{
"info": {
"nct_id": "NCT01778920",
"official_title": "Intraoperative Imaging of Pulmonary Adenocarcinoma",
"inclusion_criteria": "* Adult patients over 18 years of age\n* Patients presenting with a lung or pleural nodule or mass presumed to be resectable on pre-operative assessment\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery\n* Patients with a history of anaphylactic reactions to Folate-FITC or insects\n* At-risk patient populations:\n\n * Homeless patients\n * Patients with drug or alcohol dependence\n * Children and neonates\n * Patients unable to participate in the consent process",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Adult patients over 18 years of age",
"criterions": [
{
"exact_snippets": "Adult patients over 18 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Patients presenting with a lung or pleural nodule or mass presumed to be resectable on pre-operative assessment",
"criterions": [
{
"exact_snippets": "Patients presenting with a lung or pleural nodule or mass",
"criterion": "lung or pleural nodule or mass",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "presumed to be resectable on pre-operative assessment",
"criterion": "resectability",
"requirements": [
{
"requirement_type": "pre-operative assessment",
"expected_value": "presumed resectable"
}
]
}
]
},
{
"line": "* Good operative candidate",
"criterions": [
{
"exact_snippets": "Good operative candidate",
"criterion": "operative candidacy",
"requirements": [
{
"requirement_type": "status",
"expected_value": "good"
}
]
}
]
},
{
"line": "* Subject capable of giving informed consent and participating in the process of consent",
"criterions": [
{
"exact_snippets": "Subject capable of giving informed consent",
"criterion": "informed consent capability",
"requirements": [
{
"requirement_type": "capability",
"expected_value": true
}
]
},
{
"exact_snippets": "participating in the process of consent",
"criterion": "consent process participation",
"requirements": [
{
"requirement_type": "participation",
"expected_value": true
}
]
}
]
},
{
"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": "* Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery",
"criterions": [
{
"exact_snippets": "Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG)",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "determination method",
"expected_value": [
"urinary beta human chorionic gonadotropin (hCG)",
"serum beta human chorionic gonadotropin (hCG)"
]
}
]
},
{
"exact_snippets": "within 72 hours of surgery",
"criterion": "timing of pregnancy test",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "within 72 hours of surgery"
}
]
}
]
},
{
"line": "* Patients with a history of anaphylactic reactions to Folate-FITC or insects",
"criterions": [
{
"exact_snippets": "history of anaphylactic reactions to Folate-FITC",
"criterion": "anaphylactic reactions to Folate-FITC",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "history of anaphylactic reactions to ... insects",
"criterion": "anaphylactic reactions to insects",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* At-risk patient populations:",
"criterions": [
{
"exact_snippets": "At-risk patient populations",
"criterion": "patient population risk status",
"requirements": [
{
"requirement_type": "risk status",
"expected_value": "at-risk"
}
]
}
]
},
{
"line": "* Homeless patients",
"criterions": [
{
"exact_snippets": "Homeless patients",
"criterion": "housing status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "homeless"
}
]
}
]
},
{
"line": "* Patients with drug or alcohol dependence",
"criterions": [
{
"exact_snippets": "drug or alcohol dependence",
"criterion": "drug dependence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "drug or alcohol dependence",
"criterion": "alcohol dependence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Children and neonates",
"criterions": [
{
"exact_snippets": "Children",
"criterion": "age group",
"requirements": [
{
"requirement_type": "category",
"expected_value": "children"
}
]
},
{
"exact_snippets": "neonates",
"criterion": "age group",
"requirements": [
{
"requirement_type": "category",
"expected_value": "neonates"
}
]
}
]
},
{
"line": "* Patients unable to participate in the consent process",
"criterions": [
{
"exact_snippets": "Patients unable to participate in the consent process",
"criterion": "ability to participate in the consent process",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}