{
    "info": {
        "nct_id": "NCT02007148",
        "official_title": "MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer Patients Previously Treated With Fluoropyrimidine and Platinum Agents MiCADO Study",
        "inclusion_criteria": "1. At least 18 years of age\n2. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)\n3. Measurable disease based on computed tomography\n4. Eastern Cooperative Oncology Group performance status 0 or 1\n5. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum agent\n6. Disease progression after the start of the prior regimen based on computed tomography (or magnetic resonance imaging in the event of allergy to contrast medium)\n7. Adequate bone marrow, hepatic, and renal function,\n8. At least 4 weeks and recovery from effects of prior major surgery or radiation therapy\n9. If previously administered as treatment for gastric cancer, prior to study entry a washout period equivalent to at least 5 half-lives for antibodies and of at least 28 days for chemotherapy (Concurrent use of bisphosphonates is permitted.)\n10. Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present\n11. A negative serum pregnancy test within 7 days prior to accrual in women of childbearing potential\n12. Agreement to use an effective form of contraception\n13. Signed written informed consent.\n14. Ability to comprehend and to comply with the requirements of the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Squamous cell gastric carcinoma\n2. Bone-only metastatic disease\n3. History or presence of brain metastasis or leptomeningeal disease\n4. Operable gastric or GEJ cancer\n5. Herceptin 2 (HER2) -positive disease if the subject has not previously been treated with an anti-HER2 agent\n6. Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry\n7. Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy\n8. Known malabsorptive disorder\n9. Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)\n10. Human immunodeficiency virus infection based on history of positive serology\n11. Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study\n12. Presence of neuropathy > Grade 1\n13. Prior treatment including docetaxel\n14. Prior radiation therapy to more than 25% of the bone marrow\n15. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy\n16. History of severe or unexpected reaction to fluoropyrimidine therapy\n17. History of hypersensitivity to fluoropyrimidine agents or any of their ingredients.\n18. Known dihydropyrimidine dehydrogenase deficiency\n19. Pregnancy or lactation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. At least 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "gastric or gastroesophageal-junction adenocarcinoma (GEJ)",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "gastric",
                                "gastroesophageal-junction"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Measurable disease based on computed tomography",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease based on computed tomography",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "assessment method",
                            "expected_value": "computed tomography"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status 0 or 1",
                    "criterion": "Eastern Cooperative Oncology Group performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum agent",
            "criterions": [
                {
                    "exact_snippets": "Treatment with only 1 prior regimen",
                    "criterion": "prior treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(as first-line therapy)",
                    "criterion": "first-line therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have included a fluoropyrimidine",
                    "criterion": "fluoropyrimidine in prior regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have included ... a platinum agent",
                    "criterion": "platinum agent in prior regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Disease progression after the start of the prior regimen based on computed tomography (or magnetic resonance imaging in the event of allergy to contrast medium)",
            "criterions": [
                {
                    "exact_snippets": "Disease progression after the start of the prior regimen",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after the start of the prior regimen"
                        }
                    ]
                },
                {
                    "exact_snippets": "based on computed tomography (or magnetic resonance imaging in the event of allergy to contrast medium)",
                    "criterion": "imaging method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "computed tomography",
                                "magnetic resonance imaging"
                            ]
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "allergy to contrast medium"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate bone marrow, hepatic, and renal function,",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow ... function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. At least 4 weeks and recovery from effects of prior major surgery or radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "At least 4 weeks and recovery from effects of prior major surgery",
                    "criterion": "time since major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 4 weeks and recovery from effects of prior ... radiation therapy",
                    "criterion": "time since radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. If previously administered as treatment for gastric cancer, prior to study entry a washout period equivalent to at least 5 half-lives for antibodies and of at least 28 days for chemotherapy (Concurrent use of bisphosphonates is permitted.)",
            "criterions": [
                {
                    "exact_snippets": "previously administered as treatment for gastric cancer",
                    "criterion": "prior treatment for gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "washout period equivalent to at least 5 half-lives for antibodies",
                    "criterion": "washout period for antibodies",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "washout period ... of at least 28 days for chemotherapy",
                    "criterion": "washout period for chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent use of bisphosphonates is permitted",
                    "criterion": "concurrent use of bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present",
            "criterions": [
                {
                    "exact_snippets": "Ability to swallow an oral solid-dosage form of medication",
                    "criterion": "ability to swallow oral solid-dosage medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including when a feeding tube is present",
                    "criterion": "presence of feeding tube",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. A negative serum pregnancy test within 7 days prior to accrual in women of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": "negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days prior to accrual",
