{
    "info": {
        "nct_id": "NCT00001073",
        "official_title": "A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 13 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\nYou may be eligible for this study if you:\n\n* Are an HIV-positive female.\n* Are at least 13 years old. (Need consent of parent or guardian if under 18.)\n* Have cervical tumors, as determined by a biopsy performed by a doctor.\n* Agree to use both condoms and the pill during the study.\n\nExclusion Criteria\n\nYou will not be eligible for this study if you:\n\n* Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months.\n* Have had a hysterectomy (uterus removed) within the past 4 months.\n* Are taking tetracycline or Vitamin A.\n* Have taken certain medications. (Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.)\n* Are pregnant."
    },
    "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 gender",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 13 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 13 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Are an HIV-positive female.",
            "criterions": [
                {
                    "exact_snippets": "HIV-positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are at least 13 years old. (Need consent of parent or guardian if under 18.)",
            "criterions": [
                {
                    "exact_snippets": "at least 13 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 13,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Need consent of parent or guardian if under 18",
                    "criterion": "parental consent",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "required if under 18"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have cervical tumors, as determined by a biopsy performed by a doctor.",
            "criterions": [
                {
                    "exact_snippets": "cervical tumors, as determined by a biopsy",
                    "criterion": "cervical tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "determination method",
                            "expected_value": "biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Agree to use both condoms and the pill during the study.",
            "criterions": [
                {
                    "exact_snippets": "use both condoms and the pill during the study",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "condoms",
                                "the pill"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months.",
            "criterions": [
                {
                    "exact_snippets": "Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months.",
                    "criterion": "cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have had a hysterectomy (uterus removed) within the past 4 months.",
            "criterions": [
                {
                    "exact_snippets": "Have had a hysterectomy (uterus removed) within the past 4 months.",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are taking tetracycline or Vitamin A.",
            "criterions": [
                {
                    "exact_snippets": "taking tetracycline",
                    "criterion": "tetracycline usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "taking ... Vitamin A",
                    "criterion": "Vitamin A usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have taken certain medications. (Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.)",
            "criterions": [
                {
                    "exact_snippets": "Have taken certain medications.",
                    "criterion": "medication history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.",
                    "criterion": "anti-HIV drugs and medications to prevent AIDS-related opportunistic infections",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are pregnant.",
            "criterions": [
                {
                    "exact_snippets": "Are pregnant.",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "You may be eligible for this study if you:",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        },
        {
            "line": "You will not be eligible for this study if you:",
            "criterions": []
        }
    ]
}