[96a5a0]: / output / allTrials / identified / NCT02941562_identified.json

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{
"info": {
"nct_id": "NCT02941562",
"official_title": "",
"inclusion_criteria": "* 1. Consent to this study\n* 2. Histological or cytological confirmed diagnostic of rectal carcinoma\n* 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)\n* 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction\n* 5.With no presence of other organ metastasis or extra-regional lymph node involvement\n* 6.With no history of chemotherapy\n* 7.ECOG score is 0 or 1\n* 8.Adequate ability of bone marrow, liver and kidney function\n* 9.No pregnancy\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "1. Unable to intake oral medicine\n2. Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ;Congestive Heart Failure NYHA II grade or severe\n3. HIV infection or Active chronic HBV or HCV\n4. Severe clinical infection at active stage\n5. Epileptic seizure need treatment\n6. History of organ transplantation\n7. Renal failure or intaking renal dialysis\n8. Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics\n9. Severe unhealed wound or skin ulcer or bone fraction\n10. Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years\n\n12.Chronic inflammatory bowel disease, bowel obstruction,hereditary fructose intolerance 13.Medicine abuse;medical,psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* 1. Consent to this study",
"criterions": [
{
"exact_snippets": "Consent to this study",
"criterion": "consent",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
}
]
},
{
"line": "* 2. Histological or cytological confirmed diagnostic of rectal carcinoma",
"criterions": [
{
"exact_snippets": "Histological or cytological confirmed diagnostic of rectal carcinoma",
"criterion": "rectal carcinoma",
"requirements": [
{
"requirement_type": "diagnostic confirmation",
"expected_value": [
"histological",
"cytological"
]
}
]
}
]
},
{
"line": "* 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)",
"criterions": [
{
"exact_snippets": "Locally advanced rectal cancer",
"criterion": "rectal cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "locally advanced"
}
]
},
{
"exact_snippets": "without metastasis",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "confirmed by pelvic MRI",
"criterion": "confirmation method",
"requirements": [
{
"requirement_type": "method",
"expected_value": "pelvic MRI"
}
]
},
{
"exact_snippets": "cT3CRM+",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "cT3CRM+"
}
]
},
{
"exact_snippets": "cT4NX",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "cT4NX"
}
]
},
{
"exact_snippets": "cTxN2M0",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "cTxN2M0"
}
]
},
{
"exact_snippets": "margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI",
"criterion": "tumor margin",
"requirements": [
{
"requirement_type": "distance",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "mm"
}
}
]
}
]
},
{
"line": "* 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction",
"criterions": [
{
"exact_snippets": "no presence of anemia",
"criterion": "anemia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "anemia (Hb≤60g/l)",
"criterion": "hemoglobin level",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "g/l"
}
}
]
},
{
"exact_snippets": "anemia ... induced by tumor bleeding",
"criterion": "tumor bleeding",
"requirements": [
{
"requirement_type": "induction of anemia",
"expected_value": false
}
]
},
{
"exact_snippets": "anemia ... induced by ... bowel obstruction",
"criterion": "bowel obstruction",
"requirements": [
{
"requirement_type": "induction of anemia",
"expected_value": false
}
]
}
]
},
{
"line": "* 5.With no presence of other organ metastasis or extra-regional lymph node involvement",
"criterions": [
{
"exact_snippets": "no presence of other organ metastasis",
"criterion": "other organ metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "no presence of ... extra-regional lymph node involvement",
"criterion": "extra-regional lymph node involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* 6.With no history of chemotherapy",
"criterions": [
{
"exact_snippets": "no history of chemotherapy",
"criterion": "chemotherapy history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* 7.ECOG score is 0 or 1",
"criterions": [
{
"exact_snippets": "ECOG score is 0 or 1",
"criterion": "ECOG score",
"requirements": [
{
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
}
]
},
{
"line": "* 8.Adequate ability of bone marrow, liver and kidney function",
"criterions": [
{
"exact_snippets": "Adequate ability of bone marrow",
"criterion": "bone marrow function",
"requirements": [
{
"requirement_type": "ability",
"expected_value": "adequate"
}
]
},
{
"exact_snippets": "Adequate ability of ... liver",
"criterion": "liver function",
"requirements": [
{
"requirement_type": "ability",
"expected_value": "adequate"
}
]
},
{
"exact_snippets": "Adequate ability of ... kidney function",
"criterion": "kidney function",
"requirements": [
{
"requirement_type": "ability",
"expected_value": "adequate"
}
]
}
]
},
{
"line": "* 9.No pregnancy",
"criterions": [
{
"exact_snippets": "No pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Unable to intake oral medicine",
"criterions": [
{
"exact_snippets": "Unable to intake oral medicine",
"criterion": "oral medicine intake",
"requirements": [
{
"requirement_type": "ability",
"expected_value": false
}
]
}
]
},
{
"line": "2. Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ;Congestive Heart Failure NYHA II grade or severe",
"criterions": [
{
