{
"info": {
"nct_id": "NCT00014248",
"official_title": "A Phase I Study And Pharmacokinetics Of Adenosine 5'- Triphosphate (ATP) When Administered By Intravenous Infusion On A Multiple Weekly Dose Schedule To Patients With Advanced Malignancies (Solid Tumors)",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed advanced solid tumor that is not curable by conventional therapy\n* Brain metastases allowed if adequately controlled with radiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* WBC at least 3,500/mm^3\n* Absolute neutrophil count at least 2,000/mm^3\n* Platelet count at least 100,000/mm^3\n\nHepatic:\n\n* SGOT and SGPT no greater than 3 times normal\n* Bilirubin no greater than 2.0 mg/dL\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n* Creatinine clearance greater than 60 mL/min\n* BUN no greater than 25 mg/dL\n\nCardiovascular:\n\n* Adequate cardiovascular function\n* No congestive heart failure (New York Heart Association class III or IV heart disease)\n* No angina pectoris AND/OR\n* No significant arrhythmia\n* No myocardial infarction within the past 6 months\n* No clinically significant ischemic cardiac disease currently under treatment\n* No clinically significant conduction system disease in the absence of a pacemaker (e.g., sick sinus syndrome, or second or third degree atrioventricular block)\n\nPulmonary:\n\n* Adequate pulmonary function\n* No clinical evidence of acute chronic obstructive pulmonary disease\n* FEV1 at least 50% predicted\n* Arterial oxygen tension at least 90% by pulse oximetry and on breathing room air\n* No asthma OR\n* No evidence of more than 20% reversibility in FEV1 with albuterol therapy\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No history of severe adverse reaction to adenosine\n* No uncontrolled medical illness\n* No average daily pain scores of at least 5 on a simple Visual Analogue Self pain assessment (0-10) scale\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 3 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* At least 30 days since prior investigational therapy\n* At least 14 days since prior long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy\n* No concurrent long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy\n* No concurrent maintenance anti-anginal drug therapy"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"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",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
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"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS:",
"criterions": [
{
"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "DISEASE CHARACTERISTICS",
"criterion": "disease characteristics",
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}
}
]
}
},
{
"identified_line": {
"line": "* Histologically or cytologically confirmed advanced solid tumor that is not curable by conventional therapy",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed advanced solid tumor",
"criterion": "advanced solid tumor",
"requirement": {
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"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "not curable by conventional therapy",
"criterion": "curability by conventional therapy",
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"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically or cytologically confirmed advanced solid tumor",
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]
}
},
{
"exact_snippets": "not curable by conventional therapy",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Brain metastases allowed if adequately controlled with radiotherapy",
"criterions": [
{
"exact_snippets": "Brain metastases allowed ... adequately controlled with radiotherapy",
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}
}
]
},
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"exact_snippets": "Brain metastases allowed ... adequately controlled with radiotherapy",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Age:",
"criterion": "age",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
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"exact_snippets": "Age:",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Over 18",
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"operator": ">",
"value": 18,
"unit": "years"
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}
}
]
},
"logical_structure": {
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"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Performance status:",
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{
"exact_snippets": "Performance status:",
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"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": "* Karnofsky 60-100%",
"criterions": [
{
"exact_snippets": "Karnofsky 60-100%",
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"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky 60-100%",
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{
"operator": ">=",
"value": 60,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Life expectancy:",
"criterions": [
{
"exact_snippets": "Life expectancy",
"criterion": "life expectancy",
"requirement": {
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"expected_value": "N/A"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Life expectancy",
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"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "* At least 12 weeks",
"criterions": [
{
"exact_snippets": "At least 12 weeks",
"criterion": "duration",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least 12 weeks",
"criterion": "duration",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "Hematopoietic:",
"criterions": [
{
"exact_snippets": "Hematopoietic:",
"criterion": "hematopoietic system",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hematopoietic:",
"criterion": "hematopoietic system",
"requirement": {
"requirement_type": "N/A",
"expected_value": "N/A"
}
}
]
}
},
{
"identified_line": {
"line": "* WBC at least 3,500/mm^3",
"criterions": [
{
"exact_snippets": "WBC at least 3,500/mm^3",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3500,
"unit": "mm^3"
}
}
}
]
},
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{
"exact_snippets": "WBC at least 3,500/mm^3",
"criterion": "WBC",
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"operator": ">=",
"value": 3500,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count at least 2,000/mm^3",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count at least 2,000/mm^3",
"criterion": "absolute neutrophil count",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 2000,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Absolute neutrophil count at least 2,000/mm^3",
"criterion": "absolute neutrophil count",
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"expected_value": {
"operator": ">=",
"value": 2000,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count at least 100,000/mm^3",
"criterions": [
{
"exact_snippets": "Platelet count at least 100,000/mm^3",
"criterion": "platelet count",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
}
]
},
