{
    "info": {
        "nct_id": "NCT06107920",
        "official_title": "Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy : A Randomized Phase III Trial - COnCERTO (French 01-18)",
        "inclusion_criteria": "* Age ≥ 18 years\n* ECOG performance status 0 or 1\n* Patients with obstructive colon cancer treated by defunctioning stoma\n* Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge- left transverse colon) - MSS/pMMR (microsatellites stable primary tumor) status\n* Patient requiring colectomy\n* Laboratory data including : White blood cell count ≥ 3.109 /L with Neutrophils ≥ 1,5.109 / L, Platelet count ≥ 100.109 / L, Hemoglobin ≥ 9 g/dL (5,6 mmol/L), Total bilirubin ≤ 1,5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2,5 x ULN, Alkaline phosphatase ≤ 1,5 x ULN, Serum creatinine ≤ 1,5 x ULN (performed 10-15 days prior to randomization).\n* Non metastatic colon cancer (lung, liver, peritoneal) on thoracic-abdomino-pelvis CT scan\n* Absence of synchronous colorectal cancer\n* No prior chemotherapy or abdominal or pelvic irradiation\n* No history of colorectal cancer\n* No serious medical co-morbidity : uncontrolled inflammatory bowel disease, uncontrolled angina, recent [within the past 6 months] myocardial infarction, or another serious medical condition, judged to compromise ability to tolerate chemotherapy and/or surgery\n* Women of childbearing potential with effective contraception will be required during chemotherapy treatment and for 6 months after cessation of chemotherapy treatment and a negative blood pregnancy test by beta-HCG at inclusion.\n* Women surgically sterile (absence of ovaries and/or uterus)\n* Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)\n* For men participating in the study, contraception is required during the trial and for 6 months after stopping chemotherapy treatment.\n* Patient able to comply with the study protocol, in the investigator's judgment\n* Patient affiliated with, or beneficiary of a social security (national health insurance) category\n* Person informed and having signed his consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Contraindication to colectomy and/or anesthesia\n* Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery\n* Patient having received radiation therapy prior to surgery\n* Metastatic spread at baseline assessment (lung, liver, peritoneal)\n* History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1\n* Contraindication to study neoadjuvant chemotherapy treatments\n* Presence of inflammatory bowel disease, HNPCC syndrome or polyposis Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, or high risk of uncontrolled arrhythmia\n* Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)\n* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent\n* Any significant disease, which, in the investigator's opinion, would exclude the patient from the study.\n* Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 6 months after the treatment termination\n* Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)\n* Simultaneous participation in another interventional research",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with obstructive colon cancer treated by defunctioning stoma",
            "criterions": [
                {
                    "exact_snippets": "obstructive colon cancer",
                    "criterion": "obstructive colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated by defunctioning stoma",
                    "criterion": "treatment by defunctioning stoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathologically confirmed adenocarcinoma (≥10 cm from the anal verge- left transverse colon) - MSS/pMMR (microsatellites stable primary tumor) status",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma (≥10 cm from the anal verge- left transverse colon)",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "≥10 cm from the anal verge- left transverse colon"
                        }
                    ]
                },
                {
                    "exact_snippets": "MSS/pMMR (microsatellites stable primary tumor) status",
                    "criterion": "microsatellite stability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "MSS/pMMR"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient requiring colectomy",
            "criterions": [
                {
                    "exact_snippets": "Patient requiring colectomy",
                    "criterion": "colectomy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Laboratory data including : White blood cell count ≥ 3.109 /L with Neutrophils ≥ 1,5.109 / L, Platelet count ≥ 100.109 / L, Hemoglobin ≥ 9 g/dL (5,6 mmol/L), Total bilirubin ≤ 1,5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2,5 x ULN, Alkaline phosphatase ≤ 1,5 x ULN, Serum creatinine ≤ 1,5 x ULN (performed 10-15 days prior to randomization).",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count ≥ 3.109 /L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.109,
                                "unit": "/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Neutrophils ≥ 1,5.109 / L",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "109 / L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥ 100.109 / L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100.109,
                                "unit": "/ L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥ 9 g/dL (5,6 mmol/L)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤ 1,5 x ULN (upper limit of normal)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ASAT and ALAT ≤ 2,5 x ULN",
                    "criterion": "ASAT and ALAT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 1,5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine ≤ 1,5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non metastatic colon cancer (lung, liver, peritoneal) on thoracic-abdomino-pelvis CT scan",
            "criterions": [
                {
                    "exact_snippets": "Non metastatic colon cancer",
                    "criterion": "colon cancer",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "thoracic-abdomino-pelvis CT scan",
                    "criterion": "CT scan",
                    "requirements": [
                        {
                            "requirement_type": "regions",
