{
    "info": {
        "nct_id": "NCT00302120",
        "official_title": "MR Mammography: Randomized Controlled Trial to Study Efficiency of MR Mammography in Reducing the Number of Invasive Interventions in Nonpalpable Suspicious Breast Lesions. The MONET - Study",
        "inclusion_criteria": "* patients with a nonpalpable, mammographically suspicious breast lesion (BI-RADS 3, 4 or 5)\n* referred for large core needle biopsy\n* 18 to 75 years\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* previous breast surgery or radiation therapy of the breast less than 9 months before MR mammography\n* pregnant or lactating\n* claustrophobia or adiposity ( > 130 kg)\n* general contraindications for MRI\n* unable to maintain prone position for one hour\n* medically unstable patients",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* patients with a nonpalpable, mammographically suspicious breast lesion (BI-RADS 3, 4 or 5)",
            "criterions": [
                {
                    "exact_snippets": "nonpalpable",
                    "criterion": "breast lesion",
                    "requirements": [
                        {
                            "requirement_type": "palpability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mammographically suspicious",
                    "criterion": "breast lesion",
                    "requirements": [
                        {
                            "requirement_type": "suspicion level",
                            "expected_value": "mammographically suspicious"
                        }
                    ]
                },
                {
                    "exact_snippets": "BI-RADS 3, 4 or 5",
                    "criterion": "breast lesion",
                    "requirements": [
                        {
                            "requirement_type": "BI-RADS category",
                            "expected_value": [
                                "3",
                                "4",
                                "5"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* referred for large core needle biopsy",
            "criterions": [
                {
                    "exact_snippets": "large core needle biopsy",
                    "criterion": "biopsy type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "large core needle"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 to 75 years",
            "criterions": [
                {
                    "exact_snippets": "18 to 75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* previous breast surgery or radiation therapy of the breast less than 9 months before MR mammography",
            "criterions": [
                {
                    "exact_snippets": "previous breast surgery",
                    "criterion": "breast surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 9,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy of the breast less than 9 months before MR mammography",
                    "criterion": "breast radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 9,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* claustrophobia or adiposity ( > 130 kg)",
            "criterions": [
                {
                    "exact_snippets": "claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adiposity ( > 130 kg)",
                    "criterion": "adiposity",
                    "requirements": [
                        {
                            "requirement_type": "weight",
                            "expected_value": {
                                "operator": ">",
                                "value": 130,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* general contraindications for MRI",
            "criterions": [
                {
                    "exact_snippets": "general contraindications for MRI",
                    "criterion": "MRI contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* unable to maintain prone position for one hour",
            "criterions": [
                {
                    "exact_snippets": "unable to maintain prone position for one hour",
                    "criterion": "ability to maintain prone position",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "hour"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* medically unstable patients",
            "criterions": [
                {
                    "exact_snippets": "medically unstable patients",
                    "criterion": "medical stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}