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"exact_snippets": "Platelet count at least 100,000/mm^3",
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"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "Hepatic:",
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{
"exact_snippets": "Hepatic",
"criterion": "hepatic function",
"requirement": {
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"expected_value": true
}
}
]
},
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"exact_snippets": "Hepatic",
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* SGOT and SGPT no greater than 3 times normal",
"criterions": [
{
"exact_snippets": "SGOT ... no greater than 3 times normal",
"criterion": "SGOT",
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"operator": "<=",
"value": 3,
"unit": "times normal"
}
}
},
{
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"unit": "times normal"
}
}
}
]
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}
},
{
"exact_snippets": "SGPT no greater than 3 times normal",
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"unit": "times normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin no greater than 2.0 mg/dL",
"criterions": [
{
"exact_snippets": "Bilirubin no greater than 2.0 mg/dL",
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"requirement": {
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"operator": "<=",
"value": 2.0,
"unit": "mg/dL"
}
}
}
]
},
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"exact_snippets": "Bilirubin no greater than 2.0 mg/dL",
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"operator": "<=",
"value": 2.0,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "Renal:",
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"exact_snippets": "Renal:",
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}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Renal:",
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}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine no greater than 1.5 mg/dL",
"criterions": [
{
"exact_snippets": "Creatinine no greater than 1.5 mg/dL",
"criterion": "creatinine level",
"requirement": {
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"value": 1.5,
"unit": "mg/dL"
}
}
}
]
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"operator": "<=",
"value": 1.5,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine clearance greater than 60 mL/min",
"criterions": [
{
"exact_snippets": "Creatinine clearance greater than 60 mL/min",
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"operator": ">",
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"unit": "mL/min"
}
}
}
]
},
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"exact_snippets": "Creatinine clearance greater than 60 mL/min",
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"expected_value": {
"operator": ">",
"value": 60,
"unit": "mL/min"
}
}
}
]
}
},
{
"identified_line": {
"line": "* BUN no greater than 25 mg/dL",
"criterions": [
{
"exact_snippets": "BUN no greater than 25 mg/dL",
"criterion": "BUN",
"requirement": {
"requirement_type": "level",
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"operator": "<=",
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"unit": "mg/dL"
}
}
}
]
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"exact_snippets": "BUN no greater than 25 mg/dL",
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"value": 25,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Cardiovascular:",
"criterion": "cardiovascular condition",
"requirement": {
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}
}
]
},
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}
]
}
},
{
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"line": "* Adequate cardiovascular function",
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{
"exact_snippets": "Adequate cardiovascular function",
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}
}
]
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}
}
]
}
},
{
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"criterions": [
{
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}
},
{
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"value": 3,
"unit": "class"
}
}
},
{
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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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{
"exact_snippets": "No significant arrhythmia",
"criterion": "arrhythmia",
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"expected_value": "not significant"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "No significant arrhythmia",
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}
}
]
}
},
{
"identified_line": {
"line": "* No myocardial infarction within the past 6 months",
"criterions": [
{
"exact_snippets": "No myocardial infarction within the past 6 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
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"criterion": "myocardial infarction",
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"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
}
}
},
{
"identified_line": {
"line": "* No clinically significant conduction system disease in the absence of a pacemaker (e.g., sick sinus syndrome, or second or third degree atrioventricular block)",
"criterions": [
{
"exact_snippets": "No clinically significant conduction system disease",
"criterion": "conduction system disease",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "absence of a pacemaker",
"criterion": "pacemaker",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "sick sinus syndrome",
"criterion": "sick sinus syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
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"line": "* No clinically significant ischemic cardiac disease currently under treatment",
"criterions": [
{
"exact_snippets": "clinically significant ischemic cardiac disease",
"criterion": "ischemic cardiac disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "currently under treatment",
"criterion": "treatment status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "clinically significant ischemic cardiac disease",
"criterion": "ischemic cardiac disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "currently under treatment",
"criterion": "treatment status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* No uncontrolled medical illness",
"criterions": [
{
"exact_snippets": "No uncontrolled medical illness",
"criterion": "uncontrolled medical illness",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No uncontrolled medical illness",
"criterion": "uncontrolled medical illness",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No concurrent maintenance anti-anginal drug therapy",
"criterions": [
{
"exact_snippets": "No concurrent maintenance anti-anginal drug therapy",
"criterion": "anti-anginal drug therapy",
"requirement": {
"requirement_type": "concurrent maintenance",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No concurrent maintenance anti-anginal drug therapy",
"criterion": "anti-anginal drug therapy",
"requirement": {
"requirement_type": "concurrent maintenance",
"expected_value": true
}
}
}
}
]
}