{
"info": {
"nct_id": "NCT00753220",
"official_title": "A Phase I/IIa Trial of Combined Cryotherapy and Intra-tumoral Immunotherapy With Autologous Immature Dendritic Cells (VDC2008) in Chemo-naïve Men With Prostatic Adenocarcinoma and Limited Metastases to Lymph Nodes and/or Bone",
"inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion Criteria\n\n* Men ≥ 18 years of age and any race.\n* Signed Informed Consent document obtained prior to the initiation of screening procedures.\n* Histologically documented primary adenocarcinoma of the prostate. A specimen of the primary tumor must be submitted to the Central Pathology Laboratory for confirmation of prostatic adenocarcinoma and determination of Gleason Sum grading.\n* Prior history of:\n\n 1. Androgen Deprivation Therapy; or\n 2. Organ-preserving therapy (i.e., non-prostatectomy) for primary prostate cancer (e.g., radiation therapy).\n* In case of recurrence, subject must have evidence of prostate cancer by a positive biopsy revealing adenocarcinoma within the past 6 months of screening and confirmed by the Central Pathology Laboratory.\n* TxNxM1a and/or TxNxM1b disease limited to three total metastatic sites as evidenced by lymph node metastases and /or bone metastases at time of screening.\n\n 1. TxNxM1a : Lymph node metastases histologically proven and confirmed by Central Pathology Laboratory;\n 2. TxNxM1a: Lymph node metastases not histologically proven, given that the following are satisfied in the temporal order listed:\n\n 1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) for positive lymph nodes negative at original diagnosis of prostate cancer;\n 2. Definitive local treatment undertaken;\n 3. Evidence of local treatment failure on the basis of rising serum PSA;\n 4. Prostatic biopsy positive for carcinoma;\n 5. Subsequent CT or MRI reveals lymph node(s) of 2 cm diameter or greater\n 3. TxNxM1b: Bone metastases demonstrated by radionuclide bone scan, CT, or MRI.\n* Androgen-independent prostate cancer as defined by:\n\n 1. Three consecutive rises of at least 10% each in serum PSA, in which all serum PSA measurements are separated by at least one week and results are obtained within 60 days of study screening; OR\n 2. Three rises that involve an increase of 50% over the nadir serum PSA, in which all serum PSA measurements are separated by at least one week and results are obtained within 60 days of study screening;\n 3. A castrate level of testosterone (<50 ng/dl) obtained within 60 days of study screening.\n* Life expectancy of greater than or equal to 12 months.\n* Adequate hematological function as defined by:\n\n 1. Total WBC > 4,500/mm3\n 2. Total lymphocyte count > 500/mm3\n 3. Hemoglobin > 12.0 g/dl\n 4. Neutrophils > 1,500/mm3\n 5. Platelets > 150,000/mm3\n* Adequate renal function with creatinine < 2.0 mg/dl.\n* Adequate liver function as defined by:\n\n 1. AST and ALT < 2 times the upper limit of normal;\n 2. Serum bilirubin < 2.0 mg/dl;\n 3. Alkaline Phosphatase < 2.0 upper limit of normal.\n* Assessment of superficial veins as adequate for the performance of leukapheresis.\n* No active major medical or psychological problems that could be complicated by study participation.\n\nExclusion Criteria\n\n* The presence of lung, liver or brain metastases, malignant pleural effusions or malignant ascites.\n* Moderate or severe symptomatic metastatic disease. Subjects who meet either of the following criteria must be excluded:\n\n 1. A requirement for treatment with opioid analgesics for any reason within 21 days prior to study screening;\n 2. Average weekly pain score of 4 or more as reported on the 11-point Pain Intensity - Numerical Rating Scale (Appendix III) over the two weeks prior to study enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2 accessed at study screening visit.\n* Chemotherapy treatment at any time prior to study screening.\n* Radiation therapy for metastatic disease, including intravenous radioactive strontium therapy.\n* Initiation or discontinuation of bisphosphonate therapy within 28 days prior to study screening. Subjects taking bisphosphonate medication must not have their dosing regimen altered until objective disease progression is independently confirmed.\n* Treatment with any of the following medications or interventions within 28 days of study screening:\n\n 1. Systemic corticosteroids (use of inhaled, intranasal and topical steroids is acceptable);\n 2. External beam radiation therapy or surgery;\n 3. PC-SPES (or PC-SPEC) or Saw Palmetto extract;\n 4. Megestrol acetate (Megace®), diethyl stilbesterol (DES), or cyproterone acetate;\n 5. Ketoconazole;\n 6. High dose calcitriol (i.e., > 7.0 μg/week);\n 7. Any other systemic therapy for prostate cancer.\n* Treatment with any investigational vaccine within 2 years of enrollment to this study.\n* Treatment with any other investigational product within 28 days of study screening.\n* Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.\n* Impending untreated spinal cord compression or urinary outlet obstruction.\n* Paget's Disease of bone.\n* History of stage III or greater cancer, excluding prostate cancer:\n\n 1. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of study screening visit;\n 2. Subjects with a history of stage I or II cancer must have been adequately treated and be disease-free for ≥ 3 years at the time of study screening\n* Requirement for systemic immunosuppressive therapy for any reason\n* Prior or currently active autoimmune disease requiring management with systemic immunosuppression. Such conditions include inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-related thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatological disease.\n* Any infection requiring parenteral antibiotic therapy or causing fever (body temperature > 100.5°F or 38.1°C) within 1 week prior to study screening.\n* Known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging\n* History of asthma, anaphylaxis, or other known serious adverse reactions to vaccines.\n* Any medical intervention or other condition which, in the opinion of the Physician-Investigator could compromise adherence with study requirements or otherwise compromise study subject safety and the study's objectives."
