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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\nRadiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining chemotherapy with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or\r without chemotherapy in treating patients who have anaplastic oligodendroglioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Compare the overall survival and time to tumor progression in patients with unifocal or\r multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma treated with\r radiotherapy with or without procarbazine, lomustine, and vincristine (PCV).\r\n\r - Compare the toxic effects of these 2 regimens in these patients.\r\n\r - Compare the quality of life and neurologic function of patients treated with these 2\r regimens.\r\n\r OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and\r over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs\r highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of\r 2 treatment arms.\r\n\r - Arm I: Within 2 weeks after randomization, patients receive oral lomustine on day 1,\r oral procarbazine on days 8-21, and vincristine IV on days 8 and 29 (PCV). Treatment\r continues every 6 weeks for 4 courses in the absence of disease progression or\r unacceptable toxicity. Beginning within 6 weeks after day 29 of course 4, patients\r undergo radiotherapy 5 days a week for 5.6 weeks followed by boost radiotherapy 5 days a\r week for 1 week.\r\n\r - Arm II: Within 2 weeks after randomization, patients undergo radiotherapy as in arm I.\r\n\r Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3\r months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually\r thereafter after completion of study therapy.\r\n\r Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months\r for 3 years, and then annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study\r within 5.4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic\r oligodendroglioma\r\n\r - Prior suspected or proven low-grade glioma allowed if current histologic proof of\r pure or mixed anaplastic oligodendroglioma\r\n\r - Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2\r or more anaplastic features, 1 of which must be frequent mitoses or endothelial\r proliferation\r\n\r - For mixed tumors, the non-oligodendroglial element must be astrocytic and the\r oligodendroglial or astroglial component may be anaplastic\r\n\r - No evidence of spinal drop metastasis or spread to noncontiguous meninges\r\n\r - MRI of spine not required for asymptomatic patients and patients not excluded\r based on pathologic evidence of local meningeal infiltration by underlying tumor\r\n\r - No tumor that is predominantly located in the posterior fossa (i.e., brainstem or\r cerebellum)\r\n\r - No spinal cord tumors\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Absolute granulocyte count at least 1,500/mm^3\r\n\r - Platelet count at least 150,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2 times normal\r\n\r - Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal\r\n\r - Alkaline phosphatase no greater than 2 times normal\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 times normal\r\n\r Pulmonary:\r\n\r - No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO)\r is at least 60% predicted\r\n\r Other:\r\n\r - No active infection\r\n\r - No other malignancy within the past 5 years except nonmelanomatous skin cancer or\r carcinoma in situ of the cervix\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - No concurrent steroids as antiemetics\r\n\r - Concurrent steroids allowed to control central nervous system (CNS) symptoms due to\r tumor-associated or radiotherapy-associated cerebral edema\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy to brain or head/neck\r\n\r Surgery:\r\n\r - Prior surgery 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:** possibly relevant"
}
] |
possibly relevant
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1
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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\nRadiation Therapy in Treating Patients With Brain Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an\r effective treatment for patients with anaplastic astrocytomas.\r\n\r PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in\r treating patients with anaplastic astrocytomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Compare the disease-free interval and survival in patients with supratentorial\r malignant brain gliomas randomized to radiotherapy alone vs. radiotherapy plus\r radiosensitization with mitolactol (DBD) followed by DBD and carmustine.\r\n\r OUTLINE: Randomized study. Group I: Radiotherapy. External-beam cranial irradiation with\r megavoltage equipment. Group II: Radiotherapy with Radiosensitization followed by Maintenance\r Chemotherapy. Radiotherapy as in Group I; with Mitolactol, DBD, NSC-104800; followed by DBD;\r Carmustine, BCNU, NSC-409962.\r\n\r PROJECTED ACCRUAL: A total of 212 patients will be entered over more than 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum\r resection or stereotactic biopsy required within 4 weeks prior to therapy\r\n\r PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life\r expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than\r 100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine\r less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl\r Other: No major medical illness\r\n\r PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No\r steroids after 10 days following surgery (may be resumed occasionally during 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
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2
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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\nChemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining radiation therapy with chemotherapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and\r vincristine followed by radiation therapy in treating adults who have supratentorial glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Estimate the response rate of patients with newly diagnosed supratentorial\r low-grade glioma following neoadjuvant chemotherapy with PCV\r (procarbazine/lomustine/vincristine). II. Describe the toxicity of PCV. III. Determine the\r incidence of disease progression in these patients during PCV treatment.\r\n\r OUTLINE: The following acronyms are used: CCNU Lomustine, NSC-79037 PCB Procarbazine,\r NSC-77213 PCV PCB/CCNU/VCR VCR Vincristine, NSC-67574 3-Drug Combination Chemotherapy\r Followed by Radiotherapy. PCV; followed by external-beam cranial irradiation using at least 6\r MV photons.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed supratentorial * grade I/II glioma,\r including: Diffuse fibrillary astrocytoma No pilocytic astrocytoma No mixed tumor with\r ependymoma elements * Supratentorial sites include: Frontal, temporal, parietal, or\r occipital lobes Thalamus, basal ganglia, or midbrain Lateral or third ventricles Pons,\r medulla, or optic chiasm tumors allowed only if secondary to eligible tumor More than 1\r separate tumor allowed Diagnosis based on surgical biopsy or subtotal resection Measurable\r or evaluable disease on T2-weighted MRI required\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC\r greater than 3,500/mm3 Platelet count greater than 130,000/mm3 Hemoglobin greater than 9\r g/dL Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 2 times\r ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 times ULN\r Other: No active or uncontrolled infection No second malignancy within 3 years except:\r Nonmelanomatous skin cancer In situ cervical cancer No pregnant or nursing women Negative\r pregnancy test required within 7 days prior to entry Effective contraception required of\r fertile patients\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior\r chemotherapy Endocrine therapy: At least 1 week since prior steroids OR Stable steroid dose\r for at least 1 week prior to study Radiotherapy: No prior cranial or head and neck\r irradiation Surgery: See Disease Characteristics\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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3
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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\nCombination Chemotherapy for Patients With Brain Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using\r paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or\r anaplastic astrocytoma that is refractory or recurrent.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the response rate in patients with refractory or recurrent\r glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and topotecan\r (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine survival in\r these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor p53\r expression in relation to response to TAX/TOPO/G-CSF.\r\n\r OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2\r courses and until 2 courses beyond maximum response. Patients are followed every 3 months for\r 2 years, then every 6 months for relapse and survival.\r\n\r PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the\r first 20 patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Biopsy proven glioblastoma multiforme or anaplastic astrocytoma\r Central pathologic review at Dartmouth-Hitchcock Medical Center, including assay for tumor\r p53 expression No anaplastic oligodendroglioma No mixed oligodendroastrocytoma Recurrent or\r progressive disease following radiotherapy documented by CT or MRI within 2 weeks of entry\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100%\r Hematopoietic: WBC at least 3,000 ANC at least 1,500 Platelets at least 100,000 Hepatic:\r Bilirubin no greater than 1.0 mg/dL AST/ALT no greater than 2.5 times normal Renal:\r Creatinine no greater than 1.5 mg/dL Other: No documented sensitivity to E. coli-derived\r products No major medical or psychiatric illness that would interfere with therapy or\r compliance with scheduled follow-up No pregnant or nursing women Adequate contraception\r required of fertile patients\r\n\r PRIOR CONCURRENT THERAPY: No prior taxanes or topoisomerase I inhibitors At least 4 weeks\r since chemotherapy (6 weeks since nitrosoureas) At least 4 weeks since 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:** definitely relevant"
}
] |
definitely relevant
|
4
|
[
{
"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\nMonoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver\r tumor-killing substances to them without harming normal cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating\r patients who have leptomeningeal metastases.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8\r (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.\r\n\r - Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.\r\n\r - Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in\r these patients.\r\n\r OUTLINE: This is a dose escalation study.\r\n\r Patients receive a single injection of intraventricular or intrathecal iodine I 131\r monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4\r toxicity 6 weeks after the first dose may receive a second injection.\r\n\r Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse\r toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients\r are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade\r 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).\r\n\r Patients are followed weekly for 4 weeks.\r\n\r PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed malignancy expressing GD2, including, but not limited to:\r\n\r - Medulloblastoma/primitive neuroectodermal tumor of the CNS\r\n\r - Malignant glioma\r\n\r - Neuroblastoma\r\n\r - Retinoblastoma\r\n\r - Ependymoma\r\n\r - Sarcoma\r\n\r - Melanoma\r\n\r - Small cell lung carcinoma\r\n\r - Other tumor types must have GD2 expression confirmed by immunohistochemical\r staining\r\n\r - Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional\r therapy or for which no conventional therapy exists\r\n\r - Prior measurable human anti-mouse monoclonal antibody titer allowed\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 3 and over\r\n\r Performance status:\r\n\r - Not specified\r\n\r Life expectancy:\r\n\r - At least 2 months\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count greater than 1,000/mm^3\r\n\r - Platelet count greater than 50,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin less than 3 mg/dL\r\n\r Renal:\r\n\r - Creatinine less than 2 mg/dL\r\n\r - Blood urea nitrogen less than 30 mg/dL\r\n\r Other:\r\n\r - May have active malignancy outside the central nervous system\r\n\r - No obstructive hydrocephalus\r\n\r - No CNS grade 3 or 4 toxicity as a consequence of prior treatments\r\n\r - No life threatening infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Prior monoclonal antibody treatment allowed\r\n\r Chemotherapy:\r\n\r - Prior chemotherapy allowed\r\n\r - Must have recovered from all hematopoietic and neurologic side effects of prior\r chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - Prior radiotherapy allowed\r\n\r - At least 6 weeks since prior cranial or spinal irradiation\r\n\r Surgery:\r\n\r - Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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5
|
[
{
"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 Carmustine in Treating Patients With Anaplastic Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating\r patients with anaplastic glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Evaluate the activity, measured in terms of progression free survival, of\r carmustine plus temozolomide in recurrent glioblastoma. II. Estimate the response rate of\r recurrent glioblastomas to this combination. III. Estimate the response rate of newly\r diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination. IV.\r Evaluate the qualitative and quantitative toxicities of this combination in patients with\r anaplastic gliomas.\r\n\r OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent\r glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma). Patients receive\r carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is\r administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with\r recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or\r unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may\r continue further at the investigator's discretion. Patients with anaplastic astrocytoma or\r mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed\r periodically at the investigator's discretion, at least twice in the first 4 months, and then\r until death.\r\n\r PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in\r the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic\r astrocytoma and mixed anaplastic glioma stratum.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed malignant glioma - Recurrent glioblastoma\r - Anaplastic astrocytoma - Mixed anaplastic glioma For recurrent glioblastoma: Required\r documented progression must include an increase in tumor size of at least 25% or appearance\r of new lesion For anaplastic astrocytoma or mixed anaplastic glioma: Must have measurable,\r contrast enhancing disease on postoperative CT or MRI scan No postoperative radiation or\r chemotherapy If patients have received prior brachytherapy or stereotactic radiosurgery,\r they must have confirmation of true progressive disease rather than radiation necrosis by\r PET scanning or biopsy\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count\r at least 1,800/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 9 g/dL\r (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times upper\r limit of normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than\r 70 mL/min Cardiovascular: No uncontrolled arrhythmias or conduction defects No unstable or\r newly diagnosed angina pectoris No New York Heart Association class II-IV heart disease No\r congestive heart failure No major problems with edema (e.g., severe Cushing's syndrome,\r residual leg swelling from deep-vein thrombosis) No recent coronary artery disease No\r poorly controlled hypertension (diastolic greater than 110 mmHg and systolic greater than\r 180 mmHg) Pulmonary: DLCO greater than 80% of expected value Other: HIV negative No major\r psychiatric illness No other prior malignancy except adequately treated basal cell or\r squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer\r from which the patient is currently in complete remission, or any other cancer from which\r the patient has been free of disease for 5 years Not pregnant or nursing Adequate\r contraception required of all fertile patients\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No\r prior nitrosourea or temozolomide No more than 1 prior chemotherapy regimen allowed for\r patients with glioblastoma At least 6 weeks since mitomycin or procarbazine and recovered\r At least 4 weeks since other prior chemotherapy and recovered No other concurrent\r chemotherapy Endocrine therapy: If receiving steroids, must be on a stable steroid dose for\r at least 72 hours prior to study No other concurrent endocrine therapy Radiotherapy: At\r least 6 weeks since radiotherapy No greater than 10-20% of marrow irradiated in prior\r radiotherapy No other concurrent radiotherapy Surgery: Surgery 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:** possibly relevant"
}
] |
possibly relevant
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6
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nTopotecan in Treating Patients With Recurrent Brain Tumors\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with\r recurrent brain tumor.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy of topotecan in patients with recurrent anaplastic\r oligodendroglioma or anaplastic mixed oligoastrocytoma. II. Determine the qualitative and\r quantitative toxicity of topotecan in this patient population on this schedule.\r\n\r OUTLINE: This is a multicenter study. Patients receive intravenous topotecan over 30 minutes\r daily for 5 days every 3 weeks. Treatment continues in the absence of disease progression or\r unacceptable toxicity. Patients will be followed every 3 months until death.\r\n\r PROJECTED ACCRUAL: Up to 30 evaluable patients will be accrued within 2-3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven recurrent anaplastic oligodendroglioma or\r anaplastic mixed oligoastrocytoma following primary surgery and radiation therapy Tumors\r for anaplastic mixed oligoastrocytoma must contain at least 25% oligodendroglial elements\r Tumors must be clinically aggressive for patients with only 1 anaplastic feature Prior low\r grade oligodendrogliomas or oligoastrocytomas undergoing repeat biopsy following clinical\r or radiological progression are eligible Bidimensionally measurable and progressive lesions\r by CT or MRI\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not\r specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at\r least 100,000/mm3 Hepatic: Not specified Renal: Creatinine normal Other: Not pregnant or\r nursing Fertile patients must use effective contraception No prior malignancies except\r curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer No other\r serious illness or medical condition No active uncontrolled infection No history of\r neurologic or psychiatric disorder\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks\r since chemotherapy No more than 1 prior chemotherapy regimen No prior camptothecin\r derivatives Endocrine therapy: At least 2 weeks on stable steroid therapy, if necessary\r Radiotherapy: At least 2 months since prior radiotherapy No prior radiation therapy for\r recurrent disease Surgery: At least 6 weeks since prior surgery (except biopsy only) Prior\r surgery for recurrent disease allowed (including stereotactic biopsy or partial resection)\r Other: No concurrent experimental drugs or anticancer 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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7
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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\nObservation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in\r chemotherapy use different ways to stop tumor cells from dividing so they stop growing or\r die. It is not yet known whether radiation therapy combined with chemotherapy is more\r effective than radiation therapy alone in treating patients with low-grade glioma.\r\n\r PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of\r radiation therapy with or without combination chemotherapy in treating patients with\r low-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Identify the overall survival of low-risk adult patients with supratentorial low-grade\r glioma who are observed postoperatively.\r\n\r - Compare the overall survival of high-risk adult patients with supratentorial low-grade\r glioma who receive postoperative external beam radiotherapy with or without\r procarbazine, lomustine, and vincristine (PCV) chemotherapy.\r\n\r - Compare the toxic effects of postoperative radiotherapy with or without PCV chemotherapy\r in patients with unfavorable low-grade glioma.\r\n\r OUTLINE: This is a randomized study. Patients are stratified according to tumor subtype\r (astrocytoma [mixed-astro dominant or equal astro/oligo mix] vs oligodendroglioma\r [mixed-oligo dominant]), age (younger than 40 vs at least 40), Karnofsky performance status\r (60-80% vs 90-100%), and contrast enhancement on preoperative scan (present vs absent).\r Patients with low-risk disease (younger than 40 years old whose tumors have been surgically\r removed) are assigned to arm I. Patients with high-risk disease (at least 40 years old or who\r have had incomplete tumor removal) are randomized to arm II or III.\r\n\r - Arm I (low-risk patients): Patients are observed. Patients may receive treatment if\r tumor recurs.\r\n\r - Arm II (high-risk patients): Patients receive daily external beam radiotherapy 5 days a\r week for 6 weeks.\r\n\r - Arm III (high-risk patients): Patients receive radiotherapy as in arm II followed by\r chemotherapy 1 month later. Chemotherapy consists of oral lomustine on day 1,\r vincristine IV on days 8 and 29, and oral procarbazine on days 8-21. Each course of\r chemotherapy lasts 8 weeks. Patients may receive up to 6 courses of chemotherapy.\r\n\r Patients are followed every 4 months for 1 year, every 6 months for 2 years, and then\r annually thereafter.\r\n\r PROJECTED ACCRUAL: Approximately 252 patients will be accrued within 5.25 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed unifocal or multifocal supratentorial WHO grade II\r astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic), oligodendroglioma, or\r oligoastrocytoma\r\n\r - Patients with neurofibromatosis are eligible\r\n\r - No other low-grade histologies, including:\r\n\r - Pilocytic astrocytoma\r\n\r - Subependymal giant cell astrocytoma of tuberous sclerosis\r\n\r - Subependymoma\r\n\r - Pleomorphic xanthoastrocytoma\r\n\r - Presence of a neuronal element such as ganglioglioma\r\n\r - Dysneuroembryoplastic epithelial tumor\r\n\r - No presence of any high-grade glioma, including:\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - No tumors in nonsupratentorial or other locations including optic chiasm, optic\r nerve(s), pons, medulla, cerebellum, or spinal cord\r\n\r - No evidence of spread to spinal meninges or noncontiguous cranial meninges (i.e.,\r leptomeningeal gliomatosis)\r\n\r - No gliomatosis cerebri\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Hematopoietic:\r\n\r - For high-risk patients:\r\n\r - Granulocyte count at least 1,500/mm^3\r\n\r - Platelet count normal\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2 times normal\r\n\r - SGOT or SGPT no greater than 4 times normal\r\n\r - Alkaline phosphatase no greater than 2 times normal\r\n\r Renal:\r\n\r - Creatinine no greater than 2 times normal\r\n\r Pulmonary:\r\n\r - No chronic lung disease (unless DLCO at least 60%)\r\n\r Neurological:\r\n\r - Neurologic function score no greater than 3\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\r\n\r - No other malignancy within the past 5 years except carcinoma in situ of the cervix or\r nonmelanoma skin cancer\r\n\r - No active infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy to the head or neck (unless brain is clearly excluded, such as\r radiotherapy for localized vocal cord cancer)\r\n\r Surgery:\r\n\r - Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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8
|
[
{
"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 in Treating Patients With Anaplastic Oligodendroglioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with\r anaplastic oligodendroglioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the activity of temozolomide in patients with newly diagnosed,\r progressive, or recurrent anaplastic oligodendroglioma. II. Determine the toxicity of this\r drug in this patient population.\r\n\r OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed\r anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive\r oral temozolomide once daily on days 1-5. Treatment repeats every 28 days. Patients with\r progressive or recurrent disease (at baseline) continue treatment in the absence of disease\r progression or unacceptable toxicity. Patients with newly diagnosed disease continue\r treatment for a maximum of 4 courses before radiotherapy in the absence of disease\r progression or unacceptable toxicity. Patients with responding disease may receive an\r additional 6 courses after completion of radiotherapy. (Radiotherapy is not part of study\r treatment.) Patients are followed every 8 weeks for 2 years.\r\n\r PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic\r oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiotherapy Newly\r diagnosed, progressive, or recurrent disease Bidimensionally measurable disease At least\r 1.5 cm2 by MRI\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life\r expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet\r count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5\r times upper limit of normal (ULN) SGOT/SGPT less than 2.5 times ULN Alkaline phosphatase\r less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN\r Other: Neurologically stable No nonmalignant systemic disease No acute infection treated\r with intravenous antibiotics No frequent vomiting No medical condition (e.g., partial bowel\r obstruction) that would interfere with oral medication intake No other prior or concurrent\r malignancy except surgically cured carcinoma in situ of the cervix or basal cell or\r squamous cell carcinoma of the skin No AIDS-related illness HIV negative Not pregnant or\r nursing Negative pregnancy test Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy No\r concurrent biologic therapy No concurrent growth factors (e.g., epoetin alfa) Chemotherapy:\r No more than 1 prior chemotherapy regimen No other concurrent chemotherapy Endocrine\r therapy: Must be on stable dose of steroids for at least 1 week prior to study Concurrent\r steroids allowed Radiotherapy: See Disease Characteristics No concurrent radiotherapy\r Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be\r enrolled within 28 days of surgery or biopsy) Recovered from prior major surgery Other: No\r other concurrent investigational 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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9
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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 in Treating Patients With Progressive Low-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: This phase II trial is studying how well temozolomide works in treating patients\r with progressive low-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Assess the response rate in patients with progressive low-grade gliomas treated with\r temozolomide.\r\n\r - Determine the activity of this drug, in terms of stabilizing growth of progressive\r low-grade gliomas, in adult patients.\r\n\r OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma,\r well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine\r glioma).\r\n\r Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In\r the absence of disease progression or unacceptable toxicity, patients may continue with\r treatment until tumor has remained stable for 12 courses.\r\n\r Patients are followed every 8-12 weeks for 2 years.\r\n\r PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this\r study within 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade\r glioma including:\r\n\r - Astrocytoma\r\n\r - Oligodendroglioma\r\n\r - Mixed glioma\r\n\r - Optic pathway glioma*\r\n\r - Pontine glioma* NOTE: *Biopsy not required\r\n\r - Patients with optic pathway glioma must also meet the following criteria:\r\n\r - Progressive loss of vision as defined by doubling of octaves\r\n\r - Visual acuity loss not explained by other causes\r\n\r - Increase in proptosis of greater than 3 mm\r\n\r - Increase in diameter of optic nerve of at least 2 mm on neuroimaging\r\n\r - Increase in distribution of tumor involving optic tracts or optic radiations as\r indicated by CT scan or MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 4 and over\r\n\r Performance status:\r\n\r - Karnofsky 70-100%\r\n\r Life expectancy:\r\n\r - More than 12 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGOT and SGPT less than 2.5 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - Creatinine less than 1.5 times ULN\r\n\r - BUN less than 1.5 times ULN\r\n\r Other:\r\n\r - Must be neurologically stable\r\n\r - No systemic disease\r\n\r - No acute infection requiring IV antibiotics\r\n\r - No frequent vomiting\r\n\r - No other medical condition that would interfere with oral medication (e.g., partial\r bowel obstruction)\r\n\r - No other prior or concurrent malignancies except:\r\n\r - Surgically cured carcinoma in situ of the cervix\r\n\r - Basal or squamous cell skin cancer\r\n\r - HIV negative\r\n\r - No AIDS-related illness\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No concurrent biologic therapy (growth factors or epoetin alfa)\r\n\r Chemotherapy:\r\n\r - At least 6 weeks since prior chemotherapy unless evidence of disease progression\r\n\r - No other concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - At least 6 weeks since prior radiotherapy unless evidence of disease progression\r\n\r - No concurrent radiotherapy\r\n\r Surgery:\r\n\r - At least 3 weeks since prior surgery unless evidence of disease progression\r\n\r - Recovered from all prior surgery\r\n\r Other:\r\n\r - No other concurrent investigational 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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10
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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\nAntineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Current therapies for adults with anaplastic astrocytomas that have not responded\r to standard therapy provide very limited benefit to the patient. The anti-cancer properties\r of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults\r with anaplastic astrocytomas that have not responded to standard therapy.\r\n\r PURPOSE: This study is being performed to determine the effects (good and bad) that\r Antineoplaston therapy has on adults with anaplastic astrocytomas that have not responded to\r standard therapy.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - To determine the efficacy of Antineoplaston therapy in patients with anaplastic\r astrocytomas that have not responded to standard therapy, as measured by an objective\r response to therapy (complete response, partial response or stable disease).\r\n\r - To determine the safety and tolerance of Antineoplaston therapy in patients with a\r anaplastic astrocytoma\r\n\r OVERVIEW: This is a single arm, open-label study in which adults withanaplastic astrocytomas\r that have not responded to standard therapy receive gradually escalating doses of intravenous\r Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.\r Treatment continues for at least 12 months in the absence of disease progression or\r unacceptable toxicity. After 12 months, patients with a complete or partial response or with\r stable disease may continue treatment.\r\n\r To determine objective response, tumor size is measured utilizing MRI scans, which are\r performed every 8 weeks for the first two years, every 3 months for the third and fourth\r years, every 6 months for the 5th and sixth years, and annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed incurable adult anaplastic astrocytoma\r\n\r - Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior\r to study entry\r\n\r - Must have received and failed standard therapy\r\n\r - Tumor must be at least 5 mm\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - At least 2 months\r\n\r Hematopoietic:\r\n\r - WBC at least 2000/mm^3\r\n\r - Platelet count at least 50,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT and SGPT no greater than 5 times upper limit of normal\r\n\r - No hepatic failure\r\n\r Renal:\r\n\r - Creatinine no greater than 2.5 mg/dL\r\n\r - No history of renal conditions that contraindicate high dosages of sodium\r\n\r Cardiovascular:\r\n\r - No uncontrolled hypertension\r\n\r - No history of congestive heart failure\r\n\r - No history of other cardiovascular conditions that contraindicate high dosages of\r sodium\r\n\r Pulmonary:\r\n\r - No serious lung disease such as severe chronic obstructive pulmonary disease\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 4 weeks after study\r\n\r - No active infection\r\n\r - No other serious concurrent disease\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - At least 4 weeks since prior immunotherapy and recovered\r\n\r - No concurrent immunomodulating agents\r\n\r Chemotherapy:\r\n\r - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\r\n\r - No concurrent antineoplastic agents\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - At least 8 weeks since prior radiotherapy and recovered\r\n\r Surgery:\r\n\r - Fully recovered from any prior surgery\r\n\r Other:\r\n\r - Prior cytodifferentiating agent allowed\r\n\r - No prior antineoplaston 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
11
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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\nAntineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Current therapies for adult recurrent/progressive low grade astrocytoma provide\r limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest\r that it may prove beneficial in the treatment of adult recurrent/progressive low grade\r astrocytoma.\r\n\r PURPOSE: This study is being performed to determine the effects (good and bad) that\r Antineoplaston therapy has on adults with a recurrent/progressive low grade astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOVERVIEW: This is a single arm, open-label study in which adults with a recurrent/progressive\r low grade astrocytoma receive gradually escalating doses of intravenous Antineoplaston\r therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment\r continues for at least 12 months in the absence of disease progression or unacceptable\r toxicity.\r\n\r OBJECTIVES:\r\n\r - To determine the efficacy of Antineoplaston therapy in adults with a\r recurrent/progressive low grade astrocytoma, as measured by an objective response to\r therapy (complete response, partial response or stable disease).\r\n\r - To determine the safety and tolerance of Antineoplaston therapy in adults with a\r recurrent/progressive low grade astrocytoma.\r\n\r - To determine objective response, tumor size is measured utilizing MRI scans, which are\r performed every 8 weeks for the first two years, every 3 months for the third and fourth\r years, every 6 months for the 5th and sixth years, and annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed low-grade astrocytoma that has progressed,\r recurred, or persisted after initial therapy, including radiotherapy\r\n\r - Previously treated with at least 1 prior standard therapy (e.g., radiotherapy,\r chemotherapy, immunotherapy, or cytodifferentiating agent)\r\n\r - Measurable tumor by MRI scan performed within two weeks prior to study entry\r\n\r - Tumor must be at least 5 mm\r\n\r - No brain stem tumors\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 2 months\r\n\r Hematopoietic:\r\n\r - WBC at least 2,000/mm^3\r\n\r - Platelet count at least 50,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT and SGPT no greater than 5 times upper limit of normal\r\n\r - No hepatic failure\r\n\r Renal:\r\n\r - Creatinine no greater than 2.5 mg/dL\r\n\r - No renal insufficiency\r\n\r - No history of renal conditions that contraindicate high dosages of sodium\r\n\r Cardiovascular:\r\n\r - No uncontrolled hypertension\r\n\r - No chronic heart failure\r\n\r - No history of congestive heart failure\r\n\r - No history of other cardiovascular conditions that contraindicate high dosages of\r sodium\r\n\r Pulmonary:\r\n\r - No severe lung disease (e.g., chronic obstructive pulmonary disease)\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 4 weeks after study\r participation\r\n\r - No other concurrent serious disease\r\n\r - No active infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - See Disease Characteristics\r\n\r - At least 4 weeks since prior immunotherapy and recovered\r\n\r - No concurrent immunomodulating agents\r\n\r Chemotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered\r\n\r - No concurrent antineoplastic agents\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 8 weeks since prior radiotherapy and recovered\r\n\r Surgery:\r\n\r - Must recover from prior surgery\r\n\r Other:\r\n\r - No prior antineoplastons\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
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12
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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\nAntineoplaston Therapy in Treating Adult Patients With Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit\r to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may\r prove beneficial in the treatment of adults with anaplastic astrocytoma.\r\n\r PURPOSE: This study is being performed to determine the effects (good and bad) that\r Antineoplaston therapy has on adults with anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - To determine the efficacy of Antineoplaston therapy in adults with anaplastic\r astrocytoma as measured by an objective response to therapy (complete response, partial\r response) or stable disease.\r\n\r - To determine the safety and tolerance of Antineoplaston therapy in adults with\r anaplastic astrocytoma.\r\n\r OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma\r receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal +\r Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12\r months in the absence of disease progression or unacceptable toxicity. After 12 months,\r patients with a complete or partial response or with stable disease may continue treatment.\r\n\r To determine objective response, tumor size is measured utilizing MRI scans, which are\r performed every 8 weeks for the first two years, every 3 months for the third and fourth\r years, every 6 months for the 5th and sixth years, and annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed diagnosis of anaplastic astrocytoma\r\n\r - Tumor subtotally resected or biopsied prior to therapy\r\n\r - Evidence of residual tumor by MRI scan performed within two weeks prior to study entry\r\n\r - No brain stem tumors\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 2 months\r\n\r Hematopoietic:\r\n\r - WBC at least 1,500/mm^3\r\n\r - Platelet count at least 50,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT and SGPT no greater than 5 times upper limit of normal\r\n\r - No hepatic failure\r\n\r Renal:\r\n\r - Creatinine no greater than 2.5 mg/dL\r\n\r - No renal failure\r\n\r Cardiovascular:\r\n\r - No prior congestive heart failure\r\n\r - No coronary artery disease\r\n\r - No myocardial infarction within the past year\r\n\r - No angina requiring medication\r\n\r - No uncontrolled hypertension\r\n\r Pulmonary:\r\n\r - No moderate to severe chronic obstructive pulmonary disease\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 4 weeks after study\r participation\r\n\r - No active infection\r\n\r - No other concurrent serious disease\r\n\r - No other prior malignancy except carcinoma in situ of the cervix or superficial\r nonmelanoma skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior immunotherapy\r\n\r - No concurrent immunomodulating agents\r\n\r Chemotherapy:\r\n\r - No prior myelosuppressive chemotherapy\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids for cerebral edema allowed\r\n\r Radiotherapy:\r\n\r - No prior myelosuppressive radiotherapy\r\n\r - No concurrent radiotherapy\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r - Recovered from any prior surgery\r\n\r Other:\r\n\r - No prior cytodifferentiating agents\r\n\r - No prior antineoplaston therapy\r\n\r - No other concurrent antineoplastic agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
|
13
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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\nProcarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells. It is not\r yet known whether giving procarbazine alone or with isotretinoin is more effective for\r recurrent primary malignant glioma.\r\n\r PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or\r with isotretinoin in treating patients with recurrent primary malignant gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine whether the combination of isotretinoin and procarbazine can improve\r time to progression and survival compared to procarbazine alone in patients with recurrent\r malignant gliomas. II. Document the toxicity of these two regimens in these patients.\r\n\r OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive\r procarbazine alone or in combination with isotretinoin. Arm I: Patients receive oral\r procarbazine once daily on days 1-14 every 28 days. Oral isotretinoin is administered every\r 12 hours on days 15-28 every 28 days. Patient receive 6 courses of combined therapy, then\r continue with oral isotretinoin alone on days 15-28 of each 28 day course, until disease\r progression or unacceptable toxicity. Arm II: Patients receive procarbazine by mouth once\r daily on days 1-14 followed by 2 weeks of rest. Patients receive a total of 6 courses of\r treatment in the absence of disease progression and unacceptable toxicity. Patients are\r followed until death.\r\n\r PROJECTED ACCRUAL: This study will accrue a total of 194 patients (97 per treatment group).\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven primary malignant gliomas including the\r following: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic\r oligodendroglioma Anaplastic infiltrating glioma Mixed malignant gliomas Must show evidence\r of tumor recurrence or progression on at least 2 serial enhanced MRI scans Must have\r measurably enhancing residual disease on MRI or CT scan of brain\r\n\r PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life\r expectancy: Greater than 8 weeks Hematopoietic: Absolute granulocyte count at least\r 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times institutional\r normal Alkaline phosphatase less than 2 times institutional normal Bilirubin less than 1.5\r mg/dL Renal: BUN less than 1.5 times institutional normal OR Creatinine less than 1.5 times\r institutional normal Other: No active infection Not pregnant or nursing Fertile patients\r must use effective contraception 1 month before, during, and 1 month after study No other\r disease that will obscure toxicity or alter drug metabolism No other concurrent medical\r illness\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior\r procarbazine No prior isotretinoin At least 4 weeks since prior chemotherapy (6 weeks for\r nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Prior\r radiotherapy allowed Surgery: Not specified Other: No concurrent tetracyclines\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
|
14
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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\nCombination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining more than one drug with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation\r therapy in treating patients who have newly diagnosed anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to\r and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic effects\r associated with this regimen in these patients. III. Evaluate this regimen in terms of\r fatigue, depression, excessive daytime somnolence, and quality of life in these patients.\r\n\r OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21\r and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8\r weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of\r chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4\r years, and then annually for 5 years. Patients are followed every 3 months for 5 years and\r then annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, anaplastic astrocytoma\r No oligodendrogliomas or oligoastrocytomas\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not\r specified Hematopoietic: WBC at least 3500/mm3 Platelet count at least 130,000/mm3 Hepatic:\r Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2\r times ULN Renal: Creatinine no greater than 0.5 mg/dL Other: Not pregnant or nursing\r Fertile patients must use effective contraception No uncontrolled infection No concurrent\r malignant disease or major medical problem except superficial skin cancers\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years\r since prior chemotherapy Endocrine therapy: Concurrent corticosteroids allowed\r Radiotherapy: At least 5 years since prior radiotherapy Surgery: Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
|
15
