{
"info": {
"nct_id": "NCT05198648",
"official_title": "Trigeminal Nerve Cardiac Reflex During Resection of Cerebellopontine Angle Tumors and Postoperative Myocardial Injury: a Prospective Cohort Study",
"inclusion_criteria": "* Patients undergoing elective skull base tumor surgery.\n* Age ≥ 18 years old.\n* ASA class I to III.\n* All those who sign the informed consent form.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients with severe heart disease (including patients with preoperative heart rate < 50 beats / min, severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation, patients with myocardial ischemia < 6 months, heart failure, myocarditis, pericarditis or cardiomyopathy).\n* Patients unable to complete preoperative cardiac assessment.\n* Patients with chronic kidney disease.",
"miscellaneous_criteria": ""
},
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{
"identified_line": {
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"criterions": [
{
"exact_snippets": "elective skull base tumor surgery",
"criterion": "surgery type",
"requirement": {
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"expected_value": "elective skull base tumor surgery"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "elective skull base tumor surgery",
"criterion": "surgery type",
"requirement": {
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"expected_value": "elective skull base tumor surgery"
}
}
]
}
},
{
"identified_line": {
"line": "* Age ≥ 18 years old.",
"criterions": [
{
"exact_snippets": "Age ≥ 18 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥ 18 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* ASA class I to III.",
"criterions": [
{
"exact_snippets": "ASA class I to III",
"criterion": "ASA class",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
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"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"requirement": {
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"expected_value": {
"comparisons": [
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"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 3,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* All those who sign the informed consent form.",
"criterions": [
{
"exact_snippets": "sign the informed consent form",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "sign the informed consent form",
"criterion": "informed consent",
"requirement": {
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"expected_value": true
}
}
]
}
},
{
"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"
}
}
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},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
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"value": 18,
"unit": "Years"
}
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],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients with severe heart disease (including patients with preoperative heart rate < 50 beats / min, severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation, patients with myocardial ischemia < 6 months, heart failure, myocarditis, pericarditis or cardiomyopathy).",
"criterions": [
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"criterion": "severe heart disease",
"requirement": {
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"expected_value": true
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{
"exact_snippets": "preoperative heart rate < 50 beats / min",
"criterion": "preoperative heart rate",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "beats / min"
}
}
},
{
"exact_snippets": "severe arrhythmias, such as premature beats, paroxysmal supraventricular tachycardia, atrial flutter or fibrillation",
"criterion": "severe arrhythmias",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myocardial ischemia < 6 months",
"criterion": "myocardial ischemia",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "heart failure",
"criterion": "heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myocarditis",
"criterion": "myocarditis",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "pericarditis",
"criterion": "pericarditis",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "cardiomyopathy",
"criterion": "cardiomyopathy",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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{
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"criterion": "severe heart disease",
"requirement": {
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"expected_value": true
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"exact_snippets": "preoperative heart rate < 50 beats / min",
"criterion": "preoperative heart rate",
"requirement": {
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"expected_value": {
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"value": 50,
"unit": "beats / min"
}
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{
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"criterion": "severe arrhythmias",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "myocardial ischemia < 6 months",
"criterion": "myocardial ischemia",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "heart failure",
"criterion": "heart failure",
"requirement": {
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"expected_value": true
}
},
{
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"requirement": {
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"expected_value": true
}
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{
"exact_snippets": "pericarditis",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
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"requirement": {
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"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients unable to complete preoperative cardiac assessment.",
"criterions": [
{
"exact_snippets": "unable to complete preoperative cardiac assessment",
"criterion": "preoperative cardiac assessment",
"requirement": {
"requirement_type": "completion",
"expected_value": false
}
}
]
},
"logical_structure": {
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"criterion": "preoperative cardiac assessment",
"requirement": {
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"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Patients with chronic kidney disease.",
"criterions": [
{
"exact_snippets": "chronic kidney disease",
"criterion": "chronic kidney disease",
"requirement": {
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"expected_value": true
}
}
]
},
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}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}