{
    "info": {
        "nct_id": "NCT03339882",
        "official_title": "The Effect of Remifemin in Preventing the Climacteric Symptoms Caused by LHRH-a Treatment in Breast Cancer: a Randomized II-stage Clinic Research",
        "inclusion_criteria": "1. provision of informed consent\n2. clinical stage I~IIIC\n3. histologically proven invasive breast cancer\n4. women defined as premenopausal according to NCCN guideline\n5. plan to accept the LHRH-a as endocrine treatment or ovarian function protection\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 55 Years",
        "exclusion_criteria": "1. clinical evidence of metastatic disease\n2. bilateral oophorectomy\n3. patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements\n4. patients who accepted anti-cancer treatment before\n5. previous hormonal therapy as adjuvant treatment for non-cancer disease\n6. patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied\n7. treatment with a non-approved or experimental drug during 1 month before entry into the study\n8. history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)\n9. leukopenia and/or thrombocytopenia\n10. history of ocular fundus diseases\n11. history of thromboembolic diseases\n12. history of osteoporotic fractures",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. provision of informed consent",
            "criterions": [
                {
                    "exact_snippets": "provision of informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. clinical stage I~IIIC",
            "criterions": [
                {
                    "exact_snippets": "clinical stage I~IIIC",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. histologically proven invasive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "histologically proven invasive breast cancer",
                    "criterion": "invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "histologically proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. women defined as premenopausal according to NCCN guideline",
            "criterions": [
                {
                    "exact_snippets": "women defined as premenopausal according to NCCN guideline",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "NCCN guideline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. plan to accept the LHRH-a as endocrine treatment or ovarian function protection",
            "criterions": [
                {
                    "exact_snippets": "accept the LHRH-a as endocrine treatment",
                    "criterion": "LHRH-a acceptance",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "endocrine treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "accept the LHRH-a as ... ovarian function protection",
                    "criterion": "LHRH-a acceptance",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "ovarian function protection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 55 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 55 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 55,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. clinical evidence of metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "clinical evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. bilateral oophorectomy",
            "criterions": [
                {
                    "exact_snippets": "bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements",
            "criterions": [
                {
                    "exact_snippets": "patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements",
                    "criterion": "compliance with trial requirements",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. patients who accepted anti-cancer treatment before",
            "criterions": [
                {
                    "exact_snippets": "patients who accepted anti-cancer treatment before",
                    "criterion": "anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "before"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. previous hormonal therapy as adjuvant treatment for non-cancer disease",
            "criterions": [
                {
                    "exact_snippets": "previous hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant treatment",
                    "criterion": "adjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-cancer disease",
                    "criterion": "non-cancer disease",
                    "requirements": [
                        {
                            "requirement_type": "disease type",
                            "expected_value": "non-cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied",
            "criterions": [
                {
                    "exact_snippets": "patients unwilling to stop taking any drug known to affect sex hormonal status",
                    "criterion": "willingness to stop taking drugs affecting sex hormonal status",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous history of invasive malignancy within the last 5 years",
                    "criterion": "history of invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous or basal cell carcinoma of the skin",
                    "criterion": "squamous or basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of the cervix, adequately cone biopsied",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "adequately cone biopsied"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. treatment with a non-approved or experimental drug during 1 month before entry into the study",
            "criterions": [
                {
                    "exact_snippets": "treatment with a non-approved or experimental drug during 1 month before entry into the study",
                    "criterion": "treatment with a non-approved or experimental drug",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "1 month before entry into the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)",
            "criterions": [
                {
                    "exact_snippets": "history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency)",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "long term"
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "antiplatelet therapy",
                                "low dose warfarin"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. leukopenia and/or thrombocytopenia",
            "criterions": [
                {
                    "exact_snippets": "leukopenia",
                    "criterion": "leukopenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thrombocytopenia",
                    "criterion": "thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. history of ocular fundus diseases",
            "criterions": [
                {
                    "exact_snippets": "history of ocular fundus diseases",
                    "criterion": "ocular fundus diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. history of thromboembolic diseases",
            "criterions": [
                {
                    "exact_snippets": "history of thromboembolic diseases",
                    "criterion": "thromboembolic diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. history of osteoporotic fractures",
            "criterions": [
                {
                    "exact_snippets": "history of osteoporotic fractures",
                    "criterion": "osteoporotic fractures",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}