{
    "info": {
        "nct_id": "NCT02411760",
        "official_title": "Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection",
        "inclusion_criteria": "Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination.\n\nContraindications to MRI examinations include:\n\nMedically unstable\n\n* Heart failure\n* Unstable angina\n* Child bearing\n* Lactating Any contraindication per MRI Screening Form (Appendix A attached).\n* Implants contraindicated at 3T, pacemakers\n* Poorly controlled diabetes\n* Body weight greater than 300 pounds\n* Claustrophobic Since each patient is receiving a gadolinium based contrast agent intravenously:\n* eGFR < 60 mL/min/1.73m2\n* Sickle cell disease\n* Hemolytic anemia\n\nSubjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5",
                    "criterion": "BI-RADS category",
                    "requirements": [
                        {
                            "requirement_type": "category",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 4,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 5,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Ability to understand and the willingness to sign a written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability to understand",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness to sign",
                            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination.",
            "criterions": [
                {
                    "exact_snippets": "needle biopsy of the suspicious area within the last 6 weeks",
                    "criterion": "needle biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindication to contrast enhanced MRI examination",
                    "criterion": "contraindication to contrast enhanced MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Contraindications to MRI examinations include:",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to MRI examinations",
                    "criterion": "MRI contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Medically unstable",
            "criterions": [
                {
                    "exact_snippets": "Medically unstable",
                    "criterion": "medical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Heart failure",
            "criterions": [
                {
                    "exact_snippets": "Heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable angina",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Child bearing",
            "criterions": [
                {
                    "exact_snippets": "Child bearing",
                    "criterion": "child bearing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "child bearing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lactating Any contraindication per MRI Screening Form (Appendix A attached).",
            "criterions": [
                {
                    "exact_snippets": "Lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any contraindication per MRI Screening Form (Appendix A attached)",
                    "criterion": "MRI contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Implants contraindicated at 3T, pacemakers",
            "criterions": [
                {
                    "exact_snippets": "Implants contraindicated at 3T",
                    "criterion": "implants",
                    "requirements": [
                        {
                            "requirement_type": "contraindication at 3T",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pacemakers",
                    "criterion": "pacemakers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poorly controlled diabetes",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Body weight greater than 300 pounds",
            "criterions": [
                {
                    "exact_snippets": "Body weight greater than 300 pounds",
                    "criterion": "body weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 300,
                                "unit": "pounds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Claustrophobic Since each patient is receiving a gadolinium based contrast agent intravenously:",
            "criterions": [
                {
                    "exact_snippets": "Claustrophobic",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* eGFR < 60 mL/min/1.73m2",
            "criterions": [
                {
                    "exact_snippets": "eGFR < 60 mL/min/1.73m2",
                    "criterion": "eGFR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "mL/min/1.73m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sickle cell disease",
            "criterions": [
                {
                    "exact_snippets": "Sickle cell disease",
                    "criterion": "sickle cell disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemolytic anemia",
            "criterions": [
                {
                    "exact_snippets": "Hemolytic anemia",
                    "criterion": "hemolytic anemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must not be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not be ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}