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Safety, Tolerability, and Pharmacokinetics of a Novel Anti-obesity Agent, S-309309, in Healthy Adults with or Without Obesity.
Clin Drug Investig
January 2025
Medical Science Department, Shionogi & Co., Ltd., Osaka, Japan.
Background: Anti-obesity medications are recommended for patients who do not achieve and maintain weight loss despite lifestyle interventions. S-309309 is a novel oral inhibitor of monoacylglycerol O-acyltransferase 2 being developed as a treatment for obesity.
Objective: The objective of the study was to investigate the safety, clinical pharmacology, pharmacokinetics and pharmacodynamic biomarker of S-309309.
IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial.
Med
January 2025
National Clinical Research Center for Obstetrics and Gynecology, Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, China; Cancer Biology Research Center (Key Laboratory of the Ministry of Education, Hubei Provincial Key Laboratory of Tumor Invasion and Metastasis), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430000, China. Electronic address:
Background: It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC).
Methods: In this randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov: NCT04590599), patients with recurrent/metastatic CC (R/M CC) who experienced disease progression after or during platinum-based chemotherapy were enrolled from 37 centers across China and randomly assigned (1:1), stratified by PD-L1 expression and prior treatment lines, to receive either IBI310 plus sintilimab or placebo plus sintilimab intravenously every 3 weeks for 12 weeks, followed by sintilimab alone.
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of CZ1S Injection for Unilateral Brachial Plexus Blockade in Healthy Chinese Adults: Double-blind, Randomized, Positive-controlled Phase I Study.
J Pharm Sci
January 2025
Center of Clinical Pharmacology, the Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310009, China. Electronic address:
CZ1S injection is a novel, extended-release local anaesthetic formulation of ropivacaine, classified as a type 2.2 new drug, with potential for post-operative analgesia by subcutaneous infiltration and peripheral nerve blockade. This study aimed to validate the superior properties of CZ1S over ropivacaine hydrochloride injection and to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of a single dose of brachial plexus block with CZ1S in healthy Chinese adults.
View Article and Find Full Text PDFEfficacy and safety of perioperative analgesia in PENG block for children undergoing hip surgery with developmental dysplasia: study protocol for a randomized, double-blinded, non-inferiority trial.
Trials
January 2025
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Background: Surgical intervention is critical in the treatment of hip developmental dysplasia in children. Perioperative analgesia, usually based on high opioid dosages, is frequently used in these patients. In some circumstances, regional anesthetic procedures such as caudal block and lumbar plexus block have also been used.
View Article and Find Full Text PDFEffects of Combined Antiemetic Protocol for the Prevention of Postoperative Nausea and Vomiting in Orthognathic Surgery: A Randomized Double Blinded Clinical Study.
J Oral Maxillofac Surg
December 2024
Professor, Private Practice, Proimtech A.Ş., Istanbul, Turkey.
Background: Postoperative nausea and vomiting (PONV) after orthognathic surgery remains one of the most common side effects despite the use of several medications.
Purpose: The study aimed to compare the frequencies of PONV between a combination of metoclopramide with granisetron and granisetron alone.
Study Design, Setting, Sample: A randomized double-blind clinical trial was conducted in 66 consecutive patients who underwent orthognathic surgery at the Department of Oral and Maxillofacial Surgery at Bezmialem Vakif University.
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