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
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"unit": "Years"
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"line": "* Histologically documented primary adenocarcinoma of the prostate. A specimen of the primary tumor must be submitted to the Central Pathology Laboratory for confirmation of prostatic adenocarcinoma and determination of Gleason Sum grading.",
"criterions": [
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"criterion": "primary adenocarcinoma of the prostate",
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"criterion": "primary tumor specimen",
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"exact_snippets": "confirmation of prostatic adenocarcinoma",
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"expected_value": true
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},
{
"exact_snippets": "determination of Gleason Sum grading",
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"and_criteria": [
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"expected_value": true
}
}
]
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"exact_snippets": "Prior history of",
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},
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"identified_line": {
"line": "1. Androgen Deprivation Therapy; or",
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"exact_snippets": "Androgen Deprivation Therapy",
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}
]
},
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}
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}
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"line": "2. Organ-preserving therapy (i.e., non-prostatectomy) for primary prostate cancer (e.g., radiation therapy).",
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{
"exact_snippets": "Organ-preserving therapy (i.e., non-prostatectomy) for primary prostate cancer",
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"non-prostatectomy"
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}
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{
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"expected_value": "primary prostate cancer"
}
}
]
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{
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}
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}
]
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},
{
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"operator": "<=",
"value": 6,
"unit": "months"
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]
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}
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"line": "2. TxNxM1a: Lymph node metastases not histologically proven, given that the following are satisfied in the temporal order listed:",
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}
}
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}
},
"then_criteria": null,
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"line": "1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) for positive lymph nodes negative at original diagnosis of prostate cancer;",
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{
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]
}
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]
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}
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"line": "3. Evidence of local treatment failure on the basis of rising serum PSA;",
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"expected_value": true
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}
}
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"identified_line": {
"line": "5. Subsequent CT or MRI reveals lymph node(s) of 2 cm diameter or greater",
"criterions": [
{
"exact_snippets": "CT or MRI reveals lymph node(s) of 2 cm diameter or greater",
"criterion": "lymph node size",
"requirement": {
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"expected_value": {
"operator": ">=",
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"unit": "cm"
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}
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "week"
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}
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"operator": "<=",
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"unit": "days"
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "week"
}
}
}
]
},
{
"exact_snippets": "results are obtained within 60 days of study screening",
"criterion": "PSA measurement timing",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "days"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Three rises that involve an increase of 50% over the nadir serum PSA, in which all serum PSA measurements are separated by at least one week and results are obtained within 60 days of study screening;",
"criterions": [
{
"exact_snippets": "Three rises that involve an increase of 50% over the nadir serum PSA",
"criterion": "serum PSA rise",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "rises"
}
}
},
{
"exact_snippets": "Three rises that involve an increase of 50% over the nadir serum PSA",
"criterion": "serum PSA rise",
"requirement": {
"requirement_type": "increase",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "all serum PSA measurements are separated by at least one week",
"criterion": "serum PSA measurement separation",
"requirement": {
"requirement_type": "time separation",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "week"
}
}
},
{
"exact_snippets": "results are obtained within 60 days of study screening",
"criterion": "serum PSA results timing",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Three rises that involve an increase of 50% over the nadir serum PSA",
"criterion": "serum PSA rise",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "rises"
}
}
},
{
"exact_snippets": "Three rises that involve an increase of 50% over the nadir serum PSA",
