{
"info": {
"nct_id": "NCT03271073",
"official_title": "A Exploratory Study of Apatinib in Combination With S1 in Patients With Advanced Gastric Evaluating the Efficacy and Safety",
"inclusion_criteria": "1. Adult patients, aged between 18 and 75 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;\n3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;\n4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;\n5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10*9/L, neutrophil ≥1.5 × 10*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);\n6. Expected survival of ≥ 12 weeks.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;\n2. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;\n3. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;\n4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);\n5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);\n6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;\n7. Associated with CNS (central nervous system) metastases;\n8. Active bacterial infections;\n9. Pregnant or breast-feeding women;\n10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Adult patients, aged between 18 and 75 years old;",
"criterions": [
{
"exact_snippets": "Adult patients",
"criterion": "age group",
"requirement": {
"requirement_type": "expected value",
"expected_value": "adult"
}
},
{
"exact_snippets": "aged between 18 and 75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adult patients",
"criterion": "age group",
"requirement": {
"requirement_type": "expected value",
"expected_value": "adult"
}
},
{
"exact_snippets": "aged between 18 and 75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 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 of ≤ 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;",
"criterions": [
{
"exact_snippets": "Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)",
"criterion": "adenocarcinoma of gastric cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically"
}
},
{
"exact_snippets": "Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)",
"criterion": "adenocarcinoma of gastric cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"advanced",
"metastatic"
]
}
},
{
"exact_snippets": "adenocarcinoma of the gastroesophageal junction",
"criterion": "adenocarcinoma of the gastroesophageal junction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesions"
}
}
},
{
"exact_snippets": "one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": [
"measurable",
"nonmeasurable"
]
}
},
{
"exact_snippets": "one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "evaluation standard",
"expected_value": "RECIST 1.1"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)",
"criterion": "adenocarcinoma of gastric cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically"
}
},
{
"exact_snippets": "Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)",
"criterion": "adenocarcinoma of gastric cancer",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"advanced",
"metastatic"
]
}
}
]
},
{
"exact_snippets": "adenocarcinoma of the gastroesophageal junction",
"criterion": "adenocarcinoma of the gastroesophageal junction",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesions"
}
}
},
{
"exact_snippets": "one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": [
"measurable",
"nonmeasurable"
]
}
},
{
"exact_snippets": "one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1",
"criterion": "evaluable lesions",
"requirement": {
"requirement_type": "evaluation standard",
"expected_value": "RECIST 1.1"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;",
"criterions": [
{
"exact_snippets": "Failure or intolerance to at least one prior line of systemic chemotherapy regimen",
"criterion": "prior systemic chemotherapy regimen",
"requirement": {
"requirement_type": "failure or intolerance",
"expected_value": true
}
},
{
"exact_snippets": "Failure or intolerance to at least one prior line of systemic chemotherapy regimen",
"criterion": "prior systemic chemotherapy regimen",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "line"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Failure or intolerance to at least one prior line of systemic chemotherapy regimen",
"criterion": "prior systemic chemotherapy regimen",
"requirement": {
"requirement_type": "failure or intolerance",
"expected_value": true
}
},
{
"exact_snippets": "Failure or intolerance to at least one prior line of systemic chemotherapy regimen",
"criterion": "prior systemic chemotherapy regimen",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "line"
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10*9/L, neutrophil ≥1.5 × 10*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);",
"criterions": [
{
"exact_snippets": "Adequate liver, renal, heart, and bone-marrow functions",
"criterion": "liver, renal, heart, and bone-marrow functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "hemoglobin≥ 80g/L",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 80,
"unit": "g/L"
}
}
},
{
"exact_snippets": "platelets ≥ 100 × 10*9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "10*9/L"
}
}
},
{
"exact_snippets": "neutrophil ≥1.5 × 10*9/L",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "10*9/L"
}
}
},
{
"exact_snippets": "total bilirubin ≤1.5 ×ULN",
"criterion": "total bilirubin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "serum transaminase≤2.5×ULN",
"criterion": "serum transaminase level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adequate liver, renal, heart, and bone-marrow functions",
"criterion": "liver, renal, heart, and bone-marrow functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "hemoglobin≥ 80g/L",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 80,
"unit": "g/L"
}
}
},
{
"exact_snippets": "platelets ≥ 100 × 10*9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "10*9/L"
}
}
},
{
"exact_snippets": "neutrophil ≥1.5 × 10*9/L",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "10*9/L"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "total bilirubin ≤1.5 ×ULN",
"criterion": "total bilirubin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "serum transaminase≤2.5×ULN",
"criterion": "serum transaminase level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "ULN"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "6. Expected survival of ≥ 12 weeks.",
"criterions": [
{
"exact_snippets": "Expected survival of ≥ 12 weeks.",
"criterion": "expected survival",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Expected survival of ≥ 12 weeks.",
"criterion": "expected survival",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "healthy volunteers",
"requirement": {
"requirement_type": "participation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "healthy volunteers",
"requirement": {
"requirement_type": "participation",
"expected_value": true
}
}
]
}
},
{
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;",
"criterions": [
{
"exact_snippets": "poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg)",
"criterion": "arterial hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": "poor-controlled"
}
},
{
"exact_snippets": "poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg)",
"criterion": "arterial hypertension",
"requirement": {
"requirement_type": "systolic blood pressure",
"expected_value": {
"operator": ">",
"value": 140,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg)",
"criterion": "arterial hypertension",
"requirement": {
"requirement_type": "diastolic blood pressure",
"expected_value": {
"operator": ">",
"value": 90,
"unit": "mm Hg"
}
}
},
{
"exact_snippets": "Coronary heart disease greater than ClassI",
"criterion": "coronary heart disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "> Class I"
}
},
{
"exact_snippets": "I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms)",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "severity",
"expected_value": "I-level"
}
},
{