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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\nLeflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of leflunomide in treating patients who\r have anaplastic astrocytoma in first relapse.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the median time to progression, median survival, and objective\r response of patients with anaplastic astrocytoma or anaplastic oligoastrocytoma in first\r relapse treated with intravenous leflunomide (SU101). II. Assess the safety of SU101 in these\r patients. III. Describe the health-related quality of life of patients treated with\r intravenous SU101.\r\n\r OUTLINE: This is an open label, multicenter study. Patients receive leflunomide (SU101) IV\r over 6 hours on days 1-4. Patients then receive SU101 IV over 6 hours weekly for 6 weeks\r (beginning between days 8-12). Patients exhibiting complete response, partial response, or\r stable disease may continue on treatment for up to a year or until disease progression or\r unacceptable toxicity occurs. Patients continuing therapy receive SU101 IV over 6 hours every\r week for 7 weeks, followed by 1 week of rest. Quality of life is assessed every 8 weeks and\r at the end of the study. Patients are followed every 8 weeks or until tumor progression.\r\n\r PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma or anaplastic\r oligoastrocytoma in first relapse Recurrence or progression at least 6 months from initial\r diagnosis Must have received maximally feasible surgical resection and fractionated\r external beam radiotherapy Must have received no more than 1 prior systemic cytotoxic\r chemotherapy regimen for initial disease Bidimensionally measurable disease by MRI scan\r (stable dose of corticosteroids for at least 7 days prior to scan)\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3\r Platelet count at least 75,000/mm3 Hemoglobin at least 9 g/dL Hepatic: AST no greater than\r 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine no\r greater than 2 mg/dL OR Creatinine clearance at least 40 mL/min Other: Not pregnant or\r nursing Negative pregnancy test Fertile patients must use effective contraception during\r and for 3 months after the study No known allergy to etoposide No other acute or chronic\r medical illness or psychiatric disorder\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior epoetin alfa,\r filgrastim (G-CSF), or sargramostim (GM-CSF) and recovered No concurrent immunotherapy\r Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (2\r weeks since vincristine; 6 weeks since nitrosoureas or mitomycin) and recovered No prior\r leflunomide (SU101) therapy No other concurrent chemotherapy Endocrine therapy: No\r concurrent hormonal therapy (except medroxyprogesterone acetate for appetite stimulation)\r Radiotherapy: See Disease Characteristics No more than 1 prior course of radiotherapy At\r least 8 weeks since prior radiotherapy and recovered No prior interstitial radiotherapy or\r implanted carmustine wafers Prior radiosensitizer(s) concurrent with radiotherapy or used\r as neoadjuvant therapy allowed No concurrent radiotherapy Surgery: See Disease\r Characteristics No more than 2 prior surgical resections At least 1 week since prior\r surgery or biopsy for anaplastic astrocytoma No concurrent surgery (including resection,\r stereotactic surgery, or interstitial implants) Other: At least 4 weeks since prior\r investigational agents No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nIL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without\r harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma.\r\n\r PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in\r treating patients who have recurrent malignant astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the maximum tolerated dose of intratumorally infused\r IL-4(38-37)-PE38KDEL immunotoxin in patients with recurrent malignant astrocytoma. II.\r Determine the safety of this regimen in these patients. III. Determine preliminarily any\r efficacy of this regimen in these patients.\r\n\r OUTLINE: This is a dose escalation, multicenter study. Patients undergo a stereotactic biopsy\r under MR/CT guidance. Catheters are then placed into the tumor under stereotactic guidance.\r The catheter is filled with IL-4(38-37)-PE38KDEL immunotoxin (IL-4 toxin), with infusion\r beginning 24 hours after catheter insertion. The IL-4 toxin is infused over 4 days. The\r catheter is removed 45 minutes after the infusion is completed and a MR scan is performed.\r Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated\r dose (MTD) is reached. The MTD is defined as the dose preceding the dose at which 2 of 3\r patients experience dose limiting toxicity. Patients are followed every 4 weeks for 16 weeks,\r then every 8 weeks for up to 3 years.\r\n\r PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven recurrent glioblastoma or anaplastic\r astrocytoma Stereotactically accessible, enhancing mass no greater than 50 mL total volume\r by MRI No significant mass effect Recent craniotomy allowed No anaplastic oligodendroglioma\r No tumors of the brainstem, cerebellum, or both hemispheres No diffuse subependymal or CSF\r disease If on stable or increasing dose of steroid, must have evidence of increasing\r contrast enhancement by MRI or CT scan Prior external beam radiotherapy required\r\n\r PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3\r Platelet count greater than 100,000/mm3 Hemoglobin greater than 9.5 g/dL Hepatic: Bilirubin\r less than 2 mg/dL AST and ALT less than 2 times upper limit of normal (ULN) PT/PTT no\r greater than ULN Renal: Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy\r test Fertile patients must use effective contraception No systemic diseases to cause\r unacceptable anesthetic/operative risk No active infection requiring treatment No\r unexplained febrile illness\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent blood or platelet transfusions\r Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease\r Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior\r radiotherapy Surgery: See Disease Characteristics Medically able to undergo surgery Other:\r No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nRadiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver\r tumor-killing substances to them without harming normal cells. This may be an effective\r treatment for some types of brain tumors.\r\n\r PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in\r treating patients who have glioblastoma multiforme or anaplastic astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the median time to disease progression in patients with newly diagnosed\r unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic\r astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B.\r\n\r - Determine the median survival time of these patients treated with this regimen.\r\n\r - Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic,\r hematologic, and biochemical profiles in these patients.\r\n\r - Confirm the maximum tolerated dose of this regimen in these patients.\r\n\r - Optimize the drug delivery of this regimen in these patients.\r\n\r - Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor\r volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of\r study drug.\r\n\r OUTLINE: This is a multicenter study.\r\n\r Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed.\r One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over\r approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each\r will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the\r infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial\r response, minimal response, or stable disease repeat the above treatments during week 9.\r Patients with complete response, progressive disease, or unacceptable toxicity receive no\r additional treatment.\r\n\r Patients are followed every month until disease progression. All patients regardless of\r disease progression or retreatment are followed at 36 weeks.\r\n\r PROJECTED ACCRUAL: A total of 60 patients (20 patients with newly diagnosed unresectable\r glioblastoma multiforme [GBM]; 20 patients with recurrent GBM; and 20 patients with recurrent\r anaplastic astrocytoma) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM),\r recurrent GBM, or recurrent anaplastic astrocytoma (AA)\r\n\r - MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no\r greater than 60 cm^3\r\n\r - Recurrent GBM and AA must be documented by MRI after the most recent treatment\r and before any planned surgical debulking\r\n\r - At least 5 days since prior surgical debulking\r\n\r - No planned resection of newly diagnosed GBM before or during study\r\n\r - No bilateral noncontiguous gadolinium enhancing tumors\r\n\r - No satellite lesions greater than 1.5 cm from anticipated location of interstitial\r catheter tip\r\n\r - No more than 2 satellite lesions\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - WBC at least 3,000/mm^3\r\n\r Hepatic:\r\n\r - Hepatitis B surface antigen negative\r\n\r - Bilirubin no greater than 2.5 times upper limit of normal (ULN)\r\n\r - SGOT and SGPT no greater than 3 times ULN\r\n\r - Alkaline phosphatase no greater than 3 times ULN\r\n\r - Lactic dehydrogenase no greater than 3 times ULN\r\n\r - Prothrombin time no greater than 1.5 times ULN\r\n\r Renal:\r\n\r - Creatinine clearance at least 50 mL/min\r\n\r Cardiovascular:\r\n\r - No significant unstable cardiovascular disease\r\n\r - No New York Heart Association class III/IV heart disease\r\n\r - No evidence of myocardial infarction within the past 3 months\r\n\r Other:\r\n\r - Not pregnant\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - Human antichimeric antibody (HACA) titer no greater than 48 ng/mL\r\n\r - No anatomical or physiological considerations that would preclude study participation\r\n\r - No active autoimmune disease, active infection, or traumatic injury requiring\r treatment\r\n\r - HIV negative\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - At least 8 weeks since prior external beam or gamma knife radiotherapy\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r Other:\r\n\r - At least 30 days since prior investigational 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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18
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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\nIrinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining chemotherapy with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation\r therapy and temozolomide in treating children who have newly diagnosed brain tumor.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high grade\r gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of complete and\r partial response rate in patients with postoperative measurable disease, and in terms of\r the rate of freedom from recurrence in patients with no postoperative measurable\r disease.\r\n\r - Determine the 3 year overall and progression free survival rates in this patient\r population when treated with adjuvant irinotecan followed by radiotherapy and\r temozolomide.\r\n\r - Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this\r patient population.\r\n\r OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on\r weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan\r and if appropriate, patients may undergo a second surgical resection.\r\n\r Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second\r resection, patients receive image guided external beam radiotherapy 5 days per week for 6\r weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost\r radiosurgery.\r\n\r At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5\r days. Treatment repeats every 3 weeks for 6 courses.\r\n\r Patients are followed every 3 months for 2 years, then every 4 months for 3 years.\r\n\r PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed brain tumors\r\n\r - Grade III or IV disease:\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic pleomorphic xanthoastrocytoma\r\n\r - Anaplastic or malignant oligoastrocytoma\r\n\r - Gemistocytic astrocytoma\r\n\r - Malignant glioma\r\n\r - Grade II glial tumors in unfavorable locations (i.e., imaging evidence of\r gliomatosis cerebri and/or bithalamic involvement)\r\n\r - Diffuse pontine gliomas with greater than 2/3 involvement of the pon\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 3 to 21\r\n\r Performance status:\r\n\r - Not specified\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - WBC greater than 2,500/mm^3\r\n\r - Platelet count greater than 100,000/mm^3\r\n\r - Hemoglobin greater than 8.0 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.5 mg/dL\r\n\r - SGOT/SGPT less than 5 times normal\r\n\r Renal:\r\n\r - Creatinine no greater than 2.0 mg/dL\r\n\r Other:\r\n\r - Not pregnant\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - HIV negative\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Prior corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy\r\n\r Surgery:\r\n\r - No more than 28 days since prior definitive surgery for brain tumor\r\n\r Other:\r\n\r - Concurrent anticonvulsants 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:** possibly relevant"
}
] |
possibly relevant
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19
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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 Therapy in Treating Patients With Recurrent or Progressive Brain Tumors\n\n**Clinical Trial Summary:**\n\nRATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's\r ability to fight cancer.\r\n\r PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in\r treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic\r astrocytoma, or anaplastic mixed glioma that can be removed during surgery.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Estimate the efficiency of tumor cell transduction with adenovirus p53\r delivered stereotactically to patients with recurrent or progressive resectable glioblastoma\r multiforme, anaplastic astrocytoma, or anaplastic mixed glioma. II. Determine the maximum\r tolerated dose of adenovirus p53 delivered stereotactically and with craniotomy in these\r patients. III. Correlate analysis of predelivery tumor specimen p53 gene status with\r postdelivery p53 gene status, clinical status, and tumor staging in these patients treated\r with this regimen. IV. Correlate analysis of postdelivery tumor specimen p53 gene status and\r local tumor immune response with postdelivery clinical status and tumor imaging in these\r patients treated with this regimen.\r\n\r OUTLINE: This is a dose escalation, multicenter study. Patients receive SCH-58500 via\r stereotactic injection into the tumor, followed 24-72 hours later by craniotomy. Patients\r undergo tumor resection, followed by injection of SCH-58500 into the tumor bed during\r craniotomy. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum\r tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that\r at which 3 of 3-6 patients experience dose limiting toxicity. Patients are followed at day\r 28, then every 2 months for 1 year, and then annually thereafter, until another therapy is\r begun or disease progression is documented.\r\n\r PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study over 14-27\r months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme, anaplastic\r astrocytoma, or anaplastic mixed glioma Progressive or recurrent disease following\r radiotherapy (54-64 Gy) and/or chemotherapy Tumor recurrence must have anatomic\r characteristics that allow safe and reasonable surgical intervention Measurable disease by\r serial MR or CT imaging No Li-Fraumeni syndrome or known germline defect in p53 gene No\r radiographically or surgically proven gliomatosis cerebri No tumors requiring immediate\r excision due to impending neurologic decline\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count\r at least 1,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 25% Hepatic:\r Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2.5 times upper limit of normal (ULN)\r PT or PTT no greater than ULN Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular:\r No uncontrolled hypertension No uncontrolled or unstable angina pectoris No uncontrolled\r cardiac dysrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients\r must use effective contraception during and for 6 months after study HIV negative No other\r active malignancy within the past 5 years except curatively treated basal or squamous cell\r skin cancer or carcinoma in situ of the cervix No uncontrolled or serious concurrent\r infection or other serious medical illness that would preclude study therapy No viral\r syndrome diagnosed within 2 weeks prior to study No other underlying medical condition that\r would increase risk of study or obscure interpretation of adverse results No active\r adenoviral infection\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy\r and recovered No concurrent biologic therapy Chemotherapy: See Disease Characteristics No\r more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (6 weeks\r for nitrosoureas) and recovered No prior interstitial chemotherapy such as Gliadel wafer\r implantation for present brain tumor No concurrent chemotherapy Endocrine therapy: At least\r 3 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy\r Radiotherapy: See Disease Characteristics No prior brachytherapy for present brain tumor At\r least 3 months since other prior radiotherapy and recovered No concurrent radiotherapy\r Surgery: See Disease Characteristics No prior radiosurgery for present brain tumor At least\r 3 weeks since other prior oncologic surgery No other concurrent oncologic surgery Other: No\r other concurrent investigational 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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20
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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 in Treating Patients With Recurrent or Progressive Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who\r have recurrent or progressive malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the progression-free survival and response rate of patients with recurrent or\r progressive malignant glioma treated with temozolomide.\r\n\r - Determine whether certain categories of malignant gliomas, such as oligodendroglioma,\r are more sensitive to temozolomide.\r\n\r - Determine the toxicity of this regimen in these patients.\r\n\r OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma\r multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent\r anaplastic oligodendroglioma).\r\n\r Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every\r 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.\r\n\r PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven recurrent or progressive malignant glioma of one of the\r following types:\r\n\r - Anaplastic oligodendroglioma or oligoastrocytoma\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme (stratum closed to accrual 11/30/01)\r\n\r - Patients who have failed radiotherapy are eligible\r\n\r - Measurable disease by CT scan or MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 70-100%\r\n\r Life expectancy:\r\n\r - At least 12 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count greater than 1,500/mm^3\r\n\r - Platelet count greater than 100,000/mm^3\r\n\r - Hemoglobin greater than 10 g/dL\r\n\r Hepatic:\r\n\r - SGOT or SGPT less than 3 times upper limit of normal (ULN)\r\n\r - Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma\r glutamyl transferase test must be performed)\r\n\r Renal:\r\n\r - BUN less than 1.5 times ULN\r\n\r - Creatinine less than 1.5 times ULN\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective barrier contraception\r\n\r - No other serious concurrent infection or other medical illness that would preclude\r study entry\r\n\r - No frequent vomiting or partial bowel obstruction\r\n\r - HIV negative\r\n\r - No AIDS-related illness\r\n\r - No other concurrent malignancy except carcinoma in situ of the cervix or basal cell\r skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No concurrent epoetin alfa\r\n\r Chemotherapy:\r\n\r - At least 6 weeks since other prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 3 months since prior radiotherapy (exceptions allowed for\r recurrent/progressive disease at discretion of primary investigator)\r\n\r Surgery:\r\n\r - Recovered from prior surgery\r\n\r Other:\r\n\r - No other concurrent investigational agents\r\n\r - Concurrent anticonvulsant therapy allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"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\nRadiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in\r chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop\r tumor cells from dividing so they stop growing or die. Combining radiation therapy with\r chemotherapy may kill more tumor cells.\r\n\r PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to\r see how well they work compared to radiation therapy and carmustine or lomustine in treating\r patients with anaplastic astrocytoma or mixed gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Compare the overall survival and time to tumor progression in patients with anaplastic\r astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs\r carmustine or lomustine vs temozolomide and carmustine (arm discontinued as of 8/15/02).\r\n\r - Compare the relative toxic effects of these regimens in these patients.\r\n\r - Correlate molecular analyses with overall survival and time to tumor progression in\r patients treated with these regimens.\r\n\r OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age\r (under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior\r surgery (biopsy only vs resection).\r\n\r Phase I\r\n\r - Pilot Arms I and II: Prior to initiating the randomization to 1 of 3 treatment arms in\r phase III, Patients are accrued to Arm III regimen to determine tolerability.\r\n\r Phase III\r\n\r - Patients are randomized to 1 of 2 treatment arms (3rd arm was dropped).\r\n\r - Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive\r oral temozolomide on days 1-5 of the first week of radiotherapy. Chemotherapy\r repeats every 4 weeks for a total of 12 courses.\r\n\r - Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV\r or lomustine IV over 1-2 hours on days 1-3 of the first week of radiotherapy and a\r second course on days 56-58. Chemotherapy repeats every 8 weeks for a total of 6\r courses.\r\n\r - Arm III (dropped, did not open): Patients undergo radiotherapy as in arm I.\r Patients receive carmustine IV or lomustine IV over 3 hours on day 5 and oral\r temozolomide (2 hours after completion of carmustine or lomustine infusion) on days\r 1-5 of the first week of radiotherapy. Combination chemotherapy repeats every 8\r weeks for 6 courses.\r\n\r Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then\r annually thereafter.\r\n\r PROJECTED ACCRUAL: Phase I: 30 patients; Phase III: 454 patients (227 per treatment arm)\r within 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the\r following:\r\n\r - Anaplastic astrocytoma\r\n\r - Mixed oligodendroglial/astrocytic tumors\r\n\r - Oligodendroglial component must be no greater than 25%\r\n\r - No vascular proliferation and necrosis\r\n\r - Increased cellularity, pleomorphism, and nuclear atypia allowed\r\n\r - No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum)\r\n\r - Patients with prior biopsy proven low grade astrocytoma who now have anaplastic\r astrocytoma and have had no prior radiotherapy or chemotherapy also eligible\r\n\r - Study therapy must begin within 6 weeks of diagnosis\r\n\r - No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges\r\n\r - Pathologic evidence of local meningeal infiltration by underlying tumor allowed\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - At least 1 year\r\n\r Hematopoietic:\r\n\r - Hemoglobin at least 10 g/dL\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 150,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin less than 2 times upper limit of normal (ULN)\r\n\r - Aspartate aminotransferase (AST) less than 2 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - Blood urea nitrogen no greater than 25 mg/dL\r\n\r - Creatinine less than 1.5 times normal\r\n\r Pulmonary:\r\n\r - No pre-existing lung disease that, in the investigator's opinion, would preclude\r administration of carmustine or lomustine or completion of therapy\r\n\r Other:\r\n\r - No other major medical illness or psychiatric impairment that would preclude study\r compliance\r\n\r - No other malignancy within the past 5 years except nonmelanomatous skin cancer or\r carcinoma in situ of the cervix\r\n\r - No known hypersensitivity to 1 of the components of carmustine, lomustine,\r temozolomide, dacarbazine, or any other nitrosourea\r\n\r - No active infection\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior biologic therapy\r\n\r Chemotherapy:\r\n\r - See Disease Characteristics\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - No prior radiotherapy to brain or head and neck\r\n\r Surgery:\r\n\r - Not specified\r\n\r Other:\r\n\r - No other concurrent anticancer treatment for anaplastic astrocytoma until a recurrence\r is detected\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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 III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis\n\n**Clinical Trial Summary:**\n\nOBJECTIVES: I. Compare the rate of treatment failure in osteopetrosis patients receiving\r interferon gamma in combination with calcitriol to the rate of treatment failure in patients\r receiving calcitriol alone.\r\n\r II. Compare the number of adverse events or clinical manifestations of disease progression\r occurring in these patients.\r\n\r III. Assess the effects of interferon gamma on hematopoiesis, cranial nerve function, and\r rate of infection in these patients.\n\n**Clinical Trial Detailed Description:**\n\nPROTOCOL OUTLINE: This is a randomized, placebo controlled, open label study. Patients are\r randomized to one of two arms (interferon gamma in combination with calcitriol or calcitriol\r alone).\r\n\r Arm I: Patients receive calcitriol once daily. Interferon gamma is administered by\r subcutaneous injection three times a week.\r\n\r Arm II: Patients receive calcitriol once daily. Patients may continue treatment in the\r absence of toxicity and disease progression. If disease progression is diagnosed in the\r control group, patients will then receive interferon gamma in combination with calcitriol.\r\n\r Patients are followed every 4 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nPROTOCOL ENTRY CRITERIA:\r\n\r --Disease Characteristics--\r\n\r - Biopsy and x-ray confirmed primary osteopetrosis\r\n\r - Presence of anemia and/or cranial nerve compression\r\n\r --Prior/Concurrent Therapy--\r\n\r - Biologic therapy: No prior/concurrent bone marrow transplantation No prior interferon\r gamma No other investigational biologic agents\r\n\r - Chemotherapy: No prior/concurrent chemotherapeutic agents for bone marrow\r transplantation\r\n\r - Endocrine therapy: Prior/concurrent corticosteroid as supportive therapy allowed\r\n\r - Radiotherapy: Not specified\r\n\r - Surgery: At least 5 days since major surgery\r\n\r - Other: Prior/concurrent calcitriol as supportive therapy allowed Prior/concurrent\r transfusion as supportive therapy allowed Prior/concurrent dietary therapy allowed\r\n\r --Patient Characteristics--\r\n\r - Age: 2 months to 10 years\r\n\r - Performance status: Not specified\r\n\r - Life expectancy: At least 6 months\r\n\r - Hematopoietic: Not specified\r\n\r - Hepatic: Bilirubin less than 2 mg/dL\r\n\r - Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min\r\n\r - Pulmonary: No uncorrected airway obstruction\r\n\r - Other: No active infection requiring intravenous antibiotics No known seizure disorder\r not related to hypocalcemia No uncorrected hydrocephalus No MRI evidence of cerebral\r atrophy Must maintain or gain body weight No sleep apnea No thrombocytopenia No\r massive splenomegaly\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nSU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy\n\n**Clinical Trial Summary:**\n\nRATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the\r tumor.\r\n\r PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have\r recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: Phase I:\r\n\r - Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant\r glioma who are, as well as those who are not, taking enzyme-inducing antiepileptic\r drugs.\r\n\r - Determine the toxic effects (safety profile) of this drug in this patient population.\r\n\r - Characterize the pharmacokinetics of this drug in these patients.\r\n\r - Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo,\r including functional imaging and in vitro assays of endothelial cell inhibition and\r serum angiogenic peptides.\r\n\r Phase II:\r\n\r - Determine the efficacy of SU5416, in terms of 6-month progression-free survival, in\r patients with recurrent high-grade glioma.\r\n\r - Determine, further, the safety profile of the phase II dose of this drug in this patient\r population.\r\n\r - Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo\r including functional imaging and in vitro assays of endothelial cell inhibition and\r serum angiogenic peptides.\r\n\r OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to\r concurrent enzyme-inducing antiepileptic drugs (no vs yes).\r\n\r Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks. Courses repeat every 4 weeks\r in the absence of unacceptable toxicity or disease progression.\r\n\r Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose\r (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6\r patients experience dose-limiting toxicity. Once the MTD has been determined, additional\r patients are accrued to the phase II portion of the study. These patients receive SU5416 IV,\r as in the phase I portion, at the appropriate MTD established in phase I.\r\n\r Patients are followed for survival.\r\n\r PROJECTED ACCRUAL: At least 30 patients will be accrued for the phase I dose-escalation\r portion of this study within 10 months. An additional 48 patients (32 with glioblastoma\r multiforme and 16 with anaplastic glioma) will be accrued for the phase II portion of this\r study within 6-8 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven supratentorial malignant primary glioma, including:\r\n\r - Glioblastoma multiforme\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 - Benign or malignant meningiomas, including brain and spinal meningiomas\r\n\r - Patients with meningiomas are excluded from phase II portion of study\r\n\r - Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or\r MRI\r\n\r - Must have failed prior radiotherapy\r\n\r - Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose\r within the past 14 days\r\n\r - Must be on stable (unchanged) dose of steroids for at least 5 days before scans\r\n\r - Phase II:\r\n\r - Must have completed radiotherapy at least 2 months prior to enrollment\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 8 weeks\r\n\r Hematopoietic:\r\n\r - WBC at least 2,300/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 8 g/dL (transfusion allowed)\r\n\r Hepatic:\r\n\r - SGOT less than 2.5 times upper limit of normal\r\n\r - Bilirubin normal\r\n\r - No significant active hepatic disease\r\n\r Renal:\r\n\r - Creatinine less than 1.5 mg/dL OR\r\n\r - Creatinine clearance at least 60 mL/min\r\n\r - No significant active renal disease\r\n\r Cardiovascular:\r\n\r - No uncompensated coronary artery disease on ECG or physical examination\r\n\r - No history of myocardial infarction or severe/unstable angina within the past 6 months\r\n\r - No deep venous or arterial thrombosis within the past 3 months\r\n\r Pulmonary:\r\n\r - No pulmonary embolism within the past 3 months\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception during and for 2 months after study\r\n\r - No other serious concurrent illness\r\n\r - No significant active psychiatric disease\r\n\r - No diabetes mellitus with severe peripheral vascular disease\r\n\r - No other malignancy within the past 3 years except nonmelanoma skin cancer or\r carcinoma in situ of the cervix\r\n\r - No serious active infection\r\n\r - No other concurrent disease that would obscure toxic effects or dangerously alter drug\r metabolism\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered\r\n\r - No concurrent immunotherapy\r\n\r Chemotherapy:\r\n\r - Phase I:\r\n\r - No more than 2 prior chemotherapy regimens for recurrent disease\r\n\r - Phase II:\r\n\r - No more than 1 prior chemotherapy regimen for recurrent disease\r\n\r - At least 2 weeks since prior vincristine\r\n\r - At least 6 weeks since prior nitrosoureas\r\n\r - At least 3 weeks since prior procarbazine\r\n\r - Recovered from prior chemotherapy\r\n\r - No concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - See Disease Characteristics\r\n\r - At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - No concurrent radiotherapy\r\n\r Surgery:\r\n\r - Recovered from prior surgery\r\n\r - Recent prior resection of recurrent or progressive tumor allowed\r\n\r Other:\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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{
"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\nCarmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combining carmustine and\r O6-benzylguanine in treating patients who have recurrent or progressive glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the activity of carmustine and O6-benzylguanine in patients with\r recurrent or progressive glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma\r resistant to nitrosourea. II. Determine the toxic effects of this regimen in these patients.\r\n\r OUTLINE: Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by\r carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks in the absence of disease\r progression or unacceptable toxicity.\r\n\r PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 12-18\r months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma\r multiforme, anaplastic astrocytoma, or gliosarcoma Resistant to nitrosourea (defined as\r progressive or recurrent disease within 8 weeks of receiving nitrosourea) Measurable\r residual disease by MRI or CT scan\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life\r expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3\r Platelet count at least 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin\r normal SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater\r than 1.5 mg/dL BUN no greater than 25 mg/dL Pulmonary: DLCO greater than 80% predicted\r Other: Not pregnant or nursing Fertile patients must use effective contraception during and\r for 2 months after study\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease\r Characteristics At least 4 weeks since prior chemotherapy At least 6 weeks since prior\r nitrosourea, procarbazine, or mitomycin and recovered No prior nitrosourea greater than\r 1,200 mg/m2 Endocrine therapy: Concurrent stable dose corticosteroids allowed if on for at\r least two weeks prior to study Radiotherapy: At least 4 weeks since prior radiotherapy\r Surgery: Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nCombination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one chemotherapy drug may kill more tumor\r cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following\r radiation therapy in treating patients who have malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the safety and efficacy of extended low-dose temozolomide when combined with\r carmustine after radiotherapy in patients with malignant glioma.\r\n\r - Determine the maximum tolerated dose of this combination in this patient population.\r\n\r - Determine time to progression as measured from baseline gadolinium-enhanced magnetic\r resonance imaging in patients treated with this regimen.\r\n\r OUTLINE: This is a dose-escalation study of temozolomide.\r\n\r Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours\r beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up to\r 1 year in the absence of unacceptable toxicity or disease progression.\r\n\r Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated\r dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6\r patients experience dose-limiting toxicity.\r\n\r Patients are followed every 2 months.\r\n\r PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed malignant glioma\r\n\r - Glioblastoma\r\n\r - Gliosarcoma\r\n\r - High-grade glioma\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic mixed oligoastrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic ependymoma\r\n\r - Must have completed radiotherapy\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - More than 3 months\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGOT/SGPT less than 3 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - BUN less than 1.5 times ULN\r\n\r - Creatinine less than 1.5 times ULN\r\n\r Pulmonary:\r\n\r - Pulmonary function test with diffusion greater than 50 OR\r\n\r - Clearance by the pulmonary service\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - HIV negative\r\n\r - No AIDS-related illness\r\n\r - No nonmalignant systemic disease that would preclude study\r\n\r - No acute infection requiring IV antibiotics\r\n\r - No psychiatric condition that would preclude study compliance\r\n\r - No frequent vomiting or medical condition that would interfere with oral medication\r intake (e.g., partial bowel obstruction)\r\n\r - No other prior or concurrent malignancy except surgically cured carcinoma in situ of\r the cervix or basal cell or squamous cell skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior immunotherapy\r\n\r - No prior biologic therapy\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 2 weeks since prior radiotherapy\r\n\r Surgery:\r\n\r - Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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"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\nOxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nThis phase I/II trial is studying the side effects and best dose of oxaliplatin in treating\r patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as\r oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the\r cells or by stopping them from dividing\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r I. Determine the maximum tolerated dose of oxaliplatin in patients with newly diagnosed\r glioblastoma multiforme who are receiving or not receiving anticonvulsants known to be\r metabolized by P450.\r\n\r II. Determine the dose-limiting toxicity and safety profile of this drug in this patient\r population.\r\n\r III. Assess the pharmacokinetics of this drug on this schedule and determine the effects of\r P450-inducing anticonvulsants on the pharmacokinetics in these patients.\r\n\r IV. Determine the radiographic response rate in patients treated with this drug.\r\n\r V. Determine survival and drug toxicity in these patients.\r\n\r OUTLINE: This is a phase I dose-escalation study of oxaliplatin followed by a phase II study.\r Patients are stratified according to whether concurrent anticonvulsant drugs induce P450 (yes\r vs modest/no or no drugs).\r\n\r Phase I: Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14\r days for a maximum of 6 courses in the absence of unacceptable toxicity or disease\r progression.\r\n\r Cohorts of 3-6 patients (per stratum) receive escalating doses of oxaliplatin until the\r maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at\r which 2 of 6 patients experience dose-limiting toxicity.\r\n\r Phase II: Patients receive oxaliplatin as in phase I at the MTD determined in phase I.\r\n\r Patients are followed at 1 month, every 2 months until disease progression, and then monthly\r thereafter.\r\n\r PROJECTED ACCRUAL: Approximately 24 patients (12 per stratum) will be accrued for the phase I\r part of this study within 8-12 months. A total of 18-35 patients will be accrued for the\r phase II part of this study within 5-12 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed supratentorial grade IV astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Subtotal resection or biopsy with measurable and contrast-enhancing disease on the\r postoperative, pretreatment MRI/CT scan\r\n\r - Performance status - Karnofsky 60-100%\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 9.0 g/dL\r\n\r - Bilirubin normal\r\n\r - Creatinine normal\r\n\r - Creatinine clearance at least 60 mL/min\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - No serious concurrent infection or medical illness that would jeopardize ability to\r receive protocol chemotherapy with reasonable safety\r\n\r - No other prior malignancy within the past 5 years except curatively treated carcinoma\r in situ or basal cell skin cancer\r\n\r - No grade 2 or greater pre-existing sensory neuropathy\r\n\r - No history of allergy to platinum compounds or to antiemetics appropriate for\r administration in conjunction with protocol chemotherapy\r\n\r - Mini mental score at least 15\r\n\r - No prior immunotherapy for glioblastoma multiforme\r\n\r - No prior biologic therapy for glioblastoma multiforme, including:\r\n\r - Immunotoxins\r\n\r - Immunoconjugates\r\n\r - Antiangiogenesis compounds\r\n\r - Antisense\r\n\r - Peptide receptor antagonists\r\n\r - Interferons\r\n\r - Interleukins\r\n\r - Tumor infiltrating lymphocytes\r\n\r - Lymphokine activated killer cells\r\n\r - Gene therapy\r\n\r - No concurrent filgrastim (G-CSF)\r\n\r - No prior chemotherapy for glioblastoma multiforme\r\n\r - No prior hormonal therapy for glioblastoma multiforme\r\n\r - Prior glucocorticoid therapy for glioblastoma multiforme allowed\r\n\r - Must be maintained on a stable (lowest required dose) corticosteroid regimen for at\r least 5 days before and during study\r\n\r - No concurrent dexamethasone as an antiemetic\r\n\r - No prior radiotherapy for glioblastoma multiforme\r\n\r - Recovered from immediate postoperative period\r\n\r - At least 10 days since prior anticonvulsant drug that induces hepatic metabolic\r enzymes\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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{
"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\nIrinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating\r patients who have recurrent primary malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose of irinotecan administered in combination with\r temozolomide in patients with recurrent primary malignant glioma.\r\n\r - Determine the toxicity of this combination therapy in these patients.\r\n\r OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to\r concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or\r none).\r\n\r Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral temozolomide\r on days 1-5. Treatment continues every 43 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated\r dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6\r patients experience dose limiting toxicities.\r\n\r PROJECTED ACCRUAL: Not specified\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed recurrent primary malignant glioma\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic oligodendroglioma\r\n\r - Gliosarcoma\r\n\r - Anaplastic mixed oligoastrocytoma\r\n\r - Measurable disease by MRI or CT\r\n\r - No immediate radiotherapy required\r\n\r - Neurologically stable for at least 2 weeks prior to study\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Greater than 12 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGOT and SGPT less than 2.5 times ULN\r\n\r - Alkaline phosphatase less than 2 times ULN\r\n\r Renal:\r\n\r - Blood urea nitrogen and creatinine less than 1.5 times ULN\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - HIV negative\r\n\r - No other nonmalignant systemic disease\r\n\r - No acute infection treated with IV antibiotics\r\n\r - No frequent vomiting or other condition that would preclude oral medication\r administration (e.g., partial bowel obstruction)\r\n\r - No other prior malignancies except surgically cured carcinoma in situ of the cervix or\r basal or squamous cell skin cancer\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No more than 1 prior biologic therapy regimen\r\n\r Chemotherapy:\r\n\r - No more than 1 prior chemotherapy regimen\r\n\r - At least 6 weeks since prior chemotherapy, unless evidence of disease progression\r\n\r - No prior failure of irinotecan or temozolomide\r\n\r Endocrine therapy:\r\n\r - Concurrent corticosteroids allowed\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 6 weeks since prior radiotherapy, unless evidence of disease progression\r\n\r Surgery:\r\n\r - At least 3 weeks since prior surgery, unless evidence of disease progression, and\r recovered\r\n\r Other:\r\n\r - No concurrent immunosuppressive agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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[
{
"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 Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by\r radiation therapy in treating patients who have high-grade malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose of temozolomide when administered with lomustine in\r patients with high-grade malignant gliomas.\r\n\r - Determine the dose-limiting toxic effects of this regimen in these patients.\r\n\r - Evaluate the feasibility of radiotherapy after this treatment regimen in this patient\r population.\r\n\r - Evaluate the radiographic responses in patients treated with this regimen.\r\n\r OUTLINE: This is a multicenter, dose-escalation study of temozolomide.\r\n\r Patients receive oral temozolomide on days 1-5 and oral lomustine on day 1. Treatment\r continues every 28 days, if blood counts have recovered, for 2 courses in the absence of\r disease progression or unacceptable toxicity. Patients then undergo radiotherapy on days 1-5\r weekly for 6 weeks. Patients continue the same chemotherapy regimen for up to 6 more courses\r beginning 4 weeks after completion of radiotherapy.\r\n\r Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated\r dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2\r of 6 patients experience dose-limiting toxicity.\r\n\r Patients are followed for survival.\r\n\r PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed high-grade malignant glioma of one of the following subtypes:\r\n\r - Glioblastoma\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - Gliomatosis cerebri\r\n\r - No disseminated disease or primary spinal cord malignancies\r\n\r - Measurable intracranial residual disease by MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 3 and over\r\n\r - Under 22 at time of diagnosis\r\n\r Performance status:\r\n\r - Karnofsky 50-100% if over 10 years of age\r\n\r - Lansky 50-100% if 10 years of age or under\r\n\r Life expectancy:\r\n\r - At least 8 weeks\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,000/mm^3\r\n\r - Platelet count at least 100,000/mm^3 (transfusion independent)\r\n\r - Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 1.5 times normal for age\r\n\r - SGPT no greater than 2.5 times normal for age\r\n\r - Albumin at least 2 g/dL\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 times normal for age OR\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate at least lower limit\r of normal for age\r\n\r Pulmonary:\r\n\r - No dyspnea at rest\r\n\r - No exercise intolerance\r\n\r - Pulse oximetry at least 94%\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - No uncontrolled infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior biologic therapy\r\n\r - No concurrent prophylactic hematopoietic growth factors\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy:\r\n\r - Prior corticosteroid therapy allowed\r\n\r - No concurrent corticosteroids as antiemetic\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy\r\n\r Surgery:\r\n\r - No more than 31 days since prior maximal neurosurgical procedure\r\n\r Other:\r\n\r - No concurrent phenobarbital or cimetidine\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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29
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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\nFenretinide in Treating Patients With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die.\r\n\r PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who\r have recurrent malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES: I. Determine the efficacy of fenretinide as assessed by 6-month progression- free\r survival in patients with recurrent malignant glioma. II. Determine the rate of measurable\r clinical response, time to progression, and overall survival of patients treated with this\r drug. III. Determine the unexpected toxicity of this drug in these patients.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to disease type\r (glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to\r accrual as of 05/31/2001) vs anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed\r malignant glioma). Patients receive oral fenretinide twice daily during weeks 1 and 4.\r Treatment repeats every 6 weeks in the absence of disease progression or unacceptable\r toxicity. Quality of life is assessed at baseline and then before each course of\r chemotherapy. Patients are followed every 3 months.\r\n\r PROJECTED ACCRUAL: A total of 41-85 patients (21-45 with anaplastic astrocytoma, anaplastic\r oligodendroglioma, and mixed malignant glioma and 20-40 with glioblastoma multiforme (closed\r to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001)) will be\r accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS: Histologically confirmed supratentorial malignant primary glioma\r Glioblastoma multiforme (closed to accrual as of 05/31/2001) Gliosarcoma (closed to accrual\r as of 05/31/2001) Anaplastic astrocytoma Anaplastic oligodendroglioma Mixed malignant\r gliomas Original histological diagnosis of low-grade glioma allowed if a subsequent\r histological diagnosis of malignant glioma is confirmed Prior treatment for no more than 2\r prior relapses allowed Disease progression documented by at least 2 pre-study brain scans\r Recent prior tumor resection of recurrent or progressive tumor allowed if recovered from\r the effects of prior surgery\r\n\r PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life\r expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3\r Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (may be transfusion\r dependent) Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than\r 2 times ULN Renal: Creatinine less than 1.5 mg/dL Creatinine clearance at least 60 mL/min\r Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective\r barrier contraception during and for at least 2 months after study Able to swallow capsules\r No active infection No disease or other serious concurrent medical illness that would\r preclude study\r\n\r PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior interferon At least\r 1 week since prior thalidomide Chemotherapy: Recovered from prior chemotherapy At least 4\r weeks since prior cytotoxic therapy (2 weeks for vincristine, 3 weeks for procarbazine, or\r 6 weeks for nitrosoureas) Endocrine therapy: At least 1 week since prior tamoxifen Prior\r steroids allowed if on stable or decreasing dose for at least 5-7 days before baseline MRI\r If steroid dose is increased between date of baseline MRI and initiation of study drug, a\r new baseline MRI is required Radiotherapy: Not specified Surgery: See Disease\r Characteristics No concurrent surgery Other: At least 1 week since any prior noncytotoxic\r agents (e.g., isotretinoin) No other concurrent anticancer therapy, including other\r investigational 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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[