"criterion": "serum PSA rise",
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"requirement_type": "increase",
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"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
},
{
"exact_snippets": "all serum PSA measurements are separated by at least one week",
"criterion": "serum PSA measurement separation",
"requirement": {
"requirement_type": "time separation",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "week"
}
}
}
]
},
{
"exact_snippets": "results are obtained within 60 days of study screening",
"criterion": "serum PSA results timing",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "days"
}
}
}
]
},
{
"exact_snippets": "results are obtained within 60 days of study screening",
"criterion": "serum PSA results timing",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. A castrate level of testosterone (<50 ng/dl) obtained within 60 days of study screening.",
"criterions": [
{
"exact_snippets": "castrate level of testosterone (<50 ng/dl)",
"criterion": "testosterone level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "ng/dl"
}
}
},
{
"exact_snippets": "obtained within 60 days of study screening",
"criterion": "testosterone level measurement timing",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 60 days of study screening"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "castrate level of testosterone (<50 ng/dl)",
"criterion": "testosterone level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "ng/dl"
}
}
},
{
"exact_snippets": "obtained within 60 days of study screening",
"criterion": "testosterone level measurement timing",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 60 days of study screening"
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy of greater than or equal to 12 months.",
"criterions": [
{
"exact_snippets": "Life expectancy of greater than or equal to 12 months.",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy of greater than or equal to 12 months.",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate hematological function as defined by:",
"criterions": [
{
"exact_snippets": "Adequate hematological function",
"criterion": "hematological function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate hematological function",
"criterion": "hematological function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "1. Total WBC > 4,500/mm3",
"criterions": [
{
"exact_snippets": "Total WBC > 4,500/mm3",
"criterion": "total white blood cell count (WBC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 4500,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total WBC > 4,500/mm3",
"criterion": "total white blood cell count (WBC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 4500,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Total lymphocyte count > 500/mm3",
"criterions": [
{
"exact_snippets": "Total lymphocyte count > 500/mm3",
"criterion": "total lymphocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 500,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Total lymphocyte count > 500/mm3",
"criterion": "total lymphocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 500,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Hemoglobin > 12.0 g/dl",
"criterions": [
{
"exact_snippets": "Hemoglobin > 12.0 g/dl",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 12.0,
"unit": "g/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin > 12.0 g/dl",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 12.0,
"unit": "g/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. Neutrophils > 1,500/mm3",
"criterions": [
{
"exact_snippets": "Neutrophils > 1,500/mm3",
"criterion": "neutrophils",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">",
"value": 1500,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Neutrophils > 1,500/mm3",
"criterion": "neutrophils",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">",
"value": 1500,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Platelets > 150,000/mm3",
"criterions": [
{
"exact_snippets": "Platelets > 150,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 150000,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelets > 150,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 150000,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate renal function with creatinine < 2.0 mg/dl.",
"criterions": [
{
"exact_snippets": "Adequate renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "creatinine < 2.0 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "mg/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "creatinine < 2.0 mg/dl",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "mg/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate liver function as defined by:",
"criterions": [
{
"exact_snippets": "Adequate liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate liver function",
"criterion": "liver function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
}
]
}
},
{
"identified_line": {
"line": "1. AST and ALT < 2 times the upper limit of normal;",
"criterions": [
{
"exact_snippets": "AST ... < 2 times the upper limit of normal",
"criterion": "AST level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "times the upper limit of normal"
}
}
},
{
"exact_snippets": "ALT < 2 times the upper limit of normal",
"criterion": "ALT level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "times the upper limit of normal"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "AST ... < 2 times the upper limit of normal",
"criterion": "AST level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "times the upper limit of normal"
}
}
},
{
"exact_snippets": "ALT < 2 times the upper limit of normal",
"criterion": "ALT level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "times the upper limit of normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Serum bilirubin < 2.0 mg/dl;",
"criterions": [
{
"exact_snippets": "Serum bilirubin < 2.0 mg/dl",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "mg/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Serum bilirubin < 2.0 mg/dl",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "mg/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Alkaline Phosphatase < 2.0 upper limit of normal.",
