{
    "info": {
        "nct_id": "NCT04035876",
        "official_title": "A Single Group, Open Label, Multi-center Clinical Study of Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of Hepatocellular Cancer Before Liver Transplant",
        "inclusion_criteria": "* 18-75 years\n* Pathology: hepatocellular carcinoma\n* Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor >8 cm, but 100 ng/mL < AFP <400 ng/mL)\n* No interventional therapy (TACE, RFA or I131) within 2 month\n* Expected survival for more than 3 months\n* Child-pugh grade A or grade B (≤ 7 points)\n* Absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 9 g/L, PLT ≥ 100×10^9 /L; TSH ≤ ULN; total bilirubin ≤ 1.5 ULN, albumin ≥ 28 g/L, AST, ALT ≤ 3 ULN; serum creatinine ≤ 1.5 ULN\n* ECOG: 0-2\n* Patients participate in the study voluntarily and sign informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Regional lymph node metastases or extrahepatic metastases\n* Allergic to Camrelizumab or Apatinib\n* Patients who have had or are currently complicated with other malignant tumors\n* Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive)\n* Activ pulmonary tuberculosis or pulmonary tuberculosis history\n* Active, diagnosed, or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma)\n* Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy\n* Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form of immunosuppressive therapy\n* Myocardial ischemia or myocardial infarction above grade II, hypertension and inability to reach the normal range after medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)\n* Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); history of gastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoing thrombolytic or anticoagulant treatment\n* Pregnant or lactating women\n* Patients who participated in other clinical trials within 1 month\n* Active infections which require systemic treatment\n* HIV positive\n* Other factors that may affect patients' safety or compliance",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 18-75 years",
            "criterions": [
                {
                    "exact_snippets": "18-75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathology: hepatocellular carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Pathology: hepatocellular carcinoma",
                    "criterion": "pathology",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "hepatocellular carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor >8 cm, but 100 ng/mL < AFP <400 ng/mL)",
            "criterions": [
                {
                    "exact_snippets": "diameter of tumor ≤ 8 cm",
                    "criterion": "tumor diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diameter of tumor and AFP ≤ 100 ng/mL",
                    "criterion": "AFP level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diameter of tumor >8 cm",
                    "criterion": "tumor diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "100 ng/mL < AFP <400 ng/mL",
                    "criterion": "AFP level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 100,
                                        "unit": "ng/mL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 400,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No interventional therapy (TACE, RFA or I131) within 2 month",
            "criterions": [
                {
                    "exact_snippets": "No interventional therapy (TACE, RFA or I131) within 2 month",
                    "criterion": "interventional therapy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival for more than 3 months",
            "criterions": [
                {
                    "exact_snippets": "Expected survival for more than 3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Child-pugh grade A or grade B (≤ 7 points)",
            "criterions": [
                {
                    "exact_snippets": "Child-pugh grade A",
                    "criterion": "Child-Pugh grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "A"
                        }
                    ]
                },
                {
                    "exact_snippets": "Child-pugh grade ... grade B (≤ 7 points)",
                    "criterion": "Child-Pugh grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "B"
                        },
                        {
                            "requirement_type": "points",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "points"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 9 g/L, PLT ≥ 100×10^9 /L; TSH ≤ ULN; total bilirubin ≤ 1.5 ULN, albumin ≥ 28 g/L, AST, ALT ≤ 3 ULN; serum creatinine ≤ 1.5 ULN",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1.5×10^9 /L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9 /L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hb ≥ 9 g/L",
                    "criterion": "hemoglobin (Hb)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PLT ≥ 100×10^9 /L",
                    "criterion": "platelet count (PLT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9 /L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TSH ≤ ULN",
                    "criterion": "thyroid-stimulating hormone (TSH)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤ 1.5 ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "albumin ≥ 28 g/L",
                    "criterion": "albumin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST, ALT ≤ 3 ULN",
                    "criterion": "AST, ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine ≤ 1.5 ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG: 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG: 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients participate in the study voluntarily and sign informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients participate in the study voluntarily",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Regional lymph node metastases or extrahepatic metastases",
            "criterions": [
                {
                    "exact_snippets": "Regional lymph node metastases",
                    "criterion": "regional lymph node metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extrahepatic metastases",
                    "criterion": "extrahepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergic to Camrelizumab or Apatinib",
            "criterions": [
                {
                    "exact_snippets": "Allergic to Camrelizumab",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "Camrelizumab"
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergic to ... Apatinib",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "Apatinib"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had or are currently complicated with other malignant tumors",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had ... other malignant tumors",