                            "expected_value": [
                                "thoracic",
                                "abdomino",
                                "pelvis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absence of synchronous colorectal cancer",
            "criterions": [
                {
                    "exact_snippets": "Absence of synchronous colorectal cancer",
                    "criterion": "synchronous colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy or abdominal or pelvic irradiation",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... abdominal or pelvic irradiation",
                    "criterion": "prior abdominal or pelvic irradiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of colorectal cancer",
            "criterions": [
                {
                    "exact_snippets": "No history of colorectal cancer",
                    "criterion": "colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No serious medical co-morbidity : uncontrolled inflammatory bowel disease, uncontrolled angina, recent [within the past 6 months] myocardial infarction, or another serious medical condition, judged to compromise ability to tolerate chemotherapy and/or surgery",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "recent [within the past 6 months] myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "another serious medical condition, judged to compromise ability to tolerate chemotherapy and/or surgery",
                    "criterion": "serious medical condition",
                    "requirements": [
                        {
                            "requirement_type": "impact on treatment tolerance",
                            "expected_value": "compromise ability to tolerate chemotherapy and/or surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential with effective contraception will be required during chemotherapy treatment and for 6 months after cessation of chemotherapy treatment and a negative blood pregnancy test by beta-HCG at inclusion.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "effective contraception will be required during chemotherapy treatment and for 6 months after cessation of chemotherapy treatment",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during chemotherapy treatment and for 6 months after cessation of chemotherapy treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative blood pregnancy test by beta-HCG at inclusion",
                    "criterion": "blood pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women surgically sterile (absence of ovaries and/or uterus)",
            "criterions": [
                {
                    "exact_snippets": "Women surgically sterile (absence of ovaries and/or uterus)",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of ovaries",
                    "criterion": "ovaries",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of ... uterus",
                    "criterion": "uterus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "non-medically induced amenorrhea for at least 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For men participating in the study, contraception is required during the trial and for 6 months after stopping chemotherapy treatment.",
            "criterions": [
                {
                    "exact_snippets": "For men participating in the study, contraception is required during the trial and for 6 months after stopping chemotherapy treatment.",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the trial and for 6 months after stopping chemotherapy treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient able to comply with the study protocol, in the investigator's judgment",
            "criterions": [
                {
                    "exact_snippets": "Patient able to comply with the study protocol",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient affiliated with, or beneficiary of a social security (national health insurance) category",
            "criterions": [
                {
                    "exact_snippets": "Patient affiliated with, or beneficiary of a social security (national health insurance) category",
                    "criterion": "social security affiliation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Person informed and having signed his consent",
            "criterions": [
                {
                    "exact_snippets": "Person informed and having signed his consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "signed"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Contraindication to colectomy and/or anesthesia",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to colectomy",
                    "criterion": "colectomy",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindication to ... anesthesia",
                    "criterion": "anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rectal cancer located within 10 cm of the anal verge by endoscopy or under the peritoneal reflection at surgery",
            "criterions": [
                {
                    "exact_snippets": "Rectal cancer located within 10 cm of the anal verge by endoscopy",
                    "criterion": "rectal cancer location",
                    "requirements": [
                        {
                            "requirement_type": "distance from anal verge",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Rectal cancer located ... under the peritoneal reflection at surgery",
                    "criterion": "rectal cancer location",
                    "requirements": [
                        {
                            "requirement_type": "position",
                            "expected_value": "under the peritoneal reflection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient having received radiation therapy prior to surgery",
            "criterions": [
                {
                    "exact_snippets": "Patient having received radiation therapy prior to surgery",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic spread at baseline assessment (lung, liver, peritoneal)",
            "criterions": [
                {
                    "exact_snippets": "Metastatic spread at baseline assessment (lung, liver, peritoneal)",