"criterions": [
{
"exact_snippets": "Alkaline Phosphatase < 2.0 upper limit of normal.",
"criterion": "Alkaline Phosphatase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "upper limit of normal"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Alkaline Phosphatase < 2.0 upper limit of normal.",
"criterion": "Alkaline Phosphatase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 2.0,
"unit": "upper limit of normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Assessment of superficial veins as adequate for the performance of leukapheresis.",
"criterions": [
{
"exact_snippets": "superficial veins as adequate for the performance of leukapheresis",
"criterion": "superficial veins",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate for the performance of leukapheresis"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "superficial veins as adequate for the performance of leukapheresis",
"criterion": "superficial veins",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate for the performance of leukapheresis"
}
}
]
}
},
{
"identified_line": {
"line": "* No active major medical or psychological problems that could be complicated by study participation.",
"criterions": [
{
"exact_snippets": "No active major medical ... problems",
"criterion": "major medical problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No active ... psychological problems",
"criterion": "psychological problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No active major medical ... problems",
"criterion": "major medical problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No active ... psychological problems",
"criterion": "psychological problems",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* The presence of lung, liver or brain metastases, malignant pleural effusions or malignant ascites.",
"criterions": [
{
"exact_snippets": "presence of lung ... metastases",
"criterion": "lung metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... liver ... metastases",
"criterion": "liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... malignant pleural effusions",
"criterion": "malignant pleural effusions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... malignant ascites",
"criterion": "malignant ascites",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "presence of lung ... metastases",
"criterion": "lung metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... liver ... metastases",
"criterion": "liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... malignant pleural effusions",
"criterion": "malignant pleural effusions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "presence of ... malignant ascites",
"criterion": "malignant ascites",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Moderate or severe symptomatic metastatic disease. Subjects who meet either of the following criteria must be excluded:",
"criterions": [
{
"exact_snippets": "Moderate or severe symptomatic metastatic disease",
"criterion": "symptomatic metastatic disease",
"requirement": {
"requirement_type": "severity",
"expected_value": [
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"severe"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Moderate or severe symptomatic metastatic disease",
"criterion": "symptomatic metastatic disease",
"requirement": {
"requirement_type": "severity",
"expected_value": [
"moderate",
"severe"
]
}
},
{
"not_criteria": {
"or_criteria": [
{
"exact_snippets": "Moderate or severe symptomatic metastatic disease",
"criterion": "symptomatic metastatic disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "moderate"
}
},
{
"exact_snippets": "Moderate or severe symptomatic metastatic disease",
"criterion": "symptomatic metastatic disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "1. A requirement for treatment with opioid analgesics for any reason within 21 days prior to study screening;",
"criterions": [
{
"exact_snippets": "requirement for treatment with opioid analgesics ... within 21 days prior to study screening",
"criterion": "opioid analgesics treatment",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "requirement for treatment with opioid analgesics ... within 21 days prior to study screening",
"criterion": "opioid analgesics treatment",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Average weekly pain score of 4 or more as reported on the 11-point Pain Intensity - Numerical Rating Scale (Appendix III) over the two weeks prior to study enrollment.",
"criterions": [
{
"exact_snippets": "Average weekly pain score of 4 or more ... 11-point Pain Intensity - Numerical Rating Scale",
"criterion": "pain score",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Average weekly pain score of 4 or more ... 11-point Pain Intensity - Numerical Rating Scale",
"criterion": "pain score",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2 accessed at study screening visit.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Chemotherapy treatment at any time prior to study screening.",
"criterions": [
{
"exact_snippets": "Chemotherapy treatment at any time prior to study screening.",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to study screening"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Chemotherapy treatment at any time prior to study screening.",
"criterion": "chemotherapy treatment",
"requirement": {
"requirement_type": "timing",
"expected_value": "prior to study screening"
}
}
]
}
},
{
"identified_line": {
"line": "* Radiation therapy for metastatic disease, including intravenous radioactive strontium therapy.",
"criterions": [
{
"exact_snippets": "Radiation therapy for metastatic disease",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "purpose",
"expected_value": "metastatic disease"
}
},
{
"exact_snippets": "intravenous radioactive strontium therapy",
"criterion": "intravenous radioactive strontium therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Radiation therapy for metastatic disease",
"criterion": "radiation therapy",
"requirement": {