"exact_snippets": "Arrhythmia need treatment(besides β-blocker or digoxin)",
"criterion": "arrhythmia",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
},
{
"exact_snippets": "Symptomatic coronary artery disease",
"criterion": "coronary artery disease",
"requirements": [
{
"requirement_type": "symptoms",
"expected_value": true
}
]
},
{
"exact_snippets": "history of myocardiac infarction within 6 months",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "history",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "Congestive Heart Failure NYHA II grade or severe",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "severity",
"expected_value": [
"NYHA II grade",
"severe"
]
}
]
}
]
},
{
"line": "4. Severe clinical infection at active stage",
"criterions": [
{
"exact_snippets": "Severe clinical infection at active stage",
"criterion": "clinical infection",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "stage",
"expected_value": "active"
}
]
}
]
},
{
"line": "5. Epileptic seizure need treatment",
"criterions": [
{
"exact_snippets": "Epileptic seizure need treatment",
"criterion": "epileptic seizure",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
}
]
},
{
"line": "6. History of organ transplantation",
"criterions": [
{
"exact_snippets": "History of organ transplantation",
"criterion": "organ transplantation",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "7. Renal failure or intaking renal dialysis",
"criterions": [
{
"exact_snippets": "Renal failure",
"criterion": "renal failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "intaking renal dialysis",
"criterion": "renal dialysis",
"requirements": [
{
"requirement_type": "intake",
"expected_value": true
}
]
}
]
},
{
"line": "8. Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics",
"criterions": [
{
"exact_snippets": "Clinical hemorrhagic tendency",
"criterion": "hemorrhagic tendency",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Disorders of blood coagulation",
"criterion": "blood coagulation disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "intaking anticoagulant",
"criterion": "anticoagulant intake",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "intaking ... thrombolytics",
"criterion": "thrombolytic intake",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "9. Severe unhealed wound or skin ulcer or bone fraction",
"criterions": [
{
"exact_snippets": "Severe unhealed wound",
"criterion": "wound",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "healing status",
"expected_value": "unhealed"
}
]
},
{
"exact_snippets": "skin ulcer",
"criterion": "skin ulcer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "bone fraction",
"criterion": "bone fraction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "10. Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years",
"criterions": [
{
"exact_snippets": "Measurable massive ascites",
"criterion": "massive ascites",
"requirements": [
{
"requirement_type": "measurability",
"expected_value": true
}
]
},
{
"exact_snippets": "History of other malignant tumor ... in last 5 years",
"criterion": "history of other malignant tumor",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "in last 5 years"
}
]
},
{
"exact_snippets": "except cured cervical tumor in site and cured cutaneous basal cell carcinoma",
"criterion": "exceptions for malignant tumor history",
"requirements": [
{
"requirement_type": "exceptions",
"expected_value": [
"cured cervical tumor in site",
"cured cutaneous basal cell carcinoma"
]
}
]
}
]
},
{
"line": "12.Chronic inflammatory bowel disease, bowel obstruction,hereditary fructose intolerance 13.Medicine abuse;medical,psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy",
"criterions": [
{
"exact_snippets": "Chronic inflammatory bowel disease",
"criterion": "chronic inflammatory bowel disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "bowel obstruction",
"criterion": "bowel obstruction",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "hereditary fructose intolerance",
"criterion": "hereditary fructose intolerance",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Medicine abuse",
"criterion": "medicine abuse",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "medical,psychologic or social conditions might disturb patients or results",
"criterion": "disturbing medical, psychologic, or social conditions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Known or suspected allergy to any drugs in this study",
"criterion": "allergy to study drugs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Any situation or status that might endanger patient's safety or compliance",
"criterion": "situation or status endangering safety or compliance",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Pregnant woman or suckling period woman",
"criterion": "pregnancy or lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Fertility without taking sufficient contraception",
"criterion": "fertility without contraception",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "History of pelvic radiotherapy",
"criterion": "history of pelvic radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "3. HIV infection or Active chronic HBV or HCV",
"criterions": [
{
"exact_snippets": "HIV infection",
"criterion": "HIV infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Active chronic HBV",
"criterion": "chronic HBV",
"requirements": [
{
"requirement_type": "activity",
"expected_value": "active"
}
]
},
{
"exact_snippets": "Active chronic HCV",
"criterion": "chronic HCV",
"requirements": [
{
"requirement_type": "activity",
"expected_value": "active"
}
]
}
]
}
],
"failed_miscellaneous": []
}