{
"info": {
"nct_id": "NCT03091231",
"official_title": "Multiparametric Ultrasound - Contrast Enhanced Ultrasound and Shear Wave Elastography Compared to Radical Prostatectomy Specimens in 50 Patients",
"inclusion_criteria": "* age ≥ 18 years\n* signed informed consent\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* History of any clinically evidence of cardiac right-to-left shunts\n* Receives treatment that includes dobutamine\n* Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome\n* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study\n* Is incapable of understanding the language in which the information for the patient is given",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* age ≥ 18 years",
"criterions": [
{
"exact_snippets": "age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "age ≥ 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* signed informed consent",
"criterions": [
{
"exact_snippets": "signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Must be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "male"
}
}
]
}
},
{
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* History of any clinically evidence of cardiac right-to-left shunts",
"criterions": [
{
"exact_snippets": "History of any clinically evidence of cardiac right-to-left shunts",
"criterion": "cardiac right-to-left shunts",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "History of any clinically evidence of cardiac right-to-left shunts",
"criterion": "cardiac right-to-left shunts",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Receives treatment that includes dobutamine",
"criterions": [
{
"exact_snippets": "Receives treatment that includes dobutamine",
"criterion": "treatment",
"requirement": {
"requirement_type": "inclusion",
"expected_value": "dobutamine"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Receives treatment that includes dobutamine",
"criterion": "treatment",
"requirement": {
"requirement_type": "inclusion",
"expected_value": "dobutamine"
}
}
}
},
{
"identified_line": {
"line": "* Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome",
"criterions": [
{
"exact_snippets": "Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg)",
"criterion": "pulmonary hypertension",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg)",
"criterion": "pulmonary hypertension",
"requirement": {
"requirement_type": "pulmonary artery pressure",
"expected_value": {
"operator": ">",
"value": 90,
"unit": "mmHg"
}
}
},
{
"exact_snippets": "uncontrolled systemic hypertension",
"criterion": "systemic hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "respiratory distress syndrome",
"criterion": "respiratory distress syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg)",
"criterion": "pulmonary hypertension",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg)",
"criterion": "pulmonary hypertension",
"requirement": {
"requirement_type": "pulmonary artery pressure",
"expected_value": {
"operator": ">",
"value": 90,
"unit": "mmHg"
}
}
}
]
},
{
"exact_snippets": "uncontrolled systemic hypertension",
"criterion": "systemic hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "respiratory distress syndrome",
"criterion": "respiratory distress syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study",
"criterions": [
{
"exact_snippets": "Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data",
"criterion": "medical condition or other circumstances",
"requirement": {
"requirement_type": "impact on data reliability",
"expected_value": "significantly decrease"
}
},
{
"exact_snippets": "Has any medical condition or other circumstances which would significantly decrease the chances of ... achieving study objectives",
"criterion": "medical condition or other circumstances",
"requirement": {
"requirement_type": "impact on study objectives",
"expected_value": "significantly decrease"
}
},
{
"exact_snippets": "Has any medical condition or other circumstances which would significantly decrease the chances of ... completing the study",
"criterion": "medical condition or other circumstances",
"requirement": {
"requirement_type": "impact on study completion",
"expected_value": "significantly decrease"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data",
"criterion": "medical condition or other circumstances",
"requirement": {
"requirement_type": "impact on data reliability",
"expected_value": "significantly decrease"
}
},
{
"exact_snippets": "Has any medical condition or other circumstances which would significantly decrease the chances of ... achieving study objectives",
"criterion": "medical condition or other circumstances",
"requirement": {
"requirement_type": "impact on study objectives",
"expected_value": "significantly decrease"
}
},
{
"exact_snippets": "Has any medical condition or other circumstances which would significantly decrease the chances of ... completing the study",
"criterion": "medical condition or other circumstances",
"requirement": {
"requirement_type": "impact on study completion",
"expected_value": "significantly decrease"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Is incapable of understanding the language in which the information for the patient is given",
"criterions": [
{
"exact_snippets": "incapable of understanding the language",
"criterion": "language comprehension",
"requirement": {
"requirement_type": "capability",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "incapable of understanding the language",
"criterion": "language comprehension",
"requirement": {
"requirement_type": "capability",
"expected_value": false
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}