{
"info": {
"nct_id": "NCT00024180",
"official_title": "A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of one of the following hematologic malignancies:\n\n * Chronic lymphocytic leukemia (CLL)\n * Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)\n * Acute myeloid leukemia (AML)\n * Acute lymphoblastic leukemia (ALL)\n* Stratum I (CLL and SLL):\n\n * Received at least one prior therapy containing a purine analog OR\n * Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy\n* Stratum II (AML and ALL):\n\n * Primary refractory or relapsed leukemia within the past year that is not amenable to curative therapy\n * OR\n * Untreated or previously treated poor-risk leukemia defined by any of the following:\n\n * 65 years of age and over\n * Poor-risk candidates for aggressive chemotherapy\n * Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Stratum I only:\n\n * No uncontrolled autoimmune hemolytic anemia\n * No idiopathic thrombocytopenic purpura\n* Stratum II only:\n\n * WBC no greater than 10,000/mm^3 OR\n * WBC no greater than 40,000/mm^3 that is stable for at least 1 week (may be sustained by hydroxyurea through the first week of study)\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* ALT and AST no greater than 3 times upper limit of normal\n\nRenal:\n\n* Creatinine less than 2.0 mg/dL\n\nCardiovascular:\n\n* Ejection fraction at least 50% by MUGA\n* No myocardial infarction or unstable angina within the past 6 months\n* No prior unstable ventricular or supraventricular cardiac arrhythmias\n\nOther:\n\n* HIV negative\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other medical or psychiatric problem that would preclude study\n* Stratum I only:\n\n * No active infection requiring oral or IV antibiotics\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 28 days since prior chemotherapy (except hydroxyurea)\n* At least 6 weeks since prior nitrosoureas\n* At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM)\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* At least 28 days since prior radiotherapy\n\nSurgery:\n\n* At least 28 days since prior major surgery"
},
"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": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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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": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis of one of the following hematologic malignancies:",
"criterions": [
{
"exact_snippets": "Diagnosis of one of the following hematologic malignancies",
"criterion": "hematologic malignancies",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosis of one of the following hematologic malignancies",
"criterion": "hematologic malignancies",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Chronic lymphocytic leukemia (CLL)",
"criterions": [
{
"exact_snippets": "Chronic lymphocytic leukemia (CLL)",
"criterion": "chronic lymphocytic leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Chronic lymphocytic leukemia (CLL)",
"criterion": "chronic lymphocytic leukemia",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)",
"criterions": [
{
"exact_snippets": "Small lymphocytic lymphoma (SLL)",
"criterion": "small lymphocytic lymphoma",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Waldenstrom's macroglobulinemia",
"criterion": "Waldenstrom's macroglobulinemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Small lymphocytic lymphoma (SLL)",
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"expected_value": true
}
},
{
"exact_snippets": "Waldenstrom's macroglobulinemia",
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"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Acute myeloid leukemia (AML)",
"criterions": [
{
"exact_snippets": "Acute myeloid leukemia (AML)",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Acute myeloid leukemia (AML)",
"criterion": "acute myeloid leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Acute lymphoblastic leukemia (ALL)",
"criterions": [
{
"exact_snippets": "Acute lymphoblastic leukemia (ALL)",
"criterion": "Acute lymphoblastic leukemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Acute lymphoblastic leukemia (ALL)",
"criterion": "Acute lymphoblastic leukemia",
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}
}
]
}
},
{
"identified_line": {
"line": "* Stratum I (CLL and SLL):",
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{
"exact_snippets": "Stratum I (CLL and SLL)",
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"requirement_type": "specific types",
"expected_value": [
"CLL",
"SLL"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Stratum I (CLL and SLL)",
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]
}
}
]
}
},
{
"identified_line": {
"line": "* Received at least one prior therapy containing a purine analog OR",
"criterions": [
{
"exact_snippets": "Received at least one prior therapy containing a purine analog",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "content",
"expected_value": "purine analog"
}
},
{
"exact_snippets": "Received at least one prior therapy containing a purine analog",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "therapy"
}
}
}
]
},
"logical_structure": {
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"and_criteria": [
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"exact_snippets": "Received at least one prior therapy containing a purine analog",
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}
},
{
"exact_snippets": "Received at least one prior therapy containing a purine analog",
"criterion": "prior therapy",
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"operator": ">=",
"value": 1,
"unit": "therapy"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy",
"criterions": [
{
"exact_snippets": "Received another form of therapy (including alkylating agents)",
"criterion": "previous therapy",
"requirement": {
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"alkylating agents"
]
}
},
{
"exact_snippets": "history of severe autoimmune disease",
"criterion": "autoimmune disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "requirement for chronic corticosteroid",
"criterion": "corticosteroid use",
"requirement": {
"requirement_type": "duration",
"expected_value": "chronic"
}
},
{
"exact_snippets": "contraindication to purine analog therapy",
"criterion": "purine analog therapy",
"requirement": {
"requirement_type": "contraindication",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
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{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
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}
},
{
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}
}
]
},
{
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}
]
}
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}
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"then_criteria": {
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]
}
},
"else_criteria": null
}
},
{
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{
"exact_snippets": "Stratum II (AML and ALL)",
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"ALL"
]
}
}
]
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]
}
}
]
}
},
{
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{
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"requirement": {
"requirement_type": "status",
"expected_value": [
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"relapsed"