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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\nCarboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Colony-stimulating factors such as filgrastim may increase the\r number of immune cells found in bone marrow or peripheral blood and may help a person's\r immune system recover from the side effects of chemotherapy.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide,\r and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the response rate in patients with newly diagnosed high-grade glioma treated\r with temozolomide, carboplatin, and filgrastim (G-CSF).\r\n\r - Determine the toxicity of this treatment regimen in these patients.\r\n\r - Determine the rate of tumor progression in patients treated with this regimen.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to disease category\r (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed\r gliomas).\r\n\r Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on\r days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7\r and continuing until blood counts recover. Treatment repeats every 28 days for at least 4\r courses in the absence of disease progression or unacceptable toxicity.\r\n\r PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this\r study within 4 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic\r astrocytoma\r\n\r - Residual tumor on postoperative MRI\r\n\r - Bidimensionally measurable disease\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - Under 65\r\n\r Performance status:\r\n\r - Karnofsky or Lansky 70-100% OR\r\n\r - ECOG 0-2\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,000/mm^3\r\n\r - Hemoglobin at least 8 g/dL (transfusion allowed)\r\n\r - Platelet count greater than 100,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r - SGPT no greater than 3 times ULN\r\n\r Renal:\r\n\r - Age 5 years and under: Creatinine less than 1.2 mg/dL\r\n\r - Age over 5 to 10 years: Creatinine less than 1.5 mg/dL\r\n\r - Age over 10 to 15 years: Creatinine less than 1.8 mg/dL\r\n\r - Age over 15 years: Creatinine less than 2.4 mg/dL\r\n\r Cardiovascular:\r\n\r - No myocardial infarction within the past 6 months\r\n\r Other:\r\n\r - No other concurrent serious medical condition that would preclude study\r\n\r - Able to tolerate oral medications\r\n\r - No prior malignancy for which patient received prior chemotherapy or spinal\r irradiation\r\n\r - No history of severe allergic reaction to platinum-containing compounds\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - At least 72 hours since prior filgrastim (G-CSF)\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy\r\n\r - No other concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - Concurrent steroids for tumor-related cerebral edema allowed\r\n\r - No concurrent corticosteroids for solely antiemetic purposes\r\n\r Radiotherapy:\r\n\r - No prior or concurrent radiotherapy\r\n\r Surgery:\r\n\r - Recovered from prior surgery\r\n\r - No concurrent surgery\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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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\nPyrazoloacridine Followed by Radiation Therapy in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining chemotherapy and radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase I/II trial to study the effectiveness of pyrazoloacridine followed by\r radiation therapy in treating adults who have newly diagnosed supratentorial glioblastoma\r multiforme.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose, toxicity, and pharmacokinetics of pyrazoloacridine\r in adults with newly diagnosed, supratentorial glioblastoma multiforme treated with\r pyrazoloacridine followed by radiotherapy.\r\n\r - Determine the response rate, duration of disease free survival, and survival of patients\r treated with this regimen.\r\n\r OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to\r type of anticonvulsant (hepatic metabolic enzyme inducers vs hepatic metabolic enzyme\r moderate inducers or noninducers).\r\n\r Patients receive pyrazoloacridine (PZA) IV over 3 hours on day 1. Treatment repeats every 3\r weeks for a maximum of 4 courses in the absence of disease progression or unacceptable\r toxicity. Following completion of PZA treatment, patients undergo cranial irradiation 5 days\r a week for 6 weeks.\r\n\r Cohorts of 3 patients receive escalating doses of PZA until the maximum tolerated dose (MTD)\r is determined. Additional patients receive PZA at the MTD.\r\n\r Patients are followed monthly for survival.\r\n\r PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for phase I and a total of 18-35\r patients will be accrued for phase II of this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically proven, newly diagnosed, supratentorial, grade IV astrocytoma\r (glioblastoma multiforme)\r\n\r - Incompletely resected disease\r\n\r - Must have measurable and contrast enhancing tumor on the postoperative MRI/CT scan\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 1.5 mg/dL\r\n\r - Transaminases no greater than 4 times upper limit of normal\r\n\r Renal:\r\n\r - Creatinine no greater than 1.7 mg/dL\r\n\r Other:\r\n\r - No other serious concurrent infection or medical illness that would preclude study\r therapy\r\n\r - No other active malignancy within the past 5 years except curatively treated carcinoma\r in situ of the cervix or basal cell skin cancer\r\n\r - No psychosis requiring ongoing therapy with antipsychotic medication\r\n\r - Mini mental score at least 15\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior immunotherapy or biologic agents (including immunotoxins, immunoconjugates,\r antisense compounds, peptide receptor antagonists, interferons, interleukins, tumor\r infiltrating lymphocytes, lymphokine activated killer cells, or gene therapy) for\r glioblastoma multiforme\r\n\r - No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim\r [GM-CSF])\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy for glioblastoma multiforme\r\n\r Endocrine therapy:\r\n\r - No prior hormonal therapy for glioblastoma multiforme\r\n\r - Prior glucocorticoids allowed\r\n\r - Concurrent corticosteroids allowed if on stable dose (no increase within the past 5\r days)\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy for glioblastoma multiforme\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r - Recovered from immediate postoperative period\r\n\r Other:\r\n\r - Greater than 10 days since prior anticonvulsants that induce hepatic metabolic enzymes\r (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or felbamate)\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nTemozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Combining more than one drug may kill more tumor cells.\r\n\r PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and\r O6-benzylguanine in treating patients who have newly diagnosed, recurrent, or progressive\r anaplastic glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the dose of O6-benzylguanine (O6-BG) effective in producing complete\r suppression of tumor O6-alkylguanine-DNA alkyltransferase activity in patients with\r newly diagnosed (closed to accrual 12/19/2000) or recurrent or progressive cerebral\r anaplastic glioma.\r\n\r - Determine the maximum tolerated dose of temozolomide administered after O6-BG in these\r patients.\r\n\r - Determine the toxicity of this regimen in these patients.\r\n\r - Determine the anti-tumor response in patients treated with this regimen.\r\n\r OUTLINE: This is a dose-escalation, multicenter study.\r\n\r - Part I: Patients receive escalating doses of O6-benzylguanine (O6-BG) IV continuously\r for 49 hours until the dose that produces the target depletion of tumor\r O6-alkylguanine-DNA alkyltransferase (AGT) is determined. Patients undergo a craniotomy\r after completion of the O6-BG infusion. (closed to accrual 12/19/2000)\r\n\r - Part II: After determination of the O6-BG dose in Part I, patients with recurrent\r malignant gliomas receive O6-BG IV continuously for 49 hours beginning on day 1.\r Patients also receive oral temozolomide on day 1. Treatment repeats every 28 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated\r dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6\r patients experiences dose-limiting toxicity.\r\n\r PROJECTED ACCRUAL: Approximately 20-30 patients (with 14 patients participating in Part II)\r will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Part I:\r\n\r - Histologically confirmed, newly diagnosed glioblastoma multiforme or anaplastic\r astrocytoma (closed to accrual 12/19/2000)\r\n\r - Parts I and II:\r\n\r - Histologically confirmed astrocytic, oligodendroglial, or mixed glial tumor\r\n\r - Grade III or higher\r\n\r - Recurrent or progressive after radiotherapy\r\n\r - Evaluable residual disease by contrast-enhanced MRI or CT scan\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Granulocyte count at least 1,500/mm3\r\n\r - Platelet count at least 100,000/mm3\r\n\r Hepatic:\r\n\r - SGOT no greater than 2.5 times upper limit of normal\r\n\r - Bilirubin normal\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 mg/dL OR\r\n\r - Creatinine clearance greater than 60 mL/min\r\n\r - BUN no greater than 25 mg/dL\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception during and for 2 months after study\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - At least 6 weeks since prior biologic therapy and recovered\r\n\r Chemotherapy:\r\n\r - At least 2 weeks since prior chemotherapy (including but not limited to topotecan) and\r recovered\r\n\r - Patients in trials with one of the following treatment combinations are allowed\r to enroll 6 weeks after receiving carmustine (BCNU):\r\n\r - BCNU on day 1\r\n\r - BCNU on day 1 and topotecan on days 1, 8, 15, 22, 29, and 36\r\n\r - BCNU on day 1 and irinotecan on days 1, 8, 15, and 22\r\n\r Endocrine therapy:\r\n\r - Patients on corticosteroids must be on a stable dose for at least 2 weeks before study\r\n\r - At least 6 weeks since other prior endocrine therapy and recovered\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 6 weeks since prior radiotherapy and recovered\r\n\r Surgery:\r\n\r - Not specified\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nRadiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in\r chemotherapy use different ways to stop tumor cells from dividing so they stop growing or\r die. Combining radiation therapy with chemotherapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin\r in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the median survival time of patients with newly diagnosed supratentorial\r glioblastoma multiforme treated with radiotherapy followed by sustained release\r intratumoral bleomycin.\r\n\r - Determine the feasibility of this regimen in these patients.\r\n\r OUTLINE: This is a multicenter study.\r\n\r Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week\r for 6 weeks.\r\n\r Within 2-6 weeks after completion of radiotherapy or at disease progression during\r radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within\r the central area of the tumor. Patients then receive sustained release bleomycin\r intratumorally via the reservoir once a week for up to 2 years in the absence of disease\r progression or unacceptable toxicity.\r\n\r Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then\r annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed supratentorial glioblastoma multiforme (with areas of\r necrosis) by surgical biopsy or excision within 4 weeks of study\r\n\r - Tumor and/or any associated edema limited to one hemisphere and unifocal\r\n\r - No gross invasion of a ventricular surface\r\n\r - Tumor accessible\r\n\r - No other astrocytoma\r\n\r - No multifocal or recurrent malignant glioma\r\n\r - No disease below the tentorium or beyond the cranial vault\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - Adult\r\n\r Performance status:\r\n\r - Zubrod 0-1\r\n\r Life expectancy:\r\n\r - At least 8 weeks\r\n\r Hematopoietic:\r\n\r - Hemoglobin at least 10 g/dL (transfusion allowed)\r\n\r - Absolute neutrophil count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.0 mg/dL\r\n\r - Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase\r (SGPT) no greater than 2 times normal\r\n\r Renal:\r\n\r - Blood Urea Nitrogen (BUN) no greater than 25 mg/dL\r\n\r - Creatinine no greater than 1.5 mg/dL\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\r\n\r - No hypersensitive or idiosyncratic reaction to bleomycin\r\n\r - No other prior malignancies within the past 2 years except nonmelanomatous skin cancer\r or carcinoma in situ of the cervix or urinary bladder\r\n\r - No other major medical illness or psychiatric impairment that would preclude study\r participation\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy for glioblastoma multiforme\r\n\r - No prior radiosensitizer for glioblastoma multiforme\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r - Recovered from prior surgery\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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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\nChemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing\r so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may\r allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.\r\n\r PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell\r transplant work in treating patients with central nervous system cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the response rate in patients with central nervous system malignancies treated\r with intensive chemotherapy supported by autologous peripheral blood stem cell\r transplantation following surgical resection and/or radiotherapy.\r\n\r - Determine the disease-free survival and overall survival of this patient population\r treated with these regimens.\r\n\r - Determine the toxicity of this high-dose chemotherapy regimen in these patients.\r\n\r - Assess the quality of life of these patients following these treatment regimens.\r\n\r OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or\r primary neuroectodermal tumor undergo initial surgical resection followed by conventional or\r stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also\r receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and\r cisplatin prior to high-dose chemotherapy.\r\n\r All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose\r chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3,\r carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3.\r Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered\r concurrently with stem cell harvesting and transplantation.\r\n\r Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy\r at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose\r chemotherapy.\r\n\r Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of\r life is assessed at follow-up.\r\n\r PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed malignant tumors\r\n\r - Anaplastic astrocytoma\r\n\r - Oligodendroglioma\r\n\r - Germ cell tumor\r\n\r - Medulloblastoma\r\n\r - Primary neuroectodermal tumor\r\n\r - Esthesioneuroblastoma\r\n\r - CNS lymphoma (primary or systemic disease)\r\n\r - Multifocal intracranial disease allowed\r\n\r - No extraneural metastases (except controlled systemic lymphoma)\r\n\r - Pretreatment considerations based on tumor type\r\n\r - Anaplastic astrocytoma:\r\n\r - Recurrent disease\r\n\r - Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)\r\n\r - Chemotherapy not required at recurrence\r\n\r - Oligodendroglioma:\r\n\r - Disease response (at least minor) to conventional chemotherapy OR\r\n\r - Recurrent disease\r\n\r - Esthesioneuroblastoma:\r\n\r - Attempted complete surgical resection\r\n\r - Disease progression after radiotherapy\r\n\r - Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and\r cisplatin\r\n\r - CNS lymphoma:\r\n\r - Disease refractory to methotrexate OR\r\n\r - Failure after initial treatment with methotrexate OR\r\n\r - Considered at high risk for disease relapse despite initial response\r\n\r - Radiographic or pathological confirmation of recurrent disease required\r\n\r - Not eligible for other high priority national or institutional clinical studies\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - ECOG or Zubrod 0-1\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Not specified\r\n\r Hepatic:\r\n\r - Not specified\r\n\r Renal:\r\n\r - Creatinine less than 1.5 times normal\r\n\r Cardiovascular:\r\n\r - LVEF at least 45%\r\n\r Pulmonary:\r\n\r - DLCO at least 60% predicted OR\r\n\r - Approval of pulmonologist\r\n\r Other:\r\n\r - Not pregnant or nursing\r\n\r - HIV negative\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - See Disease Characteristics\r\n\r - No other concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - No concurrent anticancer hormonal therapy\r\n\r - No concurrent steroids as antiemetics\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r Other:\r\n\r - No concurrent barbiturates or acetaminophen\r\n\r - Participation in other concurrent supportive care or gene therapy trials allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"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\nPhysiologic Studies of Spasticity\n\n**Clinical Trial Summary:**\n\nThis study will provide information about changes that occur in the motor neurons of the\r spinal cord (the nerve cells that control the muscles) when the motor cortex (the region of\r the brain that controls movement) is unable to send messages to the spinal cord and muscles\r in the normal way. This information will help elucidate how the nervous system adapts after\r injury or disease of the motor cortex.\r\n\r Healthy adult volunteers and adults with a spasticity disorder and moderate weakness may be\r eligible for this study. Patients will be screened with a medical history, physical\r examination and diagnostic studies as needed. Healthy volunteers will have a neurological\r examination. Muscle weakness and spasticity will be evaluated in both groups of subjects.\r\n\r All participants will have electromyography (measurement of electrical activity in muscles)\r during nerve stimulation and transcranial magnetic stimulation, described below. (Some\r patients, such as those with a pacemaker or implanted medication pumps, metal objects in the\r eye, history of epilepsy and others, will not have magnetic stimulation.)\r\n\r Electromyography - The electrical activity of muscles will be measured either by 1) using\r metal electrodes taped to the skin overlying a muscle, or 2) using thin wires inserted into\r the muscle through a needle.\r\n\r Nerve stimulation - The nerves will be stimulated by applying a small electrical pulse\r through metal disks on the skin of the arm or leg.\r\n\r Transcranial magnetic stimulation - A brief electrical current is passed through a wire coil\r placed on the scalp. This creates a magnetic pulse, which stimulates the brain. During the\r test, the participant may be asked to tense certain muscles slightly or perform other simple\r actions.\r\n\r Nerve block - Some patients will have a nerve block of one of the nerves in the arm. For this\r procedure, a local anesthetic is injected under the skin to produce numbness and weakness in\r some arm muscles.\n\n**Clinical Trial Detailed Description:**\n\nObjective: The purpose of this protocol is to characterize abnormalities in motoneuron\r recruitment in adult patients with corticospinal tract dysfunction using electrophysiologic\r measures. We wish to determine whether the intrinsic spinal mechanisms for recruitment are\r abnormal or whether only inputs to motoneurons are changed. This information is pertinent for\r assessing ways that can ultimately be used to enhance strength in patients with corticospinal\r tract dysfunction using the existing spinal circuitry.\r\n\r Study Design: Comparison of physiological observations in patients and age - matched control\r subjects.\r\n\r Study Population: Adults with spastic paresis aged 21-80 and healthy volunteers.\r\n\r Outcome Parameters: Measures of motor unit firing in response to peripheral nerve stimulation\r and transcranial magnetic stimulation.\n\n**Clinical Trial Eligibility Criteria:**\n\n- INCLUSION CRITERIA:\r\n\r Adult patients with selective corticospinal tract dysfunction\r\n\r Minimum age 21 years; maximum age 80 years\r\n\r Moderate severity of weakness (greater than or equal to MRC Grade 4)\r\n\r Adult normal volunteers\r\n\r EXCLUSION CRITERIA:\r\n\r Severe weakness with inability to maintain voluntary contractions\r\n\r Significant sensory impairment\r\n\r For TMS studies only: pregnancy, implanted devices such as pacemakers, medication pumps or\r defibrillators, metal in the cranium except the mouth, intracardiac lines, history of\r seizures\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nInterstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nIL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a\r bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a\r variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic\r benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the\r IL13 receptors was shown to be highly specific for human glioma cells.\r\n\r IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly\r into the malignant brain tumors of patients to determine the dose of drug these patients can\r tolerate. After that, the selected dose will be studied to give an estimate of the response\r rate, response duration, time to response, and survival after infusing that dose of\r IL13-PE38QQR into the recurrent malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r I. Determine the toxicities and maximum tolerated dose of IL13-PE38QQR delivered by\r continuous infusion into malignant glioma over 96 hours, in two courses eight weeks apart.\r\n\r II. Estimate the response rate, response duration, time to response, and survival after\r interstitial infusion of IL13-PE38QQR into recurrent malignant glioma.\r\n\r III. Describe the toxicities of interstitial infusion of IL13-PE38QQR at the selected dose.\r\n\r PROTOCOL OUTLINE: Patients are expected to receive two IL13-PE38QQR infusions at 8-week\r intervals. For each course, drug will be infused through each of two catheters; infusion rate\r will be held constant during a 96-hour infusion.\r\n\r In Phase I, the dose of IL13-PE38QQR will be increased by increasing the IL13-PE38QQR\r concentration in stepwise fashion, while holding infusion volume and duration constant. Three\r patients will be treated at each dose level until the maximum tolerated dose (MTD) is\r reached, and an additional three patients are treated at that level. In Phase II, patients\r will be treated at the selected MTD.\r\n\r PROJECTED ACCRUAL: In Phase I, up to 30 patients will be treated. In Phase II, up to 35\r patients will be treated.\n\n**Clinical Trial Eligibility Criteria:**\n\nDisease Characteristics\r\n\r - Must have had surgery (or biopsy) of a supratentorial brain tumor with pathologic\r diagnosis of malignant (grade 3 or 4) glioma, including anaplastic astrocytoma,\r glioblastoma multiforme and malignant mixed oligoastrocytoma. (Note: If diagnosis is\r dependent upon the Day 0 biopsy, pathology must be confirmed prior to start of\r IL13PE-38QQR infusion).\r\n\r - Must have received cranial radiotherapy, with tumor dose of at least 48 Gy, completed\r at least 12 weeks prior to study entry.\r\n\r - Must have radiographic evidence of recurrent or progressive supratentorial tumor\r compared with a previous study. The baseline tumor measurements must be determined\r within 2 weeks prior to study entry. The tumor must have a solid portion at least 1.0\r cm but not more than 5.0 cm in maximum diameter. A maximum of one satellite lesion is\r permitted, if separated by less than 3 cm from the primary mass.\r\n\r - Stereotaxic biopsy at study entry must confirm the presence of glioma.\r\n\r Patient Characteristics\r\n\r - Age 18 or greater.\r\n\r - Karnofsky Performance Score must be at least 60.\r\n\r - Hematologic status: Absolute neutrophils at least 1,500/mm^3; Hemoglobin at least 10\r gm/dL; Platelets at least 100,000/mm^3; PT & PTT less than or equal to the upper limit\r of normal.\r\n\r - Hepatic Status: Transaminases not more than 2.5 x upper limit of normal; Total\r Bilirubin not more than 2.0 mg/dL.\r\n\r - Must have recovered from toxicity of prior therapy; at least 6 weeks elapsed since\r receiving nitrosourea-containing chemotherapy and 3 weeks since receiving any other\r chemotherapy.\r\n\r - Must practice an effective method of birth control during the study.\r\n\r - Must understand the investigational nature of this study and its potential risks and\r benefits, and must sign informed consent.\r\n\r - No patients with more than two foci of tumor, tumor crossing the midline, or\r leptomeningeal tumor dissemination.\r\n\r - No patients with impending herniation, spinal cord compression, or uncontrolled\r seizures.\r\n\r - No patients who have received any localized antitumor therapy for the malignant\r glioma, either intralesional chemotherapy or focal radiotherapy (i.e. any form of\r stereotaxic RT or brachytherapy).\r\n\r - No patients who are receiving concurrent chemotherapy or another investigational\r agent.\r\n\r - No patients with prior or concurrent malignancy. (Patients with curatively treated\r carcinoma-in-situ or basal cell skin carcinoma OR who have been free of disease for at\r least 5 years are eligible).\r\n\r - Female patients must not be pregnant or 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\"."
}
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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\nChemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Giving chemotherapy together with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation\r therapy after surgery followed by chemotherapy alone works in children with newly diagnosed\r astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Compare the event-free survival of patients with newly diagnosed anaplastic astrocytoma,\r glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma (DIPG) treated\r with adjuvant temozolomide administered concurrently with postoperative radiotherapy and\r then alone as maintenance therapy vs historical control cohorts treated in prior\r Pediatric Oncology Group and Children's Cancer Group studies.\r\n\r - Determine the toxicity of this regimen in these patients.\r\n\r - Determine the efficacy of this regimen in patients with DIPG.\r\n\r - Determine the toxicity of this regimen in patients with DIPG.\r\n\r OUTLINE: This is a multicenter study.\r\n\r - Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or\r diagnosis*, patients without gross residual disease undergo cranial irradiation 5 days a\r week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with gross\r residual disease undergo radiotherapy as above followed by boost radiotherapy for 1\r week. All patients receive oral temozolomide once daily beginning within 5 days after\r initiation of radiotherapy and continuing for a total of 6 weeks in the absence of\r disease progression or unacceptable toxicity.\r\n\r - Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant\r chemoradiotherapy, patients receive oral temozolomide on days 1-5. Treatment repeats\r every 28 days for a total of 10 courses in the absence of disease progression or\r unacceptable toxicity.\r\n\r NOTE: *For patients with diffuse intrinsic pontine glioma only\r\n\r Patients are followed every 3-6 months for 4 years and then annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14\r months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed CNS tumor of the following types:\r\n\r - High grade glioma (HGG) of one of the following histologies:\r\n\r - Anaplastic astrocytoma (grade III)\r\n\r - Glioblastoma multiforme (grade IV)\r\n\r - Gliosarcoma\r\n\r - Primary spinal cord malignant glioma\r\n\r - Diffuse intrinsic pontine glioma (DIPG)\r\n\r - Diagnosed by gadolinium-enhanced MRI\r\n\r - At least 2/3 of tumor situated in the pons AND tumor clearly originated in\r the pons\r\n\r - No diffuse leptomeningeal disease\r\n\r - No tumors with features not typical of diffuse intrinsic brainstem glioma,\r including any of the following:\r\n\r - Dorsally exophytic brainstem glioma\r\n\r - Cervico-medullary junction tumor\r\n\r - Focal low-grade glioma of the midbrain or brainstem\r\n\r - No diffuse brainstem enlargement due to neurofibromatosis\r\n\r - No primary brain stem malignant glioma\r\n\r - No M+ disease (CSF positive for tumor or metastatic disease)\r\n\r - Must begin study radiotherapy within 6 weeks after surgical resection (for HGG\r patients) or diagnosis (for DIPG patients)\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 3 to 21\r\n\r Performance status:\r\n\r - Karnofsky 50-100% OR\r\n\r - Lansky 50-100%\r\n\r Life expectancy:\r\n\r - At least 2 months\r\n\r Hematopoietic:\r\n\r - Absolute neutrophil count at least 1,000/mm^3\r\n\r - Platelet count at least 100,000/mm^3*\r\n\r - Hemoglobin at least 10.0 g/dL* NOTE: *Transfusion independent\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 1.5 times upper limit of normal (ULN)\r\n\r - SGOT or SGPT less than 2.5 times ULN\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 times ULN\r\n\r Other:\r\n\r - No other concurrent malignancy\r\n\r - Concurrent seizure disorder allowed if well controlled on anticonvulsants\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception during and for 2 months after\r completion of study treatment\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic:\r\n\r - No concurrent routine cytokine support\r\n\r Chemotherapy:\r\n\r - Not specified\r\n\r Endocrine therapy:\r\n\r - No concurrent corticosteroids except for increased intracranial pressure in patients\r with CNS tumors\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r Other:\r\n\r - No prior therapy for HGG or DIPG\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nMotexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as\r motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.\r\n\r PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients\r with glioblastoma multiforme who are undergoing radiation therapy to the brain.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the toxicity of 2 different schedules of motexafin gadolinium as a\r radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy.\r\n\r - Determine the maximum tolerated doses of this drug on these 2 schedules in these\r patients.\r\n\r - Determine the pharmacokinetic profile of this drug in these patients.\r\n\r - Determine the biodistribution of this drug in both neoplastic tissue and normal brain\r parenchyma in these patients.\r\n\r - Determine the effect and accumulation of this drug in both normal brain parenchyma and\r neoplastic tissue in these patients.\r\n\r - Correlate the effect and accumulation of this drug in both normal brain parenchyma and\r neoplastic tissue with the pharmacokinetics of this drug in these patients.\r\n\r OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120).\r Patients are sequentially assigned to 1 of 2 treatment groups.\r\n\r - Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6\r weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6\r weeks.\r\n\r - Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during\r radiotherapy. Patients undergo cranial radiotherapy as in group I.\r\n\r Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum\r tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2\r of 6 patients experience dose-limiting toxicity.\r\n\r Patients are followed at 1 month and then every 2 months thereafter.\r\n\r PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed supratentorial grade IV astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Previously untreated disease\r\n\r - Measurable and contrast-enhancing tumor by MRI after incomplete resection/biopsy\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - WBC at least 3,000/mm^3\r\n\r - Absolute granulocyte count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2.0 mg/dL\r\n\r - SGOT/SGPT no greater than 4 times upper limit of normal (ULN)\r\n\r - Alkaline phosphatase no greater than 4 times ULN\r\n\r - PT/APTT normal\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 mg/dL\r\n\r Cardiovascular:\r\n\r - No uncontrolled hypertension\r\n\r Other:\r\n\r - Mini mental state exam score at least 15\r\n\r - No history of glucose-6-phosphate dehydrogenase deficiency or porphyria\r\n\r - No other malignancy within the past 5 years except curatively treated basal cell or\r squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of\r the breast\r\n\r - No serious infection\r\n\r - No other medical illness that would preclude study participation\r\n\r - No allergy to MRI contrast (e.g., motexafin gadolinium)\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception during and for up to 2 months after\r study\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No prior biologic therapy or immunotherapy for this disease, including any of the\r following:\r\n\r - Immunotoxins\r\n\r - Immunoconjugates\r\n\r - Antisense therapy\r\n\r - Peptide receptor antagonists\r\n\r - Interferons\r\n\r - Interleukins\r\n\r - Tumor-infiltrating lymphocytes\r\n\r - Lymphokine-activated killer cell therapy\r\n\r - Gene therapy\r\n\r Chemotherapy:\r\n\r - No prior chemotherapy for this disease\r\n\r Endocrine therapy:\r\n\r - Must be on a stable corticosteroid regimen (i.e., no increase within 5 days prior to\r treatment on this protocol)\r\n\r - No other prior hormonal therapy for this disease\r\n\r Radiotherapy:\r\n\r - No prior radiotherapy for this disease\r\n\r Surgery:\r\n\r - See Disease Characteristics\r\n\r - Recovered from prior surgery\r\n\r Other:\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nTemozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so\r they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.\r Combining chemotherapy and radiation therapy may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation\r therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed\r anaplastic oligoastrocytomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the rate of progression in patients with newly diagnosed anaplastic\r oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and\r concurrent temozolomide with radiotherapy.\r\n\r - Determine the toxicity of this regimen in these patients.\r\n\r - Determine the survival of patients treated with this regimen.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to response to\r neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).\r\n\r Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for\r up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with\r CR or PR receive 2 courses beyond CR or PR.\r\n\r Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or\r PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide\r daily for 42 days concurrently with radiotherapy.\r\n\r Patients with CR after completion of neoadjuvant temozolomide undergo observation.\r\n\r Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3\r years, and then annually thereafter.\r\n\r PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed supratentorial pure or mixed anaplastic\r oligodendroglioma\r\n\r - Unifocal or multifocal disease\r\n\r - Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure\r or mixed anaplastic oligodendroglioma that has not been previously treated with\r radiotherapy and/or chemotherapy\r\n\r - No equivocal oligodendroglial element\r\n\r - No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)\r\n\r - No spinal cord tumors\r\n\r - No evidence of spinal drop metastasis or spread to noncontiguous meninges\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 to 65\r\n\r Performance status:\r\n\r - Zubrod 0-1\r\n\r Life expectancy:\r\n\r - More than 12 weeks\r\n\r Hematopoietic:\r\n\r - Absolute granulocyte count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Hemoglobin at least 10 g/dL\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 2 times normal\r\n\r - Aspartate aminotransferase (AST) no greater than 3 times normal\r\n\r - Alkaline phosphatase no greater than 2 times normal\r\n\r Renal:\r\n\r - Creatinine no greater than 1.5 times normal\r\n\r Other:\r\n\r - No active infection\r\n\r - No other medical problems that would preclude study participation\r\n\r - No other malignancy within the past 3 years except carcinoma in situ of the cervix or\r nonmelanoma skin cancer\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - Not specified\r\n\r Chemotherapy:\r\n\r - See Disease Characteristics\r\n\r - No prior chemotherapy for this malignancy\r\n\r - No prior temozolomide\r\n\r Endocrine therapy:\r\n\r - Not specified\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - No prior radiotherapy to the brain, head, or neck\r\n\r Surgery:\r\n\r - At least 14 days since prior surgery requiring general anesthesia\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** 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\nImatinib Mesylate in Treating Patients With Gliomas\n\n**Clinical Trial Summary:**\n\nRATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth\r of the tumor.\r\n\r PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients\r who have gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the therapeutic activity of imatinib mesylate (in terms of objective response\r and progression-free survival at 6 months) in patients with gliomas.\r\n\r - Determine the safety of this drug in these patients.\r\n\r - Determine the pharmacokinetics of this drug in these patients.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to glioma\r (glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs\r anaplastic astrocytoma or recurrent low-grade astrocytoma).\r\n\r Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks\r for up to 9 courses in the absence of disease progression or unacceptable toxicity.\r\n\r Patients are followed every 2 months for 6 months and then every 3 months thereafter.\r\n\r PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24\r patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with\r anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed glioblastoma multiforme\r\n\r - Recurrent disease by CT scan or MRI\r\n\r - No prior chemotherapy OR\r\n\r - No more than 1 prior chemotherapy regimen in adjuvant setting or for recurrent\r disease OR\r\n\r - Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed\r oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma\r\n\r - Failed prior radiotherapy\r\n\r - No more than 1 prior chemotherapy regimen\r\n\r - Failed adjuvant chemotherapy OR\r\n\r - Failed first-line chemotherapy\r\n\r - At least 1 bidimensionally measurable target lesion\r\n\r - At least 2 cm on contrast-enhanced CT scan or MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age:\r\n\r - 18 and over\r\n\r Performance status:\r\n\r - ECOG 0-2\r\n\r Life expectancy:\r\n\r - Not specified\r\n\r Hematopoietic:\r\n\r - Neutrophil count at least 2,000/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r Hepatic:\r\n\r - Bilirubin no greater than 1.5 times upper limit of normal (ULN)\r\n\r - AST and ALT no greater than 2.5 times ULN\r\n\r - Alkaline phosphatase no greater than 2.5 times ULN\r\n\r Renal:\r\n\r - Creatinine less than 1.7 mg/dL\r\n\r Cardiovascular:\r\n\r - Cardiac function normal\r\n\r - No ischemic heart disease within the past 6 months\r\n\r - Normal 12-lead ECG\r\n\r Other:\r\n\r - No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix\r or adequately treated basal cell or squamous cell skin cancer\r\n\r - No unstable systemic disease\r\n\r - No active uncontrolled infection\r\n\r - No psychological, familial, sociological, or geographical condition that would\r preclude study compliance\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception during and for 3 months after study\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy:\r\n\r - No concurrent anticancer biologic agents\r\n\r - No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])\r\n\r Chemotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)\r\n\r - No concurrent chemotherapy\r\n\r Endocrine therapy:\r\n\r - Must be on stable or decreasing dose of corticosteroids for at least 2 weeks\r\n\r Radiotherapy:\r\n\r - See Disease Characteristics\r\n\r - At least 3 months since prior brain irradiation\r\n\r - No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or\r internal radiotherapy unless the recurrence is histologically confirmed\r\n\r - No concurrent radiotherapy\r\n\r Surgery:\r\n\r - Prior surgery for primary brain tumor within the past 3 months allowed provided one of\r the following conditions are present:\r\n\r - Postoperative imaging within 72 hours after surgery shows a clearly limited\r target lesion of at least 2 cm\r\n\r - Postoperative follow-up shows a progressive and measurable target lesion\r\n\r - A second measurable target lesion is present outside the surgical area\r\n\r Other:\r\n\r - No concurrent warfarin or other anticoagulants\r\n\r - No other concurrent anticancer agents\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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{
"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\nThalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood\r flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from\r dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and\r cyclophosphamide may kill more tumor cells.\r\n\r PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib\r with etoposide and cyclophosphamide in treating patients who have relapsed or refractory\r malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in\r terms of 6-month progression-free survival, in patients with relapsed or refractory\r malignant glioma.\r\n\r - Determine the overall survival of patients treated with this regimen.\r\n\r - Determine the toxic effects of this regimen in these patients.\r\n\r - Determine the radiographic response in patients treated with this regimen.\r\n\r OUTLINE: This is a multicenter study.\r\n\r Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42,\r oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42.\r Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.\r\n\r Patients are followed every 2 months.\r\n\r PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with\r anaplastic glioma) will be accrued for this study within 2 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed intracranial malignant glioma, including glioblastoma\r multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma,\r anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified\r\n\r - Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor\r resection\r\n\r - Steroid therapy prior to MRI or CT scan must have been at a stable dose for at\r least 5 days\r\n\r - Failed prior radiotherapy\r\n\r - Must have confirmation of true progression rather than radiation necrosis if\r previously treated with interstitial brachytherapy or stereotactic\r radiosurgery\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age\r\n\r - 18 and over\r\n\r Performance status\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy\r\n\r - More than 2 months\r\n\r Hematopoietic\r\n\r - Absolute neutrophil count at least 1,500/mm3\r\n\r - Platelet count at least 100,000/mm3\r\n\r - Hemoglobin greater than 9 g/dL\r\n\r - No history of bleeding disorder\r\n\r Hepatic\r\n\r - Bilirubin less than 1.5 mg/dL\r\n\r - SGPT less than 2.5 times normal\r\n\r - Alkaline phosphatase less than 2.5 times normal\r\n\r Renal\r\n\r - Creatinine less than 1.5 times upper limit of normal (ULN) OR\r\n\r - BUN less than 1.5 times ULN\r\n\r Cardiovascular\r\n\r - No deep vein thrombosis within the past 3 weeks (must be clinically stable)\r\n\r Pulmonary\r\n\r - No pulmonary embolism within the past 3 weeks (must be clinically stable)\r\n\r Other\r\n\r - No peripheral neuropathy grade 2 or greater\r\n\r - No active infection\r\n\r - No other serious concurrent medical illness\r\n\r - No concurrent illness that may obscure toxicity or dangerously alter drug metabolism\r\n\r - No other malignancy within the past 3 years except nonmelanoma skin cancer or\r carcinoma in situ of the cervix\r\n\r - Must participate in the System for Thalidomide Education and Prescribing Safety\r program\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use 2 forms of effective contraception for 1 month before,\r during, and for 1 month after study\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy\r\n\r - No prior oral thalidomide or celecoxib for more than 2 months duration\r\n\r Chemotherapy\r\n\r - No prior oral etoposide or cyclophosphamide for more than 2 months duration\r\n\r - Prior standard-dose IV etoposide and cyclophosphamide allowed\r\n\r Endocrine therapy\r\n\r - See Disease Characteristics\r\n\r - Concurrent steroids allowed\r\n\r Radiotherapy\r\n\r - See Disease Characteristics\r\n\r - At least 4 weeks since prior radiotherapy\r\n\r Surgery\r\n\r - See Disease Characteristics\r\n\r - Prior surgery for relapsed or refractory disease allowed\r\n\r - Recovered from prior surgery\r\n\r - No concurrent surgery\r\n\r Other\r\n\r - No other concurrent investigational agents or treatment\r\n\r - No other concurrent anticancer therapy\r\n\r - Concurrent antiseizure medications allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"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\nPhase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas\n\n**Clinical Trial Summary:**\n\nThis study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron)\r alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas\r are nourished by blood delivered through blood vessels whose formation is stimulated by\r substances produced by the tumor itself. Stopping the growth of new vessels can slow or\r prevent tumor growth. The Food and Drug Administration has approved various interferons for\r treating several diseases, including melanoma and some leukemias. These drugs block new\r vessel growth in patients with recurrent tumors, but in high doses they produce serious side\r effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high\r doses given several times a week. Thalidomide, currently approved to treat leprosy, also\r blocks development of new blood vessel formation. In a recent study of thalidomide given to\r 36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least\r 2 months, and at least 3 had responses to treatment lasting 6 to 14 months.\r\n\r Patients 18 years of age and older with a primary glioma whose tumor has recurred or is\r growing following standard treatment and does not respond to radiation therapy may be\r eligible for this study. Candidates will be screened with a physical examination, blood and\r urine tests (including a pregnancy test for women of childbearing potential), and magnetic\r resonance imaging (MRI) or computed tomography (CT) of the head.\r\n\r Patients will continue treatment cycles as long as the drug is tolerated without serious side\r effects and the tumor is not growing. While on the study, patients will undergo various tests\r and procedures as follows:\r\n\r Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to\r assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio\r waves to show structural and chemical changes in tissues. During the scan, the patient lies\r on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff\r member through an intercom system at all times during the procedure.\n\n**Clinical Trial Detailed Description:**\n\nBackground:\r\n\r There is a growing belief that angiogenesis inhibition represents a potentially promising,\r novel therapeutic approach to highly vascular solid tumors like malignant gliomas.\r Thalidomide and Peg-Intron (IFN - Interferon) are attractive drugs to use in combination to\r test the hypothesis of combination anti-angiogenesis therapy inhibition given their proven\r activity as single agents in patients with malignant gliomas and their spectrum of largely\r non-overlapping toxicities.\r\n\r Given recent preclinical data describing more potent antiangiogenic and anti-tumor effects of\r low dose, continuous IFN administration, we are interested in evaluating the use of pegylated\r IFN in combination with thalidomide. Thus, we are proposing a phase II trial of pegylated IFN\r with thalidomide in patients with recurrent gliomas.\r\n\r Objectives:\r\n\r To obtain preliminary evidence of anti-tumor efficacy of PEG-Intron in combination with\r thalidomide in patients with recurrent high grade gliomas as assessed by prolongation of\r progression-free survival compared to historical controls.\r\n\r A secondary endpoint in this trial is to determine the response rate associated with the\r combination therapy in each of the two strata and to evaluate and document all toxicities\r from PEG-Intron in combination with thalidomide at the doses prescribed in this protocol in\r this patient population.\r\n\r Eligibility:\r\n\r Patients with histologically proven supratentorial malignant primary gliomas will be eligible\r for this protocol. These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA),\r anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant\r astrocytoma NOS (not otherwise specified).\r\n\r Patients must not have received prior therapy with Peg-Intron or Thalidomide.\r\n\r Design:\r\n\r Patients will be treated with weekly PEG-Intron plus daily oral thalidomide. All patients\r will be treated for 6 weeks following which patients will have a repeat MRI scan to assess\r disease response.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with histologically proven supratentorial malignant primary gliomas will be\r eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic\r astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma\r (AMO), or malignant astrocytoma NOS (not otherwise specified).