the end of study (week 9-10).\r Adverse events and study outcomes will be assessed at predefined study time points.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Diagnosis of traumatic or nontraumatic suprasacral spinal cord injury (SCI) or\r multiple sclerosis (MS, based on a neurologist assessment and/or the McDonald\r criteria)(28)\r\n\r - Age >18 years\r\n\r - Stable method of bladder management for >3months (either spontaneous or provoked\r voiding, or intermittent catheterization).\r\n\r - Bothersome urinary symptoms (urinary frequency, urgency, or urgency incontinence based\r on standard ICS definitions(29)) and completed 3 day voiding diary demonstrating at\r least 1 episode of non-stress based urinary incontinence over the 72hr period (this\r may be urgency based incontinence or unaware incontinence).\r\n\r - Patient is able to read and speak English\r\n\r Exclusion criteria:\r\n\r Based on Screening visit history:\r\n\r - Participation in another drug or device study in the 60 days prior to the screening\r visit.\r\n\r - Previous urologic surgery: Transurethral prostatectomy, bladder augmentation,\r sphincterotomy, bladder neck sling, artificial urinary sphincter, catheterizable\r channel, implantable electrostimulator/neuromodulator\r\n\r - Current use of suprapubic catheter/foley catheter\r\n\r - Unstable cardiac disease (uncontrolled hypertension, myocardial infarction, unstable\r angina, severe congestive heart failure (NYHA 3 or 4), ventricular arrhythmia (such as\r torsades de pointes), or stroke within the last 6 months)\r\n\r - Clinically significant abnormal ECG\r\n\r - The investigator believes the patient has an increased risk of QT prolongation (based\r on review of the screening ECG and patients concurrent medications)\r\n\r - History of significant renal dysfunction within 1 year, or serum creatinine >150umol/L\r at screening visit (visit 1).\r\n\r - History of significant liver disease within 1 year, or serum AST/ALT >2 times upper\r limit of normal, GGT >3 times upper limit of normal, total bilirubin >2 times upper\r limit of normal at screening visit (visit 1).\r\n\r - History of pelvic radiation\r\n\r - History of bladder cancer\r\n\r - History of a concurrent malignancy or cancer (except noninvasive skin cancer) within\r the last 5 years. Subjects with a history of cancer are considered eligible if the\r subject has undergone potentially curative therapy and the subject has been considered\r disease free for at least 5 years (with the exception of basal cell or squamous cell\r carcinoma of the skin).\r\n\r - Patient has a history of interstitial cystitis/pelvic pain syndrome\r\n\r - Patient has a history of acute or chronic urinary retention within the last 3 months,\r and is currently not using intermittent catheters\r\n\r - Patient has a history of a tachyarrhythmia\r\n\r - Patient has a history of glaucoma\r\n\r - Patient has a medical condition that may cause noncompliance with the study protocol\r\n\r - In the opinion of the Investigator the patient has a history of significant stress\r urinary incontinence\r\n\r - Patient has signs and symptoms of an active urinary tract infection (symptoms of\r dysuria, foul smelling urine, cloudy urine, increased spasticity, increased autonomic\r dysreflexia, self reported fever, increased incontinence, back/suprapubic pain).\r\n\r o Patient will submit urine for culture and sensitivity, undergo treatment, and will\r be eligible for rescreening after treatment.\r\n\r - Female patient who is pregnant or breastfeeding, or plans to become pregnant.\r\n\r - Male patient who is planning on fathering a child during the study or for 28 days\r after the last dose of study drug, or who is planning to donate sperm\r\n\r - Patient refuses to provide written consent\r\n\r - Patient will be unable or unwilling to complete the questionnaires and study visits\r\n\r - In the opinion of the study investigator, it is not in the patient's best interest to\r be enrolled in this study.\r\n\r Based on medication and allergy review\r\n\r - The new addition of an anticholinergic medication, or a change to anticholinergic\r dose, within the last 30 days, (bladder specific anticholinergics include oxybutynin,\r tolterodine, fesoterodine, solifenacin, darifenacin, trospium, hyoscine, oxybutynin\r gel or patch, atropine, benzatropine). If previously used and discontinued, these\r medications must have been stopped for >2 weeks\r\n\r - Newly added bladder active medication (or dose change) within the last 2 months\r (Tamsulosin, Silodosin, Terazosin, Baclofen, Diazepam, amitriptyline, Finasteride,\r Dutasteride, DDAVP/desmopressin)\r\n\r - Use of flecainide, propafenone, donepezil, thioridazine, tramadol, aripiprazole,\r desipramine, imipramine, venlafaxine or digoxin\r\n\r - Intravesical onabotulinum toxin use within the last 1 year\r\n\r - Intravesical oxybutynin within the last 3 months\r\n\r - Patient has a previous history of treatment with mirabegron\r\n\r - Patient has a known allergy to mirabegron or a previous adverse reaction to a beta 3\r agonist.\r\n\r Based on physical exam\r\n\r - Patient has a postvoid residual > 250mL at study enrollment after repeated tested (1\r attempt to re-void to ensure complete emptying of the bladder) and is not using\r intermittent catheters\r\n\r - Patient has a resting BP >180 mmHg systolic and/or >110 mmHg diastolic after 2 minutes\r of sitting quietly\r\n\r - Patient has a resting heart rate >100bpm after 2 minutes of sitting quietly\r\n\r - In the opinion of the study investigator, it is not in the patient's best interest to\r be enrolled in this study based on a clinically significant abnormality on physical\r exam.\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\nHypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma\n\n**Clinical Trial Summary:**\n\nTo assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide\r on survival and quality of life in elderly, poor performance status patients with newly\r diagnosed HGG.\n\n**Clinical Trial Detailed Description:**\n\nInvestigators designed this study with the aim to assess the effect of IMRT using VMAT\r rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in\r elderly, poor performance status patients with newly diagnosed HGG. The potential advantage\r of this approach is deliver a more selective irradiation to tumor's target with reducing the\r dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic\r window.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients aged ≥ 70 years\r\n\r - Karnosky performance status (KPS) ≤60\r\n\r - Histologically confirmed HGG after tumor biopsy\r\n\r - GBM\r\n\r - Anaplastic Astrocytoma\r\n\r - Anaplastic Oligoastrocytoma\r\n\r - Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q\r\n\r - Estimated survival ≥ 3 months.\r\n\r - Normal liver, Kidney and bone marrow function\r\n\r - Written informed consent\r\n\r Exclusion criteria:\r\n\r - Prior radiation therapy\r\n\r - Other primary cancer\r\n\r Exclusion Criteria:\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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[
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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\nAddition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections\n\n**Clinical Trial Summary:**\n\nLiraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients\r on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight.\r However, to date there are no clinical trials of liraglutide added to insulin therapy, a\r population of patients generally having worse glycaemic control and weight gain. In clinical\r guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic\r option for type 2 diabetic patients.\r\n\r The primary study aim is to evaluate whether the addition of liraglutide, compared to\r placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with\r inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is\r defined as treatment with any basal insulin combined with separate meal time insulin\r injections before the main meals, i.e. an insulin regimen with premixed insulin is not\r considered as MDI.\r\n\r The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.\n\n**Clinical Trial Detailed Description:**\n\nBackground\r\n\r Patients with type 2 diabetes are generally treated with metformin and diet as first-line\r therapy (1). In Sweden sulphonylureas are generally recommended as the next treatment option\r due to their low cost and evidence for reducing diabetes complications (2). The next line of\r therapy includes adding basal or premixed insulin. As a final step multiple daily insulin\r injections with basal and prandial insulin have become the standard if glycaemic control does\r not meet targets. Obesity is another co-morbid condition in this population (3). The United\r Kingdom Prospective Diabetes Study (UKPDS) published 1998, the seminal trial demonstrating\r the importance of glycaemic control in type 2 diabetes, illustrated that insulin therapy\r (mostly basal insulin alone) is accompanied by significant weight gain in patients with type\r 2 diabetes (4). MDI generally results in even greater weight gain. Today there are few\r treatment options in patients with type 2 diabetes on MDI with poor glycaemic control.\r\n\r In patients with basal, intermediate or premixed insulin, addition of sitagliptin has shown\r further reduction in HbA1c of 0.6 percentage units (6 mmol/mol) with no change in weight (5).\r However, the effect in patients with the most severe disease, namely those requiring MDI, was\r not evaluated. In combination with metformin or sulphonylurea, adding the GLP-1-analogue\r liraglutide, compared with adding sitagliptin, has shown greater reductions in HbA1c and\r significant weight reductions (6). In an uncontrolled study in clinical practice, the\r addition of exanatide (n=22) or liraglutide (n=43) to patients on insulin therapy, the\r majority using MDI, was associated with a mean reduction in HbA1c by 1.0 percentage units (10\r mmol/mol), reduction in weight of 7.1 kg and, simultaneously, a mean reduction in insulin\r dose by 37 units (7). At baseline patients were generally obese (mean BMI 36kg/m2), had poor\r glycaemic control, mean HbA1c of 8.9% (74 mmol/mol) and insulin doses of 92 units. The number\r of hypoglycaemic events was low, treatment satisfaction was high and patients rated\r hypoglycaemic episodes to be fewer than with insulin therapy alone. From these results it\r seems that there may be a beneficial effect associated with liraglutide when added to type 2\r diabetic patients on MDI; however, this requires confirmation in a randomised clinical trial.\r This question is of particular concern since currently there are no treatment options for\r reducing weight and insulin doses while simultaneously improving glycaemic control for this\r patient group having most advanced disease. Further, many clinicians today use a therapeutic\r strategy consisting of MDI as a final treatment option, but many patients do still not reach\r target HbA1c and some even continue to have very poor glycaemic control (7). Therefore, the\r aim of this study is to study the effect on HbA1c when adding liraglutide to MDI in\r overweight and obese patients with impaired glycaemic control.\r\n\r The proposed study is a randomised double-blind trial for 24 weeks including patients with\r type 2 diabetes and poor glycaemic control despite being treated with MDI for at least 6\r months.\r\n\r The aim is to study the effect on HbA1c when adding liraglutide to MDI in overweight or obese\r patients with impaired glycaemic control.\r\n\r Study drug preparation\r\n\r Novo Nordisk will provide study medication and treatment codes. Apoteket AB, Sweden, will\r handle study treatment logistics.\r\n\r Site monitoring\r\n\r Gothia Forum, Gothenburg, Sweden\r\n\r Data management\r\n\r Gothia Forum will provide the eCRF system to be used in the study. Data Management (including\r the randomisation system) and statistical analysis will be performed by Statistiska\r Konsultgruppen, Gothenburg, Sweden.\r\n\r Lab and continuous glucose monitoring\r\n\r All laboratory tests will be measured at the Research Centre for Laboratory Medicine at\r Karolinska University Hospital, Stockholm, Sweden.\r\n\r The DexCom G4 CGM device will be used for 21 days (7 days during the run-in period, 7 days\r during week 12 ± 7 days and 7 days during the last 2 weeks of the trial) for blinded\r monitoring of glucose values.\r\n\r Risk-benefit assessment\r\n\r Previously published observations from clinical practice (7) have shown that patients treated\r with multiple daily insulin injections (MDI) with concomitant addition of liraglutide\r (off-label) decreases the HbA1c by approximately 10 mmol/mo (1 percentage unit), reduces the\r weight by 7 kg and decreases the insulin dose with 37 units (7). These patients were prior to\r treatment overweight (BMI around 36), had HbA1c on average 74 mmol /mol and insulin doses\r were at 92 units. Patients also rated hypoglycaemias to be fewer when insulin was combined\r with liraglutide than when used alone. In general, patients reported an improved quality of\r life.\r\n\r There is always a risk of hypoglycaemia during insulin therapy irrespective of any additional\r glucose-lowering therapy. However, previous findings from clinical practice (7) and that the\r effect of GLP-1 on insulin release is only observed under hyperglycaemic conditions (8)\r indicate that liraglutide does probably not lead to major increased risks of hypoglycaemias.\r Since, liraglutide has been associated with a reduction in body weight in previous clinical\r trials (8) it is likely that such an effect exists also in individuals treated with insulin.\r\n\r In summary, the risk of side effects or adverse reactions with the combination of insulin and\r liraglutide is probably small in relation to the improved hyperglycaemic control and weight\r reduction that may exist when adding liraglutide in type 2 diabetic patients with basal and\r prandial insulin.\r\n\r Rational\r\n\r Multiple daily insulin injections (MDI) are regarded as the most advanced treatment regimen\r in patients with type 2 diabetes. At study start all patients have been treated with MDI for\r at least 6 months but are still suffering from poor glycaemic control. The patients included\r are also overweight or obese. It is therefore of importance to evaluate whether this patient\r group have a beneficial effect, on the glycaemic control and weight reduction, by adding\r liraglutide, since liraglutide has shown such beneficial effects in combination with oral\r glucose lowering drugs.\r\n\r Moreover, beneficial effects by liraglutide have been observed when used off-label in\r combination with insulin in clinical practice (7).\r\n\r Design\r\n\r This is a double-blind, placebo-controlled clinical trial with parallel-group design. The\r study involves 120 patients at 15 health centres in Sweden and includes 10 visits over 26\r weeks.\r\n\r Treatments\r\n\r The study drug will be liraglutide which includes 3 different dosages: 0.6 mg, 1.2 mg and 1.8\r mg. Liraglutide will be titrated to 1.8 mg by increasing the dose every week. Since subjects\r will have inappropriate glycaemic control (greater than or equal to 7.5%=58 mmol/mol HbA1c)\r no general reduction in insulin doses will be made, but if glucose curves during the run-in\r period show clearly lower mean glucose levels than those corresponding to HbA1c 7.5%=58\r mmol/mol or are well-controlled before certain meals, insulin adjustments will temporarily be\r considered during the titration phase of liraglutide/placebo.\r\n\r Liraglutide will be available at a concentration of 6.0 mg/ml and supplied in a 3 ml\r disposable pen-injector. Placebo is supplied in an identical disposable pen-injector.\r\n\r Randomization\r\n\r After a run-in period of maximally 60 days, patients will be randomised to receive either 0.6\r mg liraglutide or 0.6 mg placebo. Novo Nordisk will provide (coded) medication pens and the\r associated code-list. No study personnel other than a designated data manager responsible for\r setting-up randomisation will have access to the complete code-list until the study blind is\r broken. Apoteket AB/farmaci will handle study treatment logistics.\r\n\r Minimisation (optimal allocation) using a centralised web system (handled by Statistiska\r Konsultgruppen) will be used for randomisation. At randomisation each subject will be\r assigned a randomisation code that (blindly) represents the treatment (liraglutide or\r placebo) that the patient is randomised to. The patient will also be assigned a unique and\r anonymous Subject ID.\r\n\r Breaking blind\r\n\r The study is double-blinded. The randomisation codes will not be broken until last subject's\r last visit and when all study data are collected, the study database is cleaned and declared\r locked. Apoteket AB/farmaci will be responsible for keeping the complete randomisation list.\r\n\r The code for a particular subject may be broken in a medical emergency situation.\r Apoteket/farmaci is equipped with 24 hour emergency telephone service in case of need for\r breaking blind in an individual patient.\r\n\r Telephone number:\r\n\r Weekdays 08.30-16.00: 040-33 26 74. Any other time: 040-331000 - ask for emergency telephone\r service.\r\n\r The subject should be withdrawn from the study in case of a code break but be included in the\r safety population in the statistical analyses.\r\n\r Duration\r\n\r The expected duration of subject participation is approximately 32 weeks (maximally 60 days\r run-in, and 24 weeks follow-up after randomisation).\r\n\r Study population\r\n\r The study will include 120 patients at 15 centres in Sweden. Patients requiring MDI and who\r are on no other diabetes drugs except metformin will be recruited and included in the study\r after receiving oral and written information about the study and given informed consent and\r fulfilling all the inclusion criteria and none of the exclusion criteria. The study\r population will be identified among diabetic outpatient clinics at hospitals and will be\r recruited on a community-wide basis and in communication with primary care physicians.\r\n\r The written information will include objects and purpose of the study, risks and benefits,\r and a detailed description of the events during the study. The patient will have the\r opportunity to ask additional questions at the first clinic visit The patients will be\r randomised 1:1 to liraglutide or placebo Randomisation codes will be assigned strictly\r sequentially as subjects are eligible for randomisation. If a subject discontinues\r participation in the study, his/her enrolment/subject number cannot be reused. Drop-outs\r (expected to be ~5%) will not be replaced.\r\n\r Study Stop Criteria\r\n\r The Sponsor/Investigator may decide to stop the trial or part of the trial at any time for\r medical reasons. Furthermore, the manufacturers of the study drugs may revoke their products,\r which may lead to the entire study may be interrupted.\r\n\r If a trial is prematurely terminated or suspended, the Investigator should promptly inform\r the patients and ensure appropriate therapy and follow-up. Furthermore, the Investigator\r should promptly inform the Ethics committee and provide a detailed written explanation. The\r regulatory authority should be informed according to national regulations.\r\n\r Drop-outs\r\n\r Patients who drop-out from the study or receive rescue therapy shall be requested for\r follow-up on an additional visit. HbA1c, FPG, C-peptide, pro-insulin, amylase, lipase, liver\r transaminases, creatinine, calcitonin, fasting blood lipids, adiponectin, sensitive CRP,\r apolipoproteins, weight, blood pressure, insulin dose, waist-hip ratio, abdominal sagittal\r diameter, concomitant medications and treatment satisfaction shall be checked. Blood samples\r for biobank will be taken. Insulin doses and other medications recorded. If drop-out exists\r the reason shall be recorded. Regarding rescue therapy the variables above shall be checked\r if possible before rescue therapy is given.\r\n\r Investigational product and treatment of subjects\r\n\r The trial product will be dispensed to each subject as required according to treatment group.\r The centralized web randomisation system will allocate trial product Dispensing Unit Number\r (DUN) to the subject at the randomisation visit. The correct DUN must be dispensed to the\r subject.\r\n\r The Investigator must ensure availability of proper storage conditions and record and\r evaluate the temperature (at least every working day). Storage facilities should be checked\r frequently. A log to document the temperature must be kept.\r\n\r The study is planned for 24 weeks and in addition a run-in period of maximally 60 days.\r Capillary glucose values will be measured before each meal and 1.5-2 hours after meals at 2\r days during the 60-day run-in period, 2 days per week during the first 3 weeks of the trial\r and 2 days during the last 2 weeks of the trial. Capillary glucose curves performed during\r the run-in period and the last two weeks of the study will always be measured after the week\r with CGM to not disturb the interpretation of CGM data. The Contour XT SMBG meter (Bayer)\r shall be used for capillary glucose measurements during the study. The SMBG meter shall be\r checked at eash visit before initiating CGM, i.e. during the run-in period, week 12 (+- 7\r days) and week 23-24. Calibration will be performed according to the manufacturer's\r standards. The SMBG meter shall be introduced at visit 4. During 7 days of the run-in period,\r 7 days of week 12 ± 7 days and 7 days of the 2 last weeks in the study, CGM with DexCom 4G\r will be used. CGM should be taken for 7 days, but a minimum of 5 days is acceptable. If a\r shorter period exists, a new sensor shall be set to get data for a total of 7 days (A total\r period of 5 days is acceptable). Investigators will recommend patients measure 3-4 glucose\r values per day before meals and at bedtime daily according to clinical guidelines for\r potentially adjusting insulin doses, diet or physical activity.\r\n\r Liraglutide/placebo will be administered at 0.6 mg the first week, 1.2 mg the second week and\r 1.8 mg the third week and onward. Dose increase periods can be extended based on subject's\r tolerance to the trial product. If the subject does not tolerate 1.8 mg liraglutide/placebo\r due to side effects, the dose shall be reduced to 1.2 mg liraglutide/placebo.\r Correspondingly, if 1.2 mg liraglutide/placebo is not tolerated 0.6 mg liraglutide/placebo\r shall be used.\r\n\r Since subjects will have inappropriate glycaemic control (greater than or equal to 7.5%=58\r mmol/mol in HbA1c) no general reduction in insulin doses will be made. However, glucose\r profiles during the run-in period shall be judged by the clinician. In the following cases\r the clinician will consider to take the following actions when liraglutide is added:\r\n\r A) If the patient has a mean glucose level lower than 8.5 mmol/l the clinician should\r consider reducing the total insulin dose by 10%-20% when adding liraglutide 0.6 mg B) If\r glucose levels before a certain meal are well-controlled (less than 7 mmol/l) the clinician\r should consider reducing the meal-time insulin dose administered at the previous meal by\r 10%-20% when adding liraglutide 0.6 mg. If daytime hypoglycaemia has occurred a larger than\r 20% reduction in the insulin dose at the previous meal shall be considered when adding\r liraglutide 0.6 mg.\r\n\r C) If fasting glucose is 5.0-7.0 mmol/l the basal insulin shall be reduced by 20%-30% when\r adding liraglutide 0.6 mg.\r\n\r D) If fasting glucose is less than 5 mmol/l or nocturnal hypoglycaemia has occurred during\r the run-in period basal insulin shall be reduced by 20%-40%. Novel evaluations with glucose\r measurements during 4-5 days shall be performed to confirm that FPG is greater than 5 mmol/l\r and no new nocturnal hypoglycaemia exists before adding liraglutide. A novel evaluation\r according to point A)-D) shall then be performed from the new glucose values when adding\r liraglutide.\r\n\r When increasing liraglutide from 0.6 mg to 1.2 mg as well as from 1.2 mg to 1.8 mg the\r corresponding actions as points A-D above shall be considered based on glucose values and\r hypoglycaemias during the previous week.\r\n\r After titrating liraglutide/placebo to 1.8 mg in patients where insulin doses at any stage\r have been reduced, the insulin doses will be increased until the original doses are reached.\r However, the titration will be stopped, i.e., the insulin doses will not be titrated to the\r original doses, if glucose levels at any stage in the phase of increasing doses are already\r on target. For example, if the mean glucose level before a certain meal is less than 7 mmol/l\r after adding liraglutide/placebo 1.8 mg, the insulin dose before the previous meal will not\r be increased although the dose has been reduced. Correspondingly, if mean FPG is less than\r 7.0 mmol/l the basal insulin dose will not be increased although it has been reduced.\r\n\r The total insulin dose shall not be titrated higher than the original total insulin dose at\r any point during the study, except if rescue therapy is required. The diabetes educator or\r physician will have regular telephone contact with the patient during the initial period when\r liraglutide is titrated and for possibly adjusting insulin doses. At the 6, 12 and 18 week\r follow-up visits and other contacts with the patient, e.g. telephone contacts, the insulin\r doses can be increased in patients with a lower insulin dose than the original insulin dose\r before randomisation so long as glucose levels then not are on target (less than 7.0 mmol/l\r fasting or before meal). However, the insulin doses shall not be increased higher than the\r original doses, except if rescue therapy is undertaken In daily activity, the patient will\r continue to adjust meal-time insulin doses in the same way as previously performed in\r clinical practice.\r\n\r Rescue Criteria\r\n\r If the fasting self-measured plasma glucose (fasting SMPG) values taken on three separate\r days or if any of the FPG samples analysed by the central laboratory exceeds the limit of\r 15.5 mmol/l from baseline to week 12 or 13.5 mmol/l from week 12 to week 24, the subject\r should be called for an unscheduled visit as soon as possible. The next scheduled visit\r should not be awaited. A confirmatory FPG should be obtained and analysed by the central\r laboratory. If this FPG exceeds the above described values, and no treatable intercurrent\r cause for the hyperglycaemia has been diagnosed (e.g. compliance to liraglutide/placebo,\r missing of insulin dose in the evening, infection), the subject should receive rescue\r therapy.\r\n\r Rescue therapy is defined as an increase of the total insulin dose above the original total\r insulin dose (i.e. total insulin dose at baseline, at randomisation).\r\n\r It should be noticed that rescue therapy is NOT given if the total insulin dose was initially\r reduced in the trial and the total insulin dose is increased by the physician due to FPG\r above thresholds but not higher than the total original insulin dose. Rescue therapy will not\r exist either if a patient increases the total insulin dose at any point in time above the\r total original insulin dose by, e.g., self-adjustments of meal-time insulin doses in daily\r activity.\r\n\r Other medication, which is considered necessary for the subject's safety and well-being, may\r be given at the discretion of the investigator. Medications prescribed before study entry\r should preferably remain unchanged during the study period unless changes are made for safety\r reasons.\r\n\r Procedures for Monitoring Subject Compliance\r\n\r Compliance and adherence to protocol will be checked at each contact with the patient.\r\n\r Subject compliance will be assessed by DMG monitoring accountability. The unused amount of\r trial product will be assessed against the dispensed amount and, in case of discrepancies,\r the subjects must be asked about compliance.\r\n\r The individual delegated by the Investigator must keep track of all received, used, partly\r used and unused trial products and, if possible, all empty packaging. This shall be properly\r documented. Used, partly used and unused trial products and empty packaging must be stored\r separately from non-allocated trial products. Used, partly used and unused trial products\r must be stored until the monitor has performed drug accountability.\r\n\r Destruction of trial products will be performed in accordance with local legislation and\r recorded on a destruction form.\r\n\r Liraglutide/Placebo\r\n\r Not in use: The liraglutide/placebo pen-injector must be stored in a refrigerator at a\r temperature between +2°C and +8°C. Keep away from the cooling element. Do not freeze and do\r not use if it has been frozen.\r\n\r In use: After first opening the liraglutide/placebo pen-injector can be stored for one month\r at temperatures below +30°C or in a refrigerator between +2°C and +8°C.\r\n\r The liraglutide/placebo pen-injector must be protected from all sources of light, and the pen\r cap should be kept on when the pen is not in use. The liraglutide/placebo should not be used\r if it does not appear clear and colorless.\r\n\r In case of incorrect storage the Investigator or site staff must contact Novo Nordisk without\r delay. Trial product(s) must be set on-hold and not dispensed to subjects until notified by\r Novo Nordisk.\r\n\r The individual delegated by the Investigator must keep track of all received, used, partly\r used and unused trial products and, if possible, all empty packaging, by using the drug\r accountability module in the centralised web system. No trial product should be dispensed to\r any person not enrolled in the trial.\r\n\r Returned trial product(s) (used, partly used or unused and if possible, empty packaging\r material) must be stored separately from non-allocated trial product(s). Destruction of trial\r products will be done according to local laws and will be recorded on a destruction form,\r which must be signed by the individual responsible for destruction.\r\n\r Standardised procedures for administration of questionnaires\r\n\r The questionnaires will be filled in at the study site. The patients should be allowed to sit\r alone in a reasonable quiet environment to answer the questions. It will be emphasized that\r patients complete the questionnaires prior to clinical measurements and before meeting a\r doctor. Questionnaires should be answered by the patient herself alone, however, the\r nurse/assistant will be informed about helping the patients to complete the questionnaires if\r necessary, however without influencing the patients' responses. Ensure the patient\r confidentiality. Study nurse/assistant should check the questionnaires for completeness. The\r principal investigator will assure that appropriate training relevant to the study is given\r\n\r Trial Procedures\r\n\r Run-in period\r\n\r The purpose of the run-in period is to check glucose values as a basis for possible insulin\r adjustments and to perform CGM before randomisation. Blinded CGM will be performed during 1\r week of the 60-day run-in period. Capillary glucose values before meals and 1.5 hours after\r meals will be measured during at least 2 days, after the CGM-period. Treatment satisfaction\r (DTSQs) will be checked, preferentially before initiating CGM, since CGM may influence\r treatment satisfaction.\r\n\r Randomization visit\r\n\r Glucose profiles and hypoglycaemias during the run-in period will be checked to judge whether\r insulin reductions shall be performed (See section 8.2 Titration Algorithm).\r\n\r At the randomisation visit the following variables will be measured before randomisation and\r blood samples will be sent to the Research Centre for Laboratory Medicine at Karolinska\r University Hospital. All blood samples are recommended to be fasting to facilitate logistics\r since several tests require fasting conditions.\r\n\r - Systolic and diastolic blood pressure after at least 5 minutes rest in sitting position\r with appropriate cuff-size\r\n\r - HbA1c and fasting glucose\r\n\r - Amylase, lipase, creatinine, liver transaminases\r\n\r - Fasting Blood Lipids (Triglycerides, Total-, HDL- and LDL-Cholesterol), fasting\r apolipoproteins\r\n\r - Weight\r\n\r - Waist-hip ratio and abdominal sagittal diameter\r\n\r - Type of insulin and doses of insulin and metformin\r\n\r - AE, SAE and hypoglycaemia\r\n\r - Adiponectin, sensitive CRP\r\n\r - GAD-antibodies, calcitonin, amylase, lipase\r\n\r - Fasting C-peptide and fasting pro-insulin\r\n\r - Biobank samples\r\n\r - Type of insulin, doses of insulin and doses of metformin recorded.\r\n\r - Other types of medications recorded\r\n\r - A morning urin sample of Albuminuria/Creatinine ratio will be measured with local\r laboratory analysis either at inclusion/exclusion visit or at randomisation visit.\r\n\r Web randomisation will be performed with minimisation (optimal allocation) to liraglutide or\r placebo in 1:1 proportion.\r\n\r Telephone contacts\r\n\r The diabetes educator or the physician will have telephone contact with the patient as\r follows:\r\n\r - The day after starting liraglutide/placebo\r\n\r - One of the 2 days before increasing liraglutide/placebo to 1.2 mg\r\n\r - The day after the increase to 1.2 mg\r\n\r - One of the two days before increasing liraglutide/placebo to 1.8 mg\r\n\r - The day after increasing liraglutide to 1.8 mg\r\n\r - One week after the increase of liraglutide/placebo to 1.8 mg\r\n\r More frequent telephone contacts during the initial weeks or later in the study will be made\r depending on the decision of the diabetic educator or physician if needed for the individual\r patient.\r\n\r At each telephone contact, insulin adjustments will be considered according to specified\r algorithms, i.e.:\r\n\r - if hypoglycaemia exists\r\n\r - If glucose values are well-controlled before titrating liraglutide/placebo\r\n\r In patients where insulin doses are reduced at any stage during the titration of liraglutide,\r regular telephone contacts every 3-4 day after titrating liraglutide/placebo to 1.8 mg shall\r be performed. Insulin doses will then be increased until the original insulin doses are\r reached. The increase of insulin doses will be stopped at a lower level earlier before\r original doses are reached if glucose levels already are on target.\r\n\r Clinical Visits\r\n\r Clinical visits will be performed at weeks 6, 12, 18 and 24. Visit at Week 6, 12 and 18\r\n\r At the 6 weeks follow-up visit (± 7 days), 12 weeks follow-up visit (± 7 days) and 18 weeks\r (± 7 days) follow-up visit the following variables will be measured:\r\n\r - Systolic and diastolic blood pressure after at least 5 minutes rest in sitting position\r with appropriate cuff-size\r\n\r - HbA1c, Fasting plasma glucose sent to central laboratory\r\n\r - Weight\r\n\r - Type of insulin and doses of insulin and doses of metformin\r\n\r - AE, SAE and hypoglycaemia\r\n\r - Changes to concomitant medication\r\n\r - Trial product dispensing\r\n\r - At week 12: blood lipids, lipase, amylase, liver transaminases, creatinine, calcitonin\r and biobank samples sent to central laboratory. Waist-hip ratio and abdominal sagittal\r diameter shall be measured.\r\n\r Week 12 ± 7 days\r\n\r - Blinded CGM will be performed during 1 week.\r\n\r - Treatment satisfaction (DTSQs) will be evaluated, preferentially before CGM since CGM\r may influence the treatment satisfaction.\r\n\r Two last weeks (week 23-24)\r\n\r - Blinded CGM will be performed during 7 days. Capillary glucose values measured before\r and 1.5 hours after meals during 2 days.\r\n\r - Treatment satisfaction (DTSQs and DTSQc) will be performed, preferentially before CGM\r since CGM may influence treatment satisfaction.\r\n\r Week 24\r\n\r At the final 24 weeks follow-up visit (± 7 days) the following variables will be measured\r (all blood samples sent to central laboratory):\r\n\r - Physical investigation\r\n\r - Systolic and diastolic blood pressure after at least 5 minutes rest in sitting position\r\n\r - HbA1c and fasting plasma glucose\r\n\r - Fasting blood lipids (Triglycerides, Total-, HDL- and LDL-Cholesterol) and\r apolipoproteins\r\n\r - Weight\r\n\r - Waist-hip ratio and abdominal sagittal diameter\r\n\r - Sensitive CRP, adiponectin, liver transaminases, creatinine, calcitonin, lipase and\r amylase\r\n\r - Type of insulin and doses of insulin and metformin\r\n\r - AE, SAE and hypoglycaemia\r\n\r - Changes to concomitant medication\r\n\r - Fasting C-peptide and fasting pro-insulin\r\n\r - Biobank samples\r\n\r - A morning urin sample of Albuminuria/Creatinine ratio will be measured with local\r laboratory analysis.\r\n\r Hypoglycaemias\r\n\r Hypoglycaemias will be defined according to the general guidelines from the American Diabetes\r Association of definitions of hypoglycaemias in study settings (9). Hypoglycaemias will be\r divided into documented symptomatic hypoglycaemias, documented asymptomatic hypoglycaemias\r and severe hypoglycaemias. Patients will be counselled of typical symptoms of hypoglycaemia\r and given a diabetes diary for recordings of glucose values, signs of hypoglycaemias and\r recovery from symptoms after intake of carbohydrates. The frequency of hypoglycaemia with\r glucose values below 3.0 mmol/l and 4.0 mmol/l will both be used as endpoints. Severe\r hypoglycaemias will also be recorded in the diabetes diary. If a severe hypoglycaemia appears\r the responsible physician for the patient should be informed as soon as possible. The\r following parameters of hypoglycaemia will be recorded in accordance with guidelines for\r study design of the American Diabetes Association:\r\n\r - Number of documented symptomatic hypoglycaemias (PG less than 4.0 mmol/l).\r\n\r - Number of documented asymptomatic hypoglycaemia (PG less than 4.0 mmol/l).\r\n\r - The number of symptomatic and asymptomatic documented hypoglycaemia with PG less than\r 3.0 mmol/l will also be recorded.\r\n\r - Number of glucose values recorded by CGM below 3.0 mmol/l and 4.0 mmol/l respectively.\r\n\r - Number of severe hypoglycaemias.\r\n\r Patients shall be informed regarding the symptoms of hypoglycaemia and requested to\r immediately perform a finger stick glucose measurement if symptoms occur that may be related\r to hypoglycaemia, but to avoid delay in treating these symptoms.\r\n\r Full analysis set (ITT-population) The full analysis set (ITT-population) consists of all\r randomised patients who received at least one dose of study medication and has at least one\r follow-up measurement.\r\n\r Primary Efficacy Analysis Primary efficacy analysis will be change in HbA1c from baseline to\r 24 weeks follow-up between the two treatment groups using analysis of covariance (ANCOVA)\r with HbA1c at baseline as covariate on the full analysis set (ITT-population), two-sided test\r on significance level 0.05. If HbA1c from 24 weeks follow-up is missing the last observation\r carry forward (LOCF) principle from 6, 12 and 18 weeks will be applied. All measurements\r obtained after rescue therapy should be excluded in all efficacy analyses.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Informed consent obtained before trial-related activities (i.e., any activity that\r would not have been performed during routine patient management)\r\n\r - Type 2 diabetes\r\n\r - Adult patients over 18 years of age and less than or equal to 80 years of age\r\n\r - HbA1c greater than or equal to 7.5% (NGSP standard=DCCT standard)=58 mmol/mol (IFCC\r standard) and less than or equal to 11.5%=102 mmol/mol\r\n\r - Treated with MDI for at least the last 6 months\r\n\r - Treated with/without metformin as only diabetes therapy apart from insulin\r\n\r - Fasting C-peptide of 0.10 nmol/l or greater (ref. 0.25-1.0 nmol/l)\r\n\r - BMI greater than 27,5 kg/m2 and less than 45 kg/m2\r\n\r Exclusion Criteria:\r\n\r - Type 1 diabetes\r\n\r - Fasting glucose less than 6.0 mmol/l or greater than 15.0 mmol/l\r\n\r - Unstable cardiovascular disease, NYHA Class II or greater heart failure , new symptoms\r of cardiovascular disease)\r\n\r - Proliferative diabetic retinopathy or clinically significant macula oedema. Retinal\r photograph should not be older than 3 years.\r\n\r - Systemic glucocorticoid treatment during the last 3 months, however, patients using\r systemic corticoid treatment only for substitution of cortisol deficiency (physiologic\r doses) such as Addisons Disease, do not need to be excluded\r\n\r - Acute coronary syndrome, stroke, coronary artery intervention or myocardial infarction\r during the previous 6 months\r\n\r - Creatinine greater than 150 micromol/l\r\n\r - Liver transaminases greater than double of the normal reference interval\r\n\r - Treatment with other oral antidiabetic agents than metformin during the previous 3\r months\r\n\r - Treatment with GLP-1 receptor agonists within 90 days of screening\r\n\r - Severe psychiatric disorder (untreated severe depression, schizophrenia, dementia or\r severe alcohol or drug abuse)\r\n\r - Frequent non-severe hypoglycaemia (greater than 2 times per week) or any severe\r hypoglycaemia during the previous month.\r\n\r - Hypoglycaemic unawareness\r\n\r - Current cancer or diagnosis of cancer in the previous 5 years (except basal cell skin\r cancer or squamous cell skin cancer).\r\n\r - Personal history of non-familial thyroid carcinoma or multiple endocrine neoplasia\r syndrome type 2 (MEN2)\r\n\r - Screening calcitonin values greater than 14.6 pmol/l.\r\n\r - Females of childbearing potential who are pregnant, breast-feeding or intend to become\r pregnant or are not using adequate contraceptive methods (adequate contraceptive\r measures as required by local law or practice; accepted methods: oral contraceptive\r pills, depo provera contraceptive injections, implanted contraceptive, transdermal\r patch, intrauterine device, vasectomized partner, or abstinence.)\r\n\r - Blood pressure greater than 160/100 mmHg\r\n\r - Need for continuous use of paracetamol. During the 3 periods of 7 days with CGM,\r paracetamol cannot be used. Alternative pain killers can be substituted if plausible\r because paracetamol is the only medication influencing CGM results.\r\n\r - History of chronic or acute pancreatitis\r\n\r - Inflammatory Bowel Disease\r\n\r - Participation in another 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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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\niAssist vs. Conventional Instrumentation in Total Knee Arthroplasty Using the Persona Knee System Among Patients With BMI>=30: Radiographic, Clinical and Economic Outcomes\n\n**Clinical Trial Summary:**\n\nThe purpose of this prospective randomized study is to evaluate iAssist with respect to\r radiographic, clinical and economic outcomes in comparison to conventional instrumentation in\r primary total knee arthroplasty using the Persona knee system among patients with BMI>=30.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male or female\r\n\r 2. Needs a primary TKR on the left or right knee\r\n\r 3. Diagnose of non-inflammatory degenerative joint disease (e.g., osteoarthritis,\r post-traumatic arthritis, avascular necrosis, etc.)\r\n\r 4. Over 18 years old\r\n\r 5. BMI>=30\r\n\r 6. Able to:\r\n\r - Understand what participation in the study entails and give written informed\r consent, and\r\n\r - Follow surgeon/staff instructions, and\r\n\r - Return for all follow-up evaluations, and\r\n\r - Able and willing to undergo a preoperative full-leg, standing radiographs (all\r cases)\r\n\r - Willing to consent (patient or his/her legal guardian) to participate in the\r study by signing and dating an approved consent.\r\n\r - Meet an acceptable preoperative medical clearance and is free of or treated for\r cardiac, pulmonary, hematological or other conditions that would pose excessive\r operative risk.\r\n\r 7. Presence of varus or valgus deformity of 15 degrees or less.\r\n\r Exclusion Criteria:\r\n\r 1. Currently enrolled in an investigational new drug or device study\r\n\r 2. Active Infection (including septic knee, distant infection, or osteomyelitis)\r\n\r 3. Severe hip arthrosis\r\n\r 4. Neurological disorders (including, but not limited to Parkinson's disease)\r\n\r 5. Prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy\r\n\r 6. Hip or knee ankylosis\r\n\r 7. Inflammatory joint disease.\r\n\r 8. Either rheumatoid or post-traumatic knee arthritis\r\n\r 9. Scheduled for simultaneous bilateral TKA\r\n\r 10. Indications of intra- and/or extra-articular deformations that would eliminate or tend\r to eliminate adequate implant support or prevent the use of an appropriately sized\r implant, such as polio, history of tibial plateau fracture, etc.\r\n\r 11. Any metal within 150 mm of the joint line for the operative-side knee\r\n\r 12. Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion\r contracture on initial physical examination\r\n\r 13. A female who is pregnant or lactating\r\n\r 14. Current involvement in any personal injury litigation, medical-legal or worker's\r compensation claims\r\n\r 15. Arterial disease or stents that would exclude the use of a tourniquet\r\n\r 16. Insufficient quality or quantity of bone to support the implant due to prior knee\r surgery (or surgeries), cancer, metabolic bone disease, osteoporosis/osteopenia\r (diagnosed or treated with medication), active/old/remote infection, etc.\r\n\r 17. Mental condition that may interfere with his/her ability to give an informed consent\r or interfere with his/her ability or willingness to fulfill the requirements of the\r study.\r\n\r 18. Condition that would place excessive demands on the implant (e.g., Charcot's joints,\r muscle deficiencies, multiple joint disabilities, skeletal immaturity, etc.).\r\n\r 19. Collateral ligament insufficiency.\r\n\r 20. Immunosuppressive disorder (e.g., AIDS, etc.) that would require cytotoxic drugs,\r corticosteroids, large dose of irradiation, or antilymphocytic serum.\r\n\r 21. An existing condition that would, in the opinion of the investigator, compromise\r participation or follow-up in 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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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\n5-ALA in Recurrent Glioma\n\n**Clinical Trial Summary:**\n\nThe investigators propose a single-center, non-randomized, single-arm study at the Barrow\r Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent\r glioma study will correlate presence of fluorescence in tumor tissue with pathological\r findings. This will be done using three cohorts in dose escalation. The investigators'\r hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result\r in less false positive fluorescence.\n\n**Clinical Trial Detailed Description:**\n\nThe goal is to determine the dose of 5-ALA which promotes the lowest volume of residual\r disease after resection of recurrent high grade glioma without compromising the demarcation\r between recurrent high grade glioma and postoperative bed normal tissue.\r\n\r Sub-goals:\r\n\r 1. To determine the impact of the dose of 5-ALA in improving volumetric extent of resection\r in patients with recurrent high grade gliomas\r\n\r 2. To determine the impact of the dose of 5-ALA in improving overall survival of recurrent\r high grade glioma patients\r\n\r 3. To determine the impact of the dose of 5-ALA in improving progression-free survival of\r recurrent high grade glioma patients\r\n\r 4. To determine the impact of the dose of 5-ALA on the neurological morbidity of recurrent\r high grade glioma patients.\r\n\r Patients with presumed recurrent glioma will be entered into the trial. Those with recurrent\r disease will receive study drug (5-ALA) in one of three dose-escalated cohorts (5 mg/kg; 10\r mg/kg; 20 mg/kg). Intraoperatively, patients will undergo resection with combined\r fluorescence microscopy and confocal microscopy. Resected tissue specimens corresponding to\r the presence of fluorescence will be sent to pathology for examination. Postoperatively,\r patients will have an MRI with and without contrast within 48 hours of surgery. Subsequent\r analysis of each patient will include assessment of the primary endpoint (volume of residual\r disease) by volumetrically quantifying the tumor before and after surgery using T1-weighted\r contrast-enhancement. Similarly, volumetric extent of resection will also be measured.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\r\n\r - Presumed recurrent glioma\r\n\r - Age > 18 years\r\n\r - Normal bone marrow function (WBC > 3000, Platelets > 100,000)\r\n\r Exclusion Criteria\r\n\r - Pregnancy\r\n\r - History of photosensitivity, porphyria, or exfoliative dermatitis\r\n\r - Hepatic dysfunction in the last 12 months [defined by aspartate aminotransferase(AST),\r alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin > 2.5 x\r normal]\r\n\r - Serum creatinine > 180 µmol/L\r\n\r - Estimated Glomerular Filtration Rate (eGFR)< 60 ml/min/1.73m2\r\n\r - Inability to undergo MRI with contrast\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\nAcetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome\n\n**Clinical Trial Summary:**\n\nStudy Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe\r carpal tunnel syndrome.\r\n\r Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In\r severe cases, nerve regeneration and functional recovery are incomplete even with surgery.\r The goal of this pilot project is to test a potentially promising medication,\r acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled\r study design. Along with surgery, those in the treatment group will also receive ALCAR while\r the other half in the control group will be given placebo. To gauge the effects of ALCAR, we\r will compare motor and sensory nerve growth as well as functional outcomes. The data from\r this study will provide crucial information when designing a full scale clinical trial. If\r successful, this will represent an important first step in finding a novel treatment to\r improve functional outcomes in patients with severe CTS.\n\n**Clinical Trial Detailed Description:**\n\nTrial Conduct: This study will be conducted in compliance with the protocol approved by both\r the University of Alberta Health Research Ethics Board (HREB) and Health Canada. The study\r will be carried out according to Good Clinical Practice standards. No deviation from the\r protocol will occur once approved, unless the protocol has put patients at risk. If deviation\r needs to occur, both HREB and Health Canada will be notified. Written amendments will be\r submitted to both HREB and Health Canada for their approval.\r\n\r Population Adult patients suffering from severe CTS would be a population of the interest.\r Severity of CTS is defined by clinical symptoms and electromyography (EMG) results. These\r patients will then be recruited for baseline studies, motor unit number estimation (MUNE).\r Motor unit number estimation is an EMG technique that quantifies the amount of motor units a\r muscle contains. In various forms of neuropathies, the MUNE decreases. For our study,\r patients will be included only if their MUNE is 2 standard deviations below normal. These\r patients will be identified from referrals to plastic surgery clinics or EMG clinics for\r management.Pre-study Screening and Baseline Evaluation The subject will have a complete\r physical exam including clinical labs and an ECG. Only those who have normal laboratory and\r ECG findings will be enrolled in the study.\r\n\r Randomization Randomization - After enrollment, patients will be randomized to placebo or\r acetyl-l-carnitine. A statistician will be employed to develop a randomization sequence.\r Randomization will be kept on a computer under password encryption. The randomization\r sequence will only be broken if an adverse event occurs to a patient. At the end of the study\r the statistician will provide the research team with the randomization sequence codes.\r\n\r Blinding - The study will be administered in a double-blind manner. The randomization\r sequence will be kept confidential and only accessible to authorized personnel. Pharmacy will\r distribute identical pills labelled in bottles with A or B. The research team will be unaware\r of which contains the study drug or placebo. This will be maintained until the final\r follow-up has occurred when the research team will be unblinded.\r\n\r Duration The duration of the study is approximately 13 months for each patient. Screening and\r baseline evaluation will occur within 1 month preoperatively. The investigators will review\r and document the screening laboratory tests and ECG results. Acetyl-l-carnitine regimen will\r begin immediately following surgery. This will be continued for 2 months duration. The\r patient will then complete follow-up visits at 1, 2, 3, 6, and 12 month intervals. At some of\r those visits, safety monitoring will include periodic blood chemistries, vital signs and\r evaluation of overall clinical condition (details shown in table above). All clinically\r relevant changes occurring during the study will be examined and documented. In cases where\r laboratory abnormalities are detected, appropriate medical management and advice will be\r provided.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients will be recruited from the University of Alberta Hospital referred for CTS.\r Inclusion criteria will include adult patients (over age 18) with at least one of the\r following symptoms:\r\n\r 1. numbness and parenthesis in the median nerve distribution;\r\n\r 2. Precipitation of those symptoms by repetitive motions that are relieved by\r rubbing and or shaking the hands;\r\n\r 3. Nocturnal awakening by those sensory symptoms, or\r\n\r 4. Weakness of thumb abduction and thenar atrophy.\r\n\r Exclusion Criteria:\r\n\r 1. Motor unit loss in the median nerve less than 2 SD below the mean for the age as\r determined by nerve conduction studies.\r\n\r 2. The presence of other neurologic conditions\r\n\r 3. Previous carpal tunnel release surgery\r\n\r 4. Cognitive impairment that renders the patient unable to provide informed consent;\r\n\r 5. Pregnancy\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\nUpper Extremity Strength in Cerebral Palsy\n\n**Clinical Trial Summary:**\n\nRationale:\r\n\r Children with Cerebral Palsy (CP) experience limitations in motor activities and\r participation in the community, predominantly caused by impairments in muscle function. Aside\r from abnormal posturing due to spasticity, muscle weakness can significantly contribute to\r impaired muscle function and there is increasing evidence that muscle weakness significantly\r impairs upper limb motor function and ability to perform manual tasks in children with CP.\r Studies in the last decade have shown that muscle weakness, not spasticity, is the greatest\r limiting factor of motor function in children with CP. Furthermore, there is increasing\r evidence that the strength in the upper extremities of children with CP is less compared to\r their typically developing peers (TDP). A systematic review focused on the psychometric\r properties of strength measurement instruments has shown that the number of studies\r investigating psychometric properties of strength measurement instruments is limited and that\r the methodological quality of these studies is low.\r\n\r Aim:\r\n\r The present study aims to investigate the reproducibility of the following three isometric\r strength measurements in the upper extremity of children and adolescents with unilateral CP\r as well as in TDP: Hand Held Dynamometry (HHD), pinch and grip strength using the E-link\r system and functional strength. To study to which extent upper extremity strength, both in\r the affected side and the non-affected side, differs from the strength in the upper\r extremities of TDP, these measurements will also be performed by children without\r neurological problems.\r\n\r Study Design:\r\n\r A cross-sectional study in which the reproducibility of three strength measurement\r instruments, i.e. HHD, E-link and Functional strength, will be investigated in children and\r adolescents with unilateral CP and TDP.\r\n\r Population:\r\n\r Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents),\r aged 7 to 18 years, Manual Ability Classification System (MACS) levels I-III, who are\r mentally able to perform the measurements will be included and TDP.\r\n\r Outcome measures:\r\n\r The most important psychometric property in strength measurement instruments is\r reproducibility. Reproducibility will be investigated using the following factors: Intraclass\r Correlation Coefficient (ICC), Limits of Agreement (LOA), Standard Error of Measurement (SEM)\r and the Smallest Detectable Difference (SDD). Reference values will be determined using the\r Generalised Additive Models for Location, Scale, and Shape (GAMLSS) method.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria CP:\r\n\r - Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic\r incidents),\r\n\r - aged 7 to 18 years,\r\n\r - MACS levels I-III,\r\n\r - mentally able to perform the measurements\r\n\r Inclusion criteria Healthy Controls:\r\n\r - children attending primary or secondary school\r\n\r - agd 7 to 18 years\r\n\r Exclusion Criteria CP:\r\n\r - Surgical intervention <6 months\r\n\r - Botulinum Toxin A treatment in the upper extremity < 6 months\r\n\r - contractures in the upper extremity that might interfere with task performance\r\n\r Exclusion criteria Healthy Controls:\r\n\r - muscle disease\r\n\r - lesion, fracture or cast < 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\"."
