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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy\n\n**Clinical Trial Summary:**\n\nTo determine the safety and efficacy of the ThermaRx heating device for the application of\r controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).\n\n**Clinical Trial Detailed Description:**\n\nThis study will assess the safety and efficacy of ThermaRx heat treatment in subjects who\r have urinary hesitancy.\r\n\r The rationale for this approach is based on anecdotal evidence and case reports suggesting\r that urinary hesitancy can be effectively reduced by external skin heating (hot tub \"Jacuzzi\"\r effect, perineal hot water spray). However, to date, there have been no formal studies of\r this non-invasive form of treatment, and the mechanism of action is still unclear.\r\n\r This is a two-day study in which each subject will receive an oral fluid load and then one\r (1) heating treatment with the device. Ultrasound-based measurements of bladder volume will\r be performed both before and after voiding. On Day 1, voiding will be performed in a standing\r position; on Day 2, voiding will be done in a sitting position.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male subjects 25-80 years of age at the screening visit.\r\n\r - Subject must have mild-to-moderate urinary hesitancy symptoms (shown as an American\r Urological Association Symptom Index (AUA-SI) score of 7-19).\r\n\r - Symptoms include (not limited to):\r\n\r - Leaking or dribbling of urine\r\n\r - More frequent urination, especially at night\r\n\r - Urgency to urinate\r\n\r - Urine retention (inability to urinate)\r\n\r - Hesitant, interrupter or weak stream of urine\r\n\r - Inability or difficulty to urinate in public\r\n\r Exclusion Criteria:\r\n\r - History of prostate cancer or prostate surgery\r\n\r - Currently (or within the past 30 days) on active treatment for prostate problems\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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101
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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\nAmbulatory Surgery of Lower Extremity Varicose Vein\n\n**Clinical Trial Summary:**\n\nOBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese\r patients with primary varicosities of the lower extremities including the use of endovenous\r laser, phlebectomy, and sclerotherapy.\r\n\r METHODS: We routinely used tumescent anesthesia and ultrasound-guided approaches for the\r application of endovenous laser. Vein access was achieved by either a percutaneous or stab\r wound. The laser power was usually 10 - 20 watts; laser treatment usually was begun from 4-10\r cm below the saphenofemoral junction, and stopped around the knee, not over 10 cm below the\r knee. In the same operation, we used Mueller's phlebectomy and/or sclerotherapy if there were\r prominent branch varicosities. We instructed each patient to walk around immediately after\r the operation, to go home, and to come back 1-3 days later for follow-up. Ultrasound scan and\r venous function follow-up was scheduled at 1 month, 6 months, 12 months, and then annually.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients with varicose veins who underwent endovenous laser treatment for GSV\r reflux in our hospital were reviewed\r\n\r Exclusion Criteria:\r\n\r - poor general health, inability to walk, active inflammation of varicose veins, deep\r venous occlusion disease, hypercoagulability, pregnancy and breast-feeding.\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
|
102
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the safety and tolerability of XL765 in combination\r with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide\r maintenance dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In\r preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce\r apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown\r to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered\r alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug\r Administration for the following indications: 1) treatment of newly diagnosed glioblastoma\r multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance\r treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced\r disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide\r is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial\r tumors and mixed gliomas.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed intracranial Grade 3 or 4 anaplastic glioma or glioblastoma\r (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma)\r\n\r - Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum\r cumulative dose of 40 Gy administered\r\n\r - Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on\r Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression\r\n\r - Karnofsky performance status of 60 or more\r\n\r - Adequate organ and bone marrow function as defined by hematological and serum\r chemistry limits\r\n\r - At least 18 years old.\r\n\r - Both men and women must practice adequate contraception\r\n\r - Informed consent\r\n\r Exclusion Criteria:\r\n\r - Progressed while on temozolomide\r\n\r - Evidence of acute intracranial or intratumoral hemorrhage > Grade 1\r\n\r - Restriction of some therapies/medications within specific timeframes prior to\r enrollment and during the study including cytotoxic chemotherapy other than\r temozolomide, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase\r inhibitors, non-cytotoxic hormonal agents, prior therapy with a PI3K inhibitors,\r radiation therapy, enzyme-inducing anti-convulsants, valproic acid\r\n\r - Not recovered from the toxic effects of prior therapy\r\n\r - Pregnant or breast feeding\r\n\r - History of diabetes mellitus\r\n\r - Uncontrolled intercurrent illness\r\n\r - Congestive heart failure, unstable angina, or a myocardial infarction within 3 months\r of entering the study.\r\n\r - HIV positive\r\n\r - Diagnosis of another malignancy may exclude subject from study\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
103
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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\nTemozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to confirm the safety and efficacy of temozolomide in patients\r with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy)\r and relapsed malignant glioma (as monotherapy) when used in the daily medical practices.\r\n\r Post-marketing surveys are not considered applicable clinical trials and thus the results of\r this survey will not be posted at its conclusion. The results will be submitted to public\r health officials as required by applicable national and international laws.\n\n**Clinical Trial Detailed Description:**\n\nPatients are invited to participate in the study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients treated with temozolomide for newly diagnosed malignant glioma\r (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma\r (as monotherapy).\r\n\r Exclusion Criteria:\r\n\r - Patients with a history of hypersensitivity to temozolomide or dacarbazine.\r\n\r - Pregnant women and women who may 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
104
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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\nRandomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide\n\n**Clinical Trial Summary:**\n\nBackground: The optimal treatment of anaplastic gliomas is controversial. Standard of care in\r most centers is still radiotherapy. This phase III study compared the efficacy and safety of\r radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas\r of WHO grade III.\r\n\r Methods: Pts were randomized 2:1:1 between June 1999 and February 2005 in 34 German centers\r to receive (i) a 6-week course of radiotherapy (1,8-2 Gy fractions, total dose 54-60 Gy) or\r (ii) four 6-week cycles of CCNU at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and\r 29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide\r on days 1-5. Treatment was stopped prematurely at disease progression or occurrence of\r unacceptable toxicity. At this time or at disease progression, treatment in the radiotherapy\r group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy\r in both chemotherapy groups. The primary endpoint was time-to-treatment-failure (TTF) defined\r as progression after radiotherapy and one chemotherapy in either sequence, or any time before\r if further therapy could not be employed. Assuming a 50% improvement in TTF of starting with\r chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical\r significance at a one-sided level of 0.05.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - written informed consent\r\n\r - centrally confirmed anaplastic glioma according to the WHO-classification 1998/2000\r\n\r - age ≥ 18 years\r\n\r - Karnofsky performance status (KPS) of 70 or higher\r\n\r - no prior systemic chemotherapy or radiation therapy of the brain\r\n\r - no HIV infection\r\n\r - adequate bone marrow reserve, liver function, and renal function\r\n\r - Patients on corticosteroids had to be on a stable or decreasing dosage within the 14\r days prior to randomization\r\n\r Exclusion Criteria:\r\n\r - Glioblastoma\r\n\r - infratentorial localization of the tumor\r\n\r - pregnancy or lactation period\r\n\r - serious medical or neurological comorbidity\r\n\r - additional malignancy requiring radio- or chemotherapy\r\n\r - known hypersensitivity against study drugs\r\n\r - inability to swallow\r\n\r - frequent emesis\r\n\r - psychological. familial, sociological or geographical situations impairing compliance\r with F/U examinations\r\n\r - parallel participation in other studies\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"
}
] |
possibly relevant
|
105
|
[
{
"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\nRadiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in\r chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the\r growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic\r trioxide and temozolomide may also make tumor cells more sensitive to radiation therapy.\r Giving radiation therapy together with combination chemotherapy may kill more tumor cells.\r\n\r PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide\r when given together with temozolomide and radiation therapy in treating patients with newly\r diagnosed high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose of arsenic trioxide when administered sequentially\r with temozolomide during radiotherapy in patients with newly diagnosed glioblastoma\r multiforme.\r\n\r - Determine the dose-limiting toxicities of this regimen in these patients.\r\n\r OUTLINE: This is a dose-escalation study of arsenic trioxide.\r\n\r Patients undergo radiotherapy (may be intensity-modulated) on days 1-5. Patients also receive\r arsenic trioxide IV over 1-2 hours on days 1-5, and oral temozolomide on days 1-7. Treatment\r with radiotherapy, arsenic trioxide, and temozolomide repeats every week for up to 6 weeks in\r the absence of disease progression or unacceptable toxicity.\r\n\r Patients may then receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for\r up to 12 courses in the absence of disease progression.\r\n\r After completion of study therapy, patients are followed periodically.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Newly diagnosed grade III or IV glioma including any of the following:\r\n\r - Glioblastoma\r\n\r - Anaplastic astrocytoma\r\n\r - Gliosarcoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - Measurable or nonmeasurable disease\r\n\r - No more than 5 weeks since prior brain surgery\r\n\r - Recovered from surgery, post- operative infection, and other complications\r\n\r - Preoperatively and postoperatively diagnostic contrast-enhanced MRI or CT scan of the\r brain performed prior to radiation therapy\r\n\r - Patients diagnosed by stereotactic biopsy do not require the postoperative scan\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Karnofsky performance status ≥ 60%\r\n\r - Absolute neutrophil count ≥ 1,500/mm^3\r\n\r - Platelet count ≥ 100,000/mm^3\r\n\r - Serum creatinine ≤ 1.5 times upper limit of normal (ULN)\r\n\r - Total bilirubin ≤ 2.0 mg/dL\r\n\r - AST ≤ 4.0 times ULN\r\n\r - No prolonged QT interval > 460 milliseconds on baseline electrocardiogram in the\r presence of normal serum potassium and magnesium\r\n\r - No uncontrolled electrolyte imbalance (i.e., sodium < 132 mmol/L, potassium < 3.5\r mEq/dL, magnesium < 1.7 mg/dL)\r\n\r - No history of torsades de pointes type of ventricular arrhythmia\r\n\r - Negative pregnancy test\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\r\n\r - No medical or psychiatric illness that, in the investigator's opinion, could\r potentially preclude the completion of study therapy\r\n\r - No HIV positivity\r\n\r - No active connective tissue disorders (e.g., lupus or scleroderma) that, in the\r investigator's opinion, may put the patient at high risk for radiation toxicity\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - See Disease Characteristics\r\n\r - No prior brain radiotherapy or chemotherapy for brain tumor\r\n\r - Concurrent corticosteroids to control cerebral edema allowed provided dose is stable\r or decreasing for the past 5 days\r\n\r - No concurrent or plan to receive drugs that are known to prolong the QT interval\r\n\r - No prior radiation to the head or neck (except for T1 glottic cancer) resulting in\r overlap of radiation fields\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"
}
] |
possibly relevant
|
106
|
[
{
"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\nTemodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)\n\n**Clinical Trial Summary:**\n\nThe purpose of this surveillance is to evaluate the postmarketing safety and efficacy of\r Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the\r following points that are in question and doubt:\r\n\r - Incidence of adverse events under actual conditions of use (Serious and Nonserious\r Adverse Events);\r\n\r - Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected\r Adverse Reaction);\r\n\r - Adverse Event caused by misuse, abuse, or drug interactions;\r\n\r - Other information concerned with safety or efficacy.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Participants who are prescribed with temozolomide by local labeling:\r\n\r - participants with newly diagnosed glioblastoma multiforme;\r\n\r - participants with malignant glioma, such as glioblastoma multiforme or anaplastic\r astrocytoma, showing recurrence or progression after standard therapy.\r\n\r Exclusion Criteria:\r\n\r - N/A\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"
}
] |
definitely relevant
|
107
|
[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Phase I Trial of Nanoliposomal CPT-11 (NL CPT-11) in Patients With Recurrent High-Grade Gliomas\n\n**Clinical Trial Summary:**\n\nThis is a Phase I study of Nanoliposomal CPT-11 in patients with Recurrent high-grade\r gliomas. Patients must have a histologically proven intracranial malignant glioma, which\r includes glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA),\r anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant\r astrocytoma NOS (not otherwise specified). Patients who are wild type or heterozygous for the\r UGT1A1*28 gene will received Nanoliposomal CPT-11. The total anticipated accrual will be\r approximately 36 patients (depending upon the actual MTD). The investigators hypothesis is\r that this new formulation of CPT-11 will increase survival over that seen in historical\r controls who have recurrent gliomas because CPT-11 will be encapsulated in a liposome\r nanoparticle, which has been seen to reduce toxicities from the drug.\n\n**Clinical Trial Detailed Description:**\n\nPatients with recurrent malignant glioma will receive Nanoliposomal CPT-11 at the time of\r relapse. The dose will be adjusted according to a phase-1 dose escalation scheme. Patients\r will receive drug intravenously every 3 weeks until tumor progression or excessive toxicity.\r Weekly follow up will occur to assess toxicities during the DLT phase of the trial. Patients\r will have different dose escalation if UGT1A1 is 6/6 versus UGT1A1 is 6/7. Patients with UGT\r 1A1 of 7/7 will not be eligible. All patients must have UGT 1A1 status know as an eligibility\r requirement. Patients will be followed for both toxicity and progression, and progression\r will be evaluated by MR imaging every 6 weeks. Pharmacokinetics will be obtained in the first\r treatment cycle.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with histologically proven intracranial malignant glioma are eligible . -All\r patients must sign an informed consent\r\n\r - Patients must be > 18 years old, and with a life expectancy > 8 weeks.\r\n\r - Patients must have a Karnofsky performance status of > 60.\r\n\r - Patients must have recovered from the toxic effects of prior therapy\r\n\r - Patients must have adequate bone marrow function (WBC > 3,000/µl, ANC > 1,500/mm3,\r platelet count of > 100,000/mm3, and hemoglobin > 10 gm/dl), adequate liver function\r (SGOT and bilirubin < 2 times ULN), and adequate renal function (creatinine < 1.5\r mg/dL and/or creatinine clearance > 60 cc/min) Patients must have shown radiographic\r evidence for tumor progression by MRI or CT scan. A scan should be performed within 14\r days prior to registration and on a steroid dose that has been stable for at least 5\r days. -Patients having undergone recent resection of recurrent or progressive tumor\r will be eligible as long as all of the following conditions apply:\r\n\r - They have recovered from the effects of surgery.\r\n\r - Residual disease following resection of recurrent malignant glioma is not\r mandated for eligibility into the study.\r\n\r - Patients must have failed prior radiation therapy\r\n\r - Patients with prior therapy that included interstitial brachytherapy or stereotactic\r radiosurgery must have confirmation of true progressive disease\r\n\r - Women of childbearing potential must have a negative ß-HCG pregnancy test documented\r within 14 days prior to registration.\r\n\r - Patients may have had treatment for any number of prior relapses.\r\n\r Exclusion Criteria:\r\n\r - Patients must not have any significant medical illnesses that in the investigator\r opinion cannot be adequately controlled\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 any disease that will obscure toxicity or dangerously alter\r drug metabolism.\r\n\r - Patients must not have received prior therapy with irinotecan.\r\n\r - Patients with 7/7 (homozygous) UGT1A1*28 genotyping will be excluded from the study.\r\n\r - Patients receiving enzyme-inducing anticonvulsants or other enzyme inducing drugs are\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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[
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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\nPh. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThe primary objective of this study is to determine the maximum tolerated dose (MTD) and dose\r limiting toxicity (DLT) of dasatinib when combined with protracted, daily temozolomide (TMZ).\r Secondary objectives are: To further evaluate the safety and tolerability of dasatinib plus\r protracted, daily TMZ; 2. To evaluate the pharmacokinetics of dasatinib when administered\r with protracted, daily TMZ among recurrent malignant glioma patients who are on and not on\r CYP-3A enzyme inducing anti-epileptic drugs (EIAEDs); 3. To evaluate for anti-tumor activity\r with this regimen in this patient population.\n\n**Clinical Trial Detailed Description:**\n\nThis is an open-label, single center, one-arm phase I dose-escalation study of dasatinib plus\r protracted , daily TMZ administered orally on a continuous daily dosing schedule among adult\r patients with recurrent or relapsing malignant glioma. The study format includes a classical\r \"3+3\" dose escalation design to determine the MTD and DLT of dasatinib plus protracted, daily\r TMZ among recurrent malignant glioma patients. Patients will be stratified based on whether\r they are receiving EIAED and each stratum will independently dose escalate. Additionally, the\r study will characterize the safety, tolerability, biologic activity, and pharmacokinetic\r profile of dasatinib when used in combination with protracted, daily TMZ.\r\n\r Patients will start treatment on day 1 of cycle 1 with dasatinib. For patients undergoing\r dasatinib pharmacokinetic (PK) analysis, dasatinib will be administered alone until initial\r PK assessments are collected. Protracted TMZ will be initiated after initial dasatinib PK\r assessments are collected and will continue to be administered with dasatinib on a continuous\r daily dosing schedule. The initial dasatinib PK assessments will be collected over 24 hours\r between days 3-7 of cycle 1. Patients not undergoing dasatinib PK collections will begin both\r dasatinib and protracted, daily TMZ together on day 1, cycle 1.\r\n\r The protracted, daily TMZ dose will be 50 mg/m² daily for all patients. The dose level of\r dasatinib will be increased in successive cohorts. Cohorts of 3-6 patients will accrue at\r each dose level until MTD is defined. Each cohort will consist of a minimum of 3 newly\r enrolled patients. Intra-patient dose escalation is not permitted. It is estimated that this\r study will enroll a minimum of 30 patients (up to 4 dose levels/stratum; 3 patients/dose\r level for levels 1-3 and 6 patients at level 4) and a maximum of 48 patients (6 patients/dose\r level; 4 dose levels/stratum). Cohorts may be expanded at any dose level for further\r elaboration of safety and pharmacokinetic parameters as required.\r\n\r The primary safety and efficacy analysis will be conducted on all patient data at the time\r all patients who are still receiving study drug will have completed at least 4 cycles of\r treatment. The additional data for any patients continuing to receive study drug past this\r time, as allowed by the protocol, will be further summarized in a report once these patients\r either completed or discontinued the study. Prior to the primary analysis, an additional\r safety report may be prepared.\r\n\r The most common side effects include vomiting, diarrhea, anorexia (loss of appetite), fluid\r retention, fatigue, headache, rash, hypocalcemia (low calcium level), and decreases in blood\r counts. Other possible side effects may include nausea, joint pain, muscle aches, generalized\r pain, abdominal pain, and fever. Rare side effects may include QTc prolongation (heart beat\r changes), pulmonary edema (fluid around the lungs), difficulty breathing, cough, hemorrhage,\r gastrointestinal bleeding, pneumonia, cardiac effusion (fluid in the sac surrounding the\r heart), and cardiac failure. Temodar has been well tolerated by both adults and children with\r the most common toxicity being mild myelosuppression. Other, less likely, potential\r toxicities include nausea and vomiting, constipation, headache, alopecia, rash, burning\r sensation of skin, esophagitis, pain, diarrhea, lethargy, hepatotoxicity, anorexia, fatigue\r and hyperglycemia. As in the case with many anti-cancer drugs, Temodar may be carcinogenic.\r Rats given Temodar have developed breast cancer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients must have a histologically confirmed diagnosis of a recurrent/progressive WHO\r Gr.4 malignant glioma (glioblastoma multiforme or gliosarcoma) or WHO Gr.3 malignant\r glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic mixed\r glioma). Recurrence will be defined based on the modified MacDonald criteria or based\r on histopathologic confirmation of tissue obtained via surgical intervention. Patients\r with prior low-grade glioma are eligible if histologic assessment demonstrates\r transformation to WHO Gr.III or IV malignant glioma;\r\n\r 2. > or = to 18 y/o;\r\n\r 3. KPS . or = to 60%;\r\n\r 4. Patients must be presenting in 1st, 2nd or 3rd relapse. Relapse is defined as\r progression following anti-cancer therapy other than surgery, including non-surgical\r therapies that are considered standard treatment for high-grade glioma if administered\r to patients with prior low-grade glioma. Prior therapy must have included external\r beam radiotherapy;\r\n\r 5. Adequate bone marrow, liver and renal function as assessed by the following:\r Hematocrit > or = to 29%, ANC > or = to 1,500/mm3, Platelet count > or = to\r 125,000/mm3, Total bilirubin < or = to 1.5 x ULN, ALT and AST < or = to 2.5 x the ULN\r ( < or = to 5 x ULN for patients with liver involvement), INR < 1.5 or a PT/PTT within\r normal limits (unless on therapeutic anti-coagulation). Patients receiving\r anti-coagulation treatment with a low-molecular weight heparin will be allowed to\r participate, however oral warfarin is not permitted except for low-dose warfarin (1mg\r po DAILY), Creatinine < 1.5 x ULN, Serum Na, K+, Mg2+, Phosphate and Ca2+ > or = to\r Lower Limit of Normal (LLN);\r\n\r 6. An interval of at least 2 weeks between prior surgical resection (1 week for biopsy)\r and initiation of study regimen;\r\n\r 7. An interval of at least 12 weeks from completion of standard, daily XRT, unless one of\r the following occurs: a) new area of enhancement on MRI imaging that is outside the\r XRT field; b) biopsy proven recurrent tumor; c) radiographic evidence of progressive\r tumor on 2 consecutive scans at least 4 weeks apart;\r\n\r 8. An interval of at least 4 weeks from prior chemotherapy (except nitrosoureas which\r require 6 weeks) unless there is unequivocal evidence of tumor progression and the\r patient has recovered from all anticipated toxicities from prior therapy;\r\n\r 9. An interval of a least 14 days from exposure to investigational agents, unless there\r is unequivocal evidence of tumor progression and the patients has recovered from all\r anticipated toxicities from prior therapy;\r\n\r 10. Signed written informed consent including HIPAA according to institutional guidelines.\r A signed informed consent must be obtained prior to any study specific procedures;\r\n\r 11. If sexually active, patients will take contraceptive measures for the duration of the\r treatments and for 3 months following discontinuation of dasatinib and TMZ;\r\n\r 12. Women of childbearing potential must have a negative serum or urine pregnancy test\r (sensitivity < or = to 25IU HCG/L) within 72 hours prior to the start of study drug\r administration.\r\n\r Exclusion Criteria:\r\n\r 1. Prior dasatinib. Imatinib mesylate in the prior three months;\r\n\r 2. Grade 3 or greater toxicity related to prior TMZ therapy;\r\n\r 3. Prior progression on protracted daily TMZ;\r\n\r 4. Pregnancy or breast feeding;\r\n\r 5. History of significant concurrent illness;\r\n\r 6. More than 3 prior episodes of progressive disease;\r\n\r 7. Significant cardiac disease including any of the following:\r\n\r 1. congestive heart failure > class II NYHA;\r\n\r 2. unstable angina (anginal symptoms at rest);\r\n\r 3. new onset angina (began within the last 3 months);\r\n\r 4. myocardial infarction within the past 6 months;\r\n\r 5. any history of clinically significant ventricular arrhythmias (such as\r ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);\r\n\r 6. uncontrolled congestive heart failure; diagnosed congenital long QT syndrome;\r prolonged QTc interval on pre-entry electrocardiogram (> 450 msec);\r\n\r 8. Excessive risk of bleeding as defined by stroke within the prior 6 months, history of\r CNS or intraocular bleed, or septic endocarditis;\r\n\r 9. Female patients who are pregnant or breastfeeding, or adults of reproductive potential\r not employing an effective method of birth control. (Women of childbearing potential\r must have a negative serum pregnancy test within 72 hours prior to administration of\r study regimen). Sexually active women of childbearing potential (WOCBP) must use an\r effective method of birth control during the course of the study, in a manner such\r that risk of failure is minimized. Prior to study enrollment, women of childbearing\r potential must be advised of the importance of avoiding pregnancy during trial\r participation and the potential risk factors for an unintentional pregnancy;\r\n\r 10. Concurrent severe and/or uncontrolled medical disease that could compromise\r participation in the study such as pleural or pericardial effusion of any grade,\r uncontrolled diabetes, uncontrolled hypertension (defined as systolic blood pressure >\r 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management), active\r clinically serious infection > CTCAE Gr.2, history of clinically significant bleeding\r diathesis or coagulopathy including platelet function disorder (e.g. known von\r Willebrand's disease) or acquired bleeding disorder within one year (e.g., acquired\r anti-factor VIII antibodies), impairment of GI function or GI disease that may\r significantly alter the absorption of the study regimen (i.e. ulcerative disease,\r uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or\r inability to swallow the tablets), ongoing or recent (< or = to 3 months) significant\r gastrointestinal bleeding;\r\n\r 11. Thrombolic or embolic events such as cerebrovascular accident including transient\r ischemic attacks within the past 6 months;\r\n\r 12. Any hemorrhage/bleeding event > CTCAE Gr.3 within 4 weeks of 1st dose of study drug;\r\n\r 13. Serious non-healing wound, ulcer, or bone fracture;\r\n\r 14. Major surgery, open biopsy or significant traumatic injury within 4 weeks of 1st study\r drug;\r\n\r 15. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C;\r\n\r 16. Patient is < 3 years free of another primary malignancy except: if the other primary\r malignancy is not currently clinically significant or requiring active intervention,\r or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in\r situ. Existence of any other malignant disease is not allowed;\r\n\r 17. Patient unwilling to or unable to comply with the protocol including ability to\r swallow whole pills or presence of any malabsorption syndrome;\r\n\r 18. Concurrent administration of warfarin, rifampin or St. John's Wort, except for\r low-dose warfarin (1mg po DAILY);\r\n\r 19. Clinically serious infection requiring active intervention (CTCAE Gr.2 or greater);\r\n\r 20. Hypokalemia or hypomagnesemia if it cannot be corrected;\r\n\r 21. Concomitant Medications, consider the following prohibitions:\r\n\r 1. Drugs that are generally accepted to have a risk of causing Torsades de Pointes\r including: (Patients must discontinue drug 7 days prior to starting dasatinib)\r\n\r 1. quinidine, procainamide, disopyramide\r\n\r 2. amiodarone, sotalol, ibutilide, dofetilide\r\n\r 3. erythromycin, clarithromycin\r\n\r 4. chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n\r 5. cisapride, bepridil, droperidol, methadone, arsenic, chloroquine,\r domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,\r lidoflazine.\r\n\r 2. Drugs that reduce dasatinib exposure such as H2 blockers or proton-pump\r inhibitors (eg famotidine and omeprazole), which can cause long-term suppression\r of gastric acid secretion. The concomitant use of H2 blockers or proton pump\r inhibitors with dasatinib is in general not recommended and antacids should be\r considered in place of H2 blockers or proton pump inhibitors in patients\r receiving dasatinib therapy. However, given that nearly all recurrent malignant\r brain tumor patients are on dexamethasone for increased intracranial pressure,\r such patients must also receive effective medical therapy to prevent\r complications related to increased gastric acid secretion due to chronic\r dexamethasone therapy. Therefore all patients enrolled on the current protocol\r will receive standard H2 blocker (preferred) or proton pump inhibitor (PPI)\r therapy to be administered on a daily basis each evening. Dasatinib will be\r administered each morning in order to maximize the time interval from\r administered H2 blocker (preferred) or proton pump inhibitor (PPI).\r\n\r 3. Drugs that cause hypocalcemia (i.e. IV bisphosphonates will be withheld for the\r first 8 weeks of dasatinib therapy due to risk of hypocalcemia).\r\n\r 4. Any prohibited CYP3A4 inhibitors; 22. Prisoners or subjects who are compulsorily\r detained (involuntarily incarcerated) for treatment of either a psychiatric or\r physical (e.g., infectious) illness.\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\nPhase I Study of LBH589 & Erlotinib for Advanced Aerodigestive Tract Cancers\n\n**Clinical Trial Summary:**\n\nThe main purpose of the study is to:\r\n\r - Determine the safety and tolerability of erlotinib and LBH589B.\r\n\r - Establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients\r with advanced aerodigestive tract cancers.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically or cytologically documented diagnosis of advanced/metastatic NSCLC or\r Head and Neck cancer.\r\n\r - Male or female patients aged ≥ 18 years old\r\n\r - Ability to provide written informed consent obtained prior to participation in the\r study and any related procedures being performed\r\n\r - Have progressive and measurable disease that can be measured by Response Evaluation\r Criteria in Solid Tumors (RECIST) criteria\r\n\r - Patients must have discontinued prior systemic chemotherapy by 14 days.\r\n\r - Patients must meet the following laboratory criteria:\r\n\r 1. Serum albumin ≥ 3g/dL\r\n\r 2. Aspartic transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) ≤ 2.5 x\r upper limit of normal (ULN)or ≤ 5.0 x ULN if the transaminase elevation is due to\r leukemic involvement\r\n\r 3. Serum bilirubin ≤ 1.5 x ULN\r\n\r 4. Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min\r\n\r 5. Serum potassium ≥ lower limit of normal (LLN) and ≤ ULN\r\n\r 6. Serum phosphorous ≥ LLN\r\n\r 7. Serum total calcium (corrected for serum albumin) or serum ionized calcium ≥ LLN\r\n\r 8. Serum magnesium ≥ LLN\r\n\r 9. Absolute neutrophil count (ANC) (ANC: segmented and bands) ≥ 1.5 X10^9/L\r\n\r 10. Platelets ≥ 100 X 10^9/L\r\n\r - Baseline multiple gated acquisition imaging (MUGA) or echocardiogram (ECHO) must\r demonstrate left ventricular ejection fraction (LVEF) ≥ the lower limit of the\r institutional normal\r\n\r - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\r\n\r - Reproductive potential must be either terminated (by surgery, radiation, or menopause)\r or attenuated by the use of an approved contraceptive method during and for 3 to 6\r months following the study.\r\n\r - Patient instructed that intravenous (IV) bisphosphonates will be withheld for the\r first 8 weeks of LBH589 therapy due to risk of hypocalcemia.\r\n\r Exclusion Criteria:\r\n\r - Impaired cardiac function including any one of the following:\r\n\r 1. Screening electrocardiogram (ECG) with a corrected QT (QTc) > 450 msec confirmed\r by central laboratory prior to enrollment to the study\r\n\r 2. Patients with congenital long QT syndrome\r\n\r 3. History of sustained ventricular tachycardia\r\n\r 4. Any history of ventricular fibrillation or torsades de pointes\r\n\r 5. Bradycardia defined as heart rate < 50 beats per minute. Patients with a\r pacemaker and heart rate ≥ 50 beats per minute are eligible.\r\n\r 6. Patients with a myocardial infarction or unstable angina within 6 months of study\r entry\r\n\r 7. Congestive heart failure - New York Heart Association (NYHA) class III or IV\r\n\r 8. Right bundle branch block and left anterior hemiblock (bifascicular block)\r\n\r 9. Patients with a history of uncontrolled or chronic atrial fibrillation.\r\n\r - Uncontrolled hypertension, blood pressure (BP) >180/110 on 3 separate occasions\r despite oral antihypertensive medications\r\n\r - Concomitant use of drugs with a risk of causing torsades de pointes Concomitant use of\r CYP3A4 inhibitors\r\n\r - Patients with documented central nervous system or leptomeningeal metastasis (brain\r metastasis) at the time of study entry. Patients with prior brain metastasis may be\r considered if they have completed their treatment for brain metastasis, no longer\r require corticosteroids, and are asymptomatic.\r\n\r - Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events\r (CTCAE) grade 1\r\n\r - Impairment of gastrointestinal (GI) function or GI disease that may significantly\r alter the absorption of oral LBH589\r\n\r - Other concurrent severe and/or uncontrolled medical conditions\r\n\r - Patients who have received chemotherapy < 14 days, any investigational drug < 14 days\r or undergone major surgery < 4 weeks prior to starting study drug or who have not\r recovered from side effects of such therapy.\r\n\r - Concomitant use of any anti-cancer therapy (except erlotinib) or radiation therapy.\r\n\r - Female patients who are pregnant or breast feeding or patients of reproductive\r potential not using two effective methods of birth control. Women of childbearing\r potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first\r administration of oral LBH589\r\n\r - Male patients whose sexual partners are WOCBP not using effective birth control\r\n\r - Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C;\r baseline testing for HIV and hepatitis C is not required\r\n\r - Patients with any significant history of non-compliance to medical regimens or with\r inability to grant a reliable informed consent\r\n\r - Patients who are not willing to refrain from wearing contact lenses during study\r participation 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:** not relevant"
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not relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis\n\n**Clinical Trial Summary:**\n\nThe purpose of this study was to examine a low and high dose of tapentadol extended release\r tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to\r severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily\r increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared\r to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum\r concentrations and safety of tapentadol and oxycodone were also examined.\n\n**Clinical Trial Detailed Description:**\n\nArthritis is the most common chronic debilitating disease in the United States (more than 43\r million people or 1 in 6). Osteoarthritis of the knee is a very common and a major cause of\r disability. Pharmacological treatment includes the following analgesics: non-steroidal\r anti-inflammatory drugs (NSAIDs), cyclo-oxygenase II (COX-II) inhibitors, acetaminophen and\r opioids. Despite the numerous available analgesic medications, 60% to 80% of patients\r suffering from chronic pain are currently treated inadequately. Opioid analgesics have been\r shown to be efficacious in chronic non-malignant pain and can be an important therapeutic\r asset. The study was a 4-week randomized multicenter double-blind, placebo- and\r active-controlled, parallel-group, forced-titration phase 2B study of efficacy and safety\r with tapentadol extended release (ER) to 233 mg BID and oxycodone PR to 20 mg BID vs placebo\r in subjects with moderate to severe chronic pain of knee osteoarthritis. Primary efficacy\r outcome was the average pain intensity 24 hours before the last evaluation time or 29 days.\r Safety was evaluated by reporting of adverse events, laboratory tests, vital sign measures,\r ECGs. This study hypothesis was that tapentadol extended release was effective in relieving\r chronic moderate to severe pain from knee osteoarthritis compared to treatment with placebo\r using 2 dosing regimens for tapentadol.\r\n\r tapentadol extended release white, fim-coated tablet taken orally twice a day during a 4-week\r period at a dose that steadily increased up to 100 mg or 200 mg; placebo tablets; or\r oxycodone extended release tablet, 20 mg.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or\r radiographic criteria present for at least 3 months\r\n\r - Moderate to severe chronic pain due to knee osteoarithritis\r\n\r Exclusion Criteria:\r\n\r - Previously opioid treated subject who had a history of withdrawal after cessation of\r the opioid\r\n\r - History of seizure disorder, psychiatric disease and history of head trauma requiring\r evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects\r who, in the investigator's judgment, have well-controlled depression or anxiety\r disorder may participate\r\n\r - Subjects with history of uncontrolled hypertension (systolic blood pressure > 160 mmHg\r or diastolic blood pressure > 95 mmHg)\r\n\r - Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors,\r barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs\r within the 30 days prior to the screening visit\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\nEfficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma\n\n**Clinical Trial Summary:**\n\nIn this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared\r to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed\r recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO\r grade IV).\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to compare the safety and efficacy of the 10 µM concentration of\r AP 12009 and standard chemotherapy (temozolomide, BCNU, CCNU) in adult patients with\r recurrent or refractory anaplastic astrocytoma (AA, WHO grade III) or secondary glioblastoma\r (GBM, WHO grade IV). AP 12009 (trabedersen) is a phosphorothioate antisense\r oligodeoxynucleotide specific for the mRNA of human Transforming Growth Factor beta 2\r (TGF-beta-2), which is applied intratumorally. The growth factor TGF-beta plays a key role in\r malignant progression of various tumors by inducing proliferation, invasion, metastasis,\r angiogenesis, and escape from immunosurveillance. In patients with high-grade glioma, the\r TGF-beta-2 overexpression is associated with disease stage, clinical prognosis, and the\r immunodeficient state of the patients. Main objective of the study is to determine survival\r (rate) and tumor response.\r\n\r Important note: Due to early trial termination, resulting in limited data availability, all\r analyses remain descriptive by nature, only. No conclusive endpoint analysis can be\r performed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - The patient has provided written informed consent prior to any study-related\r procedure.\r\n\r - The patient is at least 18 years of age and equal to or below 70 years.\r\n\r - The patient has a present diagnosis of AA or secondary GBM.\r\n\r - The patient has a measurable lesion (> 1 ccm in volume, central MRI review).\r\n\r - The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review).\r\n\r - The tumor is localized supratentorially (central MRI review).\r\n\r - All patients have recurrent or refractory disease, i.e. disease has progressed after\r prior surgery and radiotherapy at any time of the disease course or stage. Secondary\r GBM patients have progressed after a previous diagnosis of A and/or AA.\r\n\r - The patient has not received more than one chemotherapy regimen. Radiation with\r concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one\r chemotherapy regimen.\r\n\r - The patient is eligible for chemotherapy.\r\n\r - The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for\r other corticosteroids, which has been stable or decreasing for at least 3 weeks prior\r to Screening.\r\n\r - The patient is male or a non-pregnant, non-lactating female.\r\n\r - Females of childbearing potential must have a negative beta-HCG pregnancy test at\r Screening.\r\n\r - Females of childbearing potential and males must practice strict birth control.\r\n\r - The patient must have recovered from acute toxicity caused by any previous therapy.\r\n\r - The patient has a life expectancy of at least 3 months.\r\n\r - The patient has a Karnofsky Performance Status of at least 70%.\r\n\r - The patient shows adequate organ functions as assessed by the following screening\r laboratory values:\r\n\r 1. Adequate renal function determined by serum creatinine and urea < 2 times the\r upper limit of normal\r\n\r 2. Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal,\r and bilirubin < 2.5 mg/dL\r\n\r 3. INR < 1.5 and aPTT < 1.5 x ULN\r\n\r 4. Hemoglobin > 9 g/dL\r\n\r 5. Platelet count > 100 x 10E9/L\r\n\r 6. WBC > 3 x 10E9/L\r\n\r 7. ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)\r\n\r Exclusion Criteria:\r\n\r - Patient unable or not willing to comply with the protocol regulations.\r\n\r - The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE:\r the patient might still be eligible for randomization at a later timepoint).\r\n\r - Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to\r randomization. If a ≤48-hour routine post-surgery MRI (in accordance with study\r specifications) qualifies the patient for study participation, the patient can be\r randomized 30 ± 7 days post-surgery.\r\n\r - Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to\r randomization.\r\n\r - Prior interstitial brachytherapy of the brain with permanent implants. Prior\r interstitial brachytherapy of the brain with removable implants within 3 months prior\r to randomization.\r\n\r - Chemotherapy, hormone therapy, or any other therapy with established or suggested\r anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.\r\n\r - Prior anti-TGF-beta 2 targeted therapy.\r\n\r - Screening MRI shows a mass effect caused by the tumor defined as significant\r compression of the ventricular system and/or a midline shift (≥ 3 mm, central MRI\r review). Compression of the ventricular system and/or a midline shift ≥ 3 mm only due\r to the presence of (a) cyst(s) or scarring processes does not exclude an individual\r from the study.\r\n\r - Participation in another clinical study with another investigational medicinal product\r within 30 days prior to randomization.\r\n\r - History of a second independent malignant disorder within 5 years, except for\r carcinoma in situ of the cervix and basal cell carcinoma.\r\n\r - Presence of poorly controlled seizures.\r\n\r - Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension,\r congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial\r infarction within 6 months prior to randomization.\r\n\r - Known HIV, HBV or HCV infection.\r\n\r - Acute viral, bacterial, or fungal infection.\r\n\r - Acute medical problems that may be considered to become an unacceptable risk, or any\r conditions, which might be contraindications for starting study treatment.\r\n\r - Presence of high risk for pulmonary toxicities, defined as:\r\n\r 1. Lung function: vital capacity ≤ 70%\r\n\r 2. Status following sequential or concomitant thoracic irradiation\r\n\r 3. Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU\r (Lomustine). Risk factors include smoking, presence of a respiratory condition,\r pre-existing radiographic pulmonary abnormalities, exposure to agents that cause\r lung damage.\r\n\r - History of allergies to reagents used in this study, history of celiac disease.\r\n\r - Drug abuse or extensive use of alcohol.\r\n\r - Clinically relevant psychiatric disorders / legal incapacity or a limited legal\r capacity.\r\n\r - Concomitant treatment with yellow fever vaccine.\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\nSCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)\n\n**Clinical Trial Summary:**\n\nThe primary purpose of the study is to evaluate the efficacy (overall response) and safety of\r temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28\r day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23\r day rest period) in patients with anaplastic astrocytoma at first relapse.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject must have histologically confirmed anaplastic astrocytoma on the tentorium at\r first relapse, and satisfy the following:\r\n\r - unequivocal evidence of tumor recurrence or aggravation by MRI scan after\r treatment for initial onset; the lesions must be measurable;\r\n\r - anaplastic astrocytoma diagnosed histologically by the last pathological\r diagnostic tests (including initial diagnosis) prior to initial administration of\r temozolomide;\r\n\r - tissue samples available for Central Pathologic Reviewer;\r\n\r - pathologic diagnosis report by the study-conducting medical institution must be\r available for the sponsor.\r\n\r - MRI-related criteria:\r\n\r - MRI scan performed within 14 days before initial temozolomide administration;\r\n\r - assessable tumor site confirmed by MRI;\r\n\r - dosage of steroidal agents not increased within 7 days before MRI prior to\r initial temozolomide administration, except for postoperative subjects for first\r relapse;\r\n\r - MRI performed at the Principal Investigator's study location or designated\r radiology facility during the study.\r\n\r - Age >=18 years, either sex, inpatients or outpatients.\r\n\r - Use of medically approved contraception methods in fertile subjects.\r\n\r - Karnofsky performance status >=70.\r\n\r - Adequate clinically laboratory values obtained within 14 days before initial\r temozolomide administration.\r\n\r - Criteria regarding treatment of initial onset:\r\n\r - tumor biopsy, regardless of tumor resection at initial diagnosis;\r\n\r - prior radiation therapy;\r\n\r - prior chemotherapy with up to one nitrosourea-containing regimen.\r\n\r - Tumor may or may not have been surgically resected at first relapse, but residual\r measurable disease is required.\r\n\r - For subjects who had surgical resection of tumor at first relapse:\r\n\r - MRI scan must have been performed within 72 hours after surgery.\r\n\r - the dose of steroidal agents must be reduced before temozolomide administration.\r\n\r - Life expectancy >=12 weeks.\r\n\r - Written informed consent obtained.\r\n\r Exclusion Criteria:\r\n\r - History of treatment with dacarbazine.\r\n\r - Subjects who received chemotherapy within 6 weeks before initial temozolomide\r administration.\r\n\r - Subjects who received interstitial radiotherapy or stereotactic radiosurgery.\r\n\r - Subjects who completed radiotherapy within 12 weeks before initial temozolomide\r administration.\r\n\r - Surgery at first relapse (including biopsy) within 1 week before initial temozolomide\r administration.\r\n\r - Subjects not recovered from acute toxicity due to previous therapy.\r\n\r - High-risk subjects with complication of diseases other than malignant tumor, or who\r require systemic administration of antibiotics for infection.\r\n\r - Previous or concurrent malignancies at other sites.\r\n\r - Pregnant or nursing women.\r\n\r - Women of childbearing potential not using an effective method of contraception.\r\n\r - Subjects previously treated with temozolomide.\r\n\r - Participation in an ongoing clinical study, or in other clinical studies within 6\r months before initial temozolomide administration.\r\n\r - Subjects found inappropriate for the study by the investigator or subinvestigator.\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\nTandem High-dose Chemotherapy and Autologous Stem Cell Rescue in Patients With High-risk Neuroblastoma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCR in\r children with high-risk neuroblastoma. In the present study, a single arm trial of tandem\r HDCT/ASCR will be carried out. In the present study, the investigators will investigate\r whether tandem HDCT/ASCR might improve the survival of patients with high-risk neuroblastoma\r with acceptable toxicity.\n\n**Clinical Trial Detailed Description:**\n\nThe prognosis of high-risk neuroblastoma after conventional chemoradiotherapy is generally\r poor. Therefore, a strategy using high-dose chemotherapy and autologous stem cell rescue\r (HDCT/ASCR) has been explored to improve the prognosis of patients with high-risk\r neuroblastoma. This strategy is based on the hypothesis that dose escalation might improve\r the survival of children with high-risk neuroblastoma. The results of randomized trials\r comparing HDCT/ASCR with chemotherapy alone showed a better event-free survival (EFS) in the\r HDCT/ASCR arm than in the continuous chemotherapy arm. However, the overall EFS was\r unsatisfactory.\r\n\r In this context, investigators have examined the efficacy of double or triple tandem\r HDCT/ASCR to further improve the outcome of high-risk neuroblastoma patients. George et al.\r carried out a single arm trial of tandem transplantation as consolidation therapy, and\r reported improved long-term survival (5-year progression-free survival 47%) with acceptable\r toxicity. Kletzel et al. also conducted a single arm trial of triple tandem transplantation\r and reported improved survival (3-year EFS 57%). They demonstrated that further dose\r escalation using sequential HDCT/ASCR might result in further improvements in the survival of\r patients with high-risk neuroblastoma.\r\n\r Investigators in the present study also carried out tandem transplantation as consolidation\r therapy, and reported improved long-term survival (5-year progression-free survival 62%) with\r acceptable toxicity. However, throughout our previous study, multiple modifications were made\r in the treatment plan, which resulted in significant variability over time between patients.\r This variability may create doubt as to whether tandem HDCT/ASCR itself resulted in the\r improved outcome. In addition, toxic death rate was relatively high (15.4%), although final\r survival rate was very high (best survival rate ever reported). Therefore, prospective study\r is needed to evaluate the efficacy and toxicity of tandem HDCT/ASCR.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with high-risk neuroblastoma\r\n\r - Patients with intermediate-risk neuroblastoma if gross tumor remained after surgery\r\n\r Exclusion Criteria:\r\n\r - Patients with progressive disease before high-dose chemotherapy\r\n\r - Patients whose parents want to stop or change the planned treatment\r\n\r - Patients with organ toxicities of NCI grade >2 before high-dose chemotherapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization\n\n**Clinical Trial Summary:**\n\nTo evaluate the ease of use and comfort of a new urinary catheter, the Uro-Ease, as used in\r the Clean Intermittent Catheterization (CIC)process.\n\n**Clinical Trial Detailed Description:**\n\nUrinary retention can occur among men with Benign Prostatic Hypertrophy(BPH) or Neurologic\r co-morbidities.\r\n\r Many of these men are treated with Clean Intermittent Catheterization(CIC. For some, this can\r be a time consuming and often painful process due to difficulty with catheter insertion and\r manipulation, which may result in urethral injury or non-compliance.\r\n\r The blunt nose of a standard catheter can meet significant resistance at the external\r sphincter or within the prostate urethra. Spirus Medical has developed a urinary catheter,\r Uro-Ease, with a rounded helical thread formed on the surface of its distal end for use in\r CIC.\r\n\r This study is to determine whether the design of the Uro-Ease catheter allows for easier\r Clean Intermittent self-Catheterization(CIC) while maintaining safe bladder drainage.\r\n\r This is a prospective randomized study with two phases.\r\n\r Phase 1: Observational, 5 patients. In this phase, five patients meeting the inclusion\r criteria will be consented from the Urology Clinic. Participating Urology nurses who have\r been previously trained in the utilization of the Spirus Catheter, will perform the initial\r CIC on the patient with a 12 Fr Spirus Catheter(choice of 2 different flexibilities). The\r study nurse will document time per catheterization and effective drainage of bladder. Before\r leaving the clinic, patient's will be instructed in the use of the Spirus Catheter and\r demonstrate efficacy with using the Spirus Catheter. Patients will then fill out VAS Forms\r for ease and comfort of catheter insertion and after each subsequent catheterization.\r Patients will also record, for 3 consecutive days, time it takes for catheterization and time\r to drain the bladder . Patients will return to clinic in 1 week to return VAS forms and\r documentation. A follow-up phone call will be made to the patient in month to check on\r patient's status.\r\n\r All patients will be instructed to call clinic, nurse or on-call-urologist for any report of\r urethral trauma, which will be evaluated with flexible cystoscopy. These reports will be\r reviewed and documented.\r\n\r Phase 2: Randomized crossover trial, 20 patients. After successful completion of Phase 1,\r patients will be randomized into 2 groups-10 patients will first be randomized into the\r Spirus Catheter Group and 10 patients into the Standard 12 FR Bard Catheter Group.(Coude' or\r straight catheters may be utilized for standard group) As in Phase 1, all patients will\r receive CIC instruction for self-catheterization, specific to the selected catheter and can\r demonstrate efficacy with CIC using selected catheter, before they leave the clinic. Patients\r will then fill out VAS forms for catheter insertion ease and comfort and after each\r subsequent catheterization. Patient will also record time per catheterization and bladder\r drainage for 3 consecutive days. Patients will return to the clinic in 1 week for a progress\r report, return VAS forms and reports. At this time the patient will be switch over to the\r alternate catheter group for 1 week.\r\n\r All patients will be instructed to call clinic, nurse or on-call-urologist for any report of\r urethral trauma, defined as blood on catheter or per meatus. Any occurence of urethral trauma\r will be evaluated with flexible cystoscopy. These reports will be reviewed and documented.\r\n\r All patients will be followed up to one month to check on the patient's status.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male patients\r\n\r - Urinary retention defined as >150cc retained in bladder on post void residual\r\n\r Exclusion Criteria:\r\n\r - Female patients\r\n\r - Known urethral stricture\r\n\r - Active symptomatic Urinary Tract Infection\r\n\r - History of pelvic fracture or urethral disruption\r\n\r - History of previous urethroplasty(urethral reconstructive surgery)\r\n\r - Known Latex allergy\r\n\r - Unable to physically perform CIC\r\n\r - Unable to provide follow up\r\n\r - Unable to give consent\r\n\r - Currently taking chronic narcotic pain 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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{
