{
"info": {
"nct_id": "NCT02440620",
"official_title": "Cardiac Toxicity in Medical Treatment of Breast Cancer",
"inclusion_criteria": "* Diagnosis of HER2 positive breast cancer\n* Adjuvant treatment with trastuzumab\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Left ventricle ejection fraction (LVEF) <50%\n* Chronic or persistent atrial fibrillation\n* History of moderate or severe valvular heart disease.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Diagnosis of HER2 positive breast cancer",
"criterions": [
{
"exact_snippets": "Diagnosis of HER2 positive breast cancer",
"criterion": "HER2 status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "Diagnosis of HER2 positive breast cancer",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Adjuvant treatment with trastuzumab",
"criterions": [
{
"exact_snippets": "Adjuvant treatment with trastuzumab",
"criterion": "adjuvant treatment",
"requirements": [
{
"requirement_type": "medication",
"expected_value": "trastuzumab"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"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": "* Left ventricle ejection fraction (LVEF) <50%",
"criterions": [
{
"exact_snippets": "Left ventricle ejection fraction (LVEF) <50%",
"criterion": "left ventricle ejection fraction (LVEF)",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Chronic or persistent atrial fibrillation",
"criterions": [
{
"exact_snippets": "Chronic or persistent atrial fibrillation",
"criterion": "atrial fibrillation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"chronic",
"persistent"
]
}
]
}
]
},
{
"line": "* History of moderate or severe valvular heart disease.",
"criterions": [
{
"exact_snippets": "History of moderate or severe valvular heart disease.",
"criterion": "valvular heart disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": [
"moderate",
"severe"
]
},
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}