{
"info": {
"nct_id": "NCT04219072",
"official_title": "Clinical Classification of Pain in Breast Cancer Survivors: Nociceptive, Neuropathic or Nociplastic Pain",
"inclusion_criteria": "* diagnosed with histologically confirmed invasive or non-invasive primary breast cancer\n* completed remission and their primary treatment at least 3 months prior to study participation\n* experienced pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 3 on a numeric pain rating scale\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* patients affected by other chronic disease,\n* severe psychological disorders\n* active metastases",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterions": [
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "histological confirmation",
"expected_value": true
}
},
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "invasiveness",
"expected_value": [
"invasive",
"non-invasive"
]
}
},
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "primary",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "histological confirmation",
"expected_value": true
}
}
]
},
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "invasiveness",
"expected_value": [
"invasive",
"non-invasive"
]
}
}
]
},
{
"exact_snippets": "diagnosed with histologically confirmed invasive or non-invasive primary breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "primary",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* completed remission and their primary treatment at least 3 months prior to study participation",
"criterions": [
{
"exact_snippets": "completed remission",
"criterion": "remission status",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "completed ... primary treatment at least 3 months prior to study participation",
"criterion": "primary treatment completion",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "completed remission",
"criterion": "remission status",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "completed ... primary treatment at least 3 months prior to study participation",
"criterion": "primary treatment completion",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* experienced pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 3 on a numeric pain rating scale",
"criterions": [
{
"exact_snippets": "experienced pain ... minimum score of 3 on a numeric pain rating scale",
"criterion": "pain",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "numeric pain rating scale"
}
}
},
{
"exact_snippets": "sensitive disorder (like numbness, tingling, etc.)",
"criterion": "sensitive disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "experienced pain ... minimum score of 3 on a numeric pain rating scale",
"criterion": "pain",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "numeric pain rating scale"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "sensitive disorder (like numbness, tingling, etc.)",
"criterion": "sensitive disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* patients affected by other chronic disease,",
"criterions": [
{
"exact_snippets": "patients affected by other chronic disease",
"criterion": "chronic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "patients affected by other chronic disease",
"criterion": "chronic disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* severe psychological disorders",
"criterions": [
{
"exact_snippets": "severe psychological disorders",
"criterion": "psychological disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "severe psychological disorders",
"criterion": "psychological disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
}
},
{
"identified_line": {
"line": "* active metastases",
"criterions": [
{
"exact_snippets": "active metastases",
"criterion": "metastases",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "active metastases",
"criterion": "metastases",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}