"requirement_type": "purpose",
"expected_value": "metastatic disease"
}
},
{
"exact_snippets": "intravenous radioactive strontium therapy",
"criterion": "intravenous radioactive strontium therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Initiation or discontinuation of bisphosphonate therapy within 28 days prior to study screening. Subjects taking bisphosphonate medication must not have their dosing regimen altered until objective disease progression is independently confirmed.",
"criterions": [
{
"exact_snippets": "Initiation or discontinuation of bisphosphonate therapy within 28 days prior to study screening.",
"criterion": "bisphosphonate therapy",
"requirement": {
"requirement_type": "initiation",
"expected_value": false
}
},
{
"exact_snippets": "Initiation or discontinuation of bisphosphonate therapy within 28 days prior to study screening.",
"criterion": "bisphosphonate therapy",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": false
}
},
{
"exact_snippets": "Subjects taking bisphosphonate medication must not have their dosing regimen altered until objective disease progression is independently confirmed.",
"criterion": "bisphosphonate medication dosing regimen",
"requirement": {
"requirement_type": "alteration",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Initiation or discontinuation of bisphosphonate therapy within 28 days prior to study screening.",
"criterion": "bisphosphonate therapy",
"requirement": {
"requirement_type": "initiation",
"expected_value": false
}
},
{
"exact_snippets": "Initiation or discontinuation of bisphosphonate therapy within 28 days prior to study screening.",
"criterion": "bisphosphonate therapy",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Subjects taking bisphosphonate medication must not have their dosing regimen altered until objective disease progression is independently confirmed.",
"criterion": "bisphosphonate medication dosing regimen",
"requirement": {
"requirement_type": "alteration",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Treatment with any of the following medications or interventions within 28 days of study screening:",
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{
"exact_snippets": "Treatment with any of the following medications or interventions within 28 days of study screening",
"criterion": "treatment with specific medications or interventions",
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"requirement_type": "time frame",
"expected_value": "within 28 days of study screening"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Treatment with any of the following medications or interventions within 28 days of study screening",
"criterion": "treatment with specific medications or interventions",
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"requirement_type": "time frame",
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}
}
}
},
{
"identified_line": {
"line": "1. Systemic corticosteroids (use of inhaled, intranasal and topical steroids is acceptable);",
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{
"exact_snippets": "Systemic corticosteroids",
"criterion": "systemic corticosteroids",
"requirement": {
"requirement_type": "use",
"expected_value": false
}
},
{
"exact_snippets": "use of inhaled, intranasal and topical steroids is acceptable",
"criterion": "inhaled, intranasal and topical steroids",
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"requirement_type": "use",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Systemic corticosteroids",
"criterion": "systemic corticosteroids",
"requirement": {
"requirement_type": "use",
"expected_value": false
}
}
},
{
"exact_snippets": "use of inhaled, intranasal and topical steroids is acceptable",
"criterion": "inhaled, intranasal and topical steroids",
"requirement": {
"requirement_type": "use",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. External beam radiation therapy or surgery;",
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{
"exact_snippets": "External beam radiation therapy",
"criterion": "external beam radiation therapy",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "surgery",
"criterion": "surgery",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "External beam radiation therapy",
"criterion": "external beam radiation therapy",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "surgery",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. PC-SPES (or PC-SPEC) or Saw Palmetto extract;",
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{
"exact_snippets": "PC-SPES (or PC-SPEC)",
"criterion": "PC-SPES or PC-SPEC",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "Saw Palmetto extract",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "PC-SPES (or PC-SPEC)",
"criterion": "PC-SPES or PC-SPEC",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Saw Palmetto extract",
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"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "5. Ketoconazole;",
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{
"exact_snippets": "Ketoconazole",
"criterion": "ketoconazole",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Ketoconazole",
"criterion": "ketoconazole",
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"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "6. High dose calcitriol (i.e., > 7.0 μg/week);",
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{
"exact_snippets": "High dose calcitriol (i.e., > 7.0 μg/week)",
"criterion": "calcitriol dose",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 7.0,
"unit": "μg/week"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "High dose calcitriol (i.e., > 7.0 μg/week)",
"criterion": "calcitriol dose",
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"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 7.0,
"unit": "μg/week"
}
}
}
]
}
},
{
"identified_line": {
"line": "7. Any other systemic therapy for prostate cancer.",
"criterions": [
{
"exact_snippets": "Any other systemic therapy for prostate cancer",
"criterion": "systemic therapy for prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Any other systemic therapy for prostate cancer",