}
] |
[
{
"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\n18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors\n\n**Clinical Trial Summary:**\n\nThis pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission\r tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with\r brain tumors. Comparing results of diagnostic procedures done before, during, and after\r treatment may help doctors measure tumor growth and plan the best treatment.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in\r disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy\r or any combination of these).\r\n\r II. Determine level of change in cellular proliferation compared with baseline (scan 1) in\r brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the\r clinical follow-up period (scan 4), when possible.\r\n\r III. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and\r treatment-induced changes in brain tumor proliferation with clinical response status\r (clinical categories are complete remission, lesser degrees of response/stable disease, and\r no response).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. Assess spatial heterogeneity of FLT uptake to identify local differences in brain tumor\r disease burden.\r\n\r OUTLINE:\r\n\r Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of\r therapy, and 1 year after completion of therapy or time of suspected recurrence.\r\n\r After completion of study, patients are followed for up to 7 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Have a diagnosis or suspected diagnoses of brain tumor (primary, recurrent, or\r metastatic) by standard clinical diagnosis such as pathology or imaging\r\n\r - Planned for treatment with radiation, chemotherapy and surgical resection or any of\r these treatment strategies combined\r\n\r Exclusion Criteria:\r\n\r - Inability to provide informed consent\r\n\r - Pregnancy\r\n\r - Inability to lie still for the imaging study\r\n\r - Weight over 350 lbs.\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 Flow Restriction Training in Rehabilitation Patients\n\n**Clinical Trial Summary:**\n\nOcclusion training, resistance exercise performed with a specialized venous tourniquet, leads\r to beneficial changes in muscle at low resistance and minimal stress on the nearby joint.\r This novel resistance training has the potential to greatly improve extremity muscle strength\r gains for rehabilitation patients who are unable for medical reasons to perform high\r resistance exercise. Our study will explore this with specific rehabilitation populations:\r post-operative knee scopes, post-operative anterior cruciate ligament (ACL) reconstruction\r patients who have acute post-operative changes in thigh muscle function and chronic thigh\r weakness. The primary outcome is to achieve accelerated functional thigh recovery with\r outcome measures including thigh strength, validated questionnaires, and validated functional\r testing. Occlusion training can enhance rehab patients outcomes, reduce the cost of care, and\r improve the skills and efficiency of care providers.\n\n**Clinical Trial Detailed Description:**\n\nOcclusion training is the restriction of venous outflow from an extremity with the use of a\r tourniquet during weight-training or resistance exercises. The technique is a safe and\r effective method of improving strength through muscle hypertrophy in healthy, active\r individuals (1-7). The technique has also been shown to be safe and effective in patient\r populations with various comorbidities (8).These strength gains can be achieved while\r training with loads as low as 20% of an individual's one repetition maximum (1RM). This is\r contrary to the American College of Sports Medicine (ACSM) weight-training guidelines that\r state muscle hypertrophy can only be achieved when an individual lifts loads close to 80% of\r the 1RM (9).\r\n\r The purpose of this project is to compare occlusion resistance training to traditional\r resistance training methods for rehabilitation patients. This will include both an acute\r post-operative ACL reconstruction cohort and a chronic thigh weakness cohort. Post-operative\r lower extremity weakness as well as chronic muscle weakness after trauma correlate with lower\r functional performance.(10,11) We will treat the patients and follow these two cohorts\r simultaneously.\r\n\r Specific Aim 1: To determine if occlusion training will accelerate the recovery of thigh\r muscle function and strength in post-operative anterior cruciate ligament (ACL)\r reconstruction as compared to a standard post-operative rehabilitation protocol.\r\n\r Specific Aim 2: To determine if occlusion training will increase quadricep and hamstring\r muscle function for battlefield wounded warriors with severe thigh weakness as a result of\r trauma or volumetric muscle loss as compared to standard ACSM resistance training guidelines.\r\n\r Specific Aim 3: To determine if occlusion training will accelerate the recovery of thigh\r muscle function and strength in post-operative soft tissue knee arthroscopy as compared to a\r standard post-operative rehabilitation protocol.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - One of the following: (1) s/p ACL reconstruction within the last three months prior to\r initiation of study training, (2) s/p knee arthroscopy within the last 2 weeks prior\r to initiation of study training, (3) S/p lower extremity trauma, unilateral with thigh\r weakness of at lest a 20% deficit compared to contralateral side and at least 6 months\r out from most recent trauma or surgery\r\n\r - Fluent in English and able to consent\r\n\r Exclusion Criteria:\r\n\r - Contralateral lower extremity involvement resulting in less than normal range of\r motion, muscle strength, or daily pain greater than 5/10.\r\n\r - Pregnancy, verbal reporting\r\n\r - Recent history of deep vein thrombosis, within the 12 months or on active treatment\r\n\r - History of endothelial dysfunction, peripheral vascular disease, hypertension,\r diabetes, or people prone to capillary ruptures (bruising) (determined by verbal\r reporting by the patient)\r\n\r - Active Infection\r\n\r - Cancer (current diagnosis)\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 the Perfusion of Uterus and Lower Extremities During Cesarean Section With NIRS and Color Doppler\n\n**Clinical Trial Summary:**\n\nHypotension after spinal anesthesia for cesarean section is one of the most common\r perioperative issue, with an incidence up to 83%.Hypotension is mainly induced by the\r associated sympathetic blockade, with a drop of peripheral vascular resistance in the lower\r extremities and an increase in venous capacitance. Hypotension is a distress for both\r anesthesiologists and obstetricians as it endangers parturient's hemodynamics and compromises\r the uteroplacental blood flow. In clinical practice, there are several ways to treat\r hypotension after spinal anesthesia such as preloading with intravenous fluids and\r administrating ephedrine. Normotensive maternal blood pressure does neither guarantee the\r well-being of the fetus nor ensure the tissue perfusion of the parturient. Based on the\r anatomy and physiology basis, we hypothesize that uterine perfusion under spinal anesthesia\r would correlate with the perfusion of the lower extremities. To measure the perfusion of the\r lower extremities, we use a relative new tool, the non-invasive transcutaneous near infrared\r spectroscopy.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective observational study. Parturients who are going to receive an elective\r cesarean section will be enrolled. Before entering the operating rooms, the parturient\r enrolled receives the Doppler studies. The external iliac artery is identified and color\r Doppler is activated to locate the uterine artery crossed the external iliac artery. The\r probe is stabilized to obtain the maximum flow velocity waveform.The pulsatility index of\r these three waveforms is calculated and recorded as the baseline. Three minutes after the\r anesthetics are injected, the same procedures of color Doppler are performed again, and the\r PI after the spinal anesthesia is recorded.\r\n\r Tissue (cerebral) oximeter (INVOS Cerebral Oximeter Model 5100B; Somanetics, Troy, MI, USA)\r is used for the NIRS technique. Two adhesive sensor patches are attached to the parturient.\r One sensor patch is applied over the the biceps brachii of the upper limb while the other\r adhere to the medial side of the gastrocnemius muscle. After the oximeter shows a stable\r reading, the baseline data are recorded. The parturient then receive spinal anesthesia in the\r right lateral decubitus position. The intrathecal injection consists of 0.5% hyperbaric\r bupivacaine. NIBP is monitored at 2.5 minutes interval for 30 minutes. Tissue oximeter starts\r recording every minute right after local anesthetics are injected into the intrathecal space\r for a total of fifteen minutes.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Parturients\r\n\r - elective cesarean section\r\n\r - ASA class I or class II\r\n\r Exclusion Criteria:\r\n\r - Emergent cesarean section\r\n\r - Skin lesions over the site of local anesthetic injection\r\n\r - Skin lesions over the sites where NIRS patches are about to be attached\r\n\r - Patients with history of being allergic to NIRS patches\r\n\r - Patients with coagulopathy or other contraindications for spinal anesthesia\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\nPredictors of Decompressive Laminectomy Outcomes\n\n**Clinical Trial Summary:**\n\nDecompressive laminectomy (DL) is the most common type of back surgery performed in older\r adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal\r causes pain and trouble walking. An estimated one in three people who undergo DL do not get\r well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside\r of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do\r poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of\r treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61 The\r aim of this study is to identify conditions other than LSS that place Veterans at risk of\r poor DL outcomes so that future comparative effectiveness studies can be designed that\r examine the impact of a more comprehensive approach to treatment. Investigators believe that\r a patient-centered rather than a disease-centered approach will lead to superior outcomes,\r less suffering, and more appropriate use of health care resources.\n\n**Clinical Trial Detailed Description:**\n\nThe primary aim of this 6-site prospective cohort study is to develop algorithms usable in\r the clinical setting that predict decompressive laminectomy (DL) outcomes (i.e., success vs.\r failure) in older adults with lumbar spinal stenosis (LSS), the most common indication for\r spine surgery in older patients. The clinical algorithms developed will be based primarily on\r factors outside of LSS that are important aging-related predictors of pain and disability\r (e.g., hip osteoarthritis (OA), fibromyalgia syndrome, depression, anxiety, fear-avoidance\r beliefs, dysfunctional coping). Preliminary data support the impact of some of these factors\r on DL outcomes, but no study has included comprehensive assessment of rigorously collected\r data in the context of a prospective cohort. Thus LSS treatment remains focused exclusively\r on the lumbar spine and treatment outcomes suboptimal with, on average, < 20% reduction in\r pain. An estimated one in three DL patients does not improve at all. Further, anatomical\r evidence of LSS (i.e., based on advanced imaging) exists in many older patients without pain\r or functional compromise. Two hundred fifty patients with symptomatic LSS scheduled to\r undergo DL without fusion and who have no dementia, spinal instability, or prior lumbar\r surgery will be recruited from spine surgery practices at each of the 6 participating sites\r (VA Pittsburgh Healthcare System, Durham VA Medical Center [MC], Richmond VAMC, Ann Arbor\r VAMC, Denver VAMC, San Antonio VAMC). Within 30 days prior to DL (i.e., at baseline),\r participants will undergo comprehensive and rigorous assessment of pain and\r disability-generating factors including: 1) SS symptoms with the Brigham Spinal Stenosis\r questionnaire (BSS, the most specific available LSS measurement tool); 2) musculoskeletal\r comorbidities (scoliosis, kyphosis, hip osteoarthritis, fibromyalgia symptoms, severity of\r spinal stenosis, degenerative disc and facet disease); 3) mood (depression [with the Centre\r for Epidemiology Studies Depression Scale (CES-D)], anxiety [with the GAD-7]); 4) cognitive\r function (normal vs. mild cognitive impairment with the computer-based assessment of mild\r cognitive impairment); 5) psychological function (fear-avoidance beliefs [with the Fear\r Avoidance Beliefs Questionnaire], chronic pain self-efficacy [with the Chronic Pain\r Self-Efficacy Scales], dysfunctional pain coping skills [with the Cognitive Strategies\r Questionnaire], treatment expectancy, illicit substance use, alcohol use, smoking status,\r PTSD symptoms); 6) medical comorbidity (including BMI); 7) demographic factors (age, gender,\r race, educational/marital status). The BSS will be collected at baseline, at the first\r postoperative visit, and every 3 months for one year. Prediction rules, based on the\r comprehensive set of factors measured and DL success/failure determined by the BSS, will be\r created using multiple methods to maximize predictive accuracy and validated subsequently in\r a separate cohort of 100 individuals. Investigators will apply these rules to future\r comparative effectiveness trials that test personalized LSS treatment approaches (i.e., that\r involve targeting extra-LSS factors as part of the total treatment package) as compared with\r DL alone. An exploratory aim of the proposed study is to evaluate the use of Goal Attainment\r Scaling (GAS) as a DL outcome. This patient-centered outcomes measurement approach is used\r commonly in the rehabilitation setting, but never before in DL patients. To prepare for\r future comparative effectiveness trials, investigators want to develop GAS as an outcome\r measure because it can be used to track outcomes in SS patients across surgical and\r non-surgical interventions, and investigators anticipate that both will be employed as part\r of personalized treatment. Investigators will explore (through 10-12 patient interviews) and\r refine (with a modified Delphi panel of experts) GAS goals in patients with SS, and measure\r goal achievement in a subset of 20 participants. What might happen if older adults with LSS\r were treated in the context of a comprehensive pre-operative program before undergoing DL?\r Might long-term outcomes associated with DL improve? Might patient satisfaction improve?\r Might some patients avoid DL? These are questions that ultimately investigators hope to\r answer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Younger than 90 years old.\r\n\r - no communication barriers (e.g., English speaking, household telephone)\r\n\r - Affirmative response to each of the three following questions:\r\n\r - a) Do patients have pain, weakness, numbness, or tingling in their legs when\r walking standing?\r\n\r - b) Does this pain, weakness, numbness or tingling in their legs interfere with\r their daily activities?\r\n\r - c) Have patients tried at least one non-surgical treatment for their leg symptoms\r (e.g., physical therapy, pain medications, spinal injection)?\r\n\r - Have been scheduled for surgery on lower back for a condition called lumbar spinal\r stenosis.\r\n\r Exclusion Criteria:\r\n\r - non degenerative causes of LSS such as\r\n\r - tumor,\r\n\r - infection,\r\n\r - trauma,\r\n\r - hemorrhage,\r\n\r - or epidural lipomatosis\r\n\r - Prior lumbar spinal surgery\r\n\r - spondylolisthesis with spinal instability\r\n\r - significant cognitive 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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"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\nPrognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain\n\n**Clinical Trial Summary:**\n\nThe aim of the present study is to quantify the relative contribution of variables obtained\r during a physical fitness evaluation and a short screening questionnaire in determining the\r short-term and long term risk of persistent disabling low back pain in patients with chronic\r low back pain. It has been hypothesized that patients with higher physical fitness will\r present a lower risk of persistent disabling low back pain and so, a lower score on the\r questionnaire.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - adults between 18 and 60 years old\r\n\r - nonspecific low back pain : pain located between the twelfth rib and the inferior\r gluteal fold for which no specific source of pain could be identified\r\n\r - chronic low back pain : pain present for 12 weeks or more, and included both constant\r and recurrent patterns of pain\r\n\r - able to read and understand French\r\n\r Exclusion Criteria:\r\n\r - History of surgery or major trauma to the spine\r\n\r - Current use of medication known to impair physical effort and pain perception\r\n\r - Lumbar scoliosis of more than 20°\r\n\r - Collagenosis, severe osteoporosis\r\n\r - Neuromuscular disease\r\n\r - Malignant tumor\r\n\r - Non-controlled hypertension\r\n\r - Infection\r\n\r - Radiculopathy\r\n\r - Progressive neurologic defect\r\n\r - Myelopathy\r\n\r - Lumbar disc hernia\r\n\r - Pregnancy\r\n\r - Active lower body injury and/or severe and disabling pain limiting the capacity to\r undergo the evaluation.\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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"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\nDoxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test whether a mouthwash made with a drug called doxepin can\r reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth\r rinse preparations exist for patients with treatment-related oral mucositis pain such as the\r DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin\r compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by\r the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term\r pain management, as well as management of rash.\n\n**Clinical Trial Detailed Description:**\n\nPatients are stratified according to sex (male vs. female), concurrent use of chemotherapy\r (no vs. yes), patient age at registration (< 60 years old vs. ≥ 60 years old and RTOG acute\r radiation morbidity criteria (1 vs. 2 vs 3 or more). Protocol therapy will consist of 2\r cycles. Patients are randomized to one of three treatment regimens, which include doxepin,\r DLA and placebo. Cycle One will consist of one day. The care provider or nurse will confirm\r that the oral pain is at least 4 out of 10 severity level at the time of the rinse on the\r first day of the study. Patient will be asked to complete the baseline evaluation in the Oral\r Symptoms booklet. If the pain score is less than 4 then administration will be delayed until\r the pain is at least 4. Cycle Two will consist of an optional continuation phase lasting up\r to 7 days. Initiation of the Cycle 2/Continuation Phase may be delayed up to one week after\r Cycle 1/Day 1.\r\n\r Primary Objective:\r\n\r 1. Determine whether the doxepin rinse or DLA rinse is more effective than placebo in\r reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a\r patient-reported questionnaire at baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2\r hours, and 4 hours.\r\n\r Secondary Objectives:\r\n\r 1. Assess the adverse event profile of the doxepin rinse, the DLA rinse agent, and the\r placebo using a patient-reported questionnaire at 5 minutes, 15 minutes, 30 minutes, 1\r hour, 2 hours, and 4 hours for domains of unpleasant taste, burning or stinging\r discomfort, and drowsiness.\r\n\r 2. Compare the incidence of using additional analgesics between 1 and 4 hours after the\r initial mouthwash, between the doxepin oral rinse, the DLA rinse agent, and the placebo\r arms.\r\n\r 3. Compare the length of time that each study product is used by patients in the one-week\r continuation phase.\r\n\r 4. Compare the daily pain scores in the one-week continuation phase for the three study\r arms.\r\n\r 5. Compare the 24-hour morphine equivalent dose used in the continuation phase for the\r three study arms.\n\n**Clinical Trial Eligibility Criteria:**\n\n1. Documentation of Disease: Histologic documentation of malignancy currently undergoing\r a course of RT (with or without chemotherapy) including the oral cavity and/or\r oropharyngeal area to a dose of at least 4500 cGy using more than 5 fractions (i.e.,\r stereotactic body radiation therapy [SBRT] is not allowed).\r\n\r 2. Physical exam demonstrating evidence of radiotherapy-related mucositis in the visible\r oral cavity and/or oropharynx consistent with mucous membrane toxicity greater than 0\r using the Acute Radiation Morbidity Scoring Criteria.\r\n\r 3. At least 4 (out of 10) patient-reported oral pain related to oral mucositis secondary\r to RT for which the patient seeks relief, as measured on the Oral Pain Assessment.\r\n\r Note: The pain score must be at least 4 at the time that the patient starts the first\r dose of study medication. The patient may be enrolled to the study if s/he, at times,\r has a pain score of at least 4, so long as initiation of study treatment begins when\r the pain score is at least 4.\r\n\r 4. Ability to complete questionnaire(s) by themselves or with assistance.\r\n\r 5. No known allergy to diphenhydramine, lidocaine, antacid (aluminum hydroxide, magnesium\r hydroxide, and simethicone), doxepin, tricyclic antidepressants, or any known\r component of the drug formulation in the testing arms.\r\n\r 6. No use of any anti-arrhythmic medication (except for beta-blockers) including\r lidocaine, linezolid, ipratropium, or medications with high anti-cholinergic potency\r (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor)\r within 2 weeks prior to registration.\r\n\r 7. No current diagnosed untreated or unresolved oral candidiasis or oral HSV infection.\r\n\r 8. No history of untreated narrow angle glaucoma within 6 weeks prior to registration.\r\n\r 9. No untreated urinary retention within 6 weeks prior to registration.\r\n\r 10. No current use of glutamine or sucralfate powders at the time of registration (no\r washout required).\r\n\r 11. No cryotherapy for prophylactic mucosal protection within 6 weeks prior to\r registration.\r\n\r 12. Not pregnant, because patients eligible for this study will be receiving radiotherapy,\r which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of\r childbearing potential only, a negative pregnancy test done ≤ 28 days prior to\r registration is required.\r\n\r 13. Age ≥ 18 years\r\n\r 14. ECOG Performance Status 0, 1, or 2\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\nThrombolysis in Ischemic Spinal Cord Stroke\n\n**Clinical Trial Summary:**\n\nIschemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic\r events in the central nervous system (CNS). In most cases the consequences are catastrophic,\r with a high rate of severe functional disability and mortality rate up to 30%.\r\n\r Ischemic stroke of the spinal cord can arise from:\r\n\r 1. Dissection of the aorta.\r\n\r 2. Aneurism in the aorta.\r\n\r 3. Atherosclerotic disease of the aorta or vertebral arteries.\r\n\r 4. Spinal surgeries.\r\n\r 5. Spinal AVM.\r\n\r 6. Embolism from cardiac origin.\r\n\r 7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in\r hours until the patient becomes paralyzed in two or in all four limbs. In most cases the\r damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor\r weakness accompanied by disturbance of temperature and superficial sensation, urinary\r retention or bowel disorder, with preserved position and vibration sense.\r\n\r The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis\r of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS).\r Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the\r spinal cord is necessary upon arrival in the emergency department.\r\n\r One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and\r validated in numerous studies for ischemic events in the brain, until today no validated\r study in ischemic spinal stroke using thrombolysis has been completed.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with vascular risk factors\r\n\r 2. Patients with sudden weakness of the lower or upper limbs together with bowel\r disorder.\r\n\r 3. Window treatment - not over 6 hours since the start of the event till the start of the\r treatment.\r\n\r 4. Patient without dissection of the aorta in the abdomen.\r\n\r 5. Patient without contraindication to IVtPA.\r\n\r 6. Patient with no etiology found after clarification.\r\n\r Exclusion Criteria:\r\n\r 1. Refusal to sign an ICF. 2. Reason for weakness is known. 3. Patient with\r contraindication IVtPA.\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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"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\nMesenchymal Stem Cells Co-transplantation in Alternative Donor Transplantation of Severe Aplastic Anemia.\n\n**Clinical Trial Summary:**\n\nThe study is a phase II trial designed to evaluate the efficacy and safety of\r co-transplantation with bone marrow derived mesenchymal stem cells from related donors in\r alternative donor transplantation of severe aplastic anemia.\n\n**Clinical Trial Detailed Description:**\n\nAplastic anemia (AA) is an autoimmune hematologic stem cell disease mediated by activated\r T-lymphocytes that leads to bone marrow dysfunction. In the presence of an empty marrow,\r pancytopenia, and transfusion dependence, the severity of the disease is based on neutrophil\r (PMN) count: nonsevere AA (nSAA; PMN > 0.5 × 109/L), severe AA (SAA;PMN 0.2- 0.5 × 109/L),\r and very severe AA (vSAA; PMN< 0.2 × 109/L).\r\n\r Allogeneic BMT from an HLA-identical sibling donor or matched-alternative donor is the\r treatment of choice for patients with aplastic anaemia.Transplantation for patients with\r severe aplastic anaemia from an HLA identical sibling donor is now very successful with a\r 75-90% chance of long term cure and with overall survival of between 65% and 73% at 5 years\r for matched-alternative donor transplantation. However, these two approachs are limited by\r the availability of HLA-matched donors.\r\n\r Patients without HLA-identical sibling donor or matched-alternative donor can be offered\r immunosuppressive treatment (IST) involving injections of Anti-thymocyte globulin (ATG) in\r combination with cyclosporine (CsA). The treatment response with ATG is at best between\r 60-80%, 30%-40% patients relapse following an initial response to treatment. Moreover, a\r recent study has shown that on multivariate analysis of response at 6 months, only younger\r age, absolute reticulocyte count (ARC) and absolute lymphocyte count (ALC), correlate with\r response to ATG. Patients with SAA or vSAA, with much lower ARC and ALC, were poor response\r to IST and have high risks of dying of infection and bleeding.\r\n\r Nowadays, with advances in transplant technology, HLA-mismatched related donors and unrelated\r donors transplantation has achieved good clinical results. Data from the XJ Huang indicated\r that patients with HLA-mismatched related donors achieved 100% donor myeloid engraftment and\r have a survival rate of 64.6±12.4%. Retrospectively analyzed results for 154 patients with\r acquired SAA who received BMT from unrelated donors identified through the Japan Marrow Donor\r Program showed the probability of OS at 5 years was 56% (95% confidence interval, 34%-78%).\r\n\r Compared with malignant disease, mismatched related donor or unrelated donor HSCT for SAA\r involves distinct challenges mainly associated with high graft failure and high GVHD. So, if\r we can find a way to promote implantation meanwhile prevent or reduce GVHD , the efficacy of\r HLA-mismatched related donors transplantation can improve.\r\n\r Mesenchymal stem cells (MSCs) are multi-potent non-hematopoietic progenitors mainly found in\r BM, cord blood, and adipose tissue. MSCs are attractive because of the ease with which they\r can be isolated and expanded ex vivo, their ability to undergo multilineage differentiation,\r and their lack of immunogenicity. These cells were shown to provide support for the growth\r and differentiation of hematopoietic progenitor cells in BM micro-environments. In additon,\r preliminary studies have shown clinical effectiveness of allogeneic MSC in the treatment of\r refractory graft-versus-host disease and an improvement in or resolution of severe aGVHD when\r co-transplantation with MSCs. Due to these properties, MSCs have become an interesting\r candidate for use in cellular therapy and are considered \"theoretically perfect cells\" for\r potential clinical use against AA mismatched related donors transplantation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. In line with the 2009 Edition (United Kingdom) aplastic anemia diagnostic criteria for\r SAA or VSAA;\r\n\r 2. Age less than 50 years old,willing to transplant；\r\n\r 3. No HLA-identical sibling donor；\r\n\r 4. Have HLA-mismatched related donors or unrelated donors ( ≥5/10 HLA matched loci in\r related donors; ≥8/10 HLA matched loci in unrelated donors )\r\n\r 5. No serious infection or acute hemorrhage;\r\n\r 6. Cardiac ultrasound examination showed left ventricular ejection fraction is greater\r than 50%;\r\n\r 7. Both transaminase and serum creatinine level are no more than twice times the upper\r limit of normal value (ULN);\r\n\r 8. No acute infectious disease;\r\n\r 9. Ability to understand and the willingness to sign a written informed consent document.\r\n\r 10. ECOG score of 0-2 points.\r\n\r Exclusion Criteria:\r\n\r 1. Patients with severe infection or active bleeding;\r\n\r 2. With severe cardiac insufficiency, left ventricular ejection fraction <50%;\r\n\r 3. With severe liver dysfunction, liver function (ALT and the TBIL) is higher than the\r ULN 3 times;\r\n\r 4. With severe renal insufficiency, renal function (Cr) is twice higher than the ULN; or\r 24-hour urine creatinine clearance rate (Ccr) lower than 50ml/min;\r\n\r 5. Active tuberculosis, severe acute hepatitis and other infectious diseases in active\r period;\r\n\r 6. ECOG score more than 3 points;\r\n\r 7. Accompanied by malignant tumors and other clonal disease;\r\n\r 8. Poor compliance and the researchers considered unsuitable for MSC infusion.\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\nPost-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma\n\n**Clinical Trial Summary:**\n\nThe objective of this study is to determine the survival status of patients enrolled in study\r GLI01S (all-case observational study).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Malignant Glioma, patients enrolled in study GLI01S.\r\n\r Exclusion criteria:\r\n\r - Corresponding to contraindication of Gliadel.\r\n\r - Not applicable to indications of Gliadel.\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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"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\ndHACM in Lumbar Decompression and Microdiscectomy Surgery\n\n**Clinical Trial Summary:**\n\nProspective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar\r laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.\n\n**Clinical Trial Detailed Description:**\n\nThe objective of this prospective study is to evaluate the safety and efficacy of dHACM on\r clinical outcomes in lumbar laminectomy and microdiscectomy patients randomized to one of two\r groups: 1) without dHACM (control) or 2) dHACM.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Are 18 (eighteen) years of age or older at the time of surgery.\r\n\r 2. Patients with single- or multi-level spinal stenosis undergoing open lumbar\r laminectomy, or patients with single-level herniated nucleus pulposus undergoing\r single-level lumbar microdiscectomy\r\n\r 3. Are willing and able to return for the scheduled follow-up visits, follow post\r operative instructions and undergo the required radiographic exams for up to 5 time\r points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2\r weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery),\r including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled.\r\n\r 4. Are willing and able to sign study specific informed consent.\r\n\r Exclusion Criteria:\r\n\r 1. Non-English speaking patients\r\n\r 2. Non-surgical candidate defined as any patient deemed by the surgeon not to be a\r surgical candidate cannot participate for the following reasons: that patient does not\r meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a\r contraindication to surgery such as medical comorbidities, pregnancy, etc.\r\n\r 3. Allergic to aminoglycoside antibiotics\r\n\r 4. Is a prisoner\r\n\r 5. Is involved in worker's compensation or other litigation relative to the spine injury\r\n\r 6. Has a history of drug or alcohol abuse within the last 12 months\r\n\r 7. Is currently participating in another drug or device clinical trial\r\n\r 8. Previous spinal surgery\r\n\r 9. History of deformity, mechanical instability, or spinal fusion requirement\r\n\r 10. History of hard- or soft-tissue spinal infection\r\n\r 11. Has signs or symptoms of any disease, such as autoimmune disease, which could result\r in allograft failure, or has experienced allograft failure in the past\r\n\r 12. Patients unable to undergo a MRI\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\nBreast Cancer Survivorship & Work-Related Cognitive Limitation\n\n**Clinical Trial Summary:**\n\nThe proposed study seeks to evaluate the relationship between biopsychosocial functioning and\r work-related cognitive limitation among employed breast cancer survivors in a cross-sectional\r study with healthy control group. Specifically, this study will assess work-related cognitive\r limitation in association with depression, anxiety, pain, fatigue, sleep disturbance, and\r cognitive deficit of employed women with and without history of breast cancer. The primary\r purpose of this study is to assess the impact of objective cognitive functioning as a better\r predictor of cognitive shortcomings at work place in comparison to a self-report cognitive\r measure. The secondary purpose is to assess work related cognitive limitation in breast\r cancer survivors in comparison to their counterparts (employed women without history of\r cancer diagnosis). The third purpose is to explore how sociodemographic variables such as\r marital status, education, age, race, and ethnicity relates to perceived cognitive limitation\r at work among breast cancer survivors. Additionally, the study will examine the effects of\r medical variables as covariates on these relationships. Subsequently, the study will examine\r the level of mindful attention and awareness as a possible mediator between the\r psychological, somatic and cognitive distress and the work-related cognitive limitation.\r\n\r In this observational study, the control group is added as a mean to compare differences\r between groups and that no variables is being manipulated in this study. This precludes this\r research from being a quasi- or a true experimental design.\n\n**Clinical Trial Detailed Description:**\n\nPURPOSE AND JUSTIFICATION\r\n\r Cancer related psychological sequelae have significant impact on breast cancer survivors'\r cognitive functioning. Depression and negative affect have been shown to be highly correlated\r with reduced verbal knowledge, verbal memory, spatial ability, and figural memory. In\r addition, self-reported psychological stress was correlated with perceived cognitive deficits\r and poor performance on tests of memory, verbal fluency, and attention in breast cancer\r patients post-treatment. Similarly, depression and anxiety among breast cancer survivors have\r shown to be significantly correlated with subjective cognitive dysfunction including reduced\r attention, concentration, and memory. Moreover, persisting somatic sequelae including pain,\r fatigue, and sleep disturbances have indirect critical influence on breast cancer survivors'\r cognitive functioning. The study by Caplette-Gingras, Savard, Savard, and Ivers indicated\r that breast cancer survivors with sleep disturbance exhibited reduced cognitive functioning\r in episodic memory and executive functioning and reported subjective cognitive deficit in\r comparison to breast cancer survivors without sleep disturbances. Further, fatigue and\r cognitive dysfunction have shown significant association among breast cancer survivors.\r Somatic challenges that persist after the survivors' completion of treatment clearly exhibit\r adverse cognitive impairment.\r\n\r Cognitive deficit is one of the cognitive sequelae of breast cancer that adversely impacts\r survivors' general well-being. Persisting psychological and somatic symptoms and various\r treatments received for breast cancer are some reasons for cognitive deficits post-cancer.\r Chemotherapy and hormonal blockade therapy have been directly associated with adverse impacts\r on cognitive functioning including memory, executive functioning, and attention. Radiotherapy\r and surgery have also shown to impact breast cancer survivors' cognitive functioning. These\r cognitive impairments impact survivors' quality of life and general functioning. Therefore,\r enduring cognitive deficits resulting from breast cancer and its treatments have significant\r effect on survivors' health and re-establishment of normalcy. While breast cancer\r survivorship bolsters hope for a cancer-free life, enduring cancer-related symptoms impacts\r the survivors' occupational and social functioning, which in return may impinge on their\r recovery. Returning to the previously held roles allows a better recovery from breast cancer\r treatments, longer survivorship and lower reoccurrence rate. However, breast cancer survivors\r are among the majority of about 13% of cancer survivors that stop working 4 years post-cancer\r due to \"cancer-related reasons\". Employed women with breast cancer history report learning,\r long-term memory, attention, concentration, and executive functioning problems. Hence, these\r reported cognitive difficulties impact job performance, ability to work, and job maintenance.\r These cognitive deficits not only impact the breast cancer survivors' work performance and\r ability to retain their position but they also impact the survivors' psychological and social\r well-being and vice-versa.\r\n\r Most individuals who experience psychological (i.e., depression, anxiety) and somatic\r distress (pain, fatigue and sleep) have reported cognitive difficulties and shortcomings.\r Similarly, breast cancer survivors report experiencing cognitive difficulties in relation to\r their psychological and somatic distresses. Although, cognitive difficulties experienced by\r individuals' with and without cancer history has an impact on individuals quality of life and\r level of functioning; the cognitive deficit breast cancers survivors endure through cancer\r treatment (i.e., chemotherapy) impacts their cognitive functioning on a greater extend. This\r shortcoming post cancer treatment impacts cancer survivors' everyday functioning and quality\r of life on a different level, which impacts their survivorship experience and overall\r functioning.\r\n\r Cognitive limitation among breast cancer survivors in the context of work assesses cognitive\r deficits that survivors experience at work. Given that cognitive functioning among breast\r cancer survivors is affected by various factors, such as cancer diagnosis and treatment,\r work-related cognitive limitation might also be impacted by numerous variables. Nevertheless,\r there are more studies yet to be done exploring work-related cognitive limitation among\r employed breast cancer survivors in association with various cancer-related symptoms. Most\r studies have assessed implication of survivorship and work performance outcome among breast\r cancer survivors but few have focused on work-related cognitive limitation. For example,\r work-output and performance have been shown to be impacted negatively as a result of\r persisting symptoms experienced by breast cancer survivors, such as fatigue and reduced\r physical and mental ability. The few studies that have investigated work-related cognitive\r limitation have looked at the relationship between work-related cognitive limitation and work\r output. Other than Ottati and Feuerstein, no other study has looked at the relationship\r between cancer-related symptoms and work-related cognitive limitations among breast cancer\r survivors. Although, the study by Ottati and Feuerstein has looked at the relationship\r between cancer-related symptoms and work-related cognitive limitation, they only assessed\r depression, anxiety, fatigue and pain as cancer-related symptoms. They did not assess the\r association of cognitive functioning and sleep disturbance as cancer-related symptoms in\r relation to work-related cognitive limitation. In addition, their study did not involve a\r healthy control group to assess for any differences amongst the two groups.\r\n\r The proposed study seeks to evaluate the relationship between biopsychosocial functioning and\r work-related cognitive limitation among employed breast cancer survivors in a cross-sectional\r study with healthy control group. Specifically, this study will assess work-related cognitive\r limitation in association with depression, anxiety, pain, fatigue, sleep disturbance, and\r cognitive deficit of employed women with and without history of breast cancer. The primary\r purpose of this study is to assess the impact of objective cognitive functioning as a better\r predictor of cognitive shortcomings at work place in comparison to a self-report cognitive\r measure. The secondary purpose is to assess work related cognitive limitation in breast\r cancer survivors in comparison to their counterparts (employed women without history of\r cancer diagnosis). The third purpose is to explore how sociodemographic variables such as\r marital status, education, age, race, and ethnicity relates to perceived cognitive limitation\r at work among breast cancer survivors. Additionally, the study will examine the effects of\r medical variables as covariates on these relationships. Subsequently, the study will examine\r the level of mindful attention and awareness as a possible mediator between the\r psychological, somatic and cognitive distress and the work-related cognitive limitation.\r\n\r I. STUDY AIM AND HYPOTHESIS\r\n\r 1. Hypothesis or question (s) to be addressed: A. Psychological symptoms (increased\r depression, anxiety, and distress) will account for significant amount of variance in\r predicting work-related cognitive limitations.\r\n\r B. Somatic symptoms (fatigue, pain, and sleep disturbance) will account for significant\r amount of variance in predicting work-related cognitive limitations.\r\n\r C.Self-reported cognitive complaint will be positively correlated with work-related cognitive\r limitation in both groups.\r\n\r CI. After controlling for psychological and somatic factors, objective cognitive functioning\r will emerge as a significant predictor of cognitive difficulty at work.\r\n\r CII. After controlling for psychological and somatic factors, employed breast cancer\r survivors will present with more work-related cognitive limitation in comparison to the\r control group.\r\n\r D. Marital status, race/ethnicity, age, education, and socioeconomic status will act as\r moderators between psychological, somatic, and cognitive sequelae and work-related cognitive\r limitation.\r\n\r E. Medical variables, prior treatment, and work history will potentially act as covariates.\r\n\r F. Level of mindfulness of attention and awareness will potentially act as a moderator in\r level of cognitive performance at work place between both groups.\r\n\r II. METHOD AND MATERIALS\r\n\r 1. Participants\r\n\r 1. Number, age, and type of participants The breast cancer survivors group will\r include women between the ages of 18 to 69 who have had received a stage I-III\r diagnosis of breast cancer in the past and completed primary treatment and finished\r with treatment for at least 6 months. The healthy control group will include women\r between the ages of 18-69 who are healthy with no diagnosis of cancer. The\r participants in both groups will be employed working part-time or full-time at the\r time of assessment. Participants working between 1 to 34 hours a week will be\r considered part-time employees. The demographic sheet and questionnaires are\r printed in English, so participants must speak English to participate in the study.\r Because this is an Internet study, individuals will be required to have access to a\r computer and the Internet. The number of participants will be determined by the\r result of recruitment efforts from a variety of sources, including online and\r in-person advertisement. The expectation is for over 200 participants, 100+ for\r each group at minimum.\r\n\r 2. Procedure for selecting participants The investigator will contact agencies that\r help researchers to recruit participants by email and/or phone to ask for their\r permission to post/handout flyers as means of recruiting. The agencies will be\r provided with sample flyer and explanation of how participants' consent will be\r obtained and confidentiality protected. In addition, a description of the intended\r use of the data will be provided. The investigator will also post flyer and\r leaflets online and on hospital and universities campuses.\r\n\r Individual interested in participating in the study will have an access to the\r website indicated on the flyers. Participants will need to review the online\r consent form and agree to the conditions, before being able to proceed to complete\r the surveys. Participants will provide their informed consent by clicking on the\r \"Yes, I agree\" button. The entire survey should take about 40-45 minutes to\r complete.\r\n\r 3. Rationale for employing the type of participants selected for the study The\r rationale for using these particular participants is because the study is about the\r relationship between cancer-related symptoms and work-related cognitive functioning\r among working female breast cancer survivors. In addition, a healthy control group\r is needed for an effective and a qualitative study. By recruiting from a variety of\r places, the sample will be more generalizable.\r\n\r 4. Are participants expected to benefit from the participation in the study? If so,\r how? There are no expected benefits. However, potentially a participant might (a)\r gain a better understanding of her experiences regarding her health (i.e. post\r cancer health or general health), (b) gain a clearer idea about her psychological,\r somatic, and cognitive conditions. In addition, it is the investigators hope that\r through participation, researchers will learn more about the relationship between\r biopsychosocial functioning and work-related cognitive limitation.\r\n\r 5. Are any risks to the participants from participation in the study? If so, what are\r they? The foreseeable risks or discomfort are minimal, but could include emotional\r discomfort about the content of the questionnaires and some distress as\r participants are reminded of negative experiences. Referrals are provided at the\r beginning of survey under the ALTERNATIVE section and at the end of the survey for\r individual who may experience distress as a result of participating in the study.\r\n\r 6. Will participants be identified with the data? No identifying information will be\r linked to participants' responses. Individuals' name and email address will be\r inquired in order to access the Log in information to complete the Brain\r Performance Test on Lumosity.com. This information will be stored on a\r password-protected file and will not be linked to the survey responses.\r\n\r 2. Setting - Specify where your research will be conducted and, if appropriate, include a\r signed letter of consent from the individual who approved research at this site.\r\n\r Data collection will take place via the worldwide webs. Specifically, Qualtrics.com and\r Lumosity.com will be utilized as a tool to collect participants' responses and implement\r cognitive testing. Such a setup provides the participants with an opportunity to\r participate in the study privately, at a time that is convenient for them, and in a\r setting that is most comfortable for them.\r\n\r 3. Materials - Describe any test materials to be used, such as psychological, educational,\r or evaluative tests. Please include copies of the above materials with the protocol,\r and/or provide representative examples of computer stimulus materials.\r\n\r Data collection will occur via a worldwide web.\r\n\r Demographic Questionnaire (Developed by principle Investigator) The demographic sheet\r includes general information such as age, gender, ethnicity, marital status, and level\r of education.\r\n\r Medical and Treatment History Questionnaire (Developed by principle Investigator) The\r medical and treatment history questionnaire are questions pertaining to Breast Cancer\r such as stage of diagnosis, length of time since diagnosis, Treatment length and\r treatment status are also included. Lastly, several questions will address participants'\r medical and family history.\r\n\r Center of Epidemiological Studies of Depression (CES-D) The CES-D is a self-report\r measure that measures depressive symptomology. The CES-D consists of 20 items, four of\r which are worded in the positive direction to avoid a response set. Participants are\r asked to choose on a 4-point Liker-scale (0 = Rarely or none of the time, 1= some or a\r little of the time, 2=Occasionally or a moderate amount of time, and 3=Most or all of\r the time) how frequently in the previous week they had experience the stated feeling or\r symptoms. The total possible scores ranges from 0 to 60, with higher scores meaning\r higher distress. Scores of 16 or higher will suggest an elevated level of depression.\r The CES-D has an internal consistency of 0.85 in the general population and 0.90 in the\r patient sample, indicating the measures reliability. In addition, the construct validity\r of the scale presents four factors including depressive affect, somatic symptoms,\r interpersonal relationships, and positive affect.\r\n\r Generalized Anxiety Disorder - 7 (GAD-7) The GAD-7 is a 7 item self-report scale\r assessing the extend of generalized anxiety in the general population. It assess the\r frequency of times over the past two weeks that participants may have experienced the\r seven symptoms central to general anxiety disorder. Responses ranges from 0) not at all,\r 1) sometimes, 2) often, and 3) nearly every day. The numbers adds up for a possible\r scores ranging from 0 to 21, with higher scores indicating higher levels of generalized\r anxiety. The scores greater than 5, but less than 10 indicates mild anxiety, with scores\r 10 or greater and less than 15 indicating anxiety. Scores 15 or greater are indicative\r of severe anxiety symptoms. This measure has show good internal consistency (alpha\r coefficient of 0.89)\r\n\r Brief Pain Inventory -Short Form (BPI-SF) The BPI-SF is a 9-item self-report\r questionnaires assessing pain severity and pain interference with daily functioning. It\r assesses pain based on four pain severity items: 1) worst; 2) least; 3) average; and 4)\r now; and seven pain interference items including: 1) general activity; 2) walking; 3)\r work; 4) mood; 5) enjoyment of life; 6) relations with others; and 7) sleep. The BFI-SF\r has been found to be a valid and reliable measure for assessing pain from cancer with a\r cronbach alpha reliability of 0.77 to 0.91.\r\n\r Brief Fatigue Inventory (BFI) The BFI is a 9-item self-report questionnaire with items\r measured on 0-10 numeric rating scale assessing fatigue severity and fatigue\r interference with daily functioning in clinical and research settings. It assesses\r fatigue based on 3 items rating severity of their fatigue as \"worst\", \"usual\", and \"now\"\r during waking hours, with 0 being \"no fatigue\" and 10 being \"fatigue as bad as you can\r imagine.\" In addition, six items assess the amount of fatigue that has interfered with\r different aspects of the participants' life during the past week. The interference items\r are measures on a 0 to 10 scale, with 0 being \"does not interfere\" and 10 being\r \"completely interferes.\" The BFI is found to be an internally reliable measure best for\r interpreting the severity of fatigue and a reliable instrument used for fatigue\r assessment among cancer patients.\r\n\r Insomnia Severity Index (ISI) The ISI is a 7-item self-report questionnaire that\r measures: 1) the severity of sleep-onset (initial); 2) sleep maintenance (middle); 3)\r early morning awakening (terminal) problem; 4) satisfaction with current sleep pattern;\r 5) interference with daily functioning; 6) noticeability of the sleep problem; and 7)\r degree of distress or concern caused by the sleep problem. Each item is rated on a\r Likert scale ranging from 0 (not at all) to 4 (extremely). The ISI total score is\r obtained by adding the scores of the 7 items (range 0-28). The ISI internal consistency\r is high (r=0.78). Any score below eight is considered not clinically significant\r insomnia.\r\n\r Mindfulness Attention Awareness Scale (MAAS) The MAAS is a 15-item scale designed to\r assess a core characteristic of mindfulness by measuring the awareness of present moment\r (i.e. what is occurring, and what is taking place). This measure has shown \"excellent\r psychometric properties\". The MAAS's internal consistency levels (Cronbach's alphas)\r ranges from .80 to .90. In addition, this measure has shown high test-retest\r reliability, discrimination and convergent validity, known-group validity, and criterion\r validity.\r\n\r Multifactorial Memory Questionnaire (MMQ) The MMQ is a self-report measure that assesses\r three dimension of memory, including MMQ-Contentment, MMQ- Ability, memory, and\r MMQ-Strategy. The MMQ-Contentment consists of 18 items, which each item is rated on\r 5-point scale (i.e., \"strongly agree\", \"agree\", \"undecided\", \"disagree\", and \"strongly\r disagree\"). The MMQ-Ability consists of 20 items, which each item is rated on 5-point\r scale (i.e., \"all the time\", \"often\", \"sometimes\", \"rarely\", and \"never\"). The\r MMQ-Strategy consists of 14 items, which each item is rated on a 5-poin scale (i.e.,\r \"never\", \"rarely\", \"sometimes\", \"often\", and \"all the time\"). The MMQ is found to have a\r high reliability for each dimension measured (MMQ-Contentment = 0.93; MMQ-Ability =\r 0.86, and MMQ-Strategy= 0.88). This measure was reported to have \"excellent\" content,\r construct and factorial validity and a reliable relevance(Troyer & Rich, 2002) to be\r used in clinical applications.\r\n\r Cognitive Symptom Checklist - Work 21 Item (CSC-W21) The CSC-W21 is a 21-item\r self-report questionnaire that assesses work-related cognitive limitation among breast\r cancer survivors. The measure uses dichotomous response scale of yes or no. The higher\r scores on CSC-W21 are associated with greater work-related cognitive limitation. The\r CSC-W21 has three factor models of: working memory, executive function, and task\r completion subscales with a high demonstrated internal reliability (α =. 88). The\r CSC-W21 have found to be valid and highly correlated with other subjective cognitive\r measures such as Functional Assessment of Cancer Therapy-Cognition, Version 2 (FACT-COG)\r and CSC-W59 (CSC-W21 is a factor analysis of the CSC-W59).\r\n\r Lumosity Brain Performance Test (BPT) The BPT is an assessment battery designed by Lumos\r Labs. This measure is developed by the Lumosity Lab research and development team and is\r based on validated and liable cognitive batteries including: Trail-making, Memory Span\r assessments, Grammatical reasoning, and Stop signal task. The assessment has raw scores\r and scaled scores in which are translated into an age-normed scaled scores. These scores\r are interpreted based on a particular BPT calculation through the site.\r\n\r 4. Procedures -\r\n\r 1. Describe what participants will be required to do, step by step.\r\n\r 2. State where, when, and by whom the research will be conducted.\r\n\r 3. Time Individuals will be welcomed to the study and introduced to the nature and\r purpose of the study. They will then need to review and consent to the study prior\r to being able to proceed to the questionnaires. If the individuals choose to\r proceed with the study, they will then fill out the demographic, and medical\r questionnaires as well as the six other questionnaires. Participants will have an\r option of exiting the survey at any point by clicking on the \"Exit\" link available\r at the top of each page. If a person drops out of the study, their responses will\r not be included in the data. Participants will complete the survey a single time.\r The entire study should take no more than 40-45 minutes to complete.\r\n\r 4. Confidentiality - Describe mechanisms for maintaining confidentiality\r\n\r Participation in research may involve a loss of privacy, but information will be\r handled as confidentially as possible. To participate in the study, the individuals\r need to access the website and remain anonymous. The demographic sheet and\r questionnaires do not ask the participants to identify any information such as\r their name or home address, thus protecting the participant's privacy.\r\n\r Individuals' name and email address will be inquired separate from their survey\r response. This information is needed so that the individuals could be provided with\r a Log In ID to access the Brain Performance Test at Lumosity.com. No identifying\r information will be required on Lumosity webpage other than the Log In information,\r which will be provided on the Primary Investigators Qualtrics page. Lumos Lab will\r have no access to the survey responses or the individual's identification. They\r will only gather the data from the battery anonymously.\r\n\r No personal information shall be disclosed to anyone without the individual's\r permission or unless required by law (i.e., court-ordered release of information,\r duty to protect against imminent danger to self or others and suspicion of child,\r dependent, or elder abuse). Information obtained in this research project may be\r published in journals or presented at meetings but no identifying information shall\r be revealed.\r\n\r 5. Consent Process and Documentation\r\n\r Participating in the study is the individuals' choice, and individuals will provide their\r informed consent to become part of the study after being receiving extensive information\r about the purpose of the study by pressing the \"Yes\" button. A memo will be written on the\r survey suggesting that the participants print out a copy of the consent form for their\r records. Throughout the study, the option to end the study will be available, as consent in a\r process rather than a one-time agreement.\r\n\r Individuals 18 to 69 years of age will be invited to participate. There is no deception\r involved in the study and the consent form outlines the way data will be handled. No special\r population, such as children or inmates, will be included in the study. Therefore, no assent\r forms are necessary.\r\n\r The study will take place in English. All the measures are available in English, thus no\r translation of the measures was necessary.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria for breast cancer survivor group:\r\n\r - Female\r\n\r - Between the age of 18 to 69 years old\r\n\r - Working part-time or full-time at the time of the assessment\r\n\r - English-speaking\r\n\r - Have Internet and computer access\r\n\r - Have completed primary treatment and finished with treatment for at last 6 months\r (hormonal blockade therapy is permitted)\r\n\r - Have received a stage I-III diagnosis of cancer\r\n\r Inclusion Criteria for control group:\r\n\r - Female\r\n\r - Between the age of 18 to 69 years old\r\n\r - Working part-time or full-time at the time of the assessment\r\n\r - English-speaking\r\n\r - Have Internet and computer access\r\n\r - Have no cancer diagnosis\r\n\r Exclusion Criteria:\r\n\r - Diagnosis of dementia, history of brain injury and adult attention deficit\r hyperactivity (ADHD), epilepsy, current drug or alcohol abuse\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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"content": "**Clinical Trial Title:**\n\nEfficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2\n\n**Clinical Trial Summary:**\n\nHIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in\r China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the\r treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and\r control group. In HIPEC group, the patients undergo radical gastrectomy with D2\r lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the\r control group just undergo radical gastrectomy with D2 lymphadenectomy followed by\r postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative\r systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.\n\n**Clinical Trial Detailed Description:**\n\nGastric cancer (GC) is the fourth most common cancer, and the second leading cause of\r cancer-related death worldwide. Advances in diagnostic and therapeutic approaches have\r achieved long-term survival for early GC. However, receiving perioperative/postoperative\r systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection, 5-year survival rates\r of advanced gastric cancer remain under 30%. 40-60% of recurrences are peritoneal and/or\r locoregional. hyperthermic intraperitoneal chemotherapy (HIPEC) technique is increasingly\r used in the curative treatment of primary and digestive peritoneal carcinomatosis, in\r association with cytoreductive surgery. Theoretically, HIPEC eliminates free cancer cells\r that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal\r carcinomatosis recurrences. The benefit of using HIPEC as an adjuvant treatment for advanced\r gastric cancer has been reported in several randomized studies and a meta-analysis. Surgical\r resection combined with HIPEC significantly reduces the peritoneal recurrences and improves\r the overall survival of GC patients. But there is not a prospective and randomized phase III\r clinical study of HIPEC in the treatment of locally advanced gastric cancer after radical\r surgery in China so far.\r\n\r In order to evaluate the survival benefit and safety of radical surgery and HIPEC followed by\r postoperative chemotherapy in local advanced gastric cancer, patients who fulfill the\r inclusion and exclusion criteria will be recruited in this study and randomized to two\r treatment groups (HIPEC group and control group). In HIPEC group, the patients undergo\r radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative\r chemotherapy. Patients in the control group just undergo radical gastrectomy with D2\r lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8\r cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) . Patients are followed\r up for 5 years and the survival outcome will be analyzed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 18 < age ≤ 70 years old\r\n\r - Male or Non pregnant female\r\n\r - The Eastern Cooperative Oncology Group (ECOG) status 0-1\r\n\r - T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th\r edition)\r\n\r - No distance metastasis, eligible for D2 lymphadenectomy\r\n\r - Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy\r\n\r - White blood cells > 4,000/mm3\r\n\r - neutrophils ≥ 1,500/mm3\r\n\r - platelets ≥ 100,000/mm3\r\n\r - hemoglobin>9g/l\r\n\r - Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper\r limit of nominal (ULN)\r\n\r - total bilirubin (TBIL) < 1.5 times ULN\r\n\r - serum creatinine < 1 times ULN\r\n\r - Having given written informed consent prior to any procedure related to the study\r\n\r Exclusion Criteria:\r\n\r - Have other cancer within 5 years\r\n\r - Existence of distance metastasis during surgey (M1)\r\n\r - Prior malignant tumors with detectable signs of recurrence or distant metastasis\r\n\r - Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac\r insufficiency, persistent hypertension despite medicinal treatment, ejection\r fraction<50%\r\n\r - Epileptic seizures patients need medicine control\r\n\r - Uncontroled mental disease or mental disorder\r\n\r - Drug abuse or psychological or social factors affect the judgment of results\r\n\r - Contraindication to any therapy contained in this regimen specific to the study\r\n\r - Receiving other chemotherapy, radiotherapy or immunotherapy\r\n\r - Without given 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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"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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"content": "**Clinical Trial Title:**\n\nImmunodeficiency in Cartilage-hair Hypoplasia: Sub-project on Safety of Vaccination Against Chickenpox\n\n**Clinical Trial Summary:**\n\nThe investigatoris will carefully select cartilage-hair hypoplasia patients unexposed to\r varicella (VZV) and immunize patients in a controlled manner with VZV vaccine. Patients will\r be selected on the basis of disease severity and the degree of immunodeficiency (including\r CD4+ T-cell counts). Any potential complication of VZV immunization, such as rash, will be\r discussed with the patients/caregivers beforehand and acyclovir will be used to treat any VZV\r related symptoms, consistent with the current practices. The investigators will verify the\r development of immune response to vaccination by testing for VZV antibodies and cell-mediated\r immunity.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - genetically confirmed cartilage-hair hypoplasia diagnosis\r\n\r - age >12 months\r\n\r - no history of chickenpox\r\n\r - informed concent of the patient/caregiver.\r\n\r Exclusion Criteria:\r\n\r - positive serum IgG for varicella zoster virus\r\n\r - low CD4+ cell counts (<15% or <200 cells/mm3)\r\n\r - clinical or laboratory signs of severe immunodeficiency\r\n\r - ongoing intravenous or subcutaneous immunoglobulin treatment\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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"content": "**Clinical Trial Title:**\n\nThe Influence of Global Femoral-offset Changes After Total Hip Arthroplasty\n\n**Clinical Trial Summary:**\n\nThe femoral-offset (FO) is one of the important perioperative parameters in THA. A\r prospective cohort study was conducted between September 2010 and December 2013. All patients\r with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion.\r Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were\r excluded. Global FO was measured in each patient within 3 months before the THA and at the\r second postoperative day using a standardized protocol. According to the postoperative\r measurement, patients were divided into three groups: 1) the decreased FO group, where the FO\r of operated side was reduced more than 5mm compared with the contralateral side, 2) the\r restored FO group, where the FO of operated side was within 5mm restored compared with the\r contralateral side, and 3) the increased FO group, where the FO of operated side was\r increased more than 5mm compared with the contralateral side.\r\n\r Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and\r EQ-5D questionnaires in addition to a clinical assessment with palpation of the operated hip\r and measurement of the abductor muscle strength.\n\n**Clinical Trial Detailed Description:**\n\nThe results of total hip arthroplasty (THA) have shown great improvement during the last\r decades in terms of function, quality of life and prosthetic survival. Beside pain relief,\r surgeons aim to position the stem and cup in a correct manner to restore the biomechanical\r forces and range of motion of the operated hip. The femoral-offset (FO) is one of the\r important perioperative parameters in THA. A prospective cohort study was conducted between\r September 2010 and December 2013. All patients with unilateral primary osteoarthritis (OA)\r treated with THA were considered for inclusion. Patients with secondary OA, previous spinal,\r pelvic, or lower limb injuries or fractures were excluded. Global FO was measured in each\r patient within 3 months before the THA and at the second postoperative day using a\r standardized protocol. According to the postoperative measurement, patients were divided into\r three groups: 1) the decreased FO group, where the FO of operated side was reduced more than\r 5mm compared with the contralateral side, 2) the restored FO group, where the FO of operated\r side was within 5mm restored compared with the contralateral side, and 3) the increased FO\r group, where the FO of operated side was increased more than 5mm compared with the\r contralateral side.\r\n\r Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and\r EQ-5D questionnaires in addition to a clinical assessment. Patients completed an additional\r questionnaire enquiring about any residual problems with the use of walking aid and residual\r pain around the operated hip. During the clinical assessment, palpation of the operated hip\r and measurement of the abductor muscle strength were undertaken.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Unilateral primary osteoarthritis treated with total hip arthroplasty\r\n\r Exclusion Criteria:\r\n\r - Secondary osteoarthritis\r\n\r - Previous spinal, pelvic or lower limb injuries or fractures\r\n\r - Bilateral osteoarthritis\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\nThe Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma\n\n**Clinical Trial Summary:**\n\nThis is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus\r standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine\r or temozolomide) or bevacizumab administered to subjects undergoing resection for first or\r second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the\r inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1\r ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment\r with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation\r status. A second stratification factor is based on the patient's Karnofsky Performance Score\r (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices\r for the control arm in regions, the trial will be stratified by geographical region during\r the randomization process.