{
    "info": {
        "nct_id": "NCT04188860",
        "official_title": "Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Single Center, Open, Phase II Trial",
        "inclusion_criteria": "* Female of 18-75 years old\n* Eastern Cooperative Oncology Group score 0-1\n* Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure\n* Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen\n* At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1\n* Anticipative survival period of 3 months or more\n* Lab testing within reference ranges\n* With appropriate contraception\n* Provided consents of participating the trial\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* With brain metastasis\n* With addiction to psychiatric medications or with mental disorders\n* With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency\n* With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment\n* With infective disease which need systematic treatment within 14 days\n* With severe open trauma, fracture or major surgery with past 4 weeks\n* With potential allergy or intolerance to study regimens\n* Not eligible for the study judged by researchers",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Female of 18-75 years old",
                "criterions": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "18-75 years old",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
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                            "expected_value": "female"
                        }
                    },
                    {
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                                    {
                                        "operator": ">=",
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                                        "unit": "years"
                                    },
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                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group score 0-1",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group score 0-1",
                        "criterion": "Eastern Cooperative Oncology Group score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
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                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group score 0-1",
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                        "requirement": {
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                            "expected_value": {
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                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
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                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure",
                "criterions": [
                    {
                        "exact_snippets": "Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma",
                        "criterion": "uterine cervical cancer type",
                        "requirement": {
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                            "expected_value": [
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                                "squamous carcinoma",
                                "adenosquamous carcinoma"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "stage IA1 (with lymph-vascular space invasion) to IVB",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "IA1"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "IVB"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "which had accepted radical treatment for the purpose of cure",
                        "criterion": "treatment type",
                        "requirement": {
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                            "expected_value": "radical treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma",
                                        "criterion": "uterine cervical cancer type",
                                        "requirement": {
                                            "requirement_type": "type",
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                                                "squamous carcinoma",
                                                "adenosquamous carcinoma"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "stage IA1 (with lymph-vascular space invasion) to IVB",
                                        "criterion": "cancer stage",
                                        "requirement": {
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                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 1,
                                                        "unit": "IA1"
                                                    },
                                                    {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "IVB"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "which had accepted radical treatment for the purpose of cure",
                                "criterion": "treatment type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "radical treatment"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen",
                "criterions": [
                    {
                        "exact_snippets": "accepted at least one regimen of platinum-based chemotherapy",
                        "criterion": "platinum-based chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "accepted at least one regimen of platinum-based chemotherapy",
                        "criterion": "platinum-based chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    },
                    {
                        "exact_snippets": "diagnosis of recurrent or persistent advanced cervical cancer",
                        "criterion": "cervical cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "recurrent",
                                "persistent",
                                "advanced"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "interval of at least 4 weeks since fulfilling the last treatment regimen",
                        "criterion": "interval since last treatment regimen",
                        "requirement": {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "accepted at least one regimen of platinum-based chemotherapy",
                                "criterion": "platinum-based chemotherapy regimen",
                                "requirement": {
                                    "requirement_type": "acceptance",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "accepted at least one regimen of platinum-based chemotherapy",
                                "criterion": "platinum-based chemotherapy regimen",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "regimen"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "diagnosis of recurrent or persistent advanced cervical cancer",
                        "criterion": "cervical cancer",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "recurrent",
                                "persistent",
                                "advanced"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "interval of at least 4 weeks since fulfilling the last treatment regimen",
                        "criterion": "interval since last treatment regimen",
                        "requirement": {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1",
                "criterions": [
                    {
                        "exact_snippets": "At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "quantity",
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                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1",
                        "criterion": "measurable lesion",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Anticipative survival period of 3 months or more",
                "criterions": [
                    {
                        "exact_snippets": "Anticipative survival period of 3 months or more",
                        "criterion": "survival period",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Anticipative survival period of 3 months or more",
                        "criterion": "survival period",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Lab testing within reference ranges",
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                    {
                        "exact_snippets": "Lab testing within reference ranges",
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                        }
                    }
                ]
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                    {
                        "exact_snippets": "Lab testing within reference ranges",
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                        }
                    }
                ]
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        },
        {
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                "line": "* With appropriate contraception",
                "criterions": [
                    {
                        "exact_snippets": "appropriate contraception",
                        "criterion": "contraception",
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                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "appropriate contraception",
                        "criterion": "contraception",
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Provided consents of participating the trial",
                "criterions": [
                    {
                        "exact_snippets": "Provided consents of participating the trial",
                        "criterion": "consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "Provided consents of participating the trial",
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                        }
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                ]
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        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
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                        }
                    }
                ]
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                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
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                            "expected_value": "female"
                        }
                    }
                ]
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            "logical_structure": {
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                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
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                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "minimum age of 18 Years",
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                                "value": 18,
                                "unit": "Years"
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
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                    {
                        "exact_snippets": "maximum age of 75 Years",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
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            "logical_structure": {
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                        "exact_snippets": "maximum age of 75 Years",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* With brain metastasis",
                "criterions": [
                    {
                        "exact_snippets": "brain metastasis",
                        "criterion": "brain metastasis",
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                        }