\r\n\r - Patients must have evaluable or measurable disease and have shown unequivocal evidence\r for tumor recurrence or progression by MRI or CT scan. This scan should be performed\r within 14 days prior to registration and on a steroid dosage that has been stable for\r at least 5 days. If the steroid dose is increased between the date of imaging and the\r initiation of treatment, a new 20 baseline MR/CT scan is required. The same type of\r scan, i.e., MRI or CT must be used throughout the period of treatment for tumor\r measurement.\r\n\r - Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible as long as the following conditions apply:\r\n\r - They have recovered from the effects of surgery\r\n\r - Measurable disease following resection of recurrent tumor is not mandated for\r eligibility into the study. Patients must have evaluable disease.\r\n\r - To best assess the extent of residual disease post-operatively, a CT/MRI should be\r done no later than 96 hours in the immediate post-operative period or 4-6 weeks\r post-operatively. If the 96 hour scan is more than 2 weeks from registration, the scan\r needs to be repeated.\r\n\r - The baseline on-study MR/CT is performed within 14 days of registration and on a\r steroid dosage that has been stable. If the steroid dose is increased between the date\r of imaging and the initiation of Peg-Intron with or without Thalidomide, a new\r baseline MR/CT is required on stable steroids for 5 days.\r\n\r - Patient 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 - 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 surgical\r documentation of disease.\r\n\r - Prior therapy. There are no limitations to number of prior therapies.\r\n\r - All patients must sign an informed consent indicating that they are aware of the\r investigational nature of this study.\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 (including\r resolution of effects on laboratory values): 2 weeks from any investigational agent, 4\r weeks from prior cytotoxic therapy, 2 weeks from vincristine, 6 weeks from\r nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic\r agents e.g. tamoxifen, cis- retinoic acid, etc. (radiosensitizer does not count). Any\r questions related to the definition of non-cytotoxic agents should be directed to the\r PI.\r\n\r - Patients must have adequate bone marrow function (WBC > 3,000/l, ANC > 1,500 mm3,\r platelet count of > 100,000/mm3, and hemoglobin > 10 gm%), adequate liver function\r (SGOT and bilirubin < 2 times the upper limit of normal), and adequate renal function\r (creatinine < 1.5 mg/dL or creatinine clearance > 60 cc/min) before starting therapy.\r These tests must be performed within 14 days prior to registration. Eligibility level\r for hemoglobin may be reached by transfusion.\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 - 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. Minorities\r will actively be recruited to participate.\r\n\r - Patients must not be pregnant or nursing, and all patients (both men and women) must\r be willing to practice birth control for 1 month prior, during and for 4 months after\r treatment with thalidomide. It has been proposed that thalidomide may interfere with\r hormonal-based contraception, therefore, barrier methods of contraception (i.e.\r diaphragm, condom) MUST be used rather than, or in addition to birth control pills.\r\n\r - No peripheral neuropathy > grade 1.\r\n\r - No concurrent use of other investigational agents.\r\n\r Exclusion Criteria:\r\n\r - Patients must not have:\r\n\r - Serious active infection\r\n\r - Disease that will obscure toxicity or dangerously alter drug metabolism\r\n\r - Serious intercurrent medical illness.\r\n\r - Significant illness that in the investigator's opinion cannot be adequately controlled\r with appropriate therapy or would compromise the patients ability to tolerate this\r therapy.\r\n\r - Patients must not have received prior therapy with Peg-Intron or Thalidomide.\r\n\r - Concurrent chemotherapy, immunotherapy, or radiotherapy is not permitted.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nImmunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells.\r Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic\r astrocytoma.\r\n\r PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children\r who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric\r patients with progressive or recurrent glioblastoma multiforme or anaplastic\r astrocytoma.\r\n\r - Determine the safety of this drug in these patients.\r\n\r - Determine the efficacy of this drug in these patients.\r\n\r - Compare the efficacy of this drug in patients with different histological types of\r tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody\r titer levels.\r\n\r OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1\r of 2 treatment groups by age (5-9 vs 10-18).\r\n\r All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2\r intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107).\r\n\r - Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter.\r Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three\r cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum\r tolerated dose (MTD) is determined.\r\n\r - Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two cohorts\r of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined.\r\n\r The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6\r patients experience dose-limiting toxicity.\r\n\r Patients are followed monthly for 6 months and then every 3 months for 6 months.\r\n\r PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed glioblastoma multiforme or anaplastic astrocytoma with the\r following tumor characteristics:\r\n\r - Unifocal\r\n\r - Unilateral and supratentorial\r\n\r - Diameter no greater than 3.5 cm by contrast-enhanced MRI\r\n\r - No more than 1 satellite tumor\r\n\r - Recurrent or progressive disease\r\n\r - Progressive disease defined as at least 25% increase in tumor volume by serial\r MRI or CT scans and/or at least 15% increase in the largest cross-sectional area\r of tumor as defined by the area of contrast agent enhancement\r\n\r - Must have received prior conventional treatment comprising both of the following:\r\n\r - Surgery (biopsy or debulking)\r\n\r - Radiation therapy\r\n\r - No evidence of mass effect on CT scan or MRI with more than a 5 mm midline shift\r and/or nausea, vomiting, reduced level of consciousness, or clinically significant\r papilledema\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age\r\n\r - 5 to 18\r\n\r Performance status\r\n\r - Karnofsky 60-100% OR\r\n\r - Lansky Play 50-100%\r\n\r Life expectancy\r\n\r - At least 3 months\r\n\r Hematopoietic\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - Absolute neutrophil count at least 1,000/mm^3\r\n\r Hepatic\r\n\r - Bilirubin no greater than 2.0 mg/dL\r\n\r - AST and ALT no greater than 2.5 times the upper limit of normal (ULN)\r\n\r - PT or aPTT no greater than 1.5 times ULN\r\n\r Renal\r\n\r - Not specified\r\n\r Other\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception during and for at least 2 months\r after study\r\n\r - No acute viral, bacterial, or fungal infection requiring therapy\r\n\r - Topical treatment for oral candidiasis allowed\r\n\r - No other concurrent medical condition that would preclude anesthesia\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy\r\n\r - No prior transferrin-CRM107\r\n\r Chemotherapy\r\n\r - More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)\r\n\r - More than 3 months since prior biodegradable polymer wafers\r\n\r - No concurrent chemotherapy\r\n\r Endocrine therapy\r\n\r - Must be on stable dose of steroids for 7 days prior to infusion\r\n\r Radiotherapy\r\n\r - See Disease Characteristics\r\n\r - More than 3 months since prior radiotherapy\r\n\r - More than 3 months since prior stereotactic radiosurgery\r\n\r - More than 6 weeks since prior craniospinal irradiation\r\n\r - No prior brachytherapy\r\n\r - No concurrent radiotherapy\r\n\r Surgery\r\n\r - See Disease Characteristics\r\n\r - More than 1 month since prior surgery including tumor surgery or debulking\r\n\r - No other concurrent surgery\r\n\r Other\r\n\r - More than 30 days since prior investigational agents\r\n\r - No other concurrent investigational therapy\r\n\r - No other concurrent anti-cancer 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:** 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\nPhase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas\n\n**Clinical Trial Summary:**\n\nTo analyze the effect of Talampanel on progression free survival in patients with recurrent\r high grade gliomas.\n\n**Clinical Trial Detailed Description:**\n\nTo determine the efficacy of Talampanel in patients with recurrent malignant glioma as\r measured by 6-month progression survival, as well as to obtain preliminary information\r regarding the spectrum of toxicities of the drug among this patient population.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion\r\n\r 1. Patients with histologically proven intracranial malignant glioma will be eligible for\r this protocol. Malignant glioma include glioblastoma multiforme (GBM), anaplastic\r astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma\r (AMO), or malignant astrocytoma NOS (not otherwise specified).\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.\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 1. They have recovered from the effects of surgery.\r\n\r 2. 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 4. If the 96-hour scan is more than 21 days before registration, the scan needs to be\r repeated.\r\n\r 5. 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 6. All patients must sign an informed consent indicating that they are aware of the\r investigational nature of this study.\r\n\r 7. Patients must be > 18 years old, and with a life expectancy > 8 weeks.\r\n\r 8. Patients must have a Karnofsky performance status of > 60.\r\n\r 9. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from any\r investigational agent, 4 weeks from prior cytotoxic therapy, 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, thalidomide,\r cis-retinoic acid, etc. (radiosensitizer does not count).\r\n\r 10. Patients must have adequate bone marrow function (ANC > 1,200/mm3, platelet count of >\r 100,000/mm3, and hemoglobin > 10 gm/dl), adequate liver function (SGOT and bilirubin <\r 2 times ULN), and adequate renal function (serum creatinine < 1.5 mg/dL otherwise a\r measured 24-hour creatinine clearance > 60 cc/min) before starting therapy. These\r tests must be performed within 14 days prior to registration.\r\n\r 11. 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 patients' ability to tolerate this therapy.\r\n\r 12. This study was designed to include women and minorities, but was not designed to\r measure differences of intervention effects.\r\n\r 13. Patients must not have active infection requiring IV antibiotics.\r\n\r 14. Patients must not be pregnant or nursing, and all patients (both men and women) must\r be willing to practice birth control during and for 2 months after treatment with\r Talampanel. Women of childbearing potential (WCBP) must have a negative serum or urine\r pregnancy test. In addition, sexually active WCBP must agree to use adequate\r contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal\r ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized\r partner).\r\n\r Exclusion Criteria\r\n\r 1. Patients who, in the view of the treating physician, have significant active cardiac,\r hepatic, renal, or psychiatric diseases are ineligible that would significantly\r increase the risk of using talampanel.\r\n\r 2. No concurrent use of other standard chemotherapeutics or investigative agents.\r\n\r 3. Patients known to have an active, life-threatening malignancy.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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[
{
"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\nTalampanel in Treating Patients With Recurrent High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy such as talampanel use different ways to stop tumor\r cells from dividing so they stop growing or die.\r\n\r PURPOSE: This phase II trial is studying how well talampanel works in treating patients with\r recurrent, progressive high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the efficacy of talampanel, in terms of 6-month progression-free survival, in\r patients with recurrent high-grade gliomas.\r\n\r - Determine, preliminarily, the toxic effects of this drug in these patients.\r\n\r - Determine, preliminarily, the quality of life of patients treated with this drug.\r\n\r - Determine the pharmacokinetics of this drug in patients who are and who are not\r receiving enzyme-inducing antiepileptic drugs.\r\n\r OUTLINE: Patients are stratified according to type of glioma (anaplastic astrocytoma vs\r glioblastoma multiforme). Patients in each stratum are assigned to 1 of 3 treatment groups\r according to concurrent enzyme-inducing antiepileptic drug use (yes, no, or valproic acid).\r\n\r Patients in each group receive different doses of oral talampanel 3 times daily on days 1-42.\r Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.\r\n\r Quality of life is assessed at baseline, every 3 weeks during the first course, every 6 weeks\r before all subsequent courses, and then within 2 weeks of study completion.\r\n\r Patients are followed within 2 weeks.\r\n\r PROJECTED ACCRUAL: A total of 91 patients (50 with anaplastic astrocytoma and 41 with\r glioblastoma multiforme) will be accrued for this study within 1 year.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed high-grade glioma, including any of the following:\r\n\r - Glioblastoma multiforme\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 - Patients with clinical and radiographic diagnosis of brain stem glioma are\r also eligible\r\n\r - Evidence of tumor progression by MRI or CT scan\r\n\r - Scan must be performed while patient is on a stable steroid dose for at least 5\r days\r\n\r - Must have failed prior radiotherapy\r\n\r - Residual disease after prior resection of recurrent or progressive tumor is allowed\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age\r\n\r - 18 and over\r\n\r Performance status\r\n\r - Karnofsky 60-100%\r\n\r Life expectancy\r\n\r - More than 8 weeks\r\n\r Hematopoietic\r\n\r - Absolute neutrophil count greater than 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3 (transfusion independent)\r\n\r - Hemoglobin at least 10 g/dL (transfusion allowed)\r\n\r Hepatic\r\n\r - Bilirubin less than 2 times upper limit of normal (ULN)\r\n\r - SGOT less than 2 times ULN\r\n\r - No significant active hepatic disease\r\n\r Renal\r\n\r - Creatinine less than 1.5 mg/dL OR\r\n\r - Creatinine clearance at least 60 mL/min\r\n\r - No significant active renal disease\r\n\r Cardiac\r\n\r - No significant active cardiac disease\r\n\r Other\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use 2 effective methods of contraception during and for 2 months\r after study participation\r\n\r - Able to swallow whole capsules\r\n\r - No active infection requiring IV antibiotics\r\n\r - No significant active psychiatric disease that would preclude use of the study drug\r\n\r - No other significant uncontrolled medical illness that would preclude study\r participation\r\n\r - No other active life-threatening malignancy\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy\r\n\r - At least 1 week since prior interferon or thalidomide\r\n\r - No concurrent anticancer immunotherapy\r\n\r Chemotherapy\r\n\r - At least 2 weeks since prior vincristine\r\n\r - At least 3 weeks since prior procarbazine\r\n\r - At least 6 weeks since prior nitrosoureas\r\n\r - No other concurrent anticancer chemotherapy\r\n\r Endocrine therapy\r\n\r - See Disease Characteristics\r\n\r - At least 1 week since prior tamoxifen\r\n\r - Concurrent steroids for the control of increased intracranial pressure allowed\r\n\r Radiotherapy\r\n\r - See Disease Characteristics\r\n\r - At least 4 weeks since prior radiotherapy\r\n\r - No concurrent anticancer radiotherapy\r\n\r Surgery\r\n\r - See Disease Characteristics\r\n\r - Prior recent resection of recurrent or progressive disease allowed\r\n\r Other\r\n\r - Recovered from all prior therapy\r\n\r - At least 1 week since prior noncytotoxic agents (e.g., isotretinoin), except for\r radiosensitizers\r\n\r - At least 4 weeks since prior investigational agents\r\n\r - At least 4 weeks since prior cytotoxic therapy\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
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46
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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 Treating Patients With Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make\r the body build an immune response to kill tumor cells.\r\n\r PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in\r treating patients with malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor\r lysate-pulsed dendritic cells in patients with malignant gliomas.\r\n\r - Determine survival, tumor progression, and cellular immune response in patients treated\r with this regimen.\r\n\r OUTLINE: This is a dose-escalation study.\r\n\r Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells\r (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to\r sargramostim (GM-CSF) and interleukin-4 and pulsed with autologous tumor lysate. Patients\r receive autologous tumor lysate-pulsed DC intradermally on days 0, 14, and 28 in the absence\r of unacceptable toxicity.\r\n\r Cohorts of 6-12 patients receive escalating doses of autologous tumor lysate-pulsed DC until\r the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that\r at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\r\n\r Patients are followed every 2 months for 2 years.\r\n\r PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 9-18\r months.\n\n**Clinical Trial Eligibility Criteria:**\n\nEligibility Criteria:\r\n\r - Histologically confirmed diagnosis of one of the following malignant gliomas:\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic oligodendroglioma\r\n\r - Malignant mixed oligoastrocytoma\r\n\r - WHO grade III or IV disease\r\n\r - Newly diagnosed disease\r\n\r - Bidimensionally measurable disease by contrast-enhancing MRI\r\n\r - Surgically accessible tumor for which resection is indicated\r\n\r - Previously treated with or plan to undergo treatment with conventional external beam\r radiotherapy\r\n\r - Age 18 and over\r\n\r - Performance status Karnofsky 60-100%\r\n\r - Life expectancy at least 8 weeks\r\n\r - Hemoglobin at least 10 g/dL\r\n\r - Absolute granulocyte count at least 1,500/mm^3\r\n\r - Platelet count at least 100,000/mm^3\r\n\r - SGOT and SGPT no greater than 2 times normal\r\n\r - Alkaline phosphatase no greater than 2 times normal\r\n\r - Bilirubin no greater than 1.5 mg/dL\r\n\r - Hepatitis B negative\r\n\r - Hepatitis C negative\r\n\r - BUN no greater than 1.5 times normal\r\n\r - Creatinine no greater than 1.5 times normal\r\n\r - HIV negative\r\n\r - Syphilis serology negative\r\n\r - Afebrile\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered.\r\n\r - At least 2 weeks since prior corticosteroids\r\n\r - At least 2 weeks since prior radiotherapy and recovered\r\n\r - More than 72 hours since prior systemic antibiotics\r\n\r Exclusion Criteria:\r\n\r - active infection\r\n\r - immunodeficiency\r\n\r - autoimmune disease that may be exacerbated by immunotherapy, including any of the\r following:\r\n\r - Rheumatoid arthritis\r\n\r - Systemic lupus erythematosus\r\n\r - Vasculitis\r\n\r - Polymyositis-dermatomyositis\r\n\r - Scleroderma\r\n\r - Multiple sclerosis\r\n\r - Juvenile-onset insulin-dependent diabetes\r\n\r - allergy to study agents\r\n\r - pregnant or nursing\r\n\r - underlying condition that would contraindicate study therapy\r\n\r - concurrent severe or unstable medical condition that would preclude giving informed\r consent\r\n\r - psychiatric condition that would preclude study participation or giving informed\r consent\r\n\r - other malignancy within the past 5 years except adequately treated basal cell or\r squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the\r cervix\r\n\r - concurrent chemotherapy during and for 2 weeks after administration of study vaccine\r\n\r - concurrent corticosteroids prior organ allograft\r\n\r - antihistamine therapy within 5 days before or after administration of study vaccine\r\n\r - other concurrent investigational agents\r\n\r - concurrent adjuvant therapy during and for 2 weeks after administration of study\r 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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47
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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 of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to find out about the safety of adding the investigational drug\r motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with\r malignant glioma. Secondly, the study will determine how many patients will respond to this\r treatment.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - At least 18 years old\r\n\r - Histologically confirmed diagnosis of malignant gliomas that requires systemic\r antineoplastic treatment. Malignant glioma is defined as any of the following:\r Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic\r oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except\r low-grade glioma)\r\n\r - ECOG performance status score of 0, 1, or 2\r\n\r - Each patient must sign a study-specific informed consent form\r\n\r Exclusion Criteria:\r\n\r Laboratory values of:\r\n\r - Absolute neutrophil count < 2000/µL\r\n\r - Platelet count < 100,000/µL\r\n\r - AST or ALT > 2 x the upper limit of normal (ULN)\r\n\r - Alkaline phosphatase > 5 x ULN\r\n\r - Bilirubin > 2 x ULN\r\n\r - Creatinine > 2.0 mg/µL\r\n\r and\r\n\r - Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during\r the study period\r\n\r - Women who are pregnant or lactating\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
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48
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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 Treating Patients With Recurrent or Progressive Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThis phase I trial is studying the side effects and best dose of sorafenib in treating\r patients with recurrent or progressive malignant glioma. Sorafenib may stop the growth of\r tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for\r their growth.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine the maximum tolerated dose (MTD) of BAY 43-9006 when administered to adults\r with recurrent malignant glioma, receiving (Group A) or not receiving (Group B)\r anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.\r\n\r II. To assess and estimate the dose-related toxicities. III. To describe the pharmacokinetics\r of this route of administration, measuring BAY 43-9006, and to assess the pharmacokinetic\r difference between patients taking enzyme-inducing agents and those who are not.\r\n\r IV. To estimate overall survival.\r\n\r OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to\r the concurrent use of cytochrome P450-inducing anticonvulsants (yes vs no).\r\n\r Patients receive oral sorafenib twice daily on days 1-28 (once daily on day 1 of course 1\r only). Courses repeat every 28 days in the absence of disease progression or unacceptable\r toxicity.\r\n\r Cohorts of 3-6 patients per stratum receive escalating doses of sorafenib until the maximum\r tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2\r of 3 or 3 of 6 patients experience dose-limiting toxicity.\r\n\r Patients are followed every 2 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histologically proven malignant glioma (anaplastic astrocytoma,\r anaplastic oligodendroglioma or glioblastoma multiforme) which is progressive or\r recurrent after radiation therapy ± chemotherapy; patients with previous low grade\r glioma who progressed after radiotherapy ± chemotherapy and are biopsied and found to\r have a high grade glioma are eligible\r\n\r - Patients must have measurable progressive or recurrent malignant glioma by MRI or CT\r imaging; (Within 14 days before starting treatment)\r\n\r - Patients must have recovered from toxicity of prior therapy; an interval of at least 3\r months must have elapsed since the completion of the most recent course of radiation\r therapy, while at least 3 weeks must have elapsed since the completion of a\r non-nitrosourea containing chemotherapy regimen, and at least 6 weeks since the\r completion of a nitrosourea containing chemotherapy regimen\r\n\r - Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be\r able to care for himself/herself with occasional help from others)\r\n\r - Absolute Neutrophil Count >= 1500/mm^3\r\n\r - Platelets >= 100,000/mm^3\r\n\r - Creatinine =< 1.7mg/dl\r\n\r - Total Bilirubin =< 1.5mg/dl\r\n\r - Transaminases =< 4 times above the upper limits of the institutional norm\r\n\r - PT, PTT, INR within institutional norm\r\n\r - Patients must be able to provide written informed consent\r\n\r - Patients with the potential for pregnancy or impregnating their partner must agree to\r follow acceptable birth control methods to avoid conception; women of childbearing\r potential must have a negative serum pregnancy test; (The anti-proliferative activity\r of this experimental drug may be harmful to the developing fetus or nursing infant)\r\n\r - Patients must have a Mini Mental State Exam score >= 15\r\n\r Exclusion Criteria:\r\n\r - Patients with serious concurrent infection or medical illness which would jeopardize\r the ability of the patient to receive the treatment outlined in this protocol with\r reasonable safety; (Examples of medical illnesses are [but not limited to] the\r following: uncontrolled hypertension, symptomatic congestive heart failure, unstable\r angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that\r would limit compliance with study requirements)\r\n\r - Patients who are pregnant or breast-feeding; (The anti-proliferative activity of this\r experimental drug may be harmful to the developing fetus or nursing infant)\r\n\r - Patients who have received more than two prior treatments\r\n\r - Patients receiving concurrent therapy for their tumor (with the exception of steroids)\r\n\r - Patients with a concurrent malignancy are ineligible unless they are patients with\r curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients\r with a prior malignancy are ineligible unless they have been free of disease for >=\r five years\r\n\r - Patients must not have any evidence of bleeding diathesis\r\n\r - Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation\r (i.e. low dose warfarin) of venous or arterial access devices is allowed provided that\r the requirements for PT, INR or PTT are met; (Patients will be taken off treatment if\r they require therapeutic anticoagulation during BAY 43-9006 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
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49
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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\nRadiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas\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 temozolomide and lomustine, work in different ways to stop the growth\r of tumor cells, either by killing the cells or by stopping them from dividing. Giving\r radiation therapy together with temozolomide and lomustine after surgery may kill any\r remaining tumor cells.\r\n\r PURPOSE: This phase II trial is studying how well giving radiation therapy together with\r temozolomide and lomustine works in treating young patients with newly diagnosed gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Compare event-free survival of pediatric patients with newly diagnosed high-grade\r gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and\r lomustine with historical controls.\r\n\r - Determine the toxicity of this regimen in these patients.\r\n\r - Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with\r this regimen.\r\n\r - Correlate polymorphisms in GSTP1, GSTM1, and GSTT1 genes and GSTP1 protein expression in\r tumors with survival in patients treated with this regimen.\r\n\r OUTLINE: This is a pilot, multicenter study.\r\n\r - Chemoradiotherapy: Patients receive oral temozolomide once daily on days 1-42. Patients\r also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33,\r and 36-40. Patients who did not undergo prior gross total resection also undergo boost\r radiotherapy once daily on days 43-47.\r\n\r - Maintenance chemotherapy: Four weeks after completion of chemoradiotherapy, patients\r receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment\r repeats every 42 days for up to 6 courses in the absence of disease progression or\r unacceptable toxicity.\r\n\r Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then\r annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study within 1-1.5\r years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following\r histologies:\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Gliosarcoma\r\n\r - Primary spinal cord malignant gliomas allowed\r\n\r - No primary brainstem tumors\r\n\r - Has undergone surgical resection or biopsy of the tumor within the past 31 days\r\n\r - Pre-operative and post-operative brain MRI with and without gadolinium-contrast\r OR pre-operative and post-operative spine MRI for spinal cord primaries\r\n\r - Post-operative MRI not required for patients who undergo biopsy only\r\n\r - No evidence of neuraxis dissemination\r\n\r - Spine MRI and cerebrospinal fluid cytology required only if clinically indicated\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age\r\n\r - 3 to 21\r\n\r Performance status\r\n\r - Karnofsky 50-100% (for patients > 16 years of age)\r\n\r - Lansky 50-100% (for patients ≤ 16 years of age)\r\n\r Life expectancy\r\n\r - At least 8 weeks\r\n\r Hematopoietic\r\n\r - Absolute neutrophil count ≥ 1,000/mm^3\r\n\r - Platelet count ≥ 100,000/mm^3 (transfusion independent)\r\n\r - Hemoglobin ≥ 8 g/dL (transfusions allowed)\r\n\r Hepatic\r\n\r - Bilirubin ≤ 1.5 times upper limit of normal (ULN)\r\n\r - ALT ≤ 2.5 times ULN\r\n\r - Albumin ≥ 2 g/dL\r\n\r Renal\r\n\r - Creatinine ≤ 1.5 times ULN OR\r\n\r - Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of\r normal\r\n\r Pulmonary\r\n\r - No evidence of dyspnea at rest\r\n\r - No exercise intolerance\r\n\r - Pulse oximetry ≥ 94% (if determination is clinically indicated)\r\n\r Other\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception during and for 2 months after study\r participation\r\n\r - Able to swallow oral medication\r\n\r - Seizures allowed provided they are well controlled with anticonvulsants\r\n\r - No hypersensitivity to temozolomide\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy\r\n\r - No prior biologic agents\r\n\r Chemotherapy\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy\r\n\r - Prior corticosteroids allowed\r\n\r - No concurrent corticosteroids as an antiemetic\r\n\r - Concurrent corticosteroids allowed only for treatment of increased intracranial\r pressure\r\n\r Radiotherapy\r\n\r - No concurrent radiotherapy using cobalt-60\r\n\r Surgery\r\n\r - See Disease Characteristics\r\n\r Other\r\n\r - No other prior treatment\r\n\r - No concurrent phenobarbital or cimetidine\r\n\r - No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during\r study chemoradiotherapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\n17-N-Allylamino-17-Demethoxygeldanamycin and Bortezomib in Treating Patients With Relapsed or Refractory Hematologic Cancer\n\n**Clinical Trial Summary:**\n\nThis phase I trial is studying the side effects and best dose of\r 17-N-allylamino-17-demethoxygeldanamycin and bortezomib in treating patients with relapsed or\r refractory hematologic cancer. Drugs used in chemotherapy, such as\r 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of cancer\r cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the\r growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving\r 17-N-allylamino-17-demethoxygeldanamycin together with bortezomib may kill more cancer cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To determine the maximum tolerated dose (MTD) of PS-341 (Velcade, Bortezomib) in\r combination with 17-allyamino-17-demethoxygeldanamycin (17-AAG) in patients with relapsed or\r refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL).\r\n\r II. To determine the MTD of PS-341 in combination with 17-AAG in patients with relapsed or\r refractory chronic lymphocytic leukemia (CLL), and non-Hodgkin's lymphoma (NHL).\r\n\r III. To define the specific toxicities and the dose limiting toxicity (DLT) of PS-341 in\r combination with 17-AAG in the treatment of patients with relapsed or refractory hematologic\r malignancies.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To determine the pharmacokinetics of 17-AAG alone and in combination with PS-341 in\r patients with AML, ALL, CLL, and NHL.\r\n\r II. To evaluate 20S proteasome inhibition following combination therapy with 17-AAG and\r PS-341 in patients with AML, ALL, CLL, and NHL.\r\n\r III. To assess the relationship between FLT3 mutational status and leukemic cell response to\r PS-341 and 17-AAG in patients with AML.\r\n\r IV. To assess the relationship between Bcl-2 over-expression and response to 17-AAG and\r PS-341 in patients with AML and NHL.\r\n\r V. To evaluate the effects of the combination of PS-341 and 17-AAG on Hsp90 and NF-kappaB and\r their downstream targets including Hsp70, Akt, phosphorylated Akt, p21, and caspases 3 and 9\r in patient-derived primary AML and NHL cells.\r\n\r OUTLINE: This is a dose-escalation study. Patients are stratified according to diagnosis\r (acute myeloid leukemia [AML] or acute lymphoblastic leukemia vs chronic lymphoctyic leukemia\r or non-Hodgkin's lymphoma [NHL]).\r\n\r Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) intravenously (IV) over\r 1-6 hours on days 1, 4, 8, and 11 and bortezomib IV over 3-5 seconds on days 4, 8, and 11 of\r course 1 and on days 1, 4, 8, and 11 of all subsequent courses.\r\n\r Treatment repeats every 21 days for 3-12 courses provided patient is receiving clinical\r benefit. Patients achieving objective response may discontinue therapy to undergo stem cell\r transplantation.Cohorts of 3-6 patients with receive escalating doses of 17-AAG and\r bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the\r dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\r\n\r After the MTD is determined, an additional 20 patients (10 per stratum with AML or follicular\r NHL) are enrolled and receive 17-AAG and bortezomib as above at the MTD.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically or cytologically confirmed diagnosis of 1 of the following hematologic\r malignancies:\r\n\r - Acute myeloid leukemia or acute lymphoblastic leukemia\r\n\r - Not a candidate for potentially curative therapy\r\n\r - WBC ≤ 10,000/mm^3 OR WBC ≤ 40,000/mm^3 that is stable for 5 days\r (hydroxyurea allowed)\r\n\r - No acute promyelocytic leukemia\r\n\r - Non-Hodgkin's lymphoma (NHL), including 1 of the following subtypes:\r\n\r - Small lymphocytic lymphoma\r\n\r - Marginal zone lymphoma\r\n\r - Lymphoplasmacytic lymphoma\r\n\r - Follicular lymphoma\r\n\r - Mantle cell lymphoma\r\n\r - Diffuse large B-cell lymphoma\r\n\r - Anaplastic large cell lymphoma\r\n\r - Peripheral T-cell lymphoma\r\n\r - Extranodal NK/T cell lymphoma (nasal and nasal type)\r\n\r - Enteropathy-type T-cell lymphoma\r\n\r - Hepatosplenic T-cell lymphoma\r\n\r - Angioimmunoblastic T-cell lymphoma\r\n\r - Subcutaneous panniculitis-like T-cell lymphoma\r\n\r - Chronic lymphocytic leukemia (CLL)\r\n\r - Patients with NHL or CLL must meet the following criteria:\r\n\r - Ineligible for, or refused potentially curative stem cell transplantation\r\n\r - Transformed lymphoma/Richter's transformation, defined as the transformation of\r low-grade lymphoma, including follicular lymphoma, CLL, or small lymphocytic\r lymphoma to high-grade lymphoma (i.e., diffuse large cell lymphoma) allowed at\r time of transformation\r\n\r - Evidence of ≥ 50% bone marrow involvement at the time of enrollment OR tumor\r tissue accessible for biopsy (for patients enrolled after the maximum tolerated\r dose [MTD] is determined)\r\n\r - Absolute neutrophil count ≥ 1,000/mm^3\r\n\r - Platelet count ≥ 100,000/mm^3\r\n\r - Relapsed or refractory disease\r\n\r - Willing to undergo serial bone marrow biopsy (for patients enrolled after the MTD is\r determined)\r\n\r - No untreated or active CNS leukemia or lymphoma\r\n\r - Performance status - ECOG 0-2\r\n\r - At least 12 weeks\r\n\r - Bilirubin ≤ 1.5 mg/dL\r\n\r - AST and ALT ≤ 2.5 times upper limit of normal\r\n\r - Creatinine ≤ 2.0 mg/dL\r\n\r - No uncontrolled cardiac disease\r\n\r - No New York Heart Association class III-IV symptomatic congestive heart failure\r\n\r - No unstable angina pectoris\r\n\r - No serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular\r fibrillation > 3 beats in a row) within the past 6 months\r\n\r - No other uncontrolled cardiac arrhythmia or requiring antiarrhythmic drugs\r\n\r - No myocardial infarction within the past year\r\n\r - No active ischemic heart disease within the past year\r\n\r - No congenital long QT syndrome\r\n\r - No left bundle branch block\r\n\r - QTc ≥ 450 msec (for men) or 470 (for women) on ECG/EKG\r\n\r - No history of LVEF < 50% by MUGA or echocardiogram\r\n\r - Resting ejection fraction ≥ 50% by MUGA or echocardiogram\r\n\r - No prior history of cardiac toxicity after receiving anthracycline therapy (e.g.,\r doxorubicin hydrochloride, daunorubicin hydrochloride, or mitoxantrone hydrochloride)\r\n\r - No uncontrolled pulmonary disease\r\n\r - No symptomatic pulmonary disease requiring oxygen or medications\r\n\r - DLCO (i.e., oxygen diffusion capacity) ≥ 80% on pulmonary function testing\r\n\r - Resting and exercise oxygen saturation ≥ 90% by pulse oximetry\r\n\r - No ongoing pulmonary symptoms ≥ grade 2 including any of the following:\r\n\r - Dyspnea on or off exertion\r\n\r - Paroxysmal nocturnal dyspnea\r\n\r - Significant pulmonary disease including chronic obstructive or restrictive\r pulmonary disease\r\n\r - No prior history of pulmonary toxicity after bleomycin or carmustine\r\n\r - No Medicare requirement for home oxygen (e.g., Resting O_2 saturation ≥ 90% or\r desaturation to ≥ 90% with exertion)\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - HIV negative\r\n\r - No preexisting sensory or motor peripheral neuropathy ≥ grade 2\r\n\r - No history of allergic reaction to eggs\r\n\r - No ongoing or active infection\r\n\r - No psychiatric illness or social situation that would preclude study compliance\r\n\r - No other uncontrolled illness\r\n\r - Prior stem cell transplantation for relapsed or refractory disease allowed\r\n\r - At least 2 weeks since prior immunotherapy and recovered\r\n\r - At least 2 weeks since prior chemotherapy (excluding hydroxyurea) and recovered\r\n\r - No other concurrent chemotherapy\r\n\r - No concurrent routine corticosteroids except for treatment of other medical problems\r (e.g., pulmonary, rheumatologic, or adrenal disorders)\r\n\r - At least 2 weeks since prior radiotherapy and recovered\r\n\r - No prior radiotherapy that potentially included the heart in the field (e.g., mantle)\r\n\r - No prior history of chest radiation\r\n\r - No concurrent palliative radiotherapy\r\n\r - At least 2 weeks since prior investigational therapy\r\n\r - Prior bortezomib allowed\r\n\r - No other concurrent commercial or investigational agents or therapies for the\r malignancy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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 Gliomas\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. Giving temozolomide together\r with radiation therapy may kill more tumor cells.\r\n\r PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation\r therapy works in treating patients with low-grade gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Compare the 3-year survival of patients with high-risk low-grade gliomas treated with\r temozolomide and radiotherapy followed by temozolomide alone with that of patients\r enrolled on European Organization for Research and Treatment of Cancer (EORTC)clinical\r trials EORTC-22844 and EORTC-22845.\r\n\r - Determine the toxicity of this regimen in these patients.\r\n\r - Determine the association between progression-free survival and O6-methylguanine-DNA\r methyltransferase (MGMT) methylation status in patients treated with this regimen.\r\n\r - Determine the association between survival and MGMT methylation status in patients\r treated with this regimen.\r\n\r - Determine the quality of life (QOL) of patients treated with this regimen.\r\n\r - Determine the neurocognitive function of patients treated with this regimen.\r\n\r - Evaluate the feasibility of collecting patient-reported QOL and neurocognitive\r assessments over 3 years.\r\n\r OUTLINE: This is a non-randomized, multicenter study.\r\n\r Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once\r daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40, one hour before RT weekdays, in the\r evening weekends. Beginning 28 days after completion of chemoradiotherapy, patients receive\r oral temozolomide once daily on days 1-5. Treatment with temozolomide repeats every 28 days\r for up to 12 courses in the absence of disease progression or unacceptable toxicity.\r\n\r Quality of life is assessed at baseline, 6 months, 12 months.\r\n\r After completion of study treatment, patients are followed at 4 months, every 6 months for 2\r years, and then annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 44 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed* supratentorial glioma of 1 of the following histologies:\r\n\r - Astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic)\r\n\r - Oligodendroglioma\r\n\r - Oligoastrocytoma Note: *Histologic atypia allowed provided no other histologic\r features (i.e., frequent mitoses, endothelial proliferation, and/or acute\r necrosis) that would result in a designation of anaplastic astrocytoma,\r anaplastic mixed oligodendroglioma or oligoastrocytoma, or glioblastoma\r multiforme are present\r\n\r - Unifocal or multifocal disease\r\n\r - World Health Organization (WHO) grade II disease\r\n\r - Neurofibromatosis allowed\r\n\r - Surgical biopsy or resection for tumor tissue sampling required within the past 12\r weeks\r\n\r - Tissue block or core biopsy available for O6-methylguanine-DNA methyltransferase\r analysis and tissue banking\r\n\r - Patients who have only had a stereotactic biopsy are not eligible\r\n\r - Must have ≥ 3 of the following risk factors:\r\n\r - Age 40 and over\r\n\r - Largest preoperative tumor diameter ≥ 6 cm\r\n\r - Tumor crosses the midline\r\n\r - Astrocytoma-dominant tumor subtype\r\n\r - Preoperative Neurological Function Status > 1\r\n\r - No other low-grade glioma histologies, including any of the following:\r\n\r - Pilocytic astrocytoma\r\n\r - Subependymal giant cell astrocytoma of tuberous sclerosis\r\n\r - Subependymoma\r\n\r - Pleomorphic xanthoastrocytoma\r\n\r - Presence of a neuronal element, such as ganglioglioma\r\n\r - Dysneuroembryoplastic epithelial tumor\r\n\r - No high-grade glioma, including any of the following:\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - No tumors in any non-supratentorial location, including any of the following:\r\n\r - Optic chiasm\r\n\r - Optic nerve(s)\r\n\r - Pons\r\n\r - Medulla\r\n\r - Cerebellum\r\n\r - Spinal cord\r\n\r - No evidence of disease progression to spinal meninges or noncontiguous cranial\r meninges (i.e., leptomeningeal gliomatosis) by MRI of the spine or cerebrospinal fluid\r (CSF) cytology\r\n\r - MRI of the spine or CSF cytology are not required for patients without symptoms\r of spinal/cranial meningeal disease progression\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age\r\n\r - 18 and over\r\n\r Performance status\r\n\r - Zubrod 0-2\r\n\r Life expectancy\r\n\r - Not specified\r\n\r Hematopoietic\r\n\r - Absolute neutrophil count ≥ 1,500/mm^3\r\n\r - Platelet count ≥ 100,000/mm^3\r\n\r Hepatic\r\n\r - Total bilirubin ≤ 1.5 mg/dL\r\n\r - Serum glutamate oxaloacetate transaminase (SGOT) or Serum glutamate pyruvate\r transaminase (SGPT) ≤ 2 times normal\r\n\r - Alkaline phosphatase ≤ 2 times normal\r\n\r Renal\r\n\r - Serum creatinine ≤ 1.5 mg/dL\r\n\r Other\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - No known HIV positivity\r\n\r - No other malignancy within the past 5 years except carcinoma in situ of the cervix or\r nonmelanoma skin cancer\r\n\r - No active infection\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Biologic therapy\r\n\r - No concurrent immunotherapy or biologic therapy\r\n\r Chemotherapy\r\n\r - No prior chemotherapy\r\n\r - No other concurrent chemotherapy\r\n\r Endocrine therapy\r\n\r - Not specified\r\n\r Radiotherapy\r\n\r - No prior radiotherapy to the head and neck unless head and neck radiotherapy clearly\r excluded the brain (e.g., localized radiotherapy to the vocal cords)\r\n\r - No prior radiotherapy to the brain\r\n\r - No concurrent intensity modulated radiotherapy\r\n\r - No concurrent stereotactic boost radiotherapy\r\n\r Surgery\r\n\r - See Disease Characteristics\r\n\r Other\r\n\r - No other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\n131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma\n\n**Clinical Trial Summary:**\n\nThis drug is being developed to treat a type of brain cancer, glioma. This study was\r developed to evaluate the safety, time to disease progression and survival rates after\r treatment.\n\n**Clinical Trial Detailed Description:**\n\nThis phase II trial was designed in two sequences. The first sequence, which is now complete\r to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable\r patients with high-grade glioma.\r\n\r The second sequence is currently open and accruing eligible subjects with high-grade glioma.\r The trial is an open-label, randomized study and will accrue a total of 54 evaluable\r patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I\r labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first\r sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular\r access device into the tumor cavity for administration of 131I-TM-601. Patients who\r participated in the first sequence are not eligible to participate in the second sequence of\r the study.\r\n\r High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma\r or gliosarcoma.\r\n\r Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI)\r assessments, at defined intervals, until 12 months after the first study dose.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient must have a histologically confirmed unilateral, supratentorial malignant\r glioma (grade 3 or 4, anaplastic astrocytoma, gliosarcoma, glioblastoma multiforme or\r malignant oligoastrocytoma)\r\n\r - Patient must have glioma progression or recurrence following radiotherapy that was no\r less than 50 Gy (+/- chemotherapy; +/- surgery)\r\n\r - Patient must be a candidate for resection of the recurrent tumor (surgical\r requirements are detailed in the study protocol)\r\n\r - Imaging must show recurrent, unilateral, supratentorial tumor(s)\r\n\r - There is no diffuse leptomeningeal disease\r\n\r - For patients with previous radiosurgery or enhanced radiotherapy, based on\r neurosurgeon's judgment, the area of enhancement can be removed during the surgery\r\n\r - Patient must have recovered from toxicity of prior therapy\r\n\r - Patient must be > 18 years of age.\r\n\r - Patient has a Karnofsky Performance Status greater than or equal to 60%\r\n\r - Patient must have a life expectancy of at least 3 months\r\n\r - Patient has no uncontrolled seizures or other neurological conditions which would\r interfere with evaluation\r\n\r - Patient is not currently receiving, or is not anticipated to receive, concomitant\r anticancer agent(s) during the course of this study\r\n\r - Patient must have given informed consent\r\n\r Exclusion Criteria:\r\n\r - Patient with concurrent malignancy (except curatively treated basal or squamous cell\r carcinoma of the skin or carcinoma in situ of cervix and/or breast) or patients with\r prior malignancies that have not been disease-free for five years\r\n\r - Patient has presence of non-contiguous satellite lesions\r\n\r - Patient with known allergy to iodine, iodine containing drugs or contrast agent\r\n\r - Patient with the potential for pregnancy or impregnating their partner and who do not\r agree to follow an acceptable birth control method to avoid conception\r\n\r - Pregnant or breast feeding females\r\n\r - Patient is not maintained on a stable corticosteroid regimen\r\n\r - New onset of conditions not present prior to surgery (as detailed in Study Protocol)\r which would make patient an inappropriate study candidate, or as determined by\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\"."
