{
    "info": {
        "nct_id": "NCT01357772",
        "official_title": "Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up",
        "inclusion_criteria": "1. Women of age ≥ 18 and < 75 years\n2. Women operated on for lobular (LIN 2 and 3) or ER positive or unknown ductal DCIS, i.e DIN 1-3, but DIN 1a excluded) intraepithelial neoplasia in the 5 years (60 months) prior the inclusion in the study. Both incident (diagnosis < 12 months) and prevalent cases diagnosis ≥12, and < 60 months) will be included, including recurrent cases\n3. ECOG Performance status ≤ 1\n4. Written informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Any type of malignancy, with the exclusion of non-melanoma skin cancer\n2. Proliferative disorders of the endometrium such as atypical hyperplasia, endometriosis, unresected polyps, symptomatic myoma\n3. Liver, kidney and heart function impairment grade ≥ 2 (CTCAE criteria v.3.0)\n4. Any type of retinal disorders, severe cataract and glaucoma\n5. Presence of significant risk factors for venous events, including immobilization after trauma within the last 3 months for longer than 2 weeks, deep venous thrombophlebitis or other significant venous thrombotic event,VTE (pulmonary embolism, stroke, etc.)\n6. Use of tamoxifen, raloxifene or other selective estrogen receptor modulator (SERMs)\n7. Use of anastrozole and other aromatase inhibitors (AI) in the last 12 months for ≥ 6 months\n8. Dicoumarol anticoagulant therapy in progress\n9. Active infections\n10. Severe psychiatric disorders or inability to comply to the protocol procedures\n11. Geographic inaccessibility or difficulties in ensuring adequate compliance\n12. Women who are pregnant or breastfeeding\n13. Any other factor which, at the discretion of the investigator, may controindicate the use of tamoxifen",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Women of age ≥ 18 and < 75 years",
            "criterions": [
                {
                    "exact_snippets": "Women of age ≥ 18 and < 75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "equality",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Women operated on for lobular (LIN 2 and 3) or ER positive or unknown ductal DCIS, i.e DIN 1-3, but DIN 1a excluded) intraepithelial neoplasia in the 5 years (60 months) prior the inclusion in the study. Both incident (diagnosis < 12 months) and prevalent cases diagnosis ≥12, and < 60 months) will be included, including recurrent cases",
            "criterions": [
                {
                    "exact_snippets": "Women operated on for lobular (LIN 2 and 3)",
                    "criterion": "lobular intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "LIN 2",
                                "LIN 3"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ER positive or unknown ductal DCIS",
                    "criterion": "ductal DCIS",
                    "requirements": [
                        {
                            "requirement_type": "ER status",
                            "expected_value": [
                                "positive",
                                "unknown"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "DIN 1-3, but DIN 1a excluded",
                    "criterion": "ductal intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "DIN 1",
                                "DIN 2",
                                "DIN 3"
                            ]
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "DIN 1a"
                        }
                    ]
                },
                {
                    "exact_snippets": "intraepithelial neoplasia in the 5 years (60 months) prior the inclusion in the study",
                    "criterion": "intraepithelial neoplasia diagnosis time",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 60,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Both incident (diagnosis < 12 months) and prevalent cases diagnosis ≥12, and < 60 months)",
                    "criterion": "case type",
                    "requirements": [
                        {
                            "requirement_type": "incident case",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "prevalent case",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 12,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 60,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including recurrent cases",
                    "criterion": "recurrent cases",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG Performance status ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance status ≤ 1",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "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": "1. Any type of malignancy, with the exclusion of non-melanoma skin cancer",
            "criterions": [
                {
                    "exact_snippets": "Any type of malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exclusion of non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Proliferative disorders of the endometrium such as atypical hyperplasia, endometriosis, unresected polyps, symptomatic myoma",
            "criterions": [
                {
                    "exact_snippets": "Proliferative disorders of the endometrium such as atypical hyperplasia",
                    "criterion": "atypical hyperplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Proliferative disorders of the endometrium such as ... endometriosis",
                    "criterion": "endometriosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Proliferative disorders of the endometrium such as ... unresected polyps",
                    "criterion": "unresected polyps",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Proliferative disorders of the endometrium such as ... symptomatic myoma",
                    "criterion": "symptomatic myoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Liver, kidney and heart function impairment grade ≥ 2 (CTCAE criteria v.3.0)",
            "criterions": [
                {
                    "exact_snippets": "Liver ... function impairment grade ≥ 2 (CTCAE criteria v.3.0)",
                    "criterion": "liver function impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "kidney ... function impairment grade ≥ 2 (CTCAE criteria v.3.0)",
                    "criterion": "kidney function impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "heart function impairment grade ≥ 2 (CTCAE criteria v.3.0)",
                    "criterion": "heart function impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Any type of retinal disorders, severe cataract and glaucoma",
            "criterions": [
                {
                    "exact_snippets": "Any type of retinal disorders",
                    "criterion": "retinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe cataract",
                    "criterion": "cataract",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "glaucoma",
                    "criterion": "glaucoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Presence of significant risk factors for venous events, including immobilization after trauma within the last 3 months for longer than 2 weeks, deep venous thrombophlebitis or other significant venous thrombotic event,VTE (pulmonary embolism, stroke, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Presence of significant risk factors for venous events",
                    "criterion": "significant risk factors for venous events",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immobilization after trauma within the last 3 months for longer than 2 weeks",
                    "criterion": "immobilization after trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since trauma",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "deep venous thrombophlebitis",
                    "criterion": "deep venous thrombophlebitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant venous thrombotic event",
                    "criterion": "significant venous thrombotic event",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "VTE (pulmonary embolism, stroke, etc.)",
                    "criterion": "VTE",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Use of tamoxifen, raloxifene or other selective estrogen receptor modulator (SERMs)",
            "criterions": [
                {
                    "exact_snippets": "Use of tamoxifen, raloxifene or other selective estrogen receptor modulator (SERMs)",
                    "criterion": "use of selective estrogen receptor modulators (SERMs)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Use of anastrozole and other aromatase inhibitors (AI) in the last 12 months for ≥ 6 months",
            "criterions": [
                {
                    "exact_snippets": "Use of anastrozole and other aromatase inhibitors (AI)",
                    "criterion": "use of aromatase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the last 12 months",
                    "criterion": "timeframe of aromatase inhibitor use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "for ≥ 6 months",
                    "criterion": "duration of aromatase inhibitor use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Dicoumarol anticoagulant therapy in progress",
            "criterions": [
                {
                    "exact_snippets": "Dicoumarol anticoagulant therapy in progress",
                    "criterion": "Dicoumarol anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "in progress"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Active infections",
            "criterions": [
                {
                    "exact_snippets": "Active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Severe psychiatric disorders or inability to comply to the protocol procedures",
            "criterions": [
                {
                    "exact_snippets": "Severe psychiatric disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to comply to the protocol procedures",
                    "criterion": "ability to comply with protocol procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Geographic inaccessibility or difficulties in ensuring adequate compliance",
            "criterions": [
                {
                    "exact_snippets": "Geographic inaccessibility",
                    "criterion": "geographic accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "difficulties in ensuring adequate compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Women who are pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women who are ... breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Any other factor which, at the discretion of the investigator, may controindicate the use of tamoxifen",
            "criterions": [
                {
                    "exact_snippets": "Any other factor which, at the discretion of the investigator, may controindicate the use of tamoxifen",
                    "criterion": "factor contraindicating tamoxifen use",
                    "requirements": [
                        {
                            "requirement_type": "discretion of the investigator",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}