"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\nTemozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop\r the growth of tumor cells, either by killing the cells or by stopping them from dividing.\r Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy\r that delivers a high dose of radiation directly to the tumor may kill more tumor cells and\r cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may\r kill more tumor cells.\r\n\r PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when\r given together with radiation therapy in treating patients with newly diagnosed glioblastoma\r multiforme or anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - To determine the maximum tolerated dose of temozolomide when given in combination with\r hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients\r with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.\r\n\r Secondary\r\n\r - To determine the time to neuroradiological evidence of tumor recurrence or progression\r in patients treated with this regimen.\r\n\r - To determine the survival time of patients treated with this regimen.\r\n\r - To determine the time spent in a Karnofsky performance status of 60-100%.\r\n\r OUTLINE: This is a dose-escalation study of temozolomide.\r\n\r Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once\r daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo\r hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a\r week for 3 weeks.\r\n\r After completion of study treatment, patients are followed at 1 month, 2 months, and 3\r months, and then every 3 months thereafter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic\r oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not\r involving the brain stem or optics chiasm, diagnosed following biopsy or tumor\r removal.\r\n\r - Age > 18 years\r\n\r - Given written consent\r\n\r - Adequate bone marrow reserve(hemoglobin > 10 grams, Absolute neutrophil count > 1500 /\r mm3, platelets > 100,000/ mm3)\r\n\r - Normal renal function(BUN < 24 mg/dL, Creatinine < 1.3 mg/dL)\r\n\r - Normal liver function(Total Bilirubin < 1.5 mg/dL, SGPT/ALT < 60 U/L)\r\n\r Exclusion Criteria:\r\n\r - Have a Karnofsky score of < 60 [Appendix B] or age < 18 years.\r\n\r - Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic\r astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas,\r gliosarcoma.\r\n\r - Tumors located in the brainstem or optic chiasm.\r\n\r - Prior radiation therapy to the brain\r\n\r - Prior chemotherapy within the past 6 weeks.\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\nFludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders\n\n**Clinical Trial Summary:**\n\nThis clinical trial is studying how well giving fludarabine phosphate and melphalan together\r with total-body irradiation followed by donor stem cell transplant works in treating patients\r with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy\r and total-body irradiation before a donor peripheral blood stem cell transplant helps stop\r the growth of cancer cells or abnormal cells. It may also stop the patient's immune system\r from rejecting the donor's stem cells. The donated stem cells may replace the patient's\r immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor\r effect)\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine the transplant related mortality (TRM) of this reduced intensity\r transplantation (RIT) combination in a patient population that is usually not eligible for a\r full myeloablative allogeneic transplant.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate engraftment, safety, clinical response, evidence of graft-versus-malignancy\r effect/graft-versus-host disease (GVHD) and overall outcomes of treatment with our RIT\r regimen across a variety of hematological conditions.\r\n\r OUTLINE: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5\r to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body\r irradiation on day -1 and allogeneic stem cell transplantation on day 0.\r\n\r Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis\r congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of\r melphalan.\r\n\r After completion of study treatment, patients are followed up periodically.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of a histology documented hematologic malignancy or marrow disorder\r\n\r - Bone marrow failure disorders and other non-malignant hematologic or immunologic\r disorders:\r\n\r - Acquired bone marrow failure disorders include aplastic anemia, paroxysmal\r nocturnal hemoglobinuria (PNH):\r\n\r - Primary allogeneic hematopoietic stem cell transplantation (HSCT) is\r appropriate for selected patients with severe aplastic anemia; however,\r patients with aplastic anemia must have failed at least one cycle of\r standard immunosuppressive therapy with calcineurin inhibitor plus\r anti-thymocyte globulin (ATG) if a fully-matched donor is not available\r\n\r - Patients with PNH must have a history of thrombosis related to PNH\r\n\r - Hereditary bone marrow failure disorders include Fanconi anemia or related\r chromosomal breakage syndrome dyskeratosis congenita, Diamond-Blackfan anemia,\r Shwachman-Diamond syndrome, Kostmann syndrome, congenital amegakaryocytic\r thrombocytopenia:\r\n\r - Fanconi anemia or related chromosomal breakage syndrome: positive chromosome\r breakage analysis using diepoxybutane (DEB) or mitomycin C if applicable\r\n\r - Dyskeratosis: diagnosis is supported by using either telomerase reverse\r transcriptase (TERC) gene mutation in autosomal dominant Dyskeratosis\r Congenita or Xlinked DKC1 gene mutation\r\n\r - Other non-malignant hematologic or immunologic disorders that require\r transplantation\r\n\r - Quantitative or qualitative congenital platelet disorders (including but not\r limited to congenital amegakaryocytopenia, absent-radii syndrome,\r Glanzmann's thrombasthenia)\r\n\r - Quantitative or qualitative congenital neutrophil disorders (including but\r not limited to chronic granulomatous disease, congenital neutropenia)\r\n\r - Congenital primary immunodeficiencies (including but not limited to Severe\r Combined Immunodeficiency Syndrome, Wiskott-Aldrick syndrome, CD40 ligand\r deficiency, T-cell deficiencies)\r\n\r - Acute leukemias:\r\n\r - Subjects must be ineligible for conventional myeloablative transplantation;\r\n\r - Resistant or recurrent disease after at least one standard combination\r chemotherapy regime or first remission patients at high risk of relapse OR First\r remission patients at high risk of relapse:\r\n\r - Acute myeloid leukemia (AML)- antecedent myelodysplastic syndrome, secondary AML,\r high risk cytogenetic abnormalities or normal cytogenetics with high-risk\r molecular features (e.g. Flt3-ITD mutation, mixed-lineage leukemia [MLL],\r wildtype NPM1);\r\n\r - Acute lymphocytic leukemia (ALL)- high or standard risk ALL\r\n\r - Chronic Myeloid Leukemia (CML):\r\n\r - Chronic phase (intolerant or unresponsive to imatinib and/or other tyrosine\r kinase inhibitors), second chronic phase or accelerated phase who are ineligible\r for conventional myeloablative transplantation\r\n\r - Myeloproliferative and myelodysplastic syndromes (MDS):\r\n\r - Myelofibrosis (with/without splenectomy) with intermediate to high risk features\r\n\r - Advanced polycythemia vera not responding to standard therapy\r\n\r - MDS with an international prostate symptom score (IPSS) score of Int-2 or higher\r\n\r - MDS with lower IPSS scores Int-1 or less with severe clinical features such as\r severe neutropenia or thrombocytopenia or high risk chromosome abnormalities such\r as monosomy 7\r\n\r - Secondary massively parallel signature sequencing (MPSS) with any IPSS scores\r\n\r - Chronic myelomoncytic leukemia\r\n\r - Lymphoproliferative disease:\r\n\r - Chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin lymphoma (NHL)\r (recurrent or persistent) fludarabine refractory or with less than 6 months\r duration of complete response (CR) between courses of conventional therapy\r\n\r - Multiple myeloma, progressive disease after autologous stem cell transplant or as\r planned tandem (allogeneic transplant after prior autologous stem cell\r transplant)\r\n\r - Waldenstroms macroglobulinemia (failed one standard regimen)\r\n\r - High grade NHL and diffuse large B-cell lymphoma (DLBCL)\r\n\r - Not eligible for conventional myeloablative HSCT OR failed autologous HSCT\r\n\r - First remission lymphoblastic lymphoma, or small, non-cleaved cell lymphoma or\r mantle cell lymphoma\r\n\r - Hodgkin disease:\r\n\r - Relapsed or refractory after front-line therapy\r\n\r - Failed or were not eligible for autologous transplantation\r\n\r - Failed prior autotransplant\r\n\r - Age >= 3 and =< 75 years for blood and bone marrow transplants and age >= 3, < 60 for\r cord blood transplants\r\n\r - No serious uncontrolled psychiatric illness\r\n\r - No concomitant active malignancy other than non-melanoma skin cancer\r\n\r - Non-pregnant and non-nursing women (women or men with reproductive potential should\r agree to use an effective means of birth control)\r\n\r - Patients may have received prior autologous bone marrow transplant (BMT) or prior\r myeloablative allogeneic BMT (at least 60 days have elapsed)\r\n\r - At least 2 weeks since prior chemotherapy, radiation treatment and/or surgery\r\n\r - Informed consent\r\n\r - DONOR: Permissible HLA matching: Related donors- single antigen mismatch at HLA A, B\r or DRB 1; unrelated donors- a single antigen mismatch at HLA A, B, or C, +/-\r additional single allele level mismatch at A, B, C or DRB1; cord blood >= 4 out of 6\r antigen match at HLA A, B, DRB1)\r\n\r - DONOR: Compatibility at the four most informative HLA loci: A, B, C and DRB1 are\r important for reducing the risk of GVHD and successful transplant outcomes; the A, B,\r C and DRB1 loci comprise 8 possible alleles (a haplotype being inherited from each\r parent); one additional locus, HLA-DQ, is also typed to ascertain haplotypes and\r assist in the search for a compatible donor; however mismatching at DQ has not been\r shown to be associated with adverse outcomes; high resolution molecular typing (at the\r allele level) is now the standard of care for unrelated donor searches and allows\r greater refinement of the search strategy\r\n\r - DONOR: Matched related donor: a single antigen mismatch at A, B, or the DR transplant\r from a family member is associated with a higher risk of GVHD but similar overall\r survival when compared to full identity at these 3 regions; related donor/recipient\r pairs must be matched at 5 of 6 HLA antigens (A, B, DRBl)\r\n\r - DONOR: Unrelated donor: when evaluating patients for unrelated donor transplant, a\r higher degree of matching is preferred due to minimize the risk of GVHD; the A, B, C,\r DRB1 and DQ loci, comprising 10 possible alleles, will be typed routinely for all\r unrelated transplants; given the higher risk of TRM in mismatched transplants, RIT is\r often the best way to mitigate the risk; evolving data from the National Marrow Donor\r Program now makes it possible to estimate the risks of donor-recipient HLA mismatch at\r the allele or antigen level; the higher risk from HLA-mismatching must be carefully\r assessed with respect to the clinical urgency and the patient's risk by the transplant\r physician; antigen level mismatches at DQ are inconsequential to transplant outcomes\r and are ignored with respect to donor selection for the purposes of this protocol,\r with matching requirements confined to the 8 loci involving HLA A, B, C and DRB1; for\r the purpose of this protocol, a single antigen mismatch at HLA A, B, or C, with or\r without additional single allele level mismatch may participate in this protocol for\r voluntary unrelated donors (blood or marrow); patients must be at least antigen-level\r matched at DRB1\r\n\r - DONOR: If a patient has no suitable family donor matched for 5 of 6 HLA antigens (A,\r B, DRB1) and no suitable unrelated donor is identified or for reasons of urgency, the\r patient can be considered a candidate for cord blood transplant, provided a cord blood\r donor is identified with a >= 4 out of 6 antigen match at HLA A, B, DRB1 antigens; the\r cord blood product must provide a minimum of 2 x 10^7 nucleated cells/kg, test\r negative for HIV and Hepatitis A, Band C, and sterility assays have no growth; the\r cord blood products are located through the National Marrow Donor Program, the\r American Registry, or the Bone Marrow Donor Worldwide or other established registries,\r and may be stored in the N.Y Placental Cord Blood Bank, the St. Louis Cord Blood Bank,\r or any of the established, registered International blood and marrow banks\r\n\r - DONOR: Donor must be healthy and have nonreactive test results for all infectious\r disease assays as required by state and federal regulations; donors who screen\r seropositive for hepatitis and/or syphilis must be cleared by infectious disease\r consultation\r\n\r - DONOR: The donor must have no uncontrolled cardiopulmonary, renal, endocrine, hepatic\r or psychiatric disease to render donation unsafe\r\n\r - DONOR: The donor must be able to give informed consent for peripheral blood stem cell\r collection or bone marrow collection\r\n\r - DONOR: Syngeneic donors are not eligible\r\n\r - DONOR: Donors who have poor peripheral venous access, may require central venous line\r placement for stem cell apheresis\r\n\r Exclusion Criteria:\r\n\r - Uncontrolled central nervous system (CNS) disease (for hematologic malignancies)\r\n\r - Karnofsky (adult) or Lansky (for =< 16 years) performance status =< 50%\r\n\r - Diffusing capacity of the lung for carbon monoxide (DLCO) less than 40% predicted,\r corrected for hemoglobin (Hb) and/or alveolar ventilation\r\n\r - Cardiac: left ventricular ejection fraction less than 40%\r\n\r - Bilirubin >= 3 x upper limit of normal\r\n\r - Liver alkaline phosphatase >= 3 x upper limit of normal\r\n\r - Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase\r (SGPT) >= 3 x upper limit of normal\r\n\r - Child's class B and C liver failure\r\n\r - Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula\r for adults or the Schwartz formula for pediatrics\r\n\r - Patients who have received maximally allowed doses (given in 2 Gy fractions, or\r equivalent) of previous radiation therapy to various organs as follows:\r\n\r - Mediastinum 40 Gy\r\n\r - Heart (any volume) 36 Gy\r\n\r - Whole lungs 12 Gy\r\n\r - Small bowel (any volume) 46 Gy\r\n\r - Kidneys 12 Gy\r\n\r - Whole liver 20 Gy\r\n\r - Spinal cord (any volume) 36 Gy\r\n\r - Whole brain 30 Gy Enrollment of patients who previously receive higher than\r allowed dose of radiation to a small volume of lungs, liver, and brain will be\r determine by the discretion of the radiation oncologist on the study\r\n\r - Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or\r other condition which, in the opinion of treating physician, would make this protocol\r unreasonably hazardous for the patient\r\n\r - Human immunodeficiency virus (HIV) positive\r\n\r - Patients who in the opinion of the treating physician are unlikely to comply with the\r restrictions of allogeneic stem cell transplantation based on formal psychosocial\r screening\r\n\r - Females of childbearing potential with a positive pregnancy test\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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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\nFatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients\n\n**Clinical Trial Summary:**\n\nThis goal of this research study is to learn more about fatigue, sleep quality, and other\r symptoms in patients with primary brain tumors who are being treated with radiation therapy.\r\n\r Objectives:\r\n\r PRIMARY OBJECTIVE:\r\n\r 1. The primary objective of this study is to provide preliminary data describing the severity\r and change over time in fatigue using the Brief Fatigue Inventory (BFI) during radiation\r therapy for patients with primary gliomas.\r\n\r SECONDARY OBJECTIVES:\r\n\r 1. To evaluate longitudinal changes in the severity of symptoms and the mean symptom burden\r as measured by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) and\r mood using the Profile of Mood States (POMS) during radiation therapy.\r\n\r 2. To assess alterations in circadian rhythms using actigraphy during radiation therapy and\r the association with sleep quality tools - Pittsburgh Sleep Quality Index (PSQI) and the\r Epworth Sleepiness Scale(ESS), and the severity of BFI and MDASI-BT scores over time.\r\n\r 3. To explore the association between the levels of salivary hormones (melatonin and\r cortisol) and the occurrence of fatigue and symptom burden.\n\n**Clinical Trial Detailed Description:**\n\nQuestionnaires:\r\n\r If you decide to take part in this study, before starting radiation therapy, weekly during\r radiation therapy, and again 3-4 weeks and 6-8 weeks after completing radiation therapy, you\r will complete 4 questionnaires. Three (3) of the questionnaires will be completed during a\r study visit, and the last 1 will be completed at home the next time you come into the clinic.\r You will return the questionnaire completed at home to the study doctor at a study visit. The\r questionnaires will ask questions about fatigue, any symptoms you may have, and your sleeping\r habits. It should take about 30 minutes total to complete all of the questionnaires each\r time.\r\n\r Sleep Diary:\r\n\r You will complete a sleep diary. The sleep diary will be provided to you before starting\r radiation therapy. You will record information in it about your sleep habits, caffeinated\r beverages and drugs you may take, the quality of your sleep, and how you feel when you wake\r up. You will complete the sleep diary during the 48 hours that you are wearing the actigraphy\r watch. You will bring the sleep diary to the clinic every week for the study doctor to\r review.\r\n\r Actigraphy Watch:\r\n\r You will wear an actigraphy watch on your wrist for 48 hours before starting radiation\r therapy, for 48 hours each week during radiation therapy, and again for 48 hours 3-4 weeks\r and 6-8 weeks after completing radiation therapy. The actigraphy watch will measure your\r activity during the day and night. You will bring the actigraphy watch to the clinic every\r week for the study doctor to review.\r\n\r Saliva Collection:\r\n\r You will collect a saliva sample four times during the day before starting radiation therapy,\r one time during the third and last week of radiation therapy, and again 3-4 weeks and 6-8\r weeks after completing radiation therapy. These samples will be used to measure levels of\r neurotransmitters and hormone levels. These are substances which are released in the body\r that may affect sleep and the immune system.\r\n\r Length of Study:\r\n\r You will remain on study for about 8 weeks after you complete radiation therapy.\r\n\r This is an investigational study. Up to 20 patients will take part in this study. All will be\r enrolled at M.D. Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. A new diagnosis of a primary glioma, astrocytoma, oligodendroglioma,\r oligo-astrocytoma, ependymoma, tanycytic ependymoma, anaplastic astrocytoma,\r anaplastic oligodendroglioma, anaplastic oligo-astrocytoma, anaplastic ependymoma\r\n\r 2. Radiation therapy as part of the plan of care\r\n\r 3. Age >/= 18 years of age. Children are excluded from this study because of differences\r in tumor location and biology with differing symptom clusters. A separate study will\r be conducted in the future with children.\r\n\r 4. Ability to speak, write, and read English\r\n\r 5. On corticosteroids at the initiation of radiation therapy.\r\n\r Exclusion Criteria:\r\n\r 1. Tumors involving the suprasellar region, including the pituitary and hypothalamus\r\n\r 2. Cognitive deficits which limit ability to self-report symptoms.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"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\nSorafenib in Newly Diagnosed High Grade Glioma\n\n**Clinical Trial Summary:**\n\nThis is a phase I study to evaluate the safety and tolerability of Sorafenib in combination\r with Temodar and radiation therapy in patients with newly diagnosed high grade glioma\r (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or\r oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes\r it an interesting drug to investigate in the treatment of patients with high grade glioma as\r this agent has anti-angiogenic activity and inhibits other pathways such as Ras,\r Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which\r are potential targets against gliomas.\n\n**Clinical Trial Detailed Description:**\n\nUp to 18 patients will be included in this phase I study. The primary goal of this study will\r be to establish the maximum tolerated dose of sorafenib when used in combination with\r temozolomide and radiation therapy. Secondary goals of this study include: response rate,\r time to treatment failure, 6 month progression-free survival, event free survival and overall\r survival. A correlative study will investigate the pharmacokinetics of sorafenib used in\r combination with radiation therapy and temozolomide.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histological documentation of newly diagnosed malignant glioma\r\n\r - ECOG performance status of 0 or 1\r\n\r - Age ≥18\r\n\r - Life expectancy of at least 12 weeks\r\n\r - Hemoglobin ≥ 9.0 g/dl\r\n\r - Granulocyte count ≥1.5 X 10^9/L\r\n\r - Platelet count ≥100 X 10^9/L\r\n\r - SGOT ≤ 2.5X upper limit of normal (ULN)\r\n\r - SGPT ≤ 2.5X upper limit of normal (ULN)\r\n\r - Alkaline phosphatase ≤4x ULN\r\n\r - Serum creatinine ≤1.5X ULN\r\n\r - Bilirubin ≤1.5X ULN\r\n\r - Spontaneous PT-INR/PTT < 1.5x upper limit of normal (patients on therapeutic\r anticoagulation will be allowed to participate.\r\n\r - Patients must be on a stable or decreasing dose of corticosteroids for at least 2\r weeks\r\n\r - Patient for whom a first line treatment with temozolomide and radiotherapy is adequate\r\n\r - Prophylactic anti-emetic, pentamidine inhalation / co-trimoxazole and anticonvulsants\r are allowed\r\n\r - All patients must sign written informed consent.\r\n\r Exclusion Criteria:\r\n\r - Prior treatment for high grade glioma\r\n\r - Previous exposure to Ras pathway inhibitors\r\n\r - Other concurrent active malignancy (with the exception of cervical carcinoma in situ\r or non melanoma carcinoma of the skin, superficial bladder tumor [Ta, Tis & T1] or any\r cancer curatively treated > 3 years prior to study entry).\r\n\r - Serious medical or psychiatric illness that would, in the opinion of the investigator,\r interfere with the prescribed treatment, including but not limited to: Congestive\r heart failure > NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrythmic\r therapy or uncontrolled hypertension within the last 12 months\r\n\r - Any condition limiting the patient's judgment capacity\r\n\r - History of HIV infection, chronic hepatitis C or B as well as clinically active\r infections (> grade 2 NCI-CTC version 3.0)\r\n\r - History of organ allograft\r\n\r - Renal dialysis\r\n\r - Evidence or history of bleeding diathesis\r\n\r - Major surgery within 4 weeks of start of study treatment, except for neurosurgical\r resection\r\n\r - Autologous bone marrow transplant or stem cell rescue within 4 months of study\r\n\r - Substance abuse, medical, psychological or social conditions that may interfere with\r the patient's participation in the study or evaluation of study results.\r\n\r - Medical condition that prevents the patient from swallowing pills\r\n\r - Use of biologic response modifiers, such as G-CSF within 3 week of study entry.\r\n\r - Pregnant or breast-feeding women.\r\n\r - Refusal to use effective contraception. Women of childbearing potential must have a\r negative pregnancy test performed within 7 days of the start of treatment. Both men\r and women enrolled in this trial must use adequate barrier birth control measures\r during the course of the trial and for at least 3 months after administration of study\r medication.\r\n\r - Known or suspected allergy to the investigational agent or any agent given in\r association with this 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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"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 of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee\n\n**Clinical Trial Summary:**\n\nThe purpose of the study is to compare the efficacy and safety of flavocoxid (Limbrel) with\r Naproxen and placebo in OA of the knee.\n\n**Clinical Trial Detailed Description:**\n\nTo compare the efficacy, safety, quality of life and economic impact of flavocoxid vs\r naproxen.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:Major inclusión criteria:\r\n\r 1. Adults of either gender, ages 35-85, in general good health\r\n\r 2. Diagnosed with OA of the knee, K-L Grade 2-3\r\n\r 3. History of positive response to NSAID's or COX-2 inhibitors\r\n\r 4. Able and willing to discontinue other medicinal OA therapies for length of the study\r (subjects may continue low dose aspirin for cardioprotection)\r\n\r 5. Females of child bearing potential must use acceptable method of birth control\r\n\r Major exclusion criteria:\r\n\r 1. Unwilling or unable to read and sign informed consent document\r\n\r 2. Pregnant and nursing women\r\n\r 3. History of severe cardiovascular disease including, but not limited to chronic angina,\r congestive heart failure, uncontrolled hypertension, acute myocardial infarction\r within past year\r\n\r 4. K-L grade 1 or 4 OA of the target knee\r\n\r 5. chronic bleeding disorder or present use of anticoagulants\r\n\r 6. History of upper G-I bleed in the past 5 years\r\n\r 7. Significant renal disease including nephrotic syndrome, proteinuria >1 gm/24 hrs or\r serum Creatinine >2.0\r\n\r 8. Any arthritic disease that is or has the potential to affect the knees during the\r course of the study\r\n\r 9. Any other condition that might confound evaluation of the target joint including, but\r not limited to, bursitis, tendonitis or internal derangement in or about the knee,\r gait disturbances (e.g. mechanical, neurological conditions or disorders of the back),\r fibromyalgia, polyneuropathies, etc.\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\nThe Value of Traction in Treatment of Lumbar Radiculopathy\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the effectiveness of adding mechanical traction to\r standard physical therapy treatments for patients with low back pain.\n\n**Clinical Trial Detailed Description:**\n\nDespite the opinions of clinical experts that patients who might benefit from traction may\r represent distinct sub-groups of patients, most studies have not attempted to narrow their\r inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these\r studies seem to indicate that traction interventions will be of little benefit when\r administered to large groups of patients without a prior attempt to select which patients are\r most likely to benefit, they are not sufficient to preclude the possibility that a subgroup\r of patients may benefit substantially from the intervention. Recent preliminary studies\r suggest a there exists a subgroup of patients with LBP that is likely to benefit from\r traction.\r\n\r The two primary aims of this study are:\r\n\r 1. Determine the validity of the previously-identified prediction criteria to identify\r patients highly likely to benefit from the addition of traction to a standard physical\r therapy intervention.\r\n\r 2. Compare the overall effectiveness of addition of a traction component to a standard\r physical therapy intervention.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of\r symptoms that has extended distal to the gluteal fold on at least one lower extremity\r within the past 24 hours based on the patient's self-report.\r\n\r - Oswestry disability score of at least 20%\r\n\r - Age at least 18 years and less than 60 years\r\n\r - At least one of the following signs of nerve root compression:\r\n\r 1. Positive ipsilateral or contralateral straight leg raise test (reproduction of\r leg symptoms with straight leg raise < 70 degrees)\r\n\r 2. Sensory deficit to pinprick on the ipsilateral lower extremity\r\n\r 3. Diminished strength of a myotome (hip flexion, knee extension, ankle\r dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower\r extremity\r\n\r 4. Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic\r lower extremity\r\n\r Exclusion Criteria:\r\n\r - Red flags noted in the patient's general medical screening questionnaire (i.e., tumor,\r metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history\r of steroid use, etc.)\r\n\r - Evidence of central nervous system involvement, to include symptoms of cauda equina\r syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the\r presence of pathological reflexes (i.e., positive Babinski)\r\n\r - Patient reports the complete absence of low back and leg symptoms when seated\r\n\r - Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of\r the lumbar spine or pelvis\r\n\r - Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain\r\n\r - Current pregnancy\r\n\r - Inability to comply with the treatment schedule\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\nSuper-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)\n\n**Clinical Trial Summary:**\n\nThe high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic\r astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of\r tumors also exhibits the most aggressive behavior, resulting in median overall survival\r durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of\r either surgical resection, external beam radiation or both. All patients experience a\r recurrence after first-line therapy, so improvements in both first-line and salvage therapy\r are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently\r used intravenous (IV) therapies even cross the blood brain barrier (BBB). Superselective\r Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the\r concentration of drug delivered to the brain while sparing the body of systemic side effects.\r One currently used drug called, Bevacizumab (Avastin) has been shown to be active in human\r brain tumors but its actual CNS penetration is unknown. This phase I clinical research trial\r will test the hypothesis that Bevacizumab can be safely used by direct intracranial\r superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival\r of patients with relapsed/refractory GBM/AA. By achieving the aims of this study we will\r determine the toxicity profile and maximum tolerated dose (MTD of SIACI Bevacizumab. We\r expect that this project will provide important information regarding the utility of SIACI\r Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to\r our patients in the near future.\n\n**Clinical Trial Detailed Description:**\n\nThe current standard of care for recurring GBM is for patients to receive Bevacizumab\r (Avastin) intravenously (IV) at 10mg/kg with CPT-11 (Irinotecan) every two weeks until their\r tumor grows more than 25%. At that point, these patients are deemed treatment failures and\r are given another treatment. Because of the blood brain barrier (BBB) where IV drugs do not\r penetrate the blood vessel walls well to get into the brain, no one knows for sure if these\r IV drugs actually get into the brain after infusion. Previous studies have shown that if you\r want to increase your penetration of drug to the brain, that intra-carotid artery\r (intraarterial) delivery is superior to standard intravenous delivery. Previous techniques\r using intra arterial (intracarotid) infusion still were non-selective as drug delivery still\r went to all blood vessels in the brain, so patients still had significant adverse events,\r such as blindness. Newer techniques in interventional neuroradiology have allowed for a more\r selective delivery of catheters higher up into the arterial tree where agents such as\r chemotherapies, can be delivered without the risk of adverse affects such as blindness. In\r fact, studies here at Cornell and MSKCC have developed very new and exciting super selective\r intraarterial delivery treatment for Pediatric Eye Tumors with little toxicity. Therefore,\r this trial will ask one simple question: Is it safe to delivery a patient's first dose of\r Avastin intraarterially using these super selective delivery techniques instead of the\r standard intravenous route of administration? This should not only increase the amount of\r drug that gets to the tumor but also spare the patient any adverse effects from a less\r selective delivery. During that single dose of intraarterial Avastin, the patient will also\r receive a dose of mannitol that opens up the blood brain barrier to improve delivery of the\r agent to the brain. After that single dose of Mannitol and Avastin intraarterially, the\r patient will be evaluated for 4 weeks to assess for toxicity. If no toxicity, then the\r patient will go on and get the standard chemotherapy (Avastin and CPT-11) every two weeks as\r is routine unless they fail. After this you are done with the \"experimental\" aspects of the\r protocol. This is a Phase I trial that is designed to test the safety of the single dose\r intraarterial delivery of Avastin and Mannitol, prior to starting standard IV Avastin and\r CPT-11.\r\n\r In summary:\r\n\r Current Standard of Care:\r\n\r Day 0: Intravenous Avastin (10mg/kg) and CPT-11 Day 14, 28 (and every two weeks thereafter):\r Intravenous Avastin and CPT-11\r\n\r Experimental portion of this proposal:\r\n\r Day 0: Intraarterial Avastin single dose (starting at 2mg/kg and up to 10mg/kg) after\r Mannitol to open the blood brain barrier Day 28 (and every two weeks thereafter): Intravenous\r Avastin and CPT-11\r\n\r 1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol\r 25%; 3-10 mL/s for 30seconds) in order to disrupt the blood brain barrier. This\r technique has been used in several thousand patients in previous studies for the IA\r delivery of chemotherapy for malignant glioma.\r\n\r 2. To add a single intraarterial delivery (SIACI) of the Avastin prior to beginning the\r standard IV Avastin and CPT-11 therapy for patients with recurring or relapsing high\r grade glioma. After a one cycle observation period assess for toxicity from the IA\r infusion, the subject will receive Intravenous (IV) bevacizumab 10 mg/kg and irinotecan\r (CPT-11) 125mg/m2 every 14 days as is standard therapy for relapsing recurring GBM.\r\n\r The dose escalation algorithm is as follows: We will use a single intracranial superselective\r intraarterial infusion of Avastin, starting at a dose of 2mg/kg in the first three patients.\r Assuming no dose limiting toxicity during the first 28 days after IA infusion, the patient\r will then begin their standard chemotherapy regimen which is Avastin and CPT-11 every two\r weeks. The doses will be escalated to 4,6,8 and finally 10mg/kg in this Phase I trial.\r\n\r Inclusion criteria Include: Males or females, ≥18 years of age, with documented histologic\r diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma\r (AA) or anaplastic mixed oligoastrocytoma (AOA).\r\n\r Both hematologic and non-hematologic toxicity will be determined and scored according to the\r NCI Common Toxicity Criteria (version 3.0). Monitoring will be conducted by post procedure CT\r scan (at 6-12 hours post procedure), serial history, neurological and physical examinations\r together with serial blood counts, prothrombin time (PT), partial thromboplastin time (PTT)\r and chemistries. MRI will be performed every two cycles or approximately every two months.\r\n\r Response will be evaluated after two cycles of chemotherapy via a MRI with the injection of\r contrast. Subjects who show an objective response (reduction in tumor size) or stable disease\r after 2 cycles of treatment will be able to continue on study. Progressive disease will\r require that subjects be taken off the research protocol. The following will be evaluated\r every cycle, and then during follow-up: neurological examination, physical examination,\r performance status, laboratory parameters and review of adverse reactions. Contrast enhanced\r MRI (MRI with gadolinium is the preferable imaging study except in case where MRI is\r contraindicated i.e., in those with pacemakers or metallic implants. In these subjects, CT\r with contrast is acceptable) will be performed every two-treatment cycles under this research\r protocol. The following subjects will be taken off protocol: those with progressive disease;\r those who experience dose-limiting toxicity (DLT). Follow-up will continue until disease\r progression or death. Survival will be measured from the time of the first dose of IA\r Avastin® (given at the start of each treatment cycle).\r\n\r The patient will not be responsible for any additional costs associated with enrollment in\r the trial. All costs of the IA delivery will be submitted to the patient's insurance\r provider. WCMC will not be named as a sponsor of the study nor will it cover the cost of the\r experimental procedure.\n\n**Clinical Trial Eligibility Criteria:**\n\nINCLUSION\r\n\r - Male or female patients of greater or equal18 years of age.\r\n\r - Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma\r multiforme (GBM), anaplastic astrocytoma (AA)\r\n\r - Patients with a histologically confirmed low-grade brain tumor who relapse with an\r enhancing tumor on MRI can be evaluated for toxicity only.\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. NOTE: Radiographic\r procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have\r been performed within three weeks of treatment on this research study.\r\n\r - Patients must have a Karnofsky performance status greater or equal to 60% (or the\r equivalent ECOG level of 0-2) (see Appendix A; Performance Status Evaluation) and an\r expected survival of greater or equal to three months.\r\n\r - Patients must be able to understand informed consent. Informed consent must be\r obtained at the time of patient screening.\r\n\r - Because of known concerns with Avastin and wound healing, all craniotomy patients are\r eligible for the treatment if they have had a craniotomy > two weeks prior to IA\r therapy. Craniotomy after SIACI bevacizumab therapy should wait 4 weeks.\r\n\r - Pre-enrollment coagulation parameters (PT and PTT) must be less than or equal to1.5X\r the IUNL.\r\n\r - Patients must have adequate hematologic reserve with WBC greater than or equal to\r 2800/mm3, absolute neutrophils greater than or equal to1500/mm3 and platelets greater\r than or equal to 100,000/ mm3.\r\n\r - Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional\r upper limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.\r\n\r - No external beam radiation for four weeks prior to treatment under this research\r protocol.\r\n\r - No chemotherapy for three weeks prior to treatment under this research protocol.\r\n\r EXCLUSION:\r\n\r - Patients previously treated with more than 6 cycles (28 days each) of Bevacizumab at\r 10/mg/kg.\r\n\r - Women who are pregnant or lactating.\r\n\r - Women of childbearing potential and fertile men who decline to use effective\r contraception during and for a period of three 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.\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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"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\nLowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial\n\n**Clinical Trial Summary:**\n\nABSTRACT\r\n\r Background:\r\n\r It is well recognized that excess dietary salt intake plays a major role in the development\r of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and water\r retention (excess volume) which is associated with hypertension.\r\n\r Hypotheses:\r\n\r Hypothesis 1:\r\n\r Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as\r assessed by Bioelectrical Impedance Analysis (BIA).\r\n\r Hypothesis 2:\r\n\r Dietary salt restriction will result in improved blood pressure control in patients with CKD\r stages 3-4.\r\n\r Hypothesis 3:\r\n\r Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.\r\n\r Patients and Trial Design: This randomized crossover pilot study is designed to assess the\r effect of salt restriction on volume status in patients with CKD stages 3 and 4.\r\n\r Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of <85 mmol\r sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of\r usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary\r counseling in person at each study visit and at weekly intervals by phone calls from study\r dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical\r examination with assessments for weight, blood pressure, pulse, anthropometrics and a\r standardized clinical assessment of volume status. (ii) volume status using bioelectrical\r impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone\r Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance,\r and serum electrolytes will be assessed for safety.\r\n\r Data Analysis: BIA measurements in the low salt group will be compared with the regular diet\r group using the standard linear model analysis for 2x2 crossover trials. Additionally,\r 24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be\r compared between the two groups.\r\n\r Future Implications: A significant reduction in the degree of volume expansion (as assessed\r by BIA) and blood pressure as a result of a salt restricted diet would have implications for\r renal and cardiovascular protection and would warrant confirmation by a larger randomized\r trial.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Individuals eligible to participate in this study must meet all of the following criteria:\r\n\r - Willing and able to provide written, signed informed consent after the nature of the\r study has been explained, and prior to any research-related procedures.\r\n\r - Age ≥ 18 years and ≤ 85 years.\r\n\r - Willing and able to comply with all study procedures.\r\n\r - Patients with eGFR of 20 to 60 ml/min/173m2 by the abbreviated (4-variable) MDRD\r equation and a relatively stable clinical course.\r\n\r - Sitting systolic blood pressure ≥ 100 mmHg prior to study entry (to exclude people at\r risk from hypotension from dietary salt reduction).\r\n\r Exclusion Criteria:\r\n\r Individuals who meet any of the following exclusion criteria will not be eligible to\r participate in the study:\r\n\r - Recent acute illness (≤1 month). Minor ailments such as a recovered common cold or\r allergic rhinitis would not be considered as exclusion criteria but would be left to\r the site PI's discretion.\r\n\r - Recent hospitalization (≤1 month) unless clearly for a minor elective procedure\r unlikely to interfere with BIA measurements. The final decision will be left to the\r site PI's discretion.\r\n\r - Any psychological condition (including alcoholism) that could interfere with the\r patient's ability to comply with the study protocol.\r\n\r - Subjects with baseline 24-hour urinary sodium excretion ≤100 mmol/day.\r\n\r - Amputation of a limb other than fingers or toes.\r\n\r - Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other\r types of metal objects in the body (other than dental fillings).\r\n\r - Coronary stents or metal suture material in the heart.\r\n\r - Use of any investigational product or investigational medical device within 30 days\r prior to screening, or requirement for any investigational agent prior to completion\r of all scheduled study assessments.\r\n\r - Weight over 300 pounds (limitation for examination table).\r\n\r - Pregnancy or lactation.\r\n\r - Patients with kidney diseases known to be associated with salt wasting (see above).\r\n\r - Patients with atrial fibrillation as ambulatory blood pressure measurements may not be\r accurate in this setting.\r\n\r - Any condition that, in the view of the PI, places the subject at high risk of poor\r treatment compliance or of not completing 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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"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\nDoes Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery?\n\n**Clinical Trial Summary:**\n\nUnder the influence of epidural analgesia, patients may not feel the urge to urinate, which\r can result in urinary retention and bladder overdistension.\r\n\r The use of a transurethral catheter is associated with significant morbidity such as patient\r discomfort, urinary tract infections, urethral trauma and stricture.\r\n\r Urodynamic changes under thoracic epidural anaesthesia are still unknown. The aim of this\r study is to compare lower urinary tract function before and during thoracic epidural\r analgesia within segments T2 to T10 for postoperative pain treatment in patients undergoing\r thoracotomy or sternotomy.\n\n**Clinical Trial Detailed Description:**\n\nBackground\r\n\r 1. Background Acute urinary retention is one of the most common complications after surgery\r and anesthesia. It can occur in patients of both sexes and all age groups and after all types\r of surgical procedures. It is linked to several factors including increased intravenous\r fluids, postoperative pain and type of anaesthesia 1.\r\n\r Micturition depends on coordinated actions between the detrusor muscle and the external\r urethral sphincter. Motorneurons of both muscles are located in the sacral spinal cord and\r coordination between them occurs in the pontine tegmentum of the caudal brain stem.\r Motorneurons innervating the external urethral sphincter are located in the nucleus of Onuf,\r extending from the S1 to the S3 segment. The detrusor smooth muscle is innervated by\r parasympathetic fibers, which reside in the sacral intermediolateral cell group and are\r located in S2-4. Sympathetic fibers innervating the bladder and urethra play an important\r role in promoting continence and are located in the intermediolateral cell group of the\r lumbar cord (L1-L4). Most afferent fibers from the bladder enter the sacral cord through the\r pelvic nerve at segments L4-S2 and the majority are thin myelinated or unmyelinated.\r\n\r Unlike spinal anesthesia, which is an all or none block, epidural anesthesia has applications\r ranging from analgesia with minimal motor block to dense anesthesia (differential blockade).\r Because epidural anesthesia can be performed at various levels of the spinal cord, it is\r possible to block only a portion of the spinal cord (segmental blockade). Therefore it can be\r assumed that epidural analgesia within segments Th 4-6 to Th 10-12 has no or minimal\r influence on the micturition reflex.\r\n\r There are few studies on the urodynamic effects of various anaesthetic agents 2-8, focused on\r lumbar epidural anaesthesia. Under the influence of epidural analgesia, patients may not feel\r the urge to urinate, which can result in urinary retention and bladder overdistension.\r Overfilling of the bladder can stretch and damage the detrusor muscle.\r\n\r For example, the use of lumbar epidural analgesia for labor and delivery has frequently been\r implicated as a causative factor for postpartum urinary retention. This is supported by the\r fact that these patients demonstrate a difficulty voiding 7. Spinal and epidural opioid\r administration influence the function of the lower urinary tract by direct spinal action on\r the sacral nociceptive neurons and autonomic fibres 9.\r\n\r Long acting local anesthetics administrated intrathecally rapidly block the micturition\r reflex. Detrusor contraction is restored approximately 7-8 hours after spinal injection of\r bupivacaine 10. For this reason, bladder catheterisation is a common practice in patients\r with spinal or epidural anesthesia.\r\n\r The use of a transurethral catheter is associated with significant morbidity such as patient\r discomfort, urinary tract infections, urethral trauma and stricture. The risk of infection\r with a single catheterization is 1-2% and can rise by 3 to 7 % for every additional day with\r a indwelling catheter 11. Traumatic or prolonged catheterization may lead to urethritis and\r to urethral strictures 12. There has yet been no consensus for appropriate catheterisation\r strategy 13-15 during regional anesthesia.\r\n\r Urodynamic changes under thoracic epidural anaesthesia are still unknown. The aim of this\r study is to compare lower urinary tract function before and during thoracic epidural\r analgesia within segments T2 to T10 for postoperative pain treatment in patients undergoing\r thoracotomy or sternotomy. We expect that a better knowledge on the bladder function under\r epidural analgesia could lead to a more restrictive use of perioperative transurethral\r catheters.\r\n\r Objective\r\n\r The aim of this study is to compare lower urinary tract function before and during thoracic\r epidural analgesia within segments T2 to T10 for postoperative pain treatment in patients\r undergoing thoracotomy or sternotomy. We expect that a better knowledge on the bladder\r function under epidural analgesia could lead to a more restrictive use of perioperative\r transurethral catheters.\r\n\r Hypothesis Thoracic epidural analgesia does not influence urinary micturition in the male and\r female. Therefore transurethral catheterisation is not mandatory for all patients with\r thoracic epidural analgesia undergoing thoracic surgery.\r\n\r Methods\r\n\r Prospective, open, observational, follow up study. Setting: Department of thoracic surgery,\r University Hospital Bern\r\n\r Study population A total of 26 patients (13 men and 13 women per group) undergoing thoracic\r surgery who receive thoracic epidural anesthesia perioperatively will be needed.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Written informed consent\r\n\r - Thoracic surgery including thoracotomy and sternotomy\r\n\r - Thoracic epidural analgesia\r\n\r Exclusion Criteria\r\n\r - Contraindications to epidural anesthesia or refusal\r\n\r - Preoperative residual urine volume > 100ml\r\n\r - International Prostate Symptom Score (IPSS) > 7\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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"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\nRadiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized\r radiation therapy that delivers a high dose of radiation directly to the tumor may kill more\r tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as\r temozolomide, work in different ways to stop the growth of tumor cells, either by killing the\r cells or by stopping them from dividing. It is not yet known whether radiation therapy is\r more effective when given together with or without temozolomide in treating patients with\r low-grade glioma.\r\n\r PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it\r works when given together with or without temozolomide in treating patients with low-grade\r glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - To determine whether the addition of temozolomide to fractionated radiotherapy improves\r the progression-free survival (PFS) of patients with symptomatic or progressive\r low-grade gliomas.\r\n\r - To determine whether the addition of temozolomide to fractionated radiotherapy improves\r the median overall survival (OS) of these patients.\r\n\r Secondary\r\n\r - To determine whether combination therapy with temozolomide and radiotherapy improves or\r maintains cognition and quality of life compared to radiotherapy alone.\r\n\r - To compare the toxicities (severe or worse [≥ grade 3]) of radiotherapy with vs without\r temozolomide in these patients.\r\n\r - To assess the impact of the presence or absence of 1p and 19q deletion on PFS and OS.\r\n\r - To determine the impact of 1p and 19q status on PFS and OS of patients treated with\r temozolomide.\r\n\r - To create a tumor and tissue bank, including plasma and germ line DNA, within the ECOG\r Pathology Coordinating Office.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to age (< 40 years vs\r ≥ 40 years), 1p and 19q status (both deleted vs either/both intact vs undeterminable),\r pre-operative maximum tumor diameter (< 6 cm vs ≥ 6 cm [based on T2 or FLAIR MRI]), Karnofsky\r performance status (60-70% vs 80-100%), and contrast enhancement on pre-treatment MRI scan\r (present vs absent). Patients are randomized to 1 of 2 treatment arms.\r\n\r - Arm I: Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once\r daily 5 days a week for 5½ weeks (28 fractions).\r\n\r - Arm II: Patients undergo radiotherapy as in arm I and receive concurrent oral\r temozolomide once daily for 5½ weeks. Beginning 28 days after completion of\r chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5.\r Treatment with temozolomide repeats every 28 days for 12 courses in the absence of\r disease progression or unacceptable toxicity.\r\n\r Some patients undergo quality-of-life and neurocognitive (e.g., visual scanning speed,\r divided attention, language, memory, and fine motor skills) assessments at baseline, annually\r until disease progression, and at the time of disease progression.\r\n\r Tumor tissue samples are collected at baseline for confirmation of diagnosis and\r determination of 1p and 19q deletion status. Peripheral blood, serum, and additional tumor\r tissue samples may be collected for further research studies.\r\n\r After completion of study treatment, patients are followed up periodically for up to 15\r years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed* supratentorial low-grade glioma, including 1 of the\r following:\r\n\r - Grade 2 astrocytoma\r\n\r - Grade 2 oligodendroglioma\r\n\r - Grade 2 oligoastrocytoma (mixed glioma containing astrocytoma and\r oligodendroglioma)\r\n\r - NOTE: *If the pathology from multiple procedures supports the diagnosis of a brain\r tumor, the qualifying pathology of grade 2 astrocytoma, oligodendroglioma, or\r oligoastrocytoma must be the most recent pathological diagnosis; no pathological\r diagnosis of grade 3 or 4 glioma at any time\r\n\r - Paraffin-embedded tumor specimen available for submission for confirmation of\r pathological review and determination of 1p and 19q deletion status\r\n\r - Patients must currently meet ≥ 1 of the following criteria*:\r\n\r - Uncontrolled symptoms, defined as any of the following:\r\n\r - Headaches associated with mass effect\r\n\r - Uncontrolled seizures despite two different antiepileptic drug regimens\r (i.e., two antiepileptic drugs tested either sequentially or in combination)\r\n\r - Focal neurological symptoms\r\n\r - Cognitive symptoms or deficits\r\n\r - Tumor progression by serial MRIs, defined as any of the following:\r\n\r - New or progressive enhancement\r\n\r - New or progressive T2 or FLAIR signal abnormality\r\n\r - Age ≥ 40 years\r\n\r - NOTE: *Patients < 40 years of age whose only symptom of low-grade glioma is seizures\r that are well-controlled on antiepileptic drugs AND who have no evidence of\r radiographic progression are not eligible.\r\n\r - Patients who have undergone gross total resection and have no detectable residual\r disease are eligible\r\n\r - No pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or\r dysembryoplastic neuroepithelial tumors\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Karnofsky performance status 60-100%\r\n\r - WBC ≥ 3,000/mm^3\r\n\r - ANC ≥ 1,500/mm^3\r\n\r - Platelet count ≥ 100,000/mm^3\r\n\r - Hematocrit ≥ 30%\r\n\r - Bilirubin ≤ 2 times upper limit of normal (ULN)\r\n\r - AST and ALT ≤ 3 times ULN\r\n\r - Creatinine ≤ 2.0 times ULN\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Able to undergo MRI with and without contrast\r\n\r - No other malignancy within the past 5 years, except for nonmelanoma skin cancer or\r cervical carcinoma in situ\r\n\r - No uncontrolled infection\r\n\r - No known HIV positivity\r\n\r - No medical disorder that would increase risks associated with radiotherapy and\r temozolomide\r\n\r - No other disorder that would limit life expectancy to < 5 years\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - No prior radiotherapy, cytotoxic chemotherapy, radiosurgery, or investigational\r therapy directed at the brain tumor\r\n\r - Any number of prior surgical procedures for the brain tumor allowed\r\n\r - No prior radiotherapy to the head unless the radiotherapy ports entirely excluded the\r brain\r\n\r - At least 2 weeks since any prior brain surgery (e.g., stereotatic biopsy, open biopsy,\r or resection)\r\n\r - At least 6 weeks since prior MRI and chest x-ray\r\n\r - If resection is performed, an MRI after surgery is required\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\nPresurgery Bortezomib for Recurrent Malignant Gliomas Followed by Postop Bortezomib & Temozolomide\n\n**Clinical Trial Summary:**\n\nBortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell\r growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the\r growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving\r bortezomib before surgery may make the tumor smaller and reduce the amount of normal tissue\r that needs to be removed. Giving bortezomib together with temozolomide after surgery may kill\r any tumor cells that remain after surgery.\r\n\r This phase II trial is studying how well giving bortezomib before surgery followed by giving\r bortezomib together with temozolomide after surgery works in treating patients with recurrent\r malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nPatients receive bortezomib IV on days 1, 4, and 8. Patients then undergo surgical resection\r of the tumor on day 8 or 9.\r\n\r Beginning approximately 14 days after surgery, patients receive oral temozolomide on days 1-7\r and 14-21 and bortezomib IV on days 7 and 21. Treatment repeats every 28 days for up to 2\r years in the absence of disease progression or unacceptable toxicity.\r\n\r Tumor tissue and blood samples are collected periodically for biomarker analysis, gene\r methylation studies, and pharmacokinetic studies.\r\n\r After completion of study therapy, patients are followed up every 3 months for 2 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed malignant glioma, including any of the following subtypes:\r\n\r - Glioblastoma multiforme\r\n\r - Gliosarcoma\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic mixed oligoastrocytoma\r\n\r - Malignant astrocytoma not otherwise specified\r\n\r - Must show unequivocal evidence of tumor recurrence or progression by MRI or CT scan\r with contrast\r\n\r - Candidate for surgery AND requires surgery\r\n\r - Evaluable or measurable disease following resection of recurrent tumor is not\r required\r\n\r - Failed prior standard radiotherapy and temozolomide\r\n\r - Patients who have undergone stereotactic radiosurgery must have confirmation of\r true progressive disease (rather than radiation necrosis) by PET scan, magnetic\r resonance spectroscopy (MRS), or magnetic resonance perfusion (MRP) prior to\r surgery\r\n\r - Patients with lower-grade gliomas that have undergone radiographic malignant\r transformation allowed provided they failed radiotherapy (with or without\r temozolomide) and require surgery\r\n\r - Life expectancy > 12 weeks\r\n\r Exclusion Criteria:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - No other medical issues (e.g., bleeding, infection, HIV, or serious medical or\r psychiatric illness) that would preclude study therapy\r\n\r - Myocardial infarction within the past 6 months\r\n\r - No other active cancer(s) except non-melanoma skin cancer or carcinoma in situ of the\r cervix, unless in complete remission and off of all therapy for that cancer for ≥ 3\r years\r\n\r - No hypersensitivity to bortezomib, boron, or mannitol\r\n\r - More than 4 weeks since prior radiotherapy\r\n\r - At least 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)\r\n\r - At least 3 weeks since prior investigational drugs\r\n\r - At least 2 weeks since prior enzyme-inducing anticonvulsants\r\n\r - Concurrent non-enzyme-inducing anticonvulsants allowed\r\n\r - No other concurrent standard or investigational anticancer 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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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r - Growth of new blood vessels (angiogenesis) provides many tumors, including brain tumors,\r with needed nutrients and oxygen for cancer cells to survive. One possible treatment for\r different kinds of cancer involves treatment with drugs that slow or stop angiogenesis\r and prevent further tumor growth.\r\n\r - Vandetanib is an oral medication known to block angiogenesis and has shown significant\r antitumor activity in laboratory and animal studies. Vandetanib appears to be well\r tolerated by patients at specific daily doses.\r\n\r - Carboplatin is a drug that interrupts division of cancer cells and has been shown to be\r a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating\r brain tumors, but researchers are interested in gathering more information about how it\r works as a treatment for patients who have not responded to initial surgery, radiation,\r or chemotherapy.\r\n\r Objective:\r\n\r - To determine the safety and effectiveness of vandetanib and carboplatin, given together or\r sequentially, against recurrent high-grade gliomas.\r\n\r Eligibility:\r\n\r - Adults diagnosed with a malignant glioma who have received standard treatments that no\r longer appear to be effective.\r\n\r Design:\r\n\r - Patients will be assigned to one of two groups. Group 1 patients (combination group)\r will receive oral vandetanib for 28 days and intravenous (IV) carboplatin (once at the\r beginning of the 28-day cycle). Group 2 patients (sequential group) will receive IV\r carboplatin alone (once at the beginning of the 28-day cycle) and then oral vandetanib\r (300 mg daily) for 28 days if the tumor grows or the patient develops unacceptable\r carboplatin toxicity.\r\n\r - Treatment will continue in 28-day cycles for 1 year for both groups.\r\n\r - Patients will undergo a number of tests and procedures during the treatment cycle,\r including physical examinations, routine laboratory tests, electrocardiograms, and\r magnetic resonance imaging (MRI) scans\r\n\r - At the end of 1 year of treatment, patients will be reevaluated for possible\r continuation of drug therapy.\n\n**Clinical Trial Detailed Description:**\n\nBackground:\r\n\r In vivo experiments have documented the ability of vandetanib (ZD6474) to inhibit tumor\r growth in various preclinical tumor models. Given the pronounced neovasculature associated\r with malignant gliomas, and abundant published data demonstrating the dependence of glioma\r growth on the maintenance and proliferation of this neovasculature, vandetanib represents a\r potentially promising new therapeutic approach to these otherwise refractory tumors. Phase II\r data of vandetanib for recurrent glioblastomas conducted at the National Institutes of Health\r showed promising activity but responses were usually short-lasting.\r\n\r Carboplatin has shown activity as monotherapy in the treatment of recurrent malignant gliomas\r in adults and preclinical data generated at Dr. Fines' laboratory demonstrate additive\r anti-glioma activity with vandetanib. The safety profile of carboplatin and the preclinical\r and clinical data supports its use in combination with vandetanib in patients with malignant\r gliomas.\r\n\r Vandetanib is also an epidermal growth factor receptor (EGFR) inhibitor and it has been\r demonstrated that the presence of the EGFRvIII mutant and/or the presence of an intact\r phosphatase and tensin homolog deleted on chromosome 10 (PTEN) and non-phosphorylated protein\r kinase B (AKT) predict for a higher likelihood of response to the EGFR inhibitors Tarceva and\r Iressa.\r\n\r Objectives:\r\n\r To establish data regarding the anti-tumor activity of vandetanib in combination with\r carboplatin and single agent carboplatin and to collect information regarding the spectrum of\r toxicities.\r\n\r To determine if the presence of the EGFRvIII mutant and/or the presence of an intact PTEN and\r non-phosphorylated AKT predict for a higher likelihood of response to vandetanib.\r\n\r Eligibility:\r\n\r Patients with histologically proven malignant glioma are eligible for this study.\r\n\r Design:\r\n\r Patients will be randomized (1:1) to one of two groups. Patients in group one will be treated\r with vandetanib (300 mg daily for patients not on enzyme inducing anti-epileptic drugs\r (EIAEDs) and 400 mg daily for patients on EIAEDs) and with carboplatin (area under the\r concentration-time curve at steady-state [area under curve (AUC)], 6mg/mL x min) once every\r 4-week cycle (combination group). Patients in group two will receive carboplatin alone (AUC\r 6mg/mL x min) once every 4-week cycle. Patients who develop tumor progression or unacceptable\r toxicity on carboplatin alone (group 2) can then receive single agent vandetanib (300 mg\r daily for patients not on enzyme inducing anti-epileptic drugs (EIAEDs) and 400 mg daily for\r patients on EIAEDs) in 4-week cycles (sequential group). A total of 128 evaluable patients\r will be analyzed. The total accrual ceiling will allow for 74 patients to be enrolled in the\r glioblastoma multiforme (GBM) stratum and 74 patients in the anaplastic gliomas (AG) stratum\r (total 148) to factor in replacing those patients who come off treatment prior to cycle 1.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r Patients with histologically proven malignant primary gliomas who have progressive disease\r after radiotherapy will be eligible for this protocol. These include glioblastoma\r multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma\r (AO), anaplastic mixed oligoastrocytoma (AMO), and malignant glioma/astrocytoma NOS.\r\n\r Patients must have an magnetic resonance imaging (MRI)/computed tomography (CT) scan\r performed within 14 days prior to registration and on a fixed dose of steroids for at least\r 5 days. If the steroid dose is increased between the date of imaging and registration a new\r baseline MRI/CT is required. The same type of scan, that is, MRI or CT must be used\r throughout the period of protocol treatment for tumor measurement.\r\n\r Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible as long as all of the following conditions apply:\r\n\r Patients will be eligible four weeks after surgery if they have recovered from the effects\r of surgery.\r\n\r Residual disease following resection of recurrent tumor is not mandated for eligibility\r into the study. To best assess the extent of residual disease post-operatively, a CT/MRI\r should be done:\r\n\r - no later than 96 hours in the immediate post-operative period or\r\n\r - at least 4 weeks post-operatively, and\r\n\r - within 14 days of registration, and\r\n\r - on a steroid dosage that has been stable for at least 5 days.\r\n\r If the 96 hour scan is more than 14 days before registration, the scan needs to be\r repeated. If the steroid dose is increased between the date of imaging and registration, a\r new baseline MRI/CT is required on a stable steroid dosage for at least 5 days.\r\n\r Patients must have failed prior radiation therapy.\r\n\r All patients or their previously designated durable power of attorney (DPA) (if the patient\r is deemed by the treating physician to be cognitively impaired or questionably impaired in\r such a way that the ability of the patient to give informed consent is questionable) must\r sign an informed consent indicating that they are aware of the investigational nature of\r this study.\r\n\r Patients must be greater than or equal to 18 years old, and must have a life expectancy\r greater than 8 weeks.\r\n\r Patients must have a Karnofsky performance status of greater than or equal to 60.\r\n\r Patients must be at least six weeks from radiation therapy. Additionally, patients must be\r at least 6 weeks from nitrosoureas, 4 weeks from temozolomide, 3 weeks from procarbazine,\r and 2 weeks from last vincristine administration. Patients must be at least 4 weeks from\r other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g.,\r interferon, tamoxifen) including investigative agents.\r\n\r Patients must have adequate bone marrow function (white blood cell (WBC) greater than or\r equal to 3,000/microL, absolute neutrophil count (ANC) greater than or equal to\r 1,500/mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin\r greater than or equal to 10 gm/dl), adequate liver function (aspartate aminotransferase\r (AST), alanine aminotransferase (ALT) and alkaline phosphatase 2.5 less than or equal to\r upper limit of normal (ULN) and bilirubin less than or equal to 1.5 times ULN), and\r adequate renal function (creatinine less than or equal to 1.5 mg/dL and/or creatinine\r clearance greater than or equal to 60 cc/min) before starting therapy. Patients must also\r have serum potassium greater than or equal to 3.5 mg/dL, magnesium greater than or equal to\r 0.75 mmol/L and calcium levels within normal levels; supplementation is allowed. In cases\r where the serum calcium is below the normal range, 2 options would be available: 1) the\r calcium adjusted for albumin is to be obtained and substituted for the measured serum\r value. Exclusion is to then be based on the adjusted for albumin values falling below the\r normal limit. 2) Determine the ionized calcium levels. Exclusion is then to be based if\r these ionized calcium levels are out of normal range despite supplementation. These tests\r must be performed within 14 days prior to registration. Eligibility level for hemoglobin\r may be reached by transfusion.\r\n\r Patients must either not be receiving steroids, or be on a stable dose of steroids for at\r least five days prior to registration.\r\n\r This study was designed to include women and minorities, but was not designed to measure\r differences of intervention effects. Males and females will be recruited with no preference\r to gender. No exclusion to this study will be based on race. Minorities will actively be\r recruited to participate.\r\n\r Patients must not be pregnant or nursing, and all patients (both men and women) must be\r willing to practice birth control during and for 2 months after treatment with vandetanib\r and/or carboplatin. Women of childbearing potential (WCBP) must have a negative serum or\r urine pregnancy test. In addition, WCBP patients must agree to use adequate contraceptive\r methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation;\r intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).\r\n\r A 12 lead electrocardiogram (ECG) to be performed within 2 weeks of trial entry with\r corrected QT interval (QTc) less than 480 msec. If a patient has a QT interval corrected\r for heart rate using Bazett's) QTcB interval > 480 ms on screening ECG, the screening ECG\r may be repeated twice [at least 24 hours apart] for a total of 3 ECGs. The average QTcB\r from the 3 screening ECGs must be less than or equal to 480 ms in order for the patient to\r be eligible for the study).