{
    "info": {
        "nct_id": "NCT00719966",
        "official_title": "Effect of Aromatase Inhibitor Therapy for Breast Cancer on Endothelial Function",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 40 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Diagnosis of breast cancer\n* Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer\n* May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast\n* No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection\n* Hormone receptor status meeting 1 of the following criteria:\n\n  * Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI)\n  * Hormone receptor positive and are not receiving an AI\n\nPATIENT CHARACTERISTICS:\n\n* Postmenopausal\n* No known or symptomatic coronary artery disease\n* No significant co-morbidities, including any of the following conditions:\n\n  * Active renal or hepatic disease\n  * Known uncontrolled and/or untreated peripheral arterial disease\n  * Uncontrolled and/or untreated hypertension\n  * Uncontrolled and/or untreated diabetes\n  * Uncontrolled and/or untreated hyperlipidemia\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 7 days since prior hormone replacement therapy or hormone-based contraception\n* More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease\n* More than 12 months since prior and no concurrent chemotherapy for this disease\n* No prior bilateral mastectomy"
    },
    "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 40 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 40 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer",
            "criterions": [
                {
                    "exact_snippets": "Ductal carcinoma in situ (DCIS) allowed",
                    "criterion": "ductal carcinoma in situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided the patient will not receive tamoxifen",
                    "criterion": "tamoxifen treatment",
                    "requirements": [
                        {
                            "requirement_type": "planned treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast",
            "criterions": [
                {
                    "exact_snippets": "May not have had a prior mastectomy",
                    "criterion": "prior mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "requirement for mastectomy of the contralateral breast",
                    "criterion": "requirement for mastectomy of the contralateral breast",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection",
            "criterions": [
                {
                    "exact_snippets": "No requirement for axillary lymph node dissection",
                    "criterion": "axillary lymph node dissection",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of contralateral mastectomy",
                    "criterion": "contralateral mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... contralateral axillary lymph node dissection",
                    "criterion": "contralateral axillary lymph node dissection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor status meeting 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor status",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "meeting criteria",
                            "expected_value": "1 of the following"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI)",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor negative",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "not eligible for aromatase inhibitor therapy (AI)",
                    "criterion": "eligibility for aromatase inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormone receptor positive and are not receiving an AI",
            "criterions": [
                {
                    "exact_snippets": "Hormone receptor positive",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "not receiving an AI",
                    "criterion": "aromatase inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Postmenopausal",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known or symptomatic coronary artery disease",
            "criterions": [
                {
                    "exact_snippets": "No known or symptomatic coronary artery disease",
                    "criterion": "coronary artery disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant co-morbidities, including any of the following conditions:",
            "criterions": [
                {
                    "exact_snippets": "No significant co-morbidities",
                    "criterion": "co-morbidities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active renal or hepatic disease",
            "criterions": [
                {
                    "exact_snippets": "Active renal ... disease",
                    "criterion": "renal disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... hepatic disease",
                    "criterion": "hepatic disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known uncontrolled and/or untreated peripheral arterial disease",
            "criterions": [
                {
                    "exact_snippets": "Known uncontrolled and/or untreated peripheral arterial disease",
                    "criterion": "peripheral arterial disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled and/or untreated hypertension",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled and/or untreated hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled and/or untreated diabetes",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled and/or untreated diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled and/or untreated hyperlipidemia",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled and/or untreated hyperlipidemia",
                    "criterion": "hyperlipidemia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "See Disease Characteristics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 7 days since prior hormone replacement therapy or hormone-based contraception",
            "criterions": [
                {
                    "exact_snippets": "More than 7 days since prior hormone replacement therapy",
                    "criterion": "hormone replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since prior treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "More than 7 days since prior ... hormone-based contraception",
                    "criterion": "hormone-based contraception",
                    "requirements": [
                        {
                            "requirement_type": "time since prior treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease",
            "criterions": [
                {
                    "exact_snippets": "More than 12 months since prior ... tamoxifen or aromatase inhibitor therapy",
                    "criterion": "prior tamoxifen or aromatase inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no concurrent tamoxifen or aromatase inhibitor therapy",
                    "criterion": "concurrent tamoxifen or aromatase inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 12 months since prior and no concurrent chemotherapy for this disease",
            "criterions": [
                {
                    "exact_snippets": "More than 12 months since prior ... chemotherapy for this disease",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no concurrent chemotherapy for this disease",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior bilateral mastectomy",
            "criterions": [
                {
                    "exact_snippets": "No prior bilateral mastectomy",
                    "criterion": "bilateral mastectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}