[96a5a0]: / output / allTrials / logical / NCT03407001_logical.json

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{
"info": {
"nct_id": "NCT03407001",
"official_title": "Lesion Detection in Cirrhotic Patients With Contrast Enhanced Ultrasound and the Accuracy of Contrast Enhanced Ultrasound Li-RADS for Hepatocellular Carcinoma Diagnosis",
"inclusion_criteria": "* Able and willing to provide written informed consent\n* Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason\n* Pregnant patients-excluded by history\n* Pediatric patients, as pediatric cirrhosis is uncommon",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Able and willing to provide written informed consent",
"criterions": [
{
"exact_snippets": "Able and willing to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Able and willing to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able and willing to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Able and willing to provide written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI",
"criterions": [
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: histology",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "histology"
}
},
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: ... US",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "US"
}
},
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: ... computed tomography (CT)",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "computed tomography (CT)"
}
},
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: ... MRI showing cirrhosis",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "MRI"
}
},
{
"exact_snippets": "+/- lesions seen on CE-MRI",
"criterion": "lesions on CE-MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: histology",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "histology"
}
},
{
"exact_snippets": "+/- lesions seen on CE-MRI",
"criterion": "lesions on CE-MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: ... US",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "US"
}
},
{
"exact_snippets": "+/- lesions seen on CE-MRI",
"criterion": "lesions on CE-MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: ... computed tomography (CT)",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "computed tomography (CT)"
}
},
{
"exact_snippets": "+/- lesions seen on CE-MRI",
"criterion": "lesions on CE-MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Diagnosis of cirrhosis based on one or more of the following: ... MRI showing cirrhosis",
"criterion": "cirrhosis diagnosis",
"requirement": {
"requirement_type": "method",
"expected_value": "MRI"
}
},
{
"exact_snippets": "+/- lesions seen on CE-MRI",
"criterion": "lesions on CE-MRI",
"requirement": {
"requirement_type": "presence",
"expected_value": "optional"
}
}
]
}
]
}
},
{
"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 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": "* History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason",
"criterions": [
{
"exact_snippets": "History of hypersensitivity to sulfur hexafluoride lipid microsphere components",
"criterion": "hypersensitivity to sulfur hexafluoride lipid microsphere components",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "History of hypersensitivity ... to any of the inactive ingredients in Lumason",
"criterion": "hypersensitivity to inactive ingredients in Lumason",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of hypersensitivity to sulfur hexafluoride lipid microsphere components",
"criterion": "hypersensitivity to sulfur hexafluoride lipid microsphere components",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "History of hypersensitivity ... to any of the inactive ingredients in Lumason",
"criterion": "hypersensitivity to inactive ingredients in Lumason",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant patients-excluded by history",
"criterions": [
{
"exact_snippets": "Pregnant patients-excluded by history",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pregnant patients-excluded by history",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Pediatric patients, as pediatric cirrhosis is uncommon",
"criterions": [
{
"exact_snippets": "Pediatric patients",
"criterion": "age group",
"requirement": {
"requirement_type": "category",
"expected_value": "pediatric"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pediatric patients",
"criterion": "age group",
"requirement": {
"requirement_type": "category",
"expected_value": "pediatric"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}