Important: Models were tasked with extracting evidence from documents. Some outputs may be low quality and should be scored accordingly.
Your task: Compare the model-generated prediction (right panel) against the ground truth criteria (left panel).
Evaluation scale (0-4):
Consider both content accuracy and completeness. Some predictions may be technically "correct" but incomplete or out of order.
INCLUSION CRITERIA 1. Participants undergoing elective surgery under general anesthesia, expected to last for at least 1 hour from induction of anesthesia to wound closure. 2. Participants are expected to require or have agreed to stay, at least 1 overnight in the hospital. 3. Participants American Society of Anesthesiologists (ASA) physical status is ASA I-III. 4. Participants with 3 or more Apfel risk factors defined as:Female sex. 5. Nonsmoking status (never smoked or stopped smoking ≥12 months ago). 6. History of PONV or motion sickness. 7. Planned use of postoperative opioid analgesics. EXCLUSION CRITERIA 1. Participants who are expected to remain intubated post-anesthesia. 2. Participants who experience nausea or vomiting within 24 hours before surgery or are diagnosed with gastroparesis, cyclic vomiting syndrome, or other condition associated with acute or chronic nausea and vomiting. 3. Participants who have received, or are expected to receive, any excluded drug preoperatively within 24 hours before induction, during surgery, or within 24 hours after surgery. 4. Participants scheduled to receive neuraxial anesthesia (e.g., epidural, spinal, or caudal anesthesia), regional blocks, or total IV anesthesia, and/or planned to receive different drugs for premedication, induction, maintenance, or reversal of anesthesia than those specified in the protocol. 5. Participants who have an allergy or contraindication to the recommended and available rescue therapy for the treatment of PONV. 6. Circumstance that, in the investigator's opinion, make participation in this clinical study inappropriate. 7. Participants found at the screening to have a QT interval with Fridericia correction method (QTcF) ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events. 8. Assessments showing bundle branch block and a prolonged QTcF should be discussed with the study monitor and the sponsor for potential inclusion. 9. Participants who have a direct family history of premature sudden death or channelopathy, personal history of Brugada syndrome (right bundle branch block pattern with ST elevation in leads V1-V3), long QT, short QT, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy or catecholaminergic polymorphic ventricular tachycardia (VT). 10. Participants who have had 3 incidents of vasovagal syncope within the last 5 years. 11. Participants with an average heart rate (HR) <55 or >100 bpm or systolic blood pressure (SBP) <90 mm Hg or Diastolic blood pressure (DBP) <60 mm Hg during screening or prior to randomization on the day of surgery. 12. Participants with a clinically significant ECG abnormality indicative of acute cardiac instability as determined by the investigator at screening, including more than first-degree atrioventricular block, nonsustained or sustained VT, or ECG changes consistent with acute myocardial ischemia or infarction. 13. Participants with a history of acute myocardial ischemia within the last 12 months. 14. Participants receiving beta-blockers chronically or between screening and surgery that cannot be safely withheld on the day of surgery in the investigator's judgment. 15. Participants receiving certain other cardiovascular medications, such as vasodilators for hypertension, chronically or between screening and surgery that in the investigator's judgment cannot be adequately managed in the perioperative setting considering the potential vasodilatory effects of TAK-951 and anesthesia standard of care. 16. The investigators must consult with the medical monitor regarding the eligibility of participants who are receiving beta-blockers, vasodilators, and other classes of medications that act on HR or BP. 17. Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN.
Amended Eligibility Criteria (Version 13) INCLUSION CRITERIA 1. Male or female subjects aged ≥18 years at screening. 2. Subjects undergoing elective surgery under general anesthesia, expected to last for at least 1 hour from induction of anesthesia to wound closure. 3. Subject is expected to require, or has agreed to stay, at least 1 overnight in the hospital. 4. The subject’s American Society of Anesthesiologist physical status is ASA I-III. 5. Subjects with 3 or more Apfel risk factors: 6. a) Female sex. 7. b) Nonsmoking status (never smoked or stopped smoking ≥12 months ago). 8. c) History of PONV or motion sickness. 9. d) Planned use of postoperative opioid analgesics. 10. Subjects of nonchildbearing potential or subjects of childbearing potential willing and agreeable to use highly effective contraception or sexual abstinence during the study and up to 30 days post-treatment. 11. Subjects must demonstrate cardiovascular stability, defined as an average heart rate (HR) ≥55 and ≤100 bpm and systolic blood pressure (SBP) ≥90 mm Hg and diastolic blood pressure (DBP) ≥60 mm Hg, prior to administration of study drug. EXCLUSION CRITERIA 1. Subjects who are expected to remain intubated post-anesthesia. 2. Subjects who experience nausea or vomiting within 24 hours before surgery or are diagnosed with gastroparesis, cyclic vomiting syndrome, or other conditions associated with acute or chronic nausea and vomiting. 3. Subjects with a history of allergic reaction to, intolerances of, or contraindications for any of the study medications or required anesthetic agents, including any component of the formulation of ondansetron or TAK-951. 4. Subjects who have received, or are expected to receive, any excluded drug preoperatively within 24 hours before induction, during surgery, or within 24 hours after surgery. 5. Subjects scheduled to receive neuraxial anesthesia (e.g., epidural, spinal, or caudal anesthesia), regional blocks, or total IV anesthesia, and/or planned to receive different drugs for premedication, induction, maintenance, or reversal of anesthesia than those specified in the protocol. 6. Subjects who have an allergy or contraindication to the recommended and available rescue therapy for treatment of PONV. 7. Subjects expected to require the use of a nasogastric or oral gastric tube after surgery. 8. Female subjects who are pregnant or lactating. 9. Subjects with documented history of alcohol and/or drug abuse within 1 year of study medication. 10. Subjects who have any other significant, uncontrolled organic or systemic medical condition or social circumstance that, in the investigator’s opinion, makes participation in this clinical study inappropriate. 11. Subjects found at screening to have a QT interval with Fridericia correction method (QTcF) ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events. 12. Subjects who have a direct family history of premature sudden death or channelopathy, personal history of Brugada syndrome, long QT syndrome, short QT syndrome, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, or catecholaminergic polymorphic ventricular tachycardia (VT). 13. Subjects who have had 3 incidents of vasovagal syncope within the last 5 years. 14. Subjects with known liver disease or positive for hepatitis B or C. For hepatitis B/C, the subject has 1 of the following at screening: 15. Chronic hepatitis B virus infection: positive for hepatitis B surface antigen (HBsAg). 16. Chronic hepatitis C virus (HCV) infection: positive for HCV antibody that is confirmed with a positive HCV RNA viral load test (those treated and cured for HCV infection are allowed). 17. Subjects who have participated in an interventional clinical study or been exposed to any experimental drug within 30 days before enrollment in this study. 18. Subjects who are an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study or may consent under duress. 19. Note: All criteria must be met for inclusion, and none of the EXCLUSION CRITERIA 1. may apply for a subject to be eligible for the study.