\r\n\r Funding Source - FDA OOPD\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subject has given written informed consent\r\n\r 2. Subject is between 18 years old and 75 years old, inclusive\r\n\r 3. Subjects must have histologically proven GBM or AA and:\r\n\r 1. Must have received first-line multimodal therapy with surgery followed by\r temozolomide (unless MGMT promoter unmethylated) and radiation (subjects with GBM\r must have received temozolomide and radiation concurrently)\r\n\r 2. Must be in first or second recurrence (including this recurrence)\r\n\r 3. Recurrence must be confirmed by diagnostic biopsy with local pathology review or\r contrast-enhanced MRI. If first recurrence of GBM is documented by MRI, an\r interval of at least 12 weeks after the end of prior radiation therapy is\r required unless there is either: i) histopathologic confirmation of recurrent\r tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field\r\n\r 4. Subjects must have measurable disease preoperatively, defined as at least 1\r contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm, as per\r RANO criteria\r\n\r 5. Subjects must be at least 4 weeks post last dose of temozolomide\r\n\r 6. Prior gamma knife, stereotactic radiosurgery, or other focal high-dose radiotherapy is\r allowed but the subject must have either histopathologic confirmation of recurrent\r tumor, or new enhancement on MRI outside of the radiotherapy treatment field\r\n\r 7. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for\r ≥ 80% resection of enhancing region\r\n\r 8. IDH mutation status of the primary tumor must be available or tumor samples must be\r available for pre randomization testing\r\n\r 9. Laboratory values adequate for patient to undergo surgery, including:\r\n\r - Platelet count ≥ 60,000/mm3\r\n\r - Hgb ≥ 10 g/dL\r\n\r - Absolute neutrophil count (ANC) ≥ 1,500/mm3\r\n\r - Absolute lymphocyte count (ALC) ≥ 500/mm3\r\n\r - Adequate liver function, including:\r\n\r - Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's syndrome)\r\n\r - ALT ≤ 2.5 x ULN f. Estimated glomerular filtration rate of at least 50\r mL/min by the Cockcroft Gault formula\r\n\r 10. Women of childbearing potential (≥12 months of non-therapy-induced amenorrhea or\r surgically sterile) must have had a negative serum pregnancy test within the past 21\r days and must use a birth control method in addition to barrier methods (condoms).\r\n\r 11. Subject or subject's partner is willing to use condoms for 12 months after receiving\r Toca 511 or until there is no evidence of the virus in his/her blood, whichever is\r longer.\r\n\r 12. The subject has a KPS ≥ 70\r\n\r 13. The subject is willing and able to abide by the protocol\r\n\r Exclusion Criteria:\r\n\r 1. History of more than 2 prior recurrences (including this recurrence) of GBM or AA\r\n\r 2. History of other malignancy, unless the patient has been disease free for at least 5\r years. Adequately treated basal cell carcinoma or squamous cell skin cancer is\r acceptable regardless of time, as well as localized prostate carcinoma or cervical\r carcinoma in situ after curative treatment\r\n\r 3. Histologically confirmed oligodendroglioma or mixed glioma\r\n\r 4. Known 1p/19q co deletion\r\n\r 5. A contrast enhancing brain tumor that is any of the following:\r\n\r - Multi focal (defined as 2 separate areas of contrast enhancement measuring at\r least 1 cm in 2 planes that are not contiguous on either fluid attenuated\r inversion recovery (FLAIR) or T2 sequences);\r\n\r - Associated with either diffuse subependymal or leptomeningeal dissemination; or\r\n\r - > 5 cm in any dimension\r\n\r 6. The subject has or had any active infection requiring systemic antibiotic, antifungal\r or antiviral therapy within the past 4 weeks\r\n\r 7. The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet\r agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the\r scheduled resection that cannot be stopped for surgery\r\n\r 8. The subject is human immunodeficiency virus (HIV) positive\r\n\r 9. The subject has a history of allergy or intolerance to flucytosine\r\n\r 10. The subject has a gastrointestinal disease that would prevent him or her from being\r able to swallow or absorb flucytosine\r\n\r 11. The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for\r nitrosoureas) of the planned surgery date\r\n\r 12. The subject received any investigational treatment within the past 30 days or prior\r immunotherapy or antibody therapy within the past 45 days.\r\n\r 13. The subject is pregnant or breast feeding\r\n\r 14. The subject intends to undergo treatment with the Gliadel® wafer at the time of this\r surgery or has received the Gliadel® wafer < 30 days from W1D1 (surgery)\r\n\r 15. The subject has received bevacizumab for their disease unless in the context of\r primary therapy for newly diagnosed glioma\r\n\r 16. For subjects planned to potentially receive bevacizumab, they have no evidence of\r uncontrolled hypertension (defined as a blood pressure of ≥ 150 mm Hg systolic and/or\r ≥ 100 mm Hg diastolic on medication) or active GI perforation\r\n\r 17. The subject has received systemic dexamethasone continuously at a dose > 8 mg/day for\r 8 weeks prior to the date of the screening assessment\r\n\r 18. Severe pulmonary, cardiac or other systemic disease, specifically:\r\n\r - New York Heart Association > Grade 2 congestive heart failure within 6 months\r prior to study entry, unless asymptomatic and well controlled with medication\r\n\r - Uncontrolled or significant cardiovascular disease, clinically significant\r ventricular arrhythmia (such as ventricular tachycardia, ventricular\r fibrillation, or Torsades des pointes), clinically significant pulmonary disease\r (such as ≥ Grade 2 dyspnea, according to CTCAE 4.03)\r\n\r - Subjects who have any other disease, either metabolic or psychological, which as\r per Investigator assessment may affect the subject's compliance or place the\r subject at higher risk of potential treatment 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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"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\nContinuous Adductor Canal Block (CACB) vs. Combined Spinal Epidural (CSE) in Total Knee Arthroplasty\n\n**Clinical Trial Summary:**\n\nPurpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for\r total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.\r\n\r Hypothesis: CACB will provide better mobility than CSE post operatively.\n\n**Clinical Trial Detailed Description:**\n\nPurpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for\r total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.\r\n\r Hypothesis: CACB will provide better mobility than CSE post operatively.\r\n\r Background/Scientific Review:\r\n\r Total knee arthroplasty (TKA) is associated with varying degrees of pain post operatively\r ranging from mild to severe despite the use of comprehensive multimodal analgesic regimens1.\r Optimizing pain relief is vital for functional recovery after total knee arthroplasty2.\r Peripheral nerve blocks have been commonly used to improve pain relief and reduce opioid\r requirements. The addition of nerve blocks involving the femoral nerve have been shown to\r provide superior pain control3 and shortened hospital stay compared to epidural or\r intravenous patient controlled analgesia alone1. However, femoral nerve blocks can result in\r quadriceps weakness leading to functional impairment and an increased risk of falling post\r operatively4. Unlike Femoral Nerve Blocks (FNB), adductor canal blocks (ACB) are\r predominantly sensory blocks which preserve quadriceps muscle strength and ambulation ability\r better than FNBs, while providing equivalent pain relief5-9.\r\n\r Recent randomized studies have also shown ACB to be superior to placebo in the setting of\r spinal and general intraoperative anesthesia in terms of ambulation, pain control, and opioid\r consumption10-12. In a recent retrospective cohort study, the addition of ACB to local\r infiltration analgesia (LIA) was associated with further improvement in early ambulation\r benchmarks and a higher rate of home discharge compared with only LIA9. While CACB and CSE\r are used as part of routine care at Rush University Medical Center and around the country,\r there have been no studies directly comparing CACB to CSE.\r\n\r Study Design: Department funded, single center, prospective, randomized, parallel outcome\r based clinical trial. 300 subjects scheduled to undergo primary unilateral TKA will be\r randomized to receive CSE, CACB + General, or CACB + Spinal as per routine care. Subjects\r will be enrolled for no more than 6 weeks.\r\n\r Power Analysis: Sample size calculations were based on the primary aim, of CACB plus Spinal\r anesthesia versus standard care (combined spinal epidural, CSE) improving ambulation distance\r at postoperative day 1 (POD1). Based on results from a pilot study we found that the CSE\r group had at POD1 a mean distance traveled of 159 feet with a standard deviation (SD) of 111\r feet, while the CACB + Spinal anesthesia subjects walked over twice the distance on average\r with a similar SD.\r\n\r To be conservative we expect both the CACB + Spinal anesthesia and CACB + General Anesthesia\r groups to walk at least 35% farther on average, or at least equal to CSE group.\r\n\r Based on a one-way, 3-level AVOVA with the primary contrast of CABC + Spinal versus CSE at a\r 35% greater ambulation difference, for 90% power, with α of 5%, requires a sample size of 84\r subjects per group. Increasing the sample size to 100 will provide for a 16% dropout rate.\r Total of 300 patients.\r\n\r Treatment Groups:\r\n\r 1. General Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal\r Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.\r\n\r 2. Spinal Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal\r Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.\r\n\r 3. Spinal Intraoperative Anesthesia with standard Epidural (0.1% bupivacaine with fentanyl\r 5 mcg/mL running at 6mL/hr with 1mL q15 bolus) with standard post-operative analgesics.\r\n\r Demographics/Patient Specifics: Age, Sex, ASA score, Weight, Height, Operative Time, BMI,\r Walker, Cane, Unassisted Ambulation\r\n\r Risks/Benefits:\r\n\r Combined spinal epidural anesthesia, general anesthesia, and continuous adductor canal blocks\r are part of routine anesthesia care at Rush University Medical Center and around the country.\r Post-operative analgesia regiments are standard of care.\r\n\r Risks of general anesthesia include sore throat, nausea/vomiting, potential tooth damage,\r vocal cord injury, mental confusion, awareness, stroke, death. Risks of regional anesthesia\r (spinal) include bleeding (spinal hematoma), infection (meningitis), nerve damage, headache,\r hypotension, difficulty urinating, and seizures. There is no difference between epidural\r catheter and adductor canal catheter in terms of risks, other than the adductor canal\r catheter carries no risk of headache. These risks are present regardless of the study since\r either general or spinal anesthesia is used in all total knee arthroplasty procedures.\r\n\r The only risk involved in participating in the study is the potential for breach of\r confidentiality and/or privacy. Below is a description of the procedure for maintaining\r confidentiality. There is no direct benefit to the participants in this study.\r\n\r Procedures for Maintaining Confidentiality A breach of confidentiality and/or privacy is a\r risk of this study. To prevent this, all collected data will be stored electronically in\r password-protected files to protect patient identity and information. All information will be\r collected and reviewed by the research team only. Data will be maintained on a\r password-protected computer that will be accessible only to the study team. No patient\r identifiers will be maintained in the database.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Any patient scheduled for a primary unilateral TKA.\r\n\r Exclusion Criteria:\r\n\r - Partial knee replacement,\r\n\r - chronic opioid use,\r\n\r - history of alcohol or drug abuse,\r\n\r - preexisting neuropathy in operative limb,\r\n\r - allergy to local anesthetics,\r\n\r - ASA Class >3,\r\n\r - patients who decline to participate,\r\n\r - BMI >40,\r\n\r - sleep apnea.\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\nChronic Pain Self-management Support With Pain Education and Exercise\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether the combination of self-management support,\r pain science education, and individualized, goal-oriented exercises helps people with chronic\r pain to increase their function.\n\n**Clinical Trial Detailed Description:**\n\nPrimary objective: This study will test the hypothesis that participants with chronic pain\r experience greater change in function with ChrOnic pain self-ManageMent support with pain\r science EducatioN and exerCisE (COMMENCE) in comparison to a wait-list control.\r\n\r Secondary objective #1: This study will test the hypotheses that people with chronic pain\r experience greater change in pain intensity, pain interference, self-efficacy, catastrophic\r thinking, fear of movement/re-injury, pain neurophysiology knowledge, how much participants\r are bothered by difficulty with functional activities, fatigue, depressive symptoms, health\r care utilization and work status with COMMENCE in comparison to a wait-list control.\r\n\r Secondary objective #2: This study will identify demographic, psychological, or\r psychophysical variables that are predictive of treatment response.\r\n\r Design: This study will be a randomized trial with parallel groups, a wait-list control and\r balanced randomization. A cross-over will take place after a 12-week follow-up assessment\r (ie. the group initially receiving treatment will receive no treatment and the group\r initially on the wait-list will receive treatment for 6 weeks). The between group comparison\r will be performed using only the data up to the 12-week follow-up due to anticipated\r carry-over effects with self-management support. Data collected after the cross-over will be\r used to help identify factors that predict response to the intervention.\r\n\r Blinding: Due to the nature of the treatment and comparison, participants and the treating\r physiotherapist will not be blinded. The assessor who is completing the two objective\r measures will be blind to the treatment allocation. Data analysis will be performed by\r someone who is not blinded to the group allocation.\r\n\r Setting: 110 participants with chronic pain will be recruited at Woodstock and Area Community\r Health Centre (WACHC) in Woodstock, Ontario, Canada. WACHC has an interdisciplinary team of\r health care providers that provide care to priority populations in Oxford County, Ontario,\r Canada. The priority populations include people with the following barriers to accessing\r health care: addictions concerns, mental health challenges, low incomes, lack of health\r insurance, and isolated seniors. The investigators expect this sample to represent a\r marginalized population of people with chronic often excluded from chronic pain treatment and\r research by barriers to accessing health care.\r\n\r Sample Size: The sample size necessary for a randomized controlled trial with three repeated\r measures at 0, 7 and 18 weeks was calculated using online sample size software (GLIMMPSE\r 2.0). The calculation was performed using a significance level of 0.05, a power of 0.8, a\r minimum detectable mean difference between groups of 10 points on the Short Musculoskeletal\r Function Assessment Dysfunction Index (SMFA-DI) at both 7 weeks and 18 weeks, and a standard\r deviation of 23 points on the SMFA-DI based on clinical data at WACHC. The needed sample size\r calculated was 88 participants. To account for a potential 20% drop-out rate, 110\r participants will be recruited\r\n\r Allocation: The allocation sequence will be generated by a study investigator who is not\r involved in the enrolment of participants or assigning interventions. A computer-generated\r blocked random number schedule will be used to determine allocation sequence. The block size\r will be unknown to the other study investigators. The allocation sequence will be concealed\r through the use of sequentially numbered, opaque envelopes, opened after the initial\r assessment.\r\n\r Co-intervention: Participants will be free to continue with other treatments. Other\r treatments will be recorded through self-report at each assessment time-point and analyzed\r for between group differences.\r\n\r Withdrawing Participants from this Study: Participants may withdraw from the treatment at any\r time. Participants who choose to withdraw will be documented and data will be analyzed as a\r member of the group to which they were randomly assigned (intention-to-treat)\r\n\r Potential prognostic indicators or predictors of response: Potential predictors of response\r for secondary objective #2 will include baseline measures for each of the outcome measures\r listed under outcomes as well as post-traumatic stress measured by the Post-traumatic Stress\r Disorder Checklist, sense of perceived injustice measured by the Injustice Experience\r Questionnaire, number of medications, comorbidities measured by disease count, and\r expectations for recovery. Expectations for recovery will be assessed with two questions: i)\r Do you think your pain will improve? ii) Do you think your functional abilities will improve?\r\n\r Demographic information: The following information will be collected at the initial\r assessment and analyzed as potential covariates and predictors of response: age, sex, work\r status prior to symptom onset, length of time since symptom onset in months, diagnosis\r provided by a medical professional as reported by the patient, medication use, previous\r treatment received, and expectations for recovery.\r\n\r Treatment fidelity: Treatment fidelity will be assessed through a combination of attendance\r (categorized as <25%, 25-49%, 50-74%, ≥75% of visits) and adherence to self-management\r strategies. This will be measured by clinician report when the clinician reviews the workbook\r at each individual treatment session.\r\n\r Data monitoring and auditing: This trial will not include a data monitoring committee and\r will not be audited outside of the study investigators\r\n\r Analysis: Statistical analysis will be conducted using Stata software, version 13 (StataCorp,\r College Station, Texas, USA). Baseline characteristics for treatment and wait-list groups\r will be compared using a Student's t-test for continuous data and Chi squared or Fisher's\r exact test for categorical variables. Analysis for the primary objective and secondary\r objective #1 will be performed using linear mixed-effects modelling with data from three\r repeated measures (baseline, 7 weeks, 18 weeks). A p value of less than 0.05 will be\r considered indicative of statistical significance. The primary analysis will use intention to\r treat principles, but a secondary analysis to investigate efficacy for those that complete\r 75% of visits will be performed as well (per protocol analysis). Predictors of response\r (change in SMFA-DI) will be determined using a series of multiple regression models.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - participants will all be adults who have been experiencing non-cancer related pain for\r at least 12 weeks\r\n\r Exclusion Criteria:\r\n\r - cancer related pain\r\n\r - medical \"red flags\" suggestive of a non-neuromusculoskeletal etiology of symptoms\r\n\r - casted fracture within the last 12 weeks\r\n\r - related surgery within the last 26 weeks\r\n\r - evidence of upper motor neuron lesion\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\nAdductor Canal Block for Total Knee Arthroplasty\n\n**Clinical Trial Summary:**\n\nTotal knee arthroplasty (TKA) can be associated with a large amount of postoperative pain.\r This pain can oftentimes be severe enough to limit participation in physical therapy and\r ultimately delay discharge resulting in increased cost. Several strategies have been\r developed in an effort to decrease postoperative pain following TKA while maintaining lower\r extremity strength and maximizing participation in physical therapy. Recently, adductor canal\r blockade has gained popularity as it is reported to provide analgesia to the anterior knee\r without resulting in significant quadriceps muscle weakness. However, few studies have\r carefully evaluated the impact of volume of injection of local anesthetic into the adductor\r canal on motor weakness or pain control. The ability to achieve similar pain control with\r decreased volumes of local anesthetic would allow the surgery team to apply more local\r anesthetic to posterior knee structures. Decreased volumes of local anesthetic may also be\r associated with a decreased risk of local anesthetic toxicity. This study aims to carefully\r evaluate this relationship using a physical therapy evaluation method that relies on both\r motor strength and pain control. In addition, the investigators hope to carefully evaluate\r motor strength using a novel method of strength measurement in an effort to further evaluate\r the impact of volume of injection of local anesthetic into the adductor canal on motor\r strength.\n\n**Clinical Trial Detailed Description:**\n\nPostoperative analgesia for total knee arthroplasty (TKA) is incredibly important as it\r allows for effective physical therapy and ultimately ensures proper function of the implanted\r joint hardware. Unfortunately, TKA is oftentimes associated with pain severe enough to limit\r participation in physical therapy which can ultimately result in prolonged hospitalizations\r and perhaps decreased joint function. A number of strategies have been reported to decrease\r the pain associated with TKA. Opioids are commonly utilized but they can be associated with a\r number of potential side effects including nausea, itching, respiratory depression, tolerance\r and the potential for abuse. Epidural analgesia has been utilized for postoperative analgesia\r but this strategy requires urinary catheterization (potential source of increased incidence\r of urinary tract infections), causes significant vasodilation with resulting hypotension and\r can cause bilateral lower extremity weakness that can undermine efforts at early physical\r therapy and rehabilitation. Femoral nerve blockade and femoral nerve catheters have the\r potential to decrease pain in the anterior knee but use of this technique is limited by\r incomplete analgesia and quadriceps motor weakness. Some groups have advocated for the\r substitution or addition of sciatic or obturator nerve blocks to femoral nerve blockade but\r this is at the expense of increased lower extremity weakness and little potential clinical\r benefit.1-5\r\n\r In an effort to balance the need for effective postoperative analgesia with the need to\r maintain lower extremity muscle strength for active participation in physical therapy, a\r number of groups have begun to evaluate the adductor canal block. The adductor canal is\r located in the middle 1/3 of the thigh and includes the saphenous nerve and nerve to the\r vastus medialis. The primary advantage to adductor canal blockade versus femoral nerve\r blockade is a potential sparing of the nerves to the quadriceps muscle and therefore\r preservation of lower extremity motor strength.6-8 Kwofie et al reported in a study of 16\r volunteers that there was no change in quadriceps strength or hip adduction following the\r injection of 15 ml of local anesthetic. This is interesting as the obturator nerve is\r reported to travel within the adductor canal and is responsible for hip adduction. Kwofie et\r al also reported that SSACNB resulted in significantly decreased impairments with balance\r compared to a SSFNB.9\r\n\r To this point, the majority of studies evaluating adductor canal blockade have focused on\r continuous techniques and little has been done to evaluate single shot techniques. Continuous\r techniques have the potential to extend analgesia but this is at the expense of increased\r cost, effort, resource utilization and potentially increased risk of infection.\r\n\r The safety of CACNB technique was highlighted by a study by Henningsen et al where no cases\r of nerve injury related to analgesic technique were reported in a series of 97 patients.10\r Andersen et al compared a CACNB vs control in 40 patients and found that the intervention\r group reported decreased pain and sleep disturbances while retaining the ability to ambulate\r soon after surgery.11 Mudumbai et al evaluated 180 patients undergoing TKA and discovered\r that continuous adductor canal nerve blockade (CACNB) relative to continuous femoral nerve\r blockade (CFNB) resulted in greater ability to ambulate (37 m vs 6 m) on POD 1 and similar\r pain scores.8 Jaeger et al examined a similar group of 54 patients presenting for TKA and\r found that CACNB relative to CFNB resulted in decreased quadriceps weakness and no difference\r in pain, opioid consumption or weakness.12 Jenstrup et al reported that, compared to placebo,\r CACNB resulted in decreased pain with flexion and opioid consumption.13 Only recently has a\r study comparing SSACNB and SSFNB been published. This study demonstrated that SSACNB resulted\r in decreased postoperative quadriceps weakness and similar pain control to SSFNB.14 Of\r interest, previous research has demonstrated that 15 ml 0.5% ropivacaine is required to\r produce ultrasound guided femoral nerve blockade (including sensory and quadriceps motor\r weakness) but no such study has yet been done for the adductor canal block.15 It is possible\r that larger volumes of local anesthetic injected into the adductor canal could result in\r proximal spread of local anesthetic and increase quadriceps weakness and difficulty\r ambulating. It is also possible that decreased volumes of injection may result in inferior\r pain control and difficulties participating in physical therapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. The subject is scheduled for elective unilateral TKA\r\n\r 2. The subject is ≥ 18 years and ≤ 80 years;\r\n\r 3. The subject's weight is between 70-120 kg; and\r\n\r 4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic\r (i.e. spinal, epidural or combined-spinal epidural).\r\n\r 5. The patient agrees to receive an adductor canal block.\r\n\r 6. American Society of Anesthesiologists class 1-3\r\n\r Exclusion Criteria:\r\n\r 1. Subject is < 18 years of age or >80 years of age;\r\n\r 2. Subject is non-English speaking;\r\n\r 3. Subject is known or believed to be pregnant;\r\n\r 4. Subject is a prisoner;\r\n\r 5. Subject has impaired decision-making capacity; per discretion of the Investigator\r\n\r 6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative\r aspiration;\r\n\r 7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia\r inappropriate;\r\n\r 8. Significant pre-existing neuropathy on the operative limb;\r\n\r 9. Significant renal, cardiac or hepatic disease per discretion of the investigator.\r\n\r 10. American Society of Anesthesiologists class 4-5\r\n\r 11. Known hypersensitivity and/or allergies to local anesthetics\r\n\r 12. Chronic Opioid Use (daily or almost daily use of opioids for > 3 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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"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 Use of Technology to Improve MS Clinical Trials and Patient Care\n\n**Clinical Trial Summary:**\n\nMany patients with multiple sclerosis (MS) experience \"relapses\" of disease activity during\r which they have increased numbness, weakness, visual problems, or other symptoms. If a person\r with MS has new symptoms that are concerning to them, their doctor may want to see them in\r the office in order to confirm that these symptoms are due to a true \"relapse\" of activity\r before starting relapse treatment. This requirement can be frustrating for patients, who may\r have to take time off from work or travel long distances for such unexpected doctors' visits.\r In this study, the investigators will use input from patients with MS and MS physicians to\r create a relapse questionnaire that can be used to confirm a relapse has occurred. The\r investigators will also evaluate if having a more direct line of communication with the\r provider's office improves overall patient care and satisfaction.\n\n**Clinical Trial Detailed Description:**\n\nThis research is being done to study if a relapse questionnaire for people with multiple\r sclerosis (MS) may help more easily determine if a relapse has occurred.\r\n\r A further goal of this study is to determine if receiving periodic messages from the doctor's\r office, as well as having the direct contact information of a person in the office, improves\r the care of the patients and their experience thereof.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - English speakers\r\n\r - Relapsing-remitting MS (2010 criteria)\r\n\r - Expanded Disability Status Scale (EDSS) ≤6.0\r\n\r - Possession of a smartphone OR of a mobile telephone with text messaging AND an e-mail\r account AND web access OR willingness to be provided with, and utilize, a smartphone\r for the duration of the study\r\n\r - In the two years before screening:\r\n\r at least two relapses, OR one relapse and two new lesions (unrelated to relapse symptoms)\r on magnetic resonance imaging (MRI), OR RRMS (MAGNIMS 2010 criteria) onset within the past\r year with no exposure to disease modifying therapies (DMT)\r\n\r - Patient is starting one of the following MS therapies: injectable (subcutaneous\r interferon beta or glatiramer acetate) or oral (fingolimod, teriflunomide, or dimethyl\r fumarate) therapies\r\n\r - Relapse and MRI activity occurred while untreated or despite one single treatment, and\r no change in therapy since that activity\r\n\r - Lives within 100 miles of Johns Hopkins Medical Center (Baltimore, MD)\r\n\r Exclusion Criteria:\r\n\r - History of DMT exposure if MAGNIMS 2010 criteria used to enroll patients with disease\r onset in the past year, or change in MS therapy since qualifying relapse/MRI criteria\r occurred\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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"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\nCeritinib Rare Indications Study in ALK+ Tumors\n\n**Clinical Trial Summary:**\n\nThis is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety\r and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are\r characterized by ALK genetic alteration (and/or overexpression in some diseases).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient has a histologically or cytologically confirmed diagnosis of ALK positive\r (ALK+) tumor other than Non-Small Cell Lung Cancer (NSCLC).\r\n\r - Patient must provide an archival or fresh tumor tissue before the first dose of the\r study drug for ALK testing at a Novartis designated central laboratory.\r\n\r - Patient has WHO Performance Status (PS) ≤ 2\r\n\r - Patient must have received at least one line of prior systemic treatment for\r recurrent, locally advanced and/or metastatic disease, and may have discontinued for:\r\n\r - Disease progression as defined by RECIST 1.1 for solid tumors; by RANO for GBM\r and by Cheson assessment criteria for lymphoma, or\r\n\r - Intolerance described as any discontinuation due to an AE of any grade despite\r appropriate supportive treatment\r\n\r - Patient has at least one measurable lesion as defined by appropriate guidelines. A\r lesion at a previously irradiated site may only be counted as a target lesion if there\r is clear sign of progression since the irradiation.\r\n\r - Patient has received no chemotherapy, immunotherapy or stem cell therapy at least 4\r weeks before starting ceritinib\r\n\r - Radiotherapy and prior ALK inhibitors must be stopped at least 1 week prior to\r starting ceritinib\r\n\r - Recovered from all toxicities related to prior anticancer therapies to grade ≤ 1\r (Common Terminology Criteria for Adverse Events [CTCAE] v4.03).\r\n\r Exclusion Criteria:\r\n\r - Patient has ALK+lung cancer\r\n\r - Patient with symptomatic CNS metastases who are neurologically unstable or have\r required increasing doses of steroids within the 2 weeks prior to study entry to\r manage CNS symptoms.\r\n\r - Patient with acute or chronic GI disease that may significantly alter the absorption\r of ceritinib.\r\n\r - Patient with a history of pancreatitis or history of increased amylase or lipase that\r was due to pancreatic disease.\r\n\r - Patient has history of interstitial lung disease or interstitial pneumonitis,\r including clinically significant radiation pneumonitis.\r\n\r - Patient has clinically significant, uncontrolled heart disease and/or recent cardiac\r event (within 6 months).\r\n\r - Patient has evidence of active viral hepatitis, including Hepatitis A, B or C (testing\r for viral hepatitis is not mandatory).\r\n\r - Patient has known diagnosis of human immunodeficiency virus (HIV) infection (HIV\r testing is not mandatory).\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\nElectroacupuncture on Post-stroke Urinary Retention\n\n**Clinical Trial Summary:**\n\nThis study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for the\r post-stroke patients with urinary retention under conventional treatments, compared with sham\r electroacupuncture.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - male or female aged over 19\r\n\r - Patients diagnosed with stroke (cerebral hemorrhage or infarction) based on the CT or\r MRI examination\r\n\r - Those whose onset is within 2 years\r\n\r - Those who have urinary retention after stroke onset (every PVR result is equal or more\r than 100ml on the 2 consecutive tests)\r\n\r - Those who signed on the informed consent form\r\n\r Exclusion Criteria:\r\n\r - Patients who have any bleeding disorders based on medical history hearing\r\n\r - Patients who have ever had any medical procedures or surgeries for peripheral vascular\r diseases based on medical history hearing\r\n\r - Patients who have any psychiatry disorders based on medical history hearing\r\n\r - Patients who have any severe diseases in lower urinary tract symptom based on medical\r history hearing\r\n\r - Patients who have any acute or chronic infectious diseases in lower urinary tract\r symptom based on medical history hearing\r\n\r - Acute stage stroke patients (onset within 1 week) whose Glasgow Coma Scale ≤ 8\r\n\r - Patients who have fear about acupuncture\r\n\r - Patients who have changed medications for urinary retention or relevant symptoms, such\r as urinary incontinence drugs or diuretics, within 3 days\r\n\r - Female who diagnosed with pregnancy by urinalysis\r\n\r - Those who primary or sub investigators judge not to be suitable 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\"."
}
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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\nTo Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Patients With Spinal Cord Injuries\n\n**Clinical Trial Summary:**\n\nWe are trying to determine the therapeutic effect of the music glove and conventional hand\r exercise program to patients with spinal cord injuries. All participants will be randomized\r into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with a\r minimal 3 hours exercise time per week. Participants will receive the other intervention at\r their 3 week post therapy follow up visits. Clinical evaluations will be performed at\r baseline 1 and 2 (3 to 10 days apart), post therapy after first intervention, 3-week post\r therapy follow up, post therapy after second intervention, and 3-week post second\r intervention follow up visits.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - History of spinal cord injury affecting the arm and hand functions, at least 6 months\r prior to enrollment\r\n\r - Upper extremity weakness as measured on a standard clinical scale\r\n\r - No active major psychiatric problems, or neurological/orthopedic problems affecting\r the training upper extremity\r\n\r - No active major neurological disease other than the spinal cord injury\r\n\r - Absence of pain in the affected upper extremity\r\n\r Exclusion Criteria:\r\n\r - Severe tone at the affected upper extremity as measured on a standard clinical scale\r\n\r - Severe sensory/proprioception deficit at the affected upper extremity as measured on a\r standard clinical scale\r\n\r - Difficulty in understanding or complying with instructions given by the experimenter\r\n\r - Inability to perform the experimental task that will be studied\r\n\r - Increased pain with movement of the training upper extremity\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\nPROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms\n\n**Clinical Trial Summary:**\n\nRebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above\r pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of\r treatment and could theoretically lead to acid-related symptoms such as heartburn, acid\r regurgitation, or dyspepsia that might result in resumption of therapy. A plausible\r physiologic theory for the rebound phenomenon suggests that long-term, elevated gastric pH\r caused by blockage of the proton-pumps stimulates compensatory gastrin release.\r Interestingly, Reimer et al. demonstrated the occurrence of RAHS in healthy volunteers who\r had received eight weeks of esomperazole. The clinical symptoms occured in a different\r prevalence compared with placebo treated patients at ten weeks after withdrawal and until the\r end of the study (twelve weeks). Twenty to twenty-two percent of patients displayed symptoms\r ten or twelve weeks after having discontinued PPIs while they occured in 1.7-7% of\r placebo-treated patients. Efforts should be pursued to restrict PPI therapy use to patients\r likely to benefit from it.\r\n\r In this context, we propose to investigate the benefit of a progressive decrease in doses of\r esomeprazole compared to a sudden discontinuation. This is a randomized, double-blind,\r placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks\r least, randomized to one week of placebo or one week of esomeprazole 20mg. We want to compare\r the prevalence of clinical gastrointestinal symptoms between patients with progressive\r discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden\r discontinuation of esomeprazole 40mg.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Treatment by esomeprazole 40mg since 4 weeks or more\r\n\r - Esomeprazole withdrawal decided by the clinician\r\n\r - Male and female aged 18-90 years\r\n\r - Volunteers to participate to the study\r\n\r - Must understand and read French language\r\n\r - Must be able to give a written informed consent\r\n\r Exclusion Criteria:\r\n\r - Impairment of cognitive status\r\n\r - Current indication to continue PPI treatment\r\n\r - History of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison\r syndrome\r\n\r - Short-term treatment of documented ulcer disease, as part of a combination regimen for\r Helicobacter pylori (HP) eradication\r\n\r - Prevention of ulcers due to non-steroidal anti-inflammatory drugs.\r\n\r - Hepatic impairment (TP<60%)\r\n\r - Hypersensitivity to omeprazole (CYP2C19 activity) or esomeprazole\r\n\r - Current pregnancy or current breastfeeding\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 Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma\n\n**Clinical Trial Summary:**\n\nA recent prospective multicenter study by Dr. Grossman demonstrated that 40% of patients with\r high grade glioma undergoing radiation and chemotherapy developed severe and persistent\r lymphopenia (CD4 counts <200 cells/mm3). This lymphopenia lasted for twelve months following\r radiation treatment and on multivariate analysis was associated with shorter survival. Our\r group has data that strongly suggests that this lymphopenia is secondary to the inadvertent\r radiation of circulating lymphocytes as they pass through the radiation beam. Investigators\r propose the use of FDA approved for multiple sclerosis, fingolimod to signal lymphocytes to\r leave the circulation prior to the initiation of radiation. It is a functional antagonist of\r the sphingosine-1-phosphate receptor (S1PR) pathway and prevents lymphocyte egress from\r secondary lymphoid organs.\r\n\r Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and\r temozolomide and will be discontinued immediately upon completion of the six weeks of\r therapy. The primary objective is to evaluate if fingolimod can be safely combined with\r radiation and temozolomide. Secondary endpoint is total lymphocyte counts (TLC) for the\r proposed study participants. Investigators expect that patients receiving radiation and\r temozolomide plus fingolimod have a recovery of lymphocyte counts to 80% of baseline within\r four months, reference to historical control in which sustained lymphopenia lasted for twelve\r months.\n\n**Clinical Trial Detailed Description:**\n\nFive evaluable patients with newly diagnosed high grade gliomas who will undergo standard\r concomitant radiation and temozolomide followed by adjuvant temozolomide will be accrued to\r this open-label, single arm, safety study. Oral fingolimod will be given 1 week prior to the\r initiation of concurrent radiation and temozolomide and will be discontinued immediately upon\r completion of the six weeks of therapy.\r\n\r The primary objective is to evaluate if fingolimod can be safely combined with radiation and\r temozolomide. This standard chemoradiation causes 40% of patients to develop severe\r lymphopenia two months after initiation of therapy. Investigators expect that when this is\r combined with fingolimod, virtually all patients will have severe lymphopenia two months\r after beginning treatment. Investigators will determine if these patients who routinely\r receive pneumocystis jiroveci prophylaxis develop other severe opportunistic infections that\r would prohibit further evaluation of this novel treatment approach. Primary endpoint is\r incidence of greater than or equal to Grade III infections attributable to fingolimod-induced\r lymphopenia defined by the NIH/NCI Common Terminology Criteria for Adverse Events (CTCAE)\r within four months of starting fingolimod.\r\n\r The secondary objective is to obtain preliminary information regarding the ability of\r fingolimod to reduce radiation-related lymphopenia three months after stopping fingolimod.\r The NIH funded Adult Brain Tumor Consortium (ABTC) followed total lymphocyte and CD4 counts\r in 96 patients after treatment with radiation and temozolomide. The severe lymphopenia (CD4\r count less than 200/mm3) lasted for twelve months in this historical control. Secondary\r endpoint is total lymphocyte counts (TLC) for the proposed study participants. These will be\r compared with patient level data on TLC from an historical cohort obtained from the ABTC.\r Investigators expect that patients receiving radiation and temozolomide plus fingolimod have\r a recovery of lymphocyte counts to 80% of baseline within four months, reference to\r historical control in which sustained lymphopenia lasted for twelve months.\r\n\r Investigators will also obtain laboratory analysis on lymphocyte subtypes and cytokine levels\r (CD3, CD4, CD8, IL-7, TGF-Beta, etc.). Routine care for high grade gliomas includes weekly\r Heme-8 and absolute lymphocyte count. Research blood will be obtained at 2 weeks prior to\r chemoradiation and again at weeks 6, 10, 18, 26 and 46. Patients will be on study for\r approximately one year.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Gender: Male and Female\r\n\r - Age: Patients must be at least 18 years of age.\r\n\r - Race: Minorities will be recruited. No exclusion to this study will be based on race.\r\n\r - Patients must have histologically confirmed high grade astrocytoma, WHO grade III or\r IV, by pathology.\r\n\r - Patients' proposed post-operative treatment plan must include standard focal brain\r irradiation and temozolomide.\r\n\r - Patients must have a Karnofsky Performance Status > 60 % (i.e. the patient must be\r able to care for himself/herself with occasional help from others).\r\n\r - Patients must have normal bone marrow function, with a baseline total lymphocyte count\r > 1000.\r\n\r - Patients must be able to provide informed consent.\r\n\r - Glucocorticoid use is allowed.\r\n\r - Women of childbearing potential should use effective contraception during and for two\r months after stopping fingolimod.\r\n\r Exclusion Criteria:\r\n\r - Patients must not have received prior radiation therapy, chemotherapy, immunotherapy,\r therapy with biologic agents or hormonal therapy for their brain tumor.\r\n\r - Patients must not have recent (within six months) occurrence of myocardial infarction,\r unstable angina, stroke, transient ischemic attack, decompensated heart failure\r requiring hospitalization, or Class III/IV heart failure.\r\n\r - Patients must not have history of or presence of Mobitz Type II 2nd degree or 3rd\r degree atrioventricular block or sick sinus syndrome, unless patient has a pacemaker.\r\n\r - Patients must not have baseline QTc interval > 500 ms.\r\n\r - Patients must not be on treatment with Class Ia or Class III antiarrhythmic drugs.\r\n\r - Patients must not have a history of macular edema, uveitis or diabetes mellitus.\r\n\r - Patients must not have elevated liver transaminase levels. Adequate liver function is\r defined as total bilirubin < 1.5 times upper limit of normal, SGPT (ALT) < 5 times\r upper limit of normal and serum albumin > 2 g/dL.\r\n\r - Patients must not have an active infection.\r\n\r - Patients with known HIV will be excluded.\r\n\r - Patients with collagen vascular disease are excluded.\r\n\r - Patients taking immunosuppressive medications (other than dexamethasone) will be\r 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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"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."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPostoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases\n\n**Clinical Trial Summary:**\n\nCurrently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is\r opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the\r potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR,\r after resection of CRLM have been reported.\r\n\r The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to\r initiate protocol-directed therapy and completed median of six cycles (range, one to six).\r Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable\r patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients\r have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7\r months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met\r the prespecified end point of higher than 85% survival at 2 years and were clinically\r tolerable.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Histologically confirmed metastatic colorectal adenocarcinoma,\r\n\r 2. Curative-intent resection (or ablation) R0 of at least 4 CRLM,\r\n\r 3. Preoperative oxaliplatin- and/or irinotecan-based chemotherapy (successively or\r concomitantly) +/- non experimental biological therapy, e.g., anti-EGFR or\r antiangiogenic antibody,\r\n\r 4. Confirmed radiological tumor control before surgery (i.e., objective response or\r stable disease according to RECIST1.1 criteria),\r\n\r 5. WHO performance status of 0 or 1,\r\n\r 6. Age ≥ 18 years,\r\n\r 7. Adequate hematological function: absolute neutrophil count (ANC) > 2 x 109/L;\r platelets > 100 x 10^^9/L, hemoglobin (Hb) > 9 g/dL.\r\n\r 8. Adequate liver function: serum bilirubin </= 1.5 x ULN;\r\n\r 9. Aminotransferases levels </= 2.5 ULN (</= 5 ULN if liver metastases in place), and\r alkaline phosphatase level ≤ 5 ULN\r\n\r 10. Creatinin clearance ≥ 30 ml/min\r\n\r 11. Informed consent signed by the patient or his/her legal representative.\r\n\r 12. Negative pregnancy test in women of childbearing potential within 14 days prior to\r treatment initiation (premenopausal or less than 12 months of amenorrhea\r post-menopause, and who have not undergone surgical sterilization). Both men and women\r (of childbearing potential) who are sexually active must use adequate contraception,\r during and for at least 6 months post-treatment.\r\n\r Exclusion Criteria:\r\n\r 1. Extrahepatic metastatic disease (except ≤3 lung nodules (≤10 mm on chest CT scan)\r deemed amenable to curative-intent resection/ablation),\r\n\r 2. Symptomatic primary tumor requiring urgent surgery, asymptomatic primary colorectal\r tumor is not a non-inclusion criteria if its\r\n\r 3. Contraindication to fluoropyrimidines or oxaliplatin, as mentioned in the SMPC of\r investigational medicinal products\r\n\r 4. Known dihydropyrimidine dehydrogenase (DPD) deficiency\r\n\r 5. Disease progression during, or early hepatic relapse (< 6 months) after the end of,\r oxaliplatin-based adjuvant chemotherapy following primary tumor resection\r\n\r 6. History of hepatic arterial infusion with any treatment (chemotherapy,\r radioembolisation),\r\n\r 7. Peripheral neuropathy> grade 1,\r\n\r 8. History of cancer within 5 years prior to entry into the trial other than adequately\r treated basal-cell skin cancer or in situ carcinoma of the cervix\r\n\r 9. Concomitant administration of cimetidine\r\n\r 10. Concomitant medications/comorbidities that may prevent the patient from receiving\r study treatments,\r\n\r 11. Patient already included in another clinical trial with an experimental molecule,\r\n\r 12. Pregnancy or lactation,\r\n\r 13. Patients deprived of liberty or under guardianship,\r\n\r 14. Patients unable to undergo medical monitoring test for geographical, social or\r psychological reasons.\r\n\r 15. Patients must not have any uncontrolled concurrent illness including, but not limited\r to, severe active or uncontrolled infection, symptomatic congestive heart failure,\r unstable, angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus or\r psychiatric illness/social situations that would limit compliance with study\r requirements resection is planned (REVERSE strategy authorized)\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\nTopotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection\n\n**Clinical Trial Summary:**\n\nTopotecan is an FDA-approved drug when given by intravenous infection. The purpose of this\r study is to determine if treatment with topotecan by an alternative method, direct delivery\r into the part of the brain where the tumor has spread, is safe and well tolerated. The\r Cleveland Multiport Catheter is a new, investigational device that will be used to deliver\r topotecan into tumor-infiltrated brain. A second purpose of this study is to determine\r whether the Cleveland Multiport Catheter can be used effectively and safely to deliver\r topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to\r treatment with topotecan. This study will also look at the way topotecan is injected into\r tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be\r added to topotecan before it is injected. Pictures will be taken of the brain with an MRI\r machine. This will allow the investigators to see where in the tumor-infiltrated brain the\r topotecan has been injected. This study will collect medical information before, during, and\r after treatment in order to better understand hot to make this type of procedure accessible\r to patients.\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objectives\r\n\r - To investigate by magnetic resonance (MR) imaging the spatial and temporal distribution\r of topotecan in tumor-infiltrated brain administered by convection-enhanced delivery\r (CED) in patients with recurrent/progressive WHO grade III or IV (high grade) glioma\r (HGG) who have failed standard therapy comprising surgical biopsy and/or resection and\r adjuvant chemotherapy and radiotherapy, following a clinically-indicated resection of\r the contrast enhancing tumor mass.\r\n\r - To investigate by MR imaging the influence of catheter positioning, on the spatial and\r temporal distribution of topotecan administered by CED in patients with\r recurrent/progressive HGG\r\n\r - To evaluate the extent of spatial distribution of topotecan, by MR imaging, when\r delivered into non-enhancing tumor tissue (as defined on pre-operative conventional MRI\r imaging with and without intravenous gadolinium) in the intraoperative setting, the\r immediate peri-operative setting, and in the post-operative setting.\r\n\r Secondary Objectives\r\n\r - To investigate the extent to which CED-mediated delivery of topotecan\r\n\r - To investigate the extent to which infusate can be distributed in the 2 cm margin around\r the resection cavity by administration by CED\r\n\r - To assess the safety, tolerability and toxicity profile of topotecan administered by CED\r using different infusion rates.\r\n\r - To observe evidence of activity of single-agent topotecan administered by CED to\r patients with recurrent/progressive HGG who have failed standard therapy comprising\r surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed diagnosis of supratentorial WHO Grade III or IV Glioma (High\r Grade Glioma) that has undergone surgical biopsy or resection followed by adjuvant\r chemoradiotherapy, that has evidence of recurrence or progression based on imaging\r studies and surgical resection of the enhancing tumor is clinically indicated.\r\n\r - Karnofsky Performance Status 70-100;\r\n\r - MRI demonstration of an enhancing mass of more than 1 cm^3 and less than 100 cm^3;\r\n\r - Patient understands the procedures and agrees to comply with the study requirements by\r providing written informed consent; and\r\n\r - Laboratory values within the following ranges:\r\n\r - Absolute neutrophil count (ANC) ≥ 1,500 / μL;\r\n\r - Platelet count ≥ 100,000 / μL;\r\n\r - Hemoglobin ≥ 10 g / dL;\r\n\r - Estimated glomerular filtration rate (eGFR) of at least 50 mL/min\r\n\r Exclusion Criteria:\r\n\r - Patient is mentally or legally incapacitated at the time of the study;\r\n\r - Known HIV(+) or has been diagnosed with AIDS;\r\n\r - Participation in another investigational drug study in the prior 4 weeks;\r\n\r - Positive pregnancy test in a female;\r\n\r - Patient, in the opinion of the investigator, is likely to be poorly compliant.\r\n\r - Diffuse subependymal or CSF disease;\r\n\r - Tumors involving the cerebellum\r\n\r - Active infection requiring treatment;\r\n\r - Unexplained febrile illness;\r\n\r - Radiation or chemotherapy within 4 weeks of enrollment\r\n\r - Systemic diseases associated with unacceptable anesthesia or operative risk;\r\n\r - Personal or family history of bleeding diathesis and a coagulation profile that would\r preclude patient from undergoing a neurosurgical procedure\r\n\r - Subject must take anticoagulants, or antiplatelet agents, including NSAIDs that cannot\r be stopped for surgery\r\n\r - Inability to undergo magnetic resonance imaging.\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\nDorsal Penile Nerve Block for Rigid Cystoscopy in Men\n\n**Clinical Trial Summary:**\n\nThis study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in\r men undergoing rigid cystoscopy.\n\n**Clinical Trial Detailed Description:**\n\nPain is common in men undergoing rigid cystoscopy. Even with application of a lubricant\r containing 2% lidocaine, about 76% men suffer from mild to severe pain when undergoing rigid\r cystoscopy, and approximately 27% men could still feel mild to moderate pain 7 days after the\r procedure. The most painful part of the procedure for men is when the cystoscope passes\r through the membranous urethra. Song et al did autopsy on males found dorsal nerve of the\r penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in\r 53.3% specimens. In addition, urethral mucosa has branches of DNP innervated. Dorsal penile\r nerve block (DPNB) is usually used for circumcision in children and it has been shown to\r provide effective analgesia for penile surgeries. According to the evidence that some DNP\r branches innervate membranous urethra and urethra mucosa and most pain originates from\r cystoscope passing through membranous urethra, we speculated that DPNB could overall reduce\r pain level in men during rigid cystoscopy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - American Society of Anesthesiologists (ASA) Physical Status I-II\r\n\r - Without history of urethral or prostatic surgery\r\n\r - Without respiration or circulation disorders\r\n\r - Without chronic pain\r\n\r Exclusion Criteria:\r\n\r - Allergy to local anesthetics\r\n\r - Coagulation disorder or usage of antiplatelet drugs\r\n\r - Infection at the site of puncture point\r\n\r - Severe urethral 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"
}
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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\nClinical Reasoning Process of Physiotherapists When Observing Hemiplegic Gait\n\n**Clinical Trial Summary:**\n\nThe goal of this study is to find out what clinical reasoning process physiotherapists\r undergo when observing hemiplegic patients gait.\n\n**Clinical Trial Detailed Description:**\n\nPhysiotherapists don't usually use any assessments to evaluate gait but observe it without an\r instrument. The questions in this study are:\r\n\r - what abnormalities can physiotherapists detect when observing a patient walking?\r\n\r - what do they consider the main problem that has a negative effect on the patient's\r walking?\r\n\r - what hypothesis do they generate?\r\n\r - how is the inter-rater reliability for the \"main problem\" and the hypothesis?\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - chartered physiotherapists\r\n\r - physiotherapists in training\r\n\r - working with stroke patients\r\n\r Exclusion criteria:\r\n\r - other languages than German\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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{
"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\nStrawberries and Knee Osteoarthritis (OA)\n\n**Clinical Trial Summary:**\n\nThe proposed study aims to examine the hypothesis that strawberry supplementation will lower\r serum biomarkers of inflammation and improve knee function in patients with symptomatic\r osteoarthritis (OA).\n\n**Clinical Trial Detailed Description:**\n\nThe investigators propose the following two specific aims in a randomized crossover\r placebo-controlled trial in participants with two or more features of the metabolic syndrome\r and symptomatic osteoarthritis in this 12-week efficacy study:\r\n\r Aim 1: To assess the effects of strawberries on biomarkers of inflammation [serum levels of\r C-reactive protein: CRP; inflammatory cytokines: interleukin-6: IL-6; interleukin 1β: IL-1β;\r tumor necrosis factor-alpha: TNFα] Aim 2: To assess the effects of strawberries on knee\r function as assessed by overall musculoskeletal examination and pain score (ICOAP, KOOS and\r HAQ-DI).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical diagnosis of knee osteoarthritis\r\n\r - Must have waist circumference >35 inches for women and >40 inches for men\r\n\r Exclusion Criteria:\r\n\r - Cancer\r\n\r - Heart disease\r\n\r - Smoking\r\n\r - Berry allergy\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\nPrevention of Upper Gastrointestinal Hemorrhage Using Albis® in the Patients of Locally Advanced Pancreatic Cancer Who Underwent Concurrent Chemoradiotherapy\n\n**Clinical Trial Summary:**\n\nPancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. About 40%\r of pancreatic cancer patients were diagnosed as locally advanced unresectable status without\r distant metastasis. Concurrent chemoradiotherapy (CCRT) was a reasonable treatment modality\r for locally advanced pancreatic cancer. However, several adverse events of chemoradiation\r could lead unfavorable treatment results, which included unique gastrointestinal (GI)\r toxicities, such as ulcer and hemorrhage in the stomach and duodenum that are included in the\r radiation field. According to the study in the investigators hospital, 45% of locally\r advanced pancreatic cancer patients treated with CCRT suffered from GI ulcers, and among\r them, 65% of the patients experienced the significant hemorrhage events. Although these GI\r toxicities, the studies for radioprotective agents were limited. Albis® is a newly developed\r drug comprised of ranitidine, bismuth and sucralfate. The investigators will investigate the\r radioprotective effect of Albis® for locally advanced pancreatic cancer patients treated with\r CCRT.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Older than 20 years old and younger than 80 years old\r\n\r - Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally\r advanced stage)\r\n\r - ECOG Performance status ≤2\r\n\r - Scheduled fot concurrent chemoradiation\r\n\r - Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST\r and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver\r involvement)\r\n\r - Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl,\r platelet count ≥ 100,000/µl)\r\n\r - Not remarkable coagulation profile (PT < 1.5 international normalized ratio(INR), aPTT\r <35 sec)\r\n\r - Subjects who given written informed consent after being given a full description of\r the study\r\n\r Exclusion Criteria:\r\n\r - Coexisting of other malignancies within 5 years, except squamous cell carcinoma and\r basal cell carcinoma of the skin\r\n\r - Evidence of distant metastasis, such as liver, peritoneum and brain\r\n\r - history of receiving the chemoradiation for pancreatic cancer in the other hospital\r\n\r - History of receiving the operation which affect the anatomy of upper gastrointestinal\r tract\r\n\r - Any trouble for examination of upper endoscopy\r\n\r - Evidence of GI ulcers (A1~H2) on endoscopy before start of chemoradiotherapy.\r\n\r - Use of aspirin, anti-platelet agent, anticoagulation agent, NSAIDs, or glucocorticoid\r within 1 week or enable to stop the administration (including start during\r chemoradiation)\r\n\r - Use of PPI, Histamine-2 receptor antagonist, antacid, prostaglandin, sucralfate within\r 2 weeks or enable to stop the administration\r\n\r - Patients who are unwilling or unable to provide informed consent, such as those with\r psychiatric problem, drug abuse or alcoholism\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\nWound Healing Endpoint and Recurrence\n\n**Clinical Trial Summary:**\n\nThis prospective pilot study is to enroll patients with clinically-defined infected wounds.\r Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and\r will then begin Phase B. 265 clinically diagnosed infected burn or chronic wound patients\r will be recruited for this study in Phase A. Based on the expectation that 89% of these\r wounds will heal within 16 weeks of enrollment, 234 of these patients will continue with the\r study for Phase B.\n\n**Clinical Trial Detailed Description:**\n\nThis prospective pilot study is to enroll patients with clinically-defined infected wounds.\r Patients enrolled in the study will be followed for 16 weeks for wound closure (Phase A), and\r will then begin Phase B. Wounds will be subjected to Standard of Care (SoC) followed by all\r Comprehensive Wound Center (CWC) wound physicians in the first 16 weeks. Trans - Epidermal\r Water Loss (TEWL) will be measured with a handheld, non-invasive device, the VapoMeter®\r Closed-Chambered device or using DermaLab TEWL probe. Both of these devices are used to read\r the device. They will be placed on the subjects skin and will read the TEWL measurement. When\r the device is placed on the skin, the measurement takes between 7-20 seconds with the\r standard adapter.\r\n\r Study visit 1 will include informed consent being signed, baseline information collected, 2\r biopsies will be collected unless the wound is not appropriate for biopsy or the patient\r chooses not to receive a biopsy then a swab for culture will be collected, wound image using\r a digital camera and Wound Vision Scout (a non-invasive, infrared imaging camera), and a\r quality of life survey will be completed by the subject. The patients medical chart will be\r followed for 16 weeks following visit 1. At 16 weeks (+/- 2 weeks) or within 10 days of wound\r closure whichever comes first, all subjects will return for study visit 2. If the target\r wound(s) is not yet healed at this visit, this visit will be part of their Standard of Care\r visit per the CWC. The patient's study participation will end at this visit but wound data\r will be collected, digital imaging of wound(s) and quality of life survey will be completed\r by the subject. If the target wound is determined by visual inspection to be healed at or\r prior to this visit, this will be a research only visit; the patient will continue to Phase\r B, a continuation of study visit 2. Various information will be collected on the data\r collection sheet, digital imaging and TEWL measurements will be recorded. The TEWL device\r will be placed on the skin. There will be 5 measurements obtained over the closed wound site.\r A reference (control) TEWL measurement will be taken from intact skin at an anatomically\r matched site on the patient.\r\n\r A high TEWL/ defective closure is defined as a TEWL value that equals 2 times the value of\r the patient's control measurement. Patients who meet this criterion will be randomized to one\r of four groups: EpiCeram treatment, Ceramiseal treatment, Vaseline treatment or no treatment.\r Patients randomized to a treatment group will be supplied with study product and will be\r instructed to apply twice daily to the closed wound site for the remaining weeks of the\r study. All High TEWL patients will be asked to return for Study Visits 3-6. Distribution of\r study product as applicable. For this study, a low TEWL/ adequate closure is defined as a\r value less than 2 times the value of the patient's control measurement. Patients who meet\r this criterion will not be randomized into a treatment group, but will continue to receive\r standard of care per their physician and will be asked to return for study visits 3, 4, and\r 6. During these last visits the following activities will occur: TEWL measurements, digital\r imaging, sequential tape stripping to measure ceramide levels in the skin (up to 20 tape\r strips obtained). TEWL measurements will be obtained prior to tape stripping. The tape strips\r be completed after the TEWL measurements are obtained, wound site evaluation, various labs,\r medications review, distribution of study product (High TEWL only) and review of compliance\r and a quality of life survey is completed by the subject (visit 6 only).\r\n\r There may be some discomfort with the tissue biopsy procedure depending on the amount of\r sensation the subject has at the site of the wound and will be numbed by applying local\r anesthesia as appropriate to area being biopsied. The amount of pain that occurs with wound\r biopsies will vary from person to person, but all efforts will be made to minimize pain and\r is within the boundaries of the existing wound to avoid giving the patient a separate new\r wound. Bleeding is a possible complication, but the risk is low for the small biopsies and is\r reduced by using local anesthetics with epinephrine, and silver nitrate sticks are available\r in each patient room to cauterize biopsy sites as needed. Infection is also a potential risk;\r however, wound tissue biopsies are routinely performed as the standard of care in the CWC to\r diagnose wound infection. The biopsy site will be appropriately monitored for infection by\r the physician managing the wound during routine wound clinic visits.\r\n\r Possible risks for the use of the ceramide emulsion EpiCeram® are a temporary tingling\r sensation (10-15 minutes) and an extremely low risk of an allergic reaction. If this occurs\r the application of the cream will be stopped immediately. Possible risks for the use of\r Vaseline Petroleum and Ceramiseal™ are very low should be stopped if an allergic reaction\r occurs.There can be some minor redness and discomfort at the site of the tape stripping. The\r skin remains intact, i.e. the epidermis is not breached after the tape stripping procedure\r making this less than minimal risk. TEWL measurements are noninvasive and propose less than\r minimal risk.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 18\r\n\r - Willing to comply with protocol instructions, including all biopsies, study visits and\r study activities.\r\n\r - One of the following:\r\n\r 1. Chronic wound of multiple etiologies and open for at least 30 days, including:\r\n\r 1. Diabetic foot ulcers, Wagner grade 1-3\r\n\r 2. Pressure ulcers, stage 2-3\r\n\r 3. Venous leg ulcers, confirmed by venous duplex\r\n\r 4. Burn wounds open\r\n\r 5. Other etiology, deemed appropriate for biopsy\r\n\r 2. Wounds not appropriate for biopsy due to either:\r\n\r 1. Almost healed at the time of enrollment (per physician)\r\n\r 2. Healed within 10 days prior to enrollment visit\r\n\r 3. Clinical contraindication to biopsy in the opinion of the wound care\r provider\r\n\r - Adequate arterial blood flow as evidenced by at least one of the following (for\r subjects receiving tissue biopsy, if would is located on a lower extremity below the\r knee):\r\n\r 1. Transcutaneous oxygen measurement (TcOM) > 30 mmHg\r\n\r 2. Ankle-brachial index ≥0.7\r\n\r 3. Toe pressure > 30 mmHg\r\n\r Exclusion Criteria:\r\n\r - Individuals who are deemed unable to understand the procedures, risks and benefits of\r the study, (i.e. unable to provide informed consent)\r\n\r - Diabetics with Hemoglobin A1c > 10%\r\n\r - Subjects with marked immunodeficiency (HIV/AIDS, organ transplant patients and cancer\r patients and patients with autoimmune disease on immunosuppressive medications).\r\n\r - Wounds closed or to be closed by flap or graft coverage - including stage 4 pressure\r ulcers and Wagner grade 4 or 5 diabetic foot ulcers\r\n\r - Prisoners\r\n\r - Patients with allergies to petrolatum\r\n\r - Patients who are currently enrolled in another research study which includes\r investigational treatment and/or medication\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\nShock Wave Lithotripsy Versus Visual Cystolitholapaxy in The Management of Patients Presenting With Calcular Acute Urinary Retention: A Randomized Controlled Trial.\n\n**Clinical Trial Summary:**\n\nThe aim of the study is to compare the safety and efficacy of ESWL and visual\r cystolitholapaxy in management of calcular acute urine retention.\n\n**Clinical Trial Detailed Description:**\n\nPatients who present with acute urinary retention due to stone in the urethra or urinary\r bladder will be randomly assigned to receive treatment either by extracorporeal shock wave\r lithotripsy or by endoscopic visual cystolitholapaxy where patients and stone characteristics\r will be recorded and the outcome including the intraoperative and postoperative complications\r and the stone free rate will be also evaluated\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Adult male patients presenting with acute urinary retention due to urethral or urinary\r bladder stones.\r\n\r 2. with a stone size not more than 2 centimeters in greatest diameter.\r\n\r 3. No more than 2 stones.\r\n\r Exclusion Criteria:\r\n\r 1. Bladder cancer.\r\n\r 2. Bladder replacement of any type.\r\n\r 3. Infravesical obstruction, due to marked benign prostatic hyperplasia, prostate cancer,\r stricture urethra or external urethral meatal 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\"."
