{
"info": {
"nct_id": "NCT01929148",
"official_title": "Is Prophylactic Bilateral Salpingectomy Added to Laparoscopic Myomectomy as New Preventive Strategy for Ovarian Cancer a Safe Procedure?",
"inclusion_criteria": "* Indication to laparoscopic myomectomy\n* Accomplished reproductive desire\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 50 Years",
"exclusion_criteria": "* Age older than 50 years\n* family history of ovarian cancer, BRCA positive\n* basal FSH value of >20 IU/mL and/or E2 levels >60 pg/mL\n* presence of menopausal symptoms,irregular (cycle-to-cycle variation over 12 months >20 days orpresence of any breakthrough bleeding) menstrual cycles, hormonereplacement treatment and/or hormonal contraception for the last 3 months, history of previous uterine or ovarian surgeries, and imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Indication to laparoscopic myomectomy",
"criterions": [
{
"exact_snippets": "Indication to laparoscopic myomectomy",
"criterion": "indication for laparoscopic myomectomy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Accomplished reproductive desire",
"criterions": [
{
"exact_snippets": "Accomplished reproductive desire",
"criterion": "reproductive desire",
"requirements": [
{
"requirement_type": "status",
"expected_value": "accomplished"
}
]
}
]
},
{
"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 50 Years",
"criterions": [
{
"exact_snippets": "maximum age of 50 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 50,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Age older than 50 years",
"criterions": [
{
"exact_snippets": "Age older than 50 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "years"
}
}
]
}
]
},
{
"line": "* family history of ovarian cancer, BRCA positive",
"criterions": [
{
"exact_snippets": "family history of ovarian cancer",
"criterion": "family history of ovarian cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "BRCA positive",
"criterion": "BRCA status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "positive"
}
]
}
]
},
{
"line": "* basal FSH value of >20 IU/mL and/or E2 levels >60 pg/mL",
"criterions": [
{
"exact_snippets": "basal FSH value of >20 IU/mL",
"criterion": "basal FSH value",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "IU/mL"
}
}
]
},
{
"exact_snippets": "E2 levels >60 pg/mL",
"criterion": "E2 levels",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "pg/mL"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* presence of menopausal symptoms,irregular (cycle-to-cycle variation over 12 months >20 days orpresence of any breakthrough bleeding) menstrual cycles, hormonereplacement treatment and/or hormonal contraception for the last 3 months, history of previous uterine or ovarian surgeries, and imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound.",
"criterions": [
{
"exact_snippets": "presence of menopausal symptoms",
"criterion": "menopausal symptoms",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "irregular (cycle-to-cycle variation over 12 months >20 days",
"criterion": "menstrual cycles",
"requirements": [
{
"requirement_type": "irregularity",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "days"
}
}
]
},
{
"exact_snippets": "presence of any breakthrough bleeding",
"criterion": "breakthrough bleeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hormone replacement treatment",
"criterion": "hormone replacement treatment",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
},
{
"exact_snippets": "hormonal contraception for the last 3 months",
"criterion": "hormonal contraception",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
},
{
"exact_snippets": "history of previous uterine or ovarian surgeries",
"criterion": "uterine or ovarian surgeries",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound",
"criterion": "ovarian cyst or tubal pathology",
"requirements": [
{
"requirement_type": "imaging evidence",
"expected_value": true
}
]
}
]
}
],
"failed_miscellaneous": []
}