\r\n\r EXCLUSION CRITERIA:\r\n\r Patients who, in the view of the treating physician, have significant active hepatic,\r renal, or psychiatric diseases are ineligible.\r\n\r Prior treatment with vandetanib.\r\n\r Prior treatment with platinum-based therapy.\r\n\r Patients known to have an allergic response to mannitol.\r\n\r Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava\r syndrome (SVC), New York Heart Association (NYHA) classification of heart disease greater\r than or equal to 2 within 3 months before entry; or presence of cardiac disease that, in\r the opinion of the investigator, increases the risk of ventricular arrhythmia.\r\n\r History of arrhythmia (multifocal premature ventricular contractions PVCs), bigeminy,\r trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is\r symptomatic or requires treatment (Common Terminology Criteria for Adverse Events (CTCAE)\r grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled\r on medication is not excluded.\r\n\r QTc prolongation with other medications that required discontinuation of that medication.\r\n\r Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40\r years of age.\r\n\r Presence of left bundle branch block (LBBB.)\r\n\r QTc with Bazett's correction that is unmeasurable, or greater than or equal to 480 msec on\r screening ECG. (Note: If a subject has a QTc interval greater than or equal to 480 msec on\r screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average\r QTc from the three screening ECGs must be less than 480 msec in order for the subject to be\r eligible for the study. Patients who are receiving a drug that has a risk of QTc\r prolongation excluded if QTc is greater than or equal to 460 msec.\r\n\r Any concurrent medication that may cause QTc prolongation or induce Torsades de Pointes.\r Drugs listed in Appendix E, Table 2, that in the investigators opinion cannot be\r discontinued are allowed; however, must be monitored closely with additional ECGs and\r laboratory assessments of electrolytes to ensure the patients safety.\r\n\r Concomitant medications that are potent inducers (rifampicin, rifabutin, St. Johns Wort and\r Enzyme-Inducing Anti-Epileptic Drugs (EIAEDs) of cytochrome P450 3A4 (CYP3A4) function.\r EIAEDs are allowed.\r\n\r Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm\r Hg or diastolic blood pressure greater than 100 mm Hg)\r\n\r Currently active diarrhea that may affect the ability of the patient to absorb the\r vandetanib or tolerate diarrhea.\r\n\r Women who are currently pregnant or breast feeding.\r\n\r Patients known to have a malignancy (other than their malignant glioma) that has required\r treatment in the last 12 months and/or is expected to require treatment in the next 12\r months (except for non-melanoma skin cancer, carcinoma in situ in the cervix or ductal\r carcinoma in situ).\r\n\r Invasive procedures defined as follows:\r\n\r - Major surgical procedure, open biopsy or significant traumatic injury within 28 days\r prior to Day 1 therapy\r\n\r - Anticipation of need for major surgical procedures during the course of the study\r\n\r - Core biopsy within 7 days prior to Day 1 (D1) therapy\r\n\r Patients should not be on anti-platelet medications (aspirin, clopidogrel, ticlopidine,\r prasugel). Non-steroidal anti-inflammatory drugs should be used with caution if medically\r necessary.\r\n\r Restrictions\r\n\r - Patients who are blood donors should not donate blood during the trial and for 3\r months following their last dose of trial treatment.\r\n\r - Due to the experimental nature of vandetanib, all patients of childbearing potential\r must be one year post-menopausal, surgically sterile, or using an acceptable method of\r contraception (oral contraceptives, barrier methods in conjunction with spermicide,\r\n\r approved contraceptive implant, long-term injectable contraception, intrauterine device or\r tubal ligation) during and continued after the last dose of study medication. Contraceptive\r use will continue for at least two months, five half-lives, after the last dose on study\r 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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"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 Tissue and Blood Samples From Patients With High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the\r laboratory may help doctors learn more about changes that occur in DNA and identify\r biomarkers related to cancer. It may also help doctors predict how patients will respond to\r treatment.\r\n\r PURPOSE: This research study is looking at tissue and blood samples from patients with\r high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - To evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic,\r and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from\r patients enrolled in the Mayo Clinic or North Central Cancer Treatment Group (NCCTG)\r high-grade glioma trials conducted since 1979.\r\n\r - To evaluate alterations of specific chromosomes and chromosomal regions including 7, 9p,\r 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y using PCR analysis of microsatellite repeats\r and FISH.\r\n\r - To determine DNA ploidy by flow cytometric analysis.\r\n\r - To examine various markers of cellular proliferation and cellular function including\r flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of\r PCNA, Ki-67, and p53.\r\n\r - To evaluate additional markers identified by the Glioma Markers Network.\r\n\r - To compare the incidence of markers in the major histologic subtypes (anaplastic\r astrocytoma [AA], anaplastic oligoastrocytoma [AOA], glioblastoma multiforme [GBM]) and\r to assess their correlation in the total group, as well as within each of these\r subtypes.\r\n\r - To compare the ploidy determinations by FISH and flow cytometry.\r\n\r OUTLINE: Paraffin-embedded tissue and peripheral blood samples, previously or currently\r collected from clinical trials participants at the time she/he enrolled in the trial, are\r evaluated for as many markers as possible, changes in cytogenic and molecular genetic tumor\r markers, frequency distributions of all tumor markers and histological and clinical variables\r by polymerase chain reaction, IHC, flow cytometry, and FISH analysis.\n\n**Clinical Trial Eligibility Criteria:**\n\n- Patients with newly diagnosed high-grade gliomas\r\n\r - Patients participating in NCCTG/Alliance or Mayo protocols\r\n\r - Willing to provide mandatory blood and tissue samples for research purposes; note: 15\r unstained slides may be submitted in place of a tissue block\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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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\nEfficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy\n\n**Clinical Trial Summary:**\n\nThe hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive\r analgesia to reduce postoperative pain after lumbar diskectomies.\n\n**Clinical Trial Detailed Description:**\n\nPain suppression plays a decisive role in patients' satisfaction following lumbar\r diskectomies, as the psychological component of the pain is a major cause of treatment\r failure.\r\n\r Controversy exists whether preemptive prescription of gabapentin, as a known contributor to\r reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar\r diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of\r amitriptyline and gabapentin in this group of neurosurgical patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Signed Informed Consent\r\n\r - Age:18 to 60\r\n\r - Weight: 60 to 80 Kg\r\n\r - ASA Class: I,II\r\n\r - Concordant physical and imaging findings in favor of symptomatic lumbar disk\r herniation\r\n\r - Single level lumbar disk herniation unresponsive to medical treatment\r\n\r Exclusion Criteria:\r\n\r - Previous consumption of Gabapentin or Amitriptyline\r\n\r - Known allergy to investigated drugs\r\n\r - Reluctant to sign informed consent\r\n\r - Previous history of intolerance to narcotics\r\n\r - Simultaneous lumbar diskectomy and a fusion technique\r\n\r - Known renal failure\r\n\r - Pregnancy\r\n\r - Contraindications to Amitriptyline or Gabapentin prescription\r\n\r - Unable to use PCA\r\n\r - Habitual use of alcohol or opium\r\n\r - History of analgesic consumption during the last 24hours\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 Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise\n\n**Clinical Trial Summary:**\n\n1. Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on\r muscle pain of the calf caused by eccentric contractions\r\n\r 2. Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by\r eccentric contractions\r\n\r 3. Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the\r calf caused by eccentric contractions\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Signed and dated informed consent prior to participation\r\n\r - Subjects in good health as determined by the Investigator\r\n\r - Age 18-55\r\n\r - Willing to abstain from any physical therapy, hard physical work, exercise or sauna\r during the study observation period (Screening to Final Visit)\r\n\r - For females, subjects of childbearing potential (including peri-menopausal women who\r have had a menstrual period within 1 year) must be using appropriate birth control\r (defined as a method which results in a low failure rate, i.e., less than 1% per year\r when used consistently and correctly, such as implants, injectables, some intrauterine\r contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral\r contraceptive medications are allowed in this study. Female subjects, who are\r surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)\r are also allowed for participation\r\n\r Exclusion Criteria:\r\n\r - Participation in another clinical study within the last 30 days and during the study\r\n\r - Subjects who are inmates of psychiatric wards, prisons, or other state institutions\r\n\r - Investigator or any other team member involved directly or indirectly in the conduct\r of the clinical study\r\n\r - Pregnancy or lactation\r\n\r - Alcohol or drug abuse\r\n\r - Malignancy within the past 2 years with the exception of in situ removal of basal cell\r carcinoma\r\n\r - Skin lesions, dermatological diseases or tattoo in the treatment areas\r\n\r - Known hypersensitivity or allergy (including photoallergy) to NSAID´s including\r celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics\r including galactose\r\n\r - Varicosis, thrombophlebitis and other vascular disorders of the lower extremities\r\n\r - Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the\r musculo-skeletal system of the lower limbs\r\n\r - Pain conditions which might interfere with pain rating during the study, e.g.\r neuropathic pain\r\n\r - Significant neurological or psychiatric symptoms resulting in disorientation, memory\r impairment, or inability to report accurately (e.g. Alzheimer's disease or\r schizophrenia or other psychosis), that in the investigator's opinion may affect\r efficacy or safety assessments or may compromise subject safety during the study\r\n\r - Systemic lupus erythematodes, mixed connective tissue disease\r\n\r - Major heart disease / uncontrollable hypertension\r\n\r - Peripheral arterial disease and/or cerebrovascular disease\r\n\r - History of stroke or myocardial infarction\r\n\r - GFR < 30 ml/min\r\n\r - ALT and/or AST levels ≥ 5 times the ULN\r\n\r - Chronic obstructive pulmonary disease including asthma bronchiale\r\n\r - Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low\r dose aspirin\r\n\r - History of pancreatitis or peptic ulcers\r\n\r - Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)\r\n\r - Reflux esophagitis requiring treatment\r\n\r - Any other analgesic therapy including cough and cold drugs containing analgesic\r properties as well as any other substance used for the treatment of pain during the\r study observation period (Screening to final Visit)\r\n\r - Any other drug that might alter pain perception like CNS active drugs\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\nRaltegravir in Patients With End Stage Liver Disease and in Transplant Recipients\n\n**Clinical Trial Summary:**\n\nThis phase I/II, multi-center study is designed to determine the pharmacokinetic profile of\r Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when\r Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.\n\n**Clinical Trial Detailed Description:**\n\nHIV infected patients with stable plasma HIV-RNA below 50 copies per mL and severe liver\r dysfunction will be switched from their antiretroviral regimen to a combination of\r raltegravir (one 400 mg pill twice daily) and two fully active molecules among nucleosi(ti)de\r analogs and enfuvirtide for a first period of at least 3 months and a second period of at\r least 3 months after liver transplantation, if need be, when a steady state of the\r anticalcineurin will be reached. Pharmacokinetic parameters of raltegravir will be calculated\r during severe liver dysfunction period and after liver transplantation. Pharmacokinetic\r parameters of cyclosporine (or tacrolimus if contra indication to cyclosporine) will be\r compared when administrated alone or combined with raltegravir. Patients will be followed up\r according to standard of care. This study will be divided in two distinct periods (1 and 2)\r lasting 3 months each. Period 1 will start from the inclusion in the study and will generally\r include the switch to raltegravir. Period 2 will start from liver transplantation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age ≥ 18\r\n\r - Documented HIV-1 infection, hepatitis B or C co-infection is allowed\r\n\r - Plasma viral load at screening visit below 50 copies per mL for at least 6 months\r\n\r - Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or\r haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into\r period 1\r\n\r - Patient eligible for the liver transplant waiting list or immediate post\r transplantation for taking part into period 2\r\n\r - Abstinence from alcohol intake for at least 6 months (WHO norm)\r\n\r - Withdrawal from intravenous drug use for at least 6 months (methadone substitution is\r permitted)\r\n\r - No ongoing class C opportunistic infection (1993 CDC classification)\r\n\r - Patient whose clinical and immunovirological condition allows triple therapy with\r raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide\r\n\r - Patient whose HIV population, according to cumulative genotypes carried out on viral\r RNA together with treatment history (if available and interpreted as per the ANRS-AC11\r algorithm version no.19) does not present a profile of mutations associated with\r resistance to raltegravir and is sensitive to at least two fully active* agents\r selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir,\r lamivudine, emtricitabine, tenofovir) or enfuvirtide\r\n\r *An ARV agent is considered to be fully active if the cumulative genotypes do not show\r any mutation associated with resistance or any mutation associated with \"possible\r resistance\"\r\n\r - Patient not having experienced viral escape during treatment combining 3TC, FTC or\r raltegravir\r\n\r - Patient registered with or covered by a social security scheme\r\n\r - For women of child-bearing potential, use of a barrier contraceptive method during\r sexual intercourse and negative pregnancy test (plasma ß-HCG ) at screening visit\r\n\r - Informed consent form signed at screening visit at the latest\r\n\r Exclusion Criteria:\r\n\r - More than two virological failures during antiretroviral treatment\r\n\r - Currently receiving treatment with an agent in development (apart from an\r authorization for temporary use)\r\n\r - Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6\r months\r\n\r - Pregnant women, or women liable to become pregnant, breast-feeding women, no\r contraception, or refusal to use contraception\r\n\r - All conditions (including but not limited to alcohol intake and drug use) liable to\r compromise, in the investigator's opinion, the safety of treatment and/or the\r patient's compliance with the protocol\r\n\r - Patient not having any effective options for NRTI +/- enfuvirtide (defined in the\r inclusion criteria)\r\n\r - Ongoing treatment with interferon-alpha or ribavirin for hepatitis C\r\n\r - Concomitant medication including one or more agents liable to induce UGT1A1 and reduce\r raltegravir concentrations:\r\n\r - anti-infective agents: rifampicin/rifampin\r\n\r - psychotropic/antiepileptic agents: phenytoin, phenobarbital, carbamazepine\r\n\r - steroidal anti-inflammatory drug: dexamethasone\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\nVaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients\n\n**Clinical Trial Summary:**\n\nThe objective of this study is to assess vaccine responses to novel adjuvanted influenza\r A(H1N1) vaccines in patients at high risks of influenza A(H1N1) complications.\n\n**Clinical Trial Detailed Description:**\n\nThis prospective, open-label, parallel-cohorts study will include up to 1250 patients and 250\r controls to whom influenza A(H1N1) immunization was recommended.\r\n\r Six cohort have been established, enrolling patients with HIV infection, rheumatic diseases,\r organ transplant, cancer, pediatric patients and healthy controls.\r\n\r Subjects will be assessed for specific antibody responses (all), T cell responses (subset)\r and solicited vaccine adverse events. Vaccine safety evaluation will include the influence of\r immunization on underlying diseases (HIV infected patients, patients with auto-immune\r diseases) or graft function (transplant patients) - as appropriate.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - medically recommended influenza A(H1N1) immunization\r\n\r - signed informed consent\r\n\r Exclusion Criteria:\r\n\r - failure or refusal to provide sufficient blood for antibody determination\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\nEfficacy and Safety of Aripiprazole in First Episode Psychosis\n\n**Clinical Trial Summary:**\n\nThe aim of the study is to investigate the efficacy and safety of aripiprazole in patients\r with first episode psychosis.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of\r schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic\r disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV,\r research version.\r\n\r Exclusion Criteria:\r\n\r - Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or\r dependence\r\n\r - Needing another nonantipsychotic psychotropic medication at enrollment\r\n\r - Having a serious or unstable medical illness.\r\n\r - Pregnant or lactating women or women without adequate contraception will be also\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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[
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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\nQUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma\n\n**Clinical Trial Summary:**\n\nThis is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation\r study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the\r safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic\r profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have\r metastatic melanoma that is considered surgically incurable. The anti-tumor responses of\r ALT-801 with cisplatin will also be assessed in this trial.\n\n**Clinical Trial Detailed Description:**\n\nMost current cancer treatment strategies involve the use of chemotherapeutic or biological\r drugs that exhibit variable efficacy and considerable toxicity. The limitations are often the\r result of the adverse side effects of the therapeutic drug on normal tissues. One approach to\r control these effects is to target the therapy to the tumor site. Of the identified tumor\r antigens, the human p53 tumor suppressor protein is overexpressed in a wide range of human\r malignancies. p53 is an intracellular tumor suppressor protein that acts to arrest the\r proliferation of cells. When mutated, it loses its ability to suppress abnormal proliferation\r and exhibits a longer half-life than the wild-type protein, allowing for its accumulation in\r tumors. In addition, p53 overexpression correlates with tumor transformation and aggression\r and is associated with lower overall survival rates and resistance to chemotherapeutic\r intervention in cancer patients. Therefore, p53 appears to be a marker for a considerable\r number of human malignancies and represents a good target for immunotherapeutics. However,\r p53 cannot be used as a target for antibodies because it is not displayed independently on\r the cell surface. Instead, the p53 protein is processed intracellularly into peptide\r fragments that are then displayed on the cell surface in the context of MHC. These\r peptide/MHC complexes are recognized by T-cells via their T-cell receptors (TCRs). Recently\r it has been confirmed that a p53 peptide fragment is significantly elevated in a wide range\r of human tumor tissues, particularly in melanoma, renal, lung, breast, colorectal, and\r osteosarcoma cancers. As a result, the feasibility of using soluble TCRs to target therapies\r against tumor cells that overexpress p53 is being investigated.\r\n\r Interleukin-2 (IL-2) is a well-characterized growth factor for immune effector cells which\r play critical roles in tumor control and rejection. As a result, recombinant human IL-2\r (e.g., Proleukin®, Chiron Novartis) has been approved for treatment of metastatic melanoma\r and renal cell carcinoma. IL-2 treatment provides significant benefit to a subset of patients\r with some maintaining durable responses for over ten years post-treatment. However, the major\r drawbacks of IL-2 therapy are its limited half-life and severe systemic toxicity. Hence, the\r use of high dose IL-2 is limited to specialized programs with experienced personnel, and it\r is generally offered to patients who are responsive and have excellent organ function. The\r low dose IL-2 treatment, while less toxic and more convenient, produces lower response rates\r and appears to be less effective in treating metastatic tumors. Thus, there is a critical\r need for innovative strategies that enhance the effects of IL-2 or reduce its toxicity\r without compromising clinical benefit. Targeted approaches to concentrate therapeutic\r cytokines, such as IL-2, at the tumor sites that express p53 could provide considerable\r advantages over current treatment.\r\n\r The study drug, ALT-801, is a biologic compound composed of interleukin-2 (IL-2) genetically\r fused to a humanized soluble T-cell receptor directed against the p53-derived peptides\r expressed on tumor cells. This study is to evaluate whether directing IL-2 activity using\r ALT-801 to the patient's tumor sites that overexpress p53 results in clinical benefits if the\r ALT-801 treatment is given with cisplatin.\r\n\r Platinum-based analogues including cisplatin, alone or in combination with other\r chemotherapies, have been shown to be active in patients with metastatic melanoma.\r Additionally, it is known that cisplatin, an alkylating agent known to inhibit DNA synthesis\r of dividing cells, triggers increased intracellular level of p53. The synergistic effects of\r cisplatin and ALT-801 treatment may induce cisplatin-mediated increases in p53 peptide\r display on the tumors and subsequently enhance tumor targeting of ALT-801.\n\n**Clinical Trial Eligibility Criteria:**\n\nENTRY CRITERIA:\r\n\r DISEASE CHARACTERISTICS:\r\n\r - Locally advanced or metastatic melanoma\r\n\r - Measurable\r\n\r - Histologically or cytologically confirmed\r\n\r - Surgically incurable\r\n\r - HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes\r\n\r PRIOR/CONCURRENT THERAPY:\r\n\r - If prior Proleukin treatment, must have had clinical benefit\r\n\r - No prior systemic cytotoxic chemotherapy for melanoma\r\n\r - No concurrent radiotherapy, chemotherapy, or other immunotherapy\r\n\r - More than 4 weeks since prior major radiotherapy\r\n\r - More than 8 weeks since prior CTLA-4 antagonist immunotherapy\r\n\r - Not receiving other investigational agents\r\n\r PATIENT CHARACTERISTICS:\r\n\r Life expectancy\r\n\r - > 3 months\r\n\r Performance status\r\n\r - ECOG 0 or 1\r\n\r Bone marrow reserve\r\n\r - Absolute neutrophil count (AGC/ANC) ≥ 1,500/uL\r\n\r - Platelets ≥100,000/uL\r\n\r - Hemoglobin ≥ 10g/dL\r\n\r Renal function\r\n\r - Serum creatinine ≤ 1.5 mg/dL\r\n\r Hepatic function\r\n\r - Total bilirubin ≤ 1.5 X ULN\r\n\r - AST ≤ 2.5 X ULN\r\n\r - Alkaline phosphatase ≤ 2.5 X ULN\r\n\r - PT INR ≤ 1.5 X ULN\r\n\r - aPTT ≤ 1.5 X ULN\r\n\r Cardiovascular\r\n\r - May be safely tapered off anti-hypertensives if currently on anti-hypertensives\r\n\r - New York Heart Association classification I or II\r\n\r - No congestive heart failure <6 months\r\n\r - No unstable angina pectoris <6 months\r\n\r - No myocardial infarction <6 months\r\n\r - No history of ventricular arrhythmias\r\n\r - Normal cardiac stress test required if any of the following is present:\r\n\r - Age ≥ 50\r\n\r - History of abnormal EKG\r\n\r - Symptoms of cardiac ischemia or arrhythmia\r\n\r Pulmonary\r\n\r - Normal pulmonary function test (FEV1 ≥ 70% of predicted value) if any of the following\r is present:\r\n\r - Prolonged history of cigarette smoking\r\n\r - Symptoms of respiratory dysfunction\r\n\r Other\r\n\r - No known autoimmune disease\r\n\r - No known HIV positive\r\n\r - No psychiatric illness/social situations that would limit study compliance\r\n\r - No history or evidence of CNS disease\r\n\r - No active systemic infection requiring parental antibiotic therapy\r\n\r - No systemic steroid therapy required\r\n\r - No prior organ allograft or allogeneic transplantation\r\n\r - Not receiving chronic medication for asthma\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\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\nHypertension Monitoring in Glioma Patients Treated With Bevacizumab\n\n**Clinical Trial Summary:**\n\nProspective casecontrol study in glioma patients undergoing treatment with bevacizumab\r (Avastin). At present there are no data on the correlation between occurrence of arterial\r hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will\r investigate whether glioma patients developing hypertension under bevacizumab treatment have\r a better outcome in terms of progression free survival, response rate and overall survival\r than equally treated patients remaining normotensive. Moreover, we will describe the dynamics\r of change in blood pressure after administration of bevacizumab in those patients developing\r hypertension.\r\n\r - Trial with medicinal product\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria: Patients aged 18 or older with histological diagnosis of anaplastic\r astrocytoma (WHO grade III) or glioma (WHO grade IV) Assigned to bevacizumab treatment\r (monotherapy or adjunctive to chemotherapy) for therapeutic reasons by an oncologist\r Patients should be on a stable or decreasing dose of steroids Willingness and ability to\r comply with the protocol Patient should present with a KPS of >=70 Signed informed consent\r\n\r Exclusion criteria: Previous anti-angiogenic drugs other than bevacizumab Allergy or\r hypersensitivity against bevacizumab Contraindications to bevacizumab according to the\r Summary of Product of Characteristics Unwillingness to comply with regular assessments of\r response and performance of study-related procedures Any condition considered relevant for\r proper performance of the study or risk to the patients, at the discretion of the\r 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\"."
}
] |
[
{
"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\nRates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®\n\n**Clinical Trial Summary:**\n\nLT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is\r rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric\r ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients\r receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or\r Naprosyn® 500mg (an approved treatment for OA).\n\n**Clinical Trial Detailed Description:**\n\nThis is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn®\r for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for\r ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at\r week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary\r objectives include assessment of pain in the affected knee by WOMAC questionnaire to\r demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information\r about gastrointestinal pain and tolerability will be collected.\r\n\r The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week\r treatment period and a 4 week post treatment monitoring period.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Osteoarthritis of knee\r\n\r - Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most\r days in the 28 days before screening for study.\r\n\r Exclusion Criteria:\r\n\r - Pregnant/Nursing women\r\n\r - History of GI bleeding, perforation or obstruction\r\n\r - A documented symptomatic GI ulcer during past 5 years\r\n\r - Presence of GI ulcer or more than 2 erosions on screening endoscopy\r\n\r - Allergy to naproxen (or naproxen intolerance), acetylsalicylic acid, or other NSAID\r drug\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 if a Lower Extremity Strengthening Program Improve Quadriceps Muscle Strength\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine if a lower extremity strengthening program as part\r of pulmonary rehabilitation will improve quadriceps muscle strength, endurance and functional\r status as well as overall quality of life.\r\n\r Hypothesis:\r\n\r 1. Lower extremity resistance training as part of a pulmonary rehabilitation program will\r improve quadriceps strength, endurance and functional capacity.\r\n\r 2. Lower extremity resistance training as part of a pulmonary rehabilitation program will\r improve quality of life in patients awaiting lung transplant.\n\n**Clinical Trial Detailed Description:**\n\nObjectives:\r\n\r 1. To determine if a lower extremity strengthening program as part of pulmonary\r rehabilitation is effective at increasing quadriceps strength when measured with a hand\r held dynamometer.\r\n\r 2. To determine the effectiveness of a lower extremity strengthening program as part of\r pulmonary rehabilitation for improving endurance and functional capacity as measured by\r the six minute walk test.\r\n\r 3. To determine if the lower extremity strengthening program as part of pulmonary\r rehabilitation improves overall quality of life as measured by the St. George's\r Respiratory Questionnaire.\r\n\r 4. To provide a basic framework for a larger randomized control study evaluating if a lower\r extremity strengthening program as part of a pulmonary rehabilitation program is more\r effective than a pulmonary rehabilitation program alone at improving quadriceps\r strength, endurance, and functional level.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients preparing for lung transplant\r\n\r - Diagnoses included are: Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary\r Fibrosis, Sarcoidosis, Cystic Fibrosis, or Bronchiectasis\r\n\r Exclusion Criteria:\r\n\r - Primary Pulmonary Hypertension\r\n\r - Multi-organ transplant patients\r\n\r - Re-transplant patients\r\n\r - Patients requiring intubation greater than or equal to 7 days prior to transplant\r\n\r - Any orthopedic condition which will prevent from participation in a lower extremity\r strengthening program\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
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"role": "user",
"content": "**Clinical Trial Title:**\n\nPhase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2\n\n**Clinical Trial Summary:**\n\nRATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the\r immune system in different ways and stop tumor cells from growing. Donor T cells that are\r treated in the laboratory may be effective treatment for malignant glioma. Aldesleukin may\r stimulate the white blood cells to kill tumor cells. Combining different types of biological\r therapies may kill more tumor cells.\r\n\r PURPOSE: This phase I trial is studying the side effects and best way to give therapeutic\r donor lymphocytes together with aldesleukin in treating patients with stage III or stage IV\r malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To assess the safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy in\r research participants with recurrent or refractory/ progressive malignant glioma (WHO Grades\r 3 or 4).\r\n\r II. To assess the safety of convection enhanced delivery (CED) of recombinant human\r Interleukin-2 (rhuIL-2) used in conjunction with GRm13Z40-2 CTL adoptive transfer.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To investigate the ability of 9-(4-fluoro-3-hydroxy-methyl-butyl) guanine (18FHBG)\r positron emission tomography PET to image GRm13Z40-2 CTL's in research participants.\r\n\r II. To study the impact of concurrent dexamethasone administration on the tempo and magnitude\r of T cell allograft rejection responses in treated research participants by tracking the\r frequency of anti-GRm13Z40-2 immune responses in serially acquired peripheral blood samples.\r\n\r III. To evaluate ganciclovir administration for ablating transferred GRm13Z40-2 in vivo\r should significant graft-mediated toxicities be encountered.\r\n\r OUTLINE: Patients receive GRm13Z40-2 therapeutic allogeneic lymphocytes intratumorally (IT)\r over 10 minutes on days 1 and 3 and aldesleukin IT over 3 hours on days 2-5 (days 1-5 in week\r 2). Treatment repeats every week for 2 courses in the absence of disease progression or\r unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed annually for at least 15 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histological verification of grade III or IV MG at original diagnosis\r\n\r - Radiographic evidence of progression/recurrence of the measurable disease more than 12\r weeks after the end of radiation therapy\r\n\r - Expression of IL13Ralpha2 by immunohistochemistry\r\n\r - Karnofsky performance status (KPS) >= 60\r\n\r - Disease recurrence/progression in the cerebral hemisphere, which is in at least one\r area of enhancement amenable to biopsy after protocol enrollment in the following\r locations:\r\n\r - Adjacent or near previous resection cavity\r\n\r - Distant from primary location; this includes tumor spread to contralateral\r hemisphere, corpus callosum, thalamus, basal ganglion, or subependymal locations\r\n\r - Research participant has recovered from toxicity of prior therapies; an interval of at\r least 12 weeks must have elapsed since the completion of radiation therapy; at least 6\r weeks since the completion of a nitrosourea-containing chemotherapy regimen; and at\r least 4 weeks since the completion of a non-nitrosourea-containing cytotoxic\r chemotherapy regimen; if a patient's most recent treatment was with a targeted agent\r only, and s/he has recovered from any toxicity of this targeted agent, then a waiting\r period of only 2 weeks is needed from the last dose and the start of study treatment,\r with the exception of bevacizumab where a wash out period of at least 4 weeks is\r required before starting study treatment\r\n\r - History of prior treatment with Temodar if no evidence of intolerance; documentation\r of intolerance to Temodar is not required\r\n\r - Creatinine < 1.6\r\n\r - White blood cell (WBC) >= 2,000/dl (or absolute neutrophil count [ANC] > 1,000)\r Platelets >= 100,000/dl unsupported by transfusion or growth factor, international\r normalized ratio (INR) < 1.3\r\n\r - Bilirubin < 1.5\r\n\r - Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase\r (SGPT) < 2 X upper limits of normal\r\n\r - Female research participants of childbearing potential must not be pregnant as\r evidenced by a serum beta-HCG pregnancy test obtained within 7 days of enrollment\r\n\r - Research participants having reproductive potential must agree to use effective\r contraception during participation on this protocol\r\n\r - In the opinion of the neurosurgeon, research participant requires on-going\r dexamethasone therapy\r\n\r Exclusion Criteria:\r\n\r - Survival expectation less than 4 weeks\r\n\r - Pulmonary- Requirement for supplemental oxygen use that is not expected to resolve\r within 2 weeks, Cardiac- Uncontrolled cardiac arrhythmia, hypotension requiring\r pressor support, Renal- Dialysis dependent, Neurologic- refractory seizure disorder,\r clinically evident progressive encephalopathy\r\n\r - Tumors with the following characteristics:\r\n\r - Large tumor recurrence causing significant symptoms from brain shift or mass\r effect, and thus not requiring \"decompressive\" craniotomy\r\n\r - Tumors located primarily in the basal ganglion or thalamus\r\n\r - Tumors with significant involvement of midbrain, cerebellum, pons and medulla\r will be excluded due to neurological risks associated with edema exacerbation\r from therapy\r\n\r - Research participants with any non-malignant intercurrent illness which is either\r poorly controlled with currently available treatment, or which is of such severity\r that the investigators deem it unwise to enter the research participant on protocol\r shall be ineligible\r\n\r - Positive human immunodeficiency virus (HIV) serology based on testing within 4 weeks\r of enrollment\r\n\r - Research participants being treated for severe infection or who are recovering from\r major surgery are ineligible until recovery is deemed complete by the investigator\r\n\r - Failure to understand the basic elements of the protocol and/or the risks/benefits of\r participating in this pilot study\r\n\r - History of ganciclovir and/or magnetic resonance imaging (MRI) contrast allergy or\r intolerance History of intolerance to IL-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:** 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\nErlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThis phase I trial is studying the side effects and best dose of erlotinib hydrochloride when\r given with isotretinoin in treating patients with recurrent malignant glioma. Erlotinib\r hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for\r cell growth. Isotretinoin may help cells that are involved in the body's immune response to\r work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor\r cells\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine the recommended phase II doses of erlotinib (erlotinib hydrochloride) and\r 13-cis-retinoic acid (CRA) when administered to adults with recurrent malignant glioma who\r are not receiving cytochrome P450 enzyme-inducing antiepileptic drugs (EIAEDs).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To assess dose-related toxicities. II. To measure 6 month progression-free survival and\r overall survival. III. To estimate response rates in those patients with measurable disease.\r IV. To evaluate for epidermal growth factor receptor (EGFR)vIII, phosphatase and tensin\r homolog (PTEN), cyclin D1, cyclin E, and RARbeta1 expression in tumor samples from enrolled\r patients as predictors of clinical benefit from this combination.\r\n\r OUTLINE: This is a dose-escalation study.\r\n\r Patients receive isotretinoin orally (PO) once daily (QD) on days 1-21 and erlotinib\r hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed for up to 2 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Histologically proven malignant glioma (glioblastoma multiforme, anaplastic astrocytoma,\r anaplastic oligodendroglioma, or anaplastic mixed oligoastrocytoma) which is progressive or\r recurrent after radiation therapy +/- chemotherapy; patients with previous low grade glioma\r who progressed after radiotherapy +/- chemotherapy and are biopsied and found to have a\r high grade glioma are eligible Karnofsky performance status of >= 60% Patients - both males\r and females - with reproductive potential (i.e., premenopausal or menopausal for less than\r 1 year and not surgically sterilized) must practice at least 2 contraceptive measures\r throughout the study Patients must be registered and meet all the requirements of iPLEDGE\r in order to receive 13-cis-Retinoic Acid (CRA) Patients must provide verbal and written\r informed consent to participate in the study Patients must have a Mini Mental Status Exam\r score >= 15 Patients must have a 12-lead electrocardiogram (EKG) without evidence of any\r clinically significant abnormalities Absolute neutrophil count (ANC) >= 1,500/mm^3\r Platelets >= 100,000/mm^3 Aspartate aminotransferase (AST) =< 2.5 upper limit of normal\r (ULN) (ULN = 50 U/L) Alanine aminotransferase (ALT) =< 2.5 ULN (ULN = 50 U/L) Total\r Bilirubin =< 1.5 mg/dL Alkaline phosphatase (Alk. Phos) =< 5X ULN (ULN = 125 U/dL)\r Estimated (Estim.) creatinine (Cr) Clearance > 50 ml/min Fasting total cholesterol < 300\r mg/dL Fasting triglycerides < 250 mg/dL Two separate, laboratory pregnancy tests within 14\r days of registration (for women of childbearing potential) Patients must have recovered\r from the toxicity of prior therapy; specifically, there must be at least a 3 month interval\r from the completion of the most recent course of radiation therapy, at least a 3 month\r interval from the implantation of Gliadel wafer(s), at least a 3 week interval from the\r completion of a non-nitrosourea-containing chemotherapy regimen, and at least a 6 week\r interval from the completion of a nitrosourea-containing chemo-regimen\r\n\r Exclusion Criteria:\r\n\r Pregnant or breast-feeding women Uncontrolled intercurrent illness including, but not\r limited to, ongoing or active infection, severe cardiovascular disease including recent (<\r 6 months) myocardial infarction, severe psychiatric illness that would limit compliance\r with study requirements, or any other disorder that would be incompatible with the study\r therapy Any history of inflammatory bowel disease Any history of uncontrolled depression,\r any history of hospitalization for depression, or any history of suicidal thoughts or\r attempt(s) Patients receiving concurrent therapy for their tumor (with the exception of\r steroids) Must have at least a 10 day interval from last dose of vitamin A, tetracyclines,\r micro-dosed progesterone preparations, norethindrone/ethinyl estradiol, St. John's Wort,\r fish oil supplements, or phenytoin or other P450 enzyme inducing antiepileptic drugs\r Current smokers (Smoking >= 11 cigarettes per day), as smoking increases metabolism and\r decreases serum levels of erlotinib Participants may not have received prior EGFR\r inhibitors for any disease Patients with a history of allergic reactions to 13-cis-retinoic\r acid (CRA) or compounds of similar biologic or chemical composition to CRA Known allergy to\r proton pump inhibitors\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\nPhase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)\n\n**Clinical Trial Summary:**\n\nPhase I Objectives:\r\n\r -To determine the maximum tolerated dose (MTD) of vorinostat + erlotinib versus vorinostat +\r erlotinib + temozolomide in adult patients with recurrent glioblastoma multiforme (GBM) and\r anaplastic gliomas.\r\n\r Phase II Objectives:\r\n\r Primary: To determine the efficacy of vorinostat + erlotinib versus vorinostat + erlotinib +\r temozolomide in patients with recurrent glioblastoma multiforme as progression free survival\r using a two arm adaptive randomization phase II trial design.\r\n\r Secondary: To determine the radiological response, progression free survival (PFS) at 6\r months, overall survival and unexpected toxicity in the two treatment arms; and to obtain\r exploratory data regarding histone 3 and 4 acetylation, treatment related changes in the\r epidermal growth factor receptor (EGFR) pathway proteins, and changes in e-cadherin and\r vimentin expression (mRNA /protein) levels in tumor tissue and peripheral monocytes in a\r subset of surgical patients.\n\n**Clinical Trial Detailed Description:**\n\nPhase I:\r\n\r The Study Drugs:\r\n\r Vorinostat is designed to cause chemical changes in different groups of proteins that are\r attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or\r cause the cancer cells to die.\r\n\r Erlotinib is designed to block the activity of a protein found on the surface of many tumor\r cells that may control tumor growth and survival. This may stop tumors from growing.\r\n\r Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of\r cells). The damaged DNA may cause tumor cell death.\r\n\r Study Groups:\r\n\r There are 2 phases to this study.\r\n\r If you are found to be eligible to take part in the Phase I portion of this study, you will\r be assigned to 1 of 2 groups based on when you join this study. You will remain in the same\r group for the entire study. In this study, the dose level of the study drugs is different\r from group to group. Up to 4 dose levels of study drug combinations will be tested in Group\r 1, up to 2 dose levels in Group 2. Three (3) participants will be enrolled at each dose\r level. The first 3 participants in each group will receive the lowest dose level. Each 3 new\r participants will receive a higher dose than the one before it, if no intolerable side\r effects were seen. This will continue until the highest tolerable dose of study drugs given\r in combination is found.\r\n\r - If you are in Group 1, you will take vorinostat, erlotinib, and temozolomide.\r\n\r - If you are in Group 2, you will take vorinostat and erlotinib.\r\n\r In addition, no matter which group or dose level you are assigned to, if you are on enzyme\r inducing anti-seizure drug, you will take a higher dose of erlotinib.\r\n\r Study Drug Administration:\r\n\r Each study cycle is 28 days.\r\n\r If you are in Group 1:\r\n\r - On Days 1-7 and 15-21 of every cycle, you will take vorinostat by mouth 2 times a day.\r You should take vorinostat with food. Do not open, crush, or chew the capsules.\r\n\r - On Days 1-21 of every cycle, you will take erlotinib by mouth 1 time a day. You should\r take erlotinib in the morning 1 hour before or 2 hours after food with 1 cup (about 8\r oz.) of water.\r\n\r - On Days 1-7 and 15-21of every cycle, you will take the temozolomide by mouth 1 time a\r day. You should swallow the temozolomide capsules whole, one right after the other,\r without chewing them. If you vomit while taking temozolomide, you cannot take more\r capsules before the next scheduled dose. They should be taken on an empty stomach (at\r least 1 hour before and 2 hours after eating) with 1 cup (about 8 ounces) of water.\r\n\r If you are in Group 2:\r\n\r - On Days 1-14 of every cycle, you will take vorinostat by mouth 2 times a day. You should\r take vorinostat with food. Do not open, crush, or chew the capsules.\r\n\r - On Days 1-21 of every cycle, you will take erlotinib by mouth 1 time a day. You should\r take erlotinib in the morning 1 hour before or 2 hours after food with 1 cup (about 8\r oz.) of water.\r\n\r Study Visits:\r\n\r Every 4 weeks for the first 8 weeks, then every 8 weeks after that:\r\n\r - Your complete medical history will be recorded.\r\n\r - You will be asked about any drugs you may be taking and if you have experienced any side\r effects.\r\n\r - You will have a physical exam, including measurement of your vital signs and weight.\r\n\r - You will have a neurological exam.\r\n\r - Your performance status will be recorded.\r\n\r Every week for the first 4 weeks, then every 2 weeks after that, blood (about 3 teaspoons)\r will be drawn for routine tests and to check your blood's ability to clot normally.\r\n\r Every 4 weeks, if you are on anti-seizure drugs, blood (about 1 teaspoon) will be drawn to\r measure the amount of anti-seizure drugs in your blood.\r\n\r Every 8 weeks, you will have an MRI scan to check the status of the disease.\r\n\r Length of Study:\r\n\r You will be on study for up to 1 year. You may continue to receive the study drugs beyond 1\r year and remain on study if your doctor decides that it is in your best interest. You will be\r taken off study early if the disease gets worse or you experience intolerable side effects.\r\n\r Long-Term Follow-Up Visit:\r\n\r If you go off study after 12 cycles, blood (about 3 teaspoons) will be drawn for routine\r tests and to check your blood's ability to clot normally every 2 weeks during the 30 days\r after your last dose of study drugs.\r\n\r If you go off the study for reasons other than the worsening of the disease, you will have an\r MRI every 2 months unless the disease gets worse.\r\n\r If you have an MRI that shows worsening of the disease, every 2-3 months from then on, you\r may be called and asked how you are feeling and about any new cancer treatment that you may\r have received. This phone call should take about 5-10 minutes.\r\n\r This is an investigational study. Erlotinib is FDA approved drug for treatment of some types\r of non-small cell lung cancer, temozolomide for some types of brain cancer, and vorinostat\r for some types of lymphoma. All are commercially available. The use of these drugs in this\r combination is investigational.\r\n\r Up to 182 participants will take part in this study. Up to 72 patients will be enroll in the\r Phase 1 portion of this study. All will be enrolled at MD Anderson.\r\n\r Phase II:\r\n\r The Study Drugs:\r\n\r Vorinostat is designed to cause chemical changes in different groups of proteins that are\r attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or\r cause the cancer cells to die.\r\n\r Erlotinib is designed to block the activity of a protein found on the surface of many tumor\r cells that may control tumor growth and survival. This may stop tumors from growing.\r\n\r Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of\r cells). The damaged DNA may cause tumor cell death.\r\n\r Study Groups:\r\n\r There are 2 phases to this study.\r\n\r If you are found to be eligible to take part in the Phase 2 portion of this study, you will\r be randomly assigned (as in the roll of the dice) to 1 of 2 groups.\r\n\r - If you are in Group 1, you will take vorinostat and erlotinib.\r\n\r - If you are in Group 2, you will take vorinostat, erlotinib, and temozolomide.\r\n\r Subset Group:\r\n\r If your doctor has recommended that you have surgery to remove a tumor that has come back,\r you will be eligible for this subset group. You would have the surgery before being assigned\r to a main study group. This subset group of the study is done to learn the effects of\r vorinostat on tumor tissue and blood cells.\r\n\r Before surgery, you will be randomly assigned to 1 of 3 groups.\r\n\r - If you are in Group A, you will receive vorinostat alone.\r\n\r - If you are in Group B, you will receive erlotinib alone.\r\n\r - If you are in Group C, you will receive both vorinostat and erlotinib.\r\n\r You will take the study drug(s) for 3 days in a row before your surgery.\r\n\r About 2 weeks after the surgery, you will be randomly assigned to 1 of 2 main study groups\r described above (Group 1 or 2).\r\n\r In addition, no matter which group you are assigned to, if you are on enzyme inducing\r anti-seizure drug, you will take the higher dose of erlotinib.\r\n\r Study Drug Administration:\r\n\r Every cycle is 28 days.\r\n\r If you are in Group 1:\r\n\r - On Days 1-14 of every cycle, you will take vorinostat by mouth 2 times a day. You should\r take vorinostat with food. Do not open, crush, or chew the capsules.\r\n\r - On Days 1-21 of every cycle, you will take erlotinib by mouth 1 time a day. You should\r take erlotinib in the morning 1 hour before or 2 hours after food with 1 cup (about 8\r oz.) of water.\r\n\r If you are in Group 2:\r\n\r - On Days 1-7 and 15-21 of every cycle, you will take vorinostat by mouth 2 times a day\r .You should take vorinostat with food. Do not open, crush, or chew the capsules.\r\n\r - On Days 1-21 of every cycle, you will take erlotinib by mouth 1 time a day . You should\r take erlotinib in the morning 1 hour before or 2 hours after food with 1 cup (about 8\r oz.) of water.\r\n\r - On Days 1-7 and 15-21 of every cycle, you will take the temozolomide by mouth 1 time a\r day. You should swallow the temozolomide capsules whole, one right after the other,\r without chewing them. If you vomit while taking temozolomide, you cannot take more\r capsules before the next scheduled dose. They should be taken on an empty stomach (at\r least 1 hour before and 2 hours after eating) with 1 cup (about 8 ounces) of water.\r\n\r Subset group:\r\n\r For 3 days in row before surgery:\r\n\r - If you are in Group A, you will take vorinostat by mouth 2 times a day.\r\n\r - If you are in Group B, you will take erlotinib by mouth 1 time a day.\r\n\r - If you are in Group C, you will take vorinostat by mouth 2 time a day and erlotinib by\r mouth 1 time a day.\r\n\r After you have recovered from the effects of surgery (about 2 weeks), you will follow the\r study group schedule (Group 1 or 2) described above.\r\n\r Study Visits:\r\n\r Every 4 weeks for the first 8 weeks, then every 8 weeks after that:\r\n\r - Your complete medical history will be recorded.\r\n\r - You will be asked about any drugs you may be taking and if you have had any side\r effects.\r\n\r - You will have a physical exam, including measurement of your vital signs and weight.\r\n\r - You will have a neurological exam.\r\n\r - Your performance status will be recorded.\r\n\r Every week for the first 4 weeks, then every 2 weeks after that, blood (about 3 teaspoons)\r will be drawn for routine tests and to check your blood's ability to clot normally.\r\n\r Every 4 weeks, if you are on anti-seizure medications, blood (about 1 teaspoon) will be drawn\r to measure the amount of anti-seizure medications in your blood.\r\n\r Every 8 weeks, you will have an MRI scan to check the status of the disease.\r\n\r Subset Group:\r\n\r In addition to the above tests, blood (about 1 teaspoon each time) will be drawn 1 time\r before and 3 times after the first dose of vorinostat, and during surgery. This blood will be\r used to study the drug levels, the effects of the drug in normal blood cells, and to match\r these findings with that in the tumor.\r\n\r After the surgery, part of the leftover tumor tissue from the surgery will be used to measure\r the drug levels and the effects of vorinostat on the tumor and be used for biomarker tests.\r\n\r Length of Study:\r\n\r You will be on study for up to 1 year. You may continue to receive treatment beyond 1 year\r and remain on study if your doctor decides that it is in your best interest. You will be\r taken off study early if the disease gets worse or you have intolerable side effects.\r\n\r Long-Term Follow-Up Visit:\r\n\r If you go off study after 12 cycles, blood (about 3 teaspoons) will be drawn for routine\r tests and to check your blood's ability to clot normally every 2 weeks during the 30 days\r after your last dose of study drugs.\r\n\r If you go off the study for reasons other than the worsening of the disease, you will have an\r MRI every 2 months unless the disease gets worse.\r\n\r If you have an MRI that shows worsening of the disease, every 2-3 months from then on, you\r may be called and asked how you are feeling and about any new cancer treatment that you may\r have received. This phone call will take about 5-10 minutes.\r\n\r This is an investigational study. Erlotinib is FDA approved drug for treatment of some types\r of non-small cell lung cancer, temozolomide for some types of brain cancer, and vorinostat\r for some types of lymphoma. All are commercially available. The use of these drugs in this\r combination is investigational.\r\n\r Up to 182 participants will take part in this study. Up to 110 patients will be enrolled in\r the Phase 2 portion of this study. Up to 15 participants will take part in the subset portion\r of the study. All will be enrolled at MD Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with histologically proven glioblastoma multiforme, gliosarcoma or anaplastic\r glioma will be eligible for the Phase I component. Anaplastic gliomas include\r anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic\r oligoastrocytoma (AOA), or malignant glioma not otherwise specified (NOS). Patients\r will be eligible if the original histology was low-grade glioma and a subsequent\r histological diagnosis of a malignant glioma is made. Only patients with\r histologically proven supratentorial glioblastoma multiforme or gliosarcoma will be\r eligible for the Phase II component.\r\n\r 2. Patients must have shown unequivocal evidence for tumor recurrence or progression by\r MRI scan and should have failed radiation therapy. Patients should have completed\r radiation therapy at least 3 months prior to entry into the study. The scan done prior\r to study entry documenting progression will be reviewed by the treating physician to\r document changes in tumor dimension to confirm recurrence.\r\n\r 3. (2. continued) Patients with prior therapy that included interstitial brachytherapy or\r stereotactic radiosurgery must have reasonable confirmation of true progressive\r disease rather than radiation necrosis as determined by the treating physician and\r neuro-radiologist; for example, through MRI, magnetic resonance (MR) spectroscopy, or\r PET scan of the brain.\r\n\r 4. For the Phase I component, any number of prior relapses is allowed, provided the\r patient fulfills all other eligibility criteria particularly that of the functional\r status. For the phase II component, patients may have had up to 2 prior relapses\r\n\r 5. All patients must sign an informed consent indicating their awareness of the\r investigational nature of this study in keeping with the policies of this hospital.\r\n\r 6. The baseline on-study MRI should be performed within 14 days (+/- 3 days) prior to\r registration and on a steroid dosage that has been stable or decreasing for at least 5\r days. If the steroid dose is increased between the date of imaging and the initiation\r of therapy (or at that time), a new baseline MRI is required. The same type of scan,\r i.e., MRI, must be used throughout the period of protocol treatment for tumor\r measurement.\r\n\r 7. Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible as long as all of the following conditions apply: a) They have recovered from\r the effects of surgery. b) Evaluable or measurable disease following resection of\r recurrent tumor is not mandated for eligibility into the study. c) To best assess the\r extent of residual measurable disease post-operatively, a MRI should be done no later\r than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively.\r\n\r 8. Patients must be 18 years old or older.\r\n\r 9. Patients must have a Karnofsky performance status (KPS) equal or greater than 60\r\n\r 10. Patients must have recovered from the toxic effects of prior therapy to grade 1 non\r hematological or </= grade 2 hematological toxicity (except deep vein thrombosis): 4\r weeks from prior cytotoxic therapy or bevacizumab and/or at least two weeks from\r vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and\r 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, cis-retinoic acid, etc.\r (radiosensitizer does not count).\r\n\r 11. (10. continued) Patients who receive anticancer agents for non-therapeutic purposes\r unrelated to this study (such as presurgically for obtaining pharmacology data for the\r agent) will be eligible to enter the study provided they have recovered from the toxic\r effects of the agent if any. Any questions related to the definition of non-cytotoxic\r agents should be directed to the Study Chair.\r\n\r 12. Patients must have adequate bone marrow function (ANC>/= 1,500/mm^3 and platelet count\r of >/= 100,000/mm^3), adequate liver function (SGPT </= 3 times normal and alkaline\r phosphatase </= 2 times normal, bilirubin </= 1.5 mg/dl), adequate renal function (BUN\r and creatinine </= 1.5 times institutional normal) prior to registration.\r\n\r 13. Women of childbearing potential on treatment must not be pregnant, must not be\r breast-feeding and must practice adequate contraception. Male patients on treatment\r with vorinostat must agree to use an adequate method of contraception for the duration\r of the study, and for 30 days after the last dose of study medication.\r\n\r Exclusion Criteria:\r\n\r 1. Patients with a history of any other cancer (except non-melanoma skin cancer or\r carcinoma in-situ of the cervix or bladder), unless in complete remission and off of\r all therapy for that disease for a minimum of 3 years are ineligible.\r\n\r 2. Patients must not have: a) active infection b) disease that will obscure toxicity or\r dangerously alter drug metabolism, especially liver disease including cirrhosis or\r hepatic dysfunction c) serious intercurrent medical illness\r\n\r 3. Patients who are currently on active treatment for AIDS or hepatitis will be excluded\r due to the potential for adverse interaction with ongoing treatment agents and for\r unknown toxicity.\r\n\r 4. Patients receiving valproic acid (VPA), an anticonvulsant drug with histone\r deacetylase (HDAC) inhibitor properties, will be excluded, unless they are switched to\r an alternative agent prior to treatment initiation. A 5 day wash out period is\r required.\r\n\r 5. Prior treatment with EGFR inhibitors or temozolomide on a standard day 1-5 dosing and\r low dose daily dosing as part of chemoradiation therapy is allowed because the trial\r is based on the hypothesis that the combination of agents used will be synergistic in\r their effects, and that HDAC inhibition will potentially overcome resistance to EGFR\r inhibitors and temozolomide. However, prior treatment with dose dense regimens of\r temozolomide (7 days on/ 7 days off, 21 days/28 days or continuous low dose daily\r dosing not with chemoradiation) and HDAC inhibitors other than valproic acid (such as\r depsipeptide, LBH-589 or vorinostat) are not permitted.\r\n\r 6. Patients with a known allergy to any component of vorinostat, or a known allergy to\r Temozolomide or erlotinib will be excluded.\r\n\r 7. Patient must be able to tolerate the procedures required in this study including\r periodic blood sampling, study related assessments, and management at the treating\r institution for the duration of the study. Inability to comply with protocol or study\r procedures (for example, an inability to swallow tablets) will be an exclusion\r criteria.\r\n\r 8. This study was designed to include women and minorities, but was not designed to\r measure differences of intervention effects. Males and females will be recruited with\r no preference to gender.\r\n\r 9. No exclusion to this study will be based on race. The malignant glioma patient\r population treated at MD Anderson Cancer Center (MDACC) over the past year is as\r follows: American Indian or Alaskan Native - 0; Asian or Pacific Islander - <2%;\r Black, not of Hispanic Origin - 3%; Hispanic - 6%; White, not of Hispanic Origin -\r 88%; Other or Unknown - 2%; Total-100%.\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\nRole of Beta-Endorphin in Cancer Therapy Fatigue\n\n**Clinical Trial Summary:**\n\nThe investigators aim to test whether beta-endorphin, a substance our bodies make in response\r to painful and stressful stimuli, plays a causative role in radiation-induced fatigue that\r cancer patients receiving radiation therapy commonly experience. If this is so, the\r investigators' hope is to direct efforts at treating radiation-induced fatigue using agents\r that block the action of beta-endorphin with the aim of improving quality of life for\r patients undergoing radiation therapy\n\n**Clinical Trial Detailed Description:**\n\nParticipants will be breast cancer patients receiving radiation therapy at Massachusetts\r General Hospital. There will be two groups of patients: those receiving adjuvant radiation\r therapy alone following surgical tumor resection, and those receiving adjuvant chemotherapy\r and radiation therapy following surgical tumor resection. Patients receiving any radiation\r regimen detailed below in section 2b are eligible for the study. In this study the\r investigators will be drawing blood for beta-endorphin measurement prior to, at various times\r during, and following patients' treatment regimens. In addition, at each blood draw, patients\r will complete questionnaires that assess fatigue, mood, and pain. These questionnaires have\r all been validated for use in cancer patients (see \"Procedures Involving Human Participants\r section below), and for our study, the investigators have formatted them onto computer\r tablets for ease of patient completion and data analysis. This study will progress as\r follows:\r\n\r Patients: Patients expected to receive adjuvant radiation therapy at Massachusetts General\r Hospital will be approached for enrollment onto this study. Two groups of patients, a\r chemotherapy group and a non-chemotherapy group, will be enrolled as follows:\r\n\r 1. Adjuvant chemotherapy followed by radiation therapy\r\n\r 2. Adjuvant radiation therapy without chemotherapy\r\n\r The enrollment goal for each group is 50 patients (total of 100 patients for the study). This\r calculation is based on the approximate number of 30 patients the investigators will need to\r achieve a sensitivity of β-endorphin changes of 5 pM being statistically significant to a\r p-value of<0.05 with 95% power. Based in our finding in mice, the investigators expect\r β-endorphin levels to vary between individuals, and the investigators have increased sample\r size by 70% from our calculations to account for deviations from our β-endorphin levels\r estimations. Additionally, the investigators have added patients to account for a number of\r patient dropping out of the study, since this is a long trial for patients requiring multiple\r blood draws.