{
"info": {
"nct_id": "NCT03051776",
"official_title": "Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.",
"inclusion_criteria": "1. Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.\n2. Having a Compression Garment suitable for the lymphedema arm\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).\n2. Metastasis breast cancer or other tumour.\n3. Treated with systemic chemotherapy and /or radiotherapy at that time\n4. Heart Failure or Renal Failure.\n5. Using Diuretics.\n6. Bilateral axillary lymphadenectomy.\n7. Cognitive impairment or delay that impedes understanding the study's instructions.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.",
"criterions": [
{
"exact_snippets": "Suffering from clinically significant breast cancer-related lymphedema",
"criterion": "breast cancer-related lymphedema",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "clinically significant"
}
]
},
{
"exact_snippets": "at least since three months ago",
"criterion": "duration of lymphedema",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "2. Having a Compression Garment suitable for the lymphedema arm",
"criterions": [
{
"exact_snippets": "Compression Garment suitable for the lymphedema arm",
"criterion": "compression garment",
"requirements": [
{
"requirement_type": "suitability",
"expected_value": "lymphedema arm"
}
]
}
]
},
{
"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. Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).",
"criterions": [
{
"exact_snippets": "Physiotherapy treatment for lymphedema during the 4 weeks before study start",
"criterion": "physiotherapy treatment for lymphedema",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "4 weeks before study start"
}
]
}
]
},
{
"line": "2. Metastasis breast cancer or other tumour.",
"criterions": [
{
"exact_snippets": "Metastasis breast cancer",
"criterion": "metastasis breast cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "other tumour",
"criterion": "other tumour",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "3. Treated with systemic chemotherapy and /or radiotherapy at that time",
"criterions": [
{
"exact_snippets": "Treated with systemic chemotherapy",
"criterion": "systemic chemotherapy",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
},
{
"exact_snippets": "Treated with ... radiotherapy",
"criterion": "radiotherapy",
"requirements": [
{
"requirement_type": "treatment",
"expected_value": true
}
]
}
]
},
{
"line": "4. Heart Failure or Renal Failure.",
"criterions": [
{
"exact_snippets": "Heart Failure",
"criterion": "heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Renal Failure",
"criterion": "renal failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "5. Using Diuretics.",
"criterions": [
{
"exact_snippets": "Using Diuretics",
"criterion": "diuretics",
"requirements": [
{
"requirement_type": "usage",
"expected_value": true
}
]
}
]
},
{
"line": "6. Bilateral axillary lymphadenectomy.",
"criterions": [
{
"exact_snippets": "Bilateral axillary lymphadenectomy",
"criterion": "axillary lymphadenectomy",
"requirements": [
{
"requirement_type": "laterality",
"expected_value": "bilateral"
}
]
}
]
},
{
"line": "7. Cognitive impairment or delay that impedes understanding the study's instructions.",
"criterions": [
{
"exact_snippets": "Cognitive impairment or delay",
"criterion": "cognitive function",
"requirements": [
{
"requirement_type": "impairment",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}