{
    "info": {
        "nct_id": "NCT06417476",
        "official_title": "A Multicenter, Open, Randomized Phase II Trial：Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer",
        "inclusion_criteria": "Diagnosis: Histologically confirmed rectal adenocarcinoma. Preoperative Staging: Clinical stages cT2-4aN0-2. Tumor Location: Tumor's lower edge within 8cm from the anus, potentially affecting anal preservation or function.\n\nMetastasis Screening: Preoperative chest, abdomen, and pelvis CT to rule out distant metastasis.\n\nBiomarkers: Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry.\n\nStaging Methods: Combination of thoracic and abdominal pelvic CT, pelvic MRI, and endoscopic or transrectal ultrasound.\n\nPatient Characteristics Age: 18 to 70 years. Performance Status: ECOG score of 0-1. Life Expectancy: At least 2 years. Blood Counts: WBC >4000/mm^3, PLT >100,000/mm^3, Hb >10g/dL (chronic anemia with Hb < 10.0g/dL subject to multidisciplinary team review).\n\nLiver Function: Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome); AST and ALT ≤2.5×ULN.\n\nRenal Function: Serum creatinine ≤1.5×ULN or creatinine clearance >50 mL/min. Other Criteria: Non-pregnant, not nursing, no other malignancies (except non-melanoma skin cancer or cervical carcinoma in situ) within the past 5 years, capable of providing informed consent, no severe comorbidities affecting survival.\n\nPrior Treatment No prior surgery, chemotherapy, or radiotherapy for rectal cancer. No prior biological therapy. No restrictions on previous endocrine therapy.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "Informed Consent: Lack of signed informed consent. Genetic Markers: Tumor biopsy indicating dMMR or MSI-H detected. Advanced Tumor Stage: Preoperative assessment showing tumor invasion of surrounding tissues/organs (T4b).\n\nObstruction: Unresolved colonic obstruction; presence of tumor perforation. Metastasis: Evidence of preoperative distant metastasis. Cardiac Conditions: Arrhythmia requiring antiarrhythmic therapy (excluding beta-blockers or digoxin), symptomatic coronary artery disease or recent myocardial ischemia (within 6 months), or congestive heart failure above NYHA Grade II.\n\nHypertension: Severe, poorly controlled hypertension. Infections: HIV infection, active chronic hepatitis B or C, other serious infections; active tuberculosis or anti-TB therapy within the past year.\n\nOrgan Function: Poor fluid quality, organ function decompensation. Previous Treatment: History of pelvic or abdominal radiotherapy; multiple primary colorectal cancers.\n\nNeurological Conditions: Seizures requiring management (e.g., steroids, antiepileptic therapy).\n\nCancer History: Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin.\n\nSubstance Abuse: Substance abuse or medical, psychological, or social conditions affecting study participation or result evaluation.\n\nAllergies: Known or suspected allergy to study drugs or related medications. Stability: Any unstable condition that may compromise safety or compliance. Reproductive Status: Pregnant or lactating women, or fertile women not using effective contraception.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Diagnosis: Histologically confirmed rectal adenocarcinoma. Preoperative Staging: Clinical stages cT2-4aN0-2. Tumor Location: Tumor's lower edge within 8cm from the anus, potentially affecting anal preservation or function.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed rectal adenocarcinoma",
                    "criterion": "rectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stages cT2-4aN0-2",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "cT2",
                                "cT3",
                                "cT4a"
                            ]
                        },
                        {
                            "requirement_type": "nodal involvement",
                            "expected_value": [
                                "N0",
                                "N1",
                                "N2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor's lower edge within 8cm from the anus",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "distance from anus",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Metastasis Screening: Preoperative chest, abdomen, and pelvis CT to rule out distant metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Preoperative chest, abdomen, and pelvis CT",
                    "criterion": "CT scan",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "preoperative"
                        },
                        {
                            "requirement_type": "body parts",
                            "expected_value": [
                                "chest",
                                "abdomen",
                                "pelvis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "rule out distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biomarkers: Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry.",
            "criterions": [
                {
                    "exact_snippets": "Positive expression of pMMR (MSH1/MSH2/MSH6/PMS2) on tumor biopsy immunohistochemistry.",
                    "criterion": "pMMR expression",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Staging Methods: Combination of thoracic and abdominal pelvic CT, pelvic MRI, and endoscopic or transrectal ultrasound.",
            "criterions": [
                {
                    "exact_snippets": "thoracic and abdominal pelvic CT",
                    "criterion": "thoracic and abdominal pelvic CT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pelvic MRI",
                    "criterion": "pelvic MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "endoscopic or transrectal ultrasound",
                    "criterion": "endoscopic or transrectal ultrasound",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patient Characteristics Age: 18 to 70 years. Performance Status: ECOG score of 0-1. Life Expectancy: At least 2 years. Blood Counts: WBC >4000/mm^3, PLT >100,000/mm^3, Hb >10g/dL (chronic anemia with Hb < 10.0g/dL subject to multidisciplinary team review).",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 to 70 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance Status: ECOG score of 0-1",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "ECOG score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life Expectancy: At least 2 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood Counts: WBC >4000/mm^3",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 4000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood Counts: ... PLT >100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood Counts: ... Hb >10g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic anemia with Hb < 10.0g/dL subject to multidisciplinary team review",
                    "criterion": "chronic anemia",
                    "requirements": [
                        {
                            "requirement_type": "hemoglobin level",
                            "expected_value": {
                                "operator": "<",
                                "value": 10.0,
                                "unit": "g/dL"
                            }
                        },
                        {
                            "requirement_type": "review",
                            "expected_value": "multidisciplinary team review"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Liver Function: Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome); AST and ALT ≤2.5×ULN.",
            "criterions": [
                {
                    "exact_snippets": "Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome)",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert syndrome)",
                    "criterion": "serum total bilirubin for Gilbert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤2.5×ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤2.5×ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Renal Function: Serum creatinine ≤1.5×ULN or creatinine clearance >50 mL/min. Other Criteria: Non-pregnant, not nursing, no other malignancies (except non-melanoma skin cancer or cervical carcinoma in situ) within the past 5 years, capable of providing informed consent, no severe comorbidities affecting survival.",