"criterion": "systemic therapy for prostate cancer",
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"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Treatment with any investigational vaccine within 2 years of enrollment to this study.",
"criterions": [
{
"exact_snippets": "Treatment with any investigational vaccine within 2 years of enrollment",
"criterion": "investigational vaccine treatment",
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"requirement_type": "time since treatment",
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"comparisons": [
{
"operator": "<=",
"value": 2,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Treatment with any investigational vaccine within 2 years of enrollment",
"criterion": "investigational vaccine treatment",
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"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2,
"unit": "years"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "* Treatment with any other investigational product within 28 days of study screening.",
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{
"exact_snippets": "Treatment with any other investigational product within 28 days of study screening.",
"criterion": "treatment with investigational product",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Treatment with any other investigational product within 28 days of study screening.",
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"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
}
}
},
{
"identified_line": {
"line": "* Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.",
"criterions": [
{
"exact_snippets": "Pathologic long-bone fractures",
"criterion": "pathologic long-bone fractures",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "imminent pathologic long-bone fracture (cortical erosion on radiography > 50%)",
"criterion": "imminent pathologic long-bone fracture",
"requirement": {
"requirement_type": "cortical erosion on radiography",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pathologic long-bone fractures",
"criterion": "pathologic long-bone fractures",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "imminent pathologic long-bone fracture (cortical erosion on radiography > 50%)",
"criterion": "imminent pathologic long-bone fracture",
"requirement": {
"requirement_type": "cortical erosion on radiography",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Impending untreated spinal cord compression or urinary outlet obstruction.",
"criterions": [
{
"exact_snippets": "Impending untreated spinal cord compression",
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"requirement_type": "status",
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}
},
{
"exact_snippets": "Impending untreated spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
},
{
"exact_snippets": "urinary outlet obstruction",
"criterion": "urinary outlet obstruction",
"requirement": {
"requirement_type": "status",
"expected_value": "impending"
}
},
{
"exact_snippets": "urinary outlet obstruction",
"criterion": "urinary outlet obstruction",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Impending untreated spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "status",
"expected_value": "impending"
}
},
{
"exact_snippets": "Impending untreated spinal cord compression",
"criterion": "spinal cord compression",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "urinary outlet obstruction",
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"requirement_type": "status",
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}
},
{
"exact_snippets": "urinary outlet obstruction",
"criterion": "urinary outlet obstruction",
"requirement": {
"requirement_type": "treatment",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Paget's Disease of bone.",
"criterions": [
{
"exact_snippets": "Paget's Disease of bone",
"criterion": "Paget's Disease of bone",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Paget's Disease of bone",
"criterion": "Paget's Disease of bone",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of stage III or greater cancer, excluding prostate cancer:",
"criterions": [
{
"exact_snippets": "History of stage III or greater cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "stage"
}
}
},
{
"exact_snippets": "excluding prostate cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "prostate cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of stage III or greater cancer",
"criterion": "cancer stage",
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"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "stage"
}
}
},
{
"not_criteria": {
"exact_snippets": "excluding prostate cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "exclusion",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "1. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of study screening visit;",
"criterions": [
{
"exact_snippets": "Basal or squamous cell skin cancers must have been adequately treated",
"criterion": "basal or squamous cell skin cancers",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
},
{
"exact_snippets": "the subject must be disease-free at the time of study screening visit",
"criterion": "disease-free status",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Basal or squamous cell skin cancers must have been adequately treated",
"criterion": "basal or squamous cell skin cancers",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
},
{
"exact_snippets": "the subject must be disease-free at the time of study screening visit",
"criterion": "disease-free status",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Subjects with a history of stage I or II cancer must have been adequately treated and be disease-free for ≥ 3 years at the time of study screening",
"criterions": [
{
"exact_snippets": "history of stage I or II cancer",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "severity",
"expected_value": [
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}
},
{
"exact_snippets": "adequately treated",
"criterion": "cancer treatment",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequately treated"
