{
    "info": {
        "nct_id": "NCT03546972",
        "official_title": "Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise",
        "inclusion_criteria": "* Body Mass Index (BMI) >= 27 kg/m^2.\n* At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk > 20% or a 5 year risk >1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion.\n* 12 months without a period/menstrual cycle or having had a bilateral oophorectomy.\n* Ability to take digital time stamped photos.\n* Internet access (daily).\n* Reports being proficient in English (can read/write and speak fluently).\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 30 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible.\n* Has a current measured BMI less than 27 kg/m^2.\n* Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.\n* Currently being actively treated for cancer other than nonmelanoma skin cancer.\n* Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.\n* Reported current diagnosis or history of type I diabetes or type 2 diabetes.\n* Reported use of oral antidiabetic agents (OADs).\n* Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).\n* Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator).\n* Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide, liraglutide).\n* Fasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.\n* Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Body Mass Index (BMI) >= 27 kg/m^2.",
            "criterions": [
                {
                    "exact_snippets": "Body Mass Index (BMI) >= 27 kg/m^2",
                    "criterion": "Body Mass Index (BMI)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 27,
                                "unit": "kg/m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk > 20% or a 5 year risk >1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion.",
            "criterions": [
                {
                    "exact_snippets": "Gail model lifetime risk > 20%",
                    "criterion": "Gail model lifetime risk",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "5 year risk >1.66%",
                    "criterion": "5 year risk",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.66,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of deleterious BRCA1/2 mutation",
                    "criterion": "deleterious BRCA1/2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... mantle radiation",
                    "criterion": "mantle radiation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ductal cancer in situ",
                    "criterion": "ductal cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of high risk premalignant breast lesion",
                    "criterion": "high risk premalignant breast lesion",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 12 months without a period/menstrual cycle or having had a bilateral oophorectomy.",
            "criterions": [
                {
                    "exact_snippets": "12 months without a period/menstrual cycle",
                    "criterion": "menstrual cycle",
                    "requirements": [
                        {
                            "requirement_type": "absence_duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "having had a bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to take digital time stamped photos.",
            "criterions": [
                {
                    "exact_snippets": "Ability to take digital time stamped photos.",
                    "criterion": "ability to take digital time stamped photos",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Internet access (daily).",
            "criterions": [
                {
                    "exact_snippets": "Internet access (daily)",
                    "criterion": "internet access",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "daily"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Reports being proficient in English (can read/write and speak fluently).",
            "criterions": [
                {
                    "exact_snippets": "proficient in English (can read/write and speak fluently)",
                    "criterion": "English proficiency",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "proficient"
                        },
                        {
                            "requirement_type": "skills",
                            "expected_value": [
                                "read",
                                "write",
                                "speak"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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 30 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 30 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible.",
            "criterions": [
                {
                    "exact_snippets": "Previous participation in this trial",
                    "criterion": "previous participation in this trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Re-screening is not allowed except for individuals excluded for BMI",
                    "criterion": "re-screening",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients previous screened as ineligible due to BMI are allowed to be re-screened",
                    "criterion": "BMI exclusion",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a current measured BMI less than 27 kg/m^2.",
            "criterions": [
                {
                    "exact_snippets": "current measured BMI less than 27 kg/m^2",
                    "criterion": "BMI",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 27,
                                "unit": "kg/m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.",
            "criterions": [
                {
                    "exact_snippets": "unwilling to use Continuous Glucose Monitor (CGM)",
                    "criterion": "willingness to use Continuous Glucose Monitor (CGM)",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requires daily blood sampling by finger pricks",
                    "criterion": "ability to perform daily blood sampling by finger pricks",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently being actively treated for cancer other than nonmelanoma skin cancer.",
            "criterions": [
                {
                    "exact_snippets": "Currently being actively treated for cancer",
                    "criterion": "active cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer other than nonmelanoma skin cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "nonmelanoma skin cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.",
            "criterions": [
                {
                    "exact_snippets": "Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.",
                    "criterion": "ability to participate in ongoing appointments",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Reported current diagnosis or history of type I diabetes or type 2 diabetes.",
            "criterions": [
                {
                    "exact_snippets": "Reported current diagnosis or history of type I diabetes",
                    "criterion": "type I diabetes",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Reported current diagnosis or history of ... type 2 diabetes",
                    "criterion": "type 2 diabetes",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Reported use of oral antidiabetic agents (OADs).",
            "criterions": [
                {
                    "exact_snippets": "Reported use of oral antidiabetic agents (OADs)",
                    "criterion": "oral antidiabetic agents (OADs)",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).",
            "criterions": [
                {
                    "exact_snippets": "Current use of any drug (except metformin)",
                    "criterion": "current drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipated change in concomitant medication",
                    "criterion": "anticipated change in concomitant medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "interfere with the glucose metabolism",
                    "criterion": "interference with glucose metabolism",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator).",
            "criterions": [
                {
                    "exact_snippets": "Previous or current treatment with any insulin regimen other than basal insulin",
                    "criterion": "insulin regimen",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "basal insulin"
                        }
                    ]
                },
                {
                    "exact_snippets": "short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator",
                    "criterion": "short term treatment due to intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide, liraglutide).",
            "criterions": [
                {
                    "exact_snippets": "Previous or current treatment with GLP-1 receptor agonists",
                    "criterion": "treatment with GLP-1 receptor agonists",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exenatide, liraglutide",
                    "criterion": "specific GLP-1 receptor agonists",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "exenatide",
                                "liraglutide"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.",
            "criterions": [
                {
                    "exact_snippets": "Fasting blood glucose level > 126",
                    "criterion": "fasting blood glucose level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 126,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "glycosylated hemoglobin (HbA1c) > 7%",
                    "criterion": "glycosylated hemoglobin (HbA1c)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.",
            "criterions": [
                {
                    "exact_snippets": "Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.",
                    "criterion": "suitability for the study",
                    "requirements": [
                        {
                            "requirement_type": "investigator's assessment",
                            "expected_value": "unsuitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}