{
"info": {
"nct_id": "NCT03372720",
"official_title": "Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies",
"inclusion_criteria": "* Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment\n\n * Any form of hysterectomy, including radical hysterectomy permitted\n * Must have no evidence of recurrent disease on pelvic exam within past 3 months\n * Radiation therapy is permitted but not required\n* Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the inability to be sexually active due to pain\nHealthy volunteers allowed\nMust be FEMALE",
"exclusion_criteria": "* Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer\n* Pelvic organ prolapse stage II or higher\n* Prior reconstructive pelvic surgery involving mesh\n* Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Women with cervical, endometrial, vaginal, vulvar or ovarian cancer who have completed all cancer related treatment >= 6 months prior to enrollment",
"criterions": [
{
"exact_snippets": "Women with cervical, endometrial, vaginal, vulvar or ovarian cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"cervical",
"endometrial",
"vaginal",
"vulvar",
"ovarian"
]
}
]
},
{
"exact_snippets": "have completed all cancer related treatment >= 6 months prior to enrollment",
"criterion": "completion of cancer treatment",
"requirements": [
{
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Any form of hysterectomy, including radical hysterectomy permitted",
"criterions": [
{
"exact_snippets": "Any form of hysterectomy, including radical hysterectomy permitted",
"criterion": "hysterectomy",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"any form",
"radical"
]
}
]
}
]
},
{
"line": "* Must have no evidence of recurrent disease on pelvic exam within past 3 months",
"criterions": [
{
"exact_snippets": "no evidence of recurrent disease on pelvic exam",
"criterion": "recurrent disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "within past 3 months",
"criterion": "pelvic exam",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "within past 3 months"
}
]
}
]
},
{
"line": "* Radiation therapy is permitted but not required",
"criterions": [
{
"exact_snippets": "Radiation therapy is permitted but not required",
"criterion": "radiation therapy",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": false
},
{
"requirement_type": "permission",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient reported dyspareunia and/or vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe) that has been persistent over >= 4 weeks and/or the inability to be sexually active due to pain",
"criterions": [
{
"exact_snippets": "Patient reported dyspareunia ... severity of >= 4 on a scale from 0 (none) to 10 (most severe)",
"criterion": "dyspareunia",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "scale from 0 to 10"
}
}
]
},
{
"exact_snippets": "Patient reported ... vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe)",
"criterion": "vaginal dryness",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "scale from 0 to 10"
}
}
]
},
{
"exact_snippets": "dyspareunia and/or vaginal dryness ... persistent over >= 4 weeks",
"criterion": "dyspareunia and/or vaginal dryness",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "inability to be sexually active due to pain",
"criterion": "inability to be sexually active due to pain",
"requirements": [
{
"requirement_type": "presence",
"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": "* Patients with recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer",
"criterions": [
{
"exact_snippets": "recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"endometrial",
"vaginal",
"vulvar",
"cervical",
"ovarian"
]
}
]
},
{
"exact_snippets": "recurrent or metastatic",
"criterion": "cancer status",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"recurrent",
"metastatic"
]
}
]
}
]
},
{
"line": "* Pelvic organ prolapse stage II or higher",
"criterions": [
{
"exact_snippets": "Pelvic organ prolapse stage II or higher",
"criterion": "pelvic organ prolapse",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Prior reconstructive pelvic surgery involving mesh",
"criterions": [
{
"exact_snippets": "Prior reconstructive pelvic surgery involving mesh",
"criterion": "reconstructive pelvic surgery",
"requirements": [
{
"requirement_type": "involvement",
"expected_value": "mesh"
}
]
}
]
},
{
"line": "* Hormone replacement therapy or vaginal estrogen therapy within 6 weeks prior to enrollment",
"criterions": [
{
"exact_snippets": "Hormone replacement therapy ... within 6 weeks prior to enrollment",
"criterion": "hormone replacement therapy",
"requirements": [
{
"requirement_type": "time since last use",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "vaginal estrogen therapy within 6 weeks prior to enrollment",
"criterion": "vaginal estrogen therapy",
"requirements": [
{
"requirement_type": "time since last use",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}