}
},
{
"exact_snippets": "disease-free for ≥ 3 years",
"criterion": "disease-free status",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"condition": {
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{
"exact_snippets": "history of stage I or II cancer",
"criterion": "cancer stage",
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"requirement_type": "severity",
"expected_value": [
"stage I",
"stage II"
]
}
},
{
"exact_snippets": "adequately treated",
"criterion": "cancer treatment",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequately treated"
}
}
]
},
"then_criteria": {
"exact_snippets": "disease-free for ≥ 3 years",
"criterion": "disease-free status",
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"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "years"
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Requirement for systemic immunosuppressive therapy for any reason",
"criterions": [
{
"exact_snippets": "Requirement for systemic immunosuppressive therapy",
"criterion": "systemic immunosuppressive therapy",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Requirement for systemic immunosuppressive therapy",
"criterion": "systemic immunosuppressive therapy",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Prior or currently active autoimmune disease requiring management with systemic immunosuppression. Such conditions include inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-related thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatological disease.",
"criterions": [
{
"exact_snippets": "Prior or currently active autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "requiring management with systemic immunosuppression",
"criterion": "systemic immunosuppression",
"requirement": {
"requirement_type": "requirement",
"expected_value": "required"
}
},
{
"exact_snippets": "inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "systemic vasculitis",
"criterion": "systemic vasculitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "scleroderma",
"criterion": "scleroderma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "psoriasis",
"criterion": "psoriasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "multiple sclerosis",
"criterion": "multiple sclerosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hemolytic anemia",
"criterion": "hemolytic anemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "immune-related thrombocytopenia",
"criterion": "immune-related thrombocytopenia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "rheumatoid arthritis",
"criterion": "rheumatoid arthritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "systemic lupus erythematosus",
"criterion": "systemic lupus erythematosus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Sjögren's syndrome",
"criterion": "Sjögren's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sarcoidosis",
"criterion": "sarcoidosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other rheumatological disease",
"criterion": "rheumatological disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior or currently active autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "requiring management with systemic immunosuppression",
"criterion": "systemic immunosuppression",
"requirement": {
"requirement_type": "requirement",
"expected_value": "required"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "systemic vasculitis",
"criterion": "systemic vasculitis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "scleroderma",
"criterion": "scleroderma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "psoriasis",
"criterion": "psoriasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "multiple sclerosis",
"criterion": "multiple sclerosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hemolytic anemia",
"criterion": "hemolytic anemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "immune-related thrombocytopenia",
"criterion": "immune-related thrombocytopenia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "rheumatoid arthritis",
"criterion": "rheumatoid arthritis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "systemic lupus erythematosus",
"criterion": "systemic lupus erythematosus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Sjögren's syndrome",
"criterion": "Sjögren's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sarcoidosis",
"criterion": "sarcoidosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other rheumatological disease",
"criterion": "rheumatological disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Any infection requiring parenteral antibiotic therapy or causing fever (body temperature > 100.5°F or 38.1°C) within 1 week prior to study screening.",
"criterions": [
{
"exact_snippets": "Any infection requiring parenteral antibiotic therapy",
"criterion": "infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "parenteral antibiotic therapy"
}
},
{
"exact_snippets": "Any infection ... causing fever (body temperature > 100.5°F or 38.1°C)",
"criterion": "infection",
"requirement": {
"requirement_type": "symptom",
"expected_value": "fever"
}
},
{
"exact_snippets": "fever (body temperature > 100.5°F or 38.1°C)",
"criterion": "body temperature",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 100.5,
"unit": "°F"
},
{
"operator": ">",
"value": 38.1,
"unit": "°C"
}
]
}
}
},
{
"exact_snippets": "within 1 week prior to study screening",
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{
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{
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},
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},
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{
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}
},
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},
{
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},
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"and_criteria": []
}
},
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],
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}
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},
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]
}