}
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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\nAnalysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy\n\n**Clinical Trial Summary:**\n\nRadio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases.\r Neurological decline is observed in these patients and tumor progression or radiotherapy side\r effects have been made responsible for this. However CMV encephalitis may also be a reason.\r Therefore the investigators aim to analyze the CMV status in patients during and after\r radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and\r IgM ELISA) in the blood of the patients. These findings will be correlated with changes in\r the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral\r blood will be performed.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - brain tumours (glioblastoma or anaplastic astrocytoma)\r\n\r - brain metastases from diagnosed primary tumours\r\n\r - legal age\r\n\r - planned chemoradiation and adjuvant chemotherapy [metastases]\r\n\r - planned chemoradiation and adjuvant chemotherapy with temodal (according to Stupp et.\r al.) [brain tumors]\r\n\r Exclusion Criteria:\r\n\r - fertile patients who refuse effective contraception during study treatment\r\n\r - persistent drug and/or alcohol abuse\r\n\r - patients not able or willing to behave according to study protocol\r\n\r - patients in care\r\n\r - patients that are not able to speak German\r\n\r - patients with claustrophobia\r\n\r - patients with artificial joint or any metal parts in the body\r\n\r - patients with pacemakers\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\nStudy on Neuroepithelial Tumor Grading and Pseudoprogression After Glioma Therapy Using Advanced Functional MRI Techniques\n\n**Clinical Trial Summary:**\n\nContrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and\r monitoring for tumor recurrence,but the ability to predict tumor behavior remains very\r limited.In this study, the investigators will use multi-b-value diffusion-weighted\r imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced\r MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.\n\n**Clinical Trial Detailed Description:**\n\nGlioma is classified into 4 grades, with worse prognosis for more advanced grades.Previous\r studies have suggested that different therapeutic strategies should be applied for gliomas at\r different grades,so glioma grading before the operation is therefore of important clinical\r significance for guiding the grade-dependent therapeutic strategy.\r\n\r Combination temozolomide and radiation significantly prolongs survival compared with\r radiation alone and has become standard treatment for Patients with high-grade glioma.\r Response assessment in these patients is difficult as a result of the frequent occurrence of\r early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The\r majority of patients remain clinically stable. It is often unclear whether current therapy\r should be maintained or second-line therapy initiated.\r\n\r The ADC value can potentially reveal the differences in cellularity and nuclear atypia of\r gliomas1. Theoretically, high cellularity in advanced gliomas may impede free water diffusion\r and thus lead to a decreased ADC value.In several previous studies,recurrent tumors have\r shows significantly higher cellularity than those shown by pseudoprogression.Such high\r cellularity is associated with relative reductions in extracellular space when compared with\r low cellularity, resulting in decreased diffusivity of water molecules in the former\r circumstance when compared with the latter. DWI measures the degree of water diffusion within\r tissue Apparent diffusion coefficient (ADC) values quantify the mobility of water molecules\r at the cellular level, holding the potential to differentiate between necrosis, edema and\r recurrent tumor.\r\n\r A potential mechanism of pseudoprogression is that radiation-induced vascular changes may\r lead to focal transient increase in gadolinium enhancement.Three-dimensional arterial spin\r labeling(3D-ASL) and dynamic contrast-enhanced (DCE) MRI imaging provides a noninvasive means\r for quantifying tumor vascular properties.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic\r astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the\r patients show the measurable enhancing portion (1 cm in the long diameter according to\r the RANO criteria) in the immediate f/up MRI after CCRT.\r\n\r Exclusion Criteria:\r\n\r - Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic\r astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the\r patients do not show the measurable enhancing portion (1 cm in the long diameter\r according to the RANO criteria) in the immediate f/up MRI after CCRT.\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\nThe Use of Ultrasound to Quantify Muscle Overlying the Carpal Tunnel\n\n**Clinical Trial Summary:**\n\nCarpal tunnel syndrome (CTS) is a common condition that still lacks a reliable, objective\r screening test. Many anatomical aspects of the syndrome have been studied including the\r dimensions of the carpal tunnel and shape of the nerve within the tunnel. The investigators\r have observed varying amounts of muscle overlying the carpal tunnel in patients undergoing\r surgery for the condition. Assuming that this muscle may have a dynamic role in the\r development of the condition, the investigators attempted to quantify this muscle using\r ultrasound (US).\r\n\r The purpose of this study was to devise a technique to evaluate the amount of muscle\r overlying the carpal tunnel.\r\n\r The hypothesis is that patients with carpal tunnel syndrome will have significantly more\r muscle overlying the carpal tunnel than individuals without carpal tunnel syndrome.\n\n**Clinical Trial Detailed Description:**\n\nIntroduction:\r\n\r The pathophysiology of carpal tunnel syndrome (CTS) is in all probability multifactorial\r including many parameters that ultimately increase the pressure within the carpal tunnel. It\r is likely that the increased pressure then causes injury to the median nerve and the signs\r and symptoms of CTS. The relationship between the size or dimensions of the hand and the\r occurrence of CTS has been evaluated and \"square-shaped\" hands have also been examined to\r determine if there is an increased tendency to develop CTS. The literature remains\r inconclusive at this time. Other static anatomical parameters that have been evaluated\r include the size of the carpal tunnel and the thickness and biomechanical properties of the\r transverse carpal ligament again without absolute consensus in the literature.\r\n\r Additional studies have evaluated the role of the intrinsic musculature within and\r surrounding the carpal tunnel in the etiology of CTS. Most of these studies have evaluated\r the muscles as space occupying lesions that add to the pressure within the carpal tunnel. The\r investigators believe that some of the muscles described, specifically those that are found\r within the transverse carpal ligament and that cross the area of the carpal tunnel, actually\r have a dynamic role in the etiology of CTS, especially in manual laborers that use their\r hands in a forceful manner in a repetitive fashion. It is also possible that this anatomic\r variant (muscles crossing the area of the carpal tunnel) is related to the \"square \"hand\r configuration and that this dynamic contribution to the pressure within the carpal tunnel is\r the reason for the increased incidence of CTS in these patients. The purpose of this study is\r to quantify the amount of muscle crossing the area of the carpal tunnel in normal individuals\r and to compare it to the amount of muscle in the wrists of patients with CTS.\r\n\r Hypothesis: Participants with CTS will have more muscle crossing the carpal tunnel that\r normal controls (without CTS).\r\n\r Purpose: To compare the amount of muscle crossing the carpal tunnel in normal controls\r (without CTS) and in patients with CTS\r\n\r Specific aims:\r\n\r 1. To develop a system to quantify the amount of muscle crossing the carpal tunnel area\r using ultrasound of the wrist area.\r\n\r 2. To compare this measurement in normal wrists and in wrists with CTS\r\n\r 3. To compare the measurements in the CTS patients to intraoperative evaluation of the\r amount of muscle crossing the carpal tunnel area .\r\n\r 4. To compare these measurements to the external measurements of the hand (palm width/palm\r length)\r\n\r Methods:\r\n\r Fifty participants will be recruited for the study. Twenty five participants with no CTS- and\r twenty five with CTS.\r\n\r The CTS group inclusion criteria:\r\n\r The diagnosis of CTS will include:\r\n\r 1. Signs and symptoms of CTS: nighttime numbness and tingling or numbness and tingling in a\r median nerve distribution with a positive phalen or tinel or forearm compression test\r\n\r 2. A nerve conduction test and electromyography (NCT and EMG) that is positive for CTS.\r\n\r The participants without CTS inclusion criteria:\r\n\r 1) Individuals that do not have any signs and or symptoms of CTS.\r\n\r Exclusion criteria:\r\n\r 1. Individuals that have a known history of peripheral neuropathy or other condition in the\r hand including recent significant trauma.\r\n\r 2. Patients with incomplete or unclear evaluation and tests.\r\n\r 3. Individuals unwilling to sign a consent form to participate in the study.\r\n\r Patients that meet the inclusion criteria and that are sent for carpal tunnel release surgery\r will be consented and examined on the day of surgery. Their US results, external palmar\r measurements as well as the amount of overlying muscle will be recorded as well as\r demographic data. Demographic information, occupational history, history of hand diagnoses\r and procedures as well as history pertinent to CTS (nighttime numbness and tingling, pain,\r perceived pinch weakness, and duration of symptoms) will be collected. Results of nerve\r conduction testing (NCT) will be recorded.\r\n\r Physical examination findings pertinent to CTS will be collected including pinch strength,\r grip strength, 2-point discrimination, and the hand measurements of palm width (PW), palm\r length (PL).\r\n\r External measurements: PL is measured as the vertical length from the midline of the distal\r wrist crease to the proximal middle finger. PW is measured as the horizontal length from the\r base of the 1st metacarpophalangeal (MP) joint along the proximal palmar crease.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The diagnosis of CTS will include signs and symptoms of CTS: nighttime numbness and\r tingling or numbness and tingling in a median nerve distribution with a positive\r phalen or tinel or forearm compression test as well as a nerve conduction test and\r electromyography (NCT and EMG) that is positive for CTS.\r\n\r - The normal subjects: individuals that do not have any signs and or symptoms of CTS.\r\n\r Exclusion Criteria:\r\n\r - Patients or individuals that have a known history of peripheral neuropathy or other\r condition in the hand including recent significant trauma.\r\n\r - Patients with incomplete or unclear evaluation and tests.\r\n\r - Individuals unwilling to sign a consent form to participate in 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:** 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\nProphylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention\n\n**Clinical Trial Summary:**\n\nThis randomized open-label study will be comprised of 2 cohorts: one control group and one\r treatment group. The trial will be conducted as an open label randomized trial to evaluate\r the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study\r will include pre- and post-surgical evaluations of patients including symptoms of urinary\r retention and any adverse effects contributable to the study medication.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Any male age 40 or older\r\n\r - Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)\r\n\r - Ability to give informed consent\r\n\r Exclusion Criteria:\r\n\r - Current use of alpha blocker\r\n\r - Current use of a strong CYP 3A4 inhibitors\r\n\r - Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to\r sulfate containing medications\r\n\r - Patients with any upcoming surgery for cataracts\r\n\r - Currently enrolled in a clinical trial\r\n\r - Inability to give 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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[
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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\nProstate Embolization for Acute Urinary Retention Study\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess the feasibility and safety of Prostate Artery\r Embolization (PAE) in patients suffering of Acute Urinary Retention (AUR) in the context\r Benign Prostatic Hypertrophy (BPH).\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label prospective, multicenter (centralized procedure), single arm,\r sequentially enrolling study. Twenty subjects will be enrolled in the study.\r\n\r Patient will be referred by the attending urologists after failure of the currently\r recommended approach of Trial WithOut Catheter (TWOC) and alpha-adrenergic receptor (AR)\r blockers.\r\n\r It is expected that all AUR cases referred to the local urological clinic will be considered\r for inclusion in the trial. A trial log book will be completed by the referring local\r urologist in order to obtain preliminary data on the applicability of the trial to all AUR\r comers in the institution. This log book will be limited to a very simple questionnaire to\r ensure high rate of completion by the attending resident/fellow (Patients age, size of\r prostate, previous Benign Prostate Hypertrophy symptoms, renal function). It will be used in\r order to assess the external validity of this first phase trial and will be a help to design\r the potential next step trial.\r\n\r When a patient will present with AUR in the corresponding urological clinic, the PI and\r Clinical research coordinator will be informed by a short text message, fax or e-mail in\r order to prepare the following process.\r\n\r Patient will be informed by the urologist of the ongoing research project. In summary, this\r will consist in informing the patient that the first step is TWOC and in case of failure of\r TWOC several options are offered including PAE in the trial setting. Inclusion of the patient\r will considered only in case of failure of TWOC.\r\n\r If the patient is willing to participate, patient will be seen in clinic by the Principal\r Investigator or co-investigator in order to inform him of the protocol and obtain signed\r informed consent.\r\n\r PAE will be scheduled upon the first contact to make sure that PAE is performed in a short\r delay following failure of TWOC. The goal is to perform PAE in the week following\r recatheterization. For practical reasons this delay might be extended and will be recorded in\r the Case Report Form.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - AUR Patients presenting with a first episode of AUR related to BPH (no matter if\r previously known or not) AND\r\n\r - Failure of at least one TWOC AND\r\n\r - Prostate size > or = 50 ml (ultrasound measurement)\r\n\r Exclusion Criteria:\r\n\r - Known hypocontractile bladder\r\n\r - AUR related to other causes (Acute prostatitis or documented Prostate cancer)\r\n\r - Severe iodine allergy\r\n\r - Known prostate cancer\r\n\r - Known ongoing acute or chronic prostatitis\r\n\r - On-going acute pyelonephritis or septicemia from urinary origin\r\n\r - Patient refusing PAE\r\n\r - Severe renal failure (creatinine Clearance < 20 ml/min (MDRD)\r\n\r - Contra-indication to AR blockers (postural hypotension micturition syncope)\r\n\r - Contra-indication to anticoagulants\r\n\r - Patient catheterized with a suspubian catheter\r\n\r - Patient <18\r\n\r - Patients who are prisoners\r\n\r - Patients who are mentally incapacitated\r\n\r - Patients participating in an investigational study involving the peripheral\r vasculature\r\n\r - Patients unable or unwilling to provide written informed consent\r\n\r - Patients ineligible for pelvic angiography and embolization including severe\r atheromatous condition or any anatomical condition\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\nExpanded Access to ANG1005 for Individual Patients\n\n**Clinical Trial Summary:**\n\nThis is an expanded access study with ANG1005 treatment for two individual patients from\r Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III\r Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with\r Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Neurologically stable\r\n\r 2. Karnofsky performance status (KPS) ≥ 80\r\n\r 3. Adequate laboratory results\r\n\r Exclusion Criteria:\r\n\r 1. Radiotherapy within 3 months.\r\n\r 2. Evidence of significant intracranial hemorrhage\r\n\r 3. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy\r\n\r 4. Inadequate bone marrow reserve\r\n\r 5. Any evidence of severe or uncontrolled disease\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\nBevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III\n\n**Clinical Trial Summary:**\n\nThe aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide\r (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or\r progression, comparing to bevacizumab alone.\n\n**Clinical Trial Detailed Description:**\n\nGlioblastoma (GBM), the most frequent malignant primary brain tumor, has yet been incurable\r despite recent progress on its standard of care using TMZ as the main trunk of initial\r therapy in the newly diagnosed setting. One of the main reasons accounting for the dismal\r prognosis would attribute to lack of active therapeutic regimens at recurrence.\r\n\r Bevacizumab, a humanized monoclonal antibody against cardinal angiogenic factor vascular\r endothelial growth factor (VEGF), has recently shown efficacy for recurrent GBM, and has been\r approved in Japan, thereby being a standard care for recurrent GBM. Since there is no\r effective drugs or regimens developed at bevacizumab failure, insertion of another active\r drug prior to bevacizumab induction would enhance survival time for patients with recurrent\r GBM.\r\n\r In Japan, there are currently only few chemotherapeutic agents approved and available for\r GBM. Among them rechallenge with alternating dosing of TMZ have shown certain efficacy with\r acceptable toxicities for patients with TMZ-pretreated recurrent GBM, thus being a good\r candidate for the regimen used prior to bevacizumab at recurrence.\r\n\r The present proposal of sequential administration of dose dense TMZ (7/14d) followed by\r bevacizumab wishes to define a new standard of care for recurrent disease and hopes to\r identify the subgroups of patients with progressive or recurrent glioblastoma that respond\r particularly well to dose-dense temozolomide regimens.\r\n\r This study is carried out as a JCOG Brain Tumor Study Group multicenter randomized phase III\r trial under approval by Advanced Medical Care B system, Ministry of Health, Labour and\r Welfare, Japan.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and\r gliosarcoma) by WHO2007 criteria.\r\n\r 2. For patients who did not undergo surgery for recurrent disease; pre-registration\r contrast MRI should confirm; (i)progressive or recurrent glioblastoma; (ii)no evidence\r of acute or subacute cerebral hemorrhage at enrolment; (iii)presence of a measurable\r lesion.\r\n\r 3. For patients who underwent surgery for recurrent disease; (i)progressive or recurrent\r glioblastoma must be confirmed on contrast MRI before reoperation; (ii)glioblastoma or\r anaplastic astrocytoma must be histologically identified in the tissue resected at\r reoperation; (iii)presence of measurable lesions is not mandatory on pre-registration\r contrast MRI (more than 4 days after reoperation); (iv)no MRI evidence of aggravating\r cerebral hemorrhage.\r\n\r 4. No evidence of tumors in the cerebellum, brain stem, optic nerve, olfactory nerve, and\r pituitary gland.\r\n\r 5. No evidence of meningeal dissemination or gliomatosis cerebri.\r\n\r 6. Prior treatment for newly-diagnosed glioblastoma (or diffuse astrocytoma (Grade II) or\r anaplastic astrocytoma (Grade III)) with postoperative TMZ administered concomitantly\r with radiotherapy (>=54 Gy for <=69 years old; >=30 Gy for >=70 years old) and at\r least for two cycles (5/28d) as an adjuvant treatment have been given.\r\n\r 7. No history of prior treatment with stereotactic radiotherapy (ex.\r Gamma-knife/Cyberknife), proton beam irradiation, neutron capture therapy, and\r chemotherapies except standard dose TMZ and immunotherapy (vaccines, immune checkpoint\r inhibitors, antibodies etc.), bevacizumab (12 weeks or more after termination of prior\r upfront bevacizumab use) that were combined with TMZ, and intraoperative placement of\r carmustine wafers, for glioblastoma (including diffuse astrocytoma (Grade II) and\r anaplastic astrocytoma (Grade III) at onset) diagnosed with WHO2007 criteria.\r\n\r Time periods required from the last day of the prior treatment indicated at\r registration.\r\n\r ①Peptide vaccination, immune checkpoint inhibitors, antibodies: 4 weeks.\r\n\r ②Bevacizumab: 12 weeks.\r\n\r 8. More than 90 days after completion of radiotherapy. For those who underwent\r reoperation, between 21 and 28 days postoperatively.\r\n\r 9. Age between 20 and 75 years at enrolment.\r\n\r 10. Karnofsky Performance Status >= 60 within 14 days before enrolment.\r\n\r 11. No prior treatment with chemotherapy, molecular targeted therapy, or radiotherapy to\r head and neck area for other malignancies.\r\n\r 12. Adequate organ function.\r\n\r 13. Written informed consent.\r\n\r Exclusion Criteria:\r\n\r 1. Synchronous or metachronous (within 5 years) malignancy, except for carcinoma in situ\r or mucosal tumors curatively treated with local therapy\r\n\r 2. Active infection requiring systemic therapy\r\n\r 3. Body temperature >= 38 degrees Celsius at registration\r\n\r 4. Women during pregnancy, possible pregnancy, within 28 days after delivery, or\r breast-feeding\r\n\r 5. Psychosis or with psychotic symptom\r\n\r 6. Continuous systemic use of immunosuppressant except for steroid\r\n\r 7. Uncontrolled diabetes mellitus or routine administration of insulin\r\n\r 8. Unstable angina within 3 weeks, with a history of myocardial infarction within 6\r months, or New York Heart Association (NYHA) class II or greater congestive heart\r failure\r\n\r 9. Inadequately controlled hypertension (cannot be controlled to a systolic pressure of\r >= 150 mmHg and a diastolic pressure of >= 100 mmHg)\r\n\r 10. History of symptomatic cerebrovascular disorder (including subarachnoid hemorrhage,\r cerebral infarction and transient ischemic attack) within 6 months or history of\r vascular disorder requiring intervention (including venous/arterial thrombosis or\r embolism and aortic aneurysm) within 6 moths\r\n\r 11. History of grade >= 2 hemoptysis within 28 days\r\n\r 12. History of hemorrhagic tendency (e.g., coagulation disorder) or any grade >= 3\r hemorrhage within 28 days\r\n\r 13. History of gastrointestinal perforation, fistula, abdominal abscess or uncontrolled\r peptic ulcer within 6 months\r\n\r 14. Interstitial pneumonia, pulmonary fibrosis, or severe lung emphysema\r\n\r 15. Severe non-healing wound or traumatic fracture at enrolment\r\n\r 16. Hypersensitivity to Chinese Hamster Ovary-derived drugs or other recombinant\r antibodies\r\n\r 17. Gadolinium allergy\r\n\r 18. Positive HIV antibody\r\n\r 19. Positive Hepatitis B (HB)s antigen\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\nInvestigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients\n\n**Clinical Trial Summary:**\n\nObservational study of axial spine pain and hyperflexibility. Patients will receive physical\r exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's\r hypermobility score) and blood / urine / saliva collection. They will also be separated into\r pain groups based on their response to injections. A correlation between exam findings and\r procedure group will be measured.\n\n**Clinical Trial Detailed Description:**\n\nThis is an observational study of patients with neck and back pain followed by a pain\r management clinic. Patients with particular pain generators in the neck and back will be\r defined by a positive response to one of several targeted interventional pain procedures.\r Each patient may undergo a physical exam to determine whether they have hypermobile joints.\r The study will thus evaluate the rate of hypermobility for each pain generator. In addition\r blood, urine, or saliva samples may be taken for biomarkers for pain or rheumatologic\r factors.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical diagnosis of axial back pain (neck, mid-back, lower back) or pain radiating\r to the extremity, with suspected diagnosis of a specific pain generator amenable to a\r pain procedure, including disorders of the nerves, joints, and muscles as listed\r immediately below.\r\n\r - Clinical decision to schedule patient for a pain procedure, including procedures\r targeting the following disorders:\r\n\r - Facet arthropathy: intra-articular facet joint injection, medial branch block,\r medial branch radiofrequency ablation\r\n\r - Sacroiliac joint dysfunction: sacroiliac joint injection, lateral branch block,\r lateral branch radiofrequency ablation\r\n\r - Myofascial pain syndrome: trigger point injection\r\n\r - Radiculopathy, spinal stenosis, or herniated nucleus pulposus: epidural steroid\r injection, selective nerve root block\r\n\r - Piriformis syndrome: piriformis injection\r\n\r - Greater trochanteric bursitis: greater trochanteric bursa injection\r\n\r - Able to provide HIPAA authorization to share prior medical records/imaging.\r\n\r Exclusion Criteria:\r\n\r - Previous diagnosis of cancer.\r\n\r - Currently pregnant.\r\n\r - Previously enrolled for the same procedure or the same pain generator site. (For\r example, this would exclude a patient who had an intra-articular facet joint injection\r at the right L5/S1 if: 1) he had the same injection 3 months ago and was enrolled at\r that time, or 2) the patient was already enrolled for a medial branch block at the\r right L5 and sacral ala, as this targets the same facet joint.)\r\n\r - Inability or unwillingness of subject or legal guardian/representative to give\r informed consent (e.g., ward of the state)\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\nSurgical Treatment of Intra-spinal Canal Tumors Via Trans-Quadrant Channel\n\n**Clinical Trial Summary:**\n\nIntra-spinal canal tumors are the general term of primary tumors from spinal cord or various\r tissues in the spinal canal and adjacent to the spinal cord, while the metastatic tumors are\r those from other sites other than spinal canal. Intra-spinal canal tumor is one of the most\r common diseases in neurosurgery, and surgery is the most effective treatment. Conventional\r open surgery is required to remove the posterior structures of the spine, which would lead to\r fracture of the posterior tension band, soft tissue injury, spine instability, and even spine\r deformity. So it is very important to protect and rebuild the posterior tension band for the\r stability of the spine. The team of Dr. John P. Kostuik from the Department of Orthopedics\r and Neurosurgery, the Johns Hopkins University, firstly introduced minimally invasive surgery\r for cervical and lumbar degenerative disease. However it has not been applied to the\r treatment of intra-spinal canal tumors. To date, the microsurgery of intra-spinal tumor\r through the trans-Quadrant channel pathway has not been widely performed in clinical\r practice. The investigators performed the microsurgery of intra-spinal canal tumor through\r the trans-Quadrant pathway in some patients previously and succeeded in the surgical\r treatments. The investigators analyzed the clinical data retrospectively, including surgical\r incision length, the volume of bleeding during operation, post-operative drainage volume,\r post-operative out-of-bed time point, post-operative length of stay in hospital, and\r post-operative visual analog pain (VAP) score. The group of patients using microsurgical\r technique through trans-Quadrant channel pathway showed better outcome compared with the\r group of patients using conventional open surgery. This innovation of microsurgery showed\r fewer traumas and bleeding, more rapid recovery, better prognosis and more safety in\r practice. Since there are some limitations to the retrospective study, it is necessary to\r design a prospective randomized controlled trial of the treatment of intra-spinal canal\r tumors using microsurgical technique through trans-Quadrant channel pathway.\n\n**Clinical Trial Detailed Description:**\n\nThis study is the prospective randomized controlled clinical trial.\r\n\r 1. Patient Recruitment: Patients who meets the diagnostic criteria of intra-spinal canal\r tumor and has surgical indications from May 2016 to June 2018 in the department of\r neurosurgery of our hospital could be recruited.\r\n\r 2. Screening: Demographic characteristics, such as gender, age, history of diseases\r (including but not limited in diabetes, heart disease, smoking history, and operation\r history, etc.), related laboratory tests (blood routing test, liver and kidney\r functions, electrolytes, blood coagulation function, and ECG, etc.) before entering\r either group.\r\n\r 3. Grouping: Patients who meets the diagnostic criteria and does not meet the exclusion\r criteria would be assigned into the experimental group and control group randomly. The\r informed consent forms should be signed before grouping.\r\n\r 4. Surgery: Patients in the experimental group will receive operation using microsurgical\r techniques through trans-Quadrant channel pathway. Patients in the control group will\r receive conventional open surgery.\r\n\r 5. Post-operative Observation and Follow-up: Clinical data will be collected after surgery\r and during follow-up. The time points include the 1st day, 7th day, 30th day, 90th day,\r and 180th day after surgery.\r\n\r 6. Statistical Analysis: Statisticians are blinded to the clinical data and grouping. The\r software SPSS (V. 16.0) will be used in statistics.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The patient should meet the diagnostic criteria of intra-spinal canal tumors and the\r indications for surgery. Meanwhile, the length of tumor should no more than 5 cm, and\r the cross-sectional area should be less than 2/3 of the respective area of the spinal\r canal.\r\n\r - The patient was never be treated with any spinal surgery.\r\n\r - There was no cognitive impairment before onset of diseases or other diseases which can\r cause cognitive dysfunction.\r\n\r - The patient should sign the informed consent forms.\r\n\r Exclusion Criteria:\r\n\r - The patient is diagnozed as non intra-spinal canal tumors, spinal degenerative\r diseases, or other spinal diseases.\r\n\r - The patient received spinal surgery previously.\r\n\r - The patient suffered from serious heart, lung, liver, or kidney insufficiency.\r\n\r - The patient has other spinal and spinal cord diseases rather than intra-spinal canal\r tumor, such as disc herniation, vertebral fractures.\r\n\r - The patient has severe diabetes, coronary heart disease, coagulation disorders,\r difficult to correct before operation, or cannot tolerate surgery.\r\n\r - The patient has other surgical contraindications.\r\n\r - The patient is pregnant or breast-feeding.\r\n\r - The patient is unable to sign the informed consent voluntarily.\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\nEvaluation of WIRION™ EPS in Lower Extremities Arteries\n\n**Clinical Trial Summary:**\n\nDemonstrate the safety and performance of the WIRION™ EPS in subjects undergoing lower\r extremity atherectomy for the treatment of Peripheral Arterial Disease (PAD)\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subject is at least 18 years of age\r\n\r 2. Subject or authorized representative, signed a written Informed Consent form to\r participate in the study, prior to any study related procedures\r\n\r 3. Subject is willing to comply with the protocol requirements and return to the\r treatment center for all required clinical evaluations\r\n\r 4. Rutherford classification 2-4\r\n\r 5. Has moderate to severe calcification visualized on angiogram in the femoropopliteal\r arteries\r\n\r 6. Planned atherectomy of the native femoropopliteal arteries\r\n\r 7. Reference vessel diameter for intended filter location must be visually estimated to\r be ≥3.5mm and ≤6.0mm\r\n\r 8. An adequate \"landing zone\" for placement of the WIRION™ device distal to the target\r lesion of at least 30mm\r\n\r 9. A female subject is eligible if not of child bearing potential or has a negative\r pregnancy test within the previous 7 days and agrees to remain on birth control\r throughout the study\r\n\r Exclusion Criteria:\r\n\r 1. Any planned surgical or endovascular intervention within 30 days before or after the\r index procedure\r\n\r 2. A lesion deemed not accessible by the WIRION™ EPS\r\n\r 3. Inability to take aspirin or ADP receptor antagonists\r\n\r 4. History of bleeding diathesis or coagulopathy or will refuse blood transfusion if\r deemed necessary\r\n\r 5. Has perforation, dissection, or other injury of the access or target vessel requiring\r additional stenting or surgical intervention before enrollment\r\n\r 6. Subject is enrolled in another drug or device study protocol that has not reached its\r primary endpoint (participating in registry studies is not excluded)\r\n\r 7. Life expectancy less than 12 months\r\n\r 8. Known severe renal insufficiency (eGFR <30 ml/min/1.72m2).\r\n\r 9. ≤1-vessel tibial run-off status\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\nStudy to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to compare the efficacy and safety of eflornithine in\r combination with lomustine, compared to lomustine taken alone, in treating patients whose\r anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.\n\n**Clinical Trial Detailed Description:**\n\nThis study will consist of 4 study periods of up to 50 months in total, consisting of:\r\n\r Screening Period - A maximum screening duration of 4 weeks.\r\n\r Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.\r\n\r End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.\r\n\r Follow-Up Period - Up to approximately 36 months, or until patient death.\r\n\r A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either\r eflornithine + lomustine or lomustine alone.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Patients must meet all of the following inclusion criteria to be eligible for participation\r in this study:\r\n\r - Surgical or biopsy-proven diagnosis of WHO grade 3 AA.\r\n\r - First AA tumor progression or recurrence ≤ 6 months prior to randomization based on\r MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid\r enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors\r will be eligible if there is no necrosis seen on MRI and any of the following criteria\r is true:\r\n\r 1. Gd-contrast lesion margins are not clearly defined,\r\n\r 2. Gd-contrast lesions are only measurable in one dimension,\r\n\r 3. Gd-contrast lesion has two perpendicular diameters less than 10 mm,\r\n\r 4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less\r than 20 mm and lesion does not demonstrate central necrosis,\r\n\r 5. Recent histopathological confirmation of WHO grade 3 AA\r\n\r - Received EBRT and temozolomide chemotherapy prior to first tumor progression or\r recurrence of WHO Grade 3 AA.\r\n\r - Completion of EBRT ≥ 6 months prior to randomization.\r\n\r - A patient whose AA tumor has progressed or recurred and has had another surgical\r resection prior to randomization will be eligible if a) pathology review confirms AA,\r and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.\r\n\r - Karnofsky Performance Status (KPS) score of ≥ 70.\r\n\r Exclusion Criteria:\r\n\r Patients who meet any of the following exclusion criteria are not eligible for study\r participation:\r\n\r - MRI defining progression is consistent with a diagnosis of glioblastoma or radiation\r necrosis.\r\n\r - Patients who are considered to be refractory to EBRT and temozolomide but who have not\r progressed.\r\n\r - Prior systemic therapy for recurrence of AA.\r\n\r - Presence of extracranial or leptomeningeal disease.\r\n\r - Prior lomustine use.\r\n\r - Any other clinical condition or prior therapy that, in the opinion of the\r Investigator, would make the patient unsuitable for the study.\r\n\r - Pregnant or breastfeeding.\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\nSuper Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA\n\n**Clinical Trial Summary:**\n\nPrimary brain tumors are typically treated by surgery, radiation therapy and chemotherapy,\r either individually or in combination. Present therapies are inadequate, as evidenced by the\r low 5-year survival rate for brain cancer patients, with median survival at approximately 12\r months. Glioma is the most common form of primary brain cancer, afflicting approximately\r 7,000 patients in the United States each year. These highly malignant cancers remain a\r significant unmet clinical need in oncology. GBM often has a high expression of EFGR\r (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods\r of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and\r tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring\r GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of\r 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and\r prevent tumor progression in patients with recurrent, residual GBM.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female patients of ≥18 years of age\r\n\r - Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma\r multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)\r\n\r - Patients with pathology confirmed histologic EGFR overexpression\r\n\r - Patients must have at least one confirmed and evaluable tumor site.∗\r\n\r *A confirmed tumor site is one in which is biopsy-proven\r\n\r - Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥\r three months.\r\n\r - No chemotherapy for two weeks prior to treatment under this research protocol and no\r external beam radiation for eight weeks prior to treatment under this research\r protocol\r\n\r - Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute\r neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must\r have a platelet count of ≥150,000/ mm3\r\n\r - Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper\r limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL\r\n\r - Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL\r\n\r - Patients must agree to use a medically effective method of contraception during and\r for a period of three months after the treatment period. A pregnancy test will be\r performed on each premenopausal female of childbearing potential immediately prior to\r entry into the research study\r\n\r - Patients must be able to understand and give written informed consent. Informed\r consent must be obtained at the time of patient screening\r\n\r Exclusion Criteria:\r\n\r - Women who are pregnant or lactating.\r\n\r - Women of childbearing potential and fertile men will be informed of the potential\r unknown risk of conception while participating in this research trial and will be\r advised that they must use effective contraception during and for a period of three\r months after the treatment period\r\n\r - Patients with significant intercurrent medical or psychiatric conditions that would\r place them at increased risk or affect their ability to receive or comply with\r treatment or post-treatment clinical monitoring\r\n\r - Patients with radiological evidence of leptomeningeal disease\r\n\r - Patients with history of allergic reaction to CTX\r\n\r - Patients who completed chemo/RT less than 6 months prior to enrollment\r\n\r - Patients who have not failed standard Stupp 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\"."
}
] |
[
{
"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\nDisc Resorption in Lumbar and Cervical Disc Herniation Patients Receiving Integrative Korean Medicine Treatment\n\n**Clinical Trial Summary:**\n\nMeasurement of herniated disc resorption and assessment of satisfaction regarding\r post-treatment state and integrative Korean medicine treatment through phone interview in 500\r patients with MRI follow-up results receiving treatment for lumbar and cervical disc\r herniation at Jaseng Hospital of Korean Medicine.\n\n**Clinical Trial Detailed Description:**\n\nIntervertebral disc herniation treatment can be largely divided into conservative and\r surgical approaches, and the greater majority of patients show relief of symptoms and\r resorption of herniated disc through non-surgical, conservative management. Despite concerns\r that early surgical interventions in intervertebral disc herniation without allowing for\r sufficient conservative treatment may indicate overtreatment, awareness and understanding in\r the general public is found somewhat lacking.\r\n\r The objective of this study is to measure herniated disc resorption and assess satisfaction\r regarding post-treatment state and integrative Korean medicine treatment through phone\r interview in 500 patients with MRI follow-up results before and after receiving conservative\r treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Lumbar and/or cervical disc herniation patients with baseline MRI and follow-up\r results after receiving treatment at Jaseng Hospital of Korean Medicine visiting\r between February 2012 and December 2015.\r\n\r - Participants giving informed written consent to use of medical records for academic\r means.\r\n\r Exclusion Criteria:\r\n\r - Participants refusing to participate in study or to respond to phone interview.\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\nSafety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee\n\n**Clinical Trial Summary:**\n\nThis is a prospective open-label clinical study of 50 patients to determine safety and\r treatment potential of autologous cell therapy for pain and inflammation associated with\r Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000\r patients.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective open-label clinical study of 50 patients to determine safety and\r treatment potential of autologous cell therapy for pain and inflammation associated with\r Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000\r patients.\r\n\r Patients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic\r injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell\r Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by RegenLab (RegenKit BCT-3)\r PRP product each as direct injections to the affected joints.\r\n\r Cohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2\r weeks and 1 month.\r\n\r Cohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and\r 2 months.\r\n\r Patient outcomes will be tracked with a follow up MRI at various endpoints to 6 months,\r laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score\r (KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating scales\r (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction\r in patient medication and/or delay in pending knee replacement therapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration\r or chronic injury.\r\n\r 2. Patients range from 18-90 years of age.\r\n\r 3. Patients must be able to comply with treatment plan, laboratory tests and periodic\r interviews.\r\n\r 4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.\r\n\r 5. Patients with adequate cardiac and respiratory function.\r\n\r 6. Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT\r\n\r 7. Patients must have adequate immune system function, with no known immunodeficiency\r disease.\r\n\r 8. Greater than 6 months knee pain on the index side (left or right knee).\r\n\r Exclusion Criteria:\r\n\r 1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell\r or squamous cell cancer resolved by excision\r\n\r 2. Presence of clinically significant acute or unstable cardiovascular and\r cerebrovascular (stroke).\r\n\r 3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.\r\n\r 4. Patients infected with hepatitis B, C or HIV.\r\n\r 5. Patients with Body Mass Index (BMI) > 40kg/m2\r\n\r 6. Presence of active infection.\r\n\r 7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the\r opinion of the investigator would render a patient unsuitable to participate in the\r study.\r\n\r 8. Conditions/therapies/factors which could confound or interfere with the evaluation of\r pain/mobility including, but not limited to:\r\n\r 1. Knee instability.\r\n\r 2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or\r complex surgery.\r\n\r 3. Gout or pseudo gout\r\n\r 4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather\r than knee osteoarthritis\r\n\r 5. Corticosteroid injection at treatment site within 1 month\r\n\r 6. Consistent use of NSAIDs within 48 hours of procedure.\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\nUnrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the feasibility of comparing outcomes of patients\r treated de novo with immunosuppressive therapy (IST) versus matched unrelated donor (MUD)\r hematopoietic stem cell transplant (HSCT) for pediatric acquired severe aplastic anemia.\n\n**Clinical Trial Detailed Description:**\n\nA major challenge in treating pediatric Severe Aplastic Anemia (SAA) is the determination of\r best primary therapy for patients who lack a fully matched related donor for HSCT. Good\r survival outcomes have been seen with IST, but initial and late failures, CSA dependence,\r persistent cytopenias and secondary Myelodysplastic Syndrome (MDS) / Acute Myeloid Leukemia\r (AML) in a portion of patients leave considerable room for improvement. MUD HSCT survival in\r SAA has markedly improved, but a direct comparison of this approach with IST is necessary to\r determine whether this approach is feasible and will lead to better Event Free Survival. This\r trial will address the feasibility of randomization, test whether patients can be evaluated\r in a timely fashion and safely begin therapy with MUD HSCT or IST, and give a preliminary\r assessment of the safety of up-front MUD HSCT. If successful, this trial will lead to a\r future prospective trial comparing directly IST to MUD HSCT in this disease.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Confirmed diagnosis of idiopathic SAA, defined as:\r\n\r - Bone marrow cellularity <25%, or <30% hematopoietic cells.\r\n\r - Two out of three of the following (in peripheral blood): neutrophils <0.5 x109/L,\r platelets <20 x109/L, reticulocyte count <60 x109/L with hemoglobin <8g/dL.\r\n\r 2. Age ≤25 years old.\r\n\r 3. No suitable fully matched related donor available (minimum 6/6 match for Human\r Leukocyte antigen (HLA) -A and B at intermediate or high resolution and DRB1 at high\r resolution using DNA based typing).\r\n\r 4. At least two unrelated donors noted on National Marrow Donor Program (NMDP) search who\r are well matched (9/10 or 10/10 for HLA-A, B, C, DRB1, and DQB1 using high\r resolution).\r\n\r 5. Signed informed consent for the randomized trial by patient and/or legal guardian.\r\n\r 6. Adequate organ function defined as in the judgment of the investigator, there is not\r irreversible organ damage that would preclude the patient from meeting the organ\r function inclusion criteria for HSCT listed in section 2.3.4 by the intended time of\r HSCT (6-8 weeks after randomization) or preclude patients from receiving horse ATG.\r\n\r Exclusion Criteria:\r\n\r 1. Inherited bone marrow failure syndromes (IBMFS). The diagnosis of Fanconi anemia must\r be excluded by diepoxybutane (DEB) or equivalent testing on peripheral blood or\r marrow. Telomere length testing should be sent on all patients to exclude Dyskeratosis\r congenita, but if results are delayed or unavailable and there are no clinical\r manifestations of DC, patients may enroll. If patients have clinical characteristics\r suspicious for Shwachman Diamond syndrome, this syndrome must be excluded by\r pancreatic isoamylase testing or gene mutation analysis. Note: pancreatic isoamylase\r testing is not accurate in children less than 3 years.\r\n\r 2. Clonal cytogenetic abnormalities or fluorescence In Situ Hybridization (FISH) pattern\r consistent with pre-myelodysplastic syndrome (pre-MDS) or MDS on marrow examination\r (see section 4.2.3.1 for details of the required MDS FISH panel).\r\n\r 3. Known severe allergy to horse ATG.\r\n\r 4. Prior allogeneic stem cell transplant.\r\n\r 5. Prior solid organ transplant.\r\n\r 6. Infection with human immunodeficiency virus (HIV).\r\n\r 7. Active Hepatitis B or C. This should be excluded in patients where there is clinical\r suspicion of hepatitis (e.g. elevated LFTs).\r\n\r 8. Female patients who are pregnant or breast-feeding.\r\n\r 9. Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma\r in situ.\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\nCombination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations\n\n**Clinical Trial Summary:**\n\nThis randomized phase III trial studies how well combination chemotherapy works in treating\r young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come\r back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase\r inhibitor (TKI) sensitive mutations. Chemotherapy drugs, work in different ways to stop the\r growth of cancer cells, either by killing the cells, by stopping them from dividing, or by\r stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving\r the drugs in different doses and in different combinations may kill more cancer cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine if the administration of post-Induction age-adjusted intrathecal triple\r therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance high-dose\r methotrexate (IMHDM) backbone will improve 5-year disease-free survival (DFS) of children\r with high-risk (HR) B-acute lymphoblastic leukemia (ALL) compared to age-adjusted intrathecal\r (IT) methotrexate (MTX). (Completed effective March 19, 2018) II. To determine, in a\r randomized fashion, if the cyclophosphamide + etoposide containing regimen (Experimental Arm\r 1) will improve the 4-year DFS of children, adolescents, and young adults with very high-risk\r (VHR) B-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (Control\r Arm). (Completed effective February 15, 2017)\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To determine the toxicity and tolerability of post-Induction age-adjusted ITT compared to\r age-adjusted IT MTX in children with HR B-ALL. (Completed effective March 19, 2018) II. To\r determine the toxicity and tolerability of Experimental Arm 1 compared to the Control Arm in\r children, adolescents, and young adults with VHR B-ALL. (Completed effective February 15,\r 2017) III. To determine whether a single-arm, modified Induction with limited anthracycline\r exposure and post-Induction therapy regimen with MBFM-interim maintenance intermediate dose\r methotrexate (IMIDM) and reduced vincristine (vincristine sulfate)/steroid pulse frequency\r and enhanced supportive care in children with Down syndrome (DS) and HR B-ALL will result in\r a >= 65% 5-year DFS and < 10% Induction mortality.\r\n\r IV. To describe the outcomes for children and young adults with Philadelphia chromosome\r (Ph)-like B-ALL and a predicted TKI-sensitive mutation treated with dasatinib plus\r MBFM-IMHDM.\r\n\r V. To determine the toxicity and tolerability of MBFM-IMIDM in children with DS and HR B-ALL.\r\n\r VI. To estimate overall survival (OS) rates both overall and by regimen a) for HR B-ALL and\r b) VHR B-ALL patients.\r\n\r VII. To determine the incidence of osteonecrosis (ON), defined by magnetic resonance (MR)\r imaging, and to characterize the natural history of clinically silent ON in children,\r adolescents, and young adults 10 years of age and greater and to assess the role of drugs\r (i.e., asparaginase and methotrexate) in addition to corticosteroids, in the risk for\r development of ON. (Completed accrual July 2016) VIII. To determine if the prevalence of\r cognitive deficits measured by CogState, in children (ages 6 to < 13 years) with HR- and VHR\r B-ALL at 1 year off therapy, is significantly higher than the normative population (> 14%) in\r the following domains: working memory, executive function, visual motor, processing speed,\r and visual attention.\r\n\r EXPLORATORY OBJECTIVE:\r\n\r I. To determine if the reduction of minimal residual disease (MRD) from end-Induction to\r end-Consolidation is greater for children, adolescents, and young adults with VHR B-ALL\r receiving Experimental Arm 1 compared to the Control Arm. (Closed effective October 20, 2017)\r\n\r OUTLINE:\r\n\r INDUCTION THERAPY:\r\n\r Patients without Down syndrome receive induction chemotherapy comprising cytarabine\r intrathecally (IT) on day 1 (and twice weekly thereafter for CNS2 patients [except for days 8\r and 29]); vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, and 22;\r daunorubicin hydrochloride IV over 1-15 minutes on days 1, 8, 15, and 22; dexamethasone\r orally (PO) or IV twice daily (BID) on days 1-14 (patients under 10 years old) or prednisone\r PO or IV BID on days 1-28 (patients at least 10 years old); pegaspargase IV over 1-2 hours on\r day 4; and methotrexate IT on days 8 and 29 for CNS1 and CNS2 patients (plus days 15 and 22\r for CNS3 patients). Treatment continues for 35 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r Participants are stratified to 1 of 3 disease groups: HR B-ALL, VHR B-ALL and PH-like B-ALL a\r predicted TKI-sensitive mutation.\r\n\r GROUP I - HR B-ALL: Patients are randomized to 1 of 2 treatment arms. (RANDOMIZATION CLOSED\r 03/19/2018)\r\n\r CONSOLIDATION THERAPY (C):\r\n\r ARM A HR B-ALL C: Patients receive consolidation therapy comprising cyclophosphamide IV over\r 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or subcutaneously (SC) on\r days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42,\r methotrexate IT on days 1, 8, 15, and 22; vincristine sulfate IV over 1 minute on days 15,\r 22, 43, and 50; and pegaspargase IV over 1-2 hours on days 15 and 43. Patients with\r continuing clinical evidence of testicular leukemia undergo radiotherapy (RT) QD, 5 days a\r week, for approximately 2½ weeks (12 fractions total). Treatment continues for 56 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r ARM B HR B-ALL C: Patients receive consolidation therapy as in Arm I HR B-ALL C. Patients\r also receive ITT comprising methotrexate, hydrocortisone sodium succinate, and cytarabine on\r days 1, 8, 15, and 22. Patients with testicular leukemia also undergo RT as in Arm I HR B-ALL\r C. (CLOSED 03/19/2018)\r\n\r INTERIM MAINTENANCE THERAPY (IM) ARM A HR B-ALL IM: Patients receive IM therapy comprising\r vincristine sulfate IV over 1 minute on days 1, 15, 29, and 43; high-dose methotrexate IV\r over 24 hours on days 1, 15, 29, and 43; leucovorin calcium PO or IV on days 3-4, 17-18,\r 31-32, and 45-46; methotrexate IT on days 1 and 29; and mercaptopurine PO on days 1-56.\r Treatment continues for 63 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r ARM B HR B-ALL IM: Patients receive ITT on days 1 and 29 and IM therapy as in Arm I HR-ALL\r IM. Treatment continues for 63 days in the absence of disease progression or unacceptable\r toxicity. (CLOSED 03/19/2018)\r\n\r DELAYED INTENSIFICATION THERAPY (DI):\r\n\r ARM A HR B-ALL DI: Patients receive DI therapy comprising vincristine sulfate IV over 1\r minute on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-7 and 15-21;\r doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; methotrexate IT on days\r 1, 29, and 36; pegaspargase IV over 1-2 hours on days 4 and 43; cyclophosphamide IV over\r 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and\r thioguanine PO QD on days 29-42. Treatment continues for 56 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r ARM B HR B-ALL DI: Patients receive ITT on days 1, 29, and 36 and DI therapy as in Arm I HR\r B-ALL DI. (CLOSED 03/19/2018)\r\n\r MAINTENANCE THERAPY (M):\r\n\r ARM A HR B-ALL M: Patients receive maintenance therapy comprising vincristine sulfate IV over\r 1 minute on days 1, 29, and 57; methotrexate IT on day 1 (also day 29 of courses 1-4);\r prednisone PO BID on days 1-5, 29-33 (may receive methylprednisolone IV if PO is not\r tolerated), and 57-61; mercaptopurine PO QD on days 1-84; and methotrexate PO on days 8, 15,\r 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 2 years\r (females) or 3 years (males) in the absence of disease progression or unacceptable toxicity.\r\n\r ARM B HR B-ALL M: Patients receive ITT on day 1 (also day 29 of courses 1-4) and maintenance\r therapy as in Arm I HR B-ALL M. Treatment repeats every 12 weeks for 2 years (females) or 3\r years (males) in the absence of disease progression or unacceptable toxicity. (CLOSED\r 03/19/2018)\r\n\r GROUP II: VHR B-ALL: Patients are randomized to 1 of 3 treatment arms. (RANDOMIZATION CLOSED\r 02/15/2017)\r\n\r CONSOLIDATION THERAPY PART I: In all arms, patients receive cyclophosphamide IV over 30-60\r minutes on day 1; cytarabine IV over 1-30 minutes or SC on days 1-4 and 8-11; mercaptopurine\r PO QD on days 1-14; methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3\r patients); vincristine sulfate IV over 1 minute on days 15 and 22; and pegaspargase IV over\r 1-2 hours on day 15. Patients with continuing clinical evidence of testicular leukemia\r undergo RT QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment\r continues for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r CONSOLIDATION THERAPY PART II:\r\n\r ARM A VHR B-ALL C (CONTROL ARM): Patients receive consolidation therapy comprising\r cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on\r days 29-32 and 36-39; mercaptopurine PO QD on days 29-42; vincristine sulfate IV over 1\r minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues\r for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r ARM B VHR B-ALL C (EXPERIMENTAL ARM 1): Patients receive consolidation therapy comprising\r cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on\r days 29-33; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over\r 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or\r unacceptable toxicity. (CLOSED 02/15/2017)\r\n\r ARM C VHR B-ALL C (EXPERIMENTAL ARM 2): Patients receive clofarabine IV over 2 hours on days\r 29-33 and consolidation therapy as in Arm B VHR B-ALL C. (CLOSED 9/12/2014)\r\n\r INTERIM MAINTENANCE THERAPY PART I: In all arms, patients receive vincristine sulfate IV over\r 1 minute on days 1, 15, 29, and 43; high-dose methotrexate IV over 24 hours on days 1, 15,\r 29, and 43; leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46; mercaptopurine\r PO QD on days 1-56; and methotrexate IT on days 1 and 29. Treatment continues for 63 days in\r the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY PART I: In all arms, patients receive vincristine sulfate IV\r over 1 minute on days 1, 8, and 15; dexamethasone PO or IV BID on days 1-7 and 15-21;\r doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; methotrexate IT on day\r 1; and pegaspargase IV over 1-2 hours on day 4. Treatment continues for 28 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY PART II:\r\n\r ARM A VHR B-ALL DI (CONTROL ARM): Patients receive DI therapy comprising cyclophosphamide IV\r over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39;\r thioguanine PO QD on days 29-42; methotrexate IT on days 29 and 36; vincristine sulfate IV\r over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment\r continues for 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r ARM B VHR B-ALL DI (EXPERIMENTAL ARM 1): Patients receive DI therapy comprising\r cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on\r days 29-33; methotrexate IT on days 29 and 36; vincristine sulfate IV over 1 minute on days\r 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in\r the absence of disease progression or unacceptable toxicity. (CLOSED 02/15/2017)\r\n\r ARM C VHR B-ALL DI (EXPERIMENTAL ARM 2): Patients receive clofarabine IV over 2 hours on days\r 29-33 and DI therapy as in Arm II B VHR B-ALL DI. (Closed as of 9/12/2014)\r\n\r INTERIM MAINTENANCE THERAPY PART II: In all arms, patients receive vincristine sulfate IV\r over 1 minute and methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on\r days 1, 11, 21, 31, and 41; pegaspargase IV over 1-2 hours on days 2 and 22; and methotrexate\r IT on days 1 and 31. Treatment continues for 56 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r MAINENTANCE THERAPY: Patients with CNS3 disease at diagnosis undergo RT QD over 4 weeks (10\r fractions total). In all arms, patients receive vincristine sulfate IV over 1 minute on days\r 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61 (may receive\r methylprednisolone IV if PO is not tolerated); methotrexate PO on days 8, 15, 22, 29, 36, 43,\r 50, 57, 64, 71, and 78 (except on methotrexate IT days); mercaptopurine PO QD on days 1-84;\r methotrexate IT on day 1 (also day 29 of courses 1 and 2 for CNS patients who did not undergo\r RT). Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence\r of disease progression or unacceptable toxicities.\r\n\r GROUP III: PH-LIKE PREDICTED TKI-SENSITIVE KINASE MUTATION:\r\n\r CONSOLIDATION THERAPY: Patients receive dasatinib PO QD on days 1-56, cyclophosphamide IV\r over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11,\r 29-32 and 36-39, mercaptopurine PO on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15\r and 22 (days 1 and 8 only for CNS3 patients), vincristine sulfate IV over 1 minute on days\r 15, 22, 43 and 50, and pegaspargase IV over 1-2 hours on days 15 and 43. Treatment continues\r for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r INTERIM MAINTENANCE THERAPY I: Patients receive dasatinib PO QD on days 1-63, vincristine\r sulfate IV over 1 minute on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours\r on days 1, 15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46,\r methotrexate IT on days 1 and 29, and mercaptopurine PO on days 1-56. Treatment continues for\r 63 days in the absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY: Patients receive dasatinib PO QD on days 1-56, vincristine\r sulfate IV over 1 minute on days 1, 8, 15, 43, and 50, dexamethasone PO or IV on days 1-7 and\r 15-21, doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8 and 15, methotrexate IT on\r days 1, 29 and 36, pegaspargase IV over 1-2 hours on days 4 and 43, cyclophosphamide IV over\r 30-60 minutes day 29, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, and\r thioguanine PO on days 29-42. Treatment continues for 56 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r INTERIM MAINTENANCE THERAPY II: Patients dasatinib PO QD on days 1-56, vincristine sulfate IV\r over 1 minute days 1, 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or\r 10-15 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 days 2 and 22.