}
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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\nBNCT to Treat Glioma That Has Progressed Following Radiotherapy\n\n**Clinical Trial Summary:**\n\nBoron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which is\r based on the principle of irradiating boron atoms with neutrons. When neutrons have\r relatively low energy, boron atoms that have been targeted to cancerous tissue using a\r suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will\r capture the neutrons. As a result from the neutron capture the boron atoms will split into\r two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a\r short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect\r mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor.\r In practice, the study participants will receive BPA as an approximately 2-hour intravenous\r infusion, following which the tumor is irradiated with low energy (epithermal) neutrons\r obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose\r planning, but neutron irradiation will last approximately only for one hour. In this study\r BNCT is given once. The study hypothesis is that anaplastic astrocytomas and glioblastomas\r that have recurred following conventional radiotherapy might accumulate the boron carrier\r compound, and might respond to BNCT.\n\n**Clinical Trial Detailed Description:**\n\nThis is a single BNCT-facility, non-randomized, non-comparative, prospective, open-label,\r phase I/II study to determine the value of BNCT in the treatment of inoperable, irradiated,\r progressing anaplastic astrocytomas or glioblastomas following conventional radiation\r therapy. The neutron irradiation site is the FiR 1 reactor site, located at Otaniemi, Espoo,\r Finland, about 6 kilometers from the Helsinki University Central Hospital, Helsinki, where\r patient evaluation and post-irradiation care will take place.\r\n\r BPA is infused as a fructose complex (BPA-F) into a peripheral vein over 2 hours prior to\r neutron irradiation. Blood samples will be taken before starting the BPA infusion, and\r thereafter at 20 to 40 minute intervals during the infusion, following infusion, and after\r delivering neutron irradiation to monitor the blood boron concentration. The blood samples\r will be analyzed for boron to estimate the average blood boron level during neutron\r irradiation. A minimum tumor dose of 17 Gy (W) is given while limiting the normal brain\r maximum peak dose to 8 Gy (W), and the average normal brain dose to 6 Gy (W). The first 10\r patients will be given BPA 290 mg/kg, following which the BPA dose will be escalated in\r cohorts of 3 subjects gradually up to 450 mg/kg, provided that protocol-specified\r unacceptable toxicity will not occur.\r\n\r All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed supratentorial glioblastoma or anaplastic astrocytoma.\r\n\r - Recurred tumor after surgery and radiotherapy or tumor progressing after radiotherapy.\r\n\r - Recurrence/progression has been confirmed by serial MRI scans and a biopsy, or by\r debulking surgery.\r\n\r - The World Health Organization performance status <2.\r\n\r - WBC >2,500/mm3, platelet count >75,000/mm3, serum creatinine <180 umol/L.\r\n\r - A written informed consent\r\n\r Exclusion Criteria:\r\n\r - Age less than 18\r\n\r - Tumor infiltrates into the brain stem or the optic tracts\r\n\r - The majority of tumor tissue consists of grade II glioma with only a focal grade III\r component\r\n\r - A minimum gross tumor dose of 17 Gy (W) is not obtained in dose-planning\r\n\r - Less than 6 months has elapsed from the last date of external irradiation\r\n\r - Less than 4 weeks has elapsed from the last cancer chemotherapy dose prior to giving\r BNCT\r\n\r - The total conventional radiation therapy dose given is more than 61 Gy or less than 50\r Gy, or one of nonconventional fractionation schemes has been used (conventional:\r 1.8-2.0 Gy/day, 5 days per week, weekly dose 9 to 10 Gy)\r\n\r - More than approximately 1/3 of the total brain volume has been within the 90% isodose\r\n\r - Gliomas where the enhancing tumor volume is larger than 2/3 of the volume of one\r hemisphere in the MRI examination preceding BNCT\r\n\r - More than one radiotherapy course has been given to the brain tumor\r\n\r - Untreated congestive heart failure or renal failure\r\n\r - Uncontrolled brain oedema despite the use of corticosteroids\r\n\r - A cardiac pace-maker or an unremovable metal implant present in the head and neck\r region that will interfere with MRI-based dose-planning\r\n\r - Restlessness or inability to lie in a cast for 30 to 60 minutes\r\n\r - Clinical follow-up after therapy cannot be arranged\r\n\r - Pregnancy\r\n\r - Inability to understand treatment options\r\n\r - Unwillingness to take part in the follow-up 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:** 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\nMechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis\n\n**Clinical Trial Summary:**\n\nThe results of this study will provide sound, scientific evidence of physiologic mechanisms\r responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular\r adaptation; and will elucidate the relationship between impairment and motor disability in\r post-stroke hemiparesis.\n\n**Clinical Trial Detailed Description:**\n\nThis proposal extends the work accomplished in our initial study (project #B2405R, 'Effects\r of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present\r study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for\r the upper-extremity involving sequential delivery of functional therapy and high intensity\r resistance training. Therefore, this proposal directly compares the effects of functional and\r resistance training delivered individually. The researchers' previous work investigated a\r hybrid therapy of functional and resistance training against functional training alone. All\r subjects will participate in a 5 week run-in period of no treatment. This no-treatment block\r will afford multiple baseline measurements and, in addition, will provide information\r regarding the rate and magnitude of any spontaneous recovery without treatment. Following the\r second baseline measurement, all subjects will be randomized to upper-extremity\r rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP)\r followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance\r training (Power) followed by FTP. Re-evaluation will occur following each block of\r treatment,and retention effects will be evaluated after 6 and 12 months with no additional\r treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical\r Neurology and Rehabilitation, a battery of biomechanical performance measures including:\r strength, muscle activation, reflex modulation, and motor coordination, and with kinematics\r of free reaching movements. The researchers will investigate persons in the intermediate\r phase of recovery which they define as between 6 and 18 months post-stroke , having completed\r all inpatient and outpatient therapies, with remaining residual motor deficits.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Clinical diagnosis of cerebrovascular accident\r\n\r - Single event\r\n\r - Unilateral hemiplegia\r\n\r - Between 6 months and 18 months post-event\r\n\r - Impairment of upper-extremity function\r\n\r - Ability to produce partial range of motion out of plane of gravity at shoulder, elbow,\r and wrist\r\n\r - At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in\r 2 fingers\r\n\r - Cognitive ability to follow 3-step commands\r\n\r Exclusion Criteria:\r\n\r - Unstable or uncontrolled blood pressure\r\n\r - Uncontrolled seizures\r\n\r - Flaccid hemiplegia\r\n\r - Severe cognitive impairment\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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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\nSpinal Cord Injury Registry - North American Clinical Trials Network\n\n**Clinical Trial Summary:**\n\nThe NACTN Spinal Cord Injury Registry is a network of clinical centers collecting\r de-identified data from patients admitted through the Emergency Department of a NACTN center\r at the time of injury with an initial (first time) spinal cord injury (SCI). Information will\r be collected on the natural history of SCI and course of treatment through the first 12\r months from the date of injury or long as medically indicated. Data collected includes\r imaging information from CT or MRI scans, neurological and general medical outcome and\r rehabilitation evaluation. No intervention is given other than standard of care for spinal\r cord injury, intensive monitoring and frequent follow up care.\n\n**Clinical Trial Detailed Description:**\n\nThe participating centers include:\r\n\r University of Texas Health Science Center, Houston; University of Toronto, Toronto;\r University of Virginia, Charlottesville; University of Louisville, Louisville; University of\r Maryland, Baltimore; Walter Reed National Military Medical Center, Bethesda; Thomas Jefferson\r University, Philadelphia; University of Miami, Miami; Brooke Army Medical Center, Fort Sam\r Houston; Louisiana State University Health Sciences Center, New Orleans; Vanderbilt\r University Medical Center, Nashville; Medical College Wisconsin, Milwaukee; Duke University,\r Durham\r\n\r The NACTN Clinical Coordinating Center is located at:\r\n\r Houston Methodist Hospital, Houston\r\n\r The Center for Biostatistics is located at:\r\n\r Houston Methodist Hospital, Houston\r\n\r The Data Management Center is located at:\r\n\r University of Louisville, Louisville\r\n\r Preliminary work has been completed on the selection of data elements, data collection\r protocols, case record form design, and the design of a computer system for clinical data\r management and data quality control.\r\n\r In the first phase of the network, data will be collected on the natural history of SCI.\r Although there is considerable data in the literature about the natural history of SCI,\r current changes in treatment appear to be modifying the natural history. In particular very\r early surgery, including decompression of the spinal cord and vertebral stabilization with\r instrumentation appears, in some cases of SCI, to be improving outcomes.\r\n\r No treatment is given other than standard of care for SCI. Data is collected in hopes to help\r SCI patients in the future.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Any patient male or female > or equal to 18 years of age with first time spinal cord\r injury caused by trauma and has neurological deficit with paralysis (weakness) or loss\r of sensation (touch).\r\n\r - Has not received prior medical of surgical care for this injury at an intermediate\r hospital.\r\n\r - Must give informed consent\r\n\r Exclusion Criteria:\r\n\r - Any patient or family refusing consent\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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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\nImmunochemotherapy for Metastatic Renal Cell Carcinoma\n\n**Clinical Trial Summary:**\n\nImmunochemotherapy consisting of IL-2, INF-A, and VBL and 5FU is regarded as the treatment of\r choice in metastatic renal cell carcinoma. During the period 1996-2000, we evaluated the\r efficacy and toxicity of this immunochemotherapy, combined with an aggressive surgical\r approach: nephrectomy before treatment and resection of residual disease. The 3-year survival\r rate for the entire group and complete responder patients was 30% and 88%, respectively. The\r side effects were usually moderate and consisted mainly of a flu-like syndrome, headache,\r nausea, vomiting and depression. Most importantly, there was no drug-related death. Good\r performance status, absence of bone metastases and prior nephrectomy were associated with\r higher response rates.\r\n\r Capecitabine is a novel fluoropyrimidine carbamate, orally administered and selectively\r activated to Fluorouracil by a sequential triple-enzyme pathway in liver and tumor cells.\r Capecitabine at dose of 2,500mg/m2/d divided equally into two daily doses for 14 days in\r patients who failed to respond to \"standard\" immunotherapy achieved a 30% objective response.\r Toxicity consisted of hand-foot syndrome.\r\n\r Aim of Study:\r\n\r To evaluate efficacy and toxicity of the combination of IL-2, INF-A, VBL and Capecitabine in\r MRCC\n\n**Clinical Trial Detailed Description:**\n\nThis is a phase II study, non-randomized in patients with metastatic renal cell carcinoma.\r The treatment will include: Proleukin (produced by Chiron and supplied by Megapharm Israel\r Ltd), Roferon A and Xeloda (produced by Roche) and VBL. The treatment will be given in 8-week\r courses with an interval of two weeks of rest in which the response (on D63) and toxicity\r will be assessed.\r\n\r 45 patients with MRCC will be entered into this study during a 18-month period. All patients\r must meet all inclusion and exclusion criteria. All data of each participating patient,\r including medical history, disease characteristics, laboratory and imaging tests, response\r and toxicity to treatment will be entered into the specific form before, during, after each\r treatment course and during follow up.\r\n\r Patients will be followed up for survival status and disease status every 6 months until last\r visit or death.\r\n\r Treatment Schedule:\r\n\r Proleukin S.C. 10X106 IU/m2 three times a week (Sun, Tue, Thu), weeks 1 - 4 Roferon A S.C. 6\r X 106 IU/m2 once a week (Wed), weeks 1 - 4 Roferon A S.C. 3 X 106 IU/m2 three times a week,\r weeks 5 - 8 Xeloda Oral 1,000 mg/m2 twice a day, weeks 5, 6 Vinblastine I.V. 4mg/m2, Day 1,\r weeks 5 &\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Inclusion Criteria; Patients with the following criteria will be included in this study\r\n\r - Pathological (histology or cytology) diagnosis of renal cell carcinoma\r\n\r - Clinical evidence of metastatic disease\r\n\r - Performance status 0 - 2 (European Cooperative Oncology Group Score)\r\n\r - Nephrectomy before starting treatment\r\n\r - Normal cardiac function (left ventricular ejection fraction >45%).\r\n\r - Normal blood counts: WBC >3,000/ml3, Hb >10gr%, Platelets >100,000/ml3\r\n\r - Normal kidney function: Creatinine <1.3 mg/dl\r\n\r - Age 18 years\r\n\r - Patient's written consent (on informed consent form)\r\n\r Exclusion Criteria:\r\n\r - Life expectancy less than 3 months\r\n\r - Brain metastases\r\n\r - Ischemic heart disease - active\r\n\r - Prior immunochemotherapy\r\n\r - Performance status 3 or more (European Cooperative Oncology Group Score)\r\n\r - Schizophrenia\r\n\r - Active liver disease\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nCombination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy, such as temozolomide, busulfan, and O6-benzylguanine,\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 more than one drug (combination chemotherapy) may kill\r more tumor cells. O6-benzylguanine may also help temozolomide work better by making tumor\r cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor\r cells. Giving chemotherapy with a peripheral stem cell transplant or bone marrow transplant,\r using stem cells from the patient that are genetically-modified in the laboratory to protect\r them from the side effects of chemotherapy, may allow more chemotherapy to be given so that\r more tumor cells are killed. Giving combination chemotherapy and radiation therapy together\r with a peripheral stem cell transplant or bone marrow transplant may kill more tumor cells.\r\n\r PURPOSE: This clinical trial is studying how well giving combination chemotherapy together\r with radiation therapy works in treating younger patients who are undergoing an autologous\r stem cell transplant for newly diagnosed gliomas.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - Determine the safety and feasibility of a conditioning regimen comprising temozolomide,\r radiotherapy, and busulfan followed by an infusion of autologous stem cells genetically\r modified with the MGMT gene and temozolomide and O6-benzylguanine in younger patients\r with newly diagnosed high-grade gliomas.\r\n\r Secondary\r\n\r - Determine the tolerability of intrapatient dose escalation of temozolomide, in terms of\r transgene expression, in patients treated with this regimen.\r\n\r - Determine, preliminarily, the antitumor activity of this regimen in these patients.\r\n\r OUTLINE: This is a pilot study.\r\n\r - Surgery: Patients undergo biopsy or surgical debulking of the tumor. Two to six weeks\r later, patients proceed to stem cell mobilization and apheresis.\r\n\r - Autologous stem cell mobilization and apheresis: Patients receive filgrastim (G-CSF)\r subcutaneously or IV once daily for at least 4 days before apheresis and continuing\r until apheresis is complete. Patients undergo apheresis for up to 4 consecutive days\r until a target number of 5 X 10^6 CD34-positive peripheral blood stem cells (PBSCs) are\r collected. Patients with insufficient numbers of PBSCs either undergo bone marrow\r harvest to collect a sufficient number of cells or are removed from the study. The cells\r are selected for CD34-positive cells which are cryopreserved for later use. Patients\r then proceed to chemoradiotherapy.\r\n\r - Chemoradiotherapy: Patients receive oral temozolomide once daily on days 1-42 and\r undergo radiotherapy once daily, 5 days a week, for 6 weeks. Four to eight weeks later,\r patients proceed to the low-intensity, nonmyeloablative conditioning regimen.\r\n\r - Autologous PBSC or bone marrow transduction: Peripheral blood or bone marrow\r CD34-positive stem cells are transduced with the MGMT gene on day -4.\r\n\r - Low-intensity, nonmyeloablative conditioning regimen: Patients receive busulfan IV over\r 2 hours on days -3 and -2. Patients then proceed to autologous PBSC or bone marrow\r infusion.\r\n\r - Autologous PBSC or bone marrow infusion: Patients undergo autologous stem cell infusion\r using transduced PBSCs or bone marrow on day 0. Three to six weeks later, patients\r proceed to chemotherapy.\r\n\r - Chemotherapy: Patients receive O6-benzylguanine IV over 1 hour followed by oral\r temozolomide once daily on days 1-5. Treatment repeats every 4 weeks for up to 6 courses\r in the absence of disease progression or unacceptable toxicity. Patients experiencing\r unacceptable toxicity due to O6-benzylguanine may receive temozolomide alone. Patients\r not experiencing dose-limiting toxicity and who have at least 5% transduced neutrophils\r by peripheral blood analysis after course 1 receive escalating doses (intrapatient) of\r temozolomide during courses 2-6. Some patients undergo second-look surgery after the\r first course of chemotherapy.\r\n\r After completion of study therapy, patients are followed monthly for 3 months, every 3 months\r for 3 years, every 6 months for 4 years, and then annually thereafter.\r\n\r PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 1-2 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed newly diagnosed high-grade glioma of 1 of the following\r types:\r\n\r - Glioblastoma multiforme\r\n\r - WHO grade IV disease\r\n\r - Anaplastic astrocytoma\r\n\r - WHO grade III disease\r\n\r - No low-grade disease (i.e., WHO grade I-II disease)\r\n\r - No WHO grade III oligodendroglioma or oligoastrocytoma\r\n\r - Patients > 30 years of age who have undergone a gross total resection and have\r nonmeasurable disease as seen on postoperative MRI are eligible\r\n\r - Measurable disease, as assessed by postoperative MRI, is required in patients ≤ 30\r years of age\r\n\r - No tumor arising in the spine or brainstem\r\n\r - No metastatic disease in the spine\r\n\r PATIENT CHARACTERISTICS:\r\n\r Age\r\n\r - 5 to 55\r\n\r Performance status\r\n\r - Karnofsky 50-100% (for patients 11-30 years of age) OR\r\n\r - Lansky 50-100% (for patients 5-10 years of age)\r\n\r Life expectancy\r\n\r - At least 9 months\r\n\r Hematopoietic\r\n\r - Absolute neutrophil count ≥ 1,000/mm^3\r\n\r - Platelet count ≥ 75,000/mm^3 (transfusion independent)\r\n\r Hepatic\r\n\r - Bilirubin ≤ 2.0 mg/dL\r\n\r - ALT and AST ≤ 2.5 times upper limit of normal\r\n\r - Albumin ≥ 2.0 g/dL\r\n\r - Hepatitis B surface antigen and core antibody negative\r\n\r - Hepatitis C antibody negative\r\n\r Renal\r\n\r - Creatinine normal OR\r\n\r - Glomerular filtration rate ≥ 70 mL/min\r\n\r Other\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - Neurologic deficits must be stable or decreasing\r\n\r - No active infection\r\n\r - HIV negative\r\n\r - No other serious illness or medical condition that would preclude study participation\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r Chemotherapy\r\n\r - No prior chemotherapy\r\n\r Endocrine therapy\r\n\r - Concurrent corticosteroids allowed provided dose is stable or decreasing\r\n\r Radiotherapy\r\n\r - No prior radiotherapy\r\n\r Surgery\r\n\r - See Disease Characteristics\r\n\r Other\r\n\r - No other concurrent investigational anticancer agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nEffectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain\n\n**Clinical Trial Summary:**\n\nRecently a clinical prediction rule (CPR) has been developed and validated that accurately\r identifies patients with low back pain that are likely to benefit from a lumbo-pelvic\r manipulation. The studies that developed and validated the rule used the identical\r manipulation procedure. However, recent evidence suggests that different manual therapy\r techniques may result in the same outcome.Purpose: The purpose of this study is to\r investigate the effectiveness of three different manual therapy techniques in a subgroup of\r patient with low back pain that satisfy the CPR.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Chief complaint of pain and/or numbness in the lumbar spine, buttock, and/or lower\r extremity\r\n\r 2. Oswestry disability score of at least 25%\r\n\r 3. Age greater than 18 years and less than 60 years\r\n\r 4. At least four out of five of the following criteria:\r\n\r 1. Duration of current episode < 16 days (judged from the patient's self-report)\r\n\r 2. No symptoms extending distal to the knee (judged from the pain diagram)\r\n\r 3. FABQ-W score <19\r\n\r 4. At least one hip with >350 internal rotation range of motion (measured in prone)\r\n\r 5. Stiffness in the lumbar spine (judged from segmental mobility testing)\r\n\r Exclusion Criteria:\r\n\r 1. Red flags noted in the participant's general medical screening questionnaire (i.e.\r tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)\r\n\r 2. Signs consistent with nerve root compression, this includes any one of the following:\r\n\r 1. Reproduction of low back or leg pain with straight leg raise at less than 450\r\n\r 2. Muscle weakness involving a major muscle group of the lower extremity\r\n\r 3. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)\r\n\r 4. Diminished or absent sensation to pinprick in any lower extremity dermatome\r\n\r 3. Prior surgery to the lumbar spine or buttock\r\n\r 4. Current pregnancy\r\n\r 5. Past medical history of osteoporosis or spinal compression fracture\r\n\r 6. Inability to comply with treatment schedule (weekly sessions for four 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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[
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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\nPemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases\n\n**Clinical Trial Summary:**\n\nRATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the\r enzymes needed for cell growth.\r\n\r PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating\r patients with recurrent malignant gliomas, primary CNS lymphoma, or brain metastases.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - Determine the 6-month progression-free survival rate in patients with recurrent\r malignant gliomas treated with pemetrexed disodium.\r\n\r - Determine the time to progression in patients with recurrent malignant gliomas, primary\r CNS lymphoma (PCNSL), or brain metastases treated with pemetrexed disodium.\r\n\r Secondary\r\n\r - Determine the radiographic response in patients with recurrent malignant gliomas, PCNSL,\r or brain metastases treated with pemetrexed disodium.\r\n\r - Determine the time to response in patients treated with this drug.\r\n\r - Determine the duration of response in patients treated with this drug.\r\n\r - Determine the overall survival of patients treated with this drug.\r\n\r - Collect safety data on patients with intracranial tumors treated with this drug.\r\n\r OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat\r every 21 days in the absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed periodically.\r\n\r PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Diagnosis of 1 of the following:\r\n\r - Malignant glioma, including the following subtypes: glioblastoma or gliosarcoma,\r anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, or\r malignant glioma not otherwise specified, meeting the following criteria:\r\n\r - Not required to have measurable or evaluable disease\r\n\r - Must have failed prior radiation therapy > 4 weeks ago\r\n\r - Must have failed at least 1 prior chemotherapy regimen\r\n\r - Confirmation of tumor progression by MR spectroscopy, PET scan, or\r biopsy/resection if prior radiosurgery was performed\r\n\r - Primary CNS lymphoma, meeting the following criteria:\r\n\r - Measurable disease as defined by bidimensionally measurable lesions with\r clearly defined margins by CT scan or MRI\r\n\r - Must have failed at least one prior chemotherapy regimen\r\n\r - Must have failed at least one agent or regimen\r\n\r - Brain metastases from a solid tumor, meeting the following criteria:\r\n\r - Measurable disease as defined by bidimensionally measurable lesions with\r clearly defined margins by CT scan or MRI\r\n\r - Biopsy is not required if radiographic imaging is consistent with brain\r metastases\r\n\r - Must have failed prior whole-brain radiotherapy\r\n\r - Patients with leptomeningeal metastases with or without brain metastases are\r eligible for therapy (may be diagnosed by MRI or cytology)\r\n\r - Confirmation of tumor progression by MR spectroscopy, PET scan, or\r biopsy/resection if prior radiosurgery was performed\r\n\r - Effusions or fluid collections must be drained prior to study entry\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Karnofsky performance score ≥ 60\r\n\r - WBC > 3,000/mm^3\r\n\r - Absolute neutrophil count > 1,500/mm^3\r\n\r - Platelet count > 100,000/mm^3\r\n\r - Hemoglobin > 10 mg/dL (transfusion allowed)\r\n\r - SGOT/SGPT < 3.0 times upper limit of normal (ULN)\r\n\r - Bilirubin < 1.5 times ULN\r\n\r - Creatinine < 1.5 mg/dL\r\n\r - Creatinine clearance > 45 mL/min\r\n\r - Women of childbearing potential and sexually active males must commit to the use of\r effective contraception while on study and for 3 months after completing study\r treatment\r\n\r - Women who are pregnant or breast-feeding are not eligible for study treatment\r\n\r - Negative pregnancy test\r\n\r - Able to take steroids, vitamin B12, or folate\r\n\r - No significant medical illnesses or infection 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 - Only one active tumor type allowed, except nonmelanoma skin cancer or carcinoma in\r situ of the cervix\r\n\r - A history of other malignancies are acceptable if in complete remission and off\r all therapy for that disease for a minimum of 3 years\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - See Disease Characteristics\r\n\r - More than 4 weeks since prior whole-brain or other radiotherapy\r\n\r - Recovered from any side effects (6 weeks for a nitrosourea; 4 weeks for temozolomide,\r procarbazine, etoposide or experimental agent; 3 weeks for isotretinoin or tamoxifen)\r (for patients with gliomas)\r\n\r - No more than 2 prior chemotherapeutic agents or regimens (includes biologic agents)\r (for patients with gliomas)\r\n\r - Recovered from prior biopsy or re-resection of the tumor (10-14 days for resection or\r 3-5 days for a biopsy) (for patients with gliomas)\r\n\r - May not be on any other chemotherapy except for hormonal therapy or trastuzumab\r (Herceptin®) (for patients with brain metastases)\r\n\r - No limitations on prior CNS-directed therapies (for patients with brain metastases)\r\n\r - Able to discontinue nonsteroidal anti-inflammatory drugs (NSAIDs)\r\n\r - Patients taking NSAIDs or aspirin are required to interrupt therapy for at least 2\r days before the study treatment and 2 days after the infusion\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** 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\nRadiofrequency Nucleoplasty vs Percutaneous Nucleotomy vs Decompression Catheter in Lumbar Disc Herniation\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to learn which of three minimally invasive procedures is the\r most effective for treatment of contained lumbar disc herniation.\n\n**Clinical Trial Detailed Description:**\n\nContained herniation of the lumbar intervertebral disc is a frequent cause of leg and back\r pain. Over the last decade, there is a tendency to shift from surgical treatment of the\r intervertebral disc including laminectomy/discectomy to an excess of nonoperative management.\r Three techniques introduced recently are used as minimally invasive treatments for\r decompression of contained herniation of the nucleus pulposus. Nucleoplasty uses Coblation®\r radiofrequency vaporization of nuclear tissue to decompress the intervertebral disc. Catheter\r disc decompression uses heat from a resistive coil positioned in the area of disc herniation\r while Dekompressor® uses volume reduction to decrease an intradiscal pressure.\r\n\r This is a comparison study which investigates if intervertebral electrothermal disc\r decompression produces better pain relief measured on VAS scale, improvement in functional\r capacity, return to work and opioid use, than nucleoplasty or percutaneous disc decompression\r (Dekompressor) of the lumbar intervertebral disc in a prospective randomized controlled\r study. Patients will be randomized into four treatment groups in equal numbers. The first\r group will be treated using nucleoplasty, the second will receive Dekompressor® lumbar disc\r decompression, the third will receive thermal treatment using decompression catheter\r (Achutherm TM) and the forth will be the control group. The control group will be treated\r conservatively using medications including gabapentin, a breakthrough opioid (oxycodone 5 mg\r 1-2 tablets q 4-6 hours as needed), NSAID, epidural steroid injections and physical therapy.\r\n\r Patients will be followed and assessed at one, three, six, nine and twelve months following\r the procedure using VAS scores, Oswestry and SF-36 Short Form questionnaires, opioid use and\r return to work evaluation.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - History of concordant radicular leg pain unresponsive to conservative treatment for\r longer than 3 months\r\n\r - Leg pain must be greater than back pain\r\n\r - Contained disc herniation as evidenced by MRI\r\n\r - No evidence of psychological issues by exam or history\r\n\r Exclusion Criteria:\r\n\r - A score of greater than 10 on Beck Depression Inventory (BDI)\r\n\r - Patients with pending workers compensation claim or litigation\r\n\r - Pregnancy\r\n\r - Tumor\r\n\r - Systemic infection or localized infection at the anticipated entry needle site\r\n\r - Traumatic spinal fracture\r\n\r - History of coagulopathy\r\n\r - Unexplained bleeding\r\n\r - Progressive neurological deficits\r\n\r - History of opioid abuse or patients currently on long acting opioids\r\n\r - Patients presenting with moderate or severe lumbar central or lateral canal stenosis,\r free disc fragments or degenerative disc disease as described on MRI\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
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not relevant
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61
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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\nOral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nThis study will offer a safe treatment for patients with relapsing recurring glioblastoma\r (GBM) or anaplastic astrocytoma (AA). The trial will test the hypothesis that Erlotinib\r (Tarceva, OSI-774) can be safely used up to a dose of 150 mg two times a day for 12 months to\r ultimately enhance survival of patients with relapsed/refractory GBM/AA. Correlation of\r response to Tarceva with particular genetic alterations including epidermal growth factor\r receptor variant type III (EGFRvIII) amplification and phosphatase and tensin homolog\r (mutated in multiple advanced cancers 1) (PTEN) loss will be studied.\n\n**Clinical Trial Detailed Description:**\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, from initial diagnosis, despite\r multimodal treatment approaches. Initial therapy consists of either surgical resection,\r external beam radiation or both. The role of adjuvant or concomitant chemotherapy in the\r initial therapy of GBM and AA has not, as yet, been clearly defined. Since most of these\r patients experience a recurrence after first-line therapy, improvements in both first-line\r and salvage therapy are critical to enhancing quality-of-life and prolonging survival. In\r August 2003, the U.S. Food and Drug Administration (FDA) granted orphan drug status for\r Erlotinib in patients with malignant glioma. Erlotinib (OSI-774) has been shown to be active\r in a range of tumors including GBM, AA and non small cell lung cancer. Because of the\r promising results in preliminary studies of Erlotinib and because of significant experience\r with the safety of the dosages proposed in this study, this study will offer a safe adjuvant\r treatment for patients with relapsing recurring glioblastoma or anaplastic astrocytoma.\r Therefore, this phase I/II clinical research trial will test the hypothesis that Erlotinib\r can be safely used up to a dose of 150 mg bid for 12 cycles to ultimately enhance survival of\r patients with relapsed/refractory GBM/AA with particular genetic alterations including\r EGFRvIII amplification and PTEN loss.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Male or female patients of ≥ 18 years of age.\r\n\r - Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma\r multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma\r (AOA). All patients will have samples of their tissue evaluated for EGFRvIII\r overexpression and PTEN loss.\r\n\r - Patients with a histologically confirmed low grade brain tumor who relapse with an\r enhancing tumor on magnetic resonance imaging (MRI) can be evaluated for toxicity\r only.\r\n\r - Patients must have at least one confirmed and evaluable tumor site.*\r\n\r *A confirmed tumor site is one which is biopsy-proven. NOTE: Radiographic procedures\r (e.g., Gd-enhanced MRI or computed tomography [CT] scans) documenting existing lesions\r must have 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 Eastern\r Cooperative Oncology Group [ECOG] level of 0-2) and an expected survival of ≥ three\r months.\r\n\r - No chemotherapy for six weeks prior to treatment under this research protocol and no\r external beam radiation for eight weeks prior to treatment under this research\r protocol.\r\n\r - Patients must have adequate hematologic reserve with WBC ≥ 3000/mm3, absolute\r neutrophils ≥ 1500/mm3 and platelets ≥ 100,000/mm3. Patients who are on Coumadin must\r have a platelet count of ≥ 150,000/mm3\r\n\r - Pre-enrollment chemistry parameters must show: bilirubin < 1.5X the institutional\r upper 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\r centrail nervous system (CNS) tumors for treatment of increased intracranial\r pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving\r dexamethasone must be on a stable or decreasing dose for at least 1 week prior to\r study entry.\r\n\r - Study Specific: Patients on enzyme-inducing anticonvulsants will be changed to\r non-enzyme inducing anticonvulsants or will not be allowed on this study.\r Patients receiving proton pump inhibitor or H2 blockers will not be allowed on\r study. Patients taking antacids will be allowed on study although they should not\r take the antacid for two hours before or two hours after taking erlotinib.\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 should not have received a CYP3A4 inhibitor within 1 week of study entry and\r should not have received a CYP3A4 inducer within 4 weeks of study entry.\r\n\r - Patients should not have received proton-pump inhibitors within 5 days of study entry\r or H2 blockers within 2 days of study entry.\r\n\r - Patients on steroids must receive prophylaxis for Pneumocystis carinii pneumonia (PCP)\r with Bactrim, unless 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 - Previous treatment with Tarceva®.\r\n\r - Women who are pregnant or lactating.\r\n\r - Women of childbearing potential and fertile men will be informed as to the potential\r risk of procreation while participating in this research trial and will be advised\r that they must use effective contraception during and for a period of three months\r 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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"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\nCarboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors\n\n**Clinical Trial Summary:**\n\nThis phase I/II trial studies the side effects and best dose of melphalan when given together\r with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well\r they work in treating patients with previously treated brain tumors. Drugs used in\r chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways\r to stop the growth of tumor cells, either by killing the cells or by stopping them from\r dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD)\r uses mannitol to open the blood vessels around the brain and allow cancer-killing substances\r to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing\r loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving\r carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be\r an effective treatment for brain tumors.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To evaluate toxicity and estimate the maximum tolerated dose (MTD) of melphalan\r (intra-arterially [i.a.]) administered in conjunction with carboplatin (i.a.) and etoposide\r phosphate (intravenously [i.v.]) undergoing BBBD, in subjects with anaplastic\r oligodendroglioma or oligoastrocytoma. (Phase I) II. To examine the efficacy (one year\r progression free survival [1YPFS]) of carboplatin (i.a.), melphalan (i.a.) and etoposide\r phosphate (i.v.) in conjunction with BBBD, in subjects with anaplastic oligodendroglioma or\r oligoastrocytoma. (Phase II)\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the incidence of severe neutropenia (specifically febrile neutropenia or\r sepsis) of carboplatin (i.a.), melphalan (i.a.) and etoposide phosphate (i.v.) in conjunction\r with BBBD, in subjects with anaplastic oligodendroglioma or oligoastrocytoma.\r\n\r II. To evaluate the overall toxicity of carboplatin (i.a.), melphalan (i.a.), and etoposide\r phosphate (i.v.) in conjunction with BBBD.\r\n\r III. To estimate the differences in tumor response, 1YPFS and survival, in subjects with\r allelic loss of chromosomes 1p and 19q, and tumor protein p53 (p53) immunocytochemistry,\r versus subjects without allelic loss.\r\n\r IV. To assess quality of life, cognitive function, and performance status of subjects\r undergoing treatment with carboplatin, melphalan and etoposide phosphate in conjunction with\r BBBD.\r\n\r V. To estimate differences in 1YPFS between subjects with anaplastic oligodendroglioma and\r patients with oligoastrocytoma.\r\n\r VI. To describe the role of biopsy versus extent of surgery (sub-maximal versus maximal safe\r resection) on 1YPFS and survival.\r\n\r VII. To describe the role of prior radiation on tumor response, 1YPFS and survival.\r\n\r OUTLINE: This is a phase I, dose-escalation study of melphalan followed by a phase II study.\r\n\r Patients receive etoposide phosphate IV over 10 minutes, mannitol IA over 30 seconds,\r melphalan IA over 10 minutes, and carboplatin IA over 10 minutes on days 1 and 2. Patients\r then receive sodium thiosulfate IV over 15 minutes at 4 and 8 hours after carboplatin.\r Courses repeat every 4 to 6 weeks for up to 12 months.\r\n\r After completion of study treatment, patients are followed up every 3 months for 1 year,\r every 6 months for 2 years, and then annually thereafter.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects with pathologic evidence of an anaplastic oligodendroglioma or mixed glioma\r (i.e. oligoastrocytoma) are eligible; histopathologic diagnosis will be made using\r World Health Organization classification criteria; to qualify as a mixed tumor there\r must be a minimum of 25% oligodendroglial element\r\n\r - Surgical procedure may have been complete resection, partial resection, or biopsy\r\n\r - Subjects must have had prior treatment with temozolomide; at least 28 days must have\r elapsed since completion of temozolomide or other chemotherapy\r\n\r - If subject has not undergone radiation therapy, then subject must have undergone prior\r consultation with a radiation oncologist (who is not an investigator on this study);\r if the subject has undergone radiation therapy, then at least 14 days must have\r elapsed since completion of radiation\r\n\r - Subjects performance status must be (Karnofsky performance status [KPS] greater than\r or equal to 50; Eastern Cooperative Oncology Group [ECOG] less than or equal to 2)\r\n\r - White blood cell count >= 2.5 x 10^3/mm^3\r\n\r - Absolute granulocyte count > 1.5 x 10^3/mm^3\r\n\r - Platelets >= 100 x 10^3/mm^3\r\n\r - Serum creatinine < 1.5 x upper limit of normal\r\n\r - Bilirubin < 1.5 x upper limit of normal\r\n\r - Subjects baseline serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate\r pyruvate transaminase (SGPT) must be < 2.5 x institutional upper limit of normal\r\n\r - Subjects must sign a written informed consent in accordance with institutional\r guidelines\r\n\r - The effects of carboplatin, melphalan and etoposide phosphate on the developing human\r fetus at the recommended therapeutic dose are unknown. For this reason and because\r these agents as well as other therapeutic agents used in this trial are known to be\r teratogenic. Sexually active women of child-bearing potential and men must agree to\r use adequate contraception (hormonal or barrier method of birth control; abstinence)\r prior to study treatment and for the duration of study treatment; should a woman\r become pregnant or suspect she is pregnant while participating in this study, she\r should inform her treating physician immediately\r\n\r Exclusion Criteria:\r\n\r - Subjects with radiographic signs of excessive intracranial mass effect with associated\r rapid neurologic deterioration, and/or spinal cord block\r\n\r - Subjects at significant risk for general anesthesia\r\n\r - Subjects with uncontrolled (over the last 30 days) clinically significant confounding\r medical conditions\r\n\r - Subject is pregnant, has a positive serum human chorionic gonadotropin (hCG) or is\r lactating\r\n\r - Subjects who have contraindications to carboplatin, melphalan, etoposide phosphate, or\r sodium thiosulfate\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nEfficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)\n\n**Clinical Trial Summary:**\n\nThe primary purpose of the study is to evaluate the efficacy and safety of temozolomide\r compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic\r astrocytoma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Prior histologic confirmation of glioblastoma, anaplastic astrocytoma.\r\n\r - Evidence of tumor progression or recurrence.\r\n\r - Age >=18 years.\r\n\r - Karnofsky performance status >=60%.\r\n\r - Absolute neutrophil count >=1,500/mm^3, platelet count >=100,000/mm^3, hemoglobin\r >=8g/dL.\r\n\r - Serum BUN and creatinine <1.5 times upper normal limit of testing laboratory (ULN).\r\n\r - Total bilirubin and direct bilirubin <1.5 times ULN.\r\n\r - SGOT, SGPT <3 times ULN; alkaline phosphatase <2 times ULN.\r\n\r - Life expectancy greater than 3 months.\r\n\r - Informed consent obtained.\r\n\r - If palliative radiation is needed, agree to give it prior to initiating chemotherapy\r with study drug. If palliative radiation is required during treatment with study drug,\r the patient should be permanently discontinued from further treatment with study drug.\r\n\r - Women of childbearing potential must use a medically accepted, effective method of\r contraception.\r\n\r - Women of childbearing potential must have a negative serum pregnancy test 24 hours\r prior to administration of study drug.\r\n\r Exclusion Criteria:\r\n\r - Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or\r immunotherapy within 4 weeks, inclusive, prior to study drug administration.\r\n\r - Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study\r drug administration.\r\n\r - Vincristine within 2 weeks prior to study drug administration.\r\n\r - Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4\r weeks prior to study drug administration.\r\n\r - Surgery within 3 weeks, inclusive, prior to study drug administration.\r\n\r - Acute infection requiring intravenous antibiotics.\r\n\r - Frequent vomiting or medical condition that could interfere with oral medication\r intake (eg, partial bowel obstruction).\r\n\r - Previous or concurrent malignancies at other sites with the exception of surgically\r cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the\r skin.\r\n\r - Known HIV positive or AIDS-related illness.\r\n\r - Pregnant or nursing women.\r\n\r - Men who are not advised to use an effective method of 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\"."
