[96a5a0]: / output / allTrials / logical / NCT06095882_logical.json

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{
"info": {
"nct_id": "NCT06095882",
"official_title": "Randomized Controlled, Open Clinical Study on Efficacy and Safety of Acupuncture for Bladder Function Recovery After Radical Cervical Cancer Surgery",
"inclusion_criteria": "1) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; (2) Female, ≥18 years of age (calculated on the date of signing the informed consent); (3) Pathological diagnosis of cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma, preoperative cervical lesions ≤4cm; (4) No history of urinary system infection and urinary retention; (5) Undergoing radical abdominal hysterectomy; (6) On the third day after surgery, vital signs were stable, no discomfort symptoms (such as abnormal abdominal distension, nausea, vomiting, abdominal pain, chest tightness, etc.) of CTCAE 5.0 standard 2 or above, and no abnormal increase in body temperature (≥38.5°C); (7) The function of vital organs meets the following requirements: Absolute neutrophil count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥80g/L; Serum albumin ≥2.5g/dL; Bilirubin ≤1.5 ULN; ALT and AST≤3 times ULN; Serum creatinine ≤1.5 ULN; INR≤1.5 or prothrombin time ≤ULN+4 seconds.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Suffering from diseases that may affect bladder function, such as uterine prolapse, vaginal wall bulge, lower urinary tract obstruction, bladder tumor, urethral injury, urinary tract stones, urinary tract infection, spinal cord injury, and sequelae of cardiovascular and cerebrovascular diseases;\n2. Poor compliance and failure to strictly carry out full treatment;\n3. Use of neostigmine and other drugs that affect bladder function;\n4. Patients with serious diseases of important organs and mental diseases;\n5. There were random postoperative discomfort symptoms with the severity reaching CTCAE 5.0 level 2 or above;\n6. There is an active infection or prerandom unexplained fever ≥38.5°C;\n7. Patients with clinical symptoms or diseases of heart that are not well controlled, such as: NYHA2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;\n8. diabetic patients;\n9. In the judgment of the investigator, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects or the collection of data.",
"miscellaneous_criteria": ""
},
"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",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"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",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Suffering from diseases that may affect bladder function, such as uterine prolapse, vaginal wall bulge, lower urinary tract obstruction, bladder tumor, urethral injury, urinary tract stones, urinary tract infection, spinal cord injury, and sequelae of cardiovascular and cerebrovascular diseases;",
"criterions": [
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as uterine prolapse",
"criterion": "uterine prolapse",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... vaginal wall bulge",
"criterion": "vaginal wall bulge",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... lower urinary tract obstruction",
"criterion": "lower urinary tract obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... bladder tumor",
"criterion": "bladder tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... urethral injury",
"criterion": "urethral injury",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... urinary tract stones",
"criterion": "urinary tract stones",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... urinary tract infection",
"criterion": "urinary tract infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... spinal cord injury",
"criterion": "spinal cord injury",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... sequelae of cardiovascular and cerebrovascular diseases",
"criterion": "sequelae of cardiovascular and cerebrovascular diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as uterine prolapse",
"criterion": "uterine prolapse",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... vaginal wall bulge",
"criterion": "vaginal wall bulge",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... lower urinary tract obstruction",
"criterion": "lower urinary tract obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... bladder tumor",
"criterion": "bladder tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... urethral injury",
"criterion": "urethral injury",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... urinary tract stones",
"criterion": "urinary tract stones",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... urinary tract infection",
"criterion": "urinary tract infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... spinal cord injury",
"criterion": "spinal cord injury",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Suffering from diseases that may affect bladder function, such as ... sequelae of cardiovascular and cerebrovascular diseases",
"criterion": "sequelae of cardiovascular and cerebrovascular diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Poor compliance and failure to strictly carry out full treatment;",
"criterions": [
{
"exact_snippets": "Poor compliance",
"criterion": "compliance",
"requirement": {
"requirement_type": "quality",
"expected_value": "poor"
}
},
{
"exact_snippets": "failure to strictly carry out full treatment",
"criterion": "treatment adherence",
"requirement": {
"requirement_type": "adherence",
"expected_value": "failure to strictly carry out full treatment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Poor compliance",
"criterion": "compliance",
"requirement": {
"requirement_type": "quality",
"expected_value": "poor"
}
},
{
