{
    "info": {
        "nct_id": "NCT02399033",
        "official_title": "Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial",
        "inclusion_criteria": "1. Age: 20-70 years old;\n2. Gender: male or female;\n3. clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;\n4. The expected survival> 3 months;\n5. Child-Pugh grade in A-level;\n6. KPS score with 50-100 points;\n7. In two weeks after hepatectomy for R0 resection surgery. Preoperative must meet the following criteria:\n\n   * BCLC stage of 0-B;\n   * conform to the indications of hepatectomy;\n   * Viable tumor resection confirmed by two highly qualified surgical doctors;\n   * No other surgical contraindications.\n8. women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;\n9. Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment;\n10. All patients must be prohibited donation during the treatment process and in 28 days after treatment;\n11. In addition to the subjects, prohibitting other people taking this product.\n12. patients have a good understanding and could coordinate with investigators for the trial.\n13. Patients enrolled in the trial should sign an informed consent form, to indicate understanding the purpose and procedure of the trial, and patients volunteering to participate in the trial.\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;\n2. patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;\n3. persons who are unable to take oral drugs.\n4. coagulation dysfunction;\n5. HIV, syphilis-infected persons;\n6. persons who have a serious heart, liver and renal failure;\n7. persons who are known to allergic to the drug or any component of the drug;\n8. persons who are received experimental therapy in 28 days before the first treatment;\n9. persons who are received radiotherapy or other surgery(including of the other local surgery for cancer treatment,eg. TACE) in addition to hepatectomy in 14 days before the first treatment;\n10. lactating or pregnant women;\n11. patients in the reproductive period are unwilling or unable to contraception;\n12. persons with poor medication compliance;\n13. The researchers considered unsuitable selected patients.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age: 20-70 years old;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age: 20-70 years old"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 20
                            },
                            {
                                "operator": "<=",
                                "value": 70
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. Gender: male or female;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Gender: male or female"
                    ],
                    "criterion": "gender",
                    "requirement_type": "N/A",
                    "expected_value": [
                        "male",
                        "female"
                    ]
                }
            ]
        },
        {
            "line": "3. clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;",
            "criterions": [
                {
                    "exact_snippets": [
                        "clinical or pathological diagnosis of hepatocellular carcinoma (HCC)"
                    ],
                    "criterion": "hepatocellular carcinoma (HCC)",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "previously untreated patients"
                    ],
                    "criterion": "treatment history",
                    "requirement_type": "status",
                    "expected_value": "untreated"
                }
            ]
        },
        {
            "line": "4. The expected survival> 3 months;",
            "criterions": [
                {
                    "exact_snippets": [
                        "expected survival> 3 months"
                    ],
                    "criterion": "expected survival",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">",
                        "value": 3
                    }
                }
            ]
        },
        {
            "line": "5. Child-Pugh grade in A-level;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Child-Pugh grade",
                        "A-level"
                    ],
                    "criterion": "Child-Pugh grade",
                    "requirement_type": "level",
                    "expected_value": "A"
                }
            ]
        },
        {
            "line": "6. KPS score with 50-100 points;",
            "criterions": [
                {
                    "exact_snippets": [
                        "KPS score",
                        "50-100 points"
                    ],
                    "criterion": "KPS score",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 50
                            },
                            {
                                "operator": "<=",
                                "value": 100
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "7. In two weeks after hepatectomy for R0 resection surgery. Preoperative must meet the following criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "two weeks after hepatectomy"
                    ],
                    "criterion": "time since hepatectomy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">=",
                        "value": 2
                    }
                },
                {
                    "exact_snippets": [
                        "R0 resection surgery"
                    ],
                    "criterion": "resection surgery type",
                    "requirement_type": "type",
                    "expected_value": "R0"
                }
            ]
        },
        {
            "line": "* BCLC stage of 0-B;",
            "criterions": [
                {
                    "exact_snippets": [
                        "BCLC stage of 0-B"
                    ],
                    "criterion": "BCLC stage",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* conform to the indications of hepatectomy;",
            "criterions": [
                {
                    "exact_snippets": [
                        "conform to the indications of hepatectomy"
                    ],
                    "criterion": "hepatectomy indications",
                    "requirement_type": "conformance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Viable tumor resection confirmed by two highly qualified surgical doctors;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Viable tumor resection confirmed"
                    ],
                    "criterion": "tumor resection",
                    "requirement_type": "viability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "confirmed by two highly qualified surgical doctors"
                    ],
                    "criterion": "confirmation by surgical doctors",
                    "requirement_type": "quantity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* No other surgical contraindications.",
            "criterions": [
                {
                    "exact_snippets": [
                        "No other surgical contraindications"
                    ],
                    "criterion": "surgical contraindications",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "8. women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;",
            "criterions": [
                {
                    "exact_snippets": [
                        "women in the reproductive period"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific group",
                    "expected_value": "women in the reproductive period"
                },
                {
                    "exact_snippets": [
                        "must be completely contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "status",
                    "expected_value": "completely"
                },
                {
                    "exact_snippets": [
                        "28 days before treatment"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "duration before treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "during the treatment process"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "duration during treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "28 days after treatment"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "duration after treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "9. Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Men must be completely contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "completeness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "prohibited donation and sperm donation during the treatment process and in 28 days after treatment"
                    ],
                    "criterion": "sperm donation",
                    "requirement_type": "prohibition",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "10. All patients must be prohibited donation during the treatment process and in 28 days after treatment;",
            "criterions": [
                {
                    "exact_snippets": [
                        "prohibited donation during the treatment process and in 28 days after treatment"
                    ],
                    "criterion": "donation",
