{
"info": {
"nct_id": "NCT03235648",
"official_title": "Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 20 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Anathestically unfit patient\n* Unresectable disease\n* Patient refusal\n* No detected CPLN by preoperative radiology",
"miscellaneous_criteria": "Inclusion criteria\n\n* Ovarian cancer patient (FIGO stage III-IV)\n* Preoperative CT showing CPLN with short axis diameter > 5mm.\n* Anathestically fit patient (ASA score I or II).\n* Accepted pulmonary function test.\n* Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled\n* Written informed consent.\n* Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )"
},
"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 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Anathestically unfit patient",
"criterions": [
{
"exact_snippets": "Anathestically unfit patient",
"criterion": "anesthetic fitness",
"requirements": [
{
"requirement_type": "fitness",
"expected_value": false
}
]
}
]
},
{
"line": "* Unresectable disease",
"criterions": [
{
"exact_snippets": "Unresectable disease",
"criterion": "disease resectability",
"requirements": [
{
"requirement_type": "resectability",
"expected_value": false
}
]
}
]
},
{
"line": "* Patient refusal",
"criterions": [
{
"exact_snippets": "Patient refusal",
"criterion": "patient consent",
"requirements": [
{
"requirement_type": "consent",
"expected_value": false
}
]
}
]
},
{
"line": "* No detected CPLN by preoperative radiology",
"criterions": [
{
"exact_snippets": "No detected CPLN by preoperative radiology",
"criterion": "CPLN (central pelvic lymph nodes)",
"requirements": [
{
"requirement_type": "detection",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [
{
"line": "* Ovarian cancer patient (FIGO stage III-IV)",
"criterions": [
{
"exact_snippets": "Ovarian cancer patient",
"criterion": "ovarian cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "FIGO stage III-IV",
"criterion": "FIGO stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "stage"
},
{
"operator": "<=",
"value": 4,
"unit": "stage"
}
]
}
}
]
}
]
},
{
"line": "* Preoperative CT showing CPLN with short axis diameter > 5mm.",
"criterions": [
{
"exact_snippets": "Preoperative CT showing CPLN with short axis diameter > 5mm.",
"criterion": "CPLN short axis diameter",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "mm"
}
}
]
}
]
},
{
"line": "* Anathestically fit patient (ASA score I or II).",
"criterions": [
{
"exact_snippets": "Anathestically fit patient (ASA score I or II)",
"criterion": "anesthetic fitness",
"requirements": [
{
"requirement_type": "ASA score",
"expected_value": [
"I",
"II"
]
}
]
}
]
},
{
"line": "* Accepted pulmonary function test.",
"criterions": [
{
"exact_snippets": "Accepted pulmonary function test.",
"criterion": "pulmonary function test",
"requirements": [
{
"requirement_type": "acceptance",
"expected_value": true
}
]
}
]
},
{
"line": "* Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled",
"criterions": [
{
"exact_snippets": "Patient who received neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy",
"requirements": [
{
"requirement_type": "receipt",
"expected_value": true
}
]
},
{
"exact_snippets": "recurrent cases may be enrolled",
"criterion": "recurrent cases",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"line": "* Written informed consent.",
"criterions": [
{
"exact_snippets": "Written informed consent.",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )",
"criterions": [
{
"exact_snippets": "Achievement of optimal cytoreduction intra-abdominal",
"criterion": "optimal cytoreduction",
"requirements": [
{
"requirement_type": "achievement",
"expected_value": true
}
]
},
{
"exact_snippets": "No residual disease more than 1 cm",
"criterion": "residual disease",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "cm"
}
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "Inclusion criteria",
"criterions": []
}
]
}