{
"info": {
"nct_id": "NCT02369211",
"official_title": "Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy",
"inclusion_criteria": "* Patients undergoing robotic-assisted laparoscopic prostatectomy\n* ≥18 years old males\n* American Society of Anesthesiologists class 1-4\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
"exclusion_criteria": "* Chronic opiate use\n* Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)\n* Allergy/hypersensitivity to acetaminophen\n* Patients with baseline dementia\n* Chronic diathesis\n* Chronic kidney disease",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients undergoing robotic-assisted laparoscopic prostatectomy",
"criterions": [
{
"exact_snippets": [
"Patients undergoing robotic-assisted laparoscopic prostatectomy"
],
"criterion": "robotic-assisted laparoscopic prostatectomy",
"requirement_type": "undergoing",
"expected_value": true
}
]
},
{
"line": "* American Society of Anesthesiologists class 1-4",
"criterions": [
{
"exact_snippets": [
"American Society of Anesthesiologists class 1-4"
],
"criterion": "American Society of Anesthesiologists class",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1
},
{
"operator": "<=",
"value": 4
}
]
}
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": [
"Must be MALE"
],
"criterion": "gender",
"requirement_type": "specificity",
"expected_value": "male"
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
},
{
"line": "Must have maximum age of 85 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 85 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 85
}
}
]
}
],
"exclusion_lines": [
{
"line": "* Chronic opiate use",
"criterions": [
{
"exact_snippets": [
"Chronic opiate use"
],
"criterion": "opiate use",
"requirement_type": "chronicity",
"expected_value": true
}
]
},
{
"line": "* Allergy/hypersensitivity to acetaminophen",
"criterions": [
{
"exact_snippets": [
"Allergy/hypersensitivity to acetaminophen"
],
"criterion": "acetaminophen",
"requirement_type": "allergy/hypersensitivity",
"expected_value": true
}
]
},
{
"line": "* Patients with baseline dementia",
"criterions": [
{
"exact_snippets": [
"baseline dementia"
],
"criterion": "dementia",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* Chronic diathesis",
"criterions": [
{
"exact_snippets": [
"Chronic diathesis"
],
"criterion": "chronic diathesis",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "* Chronic kidney disease",
"criterions": [
{
"exact_snippets": [
"Chronic kidney disease"
],
"criterion": "chronic kidney disease",
"requirement_type": "presence",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* ≥18 years old males",
"criterions": [
{
"exact_snippets": [
">=18 years old"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
},
{
"exact_snippets": [
"males"
],
"criterion": "gender",
"requirement_type": "specific",
"expected_value": "male"
}
]
}
],
"failed_exclusion": [
{
"line": "* Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)",
"criterions": [
{
"exact_snippets": [
"Liver disease"
],
"criterion": "liver disease",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"known history of hepatitis B"
],
"criterion": "hepatitis B",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"known history of hepatitis C"
],
"criterion": "hepatitis C",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"cirrhosis"
],
"criterion": "cirrhosis",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"nonalcoholic steatohepatitis"
],
"criterion": "nonalcoholic steatohepatitis",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"history of alcoholism"
],
"criterion": "alcoholism",
"requirement_type": "history",
"expected_value": true
},
{
"exact_snippets": [
"liver function test results greater than 3 times upper limit of normal in the past 3 months"
],
"criterion": "liver function test results",
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 3
}
]
}
}
]
}
],
"failed_miscellaneous": []
}