"exact_snippets": "failure to strictly carry out full treatment",
"criterion": "treatment adherence",
"requirement": {
"requirement_type": "adherence",
"expected_value": "failure to strictly carry out full treatment"
}
}
]
}
},
{
"identified_line": {
"line": "3. Use of neostigmine and other drugs that affect bladder function;",
"criterions": [
{
"exact_snippets": "Use of neostigmine",
"criterion": "neostigmine use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other drugs that affect bladder function",
"criterion": "use of drugs affecting bladder function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Use of neostigmine",
"criterion": "neostigmine use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other drugs that affect bladder function",
"criterion": "use of drugs affecting bladder function",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. There were random postoperative discomfort symptoms with the severity reaching CTCAE 5.0 level 2 or above;",
"criterions": [
{
"exact_snippets": "random postoperative discomfort symptoms",
"criterion": "postoperative discomfort symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severity reaching CTCAE 5.0 level 2 or above",
"criterion": "severity of symptoms",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "CTCAE 5.0 level"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "random postoperative discomfort symptoms",
"criterion": "postoperative discomfort symptoms",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severity reaching CTCAE 5.0 level 2 or above",
"criterion": "severity of symptoms",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "CTCAE 5.0 level"
}
}
}
]
}
},
{
"identified_line": {
"line": "6. There is an active infection or prerandom unexplained fever ≥38.5°C;",
"criterions": [
{
"exact_snippets": "active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "prerandom unexplained fever ≥38.5°C",
"criterion": "unexplained fever",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 38.5,
"unit": "°C"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "prerandom unexplained fever ≥38.5°C",
"criterion": "unexplained fever",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 38.5,
"unit": "°C"
}
}
}
]
}
},
{
"identified_line": {
"line": "7. Patients with clinical symptoms or diseases of heart that are not well controlled, such as: NYHA2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;",
"criterions": [
{
"exact_snippets": "clinical symptoms or diseases of heart that are not well controlled",
"criterion": "heart condition control",
"requirement": {
"requirement_type": "control",
"expected_value": "not well controlled"
}
},
{
"exact_snippets": "NYHA2 or above heart failure",
"criterion": "NYHA heart failure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "NYHA"
}
}
},
{
"exact_snippets": "unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "myocardial infarction within 1 year",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
},
{
"exact_snippets": "clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "clinical significance",
"expected_value": true
}
},
{
"exact_snippets": "clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "treatment requirement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "clinical symptoms or diseases of heart that are not well controlled",
"criterion": "heart condition control",
"requirement": {
"requirement_type": "control",
"expected_value": "not well controlled"
}
},
{
"or_criteria": [
{
"exact_snippets": "NYHA2 or above heart failure",
"criterion": "NYHA heart failure",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "NYHA"
}
}
},
{
"exact_snippets": "unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "myocardial infarction within 1 year",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
},
{
"and_criteria": [
{
"exact_snippets": "clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention",
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"expected_value": true
}
},
{
"exact_snippets": "clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention",
"criterion": "arrhythmia",
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"expected_value": true
}
}
]
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "8. diabetic patients;",
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{
"exact_snippets": "diabetic patients",
"criterion": "diabetes",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"exact_snippets": "diabetic patients",
"criterion": "diabetes",
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"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "9. In the judgment of the investigator, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, and family or social factors that may affect the safety of the subjects or the collection of data.",
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{
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"expected_value": true
}
},
{
"exact_snippets": "serious abnormalities in laboratory tests",
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"expected_value": "serious"
}
},
{
"exact_snippets": "family or social factors that may affect the safety of the subjects or the collection of data",
"criterion": "family or social factors",
"requirement": {
"requirement_type": "impact",
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}
}
]
},
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{
"and_criteria": [
{
"exact_snippets": "other serious diseases (including mental illness) requiring combined treatment",
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"expected_value": true
}
},
{
"exact_snippets": "serious abnormalities in laboratory tests",
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}
},
{
