{
"info": {
"nct_id": "NCT00096382",
"official_title": "Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy, Total Body Irradiation and Reconstitution With CD34+ Cells",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of metastatic melanoma\n* Measurable disease\n* Resected or stable brain metastases are allowed\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* See Immunologic\n* Absolute neutrophil count > 1,000/mm^3 (without support of filgrastim [G-CSF])\n* Platelet count > 100,000/mm^3\n* Hemoglobin ≥ 8 g/dL (transfusion allowed)\n* No coagulation disorders\n\nHepatic\n\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 times upper limit of normal\n* Bilirubin ≤ 2 mg/dL (< 3 mg/dL in patients with Gilbert's syndrome)\n* No hepatitis B or C\n\nRenal\n\n* Creatinine ≤ 1.6 mg/dL\n\nCardiovascular\n\n* Left ventricular ejection fraction (LVEF) ≥ 45% by cardiac stress test*\n* No active major cardiovascular illness as evidenced by stress thallium or other comparable test\n* No myocardial infarction\n* No cardiac arrhythmias NOTE: *For patients ≥ 50 years of age receiving high-dose interleukin-2 (IL-2) OR patients with a history of electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia, or arrhythmias\n\nPulmonary\n\n* Forced expiratory volume 1 (FEV_1) ≥ 60% of predicted by pulmonary function test in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction*\n* No active major respiratory illness\n* No obstructive or restrictive pulmonary disease NOTE: *For patients receiving high-dose IL-2 only\n\nImmunologic\n\n* No active major immunologic illness\n* No active systemic infections\n* No primary or secondary immunodeficiency\n\n * Fully recovered immune competence after prior chemotherapy or radiotherapy as evidenced by both of the following:\n\n * Absolute neutrophil count > 1,000/mm^3\n * No opportunistic infections\n* Human Immunodeficiency virus (HIV) negative\n* Epstein-Barr virus positive\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 4 months after study treatment\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n\nChemotherapy\n\n* At least 6 weeks since prior nitrosourea therapy\n* No prior cyclophosphamide and fludarabine as part of a preparative regimen on National Cancer Institute (NCI) Surgery Branch adoptive cell therapy studies unless sufficient numbers of CD34+ stem cells (more than 2 x10^6/kg patient weight) have been obtained prior to the administration of chemotherapy\n\nEndocrine therapy\n\n* No concurrent systemic steroid therapy\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n* Prior minor surgery within the past 3 weeks allowed if recovered\n\nOther\n\n* Recovered from all prior therapy\n* At least 30 days since prior systemic therapy\n* No other concurrent experimental agents"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
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{
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "* Diagnosis of metastatic melanoma",
"criterions": [
{
"exact_snippets": "Diagnosis of metastatic melanoma",
"criterion": "metastatic melanoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of metastatic melanoma",
"criterion": "metastatic melanoma",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Measurable disease",
"criterions": [
{
"exact_snippets": "Measurable disease",
"criterion": "disease",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Measurable disease",
"criterion": "disease",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Resected or stable brain metastases are allowed",
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{
"exact_snippets": "Resected ... brain metastases are allowed",
"criterion": "brain metastases",
"requirement": {
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"expected_value": "resected"
}
},
{
"exact_snippets": "stable brain metastases are allowed",
"criterion": "brain metastases",
"requirement": {
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}
}
]
},
"logical_structure": {
"or_criteria": [
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}
},
{
"exact_snippets": "stable brain metastases are allowed",
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"requirement": {
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Age",
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"requirement": {
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"expected_value": "N/A"
}
}
]
},
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}
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{
"operator": ">=",
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"unit": "years"
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]
}
}
}
]
},
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"operator": ">=",
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}
}
]
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},
{
"identified_line": {
"line": "Performance status",
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{
"exact_snippets": "Performance status",
"criterion": "performance status",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Performance status",
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}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) 0-1",
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{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) 0-1",
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"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) 0-1",
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"requirement": {
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{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy",
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{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
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}
}
]
},
"logical_structure": {
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"requirement": {
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* At least 3 months",
"criterions": [
{
"exact_snippets": "At least 3 months",
"criterion": "time since a specific event",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 3 months",
"criterion": "time since a specific event",
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "Hematopoietic",
"criterions": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hematopoietic",
"criterion": "hematopoietic",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* See Immunologic",
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{
"exact_snippets": "See Immunologic",
"criterion": "immunologic condition",
"requirement": {
"requirement_type": "N/A",
"expected_value": "See Immunologic"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "See Immunologic",
"criterion": "immunologic condition",
"requirement": {
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"expected_value": "See Immunologic"
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Absolute neutrophil count > 1,000/mm^3 (without support of filgrastim [G-CSF])",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1000,
"unit": "mm^3"
}
}
},
{
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"criterion": "absolute neutrophil count",
"requirement": {
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"expected_value": false
}
}
]
},
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"and_criteria": [
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"operator": ">",
"value": 1000,
"unit": "mm^3"
}
}
},
{
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"criterion": "absolute neutrophil count",
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"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Platelet count > 100,000/mm^3",
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{
"exact_snippets": "Platelet count > 100,000/mm^3",
"criterion": "platelet count",
"requirement": {
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"expected_value": {
"operator": ">",
"value": 100000,
"unit": "mm^3"
}
}
}
]
},
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"unit": "mm^3"
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}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin ≥ 8 g/dL (transfusion allowed)",
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{
"exact_snippets": "Hemoglobin ≥ 8 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 8,
"unit": "g/dL"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Hemoglobin ≥ 8 g/dL",
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"operator": ">=",
"value": 8,
"unit": "g/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No coagulation disorders",
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{
"exact_snippets": "No coagulation disorders",
"criterion": "coagulation disorders",
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"expected_value": false
}
}
]
},
"logical_structure": {
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}
}
}
},
{
"identified_line": {
"line": "Hepatic",
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{
