{
    "info": {
        "nct_id": "NCT03801031",
        "official_title": "Sexual Dysfunction in Gynecologic Oncology Patients",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria\n\n* Female\n* Age 18-99\n* Planned to undergo primary surgical treatment at the University of Iowa Hospitals and Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal, endometrial, or cervical cancer\n* Able to give informed consent and follow study procedures\n* No previous reactions to lidocaine applications\n* Performance Status of 0 or 1\n* Reports having engaged in vaginal intercourse at least once in the last 12 months\n\nExclusion criteria:\n\n* Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or cervical cancer by pathology from primary biopsy or surgery (subjects will not be eligible to continue the trial beyond the initial completion of the questionnaires)\n* Diagnosis of another malignancy within the past five years, excluding basal cell carcinoma of the skin\n* Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant vaginal brachytherapy)\n* Previous reactions to lidocaine applications\n* Previous reactions to lidocaine for the subjects' sexual partner(s)"
    },
    "inclusion_lines": [
        {
            "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 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Female",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18-99",
            "criterions": [
                {
                    "exact_snippets": "Age 18-99",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 99,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned to undergo primary surgical treatment at the University of Iowa Hospitals and Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal, endometrial, or cervical cancer",
            "criterions": [
                {
                    "exact_snippets": "Planned to undergo primary surgical treatment",
                    "criterion": "primary surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "University of Iowa Hospitals and Clinics",
                    "criterion": "treatment location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "University of Iowa Hospitals and Clinics"
                        }
                    ]
                },
                {
                    "exact_snippets": "suspected or proven diagnosis of ovarian, fallopian tube, peritoneal, endometrial, or cervical cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "ovarian",
                                "fallopian tube",
                                "peritoneal",
                                "endometrial",
                                "cervical"
                            ]
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "suspected",
                                "proven"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to give informed consent and follow study procedures",
            "criterions": [
                {
                    "exact_snippets": "Able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "follow study procedures",
                    "criterion": "study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous reactions to lidocaine applications",
            "criterions": [
                {
                    "exact_snippets": "No previous reactions to lidocaine applications",
                    "criterion": "reactions to lidocaine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance Status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Performance Status of 0 or 1",
                    "criterion": "Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Reports having engaged in vaginal intercourse at least once in the last 12 months",
            "criterions": [
                {
                    "exact_snippets": "Reports having engaged in vaginal intercourse at least once in the last 12 months",
                    "criterion": "vaginal intercourse",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "times in the last 12 months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or cervical cancer by pathology from primary biopsy or surgery (subjects will not be eligible to continue the trial beyond the initial completion of the questionnaires)",
            "criterions": [
                {
                    "exact_snippets": "Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or cervical cancer by pathology from primary biopsy or surgery",
                    "criterion": "cancer confirmation by pathology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of another malignancy within the past five years, excluding basal cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of another malignancy within the past five years",
                    "criterion": "diagnosis of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant vaginal brachytherapy)",
            "criterions": [
                {
                    "exact_snippets": "Patients undergoing primary or adjuvant external pelvic radiation",
                    "criterion": "external pelvic radiation",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "primary",
                                "adjuvant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding adjuvant vaginal brachytherapy",
                    "criterion": "adjuvant vaginal brachytherapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous reactions to lidocaine applications",
            "criterions": [
                {
                    "exact_snippets": "Previous reactions to lidocaine applications",
                    "criterion": "reactions to lidocaine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous reactions to lidocaine for the subjects' sexual partner(s)",
            "criterions": [
                {
                    "exact_snippets": "Previous reactions to lidocaine for the subjects' sexual partner(s)",
                    "criterion": "reactions to lidocaine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria",
            "criterions": []
        },
        {
            "line": "Exclusion criteria:",
            "criterions": []
        }
    ]
}