{
"info": {
"nct_id": "NCT06697782",
"official_title": "Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma",
"inclusion_criteria": "1. Patients aged 18-80 years;\n2. Voluntary enrollment in the study and signing the informed consent form;\n3. Diagnosed with thyroid cancer and needing surgical treatment;\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;\n2. history of prior thyroid or neck surgery;\n3. Cases in which surgery requiring sternotomy is anticipated;\n4. History of long-term hormone use, period of immunosuppressive therapy;\n5. pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;\n6. Pregnant or breastfeeding patients;\n7. Patients who are allergic to any of the study medications;\n8. Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure;\n9. Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity;\n10. patients with other malignant tumors;\n11. Patients with hypothyroidism;\n12. Participating or planning to participate in other clinical studies.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients aged 18-80 years;",
"criterions": [
{
"exact_snippets": "Patients aged 18-80 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients aged 18-80 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Voluntary enrollment in the study and signing the informed consent form;",
"criterions": [
{
"exact_snippets": "Voluntary enrollment in the study",
"criterion": "enrollment",
"requirement": {
"requirement_type": "voluntary",
"expected_value": true
}
},
{
"exact_snippets": "signing the informed consent form",
"criterion": "informed consent form",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Voluntary enrollment in the study",
"criterion": "enrollment",
"requirement": {
"requirement_type": "voluntary",
"expected_value": true
}
},
{
"exact_snippets": "signing the informed consent form",
"criterion": "informed consent form",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Diagnosed with thyroid cancer and needing surgical treatment;",
"criterions": [
{
"exact_snippets": "Diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "needing surgical treatment",
"criterion": "surgical treatment",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Diagnosed with thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "needing surgical treatment",
"criterion": "surgical treatment",
"requirement": {
"requirement_type": "necessity",
"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"
}
}
}
]
},
"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 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;",
"criterions": [
{
"exact_snippets": "Patient has depression",
"criterion": "depression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of chronic pain",
"criterion": "chronic pain",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "insulin-dependent diabetes mellitus I or II",
"criterion": "insulin-dependent diabetes mellitus",
"requirement": {
"requirement_type": "type",
"expected_value": [
"I",
"II"
]
}
},
{
"exact_snippets": "history of severe vomiting",
"criterion": "severe vomiting",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patient has depression",
"criterion": "depression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of chronic pain",
"criterion": "chronic pain",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "insulin-dependent diabetes mellitus I or II",
"criterion": "insulin-dependent diabetes mellitus",
"requirement": {
"requirement_type": "type",
"expected_value": [
"I",
"II"
]
}
},
{
"exact_snippets": "history of severe vomiting",
"criterion": "severe vomiting",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. history of prior thyroid or neck surgery;",
"criterions": [
{
"exact_snippets": "history of prior thyroid or neck surgery",
"criterion": "prior thyroid or neck surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "history of prior thyroid or neck surgery",
"criterion": "prior thyroid or neck surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "3. Cases in which surgery requiring sternotomy is anticipated;",
"criterions": [
{
"exact_snippets": "surgery requiring sternotomy is anticipated",
"criterion": "surgery requiring sternotomy",
"requirement": {
"requirement_type": "anticipation",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "surgery requiring sternotomy is anticipated",
"criterion": "surgery requiring sternotomy",
"requirement": {
"requirement_type": "anticipation",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "4. History of long-term hormone use, period of immunosuppressive therapy;",
"criterions": [
{
"exact_snippets": "History of long-term hormone use",
"criterion": "long-term hormone use",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "period of immunosuppressive therapy",
"criterion": "immunosuppressive therapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of long-term hormone use",
"criterion": "long-term hormone use",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "period of immunosuppressive therapy",
"criterion": "immunosuppressive therapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "5. pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;",
"criterions": [
{
"exact_snippets": "pre-operative voice changes",
"criterion": "voice changes",
"requirement": {
"requirement_type": "timing",
"expected_value": "pre-operative"
}
},
{
"exact_snippets": "laryngoscopic confirmation of vocal cord paralysis",
"criterion": "vocal cord paralysis",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "laryngoscopic"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "pre-operative voice changes",
"criterion": "voice changes",
"requirement": {
"requirement_type": "timing",
"expected_value": "pre-operative"
}
},
{
"exact_snippets": "laryngoscopic confirmation of vocal cord paralysis",
"criterion": "vocal cord paralysis",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "laryngoscopic"
}
}
]
},
{
"exact_snippets": "laryngoscopic confirmation of vocal cord paralysis",
"criterion": "vocal cord paralysis",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "laryngoscopic"
}
}
]
}
},
{
"identified_line": {
"line": "6. Pregnant or breastfeeding patients;",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding status",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "7. Patients who are allergic to any of the study medications;",
"criterions": [
{
"exact_snippets": "Patients who are allergic to any of the study medications",
"criterion": "allergy to study medications",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients who are allergic to any of the study medications",
"criterion": "allergy to study medications",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "8. Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure;",
"criterions": [
{
"exact_snippets": "Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure",
"criterion": "medication use",
"requirement": {
"requirement_type": "type",
"expected_value": [
"sedative",
"hypnotic",
"anxiolytic",
"opioid",
"steroid",
"antiemetic"
]
}
},
{
"exact_snippets": "Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure",
"criterion": "medication use",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 24 hours prior to the procedure"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure",
"criterion": "medication use",
"requirement": {
"requirement_type": "type",
"expected_value": [
"sedative",
"hypnotic",
"anxiolytic",
"opioid",
"steroid",
"antiemetic"
]
}
},
{
"exact_snippets": "Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure",
"criterion": "medication use",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 24 hours prior to the procedure"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "10. patients with other malignant tumors;",
"criterions": [
{
"exact_snippets": "patients with other malignant tumors",
"criterion": "malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "patients with other malignant tumors",
"criterion": "malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "11. Patients with hypothyroidism;",
"criterions": [
{
"exact_snippets": "Patients with hypothyroidism",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients with hypothyroidism",
"criterion": "hypothyroidism",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "12. Participating or planning to participate in other clinical studies.",
"criterions": [
{
"exact_snippets": "Participating or planning to participate in other clinical studies.",
"criterion": "participation in other clinical studies",
"requirement": {
"requirement_type": "status",
"expected_value": [
"participating",
"planning to participate"
]
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Participating or planning to participate in other clinical studies.",
"criterion": "participation in other clinical studies",
"requirement": {
"requirement_type": "status",
"expected_value": [
"participating",
"planning to participate"
]
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "9. Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity;",
"criterions": [
{
"exact_snippets": "Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity",
"criterion": "CYP3A4-inducing drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity",
"criterion": "CYP3A4-inducing drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}