\r\n\r MAINTENANCE THERAPY: Patients receive dasatinib PO QD on days 1-84, vincristine sulfate IV\r over 1 minute on days 1, 29 and 57, prednisone PO BID or IV on days 1-5, 29-33 and 57-61,\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71 and 78 (omit on days when MTX\r [IT] is given), mercaptopurine PO on days 1-84, methotrexate IT on day 1 (also day 29 of\r course 1 and 2, for patients who did not receive CNS radiation). Treatment repeats every 12\r weeks for 2 years (females) or 3 years (males) in the absence of disease progression or\r unacceptable toxicities.\r\n\r Participants with Down syndrome are assigned to DS HR B-ALL:\r\n\r INDUCTION THERAPY: All patients receive cytarabine IT on day 1; vincristine sulfate IV over 1\r minute on days 1 and 8, dexamethasone PO or IV BID (patients under 10 years old) or\r prednisone PO BID (patients at least 10 years old) on days 1-14 (may receive\r methylprednisolone IV if PO is not tolerated), pegaspargase IV over 1-2 hours on day 4;\r methotrexate IT on day 8; and leucovorin calcium PO on days 10-11. Treatment continues for 14\r days in the absence of disease progression or unacceptable toxicity.\r\n\r RAPID EARLY RESPONDERS (RER): Patients receive induction therapy comprising vincristine\r sulfate IV over 1 minute on days 15 and 22; dexamethasone PO BID (patients under 10 years\r old) or prednisone PO BID (patients at least 10 years old) on days 15-28; methotrexate IT on\r day 29 (also days 15 and 22 for CNS3 patients); and leucovorin calcium PO on days 31-32 (also\r days 17-18 and 24-25 for CNS3 patients). Treatment continues for 14 days in the absence of\r disease progression or unacceptable toxicity.\r\n\r SLOW EARLY RESPONDERS (SER): Patients receive daunorubicin hydrochloride IV over 1-15 minutes\r on day 15 and Induction therapy as RER patients. Treatment continues for 14 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r CONSOLIDATION THERAPY: All patients receive cyclophosphamide IV over 30-60 minutes on days 1\r and 29; cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39;\r mercaptopurine PO QD on days 1-14 and 29-42; vincristine sulfate IV over 1 minute on days 15,\r 22, 43, and 50; pegaspargase IV over 1-2 hours on days 15 and 43; methotrexate IT on days 1,\r 8, 15, and 22 (days 1 and 8 only for CNS3 patients); and leucovorin calcium PO on days 3-4,\r 10-11, 17-18, and 24-25. Patients with continuing clinical evidence of testicular leukemia\r undergo RT QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment\r continues for 56 days in the absence of disease progression or unacceptable toxicity.\r\n\r INTERIM MAINTENANCE THERAPY: Patients receive vincristine sulfate IV over 1 minute on days 1,\r 15, 29, and 43; intermediate dose methotrexate IV over 24 hours on days 1, 15, 29, and 43;\r leucovorin calcium PO or IV on days 2-3, 17-18, 31-32, and 45-46; mercaptopurine PO QD on\r days 1-56; and methotrexate IT on days 1 and 29. Treatment continues for 63 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r DELAYED INTENSIFICATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on\r days 1, 8, 15, 43, and 50; dexamethasone PO BID or IV on days 1-7 and 15-21; doxorubicin\r hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on\r days 4 and 43; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO QD on days\r 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; methotrexate IT on days\r 1, 29, and 36; and leucovorin calcium PO on days 3-4, 31-32 and 38-39.\r\n\r MAINTENANCE THERAPY: Patients with CNS3 disease undergo RT QD, 5 days a week, for 2 weeks (10\r fractions total). Patients receive vincristine sulfate IV over 1 minute on day 1; prednisone\r PO BID or IV on days 1-5 (may receive methylprednisolone IV if PO not tolerated);\r methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO QD\r on days 1-84; and methotrexate IT on day 1 (also day 29 of courses 1-4 for CNS3 patients who\r did not undergo RT). Treatment repeats every 12 weeks for 2 years (females) or 3 years\r (males) in the absence of disease progression or unacceptable toxicities.\r\n\r After completion of study treatment, patients are followed up periodically for 10 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must be enrolled on APEC14B1 and consented to Eligibility Screening on the\r Part A consent form prior to enrollment on AALL1131\r\n\r - White Blood Cell Count (WBC) Criteria\r\n\r - Age 1-9.99 years: WBC >= 50 000/uL\r\n\r - Age 10-30.99 years: Any WBC\r\n\r - Age 1-30.99 years: Any WBC with:\r\n\r - Testicular leukemia\r\n\r - CNS leukemia (CNS3)\r\n\r - Steroid pretreatment\r\n\r - Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health\r Organization [WHO] classification) (also termed B-precursor acute lymphoblastic\r leukemia); patients with Down syndrome are also eligible\r\n\r - Organ function requirements for patients with Ph-like ALL and a predicted\r TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase\r mutation must have assessment of organ function performed within 3 days of study entry\r onto the dasatinib arm of AALL1131\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70mL/min/1.73\r m^2 or a serum creatinine based on age/gender as follows:\r\n\r - Age: Maximum Serum Creatinine (mg/dL)\r\n\r - 1 to < 6 months: 0.4 (male) 0.4 (female)\r\n\r - 6 months to < 1 year: 0.5 (male) 0.5 (female)\r\n\r - 1 to < 2 years: 0.6 (male) 0.6 (female)\r\n\r - 2 < 6 years: 0.8 (male) 0.8 (female)\r\n\r - 6 to < 10 years: 1.0 (male) 1.0 (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 - Direct bilirubin =< 3 x upper limit of normal (ULN) for age, and\r\n\r - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 10 x\r upper limit of normal (ULN) for age\r\n\r - Shortening fraction >= 27% by echocardiogram, or ejection fraction >= 50% by gated\r radionuclide study\r\n\r - Patients must have an electrocardiogram (EKG) fewer than 6 days prior to\r enrollment on the dasatinib arm; patients who have had cardiac assessments by\r echocardiogram or radionuclide scan at the beginning of induction do not need to\r have these repeated prior to study entry; correct QT interval (QTc) < 450 msec on\r baseline electrocardiogram as measured by the Friderica or Bazett formula\r\n\r - No major conduction abnormality (unless a cardiac pacemaker is present)\r\n\r - No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at\r sea level if there is clinical indication for determination\r\n\r - Patients with seizure disorder may be enrolled if on anticonvulsants and well\r controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine,\r phenytoin, primidone, phenobarbital) should be avoided\r\n\r - Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive\r Functioning study\r\n\r - Patients must be aged 6 to 13 years at time of B-ALL diagnosis, enrolled on\r AALL1131\r\n\r - Patients must be English-, French- or Spanish-speaking (languages in which the\r assessment is available)\r\n\r - Patients must have no known history of neurodevelopmental disorder prior to\r diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William's Syndrome, mental\r retardation)\r\n\r - Patients must have no significant visual impairment that would prevent computer\r use and recognition of the visual test stimuli\r\n\r - Eligibility criteria for the National Cancer Institute (NCI) standard risk patients\r from AALL0932 enrolling on this study at the end of Induction\r\n\r - Effective March 19, 2018, patients enrolled on AALL0932, without Down syndrome,\r meeting the following criteria will NOT be eligible to continue on AALL0932 or the HR\r B-ALL stratum of this study at the end of Induction:\r\n\r - Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day\r 8 peripheral blood (PB) minimal residual disease (MRD) >= 1% and day 29 bone\r marrow (BM) MRD < 0.01%\r\n\r - With favorable cytogenetics (ETV6-RUNX1 or double trisomies 4+10), with any day 8\r PB MRD and day 29 BM MRD >= 0.01%\r\n\r - Both NCI standard risk (SR) and HR patients without Down syndrome and with\r testicular disease at diagnosis, who do not meet other VHR criteria\r\n\r - Effective Amendment 6, patients enrolled on AALL0932, without Down syndrome, meeting\r the following criteria will NOT be eligible to continue on AALL0932 or the VHR stratum\r of AALL1131:\r\n\r - Intrachromosomal amplification of chromosome 21 (iAMP21)\r\n\r - Mixed-lineage leukemia (MLL) rearrangement\r\n\r - Hypodiploidy (n < 44 chromosomes and/or a deoxyribonucleic acid [DNA] index <\r 0.81)\r\n\r - Induction failure (M3 BM at day 29)\r\n\r - Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day\r 29 BM MRD >= 0.01%\r\n\r - Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will\r NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR\r B-ALL stratum of this study at the end of Induction:\r\n\r - Day 29 MRD >= 0.01%\r\n\r - MLL rearrangement\r\n\r - Hypodiploidy (n < 45 chromosomes and/or DNA index < 0.81)\r\n\r - DS HR B-ALL patients initially enrolled on AALL0932 or this study who have Induction\r failure (M3 BM day 29) or Philadelphia chromosome (BCR-ABL1) will not be eligible for\r post-Induction therapy on either trial (AALL0932 or AALL1131)\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 - 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 any cancer diagnosed prior to the initiation\r of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed\r after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving\r prior steroid therapy may be eligible for AALL1131\r\n\r - Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this\r study but may be eligible to enroll in a successor Children's Oncology Group (COG)\r Philadelphia positive (Ph+) ALL trial by day 15 Induction\r\n\r - DS HR B-ALL patients with Induction failure or BCR-ABL1\r\n\r - Female patients who are pregnant are ineligible since fetal toxicities and teratogenic\r effects have been noted for several of the study drugs\r\n\r - Lactating females are not eligible unless they have agreed not to breastfeed their\r infant\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\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\nEffect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention\n\n**Clinical Trial Summary:**\n\nUrinary retention is a common problem, particularly in hospitalized patients. When a Foley\r catheter is removed, a patient must be monitored for urinary retention. The usual method is a\r passive voiding trial where the catheter is removed, the bladder fills with urine and the\r patient is monitored for voiding over approximately 6 hours. Another option is an active\r voiding trial where the bladder is filled with saline before the catheter is removed and the\r patient is immediately assisted to void. This study seeks to determine the effect of active\r vs passive voiding trials on time to hospital discharge, rate of urinary tract infections,\r and rate or urinary retention in the general hospitalized population.\n\n**Clinical Trial Detailed Description:**\n\nThe intervention to be tested is an active voiding trial, where the bladder is filled with\r saline before the catheter is removed and the patient is immediately assisted to void.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Admission to one of three hospital units at the University of Virginia (5 Central, 6\r West, or the Short Stay Unit)\r\n\r - Patient has a Foley urethral catheter in place\r\n\r - The physician has ordered the Foley urethral catheter to be discontinued\r\n\r - 18 years of age and older\r\n\r Exclusion Criteria:\r\n\r - Age less than 18 years\r\n\r - Prisoners\r\n\r - Women who are 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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[
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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\nThe French National Reference Centre of GTD\n\n**Clinical Trial Summary:**\n\nThe French Gestational Trophoblastic Disease (GTD) centre has been set up and active by\r registering, monitoring and treating women with GTD since november 1999. The aim is to\r improve the management of trophoblastic disease in France.\r\n\r About 850 new cases are registered each year and 140 women treated, mostly with chemotherapy\r and surgery.\r\n\r The center works as follow, based on a multidisciplinary approach. The policy is that patient\r remains followed by her local physician, but can be seen and treated in the Center at demand\r and that the registry is done on a voluntary basis.\r\n\r Each administrative french area has a local expert team (oncologist and gynaecologist) who is\r able to look after the patients with the help of the national reference center physicians\r based in Lyon.\r\n\r - Once a doctor discovers a molar pregnancy, he contacts the center, with the agreement of\r his patient, for an opinion, an advice or simply to report the case.\r\n\r - The center sends to the doctor the informed consent form to be signed by the patient, a\r registering form and information about pathology for patient and physician, and first\r guidelines based on initial pathology report.\r\n\r The patient remains followed by her gynecologist, who stays her first interlocutor throughout\r the whole process and she goes to her local laboratory for hCG monitoring;\r\n\r - A letter is sent to the initial pathology laboratory that originally carried the\r diagnosis of molar pregnancy to require slide sending to the pathologist referral center\r (9 experts with a specific pathologist national network) that centrally review initial\r diagnosis.\r\n\r - In the mean time, the data manager collects weekly hCG values to establish a follow-up\r chart. The physician is regularly informed by mail of the hCG evolution.\r\n\r - The local physician is contacted in case of modification of the diagnosis by the\r pathologist expert. The center informs him about length and monitoring methodology.\r\n\r - Emails or letters are sent at each step of the management (at inclusion, at hCG\r negativation, and at the end of hCG follow-up).\r\n\r - In case of abnormal hCG evolution (raise, plateauing or positivity at 6 months,) or if a\r neoplasia is anatomopathologically diagnosed (choriocarcinoma, PSTT or ETT), physician\r is immediately contacted by phone or email by referent gynaecologist. A complete work up\r including pelvic US with Doppler, pelvic MRI, thoraco-abdominal CT-scan with chest\r radiography if pulmonary nodules are present and brain MRI, is planned to determine the\r adequate treatment.\r\n\r Very briefly, based on imaging results, FIGO stade and score are calculated to determine the\r risk. In case of low-risk, a monochemotherapy is settled, while a polychemotherapy is started\r in case of high-risk disease.\r\n\r The investigators have developped specific expertise at key levels of diagnosis, management,\r follow-up, fertility preservation and treatment.\r\n\r Assignments :\r\n\r - Registration and monitoring post diagnosis of complete or partial molar pregnancy,\r choriocarcinoma,PSTT, ETT, atypical placental site nodules\r\n\r - Histopathological analysis and genetics services\r\n\r - Measurement of human chorionic gonadotrophin (hCG) isoforms\r\n\r - Complex gynaecological surgery\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients are eligible if they have a histologically proven trophoblastic disease, or a\r diagnosis of gestational trophoblastic neoplasia done on an abnormal evolution of hCG\r\n\r Exclusion Criteria:\r\n\r - none\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\nBurst Optimized Stimulation Study\n\n**Clinical Trial Summary:**\n\nThis purpose of this study is to evaluate the therapeutic efficacy of burst microdosing\r stimulation paradigms in patients with chronic pain.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective, multicenter, randomized, double-blinded crossover study designed to\r compare conventional burst stimulation parameters to two different burst microdosing\r paradigms.\r\n\r Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3\r stimulation paradigms in different order.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject has been implanted with a commercially available SJM spinal cord stimulator\r for controlling chronic intractable pain associated with back and/or leg pain;\r\n\r - Subject has been exclusively using burst stimulation for at least three months;\r\n\r - Subject is 18 years of age or older;\r\n\r - Subject's pain-related medication regimen was stable in the 4 weeks prior to the\r screening evaluation;\r\n\r - Subject agrees not to add or increase pain-related medication from enrollment through\r the study duration;\r\n\r - Subject is willing to cooperate with the study requirements including compliance with\r the regimen and completion of all office visits;\r\n\r Exclusion Criteria:\r\n\r - Subject is currently participating in a clinical investigation study that includes an\r active treatment arm;\r\n\r - Subject is currently receiving, applying or considering seeking workers compensation,\r or is involved in disability litigation;\r\n\r - Subject has a non SJM neuromodulation device\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 Multi-component Intervention in Frail Community-dwelling Older People\n\n**Clinical Trial Summary:**\n\nThis study evaluates if a multi-component intervention, respecting the characteristics of\r frail older person and increasing intensity and challenge of exercises according to frail\r older person capacity/evolution will induce better functional results than a multi-component\r intervention specific to lower body. the volunteers will be randomized into experimental\r group and control group.\n\n**Clinical Trial Detailed Description:**\n\nThe interventions are separated by day (1 to 24) and by weeks (1 to 12). Each session was\r built to last between 50 and 60 minutes, beginning with a warming up. In the table are\r described the exercise as well as the support necessary to perform the exercise safely and\r necessary equipment (accessories). In cases where a minimum load is required the same are\r also described in the multimodal intervention protocol (load).\r\n\r In relation to strength training in the multimodal intervention protocol is described how the\r progression of intensity will be held. Additional to the load progression suggested, the 1\r maximal repetition test will be applied every 4 weeks for adjustment of the loads according\r to strength gain from each volunteer.\r\n\r The suggested protocol is based on balance exercises and strength but, in a careful manner,\r were included functional and mobilization exercises to ensure greater diversity.\r\n\r Multimodal intervention protocol:\r\n\r 1. a week\r\n\r Day 1. Balance Training 1.1 P: Seated on the chair; E: Position Adjustments,\r (Anterior-posterior, medial-lateral); S: Yes (parallel bar) 1.2 P: Seated on the chair;\r E: Hip mobilization, Anterior- posterior; S: Yes(parallel bar)\r\n\r Strength Training 1.1 P: Dorsal Decubitus; E: Hip Flexion 1.2 P:Lateral Decubitus; E:\r Hip Abduction 1.3 P:Seated on the chair; E: Knee Extension 1.4 P:Seated on the chair; E:\r Dorsiflexion/ Plantar Flexion 1.5 P:Seated on the chair; E: Trunk stabilization; A:\r Stick\r\n\r 2. sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 2. Balance Training 2.1 P: Seated on the chair; E: Position Adjustments\r (Anterior-posterior, medial-lateral);S: Yes(parallel bar) 2.2 P: Seated on the chair; E: Hip\r mobilization Anterior- posterior; S: Yes(parallel bar)\r\n\r Strength Training 2.1 P: Ventral Decubitus; E: Hip Extension (hollowing) 2.2 P:Lateral\r Decubitus; E: Hip Aduction 2.3 P: Standing; E: Semi-squat; A: peanut ball 2.4 P: Standing; E:\r Knee Flexion; S: Yes (parallel bar or back rest)\r\n\r 2 sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 2a week\r\n\r Day 3. Balance Training 3.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S:\r Yes (parallel bar) 3.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S:\r Yes(parallel bar) 3.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S:\r Yes(parallel bar) Strength Training 3.1 P: Dorsal Decubitus; E: Hip Flexion 3.2 P:Lateral\r Decubitus; E: Hip Abduction 3.3 P:Seated on the chair; E: Knee Extension 3.4 P:Seated on the\r chair; E: Dorsiflexion/ Plantar Flexion 3.5 P:Seated on the chair; E: Trunk stabilization; A:\r Stick 2 sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 4. Balance Training 4.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S:\r Yes (parallel bar) 4.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S: No\r 4.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: Yes(parallel bar) Strength\r Training 4.1 P:Ventral Decubitus; E: Hip Extension (hollowing) 4.2 P:Lateral Decubitus; E:\r Hip Aduction 4.3 P: Standing; E: Semi-squat; A: peanut ball 4.4 P: Standing; E: Knee Flexion;\r S: Yes (parallel bar or back rest )\r\n\r 2 sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 3a week\r\n\r Day 5. Balance Training 5.1 P: Standing; E: Side step walking; S: Yes (parallel bar) 5.2 P:\r Standing; E: Sitting to standing; S: Yes (parallel bar or) back rest 5.3 P: Standing;\r E:Romberg- feet together, semi-tandem, tandem; S: No 5.4 P: Table pose (Time: 60s )\r\n\r Strength Training 5.1 P: Dorsal Decubitus; E: Hip Flexion 5.2 P:Lateral Decubitus; E: Hip\r Abduction 5.3 P:Seated in the chair; E: Knee Extension 5.4 P:Seated on the chair; E:\r Dorsiflexion/ Plantar Flexion\r\n\r 2 sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 6. Balance Training 6.1 P: Standing; E:Side step walking; S: Yes (parallel bar) 6.2 P:\r Standing; E: Sitting to standing; S: Yes (parallel bar or back rest) 6.3 P: Standing;\r E:Romberg- feet together, semi-tandem, tandem; S: No 6.4 P: Table pose(Time: 60s )\r\n\r Strength Training 6.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 6.2\r P:Lateral Decubitus; E: Hip Aduction 6.3 P: Standing; E: Semi-squat; A: peanut ball 6.4 P:\r Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)\r\n\r 2 sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 4a week\r\n\r Day 7. Balance Training 7.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 7.2\r P: Standing; E: Side step walking; S: No 7.3 P: Seated on the chair; E: Sit to standing; S:\r Standing: No; Sitting: Yes (parallel bar or back rest) 7.4 P: Table pose(Time: 60s ) 7.5 P:\r Standing; E:Romberg- feet together, semi-tandem, tandem; S: No\r\n\r Strength Training 7.1 P: Dorsal Decubitus; E: Hip Flexion 7.2 P:Lateral Decubitus; E: Hip\r Abduction 7.3 P:Seated in the chair; E: Knee Extension 7.4 P:Standing; E: Dorsiflexion/\r Plantar Flexion; S:Yes(parallel bar or back rest )\r\n\r 2 sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 8. Balance Training 8.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 8.2\r P: Standing; E: Side step walking; S: No 8.3 P: Seated on the chair; E: Sit to standing; S:\r Standing: No; Sitting: Yes(parallel bar or back rest) 8.4 P: Table pose(Time: 60s ) 8.5 P:\r Standing; E:Romberg- feet together, semi-tandem, tandem; S: No\r\n\r Strength Training 8.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 8.2\r P:Lateral Decubitus; E: Hip Aduction 8.3 P: Standing; E: Semi-squat; L: 0.5 Kg 8.4 P:\r Standing; E: Knee Flexion; S: No\r\n\r 2 sets, 12 repetitions, 50% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 5a week\r\n\r Day 9. Balance Training 9.1 P: Seated on the chair; E: Sitting to standing; S: No 9.2 P:\r Standing; E: One leg stance; S: Yes(parallel bar) 9.3 P: Standing; E: Walk to Front and Back;\r S: No 9.4 P: Standing; E: Tandem position; S: No + ocular fixation\r\n\r Strength Training 9.1 P: Dorsal Decubitus; E:Hip Flexion 9.2 P:Lateral Decubitus; E: Hip\r Abduction 9.3 P:Seated on the chair; E: Knee Extension 9.4 P:Standing; E: Dorsiflexion/\r Plantar Flexion; S:Yes (parallel bar or back rest)\r\n\r 3 sets, 10 repetitions, 55-65% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 10. Balance Training 10.1 P: Seated on the chair; E: Sitting to standing; S: No 10.2 P:\r Standing; E: One leg stance; S: Yes (parallel bar) 10.3 P: Standing; E: Walk to Front and\r Back; S: No 10.4 P: Standing; E: Tandem position; S: No + ocular fixation\r\n\r Strength Training 10.1 P: Ventral Decubitus; E: Hip Extension (Table position) 10.2 P:Lateral\r Decubitus; E: Hip Aduction 10.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 10.4 P: Standing; E:\r Knee Flexion; S: Yes(parallel bar or back rest)\r\n\r 3 sets, 10 repetitions, 55-65% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 6a week\r\n\r Day 11. Balance Training 11.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar)\r 11.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 11.3 P: Standing; Reactive Balance\r (Ankle, Hip, Step); S:Yes(parallel bar) 11.4 P:Standing; E:Romberg- feet together; S: No+\r eyes closed 11.5 P: Standing; E: One leg stance; S: No\r\n\r Strength Training 11.1 P: Dorsal Decubitus; E:Hip Flexion 11.2 P:Lateral Decubitus; E: Hip\r Abduction 11.3 P:Seated on the chair; E: Knee Extension 11.4 P:Standing; E: Dorsiflexion/\r Plantar Flexion; S:Yes(parallel bar or back rest)\r\n\r 3 sets, 10 repetitions, 55-65% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 12. Balance Training 12.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar)\r 12.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 12.3 P: Standing; Reactive Balance\r (Ankle, Hip, Step); S:Yes(parallel bar) 12.4 P:Standing; E:Romberg- feet together; S: No+\r eyes closed 12.5 P: Standing; E: One leg stance; S: No\r\n\r Strength Training 12.1 P: Ventral Decubitus; E: Hip Extension (Table position) 12.2 P:Lateral\r Decubitus; E: Hip Aduction 12.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 12.4 P: Standing; E:\r Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 7a week\r\n\r Day 13. Balance Training 13.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S: Yes,\r (parallel bar) 13.2 P: Standing; E: Turn 180º ou 360º; S:Yes(parallel bar) 13.3 P: Standing;\r E:Walk (6 meters) increasing step length; S: No 13.4 P: Standing; E:Tandem Posture; S: No\r 13.5 P: Standing; E: One leg stance; S: No + eyes closed\r\n\r Strength Training 13.1 P: Dorsal Decubitus; E: Hip Flexion 13.2 P:Lateral Decubitus; E: Hip\r Abduction 13.3 P:Seated on the chair; E: Knee Extension 13.4 P:Standing; E: Dorsiflexion/\r Plantar Flexion; S:Yes(parallel bar or back rest)\r\n\r 3 sets, 10 repetitions, 55-65% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 14. Balance Training 14.1 P: Standing; E:Walk with Hip flexion 90o like soldier);\r S:Yes(parallel bar) 14.2 P: Standing; E: Turn 180º ou 360º; S:Ye(parallel bar)s 14.3 P:\r Standing; E:Walk (6 meters) increasing step length; S: No 14.4 P: Standing; E:Tandem Posture;\r S: No 14.5 P: Standing; E: One leg stance; S: No + eyes closed\r\n\r Strength Training 14.1 P: Ventral Decubitus; E: Hip Extension (Table position) 14.2 P:Lateral\r Decubitus; E: Hip Aduction 14.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 14.4 P: Standing; E:\r Knee Flexion; S: Yes(parallel bar or back rest)\r\n\r 3 sets, 10 repetitions, 55-65% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 8a week\r\n\r Day 15. Balance Training 15.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No\r 15.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 15.3 P: Standing; E: Step up and down;\r S: No 15.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 15.5 P:Standing;\r E:Romberg- feet together; S: No+ ball reach\r\n\r Strength Training 15.1 P: Dorsal Decubitus; E: Hip Flexion 15.2 P:Lateral Decubitus; E: Hip\r Abduction 15.3 P:Seated on the chair; E: Knee Extension 15.4 P:Standing; E: Dorsiflexion/\r Plantar Flexion; S:Yes(parallel bar or back rest)\r\n\r 3 sets, 10 repetitions, 55-65% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 16. Balance Training 16.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No\r 16.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 16.3 P: Standing; E: Step up and down;\r S: No 16.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 16.5 P:Standing;\r E:Romberg- feet together; S: No+ ball reach\r\n\r Strength Training 16.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise one\r arm) 16.2 P:Lateral Decubitus; E: Hip Aduction 16.3 P:Standing; E: Squat; S:No 16.4 P:\r Standing; E: Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65%\r RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 9a week\r\n\r Day 17. Balance Training 17.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 17.2 P:\r Standing; E: Step up and down; S: No 17.3 P: Seated on the chair; E:TUG habitual walk speed;\r S: No + Dual task (cognitive) 17.4 P: Standing; E:Walk (6 meters) increasing speed; S: No\r\n\r Strength Training 17.1 P: Dorsal Decubitus; E:Hip Flexion 17.2 P:Lateral Decubitus; E: Hip\r Abduction 17.3 P:Seated on the chair; E: knee extension 17.4 P:Standing; E: Dorsiflexion/\r Plantar Flexion; S:Yes (parallel bar or back rest) 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 18. Balance Training 18.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 18.2 P:\r Standing; E: Step up and down; S: No 18.3 P: Seated on the chair; E:TUG habitual walk speed;\r S: No + Dual task (cognitive) 18.4 P: Standing; E:Walk (6 meters) increasing step length; S:\r No\r\n\r Strength Training 18.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and\r leg) 18.2 P:Lateral Decubitus; E: Hip Aduction 18.3 P:Standing; E: Split Squat; S:No; L:0.5\r Kg 18.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest)\r\n\r 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 10a week\r\n\r Day 19. Balance Training\r\n\r 19.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 19.2 P: Standing E:Side step\r walking; S: No+ ball reach 19.3 P:Standing; E:Romberg- feet together; S: No+ unstable\r surface+ eyes opened and closed 19.4 P: Standing; E:Walk (6 meters) increasing step length;\r S: No Strength Training 19.1 P: Dorsal Decubitus; E:Hip Flexion 19.2 P:Lateral Decubitus; E:\r Hip Abduction 19.3 P:Seated on the chair; E: Knee Extension 19.4 P:Standing; E: Dorsiflexion/\r Plantar Flexion; S:Yes (parallel bar or back res)\r\n\r 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 20. Balance Training 20.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 20.2\r P: Standing; E:Side step walking; S: No+ ball reach 20.3 P: Standing; E: One leg stance; S:\r No + unstable surface 20.4 P: Standing; E:Walk (6 meters) with scapular dissociation and\r cervical rotation; S: No\r\n\r Strength Training 20.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and\r leg) 20.2 P:Lateral Decubitus; E: Hip Aduction 20.3 P:Standing; E: Split Squat; S:No; L:0.5\r Kg 20.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)\r\n\r 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 11a week\r\n\r Day 21. Balance Training\r\n\r Circuit Training:\r\n\r 1. Stepping over barriers (Rolls, Steps)\r\n\r 2. Gait Training (increasing step length, changing speed, with scapular dissociation and\r cervical rotation)\r\n\r 3. Gait with motor tasks (Ball reach )\r\n\r 4. Balance Boards\r\n\r Strength Training 21.1 P: Dorsal Decubitus; E:Hip Flexion 21.2 P:Lateral Decubitus; E: Hip\r Abduction 21.3 P:Seated on the chair; E: Knee Extension; S:Yes(parallel bar or back rest)\r 21.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)\r\n\r 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 22. Balance Training\r\n\r Circuit Training:\r\n\r 1. Stepping over barriers (Rolls, Steps)\r\n\r 2. Gait Training (increasing step length, changing speed, with scapular dissociation and\r cervical rotation)\r\n\r 3. Gait with motor tasks (Ball reach)\r\n\r 4. Balance Boards\r\n\r Strength Training\r\n\r 22.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg); L: 0.5 Kg\r 22.2 P:Lateral Decubitus 22.3 P:Standing; E: Split Squat; S:No; E: Hip Aduction; L:1.0 Kg\r 22.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)\r\n\r 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r 12a week\r\n\r Day 23. Balance Training\r\n\r Circuit Training:\r\n\r 1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing\r speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks\r 4.Balance Boards\r\n\r Strength Training\r\n\r 23.1 P: Dorsal Decubitus; E:Hip Flexion 23.2 P:Lateral Decubitus; E: Hip Abduction 23.3\r P:Seated on the chair; E: Knee Extension 23.4 P:Standing; E: Dorsiflexion/ Plantar Flexion;\r S:Yes (parallel bar or back rest)\r\n\r 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\r\n\r Day 24. Balance Training\r\n\r Circuit Training:\r\n\r 1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing\r speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks\r 4.Balance Boards\r\n\r Strength Training 24.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and\r leg); L: 0.5 Kg 24.2 P:Lateral Decubitus; E: Hip Aduction 24.3 P:Standing; E: Split Squat;\r S:No; L:0.5 Kg 24.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)\r\n\r 3 sets, 8 repetitions, 65-75% RM\r\n\r P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - volunteers above the age of 65 who are community residents and classified as frail\r according to the criteria established by Fried et al. will be selected for inclusion\r in the study\r\n\r Exclusion Criteria:\r\n\r - previous lower extremities orthopedic surgery, a history of fractures within the past\r year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute\r inflammatory disease that could interfere in the assessments and the program, tumor\r growth in the last five years and cognitive impairment based on the mini-mental state\r examination [4]. Moreover, will be excluded volunteers who are absent more than three\r consecutive training and / or more than 25% of the sessions, and / or present the\r course of the physical program changes or decompensation and / or disease injury.\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\nComparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse\n\n**Clinical Trial Summary:**\n\nThis is an investigator-initiated study. The primary goal is to evaluate the efficacy of two\r different cervical disc prosthetic devices with respect to postoperative change in neck\r disability index. The evaluation will include clinical and radiological parameters.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Indication for monosegmental anterior cervical discectomy with implantation of a disc\r prosthesis\r\n\r Exclusion Criteria:\r\n\r - Radiologic signs of extensive bone degeneration in the affected segment\r\n\r - Necessity of implantation of a device smaller in height than 5 mm (as predicted with\r teh use of the Vertaplan (TM) software\r\n\r - Transversal spine cord lesion\r\n\r - Cervical myelopathy\r\n\r - Preceding surgery on the cervical spine\r\n\r - Traumatic lesions of the cervical spine\r\n\r - Radiographic instability in the affected segment: flexion / extension: shift sagittal\r plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray\r examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width\r and relative sagittal plane angulation > 11º\r\n\r - signs of instability (Olisthesis) in another segment of the cervical spine\r\n\r - Active systemic infection\r\n\r - diseases of the rheumatic type and all autoimmune diseases\r\n\r - bone metabolic diseases (for example, Paget's disease)\r\n\r - skeletal metastases\r\n\r - infections in the cervical spine\r\n\r - Neurological seizure disorders or other serious neurological disease with risk of\r falls\r\n\r - Severe heart failure (NYHA III-IV)\r\n\r - Bleeding disorders or clopidogrel / coumarins - treatment\r\n\r - Systemic use of corticosteroids for more than a month in the last 12 months\r\n\r - Pregnancy\r\n\r - Legally incompetent patient\r\n\r - Lactation\r\n\r - Deformity, anomalies, not fully developed skeleton\r\n\r - Local tumor disease\r\n\r - Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's\r disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy\r\n\r - Drug / drug or alcohol dependence\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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268
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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 Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse\n\n**Clinical Trial Summary:**\n\nThis is an investigator-initiated study. The primary goal is to evaluate the efficacy of two\r different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative\r change in neck disability index. The evaluation will include clinical and radiological\r parameters.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Indication for monosegmental anterior cervical discectomy with implantation of a disc\r prosthesis\r\n\r Exclusion Criteria:\r\n\r - Radiologic signs of extensive bone degeneration in the affected segment\r\n\r - Necessity of implantation of a device smaller in height than 5 mm (as predicted with\r teh use of the Vertaplan (TM) software\r\n\r - Transversal spine cord lesion\r\n\r - Cervical myelopathy\r\n\r - Preceding surgery on the cervical spine\r\n\r - Traumatic lesions of the cervical spine\r\n\r - Radiographic instability in the affected segment: flexion / extension: shift sagittal\r plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray\r examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width\r and relative sagittal plane angulation > 11º\r\n\r - signs of instability (Olisthesis) in another segment of the cervical spine\r\n\r - Active systemic infection\r\n\r - diseases of the rheumatic type and all autoimmune diseases\r\n\r - bone metabolic diseases (for example, Paget's disease)\r\n\r - skeletal metastases\r\n\r - infections in the cervical spine\r\n\r - Neurological seizure disorders or other serious neurological disease with risk of\r falls\r\n\r - Severe heart failure (NYHA III-IV)\r\n\r - Bleeding disorders or clopidogrel / coumarins - treatment\r\n\r - Systemic use of corticosteroids for more than a month in the last 12 months\r\n\r - Pregnancy\r\n\r - Legally incompetent patient\r\n\r - Lactation\r\n\r - Deformity, anomalies, not fully developed skeleton\r\n\r - Local tumor disease\r\n\r - Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's\r disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy\r\n\r - Drug / drug or alcohol dependence\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\nZotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of Zotiraciclib (TG02) Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r Zotiraciclib (TG02) is an investigational drug that penetrates the blood-brain barrier and\r might treat brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors.\r\n\r Objective:\r\n\r To find out if Zotiraciclib (TG02) is safe, and to find out if it in combination with TMZ is\r as effective as TMZ alone in people with brain tumors.\r\n\r Eligibility:\r\n\r People ages 18 and older with a brain tumor that has progressed after standard treatment\r\n\r Design:\r\n\r In phase I part, the Bayesian optimal interval (BOIN) design will be used to find the MTD of\r Zotiraciclib (TG02) for Arm 1 (dose dense TMZ) and Arm 2 (metronomic TMZ) independently.\r\n\r In Phase II part, a Bayesian design based on posterior probability will be used to monitor\r eficacy.\r\n\r Participants will be screened with:\r\n\r - Medical history\r\n\r - Physical exam\r\n\r - Blood and urine tests\r\n\r - MRI of the brain if they have not had one in 14 days\r\n\r - Heart test\r\n\r - Tissue sample from prior surgeries\r\n\r Participants will take Zotiraciclib (TG02) plus TMZ by mouth in 28-day cycles.\r\n\r - Some will take TMZ for 7 days on and 7 days off. Others will take it every day.\r\n\r - They will all take Zotiraciclib (TG02) three days before Cycle 1, and then on four days\r during every cycle.\r\n\r - They will all get treatment to prevent vomiting and diarrhea before and for 24 hours\r after each Zotiraciclib (TG02) dose.\r\n\r - They will all keep a diary of when they take the drugs and their symptoms.\r\n\r Participants will have study visits. These include:\r\n\r - Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests\r every 4 weeks\r\n\r - Blood tests every 2 weeks\r\n\r Participants will continue treatment until their disease gets worse or they have intolerable\r side effects.\r\n\r Participants will also be enrolled in another protocol to test molecular markers for their\r brain tumor.\n\n**Clinical Trial Detailed Description:**\n\nBackground:\r\n\r - Zotiraciclib (TG02) is a pyrimidine-based multi-kinase inhibitor that has been shown to\r have inhibitory effects on CDKs, Janus Kinase 2 (JAK2) and Fm-like tyrosine kinase 3\r (Flt3). It is orally administered and penetrates blood brain barrier (BBB). There is\r clinical experience in using Zotiraciclib (TG02) as both a single agent and in\r combination with other chemotherapy agents for cancer treatment.\r\n\r - Temozolomide (TMZ) is an oral alkylating agent that has proven efficacy in anaplastic\r glioma and glioblastoma. It was approved by the U.S. Food and Drug Administration (FDA)\r to treat anaplastic astrocytoma and glioblastoma in adults. Both a dose-dense (dd)\r schedule, 7 days on and 7 days off and a metronomic (mn) daily dosing schedule have been\r used to treat recurrent high-grade gliomas.\r\n\r - Our preclinical data have demonstrated that Zotiraciclib (TG02) down-regulates CDK9\r activity and its target proteins, such as anti-apoptotic protein Mcl-1, XIAP and\r survivin. A treatment with Zotiraciclib (TG02) and TMZ has synergistic anti-glioma\r effects in a variety of glioma models with different genetic background. This serves as\r the basis for this proposed clinical trial.\r\n\r Objectives:\r\n\r Phase I:\r\n\r -To determine the maximum tolerated dose (MTD) of Zotiraciclib (TG02) plus TMZ using both the\r dd and mn TMZ schedules in adult patients with recurrent anaplastic astrocytoma or\r glioblastoma/gliosarcoma.\r\n\r Phase II:\r\n\r -To determine the efficacy of Zotiraciclib (TG02) plus TMZ versus TMZ alone in patients with\r recurrent WHO grade III or IV astrocytoma as determined by progression free survival.\r\n\r Eligibility:\r\n\r - Documented pathology diagnosis of anaplastic astrocytoma [WHO grade III], or\r glioblastoma/gliosarcoma (WHO grade IV) with recurrent disease. If the pathology\r diagnosis is anaplastic glioma or anaplastic oligoastrocytoma, evidence of either intact\r 1p/19q chromosomes or molecular features suggesting astrocytic tumor must be present.\r (including, but not limited to ATRX and/or TP53 mutation)\r\n\r - No prior use of bevacizumab as a treatment for brain tumor.\r\n\r - No more than two prior relapses for Phase I and no more than one prior relapse for Phase\r II.\r\n\r - Patients must have recurrent disease, either histologically proven or with imaging\r suggestive of recurrent disease\r\n\r - Tumor tissues available for review to confirm the histologic diagnosis.\r\n\r - Tumor tissue blocks available for molecular profiling analysis.\r\n\r Design:\r\n\r - Phase I:\r\n\r - This portion of the study is conducted in two stages: The MTD finding and cohort\r extension. Two treatment arms and several dose levels are planned.\r\n\r - In the MTD finding part, TMZ with two alternate schedules (dd and mn) in\r combination with Zotiraciclib (TG02) will be administered.\r\n\r - A cohort extension of both arms will be performed at each MTD and the treatment arm\r with a better progression free survival at 4 months (PFS4) will be selected for the\r combination treatment arm for Phase II.\r\n\r - Pharmacokinetic, pharmacogenetic studies and neutrophil analysis will be performed\r during the cohort extension of both arms.\r\n\r - A maximum of 72 patients will be enrolled to this component for the trial.\r\n\r - Phase II:\r\n\r - Patients will be randomized between two competing treatment arms: (\"winner\" of dd\r vs mn) TMZ + Zotiraciclib (TG02) versus dd/mn TMZ alone using a Bayesian clinical\r trial design. The dosage for the combination arm will be derived from the MTD\r determined in the Phase I\r\n\r component of the study.\r\n\r - The treatment schedule will be identical to that described above in the phase I\r component, with each cycle comprising 28 days.\r\n\r - Patients will continue treatment until tumor progression or unacceptable toxicity\r occurs.\r\n\r - At progression, patients randomized to the control arm (Temozolomide [TMZ] alone) will\r be offered the opportunity to continue TMZ and additional treatment with Zotiraciclib\r (TG02).\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r - Inclusion criteria are same in both Phase I and Phase II parts, except for the number\r of prior disease relapses\r\n\r - Patients must have pathologic diagnosis of anaplastic astrocytoma defined as WHO grade\r III or glioblastoma/gliosarcoma, WHO grade IV, which are confirmed by NCI Laboratory\r of Pathology. If the pathology diagnosis is anaplastic glioma or anaplastic\r oligoastrocytoma, evidence of either intact 1p/19q chromosomes or molecular features\r suggesting astrocytic tumor must be present.\r\n\r (including, but not limited to ATRX, TP53).\r\n\r - Patients must have recurrent disease, histologically proven or imaging suggestive of\r recurrent disease as determined by PI. Prior implantation of Gliadel wafers is\r acceptable, if tumor recurrence is confirmed by histologic examination of the\r recurrent tumor\r\n\r - Patients must have the ability to understand and the willingness to sign a written\r informed consent document.\r\n\r - Patients must be greater than or equal to 18 years old.\r\n\r - No more than two prior disease relapses to be eligible for the phase I portion of the\r study and no more than one prior relapse to be eligible for phase II.\r\n\r - Patients must have undergone prior standard therapy for their primary disease. For\r patients with glioblastoma, this would include surgical resection, or biopsy, if safe\r resection was not permitted due to the tumor location, radiation and adjuvant\r temozolomide. For patients with anaplastic astrocytoma, this would include surgical\r resection, radiation and adjuvant chemotherapy PCV or temozolomide.\r\n\r - Tumor tissue must be available for review to confirm histological diagnosis.\r\n\r - Tumor block or unstained slides must be available for molecular profiling.\r\n\r - Karnofsky > 60 percent\r\n\r - Patients must have adequate bone marrow function (ANC > 1,500/mm3, platelet count of >\r 100,000/mm3), adequate liver function (ALT and AST< 3 times upper limit normal and\r alkaline phosphatase < 2 times upper limit normal, total bilirubin < 1.5mg/dl), and\r adequate renal function (BUN < 1.5 times institutional normal and serum creatinine <\r 1.5 mg/dl) prior to registration. These tests must be performed within 14 days prior\r to registration. Total bilirubin: patients with Gilbert s Syndrome are eligible for\r the study. (Total bilirubin level can be exempted from the eligibility criterion.)\r\n\r - Patients must have recovered from the toxic effects of prior therapy to less than\r grade 2 toxicity per CTC version 4 (except deep vein thrombosis)\r\n\r - At the time of registration, subject must be removed from prior therapy as follows:\r\n\r - greater than or equal to (28 days) from any investigational agent,\r\n\r - greater than or equal to 4 weeks (28 days) from prior cytotoxic therapy,\r\n\r - greater than or equal to 2 weeks (14 days) from vincristine,\r\n\r - greater than or equal to 6 weeks (42 days) from nitrosoureas,\r\n\r - greater than or equal to 3 weeks (21 days) from procarbazine administration,\r\n\r - greater than or equal to 1 week (7 days) for non-cytotoxic agents, e.g.,\r interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. radiosensitizer does\r not count.\r\n\r - Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible given all of the following conditions apply:\r\n\r - At least 2 weeks (14 days) have elapsed from the date of surgery and the patients\r have recovered from the effects of surgery.\r\n\r - Evaluable or measureable disease following resection of recurrent malignant\r glioma is not mandated for eligibility into the study.\r\n\r - To best assess the extent of residual disease post-operatively, an MRI should be\r done no later than 96 hours in the immediate post-operative period or at least\r within 4 weeks post- operatively, within 14 days prior to registration. If the\r 96-hour scan is more than 14 days before registration, the scan needs to be\r repeated. The patient must have been on a stable steroid dose for at least 5 days\r prior to the baseline MRI. Steroids may be initiated as clinically indicated once\r baseline imaging has been completed with a goal of titrating steroids as soon as\r clinically warranted.\r\n\r - Patients must have received prior radiation therapy and must have an interval of\r greater than or equal to 12 weeks (84 days) from the completion of radiation therapy\r to study entry except if there is unequivocal evidence for tumor recurrence (such as\r histological confirmation or advanced imaging data such as PET scan) in which case the\r principal investigator s discretion may determine appropriate timepoint at which study\r therapy may begin.\r\n\r - Women of childbearing potential must have a negative beta-HCG pregnancy test\r documented within 14 days prior to registration. The effects of Zotiraciclib (TG02) on\r the developing human fetus are unknown. For this reason, women of childbearing\r potential must not be pregnant, must not be breast-feeding, and must practice adequate\r contraception for the duration of the study, and for 30 days after the last dose of\r study medication.\r\n\r - Male patients on treatment with Zotiraciclib (TG02) must agree to use an adequate\r method of contraception for the duration of the study, and for 30 days after the last\r dose of study medication as the effects of Zotiraciclib (TG02) on the developing human\r fetus are unknown.\r\n\r - Patients must agree to enroll on the NOB Natural History protocol to allow the\r assessment of molecular tumor markers.\r\n\r EXCLUSION CRITERIA:\r\n\r - Patients who are receiving any other investigational agents. However, prior enrollment\r on a study using investigational agents is acceptable\r\n\r - Patients with prior bevacizumab use for tumor treatment. Patients who received\r bevacizumab for symptom management, including but not limited to cerebral edema,\r pseudoprogression can be included in the study(To date, there have been no effective\r regimens developed for recurrent malignant gliomas that are refractory to bevacizumab.\r Inclusion of this patient population may impact the ability to determine the efficacy\r of Zotiraciclib (TG02) with TMZ.)\r\n\r - Any serious medical condition, laboratory abnormality, or psychiatric illness that\r would prevent the subject from providing informed consent.\r\n\r - Any condition, including the presence of clinically significant laboratory\r abnormalities, which places the patient at unacceptable risk if he/she were to\r participate in the study or confounds the ability to interpret data from the study.\r These would include:\r\n\r - Active infection (including persistent fever) including known history of HIV or\r Hepatitis C infection, because these patients are at increased risk of lethal\r infections when treated with marrow-suppressive therapy.\r\n\r - Diseases or conditions that obscure toxicity or dangerously alter drug metabolism\r\n\r - Serious concurrent medical illness e.g. symptomatic congestive heart failure\r\n\r - History of allergic reactions attributed to compounds of similar chemical or biologic\r composition to temozolomide and/or Zotiraciclib (TG02).\r\n\r - Patients with a history of any other cancer (except non-melanoma skin cancer or\r melanoma in-situ following curative surgical resection; or carcinoma in-situ of the\r cervix or bladder), unless in complete remission and off all therapy for that disease\r for a minimum of 3 years, are ineligible.\r\n\r - Zotiraciclib (TG02) is primarily metabolized by CYP1A2 and CYP3A4. Patients receiving\r any medications or substances that are strong inhibitors or inducers of CYP1A2 and/or\r CYP3A4 are ineligible.\r\n\r - Patients, who continue to have prolonged QTc (males: greater than 450ms; females:\r greater than 470ms as calculated by Fridericia s correction formula) despite normal\r electrolyte balance and discontinuation of medications known to prolong QTc, will be\r excluded from 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:** 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."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIndwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention\n\n**Clinical Trial Summary:**\n\nObjective: Acute urinary retention (AUR) is a common problem in hospitalized patients. Either\r indwelling urethral catheterization or clean intermittent catheterization (CIC) can be the\r choice of treatment. In chronic urinary retention, most physicians prefer CIC to chronic\r indwelling urethral catheter on the basis of the claim that the rate of catheter-associated\r urinary tract infection (CAUTI) is lower.\r\n\r Method: The patients were randomized into indwelling urethral catheter and CIC groups. The\r primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI.\r The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.\n\n**Clinical Trial Detailed Description:**\n\nWe queried the hospitalized patients in Ramathibodi Hospital who developed first-time AUR\r from June 2014 to May 2015. Patients under 18 years of age with a history of urinary\r retention, urinary tract infection, and poor compliance were excluded from this study. All\r the patients gave their written informed consents. The patients were randomly divided into\r two groups depending on the type of assigned intervention: CIC and indwelling urethral\r catheter groups.\r\n\r All the patients were followed up after 2 weeks; urinalysis and urine culture were obtained\r at the time of AUR and whenever the patients developed UTI-associated symptoms. The patients\r with positive urine culture at the time of AUR were excluded from the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June\r 2014 to May 2015.\r\n\r Exclusion Criteria:\r\n\r - Patients under 18 years of age\r\n\r - History of urinary retention\r\n\r - Urinary tract infection\r\n\r - Poor compliance\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."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nEffects of Intermittent Hypoxia (IH) on Metabolism and Dysglycemia, in Overweight/Obese Persons SCI\n\n**Clinical Trial Summary:**\n\nThe purpose of this research is to examine changes in blood glucose control and metabolism in\r individuals with SCI and non injured controls at rest and during exercise after five days of\r exposure to IH. This response will be compared with breathing normal room air (a SHAM\r control).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r SCI only:\r\n\r 1. Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury\r for at least one year.\r\n\r 2. ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI)\r (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).\r\n\r SCI and non injured control:\r\n\r Resting SaO2 ≥ 95%\r\n\r Exclusion Criteria (SCI and non injured control):\r\n\r 1. Currently hospitalized\r\n\r 2. Resting heart rate ≥120 BPM\r\n\r 3. Resting systolic blood pressure >180 mm Hg\r\n\r 4. Resting diastolic Blood Pressure >100 mmHg\r\n\r 5. Self-reported history of unstable angina or myocardial infarction within the previous\r month\r\n\r 6. Previous cardiac surgery or condition that evidences ischemic heart disease\r\n\r 7. Cardiopulmonary complication such as COPD\r\n\r 8. Pregnancy determined by urine testing in sexually active females.\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\nRolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide\n\n**Clinical Trial Summary:**\n\nThe purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral\r rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG)\r patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a\r randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the\r prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT\r and concomitant multi-dose TMZ.\n\n**Clinical Trial Detailed Description:**\n\nAll eligible subjects should receive a planned total dose of 54-60 gray (GY) of radiation and\r 75 mg/m2 of TMZ daily for a total of six weeks. Patients will be randomized to receive one of\r two antiemetic treatment sequences: sequence A that involves administration of ondansetron\r alone for 3 weeks followed by a single dose of rolapitant (day 22) plus daily ondansetron for\r 3 weeks or sequence B that involves a single dose of rolapitant (day 1) plus daily\r ondansetron for 3 weeks followed by 3 weeks of daily ondansetron alone. The study has one\r primary endpoint: complete response (CR) rate. Participation in this study may result in\r reduced chemo-radiation induced nausea and vomiting, however, risks include the common side\r effects of rolapitant including decreased appetite, neutropenia, dizziness, dyspepsia,\r urinary tract infection, stomatitis, and anemia.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histologically-confirmed, newly-diagnosed malignant glioma\r (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligoastrocytoma,\r anaplastic pleomorphic xanthoastrocytoma, or anaplastic oligodendroglioma) and are\r scheduled to receive radiotherapy (for a total of 54-60 Gy) and concomitant daily\r temozolomide therapy (at a dose of 75 mg/m^2 for one complete 6-week cycle).\r\n\r - Age ≥ 18 years\r\n\r - Karnofsky ≥ 60% or ECOG 0-2\r\n\r - Hematocrit >29%, Absolute Neutrophil Count >1,000 cells/mm^3, platelets >100,000\r cells/mm^3\r\n\r - Serum creatinine <1.4 mg/dl, bilirubin <1.5 times upper limit of normal (ULN)\r\n\r - Aspartate aminotransferase (AST) ≤ 2.5 x ULN. For subjects with known liver metastases\r ≤ 5 x ULN, and alanine aminotransferase (ALT) ≤ 2.5 x ULN. For subjects with known\r liver metastases ≤ 5 x ULN\r\n\r - For patients on higher than physiological level of corticosteroids, they must have\r been on a stable dose for 1 week prior to initiating study drug, and the dose should\r not be escalated over entry dose level, if clinically possible\r\n\r - Ability and willingness to give informed consent\r\n\r - Female patients of childbearing potential must have a negative pregnancy test at\r Screening\r\n\r - Female patients of childbearing potential must agree to use an acceptable method of\r birth control from the signing of informed consent and to continue its use during the\r study and for at least 90 days after the final dose\r\n\r - Male patients must agree to use an acceptable form of birth control from study Day 1\r through at least 90 days after the final dose\r\n\r Exclusion Criteria:\r\n\r - Co-medications that may interact with rolapitant as reviewed by Duke Preston Robert\r Tisch Brain Tumor investigator pharmacist.\r\n\r - Co-medications that are contraindicated in patients on rolapitant including pimozide,\r thioridazine, carbamazepine, colchicine, dabigatran (Pradaxa), edoxaban (Savaysa),\r fosphenytoin, metoprolol, phenobarbital, phenytoin, primidone, and warfarin\r\n\r - Inability or unwillingness to cooperate with the study procedures\r\n\r - Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to\r the start of radiation therapy through the full course of radiation therapy is\r prohibited, with the exception of the study drug. Corticosteroids will be allowed for\r treatment of cerebral swelling\r\n\r - Previous participation in any clinical trial involving rolapitant\r\n\r - Any vomiting, retching, dry heaves, or clinically significant nausea (i.e., NCI Common\r Toxicity Criteria version 4.0 grade 2-4 nausea) caused by any etiology in the 24 hrs.\r preceding day 1 of the study intervention (ondansetron or ondansetron with rolapitant)\r as scheduled to begin on day 1 of radiation and chemotherapy. Or a patient who has a\r history of anticipatory nausea and vomiting.\r\n\r - Ongoing vomiting from any organic etiology\r\n\r - Received rolapitant within 21 days prior to study enrollment\r\n\r - Prior cancer chemotherapy or radiotherapy\r\n\r - Any current treatment, medical history, or uncontrolled condition, other than\r malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or\r psychiatric condition) that, in the opinion of the investigator, would confound the\r results of the study or pose any unwarranted risk in administering study drug to the\r subject\r\n\r - Patient has a known hypersensitivity to the administration of rolapitant or its\r excipients\r\n\r - Patient has a history of severe renal or hepatic impairment, severe bone marrow\r suppression, or systemic infection\r\n\r - Patient is a woman with a positive serum pregnancy test at Screening, is pregnant,\r breast-feeding, or is planning to conceive children within the projected duration of\r the study treatment\r\n\r - Patient has taken the following agents within the last 48 hours prior to the start of\r treatment with study drug:\r\n\r - 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.).\r\n\r - Benzamides (metoclopramide, alizapride, etc.)\r\n\r - Domperidone\r\n\r - Cannabinoids\r\n\r - Natural Killer (NK)-1 antagonist (aprepitant)\r\n\r - Benzodiazepines (lorazepam, alprazolam, etc.)\r\n\r - herbal medications or preparations in doses designed to ameliorate nausea or emesis\r\n\r - Patient has taken phenothiazines (prochlorperazine, fluphenazine, perphenazine,\r thiethylperazine, chlorpromazine, etc.) for any indication within the last 48 hours\r prior to the start of treatment with study drug\r\n\r - Palonosetron is not permitted within 7 days prior to administration of investigational\r product\r\n\r - Patient must not have been dosed with a test drug or blinded study drug in another\r investigational study within 30 days or 5 half-lives of the biologic activity of the\r test drug, whichever is longer, before the time of first study dose\r\n\r - Patient who is receiving investigational agent(s) as part of another clinical study at\r the time of screening or who anticipates receiving investigational agent(s) during\r their scheduled radiotherapy and concomitant daily temozolomide therapy (Any exception\r to this criteria will be noted in a study Memo to File)\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\nPatient Adherence to a Physical Activity Advice\n\n**Clinical Trial Summary:**\n\nLow back pain is worldwide a common musculoskeletal condition with a high number of\r recurrences. Recurrence rate and the number of recurrences could be reduced and time to a\r next episode could be prolonged by advising an active lifestyle. Advising regular physical\r activity is the mainstay in physical therapy treatment. This includes an appeal to patients\r to adhere to an activity advice. Patient adherence to an activity advice is poor. In this\r study an intervention consisting of treatment of illness perceptions with or without\r organizing social support to increase adherence to an activity advice will be investigated.