{
    "info": {
        "nct_id": "NCT06266091",
        "official_title": "A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 Combined With Systemic Therapy in Patients With Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer.",
        "inclusion_criteria": "* Able to understand and voluntarily sign the written informed consent form.\n* Histologically or pathologically confirmed epithelial malignancies, including advanced gastric cancer or colorectal cancer that has failed at least two lines of treatment, or platinum-resistant advanced ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma.\n* Clinical diagnosis of malignant ascites with a moderate or higher amount of ascites. Moderate or higher is defined as having a volume of ascites ≥1L based on CT assessment or actual drainage of ≥1L.\n* The time interval between the most recent anti-tumor treatment and the first dose of M701 must meet the following criteria:\n\nIntraperitoneal treatment: ≥2 weeks since the most recent intraperitoneal treatment.\n\n* Adverse events (AEs) from previous treatments have recovered to grade ≤1 (excluding other AEs deemed by the investigator not to affect the safety of the study drug, such as hair loss).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Estimated survival time ≥8 weeks.\n* Organ function levels must meet the following requirements:\n\nHematology: Absolute neutrophil count (ANC) ≥1.5 × 10^9/L, platelets ≥80 × 10^9/L, hemoglobin ≥8.5 g/dL, lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days).\n\nLiver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN (AST and ALT ≤5 times ULN allowed in the presence of liver metastasis).\n\nSerum albumin ≥28 g/L. Renal function: Serum creatinine ≤1.5 times ULN.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients who have previously received M701 or any antibody-based drugs targeting EpCAM and/or CD3 within the 4 months prior to the first dose.\n* Patients with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colorectal cancer who have not previously received immunotherapy.\n* Patients who have undergone major surgery within the 4 weeks prior to the first dose.\n* Patients with extensive liver metastases (tumor volume occupying approximately >70% of total liver volume).\n* Active infections requiring intravenous antibiotics within 14 days before the first dose.\n* Severe diarrhea (CTCAE grade ≥2).\n* Severe respiratory distress requiring oxygen therapy.\n* Active autoimmune diseases, except for the following conditions that are allowed for screening: type 1 diabetes, controlled hypothyroidism with replacement therapy only, skin diseases that do not require systemic treatment。\n* Other severe medical conditions that may limit the patient's participation in the trial。\n* Impaired cardiac function with New York Heart Association (NYHA) class 3 or 4.\n* Occurrence of complete intestinal obstruction within 30 days before the first dose, or diagnosis of incomplete intestinal obstruction deemed unsuitable for participation in the trial based on symptoms and signs as determined by the investigator.\n* Inability to adequately drain ascites due to objective reasons (including loculated ascites).\n* Confirmed portal vein obstruction.\n* History of immunodeficiency, including positive HIV test.\n* Active hepatitis B virus infection, active hepatitis C virus infection, active syphilis, or positive HIV antibody.\n* Pregnant or lactating women.\n* Patients with fertility requirements during or within 6 months after treatment.\n* Known history of neurological or psychiatric disorders deemed by the investigator to affect cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Able to understand and voluntarily sign the written informed consent form.",
                "criterions": [
                    {
                        "exact_snippets": "Able to understand",
                        "criterion": "understanding",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "voluntarily sign the written informed consent form",
                        "criterion": "consent form signing",
                        "requirement": {
                            "requirement_type": "voluntariness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Able to understand",
                        "criterion": "understanding",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "voluntarily sign the written informed consent form",
                        "criterion": "consent form signing",
                        "requirement": {
                            "requirement_type": "voluntariness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Clinical diagnosis of malignant ascites with a moderate or higher amount of ascites. Moderate or higher is defined as having a volume of ascites ≥1L based on CT assessment or actual drainage of ≥1L.",
                "criterions": [
                    {
                        "exact_snippets": "Clinical diagnosis of malignant ascites",
                        "criterion": "malignant ascites",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "moderate or higher amount of ascites ... volume of ascites ≥1L",
                        "criterion": "ascites volume",
                        "requirement": {
                            "requirement_type": "volume",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Clinical diagnosis of malignant ascites",
                        "criterion": "malignant ascites",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "moderate or higher amount of ascites ... volume of ascites ≥1L",
                                "criterion": "ascites volume",
                                "requirement": {
                                    "requirement_type": "volume",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "moderate or higher amount of ascites ... volume of ascites ≥1L",
                                "criterion": "ascites volume",
                                "requirement": {
                                    "requirement_type": "volume",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "L"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The time interval between the most recent anti-tumor treatment and the first dose of M701 must meet the following criteria:",
                "criterions": [
                    {
                        "exact_snippets": "The time interval between the most recent anti-tumor treatment and the first dose of M701",
                        "criterion": "time interval between anti-tumor treatment and first dose of M701",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "must meet the following criteria"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "The time interval between the most recent anti-tumor treatment and the first dose of M701",
                        "criterion": "time interval between anti-tumor treatment and first dose of M701",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "must meet the following criteria"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Intraperitoneal treatment: ≥2 weeks since the most recent intraperitoneal treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Intraperitoneal treatment: ≥2 weeks since the most recent intraperitoneal treatment.",
