{
    "info": {
        "nct_id": "NCT00784862",
        "official_title": "A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alone, Nolvadex Alone, or Arimidex and Nolvadex in Combination, When Used as Adjuvant Treatment for Breast Cancer in Postmenopausal Women",
        "inclusion_criteria": "* Eligible for entry into the main ATAC trial 1033IL/0029\n* Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study)\n* Patients should be taking their medication in the mornings for at least 3 months\n* Patients must be 100% compliant over the preceding fourteen days\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 45 Years",
        "exclusion_criteria": "* Excluded from entry into the main ATAC trial (1033IL/0029)\n* Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Eligible for entry into the main ATAC trial 1033IL/0029",
            "criterions": [
                {
                    "exact_snippets": "Eligible for entry into the main ATAC trial 1033IL/0029",
                    "criterion": "eligibility for ATAC trial 1033IL/0029",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have been taking ATAC trial medication for at least 3 months (i.e. patients must have reached at least visit 2 of the main ATAC study)",
            "criterions": [
                {
                    "exact_snippets": "Patients must have been taking ATAC trial medication for at least 3 months",
                    "criterion": "ATAC trial medication duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must have reached at least visit 2 of the main ATAC study",
                    "criterion": "ATAC study visit",
                    "requirements": [
                        {
                            "requirement_type": "visit number",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "visit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients should be taking their medication in the mornings for at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "Patients should be taking their medication in the mornings",
                    "criterion": "medication timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "mornings"
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 3 months",
                    "criterion": "medication duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be 100% compliant over the preceding fourteen days",
            "criterions": [
                {
                    "exact_snippets": "Patients must be 100% compliant over the preceding fourteen days",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "=",
                                "value": 100,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time period",
                            "expected_value": "preceding fourteen days"
                        }
                    ]
                }
            ]
        },
        {
            "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 45 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 45 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Excluded from entry into the main ATAC trial (1033IL/0029)",
            "criterions": [
                {
                    "exact_snippets": "Excluded from entry into the main ATAC trial (1033IL/0029)",
                    "criterion": "entry into the main ATAC trial",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients whose concurrent treatment includes diazepam or drugs which might affect tamoxifen steady state levels or steroid hormone status. These include ketoconazole (antifungal) or related compounds",
            "criterions": [
                {
                    "exact_snippets": "concurrent treatment includes diazepam",
                    "criterion": "concurrent treatment with diazepam",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drugs which might affect tamoxifen steady state levels",
                    "criterion": "drugs affecting tamoxifen steady state levels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "drugs which might affect ... steroid hormone status",
                    "criterion": "drugs affecting steroid hormone status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "These include ketoconazole (antifungal) or related compounds",
                    "criterion": "treatment with ketoconazole or related compounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}