                    "criterion": "history of other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who ... are currently complicated with other malignant tumors",
                    "criterion": "current complication with other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive)",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis (hepatitis B: HBsAg positive",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "HBsAg status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active hepatitis (hepatitis B: ... HBV- DNA≥10⁴copies/ml",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "HBV-DNA level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10000,
                                "unit": "copies/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Active hepatitis ... hepatitis C: HCV antibodies ... positive",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "HCV antibodies status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active hepatitis ... hepatitis C: ... HCV-RNA positive",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "HCV-RNA status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Activ pulmonary tuberculosis or pulmonary tuberculosis history",
            "criterions": [
                {
                    "exact_snippets": "Activ pulmonary tuberculosis",
                    "criterion": "active pulmonary tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary tuberculosis history",
                    "criterion": "pulmonary tuberculosis history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active, diagnosed, or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma)",
            "criterions": [
                {
                    "exact_snippets": "Active, diagnosed, or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "diagnosed",
                                "suspected"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "uveitis",
                    "criterion": "uveitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "enteritis",
                    "criterion": "enteritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pituitary",
                    "criterion": "pituitary",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "nephritis",
                    "criterion": "nephritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vasculitis",
                    "criterion": "vasculitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hyperthyroidism",
                    "criterion": "hyperthyroidism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypothyroidism",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asthma",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy",
            "criterions": [
                {
                    "exact_snippets": "Interstitial lung disease history",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-infectious pneumonia requiring oral or intravenous steroid therapy",
                    "criterion": "non-infectious pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "oral or intravenous steroid therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form of immunosuppressive therapy",
            "criterions": [
                {
                    "exact_snippets": "Long-term systemic hormone therapy (dose > 10mg prednisone/day)",
                    "criterion": "systemic hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial ischemia or myocardial infarction above grade II, hypertension and inability to reach the normal range after medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)",
            "criterions": [
                {
                    "exact_snippets": "Myocardial ischemia",
                    "criterion": "myocardial ischemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction above grade II",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "inability to reach the normal range after medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure >140mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure >90mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); history of gastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoing thrombolytic or anticoagulant treatment",
            "criterions": [
                {
                    "exact_snippets": "Abnormal coagulation function (PT>16s",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 16,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal coagulation function ... APTT>43s",
                    "criterion": "activated partial thromboplastin time (APTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 43,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal coagulation function ... TT>21s",
                    "criterion": "thrombin time (TT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 21,
                                "unit": "s"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal coagulation function ... Fbg<2g/L",
                    "criterion": "fibrinogen (Fbg)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of gastrointestinal bleeding within 6 months",
                    "criterion": "history of gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "obvious bleeding tendency",
                    "criterion": "bleeding tendency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "obvious"
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing thrombolytic or anticoagulant treatment",
                    "criterion": "thrombolytic or anticoagulant treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "undergoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who participated in other clinical trials within 1 month",
            "criterions": [
                {
                    "exact_snippets": "Patients who participated in other clinical trials within 1 month",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infections which require systemic treatment",
            "criterions": [
                {
                    "exact_snippets": "Active infections which require systemic treatment",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV positive",
            "criterions": [
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other factors that may affect patients' safety or compliance",
            "criterions": [
                {
                    "exact_snippets": "factors that may affect patients' safety",
                    "criterion": "factors affecting safety",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "factors that may affect ... compliance",
                    "criterion": "factors affecting compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}