                        "criterion": "intraperitoneal treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Intraperitoneal treatment: ≥2 weeks since the most recent intraperitoneal treatment.",
                        "criterion": "intraperitoneal treatment",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adverse events (AEs) from previous treatments have recovered to grade ≤1 (excluding other AEs deemed by the investigator not to affect the safety of the study drug, such as hair loss).",
                "criterions": [
                    {
                        "exact_snippets": "Adverse events (AEs) from previous treatments have recovered to grade ≤1",
                        "criterion": "adverse events from previous treatments",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "excluding other AEs deemed by the investigator not to affect the safety of the study drug, such as hair loss",
                        "criterion": "adverse events not affecting study drug safety",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adverse events (AEs) from previous treatments have recovered to grade ≤1",
                                "criterion": "adverse events from previous treatments",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "grade"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "excluding other AEs deemed by the investigator not to affect the safety of the study drug, such as hair loss",
                                    "criterion": "adverse events not affecting study drug safety",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. Estimated survival time ≥8 weeks.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Estimated survival time ≥8 weeks",
                        "criterion": "estimated survival time",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Estimated survival time ≥8 weeks",
                        "criterion": "estimated survival time",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Organ function levels must meet the following requirements:",
                "criterions": [
                    {
                        "exact_snippets": "Organ function levels",
                        "criterion": "organ function levels",
                        "requirement": {
                            "requirement_type": "levels",
                            "expected_value": "must meet the following requirements"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Organ function levels",
                        "criterion": "organ function levels",
                        "requirement": {
                            "requirement_type": "levels",
                            "expected_value": "must meet the following requirements"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10^9/L, platelets ≥80 × 10^9/L, hemoglobin ≥8.5 g/dL, lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days).",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1.5 × 10^9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ≥80 × 10^9/L",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥8.5 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.5,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days)",
                        "criterion": "lymphocyte ratio (lymphocyte count/leukocyte count)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days)",
                        "criterion": "lymphocyte ratio (lymphocyte count/leukocyte count)",
                        "requirement": {
                            "requirement_type": "transfusion",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1.5 × 10^9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets ≥80 × 10^9/L",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "× 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "hemoglobin ≥8.5 g/dL",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.5,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days)",
                                "criterion": "lymphocyte ratio (lymphocyte count/leukocyte count)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "lymphocyte ratio (lymphocyte count/leukocyte count) ≥10% (without transfusion within 14 days)",
                                "criterion": "lymphocyte ratio (lymphocyte count/leukocyte count)",
                                "requirement": {
                                    "requirement_type": "transfusion",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Serum albumin ≥28 g/L. Renal function: Serum creatinine ≤1.5 times ULN.",
                "criterions": [
                    {
                        "exact_snippets": "Serum albumin ≥28 g/L.",
                        "criterion": "serum albumin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Renal function: Serum creatinine ≤1.5 times ULN.",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Serum albumin ≥28 g/L.",
                        "criterion": "serum albumin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Renal function: Serum creatinine ≤1.5 times ULN.",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Patients who have previously received M701 or any antibody-based drugs targeting EpCAM and/or CD3 within the 4 months prior to the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have previously received M701",
                        "criterion": "previous M701 treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any antibody-based drugs targeting EpCAM",
                        "criterion": "previous EpCAM-targeting antibody-based drug treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any antibody-based drugs targeting ... CD3",
                        "criterion": "previous CD3-targeting antibody-based drug treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within the 4 months prior to the first dose",
                        "criterion": "time since last treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Patients who have previously received M701",
                                                "criterion": "previous M701 treatment",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "within the 4 months prior to the first dose",
                                                "criterion": "time since last treatment",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "months"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "any antibody-based drugs targeting EpCAM",
                                                "criterion": "previous EpCAM-targeting antibody-based drug treatment",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "within the 4 months prior to the first dose",
                                                "criterion": "time since last treatment",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "months"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "any antibody-based drugs targeting ... CD3",
                                                "criterion": "previous CD3-targeting antibody-based drug treatment",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "within the 4 months prior to the first dose",
                                                "criterion": "time since last treatment",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "months"
                                                    }
