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First-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a randomized, double-blind, phase 3 trial.
Nat Med
January 2025
State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Peking University Cancer Hospital & Institute, Beijing, China.
Programmed cell death protein-1 (PD-1) inhibitors plus chemotherapy have been the standard of care in the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma; however, the survival benefits are modest in patients with low programmed death ligand 1 (PD-L1) expression. Here we investigated the efficacy and safety of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) plus chemotherapy as first-line treatment in G/GEJ adenocarcinoma. The prespecified interim analysis is reported here.
View Article and Find Full Text PDFEffect of propofol and ciprofol in patients undergoing bronchoscopy: protocol for a double-blind, randomised controlled trial.
BMJ Open
January 2025
Department of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China
Introduction: Propofol is a fast-acting intravenous anaesthetic widely used for sedation and anaesthesia in gastrointestinal endoscopy, bronchoscopy, and the induction/maintenance of general anaesthesia in outpatients and inpatients; however, propofol has several undesirable effects, including injection pain, which affects the physical and mental health of patients, and cardiopulmonary depression, characterised by hypotension, bradycardia and apnea, which commonly occur in clinical practice. Ciprofol (HSK3486) is a propofol analogue with good clinical safety, high potency and some advantages over propofol, including lower injection pain and haemodynamic depression in patients undergoing gastroscopy and colonoscopy. This study aims to compare the impact of equivalent effective doses of propofol and ciprofol on haemodynamic changes in patients undergoing bronchoscopy under general anaesthesia.
View Article and Find Full Text PDFBlinding assessment in randomised sham-controlled trials of acupuncture:protocol for a systematic survey.
BMJ Open
January 2025
Institute of Integrated Traditional Chinese and Western Medicine and Chinese Evidence-based Medicine Center, Cochrane China Center and IDEAL China Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Introduction: Although various sham acupuncture techniques have been employed to ensure blinding in randomised controlled trials (RCTs) of acupuncture, the effectiveness of blinding in these trials and its influence on trial effect size estimates remain unclear. The objectives of this study are the following: (1) to investigate the proportion and study characteristics of sham-controlled trials reporting on blinding assessment, (2) to assess the blinding effectiveness of different types of sham acupuncture, (3) to investigate the relationship between blinding effectiveness and effect sizes in acupuncture RCTs.
Methods And Analysis: We will search PubMed and EMBASE from inception to 1 January 2025 to identify RCTs that compared acupuncture with sham acupuncture in humans with any disease or symptom, with no restrictions on language.
Effect of photobiomodulation as preventive treatment of diabetic foot ulcer: randomised, controlled, double-blind, clinical trial protocol.
BMJ Open
January 2025
Biophotonics Medicine, Universidade Nove de Julho, Sao Paulo, Brazil
Introduction: The prevention of diabetic foot ulcer (DFU) involves the classification of risk, systemic care, regular examinations, foot care, therapeutic education and adjunct treatments. Photobiomodulation (PBM) has been successfully administered for the healing of DFU and its preventive effects have drawn the interest of researchers.
Methods And Analysis: The purpose of the study is to assess the effect of PBM for the prevention of DFU through a randomised, controlled, double-blind, clinical trial.
Effect of empagliflozin on plasma lipids and lipoproteins in type 2 diabetes and heart failure - Empire HF and SIMPLE.
J Clin Lipidol
December 2024
Department of Clinical Biochemistry, Copenhagen University Hospital - Rigshospitalet, Centre of Diagnostic Investigation, Copenhagen, Denmark; Faculty of Health and Medical Sciences, Department of Clinical Medicine, University of Copenhagen, Denmark. Electronic address:
Objective: Beyond glucose-lowering, sodium-glucose co-transporter 2 (SGLT2) inhibitors have cardioprotective effects with unclear mechanisms. We examined changes in an extensive panel of plasma lipids, lipoproteins, and apolipoproteins and whether these changes were independent of weight loss, hemoglobin A1c, and hematocrit in patients treated with empagliflozin versus placebo to better understand the observed cardioprotective effects.
Methods: Post-hoc analyses of two double-blind, placebo-controlled trials, the Empire HF trial including 190 patients with heart failure and reduced ejection fraction and the SIMPLE trial including 90 patients with type 2 diabetes randomized to, respectively, 10 mg and 25 mg empagliflozin daily or placebo for 12 weeks.
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