                    "criterion": "metastatic spread",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastatic spread at baseline assessment (lung, liver, peritoneal)",
                    "criterion": "lung metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastatic spread at baseline assessment (lung, liver, peritoneal)",
                    "criterion": "liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Metastatic spread at baseline assessment (lung, liver, peritoneal)",
                    "criterion": "peritoneal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or current evidence on physical examination of central nervous system disease or; Peripheral neuropathy ≥ grade 1",
            "criterions": [
                {
                    "exact_snippets": "History or current evidence on physical examination of central nervous system disease",
                    "criterion": "central nervous system disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Peripheral neuropathy ≥ grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to study neoadjuvant chemotherapy treatments",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to study neoadjuvant chemotherapy treatments",
                    "criterion": "contraindication to neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of inflammatory bowel disease, HNPCC syndrome or polyposis Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, or high risk of uncontrolled arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "Presence of inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of ... HNPCC syndrome",
                    "criterion": "HNPCC syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of ... polyposis",
                    "criterion": "polyposis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically relevant coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "clinical relevance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of myocardial infarction in the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "high risk of uncontrolled arrhythmia",
                    "criterion": "uncontrolled arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)",
            "criterions": [
                {
                    "exact_snippets": "Uracilemia ≥ 150 ng/ml",
                    "criterion": "uracilemia",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 150,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent",
            "criterions": [
                {
                    "exact_snippets": "Medical ... conditions that would not permit the patient to complete the study or sign informed consent",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would not permit the patient to complete the study or sign informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical ... conditions that would not permit the patient to complete the study or sign informed consent",
                    "criterion": "geographical conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would not permit the patient to complete the study or sign informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "sociological ... conditions that would not permit the patient to complete the study or sign informed consent",
                    "criterion": "sociological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would not permit the patient to complete the study or sign informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "psychological ... conditions that would not permit the patient to complete the study or sign informed consent",
                    "criterion": "psychological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would not permit the patient to complete the study or sign informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "legal conditions that would not permit the patient to complete the study or sign informed consent",
                    "criterion": "legal conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would not permit the patient to complete the study or sign informed consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any significant disease, which, in the investigator's opinion, would exclude the patient from the study.",
            "criterions": [
                {
                    "exact_snippets": "Any significant disease, which, in the investigator's opinion, would exclude the patient from the study.",
                    "criterion": "significant disease",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study and for at least 6 months after the treatment termination",
            "criterions": [
                {
                    "exact_snippets": "Patient is a pregnant (positive blood pregnancy test)",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding (lactating) woman",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intending to become pregnant during the study and for at least 6 months after the treatment termination",
                    "criterion": "intention to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "during the study and for at least 6 months after the treatment termination"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)",
            "criterions": [
                {
                    "exact_snippets": "Person deprived of liberty by administrative or judicial decision",
                    "criterion": "deprivation of liberty",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": [
                                "administrative decision",
                                "judicial decision"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "placed under judicial protection (guardianship or supervision)",
                    "criterion": "judicial protection",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "guardianship",
                                "supervision"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Simultaneous participation in another interventional research",
            "criterions": [
                {
                    "exact_snippets": "Simultaneous participation in another interventional research",
                    "criterion": "participation in another interventional research",
                    "requirements": [
                        {
                            "requirement_type": "simultaneity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}