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Severe respiratory distress requiring oxygen therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Severe respiratory distress",
                        "criterion": "respiratory distress",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "requiring oxygen therapy",
                        "criterion": "oxygen therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Severe respiratory distress",
                        "criterion": "respiratory distress",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "requiring oxygen therapy",
                        "criterion": "oxygen therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active autoimmune diseases, except for the following conditions that are allowed for screening: type 1 diabetes, controlled hypothyroidism with replacement therapy only, skin diseases that do not require systemic treatment。",
                "criterions": [
                    {
                        "exact_snippets": "Active autoimmune diseases",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "type 1 diabetes",
                        "criterion": "type 1 diabetes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "controlled hypothyroidism with replacement therapy only",
                        "criterion": "controlled hypothyroidism",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "controlled hypothyroidism with replacement therapy only",
                        "criterion": "controlled hypothyroidism",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "replacement therapy only"
                        }
                    },
                    {
                        "exact_snippets": "skin diseases that do not require systemic treatment",
                        "criterion": "skin diseases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "do not require systemic treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Active autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirement": {
                        "requirement_type": "activity",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "or_criteria": [
                            {
                                "exact_snippets": "type 1 diabetes",
                                "criterion": "type 1 diabetes",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "controlled hypothyroidism with replacement therapy only",
                                        "criterion": "controlled hypothyroidism",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "controlled hypothyroidism with replacement therapy only",
                                        "criterion": "controlled hypothyroidism",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": "replacement therapy only"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "skin diseases that do not require systemic treatment",
                                "criterion": "skin diseases",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "do not require systemic treatment"
                                }
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Other severe medical conditions that may limit the patient's participation in the trial。",
                "criterions": [
                    {
                        "exact_snippets": "Other severe medical conditions that may limit the patient's participation in the trial",
                        "criterion": "severe medical conditions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Other severe medical conditions that may limit the patient's participation in the trial",
                        "criterion": "severe medical conditions",
                        "requirement": {
                            "requirement_type": "impact on participation",
                            "expected_value": "may limit"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Other severe medical conditions that may limit the patient's participation in the trial",
                        "criterion": "severe medical conditions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Other severe medical conditions that may limit the patient's participation in the trial",
                        "criterion": "severe medical conditions",
                        "requirement": {
                            "requirement_type": "impact on participation",
                            "expected_value": "may limit"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Impaired cardiac function with New York Heart Association (NYHA) class 3 or 4.",
                "criterions": [
                    {
                        "exact_snippets": "Impaired cardiac function with New York Heart Association (NYHA) class 3 or 4.",
                        "criterion": "cardiac function",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "NYHA class 3",
                                "NYHA class 4"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Impaired cardiac function with New York Heart Association (NYHA) class 3 or 4.",
                        "criterion": "cardiac function",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "NYHA class 3",
                                "NYHA class 4"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Occurrence of complete intestinal obstruction within 30 days before the first dose, or diagnosis of incomplete intestinal obstruction deemed unsuitable for participation in the trial based on symptoms and signs as determined by the investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Occurrence of complete intestinal obstruction within 30 days before the first dose",
                        "criterion": "complete intestinal obstruction",
                        "requirement": {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days before the first dose"
                            }
                        }
                    },
                    {
                        "exact_snippets": "diagnosis of incomplete intestinal obstruction deemed unsuitable for participation in the trial based on symptoms and signs as determined by the investigator",
                        "criterion": "incomplete intestinal obstruction",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": "unsuitable based on symptoms and signs as determined by the investigator"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Occurrence of complete intestinal obstruction within 30 days before the first dose",
                                "criterion": "complete intestinal obstruction",
                                "requirement": {
                                    "requirement_type": "occurrence",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days before the first dose"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "diagnosis of incomplete intestinal obstruction deemed unsuitable for participation in the trial based on symptoms and signs as determined by the investigator",
                                "criterion": "incomplete intestinal obstruction",
                                "requirement": {
                                    "requirement_type": "suitability",
                                    "expected_value": "unsuitable based on symptoms and signs as determined by the investigator"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inability to adequately drain ascites due to objective reasons (including loculated ascites).",
