{
"info": {
"nct_id": "NCT06339372",
"official_title": "Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours",
"inclusion_criteria": "* Age between 18 and 60 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status I or II .\n* Patient undergoing mandibular or oral cavity tumour resection.\n* Body mass index (BMI) between 18.5-24.9.\n* Patient with serum albumen above 3 gm.\n* Patient with written valid consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 60 Years",
"exclusion_criteria": "* Patient refusal and uncooperative patients.\n* Patient ASA III or IV.\n* Age more than 60 or less than 18.\n* Serum albumen less than 3.\n* Pre-existing severe malnourishment.\n* Allergy to test drugs.\n* Patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and NSAID.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age between 18 and 60 years.",
"criterions": [
{
"exact_snippets": "Age between 18 and 60 years.",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 60,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age between 18 and 60 years.",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 60,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Both sexes.",
"criterions": [
{
"exact_snippets": "Both sexes.",
"criterion": "sex",
"requirement": {
"requirement_type": "allowed",
"expected_value": [
"male",
"female"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Both sexes.",
"criterion": "sex",
"requirement": {
"requirement_type": "allowed",
"expected_value": [
"male",
"female"
]
}
}
]
}
},
{
"identified_line": {
"line": "* American Society of Anesthesiologists (ASA) physical status I or II .",
"criterions": [
{
"exact_snippets": "American Society of Anesthesiologists (ASA) physical status I or II",
"criterion": "ASA physical status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"I",
"II"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "American Society of Anesthesiologists (ASA) physical status I or II",
"criterion": "ASA physical status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"I",
"II"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Body mass index (BMI) between 18.5-24.9.",
"criterions": [
{
"exact_snippets": "Body mass index (BMI) between 18.5-24.9.",
"criterion": "body mass index (BMI)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18.5,
"unit": ""
},
{
"operator": "<=",
"value": 24.9,
"unit": ""
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Body mass index (BMI) between 18.5-24.9.",
"criterion": "body mass index (BMI)",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18.5,
"unit": ""
},
{
"operator": "<=",
"value": 24.9,
"unit": ""
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient with serum albumen above 3 gm.",
"criterions": [
{
"exact_snippets": "serum albumen above 3 gm",
"criterion": "serum albumen",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "gm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "serum albumen above 3 gm",
"criterion": "serum albumen",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "gm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patient with written valid consent",
"criterions": [
{
"exact_snippets": "written valid consent",
"criterion": "consent",
"requirement": {
"requirement_type": "validity",
"expected_value": true
}
},
{
"exact_snippets": "written valid consent",
"criterion": "consent",
"requirement": {
"requirement_type": "form",
"expected_value": "written"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "written valid consent",
"criterion": "consent",
"requirement": {
"requirement_type": "validity",
"expected_value": true
}
},
{
"exact_snippets": "written valid consent",
"criterion": "consent",
"requirement": {
"requirement_type": "form",
"expected_value": "written"
}
}
]
}
},
{
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 60 Years",
"criterions": [
{
"exact_snippets": "maximum age of 60 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 60 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 60,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patient refusal and uncooperative patients.",
"criterions": [
{
"exact_snippets": "Patient refusal",
"criterion": "patient consent",
"requirement": {
"requirement_type": "consent",
"expected_value": true
}
},
{
"exact_snippets": "uncooperative patients",
"criterion": "patient cooperation",
"requirement": {
"requirement_type": "cooperation",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Patient refusal",
"criterion": "patient consent",
"requirement": {
"requirement_type": "consent",
"expected_value": true
}
},
{
"exact_snippets": "uncooperative patients",
"criterion": "patient cooperation",
"requirement": {
"requirement_type": "cooperation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patient ASA III or IV.",
"criterions": [
{
"exact_snippets": "Patient ASA III or IV",
"criterion": "ASA classification",
"requirement": {
"requirement_type": "classification",
"expected_value": [
"III",
"IV"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient ASA III or IV",
"criterion": "ASA classification",
"requirement": {
"requirement_type": "classification",
"expected_value": [
"III",
"IV"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Age more than 60 or less than 18.",
"criterions": [
{
"exact_snippets": "Age more than 60",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "years"
}
}
},
{
"exact_snippets": "less than 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Age more than 60",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "years"
}
}
},
{
"exact_snippets": "less than 18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum albumen less than 3.",
"criterions": [
{
"exact_snippets": "Serum albumen less than 3",
"criterion": "serum albumen",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Serum albumen less than 3",
"criterion": "serum albumen",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 3,
"unit": "N/A"
}
}
}
}
},
{
"identified_line": {
"line": "* Pre-existing severe malnourishment.",
"criterions": [
{
"exact_snippets": "Pre-existing severe malnourishment",
"criterion": "malnourishment",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Pre-existing severe malnourishment",
"criterion": "malnourishment",
"requirement": {
"requirement_type": "pre-existing",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pre-existing severe malnourishment",
"criterion": "malnourishment",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Pre-existing severe malnourishment",
"criterion": "malnourishment",
"requirement": {
"requirement_type": "pre-existing",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Allergy to test drugs.",
"criterions": [
{
"exact_snippets": "Allergy to test drugs",
"criterion": "allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Allergy to test drugs",
"criterion": "allergy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and NSAID.",
"criterions": [
{
"exact_snippets": "Patients on tranquilizers",
"criterion": "use of tranquilizers",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypnotics",
"criterion": "use of hypnotics",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sedatives",
"criterion": "use of sedatives",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other psychotropic",
"criterion": "use of other psychotropic drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "patient on steroids",
"criterion": "use of steroids",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "NSAID",
"criterion": "use of NSAIDs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients on tranquilizers",
"criterion": "use of tranquilizers",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hypnotics",
"criterion": "use of hypnotics",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "sedatives",
"criterion": "use of sedatives",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other psychotropic",
"criterion": "use of other psychotropic drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "patient on steroids",
"criterion": "use of steroids",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "NSAID",
"criterion": "use of NSAIDs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patient undergoing mandibular or oral cavity tumour resection.",
"criterions": [
{
"exact_snippets": "mandibular or oral cavity tumour resection",
"criterion": "tumour resection",
"requirement": {
"requirement_type": "location",
"expected_value": [
"mandibular",
"oral cavity"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "mandibular or oral cavity tumour resection",
"criterion": "tumour resection",
"requirement": {
"requirement_type": "location",
"expected_value": "mandibular"
}
},
{
"exact_snippets": "mandibular or oral cavity tumour resection",
"criterion": "tumour resection",
"requirement": {
"requirement_type": "location",
"expected_value": "oral cavity"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}