                    "requirement_type": "prohibition",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "11. In addition to the subjects, prohibitting other people taking this product.",
            "criterions": [
                {
                    "exact_snippets": [
                        "prohibitting other people taking this product"
                    ],
                    "criterion": "other people taking this product",
                    "requirement_type": "prohibition",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "12. patients have a good understanding and could coordinate with investigators for the trial.",
            "criterions": [
                {
                    "exact_snippets": [
                        "patients have a good understanding"
                    ],
                    "criterion": "understanding",
                    "requirement_type": "quality",
                    "expected_value": "good"
                },
                {
                    "exact_snippets": [
                        "could coordinate with investigators"
                    ],
                    "criterion": "coordination with investigators",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "13. Patients enrolled in the trial should sign an informed consent form, to indicate understanding the purpose and procedure of the trial, and patients volunteering to participate in the trial.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients enrolled in the trial should sign an informed consent form"
                    ],
                    "criterion": "informed consent form",
                    "requirement_type": "signature",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "to indicate understanding the purpose and procedure of the trial"
                    ],
                    "criterion": "understanding of trial purpose and procedure",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "patients volunteering to participate in the trial"
                    ],
                    "criterion": "volunteering",
                    "requirement_type": "willingness",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 20 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 20 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 20
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 70 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 70
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;",
            "criterions": [
                {
                    "exact_snippets": [
                        "suffering from any serious illness"
                    ],
                    "criterion": "serious illness",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "laboratory abnormalities"
                    ],
                    "criterion": "laboratory abnormalities",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "mental abnormalities"
                    ],
                    "criterion": "mental abnormalities",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unable to sign an informed consent form"
                    ],
                    "criterion": "ability to sign informed consent form",
                    "requirement_type": "ability",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "2. patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;",
            "criterions": [
                {
                    "exact_snippets": [
                        "medical abnormalities"
                    ],
                    "criterion": "medical abnormalities",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. persons who are unable to take oral drugs.",
            "criterions": [
                {
                    "exact_snippets": [
                        "unable to take oral drugs"
                    ],
                    "criterion": "oral drug administration",
                    "requirement_type": "ability",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "4. coagulation dysfunction;",
            "criterions": [
                {
                    "exact_snippets": [
                        "coagulation dysfunction"
                    ],
                    "criterion": "coagulation",
                    "requirement_type": "dysfunction",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. HIV, syphilis-infected persons;",
            "criterions": [
                {
                    "exact_snippets": [
                        "HIV"
                    ],
                    "criterion": "HIV",
                    "requirement_type": "infection status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "syphilis-infected"
                    ],
                    "criterion": "syphilis",
                    "requirement_type": "infection status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "6. persons who have a serious heart, liver and renal failure;",
            "criterions": [
                {
                    "exact_snippets": [
                        "serious heart"
                    ],
                    "criterion": "heart failure",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                },
                {
                    "exact_snippets": [
                        "serious",
                        "liver"
                    ],
                    "criterion": "liver failure",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                },
                {
                    "exact_snippets": [
                        "serious",
                        "renal"
                    ],
                    "criterion": "renal failure",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                }
            ]
        },
        {
            "line": "7. persons who are known to allergic to the drug or any component of the drug;",
            "criterions": [
                {
                    "exact_snippets": [
                        "allergic to the drug"
                    ],
                    "criterion": "drug allergy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "allergic to",
                        "any component of the drug"
                    ],
                    "criterion": "component allergy",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "8. persons who are received experimental therapy in 28 days before the first treatment;",
            "criterions": [
                {
                    "exact_snippets": [
                        "received experimental therapy in 28 days before the first treatment"
                    ],
                    "criterion": "experimental therapy",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 28
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "9. persons who are received radiotherapy or other surgery(including of the other local surgery for cancer treatment,eg. TACE) in addition to hepatectomy in 14 days before the first treatment;",
            "criterions": [
                {
                    "exact_snippets": [
                        "received radiotherapy"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other surgery"
                    ],
                    "criterion": "surgery",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other local surgery for cancer treatment"
                    ],
                    "criterion": "local surgery for cancer treatment",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "TACE"
                    ],
                    "criterion": "TACE",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "hepatectomy"
                    ],
                    "criterion": "hepatectomy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "in 14 days before the first treatment"
                    ],
                    "criterion": "time since treatment",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 14
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "10. lactating or pregnant women;",
            "criterions": [
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "11. patients in the reproductive period are unwilling or unable to contraception;",
            "criterions": [
                {
                    "exact_snippets": [
                        "patients in the reproductive period"
                    ],
                    "criterion": "reproductive period",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unwilling or unable to contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "willingness or ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "12. persons with poor medication compliance;",
            "criterions": [
                {
                    "exact_snippets": [
                        "poor medication compliance"
                    ],
                    "criterion": "medication compliance",
                    "requirement_type": "quality",
                    "expected_value": "poor"
                }
            ]
        },
        {
            "line": "13. The researchers considered unsuitable selected patients.",
            "criterions": [
                {
                    "exact_snippets": [
                        "unsuitable"
                    ],
                    "criterion": "suitability",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}