]
}
},
{
"exact_snippets": "within the past year",
"criterion": "time since leukemia status",
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"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
},
{
"exact_snippets": "not amenable to curative therapy",
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}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "Primary refractory or relapsed leukemia",
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"relapsed"
]
}
},
{
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"value": 1,
"unit": "year"
}
}
}
]
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Untreated or previously treated poor-risk leukemia",
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]
}
}
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"and_criteria": [
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"exact_snippets": "Untreated or previously treated poor-risk leukemia",
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}
}
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}
]
}
},
{
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{
"exact_snippets": "65 years of age and over",
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"operator": ">=",
"value": 65,
"unit": "years"
}
}
}
]
},
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"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Poor-risk candidates for aggressive chemotherapy",
"criterions": [
{
"exact_snippets": "Poor-risk candidates for aggressive chemotherapy",
"criterion": "risk level for aggressive chemotherapy",
"requirement": {
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"expected_value": "poor"
}
}
]
},
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"exact_snippets": "Poor-risk candidates for aggressive chemotherapy",
"criterion": "risk level for aggressive chemotherapy",
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"expected_value": "poor"
}
}
]
}
},
{
"identified_line": {
"line": "* Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))",
"criterions": [
{
"exact_snippets": "Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))",
"criterion": "cytogenetics",
"requirement": {
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"expected_value": "poor"
}
},
{
"exact_snippets": "Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))",
"criterion": "cytogenetics",
"requirement": {
"requirement_type": "karyotype abnormalities",
"expected_value": {
"operator": "!=",
"value": 0,
"unit": "t(8;21), inv(16), t(15;17)"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))",
"criterion": "cytogenetics",
"requirement": {
"requirement_type": "risk",
"expected_value": "poor"
}
},
{
"exact_snippets": "Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))",
"criterion": "cytogenetics",
"requirement": {
"requirement_type": "karyotype abnormalities",
"expected_value": {
"operator": "!=",
"value": 0,
"unit": "t(8;21), inv(16), t(15;17)"
}
}
}
]
}
},
{
"identified_line": {
"line": "Age:",
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{
"exact_snippets": "Age:",
"criterion": "age",
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Age:",
"criterion": "age",
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}
}
]
}
},
{
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"line": "* 18 and over",
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{
"exact_snippets": "18 and over",
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{
"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
},
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{
"exact_snippets": "18 and over",
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"operator": ">=",
"value": 18,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Performance status:",
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{
"exact_snippets": "Performance status:",
"criterion": "performance status",
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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": "* ECOG 0-2",
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{
"exact_snippets": "ECOG 0-2",
"criterion": "ECOG performance status",
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"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
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"exact_snippets": "ECOG 0-2",
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"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy:",
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{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* At least 12 weeks",
"criterions": [
{
"exact_snippets": "At least 12 weeks",
"criterion": "duration",
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"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 12 weeks",
"criterion": "duration",
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"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "Hematopoietic:",
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{
"exact_snippets": "Hematopoietic:",
"criterion": "hematopoietic system",
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"expected_value": "N/A"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Hematopoietic:",
"criterion": "hematopoietic system",
"requirement": {
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"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* Stratum I only:",
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{
"exact_snippets": "Stratum I only",
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"expected_value": "I"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Stratum I only",
"criterion": "stratum",
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}
}
]
}
},
{
"identified_line": {
"line": "* No uncontrolled autoimmune hemolytic anemia",
"criterions": [
{
"exact_snippets": "uncontrolled autoimmune hemolytic anemia",
"criterion": "autoimmune hemolytic anemia",
"requirement": {
"requirement_type": "control status",
"expected_value": "controlled"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "uncontrolled autoimmune hemolytic anemia",
"criterion": "autoimmune hemolytic anemia",
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"requirement_type": "control status",
"expected_value": "controlled"
}
}
]
}
},
{
"identified_line": {
"line": "* No idiopathic thrombocytopenic purpura",
"criterions": [
{
"exact_snippets": "No idiopathic thrombocytopenic purpura",
"criterion": "idiopathic thrombocytopenic purpura",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No idiopathic thrombocytopenic purpura",
"criterion": "idiopathic thrombocytopenic purpura",
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"line": "* OR",
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},
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"identified_line": {
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"and_criteria": []
}
},
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],
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"exact_snippets": "Renal:",
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"identified_line": {
"line": "Cardiovascular:",
"criterions": [
{
"exact_snippets": "Cardiovascular:",
"criterion": "cardiovascular condition",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Ejection fraction at least 50% by MUGA",
"criterions": [
{
"exact_snippets": "Ejection fraction at least 50%",
"criterion": "ejection fraction",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
]
}