{
    "info": {
        "nct_id": "NCT01559194",
        "official_title": "A Randomized Comparison of a Low Fat or Low Carbohydrate Dietary Pattern for Weight Loss and Impact on Biomarkers Associated With Breast Cancer Risk in Overweight and Obese Premenopausal Women: Lifestyle Eating and Fitness",
        "inclusion_criteria": "* Aged 30 and older\n* Premenopausal (may be confirmed by FSH)\n* No previous diagnosis of cancer (except non-melanomatous skin cancer)\n* Body mass index between 25-34 kg/m2\n* Women must be expected to live in the Columbus area for the next 18 months.\n* All women must present a letter of medical clearance from their primary care physician.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 30 Years",
        "exclusion_criteria": "* Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.\n* Women who are already participating in a formal weight loss program (such as Weight Watchers)will not be eligible.\n* Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.\n* All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Aged 30 and older",
            "criterions": [
                {
                    "exact_snippets": "Aged 30 and older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Premenopausal (may be confirmed by FSH)",
            "criterions": [
                {
                    "exact_snippets": "Premenopausal (may be confirmed by FSH)",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "FSH"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous diagnosis of cancer (except non-melanomatous skin cancer)",
            "criterions": [
                {
                    "exact_snippets": "No previous diagnosis of cancer",
                    "criterion": "previous cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except non-melanomatous skin cancer",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Body mass index between 25-34 kg/m2",
            "criterions": [
                {
                    "exact_snippets": "Body mass index between 25-34 kg/m2",
                    "criterion": "body mass index",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 25,
                                        "unit": "kg/m2"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 34,
                                        "unit": "kg/m2"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must be expected to live in the Columbus area for the next 18 months.",
            "criterions": [
                {
                    "exact_snippets": "Women must be expected to live in the Columbus area",
                    "criterion": "residence",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "Columbus area"
                        }
                    ]
                },
                {
                    "exact_snippets": "for the next 18 months",
                    "criterion": "residence duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All women must present a letter of medical clearance from their primary care physician.",
            "criterions": [
                {
                    "exact_snippets": "All women must present a letter of medical clearance from their primary care physician.",
                    "criterion": "letter of medical clearance",
                    "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"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnant women or women who plan to become pregnant during the study period will not be enrolled. Women who become pregnant during the intervention will be withdrawn from the study.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women ... will not be enrolled.",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "women who plan to become pregnant during the study period will not be enrolled.",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "not planning to become pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who become pregnant during the intervention will be withdrawn from the study.",
                    "criterion": "pregnancy status during intervention",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not pregnant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are already participating in a formal weight loss program (such as Weight Watchers)will not be eligible.",
            "criterions": [
                {
                    "exact_snippets": "Women who are already participating in a formal weight loss program (such as Weight Watchers)",
                    "criterion": "participation in a formal weight loss program",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All medical problems must be managed and controlled. Lipid profile, blood glucose, hemoglobin A1c, and blood pressure will be assessed at the screening visit. These results will be reviewed by the study physician. Women who have abnormal values that, at the discretion of the study physician, would benefit from medical management will be referred to a primary care physician prior to considering them for enrollment.",
            "criterions": [
                {
                    "exact_snippets": "All medical problems must be managed and controlled.",
                    "criterion": "medical problems",
                    "requirements": [
                        {
                            "requirement_type": "management and control",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Lipid profile ... will be assessed at the screening visit.",
                    "criterion": "lipid profile",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood glucose ... will be assessed at the screening visit.",
                    "criterion": "blood glucose",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin A1c ... will be assessed at the screening visit.",
                    "criterion": "hemoglobin A1c",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood pressure ... will be assessed at the screening visit.",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Women with a medical history that precludes adherence to either of the two dietary patterns will also be excluded. This includes a history of renal insufficiency, gluten enteropathy, Crohn's disease or other medical conditions that significantly impact nutritional status or metabolism. Women with either type I or controlled type II diabetes will be eligible to participate in this trial.",
            "criterions": [
                {
                    "exact_snippets": "medical history that precludes adherence to either of the two dietary patterns",
                    "criterion": "adherence to dietary patterns",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of renal insufficiency",
                    "criterion": "renal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of gluten enteropathy",
                    "criterion": "gluten enteropathy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of Crohn's disease",
                    "criterion": "Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other medical conditions that significantly impact nutritional status or metabolism",
                    "criterion": "medical conditions impacting nutritional status or metabolism",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women with either type I or controlled type II diabetes will be eligible",
                    "criterion": "type I or controlled type II diabetes",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}