}
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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\nATN-161 and Carboplatin in Treating Patients With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor.\r Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of\r tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161\r together with carboplatin may kill more tumor cells.\r\n\r PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when\r given together with carboplatin and to see how well they work in treating patients with\r recurrent malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - Establish the safety of ATN-161 and carboplatin in patients with recurrent intracranial\r malignant glioma.\r\n\r - Determine the maximum tolerated dose of ATN-161 when administered with carboplatin in\r these patients. (phase I)\r\n\r - Determine the antitumor activity of ATN-161 when administered with carboplatin in these\r patients. (phase II)\r\n\r Secondary\r\n\r - Describe the effects of this regimen on potential biomarkers of activity, including\r functional imaging with brain perfusion scans and circulating endothelial progenitor\r cells.\r\n\r - Obtain preliminary evidence of efficacy of this regimen in these patients. (phase I)\r\n\r - Characterize the plasma concentrations of this regimen in these patients. (phase I)\r\n\r OUTLINE: This is an open-label, phase I dose-escalation study of ATN-161 followed by a phase\r II study. Patients in the phase II portion of the study are stratified according to tumor\r type (glioblastoma multiforme vs anaplastic glioma).\r\n\r - Phase I: Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and\r carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2,\r patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes\r 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease\r progression or unacceptable toxicity.\r\n\r Cohorts of 3-6 patients receive escalating doses of ATN-161 until the maximum tolerated dose\r (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients\r experience dose-limiting toxicity during the first 6 weeks of treatment.\r\n\r - Phase II: Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD\r determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for\r up to 12 courses in the absence of disease progression or unacceptable toxicity.\r\n\r Patients undergo blood collection at baseline and then periodically during phase I course 1\r for pharmacokinetic and pharmacodynamic analysis and at baseline and then periodically during\r study for biomarker (e.g., circulating endothelial progenitor cells) correlative studies.\r\n\r After completion of study treatment, patients are followed for 28 days.\r\n\r PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed intracranial malignant glioma\r\n\r - Original low-grade glioma histology allowed provided there is subsequent\r histologic confirmation of malignant glioma\r\n\r - Any of the following diagnoses:\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 - Recurrent disease\r\n\r - Must have failed prior radiotherapy\r\n\r - Must have confirmation of true progressive disease (rather than radiation\r necrosis) based upon either positron emission tomography or thallium\r scanning, MR spectroscopy, or surgical documentation of disease if\r radiographic recurrence is within the high-dose radiation field (for\r patients who underwent prior interstitial brachytherapy or stereotactic\r radiosurgery)\r\n\r - Prior recent resection of recurrent or progressive tumors allowed if all of the\r following criteria are met:\r\n\r - Recovered from prior surgery\r\n\r - Evaluable disease after resection\r\n\r - Unequivocal evidence of tumor progression by MRI\r\n\r - Steroid dose must be stable for ≥ 5 days prior to MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Karnofsky performance status 60-100%\r\n\r - Life expectancy > 8 weeks\r\n\r - WBC ≥ 3,000/mm³\r\n\r - Absolute neutrophil count ≥ 1,500/mm³\r\n\r - Platelet count ≥ 100,000/mm³\r\n\r - Hemoglobin ≥ 10 g/dL (transfusion allowed)\r\n\r - AST < 2.5 times upper limit of normal (ULN)\r\n\r - Bilirubin < 2.5 times ULN\r\n\r - Creatinine < 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception during and for 1 month after\r completion of study treatment\r\n\r - No significant medical illness that would preclude study treatment\r\n\r - No history of other cancer (except nonmelanoma skin cancer or carcinoma in situ of the\r cervix) unless disease is in complete remission and off all therapy for ≥ 1 year\r\n\r - No active infection or serious intercurrent medical illness\r\n\r - No disease that will obscure toxicity or dangerously alter drug metabolism\r\n\r - Able to undergo MRI scan and receive contrast agents for perfusion scanning\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - See Disease Characteristics\r\n\r - Recovered from prior therapy\r\n\r - At least 28 days since prior cytotoxic therapy\r\n\r - At least 14 days since prior vincristine\r\n\r - At least 42 days since prior nitrosoureas\r\n\r - At least 21 days since prior procarbazine\r\n\r - At least 7 days since prior interferon, tamoxifen, thalidomide, isotretinoin, or other\r noncytotoxic agents (radiosensitizer does not count)\r\n\r - At least 14 days since prior noncytotoxic investigational agents\r\n\r - At least 42 days since prior radiotherapy\r\n\r - No prior cisplatin, carboplatin, oxaliplatin, or platinum-containing analogue\r\n\r - No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)\r\n\r - No other concurrent anticancer therapy (including chemotherapy, radiotherapy, hormonal\r therapy, or immunotherapy)\r\n\r - No other concurrent investigational 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:** possibly relevant"
}
] |
possibly relevant
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65
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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\nImatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the\r enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in\r different ways to stop the growth of tumor cells, either by killing the cells or by stopping\r them from dividing. Giving imatinib mesylate together with temozolomide may kill more tumor\r cells.\r\n\r PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate\r when given together with temozolomide in treating patients with malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the maximum tolerated dose and dose-limiting toxicity, if attainable, of\r imatinib mesylate in combination with temozolomide in patients with malignant glioma.\r\n\r - Characterize the safety and tolerability of imatinib mesylate, including acute and\r chronic toxicities, in these patients.\r\n\r - Determine the effect of temozolomide on the pharmacokinetics (PK) of imatinib mesylate\r at each dose level.\r\n\r - Evaluate the impact of enzyme-inducing anti-epileptic drug (EIAED) coadministration on\r the PK of imatinib mesylate using a population-based PK approach.\r\n\r - Evaluate the antitumor activity of imatinib mesylate plus temozolomide.\r\n\r OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients are stratified\r according to concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital,\r carbamazepine, fosphenytoin, primidone, oxcarbazepine) (yes vs no).\r\n\r Patients receive oral imatinib mesylate once or twice daily on days 1-8 and oral temozolomide\r once daily on days 4-8. Courses repeat every 28 days in the absence of disease progression or\r unacceptable toxicity.\r\n\r Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated\r dose is determined.\r\n\r On days 1 and 8 of course 1, blood is drawn for pharmacokinetic studies.\r\n\r PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed malignant glioma\r\n\r - 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 oligoastrocytoma\r\n\r - Previous histologic diagnosis of a lower grade of glioma allowed if there is\r histologic evidence of progression to a diagnosis of malignant glioma\r\n\r - Multifocal disease allowed\r\n\r - Must have undergone prior conventional external-beam radiation therapy\r\n\r - Stable disease, disease recurrence, or relapsed disease\r\n\r - Must not have received any systemic therapy for this recurrence or relapse\r\n\r - No prior progressive disease\r\n\r - No central/systemic fluid collections (pericardial effusion, pulmonary effusion,\r ascites) ≥ grade 2\r\n\r - No evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for\r stable post-operative grade 1 hemorrhage\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Karnofsky performance status 70-100%\r\n\r - Absolute neutrophil count > 1,500/mm³\r\n\r - Hemoglobin > 9 g/dL\r\n\r - Platelet count > 100,000/mm³\r\n\r - AST and ALT < 2.5 times upper limit of normal (ULN)\r\n\r - Bilirubin < 1.5 times ULN\r\n\r - Creatinine < 1.5 times ULN\r\n\r - No chronic renal disease\r\n\r - No active uncontrolled infection\r\n\r - No uncontrolled diabetes\r\n\r - No excessive risk of bleeding, as defined by occurrence of any of the following:\r\n\r - Stroke within the past 6 months\r\n\r - History of CNS or intraocular bleed\r\n\r - Septic endocarditis\r\n\r - No history of labile hypertension\r\n\r - No congestive heart failure\r\n\r - No poorly controlled hypertension\r\n\r - No myocardial infarction within the past 6 months\r\n\r - No history of poor compliance with antihypertensive regimen\r\n\r - No other severe and/or uncontrolled medical disease that would preclude study\r participation\r\n\r - No peripheral edema ≥ grade 2\r\n\r - No gastrointestinal bleeding\r\n\r - No gross hematuria\r\n\r - No other active systemic bleeding\r\n\r - Patients must not have experienced toxicity ≥ grade 3 with prior treatment with either\r temozolomide or imatinib mesylate\r\n\r - No other primary malignancy within the past 5 years except basal cell skin cancer or\r carcinoma in situ of the cervix or other cancer not currently clinically significant\r nor requiring active interventions\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - See Disease Characteristics\r\n\r - Recovered from all prior therapy\r\n\r - Prior surgical resection(s) allowed\r\n\r - At least 2 weeks since prior surgery\r\n\r - At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas)\r\n\r - At least 2 weeks since prior external-beam radiotherapy\r\n\r - At least 2 weeks since prior investigational drugs\r\n\r - More than 1 week since prior biologic, immunotherapeutic, or cytostatic agents\r\n\r - No concurrent warfarin\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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 II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas\n\n**Clinical Trial Summary:**\n\nPhase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at\r each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.\r\n\r At each cycle, patient exams and interviews as well as lab results were to help the research\r team to determine the symptomatic side effects of the treatment. Recorded past toxicities\r were to be compared with current side effects.\n\n**Clinical Trial Detailed Description:**\n\nPhase 2 trial to explore the efficacy and safety of irinotecan (CPT-11) in patients with\r recurrent anaplastic astrocytomas (AA), mixed malignant glioma, and oligodendrogliomas (OA).\r Patients were to be stratified by tumor histology and treated with CPT-11 every 21 days\r (treatment cycle).\r\n\r Baseline data (collected <14 days) was to consist of a neurological/oncological history,\r neurological examination, height, weight, performance status, Quality Of Life FACT-L\r questionnaire, laboratory studies to include complete blood count (CBC), differential,\r platelets, prothrombin time (PT), complete metabolic panel (CMP), Lactose dehydrogenase\r (LDH), and a pregnancy test, as well as a cranial Computerized Tomography/Magnetic Resonance\r Imaging (CT/MRI) with and without contrast (to measure or evaluate the size and location of\r the tumor before treatment).\r\n\r Administered every 21 days was a dose of irinotecan (CPT-11), zofran/Kytril/Anzemet,\r decadron, and intravenous (IV) atropine. At each cycle, patient exams and interviews as well\r as lab results were to help the research team to determine the symptomatic side effects of\r the treatment. Recorded past toxicities were to be compared with current side effects.\r\n\r Between days 15-21 (within 7 days of next scheduled CPT-11 treatment) the following tests\r were to be repeated - a neurological/oncological history and neurological examination,\r weight, blood drawn (CMP, LDH), performance status, and Quality Of Life FACT-L questionnaire.\r Also, a MRI (Cranial CT/MRI with and without contrast) was to be performed for tumor\r assessments at week 9, 18, 27, 36, and after every nine weeks thereafter until progression.\r Response was to be measured by a reduction in tumor size.\r\n\r These supportive therapies were provided as necessary:\r\n\r - Antiemetic Therapy\r\n\r - Anticholinergics\r\n\r - Loperamide (Imodium®)\r\n\r - Growth Factors\r\n\r - Other Concomitant Medications\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histological or neuroradiographic documented recurrent glioma\r defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma. All\r patients must have had prior pathologic confirmation of primary tumor histology.\r\n\r - Patients must be > than or equal to 18 years old.\r\n\r - Patients must have a Karnofsky performance score (KPS) of > or equal to 50\r\n\r - Measurable disease per MacDonald criteria is required\r\n\r - Patients must have a predicted life expectancy of at least 12 weeks\r\n\r - Required initial laboratory data:\r\n\r 1. Absolute Neutrophil Count (ANC) > 1,500\r\n\r 2. Platelets > 100,000\r\n\r 3. Serum Creatinine < 2.0\r\n\r 4. Serum Bilirubin < 2.0\r\n\r 5. Aspartamine transaminase/ Alanine transaminase (AST/ALT) < 3x normal\r\n\r 6. Pregnancy test for females with child-bearing potential negative\r\n\r - Patients must sign and date an IRB approved informed consent form stating he or she is\r aware of the neoplastic nature of the disease. Patient must willingly provide written\r consent after being informed of the procedure to be followed, the experimental nature\r of the therapy, alternatives, potential benefits, side effects, risks, and\r discomforts. (Human protection committee approval of this protocol and consent form is\r required).\r\n\r - Patients must be willing and able to comply with scheduled visits, treatment plan, and\r laboratory tests and accessible for follow-up.\r\n\r - Patients must have been previously treated with both surgery and radiotherapy.\r\n\r - Prior adjuvant and one salvage chemotherapy regimen is permitted.\r\n\r - Prior stereotactic radiotherapy is permitted.\r\n\r Exclusion Criteria:\r\n\r - Patients have evidence of leptomeningeal spread of disease.\r\n\r - Patients having been treated with 2 or more salvage regimens.\r\n\r - Pregnant or breast-feeding women. With the exception of post-menopausal or infertile\r women, a negative blood test for pregnancy is mandatory before entry on study. Fertile\r persons refusing to use adequate contraceptives may not participate.\r\n\r - Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic\r diarrhea or presence of a bowel obstruction.\r\n\r - Patients with a second active malignancy or diagnosis of other cancer within 3 years\r of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma\r of the cervix.\r\n\r - Mentally incapacitated patients or psychiatric illness that would prevent the patient\r from giving informed consent.\r\n\r - Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood\r pressure, unstable angina, symptomatic congestive heart failure, and myocardial\r infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.\r\n\r - Known to be human immunodeficiency virus (HIV) positive or to have an acquired\r immunodeficiency syndrome (AIDS) related illness.\r\n\r - Patients with an active infection that is not adequately controlled with antibiotics.\r\n\r - Patients with other severe concurrent disease, which, in the judgment of the\r investigator, would make the patient inappropriate for entry into this study.\r\n\r - Patients with a known sensitivity to any of the products to be administered during\r treatment.\r\n\r - Patients currently enrolled in another clinical trial or patients who have\r participated in a trial of an investigational device or drug within the last 30 days.\r\n\r - Patients previously treated with CPT-11.\r\n\r - Concurrent stereotactic 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\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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67
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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\nCisplatin and Temozolomide in Treating Young Patients With Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different\r ways to stop the growth of tumor cells, either by killing the cells or by stopping them from\r dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.\r\n\r PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide\r works in treating young patients with malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - Determine the objective response rate (complete and partial response) in pediatric\r patients with malignant gliomas treated with temozolomide and cisplatin.\r\n\r Secondary\r\n\r - Identify genetic, metabolic, and proteomic profiles that will provide an insight into\r the molecular pathways involved in the pathogenesis of these tumors.\r\n\r - Link genetic changes with clinical details, histopathology, and patient outcome, thereby\r developing a biological basis for diagnosis, prognosis, and treatment monitoring.\r\n\r - Evaluate relapse-free survival at 1 and 2 years in patients treated at diagnosis.\r\n\r - Evaluate the duration of clinical response in patients treated at relapse.\r\n\r - Study the health status and quality of life of these patients.\r\n\r - Evaluate long-term toxicity of this therapeutic combination.\r\n\r - Evaluate the ability of magnetic resonance spectroscopy vs CT scan to predict response\r in patients with high-grade astrocytomas.\r\n\r OUTLINE: This is a multicenter, open-label, nonrandomized, parallel-group study. Patients are\r stratified according to disease status (newly diagnosed vs relapsed). Patients with newly\r diagnosed disease are further stratified according to spread of disease (localized and\r measurable vs diffuse unmeasurable).\r\n\r - Stratum I (newly diagnosed disease): Patients receive CISTEM chemotherapy comprising\r cisplatin IV over 3 hours on day 1 and oral temozolomide once daily on days 2-6.\r Treatment repeats every 28 days for up to 7 courses. Patients who achieve responsive or\r stable disease after 2 courses receive 2 more courses of CISTEM chemotherapy and then\r undergo radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy,\r patients may receive up to 3 more courses of CISTEM chemotherapy for a total of 7\r courses.\r\n\r - Stratum II (relapsed disease): Patients receive CISTEM chemotherapy for up to 7 courses\r as in stratum I. Patients who reach the maximum dose allowed for cisplatin may receive\r oral temozolomide alone indefinitely.\r\n\r Tissue and blood samples are obtained at baseline and examined by immunohistochemistry,\r fluorescent in situ hybridization (FISH), and loss of heterozygosity. The tumor tissue is\r analyzed for p53, MSH2, MLH1, and MGMT.\r\n\r After completion of study treatment, patients are followed periodically for 2 years.\r\n\r PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed diagnosis of 1 of the following grade III or\r grade IV malignant glial tumors*:\r\n\r - Glioblastoma\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - Anaplastic ganglioglioma\r\n\r - Anaplastic mixed tumor\r\n\r - Glial component is essential NOTE: *Malignant gliomas occurring as a second\r primary malignancy allowed\r\n\r - Newly diagnosed or recurrent disease\r\n\r - No malignant brain stem tumors\r\n\r - Incompletely resected tumors\r\n\r - No completely resected tumors\r\n\r - Measurable or evaluable disease by conventional MRI\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Lansky performance status 40-100%\r\n\r - Organ toxicity ≤ grade 2\r\n\r - Absolute neutrophil count ≥ 1,000/mm³\r\n\r - Platelet count ≥ 100,000/mm³\r\n\r - Bilirubin ≤ 1.5 times upper limit of normal (ULN)\r\n\r - AST and ALT ≤ 2.5 times ULN\r\n\r - Prothrombin ≥ 50%\r\n\r - Fibrinogen ≥ 1.5 g/L\r\n\r - Creatinine normal for age\r\n\r - Creatinine ≤ 65 µmol/L (4-15 years of age)\r\n\r - Creatinine ≤ 110 µmol/L (15-20 years of age)\r\n\r - Audiogram with toxicity grade ≤ 2\r\n\r - ECG normal\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - No severe or life-threatening infection\r\n\r - No uncontrolled developing or symptomatic intracranial hypertension\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) or radiotherapy\r for patients with relapsed disease\r\n\r - No prior cisplatin or temozolomide\r\n\r - No other concurrent anticancer therapy\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
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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\nTemozolomide in Patients With Newly Diagnosed Anaplastic Oligodendroglioma and Mixed Oligoastrocytoma\n\n**Clinical Trial Summary:**\n\nRationale:\r\n\r Standard therapy for anaplastic oligodendrogliomas and mixed oligoastrocytomas includes\r radiation and chemotherapy. However, due to the potential long-term central nervous system\r toxicity from radiation, researchers speculate that it may be better to reserve radiation\r therapy for progressive disease. In addition, some patients with anaplastic oligodendroglioma\r and mixed oligoastrocytoma have unusually chemosensitive tumors. Previous research indicates\r that brain tumor patients with a deletion of the 1p chromosome have a higher response to the\r chemotherapy drug temozolomide.\n\n**Clinical Trial Detailed Description:**\n\nTemozolomide has demonstrated clinical antitumor efficacy against malignant gliomas at both\r relapse and initial diagnosis. This drug appears to have less adverse effects compared to\r other drugs used against brain tumors. Therefore, temozolomide is often better tolerated in\r brain tumor patients compared to other brain tumor drugs. The current study builds on\r previous research to test the efficacy of chemotherapy alone in patients with anaplastic\r oligodendroglioma and mixed oligoastrocytoma.\r\n\r Purpose:\r\n\r This study will evaluate response rate, or how the disease size changes in patients, and\r survival without disease growth, in patients with anaplastic oligodendroglioma and mixed\r oligoastrocytoma treated with temozolomide. Quality of life will also be assessed in this\r patient population treated with the study regimen.\r\n\r Treatment:\r\n\r Study participants will be treated with the drug temozolomide. This drug will be administered\r in oral pills. Temozolomide will be taken for seven consecutive days followed by seven days\r without the drug. This treatment schedule of seven days on temozolomide followed by seven\r days off will continue throughout the study. Several tests and exams will be given to closely\r monitor patients. MRI scans will be performed every 8 weeks to measure disease response.\r Temozolomide as a study drug will be given to study participants for a total of 8 week four\r cycles. However, treatments will be discontinued due to disease growth or unacceptable\r adverse events.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - anaplastic oligodendroglioma or mixed oligoastrocytoma\r\n\r - age > 18\r\n\r - Karnofsky status > 70%\r\n\r - adequate bone marrow, liver and renal function\r\n\r Exclusion Criteria:\r\n\r - prior chemotherapy or cranial irradiation\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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69
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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\nVEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide\n\n**Clinical Trial Summary:**\n\nThis phase II trial is studying how well VEGF Trap works in treating patients with recurrent\r malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the\r growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. Determine the therapeutic efficacy of VEGF Trap in patients with temozolomide-resistant\r malignant gliomas at first recurrence as measured by 6-month progression-free survival (PFS).\r\n\r II. Determine the safety profile of VEGF Trap in these patients.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. Determine the efficacy of this regimen as measured by radiographic response, PFS, time to\r progression, and overall survival.\r\n\r II. Characterize the single-dose and repeated-dose pharmacokinetic profiles of VEGF Trap in\r these patients.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to histology\r (glioblastoma vs anaplastic glioma).\r\n\r Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the\r absence of disease progression or unacceptable toxicity.\r\n\r After completion of study treatment, patients are followed periodically.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - International Normalized Ratio (INR) < = 1.5\r\n\r - Platelet count => 100,000/mm³\r\n\r - Hemoglobin => 10 g/dL (transfusion allowed)\r\n\r - Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase\r (SGPT) < = 2 times upper limit of normal (ULN)\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - No previous Vascular endothelial growth factor (VEGF) Trap\r\n\r - At least 4 weeks since chemotherapy, surgery, or open biopsy\r\n\r - At least 2 weeks since vincristine\r\n\r - At least 6 weeks since carmustine, lomustine, fotemustine, or radiation therapy\r\n\r - At least 42 days since prior nitrosoureas\r\n\r - At least 3 weeks since procarbazine\r\n\r - No previous Gliadel wafers or bevacizumab\r\n\r - Tumor did not respond to previous radiation therapy and temozolomide\r\n\r - Karnofsky performance status (KPS) 60-100%\r\n\r - Life expectancy = > 8 weeks\r\n\r - White blood count (WBC) = >3,000/mm³\r\n\r - Absolute neutrophil count = > 1,500/mm³\r\n\r - Bilirubin < = 2 times ULN\r\n\r - Creatinine < = 1.5 mg/dL OR creatinine clearance= > 60 mL/min\r\n\r - Urine protein:creatinine ratio < = 1 OR 24-hour urine protein < = 500 mg/dL\r\n\r - Fertile patients must use effective contraception prior to, during, and for = > 6\r months after completion of study treatment\r\n\r - No significant medical illnesses that, in the opinion of the investigator, cannot be\r adequately controlled with appropriate therapy or would preclude compliance with study\r treatment\r\n\r - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant\r human antibodies\r\n\r - No history of allergic reactions attributed to compounds of similar chemical or\r biological composition to other agents used in the study\r\n\r - No history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of\r the cervix), unless in complete remission and off of all therapy for that disease for\r = >3 years\r\n\r - At least 7 days since prior noncytotoxic agents (e.g., interferon, tamoxifen,\r thalidomide, or isotretinoin [radiosensitizer does not count])\r\n\r - At least 7 days since prior core biopsy\r\n\r - At least 28 days since prior investigational agents\r\n\r - No prior bevacizumab or vascular endothelial growth factor receptor inhibitors\r\n\r - No concurrent full-dose anticoagulants (e.g., warfarin or low molecular-weight\r heparin)\r\n\r - No clinically significant cardiovascular disease, including any of the following:\r\n\r - Cerebrovascular accident within the past 6 months\r\n\r - Uncontrolled hypertension, defined as blood pressure (BP) > 140/90 mm Hg or\r systolic BP > 180 mm Hg if diastolic BP < 90 mm Hg, on ≥ 2 repeated\r determinations on separate days within the past 3 months\r\n\r - Myocardial infarction, coronary artery bypass graft (CABG), or unstable angina\r pectoris within the past 6 months\r\n\r - New York Heart Association class III-IV congestive heart failure\r\n\r - No serious cardiac arrhythmia requiring medication\r\n\r - Clinically significant peripheral vascular disease within the past 6 months\r\n\r - Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within\r the past 6 months\r\n\r - No evidence of bleeding diathesis or coagulopathy\r\n\r - No more than 1 prior chemotherapy regimen (initial treatment and treatment for 1\r relapse)\r\n\r - Surgical resection for relapsed disease with no anticancer therapy instituted for up\r to 12 weeks followed by another surgical resection is considered 1 relapse\r\n\r - If prior therapy for a grade 3 glioma was given, surgical diagnosis of a high-grade\r glioma is considered the first relapse\r\n\r - Prior surgical, interstitial brachytherapy, or stereotactic radiosurgery not\r considered prior therapy\r\n\r - If prior therapy included interstitial brachytherapy or stereotactic radiosurgery,\r must have confirmation of true progressive disease rather than radiation necrosis\r based upon either positron emission tomography (PET) scan, thallium scanning, Magnetic\r Resonance (MR) spectroscopy, or surgical documentation of disease\r\n\r - Must show unequivocal radiographic evidence of tumor progression by MRI\r\n\r - Recent resection of recurrent or progressive tumor allowed\r\n\r - Residual disease not required\r\n\r - Temozolomide-resistant recurrent glioblastoma is defined as tumor progression or tumor\r recurrence during or after treatment with temozolomide-based chemotherapy regimens\r\n\r - Recovered from prior therapy\r\n\r - No other disease that would obscure toxicity or dangerously alter drug metabolism\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 - Psychiatric illness or social situations that would limit compliance with study\r requirements\r\n\r - No serious or nonhealing wound, ulcer, or bone fracture\r\n\r - No history of intracerebral or intratumoral hemorrhage\r\n\r - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\r within the past 28 days\r\n\r - No significant traumatic injury within the past 28 days\r\n\r - At least 28 days since prior cytotoxic therapy\r\n\r - Histologically confirmed diagnosis of 1 of the following:\r\n\r - Intracranial glioblastoma or 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 - NOTE: If original histology was grade 3 glioma, subsequent histological\r diagnosis of 1 of these diseases is allowed provided no prior diagnosis of\r grade 2 glioma\r\n\r - At least 20 unstained slides OR 1 tissue block available from original diagnostic\r biopsy/surgery or from biopsy/surgery at recurrence\r\n\r - Patients presenting at the time of first recurrence or relapse, defined as progression\r after initial therapy (i.e., radiotherapy +/- chemotherapy if that was used as initial\r therapy) are eligible\r\n\r - No other concurrent investigational drugs\r\n\r - No other concurrent investigational drugs\r\n\r - No concurrent cytotoxic or noncytotoxic therapy, including chemotherapy, radiotherapy,\r hormonal therapy, or immunotherapy\r\n\r - No concurrent major surgery\r\n\r - No concurrent combination antiretroviral therapy for HIV-positive patients\r\n\r - Concurrent anticonvulsant therapy allowed\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
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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/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nIL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a\r bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a\r variety of IL13-receptor positive tumor cell lines indicating that it may show a therapeutic\r benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the\r IL13 receptors was shown to be highly specific for human glioma cells.\n\n**Clinical Trial Detailed Description:**\n\nPHASE I OBJECTIVES:\r\n\r I. To describe toxicities and estimate the maximum safe flow rate and maximum tolerated\r infusion concentration, of IL13-PE38QQR delivered after surgical resection by peritumoral\r infusion via 2 to 4 catheters positioned in the brain adjacent to the resection cavity, from\r the start of infusion through the DLT observation period.\r\n\r II. To determine the IL13 receptor alpha-2 chain expression status and distribution in\r pediatric recurrent or progressive malignant gliomas.\r\n\r III. To describe the overall safety and tolerability of IL13PE38QQR infusion from the start\r of infusion through disease progression or initiation of alternative treatment.\r\n\r PHASE II OBJECTIVES:\r\n\r I. To estimate the survival distribution post initial progression, at the maximum safe total\r flow rate and MTiC established in phase I.\r\n\r II. To estimate the progression-free survival distribution for patients post-initial\r progression or recurrence at the maximum safe total flow rate and MTiC established in phase\r I.\r\n\r III. To determine the serum levels of IL13-PE38QQR and distribution in pediatric recurrent or\r progressive malignant gliomas.\r\n\r IV. To describe the overall safety and tolerability of IL13-PE38QQR infusion from the start\r of infusion through disease progression or initiation of alternative treatment.\r\n\r PROTOCOL OUTLINE: At study entry, all patients will be registered prior to planned gross\r total resection (> 95% resection of the solid, contrast enhancing tumor component). On the\r day of catheter placement (CP, 2-7 days after resection), if the patient is neurologically\r stable, 2-4 catheters will be stereotactically placed. On day 1 after catheter placement,\r infusion of IL3-PE38QQR will begin if the patient is neurologically stable and will continue\r for 96 hours. In Phase I, the total flow rate and the concentration of IL3-PE38QQR will be\r determined by the dose escalation plan. In the Phase II evaluations of safety and efficacy,\r patients will be treated at the flow rate and concentration identified in Phase I.\r\n\r PROJECTED ACCRUAL: Approximately 24 patients will participate in the Phase I portion of the\r study. During the Phase I portion, the rate-limiting factor is the time the study must be\r closed during the toxicity assessment period. Although it is estimated that 1.5 patients per\r month will enroll in the Phase I portion, the observed rate may be lower due to temporary\r suspensions in accrual. It is not possible to estimate the time required to complete the\r Phase I portion of the trial. It is estimated that approximately 26 patients will contribute\r to the Phase II portion. Using the same rough estimate of accrual, the Phase II portion may\r last about 3 years.\n\n**Clinical Trial Eligibility Criteria:**\n\n-Disease Characteristics-\r\n\r Must be at least 3 years but not more than 21 years of age.\r\n\r Must have had surgery (or biopsy) of a supratentorial brain tumor with pathologic diagnosis\r of malignant (grade 3 or 4) glioma, including anaplastic astrocytoma, mixed anaplastic\r astrocytoma, or glioblastoma multiforme.\r\n\r Must have radiographic evidence of recurrent or progressive supratentorial malignant glioma\r compared with a prior imaging study. The baseline tumor measurements must be determined\r within 2 weeks prior to study entry.\r\n\r The tumor must have a solid component at least 1.0 cm in diameter.\r\n\r Gross total resection must be planned, with the intent of removing all contrast-enhancing\r components of the tumor.\r\n\r Must have received external beam radiotherapy, with tumor dose of at least 48 Gy; and must\r be completed at least 8 weeks prior to study entry.\r\n\r -Patient Characteristics-\r\n\r Karnofsky Performance Score for patients older than 16 years, or the Lansky Performance\r Scale for patients 16 years old or younger, must be at least 60.\r\n\r Hematologic status: Absolute neutrophils at least 1,500/mm3; Hemoglobin at least 10 gm/dL\r (transfusion independent); Platelets at least 100,000/mm3 (transfusion independent); PT &\r aPTT less than or equal to the institutional upper limit of normal.\r\n\r Must have recovered from toxicity of prior therapy: at least 6 months after Gliadel® wafer;\r at least 8 weeks after hematopoietic stem cell transplant; at least 4 weeks after any\r cytotoxic chemotherapy or any systemic investigational agent; at least 6 weeks after\r nitrosoureas; at least 2 weeks after vincristine or non-cytotoxic chemotherapy.\r\n\r Patient's legal guardian must understand the investigational nature of this study and its\r potential risks and benefits; must sign informed consent.\r\n\r No pregnant or breast-feeding patients. All patients of child-bearing age, male and female,\r must practice an effective method of birth control during the study.\r\n\r No patients with multi-focal tumor not amenable to gross total resection or tumor\r dissemination (subependymal or leptomeningeal).\r\n\r No patients with clinically significant increased intracranial pressure (e.g., impending\r herniation) uncontrolled seizures, or requirement for immediate palliative treatment.\r\n\r No patients who received any localized antitumor therapy for the malignant glioma, either\r intracerebral chemotherapy (other than Gliadel®) or focal radiation therapy (e.g.,\r stereotactic radiosurgery or brachytherapy).\r\n\r No patients who are receiving concurrent chemotherapy (other than steroids) or any other\r investigational agent.\r\n\r No patients unwilling to follow protocol requirements.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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71
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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 II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma\n\n**Clinical Trial Summary:**\n\nThis is an open-label, multicenter, phase II trial, assessing the antitumor activity, and\r safety of temozolomide in combination with O6-BG in patients with temozolomide-resistant\r anaplastic glioma.\n\n**Clinical Trial Detailed Description:**\n\nThis open-label, multicenter, phase II trial will assess the antitumor activity and safety of\r temozolomide in combination with O6-BG in patients with temozolomide-resistant anaplastic\r glioma.\r\n\r Forty-one to 104 evaluable patients with temozolomide-resistant anaplastic glioma will be\r enrolled in this study. Total accrual on this study will not exceed 116 patients. The\r patients will receive daily temozolomide on 5 consecutive days (days 1-5) along with bolus\r infusions of O6-BG on days 1, 3, and 5 and a continuous infusion of O6-BG beginning\r immediately after the first bolus infusion and continuing until immediately prior to the last\r bolus injection. Patients will be evaluated for AEs during the course of therapy. Patients\r may receive treatment at the same dose level until appearance of significant\r treatment-related toxicities, disease progression or withdrawal of consent.\r\n\r Tumor response will be evaluated at the end of cycle 1, cycle 2 and then every two cycles for\r the duration of therapy, using physical and neurological examinations and diagnostic imaging.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Patients with histologically documented anaplastic glioma (anaplastic astrocytoma,\r anaplastic oligodendroglioma or mixed anaplastic oligoastrocytoma).\r\n\r 2. Temozolomide-resistant defined as patients who have progressed while receiving or\r within 8 weeks of completing the last dose of temozolomide.\r\n\r 3. Disease progression >= 12 weeks after the completion of any radiotherapy.\r\n\r 4. If patient received chemotherapy or an investigational agent as part of their prior\r therapy, the patient must recover from all toxicities (<= Grade 1) prior to enrollment\r on this protocol.\r\n\r 5. Bi-dimensionally measurable disease on contrast-enhanced magnetic resonance imaging\r study (MRI) performed within two weeks of study drug administration.\r\n\r 6. If patient received intratumoral chemotherapy or immunotherapy as part of their prior\r therapy then histological confirmation of recurrence is mandated.\r\n\r 7. KPS >= 70%.\r\n\r 8. The following laboratory results:\r\n\r - Absolute neutrophil count >= 1500 cells/microliter\r\n\r - Platelet count >= 100,000 cells/microliter\r\n\r - SGOT <= 2.5 x ULN\r\n\r - Serum creatinine <= 1.5 x ULN\r\n\r 9. Signed informed consent approved by Institutional Review Board.\r\n\r 10. If sexually active, patients will take contraceptive measures for the duration of the\r treatment.\r\n\r 11. For patients on corticosteroids, they must have been on a stable dose 1 week prior to\r baseline MRI and the dose should not be escalated over entry dose level, if clinically\r possible.\r\n\r Exclusion Criteria:\r\n\r 1. Pregnant or breast feeding women.\r\n\r 2. Prior treatment with O6-BG plus temozolomide in combination.\r\n\r 3. Active infection requiring intravenous antibiotics.\r\n\r 4. Known diagnosis of Human Immunodeficiency Virus (HIV) infection (HIV testing is not\r mandatory).\r\n\r 5. Patients with a history of another primary malignancy that is currently clinically\r significant or currently requires active intervention.\r\n\r 6. Patients unwilling or unable to comply with the protocol.\r\n\r 7. Patients who have received stereotactic radiosurgery or brachytherapy as part of their\r prior therapy.\r\n\r 8. Comedication that may interfere with study results; eg. immunosuppressive agents other\r than 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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72
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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\nViral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme\n\n**Clinical Trial Summary:**\n\nThis phase I trial studies the side effects and best dose of carcinoembryonic\r antigen-expressing measles virus (MV-CEA) in treating patients with glioblastoma multiforme\r that has come back. A virus, called MV-CEA, which has been changed in a certain way, may be\r able to kill tumor cells without damaging normal cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To assess the safety and toxicity of intratumoral and resection cavity administration of\r an Edmonston's strain measles virus genetically engineered to produce CEA (MV-CEA) in\r patients with recurrent glioblastoma multiforme.\r\n\r II. To determine the maximum tolerated dose (MTD) of MV-CEA. III. To characterize viral gene\r expression at each dose level as manifested by CEA titers.\r\n\r IV. To assess viremia, viral replication, and measles virus shedding/persistence following\r intratumoral administration.\r\n\r V. To assess humoral and cellular immune response to the injected virus. VI. To assess in a\r preliminary fashion antitumor efficacy of this approach.\r\n\r OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 sequential\r treatment arms.\r\n\r ARM A (RESECTION CAVITY ADMINISTRATION): Patients undergo en block resection of their tumor\r (after confirming diagnosis) on day 1, followed by MV-CEA administered into the resection\r cavity.\r\n\r ARM B (INTRATUMORAL AND RESECTION CAVITY ADMINISTRATION): Patients undergo stereotactic\r biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by\r carcinoembryonic antigen-expressing measles virus intratumorally (IT) through the catheter\r over 10 minutes on day 1. Patients then undergo en block resection of their tumor with\r computer-assisted stereotactic techniques on day 5, followed by MV-CEA administered around\r the tumor bed.\r\n\r After completion of study treatment, patients are followed up at 28 days (non-cohort I\r patients), 7 weeks (patients in cohort I only), every 2 months until progression, every 3 and\r 12 months after progression, and then yearly thereafter for up to 15 years.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Recurrent grade 3 or 4 glioma, including astrocytoma, oligodendroglioma or mixed\r glioma with histologic confirmation at initial diagnosis or recurrence\r\n\r - Candidate for gross total or subtotal resection\r\n\r - Absolute neutrophil count (ANC) >= 1500/uL\r\n\r - Platelets (PLT) >= 100,000/uL\r\n\r - Total bilirubin =< 1.5 x upper normal limit (ULN)\r\n\r - Aspartate aminotransferase (AST) =< 2 x ULN\r\n\r - Creatinine =< 2.0 x ULN\r\n\r - Hemoglobin (Hgb) >= 9.0 gm/dL\r\n\r - Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULN\r\n\r - Ability to provide informed consent\r\n\r - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\r\n\r - Anti-measles virus immunity as demonstrated by immunoglobulin G (IgG) anti-measles\r antibody levels of >= 1.1 EU/ml as determined by enzyme immunoassay\r\n\r - Normal serum CEA levels (< 3 ng/ml) at the time of registration\r\n\r - Willing to provide biologic specimens as required by the protocol\r\n\r - Negative serum pregnancy test done =< 7 days prior to registration (for women of\r childbearing potential only)\r\n\r Exclusion Criteria:\r\n\r - Any of the following:\r\n\r - Pregnant women\r\n\r - Nursing women\r\n\r - Men or women of childbearing potential who are unwilling to employ adequate\r contraception\r\n\r - Active infection =< 5 days prior to registration\r\n\r - History of tuberculosis or history of purified protein derivative (PPD) positivity\r\n\r - Any of the following therapies:\r\n\r - Chemotherapy =< 4 weeks prior to registration (6 wks for nitrosourea-based\r chemotherapy)\r\n\r - Immunotherapy =< 4 weeks prior to registration\r\n\r - Biologic therapy =< 4 weeks prior to registration\r\n\r - Bevacizumab =< 12 weeks prior to registration\r\n\r - Non-cytotoxic antitumor drugs, i.e., small molecule cell cycle inhibitors =< 2\r weeks prior to registration\r\n\r - Radiation therapy =< 6 weeks prior to registration\r\n\r - Any viral or gene therapy prior to registration\r\n\r - Failure to fully recover from acute, reversible effects of prior chemotherapy\r regardless of interval since last treatment\r\n\r - New York Heart Association classification III or IV\r\n\r - Requiring blood product support\r\n\r - Inadequate seizure control\r\n\r - Expected communication between ventricles and resection cavity as a result of surgery\r\n\r - Human immunodeficiency virus (HIV)-positive test result, or history of other\r immunodeficiency\r\n\r - History of organ transplantation\r\n\r - History of chronic hepatitis B or C\r\n\r - Other concurrent chemotherapy, immunotherapy, radiotherapy or any ancillary therapy\r considered investigational (utilized for a non-Food and Drug Administration\r [FDA]-approved indication and in the context of a research investigation)\r\n\r - Exposure to household contacts =< 15 months old or household contact with known\r immunodeficiency\r\n\r - Allergy to measles vaccine or history of severe reaction to prior measles vaccination\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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73
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[
{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)\n\n**Clinical Trial Summary:**\n\nThe purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE\r study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense\r temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the\r management of adult patients with malignant glioma who have failed following at least 2\r cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200\r mg/m^2).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Adult patients, greater than 18 years old.\r\n\r - Surgically confirmed diagnosis of malignant glioma, specifically anaplastic glioma\r (anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic\r oligoastrocytoma [AOA]) or glioblastoma multiforme (GBM).\r\n\r - Must have completed at least 2 cycles (2 months) of conventional 5/28 temozolomide,\r with radiological evidence of progression.\r\n\r - GBM treated with concurrent chemoradiation with temozolomide according to the\r EORTC/NCIC (European Organization for Research & Treatment of Cancer/National Cancer\r Institute of Canada) protocol.\r\n\r - Evidence of progression confirmed radiologically (CT [computed tomography] or MRI\r [magnetic resonance imaging]).\r\n\r - Patients must be enrolled within 2 weeks of last radiological confirmation of\r progression, except for patients undergoing surgical resection.\r\n\r - Patients undergoing surgical resection for recurrent disease must be enrolled within 2\r weeks of the post-surgical scan.\r\n\r - Patients with no residual disease after surgery are allowed.\r\n\r - Steroids dose should have been stabilized during the last 2 weeks prior to enrollment.\r\n\r - Use of medically approved contraception in fertile males and females.\r\n\r - Women of childbearing potential must have a negative urine or serum pregnancy test\r (urinary excretion or serum level of bHCG [beta human chorionic gonadotropin]) within\r 24 hours of inclusion in the study.\r\n\r - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\r\n\r - Signed informed consent form.\r\n\r Exclusion Criteria:\r\n\r - GBM progression during the first 2 months of adjuvant temozolomide (5/28).\r\n\r - AA progression during the first 2 months of standard temozolomide therapy (5/28).\r\n\r - Chemotherapy for the malignant glioma other than temozolomide.\r\n\r - More than one prior course of chemotherapy with temozolomide.\r\n\r - Patient evolving from anaplastic glioma to GBM following primary therapy.\r\n\r - Patient older than 70 years or who received no conventional chemoradiation regimen.\r\n\r - Patient who received radiotherapy for recurrent disease.\r\n\r - Patient with metastatic disease.\r\n\r - Known human immunodeficiency virus (HIV) infection.\r\n\r - History of non-compliance to other therapies.\r\n\r - Inadequate hematological, renal and hepatic function according to all of the following\r laboratory values (to be performed within 14 days, inclusive, prior to study\r inclusion):\r\n\r - Absolute neutrophil count <=1.5 ×10^9/L;\r\n\r - Platelets <=100 ×10^9/L;\r\n\r - Hemoglobin <90 g/L;\r\n\r - Serum creatinine >=1.5 times upper limit of laboratory normal (ULN);\r\n\r - Total serum bilirubin >=1.5 times ULN;\r\n\r - ASAT (AST [aspartate aminotransferase]) or ALAT (ALT [alanine aminotransferase) >2.0\r times ULN;\r\n\r - Alkaline phosphatase of >2.5 times ULN.\r\n\r - Known chronic hepatitis B or hepatitis C infection.\r\n\r - Any other serious medical condition, according to the medical judgment of the\r physician prior to inclusion in the study.\r\n\r - Any medical condition that could interfere with oral medication intake (e.g., frequent\r vomiting, partial bowel obstruction).\r\n\r - Other malignancies during the previous 5 years with the exception of surgically cured\r carcinoma in-situ of the cervix and basal cell carcinoma or non-melanoma skin cancer.\r\n\r - Any psychological, familial, sociological, or geographical condition potentially\r hampering compliance with the study protocol and follow-up schedule as discussed with\r the patient before inclusion in the study.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** 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 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011)\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to test MK0822 on disease activity in patients with\r osteoarthritis in the knee. Disease modifying activity of MK0822 will be assessed by\r measurements of knee cartilage using Magnetic Resonance Imaging (MRI) of the knee.\r\n\r This is an early phase trial and some specific protocol information is proprietary and not\r publicly available at this time. (Full information is available to trial participants).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with symptomatic knee osteoarthritis for at least 6 months based on clinical\r and radiographic criteria\r\n\r - Patients should be in general good health and must have a certain level of knee pain\r or be taking pain medicines on most days\r\n\r - Specific radiographic (X-ray) and MRI features must also be satisfied\r\n\r Exclusion Criteria:\r\n\r - Non-osteoarthritic causes of knee pain\r\n\r - Ineligibility to undergo MRI of the knee due to patient tolerability or safety reasons\r\n\r - Previous septic arthritis, tibial osteotomy or knee replacement in both knees\r\n\r - Acute injury of knee ligaments or meniscus in past 2 years\r\n\r - Knee arthroscopy in past 12 months\r\n\r - Anticipated arthroscopy or surgery in next 18 months\r\n\r - Use of intra-articular injections of hyaluronan (e.g. Hyalgan (TM), Synvisc (TM),\r Orthovisc (TM)) in past 6 months, or injections of glucocorticoids (e.g. Kenalog (TM),\r Aristospan (TM), Depo-Medrol (TM)) in past 3 months or anticipated knee injections\r during the study\r\n\r - Glucosamine or chondroitin sulfate are allowable if they are at a stable dose for past\r 3 months and will continue at that dose during the study\r\n\r - Other exclusion criteria apply-Please ask the study doctor for details\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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75
