{
    "info": {
        "nct_id": "NCT00968682",
        "official_title": "Detection of Cardiac Dysfunction in Patients Treated With Trastuzumab for HER-2 Positive Breast Cancer. The CADY Study",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.\n2. Evidence of metastatic disease.\n3. Patients with uncontrolled hypertension (sustained systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.\n4. Prior anthracycline or Trastuzumab therapy.\n5. Inability to give informed consent for any reason.",
        "miscellaneous_criteria": "Inclusion Criteria\n\n1. HER-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.\n2. Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab.\n3. 18 years of age or older.\n4. Disease Stage I-III, whose treatment plan includes Trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.\n5. As this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.\n6. Treatment with curative intent.\n7. ECOG Performance status 0, 1 or 2.\n8. Adequate cardiac function, with MUGA or Echocardiograph > 50%.\n9. Written informed consent."
    },
    "inclusion_lines": [
        {
            "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": "1. Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.",
            "criterions": [
                {
                    "exact_snippets": "Presence of a medical or psychiatric condition",
                    "criterion": "medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Evidence of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with uncontrolled hypertension (sustained systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension (sustained systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 180,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve)",
                    "criterion": "valvular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "regurgitation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "severity scale"
                            }
                        },
                        {
                            "requirement_type": "stenosis",
                            "expected_value": "present"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of uncontrolled cardiac arrhythmias",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior symptomatic or asymptomatic myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "asymptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "angina pectoris requiring anti-anginal medication",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "medication requirement",
                            "expected_value": "anti-anginal medication"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Prior anthracycline or Trastuzumab therapy.",
            "criterions": [
                {
                    "exact_snippets": "Prior anthracycline ... therapy",
                    "criterion": "anthracycline therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... Trastuzumab therapy",
                    "criterion": "Trastuzumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Inability to give informed consent for any reason.",
            "criterions": [
                {
                    "exact_snippets": "Inability to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "1. HER-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.",
            "criterions": [
                {
                    "exact_snippets": "HER-2 positive breast cancer",
                    "criterion": "HER-2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "immunohistochemistry",
                    "criterion": "immunohistochemistry",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "used"
                        }
                    ]
                },
                {
                    "exact_snippets": "fluorescence in-situ hybridisation",
                    "criterion": "fluorescence in-situ hybridisation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "used"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab.",
            "criterions": [
                {
                    "exact_snippets": "Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination",
                    "criterion": "planned neoadjuvant and/or adjuvant treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "chemotherapy",
                                "Trastuzumab"
                            ]
                        },
                        {
                            "requirement_type": "treatment sequence",
                            "expected_value": [
                                "sequentially",
                                "in combination"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "single agent Trastuzumab",
                    "criterion": "planned treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "single agent Trastuzumab"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Disease Stage I-III, whose treatment plan includes Trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.",
            "criterions": [
                {
                    "exact_snippets": "Disease Stage I-III",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment plan includes Trastuzumab",
                    "criterion": "treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "Trastuzumab"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. As this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.",
            "criterions": [
                {
                    "exact_snippets": "patients enrolled in therapeutic clinical trials",
                    "criterion": "enrollment in therapeutic clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Treatment with curative intent.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with curative intent.",
                    "criterion": "treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. ECOG Performance status 0, 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance status 0, 1 or 2.",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Adequate cardiac function, with MUGA or Echocardiograph > 50%.",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MUGA or Echocardiograph > 50%",
                    "criterion": "MUGA or Echocardiograph",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        }
    ]
}