\r\n\r The primary objective of this study is to investigate whether social support by a partner or\r friend and treatment of patients' illness perceptions influences the rate of adherence to an\r activity advice compared to treatment of patients' illness perceptions alone in patients\r suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of\r illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,\r b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or\r rate of recurrences of non-specific low back pain and/or attitude and intention to physical\r activity influences patient's adherence .\r\n\r This study is a multi-centre randomized two-arm controlled clinical trial. Patients ≥18 years\r presenting with at least a second episode of non-specific low back pain.\r\n\r Patients in the intervention and control group will be asked to perform a physical activity\r advice. During two physiotherapy treatment sessions treatment of illness perceptions is\r performed in both groups. In the intervention group organizing social support by a partner or\r friend is added.\r\n\r Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the\r intervention group is clinically relevant.\r\n\r During four appointments several questionnaires have to be filled in and during two\r physiotherapy treatment sessions half an hour treatment of illness perceptions will be\r performed. Social support by a partner or friend will be organized during the same\r physiotherapy treatment sessions in the intervention group. During three separate weeks\r patients have to wear an activity monitor. Patients will be treated according to the Dutch\r Low Back Pain guideline; no adverse effects will be expected.\n\n**Clinical Trial Detailed Description:**\n\nObjective of the study:\r\n\r The primary objective of this study is to investigate whether social support by a partner or\r friend and treatment of patients' illness perceptions influences the rate of adherence to an\r activity advice compared to treatment of patients' illness perceptions alone in patients\r suffering non-specific low back pain. Secondary objectives are; 1) Whether 'treatment of\r illness perceptions' changes patients' maladaptive illness perceptions into realistic ones,\r 2) Whether maladaptive illness perceptions, comorbidity and/or obesity and/or rate of\r recurrences of non-specific low back pain and/or attitude and intention to physical activity\r influences patient's adherence to an activity advice.\r\n\r Study design:\r\n\r This study is a multicentre randomized two arm, controlled clinical trial. During a\r twelve-week intervention period, one group of patients will receive an activity advice added\r to usual treatment including 'treatment of illness perceptions' (C-group). The other group\r will receive an activity advice and the intervention addressing social support by a partner\r or friend added to usual treatment including 'treatment of illness perceptions'\r (SoSup-group). Patients will be assessed at baseline, and after one, 6 and 12 weeks.\r Recruitment is scheduled from October 2016 to July 2017. The study will be performed in 12\r centres for physiotherapy in the province Zuid-Holland, the Netherlands.\r\n\r Study population:\r\n\r It is mentioned that individuals with recurrent non-specific low back pain score more\r unfavourable on lifestyle risk factors including physical inactivity than individuals without\r or first time non-specific low back pain (van Oostrom et al., 2012). To include potential\r physically inactive non-specific low back pain sufferers, patients ≥18 years presenting with\r at least a second episode of non-specific low back pain who are not physical active in\r accordance with the NNGB are recruited for the study.\r\n\r Intervention (if applicable):\r\n\r In both the C- and SoSup-group an activity advice will be added to usual treatment. The\r advised activities will be walking and/or cycling outdoors, meeting the Dutch Standard\r Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007). In both groups cognitive\r treatment on illness perceptions according to the common sense model to the patient in the\r presence of the partner or friend will be given. During a maximum of two half-hour contacts\r in a standardised dialogue on maladaptive beliefs and feelings about identity, time-line,\r causes, controllability, and curability of low back pain are mapped, maladaptive perceptions\r are challenged, alternative perceptions are formulated (Siemonsma et al., 2013). The\r intervention in the SoSup-group (intervention group), organizing social support by a partner\r or friend depending on patient's preferences, will be added. During a maximum of two\r half-hour contacts (one for explanation and one for evaluation), in a standardised discussion\r the partner or friend will be stimulated to support the patient in executing the activity\r advice. During 12 weeks the social support by a partner or friend will be executed for at\r least 5 times a week.\r\n\r Primary study parameters/outcome of the study:\r\n\r The primary outcome measure will be walking and/or cycling according to the NNGB and social\r support.\r\n\r Secundary study parameters/outcome of the study (if applicable):\r\n\r Other outcomes will be 1. measures of illness perceptions. 2. measures of comorbidity, BMI,\r number of recurrences of non-specific low back pain, measures of attitude and intention to\r physical activity 3. measures of refusal of the study.\r\n\r Nature and extent of the burden and risks associated with participation, benefit and group\r relatedness (if applicable):\r\n\r The social support described in this study is designed for better outcomes of physical\r activity levels patients suffering low back pain, and has no proven advantage on better\r outcomes on pain and disability in non-specific low back pain sufferers. Therefore we\r consider there is no disadvantage in the SoSup-group versus the C-group because patients in\r both groups receive concomitant best evidence healthcare according to the Dutch guideline for\r low back pain (Staal et al., 2013). No adverse effects of the interventions are expected.\r There are no ethical implications to be expected as a result of this study, treatment of all\r patients during the intervention period will be according to the Dutch guideline for low back\r pain.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r • Non-specific low back pain\r\n\r Exclusion Criteria:\r\n\r - Patients physical active in accordance with the Dutch Standard Healthy Physical\r Activity (NNGB) (Hildebrandt et al., 2007)\r\n\r - Patients with specific low back pain\r\n\r - Onset of the low back pain after age 50 years,\r\n\r - Continuous pain regardless of posture or movement,\r\n\r - Nocturnal pain,\r\n\r - General malaise,\r\n\r - History of malignancy,\r\n\r - Unexplained weight loss,\r\n\r - Elevated erythrocyte sedimentation rate (ESR)\r\n\r - Previous vertebral fracture,\r\n\r - Older person with hip fracture,\r\n\r - Prolonged use of corticosteroids,\r\n\r - Onset of low back pain before age 20 years,\r\n\r - Iridocyclitis,\r\n\r - History of unexplained peripheral arthritis or inflammatory bowel disease,\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\nLaser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies how well laser interstitial thermal therapy and lomustine work in\r treating patients with glioblastoma or anaplastic astrocytoma that has come back. Using laser\r to heat the tumor cells may help to kill them. Drugs used in chemotherapy, such as lomustine,\r work in different ways to stop the growth of tumor cells, either by killing the cells, by\r stopping them from dividing, or by stopping them from spreading. Giving laser interstitial\r thermal therapy and lomustine may work better in treating patients with glioblastoma or\r anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. Determine the disease control rate at 6 months in patients with recurrent glioblastoma or\r isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with Laser\r Interstitial Thermal Therapy (LITT) at recurrence, followed by salvage chemotherapy.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. Estimate overall survival (OS) of patients with recurrent glioblastoma, or isocitrate\r dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with LITT at tumor recurrence,\r followed by salvage chemotherapy.\r\n\r II. Estimate time to progression (TTP) of patients with recurrent glioblastoma, or isocitrate\r dehydrogenase (IDH)-wildtype anaplastic astrocytoma that are treated with LITT at tumor\r recurrence, followed by salvage chemotherapy.\r\n\r III. Analyze volumetric data consisting of thermal damage threshold lines and overall tumor\r volume to determine any role of 'extent of ablation' in outcomes (OS and/or TTP).\r\n\r IV. Characterize the safety profile of LITT followed by treatment with lomustine chemotherapy\r in the recurrent disease setting, using the Common Terminology Criteria for Adverse Events\r (CTCAE) version 4.0.\r\n\r V. Assess the long-term steroid requirements following LITT, compared to historical controls.\r\n\r VI. Determine the radiographic evolution of LITT-treated glioblastoma over time, using\r conventional magnetic resonance imaging (MRI) (T1 pre and post-contrast images, T2-weighted\r images [T2WI], fluid attenuating inversion recovery [FLAIR] images) and advanced brain tumor\r imaging (ABTI) [magnetic resonance (MR) perfusion [dynamic susceptibility contrast (DSC),\r dynamic contrast enhancement (DCE) and arterial spin labeling (ASL)], MR-diffusion, and MR\r spectroscopy), to include quantitative tumor metrics (volumetric extent of ablation and\r Response Assessment in Neuro-Oncology [RANO] criteria).\r\n\r VII. Analyze health care utilization as measured by length of hospital stay following LITT\r (including inpatient rehabilitation care).\r\n\r VIII. Evaluate patients' functional status (using the Karnofsky performance score [KPS] and\r the occurrence of symptoms [using the MD Anderson Symptom Inventory-Brain Tumor Module\r (MDASI-BT[English])] self-reporting tool), and correlate to disease progression and tolerance\r to treatment.\r\n\r EXPLORATORY OBJECTIVES:\r\n\r I. Identify correlative tumor and peripheral blood molecular markers that impact outcomes,\r etc, and identify inflammatory/immunologic markers to assess neoantigen expression, etc, if\r sufficient tissue is available.\r\n\r II. Identify and characterize changes in tumor tissue following LITT, by analyzing and\r comparing pre- and post-procedure tissue samples, if sufficient tissue is available.\r\n\r OUTLINE:\r\n\r Patients undergo LITT at baseline and receive lomustine orally (PO) on day 1. Treatment with\r lomustine repeats every 42 days for up to 6 cycles in the absence of disease progression or\r unaccepted toxicity.\r\n\r After completion of study treatment, patients are followed up every 3 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histologically-proven, recurrent supratentorial grade IV\r glioblastoma (or grade III IDH-wildtype anaplastic astrocytoma), for which a complete\r surgical resection is unsafe due to location, shape, or size of the tumor. Diagnosis\r of recurrence will be established by biopsy and frozen section immediately prior to\r initiating LITT procedure. If findings on frozen section are not consistent with\r recurrence (glioblastoma or recurrent IDH-wildtype anaplastic astrocytoma), decision\r to proceed with LITT procedure will be at the discretion of the neurosurgeon (only\r patients with histologically-proven recurrent tumor will be evaluable for efficacy).\r\n\r - All patients must sign an informed consent indicating that they are aware of the\r investigational nature of this study. Patients must have signed an authorization for\r the release of their protected health information. Patients must be registered prior\r to treatment on study.\r\n\r - Patients must have a Karnofsky performance score (KPS) > 60.\r\n\r - Patients must have received standard of care therapy with chemoradiation with\r temozolomide followed by adjuvant chemotherapy with temozolomide. Patients may have\r received one additional chemotherapy regimen (other than lomustine) in addition to\r adjuvant temozolomide prior to study entry (patients at either first or second\r recurrence are eligible).\r\n\r - In the context of this clinical trial, a lesion suitable for LITT is single,\r enhancing, supratentorial, at least 2 cm from inner table of skull over the\r hemispheric convexity, and > 1 cm, but < 4 cm in cross-sectional dimension, including\r thalamic tumor (=< 3 cm).\r\n\r - Patients must have stable cardiovascular, neurovascular and neurological status, and\r be considered surgical candidates, as determined by any relevant pre-operative\r assessments, at the neurosurgeon's discretion.\r\n\r - Patients must not be receiving concurrent anti-tumor treatment and must have recovered\r from toxicity of prior treatment. Minimum interval required: 1) > 6 weeks following\r nitrosourea chemotherapy; 2) > 4 weeks after recovering from any non-nitrosourea drug\r or systemic investigational agent; 3) > 2 weeks after receiving any non-cytotoxic\r anti-tumor drug; 4) > 4 weeks after receiving radiation therapy (> 12 weeks following\r upfront concurrent chemoradiation); 5) > 2 weeks following Optune device use.\r\n\r - Patients must not have previously undergone an intracranial LITT procedure.\r\n\r - White blood cell (WBC) > 3,000/ul (performed within 14 days (+ 3 working days) prior\r to registration)\r\n\r - Absolute neutrophil count (ANC) > 1,500/mm^3 (performed within 14 days (+ 3 working\r days) prior to registration)\r\n\r - Platelet count of > 100,000/mm^3 (may be reached by transfusion) (performed within 14\r days (+ 3 working days) prior to registration)\r\n\r - Hemoglobin > 10 gm/dl (may be reached by transfusion) (performed within 14 days (+ 3\r working days) prior to registration)\r\n\r - Serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin < 2 times upper limit of\r normal (ULN) (erformed within 14 days (+ 3 working days) prior to registration)\r\n\r - Creatinine < 1.5 mg/dL (performed within 14 days (+ 3 working days) prior to\r registration)\r\n\r - Women of childbearing potential must have a negative B-Human chorionic gonadotropin\r (HCG) documented within 7 days prior to registration and must agree to practice\r adequate contraception as defined below. Non-childbearing potential (i.e.,\r physiologically incapable of becoming pregnant), includes any female who has had:\r\n\r - A hysterectomy\r\n\r - A bilateral oophorectomy\r\n\r - A bilateral tubal ligation\r\n\r - Is post-menopausal: Subjects not using hormone replacement therapy (HRT) must\r have experienced total cessation of menses for >= 1 year and be greater than 45\r years in age, OR, in questionable cases, have a follicle stimulating hormone\r (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L).\r\n\r - Subjects using HRT must have experienced total cessation of menses for >= 1 year and\r be greater than 45 years of age OR have had documented evidence of menopause based on\r FSH and estradiol concentrations prior to initiation of HRT.\r\n\r - Childbearing potential includes any female who has had a negative serum pregnancy test\r within 7 days of study registration, and agrees to use adequate contraception.\r Acceptable contraceptive methods, when used consistently and in accordance with both\r the product label and the instructions of the physician, are as follows:\r\n\r - Complete abstinence from sexual intercourse for 14 days before starting\r treatment, through the treatment, and for at least 1 month after the last dose of\r temozolomide\r\n\r - Oral contraceptive, either combined or progestogen alone. A second barrier method\r is required during the first month of treatment with oral contraceptives\r\n\r - Injectable progesterone\r\n\r - Implants of levonorgestrel\r\n\r - Estrogenic vaginal ring\r\n\r - Percutaneous contraceptive patches\r\n\r - Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure\r rate of less than 1% per year\r\n\r - Male partner sterilization (vasectomy with documentation of azoospermia) prior to\r the female subject's entry into the study, and this male is the sole partner for\r that subject\r\n\r - Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault\r caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). Female\r participants who are lactating should discontinue nursing prior to the first dose\r of temozolomide and should refrain from nursing throughout the treatment period\r and for 42 days following the last dose of lomustine.\r\n\r Exclusion Criteria:\r\n\r - Patients must not have received prior treatment with bevacizumab.\r\n\r - Patients must not have had prior treatment of glioblastoma with stereotactic\r radiosurgery, brachytherapy, or carmustine-impregnated wafers (Gliadel).\r\n\r - Patients must not have symptoms attributed to mass effect of the tumor (despite\r corticosteroid treatment) that would be better treated with debulking surgery, or\r wherein surgical debulking in the first 30 days following LITT procedure would be\r anticipated for symptom management.\r\n\r - Patients unable to undergo MRI are not eligible.\r\n\r - Patients with progression of multifocal tumors or tumors involving the posterior fossa\r (brainstem and cerebellum) will be excluded, as will patients where the anticipated\r treatment margin will be within 5 mm of critical intracranial structures (e.g.,\r primary branches of cerebral vessels, dural sinuses, hypophysis or cranial nerves).\r\n\r - Patients may not have undergone previous treatment with lomustine.\r\n\r - Patients must not have any significant medical illnesses that in the investigator's\r opinion cannot be adequately controlled with appropriate therapy or would compromise\r the patient's ability to tolerate this therapy.\r\n\r - Patients with a history of any other cancer (except non-melanoma skin cancer or\r carcinoma in-situ of the cervix), unless in complete remission and off of all therapy\r for that disease for a minimum of 3 years are ineligible.\r\n\r - Patients must not have active infection or serious intercurrent medical illness.\r\n\r - Patients must not be pregnant/breast feeding and must agree to practice adequate\r contraception.\r\n\r - Patients must not have uncontrolled hypertension (systolic >180 mm hg or diastolic >\r 100 mg Hg), angina pectoris, cardiac dysrhythmia, or recent (within 6 weeks)\r intracranial hemorrhage.\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\nAssessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access\n\n**Clinical Trial Summary:**\n\nExpand the indication of the Portico TF Delivery System and obtain approval of the\r Alternative Access Delivery System\n\n**Clinical Trial Detailed Description:**\n\nExpand the indication of the Portico TF Delivery System and obtain approval of the\r Alternative Access Delivery System to place a Portico transcatheter aortic valve through an\r alternative access site, specifically subclavian/axillary or transaortic (TAo) in subjects\r with symptomatic severe native aortic stenosis who are considered high surgical risk\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subject has provided written informed consent prior to uploading CT scan to core lab.\r\n\r 2. Subject is ≥ 18 years of age or legal age in host country.\r\n\r 3. Subject's aortic annulus diameter meets the range indicated in the Instructions for\r Use as measured by multislice CT conducted within 180 days prior to the index\r procedure.\r\n\r 4. Subject has senile degenerative aortic stenosis seen by echocardiography within 90\r days of index procedure as measured by:\r\n\r 1. mean gradient >40 mmHg\r\n\r 2. Peak velocity ≥ 4.0 m/s\r\n\r 3. Doppler Velocity Index <0.25\r\n\r 4. Aortic valve area (AVA) of ≤ 1.0 cm2 or indexed EOA ≤ 0.6 cm2/m2).\r\n\r 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional\r Classification of Class II, or greater or other symptoms of aortic stenosis (e.g.\r syncope).\r\n\r 6. Subject is deemed high operable risk and preferred TAVI delivery route is alternate\r access (subclavian/axillary or direct aortic) per the medical opinion of the center's\r heart team and confirmed by SSC.\r\n\r - High risk is defined as an STS mortality > 8% or documented heart team agreement\r ≥ high risk for SAVR due to frailty or co-morbidities\r\n\r Exclusion Criteria:\r\n\r 1. Subject is unwilling or unable to comply with all study-required follow-up\r evaluations.\r\n\r 2. Subject has a documented history of a cerebral vascular accident (CVA) or transient\r ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the\r index procedure.\r\n\r 3. Subject has carotid artery disease requiring intervention.\r\n\r 4. Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient\r index procedure.\r\n\r 5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid,\r quadricuspid or non-calcified as seen by echocardiography.\r\n\r 6. Subject has severe mitral valvular regurgitation.\r\n\r 7. Subject has severe mitral stenosis.\r\n\r 8. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any\r position.\r\n\r 9. Subject refuses any blood product transfusion.\r\n\r 10. Subject has resting left ventricular ejection fraction (LVEF) less than 20%.\r\n\r 11. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring\r revascularization.\r\n\r 12. Subject has had a percutaneous interventional or other invasive cardiovascular or\r peripheral vascular procedure less than or equal to 14 days prior to index procedure.\r\n\r 13. Subject has severe basal septal hypertrophy that would interfere with transcatheter\r aortic valve placement.\r\n\r 14. Subject has a history of, or is currently diagnosed with, endocarditis.\r\n\r 15. There is imaging evidence of intracardiac mass, thrombus, or vegetation.\r\n\r 16. Subject is considered hemodynamically unstable (requiring inotropic support or\r mechanical heart assistance).\r\n\r 17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to\r stabilize heart failure.\r\n\r 18. Subject with severe pulmonary disease as determined by STS score.\r\n\r 19. Subject is on chronic oral steroid therapy.\r\n\r 20. Subject has a documented hypersensitivity or contraindication to anticoagulant or\r antiplatelet medication.\r\n\r 21. Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0\r mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis.\r\n\r 22. Subject has morbid obesity defined as a BMI greater than or equal to 40.\r\n\r 23. Subject has ongoing infection or sepsis.\r\n\r 24. Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute\r anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,).\r\n\r 25. Anatomy falling outside the recommended values in the IFU, unless specifically\r approved by the Subject Selection Committee.\r\n\r 26. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90\r days prior to the index procedure.\r\n\r 27. Subject is currently participating in another investigational drug or device study,\r unless approved by the Sponsor.\r\n\r 28. Subject has/had emergency surgery for any reason within 30 days of the index\r procedure.\r\n\r 29. Subject has a life expectancy less than 1 year.\r\n\r 30. Subject has other medical, social or psychological conditions that, in the opinion of\r the Principal Investigator or the Subject Selection Committee, preclude the subject\r from study participation.\r\n\r 31. Subject is diagnosed with a state of dementia which would fundamentally complicate\r rehabilitation from the procedure or compliance with follow-up visits.\r\n\r 32. Subject has a documented allergy to contrast media that cannot adequately be treated,\r nitinol alloys, porcine tissue, or bovine tissue.\r\n\r 33. Significant aortic disease including abdominal aortic or thoracic aneurysm defined as\r maximal luminal diameter 5cm or greater\r\n\r 34. Subjects with severe pulmonary hypertension and severe RV dysfunction\r\n\r 35. Subjects with hypertrophic cardiomyopathy\r\n\r Transaortic Subject Cohort Specific Exclusion Criteria\r\n\r Subjects are not eligible for participation in the TAo access arm if they meet any of the\r following exclusion criteria:\r\n\r 1. Subject has a chest condition (anatomical or otherwise) that prevents TAo access.\r\n\r 2. Subject has pre-existing patent RIMA graft that would preclude access.\r\n\r 3. Subject has a porcelain aorta, defined as an extensive circumferential calcification\r of the ascending aorta that would complicate TAo access.\r\n\r Subclavian/Axillary Subject Cohort Specific Exclusion Criteria\r\n\r Subjects are not eligible for participation in the subclavian/axillary access arm if they\r meet any of the following exclusion criteria:\r\n\r 1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction\r of the 18/19 Fr delivery system.\r\n\r 2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.\r\n\r 3. Subject has a history of LIMA/RIMA graft that would preclude access\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\nDifferentiation of Progression From Treatment Effects in High-Grade Gliomas: A Clinical Trial With Multimodality MR Imaging\n\n**Clinical Trial Summary:**\n\nTo evaluate the efficacy of multi-modality magnetic resonance quantitative parameters in\r evaluating the treatment effects of high-grade gliomas, and to provide new biomarkers for the\r establishment of new diagnostic criteria for the identification of true and pseudoprogression\r of high-grade gliomas.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with high-grade gliomas confirmed by pathology and have not been treated with\r concurrent chemoradiotherapy;\r\n\r 2. Written informed consent is obtained.\r\n\r Exclusion Criteria:\r\n\r 1. Patients not suitable for enhanced MRI scanning of patients;\r\n\r 2. Patients who have not finished follow-up concurrent chemoradiotherapy or MR scanning.\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:** possibly relevant"
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possibly relevant
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277
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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\nAdaptation of Mindfulness Training to Treat Chronic Pain in the Military\n\n**Clinical Trial Summary:**\n\nThe overall aim of this study is to test the acceptability and feasibility of an interactive,\r web-based mindfulness training with active duty soldiers being treated for chronic pain.\n\n**Clinical Trial Detailed Description:**\n\nThe overall aim of study is to test the acceptability and feasibility of an interactive,\r web-based mindfulness training with active duty soldiers being treated for chronic pain. We\r will adapt the evidence-based Mindfulness-based Stress Reduction (MBSR) training for use with\r this population. The adapted training will be enhanced by mobile applications (apps) for\r skills practice, using an existing apps platform.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adult patients who have experienced chronic pain for at least 6 months\r\n\r Exclusion Criteria:\r\n\r - Do not have any of the following conditions: substance abuse or dependence, psychosis,\r suicidal ideation in the last 2 months, high levels of trauma symptoms,\r\n\r - plans to have a permanent change of station or deploy in the coming 6 months, or\r\n\r - pregnancy\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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278
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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\nCobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies how well cobimetinib and atezolizumab work in treating\r participants with rare tumors that have spread to other places in the body (advanced) or that\r does not respond to treatment (refractory). Cobimetinib may stop the growth of tumor cells by\r blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal\r antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and\r may interfere with the ability of tumor cells to grow and spread. Giving cobimetinib and\r atezolizumab may work better in treating participants with advanced or refractory rare\r tumors.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVE:\r\n\r I. To evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced\r rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid\r Tumors (RECIST) version (v)1.1.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To determine progression-free survival (PFS) on COTEZO in cohorts of advanced rare tumors\r per RECIST v1.1 and immune-related (ir)RECIST.\r\n\r II. To determine overall survival (OS) on COTEZO in cohorts of advanced rare tumors.\r\n\r III. To determine disease control rate (DCR) and duration of response (DOR) on COTEZO in\r cohorts of advanced rare tumors per RECIST v1.1 and irRECIST.\r\n\r IV. To determine objective response rate (ORR) per immune-related RECIST criteria.\r\n\r V. To determine safety profile and adverse events encountered by patients with advanced rare\r tumors treated with COTEZO.\r\n\r VI. To collect and bank tumor tissue and peripheral blood for future correlative analyses\r from patients with advanced rare tumors treated with COTEZO.\r\n\r OUTLINE:\r\n\r Participants receive cobimetinib orally (PO) once daily (QD) on days 1-21 and atezolizumab\r intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, participants followed up every 3 months thereafter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must be informed of the investigational nature of this study and must be\r willing to give written informed consent in accordance with institutional and federal\r guidelines. Patients must be able to comply with the requirements and assessments of\r the study protocol\r\n\r - Must have histologically or cytologically documented rare tumor as defined per\r protocol that is metastatic or locally advanced and unresectable. Patients with\r locally advanced cutaneous squamous cell carcinoma that are technically resectable but\r in whom surgery is expected to lead to substantial function impairment or\r disfigurement are eligible\r\n\r - Must be refractory or intolerant to standard lines of therapy\r\n\r - Must have completed prior chemotherapy, immunotherapy, or radiation therapy at least\r 14 days prior to start of treatment and all toxicity must be resolved to Common\r Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 1 (with the exception of\r CTCAE v4.0 grade 2 neuropathy) prior to start of treatment\r\n\r - Presence of radiographically evaluable disease\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status of =< 2\r\n\r - Tissue Parameters: a. Representative formalin-fixed paraffin-embedded (FFPE) tumor\r specimens in paraffin blocks (blocks are preferred) or at least 4 unstained slides,\r with an associated pathology report, for testing of tumor PD-L1 expression (tumor\r tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not\r acceptable). b. Tumor tissue should be of good quality based on total and viable tumor\r content. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone\r metastases, and lavage samples are not acceptable. For core-needle biopsy specimens,\r at least three cores should be submitted for evaluation. c. Patients who do not have\r tissue specimens meeting eligibility requirements must be willing to undergo a biopsy\r during the screening period\r\n\r - Absolute neutrophil count (ANC) >= 1,000/mcL (obtained within 14 days prior to\r enrollment)\r\n\r - Platelets >= 75,000/mcL (obtained within 14 days prior to enrollment)\r\n\r - Hemoglobin >= 9 g/dL (obtained within 14 days prior to enrollment)\r\n\r - Calculated creatinine clearance > 30 ml/min (obtained within 14 days prior to\r enrollment)\r\n\r - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline\r phosphatase (ALP) =< 3 x institutional upper limit of normal (IULN) without liver mets\r or =< 5 x IULN with liver metastases (obtained within 14 days prior to enrollment)\r\n\r - Bilirubin =< 1.5 mg/dL (obtained within 14 days prior to enrollment)\r\n\r - Able to swallow pills\r\n\r - Negative serum pregnancy test within 7 days prior to commencement of dosing in\r premenopausal women. Women of non-childbearing potential may be included without serum\r pregnancy test if they are either surgically sterile or have been postmenopausal for\r >= 1 year\r\n\r - Fertile men and women must use an effective method of contraception during treatment\r and for at least 6 months after completion of treatment as directed by their\r physician. Effective methods of contraception are defined as those that result in a\r low failure rate (i.e., less than 1% per year) when used consistently and correctly\r (e.g., implants, injectables, combined oral contraception or intra-uterine devices).\r At the discretion of the Investigator, acceptable methods of contraception may include\r total abstinence in cases where the lifestyle of the patient ensures compliance.\r (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation\r methods] and withdrawal are not acceptable methods of contraception)\r\n\r - For individual baskets:\r\n\r - Appendiceal adenocarcinoma\r\n\r - Not considered candidate for curative surgery\r\n\r - Cutaneous squamous cell carcinoma\r\n\r - Patients with either metastatic or locally advanced cutaneous squamous cell\r carcinoma that are technically resectable but in whom surgery is expected to\r lead to substantial function impairment or disfigurement are eligible\r\n\r - Small bowel adenocarcinoma\r\n\r - Must be refractory or intolerant to at least one line of fluorouracil\r (5FU)-based chemotherapy for metastatic disease\r\n\r Exclusion Criteria:\r\n\r - Presence of brain metastases (unless they have been adequately treated with\r radiotherapy or surgery and stable for at least 30 days prior to enrollment provided\r patient is neurologically asymptomatic and without corticosteroid treatment for at\r least 7 days prior to enrollment)\r\n\r - Uncontrolled intercurrent illness including, but not limited to diabetes,\r hypertension, severe infection, severe malnutrition, unstable angina, class III-IV New\r York Heart Association (NYHA) congestive heart failure, ventricular arrhythmias,\r active ischemic heart disease, or myocardial infarction within 6 months prior to\r enrollment\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 - Patients will be excluded from study participation if they currently are known to have\r any of the following risk factors for RVO: a. Glaucoma with intraocular pressure >= 21\r mmHg b. Grade >= 2 serum cholesterol c. Grade >= 2 hypertriglyceridemia d. Grade >= 2\r or symptomatic hyperglycemia (fasting) e. Grade >= 2 uncontrolled hypertension\r (patients with a history of hypertension controlled with anti-hypertensive medication\r to grade =< 1 are eligible)\r\n\r - Active malignancy (other than colorectal carcinoma [CRC]) or a history of prior\r malignancy within the past 3 years. Adequately treated basal cell or squamous cell\r skin cancer, in situ cervical cancer, ductal carcinoma in situ, other low grade\r lesions such as incidental appendix carcinoid, or any other cancer from which the\r patient has been disease and treatment free for two years are allowed. Prostate cancer\r patients on active surveillance are eligible\r\n\r - Pregnant or nursing patients due to risk of fetal or nursing infant harm. Women/men of\r reproductive potential who do not agree to use an effective contraceptive method while\r on study and for at least 6 months after study treatment\r\n\r - Exclusion criteria related to study medication (any cancer immunotherapy including\r CD137 agonists, anti-PD-1, anti-PD-L1, or anti-CTLA4 or any MEK or ERK inhibitor)\r\n\r - Left ventricular ejection fraction (LVEF) < institutional lower limit of normal or <\r 50%\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, Wegener's granulomatosis, Sjogren's\r syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune\r thyroid disease, vasculitis, or glomerulonephritis a. Patients with a history of\r autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be\r eligible. b. Patients with controlled type 1 diabetes mellitus on a stable insulin\r regimen may be eligible. c. Patients with eczema, psoriasis, lichen simplex chronicus\r of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic\r arthritis would be excluded) are permitted provided that they meet the following\r 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 topical\r steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone\r 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n\r - No acute exacerbations of underlying condition within the last 12 months (not\r requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids,\r biologic agents, oral calcineurin inhibitors; high potency or 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 a. History of radiation pneumonitis in the radiation field\r (fibrosis) is permitted\r\n\r - History of human immunodeficiency virus (HIV) infection or active hepatitis B (chronic\r or acute) or hepatitis C infection. a. Patients with past or resolved hepatitis B\r infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a\r positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.\r b. 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 - Active tuberculosis or severe infections within 4 weeks prior to cycle 1, day 1,\r including but not limited to hospitalization for complications of infection,\r bacteremia, or severe pneumonia\r\n\r - Treatment with systemic immuno-stimulatory agents (including but not limited to\r interferon [IFN] or interleukin [IL]-2) within 6 weeks or five half-lives of the drug\r (whichever is shorter) prior to cycle 1, day 1\r\n\r - History of severe allergic, anaphylactic, or other hypersensitivity reactions to\r chimeric or humanized antibodies or fusion proteins\r\n\r - Prior allogeneic bone marrow transplantation or prior solid organ transplantation\r\n\r - For individual baskets:\r\n\r - Appendiceal adenocarcinoma\r\n\r - Must not have clinically symptomatic malignant bowel obstruction\r\n\r - Cutaneous squamous cell carcinoma\r\n\r - None\r\n\r - Small bowel adenocarcinoma\r\n\r - Must not have clinically symptomatic malignant small bowel obstruction\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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279
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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 High Velocity Low Amplitude Hip Mobilization on Strength in Subjects With Lower Extremity Pathology\n\n**Clinical Trial Summary:**\n\nIntroduction: Lower extremity weakness associated with musculoskeletal pathology can cause\r activity limitations. Physical therapy intervention in the form of exercise is commonly\r directed at improving muscular performance, however, neuromuscular adaptations may limit the\r effectiveness of traditional strengthening exercises. Manual therapy techniques have been\r used as a disinhibitory intervention to increase muscle activation and strength before\r participating in strengthening exercises or performing functional tasks While there is recent\r evidence to support joint mobilization as a valuable manual therapy disinhibitory\r intervention Currently, there is no evidence to substantiate anecdotal experience that a\r HVLAT hip distraction mobilization improves muscle performance in subjects with lower\r extremity pathology and lower extremity weakness. The purpose of this study was to determine\r if a HVLAT hip distraction mobilization would result in an immediate change of maximal force\r output of the quadriceps, gluteus maximus and gluteus medius.\r\n\r Methods: Forty individuals with a lower extremity pathology volunteered for this study.\r Inclusion criteria were having a unilateral musculoskeletal pathology, being greater than 18\r years of age, 10% decrease in muscle strength in symptomatic side compared to healthy side,\r and absence of medical precautions that would prevent a maximal effort strength test and\r exclusion criteria included individuals with a history lower extremity recent muscle or\r tendon ruptures (within the past 6 months) and postoperative knee, hip and ankle surgery.\r Demographic data, including diagnosis from referring physician were collected. All subjects\r completed the Lower extremity function scale (LEFS). A single evaluator blinded to the\r involved extremity was responsible for quadriceps, gluteus medius and maximus strength\r analysis pre and post mobilization of both symptomatic and non-symptomatic sides. The subject\r underwent the HVLAT hip distraction mobilization of the symptomatic side, and an immediate\r re-assessment of strength of both symptomatic and non-symptomatic sides followed the\r mobilization.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Individuals with a lower extremity pathology volunteered for this study\r\n\r - Being greater than 18 years of age\r\n\r - 10% decrease in muscle strength in symptomatic side compared to healthy side\r\n\r - Absence of medical precautions that would prevent a maximal effort strength test.\r\n\r Exclusion Criteria:\r\n\r - Included individuals with a history lower extremity arthroplasty.\r\n\r - Recent muscle or tendon ruptures (within the past 6 months)\r\n\r - Unhealed fractures\r\n\r - Neurological diseases\r\n\r - Malignant cancer\r\n\r - Osteoporosis\r\n\r - Active infections processes\r\n\r - Early postoperative knee, hip and ankle surgery with range of motion and weight\r bearing restrictions.\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\nComparison of Ultrasound and X-ray as Screening Tests for Diagnosis of Lower Extremity Stress Fracture.\n\n**Clinical Trial Summary:**\n\nHypothesis: Diagnostic ultrasound is an appropriate screening test for acute stress fracture\r in the lower extremity and is superior to x-ray.\r\n\r Primary Aims: To determine if diagnostic ultrasound is an appropriate screening test with\r high sensitivity and at least moderate specificity for the identification of acute stress\r fractures of the lower extremity.\r\n\r Methods: In this double-blind, prospective clinical study, subjects (age 14 years and up)\r suspected to have an acute stress fracture of the lower extremity will be recruited from the\r Sports Medicine clinic at the University of Virginia Health System in the Department of\r Physical Medicine & Rehabilitation. Subjects will undergo the traditional diagnostic\r algorithm including screening x-ray as part of standard care. Subjects will then undergo a\r confirmatory MRI of the region of concern if the initial x-ray was negative as part of\r standard care. Any subject who does not require an MRI for clinical purposes (initial X-ray\r was positive) will have one completed for research purposes. All subjects will also undergo\r diagnostic ultrasound performed by a separate, blinded physician competent in diagnostic\r ultrasound for research purposes. A statistician in the Department of Public Health at the\r University of Virginia will be performing statistical analysis during data analysis. Findings\r will be analyzed using a McNemar chi-square test to evaluate for significant differences\r between the sensitivities of ultrasound and x-ray.\n\n**Clinical Trial Detailed Description:**\n\nPrimary aims: To determine if diagnostic ultrasound is an appropriate screening test (high\r sensitivity and at least moderate specificity) and non-inferior to x-ray for diagnosis of\r acute stress fracture of the lower extremity.\r\n\r Secondary Aims: To determine what grade(s) of acute stress fracture that x-ray and ultrasound\r are capable of detecting reliably and accurately.\r\n\r Population: Subjects will be recruited from the Sports Medicine clinic at the University of\r Virginia Health System in the Department of Physical Medicine and Rehabilitation. Subjects\r will have suspected acute stress fracture of the lower extremity and will be age 14 years and\r older. Anatomic locations included in this study are as follows: all bones of the foot and\r ankle, tibia, fibula, and femoral shaft. Patients with suspected stress fracture of the\r femoral neck will be excluded due to the difficulty of appropriate ultrasound evaluation\r secondary to depth as well as the potential for significant morbidity if not diagnosed\r properly. We estimate that the Sports Medicine clinic diagnoses approximately 12 acute stress\r fractures per month per physician amongst the three physician's clinics involved in this\r study. Therefore, our anticipated number of subjects over a 6 month period will be at least\r 216 patients.\r\n\r Design: In this double-blind , prospective clinical study, subjects suspected to have an\r acute stress fracture of the lower extremity will be recruited from Sports Medicine Clinic\r (conducted by two physicians boarded in Physical Medicine and Rehabilitation and one\r physician board in Family Medicine and all boarded in Sports Medicine). When patients present\r to one of three physicians in Sports Medicine Clinic with a suspected acute stress fracture\r of the lower extremity, they will be offered the opportunity to enroll. Subjects will be\r required to have already undergone the initial step of the traditional diagnostic algorithm\r with x-ray of the suspicious region on the day of enrollment. All subjects will then be\r scheduled to undergo diagnostic ultrasound at a separate appointment with ultrasound\r procedure performed by a blinded clinical physician boarded in Physical Medicine and\r Rehabilitation, competent in performing and reading diagnostic ultrasound. All patients will\r then undergo a confirmatory MRI of the region of concern. Subject recruitment and data\r collection are expected to be completed over a six-month period. A statistician in the\r Department of Public Health at the University of Virginia will be performing statistical\r analysis. We plan to analyze findings using a McNemar chi-square test to evaluate for\r significant differences between the sensitivities of ultrasound and x-ray in diagnosing acute\r stress fracture of the lower extremity. All x-ray and MRI obtained for this study will be\r read by a Radiologist board certified in Musculoskeletal Radiology.\r\n\r Diagnostic ultrasound performance: The physician performing the ultrasound will be blinded to\r the results of the x-ray and MRI. The physician performing the ultrasound will be informed of\r the bone in question (ex. Tibia) and will be able to perform a focused history and exam. The\r bone in which acute stress fracture is suspected will then be scanned throughout its length\r in two orthogonal views. The criteria for diagnosing acute stress fracture on ultrasound\r include displaying 2 out of 3 of the following: hypoechoic periosteal elevation of cortical\r bone, visible cortical disruption, hyperemia surrounding the periosteal lesion on power\r Doppler. The ultrasound physician will then be asked to make a determination whether the\r ultrasound study is positive for acute stress fracture or negative/indeterminate.\r\n\r Statistical Analysis/Power Analysis: Sensitivity and specificity of diagnostic ultrasound and\r x-ray were calculated. MRI was used as the gold standard confirmatory test. Positive\r predictive value and Negative predictive value were also calculated for comparison. A priori\r power analysis determined a sample size of 186 was needed to obtain a power of 80%. The\r primary aim will be analyzed using a bootstrap test to compare the x-ray sensitivity to the\r ultrasound sensitivity. In order to account for the paired nature of the data, the bootstrap\r sampling will be at the subject level and will draw pairs with the x-ray and ultrasound\r outcomes associated with individual subjects. A statistician from the University of Virginia\r was hired for all statistical calculations.\r\n\r Subject Recruitment: Subjects presenting to the Sports Medicine clinic with suspected acute\r stress fracture of the lower extremity on initial presentation will be offered participation.\r Participation includes an additional clinic visit with a separate physician to perform a\r diagnostic ultrasound of the area of concern in addition to the standard work up they would\r receive for their presenting complaint. Informed consent was obtained at the time of study\r enrollment. Subjective will be offered ultrasound evaluation as well as follow up\r confirmatory MRI. The cost of follow up MRI is included in the study to prevent selection\r bias based on insurance coverage for MRI. The costs associated with the additional clinic\r visit for diagnostic ultrasound is also included in the study budget.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - age 14 years and up\r\n\r - suspected acute stress fracture of the lower extremity\r\n\r - symptoms < 4 weeks\r\n\r - x-ray ordered by clinician to which subjects originally present with suspected stress\r fracture\r\n\r Exclusion Criteria:\r\n\r - age < 14\r\n\r - unable to provide consent\r\n\r - unable to undergo MRI (implantable pacemaker or other device not compatible for MRI)\r\n\r - previous diagnosis of acute stress fracture in the location of interest\r\n\r - previous XR or MRI obtained at an outside clinic/facility prior to presentation\r\n\r - previously implanted hardware (ex. orthopedic screws or plates) at location of\r interest\r\n\r - symptoms > 8 weeks\r\n\r - depth from skin surface to bone surface that exceeds the capability of ultrasound for\r visualization\r\n\r - Pregnant (self-reported)\r\n\r - Subject is known to all clinicians who would be completing the diagnostic ultrasound\r component of the study\r\n\r - Open wound at site of suspected stress fracture\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\nLevofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections\n\n**Clinical Trial Summary:**\n\nStudy is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI\n\n**Clinical Trial Detailed Description:**\n\nA complicated urinary tract infection is a urinary infection occurring in a patient with a\r structural or functional abnormality of the genitourinary tract.\r\n\r Fluoroquinolones have been recommended as the antimicrobials of choice for the empirical\r treatment of complicated urinary tract. Levofloxacin is a broad spectrum agent, which is\r known to demonstrate good clinical efficacy against urinary tract infection (UTI).\r\n\r There is no published evidence available on the empirical use of Levofloxacin 500 mg OD and\r its optimal duration of therapy in patients with Complicated Urinary Tract Infections (cUTI).\r The present study evaluates the efficacy and safety, and optimal duration of therapy of\r levofloxacin 500 mg OD in patients with complicated UTI.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Men or non-pregnant women over 18 years of age with cUTI in\r\n\r - One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally),\r chills, frequency of micturition, dysuria, urge sensation.\r\n\r - One or more of the following underlying conditions suggestive of cUTI:\r\n\r - Indwelling urinary catheter.\r\n\r - Neurogenic bladder.\r\n\r - Obstructive uropathy due to lithiasis, tumor or fibrosis.\r\n\r - Acute urinary retention in men\r\n\r Exclusion Criteria:\r\n\r - History of allergy to quinolones\r\n\r - Are unable to take oral medication\r\n\r - Have an intractable infection requiring > 14 days of therapy\r\n\r - Have a requirement for concomitant administration of sucralfate or divalent and\r trivalent cations such as iron or antacids containing magnesium, aluminum or calcium\r\n\r - Have prostatitis or epididymitis\r\n\r - Have had a renal transplant\r\n\r - Have ileal loop or vesica- urethral reflux\r\n\r - Have significant liver or kidney impairment\r\n\r - Have a history of tendinopathy associated with fluoroquinolones\r\n\r - Are pregnant, nursing\r\n\r - Have a history of convulsions or CNS 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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"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\nPeripheral Nerve Blocks for Major Lower Extremity Amputations\n\n**Clinical Trial Summary:**\n\nThis study will be a double-blinded randomized controlled trial analyzing all patients who\r will undergo major lower extremity amputations by the vascular surgery service at UCSF Fresno\r between July 2017 and June 2018 to determine if regional nerve blocks (sciatic and femoral)\r have any effect on postoperative pain control, narcotic requirements, and length of stay\r compared with standard post-operative narcotic regimens.\n\n**Clinical Trial Detailed Description:**\n\nMajor lower extremity amputations (above knee amputation or below knee amputation) are common\r procedures performed for patients with end stage ischemia, infection, and/or disfiguration.\r Patients undergoing major lower extremity amputations have significant morbidity and\r mortality. Up to 95% of amputees report chronic pain, and inadequate pre- and postoperative\r pain control may increase the risk of chronic amputation pain. Additionally, there is a\r growing epidemic of narcotic overdoses in the United States. From 2000 to 2014, the\r age-adjusted drug overdose death rate has more than doubled from 6.2 per 100,000 persons to\r 14.7 per 100,000. The main drugs associated with overdose deaths are prescription pain\r medications.\r\n\r Regional nerve block is part of usual care and may serve as adjuncts for pain control after\r major lower extremity amputations. This pain control may be achieved by injecting bupivacaine\r into the sciatic and femoral nerves. Bupivacaine is an amide-type local anesthetic approved\r by the Food and Drug Administration (FDA) for local or regional anesthesia or analgesia for\r surgery. The dosage approved by the FDA for peripheral nerve blocks are 0.25% and 0.5%. The\r potential risks are central nervous system and cardiovascular system reactions. The central\r nervous system reactions are characterized by restlessness, anxiety, dizziness, or tremors.\r The cardiovascular system reactions are characterized by decreased cardiac output, heart\r block, hypotension, bradycardia, or arrhythmia. These risks are small and can be minimized\r further by slow administration and aspiration prior to administration to avoid intravascular\r injection. Other rare but potential risks of regional nerve block are nerve injury and\r hematoma formation.\r\n\r Although bupivacaine is widely used for pain control, there are very few studies looking at\r regional nerve blocks as adjuncts for pain control after major lower extremity amputations.\r The number of randomized controlled trials is even fewer and none have been conducted in the\r United States. Baddoo looked at ten patients undergoing major lower extremity amputations\r (nine above knee amputations and one below knee amputation) with regional nerve blocks (a\r sciatic nerve block combined with either a 3-in-1 block or a psoas compartment lumbar plexus\r block). All ten patients were hemodynamically stable throughout surgery. Seven patients had\r good block, and three patients had fair block. Bech et al. presented a case report of four\r patients with severe cardiac insufficiency where they successfully utilized peripheral nerve\r blocks for trans-femoral amputation. The first patient was an 88-year-old man with American\r Society of Anesthesiologists (ASA) class 4. His echocardiogram showed an ejection fraction of\r 10%, mitral valve insufficiency and aortic valve sclerosis. The second patient was a\r 90-year-old woman with ASA class 4. Her echocardiogram showed an ejection fraction of 25% and\r severe mitral valve insufficiency. The third patient was a 64-year-old man with ASA class 4.\r His echocardiogram showed an ejection fraction of 25%, mitral valve insufficiency and\r tricuspid valve insufficiency. The fourth patient was a 74-year-old man with ASA class 4. His\r echocardiogram showed an ejection fraction of 15%, right-sided heart failure and both mitral\r and aortic valve insufficiency. All patients had successful outcomes in the postoperative\r course. Palkhiwala et al. looked at combined femoral and sciatic nerve blocks for lower limb\r procedures. With a randomized study involving 50 patients, they concluded that combined\r femoral and sciatic nerve blocks are effective for pain control with very low incidence of\r side effects. Forty-six out of fifty patients had complete block, and none of the patients\r had any cardiovascular or neurologic adverse events. Our study design is one of the first\r randomized controlled trials that looks at the effect of regional nerve blocks on\r postoperative pain and length of hospital stay.\r\n\r This study will be a double-blinded randomized controlled trial analyzing patients undergoing\r major lower extremity amputation by the vascular surgery service at UCSF Fresno between July\r 2017 and June 2018 at Community Regional Medical Center, Clovis Community Medical Center, and\r Fresno Heart and Surgical Hospital. All patients who have been evaluated by the vascular\r surgery service and have had lower extremity amputation deemed necessary based on ischemic\r disease, infectious disease, and/or disfiguration will be included. Patients will be excluded\r if they are less than 18 years of age, pregnant, undergoing emergency amputations, staged\r amputations, or amputations by non-vascular surgeons, have known allergies to bupivacaine,\r are unable to communicate symptoms of pain, or refuse to participate in the study. Eligible\r patients may be identified by the vascular surgery service in their private office or\r following a consultation by the vascular surgery service in the hospital. Upon\r identification, eligible patients or their surrogate decision maker will be approached for\r consent by a member of the study team.\r\n\r To randomize patients, consent forms will be pre-labeled with a random subject identification\r number. This number will serve as the participants' study ID for all data collection in order\r to maintain privacy and confidentiality. Additionally, this number will be linked to a sealed\r envelope containing the random treatment group. The study coordinator will create the labels\r and assemble the envelopes to ensure all investigators remain blind to the treatment groups.\r This sealed envelope will be given to the anesthesia providers for the amputation. The\r anesthesia team will then administer the assigned treatment prior to induction of general\r anesthesia. Half of the patients will be randomized into the treatment group, and half of the\r patients will be randomized into the control group.\r\n\r Patients randomized to the treatment group will receive regional nerve blocks (sciatic and\r femoral) with bupivacaine at the dose of 1 mg/kg. The anesthesiologists are experts in pain\r management, and they are trained to perform regional nerve blocks. Femoral and sciatic nerve\r blocks are within their scope of practice, and they have been performing them quite\r frequently especially in orthopedic operations. Patients randomized to the control group will\r receive two needle sticks (in the sciatic and femoral distributions) with normal saline to\r maintain the double-blinded investigation. The anesthesiologists are not blinded in this\r study, and they will be able to provide the appropriate billing for the saline and the\r bupivacaine injections.\r\n\r The remainder of the operation and post-operative course will proceed per the standard of\r care. Post-operative pain will be evaluated daily until discharge by the vascular surgery\r service using the McGill pain questionnaire. Additional data collected will include age,\r gender, race, BMI, ASA class, length of operation, hospital length of stay, oral and\r parenteral narcotic pain requirements. Any adverse events will immediately be reported to the\r Principal Investigator and the IRB. A Medical Monitor with suitable expertise will be\r provided with all the study data on a monthly basis. The medical monitor will use that data\r especially the unforeseen adverse events and complications to ensure the study safety. The\r patients will be monitored and the data will be collected until six months after discharge.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - patients who require major lower extremity amputations\r\n\r Exclusion Criteria:\r\n\r - less than 18 years old, pregnant, emergency amputation, staged amputation, amputations\r performed by non-vascular surgeons, patients who are allergic to bupivacaine, patients\r who are unable to communicate symptoms 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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"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 Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe Acute Pancreatitis\n\n**Clinical Trial Summary:**\n\nThe acute peripancreatic fluid collections (AFPCs) is the most common complication in severe\r acute pancreatitis (SAP). There are controversies on optimal timing for drainage of APFCs in\r SAP. The early-stage percutaneous catheter drainage (PCD) of sterile peripancreatic fluid\r collections is questioned as a result of the major cause of secondary infection. The aim of\r the present randomized controlled trial is to compare the outcomes in terms of mortality,\r secondary infection of peripancreatic collections, organ failure, length of hospital/ICU stay\r and inflammatory biomarkers between the early-stage PCD of sterile AFPCs and conservative\r therapy.\n\n**Clinical Trial Detailed Description:**\n\nThe AFPCs is the most common complication in SAP and debate continues regarding the\r appropriate timing for drainage of sterile APFCs in SAP patients. Some researchers have\r reported that the massive amounts of inflammatory mediators in the peripancreatic fluid may\r aggravate the inflammatory reaction and contribute to organ failure (OF) when liberated into\r the bloodstream by peritoneal absorption. Additionally, bacterial colonization of APFCs may\r lead to peritoneal abscess formation and sepsis. In a recent study, Wang et al. revealed that\r early-stage PCD effectively attenuated the peritoneal pressure and decreased the incidence of\r infection and OF. Finally, APFCs and secondary infection are considered major causes of\r alimentary tract hemorrhage. Based on these factors, prompt drainage of APFCs seems\r reasonable for patients in early SAP. In addition, unlike the original 1992 Atlanta\r classification guidelines (1992-AC), the revision of the 1992-AC by international consensus\r in 2012 (2012-RAC) highlighted the significance of persistent OF in the classification of\r SAP. To be exact, those patients diagnosed with SAP according to the 1992-AC without OF or\r with transient OF were reclassified as having mild AP (MAP) or moderate severity AP (MSAP) by\r the 2012-RAC. Therefore, many studies have reported changes in the treatment of SAP in the\r early stages since the 2012-RAC were published. We have retrospectively analyzed 361 patients\r with AP and found that the early-stage PCD of sterile APFCs in SAP-2012RAC patients can\r significantly reduce the mortality rate. However, on the contrary, the mainstream viewpoint\r holds that drainage is not necessary in the absence of infection of the peripancreatic fluid\r as the fluid can be absorbed completely and sterile PCD may increase the risk of iatrogenic\r infection. However, these mainstream views aimed at 1992-AC's SAP patients, which actually\r contain 2012-RAC's SAP and MSAP. Therefore, we hypothesized that the introduction of new AP\r severity classification methods may alter the indications for early aseptic drainage of\r AFPCs.