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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 in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma\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\n\r PURPOSE: This phase II trial is studying how well temozolomide works in treating patients\r with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine progression-free survival of patients with newly diagnosed anaplastic\r oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.\r\n\r - Determine the response rate in these patients.\r\n\r - Assess the quality of life of patients with AO or MOA treated with this regimen.\r\n\r OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to\r disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).\r\n\r Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every\r 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.\r\n\r Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for\r the first year after completion of treatment, every 4 months for the second year, every 6\r months for the third and fourth years, and once a year thereafter.\r\n\r After completion of study treatment, patients are followed periodically.\r\n\r PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma\r meeting 1 of the following criteria:\r\n\r - Bidimensionally measurable disease\r\n\r - Evaluable disease\r\n\r - Nonevaluable disease as demonstrated by gross total surgical resection\r\n\r - No immediate need for cranial irradiation\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Karnofsky performance status 70-100%\r\n\r - Life expectancy ≥ 12 weeks\r\n\r - Absolute granulocyte count ≥ 1,500/mm³\r\n\r - Hemoglobin ≥ 10.0 g/dL\r\n\r - Platelet count ≥ 100,000/mm³\r\n\r - Creatinine ≤ 1.5 times upper limit of normal (ULN)\r\n\r - Bilirubin ≤ 2.0 times ULN\r\n\r - AST ≤ 3.0 times ULN\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - No infection requiring systemic antibiotics within the past 14 days\r\n\r - No other malignancy within the past 5 years except for carcinoma in situ of the cervix\r or nonmelanoma skin cancer\r\n\r - No unrelated medical problems that would preclude study compliance\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - No prior chemotherapy for this malignancy\r\n\r - No prior radiotherapy to the brain\r\n\r - No surgery requiring general anesthesia > 2 hours in duration within the past 10 days\r\n\r - No prior temozolomide\r\n\r - Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week\r prior to study entry\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
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[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nPhase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma\n\n**Clinical Trial Summary:**\n\nThe pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the\r zone of tumor destruction with escalated light doses following intraoperative treatment of\r primary or recurrent glioma.\n\n**Clinical Trial Detailed Description:**\n\nLight Infusion Technology (Litx™) is a locoregional cancer treatment in which a systemically\r administered light-activated drug (LS11) is activated locally by illuminating the diseased\r tissue using light-emitting diodes (LEDs) of a specific wavelength. The activated\r photosensitizer reacts with endogenous oxygen to yield highly reactive species of oxygen that\r cause destruction of cellular structures such as mitochondria, lysosomes and cell walls\r leading to irreversible cell damage and tissue death.\r\n\r Either twenty-four or twelve hours prior to surgery, the patient will receive an intravenous\r dose of 1 mg/kg of LS11, given IV by slow push over 3-5 minutes.\r\n\r Following craniotomy, patients will undergo intraoperative placement of a single Light\r Source, centrally placed within the tumor, under direct visualization prior to tumor\r resection. Following placement of the light source (with the depth of the end of the light\r bar from the cortical surface to be calculated from the pre-operative MRI and spiral CT scan,\r so as to be centralized within the main tumor bulk), light will be delivered following a\r predetermined escalation schedule (either 100 J/cm or 200 J/cm) at 20 mW/cm light energy for\r a treatment time of 1 hour 24 minutes (100J/cm) or 2 hours 46 minutes (200 J/cm). The Light\r Source will then be manually removed and the tumor maximally resected.\r\n\r The resected tumor and marginal tissue will be submitted for pathology to determine depth of\r cell death, extent of tumor tissue containing closed vessels, any evidence of vessel closure\r or other damage to tissues outside of the projected kill zone.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Have primary or recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)\r undergoing planned tumor resection\r\n\r - Have a right sided, supratentorial frontal or temporal lobe tumor\r\n\r - Have right hand dominance\r\n\r - Be adults aged >18 years\r\n\r - Have a Karnofsky Performance Status score >70\r\n\r - Have a estimated life expectancy of >12 weeks\r\n\r - Have completed any prior antineoplastic therapy at least 4 weeks prior to surgery and\r be recovered from acute side effects\r\n\r - Must have the understanding and ability to sign an informed consent document\r\n\r - Be male or non-pregnant, non-lactating females. Patients who are fertile must agree to\r use an effective method of contraception during participation in the study\r\n\r - Have a negative serum or urine pregnancy test within 14 days prior to treatment (if\r patient is a female of childbearing potential).\r\n\r Exclusion Criteria:\r\n\r Patients must be excluded if any of the following apply:\r\n\r - Have tumors <2 cm in diameter\r\n\r - Have inadequate organ function as evidenced by: PT or PTT >1.5 × control ; Platelet\r count <100,000/mm3 ; WBC <2,500/mm3 ; Neutrophils <2000/mm3 ; Hemoglobin <9 g/dL\r\n\r - Be concurrently participating in another clinical trial involving experimental\r treatment\r\n\r - Have any concurrent diseases or conditions that in the opinion of the investigator\r impair the patient's ability to complete the trial such as psychological, familial,\r sociological, geographical or medical conditions which in the Principal Investigator's\r opinion could compromise compliance with the objectives and procedures of this\r protocol or obscure interpretation of the trial's data are excluded.\r\n\r - Have psychological, familial, sociological, geographical, or medical conditions which,\r in the Investigator's opinion, could compromise compliance with the objectives and\r procedures of this protocol or obscure interpretation of the trial data.\r\n\r - Have a known sensitivity to porphyrin-type drugs or known history of porphyria\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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77
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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\nThalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas\n\n**Clinical Trial Summary:**\n\nObjectives:\r\n\r 1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy\r with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or\r progressive malignant gliomas.\r\n\r 1.2 To determine the rate of measureable clinical response in patients treated with\r Thalidomide and CPT-11.\r\n\r 1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected\r toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.\r\n\r 1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker\r for treatment effect.\n\n**Clinical Trial Detailed Description:**\n\nThalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help\r to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that\r was designed to stop cancer cells from dividing.\r\n\r All participants will take thalidomide capsules by mouth every evening at bedtime. You will\r begin with 1 capsule every night for the first week then increase to 2 capsules every night\r for a week and then 3 capsules a night for the third week. After that, you will increase the\r dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you\r experience any severe side effects.\r\n\r In addition to thalidomide, you will receive treatment with CPT-11 through a continuous\r injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest\r from the drug. This 6 week period is called a course of therapy. The courses of therapy will\r be repeated as long as the disease is responding to treatment for up to 2 years.\r\n\r THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and\r CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is\r investigational.\r\n\r Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nIs there an age limit? No\r\n\r Inclusion Criteria:\r\n\r 1. Patients with histologically proven supratentorial malignant primary gliomas\r (Glioblastoma multiforme (GBM), Gliosarcoma (GS) Anaplastic astrocytoma (AA),\r Anaplastic oligodendroglioma (AO), mixed anaplastic glioma (MAG)) will be eligible for\r this protocol.\r\n\r 2. Patients must have shown unequivocal evidence for tumor recurrence or progression by\r MRI scan after radiation therapy.\r\n\r 3. Patients in the GBM stratum may have had treatment for no more than 2 prior relapses;\r for the AA stratum, there is no limitation for the number of relapses provided all\r other eligibility criteria particularly the functional status are met.\r\n\r 4. All patients must sign an informed consent.\r\n\r 5. The baseline on-study MRI should be performed within 14 days prior to registration and\r on a stable or decreasing steroid dosage.\r\n\r 6. Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible.\r\n\r 7. Patients must have a life expectancy > 8 weeks.\r\n\r 8. Patients must have a Karnofsky performance status of >= 70\r\n\r 9. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from\r prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from\r nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic\r agents, e.g., interferon, tamoxifen, cis-retinoic acid, etc. (radiosensitizer does not\r count). Patients who receive either Temozolomide or CPT-11 for non-therapeutic\r purposes (such as presurgically for obtaining pharmacology data for the agent) will be\r eligible for study entry provided they have recovered from the toxic effects of the\r agent if any.\r\n\r 10. Patients must have adequate bone marrow function (Absolute neutrophil count (ANC)>\r 1,500/mm3 and platelet count of > 100,000/mm3), adequate liver function (alanine\r aminotransferase (ALT or SGPT) and alkaline phosphatase <2 times normal, bilirubin\r <1.5 mg/dl), and adequate renal function (blood urea nitrogen (BUN) and creatinine\r <1.5 times institutional normal) prior to starting therapy.\r\n\r 11. Patients must not be pregnant and must practice adequate contraception during the\r study and for 2 months after participation in study.\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), unless in complete remission and off of all therapy\r 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 c) serious intercurrent medical illness. d) prior\r recurrence with CPT-11 (for the CPT-11 + Thalidomide arm) (prior treatment with\r thalidomide is permitted). e) grade 2 or higher peripheral neuropathy. Patients who\r have received Temozolomide or CPT-11 for non-therapeutic purposes (for eg., as part of\r a pharmacology study without therapeutic intent) will remain eligible for enrollment\r into the study.\r\n\r 3. No exclusion to this study will be based on race. Minorities will actively be\r recruited to participate. The malignant glioma patient population treated at MDACC\r over the past year is as follows: American Indian or Alaskan Native - 0 Asian or\r Pacific Islander - <2% Black, not of Hispanic Origin - 3% Hispanic - 6% White, not of\r Hispanic Origin - 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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78
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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\nDevelopment of the MDASI-Spine Tumor Module\n\n**Clinical Trial Summary:**\n\nThe goal of this research study is to learn the severity of certain symptoms in patients with\r tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson\r Symptom Inventory-Spine is a good way to rate these symptoms.\r\n\r Primary Objective:\r\n\r 1. To evaluate the psychometric properties of the MDASI-Spine in patients with tumors\r involving the spine or spinal cord.\r\n\r Secondary Objective:\r\n\r 1. To describe the severity of commonly occurring symptoms experienced by persons with spine\r tumors.\n\n**Clinical Trial Detailed Description:**\n\nIf you agree to take part in this study, you will complete the M. D. Anderson Symptom\r Inventory-Spine Tumor Module survey. This survey will ask you to rate the severity of certain\r symptoms you may have had in the last 24 hours on a scale of 0 (not present) to 10 (the most\r severe you can imagine). You will also be asked to rate how your symptoms get in the way of\r your daily activities using the same 0 to 10 scale. This survey should take about 10-15\r minutes to complete.\r\n\r Information regarding your clinical history (tumor type, location, treatment, and other\r medications) and demographic information (age, gender, ethnicity, religion, educational\r level, and marital status) will also be collected. This information will be used to\r evaluation whether there is an association between symptom severity and these factors.\r\n\r Once you have completed the survey, your participation on this study will be over.\r\n\r This is an investigational study. Up to 128 patients will take part in this study. All will\r be enrolled at M. D. Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. Diagnosis of a tumor involving the spinal cord (intramedullary or extramedullary)\r\n\r 2. Age > or = to 18 years of age\r\n\r 3. Ability to speak and read English. Non-English speaking subjects will be included in\r future studies, once the final instrument has been developed.\r\n\r Exclusion Criteria:\r\n\r 1. Patients < 18 years of age\r\n\r 2. Evidence of gross cognitive dysfunction limiting memory or ability to complete a\r self-report questionnaire as determined by evaluation of physician or mid-level\r provider.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nRadiotherapy for Malignant Astrocytomas in the Elderly\n\n**Clinical Trial Summary:**\n\nA randomized trial comparing radiotherapy with supportive care in patients aged 70 years or\r older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma,\r and a Karnofsky performance status > 70.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Glioblastoma and anaplastic astrocytoma, supratentorial, histologically confirmed\r\n\r - Brain CT scan or MRI within 28 days before surgery\r\n\r - Age: 70 years or older\r\n\r - Karnofsky performance status, 70 or more.\r\n\r - Life expectancy over 12 weeks\r\n\r - Informed consent\r\n\r Exclusion Criteria:\r\n\r - Brain radiotherapy\r\n\r - Chemotherapy\r\n\r - Severe systemic disease\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"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 IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma\n\n**Clinical Trial Summary:**\n\nIn this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP\r 12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult\r patients with confirmed recurrent high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nThe purpose of this study is to compare the safety and efficacy of two doses of AP 12009 and\r standard chemotherapy in adult patients with recurrent high-grade glioma (anaplastic\r astrocytoma [AA], WHO grade III; or glioblastoma [GBM], WHO grade IV). AP 12009 is a\r phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human transforming\r growth factor-beta2 (TGF-beta2). The growth factor TGF-beta plays a key role in malignant\r progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis\r and escape from immunosurveillance. It has been shown that in a number of tumor types the\r degree of TGF-beta production strongly correlates with tumor grade and stage. In patients\r with high-grade glioma, the TGF-beta2 overexpression is associated with disease stage,\r clinical prognosis and the immunodeficient state of the patients.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma\r (anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV)\r\n\r - Supratentorial localization\r\n\r - No more than two chemotherapy regimens including radiochemotherapy since primary\r diagnosis\r\n\r - Eligible for either TMZ or PCV treatment\r\n\r - Recovery from acute toxicity caused by any previous therapy\r\n\r - Adequate organ functions\r\n\r - KPS at least 70%\r\n\r Exclusion Criteria:\r\n\r - Tumor surgery within 2 weeks prior to study entry\r\n\r - Radiation therapy within 8 weeks prior to study entry\r\n\r - Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks)\r\n\r - No more than 3 mg/day dexamethasone (or equivalent) at baseline\r\n\r - Prior TGF-beta targeted therapy or tumor vaccination\r\n\r - Baseline MRI shows mass effect\r\n\r - Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal\r infection\r\n\r - Significant psychiatric disorders/legal incapacity or a limited legal capacity\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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[
{
"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\nIodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer\n\n**Clinical Trial Summary:**\n\nRATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8,\r can find tumor cells and carry tumor-killing substances to them without harming normal cells.\r This may be an effective treatment for central nervous system cancer or leptomeningeal\r metastases.\r\n\r PURPOSE: This phase II trial is studying the side effects and how well iodine I 131\r monoclonal antibody 3F8 works in treating patients with central nervous system cancer or\r leptomeningeal cancer.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine if intrathecal iodine I 131 monoclonal antibody 3F8 activity in patients with\r GD2-expressing central nervous system or leptomeningeal neoplasms is sufficiently\r promising (i.e., 6-month overall survival rate ≥ 25%) to warrant further study.\r\n\r - Determine the response rate in patients treated with this drug.\r\n\r - Determine the cumulative toxicities of this drug in these patients.\r\n\r - Describe the effects of human-antimouse antibody on cerebrospinal fluid and serum\r pharmacokinetics in patients treated with this drug.\r\n\r OUTLINE: This is an open-label study.\r\n\r Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 for dosimetry. Beginning\r approximately 1 week later, patients receive intrathecal iodine I 131 monoclonal antibody 3F8\r on day 1. Treatment intrathecal iodine I 131 monoclonal antibody 3F8 repeats weekly for up to\r 4 courses in the absence of disease progression or unacceptable toxicity.\r\n\r Blood and cerebrospinal fluid samples are collected prior to and after administration of each\r course of study drug. Samples are analyzed to assess the intrathecal and blood\r pharmacokinetics of iodine I 131 monoclonal antibody 3F8 and serum human antimouse\r antibodies. Samples are also analyzed in tumor genetic studies.\r\n\r After completion of study treatment, patients are followed periodically for 3 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have a histologically confirmed diagnosis of a malignancy known to\r expressGD2. Such tumors include medulloblastoma/primitive neuroectodermal tumor of the\r CNS, high grade astrocytomas, malignant glioma, neuroblastoma, retinoblastoma,\r ependymoma, rhabdoid tumors, sarcomas, melanoma or small cell lung carcinoma. For\r patients with other tumor types, GD2 expression must be confirmed by\r immunohistochemical staining and assessed by the Department of Pathology using prior\r frozen tissue, bone marrow or CSF cytology (send to Research Lab).\r\n\r - Patients must have CNS/ leptomeningeal disease including high risk medulloblastoma, or\r a CNS/leptomeningeal malignancy which is refractory to conventional therapies, or for\r which no conventional therapy exists, OR a recurrent brain tumors with a predilection\r for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).\r\n\r - Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count >\r 50,000/ul.\r\n\r - Patients may have active malignancy outside the central nervous system.\r\n\r - Patients who have a programmable shunt will not be excluded.\r\n\r - Both pediatric and adult patients of any age are eligible.\r\n\r - Patients or a legal guardian will sign an informed consent form approved by the IRB\r and obtained by the Principal or a Co- Investigator before patient entry. Minors will\r provide assent.\r\n\r Exclusion Criteria:\r\n\r - Patients with obstructive or symptomatic communicating hydrocephalus.\r\n\r - Patients with an uncontrolled life-threatening infection.\r\n\r - Patients who are pregnant: Pregnant women are excluded for fear of danger to the\r fetus. Therefore negative pregnancy test is required for all women of child-bearing\r age, and appropriate contraception is required during the study period.\r\n\r - Patients who have received cranial or spinal irradiation less than 3 weeks prior to\r the start of this protocol.\r\n\r - Patients who have received systemic chemotherapy (corticosteroids not included) less\r than 3 weeks prior to the start of this protocol.\r\n\r - Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and\r gastrointestinal system toxicity should all be less than or equal to grade 2. Patients\r with stable neurological deficits (because of their brain tumor) are not excluded.\r Patients with <= 3 hearing loss are not excluded.\r\n\r - Patients must have no rapidly progressing or deteriorating neurologic examination.\r\n\r - Patients who have already received >45 Gy to the craniospinal radiation or >72 Gy\r focal brain radiation.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nBevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma\n\n**Clinical Trial Summary:**\n\nThis phase I trial is studying the side effects and best dose of bevacizumab and cediranib\r maleate in treating patients with metastatic or unresectable solid tumor, lymphoma,\r intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma. Monoclonal antibodies, such\r as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer\r cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing\r substances to them. Cediranib maleate may stop the growth of cancer cells by blocking some of\r the enzymes needed for cell growth. Bevacizumab and cediranib maleate may also stop the\r growth of cancer cells by blocking blood flow to the cancer. Giving bevacizumab together with\r cediranib maleate may kill more cancer cells.\n\n**Clinical Trial Detailed Description:**\n\nPRIMARY OBJECTIVES:\r\n\r I. To evaluate the safety and toxicity profile of intravenous bevacizumab (avastin)\r administered in combination with oral AZD2171 (cediranib maleate) for patients with advanced\r malignancies.\r\n\r II. To determine the pharmacokinetic profile of oral AZD2171 in combination with bevacizumab\r (avastin) administered to patients with advanced malignancies.\r\n\r SECONDARY OBJECTIVES:\r\n\r I. To evaluate the serum concentrations of Nitric Oxide (NO) and Nitric oxide synthase (NOS)\r among patients treated with this regimen and to correlate with VEGF expression.\r\n\r II. To determine changes in the tumor vasculature detected by DCE-MRI among patients treated\r with this combination of VEGF receptor blocking agents.\r\n\r III. To evaluate the potential predictive role of angiogenesis molecular endpoints in\r malignant effusion samples.\r\n\r IV. To assess in a descriptive fashion the efficacy of the studied regimen.\r\n\r OUTLINE: This is a dose-escalation study.\r\n\r Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral cediranib\r maleate once daily on days 1-21. Treatment repeats every 28 days in the absence of disease\r progression or unacceptable toxicity.\r\n\r Cohorts of 3-6 patients receive escalating doses of bevacizumab and cediranib maleate until\r the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that\r at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\r\n\r Blood samples are acquired at baseline, on day 2, and after 2 courses of treatment for\r pharmacokinetic studies. Samples are analyzed by TUNEL, immunofluorescence staining,\r laser-scanning cytometry, flow cytometry, enzyme-linked immunosorbent assay, and\r immunohistochemistry to assess apoptosis in tumor and endothelial cells, microvessel density\r mean vessel volume, nitric oxide concentration, and signal transduction pathways (i.e., ERK\r ½, P38 mitogen-activated protein kinase, protein kinase B, circulating endothelial and\r progenitor cells, basic fibroblast growth factor, vascular endothelial growth factor (VEGF)\r receptor phosphorylation, VEGF, and hypoxia inducible factor-1α). Some patients also undergo\r tissue biopsy at baseline and after 2 courses of treatment for characterization of vascular\r and angiogenesis markers. Some patients also undergo DCE-MRI at baseline, once between days\r 22-24, and after every 2 courses of treatment to assess blood perfusion.\r\n\r After completion of study treatment, patients are followed for 6 weeks.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients must have histological confirmation of Solid Tumor or Lymphoma that is\r metastatic or unresectable; if assessing a single target lesion, histological\r confirmation of that particular lesion MUST be carried out\r\n\r - Patients may have received an unlimited number of prior therapies; however, At least 4\r weeks MUST have passed since the last chemotherapy to day 1 of registration (6 weeks\r for regimens containing nitrosoureas or Mitomycin C)\r\n\r - ECOG performance status =< 2 (Karnofsky >= 60%)\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 =< 2.0 mg/dL (does NOT apply to patients with Gilbert's Syndrome)\r\n\r - AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (Patients with liver\r involvement will be allowed =< 5.0 X institutional upper normal limit)\r\n\r - Serum creatinine =< 2.0 mg/dL\r\n\r - Patients MUST have recovered from all treatment related toxicities to Grade 1 NCI CTC\r (v 4.0) in severity\r\n\r - Patients must be willing and able to review, understand, and provide written consent\r before starting therapy\r\n\r - Patients with stable brain metastasis (stable disease on one MRI assessment at least 4\r weeks after completion of whole brain radiation, no evidence of progression on MRI\r assessment 4 weeks after stereotactic radiosurgery or complete surgical excision) will\r also be allowed to participate in this trial\r\n\r - Patients with histologically proven intracranial glioblastoma, gliosarcoma or\r anaplastic astrocytoma will be eligible; patients must have shown unequivocal\r radiographic evidence for tumor progression by MRI scan; scan should be performed\r within 14 days prior to registration and on a steroid dose that has been stable for at\r least 5 days; if the steroid dose is increased between the date of imaging and\r registration, a new baseline MRI is required\r\n\r Exclusion Criteria:\r\n\r - Patients with squamous non-small cell lung carcinoma\r\n\r - Serious or non-healing wound, ulcer or bone fracture\r\n\r - History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess\r within 28 days of day 1 of registration\r\n\r - Invasive procedures defined as follows:\r\n\r - Major surgical procedure, open biopsy or significant traumatic injury within 28\r days prior to Day 1 registration\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 of therapy\r\n\r - Patients may not be receiving any other investigational agents\r\n\r - Patients with bleeding diathesis (clinical bleeding, prothrombin time >= 1.5 X upper\r institutional normal value, INR >= 1.5, activated partial thromboplastin time aPTT >=\r 1.5 X upper institutional normal value), active gastric or duodenal ulcer\r\n\r - Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg,\r Diastolic Blood Pressure > 90 mmHg)\r\n\r - Urine protein should be screened by dipstick or urine analysis; for proteinuria > 1+\r or urine protein:creatinine ratio > 1.0, 24-hour urine protein should be obtained and\r the level should be < 1000 mg for patient enrollment\r\n\r - Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r infection requiring parenteral antibiotics on Day 1\r\n\r - Patients with clinically significant cardiovascular disease:\r\n\r - History of CVA within 6 months\r\n\r - Myocardial Infarction or unstable angina within 6 months\r\n\r - New York Heart Association Grade II or greater congestive heart failure, serious\r cardiac arrhythmia requiring medication, unstable angina pectoris\r\n\r - Clinically significant peripheral vascular disease\r\n\r - QTc prolongation > 500msec or other significant ECG abnormality noted within 14\r days of registration\r\n\r - Conditions requiring concurrent use of drugs or biologics with proarrythmic\r potential; these drugs are prohibited during studies with AZD2171 (refer to\r appendix V for a listing of these agents)\r\n\r - Patients with history of hemoptysis\r\n\r - Patients with tumor mass abutting a major vessel\r\n\r - Pregnant women are excluded from this study because AZD-2171 is an angiogenesis\r inhibiting agent with potential teratogenic or abortifacient effects; because of the\r potential risk for adverse events in nursing infants secondary to treatment of the\r mother with AZD-2171, breastfeeding should be discontinued if the mother is treated\r with AZD-2171; these potential risks may also apply to other agents used in this\r study; women of child-bearing potential and men must agree to use contraception prior\r to study entry and for the duration of study participation; should a woman become\r pregnant or suspect she is pregnant while participating in this study, she should\r inform her treating physician immediately\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
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83
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nThe Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas\n\n**Clinical Trial Summary:**\n\nThe purpose of the current trial is to explore whether the standard treatment with\r radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade\r astrocytomas. If vascular effects are identified, future clinical trials can be proposed\r wherein anti-angiogenic agents are added to increase patient survival.\n\n**Clinical Trial Detailed Description:**\n\nToday's standard treatment with radiotherapy and temozolomide yields a life expectancy of\r 1.5-3 years in patients with high-grade astrocytomas. Thus, there is a need for further\r therapeutic improvements in this patient population. The purpose of the current trial is to\r explore whether radiotherapy and temozolomide affect the tumor vasculature in patients with\r high-grade astrocytomas. If vascular effects are identified, future clinical trials can be\r proposed wherein anti-angiogenic agents are added to increase patient survival. Additionally,\r stem cells within malignant brain tumors is an important new area of research in this patient\r population, and investigations herein could contribute to identify new predictive markers and\r therapeutic targets.\r\n\r Primary objective: To assess the vascular perfusion and permeability characteristics of\r high-grade astrocytomas (anaplastic astrocytoma and glioblastoma multiforme) using dynamic\r contrast-enhanced magnetic resonance imaging (DCE-MRI) in patients receiving radiotherapy and\r temozolomide. Furthermore to assess whether therapy-induced changes in tumor perfusion is\r correlated with progression-free survival.\r\n\r Secondary objectives:\r\n\r - Analyze circulating endothelial cells in the blood by flow cytometry to explore whether\r these cells can be used as an indirect estimate of angiogenesis in high-grade\r astrocytomas\r\n\r - Analyze tumor specimens from patients that have had their gliomas debulked before\r commencing therapy\r\n\r - immunostaining of the tumor vasculature to assess microvessel density\r\n\r - immunostaining for tumor stem cells\r\n\r - flow cytometric assessment of dissolved tumor tissue to look for tumor stem cells\r\n\r - Assess progression-free survival of all patients included in the study, in order to\r correlate the survival data with the above tissue sampling results.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed primary high-grade astrocytoma, i.e. anaplastic astrocytoma\r or glioblastoma multiforme.\r\n\r - Have a WHO performance status 0-2 and be able to undergo outpatient treatment.\r\n\r - Age ≥18 years.\r\n\r - No pregnant or lactating patients can be included.\r\n\r - Patients must have radiographically documented measurable disease postoperatively. At\r least one tumor lesion must be unidimensionally measurable as follows:\r\n\r - Tumor lesion > 10 mm on conventional MRI scan, T1-weighted series, after\r intravenous (i.v.) gadolinium chelate contrast.\r\n\r - All diagnostic radiology studies must be performed within 28 days prior to\r registration.\r\n\r - Absence of conditions making MRI scans impossible;\r\n\r - Cardiac pacemaker\r\n\r - Other ferromagnetic metal implants not authorised for use in MRI such as some\r types of cerebral aneurysm clips\r\n\r - Serious claustrophobia\r\n\r - Obesity (> 300 lb., 140 Kg)\r\n\r - Patients who are receiving corticosteroids have to receive stable or decreasing doses\r for at least 14 days before entering the trial.\r\n\r - No prior chemotherapy for high-grade astrocytoma\r\n\r - Absence of opportunistic infections making temozolomide contraindicated.\r\n\r - Minimum required laboratory data:\r\n\r - Hematology:\r\n\r - Absolute granulocytes > 1.0 x 10^9/L\r\n\r - Platelets > 100 x 10^9/L\r\n\r - Biochemistry:\r\n\r - Bilirubin < 1.5 x upper normal limit\r\n\r - INR < 1.5\r\n\r - Serum creatinine <1.5 x upper normal limit\r\n\r - Adequate cognitive function in order to give informed consent.\r\n\r - Absence of any psychological, familial or sociological condition potentially hampering\r compliance with the study protocol and follow-up schedule; those conditions should be\r discussed with the patient before registration in the trial\r\n\r - Before patient registration/randomization, written informed consent must be given\r according to national and local regulations.\r\n\r Exclusion Criteria:\r\n\r - Lack of fulfillment of inclusion criteria.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\n6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients\n\n**Clinical Trial Summary:**\n\nThe goal of this clinical research study is to learn if the combination of 6-Thioguanine,\r Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine\r (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or\r glioblastoma multiforme in patients who have failed previous treatments. The safety of these\r combination treatment will also be studied.\r\n\r Objectives:\r\n\r 1.1 To determine the efficacy, as measured by 12 month progression-free survival, of\r TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in the\r treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma\r multiforme.\r\n\r 1.2 To determine the long-term toxicity of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed\r by CAPECITABINE and CELECOXIB in recurrent anaplastic glioma or glioblastoma multiforme\r patients treated in this manner.\r\n\r 1.3 To determine the clinical relevance of genetic subtyping tumors as a predictor of\r response to this chemotherapy and long term survival\n\n**Clinical Trial Detailed Description:**\n\nCapecitabine is a drug that damages the DNA (deoxyribonucleic acid) of tumor cells and blocks\r the function of DNA and RNA (ribonucleic acid) of tumor cells. These actions help to kill the\r tumor cells.\r\n\r Celecoxib is a drug that may help to prevent the development of some types of cancer by\r blocking a type of enzyme (COX-2) that is found in tumor cells.\r\n\r Temozolomide and CCNU are the current standard treatment for malignant brain tumors. Both\r drugs work by damaging the DNA (deoxyribonucleic acid) of tumor cells to kill these tumor\r cells.\r\n\r 6-Thioguanine is a drug that helps to increase the effects of Temozolomide and CCNU on tumor\r cells.\r\n\r Depending on the previous treatment you have received, you will be treated according to Arms\r 1, 2, or 3.\r\n\r If you have not received temozolomide before, you will be treated on Arm 1. If you have\r received temozolomide before but only during radiation therapy and not as chemotherapy\r afterwards and the treatment was over 6 months ago, you will be treated with temozolomide\r according to Arm 1.\r\n\r If you have not received lomustine or carmustine, you will be treated on Arm 2. If you have\r received Gliadel wafers at surgery greater than 6 months ago and have not been treated with\r lomustine or carmustine, you will be treated with CCNU according to Arm 2.\r\n\r Arm 3 will include glioblastoma multiforme patients who may be treated with either\r temozolomide or lomustine according to the above guidelines and regimens described in Arms 1\r and 2.\r\n\r Arm 1:\r\n\r Treatment will begin with 6-thioguanine taken by mouth 4 times a day (every 6 hours) for 3\r days in a row (Days 1-3). This will be followed by temozolomide taken by mouth at bedtime for\r 5 days in a row (Days 4-8). After a rest period of 6 days, capecitabine and celecoxib will be\r taken by mouth twice a day (12 hours apart) for 14 days (Days 14-27). Each cycle of treatment\r on arm 1 will be 28 days.\r\n\r Arm 2:\r\n\r Treatment will begin with 6-thioguanine taken by mouth 4 times a day (every 6 hours) for 3\r days in a row (Days 1-3). This will be followed by lomustine taken by mouth at bedtime for 1\r day (Day 4). After a rest period of 1 week, capecitabine and celecoxib will be taken by mouth\r twice a day (12 hours apart) for 14 days (Days 11-24). Each cycle of treatment on arm 2 will\r take 42 days.\r\n\r Blood tests (less than 2 teaspoons) will be repeated every 2 weeks and before each new cycle\r of treatment (a total of about 2 tablespoons). The neurological exam, anticonvulsant level\r blood tests and the stool test for blood, will be repeated before every cycle on Arms 2 and 3\r (CCNU) and before every 2 cycles on Arms 1 and 3 (temozolomide). Kidney function will be\r evaluated from the blood tests before every other course. Patients taking anticoagulants\r (coumadin, warfarin) will have procedures to test the clotting ability of the blood before\r each cycle or more frequently if the doctor feels it is necessary.\r\n\r Arm 3:\r\n\r Glioblastoma Multiforme patients will be treated on Arm 3 which will include the drug regimen\r from either Arm 1 or Arm 2.\r\n\r Treatment on all arms will continue for 1 year as long as the tumor does not grow and any\r side effects are tolerable. Treatment may continue beyond one year if your doctor feels it is\r needed. During the study, you may not receive any other investigational drug or have any\r other treatment for the cancer, including surgery.\r\n\r This is an investigational study. All drugs used in this study are FDA approved and are\r commercially available. A total of 140 patients will take part in this study. All patients\r will be enrolled at M. D. Anderson.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r 1. All patients must sign an informed consent indicating that they are aware of the\r investigational nature of this study in keeping with the policies of this hospital.\r\n\r 2. Patients with histologically proven supratentorial anaplastic oligodendrogliomas,\r anaplastic mixed oligoastrocytomas anaplastic astrocytomas or glioblastoma multiforme.\r\n\r 3. Patients must have unequivocal evidence for tumor recurrence or progression by MRI\r scan performed within 14 days prior to enrollment or documented recurrence by tumor\r resection. Patients must have received radiation therapy previously.\r\n\r 4. Patients having undergone recent resection of recurrent or progressive tumor will be\r eligible as long as all the following conditions are met: a) Patients have recovered\r from the effects of surgery; b) Extent of residual disease (if present) has been\r documented by MRI performed no later than 72 hours after surgery or, if not possible,\r at least 4 weeks post-operative. Radiographic evidence of residual disease is not\r mandated for enrollment.\r\n\r 5. The baseline on-study MRI is performed within 14 days of enrollment and on a steroid\r dosage that has been stable. If the steroid dose is increased between the date of\r imaging and the initiation of chemotherapy, a new baseline MRI is required on stable\r steroids for 7 days.\r\n\r 6. Patients must be equal to or greater than 12 years old.\r\n\r 7. Patients must have a Karnofsky performance status of equal to or greater than 60\r (Karnofsky Performance Scale; Appendix D).\r\n\r 8. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from\r prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from\r nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic\r agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.\r (radiosensitizer does not count). Any questions related to the definition of\r non-cytotoxic agents should be directed to the Study Chair.\r\n\r 9. Patients must have adequate bone marrow function (ANC equal or greater than 1,500/mm3\r and platelet count of equal or greater than 100,000/mm3), adequate liver function\r (SGPT and alkaline phosphatase <2 times normal, bilirubin <1.5 mg%), and adequate\r renal function (BUN and creatinine <1.5 times institutional normal) prior to starting\r therapy.\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), unless in complete remission and off of all therapy\r for that disease for a minimum of 3 years (1 year for localized prostate carcinoma\r treated by prostatectomy or irradiation) are ineligible.\r\n\r 2. Patients of childbearing potential must not be pregnant or become pregnant.\r\n\r 3. Patients must not have: a) active infection; b) disease that will obscure toxicity or\r dangerously alter drug metabolism; c) serious intercurrent medical illness; d) acute\r or chronic pulmonary disease, pulmonary embolus, hypertension, diabetes, metabolic\r syndrome, stroke, heart disease,myocardial infarction, angina, coronary angioplasty,\r congestive heart failure, or coronary bypass surgery; e) allergies to sulfa drugs; f)\r severe psychiatric illness; g) uncontrolled hypertension (i.e. ->135/>85 mm Hg) on\r three repeated measurements during the 6 weeks prior to enrollment on the study\r\n\r 4. Patients must not have (continued): h) family history of premature coronary disease\r (i.e. - onset < 55 years of age); i) uncontrolled hypercholesteremia [low-density\r lipoprotein cholesterol (LDL-C >130]. Hypercholesteremia must be controlled for at\r least 3 months prior to enrollment on study; j) history of systemic lupus\r erythematous, family history of protein S or C deficiencies, prior heparin-induced\r thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels; k) any\r indications for ASA deficiency\r\n\r 5. Patients must not have had prior treatment with Capecitabine, 5-FU or a combination of\r Temozolomide with CCNU (Lomustine) or BCNU (Carmustine). Patients who received only\r Temozolomide during radiation therapy and did not receive adjuvant chemotherapy with\r Temozolomide and/or those who received Gliadel (BCNU) wafers at surgery without\r adjuvant chemotherapy with BCNU or CCNU are eligible if 6 months has passed since the\r treatment(s).\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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 Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas\n\n**Clinical Trial Summary:**\n\nThis study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in\r recurrent high-grade gliomas.\n\n**Clinical Trial Detailed Description:**\n\nMalignant gliomas, glioblastoma multiforme and anaplastic astrocytoma, are rapidly growing\r primary brain tumors associated with a high degree of morbidity and mortality. Despite\r aggressive treatment, the median survival rate for GBM is approximately 12 months, with\r two-year survival rates no more than 8 to 12%, while median survival for patients with AA\r ranges from 2 to 3 years from time of first diagnosis.\r\n\r RTA 744 is a close chemical analogue of the well characterized anti-cancer agent doxorubicin.\r Unlike doxorubicin, RTA 744 has shown ability to cross the blood brain barrier and to achieve\r high concentration in CNS tumor tissue in animal models. It will be administered by i.v.\r infusions either daily for 3 consecutive days repeated every three weeks, or once weekly for\r 4 consecutive weeks repeated every 5 weeks. Once the maximum tolerated dose is determined , a\r new group of patients will be enrolled into the study to evaluate the tolerability and MTD\r when administered on an expanded schedule (once a week).\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Prior histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma,\r anaplastic mixed oligo-astrocytoma, glioblastoma multiforme, or gliosarcoma, for whom\r no other effective therapy is available.\r\n\r - A prior histologic diagnosis of a lower grade of glioma is allowed if there is current\r histologic proof of progression to a diagnosis of AA, AO, AOA, GBM or GS\r\n\r - Unequivocal evidence of recurrence or progression by neuroimaging procedure.\r\n\r - Surgical resection at least 2 weeks prior to enrollment and must have completely\r recovered from the side effects.\r\n\r - A stable dose of steroids for at least 7 days prior to obtaining the Gd-MRI of the\r brain.\r\n\r - Previously implanted Gliadel® wafer may be eligible.\r\n\r - Karnofsky Performance Status (KPS) of ≥ 60.\r\n\r - Laboratory parameters: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb)\r ≥ 9 g/dl, Platelets ≥ 100 x 109/L, AST and ALT ≤ 3.0 x Upper Limit of Normal (ULN),\r Serum bilirubin ≤ 1.5 x ULN, Serum creatinine ≤ 1.5 x ULN and 24 hour creatinine\r clearance ≥ 50 ml/min\r\n\r - Life expectancy of greater than 12 weeks.\r\n\r - Written informed consent obtained.\r\n\r Exclusion Criteria:\r\n\r - Pregnancy or breast feeding, or adults of reproductive potential not employing an\r effective method of birth control\r\n\r - Total urinary protein in 24 hours urine collection > 500 mg\r\n\r - Any concurrent severe and/or uncontrolled medical conditions which could compromise\r participation in the study.\r\n\r - Impaired cardiac function, other significant prior cardiac disease or arrhythmia of\r any\r\n\r - A history of CHF or arrhythmias.\r\n\r - Therapeutic doses of warfarin sodium (Coumadin®).\r\n\r - Prior or concurrent therapy, or not recovered from the toxic effects of such therapy:\r investigational drugs, chemotherapy, metronomic daily dosing of chemotherapy agents,\r biologic, immunotherapy or cytostatic agents within 4 weeks prior to study entry;\r radiation therapy within 2 weeks prior to study entry, any medication known to cause\r QT interval prolongation\r\n\r - Any surgery other than resection of a brain tumor within 2 weeks prior to enrollment.\r\n\r - A contraindication to MRI imaging.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
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"role": "assistant",
"content": "**Answer:** possibly relevant"
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possibly relevant
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"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\nCarboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery\n\n**Clinical Trial Summary:**\n\nRATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized\r nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by\r killing the cells or by stopping them from dividing. Radiation therapy uses high-energy\r x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation\r therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation\r together with radiation therapy and erlotinib may kill more tumor cells.\r\n\r PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel\r albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib\r works in treating patients with stage III non-small cell lung cancer that cannot be removed\r by surgery.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - To determine the activity of induction chemotherapy comprising carboplatin and\r paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic\r radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage\r IIIA or IIIB non-small cell lung cancer.\r\n\r Secondary\r\n\r - To determine the response rate and progression-free survival of these patients.\r\n\r OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized\r nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30\r minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease\r progression outside of the chest after induction therapy are removed from study. Patients\r with intrathoracic disease progression within the potential radiation field may continue\r protocol therapy at the discretion of the Study Chair. Patients with no disease progression\r outside the planned radiation field (either regional or distant) proceed to concurrent\r erlotinib hydrochloride and radiotherapy.\r\n\r Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily.\r Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions)\r in the absence of rapid disease progression outside of the chest or unacceptable toxicity.\r\n\r After completion of study therapy, patients are followed every 3 months for 1 year, and then\r every 6 months for up to 2 years\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),\r including any of the following histologies:\r\n\r - Squamous cell carcinoma\r\n\r - Adenocarcinoma (including bronchoalveolar cell)\r\n\r - Large cell anaplastic carcinoma (including giant and clear cell carcinomas)\r\n\r - Must meet the following criteria:\r\n\r - T1-3 with N2 and selected N3*\r\n\r - T4 with N0, N1, N2 and selected N3*\r\n\r - M0 (no M1 patients) NOTE: *Patients with contralateral mediastinal disease (i.e.,\r N3) are eligible, provided all gross disease can be encompassed within the\r radiation boost field in accordance with the homogeneity criteria. Patients with\r ipsilateral scalene or supraclavicular disease are also eligible. Patients with\r contralateral hilar or supraclavicular node involvement are not eligible.\r\n\r - Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20\r mm by conventional techniques or ≥ 10 mm by spiral CT scan\r\n\r - Nonmeasurable lesions include the following:\r\n\r - Bone lesions\r\n\r - Leptomeningeal disease\r\n\r - Ascites\r\n\r - Pleural or pericardial effusion\r\n\r - Abdominal masses that are not confirmed and followed by imaging techniques\r\n\r - Cystic lesions\r\n\r - Tumor lesions situated in a previously irradiated area\r\n\r - Patients must be considered unresectable or inoperable AND be deemed candidates for\r combined modality therapy by a medical oncologist and a radiation oncologist\r\n\r - Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10%\r weight loss within the past 3 months\r\n\r - Patients with tumors adjacent to a vertebral body are eligible, provided all gross\r disease can be encompassed within the radiation boost field in accordance with the\r homogeneity criteria\r\n\r - Pleural effusions meeting the following criteria allowed:\r\n\r - Effusion is transudate, cytologically negative, and non-bloody\r\n\r - Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too\r small to tap\r\n\r - Effusion appears only after a thoracotomy or other invasive thoracic procedure\r was attempted\r\n\r PATIENT CHARACTERISTICS:\r\n\r - See Disease Characteristics\r\n\r - Granulocytes ≥ 1,500/μL\r\n\r - Platelet count ≥ 100,000/μL\r\n\r - Creatinine ≤ 1.5 x upper limit of normal (ULN)\r\n\r - AST < 2 x ULN\r\n\r - Bilirubin ≤ ULN\r\n\r - Not pregnant or nursing\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - No prior chemotherapy or radiotherapy for NSCLC\r\n\r - At least 2 weeks since formal exploratory thoracotomy\r\n\r - No concurrent administration of sucralfate suspension and erlotinib hydrochloride\r\n\r - No concurrent intensity-modulated radiotherapy\r\n\r - No concurrent hormones or other chemotherapeutic agents except steroids given for\r adrenal failure, hormones administered for non-disease-related conditions (e.g.,\r insulin for diabetes), and intermittent use of dexamethasone as an antiemetic\r\n\r - No concurrent palliative 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\"."
}
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"role": "assistant",
"content": "**Answer:** not relevant"
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not relevant
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{
"role": "system",
"content": "You are a medical expert tasked with determining wether a Clinical Trial is relevant to a specific Patient Description. Your task is to evaluate the relevance of a Clinical Trial based on the provided information, including the **Clinical Trial Title:**, **Clinical Trial Summary:**, **Clinical Trial Detailed Description:**, **Clinical Trial Eligibility Criteria:**, and finally the **Patient Description:**.\n\nThe information present in the Clinical Trial is in the Clinical Trial Report (CTR) format, which highlights the key aspects of the trial. The **Patient Description:** includes details about the diseases, symptoms, demographics, and other factors to assessing the relevance.\n\nYour relevance output will be one of the following, preceded by **Answer:**: \"not relevant\", \"possibly relevant\", or \"definitely relevant\", based on how well the Clinical Trial aligns with the Patient Description.\n\nBe as accurate as possible in your evaluation."
