{
    "info": {
        "nct_id": "NCT01693731",
        "official_title": "Oral Health in Breast Cancer Survivors on Aromatase Inhibitors",
        "inclusion_criteria": "Postmenopausal as defined by NCCN (any of the following)\n\n* Prior bilateral oophorectomy\n* Age equal to or greater then 60 years of age\n* Age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifen or ovarian suppression and FSH and estradiol in the postmenopausal range\n* If taking tamoxifen or toremifen and age less then 60y, then FSH and plasma estradiol level in postmenopausal ranges\n\nInformed consent- Individuals capable of consenting and self administering the survey instrument Dentate- At least 15 teeth present.\n\nAI users:\n\n* Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease.\n* Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole) > 1 month. Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study.\n\nControls:\n\n* No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of localized thyroid or skin cancer).\nHealthy volunteers allowed\nMust be FEMALE",
        "exclusion_criteria": "Medical history\n\n* Metastatic BCa (AI treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).\n* Significant psychiatric illness/social situations that would preclude completion of questionnaire.\n\nMedications\n\n* Chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). NSAIDS and bisphosphonates are permitted.\n* Premedication- Conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (Patients taking prophylaxis for joint replacements will not be excluded.)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Postmenopausal as defined by NCCN (any of the following)",
            "criterions": [
                {
                    "exact_snippets": "Postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior bilateral oophorectomy",
            "criterions": [
                {
                    "exact_snippets": "Prior bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age equal to or greater then 60 years of age",
            "criterions": [
                {
                    "exact_snippets": "Age equal to or greater then 60 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifen or ovarian suppression and FSH and estradiol in the postmenopausal range",
            "criterions": [
                {
                    "exact_snippets": "Age less then 60",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "amenorrheic for 12 or more months",
                    "criterion": "amenorrhea",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of chemotherapy, tamoxifen, toremifen or ovarian suppression",
                    "criterion": "absence of specific treatments",
                    "requirements": [
                        {
                            "requirement_type": "treatments",
                            "expected_value": [
                                "chemotherapy",
                                "tamoxifen",
                                "toremifen",
                                "ovarian suppression"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "FSH and estradiol in the postmenopausal range",
                    "criterion": "FSH and estradiol levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If taking tamoxifen or toremifen and age less then 60y, then FSH and plasma estradiol level in postmenopausal ranges",
            "criterions": [
                {
                    "exact_snippets": "taking tamoxifen or toremifen",
                    "criterion": "medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "tamoxifen",
                                "toremifen"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "age less then 60y",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "y"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "FSH ... in postmenopausal ranges",
                    "criterion": "FSH level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal ranges"
                        }
                    ]
                },
                {
                    "exact_snippets": "plasma estradiol level in postmenopausal ranges",
                    "criterion": "plasma estradiol level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal ranges"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Informed consent- Individuals capable of consenting and self administering the survey instrument Dentate- At least 15 teeth present.",
            "criterions": [
                {
                    "exact_snippets": "Informed consent- Individuals capable of consenting",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "capable of consenting"
                        }
                    ]
                },
                {
                    "exact_snippets": "self administering the survey instrument",
                    "criterion": "survey instrument administration",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "self administering"
                        }
                    ]
                },
                {
                    "exact_snippets": "Dentate- At least 15 teeth present.",
                    "criterion": "dentition",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "teeth"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "AI users:",
            "criterions": [
                {
                    "exact_snippets": "AI users",
                    "criterion": "AI users",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with no evidence of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of BCa",
                    "criterion": "BCa diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologic confirmed diagnosis of BCa",
                    "criterion": "histologic confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage 0, I, II, or III",
                    "criterion": "BCa stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "0",
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole) > 1 month. Subjects may have had prior tamoxifen or raloxifene. Subjects may have had chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI therapy. If a subject started AI, discontinued, then restarted, they will be accepted into the study.",
            "criterions": [
                {
                    "exact_snippets": "Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole) > 1 month.",
                    "criterion": "AI treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects may have had prior tamoxifen or raloxifene.",
                    "criterion": "prior tamoxifen or raloxifene treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects may have had chemotherapy and/or radiation therapy.",
                    "criterion": "prior chemotherapy or radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Must be within the first year of consecutive AI therapy.",
                    "criterion": "consecutive AI therapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If a subject started AI, discontinued, then restarted, they will be accepted into the study.",
                    "criterion": "AI treatment discontinuation and restart",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not including a history of localized thyroid or skin cancer).",
            "criterions": [
                {
                    "exact_snippets": "No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Not including a history of localized thyroid or skin cancer",
                    "criterion": "history of localized thyroid or skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "Medical history",
            "criterions": [
                {
                    "exact_snippets": "Medical history",
                    "criterion": "medical history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic BCa (AI treated group: fully resected locally recurrent disease is permitted if the patient has been rendered without evidence of disease).",
            "criterions": [
                {
                    "exact_snippets": "Metastatic BCa",
                    "criterion": "metastatic bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "AI treated group: fully resected locally recurrent disease is permitted",
                    "criterion": "locally recurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "fully resected"
                        }
                    ]
                },
                {
                    "exact_snippets": "if the patient has been rendered without evidence of disease",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant psychiatric illness/social situations that would preclude completion of questionnaire.",
            "criterions": [
                {
                    "exact_snippets": "Significant psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "social situations that would preclude completion of questionnaire",
                    "criterion": "social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on questionnaire completion",
                            "expected_value": "preclude"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Medications",
            "criterions": [
                {
                    "exact_snippets": "Medications",
                    "criterion": "medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily). NSAIDS and bisphosphonates are permitted.",
            "criterions": [
                {
                    "exact_snippets": "Chronic medications known to affect the periodontal status (calcium antagonist, anti-convulsives, immunosuppressives (> prednisone 7.5mg daily)",
                    "criterion": "chronic medications affecting periodontal status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "NSAIDS and bisphosphonates are permitted",
                    "criterion": "NSAIDS and bisphosphonates",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Premedication- Conditions that require antibiotic therapy will be evaluated on a case-by-case basis. (Patients taking prophylaxis for joint replacements will not be excluded.)",
            "criterions": [
                {
                    "exact_snippets": "Conditions that require antibiotic therapy",
                    "criterion": "conditions requiring antibiotic therapy",
                    "requirements": [
                        {
                            "requirement_type": "evaluation",
                            "expected_value": "case-by-case basis"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients taking prophylaxis for joint replacements will not be excluded",
                    "criterion": "prophylaxis for joint replacements",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Controls:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}