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age > 18 years\r\n\r 2. Pathologic diagnosis of stage 0-III breast cancer (any histologic subtype) in either\r breast or both breasts\r\n\r 3. Previous resection of tumor, either by mastectomy or partial mastectomy, ±sentinel\r lymph node biopsy, ±axillary lymph node dissection\r\n\r 4. A likelihood of having radiation therapy or chemotherapy following surgery as\r determined by the on-site principal investigator (PI) or co-investigator\r\n\r 5. Signed informed consent which has been reviewed and approved by the Institutional\r Review Board and no condition that impairs the ability to provide informed consent\r (e.g. uncontrolled psychiatric illness)\r\n\r Eligibility for the radiation therapy (RT) alone group will include:\r\n\r 1. Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields,\r unilateral or bilateral) via standard or Canadian Fractionation, +/- regional nodal\r irradiation.\r\n\r 2. No planned chemotherapy for this tumor\r\n\r Eligibility for the RT + chemotherapy (CT) group will include:\r\n\r 1. Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields,\r unilateral or bilateral) via standard or Canadian fractionation (photons followed by a\r photon, electron, or mixed photon/electron boost), +/- regional nodal irradiation.\r\n\r 2. Planned adjuvant chemotherapy (any regimen except for biologic therapy alone)\r\n\r Exclusion Criteria:\r\n\r 1. Continuous/chronic treatment with opiate/opioid analgesics for 3-6 months prior to\r enrollment. In addition, patients receiving radiation therapy alone who have taken\r opiate analgesics from their surgery within 72 hours of the post-surgery/pre-radiation\r therapy blood draw (at 1-6 weeks prior to the start of radiation therapy) will be\r removed from the study. Patients receiving chemotherapy and radiation therapy who have\r taken opiate analgesics from their surgery within 72 hours of the blood draw prior to\r cycle 1 of chemotherapy will be removed from the study.\r\n\r 2. Prior radiation therapy to the chest or brain\r\n\r 3. Patients diagnosed with Stage IV breast cancer\r\n\r 4. History of illegal drug use within 6 months prior to enrollment\r\n\r 5. At point of enrollment, diagnosis of major depression, bipolar disorder, seasonal\r affective disorder, or anxiety disorder for which the patient is currently taking any\r of the following medications: selective serotonin reuptake inhibitors (SSRIs),\r Tricyclic antidepressants, monoamine oxidase inhibitors, lithium, benzodiazepines,\r barbiturates, drugs acting on the 5-HT receptors. Patients meeting these criteria may\r still enroll in the study if they are on a chronic, stable, low-dose regimen for at\r least 3 months prior to enrollment, as determined by the on-site PIs and\r co-investigating physicians. Patients having to begin on a regimen of any of these\r medications while on the study may continue on the study.\r\n\r 6. Anemia of any etiology at initial visit (Hct <33%) and the following baseline fatigue\r scores on the Fatigue Symptom Inventory (FSI): Average score for question #s 1-4 > 5;\r and/or Average score for question #s 5-11 > 5. Patients with Hct<33% but who have no\r baseline fatigue (as indicated by baseline scores on the FSI as follows: average score\r for question #s 1-4 < 5 and average scores for question #s 5-11 < 5) are eligible to\r participate.\r\n\r 7. Endocrine disorders that can cause fatigue: Addison's disease, uncorrected\r hypothyroidism (patients taking thyroid replacement therapy for at least 3 months\r prior to enrollment patients are eligible), central endocrine deficiency,\r polyglandular autoimmune failure.\r\n\r 8. Patients with thyroid disease (hypothyroidism or hyperthyroidism) that was diagnosed\r within 3 months of cancer diagnosis or patients with previously stable thyroid disease\r who have experienced symptoms or have had to change their medication doses within 3\r months of cancer diagnosis. Patients with stable disease who have no had to change\r medication doses within 3 months of cancer diagnosis. Patients with stable disease who\r have not had to change medication doses within 3 months of cancer diagnosis may enroll\r as long as baseline fatigue scores do not meet criteria for exclusion. Patients\r enrolled in the study who have to alter doses of thyroid medications or who are newly\r diagnosed with thyroid disease while on the study will be removed from the study, and\r will not count towards our total patient accrual.\r\n\r 9. Uncontrolled autoimmune diseases that can cause fatigue, including fibromyalgia and\r fatigue syndromes. If these are controlled, enrollment or maintenance of the patient\r on the protocol may continue at the discretion of the enrolling principal\r investigator.\r\n\r 10. Sleep disorder diagnosed within 3 months of enrollment and the following baseline\r fatigue scores on the FSI: Average score for question #s 1-4 > 5; and/or average score\r for question #s 5-11 > 5. Patients diagnosed with a sleep disorder within 3 months of\r enrollment and with FSI scores < 5 on question #s 1-4 and #s 5-11 are eligible.\r\n\r 11. Activity-limiting heart or lung disease\r\n\r 12. Renal failure (BUN and creatinine should be within the normal range for the prior 6\r months)\r\n\r 13. Baseline fatigue as indicated by the following baseline scores on the FSI: Average\r score for question #s 1-4 > 5; and/or Average score for question #s 5-11 > 5.\r\n\r 14. Patients receiving chemotherapy or radiation therapy at any site other than\r Massachusetts General Hospital\r\n\r 15. Hepatitis or chronic liver disease (albumin <3 g/dL or >6 g/dL; ALT >60 U/L or < 5\r U/L, AST > 40 U/L or <5 U/L)\r\n\r 16. Untreated chronic infection (e.g. tuberculosis, osteomyelitis, abscess). Patients\r being treated for these may be enrolled in, or continue on the protocol at the\r discretion of the principal investigators.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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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\nRO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThis phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling\r pathway inhibitor RO4929097 (RO4929097) when given together with temozolomide and radiation\r therapy in treating patients with newly diagnosed malignant glioma. Enzyme inhibitors, such\r as gamma-secretase/Notch signalling pathway inhibitor RO4929097, may stop the growth of tumor\r cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy,\r such as temozolomide, work in different ways to stop the growth of tumor cells, either by\r killing the cells, by stopping them from dividing, or by stopping them from spreading.\r Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gamma-secretase/Notch\r signalling pathway inhibitor RO4929097 together with temozolomide and radiation therapy may\r kill more tumor cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To establish the maximum tolerated dose/recommended phase II dose of RO4929097 in\r combination with temozolomide and radiotherapy in patients with glioblastoma or malignant\r gliomas.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the pharmacokinetics of RO4929097 when given in combination with temozolomide\r (correlative study C1).\r\n\r II. To evaluate brain and tumor penetration of RO4929097 when given in recommended phase II\r single agent schedule and when given at the maximum tolerated dose (MTD) for the combination\r with radiotherapy and temozolomide (correlative study C2).\r\n\r TERTIARY OBJECTIVES:\r\n\r I. To evaluate pharmacodynamic effects of RO4929097 in the resected specimens, and comparison\r with specimens obtained from untreated patients.\r\n\r II. Effects of RO4929097 on the cancer stem cell population (correlative study C4).\r\n\r III. Effects of RO4929097 on angiogenesis (correlative study C5). IV. To evaluate the\r combined effects of RO4929097, radiation and temozolomide in explants established from\r patients' tumor specimens (correlative study C6).\r\n\r V. To evaluate the effects of RO4929097 on magnetic resonance imaging (MRI) parameters\r (correlative study C7), including dynamic contrast enhanced (DCE) MRI perfusion, diffusion\r weighted imaging and volumetric analysis.\r\n\r VI. Preliminary evaluation of efficacy of this treatment regimen: 6 month (6m) and median\r progression-free and overall survival, and response rates.\r\n\r VII. To evaluate potential biomarkers of gamma-secretase and Notch inhibition activity\r (correlative study C8).\r\n\r OUTLINE: This is a dose-escalation study of gamma-secretase/Notch signalling pathway\r inhibitor RO4929097. Patients are assigned to 1 of 2 treatment arms.\r\n\r PRE-SURGERY TREATMENT: Patients receive gamma-secretase/Notch signalling pathway inhibitor\r RO4929097 orally (PO) once daily (QD) on days 1-7 of week 1 and day 1 of week 2.\r\n\r SURGERY: Patients undergo surgery 2-3 hours after administration of gamma-secretase/Notch\r signalling pathway inhibitor RO4929097 on day 1 of week 2.\r\n\r TREATMENT CONCURRENT WITH RADIOTHERAPY: Beginning 3-4 weeks after surgery, patients undergo\r conventional focal (intensity-modulated radiation therapy [IMRT] or 3-D conformal)\r radiotherapy 5 days a week for approximately 6 weeks. Patients also receive\r gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD for approximately 10 weeks\r beginning the day of radiotherapy and temozolomide PO QD for approximately 6 weeks beginning\r the day before radiotherapy.\r\n\r ADJUVANT TREATMENT FOLLOWING RADIOTHERAPY: Approximately 4 weeks after completion of\r radiotherapy, patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097\r PO QD on days 1-28 and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 12\r courses in the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up every 2 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have newly diagnosed glioblastoma, anaplastic astrocytoma, gliosarcoma\r or other malignant gliomas with the exception of pure anaplastic oligodendroglioma;\r note: patients with presumed malignant glioma based on radiographic assessment may be\r enrolled onto Arm A of the study without histological confirmation provided they meet\r the following additional eligibility criteria:\r\n\r - The MRI of the brain shows typical findings of a malignant glioma or glioblastoma\r (single ring-enhancing mass with necrotic portions)\r\n\r - To exclude brain abscess, diffusion-weighted MRI must show absence of restricted\r diffusion corresponding to the necrotic center of the lesion\r\n\r - To confirm the diagnosis of neoplastic disease, MR perfusion must show that the\r lesion has increased perfusion\r\n\r - To exclude pilocytic astrocytoma, the patient's age must be over 25\r\n\r - To exclude brain metastasis, a computed tomography (CT) of the chest, abdomen and\r pelvis must demonstrate absence of other malignancy\r\n\r - The principal investigator must review MRI and CT findings and agree with\r diagnosis of presumed malignant glioma\r\n\r - Note: If after the on-protocol surgery the patient is found not to meet\r histological criteria described (diagnosis of glioblastoma, anaplastic\r astrocytoma, gliosarcoma or other malignant gliomas with the exception of\r pure anaplastic oligodendroglioma), the patient will be removed from the\r study and replaced\r\n\r - ARM A ONLY: Patients must have an indication for additional debulking surgery as part\r of their initial treatment\r\n\r - Life expectancy of greater than 2 months\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%)\r\n\r - Hemoglobin >= 9 g/dL\r\n\r - Leukocytes > 3,000/mcL\r\n\r - Absolute neutrophil count > 1,500/mcL\r\n\r - Platelets > 100,000/mcL\r\n\r - Total bilirubin < 1.5 X institutional upper limit of normal\r\n\r - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase\r [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r < 2.5 X institutional upper limit of normal\r\n\r - Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73\r m^2 for patients with creatinine levels above institutional normal\r\n\r - Women of childbearing potential and men must use two forms of contraception (i.e.,\r barrier contraception and one other method of contraception) at least 4 weeks prior to\r study entry, for the duration of study participation, and for at least 12 months\r post-treatment; should a woman become pregnant or suspect she is pregnant while she or\r her partner are participating in this study and for 12 months after study\r participation, the patient should inform the treating physician immediately\r\n\r - Women of childbearing potential are required to have a negative serum pregnancy test\r (with a sensitivity of at least 25 mIU/mL) within 10-14 days and within 24 hours prior\r to the first dose of RO4929097 (serum or urine); a pregnancy test (serum or urine)\r will be administered every 4 weeks if their menstrual cycles are regular or every 2\r weeks if their cycles are irregular while on study within the 24-hour period prior to\r the administration of RO4929097; a positive urine test must be confirmed by a serum\r pregnancy test; prior to dispensing RO4929097, the investigator must confirm and\r document the patient's use of two contraceptive methods, dates of negative pregnancy\r test, and confirm the patient's understanding of the teratogenic potential of\r RO4929097\r\n\r - Female patients of childbearing potential are defined as follows:\r\n\r - Patients with regular menses\r\n\r - Patients, after menarche with amenorrhea, irregular cycles, or using a\r contraceptive method that precludes withdrawal bleeding\r\n\r - Women who have had tubal ligation\r\n\r - Female patients may be considered to NOT be of childbearing potential for the\r following reasons:\r\n\r - The patient has undergone total abdominal hysterectomy with bilateral\r salpingo-oophorectomy or bilateral oophorectomy\r\n\r - The patient is medically confirmed to be menopausal (no menstrual period) for 24\r consecutive months\r\n\r - Pre-pubertal females; the parent or guardian of young female patients who have\r not yet started menstruation should verify that menstruation has not begun. If a\r young female patient reaches menarche during the study, then she is to be\r considered as a woman of childbearing potential from that time forward\r\n\r - Ability to understand and the willingness to sign a written informed consent document\r\n\r Exclusion Criteria:\r\n\r - Prior chemotherapy, radiotherapy, biological or experimental therapy for glioma\r\n\r - Prior history of radiotherapy to the brain, head or neck\r\n\r - Patients may not be receiving any other investigational agents\r\n\r - History of allergic reactions attributed to compounds of similar chemical or biologic\r composition to RO4929097 or other agents used in the study\r\n\r - Patients taking medications with narrow therapeutic indices that are metabolized by\r cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible\r\n\r - Preclinical studies indicate that RO4929097 is a substrate of CYP3A4 and inducer of\r CYP3A4 enzyme activity; caution should be exercised when dosing RO4929097 concurrently\r with CYP3A4 substrates, inducers, and/or inhibitors; furthermore, patients who are\r taking concurrent medications that are strong inducers/inhibitors or substrates of\r CYP3A4 should be switched to alternative medications to minimize any potential risk;\r if such patients cannot be switched to alternative medications, they will be\r ineligible to participate in this study\r\n\r - Patients with malabsorption syndrome or other condition that would interfere with\r intestinal absorption; patients must be able to swallow tablets\r\n\r - Patients with known history of hepatitis B or C, or who have a history of liver\r disease, other forms of hepatitis or cirrhosis are ineligible; (hepatitis B and C\r serology should be obtained as part of pre-treatment evaluation but are not required\r for eligibility)\r\n\r - Patients with uncontrolled electrolyte abnormalities including hypocalcemia,\r hypomagnesemia, hyponatremia, hypophosphatemia, and hypokalemia defined as less than\r the lower limit of normal for the institution, despite adequate electrolyte\r supplementation are excluded from this study\r\n\r - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r infection, symptomatic congestive heart failure, unstable angina pectoris, history of\r torsades de pointes or other significant cardiac arrhythmias, or psychiatric\r illness/social situations that would limit compliance with study requirements\r\n\r - Pregnant women are excluded from this study; breastfeeding should be discontinued if\r the mother is treated with RO4929097 or temozolomide; these potential risks may also\r apply to other agents used in this study\r\n\r - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral\r therapy are ineligible; appropriate studies will be undertaken in patients receiving\r combination antiretroviral therapy when indicated\r\n\r - A corrected QT (QTc) > 450 msec in males and a QTc > 470 msec in females\r\n\r - Patients who have not recovered to < Common Terminology Criteria for Adverse Events\r (CTCAE) grade 2 toxicities related to prior therapy are not eligible to participate in\r this study\r\n\r - ARM A ONLY: Patients with contraindication to a brain surgical procedure\r\n\r - A requirement for antiarrhythmics or other medications known to prolong QTc\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\nVismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma\n\n**Clinical Trial Summary:**\n\nThis randomized phase I/II clinical trial is studying the side effects and best dose of\r gamma-secretase/notch signalling pathway inhibitor RO4929097 when given together with\r vismodegib and to see how well they work in treating patients with advanced or metastatic\r sarcoma. Vismodegib may slow the growth of tumor cells. Gamma-secretase/notch signalling\r pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the\r enzymes needed for cell growth. Giving vismodegib together with gamma-secretase/notch\r signalling pathway inhibitor RO4929097 may be an effective treatment for sarcoma.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine the maximum-tolerated dose (MTD) of gamma-secretase inhibitor RO4929097\r (RO4929097) when given in combination with fixed-dose Hedgehog antagonist GDC-0449 (GDC-0449)\r which will become the recommended dose for the phase II portion of this study. (Phase Ib) II.\r To assess the progression-free survival (PFS) of the combination of RO4929097 with and\r without GDC-0449 in two arms of patients with advanced sarcoma. (Phase II)\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To describe the tolerability and adverse event profile of daily GDC-0449 administered\r orally in combination with daily RO4929097 administered orally for 21 consecutive days.\r (Phase Ib) II. To describe the pharmacokinetics of the combination of the combination of\r GDC-0449 and RO4929097. (Phase Ib) III. To assess Response Evaluation Criteria In Solid\r Tumors (RECIST) 1.1 overall response rates (complete and partial response [CR+PR]) for\r combination therapy. (Phase Ib and II) IV. To conduct pharmacodynamic studies in tissue\r biopsies (pre- and post-study) for explorative and hypothesis-generating studies. (Phase Ib\r and II) V. To assess overall survival. (Phase II) VI. To further describe the\r pharmacokinetics and pharmacodynamics of the combination of GDC-0449 and RO4929097 at the\r phase II dose at the continuous schedule. (Phase II) V. To conduct pharmacodynamic studies in\r tissue biopsies (pre- and post- study drug[s]) for explorative and hypothesis generating\r studies. (Phase II)\r\n\r OUTLINE: This is a phase I, dose-escalation study of gamma-secretase/notch signalling pathway\r inhibitor RO4929097 followed by a phase II study.\r\n\r PHASE IB:\r\n\r PART A: Patients receive vismodegib orally (PO) once daily (QD) on days 1-21.\r\n\r PART B: Beginning within 7 days of finishing part A, patients receive vismodegib PO and\r gamma-secretase/notch signalling pathway inhibitor RO4929097 PO QD on days 1-21. Courses\r repeat every 21 days in the absence of disease progression or unacceptable toxicity.\r\n\r PHASE II: Patients are randomized to 1 of 2 treatment arms.\r\n\r ARM I: Patients receive gamma-secretase/notch signalling pathway inhibitor RO4929097 PO QD on\r days 1-21.\r\n\r ARM II: Patients receive vismodegib PO and gamma-secretase/notch signalling pathway inhibitor\r RO4929097 PO QD on days 1-21.\r\n\r In both arms, courses repeat every 21 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up for 4 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histologically or cytologically confirmed sarcoma\r\n\r - All Patients must have measurable disease as defined by RECIST 1.1\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\r\n\r - There is a minimum of 1 prior therapy; however, there are no minimum systemic therapy\r requirements for well differentiated or de-differentiated liposarcoma, clear cell\r sarcoma, chondrosarcoma, alveolar soft part sarcoma and chordomas which have no\r effective therapies; for Phase Ib, there are no maximum limits to number of prior\r therapies; for Phase II, there is a maximum of 5 prior chemotherapy regimens including\r tyrosine kinase inhibitors (TKI); the last dose of systemic therapy (including TKI)\r must have been given at least 2 weeks prior to initiation of therapy; patients\r receiving nitrosourea (such as BCNU) or mitomycin C must have received their last dose\r of such therapy at least 6 weeks prior to initiation of therapy; patients receiving\r bevacizumab must wait at least 4 weeks; patients receiving experimental immunotherapy\r or antibody based therapies must wait a minimum of 4 weeks or 4 half-lives, whichever\r is longer; this should be discussed with the principal investigator before\r registration; tumor biopsies should be performed only after meeting these\r requirements; patients should recover to less than Common Terminology Criteria for\r Adverse Events (CTCAE) grade 2 toxicities related to previous therapies to be eligible\r\n\r - Patients with metastatic or locally advanced (inoperable) gastrointestinal stromal\r tumor (GIST) must have progressed on imatinib and sunitinib or be intolerant to both\r drugs; the last dose of tyrosine kinase inhibitors imatinib or sunitinib should be\r given at least 2 weeks prior to initiation of therapy\r\n\r - Patients with brain metastasis that have been treated with definitive surgery or\r radiation and have been clinically stable for 3 months following the procedure with no\r neurological signs or symptoms and no requirement for systemic glucocorticoids are\r eligible for study\r\n\r - Patients must not have current evidence of another malignancy except non-melanoma skin\r cancer and superficial bladder cancer\r\n\r - Leukocytes >= 3,000/mcL\r\n\r - Absolute neutrophil count >= 1,500/mcL\r\n\r - Hemoglobin >= 9 g/dl\r\n\r - Platelets >= 100,000/mcL\r\n\r - Total bilirubin =< upper limit of normal\r\n\r - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase\r [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r =< 3 X upper limit of normal\r\n\r - Creatinine =< 1.5 or creatinine clearance >= 60 mL/min/1.73 m^2 for patients with\r creatinine levels above 1.5\r\n\r - Patients treated at Memorial Sloan-Kettering Cancer Center may consent to optional\r tumor biopsies before and after initiation of study drug; tumor biopsies should be\r obtained after fulfilling requirements\r\n\r - Women of child-bearing potential and men must use two forms of contraception (i.e.,\r barrier contraception and one other method of contraception) at least 4 weeks prior to\r study entry, for the duration of study participation, and for at least 12 months\r post-treatment; should a woman become pregnant or suspect she is pregnant while\r participating in this study, she should inform her treating physician immediately;\r women of childbearing potential are required to have a negative pregnancy test (with a\r sensitivity of at least 25 mIU/mL) within 7 days and within 24 hours prior to the\r first dose of GDC-0449 and/or RO4929097 (serum or urine); a pregnancy test (serum or\r urine) will be administered every 3 weeks to all women of childbearing potential, at\r the start of each drug cycle; a positive urine test must be confirmed by a serum\r pregnancy test; prior to dispensing GDC-0449 and/or RO4929097, the investigator must\r confirm and document the patient's use of two contraceptive methods, dates of negative\r pregnancy test, and confirm that patient understands the teratogenic potential of\r GDC-0449 and/or RO4929097\r\n\r - Female patients of childbearing potential are defined as follows:\r\n\r - Patients with regular menses\r\n\r - Patients, after menarche with amenorrhea, irregular cycles, or using a\r contraceptive method that precludes withdrawal bleeding\r\n\r - Women who have had tubal ligation\r\n\r - Female patients may be considered to NOT be of childbearing potential for the\r following reasons:\r\n\r - The patient has undergone total abdominal hysterectomy with bilateral\r salpingo-oophorectomy or bilateral oophorectomy\r\n\r - The patient is medically confirmed to be menopausal (no menstrual period)\r for 24 consecutive months.\r\n\r - The patient is post-menopausal defined by amenorrhea for at least 1 year in\r a woman > 45 years old\r\n\r - Ability to understand and the willingness to sign a written informed consent document\r\n\r Exclusion Criteria:\r\n\r - Patients may not receive other investigational agents within 2 weeks of enrollment in\r this study; patients treated with bevacizumab should be off therapy for 4 weeks; other\r experimental or immuno therapies should wait for 4 half-lives or 4 weeks, whichever is\r longer; prior exposure to Notch or Hedgehog inhibitors is not allowed; patients who\r have not recovered to less than CTCAE grade 2 from prior therapies are ineligible\r\n\r - History of allergic reactions attributed to compounds of similar chemical or biologic\r composition to GDC-0449 or RO4929097 used in the study\r\n\r - Patients taking medications with narrow therapeutic indices that are metabolized by\r cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible;\r patients on warfarin may be considered for enrollment after cessation of warfarin and\r appropriate transition to alternate anti-coagulation agents\r\n\r - Preclinical studies indicate that RO4929097 is a substrate of cytochrome P450, family\r 3, subfamily A, polypeptide 4 (CYP3A4) and inducer of CYP3A4 enzyme activity; caution\r should be exercised when dosing RO4929097 concurrently with CYP3A4 substrates,\r inducers, and/or inhibitors; furthermore, patients who are taking concurrent\r medications that are strong inducers/inhibitors or substrates of CYP3A4 should be\r switched to alternative medications to minimize any potential risk; the following\r medications with strong potential for interaction are not allowed: indinavir,\r nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone\r\n\r - Caution should be exercised when dosing GDC-0449 concurrently with medications that\r are substrates of cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8),\r CYP2C9, and CYP2C19 and have narrow therapeutic windows; caution should be exercised\r when dosing GDC-0449 concurrently with inhibitors of CYP3A4\r\n\r - Patients must be able to swallow pills; patients with malabsorption syndrome or other\r condition that would interfere with intestinal absorption\r\n\r - Patients with clinically active liver disease, including active viral or other\r hepatitis or cirrhosis, are ineligible\r\n\r - Patients with uncontrolled electrolyte abnormalities including hypophosphatemia,\r hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia or defined as less than the\r lower limit of normal for the institution, despite adequate electrolyte\r supplementation are excluded from this study\r\n\r - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r infection, symptomatic congestive heart failure, unstable angina pectoris, a history\r of torsades de pointes or other significant cardiac arrhythmias that require\r antiarrhythmics or other medications known to prolong corrected QT interval (QTc);\r psychiatric illness/social situations that would limit compliance with study\r requirements\r\n\r - Pregnant women are excluded from this study; breastfeeding should be discontinued if\r the mother is treated with GDC-0449 and/or RO4929097\r\n\r - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral\r therapy are ineligible\r\n\r - Cardiovascular: baseline QTc > 450 msec (male) or QTc > 470 msec (female)\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\nA Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThis is a multicenter, open-label, ascending-dose trial of the safety and tolerability of\r increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients\r with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant\r radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic,\r transcranial injection into their tumor or as an intravenous injection given daily for 3 & 5\r days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment\r with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6\r weeks until study completion. After completion of this study, all patients will be eligible\r for enrollment and encouraged to enter a long-term continuation protocol that enables\r additional Toca FC treatment cycles to be given, as well as permits the collection of\r long-term safety and survival data.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - at least 18 years of age\r\n\r - for intratumoral cohorts, supratentorial HGG (WHO grade III or IV)\r\n\r - technically unresectable HGG\r\n\r - initial definitive therapy such as surgery with or without adjuvant radiation\r\n\r - subject elected not to undergo treatment with Gliadel wafer\r\n\r - if receiving corticosteroids, dose is stable or decreasing for past 7 days\r\n\r - KPS: at least 70\r\n\r - absolute neutrophil count > 1500/mm^3\r\n\r - absolute lymphocyte count > 500/mm^3\r\n\r - platelet count > 100,000/mm^3\r\n\r - hemoglobin > 10 g/dL\r\n\r - for intratumoral cohort, coagulation profile favorable to surgery\r\n\r - estimated glomerular filtration rate > 50 mL/min\r\n\r - ALT < 3 times ULN and bilirubin < 1.5 mg/dL\r\n\r - negative serum pregnancy test\r\n\r Exclusion Criteria:\r\n\r - cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)\r\n\r - more than 2 recurrences including present recurrence\r\n\r - Gliadel wafer or wafers implanted within the past 8 weeks\r\n\r - taking more than 8 mg of dexamethasone per day\r\n\r - for intratumoral cohorts, injection of tumor would require violation of ventricular\r system\r\n\r - any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the\r past 4 weeks\r\n\r - for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet\r agents that cannot be stopped\r\n\r - allergy or intolerance to 5-FC\r\n\r - HIV positive\r\n\r - g.i. condition that would prevent ingestion or absorption of 5-FC\r\n\r - any investigational treatment within the past 30 days\r\n\r - pregnant or breast feeding\r\n\r - received Avastin\r\n\r - history of prior malignancy, excluding basal or squamous cell carcinoma of the skin,\r with an expected survival of less than 5 years.\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\nSuper-Selective Intraarterial Cerebral Infusion Of Temozolomide (Temodar) For Treatment Of Newly Diagnosed GBM And AA\n\n**Clinical Trial Summary:**\n\nThe high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic\r astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of\r tumors also exhibits the most aggressive behavior, resulting in median overall survival\r durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy has consisted of\r surgical resection, external beam radiation or both. More recently, a Phase 3 clinical\r published by Stupp et al in 2005 showed a benefit for using radiotherapy plus concomitant and\r adjuvant Temozolomide. Still, all patients experience a recurrence after first-line therapy,\r so improvements in both first-line and salvage therapy are critical to enhancing\r quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV)\r therapies even cross the blood brain barrier (BBB). Superselective Intra-arterial Cerebral\r Infusion (SIACI) is a technique that can effectively increase the concentration of drug\r delivered to the brain while sparing the body of systemic side effects. One currently used\r drug called Temozolomide (Temodar) has been shown to be active in human brain tumors but its\r actual central nervous system (CNS) penetration is unknown. This phase I clinical research\r trial will test the hypothesis that following the standard 42 day Temozolomide/radiotherapy\r regimen, Temozolomide can be safely used by direct intracranial superselective intra-arterial\r cerebral infusion (SIACI) up to a dose of 250mg/m2, followed by the standard maintenance\r cycle of temozolomide to ultimately enhance survival of patients with newly diagnosed GBM/AA.\r The investigators will determine the toxicity profile and maximum tolerated dose (MTD) of\r SIACI Temozolomide. The investigators expect that this project will provide important\r information regarding the utility of SIACI Temozolomide therapy for malignant gliomas, and\r may alter the way these drugs are delivered to our patients in the near future.\n\n**Clinical Trial Detailed Description:**\n\nThe current standard of care for newly diagnosed GBM is radiation therapy plus concomitant\r oral Temozolomide of doses of 75mg/m2 up to 150mg/m2. Because of the blood brain barrier\r (BBB) where drugs do not penetrate the blood vessel walls well to get into the brain, no one\r knows for sure if these oral drugs actually get into the brain after infusion. Previous\r studies have shown that intra-carotid artery (intra-arterial) delivery is superior to\r standard intravenous or oral delivery for increasing the penetration of drug to the brain.\r Previous techniques using intra arterial (intracarotid) infusion still were non-selective as\r drug delivery still went to all blood vessels in the brain, so patients still had significant\r adverse events, such as blindness. Newer techniques in interventional neuroradiology have\r allowed for a more selective delivery of catheters into the arterial tree where\r chemotherapies can be delivered without the risk of adverse affects such as blindness.\r Therefore, this trial will ask one simple question: Is it safe to deliver a dose of\r Temozolomide intraarterially using these super selective delivery techniques in addition to\r the standard oral route of administration? This should not only increase the amount of drug\r that gets to the tumor but also spare the patient many of the adverse effects from a less\r selective delivery. Prior to this single dose of intra-arterial Temozolomide, the patient\r will also receive a dose of mannitol that will increase the permeability of the blood brain\r barrier to improve delivery of the agent to the brain. After this single dose of mannitol and\r Temozolomide, the patient will be evaluated for 4 weeks to assess for toxicity. If there is\r no toxicity at this point, then the patient will proceed with oral maintenance Temozolomide\r chemotherapy. In summary, this is a Phase I trial that is designed to test the safety of a\r single dose of intra-arterial delivery of Temozolomide immediately following 42 days of\r radiotherapy/oral temozolomide and prior to starting oral maintenance Temozolomide.\r\n\r To summarize:\r\n\r Current Standard of Care Therapy:\r\n\r Days 1-42: Adjuvant dose of Temozolomide 75mg/m2 for 42 days concomitant with focal\r radiotherapy Day 42: 4 week rest period Day 70: Maintenance dose of Temozolomide 150mg/m2\r once daily for Days 1-5 of a 28 day cycle for 6 cycles\r\n\r Experimental portion of this proposal:\r\n\r Days 1-42: Adjuvant dose of Temozolomide 75mg/m2 for 42 days concomitant with focal\r radiotherapy Day 42: Single Intra-arterial Mannitol to increase the permeability of the blood\r brain barrier followed by Intra-arterial Temozolomide single dose (starting at 75mg/m2 and up\r to 250mg/m2) followed by 4 week rest period Day 70: Maintenance dose of Temozolomide 150mg/m2\r once daily for Days 1-5 of a 28 day cycle for 6 cycles\r\n\r Therefore the experimental aspects of this treatment plan will include:\r\n\r 1. On day 42, subjects will first be treated with Mannitol prior to chemotherapy infusion\r (Mannitol 25%; 3-10 mLs for 30seconds) in order to disrupt the blood brain barrier. This\r technique has been used in several thousand patients in previous studies for the\r intraarterial (IA) delivery of chemotherapy for malignant glioma.\r\n\r 2. Following the addition of mannitol, the investigators will deliver a single SIACI dose\r of Temozolomide for patients with high-grade glioma. After a one-cycle observation\r period to assess for toxicity from the IA infusion, the subject will receive the\r standard oral maintenance regimen of Temozolomide chemotherapy. The Intra-Arterial\r Infusion Procedure will be done under general anesthesia and standard monitoring will\r occur.\r\n\r The dose escalation algorithm is as follows: The investigators will use a single intracranial\r superselective intra-arterial infusion of Temozolomide, starting at a dose of 75mg/m2 in the\r first three patients. Assuming no dose limiting toxicity during the next 28 days after the\r infusion, the patient will then begin standard maintenance oral Temozolomide chemotherapy\r regimen. The doses will be escalated from 75 to 100, to 150, 200, and finally 250mg/m2 in\r this Phase I trial.\r\n\r Most patients with GBM are also monitored every two months with serial history, neurological\r and physical examinations together with serial blood counts, prothrombin time (PT), partial\r thromboplastin time (PTT) and chemistries. In addition, most patients with GBM have an MRI\r performed every two cycles or approximately every two months to assess for tumor progression.\r .\r\n\r Since this is a Phase I trial, response is not a primary endpoint. However, the investigators\r will evaluate response to the one time IA Temozolomide therapy with a MRI with the injection\r of contrast approximately 4 weeks after infusion. Follow-up of all patients in the trial\r after the IA Temozolomide therapy will continue until disease progression or death. Survival\r will be measured from the time of the dose of IA Temozolomide®. The investigators expect\r patients in the trial to be monitored for 12 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nCriteria for Inclusion:\r\n\r - Male or female patients of ≥18 years of age.\r\n\r - Patients with a documented histologic diagnosis of newly diagnosed or glioblastoma\r multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma\r (AOA).\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. NOTE: Radiographic\r procedures (e.g., Gad-enhanced MRI or CT scans) documenting existing lesions must have\r been performed within three weeks of treatment on this research study.\r\n\r - Patients must have a Karnofsky performance status ≥60% (or the equivalent ECOG level\r of 0-2) and an expected survival of ≥ three months.\r\n\r - No other chemotherapy for two weeks prior to treatment under this research protocol\r\n\r - Patients must have adequate hematologic reserve with WBC≥3000mm3, absolute neutrophils\r ≥1500mm3 and platelets ≥100,000 mm3. Patients who are on Coumadin must have a platelet\r 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 - Concomitant Medications:\r\n\r - Growth factor(s): Must not have received within 1 week of entry onto this study.\r\n\r - Steroids: Systemic corticosteroid therapy is permissible in patients with CNS tumors\r for treatment of increased intracranial pressure or symptomatic tumor edema. Patients\r with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose\r for at least 1 week prior to study entry.\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 on steroids must receive prophylaxis for PCP pneumonia with Bactrim, unless\r they have a history of allergy to sulfa drugs.\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 - Subjects who decline birth control. Women of childbearing potential and fertile men\r will be informed as to the potential risk of procreation while participating in this\r research trial and will be advised that they must use effective contraception during\r and for a period of three 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.\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\nRO4929097and Bevacizumab in Treating Patients With Progressive or Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThis phase I/II trial is studying the side effects and the best dose of RO4929097 to see how\r well it works when given together with bevacizumab compared to bevacizumab alone in treating\r patients with progressive or recurrent malignant glioma. RO4929097 may stop the growth of\r tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies,\r such as bevacizumab, can block tumor growth in different ways. Some block the ability of\r tumor cells to grow and spread. Others find tumor cells and help kill them or carry\r tumor-killing substances to them. Giving RO4929097 together with bevacizumab may kill more\r tumor cells.\n\n**Clinical Trial Detailed Description:**\n\nPhase I\r\n\r Primary Objective:\r\n\r 1. To assess the safety profile of R04929097 in combination with bevacizumab and to\r determine a recommended Phase II dose of R04929097 in combination with bevacizumab in\r patients with recurrent malignant glioma\r\n\r Secondary Objectives:\r\n\r 2. To describe the toxicity associated with this combination regimen\r\n\r 3. To assess pharmacokinetics of R04929097 in combination with bevacizumab\r\n\r Phase II I. Assess the safety profile and the recommended phase II dose of gamma-secretase\r inhibitor RO4929097 (RO4929097) in combination with bevacizumab in patients with recurrent\r malignant glioma.\r\n\r II. Assess the progression-free survival at 6 months of patients treated with this regimen.\r\n\r III. Compare the overall survival of patients with recurrent glioblastoma treated with\r RO4929097 and bevacizumab versus bevacizumab alone.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. Describe the toxicity associated with this regimen in these patients. II. Assess the\r pharmacokinetics of this regimen in these patients. III. Estimate the proportion of patients\r alive and progression-free survival at 6 months in patients treated with RO4929097 and\r bevacizumab versus bevacizumab alone.\r\n\r IV. Evaluate the safety and tolerability of these regimens in these patients. V. Explore\r potential prognostic biomarkers from glioma tissue at baseline and potential association with\r Notch pathway inhibition.\r\n\r OUTLINE: This is a multicenter, phase I, dose-escalation study of gamma-secretase inhibitor\r RO4929097 (RO4929097) followed by a randomized phase II study.\r\n\r PHASE I: Patients receive oral RO4929097 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab\r IV over 30-90 minutes on days 1 and 15 (days 2 or 3 and 15 of course 1 only). Courses repeat\r every 28 days in the absence of disease progression or unacceptable toxicity.\r\n\r PHASE II: Patients are randomized* to 1 of 2 treatment arms.\r\n\r ARM I: Patients receive oral RO4929097 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab\r IV over 30-90 minutes on days 1 and 15.\r\n\r ARM II: Patients receive bevacizumab as in arm I.\r\n\r In both arms, courses repeat every 28 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r NOTE: *If phase II single-arm study demonstrates effectiveness, it will proceed to the phase\r II randomized study.\r\n\r Some patients undergo blood sample collection for pharmacokinetic studies. Archived tumor\r tissue samples are analyzed for potential biomarkers and Notch pathway inhibition.\r\n\r After completion of study therapy, patients are followed up every 2 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed malignant glioma (phase I)\r\n\r - Glioblastoma\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Mixed anaplastic oligoastrocytoma\r\n\r - Histologically confirmed glioblastoma following radiotherapy and temozolomide (phase\r II)\r\n\r - Progressive or recurrent disease after conformal external-beam radiation therapy and\r concurrent temozolomide, followed by ≥ 1 adjuvant course of temozolomide\r\n\r - Measurable disease by MRI within the past 2 weeks\r\n\r - Tumor tissue form indicating availability of archived tissue from initial resection at\r diagnosis of malignant glioma completed and signed by a pathologist\r\n\r - Karnofsky performance status 60-100%\r\n\r - ANC ≥ 1,500/mm³\r\n\r - Platelet count ≥ 100,000/mm³\r\n\r - Hemoglobin ≥ 9 g/dL\r\n\r - Total bilirubin normal\r\n\r - AST and ALT ≤ 2.5 times upper limit of normal\r\n\r - Creatinine normal OR creatinine clearance ≥ 60 mL/min\r\n\r - Urine protein: If proteinuria ≥ +2 protein, a protein level should be < 1,000 mg\r by a 24-hour urine collection\r\n\r - Electrolytes (calcium, chloride, magnesium, potassium, phosphorus, sodium) within\r institutional normal limits\r\n\r - Fertile patients must use 2 forms of effective contraception before, during, and for ≥\r 12 months (6 months phase II, bevacizumab arm only) after treatment\r\n\r - Negative pregnancy test\r\n\r - Not pregnant or nursing\r\n\r - At least 5 years since prior malignancy except nonmelanoma skin cancer, or carcinoma\r in situ of the cervix, breast, or bladder\r\n\r - Mini Mental State Exam score of ≥ 15\r\n\r - Must be able to tolerate MRI\r\n\r Exclusion Criteria:\r\n\r - No serious concurrent infection or medical illness that would jeopardize the ability\r of the patient to receive the treatment outline in this protocol with reasonable\r safety\r\n\r - No history of allergic reactions attributed to compounds of similar chemical or\r biological composition to gamma-secretase inhibitor RO4929097 or bevacizumab\r\n\r - Must be able to swallow capsules\r\n\r - No malabsorption syndrome or other condition that would interfere with intestinal\r absorption\r\n\r - No baseline QTcF > 450 msec (male) or QTcF > 470 msec (female)\r\n\r - Not history of being serologically positive for hepatitis A, B, or C\r\n\r - No history of cirrhosis\r\n\r - No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia despite\r adequate electrolyte supplementation\r\n\r - No uncontrolled intercurrent illness including, but not limited to, any of the\r following:\r\n\r - Ongoing or active infection\r\n\r - Symptomatic congestive heart failure\r\n\r - Unstable angina pectoris\r\n\r - A history of torsades de pointes or other significant cardiac arrhythmias other\r than chronic, stable atrial fibrillation\r\n\r - Psychiatric illness and/or social situations that would limit compliance with\r study requirements\r\n\r - No serious or non-healing wound, ulcer, or bone fracture\r\n\r - No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal\r abscess within the past 6 months\r\n\r - No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or\r recent peripheral arterial thrombosis) within the past 6 months\r\n\r - No clinically significant cardiovascular disease, including any of the following:\r\n\r - Inadequately controlled hypertension (systolic BP > 160 mm Hg and/or diastolic BP\r > 90 mm Hg) despite antihypertensive medication\r\n\r - History of cerebrovascular accident or transient ischemic attack at any time\r\n\r - Myocardial infarction or unstable angina within the past 12 months\r\n\r - NYHA grade II-IV congestive heart failure\r\n\r - Serious and inadequately controlled cardiac arrhythmia\r\n\r - Significant vascular disease (e.g., aortic aneurysm or history of aortic\r dissection)\r\n\r - Clinically significant peripheral vascular disease\r\n\r - No evidence of bleeding diathesis or coagulopathy\r\n\r - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant\r human antibodies\r\n\r - No requirement for antiarrhythmics or other medications known to prolong QTc\r\n\r - One or 2 prior treatment regimens allowed\r\n\r - Recovered from severe toxicity of prior therapy\r\n\r - At least 3 months since prior radiotherapy\r\n\r - At least 6 weeks since prior nitrosourea\r\n\r - At least 3 weeks since prior chemotherapy\r\n\r - At least 4 weeks since prior and no other concurrent investigational agents\r\n\r - At least 2 weeks since prior non-cytotoxic, FDA-approved agent (e.g., Tarceva\r [erlotinib hydrochloride], hydroxychloroquine, bevacizumab, etc.)\r\n\r - At least 28 days since any prior surgery\r\n\r - No prior γ-secretase inhibitors and/or bevacizumab\r\n\r - At least 10 days since prior and no concurrent enzyme-inducing anti-epileptic drug\r\n\r - No concurrent combination antiretroviral therapy for HIV-positive patients\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\nDiscovering the Gene(s) Causing Developmental Dysplasia of the Hip (DDH)\n\n**Clinical Trial Summary:**\n\nThe primary objective of the study is to find the gene(s) responsible for causing DDH. The\r secondary objective of the study is to determine the mode of genetic transmission of DDH.\n\n**Clinical Trial Detailed Description:**\n\nDevelopmental dysplasia of the hip (DDH), formerly known as Congenital Dislocation of the Hip\r (CDH) is a relatively common disorder that can lead to early onset arthritis of the hip. It\r is believed that DDH is the major cause of arthritis of the hip in young patients. The\r majority of patients with DDH are unaware of their condition. Only a very small number of\r these patients with the extremely severe form of the disease (dislocated hip) are identified\r at birth. The remaining patients usually seek help when severe arthritis is present and joint\r preservation treatment is not possible. The exact etiology of this condition remains elusive.\r Based on reports in the literature, DDH is believed to have a genetic basis.\r\n\r Dr. Javad Parvizi at Rothman Institute (RT) in Philadelphia has extensive experience with\r this condition because their center provides joint preservation procedures such as pelvic and\r femoral osteotomy. They also have extensive experience with hip replacement in these\r patients. They are aware of some families with many affected individuals. Close history\r taking and examination of these patients has suggested that there may indeed be a genetic\r basis for DDH. Based on our findings so far, we believe that a dominant pattern of\r inheritance may exist, implying that this disorder may be inherited in a Mendelian manner\r (Single gene disorder).\r\n\r Furthermore, Dr. Parvizi's group have documented a peculiar pattern of dominant inheritance\r in which all affected males give rise to only affected female children, suggesting that the\r disorder may be inherited as an X-linked dominant trait. X-linked dominant is the mode of\r inheritance in which a gene on the X chromosome is dominant. The X-linked dominant\r inheritance may in part account for the large number of females affected with the trait.\r Understanding the inheritance mechanism of this disease will allow better genetic counseling\r and monitoring of affected individuals and their families.\r\n\r The reason behind this study is to investigate the possible genetic inheritance of the\r disease. Knowing this information will allow us to test patients for the disease early and\r before arthritis develops. In addition it is possible that better treatments may be designed\r based on this knowledge.\r\n\r DDH is a relatively common condition. Although the most severe form of DDH is usually\r diagnosed during birth (dislocated hip), the majority (>80%) of patients with this condition\r do not even know that they suffer from this disease and usually discover their condition when\r disabling arthritis of the hip develops in early adulthood.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - All patients with radiographic and clinical diagnosis of DDH will be included.\r\n\r Exclusion Criteria:\r\n\r - Other forms of arthritis:\r\n\r - osteoarthritis\r\n\r - inflammatory arthropathies\r\n\r - vascular necrosis\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\nDendritic Cell (DC) Activated Cytokine-induced Killer Cell (DCIK) Combined With DC Treatment for Glioma\n\n**Clinical Trial Summary:**\n\nMalignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis\r carries with it a median survival of approximately 12 months, with 90 - 95% of patients\r surviving less than 2 years. The current standard treatment of surgical resection followed by\r radiation therapy and chemotherapy has not substantially prolonged survival.\r\n\r Dendritic cells (DCs) are immune cells that form part of the mammalian immune system. Their\r main function is to process antigen material and present it on the surface to other cells of\r the immune system, thus functioning as antigen-presenting cells.In the present study, DCs\r were used for antigen presentation of glioma antigens to directly induce a cytotoxic T-cell\r response. Cytokine-induced killer (CIK)cells are shown to be a heterogeneous population, and\r the major population expresses both the T cell marker CD3 and the NK cell marker CD56, and is\r termed NKT cells, which has shown significant anti-tumor activity in both clinical trials and\r animal studies.\r\n\r Furthermore, CIK cells are able to expand significantly when they are cultured with DCs, and\r the CIK cells activated by DCs stimulation (DCIKs)have a characteristic which cytotoxic\r activity enhanced and show increased anti-tumor activity.\r\n\r This study aimed to evaluate the clinical efficacy of DCIK cells treatment combined with DCs\r following tumor resection and radiotherapy in patients with malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Female or male, adult patients of 18 to 70 years of age at time of diagnosis that\r qualify for standard treatment including surgery and radiotherapy.\r\n\r 2. Histologically confirmed diagnosis of 1 of the following malignant gliomas:\r\n\r Anaplastic astrocytoma Glioblastoma multiforme Oligodendroglioma Oligoastrocytoma\r\n\r 3. Newly diagnosed or recurrent disease\r\n\r 4. Patients must have had surgical resection at UCLA for the collection of their tumor.\r Total, subtotal, or partial resection of more then 70% of tumor mass defined by MRI.\r\n\r 5. After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will\r need to be established.\r\n\r 6. Supratentorial tumour localisation.\r\n\r 7. Karnofsky performance status 60-100%\r\n\r 8. Life expectancy ≥ 12 weeks\r\n\r 9. Written informed consent of patient and/or legal guardian.\r\n\r 10. Must be off of steroid at least two weeks prior to vaccination\r\n\r 11. Hematologic and metabolic panel results will be within the parameters of the protocol.\r\n\r 12. Negative pregnancy test\r\n\r 13. Fertile patients must use effective contraception\r\n\r 14. Hepatitis B negative\r\n\r 15. Hepatitis C negative\r\n\r 16. HIV negative\r\n\r 17. Syphilis serology negative\r\n\r 18. Patient must have no prior sensitivity to the components of the dendritic cell\r vaccine.\r\n\r Exclusion Criteria:\r\n\r 1. Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study,\r\n\r 2. Presence of acute infection\r\n\r 3. Inability to obtain informed consent because of psychiatric or complicating medical\r problems.\r\n\r 4. Unstable or severe intercurrent medical or psychiatric conditions as determined by the\r Investigator.\r\n\r 5. Subjects with organ allografts.\r\n\r 6. Contraindication to MRI\r\n\r 7. Known history of autoimmune disorder\r\n\r 8. Subjects who have an uncontrolled systemic malignancy that is not in remission.\r\n\r 9. Pregnancy or breast-feeding.\r\n\r 10. Positive for hepatitis B, C, HIV, syphilis\r\n\r 11. Patients unwilling to perform a save method of birth control.\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\nSingle Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression\n\n**Clinical Trial Summary:**\n\nThe goal of this clinical study is to learn the feasibility of using a single session of\r radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural\r spinal cord compression.\n\n**Clinical Trial Detailed Description:**\n\nSpinal cord compression is often treated with surgery followed by radiation in small doses\r every day for a number of days. When a patient cannot or will not have surgery, radiation is\r given daily. With increased accuracy and precision, higher doses of radiation can be given in\r a single session. Giving a higher dose in a single session may increase the chance that the\r tumor will stop growing into the spinal canal and will prevent spinal cord injury. This study\r will also help to identify the tolerance of the spinal cord to radiation in a single session.\r\n\r Spine Stereotactic Radiosurgery:\r\n\r You will lie in the mold that was made for you for 45-120 minutes while you receive your\r radiation treatment.\r\n\r Follow-up Visits:\r\n\r You will have follow-up visits at Months 3 (+/-2 weeks ), 6 (+/-4 weeks), 9 (+/-4 weeks), 12\r (+/-8 weeks), 18 (+/-8 weeks), and 24 (+/-8 weeks) and then every 6 months after that. At\r each follow-up visit:\r\n\r - Your medical history will be recorded, including usage of steroids.\r\n\r - You will have a neurological exam.\r\n\r - You will complete the 3 questionnaires about health, symptoms you may be having, and\r about pain.\r\n\r - You will have an MRI of the spine.\r\n\r If you are unable to return for follow-up clinic visits, you will be called and asked about\r your medical history, and you will complete the 3 questionnaires about your health, symptoms\r you may be having, and about pain. This call should take about 20 minutes.\r\n\r Length of Study:\r\n\r Your treatment will last 1 day. You will continue having follow-up visits or phone calls for\r as long as possible.\r\n\r This is an investigational study. SSRS is FDA approved. The use of SSRS to treat metastatic\r epidural spinal cord compression is investigational.\r\n\r Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Greater than or equal to 18 years old\r\n\r 2. Radiographically documented metastatic epidural compression on spine Magnetic\r resonance imaging (MRI) within 4 weeks of registration, defined radiographically,\r ranging from minimal canal compromise and thecal indentation to actual displacement of\r the spinal cord.\r\n\r 3. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be\r irradiated in a single session\r\n\r 4. Signed Informed consent for irradiation\r\n\r 5. Diagnosis of cancer including but not limited to non-small cell lung cancer, breast,\r prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck\r primary, and unknown primary tumors\r\n\r 6. Motor Strength >/= 4 out of 5 in extremity or extremities affected by the level of the\r spinal cord compression\r\n\r 7. Karnofsky performance status (KPS) >/= 40\r\n\r 8. Patients deemed to be inoperable due to patient refusal, by neurosurgical evaluation,\r or for any reason\r\n\r 9. 1 prior course of spine radiotherapy to the current region of interest\r\n\r Exclusion Criteria:\r\n\r 1. Prior irradiation of the site to be treated </= 3 months prior to registration\r\n\r 2. Inability to tolerate lying flat on treatment table for greater than 30 minutes.\r\n\r 3. Patients unable to undergo MRI of the spine\r\n\r 4. Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks\r conventional fractionation or similar biologically effective dose (BED) to the area of\r the spine to be treated. Below are the normalized BED at 2 Gy per fraction with\r alpha/beta=2 for spinal cord in commonly used fractionation schemes in previously\r irradiated patients. Conventional Radiotherapy (Normalized Biologically Effective\r Dose) 20 Gy in 5 fractions(30 Gy 2/2), 30 Gy in 10 fractions(37.5 Gy 2/2), 37.5 Gy in\r 15 fractions(42 Gy 2/2), 40 Gy in 20 fractions(40 Gy 2/2), 45 Gy in 25 fractions(43 Gy\r 2/2), 50 Gy in 25 fractions(50 Gy 2/2) following equation: nBED is calculated by\r dividing BED by (1 + d/a/b), where d is 2 Gy and for spinal cord late effect a/b is 2,\r and we describe the units as Gy 2/2 (i.e., Gy 2/2 = 2-Gy equivalent with a/b = 2)\r\n\r 5. Patients who are pregnant.\r\n\r 6. Patients who have cord compression from bone components or configuration\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\nEffects of Breathing and Walking Treatments on Recovery Post-Spinal Cord Injury\n\n**Clinical Trial Summary:**\n\nChange to Reflect What Was Done and reason Changes Were Made.\r\n\r The purpose of this study is to determine (1) if a specific breathing treatment (intermittent\r hypoxia) can promote changes in breathing function and (2) if pairing breathing treatments\r (hypoxia) with locomotor training can enhance the benefits of walking recovery observed with\r locomotor training alone (without breathing treatments).\n\n**Clinical Trial Detailed Description:**\n\nSpinal cord injury (SCI) is a very disabling health problem. Paralysis and paresis of limb\r and trunk muscles are major consequences of SCI and result in the inability to walk or\r difficulty walking. The most commonly stated goal by individuals with SCI during\r rehabilitation is the desire to walk again. Locomotor training (LT) that uses a body-weight\r support system and treadmill (BWST) is a task-specific rehabilitation intervention that\r allows practice of walking at normal speeds while loading the lower extremities, facilitating\r upright posture, and hip extension. Substantial improvement in ambulation can occur following\r locomotor training (LT) in individuals with motor incomplete spinal cord injury (iSCI).\r Despite these advances in activity-dependent rehabilitation, a need exists for defining\r complementary strategies that further amplify endogenous neuroplasticity. The proposed study\r will assess the therapeutic potential of (1) a respiratory training intervention (acute\r intermittent hypoxia, or AIH) on breathing function and (2) a combined locomotor (LT) and\r respiratory (AIH) training intervention for enhancing walking recovery.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adults at least 18 years of age\r\n\r - At least 12 months post-incomplete spinal cord injury (I-SCI), including but not\r limited to the following syndromes: Brown Sequard and Central Cord Syndromes\r\n\r - Upper motor neuron lesion (with upper motor neuron signs (i.e. presence of clonus,\r spasms, and/or hyperreflexia))\r\n\r - A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic\r pathology\r\n\r - Resting oxygen saturation (SpO2) levels of 95-99%\r\n\r - Individuals who ambulate independently, with an assistive device, or who can walk when\r provided manual assistance\r\n\r - Persons using anti-spasticity medication must maintain stable medication dosage during\r the study\r\n\r - Able to give informed consent.\r\n\r - Medical approval by individual's physician\r\n\r Exclusion Criteria:\r\n\r - Current participation in a rehabilitation program/research protocol that could\r interfere or influence the outcome measures of the current study\r\n\r - History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Frederich's\r ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration,\r syringomyelia) that may complicate the protocol\r\n\r - Inappropriate or unsafe fit of the harness due to the participant's body size and/or\r joint contractures or severe spasticity that would prohibit the safe provision of\r either training modality.\r\n\r - Severe spasticity that would prohibit the safe provision of training.\r\n\r - Pregnancy - all women of childbearing age will be required to undergo pregnancy\r testing prior to enrollment\r\n\r - Unstable medical condition that could interfere with safety during participation in\r study (i.e. symptomatic cardiopulmonary complication, osteoporosis, contractures or\r other significant medical complications that would prohibit or interfere with testing\r of walking function and training or alter compliance with a training 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:** not relevant"