},
{
"role": "user",
"content": "**Clinical Trial Title:**\n\nEfficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the efficacy of temozolomide on a protracted\r schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive\r high grade glioma.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patient age >18 years old\r\n\r - Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic\r oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme)\r\n\r - Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or\r adjuvant treatment approved in Magnetic Resonance imaging\r\n\r - Karnofsky Performance Status scale >/=50 (due to brain pathology)\r\n\r - Adequate hematological, renal and hepatic function\r\n\r - Patients willing to participate in the study and signing the informed consent\r\n\r Exclusion Criteria:\r\n\r - Karnofsky Performance Status scale <50\r\n\r - Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility\r will be warned for appropriate contraception during the study\r\n\r - Patients not suitable for follow-up\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
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88
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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\nI-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma\n\n**Clinical Trial Summary:**\n\nI-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural\r crest tumors\n\n**Clinical Trial Detailed Description:**\n\nEntry criteria--Histologically documented neuroblastoma or pheochromocytoma or strong\r suspicion of neuroblastoma or pheochromocytoma.\r\n\r Exclusion criteria--Pregnancy Randomization--None Procedure--Patients will receive a dose of\r I-123-MIBG by intravenous injection. Images will obtained at 18-24 hours after administration\r of the drug and at 42-48 hours as needed. SSKI will be used to block thyroid uptake of free\r I-123-iodide\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically proven neuroblastoma or pheochromocytoma or strong suspicion of\r neuroblastoma or pheochromocytoma\r\n\r Exclusion Criteria:\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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
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89
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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 II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma\n\n**Clinical Trial Summary:**\n\nWe are asked patients to take part in this study because they had recurrent (returned) (1st\r or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).\r\n\r The purposes of this study are:\r\n\r - To see if Sutent has any change on the patient and their cancer.\r\n\r - To see if Sutent will slow or stop the growth of their tumor.\r\n\r - To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved\r to treat patients with a gastrointestinal stromal tumor after the disease worsened while\r taking another medicine called imatinib mesylate or when imatinib mesylate cannot be\r taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma.\r At this time, it is not known whether Sutent will improve symptoms, or help patients\r with this disease live longer.\n\n**Clinical Trial Detailed Description:**\n\nTrial patients received sunitinib 50 mg daily for 4 weeks without regard to meals, followed\r by a 2-week rest period. This 6-week regimen constituted 1 cycle. Patients were treated for\r up to 9 cycles [~ year) or until disease progression or death or if persistent toxicities\r occurred. Complete blood count with differential, complete metabolic profile, neurologic\r exam, and brain magnetic resonance imaging (MRI) with contrast were obtained after each\r cycle. Toxicity assessments were obtained after each cycle. Toxicity was graded according to\r National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version\r 3.0.\r\n\r SCHEDULE OF EVENTS - PROTOCOL ACTIVITIES\r\n\r <14 Days Prior to Initial Study Treatment:\r\n\r - Neurological/Oncological History\r\n\r - Neurological Examination\r\n\r - Height/Weight/Body Surface Area\r\n\r - Performance Status\r\n\r - Quality of Life (QOL) FACT-L\r\n\r - Laboratory Studies; complete blood count (CBC), Differential, Platelets, prothrombin\r time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), Serum\r Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), aspartate\r aminotransferase (AST), lactate dehydrogenase (LDH), Total Bilirubin, alkaline\r phosphatase (AlkPHs), Pregnancy Test, electrocardiogram (EKG)\r\n\r - Cranial MRI or CT with and without contrast\r\n\r - Multiple uptake gated acquisition (MUGA) Scan\r\n\r Day 1, At the Beginning of Each Treatment Cycle:\r\n\r - Adverse Event Assessment\r\n\r - Laboratory Studies; CBC, Differential, Platelets\r\n\r Every Cycle, Days 42-45 (within 3 days of next scheduled Sutent treatment):\r\n\r - Neurological/Oncological History\r\n\r - Neurological Examination\r\n\r - Height/Weight/Body Surface Area\r\n\r - Performance Status\r\n\r - QOL FACT-L\r\n\r - Laboratory Studies; Serum Creatinine, BUN, ALT, AST, LDH, Total Bilirubin, AlkPHs\r\n\r - Cranial MRI or CT with and without contrast\r\n\r - Survival\r\n\r At Off Study:\r\n\r - Performance Status\r\n\r - Cranial MRI or CT with and without contrast\r\n\r - Survival\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or\r surgical procedures to NCI CTCAE Version 3.0 grade ≤1.\r\n\r - Adequate organ function as defined by the following criteria:\r\n\r - Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase\r [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase\r [SGPT]) ≤3 x local laboratory upper limit of normal (ULN), or AST and ALT ≤3 x\r ULN if liver function abnormalities are due to underlying malignancy\r\n\r - Total serum bilirubin ≤1.5 x ULN\r\n\r - Absolute neutrophil count (ANC) ≥1500/µL\r\n\r - Platelets ≥100,000/µL\r\n\r - Hemoglobin ≥9.0 g/dL\r\n\r - Serum calcium ≤12.0 mg/dL\r\n\r - Serum creatinine ≤1.5 x ULN\r\n\r - Patients must have histologically or neuroradiographically recurrent anaplastic\r astrocytoma (AA) or glioblastoma (GBM). Must have had prior pathologic confirmation of\r primary tumor histology.\r\n\r - Must be ≥ 18 years old.\r\n\r - Must have a Karnofsky performance status (KPS) ≥ 60%\r\n\r - Measurable disease per MacDonald criteria required using contrast enhanced cranial\r MRI.\r\n\r - Life expectancy ≥ 12 weeks.\r\n\r - Must sign and date an Institutional Review Board (IRB) approved informed consent\r stating that he or she is aware of the neoplastic nature of the disease. Must\r willingly provide written consent after being informed of procedure to be followed,\r the experimental nature of the therapy, alternatives, potential benefits, side\r effects, risks, and discomforts.\r\n\r - Willing and able to comply with scheduled visits, treatment plan, laboratory tests and\r accessible for follow-up.\r\n\r - Have undergone surgery documenting tumor histology though repeat surgery at time of\r tumor recurrence is not mandatory.\r\n\r - Have received prior external beam radiotherapy.\r\n\r - Patients may have received one or two prior salvage chemotherapy and may have received\r adjuvant chemotherapy following initial surgery.\r\n\r - May not have received prior stereotactic radiotherapy.\r\n\r - May have been treated with Gliadel at initial surgery only.\r\n\r Exclusion Criteria:\r\n\r - Major surgery or radiation therapy within 4 weeks of starting study treatment.\r\n\r - NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment.\r\n\r - History of or known spinal cord compression or carcinomatous meningitis, or evidence\r of leptomeningeal disease on screening CT or MRI scan.\r\n\r - Any of the following within 6 months prior to study drug administration: myocardial\r infarction, severe/unstable angina, coronary/peripheral artery bypass graft,\r symptomatic congestive heart failure, cerebrovascular accident or transient ischemic\r attack, or pulmonary embolism.\r\n\r - Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.\r\n\r - Prolonged QTc interval on baseline EKG.\r\n\r - Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal\r medical therapy).\r\n\r - Pre-existing thyroid abnormality with thyroid function that cannot be maintained in\r normal range with medication.\r\n\r - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome\r (AIDS)-related illness or other active infection.\r\n\r - Concurrent treatment on another clinical trial. Supportive care trials or\r non-treatment trials, e.g. QOL, are allowed.\r\n\r - Concomitant use of ketoconazole and other agents known to inhibit Cytochrome P450 3A4\r (CYP3A4).\r\n\r - Concomitant use of theophylline and phenobarbital and/or other agents metabolized by\r the cytochrome P450 system.\r\n\r - Ongoing treatment with therapeutic doses of Coumadin (low dose up to 2 mg po daily for\r thrombo-prophylaxis is allowed).\r\n\r - Pregnancy or breastfeeding. Female subjects must be surgically sterile,\r postmenopausal, or must agree to use effective contraception during the period of\r therapy. Female subjects with reproductive potential must have a negative pregnancy\r test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or\r must agree to use effective contraception during the period of therapy.\r\n\r - Other severe acute or chronic medical or psychiatric condition or laboratory\r abnormality that may increase the risk associated with study participation or study\r drug administration, or may interfere with interpretation of study results, and in the\r judgment of investigator would make patient inappropriate for entry into this study.\r\n\r - Patients having been treated with 3 or more salvage regimens.\r\n\r - Patients with a second active malignancy or diagnosis of other cancer within 3 years\r of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma\r of the cervix.\r\n\r - Mentally incapacitated patients or psychiatric illness that would prevent them from\r giving informed consent.\r\n\r - Poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure,\r unstable angina, symptomatic congestive heart failure, and myocardial infarction\r within previous 6 months, or serious uncontrolled cardiac arrhythmia.\r\n\r - Known to be HIV positive or to have an AIDS-related illness.\r\n\r - Patients with an active infection that is not adequately controlled with antibiotics.\r\n\r - Patients with other severe concurrent disease, which, in the judgment of the\r investigator, would make the patient inappropriate for entry into this study.\r\n\r - Known sensitivity to any of the products to be administered during treatment.\r\n\r - Currently enrolled in another clinical trial or patients who have participated in a\r trial of an investigational device or drug within the last 30 days.\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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90
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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 Treating Patients With Malignant Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build\r an effective immune response to kill tumor cells.\r\n\r PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in\r treating patients with malignant glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r - Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic\r cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with\r malignant gliomas.\r\n\r - Determine survival, tumor progression, and cellular immune response in patients treated\r with this regimen.\r\n\r OUTLINE: Patients undergo leukapheresis for the collection of peripheral blood mononuclear\r cells (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to\r sargramostim (GM-CSF) and interleukin-4 (IL-4), matured with a cytokine cocktail, and pulsed\r with synthetic glioma-associated antigen (GAA) peptides. Cohorts of patients receive\r escalating doses of GAA peptide-pulsed autologous dendritic cell vaccine until the maximum\r tolerated dose is determined.\r\n\r After completion of study treatment, patients are followed every 2 months for 1 year.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed diagnosis of 1 of the following malignant gliomas:\r\n\r - Anaplastic astrocytoma\r\n\r - Glioblastoma multiforme\r\n\r - Oligodendroglioma\r\n\r - Oligoastrocytoma\r\n\r - WHO grade III or IV disease\r\n\r - Newly diagnosed or recurrent disease\r\n\r - Bidimensionally measurable disease by contrast-enhancing MRI\r\n\r - Surgically accessible tumor for which resection is indicated\r\n\r - Previously treated with or planning to undergo treatment with conventional external\r beam radiotherapy\r\n\r - HLA-A*201 positive\r\n\r - Karnofsky performance status 60-100%\r\n\r - Life expectancy ≥ 8 weeks\r\n\r - Hemoglobin ≥ 10 g/dL\r\n\r - Absolute granulocyte count ≥ 1,500/mm³\r\n\r - Platelet count ≥ 100,000/mm³\r\n\r - SGOT and SGPT ≤ 2 times normal\r\n\r - Alkaline phosphatase ≤ 2 times normal\r\n\r - Bilirubin ≤ 1.5 mg/dL\r\n\r - BUN ≤ 1.5 times normal OR creatinine ≤ 1.5 times normal\r\n\r - Negative pregnancy test\r\n\r - Fertile patients must use effective contraception\r\n\r - Hepatitis B negative\r\n\r - Hepatitis C negative\r\n\r - HIV negative\r\n\r - Syphilis serology negative\r\n\r - Afebrile\r\n\r Exclusion Criteria:\r\n\r - active infection\r\n\r - immunodeficiency\r\n\r - autoimmune disease that may be exacerbated by immunotherapy, including any of the\r following:\r\n\r - Rheumatoid arthritis\r\n\r - Systemic lupus erythematosus\r\n\r - Vasculitis\r\n\r - Polymyositis-dermatomyositis\r\n\r - Scleroderma\r\n\r - Multiple sclerosis\r\n\r - Juvenile-onset insulin-dependent diabetes\r\n\r - allergy to study agents\r\n\r - underlying condition that would contraindicate study therapy\r\n\r - concurrent severe or unstable medical condition that would preclude giving informed\r consent\r\n\r - psychiatric condition that would preclude study participation or giving informed\r consent\r\n\r - other malignancy within the past 5 years except adequately treated basal cell or\r squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the\r cervix\r\n\r - prior chemotherapy (6 weeks for nitrosoureas) within last 4 weeks of starting\r treatment\r\n\r - concurrent corticosteroids within 2 weeks prior to treatment\r\n\r - radiotherapy within 2 weeks prior to treatment\r\n\r - systemic antibiotics within 72 hours prior to treatment\r\n\r - prior organ allograft\r\n\r - antihistamine therapy within 5 days before or after administration of study vaccine\r\n\r - chemotherapy during and for 4 weeks after administration of study vaccine\r\n\r - adjuvant therapy during and for 4 weeks after administration of study vaccine\r\n\r - other concurrent investigational agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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
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91
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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. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma\n\n**Clinical Trial Summary:**\n\nObjectives:\r\n\r To define role of O6-Benzylguanine (BG) in restoring Temodar (temozolomide) sensitivity in\r patients with Temodar-resistant malignant glioma.\r\n\r To further define toxicity of combo therapy using Temodar + BG.\n\n**Clinical Trial Detailed Description:**\n\n2 separate strata accrued independently of each other: Stratum 1-patients with Glioblastoma\r Multiforme (GBM). Stratum 2-patients with Anaplastic Glioma [anaplastic astrocytoma (AA),\r anaplastic oligodendroglioma (AO), anaplastic mixed (AA and AO)] .\r\n\r BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour\r infusion at 30mg/m2/24hrs. Temozolomide 472mg/m2 administered orally, in fasting state,\r within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be\r repeated every 28 days following dose of Temodar from previous cycle.\r\n\r Temodar has been well tolerated by both adults and children with most common toxicity being\r mild myelosuppression. Other, less likely, potential toxicities include nausea and vomiting,\r constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain,\r diarrhea, lethargy, hepatotoxicity, anorexia, fatigue and hyperglycemia. Hypersensitivity\r reactions have not yet been noted with Temodar. As in the case with many anti-cancer drugs,\r Temodar may be carcinogenic. BG toxicities include agitation, lethargy, nausea, vomiting,\r rapid heart rate, elevated liver functions, & leukemia; but, not with BG as single agent.\r Transient lymphopenia has been seen with BG as single agent.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients have recurrent/progressive Malignant Glioma (MG). Stereotactic biopsy at time\r of recurrence/progression is only required if radiation-induced necrosis is suspected\r\n\r - Patients have MG resistant to Temodar, which is defined as > or = to 25 percent\r increase in tumor growth on contrast enhanced MRI/CT within 8 weeks of last dose of\r Temodar\r\n\r - Age > or = to 18 years\r\n\r - Evidence of measurable enhancing disease on contrast-enhanced MRI, unless medically\r contraindicated.\r\n\r - Interval of at least 2 weeks between prior surgical resection/ 4 weeks between prior\r radiotherapy/chemotherapy, and enrollment on protocol unless there is unequivocal\r evidence of tumor progression. However, patients treated with chemotherapy agents such\r as VP-16 who would normally be retreated after shorter intervals may be treated at\r usual starting time even if less than 4 weeks from last prior dose of chemotherapy\r\n\r - Karnofsky performance score > or = to 60 percent\r\n\r - Hematocrit > 29 percent, absolute neutrophil count (ANC) > 1,500 cells/microliter,\r platelets > 100,000 cells/microliter\r\n\r - Serum creatinine <1.5 mg/dl, Blood Urea Nitrogen (BUN) <25 mg/dl, Serum Glutamic\r Oxaloacetic Transaminase (SGOT) & bilirubin <1.5 x upper limit of normal (ULN)\r\n\r - For patients on corticosteroids, they must have been on stable dose for 1 week prior\r to entry, if clinically possible, and dose should not be escalated over entry dose\r level\r\n\r - Signed informed consent approved by Institutional Review Board (IRB) prior to patient\r entry\r\n\r - If sexually active, patients will take contraceptive measures for duration of\r treatments\r\n\r Exclusion criteria:\r\n\r - Pregnancy\r\n\r - Co-medication that may interfere with study results\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
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92
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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. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide\n\n**Clinical Trial Summary:**\n\nObjective:\r\n\r To determine activity of combo of Irinotecan + Temozolomide To further characterize any\r toxicity associated w combo of Irinotecan + Temozolomide\n\n**Clinical Trial Detailed Description:**\n\nObjectives of study are to determine activity of combo of Irinotecan + Temozolomide & to\r further characterize any toxicity associated w combo of Irinotecan + Temozolomide.\r Temozolomide administered orally at 200mg/m2 in fasting state 1hr prior to CPT-11 infusion.\r Temozolomide administered on day 1 of treatment cycle & every 24hrs thereafter for 5 days w\r treatment cycles repeated every 6wks. Treatment cycles may be repeated up to maxi of 3 cycles\r until occurrence of either unacceptable toxicity/evidence of disease progression. At end of\r 3rd cycle/if cycles are stopped early for toxicity or progression, subject will undergo\r radiation therapy. CPT-11 administered intravenously in fasting state over 90min. CPT-11 will\r begin 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11 administered\r on days 1, 8, 22, & 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of\r 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression.\r Dose of CPT-11 will be based on whether pt is receiving CYP3A4-inducing antiepileptic drugs\r due to increased drug clearance produced by these agents. For pts receiving EIAEDs including\r phenytoin, fosphenytoin, oxcarbazepine, phenobarbital/ primidone, CPT-11 dose of 325mg/m2\r administered. For pts not receiving EIAEDs, CPT-11 dose of125 mg/m2 administered.\r\n\r Subjects have newly diagnosed histologically proven supratentorial glioblastoma multiforme.\r Toxicities associated w CPT-11 are anemia, decreased blood counts, diarrhea, constipation,\r nausea, vomiting, tiredness, fever, mouth sores, dehydration, rash, itching, changes in skin\r color, swelling, numbness, tingling, dizziness, confusion, low blood pressure, sweating, hot\r flashes, hair loss, inflammation of liver, flu-like symptoms, decreased urine output,\r shortness of breath,& pneumonia. Low white blood cell & platelet counts may be associated w\r risk of infection/bleeding, respectively. Irinotecan has also caused birth defects in\r animals. Most frequent toxicities in earlier studies have been low white blood cells &\r diarrhea, & death has been seen from these & other side effects. Temozolomide has been well\r tolerated by both adults & children w most common toxicity being mild myelosuppression.\r Other, less likely, potential toxicities include nausea & vomiting, constipation, headache,\r alopecia, rash, burning sensation of skin, esophagitis, pain, diarrhea, lethargy,\r hepatotoxicity, anorexia, fatigue & hyperglycemia. Hypersensitivity reactions have not yet\r been noted w Temozolomide. As in case w many anti-cancer drugs, Temozolomide may be\r carcinogenic.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Pts have histologically proven supratentorial GBM\r\n\r - Pts have newly diagnosed disease\r\n\r - There must be measurable disease on contrast-enhanced magnetic resonance imaging\r performed <14 days before drug administration. Those who underwent resection must have\r MRI <72 hrs/ >14 days after surgery\r\n\r - Prior Surgical Resection/Biopsy: Although surgical resection is not required, pts must\r be treated <42 days of surgery or biopsy\r\n\r - Age >18 yrs\r\n\r - Karnofsky Performance Status >70 percent\r\n\r - Serum creatinine < 1.5 x ULN\r\n\r - Absolute neutrophil count >1500 cells/microliter; platelet count >100,000\r cells/microliter\r\n\r - Serum SGOT & total bilirubin <2.5 x ULN\r\n\r - Signed informed consent, approved by IRB, will be obtained prior to initiating\r treatment\r\n\r - Pts must agree to practice effective birth control measures while on study & for 2\r months after completing therapy\r\n\r Exclusion Criteria:\r\n\r - Pregnant/breast feeding women / women/men w reproductive potential not practicing\r adequate contraception. This therapy may be associated w potential toxicity to\r fetus/child that exceeds minimum risks necessary to meet health needs of mother\r\n\r - Active infection requiring intravenous antibiotics\r\n\r - Known diagnosis of HIV infection\r\n\r - Pts w history of another primary malignancy that currently requires active\r intervention\r\n\r - Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition\r\n\r - Pts who underwent surgical resection for GBM <2 weeks of start of treatment\r\n\r - Pts who have received prior chemo, biologic therapy, XRT, interstitial\r brachytherapy/radiosurgery to brain\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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\nValidation Study of Neuropathic Pain\n\n**Clinical Trial Summary:**\n\nThis study seeks to validate clinically evoked or obtained objective pain signs with the\r patient's corresponding quantified subjective pain symptoms. This will allow for validation\r of objective clinical pain signs to then be used to begin to classify patients with pain\r based on symptoms and signs. This then can be used as a basis for further study of\r neuropathic pain mechanisms in human patients.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Subjects must be 18 years of age and older, and able to provide informed consent and\r communicate in English. Pain rating inclusion criteria will be pain greater than 3 up\r to 9, as rated on the 0-10 pain scale, where 10 is the worst pain imaginable. This\r rating is based on the numeric pain rating scale (NPRS).\r\n\r - PHN - Subjects with PHN will have a history of pain of at least 6 months duration in\r the area that was the site of a zoster rash resulting in nerve injury. In most cases,\r subjects experience a number of sensory abnormalities in the affected area, ranging\r from pain to numbness, and various degrees of hypersensitivity. Subjects with PHN must\r otherwise be in stable health. Pain rating inclusion criteria for PHN subjects will be\r pain greater than 3 up to 9, as rated on the 0-10 pain scale, where 10 is the worst\r pain imaginable.\r\n\r - PDN - Subjects with diabetes mellitus and neuropathy who have a history of pain,\r predominantly in the lower extremities, of at least 6 months duration qualify for the\r diagnosis of PDN for purposes of this study. In most cases PDN is due to small fiber\r neuropathy, so physical examination should yield sensory abnormalities, such as pain,\r paresthesiae and numbness. Motor function and stretch reflex abnormalities are common\r but not necessary for inclusion. PDN patients in whom large fiber functions are\r affected, experience weakness and decreased or absent stretch reflexes, respectively,\r and are eligible for this study. Other causes of neuropathy will be excluded. PDN\r patients with pain rating of greater than 3 up to 9 on 0-10 scale will be included.\r\n\r - SCI pain - Subjects with SCI and pain of at least 6 months duration will be invited to\r participate. In most cases, these subjects' sensory, motor and stretch reflex\r abnormalities are consistent with SCI. Sensory findings range form complete loss of\r sensation to preservation of all sensory modalities. Motor findings range from mild\r weakness to complete paralysis. Stretch reflexes are most frequently increased though\r in a few patients they can be absent. Based on the constellation of sensory and motor\r findings in particular patients, diagnosis of complete versus incomplete SCI is made.\r In this study we will study patients with incomplete SCI who have pain at level of\r injury or below level of injury, or both. Subjects with SCI who have pain rating of\r greater than 3 up to 9 on 0-10 scale will be included.\r\n\r Exclusion Criteria:\r\n\r - Patients with pain due to disorders other than PDN, PTN, or SCI, as well as unknown\r causes, will be excluded.\r\n\r - Patients with neuropathies from causes such as vasculitis, demyelinating\r polyneuropathies, HIV-associated neuropathy, and paraneoplastic and post-infectious\r neuropathies will be excluded.\r\n\r - Patients with chemotherapy-induced neuropathy will be excluded.\r\n\r - Patients who suffer from pain due to different pain mechanisms will be excluded.\r\n\r - Patients with other pain (at a different site) that is more severe than their PDN or\r PTN pain will be excluded.\r\n\r - Patients with a history of recent or ongoing alcohol or other drug addiction disorders\r (as self-reported or previously documented in the medical record) will be excluded.\r\n\r - Patients who are determined to have cognitive and reading impairments which would\r preclude them from completing questionnaires will be excluded.\r\n\r - Patients whose chronic medical and psychiatric comorbidities are not under optimal\r control, or who are currently experiencing an acute exacerbation of a medical or\r psychiatric comorbidity, 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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94
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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 Anaplastic Glioma Without 1p/19q LOH\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 temozolomide, work in different ways to stop the growth of tumor cells,\r either by killing the cells or by stopping them from dividing. Giving radiation therapy\r together with temozolomide may kill more tumor cells. It is not yet known whether giving\r temozolomide during and/or after radiation therapy is more effective than radiation therapy\r alone in treating anaplastic glioma.\r\n\r PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after\r radiation therapy to see how well it works compared to radiation therapy alone in treating\r patients with anaplastic glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - To assess whether concurrent radiotherapy with daily temozolomide improves overall\r survival as compared to no daily temozolomide in patients with non-1p/19q deleted\r anaplastic glioma.\r\n\r - To assess whether adjuvant temozolomide improves survival as compared to no adjuvant\r temozolomide in patients with non-1p/19q deleted anaplastic glioma.\r\n\r Secondary\r\n\r - To assess whether concurrent and adjuvant temozolomide prolongs progression-free\r survival and neurological deterioration-free survival in patients with non-1p/19q\r deleted anaplastic glioma.\r\n\r - To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q\r deleted anaplastic glioma, including late effects on cognition.\r\n\r - To assess the impact of concurrent and adjuvant temozolomide on the quality of life of\r patients with non-1p/19q deleted anaplastic glioma.\r\n\r OUTLINE: This is a multicenter study. Patients are stratified according to institution, WHO\r performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no),\r presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA methyltransferase\r promoter methylation status (methylated vs unmethylated vs indeterminate). Patients are\r randomized to 1 of 4 treatment arms.\r\n\r - Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total of\r 33 fractions).\r\n\r - Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral\r temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).\r\n\r - Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total\r of 33 fractions). Beginning 4 weeks after completion of radiotherapy, patients receive\r adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide\r repeats every 28 days for up to 12 courses.\r\n\r - Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral\r temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy). Beginning\r 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide\r once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for\r up to 12 courses.\r\n\r NOTE: *Patients must begin radiotherapy within 8 days after randomization and within 7 weeks\r after surgery.\r\n\r In all arms, treatment continues in the absence of disease progression or unacceptable\r toxicity.\r\n\r Patients complete quality-of-life questionnaires, including QLQ-C30 version 3, BCM20, and the\r Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and then\r every 3 months for 5 years.\r\n\r Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation\r status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase\r mutation analysis.\r\n\r After completion of study treatment, patients are followed every 3 months.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Histologically confirmed diagnosis of 1 of the following:\r\n\r - Anaplastic oligodendroglioma\r\n\r - Anaplastic oligoastrocytoma\r\n\r - Anaplastic astrocytoma\r\n\r - Newly diagnosed disease\r\n\r - Prior surgery for a low grade tumor is allowed, provided histological confirmation of\r an anaplastic tumor is present at the time of progression\r\n\r - Absence of combined 1p/19q loss\r\n\r - Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA\r methyltransferase promoter methylation status assessment, isocitrate dehydrogenase\r mutation analysis, and central pathology review\r\n\r - Patients must be on a stable or decreasing dose of steroids for at least two weeks\r prior to randomization\r\n\r PATIENT CHARACTERISTICS:\r\n\r - WHO performance status 0-2\r\n\r - ANC ≥ 1.5 x 10^9 cells/L\r\n\r - Platelet count ≥ 100 x 10^9 cells/L\r\n\r - Bilirubin < 1.5 x upper limit of normal (ULN)\r\n\r - Alkaline phosphatase < 2.5 x ULN\r\n\r - AST and ALT < 2.5 x ULN\r\n\r - Serum creatinine < 1.5 x ULN\r\n\r - Not pregnant or nursing\r\n\r - Fertile patients must use effective contraception\r\n\r - No known HIV infection or chronic hepatitis B or hepatitis C infection\r\n\r - No other serious medical condition that would interfere with follow-up\r\n\r - No medical condition that could interfere with oral medication intake (e.g., frequent\r vomiting or partial bowel obstruction)\r\n\r - No other prior malignancies except for any malignancy which was treated with curative\r intent more than 5 years prior to registration and adequately controlled limited basal\r cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ\r of the cervix\r\n\r - No prior or concurrent malignancies at other sites except for surgically cured\r carcinoma in situ of the cervix or nonmelanoma skin cancer\r\n\r - No psychological, familial, sociological, or geographical condition that would\r potentially hamper compliance with the study protocol and follow-up schedule\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - See Disease Characteristics\r\n\r - No prior chemotherapy, including carmustine-containing wafers (Gliadel®)\r\n\r - No prior radiotherapy to the brain\r\n\r - No concurrent growth factors unless vital for the patient\r\n\r - No other concurrent investigational treatment\r\n\r - No other concurrent anticancer agents\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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95
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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\nQuantitative Ultrasonography (US) Evaluation on Femoral Condyle Cartilage\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to investigate the feasibility of using quantitative\r ultrasonography (US) evaluation to determine the severity of osteoarthritic femoral condyle\r cartilage erosion.\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Patients with knee OA who were going to receive total knee arthroplasty\r\n\r Exclusion Criteria:\r\n\r - Patients with inflammatory arthritis (e.g. rheumatic arthritis) and infectious disease\r (e.g. hepatitis B)\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility 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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96
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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\nTestosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma\n\n**Clinical Trial Summary:**\n\nRATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness\r caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade\r glioma.\r\n\r PURPOSE: This randomized clinical trial is studying how well testosterone gel works in\r preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly\r diagnosed high-grade glioma.\n\n**Clinical Trial Detailed Description:**\n\nOBJECTIVES:\r\n\r Primary\r\n\r - To determine if daily administration of testosterone gel can prevent the development or\r reduce the severity of muscle weakness in men receiving glucocorticoids for newly\r diagnosed high-grade glioma.\r\n\r Secondary\r\n\r - To compare the difference in percent change from baseline timed functional tests (TFT)\r between patients who are treated with testosterone gel and those who are not.\r\n\r - To compare the difference in percent change from baseline activities of daily living as\r assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) between\r patients who are treated with testosterone gel and those who are not.\r\n\r - To compare the difference in percent change from baseline leg muscle mass as assessed by\r CT scan imaging between patients who are treated with testosterone gel and those who are\r not.\r\n\r - To estimate the side effects of testosterone gel in these patients.\r\n\r OUTLINE: Patients are stratified according to daily glucocorticoid dose (< 16 mg/day vs ≥ 16\r mg/day), Karnofsky performance status (≤ 80% vs > 80%), and age (≤ 50 years of age vs > 50\r years of age). Patients are randomized to 1 of 2 treatment arms.\r\n\r - Arm I (control): Patients receive oral whey protein powder once daily for 7 months.\r\n\r - Arm II (treatment): Patients apply topical testosterone gel to the shoulder, upper\r chest, or forearm once daily for 7 months.\r\n\r Patients undergo strength testing and functional testing (TFT) and complete an activities of\r daily living questionnaire at baseline and at 1, 3, 5, and 7 months. Patients also undergo CT\r scan of the leg and laboratory testing at baseline and at 3 and 7 months. Testosterone levels\r are obtained at baseline and at 1, 3, and 7 months.\r\n\r Patients complete a daily log of their glucocorticoid dose and to affirm compliance with\r therapy. Major clinical events related to underlying tumor (i.e., surgery, radiotherapy,\r initiating chemotherapy, concurrent antiepileptic therapy, deep vein thrombosis, pulmonary\r embolism, transfusions, seizures, pneumonia, and other forms of infection) are also recorded.\n\n**Clinical Trial Eligibility Criteria:**\n\nDISEASE CHARACTERISTICS:\r\n\r - Newly diagnosed high-grade glioma, including the following subtypes:\r\n\r - Anaplastic astrocytoma\r\n\r - Anaplastic oligodendroglioma\r\n\r - Glioblastoma multiforme\r\n\r - Requires dexamethasone at a dose of > 4 mg/day to control symptoms of tumor-related\r edema at time of study enrollment AND has been on a stable dose of steroids for ≥ 5\r days prior to study enrollment\r\n\r - Completed ≥ 80% of prescribed radiotherapy\r\n\r - Hypogonadal, defined as serum testosterone level < 350 ng/dL\r\n\r - No history of prostate or breast cancer\r\n\r - No benign prostatic hypertrophy requiring therapy OR AUA score of ≥ 8\r\n\r - PSA ≤ 4 ng/mL\r\n\r PATIENT CHARACTERISTICS:\r\n\r - Karnofsky performance status 60-100%\r\n\r - Able to keep daily records or has a care provider that agrees to keep daily records of\r drug administration\r\n\r - No clinical history of congestive heart failure requiring therapy\r\n\r - No psychotic disorder requiring active treatment\r\n\r - No structured exercise program involving exercise for > 3 hours/week\r\n\r - No polycythemia (i.e., hematocrit > 52%)\r\n\r PRIOR CONCURRENT THERAPY:\r\n\r - More than 6 months since prior androgen 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
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definitely relevant
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97
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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\nPositron Emission Tomography-Computed Tomography (PET-CT) High-grade Glioma\n\n**Clinical Trial Summary:**\n\nThe objectives of the trial are:\r\n\r - To determine the localisation within the primary tumor of the therapy resistant cells,\r before and during radiotherapy to determine a possible accurate boost volume.\r\n\r - To determine changes during treatment intra- and extratumoral within the irradiated\r area.(Intratumoral: change of up-take - decrease, increase, change of localization/\r Extratumoral: effects of temporal changes in up-take - e.g. due to oedema).\n\n**Clinical Trial Detailed Description:**\n\nPatients harboring a primary intracerebral high grade tumor (WHO III- IV) have a median\r survival of six to 12 months. Combined chemoradiotherapy with temozolomide is now the\r standard of care since results of the joint EORTC-NCIC phase III study randomizing between\r radiotherapy alone and combined radiochemotherapy with temozolomide showed a significant\r improvement in 2-years survival from 8% to 24% for the combined treatment arm (Stupp 2005).\r\n\r A differentiation between possible responders and non-responders before the start of\r irradiation may eventual be possible by the use of 18F-FDG PET-CT. Preliminary own results\r have shown that a higher metabolic activity in glioblastoma as measured on a simulation\r 18F-FDG PET-CT scan can be a prognosticator for shortened survival (Baumert, 2006).\r\n\r Our preliminary data show that a high uptake of 18F-FDG on a PET-CT scan before radiotherapy\r in glioblastoma could be a marker for reduced survival.\r\n\r Popperl et al showed that dual phase FDG PET imaging is superior in differentiating low-grade\r from high-grade recurrent astrocytomas (Popperl, 2006). Visual analysis of delineation of\r glioma showed that the delayed images (imaged first 0-90 min and once or twice later at\r 180-480 min after injection) better distinguished the high uptake in tumors relative to\r uptake in gray matter. SUV comparisons also showed greater uptake in the tumors than in gray\r matter, brain, or white matter at the delayed times (Spence et al).\r\n\r These findings support the view that by using FDG-PET scans we could image active areas\r within the tumor. Indeed, in vivo, a cancer is made up by different types of cells, including\r hypoxic cells, cells that proliferate more fast, as well as by non-malignant tissues,\r including inflammatory cells and vasculature.\r\n\r Intra-tumor heterogeneity in malignant glioma is often observed and can be visualised also by\r current PET-CT techniques.\r\n\r The dynamics of the tracer uptake in the different tumor sub-volumes may give important\r information about the biological characteristics as well. Indeed, the dynamics of FDG uptake\r per cell are dependent on the blood flow, the uptake in the cell and the phosphorylation. All\r these of these steps give information on the biology of the cancer in that particular area of\r the tumor.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r - Histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma,\r gliosarcoma) at primary diagnosis;\r\n\r - WhO PFS <= 2\r\n\r - Tumours which do enhance on pre-operative imaging.\r\n\r - Post-operative enough visible residual tumour on PET or status after biopsy only\r\n\r - Age >18 years\r\n\r - Availability of deep fresh frozen tissue for molecular biologic evaluation - if\r possible\r\n\r - Patient able to tolerate full course of conventional RT and follow serial scanning\r\n\r - No previous radiotherapy to the head and neck and brain area.\r\n\r - Prior neurosurgery within 6 weeks of treatment\r\n\r - No previous chemotherapy before treatment of the glioma. Standard radiochemotherapy\r with temozolomide is not excluded\r\n\r - No prior or concurrent medical condition which would make treatment difficult to\r complete. Medication with steroids is allowed.\r\n\r - No incapacitated patients.\r\n\r Exclusion Criteria:\r\n\r - Not histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma,\r gliosarcoma) at primary diagnosis;\r\n\r - WhO PFS > 2\r\n\r - No tumours which do enhance on pre-operative imaging.\r\n\r - Post-operative not enough visible residual tumor on PET or status after biopsy only\r\n\r - Age <18 years\r\n\r - No availability of deep fresh frozen tissue for molecular biologic evaluation\r\n\r - Patient not able to tolerate full course of conventional RT and follow serial scanning\r\n\r - Previous radiotherapy to the head and neck and brain area.\r\n\r - Prior neurosurgery not within 6 weeks of treatment\r\n\r - Previous chemotherapy before treatment of the glioma.\r\n\r - Prior or concurrent medical condition which would make treatment difficult to\r complete.\r\n\r - Incapacitated 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** definitely relevant"
}
] |
definitely relevant
|
98
|
[
{
"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 CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections\n\n**Clinical Trial Summary:**\n\nTo assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR)\r tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet\r 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial\r urinary tract infections (cUTI).\n\n**Clinical Trial Detailed Description:**\n\n\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18\r years of age. Other main inclusion criteria:\r\n\r - One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally),\r chills, frequency of micturition, dysuria, urge sensation.\r\n\r - One or more of the following underlying conditions suggestive of cUTI:\r\n\r - Indwelling urinary catheter.\r\n\r - 100 mL of residual urine after voiding.\r\n\r - Neurogenic bladder.\r\n\r - Obstructive uropathy due to lithiasis, tumor or fibrosis.\r\n\r - Acute urinary retention in men.\r\n\r Exclusion Criteria:\r\n\r Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (>38°C orally),\r chills and flank pain (all 3 signs/symptoms must be present).\r\n\r - Have a history of allergy to quinolones\r\n\r - Are unable to take oral medication\r\n\r - Have an intractable infection requiring > 14 days of therapy\r\n\r - Have a requirement for concomitant administration of sucralfate or divalent and\r trivalent cations such as iron or antacids containing magnesium, aluminum or calcium\r\n\r - Have prostatitis or epididymitis\r\n\r - Have had a renal transplant\r\n\r - Have ileal loop or vesica- urethral reflux\r\n\r - Have significant liver or kidney impairment\r\n\r - Have a history of tendinopathy associated with fluoroquinolones\r\n\r - Are pregnant, nursing\r\n\r - Have a history of convulsions or CNS disorders\n\n**Patient Description:** \n\nPatient is a 45-year-old man with a history of anaplastic astrocytoma of the spine complicated by severe lower extremity weakness and urinary retention s/p Foley catheter, high-dose steroids, hypertension, and chronic pain. The tumor is located in the T-L spine, unresectable anaplastic astrocytoma s/p radiation. Complicated by progressive lower extremity weakness and urinary retention. Patient initially presented with RLE weakness where his right knee gave out with difficulty walking and right anterior thigh numbness. MRI showed a spinal cord conus mass which was biopsied and found to be anaplastic astrocytoma. Therapy included field radiation t10-l1 followed by 11 cycles of temozolomide 7 days on and 7 days off. This was followed by CPT-11 Weekly x4 with Avastin Q2 weeks/ 2 weeks rest and repeat cycle. \n\n\nBased on the above information, provide your judgement wether the Clinical Trial is relevant to the Patient Description. Focus on the patitent's information in relation to the Eligibility Criteria and other sections of the Clinical Trial.\n\nPlease provide your judgement in short form, using \"not relevant\", \"possibly relevant\" and \"definitely relevant\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** not relevant"
}
] |
not relevant
|
99
|
[
{
"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 131I-TM601 in Adults With Recurrent Malignant Glioma\n\n**Clinical Trial Summary:**\n\nThe purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the\r treatment of adult patients with progressive or recurrent malignant gliomas.\n\n**Clinical Trial Detailed Description:**\n\nThis is a multi-center, open label, non-randomized, Phase 1/2 study evaluating the use of\r multiple intravenous doses of 131I-TM601 in patients with progressive and/or recurrent\r malignant glioma.\r\n\r The study will be conducted in two phases. Prior to initiating treatment as part of this\r study, patients will be administered a single imaging dose of 131I-TM601, IV, to demonstrate\r tumor uptake. Only patients demonstrating tumor uptake will remain on the study. During the\r first, Dose Escalation Phase of the study, eligible patients will be assigned in groups of\r 3-6 (depending upon the treatment response seen at each dose) to dose cohorts of between 2-5\r weekly IV doses of 131I-TM601, with escalation to the next highest dose dependent upon\r demonstrated tolerance in the previous dosing group. Patients enrolled in the second phase\r will be assigned to a dose determined by the experience in the first phase.\r\n\r Patients in both study phases will have safety parameters evaluated continuously throughout\r the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28 days\r following the final study dose, and then at quarterly intervals scheduled at 3 month\r intervals following the first study dose, until disease progression.\n\n**Clinical Trial Eligibility Criteria:**\n\nInclusion Criteria:\r\n\r Patients must:\r\n\r 1. Have histologically proven malignant glioma (anaplastic astrocytoma, anaplastic\r oligodendroglioma or glioblastoma multiforme) which is progressive and/or recurrent\r after external beam radiation therapy (to at least 50 Gy) ± chemotherapy with or\r without a history of surgical resection. Patients with previous low grade glioma who\r progressed after radiotherapy ± chemotherapy and are biopsied and found to have a high\r grade glioma are eligible. Patients with prior therapy that included interstitial\r brachytherapy, stereotactic radiosurgery, or local radiopharmaceutical injection must\r have confirmation of true progressive disease rather than radiation necrosis based\r upon PET or Thallium scanning or pathological documentation of disease.\r\n\r 2. Have bi-dimensional measurable disease, defined as ≥ 1 lesion that can be accurately\r measured in ≥ 2 planes on post-contrast MRI.\r\n\r Note - a CT scan will be acceptable in place of an MRI only in patients who are unable\r to undergo an MRI.\r\n\r 3. Be ≥18 years of age.\r\n\r 4. Have a baseline Karnofsky Performance Status (KPS) of ≥60%.\r\n\r 5. Have a Mini Mental State Exam score of ≥ 19.\r\n\r 6. Have a life expectancy, based on the Investigator's judgment, of >3 months.\r\n\r 7. On screening ECG, have a QTc interval of <450 ms.\r\n\r 8. If taking steroids, be on a dose that is stable for at least 5 days prior to the\r Imaging Dose.\r\n\r 9. Have recovered from the toxicity of all previous therapy prior to enrollment. If the\r patient has undergone recent major surgery, an interval of at least 3 weeks must have\r elapsed between the surgery and the date of the Imaging Dose.\r\n\r 10. Have adequate organ and marrow function as defined by serum chemistry evaluations\r (defined in study protocol).\r\n\r 11. Have a negative serum pregnancy test within 14 days of study drug administration, if\r female and of child bearing potential.\r\n\r 12. Agree to use an effective form of contraception to avoid pregnancy, if fertile\r (applicable to both male and female patients).\r\n\r 13. Agree to refrain from nursing, if female.\r\n\r 14. Have signed and dated written informed consent.\r\n\r 15. Be able to comply with treatment plan, study procedures and follow-up examinations.\r\n\r Exclusion Criteria:\r\n\r Patients may not:\r\n\r 1. Have a serious concurrent infection or medical illness which would jeopardize the\r ability of the patient to receive the treatment outlined in this protocol with\r reasonable safety. Examples of medical illnesses include, but are not limited to, the\r following: uncontrolled hypertension, symptomatic congestive heart failure, unstable\r angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that\r would limit compliance with study requirements.\r\n\r 2. Have a prior malignancy with less than 5-year disease free interval, except for\r adequately treated basal cell or squamous cell carcinoma of the skin, or in situ\r cancer of the cervix.\r\n\r 3. Have received radiation treatments ≤ 3 months prior to first study drug administration\r (Imaging Dose).\r\n\r 4. Have received any cytotoxic chemotherapy, whether conventional or investigational, ≤ 4\r weeks prior to receiving the first study drug (Imaging Dose) administration in this\r study (6 weeks for mitomycin-C or nitrosoureas).\r\n\r 5. Have a history of allergic reactions attributed to compounds of similar chemical or\r biologic composition to 131I-TM601 e.g. iodine or iodine-containing 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\"."
}
] |
[
{
"role": "assistant",
"content": "**Answer:** possibly relevant"
}
] |
possibly relevant
|
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