\r\n\r Does early PCD of sterile APFCs benefits patients or increases the secondary infection rate?\r In view of these problems, we plan to design a randomized controlled trial to compare the\r outcomes in terms of mortality, secondary infection of peripancreatic collections, organ\r failure, length of hospital/ICU stay and inflammatory biomarkers between the early-stage PCD\r of sterile AFPCs and conservative therapy. The aim of this prospective study is to\r investigate whether early PCD of sterile AFPCs can be used to SAP patients with AFPCs at\r early stage.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age of 18 years to 70 years; and\r\n\r 2. Pain characteristic of pancreatitis; and\r\n\r 3. Elevated serum lipase or amylase (≥3-fold upper normal range); and\r\n\r 4. Persistent organ failure >48 hours; and\r\n\r 5. Organ dysfunction occurred within 7 days after onset of pain; and\r\n\r 6. Presentation with a width of ≥2cm of APFCs in the peripheral tissues of the pancreas,\r the cyst of lesser omentum , or the paracolic sulci on CT image.\r\n\r Exclusion Criteria:\r\n\r 1. History diseases of chronic organ dysfunction; or\r\n\r 2. Traumatic pancreatitis; or\r\n\r 3. Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis; or\r\n\r 4. Severe coagulopathy (INR>2); or\r\n\r 5. Severe thrombocytopenia (PLT≤50×109/L); or\r\n\r 6. No suitable route for puncturing; or\r\n\r 7. Pregnancy; or\r\n\r 8. Absent of informed consent from patient or representative.\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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"content": "**Clinical Trial Title:**\n\nStudy to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old\n\n**Clinical Trial Summary:**\n\nThe purpose of this research study is to evaluate the efficacy and safety of the drugs\r dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18\r years old and are currently taking metformin, insulin, or both drugs.\r\n\r Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged\r 18 years or older. Dapagliflozin (alone or in combination with other antidiabetic drugs) is\r available for use in adults in approximately 40 countries worldwide including the USA and\r Europe. Saxagliptin (alone or in combination with other antidiabetic drugs) is available for\r use in adults in approximately 90 countries worldwide. This study will assess how well\r dapagliflozin and saxagliptin work by finding out how these treatments affect blood glucose\r (sugar) levels compared to placebo (a pill that contains no active drug), in children and\r adolescents. Dapagliflozin and saxagliptin are considered investigational products in this\r study since while they have been approved for use in adults (patients 18 years or older),\r they haven't been approved for children and adolescents due to lack of clinical studies in\r this specific population.\r\n\r Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who\r do not have this disease. The high level of sugar in the blood can lead to serious short-term\r and long-term medical problems. The main goal of treating diabetic patients is to lower blood\r glucose to a normal level. Lowering and controlling blood glucose help prevent or delay\r complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the\r possibility of amputation.\r\n\r Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the\r kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the\r kidneys from returning glucose from the urine back into the bloodstream.\r\n\r Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a\r hormone made by the pancreas that allows the body to use sugar (glucose) from the food that\r is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood\r sugar levels in response to a meal and between meals if blood glucose levels are not lowered\r effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps\r to decrease the amount of sugar made by the body. Together, these processes reduce blood\r glucose levels and help to control Type 2 Diabetes.\r\n\r The subject will either receive one of the active study drugs or a placebo (a pill that looks\r identical but contains inactive drug). This study will be double blind; this means that\r neither the subject, nor the study doctor will know which treatment the subject will receive.\r\n\r Which treatment the subject receives is decided by a computer, purely by chance; this is\r called a \"random assignment\".\r\n\r For this study, there will first be a screening phase of up to 6 months if Investigator\r thinks that some of the screening tests can be repeated, followed by a 2 week lead in phase.\r Thereafter there will be a 26W short-term treatment phase (W1-26), and a 26 W long-term\r treatment phase (W27-52). Following this there will be a follow-up telephone call on week 56\r and a post study visit at W104. At day 1 visit after the lead in phase the subject will be\r randomly assigned to receive one of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or\r placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14,\r and until the end of the study, the subject will be assigned to receive one of the following\r 5 treatments: dapagliflozin 5 mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg\r or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as at\r Day 1, but some of the groups will receive them at a higher dose.Starting at W32 or W40,\r i.e., after the end of the primary endpoints, patients with background medication of\r metformin only, and an HbA1c value < 7.5% at W26 or W32, will undergo a third randomization.\r Eligible subjects from the treatment arms will undergo the randomized withdrawal of\r background medication, while eligible patients from the placebo arm will undergo, in addition\r to randomized withdrawal of background medication a randomized switch to active treatment.\r\n\r Short- and long-term period study visits can be delayed by a maximum of 11 months in total.\r If the duration of investigational product administration is longer than 52 (+1) weeks, the\r safety follow-up period should be shortened such that the complete study duration does not\r exceed 104 weeks. The W104 visit should not be delayed.If more than 12 weeks elapse between\r the HbA1c collection at W26 and the third rand at W32, or the HbA1c collection at W32 and the\r third rand at W40, the subject should not go through this rand as the HbA1c value would no\r longer be reliable to ascertain eligibility for the third rand\n\n**Clinical Trial Detailed Description:**\n\nIn pediatric Type 2 Diabetes Mellitus (T2DM) subjects on diet and exercise and metformin, or\r insulin, or metformin and insulin:\r\n\r The primary research hypothesis for dapagliflozin is whether addition of dapagliflozin,\r including up-titration if needed, results in a greater mean reduction from baseline in\r glycosylated hemoglobin (HbA1c) as compared to placebo when each are administered over 26\r weeks of oral double-blind add-on treatment.\r\n\r The primary research hypothesis for saxagliptin is whether addition of saxagliptin, including\r up-titration if needed, results in a greater mean reduction from baseline in HbA1c as\r compared to placebo when each are administered over 26 weeks of oral double-blind add-on\r treatment.\r\n\r Study Design: The proposed study is a 26-week Phase 3b, multicenter, randomized,\r placebo-controlled, double-blind, parallel group study with a 26-week safety extension period\r to evaluate the safety and efficacy of dapagliflozin (5 mg and 10 mg), and, separately,\r saxagliptin (2.5 mg and 5 mg) in pediatric subjects with T2DM, and an additional post study\r visit at Week 104 for assessment of measures of growth and maturity. Approximately 243\r pediatric subjects will be randomized in a 1:1:1 ratio to receive dapagliflozin 5 mg,\r saxagliptin 2.5 mg, or placebo. Approximately 81 subjects will be randomized to each\r treatment arm.\r\n\r After a 26-week, double-blind, ST treatment period, the primary efficacy endpoint will be\r assessed. This will be followed by a 26-week, site- and subject-blind LT safety extension\r period. Dapagliflozin and, separately, saxagliptin will be compared against the single shared\r placebo comparator.\r\n\r Measures of growth and maturity will be assessed at the Week 104 post study visit.\r\n\r Subjects will be required to have been treated with diet and exercise and a stable dose of at\r least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or a stable baseline dose of\r insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin and\r insulin for a minimum of 8 weeks prior to randomization. At least 50% of subjects will be on\r a stable baseline dose of metformin, with or without concurrent insulin therapy. At least 30%\r of total subjects will be between the ages of 10 and 14 years and at least one third, but no\r more than two thirds, female subjects.\r\n\r During the 2-week lead-in period, subjects will be instructed on a diet and exercise program\r (in accordance with the American Diabetes Association [ADA] or similar local guidelines) to\r be followed for the study duration. Subjects will maintain their baseline types and/or doses\r of antidiabetic therapy throughout the study (2-week lead-in, 26-week double-blind ST\r treatment period, and the 26-week blinded safety extension LT treatment period). If\r applicable, investigators will encourage subjects to keep their insulin doses stable.\r Down-titration of insulin will be allowed only as necessary to prevent hypoglycemia and will\r be at the discretion of the Investigator. Home glucose meters to monitor glucose control will\r be dispensed to subjects and self-blood glucose monitoring (SBGM) requirements and procedures\r will be explained. Subjects will also be instructed on the use of the subject diary to record\r self-monitored glucose levels and daily insulin dose, if applicable. Subjects will also\r receive a blood ketone meter for testing when DKA is suspected.\r\n\r After the lead-in period, eligible subjects with HbA1c of 6.5% to 10.5% at screening will be\r randomized 1:1:1 to receive oral, double-blind, dapagliflozin 5 mg (approximately 81\r subjects), saxagliptin 2.5 mg (approximately 81 subjects), or placebo (approximately 81\r subjects). Randomization will be stratified based on baseline anti-diabetes treatment regimen\r (stable baseline dose of metformin (IR or XR), a stable baseline dose of insulin, or a stable\r combination of metformin and insulin), gender, and age (10 to below 15 years of age, 15 to\r below 18 years of age).\r\n\r A blinded HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c\r values < 7% will remain on previously assigned randomized treatment (dapagliflozin 5 mg, or\r saxagliptin 2.5 mg, or placebo) after the Week 12 assessment. Subjects assigned to the\r dapagliflozin treatment arm at Day 1 Randomization with Week 12 HbA1c values >= 7% will be\r re-randomized in a 1:1 ratio to continue on the low-dose treatment (dapagliflozin 5 mg) or\r up-titrate to the high-dose treatment (dapagliflozin 10 mg) after the Week 12 assessment.\r Similarly, subjects assigned to the saxagliptin treatment arm at Day 1 Randomization with\r Week 12 HbA1c values >= 7% will be re randomized in a 1:1 ratio to continue on the low-dose\r treatment (saxagliptin 2.5 mg) or up-titrate to the high-dose treatment (saxagliptin 5 mg)\r after the Week 12 assessment. Subjects assigned to the placebo treatment arm at Day 1\r Randomization with Week 12 HbA1c values >= 7% will continue on placebo treatment. To maintain\r the blinding of treatments as well as HbA1c results, all placebo subjects and all subjects\r taking saxagliptin or dapagliflozin with an HbA1c < 7% at week 12 will go through a dummy 2nd\r randomization process that will be indistinguishable (for the subjects and site personnel)\r from the actual 2nd randomization. During the Week 14 visit, blinded study drug will be\r dispensed to all subjects in accordance with new treatment assignments based on Week 12 HbA1c\r assessments. After completion of assessments at Week 26, a subset of eligible subjects who\r are receiving background medication with metformin only will undergo a third randomization\r (randomized withdrawal of background medication) at either Week 32 or Week 40. Eligibility\r for randomized withdrawal from background medication will be restricted to subjects who are\r receiving background treatment with metformin only, and who have HbA1c < 7.5% at Week 26 or\r Week 32 provided they have not initiated rescue glycemic control therapy or been withdrawn\r from study drug. Subjects who are receiving background medication with metformin only, who do\r not qualify for the third randomization at Week 32 due to an HbA1c ≥ 7.5% at Week 26, may\r qualify for the third randomization at Week 40 if HbA1c < 7.5% at Week 32. Subjects who have\r passed Week 40 will not be included in the randomized withdrawal of background medication\r\n\r After completion of the ST treatment period, all subjects will enter the LT treatment period.\r All subjects, including those randomized to receive placebo, will continue with their\r randomized study medication assigned after the Week 12 assessment in the site- and subject\r blind LT treatment period. Adverse events (AEs) and serious adverse events (SAEs) will be\r assessed during a Week 56 phone visit.In case a visit is delayed for any reason, subsequent\r visits should be scheduled such that an interval of at least 12 weeks is maintained between\r the:\r\n\r - Week 14 visit and the Week 26 visit.\r\n\r - Third randomization (for subjects undergoing third randomization; occurring at the Week\r 32 or the Week 40 visit) and the Week 52 visit.\r\n\r If more than 12 weeks elapse between the HbA1c collection at Week 26 and the third\r randomization at Week 32, or the HbA1c collection at Week 32 and the third randomization at\r Week 40, the subject should not go through this randomization as the HbA1c value would no\r longer be reliable to ascertain eligibility for the third randomization. Short- and long term\r period study visits can be delayed by a maximum of 11 months in total. If the duration of IP\r administration is longer than 52 (+1) weeks, the safety follow-up period should be shortened\r such that the complete study duration does not exceed 104 weeks.\r\n\r Subjects who discontinue study drug before the end of the study treatment period will enter a\r non-treatment, follow up phase, in which subjects will follow their visit schedules with\r modified assessments until study completion. Subjects will attend a post-study visit at Week\r 104, for assessment of measures of growth and maturity.This visit should be completed without\r delay (at 104 weeks from Day 1 + 7 days), regardless of whether any other study visits were\r delayed.\r\n\r If scheduled visits at clinical sites will be significantly impacted by the COVID-19 pandemic\r (e.g., there is a risk that the subject may be exposed to COVID-19 when visiting the site),\r home visits by study site personnel/vendor are allowed in countries where this is\r logistically feasible and considered acceptable. Before such a visit, a risk assessment that\r considers the potential risks to both the subject and the study personnel has to be\r performed.\r\n\r Discontinued subjects will not be replaced. Samples for analysis of plasma levels of\r dapagliflozin, saxagliptin and its metabolite 5-Hydroxy saxagliptin (5 OH saxagliptin) will\r be collected pre-dose and approximately 2 hours post-dose (+/- 1 hour) during the Week 6, 12,\r 20, and 26 visits.\r\n\r Samples for analysis of plasma glucose will be collected pre-dose during the Day 1 visit, and\r pre-dose and approximately 2 hours post-dose (+/- 1 hour) during the Week 6, 12, 20, and 26\r visits.\r\n\r Plasma samples for analysis of dipeptidyl peptidase-4 (DPP-4) activity will be collected\r pre-dose during the Day 1 visit, and at 2 (+/-1) hours post-dose during the Week 6, 12, 20,\r and 26 visits.Samples may be collected at additional time points during the study if\r warranted and agreed upon between the investigator and the Sponsor, eg, for safety reasons.\r\n\r All plasma samples will be drawn in the fasting condition. During the course of the trial,\r subjects may be eligible for the addition of open-label rescue medication to their blinded\r treatment regimen in order to treat ongoing hyperglycemia. Insulin may be used as rescue, at\r the Investigator's discretion.\r\n\r Pre-specified glycemic criteria, based upon self-monitored blood glucose (SMBG) FPG, or\r single central laboratory FPG and repeat confirmatory FPG have been established during the\r treatment period, starting at Week 6, and up to but not including the Week 52 visit, to\r determine eligibility for open-label rescue medication.\r\n\r Sample Size:\r\n\r The sample size for this study was selected to be consistent with the research hypotheses.\r\n\r Dapagliflozin and saxagliptin will be compared with placebo separately. The Bonferroni method\r to control the type 1 error rate across two comparisons with respect to the two groups of\r research hypotheses (dapagliflozin vs placebo and saxagliptin vs placebo) will be used. No\r comparisons between saxagliptin and dapagliflozin will be performed.\r\n\r The sample size for this study is based on the ability to detect a 0.5% improvement over\r placebo for dapagliflozin and saxagliptin in change from baseline in HbA1c at Week 26 (ST)\r with at least 80% power for each comparison at a two sided alpha level of 0.025. Assuming a\r standard deviation of 0.9% for change from baseline HbA1c at Week 26, a total of 237\r pediatric subjects will be randomized in a 1:1:1 ratio to receive dapagliflozin 5 mg (79\r subjects), saxagliptin 2.5 mg (79 subjects), or placebo (79 subjects) respectively. Assuming\r that 2% of subjectsdo not have a primary endpoint, a total of approximately 243 subjects will\r be randomized. Randomization will be stratified based on the baseline anti-diabetic treatment\r regimen (stable baseline dose of metformin [IR or XR]), a stable baseline dose of insulin, or\r a stable combination of metformin [IR or XR] and insulin), gender, and age (10 to below 15\r years of age, 15 to below 18 years of age).\r\n\r The anticipated difference of 0.5% between each study drug (saxagliptin and dapagliflozin)\r and placebo used in sample size estimation is consistent with estimates that were obtained in\r adult clinical trials with saxagliptin or dapagliflozin as add on to anti-diabetic medication\r where the primary endpoint was improvement in HbA1c after 24 weeks treatment. The standard\r deviation estimate of 0.9% is consistent with estimates obtained in these adult studies as\r well as with published estimates from pediatric trials of other anti-diabetic medications.\r\n\r Analyses:\r\n\r Dapagliflozin and saxagliptin will be summarized separately. A common placebo group will be\r included in each summary.\r\n\r In addition, within the analyses of saxagliptin, the overall (combined low-dose and\r high-dose) efficacy and safety analyses will be repeated for the subgroup of subjects on a\r stable baseline dose of metformin (IR or XR) (with or without insulin). For these analyses,\r the saxagliptin treatment regimens will be combined into one group and compared to the\r (common) placebo group. P values corresponding to subgroup comparisons will be reported for\r the primary and secondary efficacy endpoints, and will be reported at the nominal\r significance level.\r\n\r All efficacy analyses will be performed using the Randomized Subjects Data Set (all\r randomized subjects who receive at least one dose of study medication during the treatment\r period) unless otherwise specified.\r\n\r The following treatment regimens are considered for analysis:\r\n\r - Low-dose/high-dose: Initial treatment of the low-dose followed by up-titrating to the\r high-dose for those who do not achieve the glycemic target of HbA1c <7% at week 12\r\n\r - Low-dose: Initial treatment of the low-dose followed by continuing treatment on the\r low-dose drug for those who do not achieve the glycemic target of HbA1c <7% at week 12\r For each drug, the primary comparison between the low-dose/high-dose and placebo\r regimens will be tested at a two sided alpha level of 0.025.\r\n\r The primary efficacy analysis will be performed using a weighted analysis of covariance\r (ANCOVA). Separate models will be used for saxagliptin and dapagliflozin analyses, and each\r analysis will include the (common) placebo control. Each model will have terms for baseline\r value, treatment group, and randomization strata.\r\n\r For the comparison of the low-dose/high-dose treatment regimen versus placebo, all subjects\r who had HbA1c<7% at Week 12 and remained on the low-dose will get a weight of one. The\r subjects who had HbA1c >= 7% at Week 12 and continued on the low-dose will get a weight of 0.\r The subjects who had HbA1c>= 7% at Week 12 and received the high-dose will have a weight of\r 2. All subjects who do not undergo the second randomization and all placebo subjects will get\r a weight of one. The intent-to-treat (ITT) estimand will be evaluated as the primary\r estimand. Missing values for Week 26 will be imputed using the multiple imputation method.\r The details of the imputation method will be presented in the statistical analysis plan.\r Point estimates and 95% confidence intervals will be calculated based on maximum likelihood\r for the adjusted mean changes within each treatment group as well as for the differences in\r adjusted mean changes between treatment groups.\r\n\r To assess the robustness of the primary efficacy analysis for the change in HbA1c from\r baseline to Week 26, additional sensitivity analysis may be performed using the Evaluable\r Subjects Data Set if > 10% of the subjects in any treatment group in the Randomized Subjects\r Data Set have relevant protocol deviations.\r\n\r The primary endpoint will also be compared between the low-dose treatment regimen and\r placebo. In addition, up titrating to high-dose and continuing on low-dose will be compared\r in the subset of saxagliptin and dapagliflozin subjects who had HbA1c >= 7% at Week 12. These\r analyses are described under secondary efficacy analyses.\r\n\r Secondary efficacy analyses will also be performed separately for each drug (saxagliptin and\r dapagliflozin). For each drug, the following sequential testing order will be employed to\r control multiplicity of testing for the secondary objectives.\r\n\r 1. Comparison of mean reduction in HbA1c from baseline at Week 26 between the low-dose\r treatment regimen and placebo\r\n\r 2. Comparison of mean reduction in HbA1c from baseline at Week 26 between overall drug\r treatment and placebo\r\n\r 3. Comparison of mean reduction in FPG from baseline at Week 26 between the low\r dose/high-dose treatment regimen and placebo\r\n\r 4. Comparison of mean reduction in FPG from baseline at Week 26 between the low-dose\r treatment regimen and placebo\r\n\r 5. Comparison of mean reduction in FPG from baseline at Week 26 between overall drug\r treatment and placebo\r\n\r 6. Comparison of the percentage of subjects with baseline HbA1c>= 7% who achieve an HbA1c\r level < 7.0% at Week 26 between the low-dose/high-dose treatment regimen and placebo\r\n\r 7. Comparison of the percentage of subjects with baseline HbA1c >= 7% who achieve an HbA1c\r level < 7.0% at Week 26 between the low-dose treatment regimen and placebo\r\n\r 8. Comparison of the percentage of subjects with baseline HbA1c >= 7% who achieve an HbA1c\r level < 7.0% at Week 26 between overall drug treatment and placebo\r\n\r 9. Comparison of mean reduction in HbA1c from baseline at Week 26 between the high dose and\r the low-dose in subjects who do not achieve an HbA1c < 7% at Week 12\r\n\r 10. Comparison of mean reduction in FPG from baseline at Week 26 between the high dose and\r the low-dose in subjects who do not achieve an HbA1c < 7% at Week 12\r\n\r 11. Comparison of the percentage of subjects with baseline HbA1c >= 7% who achieve an HbA1c\r level < 7.0% at Week 26 between the high-dose and the low-dose in subjects who do not\r achieve an HbA1c < 7% at Week 12 When the sequential testing stops for non-significance,\r nominal p-values and adjusted means will be provided for the remaining comparisons.\r\n\r For each drug, weighted ANCOVA analysis will be performed for the change from baseline in\r HbA1c at Week 26 to compare the placebo and the low-dose treatment regimen. For this\r analysis, all subjects who had HbA1c < 7% at Week 12 and remained on the low-dose will get a\r weight of one. The subjects who had HbA1c >= 7% at Week 12 and continued on the low-dose will\r get a weight of 2. The subjects who had HbA1c >= 7% at Week 12 and received the high-dose\r will have a weight of 0. All subjects who do not undergo the second randomization and all\r placebo subjects will get a weight of one.\r\n\r For subjects on saxagliptin and dapagliflozin and who had HbA1c >= 7% at Week 12, the change\r from baseline HbA1c at Week 26 (ST) will be compared between the subjects re-randomized to\r remain on the low-dose and the subjects who are re-randomized to the high- dose using an\r ANCOVA.\r\n\r Change from baseline of HbA1c at Week 26 (ST) will be compared also using a repeated measures\r analysis between overall drug and placebo. For this analysis, both treatment regimens will be\r combined into one treatment group for each drug.\r\n\r Change from baseline at Week 26 (ST) in FPG will be analyzed similar to the primary weighted\r analyses of change from baseline in HbA1c at Week 26.\r\n\r The proportion of subjects achieving HbA1c < 7.0% at Week 26 (ST) will be analyzed using\r weighted logistic regression with adjustment for the baseline HbA1c measurement and the\r randomization strata. Weighting for the subjects will be applied similarly to a weighting in\r the analysis of change from baseline in HbA1c. Subjects with missing a response at Week 26\r will be imputed by dichotomizing the imputed values of HbA1c at Week 26.\r\n\r The assessment of safety will be based on the analyses of AEs, vital signs, physical\r examinations, electrocardiograms, hypoglycemia, DKA, safety laboratory evaluations, and\r measures of growth and maturity. All safety analyses will be performed using the Treated\r Subjects Data Set. Dapagliflozin and saxagliptin will be summarized separately. Treatment\r regimens (low-dose or low-dose/high-dose) will be combined for saxagliptin and dapagliflozin\r to provide the safety summary for overall saxagliptin and overall dapagliflozin compared to\r placebo. A common placebo group will be included in each summary.\r\n\r Measures of growth, bone and maturation markers will also be summarized for the combined ST +\r LT + additional post study visit at Week 104.\r\n\r Monitoring The Sponsor/designee representatives will review data centrally to identify\r potential issues to determine a schedule of on-site visits for targeted review of study\r records.\r\n\r Representatives of the Sponsor (or designee) must be allowed to visit all study site\r locations periodically to assess the data quality and study integrity. On site they will\r review study records and directly compare them with source documents, discuss the conduct of\r the study with the Investigator, and verify that the facilities remain acceptable.Off-site\r monitoring visits and remote source data verification are allowed when restrictions due to\r the COVID-19 pandemic prevent on site visits (e.g., monitors may not be able to access the\r sites in a timely manner). Should this occur, it should be documented and the reasons be\r available for review by the Sponsor and during inspections by any Regulatory Authorities In\r addition, the study may be evaluated by the Sponsor (or designee) internal auditors and\r government inspectors who must be allowed access to Case Report Forms (CRFs), source\r documents, other study files, and study facilities. The Sponsor (or designee) audit reports\r will be kept confidential.\r\n\r The investigator must notify the Sponsor (or designee) promptly of any inspections scheduled\r by regulatory authorities, and promptly forward copies of inspection reports to the\r Sponsor/designee.\r\n\r Records Retention The investigator must retain all study records and source documents for the\r maximum period required by applicable regulations and guidelines, or institution procedures,\r or for the period specified by the Sponsor/designee, whichever is longer. The investigator\r must contact the Sponsor/designee prior to destroying any records associated with the study.\r\n\r The Sponsor/designee will notify the Investigator when the study records are no longer\r needed.\r\n\r If the Investigator withdraws from the study (e.g., relocation, retirement), the records\r shall be transferred to a mutually agreed upon designee (e.g., another investigator, IRB).\r Notice of such transfer will be given in writing to the Sponsor/designee.\r\n\r Study Drug Records\r\n\r It is the responsibility of the Investigator to ensure that a current disposition record of\r study drug (inventoried and dispensed) is maintained at the study site to include\r Investigational Products (IPs). Except where the IP has to be sent directly to the subjects'\r homes due to the coronavirus disease 2019 (COVID 19) pandemic. Any unused IP sent directly to\r subjects' homes should be returned to the site at the next on-site visit.Records or logs must\r comply with applicable regulations and guidelines and should include:\r\n\r - Amount received and placed in storage area\r\n\r - Amount currently in storage area\r\n\r - Label identification number or batch number\r\n\r - Amount dispensed to and returned by each subject, including unique subject identifiers\r\n\r - Amount transferred to another area/site for dispensing or storage\r\n\r - Non study disposition (e.g., lost, wasted)\r\n\r - Amount destroyed at study site, if applicable\r\n\r - Amount returned to the Sponsor/designee\r\n\r - Retain samples for bioavailability/bioequivalence, if applicable\r\n\r - Dates and initials of person responsible for IP dispensing/accountability, as per the\r Delegation of Authority Form The Sponsor/designee will provide forms to facilitate\r inventory control if the investigational site does not have an established system that\r meets these requirements.\r\n\r Case Report Forms An investigator is required to prepare and maintain adequate and accurate\r case histories designed to record all observations and other data pertinent to the\r investigation on each individual treated or entered as a control in the investigation. Data\r that are derived from source documents and reported on the CRF must be consistent with the\r source documents or the discrepancies must be explained. Additional clinical information may\r be collected and analyzed in an effort to enhance understanding of product safety. Case\r report forms may be requested for AEs and/or laboratory abnormalities that are reported or\r identified during the course of the study.\r\n\r For sites using the Sponsor/designee's Electronic Data Capture (EDC) tool, electronic CRFs\r will be prepared for all data collection fields except for fields specific to SAEs and\r pregnancy, which will be reported on the electronic SAE form and Pregnancy Surveillance Form,\r respectively. If electronic SAE form is not available, a paper SAE form can be used. Spaces\r may be left blank only in those circumstances permitted by study-specific CRF completion\r guidelines provided by the Sponsor/designee.\r\n\r The confidentiality of records that could identify subjects must be protected, respecting the\r privacy and confidentiality rules in accordance with the applicable regulatory\r requirement(s).\r\n\r The investigator will maintain a signature sheet to document signatures and initials of all\r persons authorized to make entries and/or corrections on CRFs.\r\n\r The completed CRF, including any paper or electronic SAE/pregnancy CRFs, must be promptly\r reviewed, signed, and dated by the Investigator or qualified physician who is a\r co-investigator and who is delegated this task on the Delegation of Authority Form. For\r electronic CRFs, review and approval/signature is completed electronically through the\r Sponsor/designee's EDC tool. The investigator must retain a copy of the CRFs including\r records of the changes and corrections.Data entered in the eCRF that are transcribed from\r source documents must be consistent with the source documents or the discrepancies must be\r explained.\r\n\r Each individual electronically signing electronic CRFs must meet Sponsor/designee training\r requirements and must only access the Sponsor/designee's EDC tool using the unique user\r account provided by the Sponsor/designee. User accounts are not to be shared or reassigned to\r other individuals.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Signed Written Informed Consent\r\n\r - Target Population\r\n\r - Previously diagnosed with Type 2 Diabetes Mellitus by World Health Organization/ADA\r criteria\r\n\r - HbA1c between 6.5% and 10.5% obtained at screening.\r\n\r - Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or\r XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a\r stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum\r of 8 weeks prior to randomization. For those children on insulin, investigators will\r confirm that attempts at removing insulin from the subject's therapeutic regimen had\r been previously made but had not been successful.\r\n\r - Age and Reproductive Status\r\n\r - Male and female patients eligible if 10 years of age, up to but not including 18 years\r of age at the time of enrollment/screening. At least 30% of total subjects will be\r between the ages of 10 and 14 years and at least one third, but no more than two\r thirds, female subjects.\r\n\r - Women of childbearing potential must have a negative pregnancy test within 24 hours\r prior to the start of study drug.\r\n\r - Women must not be breastfeeding.\r\n\r - Women of childbearing potential must agree to follow instructions for method(s) of\r contraception for the duration of treatment with study drugs: saxagliptin, and\r dapagliflozin, plus 5 half-lives of study drugs or 30 days (whichever is longer), plus\r 30 days (duration of ovulatory cycle) for a total of 60 days post treatment\r completion.\r\n\r Exclusion Criteria:\r\n\r - Target Disease Exceptions\r\n\r - Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1\r diabetes,\r\n\r - Previous diagnosis of monogenic etiology of Type 2 diabetes\r\n\r - Diabetes ketoacidosis (DKA) within 6 months of screening\r\n\r - Current use of the following medications for the treatment of diabetes, or use within\r the specified timeframe prior to screening for the main study:\r\n\r - Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or\r injectable incretins or incretin mimetics, other antidiabetes medications not\r otherwise specified.\r\n\r - Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication\r related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2)\r inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors)\r\n\r - Initiation or discontinuation of prescription or non-prescription weight loss drugs\r within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs\r must be stable during the study.\r\n\r - Medical History and Concurrent Diseases\r\n\r - Pregnant, positive serum pregnancy test, planning to become pregnant during the\r clinical trials, or breastfeeding\r\n\r - History of unstable or rapidly progressive renal disease\r\n\r - History of unresolved vesico-ureteral reflux\r\n\r - History of or current, acute or chronic pancreatitis\r\n\r - History of hemoglobinopathy, with the exception of sickle cell trait or thalassemia\r minor; or chronic or recurrent hemolysis\r\n\r - Malignancy within 5 years of the screening visit (with the exception of treated basal\r cell or treated squamous cell carcinoma)\r\n\r - Replacement or chronic systemic corticosteroid therapy, defined as any dose of\r systemic corticosteroid taken for > 4 weeks within 3 months prior to the Day 1 visit\r\n\r - Physical and Laboratory Test Findings\r\n\r - Abnormal renal function,\r\n\r - An abnormal thyroid-stimulating hormone (TSH) value at enrollment will be further\r evaluated for free T4. Subjects with abnormal free T4 values will be excluded.\r\n\r - Hematuria (confirmed by microscopy at screening) with no explanation as judged by the\r Investigator up to randomization.\r\n\r - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2× upper limit of\r normal (ULN), or clinically significant hepatic disease.\r\n\r - Serum total bilirubin (TB) > 2x ULN unless exclusively caused by Gilbert's syndrome\r\n\r - Positive serologic evidence of current infectious liver disease including anti\r hepatitis A virus (HAV) (IgM), hepatitis B surface antigen (HBsAg), or anti hepatitis\r C virus (HCV). Patients who have isolated positive anti-hepatitis B surface antibodies\r may be included.\r\n\r - Anemia of any etiology\r\n\r - Volume-depleted subjects.\r\n\r - Allergies and Adverse Drug Reaction\r\n\r - Known allergy, sensitivity or contraindication to any study drug or its\r excipient/vehicle\r\n\r - Other Exclusion Criteria\r\n\r - Subject is currently abusing alcohol or other drugs or has done so within the last 6\r months prior to the screening visit.\r\n\r - Prisoners or subjects who are involuntarily incarcerated. (Note: under certain\r specific circumstances a person who has been imprisoned may be included or permitted\r to continue as a subject. Strict conditions apply and Sponsor/designee approval is\r required.)\r\n\r - Subjects who are compulsorily detained for treatment of either a psychiatric or\r physical (e.g., infectious disease) illness.\r\n\r - Psychiatric or cognitive disorder that will, in the opinion of investigators, limit\r the subject's ability to comply with the study medications and monitoring.\r\n\r - Subjects who have contraindications to therapy as outlined in the saxagliptin and\r dapagliflozin Investigator Brochure or local package inserts.\r\n\r - Participation and receiving IP in another clinical study during the prior 3 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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"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\nEffect of Body Weight Loading on Urinary Electrolyte Excretion\n\n**Clinical Trial Summary:**\n\nTitle: Effect of body weight loading on urinary electrolyte excretion\r\n\r Swedish Title: Effekt av belastning på utsöndring av elektrolyter\r\n\r Study period: Q2-Q3 2017\r\n\r Study site: The study will be performed at the Institution for Neurology and Physiology,\r Sahlgrenska Academy, University of Gothenburg. Principal Investigator is John-Olov Jansson,\r MD, PhD, Professor at Institute of Neuroscience and Physiology, University of Gothenburg\r\n\r Background and study design: Weight reduction can be obtained by decreased appetite or\r increased metabolism. However, acute weight loss can also be obtained by loss of fluids - for\r example by increased urinary loss of fluid and salts, so called elctrolytes. Preliminary\r results from a laboratory lesson for the Master of Science in Medicine program at University\r of Gothenburg suggest that carrying a 10 kg weight vest could increase urinary excretion of\r Na+, K+ and Cl-. The purpose of this study is to investigate this further in a more\r controlled research setting. If confirmed, the results could potentially contribute to the\r development of potent diuretics or obesity medicines.\r\n\r The study will include 15 healthy volunteers and consist of three study days with about one\r week between each study day. The study subjects will go through a different study procedure\r each study day, and a randomized cross-over study design will be used to determine which\r procedure each day.\r\n\r Procedure 1: Wearing a weight vest with 10 % of body weight standing for seven hours. The\r study subject is allowed to sit for 10 minutes each hour. The reason for this is that it has\r been considered that the effect may be transmitted by weight loading of the lower\r extremities.\r\n\r Procedure 2: Wearing a weight vest with 1 % of body weight standing for seven hours, as a\r control for procedure 1, with lower loading. The study subject is allowed to sit for 10\r minutes each hour.\r\n\r Procedure 3: Wearing a weight vest with 1 % of body weight sitting for seven hours. This is a\r procedure with even less loading of the lower extremities than during procedure 2.\r\n\r Urine- and blood samples, as well as heart rate and blood pressure measurements, will be\r collected during the study days and analyzed in order to address the primary and secondary\r objectives of the study.\n\n**Clinical Trial Detailed Description:**\n\n1. INTRODUCTION\r\n\r 1.1. Background\r\n\r Weight reduction can be obtained by decreased appetite or increased metabolism. However,\r acute weight loss can also be obtained by loss of fluids - for example, urinary loss.\r The last of these effects was investigated during 2016.\r\n\r The medical education at The Sahlgrenska Academy in Gothenburg offers in its third\r semester a student lab called \"Vattenbalans\" [=Water balance]. The purpose of this lab\r is to study fluid loss by the kidneys. In total more than 120 students participate,\r although the urine flow rate is only measured on approximately 50 students each\r semester. The rest of the students function as secretaries. The lab protocol can be\r found in \"Komplett-laborationskompendium-T2-T3-uppdaterat-150318\" pp. 123-134.\r\n\r In summary a total of 50 students wore a weight west. Half of the students wore a 10 kg\r weight vest and half of the students wore a 1 kg weight vest. The study lasted for four\r hours. The students were only allowed to sit a maximum of 10 minutes during each hour.\r No significant difference was observed in urine flow rate. Surprisingly however, the\r investigators found that the students who wore a 10 kg weight vest excreted more\r electrolytes than those wearing a 1 kg weight vest. In the group free from treatment\r (see below) only consisted of 13 subjects and the investigators were therefore not able\r to obtain significant results (p=0,088). The investigators believe that with a larger\r study population and better matched controls the investigators will reach significant\r results.\r\n\r It shall be noted that these results were obtained during a student lab with a fixed\r protocol. In addition to wearing a weight vest the students also received one of the\r following treatments: one liter of water orally, one liter of water orally and oral\r administration of a vasopressin analogue called Minirin© (desmopressin, 60 µg), a loop\r diuretic called Furix© (furosemide, 40 mg) or one liter water orally and eight tablets\r of Resorb© which is a rehydration therapy. The multiple treatments and the fixed\r protocol are confounders and support the repetition of these experiments with a more\r suitable design.\r\n\r 1.2. Rationale for conducting this study\r\n\r The medical relevance of these experimental results is still unclear because of the\r short duration of four hours. With more experimental support, it is possible that this\r strategy could be used to create potent diuretics. It is also possible that long-term\r body weight loading could decrease body weight in a different way, especially by\r decreasing fat mass. This mechanism could therefore be used to create potent drugs for\r obesity.\r\n\r 1.3. Risk/Benefit evaluation\r\n\r In general this is a study with few risks. The weight vests used in this experiment are\r in daily use by thousands of people during exercise . During the experiment with medical\r students only one of the students experienced an adverse event. This student experienced\r mild dizziness which subsided within a few minutes after removing the weight vest and\r sitting down. To further minimize the risks in our future study the investigatorshave\r decided to include only healthy research subjects consuming no medications. The\r investigators will also have medically trained personnel available during the study and\r perform it in close vicinity to the Sahlgrenska University Hospital.\r\n\r Blood sampling can be experienced as somewhat uncomfortable by a few individuals.\r However it is generally free from complications. In some subjects, there may be small\r local bruising or inflammation.\r\n\r In summary the investigators believe the risks to be very low compared to the potential\r of exploring a new physiological mechanism with potentially important applications such\r as new diuretics or anti-obesity medicine.\r\n\r 2. STUDY DESIGN AND PROCEDURES\r\n\r The study is executed with all 15 study subjects over three study days with one week between\r each study day. In order to decrease the variation of the measurement values and increase the\r power of the study cross-over study design will be used. The study subjects will on one of\r the days wear a weight vest with 10 % of body weight in the standing position, on one of the\r days the same study subject will wear a weight vest with 1 % of body weight in the standing\r position and on one of the days the same study subject will wear a weight vest with 1 % of\r body weight in the sitting position.\r\n\r Hence, three procedures are included in the study. Each of the procedure corresponds to a\r separate day.\r\n\r Procedure 1: Wearing a weight vest with 10 % of body weight standing for seven hours. The\r study subject is allowed to sit for 10 minutes each hour. The reason for this is because it\r has been considered that the effect may be transmitted by weight loading of the lower\r extremities.\r\n\r Procedure 2: Wearing a weight vest with 1 % of body weight standing for seven hours. The\r study subject is allowed to sit for 10 minutes each hour.\r\n\r Procedure 3: Wearing a weight vest with 1 % of body weight sitting for seven hours. This is a\r control group without loading of the lower extremities. This is also the normal working\r position for many sedentary jobs (e.g. office workers) and why this is of special interest\r for further investigation. There is a large body of investigative literature showing the\r negative health consequences of the sitting working position.\r\n\r Blood drawing will be performed with a peripheral venous catheter of the smallest size.\r Furthermore there will be several steps each day which will be uniform for each of the\r procedures.\r\n\r Time point 1 (0 h): \"Oral water load\"\r\n\r The catheter will be placed by an experienced nurse from Gothia Forum and is removed seven\r hours later when the procedure day is finished. Study proceedings and record keeping will be\r told to the research subject before the experiment officially starts.\r\n\r Just before the experiment starts the study subject will drink 5 ml of water per kg body\r weight. For example, if the study subject weighs 70 kg (no weight vest), he or she will drink\r 350 ml of water.\r\n\r To maintain a normal hydration level and urine production the study subject will continue to\r replace with fluids during the experiment. The volume of fluids that will be replaced will be\r equal to the amount of lost urine volume. If for example the study subject loses 100 ml urine\r he or she will drink of 100 ml water before continuing the experiment. By this method a urine\r production of approximately 200 ml per hour is maintained which is more than enough to\r perform all the required urine measurements.\r\n\r This approach mimics physiological conditions wherein urinary losses are matched by water\r intake. It will avoid water intake in excess of replacement amounts which, in some\r circumstances, is viewed as treatment.\r\n\r It is then decided by dice throw if a study subject will start with procedure 1, 2 or 3. When\r two of the procedure groups are full, with five individuals in each of them, the rest is\r transferred to the last procedure group. Rotation between the procedures occurs in random.\r Each study subject will have one week between performing each procedure.\r\n\r The study subjects will empty their urine bladder just before the study starts. The study\r subjects start with five minutes separation to avoid congestioin to the toilets. The study\r starts when a study subject put on a weight vest.\r\n\r Time Point 2 (0-7 h): Measurements and blood drawing\r\n\r This time period consists of the part from when the study subject puts on the weight vest\r until the he or she takes it off.\r\n\r The study subject shall each hour collect his or her urine volume in a specially designated\r measurement cup. The Urine Volume is noted. 10 ml of the urine are then used to measure the\r electrolyte concentration. Another 10 ml of urine is saved for further analyses at the\r Sahlgrenska University central lab. These analyses are routine but samples may be stored for\r a few days before the measurement takes place. This depends on when the central lab can\r accept our samples and on their specific working load. Sample storage and handling will be\r performed according to the central lab recommendations. The samples will at maximum be frozen\r down once at a temperature of -80°C.\r\n\r When the urine measurements are complete the study subject will have five minutes to relax\r before measuring his or her heart rate and blood pressure. Heart rate and blood pressure are\r both measured standing and sitting with digital blood pressure monitors for quick and\r reliable values.\r\n\r Blood will be drawn four times. The samples will be analyzed as soon as possible after each\r procedure day. Some analyses will be at the Sahlgrenska Academy directly, others will be\r delivered to Sahlgrenska University central lab (please see section 6.1 for details). These\r analyses are routine but samples may be stored for a few days before the measurement takes\r place. This depends on when the central lab can accept our samples and on their specific\r working load. Sample storage and handling will be performed according to the central labs\r recommendations.\r\n\r Time point 3 (7 h -): The experiment is finished\r\n\r Weight vest and peripheral venous catheter are removed. A procedure protocol is handed in\r from the study subject to the investigator who confirms its completeness. . The procedure\r protocol is either handed in digitally by uploading an excel file or handed in printed out.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r For inclusion in the study, subjects must fulfil the following criteria:\r\n\r 1. Healthy volunteers\r\n\r 2. Signed informed consent\r\n\r 3. Willingness to comply with study restrictions of not using alcohol, coffee etc during\r the hours specified below prior to each study day\r\n\r Exclusion Criteria:\r\n\r Subjects must not enter the study if any of the following are present:\r\n\r 1. Chronic disease requiring continuous medication or harden the participation in the\r study as judged by the investigator\r\n\r 2. High blood pressure (>140/90 mm Hg)\r\n\r 3. Chronic pain such as pain that is constant and impairs quality of life\r\n\r 4. Consumption of medications during the last 7 days prior the study day, not including\r contraceptives\r\n\r 5. Consumption of nature medicine or supplements that results in a increased intake of a\r specific compound that isn't a nutrient during the last 7 days prior the study day\r\n\r 6. Smoking, snuff use or intake of drugs during the last 7 days prior the study day\r\n\r 7. Intake of alcohol during the last 24 hours prior the study day\r\n\r 8. Intake of coffee and tea during the last 12 hours prior the study day\r\n\r 9. Strenuous physical activity before the study during the last 6 hours prior the study\r day\r\n\r 10. Pregnancy: Females of childbearing potential must confirm to use reliable\r contraception and not suspect to be 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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"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\nStudy of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma\n\n**Clinical Trial Summary:**\n\nThis is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three\r cohorts will enroll independently.\n\n**Clinical Trial Detailed Description:**\n\nGroup A will be composed of newly-diagnosed, elderly patients with IDH1R132H-non mutant and\r MGMT promoter-unmethylated anaplastic astrocytoma or glioblastoma who will receive TG02 and\r RT.\r\n\r Group B will be composed of newly-diagnosed, elderly patients with IDH1R132H-non mutant and\r MGMT promoter-methylated anaplastic astrocytoma or glioblastoma who will receive TG02 and\r temozolomide.\r\n\r For both Groups A and B, there will be a classical 3+3 dose escalation and an expansion phase\r in the study. Up to a total of 24 evaluable patients in Group A and up to a total of 12\r evaluable patients in Group B (up to 36 evaluable patients for Groups A and B).\r\n\r Group C patients will be composed of patients initially diagnosed with IDH1R132H-non-mutant\r anaplastic astrocytoma or glioblastoma at first relapse post TMZ/RT-->TMZ therapy who will\r receive TG02.\n\n**Clinical Trial Eligibility Criteria:**\n\nSpecifics for groups A and B\r\n\r - Newly diagnosed glioblastoma or anaplastic astrocytoma, IDH1R132H-non-mutant by\r immunohistochemistry locally assessed, with FFPE tissue available for central MGMT\r testing and optional biomarker studies (treatment allocation will be performed based\r on centrally assessed MGMT result)\r\n\r - Tumor debulking surgery, including partial resection\r\n\r - Age > 65 and considered non-eligible for combination therapy (TMZ/RT→TMZ) in\r Investigator's opinion\r\n\r - No prior RT with overlap of radiation fields with the planned RT in this study (Group\r A)\r\n\r - No prior therapy for glioblastoma or anaplastic astrocytoma before surgery\r\n\r - Brain MRI within 14 days before the first dose of TG02\r\n\r Specifics for group C\r\n\r - IDH1R132H-non-mutant glioblastoma or anaplastic astrocytoma at first relapse with\r tissue available from first surgery. [Per 2016 WHO classification, in patients older\r than 55 years of age at diagnosis with a histological diagnosis of glioblastoma,\r without a pre-existing lower grade glioma and with non-midline tumor location,\r immunohistochemical negativity for IDH1R132H suffices for classification as\r glioblastoma. In all other instances of diffuse gliomas, lack of IDH1R132H\r immunopositivity should be followed by IDH1 and IDH2 sequencing to detect or exclude\r other less common IDH mutations.]\r\n\r - Brain MRI at the time of progression or 14 days before the first dose of TG02 and\r availability of last brain MRI before progression diagnosis for upload to the EORTC\r Imaging Platform for post-hoc central review of progression\r\n\r - Diagnosis of recurrence more than 3 months after the end of RT for initial treatment\r\n\r - Intention to be treated with standard TMZ/RT→TMZ for initial treatment (at least one\r dose of TMZ administered; RT alone or chemotherapy alone as initial treatment are not\r permitted)\r\n\r - No discontinuation of TMZ for toxicity during first-line treatment\r\n\r - No RT or stereotactic radiosurgery is allowed for the treatment of first recurrence\r prior to enrollment in this study\r\n\r - Patient may have been operated for recurrence. If operated:\r\n\r - surgery completed at least 2 weeks before initiation of TG02 and patients should have\r fully recovered as assessed by investigator. Criteria for full recovery include\r absence of active post-operative infection, recovery from medical complications (CTCAE\r grade 0 and 1 acceptable), and capacity for adequate fluid and food intake\r\n\r - residual and measurable disease after surgery is not required but surgery must have\r confirmed the recurrence\r\n\r - a post-surgery MRI should be available within 72 hours; the post-surgery MRI can be\r used as baseline if performed within 2 weeks prior to registration. If not, a baseline\r MRI has to be done within 2 weeks prior to registration\r\n\r - For non-operated patients: recurrent disease must be at least one bi-dimensionally\r measurable contrast-enhancing lesion with clearly defined margins by MRI scan, with\r minimal diameters of 10 mm, visible on 2 or more axial slices 5 mm apart, based on a\r MRI scan done within 2 weeks prior to registration\r\n\r - Age ≥ 18 years\r\n\r All groups\r\n\r - Karnofsky Performance Score (KPS) of 60-100\r\n\r - Recovered from effects of debulking surgery, postoperative infection and other\r complications of surgery (if any) (CTCAE grade 0 and 1 acceptable)\r\n\r - Adequate bone marrow, renal and hepatic function within the following ranges within 7\r days before the first dose of TG02:\r\n\r - WBC ≥ 3 x109/L\r\n\r - ANC ≥ 1.5x109/L\r\n\r - Platelet count of ≥ 100 x109/L independent of transfusion\r\n\r - Hemoglobin ≥ 10 g/dl or ≥ 6.2 mmol/L\r\n\r - Bilirubin ≤ 1.5 × ULN\r\n\r - ALT and AST ≤ 2.5 × ULN\r\n\r - Cockcroft-Gault calculated or measured creatinine clearance of ≥ 30 mL/min\r\n\r - No use of enzyme-inducing anti-epileptic drugs (EI-AED) within 7 days prior to the\r first dose of TG02\r\n\r - Life expectancy > 8 weeks\r\n\r - No history of ventricular arrhythmia or symptomatic conduction abnormality in past 12\r months prior to registration\r\n\r - No congestive heart failure (New York Heart Association Class III to IV, see Appendix\r C), symptomatic ischemia, uncontrolled by conventional intervention, or myocardial\r infarction within 6 months prior to enrollment\r\n\r - No 12-lead ECG with a prolonged QTc interval (males: > 450 ms; females: > 470 ms) as\r calculated by the Fridericia correction formula despite balancing of electrolytes at\r registration and/or discontinuing any drugs (for a time period corresponding to 5\r half-lives) known to prolong QTc interval\r\n\r - No known contraindication to imaging tracer or any product of contrast media\r\n\r - No MRI contraindications\r\n\r - No concurrent severe or uncontrolled medical disease (e.g., active systemic infection,\r diabetes, hypertension, coronary artery disease) that, in the opinion of the\r Investigator, would compromise the safety of the patient or compromise the ability of\r the patient to complete the study\r\n\r - No known human immunodeficiency virus infection or acquired immune deficiency syndrome\r\n\r - No previous other malignancies, except for any previous malignancy which was treated\r with curative intent more than 3 years prior to enrollment, or adequately controlled\r limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma\r in situ of the cervix\r\n\r - No pregnant women. Negative serum or urine pregnancy test within 72 hours prior to the\r first dose for women of childbearing potential (WOCBP). Nursing must be discontinued\r at least 1 hour before first dose.\r\n\r - For men of reproductive potential and WOCBP, adequate contraception must be used\r throughout the study and for 6 months thereafter. For this study, acceptable methods\r of contraception include a reliable intrauterine device or a spermicide in combination\r with a barrier method. Hormonal forms of birth control (oral, implantable, or\r injectable) may only be used if combined with another highly effective form of birth\r control such as a spermicide combined with a barrier method\r\n\r - Ability to understand the requirements of the study, provide written informed consent\r and authorization of use and disclosure of protected health information, and agree to\r abide by the study restrictions and return for the required assessments\r\n\r - Ability to take oral medication\r\n\r - Absence of any psychological, familial, sociological or geographical condition\r potentially hampering compliance with the study protocol and follow-up schedule; those\r conditions should be discussed with the patient before registration in the trial\r\n\r - Before patient registration, written informed consent must be given according to\r ICH/GCP, and national/local regulations.\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\nEarly Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment\n\n**Clinical Trial Summary:**\n\nThe aim of this work is to compare between early (3days) and late(7days) removal of urinary\r catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under\r Tamsulosin treatment.\n\n**Clinical Trial Detailed Description:**\n\nThis is a prospective randomized study, Men with acute urinary retention secondary to benign\r prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were\r randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days,\r After that the catheter was removed and the ability to void unaided assessed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients having first attack of acute urinary retention secondary to BPH.\r\n\r Exclusion Criteria:\r\n\r - Renal impairment.\r\n\r - Suspected urethral stricture.\r\n\r - Neurogenic bladder.\r\n\r - Cancer prostate.\r\n\r - Medically induced retention.\r\n\r - Previous use of alpha blockers.\r\n\r - History of drug hypersensitivity or allergy to Tamsulosin.\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\nProphylactic Alpha-blockers in the Prevention of Urinary Retention Post Inguinal Hernia Repair\n\n**Clinical Trial Summary:**\n\nPost operative urinary retention ( POUR) is caused by sympathetic activation of the internal\r urethral sphincter after surgery. The smooth muscles of the around the internal urethral\r sphincter have been demonstrated to be rich in alpha-1 adrenergic receptors. Our research\r idea is novel because there has been no prior prospective study conducted using\r alpha-blockers to reduce post-operative urinary retention in patients undergoing inguinal\r hernia repair. The proposed research is important as existing studies that sought to\r understand POUR have merely established the risks factors involved. Despite so, the incidence\r of POUR remains high and no studies to date have investigated the use of specific\r interventions to reduce the risk of POUR.\r\n\r This is essential as patients who develop POUR have also been successfully shown to have\r significantly longer length of hospitalisation. Besides, the development of POUR can also\r cause significant pain/discomfort, increase risks of long-term urethral catheterisation and\r predispose patients to urinary tract infections\n\n**Clinical Trial Detailed Description:**\n\nThe study will be conducted as a randomised, double blind, placebo-controlled trial. This is\r a single center trial. The experimental design and procedure will be performed in accordance\r to the CONSORT guidelines. Patients will be assessed for eligibility, and selected based on\r the inclusion and exclusion criteria. Once eligible, informed consent will be obtained for\r every patient, and those in agreement to the participation of the trial will be randomly\r provided with pre-assigned sealed envelopes containing either tamsulosin or placebo, for\r which patient and investigators will be blinded to. Patients will then consume either oral\r tamsulosin 0.4mg or placebo daily for 5 days prior to elective surgery. A baseline postural\r blood pressure measurement will be taken before and after the 1st dose, and patients will be\r informed to look out for symptoms of hypersensitivity reactions and orthostatic hypotension,\r and to cease consumption should they develop. Prior to surgery, the patients will require to\r report to the study team if they had finished all 5 drug doses. Patients who develop\r intercurrent illnesses or have urgent matters at hand that would require their surgery to be\r postponed will receive another 5 drug doses that is to be consumed prior the their next\r scheduled surgical date. During the surgery, a maximum dose of 0.1mg/kg of morphine can be\r given to patients. No ilioinguinal block will be performed for patients, but local anesthesia\r 10mls 0.5% Bupivacaine will be infiltrated into the wound sites. The patients will then be\r monitored in the 23 hour short stay ward, during which the patient's wound site, scrotum,\r pain levels and ability to pass urine will be assessed prior to being discharged. All\r patients will be provided with a maintenance drip post operatively. Patients will also be\r placed on paracetamol 1g 6 hourly strictly and tramadol 50mg 8 hourly as per required.\r Alternative analgesia will be provided should patients have existing allergies to these drug\r classes.\r\n\r Patients will be assessed for presence of voiding difficulty 6 hours post operatively, and\r patients who complain of voiding difficulty or inability to pass urine within 6 hours post\r operatively will be defined to have POUR, while a bladder scan will be performed will be\r performed . Patients with existing bladder volume of more than 400mls will be catheterised,\r while those with less than 400mls will be followed up with subsequent 2 hourly bladder scans,\r and catheterised should their bladder volume be beyond 400mls. Once discharged, patients will\r receive a phone call at 24 hours post discharge and scheduled to return for a follow up\r appointment 1 weeks later in the clinic where urinary symptoms will once again be assessed in\r both settings. The end points of incidence of POUR/catheterisation, length and cost of\r hospitalisation, rates of same day discharge, and patient satisfaction in both arms will be\r recorded and analysed. Patients will be analysed via an intention to treat basis, and\r patients who defaulted treatment (did not receive full 5 doses of medicine), did not turn up\r for surgery or lost to subsequent follow up post operatively will be taken into account, and\r reported and analysed accordingly.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Males of 41 to 80 years old who are going for elective inguinal hernia repair\r (laparoscopic or open) under general anesthesia.\r\n\r Exclusion Criteria:\r\n\r Patient whom has any of the following will be excluded:\r\n\r - Contraindication to tamsulosin : known allergy, known orthostatic hypotension,\r significant cardiac co-morbidities ( New york heart association functional\r classification >2) or heart failure\r\n\r - End stage renal failure\r\n\r - More than two anti-hypertensive use/long term alpha blockers/beta\r blockers/anticholinergic (eg : buscopan)\r\n\r - Previous urological or pelvic surgery\r\n\r - Known benign prostatic hyperplasia on medications\r\n\r - Long term indwelling catheters\r\n\r - Concurrent neurologic disease such as stroke, poliomyelitis, cerebral palsy, multiple\r sclerosis, spinal lesions, diabetic and alcoholic neuropathy\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\nBarriers and Facilitators to Cycling for Lumbar Spinal Stenosis\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether a home-based cycling program for patients\r with lumbar spinal stenosis is a feasible and acceptable\n\n**Clinical Trial Detailed Description:**\n\nLumbar spinal stenosis is a prevalent and disabling condition in elderly individuals. Lumbar\r spinal stenosis results in lumbar and/or radicular leg pain when standing and walking, while\r symptoms regress in lumbar flexion positions and at rest. The inability to stand or walk\r impairs functioning and health-related quality of life of elders, and has an important\r healthcare cost. The 2 main treatment options for lumbar spinal stenosis are conservative or\r surgical. Laminectomy may be more effective on pain and function than conservative therapy.\r However, the benefit-risk balance of surgery should be considered in this population with\r numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is\r usually the first line option to avoid or delay surgery. Data regarding exercise therapy are\r scarce. Lumbar-flexion-based exercises are usually recommended. A pilot study suggested that\r lumbar-flexion-based endurance training, namely cycling, could be an effective and safe\r method to improve pain, function and health-related quality of life in elderly patients with\r chronic low back pain but barriers to adhering to the program were detected. Investigators\r aim to assess barriers and facilitators to a 3-month home-based cycling program in lumbar\r spinal stenosis.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Fulfilment of International Society for the Study of Lumbar Spine clinical diagnosis\r criteria for lumbar spinal stenosis with the presence of at least 6 out of the 7\r following criteria: \"pain in the buttocks or legs while walking\"; \"flex forward to\r relieve symptoms\"; \"feel relief when using a shopping cart or bicycle\"; \"motor or\r sensory disturbance while walking\"; \"normal and symmetric foot pulses\"; \"lower\r extremity weakness\"; and \"low back pain\"\r\n\r - Lumbar spinal stenosis qualitatively detected on MRI or CT-scan\r\n\r Exclusion Criteria:\r\n\r - Inability to speak or read French\r\n\r - Impossibility or refusal to have an ergometric bicycle at home\r\n\r - Ongoing lumbar-flexion-based endurance training\r\n\r - History of spinal surgery\r\n\r - Cognitive impairment\r\n\r - Neurological or vascular disorder involving the lower limbs\r\n\r - Contraindication to cycling\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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290
