{
    "info": {
        "nct_id": "NCT03429582",
        "official_title": "Comparison of Cervical Intraepithelial Neoplasia 2/3 Treatment Outcomes With a Portable LMIC-adapted Thermal Ablation Device vs. Gas-based Cryotherapy",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Criteria for inclusion\n\n* Women aged 18 and older\n* Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified\n* Willing and able to provide informed consent\n* Willing and able to provide permanent or reliable address\n\nCriteria for exclusion\n\n* Pregnant or plans to become pregnant during study\n* History of total hysterectomy (verified by medical record or pelvic evaluation)\n* Previous surgery destructive to the cervix within the last 5 years\n* Patient not eligible for cryotherapy or thermoablation (lesion >75% of cervix, lesion extends into canal or there is suspicion for invasive cancer)\n* Cervix shape disfigured or hard to reach"
    },
    "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Women aged 18 and older",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 and older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified",
            "criterions": [
                {
                    "exact_snippets": "Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified",
                    "criterion": "biopsy results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "CIN2",
                                "CIN2-3",
                                "CIN3",
                                "high-grade CIN not otherwise specified"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to provide permanent or reliable address",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to provide permanent or reliable address",
                    "criterion": "address",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "permanent",
                                "reliable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or plans to become pregnant during study",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "plans to become pregnant during study",
                    "criterion": "intention to become pregnant",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of total hysterectomy (verified by medical record or pelvic evaluation)",
            "criterions": [
                {
                    "exact_snippets": "History of total hysterectomy",
                    "criterion": "total hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous surgery destructive to the cervix within the last 5 years",
            "criterions": [
                {
                    "exact_snippets": "Previous surgery destructive to the cervix",
                    "criterion": "previous surgery destructive to the cervix",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient not eligible for cryotherapy or thermoablation (lesion >75% of cervix, lesion extends into canal or there is suspicion for invasive cancer)",
            "criterions": [
                {
                    "exact_snippets": "lesion >75% of cervix",
                    "criterion": "lesion size relative to cervix",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 75,
                                "unit": "% of cervix"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion extends into canal",
                    "criterion": "lesion extension into canal",
                    "requirements": [
                        {
                            "requirement_type": "extension",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicion for invasive cancer",
                    "criterion": "suspicion for invasive cancer",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Criteria for inclusion",
            "criterions": []
        },
        {
            "line": "Criteria for exclusion",
            "criterions": []
        },
        {
            "line": "* Cervix shape disfigured or hard to reach",
            "criterions": [
                {
                    "exact_snippets": "Cervix shape disfigured",
                    "criterion": "cervix shape",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "disfigured"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervix ... hard to reach",
                    "criterion": "cervix accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "hard to reach"
                        }
                    ]
                }
            ]
        }
    ]
}