{
    "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": [
        {
            "identified_line": {
                "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",
                        "requirement": {
                            "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",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Women with cervical, endometrial, vaginal, vulvar or ovarian cancer",
                        "criterion": "cancer type",
                        "requirement": {
                            "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",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any form of hysterectomy, including radical hysterectomy permitted",
                "criterions": [
                    {
                        "exact_snippets": "Any form of hysterectomy, including radical hysterectomy permitted",
                        "criterion": "hysterectomy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "any form",
                                "radical"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Any form of hysterectomy, including radical hysterectomy permitted",
                        "criterion": "hysterectomy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "any form",
                                "radical"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "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",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within past 3 months",
                        "criterion": "pelvic exam",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within past 3 months"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "no evidence of recurrent disease on pelvic exam",
                        "criterion": "recurrent disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "within past 3 months",
                        "criterion": "pelvic exam",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within past 3 months"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Radiation therapy is permitted but not required",
                "criterions": [
                    {
                        "exact_snippets": "Radiation therapy is permitted but not required",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Radiation therapy is permitted but not required",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Radiation therapy is permitted but not required",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Radiation therapy is permitted but not required",
                        "criterion": "radiation therapy",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "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",
                        "requirement": {
                            "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",
                        "requirement": {
                            "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",
                        "requirement": {
                            "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",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Patient reported dyspareunia ... severity of >= 4 on a scale from 0 (none) to 10 (most severe)",
                                                "criterion": "dyspareunia",
                                                "requirement": {
                                                    "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",
                                                "requirement": {
                                                    "requirement_type": "duration",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 4,
                                                        "unit": "weeks"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Patient reported ... vaginal dryness with severity of >= 4 on a scale from 0 (none) to 10 (most severe)",
                                                "criterion": "vaginal dryness",
                                                "requirement": {
                                                    "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",
                                                "requirement": {
                                                    "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",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Pelvic organ prolapse stage II or higher",
                "criterions": [
                    {
                        "exact_snippets": "Pelvic organ prolapse stage II or higher",
                        "criterion": "pelvic organ prolapse",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pelvic organ prolapse stage II or higher",
                        "criterion": "pelvic organ prolapse",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior reconstructive pelvic surgery involving mesh",
                "criterions": [
                    {
                        "exact_snippets": "Prior reconstructive pelvic surgery involving mesh",
                        "criterion": "reconstructive pelvic surgery",
                        "requirement": {
                            "requirement_type": "involvement",
                            "expected_value": "mesh"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Prior reconstructive pelvic surgery involving mesh",
                    "criterion": "reconstructive pelvic surgery",
                    "requirement": {
                        "requirement_type": "involvement",
                        "expected_value": "mesh"
                    }
                }
            }
        },
        {
            "identified_line": {
                "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",
                        "requirement": {
                            "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",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Hormone replacement therapy ... within 6 weeks prior to enrollment",
                        "criterion": "hormone replacement therapy",
                        "requirement": {
                            "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",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "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",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "endometrial",
                                "vaginal",
                                "vulvar",
                                "cervical",
                                "ovarian"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "recurrent or metastatic",
                        "criterion": "cancer status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "recurrent",
                                "metastatic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "endometrial",
                                        "vaginal",
                                        "vulvar",
                                        "cervical",
                                        "ovarian"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "recurrent or metastatic",
                                "criterion": "cancer status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "recurrent"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "recurrent or metastatic endometrial, vaginal, vulvar, cervical, or ovarian cancer",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "endometrial",
                                        "vaginal",
                                        "vulvar",
                                        "cervical",
                                        "ovarian"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "recurrent or metastatic",
                                "criterion": "cancer status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "metastatic"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}