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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\nProcaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2\n\n**Clinical Trial Summary:**\n\nThe primary objectives of this study are to determine the maximal tolerated dose (MTD) of\r PAC-1 in combination with temozolomide in patients with high grade glioma: glioblastoma\r multiforme (GBM) or anaplastic astrocytoma after progression following standard first line\r therapy (Component 2), by evaluation of toxicity and tolerability.\n\n**Clinical Trial Detailed Description:**\n\nPAC-1 in combination with temozolomide (Component 2): after the MTD is established for single\r agent PAC-1 in Component 1, a modified-Fibonacci dose-escalation 3+3 design starts in\r Component 2, at a PAC-1 dose one level lower than the MTD of PAC-1 established in the single\r agent PAC-1 component (i.e., Component 1) and 150 mg/m2 dose of temozolomide given for the 5\r days starting at day 8 of cycle 1 in cohorts of 3-6 patients. The combination cohort that\r reaches MTD will expanded to at least 9 patients, similar to the PAC-1 alone cohort at MTD.\r For all dose cohorts, pharmacokinetics of PAC-1 will be assessed following doses administered\r on days 1 and 11 of the first cycle. Temozolomide pharmacokinetics will be performed on Day\r 11 of the first cycle.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Male or female ≥ 18 years of age\r\n\r 2. Diagnosis of advanced solid tumor or hematologic malignancy (limited to lymphoma) that\r has failed or become intolerant to standard therapy (Component 1 - single agent PAC-1)\r Note: Gliomas are excluded from Component 1 (see exclusion #19)\r\n\r 3. Diagnosis of high grade glioma: glioblastoma multiforme (GBM) or anaplastic\r astrocytoma after progression following treatment with standard first line therapy\r (Component 2 - PAC-1 in combination with temozolomide).\r\n\r 4. Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a\r target lesion according to RECIST 1.1 (Component 1).\r\n\r 5. For patients in study Component 2 measurable disease RANO criteria will be used.\r\n\r 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see\r Appendix 4)\r\n\r 7. Has adequate hepatic function defined as total bilirubin < 1.5 mg/dL, serum albumin >\r 3.0 gm/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 1.5 ×\r upper limit of normal (ULN) or < 3 x ULN for subjects with known hepatic metastases\r\n\r 8. Has adequate renal function defined as serum creatinine < 1.5 × ULN\r\n\r 9. Has adequate bone marrow function defined as a hemoglobin ≥ 10 g/dL, absolute\r neutrophil count (ANC) ≥ 1.5 × 109/L, and platelet count ≥ 100 × 109/L\r\n\r 10. Patients taking antiepileptic drugs (AED) must be on stable doses of AED for at least\r two weeks prior to registration and have no episode of seizures for at least 14 days\r prior to registration. Because some AEDs enhance or inhibit enzymes that may affect\r PAC-1 metabolism, those AEDs will not be permitted in this study. The AEDs that are\r and are not permissible are in Appendix 6.\r\n\r 11. Patient must be able to take oral medication and to maintain a fast as required for 2\r hours before and 1 hour after capsule(s) administration\r\n\r 12. Must be willing and able to comply with study visits and procedures\r\n\r 13. Has read, understood and signed the informed consent form (ICF) approved by the\r Institutional Review Board/Independent Ethics Committee (IRB/IEC)\r\n\r 14. Women of childbearing potential (WOCP) must not be pregnant (confirmed by a negative\r pregnancy test, with a serum B-HCG with a sensitivity of 50 mL U/L within 7 days of\r study treatment) or breast-feeding. In addition, a medically acceptable method of\r birth control must be used such as an oral, implantable, injectable, or transdermal\r hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method\r (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or\r total abstinence during the study participation and for one month after last dose of\r study drug(s). Women who are postmenopausal for at least 1 year or surgically sterile\r (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered\r to be WOCP.\r\n\r 15. Men who are not surgically or medically sterile must agree to use an acceptable method\r of contraception. Male patients with female sexual partners who are pregnant, possibly\r pregnant, or who could become pregnant during the study must agree to use condoms at\r least one month after the last dose of study drug. Total abstinence for the same study\r period is an acceptable alternative.\r\n\r 16. Prior systemic treatments for metastatic disease are permitted but may not be ongoing,\r including targeted therapies, biologic response modifiers, chemotherapy, hormonal\r therapy, or investigational therapy (see Exclusion #20).\r\n\r 17. Willingness to donate blood for biomarker studies related to the type of therapies\r used in this trial and the tumor types being treated\r\n\r Exclusion Criteria:\r\n\r 18. Had surgery within 4 weeks prior to study treatment except for minor procedures\r (hepatic biliary stent placement is allowed)\r\n\r 19. For Component 1 (PAC-1 alone), gliomas are excluded, as well as any history of brain\r metastases, seizures or underlying brain injury (e.g., traumatic brain injury, or\r hemorrhagic or ischemic stroke)\r\n\r 20. Patients may not have received cytotoxic chemotherapy, targeted therapies, biologic\r response modifiers, chemotherapy, and hormonal therapy within the last 3 weeks, or\r nitrosureas within the last 6 weeks prior to study treatment.\r\n\r 21. Has a known hypersensitivity to temozolomide (this criterion applies only in Component\r 2)\r\n\r 22. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless\r controlled by anticoagulant treatment (patient must be on stable dose for 2 weeks)\r\n\r 23. Has a history of an arterial thromboembolic event within the prior six months\r including cerebrovascular accident, transient ischemic attack, myocardial infarction,\r or unstable angina.\r\n\r 24. Has uncontrolled human immunodeficiency virus (HIV) (defined as HIV RNA >500 copies/ml\r and CD4+ count<200/mm3 on antiretroviral therapy) infection or hepatitis B (defined as\r ALT > 1 x ULN, and HBV DNA >2000 IU/ml) or hepatitis C (defined as ALT > 1 x ULN,\r persistent viremia on antiviral therapy) infections.\r\n\r 25. Has any clinically significant infection, i.e., any acute viral, bacterial, or fungal\r infection that requires specific treatment (anti-infective treatment has to be\r completed ≥ 7 days prior to study entry)\r\n\r 26. Has any other severe, uncontrolled medical condition, including uncontrolled diabetes\r mellitus (defined as a Hemoglobin A1C≥ 9% in patients with a prior history of\r diabetes, 28 days prior to study ) or clinical signs of unstable congestive heart\r failure (Stage III-IV of the New York Heart Association Functional Classification)\r (Appendix 5).\r\n\r 27. Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is\r considered to be over 25%.\r\n\r 28. Prior allogeneic bone marrow or organ transplantation.\r\n\r 29. > Grade 1 peripheral neuropathy within 14 days before enrollment.\r\n\r 30. Pregnant or breastfeeding - temozolomide is Pregnancy Category D - can cause fetal\r harm. Confirmation that the subject is not pregnant must be established by a negative\r serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained\r during screening. Pregnancy testing is not required for post-menopausal or surgically\r sterilized women.\r\n\r 31. Patient has received other investigational drugs within 14 days prior to study\r treatment.\r\n\r 32. Other severe acute or chronic medical or psychiatric conditions or laboratory\r abnormality that may increase the risk associated with study participation or\r investigational product administration or may interfere with the interpretation of\r study results and, in the judgment of the investigator, would make the patient\r inappropriate for enrollment in this study.\r\n\r 33. Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be\r clinically significant (such as acute ischemia, left bundle branch block, ventricular\r arrhythmias) or baseline prolongation of the rate-corrected QT interval (e.g.,\r repeated demonstration of QTc interval > 480 milliseconds).\r\n\r 34. Presence of any non-healing wound, fracture, or ulcer within 28 days prior to the\r first dose of study drug.\r\n\r 35. Has any condition that, in the opinion of the investigator, might jeopardize the\r safety of the patient or interfere with protocol compliance\r\n\r 36. Has any mental or medical condition that prevents the patient from giving informed\r consent or participating in the trial\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."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPembrolizumab in Combination With BCG After Ablation in Patients With UUTTCC Without Nephroureterectomy\n\n**Clinical Trial Summary:**\n\nPURPOSE: This study is being conducted to test the safety of the study drug Pembrolizumab,\r also known as MK-3475, at different dose levels in combination with the current therapy,\r (BCG), for superficial upper urinary tract transitional cell carcinoma. We want to find out\r what effects, good and/or bad, it has on upper urinary transitional cell carcinoma OBJECTIVE:\r To determine the safety of administering MK-3475 at a fixed dose of 200 mg every three weeks\r in conjunction with intrapelvic BCG treatment in high risk superficial UUTTCC patients who\r are unfit or unwilling to be treated with radical nephroureterectomy.\r\n\r STUDY DESIGN: Open-label, single center, Phase II, treatment trial TREATMENT: BCG- BCG\r treatment could be delivered both through a retrograde ureteral catheter placed under\r fluoroscopic control or through an antegrade nephrostomy tube placed by interventional\r radiology. Treatment will be once a week for 6 weeks. BCG treatment will begin on Day 1 of\r Week 7. Depending on patient's response, they may have additional treatments beyond the 6\r scheduled, but they will be outside of the patient's participation in this study.\r Pembrolizumab will be given through an intravenous needle once every 21 days (one cycle) for\r a total of 6 cycles. It will take 30 minutes for the infusion of the study drug.\r Pembrolizumab will be given on Day 1 of weeks 1, 4, 7, 10, 13, and 16 while BCG will be given\r on Day 1 of weeks 7-12.\r\n\r PROCEDURES: Following informed consent, prescreening and screening procedures will be\r performed, which will include medical history review, baseline chest x ray and EKG,\r ureteroscopy and pulmonary function tests for final eligibility status. Once subject is\r eligible, they will undergo physical exams (every 3 weeks), vital signs and weight (each\r study visit), adverse event monitoring (each study visit), ECGs (screening visit), bloodwork\r (at screening and then every 3 weeks), urinalysis at selected study visits, and concomitant\r medication review (each study visit), and questionnaires (selected study visits). After\r subject has completed week 19, they will have a study discontinuation visit, followed by a 30\r day follow up visit. The subject will then be followed at 3, 6, 9, 12, 18 and 24 months post\r treatment where vital status will be determined as well as disease recurrence status.\r Ureteroscopy will be performed as standard of care but will be considered measures for\r efficacy. Biopsy will be performed as clinically indicated.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Be willing and able to provide written informed consent for the trial.\r\n\r 2. Be at least18 years of age on day of signing informed consent.\r\n\r 3. Have pathologically documented high grade UUTTCC (CIS, Ta, T1) that could be\r completely ablated with ureteroscopy or through antegrade percutaneous access.\r\n\r 4. Subject must also unwilling or unfit to undergo treatment with radical\r nephroureterectomy\r\n\r 5. Have provided tissue from an archival tissue sample or newly obtained core or\r excisional biopsy of a tumor lesion. Tissue must be obtained from the most recent\r upper urinary tract biopsy.\r\n\r 6. Have a performance status of 0-1 on the ECOG Performance Scale (Appendix A).\r\n\r 7. Demonstrate adequate organ function, all screening labs should be performed within 28\r days of treatment initiation.\r\n\r 8. Female subject of childbearing potential should have a negative urine or serum\r pregnancy test within 72 hours prior to receiving the first dose of study medication.\r If the urine test is positive or cannot be confirmed as negative, a serum pregnancy\r test will be required.\r\n\r 9. Female subjects of childbearing potential should be willing to use 2 methods of birth\r control or abstain from heterosexual activity for the course of the study through 120\r days after the last dose of study medication (Reference Section 5.5.2). Subjects of\r childbearing potential are those who have not been surgically sterilized or have not\r been free from menses for > 1 year.\r\n\r 10. Male subjects should agree to use an adequate method of contraception starting with\r the first dose of study therapy through 120 days after the last dose of study therapy.\r\n\r 11. Patients who received prior systemic chemotherapy, targeted small molecule therapy, or\r radiation therapy for UUTTCC are allowed into the study as long as there is confirmed\r recurrence of the disease after previous treatment and the patient is unwilling or\r unfit to undergo radical surgery.\r\n\r Exclusion Criteria:\r\n\r 1. Currently has active or progressive metastatic disease. (Chest X-ray, Computerized\r Tomography [CT] urogram or Magnetic Resonance Imaging [MRI], and urogram are allowed\r to ascertain the superficial nature of the disease when indicated, but not required.\r If urogram protocol is not available or contrast allergy/poor renal function precludes\r such imaging, then non-contrast CT or MRI of the abdomen/pelvis within 90 days of\r study entry will suffice.)\r\n\r 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\r other form of immunosuppressive therapy within 7 days prior to the first dose of trial\r treatment.\r\n\r 3. Has had a prior monoclonal antibody within 4 weeks before study Day 1 or who has not\r recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents\r administered more than 4 weeks earlier.\r\n\r 4. Has had prior systemic chemotherapy, targeted small molecule therapy, or radiation\r therapy for UUTTCC.\r\n\r 5. If subject received major surgery, they must have recovered adequately from the\r toxicity and/or complications from the intervention prior to starting therapy.\r\n\r 6. Has a known additional malignancy that is progressing or requires active treatment.\r Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the\r skin, localized prostate cancer with no recurrence after curative surgery or\r radiation, or in situ cervical cancer that has undergone potentially curative therapy.\r Lower urinary tract transitional cell carcinoma is also allowable on study as high\r risk transitional cell carcinoma is commonly multifocal, and intraluminal BCG therapy\r is also used for treatment of lower urinary tract lesions in a manner similar to that\r of UUTTCC.\r\n\r 7. Active autoimmune disease that has required systemic treatment in the past 2 years\r (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive\r drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid\r replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r form of systemic treatment.\r\n\r 8. Has history of (non-infectious) pneumonitis that required steroids, evidence of\r interstitial lung disease, or active , non-infectious pneumonitis.\r\n\r 9. Has an active infection, including a concurrent febrile illness, requiring systemic\r therapy.\r\n\r 10. Has a history or current evidence of any condition, therapy, or laboratory abnormality\r that might confound the results of the trial, interfere with the subject's\r participation for the full duration of the trial, or is not in the best interest of\r the subject to participate, in the opinion of the treating investigator.\r\n\r 11. Has known psychiatric or substance abuse disorders that would interfere with\r cooperation with the requirements of the trial.\r\n\r 12. Is pregnant or breastfeeding, or expecting to conceive or father children within the\r projected duration of the trial, starting with the pre-screening or screening visit\r through 4 months after the last dose of trial treatment.\r\n\r 13. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or\r anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including\r ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation\r or checkpoint pathways) including anti-CD40 and anti-OX40 antibodies.\r\n\r 14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\r\n\r 15. Has known active Hepatitis B (e.g., HBs Ag reactive) or Hepatitis C (e.g., HCV RNA\r [qualitative] is detected).\r\n\r 16. Has known active tuberculosis. Subjects will not be specifically tested for the study;\r however, subjects that are tested within 28 days of beginning study or while on study\r and test positive with the PPD test before treatment should have active tuberculosis\r ruled out before therapy begins for their superficial renal pelvis cancer.\r\n\r 17. Has received a live vaccine within 30 days prior to the first dose of trial treatment.\r\n\r 18. Has an active urinary tract infection, gross hematuria, or known broken mucosal\r barrier of the renal pelvis.\r\n\r 19. Less than 14 days post renal pelvis biopsy, TUR, or traumatic catheterization.\r\n\r 20. Evidence of muscle invasive renal pelvis cancer, or transitional cell carcinoma of the\r upper urinary tract\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\nNSAIDs in Sciatica NSAIDS IN SCIATICA\n\n**Clinical Trial Summary:**\n\nThis study will evaluate whether treatment with Naproxen 500 mg twice daily is superior to\r placebo for the improvement of leg pain in patients with sciatica. Half of patients will\r receive Naproxen while the other half will receive placebo.\n\n**Clinical Trial Detailed Description:**\n\nSciatica is an established term for pain radiating from the lower back or buttock into the\r leg, commonly caused by a disc herniation. Given their analgesic and anti-inflammatory\r mechanisms of action, NSAIDs (Non-steroidal anti-inflammatory drugs) have been, and are still\r being regarded as standard therapy for sciatica.\r\n\r However, very few randomised controlled trials of NSAIDs have been undertaken in sciatica,\r and no study has showed clinically meaningful effects as compared to placebo.\r\n\r Since NSAIDs involve the risk of serious gastrointestinal, vascular and renal side effects\r there is a strong need to clarify their potential beneficial effects in sciatica.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria:\r\n\r - Age ≥ 18 years\r\n\r - Radiating pain below the knee with a severity score of ≥4 on a 0-10 (NRS) in the\r previous 24 hours\r\n\r - Signs of nerve root/spinal nerve involvement as indicated by at least one of the\r following features; myotomal weakness, dermatomal sensory disturbances (e.g. sensory\r loss, self-reported tingling/numbness), diminished reflexes, radiating pain\r exacerbation by SLR\r\n\r Exclusion criteria:\r\n\r - Not able to read or speak Norwegian.\r\n\r - Unlikely to adhere to treatment and/ or complete follow-up (e.g ongoing serious\r psychiatric disease, drug abuse, plans to move)\r\n\r - Sciatica of known cause other than disc herniation or degenerative stenosis.\r\n\r - Neurogenic claudication, i.e. pain in the legs on walking or standing that resolves\r with sitting down or lumbar flexion.\r\n\r - Symptoms indicating immediate surgery: cauda equina syndrome or a progressive large\r paresis.\r\n\r - Women who attempt to conceive, are pregnant or breastfeeding.\r\n\r - Previous episodes of asthma, urticaria or allergic-type reactions after taking aspirin\r or other NSAIDs.\r\n\r - Active or history of peptic ulceration, gastrointestinal bleeding, or perforation.\r\n\r - Use of drugs known to increase upper gastrointestinal adverse events in combination\r with Naproxen: anticoagulants, aspirin (acetyl salicylic acid), serotonin reuptake\r inhibitors and systemic corticosteroids.\r\n\r - Hepatic enzyme (ASAT/ALAT) values above 1,5 x upper limit of normal (ULN)\r\n\r - Renal function tests (creatinin/eGFR) outside normal range\r\n\r - Congestive heart failure, established ischaemic heart disease, peripheral arterial\r disease, and/or cerebrovascular disease.\r\n\r - Known hypersensitivity to Naproxen or any of the excipients (lactose, maize starch,\r povidone, sodium starch glycolate, talcum, magnesium stearate, polysorbate 80)\r\n\r - Ongoing treatment with aspirin, systemic corticosteroids, diuretics, ACE-inhibitors,\r lithium and anticoagulants\r\n\r - Scheduled for spinal surgery prior to end of study\r\n\r - Reservation against intake of gelatine (the capsules contains gelatine, which among\r other things is produced by ingredients from pigs)\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 Post Marketing Surveillance Study\n\n**Clinical Trial Summary:**\n\nThis study is a prospective, multi-center study to monitor the early safety and performance\r of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used\r as an adjunct to limited discectomy.\n\n**Clinical Trial Detailed Description:**\n\nThis study is planned to collect information on use of the Barricaid ACD with an anchor width\r of 6mm. Other iterations of the device are made with an 8mm wide anchor. The narrower anchor\r was designed to optimize surgeon visualization during implantation, and has undergone all\r appropriate rigorous testing prior to release. Safety will be evaluated to demonstrate\r acceptable levels of device-related and procedure-related complications. This limited market\r release will allow its performance to be evaluated by examining the effects on reoperation,\r device deficiencies, patient pain scores and disability after discectomy with ACD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age 18 to 75 years old (male or female).\r\n\r - Patients with posterior or posterolateral disc herniations at one level between L1 and\r S1 with radiographic confirmation of neural compression using CT and/or MRI.\r\n\r - At least six (6) weeks of failed, conservative treatment prior to surgery, or requires\r immediate surgery to prevent permanent disability.\r\n\r - Minimum posterior disc height of 5mm at the index level(s).\r\n\r - Lower back pain and/or sciatica with or without spinal claudication.\r\n\r - Oswestry Questionnaire score of at least 40/100 at baseline.\r\n\r - VAS leg pain of at least 40/100 at baseline.\r\n\r - Psychosocially, mentally and physically able to fully comply with the clinical\r protocol and willing to adhere to follow-up schedule and requirements.\r\n\r Exclusion Criteria:\r\n\r - Spondylolisthesis Grade II or higher.\r\n\r - Subject requires uni or bilateral facetectomy to treat leg/back pain.\r\n\r - Subject has back or non-radicular leg pain of unknown etiology.\r\n\r - Prior surgery at the index lumbar level.\r\n\r - Subject requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less\r than -2.0 at the index level. For patients with a herniation at L5/S1, the average T\r score of L1-L4 shall be used.\r\n\r - Subject has clinically compromised vertebral bodies at the index level(s) due to any\r traumatic, neoplastic, metabolic, or infectious pathology.\r\n\r - Subject has sustained pathologic fractures of the vertebra or multiple fractures of\r the vertebra or hip.\r\n\r - Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).\r\n\r - Any metabolic disease bone disease that has not been stabilized for at least three\r months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or\r parathyroid gland disorder, etc.).\r\n\r - Subject has an active infection either systemic or local.\r\n\r - Subject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.\r\n\r - Subject has severe arterial insufficiency of the legs (Screening on physical\r examination= patients with diminution or absence of dorsalis pedis or posterior\r tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is\r required with vascular plethysmography. If the absolute arterial pressure is below\r 50mm of Hg at the calf or ankle level, then the patient is to be excluded) or other\r peripheral vascular disease).\r\n\r - Subject has significant peripheral neuropathy, patient defined as a patient with Type\r I or Type II diabetes or similar systemic metabolic condition causing decreased\r sensation in a stocking-like or non-radicular and non-dermatomal distribution in the\r lower extremities.\r\n\r - Subject has insulin-dependent diabetes mellitus.\r\n\r - Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100\r lbs over ideal body weight).\r\n\r - Subject has been diagnosed with active hepatitis, AIDS, or HIV.\r\n\r - Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.\r\n\r - Subject has a known allergy to titanium, polyethylene or polyester materials.\r\n\r - Subject is pregnant or interested in becoming pregnant in the next two (2) years.\r\n\r - Subject has active tuberculosis or has had tuberculosis in the past three (3) years.\r\n\r - Subject has a history of active malignancy: A patient with a history of any invasive\r malignancy (except non-melanoma skin cancer), unless he/she has been treated with\r curative intent and there have been no signs or symptoms of the malignancy for at\r least two (2) years.\r\n\r - Subject is immunologically suppressed, received steroids >1 month over the past year.\r\n\r - Currently taking anticoagulants, other than aspirin, unless the patient can be taken\r off the anticoagulant for surgery.\r\n\r - Subject has a current chemical/alcohol dependency or significant psychosocial\r disturbance.\r\n\r - Subject has a life expectancy of less than three (3) years.\r\n\r - Subject is currently involved in another investigational study.\r\n\r - Subject is incarcerated.\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\nFET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy\n\n**Clinical Trial Summary:**\n\nGlioblastoma is the most common malignant brain tumor in adults. The primary treatment\r consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant\r temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be\r predominantly within or at the margin of the irradiated volume, but distant failure are not\r rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based\r on on planning CT with co-registered postoperative MRI, with the addition of a clinical\r target volume margin of 2-3 cm to account for infiltrative odema.\r\n\r To better characterize the disease, more specific physiological and/or metabolical markers of\r tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion,\r diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET)\r are now available and suggest that aggressive areas, like uptake of PET tracer and\r vascularity are present outside areas of contrast enhancement usually irradiated. These\r informations could be incorporated to optimize the treatment of radiotherapy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 18 Years or older\r\n\r - Histologically confirmed newly diagnosed glioblastoma or anaplastic astrocytoma\r\n\r - Patients must have undergone surgery with macroscopic complete resection or incomplete\r resection with residual disease less than 5 cm on MRI\r\n\r - An MRI or a scan 48h after surgery should be available\r\n\r - WHO ≤ 2\r\n\r - Indication for adjuvant radiotherapy\r\n\r - Surgery must have been performed 45 days before the start of radiotherapy.\r\n\r - Ability to understand and to give consent\r\n\r Exclusion Criteria:\r\n\r - Age < 18 Years.\r\n\r - Prior radiation therapy to the brain\r\n\r - Any usual formal indication against MRI (claustrophobia, metallic objects or implanted\r medical devices in body: pacemaker, clips, prostheses ...)\r\n\r - Allergic reaction to FET\r\n\r - Pregnant women or nursing mothers\r\n\r - Refusal to use effective contraception at study entry and throughout the study if\r patient is of childbearing age.\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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295
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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\nModeling Treated Recovery From Aphasia\n\n**Clinical Trial Summary:**\n\nStroke is the leading cause of adult disability in the United States, and aphasia is common\r following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia\r recover; however, very little is known about how different patients respond to different\r types of treatments.\r\n\r The purpose of this study is to understand how the following factors influence an\r individual's response to aphasia treatment: 1) biographical factors (e.g., age, education,\r gender), 2) post-stroke cognitive/linguistic abilities and learning potential, and 3) the\r location and extent of post-stroke brain damage. We are also interested in understanding the\r kinds of treatment materials that should be emphasized in speech/language treatment.\r\n\r Overall, the goal of the current research is to inform the clinical management of post-stroke\r aphasia by identifying factors that can predict how an individual will respond to different\r treatment methods.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months\r post-stroke\r\n\r - Primarily English speaker for the past 20 years\r\n\r - Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal\r implants, not claustrophobic)\r\n\r Exclusion Criteria:\r\n\r - History of a right hemisphere stroke (Bilateral stroke)\r\n\r - Clinically reported history of dementia, alcohol abuse, psychiatric disorder,\r traumatic brain injury, or extensive visual acuity or visual-spatial problems\r\n\r - Severely limited speech production and/or auditory comprehension that interferes with\r adequate participation in the therapy provided\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\nSJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors\n\n**Clinical Trial Summary:**\n\nApproximately 90% of children with malignant brain tumors that have recurred or relapsed\r after receiving conventional therapy will die of disease. Despite this terrible and\r frustrating outcome, continued treatment of this population remains fundamental to improving\r cure rates. Studying this relapsed population will help unearth clues to why conventional\r therapy fails and how cancers continue to resist modern advances. Moreover, improvements in\r the treatment of this relapsed population will lead to improvements in upfront therapy and\r reduce the chance of relapse for all. Novel therapy and, more importantly, novel approaches\r are sorely needed. This trial proposes a new approach that evaluates rational combination\r therapies of novel agents based on tumor type and molecular characteristics of these\r diseases. The investigators hypothesize that the use of two predictably active drugs (a\r doublet) will increase the chance of clinical efficacy. The purpose of this trial is to\r perform a limited dose escalation study of multiple doublets to evaluate the safety and\r tolerability of these combinations followed by a small expansion cohort to detect preliminary\r efficacy. In addition, a more extensive and robust molecular analysis of all the participant\r samples will be performed as part of the trial such that we can refine the molecular\r classification and better inform on potential response to therapy. In this manner the\r tolerability of combinations can be evaluated on a small but relevant population and the\r chance of detecting antitumor activity is potentially increased. Furthermore, the goal of the\r complementary molecular characterization will be to eventually match the therapy with better\r predictive biomarkers.\r\n\r PRIMARY OBJECTIVES:\r\n\r - To determine the safety and tolerability and estimate the maximum tolerated\r dose/recommended phase 2 dose (MTD/RP2D) of combination treatment by stratum.\r\n\r - To characterize the pharmacokinetics of combination treatment by stratum.\r\n\r SECONDARY OBJECTIVE:\r\n\r - To estimate the rate and duration of objective response and progression free survival\r (PFS) by stratum.\n\n**Clinical Trial Detailed Description:**\n\nPatients will be stratified by the molecular and histologic characteristics of their tumor to\r one of three treatment strata.\r\n\r STRATUM A:\r\n\r - Combination Treatment: ribociclib and gemcitabine.\r\n\r - Patient Population: Participants with a diagnosis of refractory or recurrent\r medulloblastoma (Group 3/4) or refractory or recurrent ependymoma (including:\r ependymoma, not otherwise specified (NOS), WHO Grade III; ependymoma, RELA fusion\r positive; anaplastic ependymoma; ependymoma, NOS, WHO grade II).\r\n\r STRATUM B:\r\n\r - Combination Treatment: ribociclib and trametinib.\r\n\r - Patient Population: Participants with a diagnosis of one of the following refractory or\r recurrent CNS diseases: medulloblastoma [sonic hedgehog (SHH)], medulloblastoma (WNT),\r high grade glioma (including: high grade glioma, (NOS), WHO Grade III or IV; anaplastic\r astrocytoma, IDH mutant; glioblastoma, IDH-wildtype; glioblastoma, IDH-mutant; diffuse\r midline glioma, H3K27-mutant; anaplastic oligodendroglioma, IDH mutant and\r 1p/19q-codeleted; anaplastic pleomorphic xanthoastrocytoma) or select central nervous\r system (CNS) embryonal tumors (including: embryonal tumors with multilayered rosettes,\r C19MC-altered; embryonal tumors with multilayered rosettes, not otherwise specified\r (NOS); medulloepithelioma; CNS neuroblastoma; CNS ganglioneuroblastoma; CNS embryonal\r tumor, NOS; atypical teratoid/rhabdoid tumor; CNS embryonal tumor with rhabdoid\r features).\r\n\r STRATUM C:\r\n\r - Combination Treatment: ribociclib and sonidegib.\r\n\r - Patient Populations: Participants with refractory or recurrent medulloblastoma (SHH) >6\r months off smoothened inhibitor, presence of 9q loss or PTCH1 mutant, skeletally mature.\r\n\r The rolling 6 design will be used separately in each stratum to estimate the MTD or RP2D and\r determine the dose-limiting toxicity (DLT) of the combination of escalating doses. Therapy\r will be administered in cycles of 28 days and may be continued for up to 24 months (26\r cycles) in the absence of disease progression or unacceptable toxicity. Stratum A\r participants may continue therapy past 24 months in absence of disease progression or\r unacceptable toxicity.\r\n\r Patients will receive doublet therapy in cycles of 28 days. The dose-limiting toxicity\r (DLT)-evaluation period will consist of the first cycle (i.e. first 4 weeks of therapy).\r Research participants will be evaluated at least once a week during the DLT-evaluation period\r and at regular intervals thereafter. Standard (e.g., physical exam, blood tests, and disease\r evaluations) tests will be obtained at regular intervals. Research-associated evaluations\r (e.g., pharmacokinetic studies, etc.) will also be obtained during therapy. Treatment may be\r continued for up to 2 years in the absence of disease progression or unacceptable toxicity.\r Stratum A participants may continue past 2 years in the absence of disease progression or\r unacceptable toxicity.\n\n**Clinical Trial Eligibility Criteria:**\n\nPotential participants will first be screened using the screening inclusion/exclusion shown\r below. If they meet the requirements of the screening phase, they will then be evaluated\r for enrollment based on the overall study's inclusion criteria as well as the\r stratum-specific inclusion/exclusion criteria for the applicable stratum, all of which are\r shown below.\r\n\r SCREENING INCLUSION CRITERIA - ALL PARTICIPANTS:\r\n\r - Participants with recurrent, progressive, or refractory brain tumors.\r\n\r - Age ≥ 1 year and < 25 years at the time of screening. Exception: Participants with\r recurrent, progressive, or refractory Medulloblastoma and are ≥ 1 and < 40 years of\r age at the time of study screening are eligible for screening.\r\n\r - Participants and/or guardian have the ability to understand and the willingness to\r sign a written informed consent document according to institutional guidelines.\r\n\r SCREENING EXCLUSION CRITERIA - ALL PARTICIPANTS:\r\n\r - Participants with a diagnosis of recurrent, progressive, or refractory low grade\r glioma (LGG).\r\n\r - Previous exposure to a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib).\r\n\r - Participants with a history of clinically significant, uncontrolled heart disease\r and/or repolarization abnormalities.\r\n\r - Participants with any history of QTc prolongation (i.e. QTc interval of > 450 msec).\r\n\r Participants who meet the requirements of the screening phase will then be evaluated for\r enrollment based on the overall study's inclusion criteria as well as the stratum-specific\r inclusion/exclusion criteria for the applicable stratum, all of which are shown below.\r\n\r INCLUSION CRITERIA - OVERALL STUDY - ALL PARTICIPANTS:\r\n\r - Evaluable disease, as defined as meeting any of the following:\r\n\r - Patients who have measurable disease\r\n\r - Patients with radiologically discernible but non-measurable lesions (i.e.\r leptomeningeal disease)\r\n\r - Patients with CSF positive disease\r\n\r - Participants must have received their last dose of anticancer therapy (including\r experimental) at least 4 weeks prior to study enrollment.\r\n\r - Note: Participants must have relapsed with recurrent, progressive or refractory\r disease on or after any prior anticancer therapy.\r\n\r - Participants must have had their last fraction of radiation at least 4 weeks prior to\r study enrollment. Participants who received radiation therapy for palliation must have\r had their last fraction of radiation at least 2 weeks prior to study enrollment.\r\n\r - Note: Participants must have relapsed with recurrent, progressive or refractory\r disease after any prior radiation therapy that is not considered palliative.\r Palliative radiation therapy is defined as local small port RT to alleviate\r and/or palliate symptoms. (CSI, whole brain RT, large field/port RT, or large\r field/port multilevel spinal RT will not be considered palliative at any dose.)\r\n\r - Participants who are receiving corticosteroids must be on a stable or decreasing dose\r for at least 1 week prior to study enrollment with no plans for escalation.\r\n\r - Participants who are receiving known strong inducers and/or strong inhibitors of\r CYP3A4/5, drugs that have a narrow therapeutic window and are predominantly\r metabolized through CYP3A4/5, and medications that carry a known risk for QT\r prolongation must discontinue these drugs at least 7 days prior to study enrollment.\r\n\r - Participants must discontinue herbal preparations, herbal medication, and dietary\r supplements, with the exception of multivitamins, at least 7 days prior to study\r enrollment.\r\n\r - Participants must be able to swallow medication. It is acceptable to administer\r medication via a g-tube if participant has a g-tube. It is not acceptable to place a\r g-tube for the purpose of delivering study medication.\r\n\r - Participants must have a Lansky (≤ 16 years) or Karnofsky (> 16 years) score of at\r least 50 and, in the opinion of the investigator, a minimum life expectancy of at\r least 6 weeks at the time of study enrollment.\r\n\r - Note: Patients who are unable to walk because of paralysis, but who are up in a\r wheelchair, will be considered ambulatory for the purpose of assessing the\r performance score.\r\n\r - Participant must have adequate bone marrow and organ function defined as:\r\n\r - ANC ≥ 1000/mm3 without growth factor support within 7 days of the test\r\n\r - Platelet count ≥ 50,000/mm^3 without support of a platelet transfusion within 7\r days of the test\r\n\r - Hemoglobin ≥ 8.0 g/dL without support of a blood transfusion within 7 days of the\r test\r\n\r - Creatinine clearance ≥ 70 mL/min/1.73 m^2 or serum creatinine ≤ the maximum serum\r creatinine based on age/gender (threshold creatinine values derived from the\r Schwartz formula for estimating GFR utilizing child length and stature data\r published by the Centers for Disease Control and Prevention or creatinine\r clearance ≥70 mL/min/1.73 m^2).\r\n\r - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.\r For the purposes of eligibility the ULN of ALT and AST is 45 U/L.\r\n\r - Total bilirubin ≤ ULN or if > ULN then direct bilirubin ≤ 1.5xULN.\r\n\r - Participants and/or guardian have the ability to understand and the willingness to\r sign a written informed consent document according to institutional guidelines.\r\n\r EXCLUSION CRITERIA - OVERALL STUDY - ALL PARTICIPANTS:\r\n\r - Participants receiving any other investigational agents.\r\n\r - Participants with other clinically significant medical disorders (serious infections\r or significant cardiac, pulmonary, hepatic, psychiatric, GI disease, or other organ\r dysfunction) that in the investigator's judgment could compromise their ability to\r tolerate or absorb protocol therapy or would interfere with the study procedures or\r results.\r\n\r - Female participants who are breastfeeding a child.\r\n\r - Participants with QTc interval of > 450 msec on screening ECG.\r\n\r - Participants with a pathogenic somatic or known germline retinoblastoma (RB1) gene\r mutation.\r\n\r (A) INCLUSION CRITERIA - STRATUM A PARTICIPANTS ONLY:\r\n\r - Participants with recurrent, progressive, or refractory Non-WNT Non-SHH (NWNS)\r Medulloblastoma or Ependymoma as confirmed through central pathology review.\r\n\r - Age ≥ 1 year and < 25 years at the time of enrollment.\r\n\r - Female participants of childbearing potential must have a negative pregnancy test at\r the time of enrollment on this study and be willing to use a highly effective method\r of contraception throughout the study and for 16 weeks after discontinuation of the\r study drug.\r\n\r - Male participants of child fathering potential must be willing to use medically\r acceptable form of contraception during treatment and for 16 weeks after stopping\r treatment.\r\n\r (A) EXCLUSION CRITERIA - STRATUM A PARTICIPANTS ONLY:\r\n\r - Participants with subependymoma or myxopapillary ependymoma.\r\n\r (B) INCLUSION CRITERIA - STRATUM B PARTICIPANTS ONLY:\r\n\r - Participants with recurrent, progressive, or refractory CNS tumors as confirmed\r through central pathology review and whose diagnosis is being treated on this study.\r\n\r - Age ≥ 1 year and < 25 years at the time of study enrollment.\r\n\r - Must meet the following weight and BSA restrictions:\r\n\r - For enrollment on dose levels 0A, must have a weight ≥16kg and <32kg.\r\n\r - For enrollment on dose level 0B, must have a weight of ≥32kg and BSA ≥ 0.55m^2.\r\n\r - For enrollment on dose level 1, must have a weight ≥16kg and BSA ≥0.55m^2.\r\n\r - For enrollment on dose level 2, must have a weight ≥16kg and BSA≥ 0.63m^2\r\n\r - For enrollment on dose levels 3 or 4A, must have a weight ≥16kg\r\n\r - For enrollment on dose levels 4B or 5, must have a weight ≥20kg and ≤106kg\r\n\r - Participant must be able to swallow trametinib tablets.\r\n\r - Female participants of childbearing potential must have a negative pregnancy test at\r the time of enrollment on this study and be willing to use a highly effective method\r of contraception throughout the study and for 16 weeks after discontinuation of the\r study drug.\r\n\r - Male participants of child fathering potential must be willing to use medically\r acceptable form of contraception during treatment and for 16 weeks after stopping\r treatment.\r\n\r (B) EXCLUSION CRITERIA - STRATUM B PARTICIPANTS ONLY: Participants eligible for this study\r must NOT meet ANY of the following criteria.\r\n\r - Participants with Low Grade Glioma (LGG) or Diffuse Intrinsic Pontine Glioma (DIPG).\r\n\r - Previous exposure to a MEK inhibitor (i.e. trametinib, selumetinib).\r\n\r - Participants with abnormal LVEF on screening, defined as > 10% below lower limit of\r normal on screening.\r\n\r - Participants with retinal vein occlusion (RVO).\r\n\r - Previous exposure to a MEK inhibitor (i.e., trametinib, selumetinib.\r\n\r (C) INCLUSION CRITERIA - STRATUM C PARTICIPANTS ONLY:\r\n\r - Participants with recurrent, progressive, or refractory SHH Medulloblastoma and\r presence of either a or b as confirmed by central pathology review of the tumor\r specimen: a) copy number loss of 9q b) PTCH1 mutation and whose diagnosis is being\r treated on this study.\r\n\r - Age ≥ 10 years and <40 years at the time of study enrollment.\r\n\r - Participant must be skeletally mature as defined as females with a bone age ≥ 15 years\r (180 months) and males with a bone age ≥ 17 years (204 months). This includes\r participants that are within 2 standard deviations of this value (i.e. if SD = 11\r months on bone age; then a male patient who has a bone age of 182 months would be\r eligible; or a female patient with a bone age of 158 months.)\r\n\r - Female participants of childbearing potential must have a negative pregnancy test at\r the time of enrollment on this study and be willing to use a highly effective method\r of contraception throughout the study and for 8 months after discontinuation of the\r study drug.\r\n\r - Male participants of child fathering potential must be willing to use medically\r acceptable form of contraception during treatment and for 8 months after stopping\r treatment.\r\n\r (C) EXCLUSION CRITERIA - STRATUM C:\r\n\r - Exposure to smoothened inhibitor (vismodegib, sonidegib) within 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:** 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\nStudy Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma\n\n**Clinical Trial Summary:**\n\nThis is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3\r astrocytoma) who had progressive disease during first or second line treatment and who have\r not previously received any BEV or any experimental agents.\n\n**Clinical Trial Detailed Description:**\n\nPrimary Objective:\r\n\r The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent\r anaplastic astrocytoma patients (6-month progression-free survival)\r\n\r Secondary Objectives:\r\n\r - To evaluate the safety of NOVOTTF-200A in the subject population.\r\n\r - To evaluate efficacy of NOVOTTF-200A in the subject population.\r\n\r - To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter\r methylation, confers a better response to NOVOTTF-200A.\r\n\r - To determine if the treatment significantly modifies the patient's quality of life.\r Sponsor will use the Functional Assessment of Cancer Therapy (FACT) questionnaires:\r\n\r - FACT-Brain (FACT-Br)\r\n\r - FACT-Cognitive Function (FACT-Cog)\r\n\r Exploratory Objectives:\r\n\r - To determine if the presence of proneural or mesenchymal phenotype (Cytoscan analysis)\r confers a better response to NovoTTF.\r\n\r - To determine if the in vitro sensitivity of the glioma cells derived from patient\r specimens before and after the NOVOTTF-200A treatment correlates with the patient's\r response to treatment.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Understand and voluntarily sign and date an informed consent document before any study\r related assessments/procedures are conducted.\r\n\r 2. Males and females of age ≥18 years at the time of the signing of the informed consent\r document.\r\n\r 3. All subjects must have histologic evidence of G3 MG and radiographic evidence of\r recurrence or disease progression (defined as either a greater than 25% increase in\r the largest bi-dimensional product of enhancement, a new enhancing lesion or a\r significant increase in T2 FLAIR).\r\n\r 4. Subjects with archival tumor tissue suitable for genetic testing must give permission\r to access and test the tissue; subjects without archival tumor tissue are eligible.\r\n\r 5. No prior treatment with BEV or any anti-angiogenesis agents.\r\n\r 6. At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior\r to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion\r outside of radiation field, or if there are two MRIs confirming progressive disease\r that are 8 weeks apart.\r\n\r 7. All AEs resulting from prior chemotherapy, surgery or radiotherapy must have resolved\r to NCI-CTCAE (v. 4.03) Grade ≤1 (except for laboratory parameters outlined below).\r\n\r 8. Laboratory results within 7 days prior to NOVOTTF-200A administration (transfusions\r and/or growth factor support may be used at the discretion of the Investigator during\r Screening):\r\n\r - Hemoglobin ≥9 g/dL.\r\n\r - Absolute neutrophil count (ANC) ≥1.5 × 109/L.\r\n\r - Platelet count ≥100 × 109/L.\r\n\r - Serum bilirubin ≤1.5 × upper limit of normal (ULN) or ≤3 × ULN if Gilbert's\r disease is documented.\r\n\r - Aspartate transaminase (AST) ≤ 2.5 ULN.\r\n\r - Serum creatinine ≤1.5 × ULN.\r\n\r 9. Karnofsky Performance Status (KPS) score ≥70%.\r\n\r 10. Willing and able to adhere to the study visit schedule and other protocol\r requirements.\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. The presence of 1p19q LOH which is diagnostic for anaplastic oligodendroglioma (AO).\r\n\r 2. Co-medication that may interfere with study results, e.g., immunosuppressive agents\r other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed\r at the discretion of the investigator. Subjects should be on a stable dose of steroids\r for at least 1 week prior to study beginning.)\r\n\r 3. Chemotherapy administered within 4 weeks (6 weeks for an IV nitrosoureas and 12 weeks\r for an implanted nitrosoureas wafer) prior to Day 1 of study treatment.\r\n\r 4. Pregnancy or breastfeeding.\r\n\r 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r infection requiring IV antibiotics & psychiatric illness/social situations that would\r limit adherence with study requirements, or disorders associated with significant\r immunocompromised state.\r\n\r 6. Known previous/current malignancy requiring treatment within ≤ 3 years except for\r cervical carcinoma in situ, squamous or basal cell skin carcinoma and superficial\r bladder carcinoma.\r\n\r 7. Any comorbid condition that confounds the ability to interpret data from the study as\r judged by the Investigator.\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\nHypoxic Exercise in Lower Extremity Artery Disease\n\n**Clinical Trial Summary:**\n\nThe aim of this randomized controlled trial is to:\r\n\r Phase I: To explore, in a first pilot phase, the adequate combination of hypoxia severity and\r exercise intensity in patients with symptomatic lower extremity artery disease (LEAD). Acute\r walking performances and physiological responses (vascular and muscular) to a normobaric\r hypoxic exercise performed will be assessed at two different altitudes (1500 m and 2500 m).\n\n**Clinical Trial Detailed Description:**\n\nThe results of this first phase will then be used to determine the optimal hypoxic level for\r the exercise training program which will be assessed during the Phase II.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with symptomatic LEAD (Fontaine stage ≥ IIa)\r\n\r - ABI ≤ 0.9\r\n\r - TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency)\r\n\r - Signed written informed consent form\r\n\r Exclusion Criteria:\r\n\r - Neurological and neuromuscular disorders which can limit balance and walking\r\n\r - Any history of altitude-related sickness\r\n\r - Any health risks (assessed during clinical history) linked to hypoxia exposure\r\n\r - Acclimatization or exposure to hypoxia of more than 2000 m for more than 48 h during a\r period of 6 months before the study\r\n\r - Medication required for the treatment of migraines, claustrophobia that may interfere\r with the interpretation of the results\r\n\r - Obstructive sleep apnea (> 25 Apnea-Hypopnea Index)\r\n\r - Prior leg/foot amputation\r\n\r - Pregnant women\r\n\r - Cardiac contraindication to exercise\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\nEpidural Lavage Study for Lumbar Stenosis\n\n**Clinical Trial Summary:**\n\nThe purpose of this research is to find out if there are inflammatory biomarkers (also known\r as biological markers) in epidural space that can predict response to an epidural steroid\r injection. This study will also be evaluating whether the results of an EMG study (also known\r as electromyography) can predict the response to an epidural steroid injection.\n\n**Clinical Trial Detailed Description:**\n\nLumbar spinal stenosis is a common cause of back pain and mobility impairment in older\r adults. It is often a multi-factorial condition resulting from degenerative changes in the\r spine, and may result in severe disability, with symptoms of lower back pain and/or pain,\r numbness and weakness of the lower extremities that are often exacerbated by walking and/or\r standing. Since lumbar spinal stenosis mostly stems from slowly progressive degenerative\r changes, symptoms often worsen over time, leading to poor health outcomes and high rates of\r healthcare utilization.\r\n\r Epidural steroid injection (ESI) with anti-inflammatory compounds such as glucocorticoids is\r commonly provided to alleviate pain from neurogenic claudication in spinal stenosis: it is\r estimated that 25% of ESI's performed in the Medicare population and 74% of ESIs in the\r Veterans Affairs system are for spinal stenosis. However, one recent, large, multi-center,\r randomized controlled trial (RCT) demonstrated no significant benefit of epidural\r corticosteroids in alleviating symptoms of spinal stenosis. In this study, Friedly et al.\r conducted a double-blind, RCT comparing patient outcomes with epidural injection of\r glucocorticoid plus anesthetic (lidocaine) vs. anesthetic (lidocaine) only. No significant\r differences were observed at 6 weeks between the two groups of patients with respect to\r pain-related functional disability or pain intensity. However, a subset of patients who\r received glucocorticoids plus lidocaine reported significantly higher treatment satisfaction\r and higher reductions in depressive symptoms. This suggests that ESIs may be effective for a\r subset of patients with spinal stenosis.\r\n\r Another treatment modality for spinal stenosis is decompression surgery, which may be\r effective for some patients but is associated with higher risk especially in the elderly and\r patients with multiple medical comorbidities. In Davis et al.'s observational study, in a\r two-year period with 68 patients, 32% of patients opted for surgery, 44% of patients were\r satisfied with non-surgical management and were discharged after 2 years, but the remaining\r 24% with non-surgical management (some of whom chose to decline surgery) did not seem to be\r satisfied with treatment. This study indicates the potential key role that non-surgical\r management options such as ESIs may play, in some patients. However, appropriate patient\r selection using indicators or biomarkers for patients who may most likely benefit from ESIs\r would be extremely beneficial.\r\n\r In studying biomarkers that may predict patients' response to ESIs, Scuderi et al. found\r interferon-gamma (IFG) levels to have high predictive value for patients with lumbar nerve\r root irritation, while Golish et al. and Smith et al. found fibronectin-aggrecan complex\r (FAC) levels to have high predictive value for patients with herniated nucleus pulposus\r (HNP). In addition, many other factors (such as lower age and higher education) have been\r found to predict better outcome for radiculopathy. In particular, needle electromyography\r (EMG) has been shown in several studies to be a strong predictor for response to lumbar\r epidural steroid injection (LESI) and transforaminal epidural steroid injection (TESI) for\r patients with lumbosacral radiculopathy (LSR). Inspired by these studies, this study aims to\r explore if certain biomarkers such as IFG & FAC along with EMG findings can help predict\r which patients with spinal stenosis and neurogenic claudication will optimally benefit from\r ESIs.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Mild-severe lumbar central canal stenosis identified by MRI or CT scan\r\n\r - Symptoms:\r\n\r - Lower extremety symptoms consistent with neurogenic claudication\r\n\r - Pain, weakness and/or numbness triggered by standing or walking, and relieved by\r sitting\r\n\r - Must be able to read English and complete assessment instruments\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 - Abnormal coagulation\r\n\r - Allergy to local anesthetic, steroid, or contrast\r\n\r - Previous lumbar spine surgery\r\n\r - Prisoners\r\n\r - Epidural steroid injection within previous 6 months\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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
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