                    "criterion": "timing of serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days prior to accrual"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "applicability",
                            "expected_value": "women of childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Agreement to use an effective form of contraception",
            "criterions": [
                {
                    "exact_snippets": "Agreement to use an effective form of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Signed written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "written",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Squamous cell gastric carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Squamous cell gastric carcinoma",
                    "criterion": "squamous cell gastric carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Bone-only metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Bone-only metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "bone-only"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. History or presence of brain metastasis or leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "History or presence of brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History or presence of ... leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Operable gastric or GEJ cancer",
            "criterions": [
                {
                    "exact_snippets": "Operable gastric",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Operable ... GEJ cancer",
                    "criterion": "GEJ cancer",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Herceptin 2 (HER2) -positive disease if the subject has not previously been treated with an anti-HER2 agent",
            "criterions": [
                {
                    "exact_snippets": "Herceptin 2 (HER2) -positive disease",
                    "criterion": "HER2-positive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if the subject has not previously been treated with an anti-HER2 agent",
                    "criterion": "previous treatment with anti-HER2 agent",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry",
                    "criterion": "uncontrolled diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy",
            "criterions": [
                {
                    "exact_snippets": "Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy",
                    "criterion": "nausea or vomiting",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within the 14 days prior to study entry"
                        },
                        {
                            "requirement_type": "treatment resistance",
                            "expected_value": "despite the administration of standard antiemetic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Known malabsorptive disorder",
            "criterions": [
                {
                    "exact_snippets": "Known malabsorptive disorder",
                    "criterion": "malabsorptive disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)",
            "criterions": [
                {
                    "exact_snippets": "Second cancer",
                    "criterion": "second cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancer for which the subject has been disease-free for 5 or more years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Human immunodeficiency virus infection based on history of positive serology",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus infection based on history of positive serology",
                    "criterion": "human immunodeficiency virus infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "positive serology"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study",
            "criterions": [
                {
                    "exact_snippets": "Significant medical disease other than gastric cancer",
                    "criterion": "significant medical disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diabetes mellitus",
                    "criterion": "uncontrolled diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active angina",
                    "criterion": "active angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active psychiatric condition",
                    "criterion": "active psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Presence of neuropathy > Grade 1",
            "criterions": [
                {
                    "exact_snippets": "Presence of neuropathy > Grade 1",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Prior treatment including docetaxel",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment including docetaxel",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "docetaxel"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Prior radiation therapy to more than 25% of the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy to more than 25% of the bone marrow",
                    "criterion": "radiation therapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy",
            "criterions": [
                {
                    "exact_snippets": "Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent)",
                    "criterion": "need for other anticancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. History of severe or unexpected reaction to fluoropyrimidine therapy",
            "criterions": [
                {
                    "exact_snippets": "History of severe or unexpected reaction to fluoropyrimidine therapy",
                    "criterion": "reaction to fluoropyrimidine therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "expectation",
                            "expected_value": "unexpected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. History of hypersensitivity to fluoropyrimidine agents or any of their ingredients.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to fluoropyrimidine agents",
                    "criterion": "hypersensitivity to fluoropyrimidine agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of their ingredients",
                    "criterion": "hypersensitivity to ingredients of fluoropyrimidine agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Known dihydropyrimidine dehydrogenase deficiency",
            "criterions": [
                {
                    "exact_snippets": "Known dihydropyrimidine dehydrogenase deficiency",
                    "criterion": "dihydropyrimidine dehydrogenase deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Pregnancy or lactation",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "14. Ability to comprehend and to comply with the requirements of the study.",
            "criterions": [
                {
                    "exact_snippets": "Ability to comprehend",
                    "criterion": "comprehension ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ability ... to comply with the requirements of the study",
                    "criterion": "compliance ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}