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not relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSafety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis\n\n**Clinical Trial Summary:**\n\nThe AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and\r gram-negative airway infection. Participants received two 28-day courses of either Aztreonam\r for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a\r 28-day off-drug period. Following the two blinded courses, all participants received a 28-day\r course of open-label AZLI then were followed for an additional 56 days.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male/Female 18 years or older with non-CF bronchiectasis\r\n\r - Chronic sputum production on most days\r\n\r - Positive sputum culture for gram-negative organisms\r\n\r - Must have met lung function requirements\r\n\r Exclusion Criteria:\r\n\r - History of CF\r\n\r - Hospitalized within 14 days prior to joining the study\r\n\r - Previous exposure to AZLI\r\n\r - Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study\r\n\r - Must have met liver and kidney function requirements\r\n\r - Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with\r activity and at night was allowed)\r\n\r - Treatment for nontuberculous mycobacteria infection or active mycobacterium\r tuberculosis infection within 1 year of enrollment\r\n\r - Other serious medical conditions.\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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151
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nSafety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis\n\n**Clinical Trial Summary:**\n\nThe AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and\r gram-negative airway infection. Participants received two 28-day courses of either Aztreonam\r for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a\r 28-day off-drug period. Following the two blinded courses, all participants received a 28-day\r course of open-label AZLI then were followed for an additional 56 days.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male/Female 18 years or older with non-CF bronchiectasis\r\n\r - Chronic sputum production on most days\r\n\r - Positive sputum culture for gram-negative organisms\r\n\r - Must have met lung function requirements\r\n\r Exclusion Criteria:\r\n\r - History of CF\r\n\r - Hospitalized within 14 days prior to joining the study\r\n\r - Previous exposure to AZLI\r\n\r - Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study\r\n\r - Must have met liver and kidney function requirements\r\n\r - Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with\r activity and at night was allowed)\r\n\r - Treatment for nontuberculous mycobacteria infection or active mycobacterium\r tuberculosis infection within 1 year of enrollment\r\n\r - Other serious medical conditions.\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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152
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nStereotactic Body Radiotherapy for Spine Tumors\n\n**Clinical Trial Summary:**\n\nThis study will evaluate the local control rate as well as acute and late toxicity rates of\r stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine\r tumors.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a single site, non-randomized, prospective, phase IV trial. Patients are\r composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include\r patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose\r received by adjacent critical normal tissues, tumor recurrence data, and acute and late\r toxicities.\r\n\r Follow up data will be collected during the patient's standard office visits. The anticipated\r duration of this study is 5 years\n\n**Clinical Trial Eligibility Criteria:**\n\nEligibility Criteria:\r\n\r - Patient age >= 18 years\r\n\r - performance status of 0-3\r\n\r - Vertebral and/or paraspinal metastases, with or without prior surgery and/or\r fractionated radiotherapy\r\n\r - Benign extradural spine tumors such as chordomas, meningiomas, schwannomas,\r neurofibromas, paragangliomas, and arteriovenous malformations (AVMs).\r\n\r - Established histologic diagnosis of a benign or malignant tumor of the spine.\r\n\r - Arteriovenous malformation of the spine identified radiographically (no biopsy)\r\n\r - Well-defined lesion involving no more than 2 adjacent vertebral levels or spinal\r segment\r\n\r - Minimal spinal canal compromise that is not rapidly progressive. Ideally, the tumor\r should not be within 5 mm of the spinal cord.\r\n\r - If chemotherapy is planned, ideally it should not have been given within 30 days of\r starting radiation and should not resume until at least 2 weeks after completing\r radiation. In addition, it is not recommended to perform SBRT when targeted\r anti-angiogenesis therapy is planned within 2 months of the procedure.\r\n\r - Signed study-specific consent form\r\n\r Exclusion Criteria:\r\n\r - Lesion involving > 3 adjacent vertebral levels\r\n\r - Overt spinal instability\r\n\r - Neurologic deficit due to bony fragments/bony compression of neural structures\r\n\r - Prior radiotherapy at the involved level(s) within 3 months of radiosurgery, more than\r one prior course of radiotherapy at the involved level(s), or more than 45 Gy previous\r radiation exposure at the involved level(s)\r\n\r - Rapidly progressive spinal cord compromise or neurological deficit\r\n\r - Paralysis, or otherwise compromised motor function due to radiographically confirmed\r cord compression\r\n\r - Patient unable to undergo an MRI\r\n\r - Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown\r effects of RT on lactating females\r\n\r - Patients with psychiatric or addictive disorder that would preclude obtaining informed\r consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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153
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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\nPlasma Levels of Glucagon-like Peptide-2 and Dyspepsia in Patients With Extraintestinal Cancer During Chemotherapy\n\n**Clinical Trial Summary:**\n\nThe specific aim of the study is to investigate the relationship between the development of\r dyspepsia and GI dyspeptic symptoms in relation to circulating levels of peculiar GI peptides\r (such gastrin, pepsinogen and GLP-2) in patients with non-gastrointestinal neoplasm well\r controlled for emesis.\n\n**Clinical Trial Detailed Description:**\n\nThe complications of anticancer treatment threaten the effectiveness of therapy because they\r lead to dose reduction, increase healthcare costs, and impair patients' quality of life.\r Gastrointestinal (GI) symptoms are the most frequent side effects of antineoplastic\r chemotherapy behind bone-marrow depression, with nausea and vomiting representing the mainly\r referred ones.\r\n\r Gastrointestinal (GI) mucositis, which represents injury of the rest of the alimentary tract\r beyond oral mucositis, is becoming recognized increasingly as a toxicity associated with many\r standard-dose chemotherapy regimens. Although clinicians consider them \"minor complaints\",\r many patients (40-100%) treated with chemotherapy and/or exposed to ionizing radiation suffer\r from such a disease. After chemotherapy, GI mucositis is most prominent in the small\r intestine, but it also occurs in the esophagus, stomach, and large intestine. The GI symptoms\r related to mucositis mimic those from other GI disease (such as dyspepsia, reflux disease or\r abdominal pain and diarrhea). Alimentary tract mucositis increases morbility and mortality\r and contribute to rising health care cost.\r\n\r The comprehension of pathophysiology will shed light on the rationale for targeting specific\r pathways and so for the use of specific agents for prevention and treatment. Since the role\r of chemotherapy in the onset of GI motility disorders in addition to minor GI complaints has\r not been clarified yet. Understanding the pathophysiology of mucositis, its measures and\r scores, are essential for progress in research and care direct at this common side-effect of\r anticancer therapy. Currently, there is not strong evidence to support a recommendation for\r and against the use of certain agents (mucosal surface protectants, antiinflammatory or\r antimicrobial agents, growth factors, etc).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with newly diagnosed cancer (lung and breast cancer),\r\n\r - Patients currently free of active disease\r\n\r Exclusion Criteria:\r\n\r - History of cerebral edema, primary and secondary brain neoplasm with signs and\r symptoms of raised intracranial pressure and/or brain metastases,\r\n\r - Signs of marked hepatic or renal dysfunction, cardiac failure\r\n\r - Signs of dyspepsia, peptic ulcer, gastric surgery or prior diagnosis of other cancer\r\n\r - Administration of drugs interfering with GI motility (i.e. antisecretory, prokinetic,\r or antibiotic drugs) as well as the exposition to radiotherapy, four weeks prior to\r the examination\r\n\r - Referred episode of nausea of any severity within 24 h prior to antiemetic therapy, if\r they had experienced vomiting in the previous 24 h,\r\n\r - Pregnancy or lactating\r\n\r - Concomitant administration of agents known to have significant antiemetic activity,\r including benzodiazepines and other corticosteroids\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\nRepeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nThe high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic\r astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group of\r tumors also exhibits the most aggressive behavior, resulting in median overall survival\r durations of only 9-12 months for GBM, and 3-4 years for AA. Initial therapy consists of\r either surgical resection, external beam radiation or both. All patients experience a\r recurrence after first-line therapy, so improvements in both first-line and salvage therapy\r are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently\r used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators\r have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral\r Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of\r recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that\r trial in that the investigators seek to test the hypothesis that repeated dosing of\r intra-arterial Bevacizumab is safe and effective in the treatment of recurrent malignant\r glioma. Additionally the investigators will analyze if a combination with IA Carboplatin will\r further improve the treatment response. By achieving the aims of this study the investigators\r will also determine if IV therapy with Bevacizumab with IV Carboplatin should be combined\r with repeated selected intra-arterial Bevacizumab plus Carboplatin to improve progression\r free and overall survival. The investigators expect that this project will provide important\r information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma,\r and may alter the way these drugs are delivered to the investigators patients in the near\r future.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 18 years of age or older.\r\n\r - Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme\r (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).\r\n\r - Circumscribed tumor recurrence with less than 3.5 cm greatest diameter\r\n\r - Patients with histologically confirmed low-grade brain tumor relapse with an enhancing\r tumor on MRI will be evaluated for toxicity only.\r\n\r - Patients must have at least one confirmed and evaluable tumor site.\r\n\r - Patients must have a Karnofsky performance status 70% (or the equivalent ECOG level of\r 0-2)\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.\r\n\r Exclusion Criteria:\r\n\r - Women who are pregnant or lactating.\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 - Low GFR or history of hepatorenal syndrome\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\nHypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThe best dose of radiation to be given with bevacizumab is currently unknown. This study will\r use higher doses of radiation with bevacizumab than have been used before. This study will\r test the safety of radiation given at different doses with bevacizumab to find out what\r effects, good and/or bad, it has on the patient and the malignant glioma or related brain\r cancers.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have EITHER\r\n\r - Histologically confirmed intracranial malignant glioma of the following types:\r Glioblastoma, Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO),\r Anaplastic oligo-astrocytoma (AOA) also called anaplastic mixed gliomas, Malignant\r glioma NOS (not otherwise specified). Patients will be eligible if the original\r histology was low-grade glioma and a subsequent histological diagnosis of a high grade\r (malignant) glioma is made.\r\n\r OR\r\n\r - Histologically confirmed low grade (WHO grade II) gliomas (such as low grade\r astrocytoma, low grade oligodendroglioma, low grade oligo-astrocytoma (mixed gliomas),\r or low grade glioma NOS) IF there is radiographic evidence by MRI of malignant\r transformation but histologic confirmation of high grade (malignant) transformation\r would not be otherwise undertaken for routine clinical care. Inclusion of patients in\r this group will allow increased accrual rapidity by enrolling patients who are\r otherwise ineligible for almost all malignant glioma trials yet whom are treated\r presumptively for malignant glioma. The primary aim of the phase I study is not\r determination of efficacy. Therefore, inclusion of such patients will not affect\r efficacy analyses.\r\n\r Participating site confirmation is adequate.\r\n\r - Able to undergo brain MRI scans.\r\n\r - MRI scan with gadolinium contrast showing geographically-circumscribed tumor ≤40 cc\r incorporating both enhancing and non-enhancing volume. This is calculated by the\r product of maximum measurements in 3 dimensions divided by 2. Tumors exceeding this\r limit may be eligible and any question should be directed to a Radiation Oncology\r Investigator and the MSK PI. (The MRI must be performed on a steroid dosage that has\r been stable or decreasing for at least 5 days. Patients on no steroids are eligible.\r If the steroid dose is increased between date of imaging and registration, a new\r baseline MRI is required).\r\n\r - Prior treatment with approximately 60 Gy of radiotherapy.\r\n\r - Patients must have recovered from the toxic effects of prior therapy including but not\r limited to:\r\n\r - An interval of ≥ 4 weeks (28 days) from prior cytotoxic therapy except 6 weeks from\r nitrosoureas\r\n\r - An interval of ≥ 1 week (7 days) from any non-cytotoxic agents\r\n\r - An interval of ≥ 3 months from the completion of radiation therapy\r\n\r - Absolute neutrophil count ≥ 1,500/mm3.\r\n\r - Platelet count ≥ 100,000/mm3.\r\n\r - Hemoglobin ≥ 10 g/dl.\r\n\r - Serum creatinine ≤ 2 times upper limit of normal.\r\n\r - Total bilirubin ≤ 2 times upper limit of normal.\r\n\r - SGOT and SGPT both ≤ 3 times upper limit of normal.\r\n\r - ≥18 years of age.\r\n\r - Karnofsky Performance Score ≥ 60\r\n\r - Life expectancy ≥ 12 weeks\r\n\r - Men and women with reproductive potential must agree to use an acceptable method of\r birth control during treatment and for six months after completion of treatment.\r\n\r - Written informed consent prior to registration on study.\r\n\r Exclusion Criteria:\r\n\r - Prior treatment with radiosurgery\r\n\r - Prior disease progression/recurrence during or immediately following treatment with\r bevacizumab. Any question should be directed to the PI.\r\n\r - Multicentric glioma\r\n\r - Other malignancy (with the exception of cervical carcinoma in situ or basal cell\r carcinoma of the skin) for which there has been treatment within the last 3 years\r\n\r - Serious medical or psychiatric illness that would in the opinion of the investigator\r interferes with the prescribed treatment.\r\n\r - Pregnant or breast feeding women\r\n\r - Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg\r and/or diastolic blood pressure > 100 mmHg)\r\n\r - Any prior history of hypertensive crisis or hypertensive encephalopathy\r\n\r - Grade 2 or greater congestive heart failure\r\n\r - History of myocardial infarction, unstable angina, stroke, or transient ischemic\r attack within 12 months prior to Day 1\r\n\r - Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or\r recent peripheral arterial thrombosis) within 6 months prior to Day 1\r\n\r - History of hemoptysis ≥1/2 teaspoon of bright red blood per episode) within 1 month\r prior to Day 1\r\n\r - Evidence of bleeding diathesis or significant coagulopathy (in the absence of\r therapeutic anticoagulation)\r\n\r - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days\r prior to Day 1 of treatment or anticipation of need for major surgical procedure\r during the course of the study\r\n\r - Core biopsy or other minor surgical procedure, excluding placement of a vascular\r access device, within 7 days prior to Day 1\r\n\r - Serious, non-healing wound, active ulcer, or untreated bone fracture\r\n\r - Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening\r\n\r - Known hypersensitivity to any component of bevacizumab\r\n\r - History of peptic ulcer within the last 6 months\r\n\r - Clinically significant peripheral vascular disease\r\n\r - Craniotomy wound that has not sufficiently healed\r\n\r - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\r within 6 months prior to study enrollment\r\n\r - Glioma showing prior spontaneous hemorrhage as determined from the clinical history or\r from any preoperative CT or MRI scan (excluding grade 1 punctate, incidentally found).\r\n\r - Longest uni-dimensional measurement of contrast enhancing tumor ≥ 4cm. Tumors\r exceeding this limit may be eligible and any question should be directed to a\r Radiation Oncology Investigator and the MSK PI.\r\n\r - Tumor must not invade the corpus callosum\r\n\r - Tumor must not invade the brainstem\r\n\r - Suspected or documented radionecrosis\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\nPhase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas\n\n**Clinical Trial Summary:**\n\nThe goal of Phase 1 of this clinical research study is to find the highest tolerable dose and\r best schedule of the combination of everolimus and sorafenib that can be given to patients\r with malignant glioma.\r\n\r The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib can\r help to control malignant glioma. The safety of this combination will also be studied in both\r phases.\r\n\r ...\n\n**Clinical Trial Detailed Description:**\n\nBackground\r\n\r - Although malignant gliomas display genetic heterogeneity, several key proliferation and\r survival signaling pathways have been identified.\r\n\r - Recent work has focused on targeting these tumor specific pathways in hopes of improving\r treatment efficacy and minimizing treatment toxicity. Because molecularly targeted\r agents have been mostly ineffective when used alone, combination therapy that inhibits\r multiple pathways is an appealing strategy.\r\n\r - Sorafenib is an oral multi-kinase inhibitor with effects on tumor proliferation and\r tumor angiogenesis. Although most GBMs lack RAF mutations, targeting the RAF/MEK/ERK\r pathway may be beneficial as this pathway may be activated by other genetic alterations\r upstream from RAF.\r\n\r - The mammalian target of rapamycin (mTOR) protein is a downstream component of the\r PI3K/Akt pathway. Everolimus (everolimus; Novartis) is a novel oral derivative of\r rapamycin.\r\n\r - Combining everolimus and sorafenib allows targeting of both the PI3K pathway and the\r RAF-MAPK pathway and in addition targets VEGF and PDGF, other active targets in\r malignant glioma.\r\n\r Objectives\r\n\r Phase 1\r\n\r -To determine the maximum tolerated dose and safety of everolimus in combination with\r\n\r sorafenib for patients with recurrent malignant gliomas.\r\n\r Phase 2\r\n\r - 6 month progression free survival rate for glioblastoma patients with no prior\r bevacizumab exposure treated with everolimus and sorafenib at the maximum tolerated dose\r as determined in the phase I study.\r\n\r - 3 month progression free survival rate for glioblastoma patients with prior bevacizumab\r exposure treated with everolimus and sorafenib at the maximum tolerated dose as\r determined in the phase I study.\r\n\r - 6 month progression free survival rate for AG patients with no prior bevacizumab\r exposure treated with everolimus and sorafenib at the maximum tolerated dose as\r determined in the phase I study.\r\n\r Eligibility\r\n\r - Patients with histologically proven recurrent intracranial malignant glioma will be\r eligible for the phase I/II component of this protocol.\r\n\r - Patients must be >= 18 years old with a Karnofsky performance status of greater than or\r equal to 60\r\n\r - No more than 2 prior chemotherapies and 1 relapse. Prior bevacizumab therapy is allowed.\r\n\r Design\r\n\r - This is a phase 1 /2 study of everolimus and sorafenib in patients with recurrent\r highgrade gliomas.\r\n\r - Phase 1: Patients will be treated with daily everolimus (days 1-28) in combination with\r sorafenib.\r\n\r - Phase 2: Patients will be treated with the combination of sorafenib and everolimus.\r Sorafenib will be taken daily for 7 days on, then 7 days off. Everolimus will be taken\r daily.\r\n\r - There is not a defined set maximum number of cycles that a patient may have. Patients\r may continue with protocol therapy until criteria for Off Treatment is met. Patients\r will then be followed every 3 months for survival status.\r\n\r - There will be an accrual of approximately 3-6 eligible patients per cohort to the Phase\r I component of the study. Patients removed at any time for toxicity are evaluable. Phase\r I patients removed from study treatment within 28 days for reasons other than toxicity\r may be replaced.\r\n\r - There will be a total accrual of approximately 82 eligible patients to the Phase II\r study (34 recurrent GBM with no prior exposure to bevacizumab, 16 recurrent Anaplastic\r Glioma with no prior exposure to bevacizumab, and 32 glioblastoma with prior exposure to\r bevacizumab).\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r General Inclusion Criteria\r\n\r 1. Patients with histologically proven recurrent intracranial malignant glioma will be\r eligible for the phase I/II component of this protocol. Malignant glioma includes\r glioblastoma (GBM), Gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic\r oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant\r astrocytoma NOS (not otherwise specified). Patients will be eligible if the original\r histology was low-grade glioma and a subsequent histological diagnosis of a malignant\r glioma is made.\r\n\r 2. 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 at all sites except the NIH.\r\n\r 3. Patients must be greater than or equal to 18 years old.\r\n\r 4. Patients must have a Karnofsky performance status of greater than or equal to 60.\r\n\r 5. No more than 2 prior chemotherapies and 1 relapse. Prior bevacizumab therapy is\r allowed.\r\n\r -Patients must have recovered from the toxic effects of prior therapy: >3 weeks for\r biologic therapies or non-cytotoxic therapies, >4 weeks for cytotoxic therapies, and\r >6 weeks for nitrosoureas. Any questions related to the definition of non- cytotoxic\r agents should be directed to the Study Chair.\r\n\r NOTE: 13 cis-retinoic acid (Accutane) as biologic therapy has a washout period of 14\r days.\r\n\r 6. Patients must have adequate bone marrow function (WBC >= 3.0 x 10^9/L, ANC >= 1.5 X\r 10^9/L, platelet count of >=100 x 10^9/L, and hemoglobin >= 10 gm/dL), adequate liver\r function (SGOT and bilirubin < 2 times ULN), and adequate renal function (creatinine <\r 1.7mg/dL or creatinine clearance greater than or equal to 60 cc/min) before starting\r therapy. These tests must be performed within 14 days prior to registration.\r Eligibility level for hemoglobin may be reached by transfusion.\r\n\r 7. Patients must have shown unequivocal radiographic evidence for tumor progression by\r MRI or CT scan. A scan should be performed within 14 days prior to registration and on\r a steroid dose that has been stable or decreasing for at least 5 days. If the steroid\r dose is increased between the date of imaging and registration a new baseline MRI/CT\r is required. The same type of scan, i.e., MRI or CT must be used throughout the period\r of protocol treatment for tumor measurement. Measurable disease is NOT required.\r\n\r Note: MRI is the preferable imaging method; CT scan may be used in cases where an MRI\r cannot be obtained.\r\n\r 8. Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible as long as all of the following conditions apply:\r\n\r - They have recovered from the effects of surgery and be > 3 weeks from surgery.\r\n\r - Residual disease following resection of recurrent malignant glioma is not\r mandated for eligibility into the study. To best assess the extent of residual\r disease post-operatively, a CT/ MRI should be done no later than 96 hours in the\r immediate post-operative period or at least 4 weeks post-operatively, within 14\r days prior to registration. If the 96-hour scan is more than 14 days before\r registration, the scan needs to be repeated. If the steroid dose is increased\r between the date of imaging and registration, a new baseline MRI/CT is required\r on a stable steroid dosage for at least 5 days.\r\n\r 9. Patients must have failed prior radiation therapy and must have an interval of greater\r than or equal to 12 weeks from the completion of radiation therapy to registration;\r except if patients underwent surgery within 12 weeks and pathology is consistent with\r recurrent tumor.\r\n\r 10. Patients with prior therapy that included interstitial brachytherapy or stereotactic\r radiosurgery must have confirmation of true progressive disease rather than radiation\r necrosis based upon either PET or Thallium scanning, MR spectroscopy or\r surgical/pathological documentation of disease.\r\n\r 11. Women of childbearing potential must have a negative B-HCG pregnancy test documented\r within 7 days prior to taking the first dose of study medications.\r\n\r 12. Patients receiving anti-coagulation treatment with an agent such as warfarin or\r heparin may be allowed to participate. For patients on warfarin, the INR should be\r measured prior to initiation of sorafenib and monitored at least weekly, or as defined\r by the local standard of care, until INR is stable.\r\n\r Phase I Inclusion Criteria:\r\n\r The following modifications to the general eligibility criteria apply to Phase I patients\r only.\r\n\r -Patients may have had treatment for any number of prior relapses. Relapse is defined as\r progression following initial therapy (i.e. surgery and radiation+/- chemo if that was used\r as initial therapy).\r\n\r Phase II Inclusion Criteria:\r\n\r Phase II patients must meet the following Eligibility Criteria in addition to the General\r Criteria described above.\r\n\r - Patients may have had treatment for no more than 1 prior relapse (i.e. failed 2 lines\r of treatment-initial therapy and therapy for first relapse) at 2nd relapse, treatment\r per BTTC09-01 is an option. Relapse is defined as progression following initial\r therapy (i.e. radiation+/- chemo if that was used as initial therapy). The intent\r therefore is that patients had no more than 2 prior therapies (initial and treatment\r for 1 relapse). If the patient had a surgical resection for relapsed disease and no\r anti-cancer therapy was instituted for up to 12 weeks, and the patient undergoes\r another surgical resection, this is considered as 1 relapse. For patients who had\r prior therapy for a low-grade glioma, the surgical diagnosis of a high-grade glioma\r will be considered the first relapse.\r\n\r - Patients must not have received prior therapy with sorafenib, everolimus, or related\r drugs such as tyrosine kinase inhibitors, VEGF inhibitors (except bevacizumab), or\r mTOR inhibitors.\r\n\r EXCLUSION CRITERIA:\r\n\r General Exclusion Criteria\r\n\r 1. Patients has any significant medical illnesses that in the investigator s opinion\r cannot be adequately controlled with appropriate therapy or would compromise the\r patient s ability to tolerate this therapy\r\n\r 2. 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 3. Patients has an active infection or serious intercurrent medical illness.\r\n\r 4. Patients has any disease that will obscure toxicity or dangerously alter drug\r metabolism.\r\n\r 5. Patients must not be on enzyme inducing anti-convulsants. If patients were previously\r on EIAEDs and these have been discontinued, patients must have been off the agent for\r at least 2 weeks prior to first study drug administration. For patients who need to\r start an AED or the AED needs to be changed, it is strongly recommended that all\r efforts should be made to use a non-EIAED.\r\n\r 6. Patients who have any severe and/or uncontrolled medical conditions or other\r conditions that could affect their participation in the study such as: Symptomatic\r congestive heart failure of New York heart Association Class III or IV unstable angina\r pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months\r of start of study drug or any other clinically significant cardiac disease severely\r impaired lung function as defined as spirometry and DLCO that is 50% of the normal\r predicted value and/or 02 saturation that is 88% or less at rest on room air\r uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN, active (acute or\r chronic) or uncontrolled severe infections, liver disease such as cirrhosis, chronic\r active hepatitis or chronic persistent hepatitis.\r\n\r 7. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\r\n\r 8. Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic\r pressure > 90 mmHg, despite optimal medical management.\r\n\r 9. Known human immunodeficiency virus (HIV) infection or chronic or acute Hepatitis B or\r C. Note: Patients who have a history of HBV and HCB infection are eligible, however,\r they must receive prophylactic antiviral therapy for 1-2 weeks prior to receiving\r study drug\r\n\r 10. Thrombolic or embolic events (except DVT or pulmonary embolus) such as a\r Cerebrovascular accident including transient ischemic attacks within the past 6\r months.\r\n\r 11. Pulmonary hemorrhage/bleeding event greater than or equal to CTCAE Grade 2 within 4\r weeks of first dose of study drug.\r\n\r 12. Any other hemorrhage/bleeding event greater than or equal to CTCAE Grade 3 within 4\r weeks of first dose of study drug.\r\n\r 13. Serious non-healing wound, non-healing ulcer, or bone fracture.\r\n\r 14. Evidence or history of bleeding diathesis or coagulopathy\r\n\r 15. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first\r study drug.\r\n\r 16. Use of St. John s Wort, orrifampin (rifampicin), or other strong CYP34A inducers.\r Dexamethasone is okay as long as the dose is 16 mg /day or less.\r\n\r Note: Patients who are on the above referenced medications may be considered eligible\r with a washout period of 14 days. Contact the coordinating center to discuss patients\r with the above aforementioned agents before patient registration.\r\n\r 17. Known or suspected allergy to sorafenib, everolimus, or any agent given in the course\r of this trial.\r\n\r 18. Any condition that impairs patient s ability to swallow whole pills.\r\n\r 19. Any malabsorption problem.\r\n\r 20. Other malignancies within the past 3 years except for adequately treated carcinoma of\r the cervix or basal or squamous cell carcinomas of the skin.\r\n\r 21. Female patients who are pregnant or breast feeding, or adults of reproductive\r potential who are not using effective birth control methods. Barrier contraceptives\r must be used throughout the trial by both sexes. Hormonal contraceptives are not\r acceptable as a sole method of contraception. (Women of childbearing potential must\r have a negative urine or serum pregnancy test within 7 days prior to administration of\r everolimus and sorafenib).\r\n\r 22. Patients who have received prior treatment with an mTOR inhibitor (sirolimus,\r temsirolimus, everolimus).\r\n\r 23. Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus,\r temsirolimus) or to its excipients.\r\n\r 24. History of noncompliance to medical regimens.\r\n\r 25. Patients unwilling to or unable to comply with the protocol.\r\n\r 26. Patients on total daily dose of dexamethasone greater than 16 mg.\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\nDanazol for Genetic Bone Marrow and Lung Disorders\n\n**Clinical Trial Summary:**\n\nBackground:\r\n\r - Some people have bone marrow and lung disorders that are caused by genetic problems. These\r problems often involve damage to the ends of the chromosomes that pass down genes. One of\r these disorders is aplastic anemia. This is a disorder in which the bone marrow does not make\r enough blood cells. Currently, doctors use a male hormone-based drug called Danazol to\r improve bone marrow function and treat aplastic anemia. More information is needed on whether\r Danazol can help repair the damaged chromosomes that cause aplastic anemia and similar\r disorders that cause low blood cell counts or lung problems.\r\n\r Objectives:\r\n\r - To study the safety and effectiveness of Danazol for bone marrow and lung disorders caused\r by damaged genes.\r\n\r Eligibility:\r\n\r - Individuals at least 2 years of age who have low blood cell counts or lung fibrosis caused\r by damaged genes.\r\n\r Design:\r\n\r - Participants will be screened with a physical exam and medical history. Then they will\r have blood and urine tests, imaging studies, and a lung function test. They will also\r take a 6-minute walking test and have a bone marrow biopsy.\r\n\r - Participants will receive Danazol to take twice a day for the duration of the study.\r\n\r - Participants will have regular study visits at 6, 12, and 24 months, with blood tests,\r imaging studies, a lung function test, and a 6-minute walking test. A bone marrow sample\r will be collected at the 12-month visit.\r\n\r - Participants will remain on the study for up to 2 years. Researchers will follow up with\r them for 2 years after the end of the study.\n\n**Clinical Trial Detailed Description:**\n\nSevere aplastic anemia (SAA) is a life-threatening bone marrow failure disorder characterized\r by pancytopenia and a hypocellular bone marrow. Telomeres were reported to be short in up to\r one-third of patients with SAA.Initially this occurrence was presumed to be secondary to\r hematopoietic stress. However, the discovery of loss-of-function mutations in genes of the\r telomerase complex (TERC, TERT) established a genetic etiology for telomere attrition in some\r patients with marrow failure who did not have the stigmata associated to an inherited bone\r marrow failure syndrome. These findings implicated telomerase dysfunction in failed\r hematopoiesis. In family members of probands with SAA, telomerase mutations have been\r observed which were associated to varying degrees of cytopenias, idiopathic pulmonary\r fibrosis (IPF) and/or cirrhosis.\r\n\r Telomere length has been associated with human cancer. Telomere attrition has been implicated\r in a variety of solid organ malignancies including esophageal and colon adenocarcinoma. In a\r longitudinal population based study, shorter telomere length associated to a higher cancer\r mortality risk overtime. It is plausible that a shorter telomere length is not just a\r biomarker associated to development of cancer, but involved in its pathogenesis. Ample\r experimental data supports an important role of critically short telomere length in genomic\r instability. Furthermore, our laboratory data (unpublished) shows that similar chromosome\r instability occurs in bone marrow cells of mutant patients, confirming the experimental data.\r Thus, a common molecular mechanism appears to underlie risk for cancer and a range of\r clinical entities.\r\n\r In vitro studies suggest that telomere length could, in theory, be modulated with sex\r hormones.15 Exposure of normal peripheral blood lymphocytes and human bone marrow derived\r CD34+ cells to androgens increased telomerase activity in vitro and androgens increased low\r baseline telomerase activity in individuals carrying a loss-of-function TERT mutation to\r normal levels. In retrospect, the beneficial effects of sex hormones on telomerase activity\r may be the mechanism by which SAA patients treated over 40 years ago with male hormones\r showed hematologic improvement in some cases.\r\n\r In recent years we have seen patients referred to our clinic with varying degree of\r cytopenia(s) who had significant family history for cytopenia(s), IPF and/or cirrhosis. We\r have identified very short telomeres in these patients and in some mutations in TERC and\r TERT. We hypothesize that male hormone therapy might modulate telomere attrition in vivo and\r ameliorate progression or reverse the clinical consequences of accelerated telomere\r attrition. Therefore, we propose male hormone therapy in patients with cytopenia(s) and/or\r IPF who show evidence of telomere dysfunction by a short age adjusted telomere length\r associated to telomerase gene mutations. The primary biologic endpoint will be delay of\r telomere attrition over time compared to known rates of telomere erosion in normal\r individuals and in those who carry mutation in the telomerase genes. The main clinical\r endpoint will be tolerability of oral danazol over two years. Secondary endpoints will be\r improvement in blood counts and/or pulmonary function. The small sample size, lack of control\r groups, and variable clinical course among those with marrow failure and IPF, will not allow\r for definitive assessment of clinical benefit. Nevertheless, we believe this protocol will\r provide insight into the possible effects of androgen therapy on telomere attrition in humans\r and of possible clinical benefit in telomere related disorders, and serve as hypothesis\r generating for further larger controlled studies.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r 1. Short age-adjusted telomere length in the first percentile and/or a mutation in\r telomerase genes\r\n\r 2. One or more of the following cytopenia(s).\r\n\r - Anemia\r\n\r 1. Symptomatic anemia with a hemoglobin < 9.5 g/dL or red cell transfusion\r requirements > 2 units/month for at least 2 months\r\n\r 2. Reticulocyte count < 60,000 /microL\r\n\r - Thrombocytopenia\r\n\r 1. Platelet count < 30,000 /microL or < 50,000 /microL associated with bleeding\r\n\r 2. Decreased megakaryocytic precursors in the bone marrow\r\n\r - Neutropenia\r\n\r 1. Absolute neutrophil count < 1,000 /microL\r\n\r OR\r\n\r 3. Idiopathic pulmonary fibrosis diagnosed by either a lung biopsy of high\r resolution computed tomography scan of the chest according to guidelines from the\r American Thoracic Society and European Respiratory Society\r\n\r 4. Age greater than or equal to 2 years\r\n\r 5. Weight > 12 kg\r\n\r EXCLUSION CRITERIA:\r\n\r 1. Moribund status or concurrent hepatic, renal, cardiac, neurologic,\r pulmonary, infectious, or metabolic disease of such severity that it would\r preclude the patient s ability to tolerate protocol therapy, or that death\r within 30 days is likely\r\n\r 2. Potential subjects with cancer who are on active chemotherapeutic treatment\r\n\r 3. Current pregnancy, or unwillingness to avoid pregnancy if of childbearing\r potential\r\n\r 4. Not able to understand the investigational nature of the study or give\r informed consent or does not have a legally authorized representative or\r surrogate that can provide informed consent.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nA Phase I Trial of Enzastaurin (LY317615) in Combination With Carboplatin in Adults With Recurrent Gliomas\n\n**Clinical Trial Summary:**\n\nThis study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug\r that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients\r who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of\r cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and\r accumulation, requiring a blood supply. Research shows that brain tumor cells can produce\r substances that stimulate new blood vessel formation. This study will look into whether the\r combination of drugs can stop that process.\r\n\r Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast\r feeding, and who do not have serious diseases may be eligible for this study. About 96\r patients will participate for 1 year. They will have a physical examination, give blood and\r urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed\r tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may\r also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to\r distinguish a live tumor from a dying one. Researchers are studying patients taking a certain\r type of antiseizure medicine and patients who are not taking it because some antiseizure\r medicines may change the way the body handles a drug such as Enzastaurin. There will be two\r groups of participants, with 16 to 48 each. Group A is not taking enzyme-inducing antiseizure\r drugs, and Group B is taking such drugs. In Groups A and B are four dose levels, with 4 to12\r patients at each level. Patients' doctors will tell them which group they belong to and how\r much Enzastaurin and Carboplatin they will take. Treatment consists of Enzastaurin every day\r for 5 weeks in Cycle 1 only and for 4 weeks beginning with Cycle 2 (each 4-week period as a\r cycle). Patients take Enzastaurin within 30 minutes after a meal. History, physical, and\r neurological examinations are repeated at the end of Cycle 1 and then every 4 weeks. Patients\r will have a repeat head MRI or CT scan before each cycle. If they tolerate the drugs without\r serious side effects and the tumor is not growing, they may continue with another cycle of\r Enzastaurin, taking the tablets every day, and Carboplatin being infused on Day 8 of Cycle 1\r and on Day 1 of each additional cycle. Routine lab tests are done regularly. Patients will\r continue the 4-week cycles of treatment for as long as they have no serious side effects and\r there are no signs of tumor growth. Side effects of Enzastaurin may be fatigue, constipation,\r cough, and nausea. In men, there may be a decrease in sperm count. Carboplatin can lead to\r low counts in blood cells and platelets, and there may also be an allergic reaction. Vomiting\r is a likely side effect. At injection sites, there may be redness, swelling, and pain.\r\n\r This study may or may not have a direct benefit for participants. However, information gained\r may help the sponsor of the study, Eli Lilly and Company, and may help patients in the future\r who have gliomas.\n\n**Clinical Trial Detailed Description:**\n\nBackground:\r\n\r - Enzastaurin, is a macrocyclic bisindolylmaleimide which disrupts the intrinsic\r phosphotransferase activity of conventional and novel PKC isoforms via an interaction at\r the ATP binding site, displays selectivity in inhibiting the isoforms. Preclinical\r studies demonstrate potent anti-angiogenic activity of enzastaurin and studies in normal\r volunteers and solid tumor patients demonstrate the drug is very well tolerated at doses\r that achieve a biologically active serum concentration.\r\n\r - Carboplatin has shown activity as monotherapy in the treatment of recurrent malignant\r gliomas in adults and preclinical data generated in our laboratory demonstrates additive\r anti-glioma activity with enzastaurin. The safety profile of carboplatin and the\r preclinical and clinical data supports its use in combination with enzastaurin in\r patients with malignant gliomas.\r\n\r Objective:\r\n\r -To establish the maximally tolerated dose of enzastaurin in combination with carboplatin in\r patients with refractory primary brain tumors not on any enzyme-inducing anti-epileptic drugs\r (nEIAED) and for patients on EIAEDs.\r\n\r Eligibility:\r\n\r -Patients with histologically proven malignant glioma are eligible for this study.\r\n\r Design:\r\n\r -Patients will be stratified into two groups based on their anti-epileptic medications\r (nEIAEDs = Group A, EIAED = Group B)\r\n\r Group A: Each cycle of therapy will consist of enzastaurin administered daily for 4 weeks\r with no breaks between cycles. All patients will receive a 7-day lead-in treatment period\r (Cycle 1) consisting of a loading dose of oral enzastaurin on Day 1 at 1125mg, followed by\r enzastaurin administered once daily at 500mg for 6 additional days in order to achieve steady\r state pharmacokinetics of enzastaurin. The first dose of carboplatin will be administered on\r Day 8 of Cycle 1, which will consist of 35 days. Following the lead-in treatment period, the\r first combination cycle of enzastaurin and carboplatin (Cycle 2) will commence as a 28-day\r cycle. Within each combination cycle, enzastaurin will be orally administered at 500mg once\r daily on Days 1 through 28 and carboplatin will be administered as an intravenous infusion\r over approximately 30 minutes on Day 1 every 28 days. The carboplatin dose will be 3 AUC for\r dose level one. For dose levels 2, 3, and 4, the carboplatin dose will be 4, 5 and 6 AUC,\r respectively.\r\n\r Group B: Each cycle of therapy will consist of enzastaurin administered daily for 4 weeks\r with no breaks between cycles. All patients will receive a 7-day lead-in treatment period\r (Cycle 1) consisting of a loading dose of oral enzastaurin on Day 1 at 1125mg, followed by\r enzastaurin administered once daily at 875mg for 6 additional days in order to achieve steady\r state pharmacokinetics of enzastaurin. The first dose of carboplatin will be administered on\r Day 8 of Cycle 1, which will consist of 35 days. Following the lead-in treatment period, the\r first combination cycle of enzastaurin and carboplatin (Cycle 2) will commence as a 28-day\r cycle. Within each combination cycle, enzastaurin will be orally administered once daily on\r Days 1 through 28 at 875mg and carboplatin will be administered as an intravenous infusion\r over approximately 30 minutes on Day 1 every 28 days. The carboplatin dose will be 3 AUC for\r dose level one. For dose levels 2, 3, and 4, the carboplatin dose will be 4, 5 and 6 AUC,\r respectively.\r\n\r National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not\r update the record. In June 2013, NCI transferred the trial to Lilly's clinicaltrials.gov\r account and Lilly updated the record with the trial status, study start date, and completion\r dates. This trial is not an applicable trial under Food and Drug Administration Amendments\r Act of 2007 (FDAAA).\n\n**Clinical Trial Eligibility Criteria:**\n\n-INCLUSION CRITERIA:\r\n\r 1. Patients with histologically proven malignant glioma who have progressive disease\r following standard treatment will be eligible for this protocol. Malignant glioma\r include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic\r oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant glioma\r NOS (not otherwise specified). Additionally, patients with primitive neuroectodermal\r tumors (PNETs) of the central nervous system, progressive low-grade gliomas and\r radiographically diagnosed brain stem gliomas will be eligible.\r\n\r 2. Patients must have unequivocal evidence for tumor progression by MRI or CT scan. This\r scan should be performed within 14 days prior to registration and on a steroid dosage\r that has been stable for at least 5 days. If the steroid dose is increased between the\r date of imaging and registration a new baseline MR/CT is required. The same type of\r scan, that is., MRI or CT must be used throughout the period of protocol treatment for\r tumor measurement.\r\n\r 3. Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible as long as all of the following conditions apply:\r\n\r A. They have recovered from the effects of surgery.\r\n\r B. Residual disease following resection of recurrent tumor is not mandated for\r eligibility into the study. To best assess the extent of residual disease\r post-operatively, a CT/ MRI should be done:\r\n\r - no later than 96 hours in the immediate post-operative period or\r\n\r - at least 4 weeks post-operatively, and\r\n\r - within 14 days of registration, and\r\n\r - on a steroid dosage that has been stable for at least 5 days.\r\n\r If the 96 hour scan is more than 14 days before registration, the scan needs to be\r repeated. If the steroid dose is increased between the date of imaging and\r registration, a new baseline MRI/CT is required on a stable steroid dosage for at\r least 5 days.\r\n\r 4. Patients must have failed prior radiation therapy and must have an interval of greater\r than or equal to 4 weeks from the completion of radiation therapy to study entry.\r\n\r 5. All patients or their previously designated LAR (Legally Authorized Representative)\r (if the patient is deemed by the treating physician to be cognitively impaired or\r questionably impaired in such a way that the ability of the patient to give informed\r consent is questionable) must sign an informed consent indicating that they are aware\r of the investigational nature of this study. Patients will be registered prior to\r starting the study.\r\n\r 6. Patients must be greater than or equal to 18 years old, and with a life expectancy\r greater than 8 weeks.\r\n\r 7. Patients must have a Karnofsky performance status of greater than or equal to 60.\r\n\r 8. Patients must have recovered from the toxic effects of prior therapy: 2 weeks from any\r noncytotoxic investigational agent, 4 weeks from prior cytotoxic therapy, two weeks\r from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration,\r and 1 week for non-cytotoxic agents, for example., interferon, tamoxifen, thalidomide,\r cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the\r definition of non-cytotoxic agents should be directed to the Study Chair.\r\n\r 9. Patients must have adequate bone marrow function (WBC greater than or equal to\r 3,000/microl, ANC greater than or equal to 1,500/mm(3), platelet count of greater than\r or equal to 100,000/mm(3), and hemoglobin greater than or equal to 10 gm/dl), adequate\r liver function (SGOT and bilirubin less than or equal to 2 times ULN), and adequate\r renal function (creatinine less than or equal to 1.5 mg/dL and/or creatinine clearance\r greater than or equal to 60 cc/min) before starting therapy. These tests must be\r performed within 14 days prior to registration. Eligibility level for hemoglobin may\r be reached by transfusion.\r\n\r 10. 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 11. This study was designed to include women and minorities, but was not designed to\r measure differences of intervention effects. Males and females will be recruited with\r no preference to gender. No exclusion to this study will be based on race.\r\n\r 12. Patients must practice adequate contraception.\r\n\r 13. Prior treatment with an enzyme inducing antiepileptic drug must have been discontinued\r at least 14 days prior to study entry for Group A patients.\r\n\r EXCLUSION CRITERIA:\r\n\r 1. Patients who, in the view of the treating physician, have significant active cardiac,\r hepatic, or renal diseases are ineligible.\r\n\r 2. No concurrent use of other standard chemotherapeutics or investigative agents.\r\n\r 3. Prior treatment with platinum-based therapy.\r\n\r 4. Patients known to have an allergic response to mannitol.\r\n\r 5. Patients known to have an active malignancy other than their malignant glioma (except\r non-melanoma skin cancer or carcinoma in-situ of the cervix).\r\n\r 6. Patients who have an active infection requiring IV antibiotics.\r\n\r 7. Patients who are pregnant or breast feeding.\r\n\r 8. Patients who have any disease that will obscure toxicity or dangerously alter drug\r metabolism.\r\n\r 9. QTc with Bazett's correction that is unmeasurable, or greater than or equal to 460\r msec on screening ECG. If a patient has QTc greater than or equal to 460 msec on\r screening ECG, a second screen ECG may be repeated at least 24 hours apart. The\r average QTc from the 2 screening ECGs must be less than 460 msec in order for the\r patient to be eligible for the study.\r\n\r 10. EKG demonstrating clinically significant arrythmia (multifocal premature ventricular\r contraction [PVC], bigeminy, trigeminy, ventricular tachycardia, bradycardia) that is\r symptomatic or requires treatment (CTCAE Grade 3), or asymptomatic sustained\r ventricular tachycardia.\r\n\r 11. Patients who have baseline EKGs suggestive of past or present cardiac ischemia will\r not be eligible unless they have an appropriate (as defined by the P.I. of this trial)\r negative cardiac work up (that is, echocardiogram, stress test).\r\n\r 12. Patients may not be on systemic anti-coagulants (that is, heparin, warfarin, small\r heparin fragments).\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\nThe Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis\n\n**Clinical Trial Summary:**\n\nThe aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids\r administered orally in narrow lumbar canal syndrome.\n\n**Clinical Trial Detailed Description:**\n\n60 patients are being randomized, plank by randomization, the patient and the examiner will\r be blinded. Will be placed in opaque brown envelopes in order to maintain the secrecy of\r allocation.\r\n\r Included patients aged between 50 and 75 years of both sexes participate in the work to\r accept and sign the Informed Consent The patient will be screened in advance after the\r acceptance of it will be an anthropometric assessment, with assessment of height, weight and\r presence of associated comorbidities.\r\n\r After clinical evaluation they headed for the initial evaluation, after this evaluation,\r patients are randomized and and delivered to the patient the medication with corticosteroids\r or placebo for an unrelated medical research. It is also given a bottle of paracetamol 750 mg\r and a sheet dated, in which the patient is instructed to register the day this sheet and\r number of capsules taken, which is also an evaluation factor.\r\n\r evaluation VAS SF 36 Roland Morris questionnaire Test 6-minute walk Likert scale ELegibility\r Criteria\r\n\r Clinical diagnosis:\r\n\r Low back pain and at least two of the following complaints in lower limbs: pain, weakness,\r burning or numbness that worsens with walking and improves with the cessation of walking.\r\n\r Radiological diagnosis:\r\n\r Presence of lumbar canal stenosis with an area less than 100mm2 Hamanishi based on criteria\r measured at lumbar spine MRI in the follow-up from L1 to S1.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Low back pain and at least two of the following complaints in lower limbs: pain,\r weakness, burning or numbness that worsens with walking and improves with the\r cessation of walking.\r\n\r Exclusion Criteria:\r\n\r - decompensated diabetes mellitus.\r\n\r - Systemic hypertension and decompensated heart\r\n\r - systemic disease affecting the lower limbs\r\n\r - Neuromuscular Disease\r\n\r - Use of steroids in the past 3 months.\r\n\r - Patients with previous surgery of the thoracic or lumbar spine.\r\n\r - cognitive disorder that interferes with the ability to understand or interpret the\r questionnaires\r\n\r - Spondylolisthesis except degenerative\r\n\r - degenerative scoliosis with Cobb angle of 10 °\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\nLow Dose Radiation Therapy for Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nTo evaluate the safety and effectiveness of low dose rate radiation therapy plus\r temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic\r Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery\r followed by radiation surgical resection followed by adjuvant radiation therapy plus\r temozolomide.\n\n**Clinical Trial Detailed Description:**\n\nIn vitro and in vivo studies have suggested that low dose fractionated radiation therapy\r (LDFRT) may be used to potentiate full dose chemotherapy, decreasing the development of\r resistance found with standard doses of radiation and chemotherapy. This is a nonrandomized,\r open label, single institution phase II trial with a safety run-in to evaluate the safety and\r efficacy of LDFRT plus temozolomide in patients with High Grade Glioma (to only include\r Anaplastic Astrocytoma or Glioblastoma Multiforme) previously treated with surgical resection\r followed by adjuvant radiation therapy plus temozolomide. The primary objective of the phase\r II study is to estimate response rate in patients treated with twice daily fractions of low\r dose radiation plus temozolomide chemotherapy.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have recurrent GBM (Glioblastoma Multiforme)or Anaplastic Astrocytoma.\r\n\r - The diagnosis of GBM or Anaplastic Astrocytoma.\r\n\r - Patients must have been previously treated with surgical resection (any extent okay)\r and adjuvant radiation therapy plus temozolomide.\r\n\r - Patients must be at least 12 months from completion of radiation therapy\r\n\r - At least 2 months from completion of temozolomide (to be consistent with the the\r \"rechallenge\" group from Perry et al. JCO 2010).\r\n\r - Age >18 years\r\n\r - ECOG performance status <2 (Karnofsky >60%, see appendix A).\r\n\r - There must be measurable disease on MRI.\r\n\r - Patients must have normal organ and marrow function as defined below:\r\n\r - Women must not be pregnant\r\n\r - Ability to understand and the willingness to sign a written informed consent document\r\n\r - Temozolomide re-treatment is planned by the treating neuro-oncologist.\r\n\r - The most recent brain tumor pathology obtained for the patient must be glioblastoma.\r\n\r Exclusion Criteria:\r\n\r - Must be able to receive an MRI\r\n\r - Patients may not be receiving any other investigational cancer treatment agents at the\r time of enrollment.\r\n\r - Patients may not have previously failed treatment with salvage temozolomide.\r\n\r - Patients may not have previously failed treatment with a VEGF inhibitor.\r\n\r - Patients may not have previously been treated with >1 course of radiotherapy.\r\n\r - Patients may not have previously been treated with radiosurgery to the brain.\r\n\r - Uncontrolled intercurrent illness\r\n\r - Pregnant and breastfeeding women are excluded. Women of child-bearing potential who\r are unwilling or unable to use and acceptable method of birth control to avoid\r pregnancy for the entire study period and up to 12 weeks after the study are excluded.\r Male subjects must also agree to use effective contraception for the same period as\r above.\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\niMRI Guided Resection in Cerebral Glioma Surgery\n\n**Clinical Trial Summary:**\n\nMany clinical studies have been reported on iMRI, however, their evidence levels are\r relatively not as good as what people hope they will be. Based on the available literature,\r there is, at best, level 2 evidence that iMRI-guided surgery is more effective than\r conventional neuronavigation-guided surgery.\r\n\r The investigators aim to do a single center prospective randomized triple-blind controlled\r clinical trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma\r resection on surgical efficiency and progression-free survival of malignant glioma to provide\r a level 2A evidence for its clinical application.\n\n**Clinical Trial Detailed Description:**\n\nSince the first introduction of the GE Signa System by the Brigham and Women's Hospital as\r the world's first intraoperative MRI in 1993, iMRI has been so increasingly applied that it\r has been one of the most important techniques and concepts in the field of neurosurgery. Many\r clinical studies have been reported on this respect, however, their evidence levels are\r relatively not as good as what people hope they will be.Based on the available literature,\r there is, at best, level 2B evidence that iMRI-guided surgery is more effective than\r conventional neuronavigation-guided surgery.\r\n\r Rationale: Intraoperative magnetic resonance imaging (MRI)-guided intracranial surgery, one\r of whose most frequently reported indications is cerebral glioma surgery, may help update\r images for navigational systems, providing data on the extent of resection and localization\r of tumor remnants, and thereby enable intraoperative reliable immediate resection control to\r eliminate the effect of brain shift on the extent of resection. Intraoperative MRI systems\r can be divided into low-field intraoperative MRI(0.5T or less) and high-field intraoperative\r MRI (1.5T or more) according to their various field strengths. The latter enables\r intraoperative imaging at higher quality and more available imaging modalities but with more\r cost and equipment requirements.\r\n\r Purpose: We aim to do a single center prospective randomized triple-blind controlled clinical\r trial to assess the effect of 3.0T high-field intraoperative MRI-guided glioma resection on\r surgical efficiency and progression-free survival of malignant glioma. We hypothesize that\r the use of high-field intraoperative MRI will enable more complete tumor resection than\r conventional neuronavigation-guided resection,reducing the morbidity and leading to more\r improved progression-free survival and quality of life in patients with malignant glioma.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Individuals aged 18-70 years with highly suspected (as assessed by study surgeon),\r newly diagnosed, untreated malignant glioma (see appendix 1)\r\n\r 2. Individuals with supratentorial gliomas with bodies involving in frontal lobe,\r temporal lobe, parietal lobe, occipital lobe or insular lobe\r\n\r 3. Individuals with the preoperative assessment that radiological radicality should be\r achieved\r\n\r 4. Individuals either with or without tumor in eloquent areas (see appendix 2)\r\n\r 5. Karnofsky performance scale 70 or more\r\n\r 6. All patients gave written informed consent.\r\n\r Appendix 1. Histological types（WHO 2007）:\r\n\r 1. Astrocytic tumours:Pilomyxoid astrocytoma 9425/3 Pleomorphic xanthoastrocytoma 9424/3\r Diffuse astrocytoma 9400/3 Fibrillary astrocytoma 9420/3 Gemistocytic astrocytoma\r 9411/3 Protoplasmic astrocytoma 9410/3 Anaplastic astrocytoma 9401/3 Glioblastoma\r 9440/3 Giant cell glioblastoma 9441/3 Gliosarcoma 9442/3\r\n\r 2. Oligodendroglial tumours:Oligodendroglioma 9450/3 Anaplastic oligodendroglioma 9451/3\r\n\r 3. Oligoastrocytic tumours:Oligoastrocytoma 9382/3 Anaplastic oligoastrocytoma 9382/3\r\n\r 4. Ependymal tumours:Ependymoma 9391/3 Cellular 9391/3 Papillary 9393/3 Clear cell 9391/3\r Tanycytic 9391/3 Anaplastic ependymoma 9392/3\r\n\r Morphology code of the International Classification of Diseases for Oncology (ICD-O) {614A}\r and the Systematized Nomenclature of Medicine (http://snomen.org). Behaviour is coded /0\r for benign tumours, /3 for malignant tumours and /1 for borderline or uncertain behaviour.\r\n\r Tumor grade: grade II~IV according to the latest WHO grading criteria;\r\n\r Appendix 2. Tumor location in eloquent areas:\r\n\r located in or close to areas of the dominant-hemisphere that associated with motor or\r language functions, including:\r\n\r 1. Frontal lobe, which divided into inferior frontal gyrus (BA44-Pars opercularis,\r BA45-Pars triangularis/Broca's area), middle frontal gyrus (BA9, BA46), superior\r frontal gyrus (BA4, BA6, BA8), primary motor cortex (BA4), premotor cortex (BA6), and\r supplementary motor area (BA6)\r\n\r 2. Parietal lobe, which divided into inferior parietal lobule (BA40-supramarginal gyrus,\r BA39-angular gyrus), parietal operculum (BA43), and primary somatosensory cortex (BA1,\r BA2, BA3)\r\n\r 3. Temporal lobe, which divided into transverse temporal gyrus (BA41, BA42), superior\r temporal gyrus (BA38, BA22/Wernicke's area), middle temporal gyrus (BA21)\r\n\r 4. Insular lobe.