                    }
                ]
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                    "exact_snippets": "brain metastasis",
                    "criterion": "brain metastasis",
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                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* With addiction to psychiatric medications or with mental disorders",
                "criterions": [
                    {
                        "exact_snippets": "addiction to psychiatric medications",
                        "criterion": "addiction to psychiatric medications",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "mental disorders",
                        "criterion": "mental disorders",
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                        }
                    }
                ]
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            "logical_structure": {
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                        "exact_snippets": "addiction to psychiatric medications",
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                    {
                        "exact_snippets": "mental disorders",
                        "criterion": "mental disorders",
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency",
                "criterions": [
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                            "expected_value": true
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                            "expected_value": true
                        }
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                    {
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                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "utilization of antitumor vaccine or other immunostimulation treatment with 3 months",
                        "criterion": "antitumor vaccine or immunostimulation treatment",
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                            "requirement_type": "utilization within",
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                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    },
                    {
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                        "criterion": "exposure to specific antibodies",
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                                "PD-1 antibody",
                                "PD-L1 antibody",
                                "PD-L2 antibody",
                                "cytotoxic T lymphocyte-associated antigen-4 antibody"
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                    },
                    {
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                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "history",
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                        }
                    },
                    {
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                        "criterion": "pulmonary tuberculosis",
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                        }
                    },
                    {
                        "exact_snippets": "interstitial pneumonia or related history",
                        "criterion": "interstitial pneumonia",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis",
                        "criterion": "active hepatitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive testing of human immunodeficiency",
                        "criterion": "human immunodeficiency virus (HIV)",
                        "requirement": {
                            "requirement_type": "positive testing",
                            "expected_value": true
                        }
                    }
                ]
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            "logical_structure": {
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                                "exact_snippets": "systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day)",
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                                    "requirement_type": "systematic utilization",
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                                "exact_snippets": "systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day)",
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                        }
                    },
                    {
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                                "value": 3,
                                "unit": "months"
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                    {
                        "exact_snippets": "exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody",
                        "criterion": "exposure to specific antibodies",
                        "requirement": {
                            "requirement_type": "exposure",
                            "expected_value": [
                                "PD-1 antibody",
                                "PD-L1 antibody",
                                "PD-L2 antibody",
                                "cytotoxic T lymphocyte-associated antigen-4 antibody"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "history of other malignancies",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary tuberculosis",
                        "criterion": "pulmonary tuberculosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "interstitial pneumonia or related history",
                        "criterion": "interstitial pneumonia",
                        "requirement": {
                            "requirement_type": "history or presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis",
                        "criterion": "active hepatitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "positive testing of human immunodeficiency",
                        "criterion": "human immunodeficiency virus (HIV)",
                        "requirement": {
                            "requirement_type": "positive testing",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment",
                "criterions": [
                    {
                        "exact_snippets": "adverse effects more than Common Terminology Criteria for Adverse Events grade 1",
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                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Common Terminology Criteria for Adverse Events grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "caused by previous anti-tumor treatment",
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                    }
                ]
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                    {
                        "and_criteria": [
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                                "and_criteria": [
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                                        "requirement": {
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                                                "value": 1,
                                                "unit": "Common Terminology Criteria for Adverse Events grade"
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                                        }
                                    },
                                    {
                                        "exact_snippets": "caused by previous anti-tumor treatment",
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                                        }
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                                ]
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                                    }
                                }
                            }
                        ]
                    }
                ]
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        },
        {
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                    {
                        "exact_snippets": "infective disease which need systematic treatment",
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                    },
                    {
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                            "expected_value": {
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                                "value": 14,
                                "unit": "days"
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                        }
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            "logical_structure": {
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                        "exact_snippets": "infective disease which need systematic treatment",
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        {
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                    },
                    {
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                    {
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                    {
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                                "value": 4,
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                        }
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                                            }
                                        }
                                    }
                                ]
                            },
                            {
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                                        "criterion": "surgery",
                                        "requirement": {
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                                            "expected_value": "major"
                                        }
                                    },
                                    {
                                        "exact_snippets": "past 4 weeks",
                                        "criterion": "time since event",
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                                            "expected_value": {
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                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* With potential allergy or intolerance to study regimens",
                "criterions": [
                    {
                        "exact_snippets": "potential allergy or intolerance to study regimens",
                        "criterion": "allergy or intolerance",
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                        }
                    }
                ]
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                    "criterion": "allergy or intolerance",
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                        "expected_value": false
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                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Not eligible for the study judged by researchers",
                "criterions": [
                    {
                        "exact_snippets": "Not eligible for the study judged by researchers",
                        "criterion": "eligibility",
                        "requirement": {
                            "requirement_type": "judgment",
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                    }
                ]
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        }
    ],
    "failed_miscellaneous": []
}