            "criterions": [
                {
                    "exact_snippets": "Renal Function: Serum creatinine ≤1.5×ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal Function: ... creatinine clearance >50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Non-pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no other malignancies (except non-melanoma skin cancer or cervical carcinoma in situ) within the past 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "capable of providing informed consent",
                    "criterion": "capability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no severe comorbidities affecting survival",
                    "criterion": "severe comorbidities affecting survival",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Prior Treatment No prior surgery, chemotherapy, or radiotherapy for rectal cancer. No prior biological therapy. No restrictions on previous endocrine therapy.",
            "criterions": [
                {
                    "exact_snippets": "No prior surgery ... for rectal cancer.",
                    "criterion": "prior surgery for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... chemotherapy ... for rectal cancer.",
                    "criterion": "prior chemotherapy for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior ... radiotherapy for rectal cancer.",
                    "criterion": "prior radiotherapy for rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior biological therapy.",
                    "criterion": "prior biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No restrictions on previous endocrine therapy.",
                    "criterion": "previous endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "restrictions",
                            "expected_value": "none"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "Informed Consent: Lack of signed informed consent. Genetic Markers: Tumor biopsy indicating dMMR or MSI-H detected. Advanced Tumor Stage: Preoperative assessment showing tumor invasion of surrounding tissues/organs (T4b).",
            "criterions": [
                {
                    "exact_snippets": "Lack of signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor biopsy indicating dMMR or MSI-H detected",
                    "criterion": "genetic markers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "dMMR",
                                "MSI-H"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Preoperative assessment showing tumor invasion of surrounding tissues/organs (T4b)",
                    "criterion": "advanced tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "T4b"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Obstruction: Unresolved colonic obstruction; presence of tumor perforation. Metastasis: Evidence of preoperative distant metastasis. Cardiac Conditions: Arrhythmia requiring antiarrhythmic therapy (excluding beta-blockers or digoxin), symptomatic coronary artery disease or recent myocardial ischemia (within 6 months), or congestive heart failure above NYHA Grade II.",
            "criterions": [
                {
                    "exact_snippets": "Unresolved colonic obstruction",
                    "criterion": "colonic obstruction",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of tumor perforation",
                    "criterion": "tumor perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of preoperative distant metastasis",
                    "criterion": "preoperative distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Arrhythmia requiring antiarrhythmic therapy (excluding beta-blockers or digoxin)",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "antiarrhythmic therapy (excluding beta-blockers or digoxin)"
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recent myocardial ischemia (within 6 months)",
                    "criterion": "myocardial ischemia",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure above NYHA Grade II",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hypertension: Severe, poorly controlled hypertension. Infections: HIV infection, active chronic hepatitis B or C, other serious infections; active tuberculosis or anti-TB therapy within the past year.",
            "criterions": [
                {
                    "exact_snippets": "Severe, poorly controlled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active chronic hepatitis B or C",
                    "criterion": "chronic hepatitis B or C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "other serious infections",
                    "criterion": "serious infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-TB therapy within the past year",
                    "criterion": "anti-TB therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Organ Function: Poor fluid quality, organ function decompensation. Previous Treatment: History of pelvic or abdominal radiotherapy; multiple primary colorectal cancers.",
            "criterions": [
                {
                    "exact_snippets": "Organ Function: Poor fluid quality",
                    "criterion": "fluid quality",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Organ Function: ... organ function decompensation",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "decompensation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous Treatment: History of pelvic or abdominal radiotherapy",
                    "criterion": "pelvic or abdominal radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous Treatment: ... multiple primary colorectal cancers",
                    "criterion": "primary colorectal cancers",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "multiple"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Neurological Conditions: Seizures requiring management (e.g., steroids, antiepileptic therapy).",
            "criterions": [
                {
                    "exact_snippets": "Neurological Conditions: Seizures requiring management",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "management",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cancer History: Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin.",
            "criterions": [
                {
                    "exact_snippets": "Other malignant tumors within the past 5 years",
                    "criterion": "malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding cured cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Substance Abuse: Substance abuse or medical, psychological, or social conditions affecting study participation or result evaluation.",
            "criterions": [
                {
                    "exact_snippets": "Substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "medical, psychological, or social conditions affecting study participation or result evaluation",
                    "criterion": "medical, psychological, or social conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation or result evaluation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Allergies: Known or suspected allergy to study drugs or related medications. Stability: Any unstable condition that may compromise safety or compliance. Reproductive Status: Pregnant or lactating women, or fertile women not using effective contraception.",
            "criterions": [
                {
                    "exact_snippets": "Known or suspected allergy to study drugs or related medications.",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any unstable condition that may compromise safety or compliance.",
                    "criterion": "unstable condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or lactating women",
                    "criterion": "pregnancy or lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fertile women not using effective contraception",
                    "criterion": "contraception use in fertile women",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}