{
"info": {
"nct_id": "NCT02412072",
"official_title": "",
"inclusion_criteria": "1. Patients who are histological confirmed as endometrial hyperplasia\n2. Patients who desire to preserve fertility potential.\n3. Patients signed the written informed consent voluntarily.\nHealthy volunteers allowed\nMust be FEMALE",
"exclusion_criteria": "1. Pregnancy or suspected pregnancy.\n2. Patients who have severe underlying disease or complication.\n3. Treatment for metastatic cancer from other organs or cancer therapy within the preceding 5 years.\n4. Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity.\n5. Acute liver disease or kidney disease\n6. Thrombosis or phlebothrombosis requiring treatment.\n7. Genital (vaginal, uterine or ovarian) infection.\n8. Acute severe disease of the arteries, such as stroke or heart infarction, or a history of artery disease.\n9. Hypersensitivity to any component of this product.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Patients who are histological confirmed as endometrial hyperplasia",
"criterions": [
{
"exact_snippets": "histological confirmed as endometrial hyperplasia",
"criterion": "endometrial hyperplasia",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histological"
}
]
}
]
},
{
"line": "2. Patients who desire to preserve fertility potential.",
"criterions": [
{
"exact_snippets": "Patients who desire to preserve fertility potential",
"criterion": "fertility preservation desire",
"requirements": [
{
"requirement_type": "desire",
"expected_value": true
}
]
}
]
},
{
"line": "3. Patients signed the written informed consent voluntarily.",
"criterions": [
{
"exact_snippets": "signed the written informed consent voluntarily",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "voluntary",
"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 be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Pregnancy or suspected pregnancy.",
"criterions": [
{
"exact_snippets": "Pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "suspected pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "suspicion",
"expected_value": false
}
]
}
]
},
{
"line": "2. Patients who have severe underlying disease or complication.",
"criterions": [
{
"exact_snippets": "severe underlying disease",
"criterion": "underlying disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "severe underlying ... complication",
"criterion": "complication",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
}
]
},
{
"line": "3. Treatment for metastatic cancer from other organs or cancer therapy within the preceding 5 years.",
"criterions": [
{
"exact_snippets": "Treatment for metastatic cancer from other organs",
"criterion": "treatment for metastatic cancer from other organs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "cancer therapy within the preceding 5 years",
"criterion": "cancer therapy",
"requirements": [
{
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "4. Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity.",
"criterions": [
{
"exact_snippets": "Congenital or acquired uterine anomaly",
"criterion": "uterine anomaly",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "fibroids if they distort the uterine cavity",
"criterion": "fibroids",
"requirements": [
{
"requirement_type": "distortion of uterine cavity",
"expected_value": true
}
]
}
]
},
{
"line": "5. Acute liver disease or kidney disease",
"criterions": [
{
"exact_snippets": "Acute liver disease",
"criterion": "liver disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "acute"
}
]
},
{
"exact_snippets": "kidney disease",
"criterion": "kidney disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "6. Thrombosis or phlebothrombosis requiring treatment.",
"criterions": [
{
"exact_snippets": "Thrombosis or phlebothrombosis requiring treatment.",
"criterion": "thrombosis",
"requirements": [
{
"requirement_type": "treatment requirement",
"expected_value": true
}
]
},
{
"exact_snippets": "Thrombosis or phlebothrombosis requiring treatment.",
"criterion": "phlebothrombosis",
"requirements": [
{
"requirement_type": "treatment requirement",
"expected_value": true
}
]
}
]
},
{
"line": "7. Genital (vaginal, uterine or ovarian) infection.",
"criterions": [
{
"exact_snippets": "Genital (vaginal, uterine or ovarian) infection.",
"criterion": "genital infection",
"requirements": [
{
"requirement_type": "location",
"expected_value": [
"vaginal",
"uterine",
"ovarian"
]
}
]
}
]
},
{
"line": "8. Acute severe disease of the arteries, such as stroke or heart infarction, or a history of artery disease.",
"criterions": [
{
"exact_snippets": "Acute severe disease of the arteries, such as stroke or heart infarction",
"criterion": "acute severe artery disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "history of artery disease",
"criterion": "history of artery disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "9. Hypersensitivity to any component of this product.",
"criterions": [
{
"exact_snippets": "Hypersensitivity to any component of this product",
"criterion": "hypersensitivity",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}