"exact_snippets": "family or social factors that may affect the safety of the subjects or the collection of data",
"criterion": "family or social factors",
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}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "1) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; (2) Female, ≥18 years of age (calculated on the date of signing the informed consent); (3) Pathological diagnosis of cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma, preoperative cervical lesions ≤4cm; (4) No history of urinary system infection and urinary retention; (5) Undergoing radical abdominal hysterectomy; (6) On the third day after surgery, vital signs were stable, no discomfort symptoms (such as abnormal abdominal distension, nausea, vomiting, abdominal pain, chest tightness, etc.) of CTCAE 5.0 standard 2 or above, and no abnormal increase in body temperature (≥38.5°C); (7) The function of vital organs meets the following requirements: Absolute neutrophil count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥80g/L; Serum albumin ≥2.5g/dL; Bilirubin ≤1.5 ULN; ALT and AST≤3 times ULN; Serum creatinine ≤1.5 ULN; INR≤1.5 or prothrombin time ≤ULN+4 seconds.",
"criterions": [
{
"exact_snippets": "The subjects voluntarily joined the study, signed the informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "good compliance",
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"requirement": {
"requirement_type": "quality",
"expected_value": "good"
}
},
{
"exact_snippets": "cooperated with the follow-up",
"criterion": "follow-up cooperation",
"requirement": {
"requirement_type": "cooperation",
"expected_value": true
}
},
{
"exact_snippets": "Female",
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"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "≥18 years of age",
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"requirement_type": "age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "Pathological diagnosis of cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma",
"criterion": "cervical cancer diagnosis",
"requirement": {
"requirement_type": "type",
"expected_value": [
"squamous cell carcinoma",
"adenocarcinoma",
"adenosquamous cell carcinoma"
]
}
},
{
"exact_snippets": "preoperative cervical lesions ≤4cm",
"criterion": "cervical lesion size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "cm"
}
}
},
{
"exact_snippets": "No history of urinary system infection",
"criterion": "urinary system infection history",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "No history of ... urinary retention",
"criterion": "urinary retention history",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "Undergoing radical abdominal hysterectomy",
"criterion": "surgical procedure",
"requirement": {
"requirement_type": "type",
"expected_value": "radical abdominal hysterectomy"
}
},
{
"exact_snippets": "On the third day after surgery, vital signs were stable",
"criterion": "post-surgery vital signs",
"requirement": {
"requirement_type": "stability",
"expected_value": true
}
},
{
"exact_snippets": "no discomfort symptoms (such as abnormal abdominal distension, nausea, vomiting, abdominal pain, chest tightness, etc.) of CTCAE 5.0 standard 2 or above",
"criterion": "post-surgery discomfort symptoms",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "CTCAE 5.0 standard"
}
}
},
{
"exact_snippets": "no abnormal increase in body temperature (≥38.5°C)",
"criterion": "body temperature",
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"requirement_type": "temperature",
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"operator": "<",
"value": 38.5,
"unit": "°C"
}
}
},
{
"exact_snippets": "Absolute neutrophil count ≥1.5×109/L",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "×10^9/L"
}
}
},
{
"exact_snippets": "Platelet ≥100×109/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "count",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "×10^9/L"
}
}
},
{
"exact_snippets": "Hemoglobin ≥80g/L",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 80,
"unit": "g/L"
}
}
},
{
"exact_snippets": "Serum albumin ≥2.5g/dL",
"criterion": "serum albumin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 2.5,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "Bilirubin ≤1.5 ULN",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "level",
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"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "ALT and AST≤3 times ULN",
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"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "Serum creatinine ≤1.5 ULN",
"criterion": "serum creatinine level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "INR≤1.5 or prothrombin time ≤ULN+4 seconds",
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"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "INR≤1.5 or prothrombin time ≤ULN+4 seconds",
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"requirement": {
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"operator": "<=",
"value": 4,
"unit": "seconds above ULN"
}
}
}
]
},
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"exact_snippets": "failed",
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"expected_value": "failed"
}
}
}
],
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{
"identified_line": {
"line": "4. Patients with serious diseases of important organs and mental diseases;",
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{
"exact_snippets": "serious diseases of important organs",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "mental diseases",
"criterion": "mental diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"expected_value": true
}
},
{
"exact_snippets": "mental diseases",
"criterion": "mental diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}