{
"info": {
"nct_id": "NCT03495609",
"official_title": "The Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers",
"inclusion_criteria": "* premenopausal women\n* BRCA1 carrier\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 30 Years",
"exclusion_criteria": "* History of allergic reaction to compounds of similar chemical or biologic composition to hCG\n* receiving medication that could interfere with the study protocol objectives (hormonal contraceptives, androgens, prednisone, thyroid hormones, insulin)\n* previous treatment with follicle stimulating hormone for assisted reproduction\n* uncontrolled intercurrent illness\n* Heart disease\n* Severe cognitive decline\n* Psychiatric desease\n* HIV positive\n* Hepatitis B or C infection",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* premenopausal women",
"criterions": [
{
"exact_snippets": [
"premenopausal women"
],
"criterion": "menopausal status",
"requirement_type": "specific status",
"expected_value": "premenopausal"
}
]
},
{
"line": "* BRCA1 carrier",
"criterions": [
{
"exact_snippets": [
"BRCA1 carrier"
],
"criterion": "BRCA1",
"requirement_type": "carrier status",
"expected_value": true
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": [
"Must be FEMALE"
],
"criterion": "gender",
"requirement_type": "specific value",
"expected_value": "female"
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
{
"line": "Must have maximum age of 30 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 30 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 30
}
}
]
}
],
"exclusion_lines": [
{
"line": "* History of allergic reaction to compounds of similar chemical or biologic composition to hCG",
"criterions": [
{
"exact_snippets": [
"History of allergic reaction"
],
"criterion": "allergic reaction",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"compounds of similar chemical or biologic composition to hCG"
],
"criterion": "compounds",
"requirement_type": "composition",
"expected_value": "similar to hCG"
}
]
},
{
"line": "* receiving medication that could interfere with the study protocol objectives (hormonal contraceptives, androgens, prednisone, thyroid hormones, insulin)",
"criterions": [
{
"exact_snippets": [
"receiving medication that could interfere with the study protocol objectives"
],
"criterion": "medication",
"requirement_type": "interference with study protocol",
"expected_value": true
},
{
"exact_snippets": [
"hormonal contraceptives"
],
"criterion": "hormonal contraceptives",
"requirement_type": "usage",
"expected_value": true
},
{
"exact_snippets": [
"androgens"
],
"criterion": "androgens",
"requirement_type": "usage",
"expected_value": true
},
{
"exact_snippets": [
"prednisone"
],
"criterion": "prednisone",
"requirement_type": "usage",
"expected_value": true
},
{
"exact_snippets": [
"thyroid hormones"
],
"criterion": "thyroid hormones",
"requirement_type": "usage",
"expected_value": true
},
{
"exact_snippets": [
"insulin"
],
"criterion": "insulin",
"requirement_type": "usage",
"expected_value": true
}
]
},
{
"line": "* previous treatment with follicle stimulating hormone for assisted reproduction",
"criterions": [
{
"exact_snippets": [
"previous treatment with follicle stimulating hormone"
],
"criterion": "follicle stimulating hormone treatment",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"assisted reproduction"
],
"criterion": "assisted reproduction",
"requirement_type": "purpose",
"expected_value": true
}
]
},
{
"line": "* uncontrolled intercurrent illness",
"criterions": [
{
"exact_snippets": [
"uncontrolled intercurrent illness"
],
"criterion": "intercurrent illness",
"requirement_type": "control status",
"expected_value": false
}
]
},
{
"line": "* Heart disease",
"criterions": [
{
"exact_snippets": [
"Heart disease"
],
"criterion": "heart disease",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* Severe cognitive decline",
"criterions": [
{
"exact_snippets": [
"Severe cognitive decline"
],
"criterion": "cognitive decline",
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"line": "* Psychiatric desease",
"criterions": [
{
"exact_snippets": [
"Psychiatric desease"
],
"criterion": "psychiatric disease",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* HIV positive",
"criterions": [
{
"exact_snippets": [
"HIV positive"
],
"criterion": "HIV",
"requirement_type": "status",
"expected_value": "positive"
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* Hepatitis B or C infection",
"criterions": [
{
"exact_snippets": [
"Hepatitis B"
],
"criterion": "Hepatitis B infection",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"Hepatitis C"
],
"criterion": "Hepatitis C infection",
"requirement_type": "presence",
"expected_value": true
}
]
}
],
"failed_miscellaneous": []
}