                "criterions": [
                    {
                        "exact_snippets": "Inability to adequately drain ascites",
                        "criterion": "ascites drainage",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "objective reasons (including loculated ascites)",
                        "criterion": "objective reasons for inability to drain ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Inability to adequately drain ascites",
                        "criterion": "ascites drainage",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "objective reasons (including loculated ascites)",
                        "criterion": "objective reasons for inability to drain ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Confirmed portal vein obstruction.",
                "criterions": [
                    {
                        "exact_snippets": "Confirmed portal vein obstruction.",
                        "criterion": "portal vein obstruction",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Confirmed portal vein obstruction.",
                    "criterion": "portal vein obstruction",
                    "requirement": {
                        "requirement_type": "confirmation",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of immunodeficiency, including positive HIV test.",
                "criterions": [
                    {
                        "exact_snippets": "History of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive HIV test",
                        "criterion": "HIV",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive HIV test",
                        "criterion": "HIV",
                        "requirement": {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Active hepatitis B virus infection, active hepatitis C virus infection, active syphilis, or positive HIV antibody.",
                "criterions": [
                    {
                        "exact_snippets": "Active hepatitis B virus infection",
                        "criterion": "hepatitis B virus infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C virus infection",
                        "criterion": "hepatitis C virus infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active syphilis",
                        "criterion": "syphilis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive HIV antibody",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Active hepatitis B virus infection",
                        "criterion": "hepatitis B virus infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis C virus infection",
                        "criterion": "hepatitis C virus infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active syphilis",
                        "criterion": "syphilis",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive HIV antibody",
                        "criterion": "HIV antibody",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pregnant or lactating women.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with fertility requirements during or within 6 months after treatment.",
                "criterions": [
                    {
                        "exact_snippets": "fertility requirements during or within 6 months after treatment",
                        "criterion": "fertility requirements",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "during or within 6 months after treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "fertility requirements during or within 6 months after treatment",
                        "criterion": "fertility requirements",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "during or within 6 months after treatment"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Histologically or pathologically confirmed epithelial malignancies, including advanced gastric cancer or colorectal cancer that has failed at least two lines of treatment, or platinum-resistant advanced ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or pathologically confirmed epithelial malignancies",
                        "criterion": "epithelial malignancies",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically or pathologically"
                        }
                    },
                    {
                        "exact_snippets": "advanced gastric cancer",
                        "criterion": "gastric cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    },
                    {
                        "exact_snippets": "colorectal cancer that has failed at least two lines of treatment",
                        "criterion": "colorectal cancer",
                        "requirement": {
                            "requirement_type": "treatment failure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines of treatment"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platinum-resistant advanced ovarian cancer",
                        "criterion": "ovarian cancer",
                        "requirement": {
                            "requirement_type": "resistance",
                            "expected_value": "platinum-resistant"
                        }
                    },
                    {
                        "exact_snippets": "platinum-resistant advanced ovarian cancer",
                        "criterion": "ovarian cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Histologically or pathologically confirmed epithelial malignancies",
                                        "criterion": "epithelial malignancies",
                                        "requirement": {
                                            "requirement_type": "confirmation",
                                            "expected_value": "histologically or pathologically"
                                        }
                                    },
                                    {
                                        "exact_snippets": "advanced gastric cancer",
                                        "criterion": "gastric cancer",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": "advanced"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "colorectal cancer that has failed at least two lines of treatment",
                                "criterion": "colorectal cancer",
                                "requirement": {
                                    "requirement_type": "treatment failure",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "lines of treatment"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN (AST and ALT ≤5 times ULN allowed in the presence of liver metastasis).",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤1.5 times the upper limit of normal (ULN)",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (AST) ... ≤3 times ULN ... ≤5 times ULN allowed in the presence of liver metastasis",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "times ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ≤3 times ULN ... ≤5 times ULN allowed in the presence of liver metastasis",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "times ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Total bilirubin \u00141.5 times the upper limit of normal (ULN)",