\r\n\r Exclusion Criteria:\r\n\r 1. Individuals with age < 18 years or > 70 years\r\n\r 2. Tumours of the midline, basal ganglia, cerebellum, or brain stem\r\n\r 3. Recurrent gliomas after surgery (except needle biopsy)\r\n\r 4. Primary gliomas with history of radiotherapy or chemotherapy\r\n\r 5. Contraindications precluding intraoperative MRI-guided surgery\r\n\r 6. Inability to give informed consent\r\n\r 7. KPS < 70\r\n\r 8. Renal insufficiency or hepatic insufficiency\r\n\r 9. History of malignant tumours at any body site\r\n\r 10. Tumour locations (in important eloquent area) do not enable complete resection of\r tumour.\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\nSteroids Versus Gabapentin\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether pharmacotherapy or epidural steroid\r injections are a better treatment for lumbosacral radicular pain.\r\n\r 142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be\r randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will\r be allocated to receive an epidural steroid injection (ESI; group I), with an equal number\r allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded.\r Follow-up will be through 3-months after treatment.\n\n**Clinical Trial Detailed Description:**\n\n142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be\r randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will\r be allocated to receive an ESI (group I), with an equal number allocated to receive\r gabapentin (group II).\r\n\r Group I patients with unilateral symptoms will receive (unilateral) transforaminal ESI, while\r those with bilateral symptoms will receive (central) interlaminar ESI, as is common practice.\r\n\r In group II patients who receive gabapentin, the dose will be titrated to between 1800 mg/d\r and 2700 mg/d in TID dosing, but may be lowered or elevated (up to 3600 mg/d) depending on\r the clinical circumstances. To ensure blinding, these patients will also receive midline (for\r patients with bilateral symptoms who would receive interlaminar ESI) or unilateral paraspinal\r (for patients with unilateral symptoms who would receive transforaminal ESI) normal saline\r into the interspinal ligaments or paraspinal musculature, respectively. Injections and\r medication titration will commence on the same day.\r\n\r Rescue medications will consist of tramadol 50 mg 1 to 2 tablets every 6 hours PRN (up to\r 8/d) and/or ibuprofen 400-800 mg every 6 hours PRN (not-to-exceed 3000 mg/d). Patients\r already taking analgesics, including opioids, can continue on these medications \"as needed\".\r\n\r The first follow-up visit will be scheduled 1-month from the start of treatment. A positive\r outcome will be defined as a > 2-point decrease in leg pain coupled with a positive\r satisfaction rating. Subjects who obtain a positive outcome at their initial 1-month\r follow-up visit will remain in the study and return for the final 3-month follow-up visit.\r Those with a negative outcome will exit the study \"per protocol\" to receive standard care,\r which may consist of unblinded ESI, medical management with drugs such as gabapentin (for\r those who did not receive gabapentin) and antidepressants, and physical therapy. Subjects who\r obtain a positive outcome at 1-month but experience a recurrence before their 3-month\r follow-up visit will also exit the study per protocol, with their final outcome measures\r recorded before they receive standard care. At all follow-up visits, pill counts will be\r conducted to determine medication compliance.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating\r into one or both lower extremities, sensory loss, muscle weakness, positive straight\r leg raising test etc.)\r\n\r - Numerical Rating Scale leg pain score > 4 (or if 3/10, greater or equal to back pain)\r\n\r - MRI evidence of spinal pathology consistent with symptoms\r\n\r Exclusion Criteria:\r\n\r - Untreated coagulopathy\r\n\r - Previous spine surgery\r\n\r - No MRI study\r\n\r - Leg pain > 4 years duration Epidural steroid injection within past 3 years Cauda\r equina syndrome Previous failed trials with gabapentin or pregabalin Allergic\r reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections\r for surgical evaluation Serious medical or psychiatric that condition that might\r preclude optimal outcome or interfere with participation, such as the need for\r uninterrupted anticoagulation.\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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"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\nPermeability Map to Distinguish Progression From Pseudoprogression in High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nThe aim of the present study is to assess whether a new method of quantifying\r therapy-associated hemodynamic alterations based on DCE MR imaging may help to distinguish\r pseudoprogression from true progression in patients with high grade glioma, who received\r CCRT.\n\n**Clinical Trial Detailed Description:**\n\nCombination temozolomide and radiation significantly prolongs survival compared with\r radiation alone and has become standard treatment for glioblastoma multiforme (GBM). Response\r assessment in GBM is difficult as a result of the frequent occurrence of early imaging\r changes indistinguishable from tumor progression, termed pseudoprogression. The majority of\r patients remain clinically stable. It is often unclear whether current therapy should be\r maintained or second-line therapy initiated. The incidence of pseudoprogression after\r concurrent chemoradiation is15%to 30%. A potential mechanism of pseudoprogression is that\r radiation-induced vascular changes may lead to focal transient increase in gadolinium\r enhancement. Dynamic contrast-enhanced (DCE) MR imaging provides a noninvasive means for\r 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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"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\nPhase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly\n\n**Clinical Trial Summary:**\n\nThe study aims to optimize the treatment of elderly subjects (> 65) with anaplastic\r astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative.\r There is no consensus as to how radical the surgery should be. Involved-field radiotherapy is\r the treatment most likely to be accepted apart from supportive and palliative measures. The\r role of chemotherapy is barely defined. Study data available to date does not suggest that\r this patient population would benefit from combined radiochemotherapy. The aim of the study\r is to verify the hypothesis that first-line chemotherapy with one week on/one week off\r temozolomide is not inferior to extended-field radiotherapy in the first-line treatment of\r anaplastic astrocytoma and glioblastoma in the elderly (> 65 age group). The primary endpoint\r is median survival, as life expectancy is limited to several months. Secondary endpoints are\r response rates in both arms (CR, PR, MacDonald et al. 1990), median progression-free\r survival, 1-year and 2-year survival rates, definition of MGMT as molecular genetic\r prognostic or predictive markers, and quality of life. Theoretically, it should be possible\r to preserve quality of life in the first-line chemotherapy arm of the study.\n\n**Clinical Trial Detailed Description:**\n\nThis study is a prospective, randomized Phase III intervention study. Following histological\r documentation of the diagnosis by biopsy or resection of an anaplastic astrocytoma or\r glioblastoma, patients will be randomized either to receive postoperative extended-field\r radiotherapy (arm A) or to receive postoperative chemotherapy with temozolomide (arm B).\r Randomization will be done for all sites at the CRO, Alcedis GmbH.\r\n\r For patients intending to participate in the study, the procedure is as follows:\r\n\r - Request a reference neuropathological review from the brain tumor reference center in\r Bonn (Prof. Dr. G. Reifenberger) through the local neuropathology department. This\r review need not be present at randomization because anaplastic astrocytoma and\r glioblastoma cases are eligible\r\n\r - Contact: Prof. Dr. W. Wick, Dep. Neurooncology, National Center for Tumor Diseases and\r Neurology Clinic, University of Heidelberg, [email protected] or CRO:\r Alcedis, Giessen at Alcedis GmbH, I. Helm, Winchester Str. 2, 35394 Gießen, Tel.: 0641\r 944360, Fax: 0641 94436 70, E-mail: [email protected]\r\n\r - Provide written confirmation that the patient signed the ethics committee-approved\r consent form\r\n\r - Submit the registration form and a copy of the EORTC-QLQ given in Annexes\r\n\r In subjects with progressive or recurrent disease, the investigating site will verify whether\r specific tumor treatment is justified. If yes, chemotherapy with temozolomide is recommended\r in arm A, possibly after further surgery. Subjects in arm B will receive radiotherapy,\r possible after further surgery. As all-cause mortality is the primary endpoint, all\r therapeutic measures following first-line therapy should be documented.\r\n\r If study treatment is discontinued (first-line therapy) because of progressive disease or if\r progression occurs after completion of study treatment, the pertinent images should be\r submitted to the reference center for neuroradiology in Tübingen for reference review.\r\n\r The treatment modalities employed in the study are chemotherapeutic and radiotherapeutic\r procedures licensed in the Federal Republic of Germany for use in human subjects.\r Temozolomide is currently licensed for treating subjects with recurrent disease and since\r 2006 in newly diagnosed glioblastoma together with radiotherapy. The time allotted for the\r individual treatment sections is 6 weeks for radiotherapy, while chemotherapy will be\r continued until progression or unacceptable adverse effects occur. The precise chemotherapy\r sequence is shown in the protocol. The criteria for withdrawal from the study are defined in\r in the protocol. Four years is the period scheduled for recruiting all patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed supratentorial anaplastic astrocytoma or glioblastoma\r\n\r - Age > 65\r\n\r - Karnofsky performance score > 60%\r\n\r - Neutrophilic granulocyte count > 1500/µl\r\n\r - Platelet count > 100 000/µl\r\n\r - Hemoglobin > 10 g/dl\r\n\r - Serum creatinine < 1.5 times the lab's upper normal limit\r\n\r - AST or ALT < 3 times the lab's upper normal limit\r\n\r - Alkaline phosphatase < 3 times the lab's upper normal limit\r\n\r - No previous systemic chemotherapy\r\n\r - No previous radiotherapy to the brain\r\n\r - Written consent\r\n\r Exclusion Criteria:\r\n\r - Serious medical or neurological condition with a poor prognosis\r\n\r - HIV infection\r\n\r - Second cancer requiring radiotherapy or chemotherapy (contact the study coordinat if\r necessary)\r\n\r - Hypersensitivity to temozolomide\r\n\r - Conditions associated with regular vomiting that might affect oral administration of\r the drugs\r\n\r - Psychological, familial, social or geographical circumstances with major implications\r for compliance with the study visit schedule\r\n\r - Patient was taking part in other intervention studies within a month of starting this\r study\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVeliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas\n\n**Clinical Trial Summary:**\n\nThis phase I/II trial studies the side effects and the best dose of veliparib when given\r together with radiation therapy and temozolomide and to see how well they work in treating\r younger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growth\r of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses\r high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide,\r work in different ways to stop the growth of tumor cells either by killing the cells or by\r stopping them from dividing. Giving veliparib with radiation therapy and temozolomide may\r kill more tumor cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To identify the maximum-tolerated dose or recommended Phase II dose of ABT-888 (veliparib)\r which can be safely administered concurrently with radiation therapy, followed by maintenance\r therapy with ABT-888 and temozolomide (TMZ), in patients with newly diagnosed diffuse pontine\r gliomas (DIPG). (Phase I) II. To study the plasma pharmacokinetics (PK) of ABT-888 during\r ABT-888 and radiation therapy. (Phase I) III. To study the feasibility of intra-patient dose\r escalation of TMZ during maintenance therapy with ABT-888 and TMZ. (Phase I) IV. To describe\r the toxicities associated with administering ABT-888 and radiation therapy, followed by\r ABT-888 and TMZ, in patients with newly diagnosed DIPG. (Phase I) V. To estimate the\r proportion of newly diagnosed DIPG patients treated on protocol that are determined to have\r experienced pseudo progression. (Phase I) VI. To estimate the overall survival distribution\r for newly diagnosed patients with DIPG treated with the combination of ABT-888 and radiation\r therapy, followed by ABT-888 and TMZ, and compare to Pediatric Brain Tumor Consortium (PBTC)\r historical controls. (Phase II) VII. To study the feasibility of intra-patient dose\r escalation of TMZ during maintenance therapy with ABT-888 and TMZ. (Phase II) VIII. To\r estimate the proportion of newly diagnosed DIPG patients treated on protocol that are\r determined to have experienced pseudo progression. (Phase II)\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To estimate the progression-free survival (PFS) distribution and to summarize the best\r tumor responses observed prior to progression or recurrence.\r\n\r II. To explore the plasma PK of ABT-888 during ABT-888 and radiation therapy. III. To explore\r peripheral blood mononuclear cell (PBMC) poly (ADP-ribose) polymerase 1(PARP) activity before\r and after treatment with ABT-888.\r\n\r IV. To explore quantifying non-homologous end-joining (NHEJ) activity or gamma-H2A histone\r family, member X (H2AX) levels (as surrogate markers of unrepaired double-strand breaks\r (DSBs)) in PBMC before and after treatment with ABT-888.\r\n\r V. To explore quantifying PARP activity and deoxyribonucleic acid (DNA)-repair protein levels\r in biopsied atypical pontine gliomas, if available.\r\n\r VI. To explore associations of molecular parameters from secondary aims III, IV, and V with\r PFS and overall survival (OS) after conclusion of clinical trial.\r\n\r VII. To explore the quantitative magnetic resonance (MR) measures of relative cerebral blood\r volume (rCBV), vascular permeability (Ktrans, fractional plasma volume [vp], and\r extravascular extracellular space volume fraction [ve] values), and apparent diffusion\r coefficient (ADC) within the first six months of initiating protocol treatment to correlate\r with disease outcome and determine whether such metrics differentiate patients with pseudo\r progression from those with true early progressive disease.\r\n\r VIII. To explore the potential utility of urine biomarkers as a novel, non-invasive method of\r detecting and tracking changes in the status of pediatric brain stem gliomas.\r\n\r OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a phase II study.\r\n\r DOSE-ESCALATION: Patients receive veliparib orally (PO) twice daily (BID) 5 days a week for\r 6-7 weeks. Patients also undergo concurrent 3-dimensional conformal radiotherapy (3D-CRT) or\r intensity-modulated radiotherapy (IMRT) once daily (QD) 5 days a week for 6-7 weeks.\r\n\r MAINTENANCE THERAPY: Beginning 3-4 weeks later, patients receive veliparib PO BID on days 1-5\r and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 courses in\r the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed up periodically for up to 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs), defined as\r tumors with a pontine epicenter and diffuse intrinsic involvement of the pons, are\r eligible without histologic confirmation; patients with brainstem tumors that do not\r meet these criteria or not considered to be typical intrinsic pontine gliomas will\r only be eligible if the tumors are biopsied and proven to be an anaplastic\r astrocytoma, glioblastoma multiforme, gliosarcoma, anaplastic mixed glioma, or\r fibrillary astrocytoma\r\n\r - Patients with juvenile pilocytic astrocytoma, pilomyxoid astrocytoma, fibrillary\r astrocytoma, gangliogliomas, or other mixed gliomas without anaplasia are not\r eligible;\r\n\r - Patients with disseminated disease are not eligible, and magnetic resonance\r imaging (MRI) of spine must be performed if disseminated disease is suspected by\r the treating physician\r\n\r - Patient must be able to swallow oral medications to be eligible for study enrollment\r\n\r - Karnofsky >= 50% for patients > 16 years of age or Lansky >= 50% for patients =< 16\r years of age; patients who are unable to walk because of paralysis, but who are up in\r a wheelchair, will be considered ambulatory for the purpose of assessing the\r performance score\r\n\r - Patients must have not received any prior therapy other than surgery and/or steroids\r\n\r - Absolute neutrophil count >= 1,000/mm^3\r\n\r - Platelets >= 100,000/mm^3 (unsupported)\r\n\r - Hemoglobin >= 10 g/dL (unsupported)\r\n\r - Total bilirubin =< 1.5 times upper limit of normal (ULN) for age\r\n\r - Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 5 x\r institutional upper limit of normal for age\r\n\r - Albumin >= 2 g/dL\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70\r mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:\r\n\r - 0.6 mg/dL (1 to < 2 years of age)\r\n\r - 0.8 mg/dL (2 to < 6 years of age)\r\n\r - 1.0 mg/dL (6 to < 10 years of age)\r\n\r - 1.2 mg/dL (10 to < 13 years of age)\r\n\r - 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)\r\n\r - 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)\r\n\r - Female patients of childbearing potential must not be pregnant or breast-feeding;\r female patients of childbearing potential must have a negative serum or urine\r pregnancy test\r\n\r - Patients of childbearing or child-fathering potential must be willing to use a\r medically acceptable form of birth control, which includes abstinence, while being\r treated on this study\r\n\r - Signed informed consent according to institutional guidelines must be obtained;\r assent, when appropriate, will be obtained according to institutional guidelines\r\n\r Exclusion Criteria:\r\n\r - Patients with any clinically significant unrelated systemic illness (serious\r infections or significant cardiac, pulmonary, hepatic or other organ dysfunction),\r that would compromise the patient's ability to tolerate protocol therapy or would\r likely interfere with the study procedures or results\r\n\r - Patients with inability to return for follow-up visits or obtain follow-up studies\r required to assess toxicity to therapy\r\n\r - Patients with active seizures or a history of seizure are not eligible for study\r entry, with the exception of patients with documented febrile seizure\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\nFludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies\n\n**Clinical Trial Summary:**\n\nThis phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose\r total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT)\r works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as\r fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the\r growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting\r the donor's stem cells. When the healthy stem cells from the donor are infused into the\r patient they may help the patient's bone marrow make stem cells, red blood cells, white blood\r cells, and platelets. Sometimes the transplanted cell from a donor can make an immune\r response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and\r methotrexate after transplant may stop this from happening\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine the transplant related mortality (TRM) of this reduced-intensity\r transplantation (RIT) combination, fludarabine (fludarabine phosphate), melphalan, and TBI in\r a patient population usually not eligible for a full a myeloablative allogeneic hematopoietic\r stem cell transplantation (HSCT).\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate clinical response, progression free survival (PFS) at one year, engraftment\r rate, and graft-versus-host disease (GvHD) incidence with the proposed RIT regimen across a\r variety of hematological conditions.\r\n\r II. Correlative studies will include chimerism analysis by molecular analysis and evaluation\r of immune reconstitution by cytomegalovirus (CMV) dextramer analysis using flow cytometry.\r\n\r OUTLINE: PREPARATIVE REGIMEN:\r\n\r Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2\r and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI twice daily (BID)\r on day -1.\r\n\r TRANSPLANTATION:\r\n\r Patients undergo allogeneic PBSCT on day 0.\r\n\r GvHD PROPHYLAXIS:\r\n\r Patients receive tacrolimus IV or orally (PO) BID on days -1 to 100 with taper over 4-6\r months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15-30 minutes\r on days 1, 3, and 6. After completion of study treatment, patients are followed up\r periodically.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosis of a histology documented hematologic malignancy or marrow disorder\r\n\r BONE MARROW FAILURE DISORDERS:\r\n\r - Acquired bone marrow failure disorders include aplastic anemia, paroxysmal nocturnal\r hemoglobinuria (PNH) * Primary allogeneic HSCT is appropriate for selected patients\r with severe aplastic anemia; however, patients with aplastic anemia must have failed\r at least one cycle of standard immunosuppressive therapy with calcineurin inhibitor\r plus anti-thymocyte globulin (ATG) if a fully matched donor is available * Patients\r with PNH should not be eligible for a myeloablative HSCT\r\n\r - Hereditary bone marrow failure disorders include Diamond-Blackfan Anemia,\r Shwachman-Diamond Syndrome, Kostmann Syndrome, congenital Amegakaryocytic\r Thrombocytopenia; Fanconi Anemia or related chromosomal breakage syndrome,\r Dyskeratosis Congenital are excluded from this study die to their poor\r deoxyribonucleic acid (DNA) repair capacity * Fanconi anemia or related chromosomal\r breakage syndrome: positive chromosome breakage analysis using diepoxybutane (DEB) or\r mitomycin C if applicable * Dyskeratosis Congenita: diagnosis is supported by using\r either telomerase RNA component (TERC) gene mutation in autosomal dominant\r Dyskeratosis Congenita or X-linked DKC1 gene mutation\r\n\r - Other non-malignant hematologic or immunologic disorders that require transplantation\r * Quantitative or qualitative congenital platelet disorders (including but not limited\r to congenital amegakaryocytopenia, absent-radii syndrome, Glanzmann's thrombasthenia)\r * Quantitative or qualitative congenital neutrophil disorders (including but not\r limited to chronic granulomatous disease, congenital neutropenia) *Congenital primary\r immunodeficiency syndrome, Wiskott-Aldrich syndrome, CD40 ligand deficiency, T-cell\r deficiencies)\r\n\r ACUTE LEUKEMIAS:\r\n\r - Subjects must be ineligible for or unable to receive a conventional myeloablative\r transplantation\r\n\r - Resistant or recurrent disease after at least one standard combination chemotherapy OR\r first remission patients at high risk of relapse * Acute myeloid leukemia (AML)\r\n\r - antecedent myelodysplastic syndrome, secondary AML, high risk cytogenetic\r abnormalities or normal cytogenetics with high-risk molecular mutations (e.g.,\r fms-like tyrosine kinase3-internal tandem duplication [Flt3-ITD] mutation) * Acute\r lymphocytic leukemia (ALL)\r\n\r - high or standard risk ALL\r\n\r CHRONIC MYELOID LEUKEMIA (CML):\r\n\r - Chronic phase (intolerant or unresponsive to imatinib and/or other tyrosine kinase\r inhibitors), second chronic phase or accelerated phase who are ineligible for\r conventional myeloablative transplantation\r\n\r MYELOPROLIFERATIVE AND MYELODYSPLASTIC SYNDROME (MDS):\r\n\r - Myelofibrosis (with/without splenectomy) with intermediate to high risk features\r\n\r - Advanced polycythemia vera nor responding to standard therapy\r\n\r - MDS with lower International Prognostic Scoring System (IPSS) score of intermediate\r (Int)-2 or higher\r\n\r - MDS with lower IPSS score Int-1 or less with severe clinical features such as severe\r neutropenia or thrombocytopenia or high risk chromosome abnormalities such as monosomy\r 7\r\n\r - Secondary MDS with any IPSS scores\r\n\r - Chronic myelomonocytic leukemia\r\n\r LYMPHOPROLIFERATIVE DISEASE:\r\n\r - Chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin lymphoma (NHL) (recurrent or\r persistent) fludarabine refractory or with less than 6 months duration or complete\r remission (CR) between courses of conventional therapy\r\n\r - Multiple myeloma (progressive disease after autologous stem cell transplant, tandem\r allogeneic transplant after prior autologous stem cell transplant)\r\n\r - Waldenstrom's macroglobulinemia (failed one standard regimen)\r\n\r - High grade NHL and diffuse large B-cell lymphoma (DLBCL)\r\n\r - Not eligible for conventional myeloablative HSCT OR failed autologous HSCT\r\n\r - First remission lymphoblastic lymphoma, or small, non-cleaved cell lymphoma or mantle\r cell lymphoma\r\n\r HODGKIN LYMPHOMA:\r\n\r - Received and failed front-line therapy\r\n\r - Failed or were not eligible for autologous transplantation DONOR: Permissible human\r leukocyte antigen (HLA) matching: related donors\r\n\r - single antigen mismatch at HLA A, B, or DRB1; unrelated donors\r\n\r - a single antigen mismatch at HLA A, B, or C, +/- additional single allele level\r mismatch at A, B, V or DRB1\r\n\r - Minimum goal for peripheral blood stem cells (PBSC) dose is 2 x 10^6 CD34+ cells/kg of\r recipient weight; minimum goal for the marrow dose is 1 x 10^8 nucleated cells/kg of\r recipient weight\r\n\r - No serious uncontrolled psychiatric illness\r\n\r - No concomitant active malignancy that would be expected to require chemotherapy within\r 3 years of transplant (other than non-melanoma skin cancer)\r\n\r - Non-pregnant and non-nursing woman; (women or men with reproductive potential should\r agree to use an effective means of birth control)\r\n\r - Patients who have failed a prior autologous or allogeneic transplant are eligible;\r however, at least 90 days must have elapsed between the start of this reduced\r intensity conditioning regimen and the last transplant if patient had a prior\r autologous or myeloablative allogeneic bone marrow transplant (BMT)\r\n\r - At least 2 weeks since prior chemotherapy, radiation treatment and/or surgery\r\n\r - Informed consent\r\n\r DONOR: Compatibility at the four most informative HLA loci:\r\n\r A, B, C and DRB1 are important for reducing the risk of GVHD and successful transplant\r outcomes; the A, B, C and DRB1 loci comprise 8 possible alleles (a haplotype being\r inherited from each parent); one additional locus, HLA-DQ, is also typed to ascertain\r haplotypes and assist in the search for a compatible donor; however mismatching at DQ has\r not been shown to be associated with adverse outcomes; high resolution molecular typing (at\r the allele level) is now the standard of care for unrelated donor searches and allows\r greater refinement of the search strategy\r\n\r DONOR: Matched related donor:\r\n\r a single antigen mismatch at A, B, or the DR transplant from a family member is associated\r with a higher risk of GVHD but similar overall survival when compared to full identity at\r these 3 regions; related donor/recipient pairs must be matched at 5 of 6 HLA antigens (A,\r B, DRB1)\r\n\r DONOR: Unrelated Donor:\r\n\r When evaluating patients for unrelated donor transplant, the higher degree of matching, the\r lower risk of GvHD; the A, B, C, DRB1 and DQB1 loci, comprising 10 possible antigen (with\r alleles), will be typed for all unrelated transplants; given the higher risk of TRM in\r mismatched transplants, RIT is often the best way to mitigate the risk; data from the\r National Marrow Donor Program makes it possible to estimate the risk of donor-recipient HLA\r mismatch at the allele or antigen level; the higher risk from HLA-mismatching must be\r balanced against the clinical urgency and the patient's risk by the transplant team; at\r this time, antigen level mismatches at DQB1 do not affect outcomes and will not be used for\r matching purposes for donor selection; thus, the matching required will be at the HLA A, B,\r C and DRB1 (8 loci); for this protocol, a single antigen mismatch at the HLA A, B, C, with\r or without additional single allele level mismatch may participate in this protocol for\r voluntary unrelated donors (blood or marrow) DONOR: Donor must be healthy and have\r non-reactive test results for all infectious disease assays as required by state and\r federal regulations; donors who screen seropositive for hepatitis an/or syphilis must be\r cleared by infectious disease consultation DONOR: Donor must have no uncontrolled\r cardiopulmonary, renal, endocrine, hepatic or psychiatric disease to render donation unsafe\r DONOR: The donor (or parent in minor) must give informed consent for peripheral blood stem\r cell collection or bone marrow collection DONOR: Syngeneic donors are not eligible DONOR:\r Donors who have poor peripheral venous access, may require central venous line placement\r for stem cell apheresis\r\n\r Exclusion Criteria:\r\n\r - Uncontrolled central nervous system (CNS) disease (for hematologic malignancies)\r\n\r - Karnofsky (adult) or Lansky (for =< 16 years) performance status < 50%\r\n\r - Diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted, corrected\r for hemoglobin and/or alveolar ventilation\r\n\r - Left ventricular ejection fraction < 40% - Bilirubin >= 3 X upper limit of normal\r\n\r - Liver alkaline phosphatase >= 3 x upper limit of normal\r\n\r - Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase\r (SGPT) >= 3 x upper limit of normal\r\n\r - Child's class B and C liver failure\r\n\r - Calculated creatinine clearance < 40 cc/min by the modified Cockroft-Gault formula for\r adults or the Schwartz formula for pediatrics\r\n\r - Patients who have received maximally allowed doses (given in 2 Gy fractionations, or\r equivalent) of previous radiation therapy to various organs as follows: * Mediastinum:\r adult -40, pediatric (=<18 yrs) - 21 * Heart: adult 36, pediatric - 26 * Whole\r lung(s): adult - 12, pediatric - 10 * Small bowel: adult - 46, pediatric - 40 *\r Kidneys: adult - 12, pediatric - 10 * Whole liver: adult - 20, pediatric - 20 * Spinal\r cord: adult - 36, pediatric - 36 * Whole Brain: adult 30, pediatric - 30\r\n\r - Patients who previously have received a higher than allowed dose of radiation to a\r small lung, liver, and brain volume, will be evaluated by the radiation oncologist to\r determine if the patient is eligible for study\r\n\r - Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or\r other condition which, in the opinion of treating physician, would make this protocol\r unreasonably hazardous for the patient\r\n\r - Human immunodeficiency virus (HIV) positive\r\n\r - Patients who in the opinion of the treating physician are unlikely to comply with the\r restrictions of allogeneic stem cell transplantation based on formal psychosocial\r screening\r\n\r - Female of childbearing potential with a positive pregnancy test\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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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 Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an\r effective treatment for HIV associated myelopathy.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to determine whether or not intravenous immunoglobulin (lVlg),\r brand name Privigen, is effective in treating a disorder called HIV-associated myelopathy\r (HIVM). This drug is currently not approved by the Food and Drug Administration (FDA) for\r treating this disorder.\r\n\r HIVM is a spinal cord disease that occurs at any stage of HIV infection. It is not known what\r causes this condition, but symptoms can include weakness in the lower body and problems with\r frequent urination or problems with bowel function, trouble walking or performing sexually.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Documented history of HIV infection.\r\n\r - Age ≥ 18\r\n\r - Males and females are eligible. Subjects must agree to practice birth control or\r abstinence. Females of child-bearing potential must have a negative urine pregnancy\r within 14 days prior to study entry.\r\n\r - Adequate baseline organ function including the following laboratory values within 14\r days prior to study entry:\r\n\r - Adequate liver function with ALT, AST and alkaline phosphatase ≤ 5 times upper limit\r of normal (ULN).\r\n\r - Total bilirubin ≤ 2.5 mg/dL Creatinine < 2.3 Serum vitamin B12 level ≥ 200 pg/ml\r\n\r - Diagnosis of HIVM by a neurologist - defined as:\r\n\r - - Presence of at least two of the following symptoms:\r\n\r - - Paresthesias and/or numbness in the lower extremities or in all four limbs; Weakness\r of the limbs, with predominance in the lower extremities; Unsteady, stiff or\r uncoordinated gait; Sensation of electrical shock through the back or the legs upon\r flexion of the neck (L'Hermitte's sign); Stiffness or spasm in the lower extremities;\r Urinary frequency, urgency, incontinence or retention; Fecal incontinence or\r retention; Sexual dysfunction with erectile impairment in men;\r\n\r - - Presence of at least two of the following neurologic signs:\r\n\r - - Reduction in vibratory or position sensation in the lower extremities; Hyperactive\r deep tendon reflexes; Abnormal response to plantar stimulation (Babinski sign);\r Presence of L'Hermitte sign (electrical-type sensation down the back, provoked by\r flexion of the neck); Weakness in the lower extremities or in all four limbs; Spastic\r or ataxic gait\r\n\r - Antiretroviral regimen stable 2 months prior to the entry of the study.\r\n\r Exclusion Criteria:\r\n\r - Presence of acute, active, opportunistic infection, except oral thrush, orogenital or\r rectal herpes and MAI bacteremia within 2 weeks before randomization.\r\n\r - Evidence of another contributing cause for myelopathy.\r\n\r - Women who are pregnant, breast-feeding or planning a pregnancy.\r\n\r - Active abuse of drugs or alcohol, which in the opinion of the investigator would\r interfere with the subject's ability to comply with the protocol.\r\n\r - Any neurologic or systemic conditions, which in the opinion of the investigator would\r interfere with the evaluation of the subject.\r\n\r - Presence of significant cardiac, pulmonary or renal disease that would place the\r subject at risk for the fluid and protein load of IVIg.\r\n\r - History of hypersensitivity to immunoglobulin, or IgA deficiency; Vaccination with\r live viruses within the past 90 days; Patients receiving IVIg or other\r immunomodulatory agent (cyclosphosphamide, azathioprine, corticosteroids, tacrolimus,\r cyclosporine, OKT3, plasma exchange, alpha, beta or gamma interferon) within the past\r 3 months.\r\n\r - Patients in whom muscle dynamometry can not be performed for any reason.\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\nUse of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery\n\n**Clinical Trial Summary:**\n\nPostoperative urinary retention is a frequent complication of spinal surgeries and impacts a\r large portion of this population which results in increased morbidity as a result of\r increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital\r stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the\r incidence and duration of postoperative urinary retention and therefore a reduction in\r morbidity related to treatment of urinary retention as well as shortened hospital stays.\n\n**Clinical Trial Detailed Description:**\n\nDecompressive laminectomy and spinal fusion procedures are among the most common\r neurosurgical procedures performed. Postoperative urinary retention (POUR) is a frequent\r complication of such surgeries and impacts a large proportion of this population resulting in\r multiple intermittent bladder catheterizations for bladder decompression, increased incidence\r of bacteremia, increased incidence of UTIs, and prolonged hospital stays. Use of a\r uroselective alpha-1-adrenergic receptor antagonist, such as tamsulosin, in the perioperative\r period (medication started five days prior to surgery and taken until hospital discharge)\r could reduce both the incidence and duration of postoperative urinary retention, resulting in\r shorter hospital stays and decreased healthcare costs.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\r\n\r - ≥ 35 years (Males & Females)\r\n\r - Cervical Laminectomy\r\n\r - Cervical Posterior Fusion\r\n\r - Cervical Anterior/Posterior Fusion\r\n\r - Lumbar Laminectomy\r\n\r - Lumbar Posterolateral Fusion\r\n\r - Lumbar Interbody Fusion\r\n\r Exclusion Criteria\r\n\r - < 35 years\r\n\r - Cervical Anterior Discectomy and Fusion\r\n\r - Cervical Anterior Corpectomy\r\n\r - Cervical Posterior Discectomy\r\n\r - Cervical Foraminotomy\r\n\r - Lumbar Discectomy (METRx or Open)\r\n\r - Lumbar Foraminotomy\r\n\r - Lumbar Anterior Fusion\r\n\r - Myelopathy with bladder dysfunction\r\n\r - Patients currently taking an alpha-antagonist\r\n\r - Patients with history of allergy or sensitivity to tamsulosin or other\r alpha-antagonist (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, and\r phenoxybenzamine)\r\n\r - History of prostatectomy or urologic surgery involving the bladder or urethra\r\n\r - Severe liver disease or end-stage renal disease\r\n\r - Patients taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole,\r clarithromycin, ritonavir, indinavir/ritonavir, lopinavir/ritonavir, and conivaptan)\r\n\r - Patients with a mental disability\r\n\r - Prisoners\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma\n\n**Clinical Trial Summary:**\n\nThe main purpose of this part of the study is to determine the Central Nervous System\r bioavailability of sulfasalazine.\n\n**Clinical Trial Detailed Description:**\n\nThis is a pilot, open-label, non-randomized, study to determine the effect that orally\r administered sulfasalazine has on glutamate levels as measured by MRS and on epileptiform\r spiking as measured by simultaneous MEG/EEG. The intent of the dose escalation is to\r determine an Optimal Biological Dose (OBD) based on changes in tumor glutamate levels. The\r OBD is defined as the dose that has the maximal reduction in tumor glutamate levels after\r normalization to uninvolved brain.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients must be > 18 years of age or older.\r\n\r 2. Patients must have histologically proven low grade astrocytoma,anaplastic astrocytoma,\r anaplastic mixed glioma, anaplastic oligodendroglioma,glioblastoma multiforme,\r astrocytoma WHO II,oligodendroglioma WHO II or mixed glioma WHO II. Patients do not\r haveto demonstrate progressive disease to participate in this study.\r\n\r 3. Patients must have completed initial glioma therapy involving radiation and be 3\r months from the completion of radiation therapy. If initial glioma therapy did not\r include radiation (example: anaplastic oligodendroglioma), then 2 cycles of\r chemotherapy must be completed prior to study entry.\r\n\r 4. Patients must be maintained on a stable corticosteroid regimen for > 5 days prior to\r entry.\r\n\r 5. Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able\r to care for himself/herself with occasional help from others).\r\n\r 6. Patients must have adequate hematologic, renal and liver function (i.e. Absolute\r neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine > 1.5 mg/dl.\r\n\r 7. Women of childbearing potential must have a negative pregnancy test.\r\n\r 8. Patients with the potential for pregnancy or impregnating their partner must agree to\r follow acceptable birth control methods to avoid conception. The effect of the\r investigational drugs on the developing human fetus is not known, but these drugs are\r likely to be harmful to the developing fetus or nursing infant. Women of child-bearing\r potential must agree to use adequate contraception (either surgical sterilization;\r approved hormonal contraceptives such as birth control pills: Depo-Provera, or Lupron\r Depot; barrier methods such as condom or diaphragm along with spermicide; or an IUD).\r Should a woman become pregnant or suspect she is pregnant while participating in this\r study, she should inform her treating physician and study PI immediately.\r\n\r 9. Ability to understand and the willingness to sign a written informed consent document.\r\n\r Exclusion Criteria:\r\n\r 1. Pregnant or breast feeding.\r\n\r 2. Exclude sexually active males and females unwilling to practice contraception during\r the study.\r\n\r 3. Serious concurrent infections.\r\n\r 4. Clinically significant cardiac disease not well controlled with medication (e.g.\r congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias)\r or myocardial infarction within the last 12 months.\r\n\r 5. Patients with other serious uncontrolled co-morbid diseases that the investigator\r feels may comprise the study findings.\r\n\r 6. Allergic or sensitivity to sulfa containing medications.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nVaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant\n\n**Clinical Trial Summary:**\n\nThis randomized phase I trial studies the side effects of vaccine therapy in preventing\r cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor\r stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body\r build an effective immune response and prevent or delay the recurrence of CMV infection in\r patients undergoing donor stem cell transplant for hematological malignancies.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES: I. To discover whether two administrations of 2.5 mg tetanus (Tet)-CMV\r peptide co-injected with 1 mg of PF-03512676 (tetanus-CMV fusion peptide vaccine), by\r subcutaneous (SC) route on days 28 and 56 post-hematopoietic cell transplantation (HCT) are\r safe and well tolerated in human leukocyte antigen (HLA) A*0201 CMV-positive recipients of\r allogeneic HCT.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To measure levels of CMV-specific T cells in vaccinated compared to unvaccinated HCT\r recipients (control arm).\r\n\r II. To assess whether vaccination of HCT recipients with Tet-CMV co-injected with PF03512676\r reduces expression of programmed death 1 (PD-1) on CMV-specific T cells.\r\n\r OUTLINE: Patients are randomized to 1 of 2 treatment arms.\r\n\r ARM I: Patients receive Tet-CMV + PF03512675 SC on days 28 and 56 post-HCT.\r\n\r ARM II: Patients undergo immune monitoring only.\r\n\r After completion of study treatment, patients are followed up at days 70, 84, 100, 130, 160,\r and 180.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - HLA A*0201 subtype\r\n\r - CMV seropositive\r\n\r - Able and willing to sign the informed consent form (ICF)\r\n\r - Willingness to be followed for the planned duration of the trial (6 months post-HCT)\r\n\r - Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and\r active hepatitis B virus (HBV) (surface antigen negative)\r\n\r - Planned related or unrelated HCT, with 8/8 or 7/8 (A, B, C, DRB1) high resolution HLA\r donor allele matching\r\n\r - HCT for the treatment of hematologic cancers including, but not limited to:\r\n\r - Acute lymphoblastic leukemia in first or second remission (for acute\r lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in\r hematologic remission by bone marrow/peripheral blood; persistent lymphadenopathy\r on computed tomography [CT] or CT/positron emission tomography [PET] scan without\r progression is allowed)\r\n\r - Chronic myelogenous leukemia in first chronic or accelerated phase, or in second\r chronic phase\r\n\r - Hodgkin and non-Hodgkin lymphoma\r\n\r - Myelodysplastic syndrome\r\n\r - Planned HCT with minimal to no-T cell depletion of graft\r\n\r - Use of contraception up to 90 days post-HCT\r\n\r - Negative pregnancy test for female recipient\r\n\r - DISEASE STATUS: Recipients to be enrolled are patients eligible for allogeneic HCT,\r who were diagnosed with hematologic cancers including:\r\n\r - Acute lymphoblastic leukemia (ALL); B-precursor ALL; T cell ALL\r\n\r - Acute myeloid leukemia (AML), acute promyelocytic leukemia; treatment related AML\r\n\r - Chronic lymphoid leukemia; adult T cell leukemia/lymphoma, chronic lymphocytic\r leukemia not otherwise specified (NOS), hairy cell leukemia; prolymphocytic leukemia\r (B or T); T cell large granular (gran.) lymphocytic (lymph.) leukemia (leuk)\r\n\r - Chronic myeloproliferative disease (CML); chronic eosinophilic leukemia\r (CEL)/hypereosinophilic syndrome; chronic idiopathic myelofibrosis; CML - Philadelphia\r chromosome; essential thrombocythemia; polycythemia vera\r\n\r - Leukemia, not otherwise specified (NOS)\r\n\r - Myelodysplastic syndrome, NOS; chronic myelomonocytic leukemia\r\n\r - Hodgkin lymphoma, NOS; Hodgkin lymphoma nodular lymphocyte predominant (LP), NOS;\r Hodgkin lymphoma - like post-transplant lymphoproliferative disorder (PTLD)\r\n\r - Lymphoma, NOS\r\n\r - Non-Hodgkin lymphoma (NHL); anaplastic large-cell lymphoma (ALCL), cutaneous, ALCL,\r systemic; Burkitt lymphoma/leukemia; cutaneous T-cell lymphoma (CTCL)/mycosis\r fungoides; CTCL/Sezary syndrome; diffuse large B-cell lymphoma; mucosa associated\r lymphoid tissue (MALT)-lymphoma; extranodal natural killer (NK)/T cell lymphoma,\r extranodal NK/T lymphoma nasal; follicular lymphoma; lymphoplasmacytic lymphoma mantle\r cell lymphoma; mediastinal large B-cell lymphoma; nodal marginal zone B-cell lymphoma\r (lymph.); NHL aggressive, NOS; NHL indolent, NOS; NHL, NOS; peripheral T cell\r lymphoma, NOS; PTLD (monoclonal); PTLD (polyclonal); precursor (precur.)\r B-lymphoblastic lymphoma; precur T-lymphoblastic lymphoma; primary central nervous\r system (CNS) lymphoma; primary effusion lymphoma; small lymphocytic lymphoma, NOS\r\n\r - Myeloma, NOS; monoclonal gammopathy of undetermined significance (MGUS); solitary\r plasmacytoma\r\n\r - Women of child-bearing potential and men must agree to use adequate contraception\r (hormonal or barrier method of birth control or abstinence) prior to study entry and\r for six months following duration of study participation; should a woman become\r pregnant or suspect that she is pregnant while participating on the trial, she should\r inform her treating physician immediately\r\n\r - All medications, supportive care, blood products or radiation therapy taken or\r administered during the trial will be documented in the subject's clinical/hospital\r and case report form (CRF), using City of Hope (COH) guidelines; the subject's\r clinical information will be recorded on the appropriate CRF\r\n\r - Concurrent enrollment in other clinical trials using an investigational product is\r prohibited\r\n\r - The use of alemtuzumab for immunosuppression is not permitted in this study\r\n\r - Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment\r is not allowed\r\n\r - Medications that might interfere with the evaluation of the investigational product\r should not be administered, from 30 days prior to participation on the trial and up to\r 14 days after the second vaccination (day 70 post-HCT); medications in this category\r include, but are not limited to:\r\n\r - Live attenuated vaccines\r\n\r - Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed\r vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen\r injections)\r\n\r - Antiviral treatment for herpes simplex virus (HSV), human herpes virus 6 (HHV6),\r Epstein-Barr virus (EBV) and adenovirus including the use of GVC/VAL, FOS, Cidofovir,\r CMX-001 may also suppress reactivation of CMV, thus it will not be allowed in this\r study; patients requiring such treatment before randomization (day 28) will be removed\r from the study and replaced; reasons for removal will be reported in the patient's CRF\r\n\r - All enrolled recipients who will require anti-CMV therapy before day 28 will be\r replaced, treated and monitored as required by COH standard of care; GVC/VAL, FOS,\r Cidofovir, CMX-001 may be used according to COH standard of care (SOC) for preemptive\r management of CMV viremia; should antiviral treatment be required after day 28, the\r planned 2nd vaccine injection at day 56 will not be administered (vaccine arm only)\r\n\r - All subjects must have the ability to understand and the willingness to sign a written\r informed consent\r\n\r Exclusion Criteria:\r\n\r - A poor-risk patient, as defined by any of the following:\r\n\r - Chronic myelogenous leukemia in blast crisis\r\n\r - Acute myeloid leukemia beyond second remission\r\n\r - Multiple myeloma\r\n\r - Aplastic anemia\r\n\r - Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting\r agent\r\n\r - In vitro T cell depleted graft\r\n\r - Planned prophylactic therapy with CMV immunoglobulin\r\n\r - Planned CMV prophylactic therapy\r\n\r - Experimental anti-CMV chemotherapy in the last 6 months\r\n\r - Diagnosed with autoimmune disease\r\n\r - Receipt of the following substances:\r\n\r - Any prior investigational CMV vaccine\r\n\r - Live attenuated vaccines, medically indicated subunit or killed vaccines from 30\r days prior to participation in the trial and up to 14 days after the second\r vaccination (day 70 post-HCT)\r\n\r - Investigational research products or allergy treatment with antigens injections\r from 30 days prior to participation in the trial and up to 14 days after the\r second vaccination (day 70 post-HCT)\r\n\r - Pregnant and/or breast feeding if a female recipient\r\n\r - Refusing to use contraception up to 90 days post-HCT\r\n\r - POST-HCT STUDY-SPECIFIC EXCLUSIONS:\r\n\r - On days 28 and 56 post-HCT (immunization day for the vaccine arm) all study recipients\r (vaccine and observation arms) will be reviewed for eligibility and ruled ineligible\r to initiate or continue in the study and receive vaccination (for the vaccine arm) if:\r\n\r - Diagnosed with > grade 2 graft-versus-host disease (GVHD) before day 28 post-HCT,\r and diagnosed with > grade 2 GVHD between day 28 post-HCT and administration of\r the 2nd vaccine at day 56\r\n\r - Received steroid therapy with prednisone > 1 mg/kg/day, less than 7 days prior to\r injection\r\n\r - Had relapse\r\n\r - Experience graft failure (absolute neutrophil count < 500/mm^3)\r\n\r - Received antiviral treatment with GVC/VAL, FOS, Cidofovir, CMX-001 at any point\r during the 28 day period\r\n\r - There are ongoing non-hematological post-HCT toxicities >= grade 3\r non-hematological (hem) adverse events (AE's), with exception of grade 3 glucose\r intolerance and grade 3 non-hem labs; cholesterol, triglyceride, and\r hyperglycemia\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\nInvestigation of Lumbo-sacral Instability Using Custom Made Table - a Pilot Study\n\n**Clinical Trial Summary:**\n\nThe aim of the study is to evaluate the feasibility and validity of conventional radiographs\r of the lumbo-sacral spine when the patient is lying on a special table which facilitates\r maximal lumbo-sacral flexion. The results gained from the radiographs with the patient on the\r table will be compared with those gained from standard flexion-extension radiographs of the\r lumbo-sacral spine.\n\n**Clinical Trial Detailed Description:**\n\nAfter enrollment in the study patients will complete a set of questionnaire concerning\r degree, extent and quality of their low back problem. Afterwards a lateral conventional\r radiograph of the lumbar spine with the patient on a custom made positioning table will be\r taken. The table facilitates optimal flexion of the lumbar spine. Afterwards sagittal\r translation and rotation are measured on the flexion-extension radiographs and the radiograph\r taken on the custom made table. Differences between the measurements will be determined.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - chronic low back pain (≥ 3 months)\r\n\r - clinical suspicion of lumbo-sacral instability\r\n\r - functional conventional radiographs of lumbar spine\r\n\r - pain intensity > 4 / 10 on visual analogue scale\r\n\r - age 20-60 years\r\n\r Exclusion Criteria:\r\n\r - radicular pain\r\n\r - pain at more than two locations\r\n\r - lumbar spine surgery\r\n\r - scoliosis\r\n\r - lumbar spondylolysis\r\n\r - lumbar spondylodiscitis\r\n\r - anatomic aberrations of lumbar spine\r\n\r - unconsolidated spine fractures\r\n\r - neurologic deficits\r\n\r - spine tumor\r\n\r - neuromuscular disease\r\n\r - rheumatic disease\r\n\r - severe osteoporosis\r\n\r - radiotherapy within the last 5 years\r\n\r - pregnancy\r\n\r - insufficient German language skills\r\n\r - no informed consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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"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 Mobilization After Total Knee Arthroplasty\n\n**Clinical Trial Summary:**\n\nPatients undergoing elective total knee arthroplasty are randomized to either intrathecal\r anesthesia, wound infiltration with local anesthetics and standardized postoperative care (NA\r = neuraxial anesthesia) or general anesthesia, intraoperative glucocorticoids with\r accelerated postoperative care principles (GA). The study hypothesis is that GA would reduce\r length-of-hospital stay. Outcome variables are postoperative nausea and vomiting,\r mobilization rate, pain, requirement of analgesics, and length-of-hospital stay.\n\n**Clinical Trial Detailed Description:**\n\nStudy design. The study design is consecutive and randomized. Patients with osteoarthritis\r scheduled for TKA at the department of orthopedic surgery, Hässleholm Hospital, Sweden, are\r eligible for participation in the study. Exclusion criteria are body mass index (BMI) > 35\r m/kg2, prior major knee surgery to the ipsilateral knee, ongoing infection, known\r immunological deficiency or ASA physical status category > IV.\r\n\r Randomization and blinding procedure Randomization is performed by an employee, not involved\r in the study, who prepared non-transparent, sealed envelopes each containing a slip of paper\r with descriptions of whether the patient should receive GA or NA. The randomization is\r computerized. On the study day a nurse, likewise not involved in the study, opens the\r appropriate envelope and prepared accordingly the procedures. From the point where\r anaesthesia is delivered both patients and staff in the operating theatre and in the recovery\r unit are, for obvious reasons, aware of the method of anaesthesia being used. However, once\r the patients leaves the recovery unit staff members assessing home readiness are blinded to\r group allocation.\r\n\r Assessments All patients are familiarized with a horizontal visual analogue scale (VAS, [100\r mm]) used for assessment of pain and PONV (0 = no symptom, 100 = worst symptom possible).\r Assessments of pain are made pre-operatively, upon arrival to the post-anesthesia care unit\r (PACU), every second hour the first day, twice a day during the remaining hospital stay and\r at follow-up visits 3 and 12 months after surgery. Plasma levels of troponin T (TNT) are\r measured three times during the first 24 postoperative hours in order to evaluate signs of\r myocardial ischemic events. The Short Portable Mental State Questionnaire (SPMSQ) is used to\r evaluate the cognitive function pre-operatively, at the discharge and at follow-up visits 3\r and 12 months after surgery. Global satisfaction score is assessed with a VAS (0 = best\r possible satisfaction, 100 = least possible satisfaction) at follow-up visits 3 and 12 months\r after surgery.\r\n\r Anesthesia Oral premedication, administered 1 hour before surgery, is with midazolam 2.5 mg,\r paracetamol 2 g, meclozine 10 mg, celecoxib 200 mg and oxycodone 10 mg. A low-volume fluid\r regimen is used with 1000 mL of Ringer's solution (Fresenius-Kabi AB, 751 74 Uppsala,\r Stockholm) and 1000 mL of glucose 2.5% during the first 24 hrs.\r\n\r In the NA group an indwelling urethral catheter is inserted prior to surgery. Intrathecal\r anesthesia is with bupivacaine 12.5-15.0 mg, morphine 0.2 mg and clonidine 30 µg (total\r volume (3.2-3.7 mL). During surgery an infusion of propofol (0.8-2.5 mg/min) is used to\r induce a light level of sedation. At the end of surgery a mixture of ropivacaine 110 mg,\r epinephrine 0.5 mg and morphine 10 mg (total volume 21 mL) is injected into the peri-surgical\r area. The mixture is injected using a systematic technique ensuring uniform delivery of the\r local anaesthetic to all tissues incised, handled or instrumented during the procedure. The\r first 7 mL of the mixture are injected into the posterior joint capsule and both collateral\r ligaments after the bone cuts had been performed. After insertion of the prosthesis another 7\r mL are to be injected along the borders of and into the capsule and cut quadriceps tendon,\r infra-patellar ligament, possible remnants of the fat pad, cruciate ligaments and the soft\r tissues surrounding the joint. The last 7 mL is infiltrated into the subcutaneous tissues\r before wound closure.\r\n\r In the GA group patients are asked to void before the transfer to the OR. The patients are\r draped before induction of anesthesia. Induction of anesthesia is with propofol and\r remifentanil, and endotracheal intubation is facilitated by succinylcholine. Maintenance of\r anesthesia is with target-controlled infusion (Marsh and Minto algorithm) with propofol\r (Braun Medical, Germany) and remifentanil (GlaxoSmithKline, Great Britain) aiming at initial\r concentrations of 5 µg/ml and 5 ng/ml, respectively. Ventilation is mechanical with oxygen in\r air (FIO2 = 0.45) and aiming at ETCO2 4.5 kPa. Betamethasone (Swedish Orphan Biovitrum,\r Sweden) 4 mg i.v. is given during surgery. At the end of surgery a mixture of ropivacaine 250\r mg and epinephrine 0.3 mg (100 mL) is injected in the tissues in the same way as described\r above. Twenty min before the end of anesthesia an i.v. bolus dose of oxycodone 7.5-10 mg is\r given.\r\n\r Surgery In the NA-group a tourniquet is applied around the thigh before the start of surgery.\r The GA-group does not receive a tourniquet. The surgeries are performed via a ventral\r incision with a parapatellar medial entrance to the joint. The patella is everted. A cemented\r single radius cruciate retaining (CR) total knee is used (the TriathlonTM Knee System\r (Stryker, Mahwah, New Jersey, USA)) for all patients. Appropriate guide instruments are used\r according to the surgical-technique manual supplied with the knee system.\r\n\r PACU In the PACU intermittent doses of oxycodone 2-8 mg i.v. is given as rescue medication.\r Patients complaining of PONV are given ondansetron 4 mg i.v.\r\n\r In the GA group bladder scans are done every second hour during the first 24 post-op hours.\r If the bladder contains > 400 ml an intermittent catheterization is performed. Mobilisation\r is started within 2 hrs of arrival to the PACU. A physiotherapist does passive bending of the\r knee to 90˚ and walks 10 meters with the patient on the floor.\r\n\r In the NA group mobilization is not started until the day after surgery, due to residual\r motor and sensory blockade.\r\n\r Ward In the NA group the indwelling urethral catheter is removed the day after surgery.\r Patients are considered ready to be discharged from the hospital when they are able to get in\r and out of bed, get dressed, sit down and get out of a chair, able to walk 50 m with or\r without walking aid, flex the knee to at least 70 º, fit for staircase climbing under\r supervision of a physiotherapist and accepting to be discharged. LOS is measured from end of\r surgery to time of discharge.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with osteoarthritis scheduled for TKA at the department of orthopedic\r surgery, Hässleholm Hospital, Sweden, are eligible for participation in the study.\r\n\r Exclusion Criteria:\r\n\r - body mass index (BMI) > 35 m/kg2,\r\n\r - prior major knee surgery to the ipsilateral knee,\r\n\r - ongoing infection, known immunological deficiency or ASA physical status category >\r IV.\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\nWar Wounded, a Comparison of Two Pain Management Approaches\n\n**Clinical Trial Summary:**\n\nThis study aims to investigate the relative effectiveness of two different pain management\r plans for injuries sustained while active duty in the military. One arm of the study has\r subjects undergo standard comprehensive medical management, while the other adds the\r placement of a spinal cord stimulator, a common procedure for the alleviation of pain.\n\n**Clinical Trial Detailed Description:**\n\nThis study aims to investigate the relative effectiveness of two different pain management\r plans for injuries sustained while active duty in the military. One arm of the study has\r subjects undergo standard comprehensive medical management, while the other adds the\r placement of a spinal cord stimulator, a common procedure for the alleviation of pain.\r\n\r This site was never activated for the research by the sponsor.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Subject is a veteran or active duty service member injured while on active military\r duty receiving care for pain related to the injury(ies) in the Department of Defense\r health care system or through the Department of Veteran's Affairs.\r\n\r 2. Subject is 18 years of age or older.\r\n\r 3. The elapsed time since the active-duty injury leading to chronic pain is not less than\r 3 months.\r\n\r 4. Subject reports constant or daily episodes of injury-related pain of at least moderate\r severity, graded 4 or higher on an 11-point NPRS (point estimate by subject and\r Investigator at time of enrolment based on overall pain or pain at a specific site).\r Pain may be nociceptive, neuropathic, or mixed. Phantom pain associated with\r amputation of an extremity or extremities is allowed.\r\n\r 5. Attempts to control pain with commercially available systemic analgesics have not\r provided adequate relief, in the judgment of the managing physician and subject.\r\n\r 6. Subject is able to localize site(s) of pain. At least one site of daily pain\r contributing to moderate severity (Inclusion Criterion 4) and intractability\r (Inclusion Criterion 5) must be in an extremity, or phantom pain at the site of an\r amputated extremity. If the extremity site of pain is not an amputated limb, then the\r pain must have a neuropathic component. This site is identified as the site of Target\r Pain (TP) for efficacy evaluations during the trial.\r\n\r 7. Subject is an acceptable candidate for surgical placement of an indwelling spinal cord\r stimulation device.\r\n\r 8. Subject is judged an appropriate candidate for treatment using the available\r techniques and interventions encompassed within the protocol's definition of\r comprehensive medical management.\r\n\r 9. For the duration of the trial, subject is willing to limit interventions for control\r of chronic pain to those approved by the Investigator.\r\n\r 10. The subject is judged psychologically appropriate for either treatment intervention,\r based on the impression of an interviewing psychologist or psychiatrist.\r\n\r 11. Subject provides informed consent.\r\n\r Exclusion Criteria:\r\n\r 1. Subject experiences phantom pain associated with amputation of both an upper and lower\r extremity.\r\n\r 2. Subject has headache or visceral truncal pain or other non-musculoskeletal pain as the\r only pain that results in constant or daily scores of ≥4 on the 11-point NPRS.\r\n\r 3. Subject has spinal disease that would, in the judgment of the investigator, preclude\r placement of a spinal cord stimulator.\r\n\r 4. Subject has ongoing chronic infection or a medical condition associated with an\r unacceptably increased risk of infection related to device implantation.\r\n\r 5. Subject has a current diagnosis or history of psychosis, cognitive impairment,\r hallucinations, or unexplained loss of consciousness, whether or not related to a\r combat injury that, in the opinion of the investigator, would exclude the patient from\r participating in the trial.\r\n\r 6. Subject has a cardiac pacemaker.