{
    "info": {
        "nct_id": "NCT00766701",
        "official_title": "Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy",
        "inclusion_criteria": "* Age 16 or above\n* Able to read or understand and give informed consent\n* Scheduled for colposcopy\n* Pap test within 120 days\n* Willing to undergo a Pap test and HPV test on day of study\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 16 Years",
        "exclusion_criteria": "* Pregnancy\n* Menstruating on the day of colposcopy and CNDS test\n* Radiation therapy to her genitourinary system within 1 year\n* Prior hysterectomy\n* Congenital anatomical cervical variant (e.g., double cervix)\n* Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)\n* Post-coital or other significant bleeding at the time of the exam\n* Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the investigator, to interfere with a Pap test or colposcopy, resulting from inflammatory, bacterial or other sources\n* History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).\n* Undergoing phototherapy\n* Recent use of photosensitizing agents, such as fluoroquinolones or retinoids).\n* Patients who are pregnant are not eligible for this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age 16 or above",
            "criterions": [
                {
                    "exact_snippets": "Age 16 or above",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to read or understand and give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to read or understand",
                    "criterion": "reading or understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled for colposcopy",
            "criterions": [
                {
                    "exact_snippets": "Scheduled for colposcopy",
                    "criterion": "colposcopy",
                    "requirements": [
                        {
                            "requirement_type": "scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pap test within 120 days",
            "criterions": [
                {
                    "exact_snippets": "Pap test within 120 days",
                    "criterion": "Pap test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to undergo a Pap test and HPV test on day of study",
            "criterions": [
                {
                    "exact_snippets": "Willing to undergo a Pap test",
                    "criterion": "Pap test",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to undergo a ... HPV test",
                    "criterion": "HPV test",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 16 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 16 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Menstruating on the day of colposcopy and CNDS test",
            "criterions": [
                {
                    "exact_snippets": "Menstruating on the day of colposcopy and CNDS test",
                    "criterion": "menstruation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "on the day of colposcopy and CNDS test"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiation therapy to her genitourinary system within 1 year",
            "criterions": [
                {
                    "exact_snippets": "Radiation therapy to her genitourinary system within 1 year",
                    "criterion": "radiation therapy to genitourinary system",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior hysterectomy",
            "criterions": [
                {
                    "exact_snippets": "Prior hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Congenital anatomical cervical variant (e.g., double cervix)",
            "criterions": [
                {
                    "exact_snippets": "Congenital anatomical cervical variant (e.g., double cervix)",
                    "criterion": "congenital anatomical cervical variant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)",
            "criterions": [
                {
                    "exact_snippets": "Friable cervix",
                    "criterion": "friable cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post-coital or other significant bleeding at the time of the exam",
            "criterions": [
                {
                    "exact_snippets": "Post-coital or other significant bleeding",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at the time of the exam",
                    "criterion": "timing of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of the exam"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the investigator, to interfere with a Pap test or colposcopy, resulting from inflammatory, bacterial or other sources",
            "criterions": [
                {
                    "exact_snippets": "Excessive cervical mucous or discharge",
                    "criterion": "cervical mucous or discharge",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "excessive"
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be removed",
                    "criterion": "cervical mucous or discharge",
                    "requirements": [
                        {
                            "requirement_type": "removability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant enough, in the opinion of the investigator, to interfere with a Pap test or colposcopy",
                    "criterion": "cervical mucous or discharge",
                    "requirements": [
                        {
                            "requirement_type": "interference with Pap test or colposcopy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resulting from inflammatory, bacterial or other sources",
                    "criterion": "source of cervical mucous or discharge",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": [
                                "inflammatory",
                                "bacterial",
                                "other"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).",
            "criterions": [
                {
                    "exact_snippets": "History of any photosensitizing disease",
                    "criterion": "photosensitizing disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other disease affected by Ultra-violet radiation",
                    "criterion": "disease affected by Ultra-violet radiation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergoing phototherapy",
            "criterions": [
                {
                    "exact_snippets": "Undergoing phototherapy",
                    "criterion": "phototherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "undergoing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recent use of photosensitizing agents, such as fluoroquinolones or retinoids).",
            "criterions": [
                {
                    "exact_snippets": "Recent use of photosensitizing agents",
                    "criterion": "photosensitizing agents",
                    "requirements": [
                        {
                            "requirement_type": "recent use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "such as fluoroquinolones",
                    "criterion": "fluoroquinolones",
                    "requirements": [
                        {
                            "requirement_type": "recent use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "such as ... retinoids",
                    "criterion": "retinoids",
                    "requirements": [
                        {
                            "requirement_type": "recent use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant are not eligible for this study.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant are not eligible",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}