                                "criterion": "total bilirubin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "times ULN"
                                    }
                                }
                            },
                            {
                                "condition": {
                                    "exact_snippets": "presence of liver metastasis",
                                    "criterion": "liver metastasis",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                "then_criteria": {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "aspartate aminotransferase (AST) ... \u00143 times ULN ... \u00145 times ULN allowed in the presence of liver metastasis",
                                            "criterion": "aspartate aminotransferase (AST)",
                                            "requirement": {
                                                "requirement_type": "level",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 5,
                                                    "unit": "times ULN"
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "alanine aminotransferase (ALT) \u00143 times ULN ... \u00145 times ULN allowed in the presence of liver metastasis",
                                            "criterion": "alanine aminotransferase (ALT)",
                                            "requirement": {
                                                "requirement_type": "level",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 5,
                                                    "unit": "times ULN"
                                                }
                                            }
                                        }
                                    ]
                                },
                                "else_criteria": {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "aspartate aminotransferase (AST) ... \u00143 times ULN ... \u00145 times ULN allowed in the presence of liver metastasis",
                                            "criterion": "aspartate aminotransferase (AST)",
                                            "requirement": {
                                                "requirement_type": "level",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 3,
                                                    "unit": "times ULN"
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "alanine aminotransferase (ALT) \u00143 times ULN ... \u00145 times ULN allowed in the presence of liver metastasis",
                                            "criterion": "alanine aminotransferase (ALT)",
                                            "requirement": {
                                                "requirement_type": "level",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 3,
                                                    "unit": "times ULN"
                                                }
                                            }
                                        }
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Patients with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colorectal cancer who have not previously received immunotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "microsatellite instability-high (MSI-H)",
                        "criterion": "microsatellite instability",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "deficient mismatch repair (dMMR)",
                        "criterion": "mismatch repair",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "deficient"
                        }
                    },
                    {
                        "exact_snippets": "colorectal cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "colorectal"
                        }
                    },
                    {
                        "exact_snippets": "who have not previously received immunotherapy",
                        "criterion": "immunotherapy history",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients who have undergone major surgery within the 4 weeks prior to the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "undergone major surgery within the 4 weeks prior to the first dose",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with extensive liver metastases (tumor volume occupying approximately >70% of total liver volume).",
                "criterions": [
                    {
                        "exact_snippets": "extensive liver metastases",
                        "criterion": "liver metastases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "extensive"
                        }
                    },
                    {
                        "exact_snippets": "tumor volume occupying approximately >70% of total liver volume",
                        "criterion": "tumor volume in liver",
                        "requirement": {
                            "requirement_type": "occupancy",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "% of total liver volume"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Active infections requiring intravenous antibiotics within 14 days before the first dose.",
                "criterions": [
                    {
                        "exact_snippets": "Active infections requiring intravenous antibiotics within 14 days before the first dose.",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "intravenous antibiotics"
                        }
                    },
                    {
                        "exact_snippets": "Active infections requiring intravenous antibiotics within 14 days before the first dose.",
                        "criterion": "active infections",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before the first dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Severe diarrhea (CTCAE grade ≥2).",
                "criterions": [
                    {
                        "exact_snippets": "Severe diarrhea (CTCAE grade ≥2)",
                        "criterion": "diarrhea",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known history of neurological or psychiatric disorders deemed by the investigator to affect cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of neurological or psychiatric disorders",
                        "criterion": "neurological or psychiatric disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "deemed by the investigator to affect cognitive function or compliance",
                        "criterion": "effect on cognitive function or compliance",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "affects cognitive function or compliance"
                        }
                    },
                    {
                        "exact_snippets": "including unstable epilepsy",
                        "criterion": "unstable epilepsy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "dementia",
                        "criterion": "dementia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "schizophrenia",
                        "criterion": "schizophrenia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}