{
"info": {
"nct_id": "NCT06428994",
"official_title": "Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study",
"inclusion_criteria": "* Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Cases with incomplete medical records.\n* Patients who did not attend at least 6 months of follow ups.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019.",
"criterions": [
{
"exact_snippets": "underwent a mandibular reconstruction with a free fibula flap",
"criterion": "mandibular reconstruction with a free fibula flap",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "due to head and neck cancer",
"criterion": "head and neck cancer",
"requirement": {
"requirement_type": "cause",
"expected_value": true
}
},
{
"exact_snippets": "through January 2014 to December 2019",
"criterion": "procedure date",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2014,
"unit": "year"
},
{
"operator": "<=",
"value": 2019,
"unit": "year"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "underwent a mandibular reconstruction with a free fibula flap",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "due to head and neck cancer",
"criterion": "head and neck cancer",
"requirement": {
"requirement_type": "cause",
"expected_value": true
}
},
{
"exact_snippets": "through January 2014 to December 2019",
"criterion": "procedure date",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2014,
"unit": "year"
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{
"operator": "<=",
"value": 2019,
"unit": "year"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
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}
]
},
"logical_structure": {
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
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"unit": "Years"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Cases with incomplete medical records.",
"criterions": [
{
"exact_snippets": "incomplete medical records",
"criterion": "medical records",
"requirement": {
"requirement_type": "completeness",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "incomplete medical records",
"criterion": "medical records",
"requirement": {
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"expected_value": false
}
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},
{
"identified_line": {
"line": "* Patients who did not attend at least 6 months of follow ups.",
"criterions": [
{
"exact_snippets": "did not attend at least 6 months of follow ups",
"criterion": "follow-up attendance",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "months"
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}
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},
"logical_structure": {
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"value": 6,
"unit": "months"
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}