\r\n\r 7. Subject has any significant medical or psychiatric condition that would interfere with\r the conduct of the study or with the outcome measures.\r\n\r 8. Subject is pregnant or is breast feeding.\r\n\r 9. Subject has participated in any drug or device trial in the past 30 days.\r\n\r 10. Subject has any planned elective or semi-elective surgery during the 6 months of the\r Primary Treatment Phase, including stump revisions or grafting.\r\n\r 11. Subject has a psychological condition of great enough severity that it would\r unacceptably increase the medical risks associated with implantation and care of the\r devices required for the treatment on the CMM + SCS arm, or would likely interfere\r with the subject's ability to sustain participation in a research study of long\r duration. Investigators are encouraged to include the medical monitor and the\r coordinating investigator in discussions about individual candidate subjects who have\r psychological diagnoses as part of the polytrauma syndrome before enrollment or\r treatment on this protocol.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"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 Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy\n\n**Clinical Trial Summary:**\n\nThe goal of the first part of this clinical research study is to learn how to deliver more\r accurate radiation treatment of tumors in the spine. Researchers also want to learn how\r internal organs might move during radiation treatment.\r\n\r The goal of the second part of this study is to learn if it is safe to allow slightly more\r radiation to the normal esophagus when spinal tumors close by are being treated. This may\r result in better tumor control.\n\n**Clinical Trial Detailed Description:**\n\nStudy Groups:\r\n\r If you are found to be eligible to take part in this study, you will be assigned to a study\r group based on when you join this study. Up to 3 groups of 10 participants will be enrolled\r in the first part of the study, and up to 2 groups of 10 participants will be enrolled in the\r second part of the study. Only participants who will receive a single spinal SBRT treatment\r are eligible for the second part of the study.\r\n\r The participants in the first part of the study will receive standard doses of radiation\r therapy to normal organs while treating the tumor. In the second part of the study, each new\r group will receive a higher dose of radiation to the esophagus than the group before it, if\r no intolerable side effects were seen.\r\n\r Radiation Planning and Treatment:\r\n\r Before starting radiation treatment, you will be asked to complete a questionnaire about any\r symptoms you might be having and any drugs that you are taking. It should take about 10\r minutes to complete. After treatment, you will be given copies of the questionnaire to take\r with you, and asked to fill it out 1 time a week for the next 4 weeks. You should return the\r questionnaires by mail. Self-addressed stamped envelopes will be given to you.\r\n\r During all radiation treatments, the images that are taken during your treatment will be\r closely analyzed after treatment is over. You will have 1 to 3 radiation treatment sessions\r depending on your doctor's decision.\r\n\r If you are in the second part of the study, you will receive slightly more radiation than\r usual to the normal esophagus.\r\n\r The rest of your radiation treatment planning and treatment delivery appointments will be\r unchanged. The dose given to the tumor and number of treatments you receive will be\r determined by your doctor, and is not affected by taking part in this study.\r\n\r Follow-Up Visits:\r\n\r After your radiation treatment schedule ends, you will return for follow-up visits at the\r following time points:\r\n\r - At 3 months\r\n\r - Then, every 3 months for 1 year\r\n\r - Every 6 months during year 2, and then\r\n\r - 1 time a year after that, for as long as possible\r\n\r Additional follow up visits may be scheduled, if your doctor thinks they are needed.\r\n\r At these visits, the following tests and procedures will be performed:\r\n\r - Any updates to your medical history will be recorded and you will be asked about any\r side effects you may be having.\r\n\r - Your performance status will be recorded.\r\n\r - Your completed symptom questionnaires will be reviewed.\r\n\r - You will have a physical, including measurement of your vital signs\r\n\r - You will have a neurological exam.\r\n\r - You will have follow-up imaging (such as an MRI) to check the status of the disease.\r\n\r This is an investigational study. Radiation therapy is delivered using FDA-approved and\r commercially available methods. It is considered investigational to give increased radiation\r to the esophagus.\r\n\r Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. STAGE 1: >/= 18 years old\r\n\r 2. STAGE 1: Pathologically confirmed diagnosis of cancer, including, but not limited to\r non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal,\r sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary\r\n\r 3. STAGE 1: Signed informed consent\r\n\r 4. STAGE 2: 1-3 above, and Patients undergoing single fraction spinal SBRT\r\n\r Exclusion Criteria:\r\n\r 1. STAGE 1: Patient with radiosensitive histologies (lymphoma, multiple myeloma, small\r cell carcinomas, germ cell tumors)\r\n\r 2. STAGE 1: Extensive (> 50%) height loss of the involved vertebral body\r\n\r 3. STAGE 1: Inability to tolerate lying flat on treatment table for greater than 30\r minutes\r\n\r 4. STAGE 1: Pregnancy\r\n\r 5. STAGE 2: Prior irradiation of the spine site and level to be treated\r\n\r 6. STAGE 2: Patients with primary disease arising in the posterior elements of the VB in\r question\r\n\r 7. STAGE 2: History of Barrett's esophagus, esophageal webbing, stricture, or fistula\r\n\r 8. STAGE 2: Prior radiation to the esophagus\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\nA Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis\n\n**Clinical Trial Summary:**\n\nThis extension study of WA19926 will assess the long-term safety and the efficacy of\r RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis.\r Participants who have completed the core study WA19926 are eligible to participate.\r Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The\r anticipated time on study drug is 104 weeks.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adult participants, >/=18 years of age who have completed the core study WA19926 and\r according to the investigator may benefit from RoActemra/Actemra treatment\r\n\r - No current or recent adverse event or laboratory finding preventing the use of the\r study drug dose at baseline\r\n\r - Receiving treatment on an outpatient basis\r\n\r Exclusion Criteria:\r\n\r - Females who are pregnant\r\n\r - Participants who have prematurely withdrawn from the core study WA19926 for any reason\r\n\r - Treatment with any investigational drug since the last administration of the study\r drug in the core study WA19926\r\n\r - Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell\r costimulation modulator since the last administration of the study drug in the core\r study WA19926\r\n\r - Immunization with live/attenuated vaccine since the last administration of the study\r drug in the core study WA19926\r\n\r - Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory\r joint disease other than rheumatoid arthritis\r\n\r - Abnormal laboratory values\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 Dose-Escalation Study in Participants With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThis is a study of oral LY2157299 as monotherapy and in combination with lomustine in\r participants with recurrent malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Have given written informed consent\r\n\r - Have histological or cytological evidence of relapsed malignant glioma (such as\r glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma) for\r which no treatment of higher priority exists\r\n\r - Available baseline tumor specimen is required prior to considering participant to\r be enrolled. The original diagnostic tumor tissue is sufficient for this\r inclusion criteria, but where possible, freshly obtained tumor biopsy material\r may be obtained\r\n\r - Measurable disease to allow assessment of tumor response based on radiographic\r assessment following Macdonald criteria and Response Evaluation Criteria In Solid\r Tumors (RECIST)\r\n\r - Have sufficient hepatic, renal, and hematological function\r\n\r - Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale\r\n\r - Have discontinued all previous therapies for cancer, including chemotherapy,\r radiotherapy or other investigational therapy for at least 30 days prior to study\r enrollment and recovered from the acute effects of therapy\r\n\r - Able to swallow tablets and capsules\r\n\r - For females, reproductive potential must be either terminated (by surgery, radiation,\r or menopause) or attenuated by the use of an approved contraceptive method (including\r intrauterine or barrier devices) during and for 3 to 6 months after the study\r\n\r - Male participants must be willing to use contraception during and for 3 to 6 months\r after the study\r\n\r Exclusion Criteria:\r\n\r - Have received treatment within the last 30 days with a drug that has not received\r regulatory approval for any indication at the time of study entry\r\n\r - Have moderate or severe cardiac disease:\r\n\r - Have the presence of cardiac disease, including a myocardial infarction within 6\r months prior to study entry, unstable angina pectoris, New York Heart Association\r (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension\r\n\r - Have documented major electrocardiogram (ECG) abnormalities at the investigator's\r discretion (for example, symptomatic or sustained atrial or ventricular\r arrhythmias, second- or third-degree atrioventricular block, bundle branch\r blocks, ventricular hypertrophy, or recent myocardial infarction)\r\n\r - Have major abnormalities documented by echocardiography with Doppler (for\r example, moderate or severe heart valve function defect and/or left ventricular\r ejection fraction (LVEF) <50%, evaluation based on the institutional lower limit\r of normal)\r\n\r - Have predisposing conditions that are consistent with development of aneurysms of\r the ascending aorta or aortic stress (for example, family history of aneurysms,\r Marfan syndrome, bicuspid aortic valve, evidence of damage to the large vessels\r of the heart documented by computerized tomography [CT] scan with contrast)\r\n\r - Have current acute or chronic leukemia\r\n\r - Women who are pregnant or lactating\r\n\r - Have received prior nitrosourea (including lomustine) therapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** 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\nPhase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nPatients with GBM, who were deemed ineligible for any active protocols at our centre,\r received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with\r conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty\r five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated\r with a median KPS of 90 (range 50-100). Four patients had multicentric disease at\r presentation. Eight patients had biopsy only while the rest had a near total resection (n=14)\r and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was\r 14.4 months.\n\n**Clinical Trial Detailed Description:**\n\nIn this proposal, the total cumulative dose of TMZ is unchanged as compared to the doses used\r in the Stupp protocol. In this proposal, the dose of TMZ is the same, with the sole\r difference that TMZ will be given in a neo-adjuvant setting for two weeks and then continued\r at the same dose concurrently with the accelerated hypofractionated EBRT delivering 60Gy in 4\r weeks. The adjuvant component of TMZ remains unchanged from current standard practice.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age: 18 years or older\r\n\r - Histological confirmation of supratentorial GBM\r\n\r - KPS > 60\r\n\r - Neurological function 0 or 1\r\n\r - Adequate bone marrow as defined below:\r\n\r - absolute neutrophil count (ANC) > 1500 cells/mm3\r\n\r - platelets > 100,000 cells/mm3\r\n\r - hemoglobin > 10g/dl\r\n\r - Adequate renal function as defined below:\r\n\r - BUN < 25mg/dl within 14 days prior to study registration\r\n\r - creatinine of 63 to 103 umol/L within 14 days prior to study registration\r\n\r - Adequate hepatic function as defined below:\r\n\r - Bilirubin of 3 to 21 umol/L within 14 days prior to study registration\r\n\r - ALT & AST < 3xnormal range within 14 days prior to study registration\r\n\r - Neoadjuvant TMZ to start within 3 weeks of surgery/biopsy if no resection was deemed\r feasible\r\n\r - A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed\r preoperatively and postoperatively.\r\n\r - History, physical and neurological examination within 14 days prior to study\r registration.\r\n\r - For females of child-bearing potential, negative pregnancy test within 72 hours prior\r to starting TMZ.\r\n\r - Able to sign an informed study-specific consent\r\n\r Exclusion Criteria:\r\n\r - Margin of contrast-enhanced residual mass closer than 15mm from the optic chiasm or\r optic nerves.\r\n\r - Prior invasive malignancy, unless disease-free for >3years\r\n\r - Recurrent or multifocal GBM\r\n\r - Severe co-morbidities such as\r\n\r - unstable angina\r\n\r - transmural myocardial infarction within 6 months\r\n\r - COPD at the time of registration\r\n\r - Hepatic insufficiency\r\n\r - Bacterial or fungal infection requiring IV antibiotics at the time of registration\r\n\r - Acquired Immune Deficiency Syndrome (AIDS)\r\n\r - Major medical illnesses or psychiatric impairments\r\n\r - Pregnant women or lactating women\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** 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\nRe-irradiation of High Grade Gliomas: a Quality of Life Study\n\n**Clinical Trial Summary:**\n\nPatients with a high grade glioma have an increasing overall survival and progression free\r survival after initial treatment. Because of a better performance status these patients are\r more often eligible for re-treatment with for example radiotherapy. However, to date only a\r few prospective studies on re-irradiation of gliomas exist and very little is known about the\r effects of re-irradiation on quality of life and cognition. This trial is designed to\r longitudinally establish the effects of re-irradiation on quality of life, cognition and\r physical performance in patients with a high grade glioma. Based on the currently available\r information the investigators hypothesize that quality of life after re-irradiation can be\r kept stable until further tumour progression.\n\n**Clinical Trial Detailed Description:**\n\nCurrent treatment regimes, with the addition of temozolomide, have improved progression-free\r survival as well as overall survival for patients with a high grade glioma. The median\r overall survival (MOS) for patients with a glioblastoma (GBM) is 14.6 months, with a\r progression free survival (PFS) of 6.9 months.\r\n\r Due to longer survival and a better performance status, patients often reach a point at which\r re-treatment is feasible. Treatment options for recurrent glioblastoma and anaplastic glioma\r can include surgery, chemotherapy and re-irradiation. Re-irradiation of patients with\r recurrent high grade glioma is slowly becoming standard of care. It provides a comparable\r overall survival to palliative chemotherapy. In case of GBM there is a median time to\r progression after treatment of 20-27 weeks and a MOS of 26 to 60 weeks.\r\n\r Patients with tumor recurrence have a significantly worse quality of life compared to\r patients without recurrence at the same follow-up. They experience significantly more\r problems with physical functioning (e.g. motor dysfunction, weakness of legs, visual\r disorders), work or other daily activities, mental health (e.g. future uncertainty) and\r general health.\r\n\r With regard to re-irradiation, current available data is mostly provided by retrospective\r studies which often lack solid quality of life data. Endpoints include e.g. performance\r status, clinical (neurological) status and decreased steroid requirement after treatment.\r These endpoints are however inadequate to determine quality of life accurately.\r\n\r Several studies have used the European Organization for Research and Treatment of Cancer\r Quality of Life Questionnaire core 30 (EORTC QLQ-C30) and the brain cancer module (QLQ-BN20)\r scales to assess quality of life. The latter consists of 20 items including visual disorder,\r motor dysfunction, various disease symptoms, treatment toxicity and future uncertainty. A\r change of 10 points or more on these scales can be considered clinically relevant.\r\n\r To date only Ernst-Stecken and colleagues have used the EORTC QLQ-C30 to prospectively\r evaluate the quality of life in patients with a recurrent malignant glioma after\r radiotherapy. In this study patients were treated with hypofractionation. The quality of life\r questionnaire score could be kept stable in two thirds of patients with a median follow-up of\r 9 months. They conclude that hypofractionated stereotactic radiotherapy is an effective\r treatment that helps to maintain quality of life for an acceptable period, comparable to the\r results found with chemotherapeutic regimes.\r\n\r In patients with glioma, the tumor, radiotherapy as well as chemotherapy can disrupt\r cognitive function. Cognitive functioning can be evaluated by a cognitive screening\r instrument and/or comprehensive neuropsychological test batteries. The most well-known and\r convenient screening instrument is the Mini Mental-State Examination (MMSE). However, the\r MMSE is developed to assess dementia and does not include items related to executive\r function. As such, the MMSE is insufficient to assess frontal-subcortical network dysfunction\r associated with cognitive damage after irradiation. More sensitive cognitive tests should be\r administered to determine the effects of re-irradiation on cognition. There is however still\r little consensus on which test should be used. Although comprehensive neuropsychological test\r batteries are most sensitive, a brief cognitive screening is preferable in the present\r setting. For this trial, the investigators intend to use a number of relevant standard tests\r including the Hopkins Verbal Learning Test-Revised (HVLT-R, the Trail Making Test and\r Controlled Oral Word Association (COWA) as suggested by the Radiation Therapy Oncology Group\r (RTOG). The Stroop colour-word test (Stroop) is added to the battery in order to assess\r visual attention.\r\n\r Physical functioning has a major impact on quality of life in patients with cancer. A number\r of studies have investigated the effects of exercise on physical functioning. They have\r shown, predominantly in patients with breast cancer, that exercise has beneficial effects on\r health and well-being. Physical performance can be measured by several means. The hand grip\r strength (HGS) test has been validated in previous studies for the evaluation of general\r health status. This test is performed with the Jamar hand dynamometer which displays hand\r strength in kilograms. By comparing data after re-irradiation to the data collected before\r the treatment the amount of muscle strength loss can be determined.\r\n\r Another method of measuring physical performance is by analyzing fatigue. This is a very\r common symptom in cancer patients and negatively influences their quality of life. Fatigue in\r patients with cancer can be determined with the use of both the EORTC QLQ-C30 and the more\r specific Fatigue Questionnaire (EORTC QLQ-FA13).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically proven high-grade glioma anaplastic astrocytoma or glioblastoma\r\n\r - Age ≥ 18 years\r\n\r - WHO performance status ≤ 2\r\n\r - Scheduled for re-irradiation of a high grade glioma\r\n\r - The patient is willing and capable to comply with study procedure\r\n\r Exclusion Criteria:\r\n\r • Life expectancy < 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:** 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\nPhase I/II Trial of Safety and Anti-tumor Efficacy of AXL1717(Picropodophyllin) in the Treatment of Recurrent Malignant Astrocytomas\n\n**Clinical Trial Summary:**\n\nThis is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the\r safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent\r formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas\r (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic\r oligoastrocytoma, and anaplastic ependymoma). Patients will be treated for up to 5 cycles. A\r treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28 days\r during cycle 5). The following cycle will not be started until the treatment continuation\r criteria are fulfilled. Concomitant supportive therapies will be allowed.\n\n**Clinical Trial Detailed Description:**\n\nAXL1717, as a ready-to-use suspension of picropodophyllin for oral administration, will be\r distributed in bottles for single use at a concentration of 25 mg/mL. Fixed doses will be\r used, i.e. there are no adjustments for weight or body surface. There will be no\r randomization or blinding in the study.\r\n\r The trial will be divided in two phases. In the first phase, 10-20 patients will be enrolled\r and treated with 300-520 mg BID of AXL1717 for 28 days. The primary endpoint of the first\r phase is to determine the recommended Phase 2 dose (RP2D) of AXL1717 in patients with\r recurrent or progressive glioblastoma and to assess the safety and toxicity of AXL1717 in\r this patient population. The study has a 3+3 design and the first cohort will be treated with\r 400 mg AXL1717 BID for 28 days repeated in up to 5 cycles. If dose-limiting toxicity (DLT)\r such as neutropenia occurs, dosing will be interrupted and the individual patient will,\r following normalization, be restarted on the same or a lower dose level according to\r standardized procedure. If two or three of the first 3 patients on a specific dose level\r experience a DLT during the first 28 days of treatment with AXL1717, the following patients\r will be treated with a lower dose level. If one DLT occurs during the first 28 days of dosing\r in the first 3 three patients another 3 patients will be treated with the same dose level. If\r 2 of the 6 patients display DLT, the next patients will be treated with a lower dose level.\r The highest dose level without DLT or with maximally one DLT out of 6 patients will be the\r RPTD. All assessments with respect to dose adjustments for subsequent cohorts will be done\r during the first 28 days of treatment. Non-progressing patients may be treated for a total of\r five 28-day cycles (24 weeks).\r\n\r In the second phase, 12 patients will be enrolled and treated with the identified RP2D of\r AXL1717 for 28 days repeated in five cycles. The primary endpoints of phase II is to assess\r the proportion of patients who are progression-free at 24 weeks and to assess safety,\r tolerability, and adverse event profile of AXL1717.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion criteria\r\n\r 1. Be informed of the nature of the study and have provided written informed consent\r\n\r 2. At least 18 years of age\r\n\r 3. ECOG performance of 0, 1, or 2, or KPS (Karnofsky performance status) ≥ 60.\r\n\r 4. Pathological verification of a WHO grade 4 astrocytoma (glioblastoma or gliosarcoma),\r or WHO Grade 3 anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic\r oligoastrocytoma, or anaplastic ependymoma.\r\n\r 5. Documented recurrent glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic\r oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic ependymoma after at\r least one failed treatment of chemotherapy and radiation\r\n\r 6. Expected survival of at least 3 months\r\n\r 7. At least 2-weeks from cytoreductive surgery, if performed, 4-weeks from bevacizumab or\r other chemotherapy (6-weeks if prior chemotherapy was nitrosourea) and 12-weeks from\r completion of radiotherapy.\r\n\r 8. Ability to undergo MRI scanning without and with imaging dye on a periodic basis as\r defined in the protocol\r\n\r 9. Preserved major organ functions, i.e: Blood leukocyte count ≥ 3.0 x 109/L Blood\r absolute neutrophil count ≥ 1.5 x 109/L Blood platelet count ≥ 100 x109/L Blood\r hemoglobin ≥ 100 g/L (transfusions are allowed) Plasma total bilirubin level ≤ 1.5\r times the upper institutional limit (ULN) of the ‖normal‖ (i.e. reference) range\r Plasma AST (aspartate aminotransferase) or ALT ≤ 2.5 times upper institutional limit\r (ULN) of the ‖normal‖ range Plasma creatinine ≤ 1.5 times upper institutional limit\r (ULN) of the ‖normal‖ range 12-lead ECG with normal tracings; or changes that are not\r clinically significant and do not require medical intervention, and QTc < 500 ms At\r least seven (7) days off of medications which inhibit or induce CYP2C9 or CYP3A4\r before first study treatment day\r\n\r Exclusion criteria\r\n\r 1. Any or other major recent or ongoing disease that, according to the Investigator,\r poses an unacceptable risk to the patient\r\n\r 2. Grade 3 or higher constipation within the past 28 days or grade 2 constipation within\r the past 14 days before randomization. (Patients with grade 2 constipation within the\r past 14 days could be re-screened if constipation decreases to ≤ grade 1 with optimal\r management of constipation.)\r\n\r 3. Coexisting uncontrolled medical condition.\r\n\r 4. Hepatitis B or Hepatitis C, or HIV infection requiring anti-retroviral therapy\r\n\r 5. Active malignancy other than basal cell skin cancer\r\n\r 6. Other active malignancy during the previous 3 years\r\n\r 7. Major surgical procedure within 4 weeks\r\n\r 8. Prior stereotactic or gamma knife radiosurgery or proton radiation, unless unequivocal\r progression by functional neuro-imaging (PET, dynamic MRI, MRS, SPECT) or by\r re-operation with documented histologic confirmation of recurrence.\r\n\r 9. Prior anti-tumor therapy, as follows: at least 12-weeks from radiation therapy; at\r least 4-weeks from prior treatment with temozolomide or bevacizumab, 6-weeks from BCNU\r or CCNU.\r\n\r 10. Women of child bearing potential (WOCBP) who do not consent to using acceptable\r methods of birth control (oral contraceptives, IUD). For purposes of this study, WOCBP\r include any female who has experienced menarche, who has not undergone tubal ligation,\r and who is not postmenopausal.\r\n\r 11. Medically uncontrolled Type 1 or Type 2 diabetes mellitus\r\n\r 12. Pregnancy or lactation\r\n\r 13. Current participation in any other investigational clinical trial within 4-weeks.\r\n\r 14. Eastern Cooperative Oncology Group (ECOG) performance status > 2 after optimization of\r medications (See Appendix 4) or KPS < 60\r\n\r 15. Anticipated Life expectancy less than 3 months\r\n\r 16. Contraindications to the investigational product or known or suspected\r hypersensitivity\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\nTamsulosin for Urinary Retention in Hospitalized Older Women\n\n**Clinical Trial Summary:**\n\nCatheter-associated urinary infections are the most common hospital-acquired infections and\r can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the\r failure of early catheter removal has been studied in elderly women hospitalized for an acute\r condition and experiencing acute urinary retention: 448 women 75-year old or more without an\r anatomical or neurological cause of urinary retention will be randomized to a 6 days course\r of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of\r tamsulosin and the need to replace another catheter within 72 hours will define a failed\r attempt.\n\n**Clinical Trial Detailed Description:**\n\nBackground: Urinary tract infections are the most frequent hospital-acquired infections. A\r majority is catheter-associated and the main risk factor is the duration of catheterization.\r Early removal is therefore a priority. Treatment with alpha-blockers in men with acute\r urinary retention due to prostatic disease increases the rate of successful early catheter\r removal. No intervention has been studied in elderly women in whom urinary retention is\r usually favored by an acute health issue. However, alpha-blockers have proved effective in\r other circumstances, as the prevention of acute urinary retention after hysterectomy and the\r treatment of chronic voiding disorders.\r\n\r Objective: To evaluate the benefit of tamsulosin for 6 days in older women hospitalized for\r an acute medical condition and experiencing urinary retention.\r\n\r Primary endpoint: Rate of failed early catheter removal (day 3), requiring placement of\r another catheter within the following 72 hours.\r\n\r Secondary endpoints: rate of hospital-acquired urinary tract infections, rate of hypotension,\r length of hospitalization.\r\n\r Design: Double-blind and multicentric randomized controlled trial (tamsulosin 0.4 mg/day or\r placebo orally for 6 days).\r\n\r Number of patients: We assume a 40% failure rate of early catheter removal in the placebo\r group. Expecting a 10% dropout rate, 448 patients need to be randomized to show a reduction\r of this rate by one third in the tamsulosin group with two-sided alpha level at 5% and beta\r level at 20%.\r\n\r Inclusion criteria: 75-year or older women hospitalized in an internal medicine or geriatric\r ward and with a bladder catheter for less than 48 hours for acute urinary retention.\r\n\r Non-inclusion criteria: chronic urinary retention; acute retention with an anatomical (pelvic\r tumor, pelvic surgery) or neurological cause (peripheral neuropathy, spinal cord compression,\r multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease); catheter placed for\r another indication (pressure ulcer protection, urine output monitoring); patients at the end\r of life; contra-indication to alpha-blockers.\r\n\r Course of the study: The patient receives a treatment dose in the evening inclusion (day 0)\r and the five following evenings. The catheter is removed after the third dose, between\r midnight and noon. The patient is followed up until day 12.\r\n\r Total time: 36 months (35 months of inclusion + 12 days of participation per patient).\r\n\r Number of participating centers: 8 Expected number of inclusions per month and center: 2-4\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - 75-year or older women hospitalized in an internal medicine or geriatric ward and with\r a bladder catheter for less than 48 hours for acute urinary retention.\r\n\r Exclusion Criteria:\r\n\r - chronic urinary retention;\r\n\r - acute retention with an anatomical (pelvic tumor, pelvic surgery) or neurological\r cause (peripheral neuropathy, spinal cord compression, multiple sclerosis, amyotrophic\r lateral sclerosis, Parkinson's disease);\r\n\r - catheter placed for another indication (pressure ulcer protection, urine output\r monitoring);\r\n\r - patient at the end of life;\r\n\r - contra-indication to alpha-blockers.\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\nA Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas\n\n**Clinical Trial Summary:**\n\nThis study is being conducted to help determine whether the addition of\r Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in\r vivo and vitro, when given along with temozolomide during the monthly cycles that follow\r radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly\r diagnosed high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nThis study is being conducted to help determine whether the addition of\r Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in\r vivo and vitro, when given along with temozolomide during the monthly cycles that follow\r radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly\r diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma\r patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Age: 18 years to 75 years\r\n\r - newly diagnosed WHO III-IV glioma after operation and radiotherapy\r\n\r - Karnofsky Performance Score ≥ 60\r\n\r - Adequate bone marrow, liver and renal function\r\n\r - Ability of subject to understand character and individual consequences of the clinical\r trial\r\n\r - Written informed consent\r\n\r - anticipating survival ≥2 months\r\n\r Exclusion Criteria:\r\n\r - Refusal to participate the study\r\n\r - Known hypersensitivity or contraindication to temozolomide\r\n\r - Incompletely radiation\r\n\r - Pregnant or lactating females\r\n\r - Malignant tumor other than brain tumor\r\n\r - Contraindicated for MRI examination\r\n\r - Unable to comply with the follow-up studies of this trial\r\n\r - Purulent and chronic infected wounds\r\n\r - Uncontrolled psychotic disorders or epilepsy\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\nArmodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma\n\n**Clinical Trial Summary:**\n\nThis randomized phase III trial studies armodafinil to see how well it works in reducing\r cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve\r fatigue in patients with high grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nPatients experiencing fatigue related to cancer will be asked to take part in this study.\r Cancer-related fatigue is a very common symptom in patients with cancer. Patients will\r receive armodafinil or placebo. Please see the \"Arms\" section for more details regarding the\r treatment assignments. The primary objective of this study is to determine preliminary\r efficacy measured by patient reported fatigue Brief Fatigue Inventory (BFI) at 8 weeks of two\r doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in\r patients with high grade glioma.\r\n\r The secondary objectives of the study are listed below.\r\n\r 1. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient\r population.\r\n\r 2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with\r high grade glioma.\r\n\r 3. To assess the impact of armodafinil on global quality of life and other fatigue\r endpoints in this patient population with high grade glioma.\r\n\r 4. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement\r Information System (PROMIS), and Patient-Reported Outcomes version of the Common\r Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as, the\r relationship of fatigue and cognitive difficulties.\r\n\r Patients will receive armodafinil or placebo for a total of 8 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma,\r glioblastoma with oligo features, glioblastoma with primitive neuroectodermal\r tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic\r oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have\r completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24\r months prior to enrollment; NOTE: clinical stability will be defined as a stable or\r improved Karnofsky performance status (KPS) compared to the prior month\r\n\r - >= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question\r 3); it is not required for the patient to complete the entire BFI to meet this\r criterion\r\n\r - Undergone surgery (gross total or subtotal resection) or biopsy and will have been\r treated with concurrent radiation therapy and chemotherapy as standard of care for\r glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with\r oligo features, glioblastoma with primitive neuroectodermal tumor-like components\r (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or\r anaplastic oligoastrocytoma patients; Note: radiation must be completed, but\r chemotherapy is allowed; patients who are currently using Optune device will be\r eligible to participate in this trial\r\n\r - Negative serum pregnancy test done =< 7 days prior to registration only for women\r determined to be of childbearing potential by their treating physician\r\n\r - Ability to complete questionnaire(s) by themselves or with assistance\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3\r\n\r - Provide informed written consent\r\n\r - Willing to return to enrolling institution for follow-up (during the Active Monitoring\r Phase of the study)\r\n\r - Stable dose of corticosteroid >= 14 days prior to registration\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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[
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"role": "assistant",
"content": "**Answer:** definitely relevant"
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definitely relevant
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"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\nPeristeen Bowel Irrigation System in Cauda Equina\n\n**Clinical Trial Summary:**\n\nTo compare the Peristeen Anal Irrigation System with conservative bowel management in a\r prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel\r dysfunction.\n\n**Clinical Trial Detailed Description:**\n\nPeople with spinal cord injury (SCI) often have severe problems with management of bowel\r function, including incontinence, impaction, lengthy bowel routines and extremely slow\r transit times.The anal irrigation system is a recently available system to help patients with\r bowel dysfunction empty their bowels by using pulse water irrigation. The system consists of\r a rectal balloon catheter, manual pump and water container.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female >18 years or older\r\n\r - Cauda equina spinal injury at least 12 months previously, with lower motor neuron\r bowel dysfunction and at least one of the following symptoms:\r\n\r - Spending 30 minutes or more attempting to defecate each day or every second day\r\n\r - Episodes of fecal incontinence once or more per month\r\n\r - Abdominal discomfort before or during defecation\r\n\r Exclusion Criteria:\r\n\r - Coexisting major unresolved physical problems due to the injury\r\n\r - Performance of transanal irrigation on a regular basis\r\n\r - Evidence of bowel obstruction or active inflammatory bowel disease\r\n\r - History of cerebral palsy, stroke, multiple sclerosis or diabetic polyneuropathy\r\n\r - Previous colorectal or perineal surgery(excluding minor surgery such as\r hemorrhoidectomy)\r\n\r - Pregnancy or lactation\r\n\r - Immunosuppression\r\n\r - Prior implant for sacral nerve stimulation\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\nChemoradiation for Bone Metastasis\n\n**Clinical Trial Summary:**\n\nPain from bone metastases of breast cancer origin is treated with localized radiation.\r Modulating doses and schedules has shown little efficacy in improving results. Given the\r synergistic therapeutic effect reported for combined systemic chemotherapy with local\r radiation in anal, rectal, and head and neck malignancies, the investigators sought to\r evaluate the tolerability and efficacy of combined capecitabine and radiation for palliation\r of pain due to bone metastases from breast cancer Hypothesis: Given the hypothesis that\r regimens employing greater intensity radiation yield higher rates of pain relief,\r radiosensitization using a tumor targeted drug like Xeloda should improve the rate of\r complete pain relief as compared to radiosensitization with 5FU alone.\r\n\r Primary Objective:\r\n\r To determine the frequency and duration of pain relief and narcotic relief for the proposed\r regimen.\r\n\r Secondary Objective:\r\n\r To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer\r patients with bone metastases.\n\n**Clinical Trial Detailed Description:**\n\nBACKGROUND\r\n\r Much of the clinical practice of oncology involves palliative care. In this setting ,the\r emphasis is on alleviation of symptoms and preservation or improvement of quality of life. A\r large body of clinical evidence documents the effectiveness of local-field external beam\r radiotherapy in palliation of pain from osseous metastases (1). Despite this general\r agreement, controversy remains regarding the optimal dose and fractionation schedule.\r Prospective phase III clinical trials (2-6), today, have failed to demonstrate superiority of\r one schedule over another ,and as a result, the patterns of practice of remain diverse in\r duration and intensity.\r\n\r Between 1974 and 1980 the RTOG conducted a large national study to determine the\r effectiveness of five different dose fractionation schedules(2). A total of 1016 patients\r were entered ,266 into a \"solitary metastasis\" stratum, and 750 into a \"multiple metastasis \"\r stratum. The former were randomly assigned to treatment with 40,5Gy in 15 fractions or 20Gy\r in 5 fractions. The latter were assigned to 30Gy in 10 fractions, 15 Gy in5 fractions ,20 Gy\r in 5 fractions, or 25 Gy in 5 fractions. A quantitative measure of pain ,based on severity\r and frequency of pain, and the type and frequency of pain medications used, was devised to\r evaluate response. Overall, 89% of patients experienced minimal relief. There were no\r significant difference between the treatment arms in both strata. The initial pain score was\r found to be a useful predictor ; patients with high score were less likely to respond and\r were less likely to experience a complete response. Patients with breast and prostate cancer\r were significantly more likely to respond than patients with lung or other primary lesions.\r Patients completing their treatment as planned had significantly higher rates of complete\r response than those who did not .While some relief was experienced almost invariably within\r the first four weeks, complete relief was first reported later than four weeks after start of\r treatment in about 50 % of patients .The median duration of minimal and complete pain relief\r was 20 and 12 weeks ,respectively. There were no significant differences in duration of pain\r relief between the different arms It was concluded that all treatment dose schedules were\r equally effective.\r\n\r A reanalysis of the RTOG study was reported by Blitzer (7).Using a stepwise logistic\r regression, he examined the effect of the number of fractions, the dose per fraction, and\r solitary versus multiple metastases, on the probability of attaining complete pain relief and\r the need for retreatment. This multivariate technique allowed patients with solitary and\r multiple metastases to be analyzed together. By increasing the number of subjects and events\r the statistical power of the analysis was outcome. There was no correlation of the time dose\r factor with outcome (8). It was concluded that the more protracted schedules resulted in\r improved pain relief.\r\n\r Price et al. randomized 288 patients to receive either 8 Gy in one fraction or 30 Gy in 10\r daily fractions. Pain was assessed using a questionnaire completed by the patients at the\r home on a daily basis. No differences were found in the probability of attaining pain relief,\r the speed of onset or the duration of relief between the two arms(4). Hoskin et al.\r randomized 270 patients to receive either 4 Gy or 8 Gy in one fraction (3) Pain assessed by\r the patient) and analgesic usage were recorded before treatment and at 2,4,8 and 12 weeks. At\r 4 weeks the response rates were 69% for 8 Gy and 44% for 4 Gy (p<0.001). The duration of the\r effect was independent of dose.\r\n\r Two other randomized trials have been reported (5,6). Given the small difference in the\r Biological Effective Dose ( BED) between the arms (6) and the small number of patients\r accrued (5,6), it is not surprising that no differences between the treatment arms were\r detected.\r\n\r RTOG have reported the results of a pooled data dose response analysis (11). A computerized\r literature search was conducted to identify prospectively randomized clinical studies which\r addressed this issue and the results of these studies (2 6) were pooled together to form a\r database for analysis. The endpoint selected for analysis was complete response (CR). It was\r felt that this endpoint was most likely to be evaluated in a consistent fashion by different\r investigators. One study (6) was excluded from the analysis because outcome was not reported\r using conventional definitions of complete and partial response. To allow comparison of the\r different study arms, the BED was calculated for each schedule. Odds ratios calculated for\r various dose levels showed a statistically significant increase from 1.00 to 3.32 as the BED\r increased from 14.4 Gy to 5 1.4 Gy.\r\n\r For the first time, RTOG analysis demonstrated a highly significant dose response\r relationship for palliation of pain from bone metastases with radiotherapy. Furthermore,\r there was no evidence of flattening of the dose¬-response curve within the dose range tested,\r suggesting that further gains can be realized at doses outside of the range tested. We\r propose a phase II clinical trial in which the biological effective dose will be increased by\r the concurrent use of a radiosensitizer. The main advantage of this approach over escalation\r of the physical dose is the avoidance of increase in the overall treatment time.\r\n\r Capecitabine is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally\r administered systemic prodrug of 5' deoxy 5 fluorouridine (5' DFUR) which is converted to 5\r Capecitabine is readily absorbed from the gastrointestinal tract. In the liver, a 60 kDa\r carboxyesterase hydrolyzes much of the compound to 5' deoxy 5 fluorocytidine (5' DFCR).\r Cytidine deaminase, an enzyme found in most tissues, including tumors, subsequently converts\r 5' DFCR to 5' deoxy 5 fluorouridine (5' DFUR).. The enzyme, thymidine phosphorylase\r (dThdPase), then hydrolyzes 5' DFUR to the active drug 5 FU. Many tissues throughout the body\r express thymidine phosphorylase. Some human carcinomas express this enzyme in higher\r concentrations than surrounding normal tissues. Both normal and tumor cells metabolize 5 FU\r to 5¬fluoro 2 deoxyuridine monophosphate (FdUMP) and 5 fluorouridine triphosphate (FUTP).\r These metabolites cause cell injury by two different mechanisms. First, HUMP and the folate\r cofactor, N5 10¬methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a\r covalently bound ternary complex. This binding inhibits the formation of thymidylate from\r uracil. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential\r for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division.\r Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine\r triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA\r processing and protein synthesis. Capecitabine is already approved for use in patients with\r metastatic breast cancer resistant to both paclitaxel and an anthracycline containing\r chemotherapy regimen.\r\n\r Although 5FU is an established radiosensitizer, the exact mechanism by which it enhances cell\r kill is not well understood. Sensitization is schedule dependent and is maximal when a\r cytocidal concentration of 5FU is given after the radiation exposure (12). The effect does\r not result from increased sublethal damage or inhibition of sublethal damage repair (12,13).\r Current evidence suggests that radiosensitization by 5FU is mediated through its effects on\r DNA rather then RNA (14). In vivo (15) as well as clinical studies (16) have demonstrated the\r superiority of continuous over bolus infusion of 5FU.\r\n\r Over the last several decades, concurrent 5FU and radiation have been used successfully in a\r variety of malignancies. Several important lessons have been learned from clinical trials\r (16). Simultaneous delivery of large (IV bolus) doses of 5 fluorouracil with irradiation is\r associated with improved survival compared to treatment with radiation alone, but at a price\r of increased normal tissue toxicity. These side effects can be ameliorated by using\r protracted venous infusion. This is an efficacious approach, with a wide therapeutic index,\r which permits concurrent treatment of micrometastatic disease and radiation sensitization.\r\n\r Combined modality therapy, including irradiation and concurrently administered 5FU based\r chemotherapy, has become the mainstay of therapy for anal and rectal cancers. Protracted\r venous infusion chemoradiation is also used in the preoperative management of rectal cancer\r and in the nonoperative management of anal cancers. The Gastrointestinal Tumor Study Group\r (GITSG) has demonstrated a significant survival advantage for patients who receive adjuvant\r combined radiation and bolus 5FU following curative resection of pancreatic cancer (17,18).\r Similar advantages have been demonstrated in unresectable pancreatic cancers. Significant\r advantages have also been shown for concurrent chemotherapy regiments containing 5FU in\r esophageal cancer (19), squamous cell carcinoma of the Head and Neck (20,21), and carcinoma\r of the cervix (22).\r\n\r There is very limited experience with the use of capecitabine and radiation. Based on its\r relative selectivity and the increase in tumor cell 5FU levels, it should be expected that\r capecitabine will provide superior radiosensitization at equivalent or reduced systemic\r toxicity levels. Interestingly, it has been recently reported that radiation induces\r thymidine phosphorylase and enhances the efficacy of capecitabine in human cancer xenografts\r (23). This may further enhance the synergistic effects, and consequently the therapeutic\r ratio.\r\n\r In RTOG study a substantial number of patients with gastrointestinal malignancies treated\r with concurrent radiotherapy and capecitabine at a dose of 1600 mg/m2/day (5 days a week)\r with very little toxicity(24 ).In phase II study of chemoradiation for rectal cancer\r 1650mg/m2/d of capecitabine for 14 days was safe and well-tolerated treatment(25).\r\n\r In this study we will investigate the feasibility of concurrent Capecitabine and external\r beam radiotherapy, as well as collect preliminary data regarding the efficacy of this\r regimen.\r\n\r OBJECTIVES\r\n\r Hypothesis: Given the hypothesis that regimens employing greater intensity radiation yield\r higher rates of pain relief, radiosensitization using a tumor targeted drug like Xeloda\r should improve the rate of complete pain relief as compared to radiosensitization with 5FU\r alone.\r\n\r Primary Objective:\r\n\r To determine the frequency and duration of pain relief and narcotic relief for the proposed\r regimen.\r\n\r Secondary Objective:\r\n\r To determine the toxicity of concurrent Capecitabine and radiotherapy in breast cancer\r patients with bone metastases.\r\n\r Eligibility Criteria\r\n\r Patients with metastatic breast will be allowed on the study regardless of their prior\r exposure to chemotherapy. Today, there is no evidence to suggest crossresistance between\r radiotherapy and prior chemotherapy, or that response to radiotherapy is related in any way\r to the number of lines of chemotherapy used in a particular patient. Good palliative\r responses can often be achieved in heavily pretreated patients.\r\n\r 1. The patient must be 18 years of age or older.\r\n\r 2. The patient must have histologically proven breast adenocarcinoma.\r\n\r 3. Radiographic evidence of bone metastasis is required .Acceptable studies include plain\r radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance\r imaging.\r\n\r 4 .The patient must have pain that appears to be related to the radiographically documented\r metastasis.\r\n\r 5. Patients receiving systemic therapy with Capecitabine to metastatic disease (according to\r health basket ).\r\n\r 6. Patients must have an estimated life expectancy of 3 months or greater.\r\n\r 7. Patients will be eligible for treatment of multiple metastases only if these can be\r included in no more than two treatment sites.\r\n\r 8. Signed study specific informed consent.\r\n\r 9 Karnofsky Performance Status > 40.\r\n\r 10. Calculated Creatinine Clearance > 50 ml/min\r\n\r 11.ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum\r creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at least\r 100,00.\r\n\r Exclusion Criteria\r\n\r 1. Prior radiation therapy or prior palliative surgery to the painful site.\r\n\r 2. Impending fracture of the treatment site or planned surgical fixation of the bone.\r\n\r 3. Patients with clinical or radiographic evidence of spinal cord or cauda equina\r compression.\r\n\r 4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days\r prior to registration.\r\n\r PRETREATMENT EVALUATION\r\n\r 1. Histologic diagnosis of the primary site. 2. Radiographic assessment, with must include\r plain x-ray of the index lesion (s) and a bone scane.\r\n\r 3. Pain assessment score (BPI ). 4. Laboratory studis within 2 weeks of registration (CBC,\r serum ALT, AST ,total bilirubin and creatinine).\r\n\r RADIATION THERAPY\r\n\r 1. Treatment must be given using 6-15MV photons or 6-18 MeV electrons .\r\n\r 2. All fields must be treated each day. Treatment volume will include the radiographic\r abnormality with at least a 2 cm margin. Treatment of the entire bone is not required.\r\n\r 3. Anterior and posterior parallel opposed fields will be used for lumbar spine, sacrum,\r and extremity sites. Equal weighting is recommended, although unequal weighting may be\r used for the lumbar or sacral spine with a ratio of doses of 1:2 AP:PA. Dose will be\r prescribed at mid depth at the central axis, or at the center of target volume if\r unequal weighting is used.\r\n\r Alternatively, the lumbar spine may be treated with a single PA field, with the dose\r prescribed to the mid vertebral body as defined by a lateral simulator film.\r\n\r 4. Single posterior fields will be used for the thoracic spine and scapula .The treatment\r depth is set at the middle of the vertebral body, as determined by a lateral simulation\r film.\r\n\r 5. The cervical spine may be treated with either parallel opposed lateral fields or with a\r single posterior field. When lateral fields are used, the isocenter should be at mid\r thickness, with the dose prescribed to the mid vertebral body.\r\n\r 6. Pubic. bone lesions will be treated with a single anterior field at a depth determined\r by lateral radiograph or CT scan.\r\n\r 7. Clavicular lesions will be treated with a single anterior field at a depth of 3 cm. The\r dose will be prescribed to the 3 cm depth. An alternative depth may be used as\r determined by CT scan or other radiographs.\r\n\r 8. Rib metastases may be treated with electrons or with photons. When electrons are used,\r the appropriate energy should be chosen such that the entire lesion is covered by the\r 90% (or higher) isodose curve. The dose will be prescribed to the 100% isodose line.\r When photons are used, parallel opposed fields may be used, with the depth prescribed to\r the mid thickness. Tangential fields are strongly encouraged to avoid treatment of\r underlying structures. A single field may be used to cover the lesion, with the depth\r set at the estimated depth of the rib lesion, and the dose prescribed to that level.\r\n\r 9. When more than one osseous site is to be included into a treatment field, the treating\r radiation oncologist may use different field arrangements at herlhis discretion, with\r the goal of providing relatively uniform coverage of the target sites and minimum\r inclusion of uninvolved tissues.\r\n\r Radiation Dose\r\n\r All patients will receive radiotherapy to a dose 30 Gy in 10fractions (3 Gy per fraction)\r over two weeks.\r\n\r CHEMOTHERAPY\r\n\r Chemotherapy with capecitabine tablets will be given concurrently with radiotherapy in the\r dose 1400 mg/m2 orally, in two daily divided doses.\r\n\r Total daily dose rounded to the nearest 500 mg and divided into morning and evening\r\n\r Doses, as per the following table:\r\n\r Number of 500 mg tablets to be taken Surface Area Total Daily Dose morning evening (m2) (mg)*\r <= 1.08 1000 1 1 1.09 1.4 1500 2 1 1.41 1.71 2000 2 2 1.72 2.02 2500 3 2\r\n\r *Total Daily Dose rounded to the nearest 500 mg and divided into morning and evening doses.\r\n\r Dose Limiting Toxicity\r\n\r i) >grade 3 non hematologic toxicity, except for diarrhea, nausea, vomiting, fatigue,\r anorexia, alopecia, fever and/or local reactions.\r\n\r ii) grade 4 diarrhea lasting >3 days which is not controllable with loperamide or other such\r medications. Or grade 4 diarrhea that requires IV hydration.\r\n\r iii) grade 4 neutropenia lasting >3 days\r\n\r iv) grade 4 thrombocytopenia\r\n\r v) grade 2 hand foot syndrome. Dose adjustments will be as per the following table:\r\n\r Toxicity NCI Grades During a Course of Therapy Grade 1 Maintain dose Grade 2 1st appearance\r (non HFS) Interrupt until resolved to grade 0 1\r\n\r 1st appearance of HFS Interrupt until resolved to grade 0 1, then continue at 75 % of\r original dose.\r\n\r 2nd appearance Interrupt until resolved to grade 0 1, then continue at 75 % of original dose.\r\n\r 3rd appearance Interrupt until resolved to grade 0 1, then continue at 50 % of original dose.\r\n\r 4th appearance Discontinue treatment permanently Grade 3\r\n\r 1. st appearance Interrupt until resolved to grade 0 1, then continue at 75 % of original\r dose with prophylaxis where possible.\r\n\r 2. nd appearance Interrupt until resolved to grade 0 1, then continue at 50 % of original\r dose.\r\n\r 3. rd appearance Discontinue treatment permanently Grade 4\r\n\r 1st appearance Discontinue permanently or If physician deems it to be in the patient's best\r interest to continue, interrupt until resolved to grade 0 1, then continue at 50 % of\r original dose .\r\n\r Dosage modifications are not recommended for grade 1 events. Therapy with capecitabine should\r be interrupted upon the occurrence of a grade 2 or 3 adverse experience. Once the adverse\r event has resolved or decreased in intensity to grade 1, then therapy may be restarted at\r full dose or as adjusted according to the above table. If a grade 4 experience occurs,\r therapy should be discontinued or interrupted until resolved or decreased to grade 1, and\r therapy should be restarted at 50% of the original dose. Doses of capecitabine omitted for\r toxicity are not replaced or restored; instead the patient should resume the planned\r treatment cycles. Once the dose has been reduced it should not be increased at a later time.\r\n\r Toxicity\r\n\r CAPECITABINE can induce diarrhea, sometimes severe. Patients with severe diarrhea should be\r carefully monitored and given fluid and electrolyte replacement if they become dehydrated.\r National Cancer Institute of Canada (NCIC grade 2 diarrhea is defined as an increase of 4 to\r 6 stools/day or nocturnal stools, grade 3 diarrhea as an increase of 7 to 9 stools/day or\r incontinence and malabsorption, and grade 4 diarrhea as an increase of >10 stools/day or\r grossly bloody diarrhea or the need for parenteral support. If grade 2, 3 or 4 diarrhea\r occurs, administration of capecitabine should be immediately interrupted until the diarrhea\r resolves or decreases in intensity to grade 1. Following grade 3 or 4 diarrhea, subsequent\r doses of capecitabine should be decreased. Standard antidiarrheal treatments (eg, loperamide)\r are recommended. Necrotizing enterocolitis (typhlitis) has also been reported.\r\n\r Hand and foot syndrome (palmar plantar erythrodysesthesia or chemotherapy induced acral\r erythema) is characterized by the following: numbness, dysesthesia/paresthesia, tingling,\r painless or painful swelling, erythema, desquamation, blistering and severe pain. Grade 2\r hand and foot syndrome is defined as painful erythema and swelling of the hands and/or feet\r and/or discomfort affecting the patient's activities of daily living. Grade 3 hand and¬foot\r syndrome is defined as moist desquamation, ulceration, blistering and severe pain of the\r hands and/or feet and/or severe discomfort that causes the patient to be unable to work or\r perform activities of daily living. If grade 2 or 3 hand and foot syndrome occurs,\r administration of capecitabine should be interrupted until the event resolves or decreases in\r intensity to grade 1. Following the occurrence of grade 2 handand foot syndrome, subsequent\r doses of capecitabine should be decreased.\r\n\r There has been cardiotoxicity associated with fluorinated pyrimidine therapy, including\r myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and\r electrocardiograph changes. These adverse events may be more common in patients with a prior\r history of coronary artery disease.\r\n\r Patients with mild to moderate hepatic dysfunction due to liver metastases should be\r carefully monitored when capecitabine is administered. The effect of severe hepatic\r dysfunction on the disposition of capecitabine is not known. If drug related grade 2 4\r elevations in bilirubin occur, administration of capecitabine should be immediately\r interrupted until the hyperbilirubinernia resolves or decreases in intensity to grade 1. NCIC\r grade 2 hyperbilirubinernia is defined as 1.5 x normal, grade 3 hyperbilirubinemia as 1.5 3 x\r normal and grade 4 hyperbilirubinemia as >3 x normal.\r\n\r Increases in adverse events have been noted in patients with reduced renal function.\r Therefore, patients will be excluded for a calculated creatinine clearance of less than 50\r ml/min.\r\n\r Myelosuppression was rare.\r\n\r Assessment of Response\r\n\r Pain scores and narcotic scores will be determined using the guidelines in following table:\r\n\r PAIN AND NARCOTIC CATEGORIES AND SCORES PAIN ANALGESIA Severity 0 No pain 0 None I Mild I\r Analgesics (ASA, Bufferin, Tylenol, Anacin, etc.) 2 Moderate 2 Mild Narcotic, (< 112 gr.\r codeine, Darvon, etc.) 3 Severe 3 Moderate Narcotic (> 112 < gr. codeine, Percoan, etc) 4\r Strong 4 Narcotic, (> 1 gr. codeine, demerol, morphine, etc) Frequency 0 None 0 None I\r Occasional (< daily) I p.r.n. (< daily) 2 Intermittent (at least daily) 2 q.d. (I tab. or\r cap./day) 3 Frequent (>. I < 3 daily) 3 b.i.d. t.i.d. (> I < 4 tab. or cap./day) 4 Constant\r (most of the time) 4 > t.i.d. (> 4 tab. or cap./day)\r\n\r Pain Score = Pain Severity Grade x Pain Frequency Grade Narcotic Score = Analgesia Severity\r Grade x Analgesic Frequency Grade\r\n\r Response will be evaluated by questionnaires at follow up visit at 2, 4 and 8 weeks after\r completion of radiotherapy and by phone call interviews (when necessary for completeness) in\r poor compliance patients.\r\n\r The \"worst pain score\" will be used as response endpoint. The time to maximal pain relief is\r the time from the first day of irradiation to the time of the lowest pain score for average\r pain.\r\n\r Response Definitions\r\n\r Complete response is defined as an average pain score of 0 for two consecutive analysis\r periods. Narcotic consumption must not be increased. Partial response. A decrease of at least\r 2 points in the worst pain score for two consecutive analysis periods. Narcotic consumption\r must not be increased. No response (any of the following): A pain score that does not change\r within 8 weeks from the start of radiation therapy.\r\n\r A 2 point increase in worst pain score that is sustained at a higher level in the month\r following the first day of radiation therapy.\r\n\r A pain score that drops by at least 2 points and subsequent sustained rise (on 2 successive\r questionnaires) of pain score by at least 2 points. Any patient with progressive pain in the\r treated area should have plain radiographs of the area to assess for bone stability and\r pathologic fracture.\r\n\r References.\r\n\r 1.\r\n\r Hoskin PJ. Scientific and clinical aspects of radiotherapy in the relief of bone pain. Cancer\r Surv. 7:69, 1988.\r\n\r 2. Tong D, Gillick L, Hendrickson FR. The palliation of symptomatic osseous metastases: the\r\n\r results of the Radiation Therapy Oncology Group. Cancer 1982; 50: 893.\r\n\r 3. Hoskin PJ, Price P, Easton D, et a]. A prospective randomized trial of 4 Gy or 8 Gy single\r doses\r\n\r in the treatment of metastatic bone pain. Radiotherapy and Oncology 23:74 78, 1992.\r\n\r 4. Price P, Hoskin PJ, Easton D, et al. Prospective randomized trial of single and\r multifraction\r\n\r radiotherapy schedules in the treatment of painful bony metastases. Radiotherapy and Oncology\r 6: 247 255, 1986.\r\n\r Okawa T, Kita M, Goto M, et al. Randomized prospective clinical study of small, large and\r twice a day fraction radiotherapy for painful bone metastases. Radiotherapy and Oncology 13:\r 99 104, 1988.\r\n\r 6. Madsen EL, Painful bone metastases: Efficacy of radiotherapy assessed by the patients: A\r\n\r randomized trial comparing 4 Gy x 6 versus 10 Gy x 2. Int. J. Radiat. Oncol. Biol. Phys.\r 9:1775¬ 1779, 1983.\r\n\r 7. Blitzer PH. Reanalysis of the RTOG study of the palliation of symptomatic osseous\r metastasis.\r\n\r Cancer 1985; 55: 1468 1472.\r\n\r 8. Orton CG, Ellis F, A simplification in the use of the NSD concept in practical\r radiotherapy. Br.\r\n\r J. Radiol. 1973; 46:529 537.\r\n\r 9. Daut R, Cleeland C, Flanery R: Development of the Wisconsin Brief Pain questionnaire to\r assess\r\n\r pain in cancer and other diseases. Pain 17:197 210, 1983.\r\n\r 10.\r\n\r 11.\r\n\r 12.\r\n\r 13.\r\n\r 14.\r\n\r Cella DF, Tulsky DS, Gray G, et al.: The Functional Assessment of Cancer Therapy Scale:\r Development and validation of the general measure. J Clin Oncol 11:570 579, 1993.\r\n\r Ben Josef E, Shamsa F, Youssef E, Porter AT. External beam radiotherapy for painful osseous\r metastases: pooled data dose response analysis. Int J Radiat Oncol Biol Phys 45(3):715 719,\r 1999.\r\n\r Byfield JE, calabro Jones P, Klisak 1, et al. Pharmacologic requirements for obtaining\r sensitization of human tumor cells in vitro to combined r fluorouracil or ftorafur and x\r rays. Int J Radiat Oncol Biol Phys 1982, 8:1923 33.\r\n\r Nakajima V, Miyamoto Y, Tanabe M, et al. Enhancement of mammalian cell killing by\r 5fluorouracil in combination with x rays. Cancer Res 39:3763 3767, 1979.\r\n\r Lawrence TS, Davis MA, Maybaum I Dependence of 5 fluorouracil mediated radiosensitization on\r DNA directed effects. Int J Radiat Oncol Biol Phys 1994, 29(3):519 23.\r\n\r 15. Weinberg MJ, Rauth AM. 5 fluorouracil infusion and fractionated doses of radiation:\r Studies with a murine sqamous cell carcinoma. Int J Radiat Oncol Biol Phys 13: 1691 1699,\r 1987.\r\n\r Rich TA. Infusional chemoradiation for rectal and anal cancers. Oncology (Huntingt) 1999,\r 13(10 Suppl 5):131 4.\r\n\r 17. Gastrointestinal Tumor Study Group. Further evidence of effective adjuvant combined\r radiation and chemotherapy following curative resection of pancreatic cancer. Cancer 1987,\r 59(12):2006¬ 10.\r\n\r 18. Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy\r following curative resection. Arch Surg 1985, 120(8):899 903.\r\n\r 19. al Sarraf M, Martz K, Herskovic A, Leichman L, Brindle JS, Vaitkevicius VK, Cooper J,\r Byhardt R, Davis L, Emami B. Progress report of combined chemoradiotherapy versus\r radiotherapy alone in patients with esophageal cancer: an intergroup study. J Clin Oncol\r 1997, 15(l):277 84.\r\n\r 20. Wendt TG, Grabenbauer GG, Rodel CM, Thiel HJ, Aydin H, Rohloff R, Wustrow TP, Iro H,\r Popella C, Schalhorn A. Simultaneous radiochemotherapy versus radiotherapy alone in advanced\r head and neck cancer: a randomized multicenter study. J Clin Oncol 1998, 16(4):1318 24.\r\n\r 21. Al Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr\r WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced\r nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol 1998,\r 16(4):1310 7.\r\n\r 22. Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM,\r Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para aortic\r radiation for high risk cervical cancer. N Engl J Med 1999, 340(15):1137 43.\r\n\r 23. Sawada N, Ishikawa T, Sekiguchi F, Tanaka Y, Ishitsuka H. X ray irradiation induces\r thymidine phosphorylase and enhances the efficacy of capecitabine in human cancer xenografts.\r Clin Cancer Res 1999, 5(10):2948 53.\r\n\r 24. U.N.Vaishampayan, E. Ben-Josef, P.A. Philip, V.K. Vaitkevicius, K.J. Levin and A.F.\r Shields. A single- institution experience with concurrent capecitabine and radiation therapy\r in gastrointestinal malignancies . Int J Radiat Oncol Biol Phys ,2002, 53,675-679.\r\n\r 25. Jun-Sang Kim, Jae-Sung Kim, Moon-June Cho and Wan-Hee Yoon .Preoperative chemoradiation\r using oral capecitabine in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys\r ,2002,54,403-408.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. The patient must be 18 years of age or older\r\n\r 2. The patient must have histologically proven breast adenocarcinoma\r\n\r 3. Radiographic evidence of bone metastasis is required .Acceptable studies include plain\r radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance\r imaging\r\n\r 4. The patient must have pain that appears to be related to the radiographically\r documented metastasis\r\n\r 5. Patients receiving systemic therapy with Capecitabine to metastatic disease (according\r to health basket)\r\n\r 6. Patients must have an estimated life expectancy of 3 months or greater\r\n\r 7. Patients will be eligible for treatment of multiple metastases only if these can be\r included in no more than two treatment sites\r\n\r 8. Signed study specific informed consent\r\n\r 9. Karnofsky Performance Status > 40\r\n\r 10. Calculated Creatinine Clearance > 50 ml/min\r\n\r 11. ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum\r creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at\r least 100,00\r\n\r Exclusion Criteria:\r\n\r 1. Prior radiation therapy or prior palliative surgery to the painful site\r\n\r 2. Impending fracture of the treatment site or planned surgical fixation of the bone\r\n\r 3. Patients with clinical or radiographic evidence of spinal cord or cauda equina\r compression\r\n\r 4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days\r prior to registration\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"content": "**Answer:** possibly relevant"