"exact_snippets": "Hepatic",
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"expected_value": true
}
}
]
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}
}
]
}
},
{
"identified_line": {
"line": "* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 times upper limit of normal",
"criterions": [
{
"exact_snippets": "Alanine aminotransferase (ALT) ... < 3 times upper limit of normal",
"criterion": "Alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "level",
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"operator": "<",
"value": 3,
"unit": "times upper limit of normal"
}
}
},
{
"exact_snippets": "aspartate aminotransferase (AST) < 3 times upper limit of normal",
"criterion": "aspartate aminotransferase (AST)",
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"unit": "times upper limit of normal"
}
}
}
]
},
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}
}
},
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"exact_snippets": "aspartate aminotransferase (AST) < 3 times upper limit of normal",
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin ≤ 2 mg/dL (< 3 mg/dL in patients with Gilbert's syndrome)",
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{
"exact_snippets": "Bilirubin ≤ 2 mg/dL",
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"operator": "<=",
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"unit": "mg/dL"
}
}
},
{
"exact_snippets": "< 3 mg/dL in patients with Gilbert's syndrome",
"criterion": "bilirubin level in patients with Gilbert's syndrome",
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"unit": "mg/dL"
}
}
}
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},
"logical_structure": {
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"criterion": "bilirubin level in patients with Gilbert's syndrome",
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"operator": "<",
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"unit": "mg/dL"
}
}
},
"then_criteria": null,
"else_criteria": {
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}
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}
},
{
"identified_line": {
"line": "* No hepatitis B or C",
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}
},
{
"exact_snippets": "No ... C",
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}
}
]
},
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}
},
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]
}
},
{
"identified_line": {
"line": "Renal",
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"exact_snippets": "Renal",
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}
]
},
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}
]
}
},
{
"identified_line": {
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}
]
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}
}
]
}
},
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{
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"unit": "%"
}
}
},
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}
}
]
},
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{
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"operator": ">=",
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}
}
},
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}
]
}
},
{
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"criterions": [
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"expected_value": false
}
},
{
"exact_snippets": "evidenced by stress thallium or other comparable test",
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}
}
]
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}
},
{
"exact_snippets": "evidenced by stress thallium or other comparable test",
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}
}
]
}
},
{
"identified_line": {
"line": "* No cardiac arrhythmias NOTE: *For patients ≥ 50 years of age receiving high-dose interleukin-2 (IL-2) OR patients with a history of electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia, or arrhythmias",
"criterions": [
{
"exact_snippets": "No cardiac arrhythmias",
"criterion": "cardiac arrhythmias",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "patients ≥ 50 years of age",
"criterion": "age",
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"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "years"
}
}
},
{
"exact_snippets": "receiving high-dose interleukin-2 (IL-2)",
"criterion": "interleukin-2 (IL-2) dosage",
"requirement": {
"requirement_type": "dosage",
"expected_value": "high-dose"
}
},
{
"exact_snippets": "history of electrocardiogram (EKG) abnormalities",
"criterion": "electrocardiogram (EKG) abnormalities",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "symptoms of cardiac ischemia",
"criterion": "cardiac ischemia",
"requirement": {
"requirement_type": "symptoms",
"expected_value": true
}
},
{
"exact_snippets": "arrhythmias",
"criterion": "arrhythmias",
"requirement": {
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
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{
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"operator": ">=",
"value": 50,
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},
{
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},
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"requirement_type": "symptoms",
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},
{
"exact_snippets": "arrhythmias",
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{
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"identified_line": {
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"exact_snippets": "PRIOR CONCURRENT THERAPY",
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"identified_line": {
"line": "* No prior cyclophosphamide and fludarabine as part of a preparative regimen on National Cancer Institute (NCI) Surgery Branch adoptive cell therapy studies unless sufficient numbers of CD34+ stem cells (more than 2 x10^6/kg patient weight) have been obtained prior to the administration of chemotherapy",
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"exact_snippets": "Endocrine therapy",
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"identified_line": {
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"identified_line": {
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}
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"identified_line": {
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},
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}
},
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"identified_line": {
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},
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}
},
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"identified_line": {
"line": "* Not pregnant or nursing",
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},
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},
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]
}
},
{
"identified_line": {
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},
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"and_criteria": []
}
},
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"identified_line": {
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},
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}
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],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
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"identified_line": {
"line": "* Creatinine ≤ 1.6 mg/dL",
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"identified_line": {
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}
},
{
"identified_line": {
"line": "* No active systemic infections",
"criterions": [
{
"exact_snippets": "No active systemic infections",
"criterion": "systemic infections",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No active systemic infections",
"criterion": "systemic infections",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No opportunistic infections",
"criterions": [
{
"exact_snippets": "No opportunistic infections",
"criterion": "opportunistic infections",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No opportunistic infections",
"criterion": "opportunistic infections",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No concurrent systemic steroid therapy",
"criterions": [
{
"exact_snippets": "No concurrent systemic steroid therapy",
"criterion": "systemic steroid therapy",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No concurrent systemic steroid therapy",
"criterion": "systemic steroid therapy",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No other concurrent experimental agents",
"criterions": [
{
"exact_snippets": "No other concurrent experimental agents",
"criterion": "concurrent experimental agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No other concurrent experimental agents",
"criterion": "concurrent experimental agents",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
]
}