"exact_snippets": "I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms)",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "QT interval prolongation",
"expected_value": [
">= 450 ms for man",
">= 470 ms for woman"
]
}
},
{
"exact_snippets": "Class I cardiac dysfunction",
"criterion": "cardiac dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "Class I"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg)",
"criterion": "arterial hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": "poor-controlled"
}
},
{
"exact_snippets": "poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg)",
"criterion": "arterial hypertension",
"requirement": {
"requirement_type": "systolic blood pressure",
"expected_value": {
"operator": ">",
"value": 140,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg)",
"criterion": "arterial hypertension",
"requirement": {
"requirement_type": "diastolic blood pressure",
"expected_value": {
"operator": ">",
"value": 90,
"unit": "mm Hg"
}
}
}
]
}
]
},
{
"exact_snippets": "Coronary heart disease greater than ClassI",
"criterion": "coronary heart disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "> Class I"
}
},
{
"and_criteria": [
{
"exact_snippets": "I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms)",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "severity",
"expected_value": "I-level"
}
},
{
"exact_snippets": "I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms)",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "QT interval prolongation",
"expected_value": [
">= 450 ms for man",
">= 470 ms for woman"
]
}
},
{
"exact_snippets": "Class I cardiac dysfunction",
"criterion": "cardiac dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "Class I"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "3. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;",
"criterions": [
{
"exact_snippets": "Abnormal Coagulation (INR>1.5",
"criterion": "INR",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Abnormal Coagulation ... APTT>1.5 UNL",
"criterion": "APTT",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "UNL"
}
}
},
{
"exact_snippets": "tendency of bleed",
"criterion": "tendency of bleed",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Abnormal Coagulation (INR>1.5",
"criterion": "INR",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Abnormal Coagulation ... APTT>1.5 UNL",
"criterion": "APTT",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "UNL"
}
}
}
]
},
{
"exact_snippets": "tendency of bleed",
"criterion": "tendency of bleed",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);",
"criterions": [
{
"exact_snippets": "inability to swallow",
"criterion": "ability to swallow",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "chronic diarrhea",
"criterion": "chronic diarrhea",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "intestinal obstruction",
"criterion": "intestinal obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"not_criteria": {
"exact_snippets": "inability to swallow",
"criterion": "ability to swallow",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "chronic diarrhea",
"criterion": "chronic diarrhea",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "intestinal obstruction",
"criterion": "intestinal obstruction",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);",
"criterions": [
{
"exact_snippets": "Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib)",
"criterion": "previous treatment with VEGFR inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib)",
"criterion": "previous treatment with VEGFR inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;",
"criterions": [
{
"exact_snippets": "psychotropic drug abuse history",
"criterion": "psychotropic drug abuse history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "can't get rid of",
"criterion": "inability to cease psychotropic drug use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "mental disorder patients",
"criterion": "mental disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "psychotropic drug abuse history",
"criterion": "psychotropic drug abuse history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "can't get rid of",
"criterion": "inability to cease psychotropic drug use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "mental disorder patients",
"criterion": "mental disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "7. Associated with CNS (central nervous system) metastases;",
"criterions": [
{
"exact_snippets": "Associated with CNS (central nervous system) metastases",
"criterion": "CNS metastases",
"requirement": {
"requirement_type": "association",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Associated with CNS (central nervous system) metastases",
"criterion": "CNS metastases",
"requirement": {
"requirement_type": "association",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "8. Active bacterial infections;",
"criterions": [
{
"exact_snippets": "Active bacterial infections",
"criterion": "bacterial infections",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Active bacterial infections",
"criterion": "bacterial infections",
"requirement": {
"requirement_type": "activity",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "9. Pregnant or breast-feeding women;",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "2. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;",
"criterions": [
{
"exact_snippets": "high gastrointestinal bleeding risk",
"criterion": "gastrointestinal bleeding risk",
"requirement": {
"requirement_type": "severity",
"expected_value": "high"
}
},
{
"exact_snippets": "local active ulcer lesions",
"criterion": "ulcer lesions",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "local active ulcer lesions",
"criterion": "ulcer lesions",
"requirement": {
"requirement_type": "location",
"expected_value": "local"
}
},
{
"exact_snippets": "positive fecal occult blood test (++)",
"criterion": "fecal occult blood test",
"requirement": {
"requirement_type": "result",
"expected_value": "positive"
}
},
{
"exact_snippets": "history of black stool",
"criterion": "black stool",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "vomiting blood in the past 2 months",
"criterion": "vomiting blood",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "local active ulcer lesions",
"criterion": "ulcer lesions",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "local active ulcer lesions",
"criterion": "ulcer lesions",
"requirement": {
"requirement_type": "location",
"expected_value": "local"
}
}
]
},
{
"exact_snippets": "positive fecal occult blood test (++)",
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"requirement": {
"requirement_type": "result",
"expected_value": "positive"
}
}
]
},
{
"exact_snippets": "history of black stool",
"criterion": "black stool",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "vomiting blood in the past 2 months",
"criterion": "vomiting blood",
"requirement": {
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.",
"criterions": [
{
"exact_snippets": "Any other condition that might place the patient at undue risk",
"criterion": "condition causing undue risk",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "condition that might ... preclude a patient from completing the study",
"criterion": "condition precluding study completion",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Any other condition that might place the patient at undue risk",
"criterion": "condition causing undue risk",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "condition that might ... preclude a patient from completing the study",
"criterion": "condition precluding study completion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "Any other condition that might place the patient at undue risk",
"criterion": "condition causing undue risk",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "condition that might ... preclude a patient from completing the study",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}