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possibly relevant
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"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
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"role": "user",
"content": "**Clinical Trial Title:**\n\nImpact of Training on Gait and Strength in Stroke Survivors\n\n**Clinical Trial Summary:**\n\nBackground: A discrepancy between strength gain and gait changes following various training\r programs aimed at improving gait function after stroke has been noted. A mismatch between the\r training program and gait parameters could explain this finding.\r\n\r Objective: To evaluate the impact of an isokinetic-strengthening program, matching the\r requirements of the affected lower-limb muscle groups involved in the energy generation of\r gait, to a control intervention, on gait performance and muscle strength.\r\n\r Hypothesis: The isokinetic training program of the affected lower-limb muscles would produce\r greater changes in gait performance and strength than a control intervention not aiming at\r training these muscle groups.\r\n\r Design: Single-blinded randomized controlled trial.\r\n\r Participants: A convenient sample of 30 individuals with chronic hemiparesis.\r\n\r Interventions: Participants were randomly assigned into two groups (n=15), each training\r three times/week for six weeks. The experimental group trained the affected plantarflexors,\r hip flexors and extensors concentrically, while the control group trained the affected\r upper-limb muscles.\r\n\r Main outcome measures: Baseline values and post-training values, taken at the end of the\r training program, of maximal voluntary concentric strength, gait speed and peak positive\r power.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - have a chronic (six months or more) unilateral stroke\r\n\r - be able to walk 10 meters independently with or without a cane\r\n\r - present residual weakness at the affected lower limb\r\n\r - have an activity tolerance of at least two hours with a rest period\r\n\r Exclusion Criteria:\r\n\r - receptive aphasia\r\n\r - incontinence\r\n\r - unstable medical condition\r\n\r - history of injury\r\n\r - anesthesia at the lower limbs\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\nLimiting Trunk Flexion as a Self-treatment for Low Back Pain\n\n**Clinical Trial Summary:**\n\nThe purpose of the proposed study is to test the effect of an intervention technique that\r reduces trunk flexion upon rising, on the outcome measures of self-reported back pain and\r functional impairment in individuals with chronic or recurrent non-specific low back pain\r (LBP). The intervention is a self-administered and requires no medical intervention or drugs.\r The technique referred to as the restrained sitting treatment (RST), involves training in\r minimizing forward bending of the trunk immediately upon rising. The technique builds upon a\r previous randomized controlled study conducted and published by members of the research team.\r The underlying premise of RST exploits the natural diurnal pattern as the intervertebral\r discs (people are tallest when they first wake up). The discs are fully hydrated upon rising,\r disc internal hydrostatic pressures and external forces acting on surrounding soft tissues\r are greatest at this time, and these pressures and forces can increase significantly with\r trunk flexion. The RST technique utilizes a back support used in sitting during the first\r hour upon rising to minimize trunk flexion during this critical period as the intervertebral\r discs begins the diurnal cycle of fluid loss. The study will test the null hypothesis that\r there are no significant difference in outcome (LBP, work or social function/disability)\r between groups performing RST, the experimental group performing RST upon rising, the control\r group performing prior to going to bed.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical diagnosis of chronic or recurrent low back pain\r\n\r - Six month or longer history of non-specific LBP\r\n\r - Minimum 90 days in pain in the last six months\r\n\r - Average pain score of past month ≥3 on a 0-10 numerical rating scale\r\n\r Exclusion Criteria:\r\n\r - Red flags (tumor, metabolic diseases, Rheumatoid arthritis, osteoporosis, prolonged\r steroid use, pregnancy, back surgery)\r\n\r - Evidence of nerve root compression (pain reproduction with SLR>45º, weakness of major\r lower extremity muscle group, decreased deep tendon reflexes at knee or ankle,\r decreased sensation to pinprick)\r\n\r - Acute trauma to low back\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\nA Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas\n\n**Clinical Trial Summary:**\n\nThis is a study to determine the safety and efficacy of the drug, mebendazole, when used in\r combination with standard chemotherapy drugs for the treatment of pediatric brain tumors.\r Mebendazole is a drug used to treat infections with intestinal parasites and has a long track\r record of safety in humans. Recently, it was discovered that mebendazole may be effective in\r treating cancer as well, in particular brain tumors. Studies using both cell cultures and\r mouse models demonstrated that mebendazole was effective in decreasing the growth of brain\r tumor cells.\r\n\r This study focuses on the treatment of a category of brain tumors called gliomas. Low-grade\r gliomas are tumors arising from the glial cells of the central nervous system and are\r characterized by slower, less aggressive growth than that of high-grade gliomas. Some\r low-grade gliomas have a more aggressive biology and an increased likelihood of resistance or\r recurrence.\r\n\r Low-grade gliomas are often able to be treated by observation alone if they receive a total\r surgical resection. However, tumors which are only partially resected and continue to grow or\r cause symptoms, or those which recur following total resection require additional treatment,\r such as chemotherapy. Due to their more aggressive nature, pilomyxoid astrocytomas, even when\r totally resected, will often be treated with chemotherapy. The current first-line treatment\r at our institution for these low-grade gliomas involves a three-drug chemotherapy regimen of\r vincristine, carboplatin, and temozolomide. However, based on our data from our own\r historical controls, over 50% of patients with pilomyxoid astrocytomas will continue to have\r disease progression while on this treatment. We believe that mebendazole in combination with\r vincristine, carboplatin, and temozolomide may provide an additional therapeutic benefit with\r increased progression-free and overall survival for low-grade glioma patients, particularly\r for those with pilomyxoid astrocytomas.\r\n\r High grade gliomas are more aggressive tumors with poor prognoses. The standard therapy is\r radiation therapy. A variety of adjuvant chemotherapeutic combinations have been used, but\r with disappointing results. For high-grade gliomas this study will add mebendazole to the\r established combination of bevacizumab and irinotecan to determine this combinations safety\r and efficacy\n\n**Clinical Trial Detailed Description:**\n\nThis is a phase I/II study of mebendazole in combination with standard of care agents for\r pediatric patients with gliomas. Patients with low-grade gliomas will receive a regimen of\r mebendazole in combination with vincristine, carboplatin, and temozolomide. Patients with\r high-grade gliomas and diffuse intrinsic pontine gliomas will receive a regimen of\r mebendazole in combination with bevacizumab and irinotecan. Surgical resection of the tumor\r will be attempted initially with the goal of achieving a gross total resection without\r substantial neurologic deficit. Subtotal resection may be preferable depending on the\r location of the tumor. Optic pathway gliomas and diffuse intrinsic pontine gliomas may remain\r unresected. Patients with high-grade gliomas or diffuse intrinsic pontine gliomas will\r undergo local irradiation of their tumor before beginning protocol treatment. Low-grade\r glioma patients will not receive radiation therapy. Patients who have been previously treated\r with chemotherapy will be eligible for the study provided they have not previously failed\r therapy with any of the chemotherapeutic agents.\r\n\r Patients with eligible tumors will be consented for enrollment into the study. The study\r patients will be divided into two groups (low-grade glioma and high-grade/pontine glioma) for\r the purpose of determining the maximally tolerated dose of mebendazole. These two groups will\r be treated independently with regard to patient accrual, dose escalation, and evaluation of\r toxicity. In addition to their standard chemotherapy regimen, patients in both cohorts will\r receive mebendazole. Mebendazole doses will be escalated from the initial dose level of 50\r mg/kg/day divided twice daily, to a second dose level of 100 mg/kg/day divided twice daily,\r to the final dose level of 200 mg/kg/day divided twice daily, in cohorts of three patients\r per dose level. A standard \"3+3\" design will be used for determining dose escalation.\r\n\r Phase I safety monitoring for the low-grade group will take place during a trial period\r beginning with start of therapy and ending following the tenth week of induction therapy.\r Phase I safety monitoring for the high-grade/pontine glioma group will take place during a\r trial period beginning with the start of maintenance therapy through the twelfth week of\r maintenance therapy (3 cycles).\r\n\r After determination of maximally tolerated dose for each group, the study will continue to\r evaluate efficacy of this regimen. The study will be amended for the maximally tolerated dose\r for each group to be used in the remainder of the study. Patients currently on study will\r continue with maintenance therapy. To document the degree of residual tumor, standard whole\r brain MRI with and without contrast (gadolinium) will be performed following a specified\r intervals. Following completion of therapy, patients will continue to be monitored by MRI to\r assess progression-free and overall-survival.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Age > 1 year of age and ≤ 21 years of age\r\n\r 2. Diagnosis\r\n\r 2.1. Group A - Low-grade Glioma Group:\r\n\r Histology: Biopsy-proven:\r\n\r - Pilocytic Astrocytoma\r\n\r - Fibrillary Astrocytoma\r\n\r - Pilomyxoid Astrocytoma\r\n\r - Pleomorphic Xanthoastrocytoma\r\n\r - Other low grade astrocytomas\r\n\r Children with optic pathway tumors must have evidence of progressive disease on MRI\r and/or symptoms of deteriorating vision or, progressive hypothalamic/pituitary\r dysfunction or, diencephalic syndrome or precocious puberty.\r\n\r Patients with relapsed low-grade gliomas who have been previously treated with\r chemotherapy will be eligible for the study provided they have not previously failed\r therapy with any of the chemotherapeutic agents used in this study.\r\n\r 2.2 Group B - High-grade Glioma/Pontine Glioma Group:\r\n\r Histology: Biopsy-proven\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Gliosarcoma.\r\n\r Patients with primary spinal cord malignant gliomas are eligible.\r\n\r For primary brainstem tumors, histologic verification is not required. Patients are\r eligible when diagnosed with clinical and radiographic (MRI) evidence of tumors which\r diffusely involve the brainstem. Patients with tumors which intrinsically (greater\r than 50% intra-axial) involve the pons or pons and medulla or pons and midbrain or\r entire brainstem are eligible. Tumors may contiguously involve the thalamus or upper\r cervical cord.\r\n\r 3. Timing of therapy:\r\n\r Patients must be enrolled before treatment begins. Treatment must start within 14 days\r of study enrollment.\r\n\r All clinical and laboratory studies to determine eligibility must be performed within\r 7 days prior to enrollment unless otherwise indicated in the eligibility section.\r\n\r 4. Adequate hematologic, renal, liver function as demonstrated by laboratory values.\r\n\r 5. Negative pregnancy test in women of childbearing potential within 7 days of initiating\r investigational therapy\r\n\r 6. Life expectancy ≥ 3 months\r\n\r 7. Concurrent medications: It is recommended that patients are weaned off or are on a\r tapering dose of corticosteroids before starting therapy on study.\r\n\r 8. Patient or legal guardian must give written, informed consent or assent (when\r applicable)\r\n\r 9. Recent mothers must agree not to breast feed while receiving medications on study.\r\n\r Exclusion criteria:\r\n\r 1. Age < 1 year or > 21 years\r\n\r 2. Patients who have known allergy to mebendazole or benzimidazole class drugs.\r\n\r 3. Patients who have previously had a severe side effect, such as agranulocytosis and\r neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for\r a parasitic infection .\r\n\r 4. Patients who are taking metronidazole and cannot be safely moved to a different\r antibiotic greater than 7 days prior to starting mebendazole therapy.\r\n\r 5. Pregnant female patients are not eligible for this study. Pregnancy tests with a\r negative result must be obtained in all post-menarchal females.\r\n\r 6. Lactating females must agree they will not breastfeed a child while on this study.\r\n\r 7. Males and females of reproductive potential may not participate unless they agree to\r use an effective contraceptive method and continue to do so for at least 6 months\r after the completion of therapy.\r\n\r 8. Patients who are unable to take oral medications because of significant vomiting will\r be excluded.\r\n\r 9. Group A - Low-grade Glioma Group ONLY:\r\n\r Patients who have failed prior chemotherapy with vincristine, carboplatin, or\r temozolomide for this tumor are excluded.\r\n\r Patients with Neurofibromatosis Type 1\r\n\r 10. Group B - High-grade Glioma/Pontine Glioma Group ONLY:\r\n\r Patients who failed prior chemotherapy with bevacizumab or irinotecan for this tumor are\r excluded.\r\n\r Patients who progressed on or within 12 weeks after completion of radiotherapy are\r excluded.\r\n\r Patients with a history or current condition that would preclude the use of bevacizumab\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\nExercise and NutraStem (NT-020): Effects on Stem Cells\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to see if an investigational supplement called NutraStem® will\r increase the amount of stem cells in human blood at rest and after exercise. The ingredients\r found in NutraStem® can be found in nutrition or vitamin shops/stores.\n\n**Clinical Trial Detailed Description:**\n\nA randomized double blinded placebo controlled trial of a nutraceutical preparation. Up to 60\r men and women between the ages of 50 and 70, and generally healthy will participate in this\r study. . Up to 30 participants will receive the nutritional supplement and up to 30 will\r receive placebo.\r\n\r Potential participants will be screened by telephone and have the study explained to them in\r detail. If they qualify and choose to participate they will come in for the first of three\r visits. Informed consent will be obtained and demographic information collected. Information\r requested on the demographic form includes ethnicity, income, education, marital status,\r smoking and alcohol use, and exercise habits. Next they will have blood pressure checked and\r if not within parameters they will be dropped from the study and informed that they need to\r follow up the abnormal result with their health care provider. Those that pass these\r screening tests will have 15 to 25 cc's of peripheral blood (serum) collected by the study\r coordinator via venipuncture while at rest. They will then stretch for 2 minutes (60 seconds\r marching in place followed by 10 toe touches) followed by accelerating treadmill walking\r exercise. The exercise intervention will consist of a 15 minute period of walking on a\r treadmill. The treadmill will not be inclined during the intervention. The participants\r target heart rate will be determined by deducting their age from 220. They will start walking\r on the treadmill at a speed of 1.7 mph and the speed will be titrated as indicated to keep\r their heart rate at 50 to 90% of target. Heart rate will be monitored via the pulse oximetry\r feature of the Welch Allyn vital signs monitor. Blood pressure will be measured every 3\r minutes during the exercise intervention and until they have returned to baseline (within 10\r points) following cessation of the exercise protocol. The test will be stopped for any\r participant complaint of chest pain, excess fatigue, difficulty breathing, a blood pressure\r reading of more than 180/94, or a participant request. If symptoms increase or do not\r completely resolve with 15 minutes of rest the study coordinator will call 911 (through\r campus police) to activate the EMS response. If symptoms resolve completely within 15 minutes\r participants will be withdrawn from the study and advised to follow up with their health care\r provider. Any participant unable to complete the exercise intervention for any reason will be\r withdrawn from the study.\r\n\r Five to fifteen minutes after the exercise intervention has been completed blood will again\r be collected in exactly the same manner as the resting sample. Participants will then receive\r a 2 week supply of either NutraStem or placebo and will be advised to take one tablet every\r morning and evening before meals for the next 2 weeks. If the participant is unable to\r complete any portion of the visit activities at any visit they will be withdrawn from the\r study due to their inability to complete the study. All visit activities will be recorded in\r detail on the visit session record.\r\n\r The second visit will occur 2 weeks later and include a blood pressure check, an at rest\r blood draw, the exercise intervention, and then a repeat blood draw five to fifteen minutes\r after completion of the intervention. Participants will then receive a 2 week supply of\r either NutraStem or placebo and will be advised to take one tablet every morning and evening\r before meals for the next 2 weeks. I Participants will be advised to bring their empty pill\r containers to their next session so we can confirm they are taking the supplement as\r required. If the blood pressure is outside of the specified range they will be dropped from\r the study and no blood collection or study intervention will take place.\r\n\r The third visit will be the same as the second visit.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Healthy men and women\r\n\r - Age 50 to 70 years old\r\n\r - Ability to walk on a treadmill for 15 minutes.\r\n\r Exclusion Criteria:\r\n\r - Age less than 50 or greater than 70 years of age.\r\n\r - A history of difficult veins/difficulty obtaining blood samples\r\n\r - Unwilling to follow the procedures of the trial\r\n\r - Participated in more than 2 sessions per week of strenuous exercise in the last month\r\n\r - Unable to tolerate the ingredients in NutraStem® or placebo, or have food allergies\r\n\r - Intentionally lost or gained 10 or more pounds of body weight in the last 3 months\r\n\r - Acute illness\r\n\r - Severe co-morbid disease\r\n\r - Use of any prescription or non-prescription products for antioxidant regimen or stem\r cell supplement within the past 4 weeks\r\n\r - Diabetic\r\n\r - Uncontrolled hypertension\r\n\r - Recent cardiovascular event (past 36 months), or a family history of sudden death or\r heart attacks before the age of 55\r\n\r - Body Mass Index (BMI) of less than 20 or greater than 35 m/kg2;\r\n\r - Participated in a clinical trial in the past 4 weeks\r\n\r - Take methadone, insulin, anticoagulants (blood thinners), MAO's or similar medications\r\n\r - Anticipate the need for surgery of any type during the entire study;\r\n\r - Plan to donate blood or blood products during the study or for thirty (30) days\r following the study\r\n\r - Active peptic ulcer disease or reliable history of gastrointestinal bleeding within\r the past five (5) years\r\n\r - Recurrent or a history of intestinal disorders that may interfere with the absorption\r of the product\r\n\r - Any disease or condition that in the investigator's opinion compromises the integrity\r of the clinical trial or the safety of the subject\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\nTemozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to determine the efficacy and safety of temozolomide in patient\r with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nPatient with relapsed or advanced anaplastic oligodendroglioma and anaplastic\r oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d\r in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were\r previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5\r days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray\r (4weeks/cycle * 6cycles = 24weeks). If the patients shows responses to Temozolomide,\r treatment can be continued by the investigator's discretion.\r\n\r During the administration of Temozolomide, vital signs, physical examination, ECOG\r performance status, height, weight, hematology and chemistry test, adverse events and\r concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be\r performed once every 12 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically proven anaplastic oligodendroglioma or oligoastrocytoma\r\n\r - Progressed or relapsed after surgery or radiation therapy\r\n\r - Female or male aged 20 years or over\r\n\r - At least 1 measurable mass lesion\r\n\r - ECOG performance status 0-3\r\n\r - Adequate organ function\r\n\r - absolute neutrophil count > 1,500/μL\r\n\r - platelet count > 75,000/μL\r\n\r - hemoglobin greater than 9 g/dL or 900g/L\r\n\r - serum creatinine less than 1.5 times the upper limit of laboratory normal\r\n\r - total serum bilirubin less than 1.5 times the upper limit of laboratory normal\r\n\r - AST or ALT less than three times the upper limit of laboratory normal\r\n\r Exclusion Criteria:\r\n\r - Prior course of temozolomide\r\n\r - Combined glioblastoma\r\n\r - Pregnant woman\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\nEvaluating the Expression Levels of MicroRNA-10b in Patients With Gliomas\n\n**Clinical Trial Summary:**\n\nMicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes.\r Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas,\r known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b\r (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue.\r This study tests the hypothesis that in primary glioma samples mir-10b expression patterns\r will serve as a prognostic and diagnostic marker. This study will also characterize the\r phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the\r critical function of anti-mir-10b in blocking established glioblastoma growth, the\r investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b\r treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from patients\r diagnosed with gliomas over a period of two years. These samples will be examined for mir-10b\r expression levels. Patient survival, as well as tumor grade and genotypic variations will be\r correlated to mir-10b expression levels.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion/Exclusion Criteria:\r\n\r - 18 years of age\r\n\r - Brain tumor(s) to be resected for clinical reasons.\r\n\r - Histological pathology confirmation that tumor is of glial origin, WHO Grade II, III\r or IV.\r\n\r - Adequate tissue available for processing as determined by Pathology.\r\n\r - Adequate decision making ability to review, discuss and sign a consent form to allow\r their tumor samples to be used for future human brain tumor biology laboratory\r research. Determination of capacity to consent is made by one of the co-investigators\r based on clinical assessment.\r\n\r - Patients opting for the standard treatment regimen for their disease as well as\r ongoing clinical trials will be are eligible to participate in this study. Standard\r care for newly-diagnosed glioblastomas typically consists of surgical resection\r followed by radiotherapy with concomitant temozolomide, followed by adjuvant\r temozolomide chemotherapy.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** 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\nPhase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma\n\n**Clinical Trial Summary:**\n\nThis research study is a Three arm Phase I clinical trial, which tests the safety of an\r investigational drug or combination of drugs and also tries to define the appropriate dose of\r the combination of investigational drugs to use for further studies. \"Investigational\" means\r that the combination of drugs is being studied. It also means that the FDA has not yet\r approved the combination of drugs for your type of cancer.\r\n\r Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase\r (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and\r enable them to continue dividing. Olaparib has been used in research studies with other\r cancers. Information from those other research studies suggests that this drug may help to\r treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for\r any use outside of research studies.\r\n\r Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor,\r glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is\r not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for\r relapsed disease.\r\n\r Irinotecan is approved by the FDA for the treatment of gastrointestinal cancers. It has been\r studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA\r for Ewing sarcoma, it is considered part of standard treatment for relapsed disease.\r\n\r Laboratory studies suggest that the combination of olaparib and temozolomide and/or\r irinotecan may help kill Ewing sarcoma or rhabdomyosarcoma cells.\r\n\r In this research study, the investigators are looking for the highest dose of the combination\r of olaparib and irinotecan and/or temozolomide that can be given safely. The investigators\r will also begin to collect information about the effects of the combination on Ewing sarcoma\r and rhabdomyosarcoma.\n\n**Clinical Trial Detailed Description:**\n\nIf the patient agrees to participate in this research study they will be asked to undergo\r some screening tests and procedures to confirm that they are eligible. Many of these tests\r and procedures are likely to be part of regular cancer care and may be done even if it turns\r out that they do not take part in the research study. If they have had some of these tests\r and procedures recently, they may or may not have to be repeated. These tests and procedures\r will include: a medical history, complete physical examination, performance status, tumor\r assessment, EKG, blood tests, pregnancy test, confirmation of pathology report and obtain\r insurance approval to receive temozolomide. If these tests show that the patient is eligible\r to participate in the research study, they will begin the study drug administration. If they\r do not meet the eligibility criteria, they will not be able to participate in this research\r study.\r\n\r Biomarkers are substances such as genes and proteins that are important biological\r \"indicators\" that can be measured in tumor tissue. The investigators would like to look at\r biomarkers before and after patients receive study drug administration. Comparing the\r biomarkers from tissue collected before and after receiving study treatments may help us find\r biomarkers that are associated with response to study treatment or lack of response to study\r drug administration.\r\n\r Before the patient starts study drug administration, if the investigators determine that the\r patient is healthy enough for a biopsy, the patient will undergo a biopsy to provide tumor\r tissue for the research tests described above. (If it is determined that the patient should\r not have a biopsy, they can still take part in this research study).\r\n\r The investigators are looking for the highest doses of olaparib and irinotecan and/or\r temozolomide that can be administered safely without severe or unmanageable side effects to\r participants that have Ewing's sarcoma or rhabdomyosarcoma. Therefore, not everyone who\r participates in this research study will receive the same doses of olaparib, irinotecan,\r and/or temozolomide. The doses the patients get will depend on the number of participants who\r have been enrolled in the study before them and how well they have tolerated their doses. The\r investigators will tell patients how the dose level you receive compares to doses given\r previously in this study.\r\n\r Olaparib and irinotecan and/or temozolomide will ge given in cycles of 21 days (3 weeks).\r Both olaparib and temozolomide are drugs that are taken by mouth. Patients will take olaparib\r and temozolomide on days 1-7 (week 1) of each cycle. Irinotecan is given by IV, once per day,\r on days 1-7 of each cycle. Patients will take olaparib twice per day and temozolomide once\r per day.\r\n\r The investigators will give patients a drug diary to record the doses of olaparib and\r temozolomide that they take each day. The diary will also include special instructions for\r taking olaparib and temozolomide. A member of the study team will show patients how to enter\r their doses in the diary.\r\n\r During cycle 1 patients will come to the clinic on Days 1 and 8 (weeks 1 and 2). During\r cycles 2-6 they will come to the clinic on Day 1 of each cycle. During cycles 8 and beyond\r they will come to the clinic every 9 weeks.\r\n\r At each study visit patients will undergo the following procedures: a physical exam,\r questions about their health (problems, medications, side effects), performance status and\r blood tests. Additionally, during the visit on Cycle 1, Day 8 patients will have an EKG. 4-6\r weeks after starting study drug administration their blood will be tested for its clotting\r ability on Day 1 of Cycle 2. They will also undergo a biopsy to provide tumor tissue for\r biomarker research tests. Every 9 weeks they wil have a CT scan or MRI to measure your tumor.\r\n\r Patients will be asked to return to the clinic about 30 days after stopping study drug. At\r this visit the following will be done: physical exam, questions about their health,\r performance status and blood tests. Patients will be asked to return study drug bottles and\r any unused study drug at this visit.\r\n\r The investigators would like to keep track of the patients' medical condition for as long as\r they allow. The investigators would like to do this by either calling patients on the\r telephone or following them at clinic visits every 3 months. Keeping in touch with patients\r and checking their condition helps the investigators look at the long-term effects of the\r research study.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed Ewing's sarcoma\r\n\r - Ewing's sarcoma must have progressed following at least one standard prior\r chemotherapy regimen\r\n\r - Life expectancy of at least 16 weeks\r\n\r - Willing to comply with the protocol for the duration of the study including pre- and\r post-treatment biopsies, undergoing treatment, scheduled visits and examinations\r including follow up\r\n\r - Presence of measurable disease\r\n\r - Prior approval from insurance company to obtain oral temozolomide for the duration of\r the study\r\n\r Exclusion Criteria:\r\n\r - Involvement in the planning and/or conduct of the study\r\n\r - Previous enrollment in the present study\r\n\r - Participation in another clinical study with an investigational product during the 21\r days prior to first dose of olaparib and temozolomide\r\n\r - Receiving any systemic chemotherapy, radiotherapy (except for palliative reasons),\r within 2 weeks from the last dose prior to study treatment\r\n\r - Concurrent use of the following classes of inhibitors of CYP3A4: azole antifungals,\r macrolide antibiotics, protease inhibitors\r\n\r - Persistent clinically significant toxicities caused by previous cancer therapy\r\n\r - Previously documented diagnosis of myelodysplastic syndrome (or any dysplastic\r leukocyte morphology suggestive of MDS) or acute myeloid leukemia\r\n\r - Symptomatic uncontrolled brain metastases\r\n\r - Major surgery within 14 days of starting study treatment\r\n\r - Considered a poor medical risk due to a serious, uncontrolled medical disorder,\r non-malignant systemic disease or active, uncontrolled infection\r\n\r - Unable to swallow orally administered medication and subjects with gastrointestinal\r disorders likely to interfere with absorption of study medication\r\n\r - Pregnant or breastfeeding\r\n\r - Known to be serologically positive for HIV and receiving antiviral therapy\r\n\r - Subjects with known active hepatitis B or C\r\n\r - Known hypersensitivity to olaparib or any of the excipients of the product\r\n\r - Uncontrolled seizures\r\n\r - Need to continue treatment with any prohibited medications or have not completed the\r appropriate washout period for a prohibited 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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[
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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\nValproic Acid in Childhood Progressive Brain Tumors\n\n**Clinical Trial Summary:**\n\nThe study investigates valproic acid added to radiation and temozolomide therapy (standard of\r care) for progressive or recurrent pediatric brain tumors.\n\n**Clinical Trial Detailed Description:**\n\nPatients with progressive or recurrent pediatric brain tumors are administered valproic acid,\r an HDAC inhibitor, along with standard of care therapy (radiation and temozolomide) for\r induction therapy. Thereafter, patients will be able to continue on valproic acid and\r temozolomide therapy as long as the combination is well tolerated and the tumor is not\r progressing.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subject, parent, or guardian willing and able to give informed consent\r\n\r - Recurrent or progressive pediatric brain tumor, with MRI evidence of disease\r\n\r - Age at first diagnosis of brain tumor 1-21 years old\r\n\r - Lansky or Karnofsky performance score of at least 50 at diagnosis\r\n\r Exclusion Criteria:\r\n\r - Pregnancy\r\n\r - Prior intolerance to valproic acid\r\n\r - History of use of temozolomide\r\n\r - Use of enzyme inducing anticonvulsant medications (see appendix B)\r\n\r - Known urea cycle disorder (e.g. ornithine transcarbamylase deficiency)\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\nPatient Registry of Intrathecal Ziconotide Management(PRIZM)\n\n**Clinical Trial Summary:**\n\nThe objectives of this study are to evaluate the effectiveness, long-term safety,\r tolerability, satisfaction with treatment, and health-related quality of life (HRQoL)\r associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient is at least 18 years of age at the time of study entry.\r\n\r - Patient who has severe chronic pain, whom IT therapy is warranted, and who is\r intolerant of, or refractory to other treatments, such as systemic analgesics,\r adjunctive therapies, and/or IT morphine.\r\n\r - Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a\r participated site.\r\n\r - Patient has not received PRIALT treatment administered continuously via Medtronic\r SynchroMed® II pump within the past 30 days.\r\n\r - Patient has a life expectancy >6 months as determined by the physician.\r\n\r - Patient is able to read, understand, and voluntarily sign the IRB-approved informed\r consent document prior to the performance of any study-specific procedures.\r\n\r - Patient is able to understand and complete required assessments.\r\n\r Exclusion Criteria:\r\n\r - Patient has a known hypersensitivity to PRIALT or any of its formulation components.\r\n\r - Patient has a pre-existing history of psychosis.\r\n\r - Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or\r known spinal canal obstruction that impairs circulation of cerebrospinal fluid.\r\n\r - Patient is being initiated with PRIALT in conjunction with other IT agents.\r\n\r - Patients with any other concomitant treatment or medical condition that, in the\r opinion of the clinician, would render IT administration hazardous.\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\nA Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm\n\n**Clinical Trial Summary:**\n\nThis is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137\r administered intravenously in participants with metastatic or unresectable advanced solid\r malignancies.\n\n**Clinical Trial Detailed Description:**\n\nThe primary objective of the study is to determine the maximally tolerated dose (MTD) and\r recommended Phase 2 dose (RP2D) of CBL0137. The secondary objectives are to describe the\r dose-limiting toxicity (DLT) and adverse event profile of CBL0137, to describe the\r pharmacokinetic profile of CBL0137, to document any objective responses to CBL0137. This is a\r study of CBL0137 with a standard \"3+3\" design. Escalation will proceed to the MTD based on\r DLT in the 1st cycle in 1 of 6 participants in a cohort.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histological or cytological evidence of a solid neoplasm\r\n\r - Patients enrolled in the expansion cohort must have at least one measureable lesion as\r defined by the RECIST 1.1 criteria for patients with systemic tumors or the RANO\r criteria for patients with gliomas;\r\n\r - Patients with a systemic tumor must:\r\n\r - have metastatic or unresectable advanced solid tumors that have recurred or\r progressed following standard therapy or\r\n\r - no longer be candidates for standard therapy or\r\n\r - have tumors for which there is no standard therapy\r\n\r - Patients with a glioma must:\r\n\r - have Grade III (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic\r oligoastrocytoma) disease, Grade IV (glioblastoma) disease, or diffuse intrinsic\r pontine glioma (DIPG) and;\r\n\r - have received prior therapy including radiation and drug therapy and;\r\n\r - have documented recurrent disease as defined in the RANO criteria;\r\n\r - Patients must be ambulatory and have an ECOG Performance Score of 0 or 1;\r\n\r - Patients or their legal representative must be able to provide written informed\r consent;\r\n\r - Patients must have adequate bone marrow reserve as evidenced by:\r\n\r - White Blood Cell Count (WBC) > 3,000/µL\r\n\r - Absolute Neutrophil Count (ANC) > 1,500/µL\r\n\r - Platelet count (PLT) > 75,000/µL\r\n\r - Hemoglobin (HGB) > 8.0 gm/dL (patients may be transfused to achieve this HGB\r level);\r\n\r - Patients must have adequate hepatic function as evidenced by:\r\n\r - Serum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X\r the ULN for patients with known hepatic metastases)\r\n\r - Serum bilirubin < 1.5 x the ULN for the reference lab;\r\n\r Exclusion Criteria:\r\n\r - Patients with active infection or with a fever > 38.50 C within 3 days of the first\r scheduled day of dosing;\r\n\r - Patients with symptomatic CNS metastases who have not undergone surgery and/or\r radiotherapy and/or who are not neurologically stable;\r\n\r - Patients with known hypersensitivity to any of the components of CBL0137;\r\n\r - Patients who are receiving concurrent anticancer therapy;\r\n\r - Patients receiving enzyme-inducing antiepileptic agents within 14 days prior to the\r start of study therapy;\r\n\r - Males with mean QTcF values of > 450 msec and females with QTcF values of > 470 msec\r following 3 ECGs conducted 5 minutes apart from each other; patients who are known to\r have congenital prolonged QT syndromes; or patients who are on medications known to\r cause prolonged QT intervals on ECG;\r\n\r Please speak with the PI for the complete Inclusion/Exclusion listing.\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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195
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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\nDetermining Optimal Post-Stroke Exercise (DOSE)\n\n**Clinical Trial Summary:**\n\nThe investigators will conduct a proof-of-concept study to provide preliminary evidence of\r efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute\r stroke rehabilitation.\n\n**Clinical Trial Detailed Description:**\n\nParticipants admitted for stroke rehabilitation will be randomly assigned to either the\r Stroke Management Group, Stroke Monitoring Group or Stroke Supplementary Group. All three\r groups will receive usual care, in addition to the intervention. The Stroke Management Group\r will be provided with periodic information about their progress in the area of mobility using\r specialized activity monitors. The Stroke Monitoring Group will be progressed according to\r customized protocols using feedback from specialized activity monitors. The Stroke\r Supplementary Group will receive the same as the Stroke Monitoring Group, but will also\r receive one additional hour of daily (5 times per week) physical exercise\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Have been admitted to a hospital unit for stroke rehabilitation\r\n\r - Within 10 weeks post-stroke\r\n\r - 19 years or older\r\n\r - Are experiencing difficulty walking\r\n\r Exclusion Criteria:\r\n\r - Requires greater than one person assist for transfer or ambulation\r\n\r - Have uncontrolled medical condition or another serious medication condition in\r addition to stroke\r\n\r - Unable to understand or follow directions\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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196
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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\nPatient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to assess patient satisfaction, the efficacy and compliance of\r granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in\r malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant\r temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing\r compliance.\r\n\r All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY\r of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized\r to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will\r received the other medication. The granisetron transdermal delivery system (supplied as a 52\r cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours\r before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken\r once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out\r questionnaires regarding the effectiveness of the medication and their satisfaction, and\r which anti-emetic they prefer.\r\n\r Safety will be assessed throughout the six weeks of radiation by the clinical research nurse\r using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who\r receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be\r included in analyses of treatment preference. However, all other efficacy and safety analyses\r will include all subjects who received ondansetron or GTDS.\n\n**Clinical Trial Detailed Description:**\n\nThe primary objective of this study is to assess whether malignant glioma patients receiving\r radiation therapy and concomitant TMZ are more satisfied with ondansetron or granisetron\r patch for the prevention of nausea and vomiting. The secondary objectives are 1) to compare\r the efficacy and compliance of granisetron patch and ondansetron in the prevention of nausea\r and vomiting during the 6 weeks of RT and concomitant TMZ, and 2) to assess the safety of the\r granisetron patch in preventing radiation induced nausea and vomiting in primary glioma\r patients receiving RT and TMZ.\r\n\r All eligible subjects should receive a planned total dose of 54-60 GY of radiation and 75\r mg/m2 of temozolomide daily for a total of six weeks. Subjects will be randomized to receive\r one of two treatment sequences of antiemetic therapy for the prevention of nausea and\r vomiting associated with RT and concomitant TMZ. Sequence #1 involves administration of\r ondansetron for 3 weeks followed by the use of granisetron patch for 3 weeks; whereas\r sequence #2 involves the use of the granisetron patch for 3 weeks followed by 3 weeks of\r ondansetron. Toxicity will be assessed each week of radiation therapy based on the Common\r Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The subject will be asked to\r complete the modified MASCC Antiemesis Tool (MAT) questionnaire at baseline, and on days 2,\r 4, and 7 of each week of radiation therapy, as well as to record the use of all study\r medication and any antiemetic rescue medication taken daily. At the end of the weeks 3 & 6,\r the subject will be asked to fill out a Treatment Satisfaction Questionnaire for Medication\r and will be asked at the end of week 6 to choose which antiemetic they prefer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients must have histologically confirmed diagnosis of malignant glioma\r (Glioblastoma, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma)\r who may or may not be chemotherapy naïve and who are scheduled to receive radiotherapy\r (for a total of 60 GY) and concomitant daily temozolomide therapy (at a dose of 75\r mg/m2 for one complete six week cycle).\r\n\r 2. Age ≥ 18 years\r\n\r 3. Karnofsky ≥ 60%\r\n\r 4. Hematocrit > 29%, ANC >1,000 cells/mm3, platelets > 100,000 cells/ mm3\r\n\r 5. Serum creatinine < 1.4 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of\r normal\r\n\r 6. For patients on corticosteroids, they must have been on a stable dose for 1 week prior\r to entry, and the dose should not be escalated over entry dose level, if clinically\r possible\r\n\r 7. Ability and willingness to give informed consent\r\n\r 8. If sexually active, patients will take contraceptive measures for the duration of the\r treatments\r\n\r 9. Negative serum pregnancy test 48 hours prior to beginning study drug\r\n\r Exclusion Criteria:\r\n\r 1. Pregnancy or breastfeeding\r\n\r 2. Co-medication that may interfere with study results; e.g., immune-suppressive agents\r other than corticosteroids\r\n\r 3. Inability or unwillingness to cooperate with the study procedures\r\n\r 4. 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. Rescue medication for treatment of nausea and vomiting\r is permitted after radiation therapy at the discretion of the investigator\r\n\r 5. Previous participation in any clinical trial involving granisetron\r\n\r 6. Any vomiting, retching, or NCI Common Toxicity Criteria version 4.0 grade 2-4 nausea\r in the 24 hours preceding radiation and chemotherapy\r\n\r 7. Ongoing vomiting from any organic etiology\r\n\r 8. Radiotherapy of abdomen within one week prior to or during the study\r\n\r 9. Received granisetron within 14 days prior to study enrollment\r\n\r 10. Prior and concomitant cancer chemotherapy and radiotherapy\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"
}
] |
possibly relevant
|
197
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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\nBallistic Strength Training in Stroke: A Pilot Study\n\n**Clinical Trial Summary:**\n\nThis pilot study intends to evaluate whether stroke patients can complete ballistic strength\r exercises for thirty minutes, three times per week over a six week training period in\r addition to their existing rehabilitation program.\r\n\r It will evaluate whether using ballistic training principles, is superior in improving\r mobility compared with usual care exercises to improve mobility and leg strength in stroke\r patients.\r\n\r In this study there will be 15 participants per group, a total of 30 participants. The\r control group will receive usual care consistent with existing rehabilitation practice and\r literature. The experimental group will perform task specific strength training in a\r ballistic fashion.\n\n**Clinical Trial Detailed Description:**\n\nResearch Aims:\r\n\r 1. To establish the feasibility of ballistic strength training in stroke and\r\n\r 2. To evaluate the effects of ballistic strength training exercises on mobility outcomes,\r strength and quality of life when compared with usual care.\r\n\r Methods:\r\n\r This wil be a prospective, randomized, controlled, assessor-blinded pilot study. It will be\r conducted 3 x per week for 6 weeks (i.e. a total of 18 sessions lasting 30 minutes).\r\n\r Primary outcome measure: Feasibility\r\n\r - Recruitment\r\n\r - Retention/Attrition\r\n\r - Clinical Feasibility\r\n\r - Safety\r\n\r Secondary outcome measures - measured at baseline and completion\r\n\r - Ten metre walk test (10MWT) comfortable pace\r\n\r - 10MWT maximum safe pace\r\n\r - High level mobility assessment tool (HiMAT): Only in participants where 10MWT is <12.5s\r at baseline\r\n\r - Timed up and go test (TUG)\r\n\r - Functional Ambulation Category (FAC)\r\n\r - Health Related Quality of Life (HRQoL) via AQoL-4D\r\n\r Description of intervention:\r\n\r Control Group:\r\n\r The control group will complete a suite of exercises based upon existing rehabilitation\r practices that aim to improve mobility after stroke. The supervising physiotherapist will\r select and progress the exercises, recording the performance of exercises in an exercise log\r and detailing incidence of adverse events. Exercise selection will include: gait retraining,\r cardiovascular fitness, lower limb strengthening, static and dynamic balance\r\n\r Experimental group:\r\n\r The experimental group will complete jump squats on the leg sled, single leg toe push offs\r (or bilateral where unable to complete single), alternating legs (i.e. bounding), mini tramp\r jumping, progressing to jogging, quick hip flexion and bounding on land.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Inpatient at Caulfield Hospital Neurological Rehabilitation Unit at the time of\r recruitment\r\n\r - Diagnosis of first stroke\r\n\r - Presence of lower limb weakness determined by >10% difference in knee extensor\r strength between sides\r\n\r - Functional Ambulation Category (FAC) > 3\r\n\r - Can walk a minimal distance of 14 metres (to allow measurement on a 10metre walk test\r (10MWT)\r\n\r Participants who meet all the inclusion criteria except for their FAC score will have their\r FAC score re-measured on a weekly basis until they reach a score of greater than or equal\r to 3, at which point they become eligible and will be approached for recruitment.\r\n\r Exclusion Criteria:\r\n\r - Unable to provide informed consent (determined by consultation with rehabilitation\r consultant and the team neuropsychologist)\r\n\r - Other diagnosed central nervous system disorder affecting mobility\r\n\r - Active oncological diagnosis\r\n\r - Unstable medication condition such as unstable diabetes or unstable cardiac condition\r that would prevent participation in cardiovascular activity\r\n\r - Recent orthopaedic trauma and/or osteoarthritis that would limit participation in\r physical exercise\r\n\r - Not willing to continue to attend the program if they discharge home before the end of\r the six week program\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
198
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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\nGene Transfer Clinical Trial for LGMD2D (Alpha-sarcoglycan Deficiency) Using scAAVrh74.tMCK.hSGCA\n\n**Clinical Trial Summary:**\n\nDose escalation study of self-complementary (sc) AAVrh74.tMCK.hSGCA delivered to single leg\r (low dose n=2) and bilaterally (n=6) via a major lower limb artery to the whole lower limb of\r limb girdle muscular dystrophy type 2D (LGMD2D; alpha-sarcoglycan deficient) patients.\n\n**Clinical Trial Detailed Description:**\n\nThe proposed clinical trial is a dose escalation study of self-complementary\r scAAVrh74.tMCK.hSGCA to LGMD2D (alpha-sarcoglycan deficient) subjects delivered via a major\r lower limb artery of each leg sequentially by isolated limb perfusion (ILP). Three cohorts\r (Cohorts 1A, 1B, and 2) will undergo gene transfer in a dose escalation scheme to establish\r maximum tolerated dose (MTD) using toxicity. Two (n=2) adult wheelchair-dependent patients\r will be enrolled in Cohort 1A and three (n =3) ambulatory subjects will be enrolled in Cohort\r 1B. Three (n =3) ambulatory subjects will be enrolled in Cohort 2. The first cohort (1A) will\r receive a dose of 1E12 vg/kg in a single limb with delivery to the whole limb. This same dose\r will be delivered to both limbs in Cohort 1B. Cohort 2 will receive a total dose escalation\r of 3E12vg/kg per limb delivered to both extremities. The vector will be infused into an\r indwelling catheter in the femoral artery. This will be a one-time vector infusion to an\r isolated limb with a 10-minute dwell time. The total vector genome dose for each subject will\r be adjusted by rounding down to the closest 10 kg.\r\n\r Safety monitoring during infusion will include: activated clotting times, limb gases, real\r time monitoring of arterial and venous access pressures, and perfusate temperature. Safety\r endpoints will be assessed by changes in hematology, serum chemistry, urinalysis, immunologic\r response to rAAVrh74 and hSGCA, and reported history and observations of symptoms. Efficacy\r will be measured by the six minute walk test as well as direct muscle testing for strength\r (MVICT) of lower limb muscles. These quantitative measures will be done at baseline, day 30,\r 60, 90, 180, and at the end of 1st and 2nd years. Subjects will be evaluated at baseline,\r infusion visit (days 0-2), and return for follow up visits on days 7, 14, 30, 60, 90, and\r 180. On Day 180, subjects will undergo a muscle biopsy on the injected muscles in one leg to\r compare with the pre-treatment biopsy done at baseline screening in the opposite leg to\r establish the size of muscle fibers and any potential toxicity from gene transfer.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria\r\n\r - Subjects age 7 or older; cohort 1A must be adult and wheelchair-dependent\r\n\r - Proven alpha-sarcoglycan deficiency by muscle biopsy or DNA testing.\r\n\r - Onset of weakness by 5 years age based on history of difficulty running, jumping and\r climbing stairs.\r\n\r - Subject enrolled in Cohort 1A must be adult and wheelchair dependent\r\n\r - Subjects enrolled in Cohorts 1B or 2 must be able to walk independently, but must\r exhibit signs of lower extremity weakness (i.e. a Gowers' sign, use a handrail for\r climbing stairs) and walk ≤ 80% of predicted distance on the 6MWT based on normative\r data.\r\n\r - Males and females of any ethnic group will be eligible\r\n\r - Ability to cooperate with muscle testing.\r\n\r - Willingness of sexually active subjects with reproductive capacity to practice\r reliable method of contraception (If appropriate), during the first six months after\r gene therapy (females) or until two negative sperm samples are obtained post gene\r transfer (males).\r\n\r Exclusion Criteria\r\n\r - Active viral infection based on clinical observations.\r\n\r - The presence of SGCA mutations without weakness or loss of function\r\n\r - Symptoms or signs of cardiomyopathy, including:\r\n\r - Dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales\r at the base of the lungs\r\n\r - Echocardiogram with ejection fraction below 40%\r\n\r - Serological evidence of HIV infection, or Hepatitis A, B or C infection\r\n\r - Diagnosis of (or ongoing treatment for) an autoimmune disease\r\n\r - Abnormal laboratory values considered clinically significant (GGT > 3XULN, bilirubin ≥\r 3.0 mg/dL , creatinine ≥ 1.8 mg/dL, Hgb < 8 or > 18 g/Dl; WBC > 15,000 per cmm)\r\n\r - Concomitant illness or requirement for chronic drug treatment that in the opinion of\r the PI creates unnecessary risks for gene transfer\r\n\r - Pregnancy\r\n\r - Subjects with AAVrh74 or AAV8 binding antibody titers ≥ 1:50 as determined by ELISA\r immunoassay\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
|
199
|
[
{
"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\nFludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia\n\n**Clinical Trial Summary:**\n\nThe goal of this research is to test if the conditioning regimen, fludarabine and total body\r irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment\r regimen for ALL patients older than 40 years of age and/or younger patients with high risk\r medical conditions. The primary objective is to establish the efficacy of allo HCT in older\r ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also\r assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative\r FluTBI conditioning regimen.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Disease Criteria:\r\n\r - ALL in complete remission (CR) at the time of transplant. Remission is defined as\r \"less than 5.0% bone marrow lymphoblasts by morphology,\" as determined by a bone\r marrow aspirate obtained within 2 weeks of study registration.\r\n\r - Philadelphia chromosome positive ALL is allowed.\r\n\r - Lymphoid blastic crisis of CML will be included (provided that patients achieve\r CR).\r\n\r - Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must\r be comorbidities which preclude the patient to undergo CyTBI conditioning regimen.\r\n\r - Organ Function Criteria: All organ function testing should be done within 28 days of\r study registration.\r\n\r - Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated\r Acquisition) scan or echocardiogram.\r\n\r - Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity)\r ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for\r hemoglobin) ≥ 50% of predicted.\r\n\r - Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60\r mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:\r\n\r CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL).\r\n\r - Hepatic:\r\n\r - Serum bilirubin 2.0 g/dL\r\n\r - Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN\r\n\r - Alkaline phosphatase 2.5 ULN\r\n\r - Performance status: Karnofsky ≥ 70%\r\n\r - Consent: Patient must be informed of the investigational nature of this study in\r accordance with institutional and federal guidelines and have the ability to provide\r written informed consent prior to initiation of any study-related procedures, and\r ability,in the opinion of the principal investigator, to comply with all the\r requirements of the study.\r\n\r - Presence of a willing adult HLA-matched sibling (excluding identical twin) or\r HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors\r will be evaluated for eligibility and suitability per the standard of care according\r to the FACT and NMDP guidelines.\r\n\r Exclusion Criteria:\r\n\r - Non-compliant to medications.\r\n\r - No appropriate caregivers identified.\r\n\r - HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive\r\n\r - Active life-threatening cancer requiring treatment other than ALL\r\n\r - Uncontrolled medical or psychiatric disorders.\r\n\r - Uncontrolled infections, defined as positive blood cultures within 72 hours of study\r entry, or evidence of progressive infection by imaging studies such as chest CT scan\r within 14 days of registration.\r\n\r - Active central nervous system (CNS) leukemia\r\n\r - Preceding allogeneic HSCT\r\n\r - Receiving intensive chemotherapy within 21 days of registration. Maintenance type of\r chemotherapy will be allowed.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
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