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'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy.
Chiropr Man Therap
January 2025
Musculoskeletal Epidemiology Research Group, University of Zurich and Balgrist University Hospital, Zurich, Switzerland.
Background: Blinding is essential for mitigating biases in trials of low back pain (LBP). Our main objectives were to assess the feasibility of blinding: (1) participants randomly allocated to active or placebo spinal manual therapy (SMT), and (2) outcome assessors. We also explored blinding by levels of SMT lifetime experience and recent LBP, and factors contributing to beliefs about the assigned intervention.
View Article and Find Full Text PDFTransarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study.
Lancet
January 2025
Mount Sinai Liver Cancer Program, Division of Liver Diseases, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Liver Cancer Translational Research Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic, Universitat de Barcelona, Barcelona, Spain; Institució Catalana de Recerca i Estudis Avançats, Barcelona, Spain. Electronic address:
Article Synopsis
- TACE is the standard treatment for patients with unresectable, non-metastatic hepatocellular carcinoma, and this study evaluates the effectiveness of adding lenvatinib and pembrolizumab to TACE compared to a placebo.
- The multicenter, randomised, double-blind phase 3 study (LEAP-012) involved participants from 137 sites across 33 countries who were randomly assigned to receive either TACE with the new drugs or TACE with a placebo.
- The primary endpoints were progression-free survival and overall survival, and the results reported are from the first interim analysis, which serves as the final analysis for progression-free survival.
Study Protocol for a Prospective, Unicentric, Double-Blind, Randomized, and Placebo-Controlled Trial on the Efficacy of a Low-Histamine Diet and DAO Enzyme Supplementation in Patients with Histamine Intolerance.
Nutrients
December 2024
Departament de Nutrició, Ciències de l'Alimentació i Gastronomia, Campus de l'Alimentació de Torribera, Universitat de Barcelona (UB), 08921 Santa Coloma de Gramenet, Spain.
Background/objectives: Histamine intolerance is primarily caused by a deficiency in the diamine oxidase (DAO) enzyme at the intestinal level. The reduced histamine degradation in the gut leads to its accumulation in plasma, thereby causing multiple clinical manifestations, such as urticaria, diarrhea, headache, dyspnea, or tachycardia, among others. The dietary management of this food intolerance consists of the follow-up of a low-histamine diet, often combined with DAO supplementation.
View Article and Find Full Text PDFEfficacy and safety of LiWei capsule in chronic non-atrophic gastritis with erosions: a randomized controlled trial.
Sci Rep
January 2025
General Hospital of Northern Theater Command, No.83 Cultural Road, Shenhe District, Shenyang, 110016, Liaoning, China.
To assess the efficacy and safety of LiWei Capsule (LWC) in the treatment of chronic non-atrophic gastritis (CNG) with erosions and damp-heat stasis syndrome, based on Traditional Chinese Medicine (TCM) principles. This phase II, multicenter, randomized, double-blind, placebo- and positive-controlled trial enrolled patients diagnosed with CNG with erosions and damp-heat stasis syndrome. Participants were allocated to LWC, Sanjiu Weitai Capsule (SJWT, positive control), and placebo groups (2:1:1 ratio) and received corresponding treatment for 4 weeks, followed by a 16-week follow-up.
View Article and Find Full Text PDFThe efficacy of Lacticaseibacillus paracasei MSMC39-1 and Bifidobacterium animalis TA-1 probiotics in modulating gut microbiota and reducing the risk of the characteristics of metabolic syndrome: A randomized, double-blinded, placebo-controlled study.
PLoS One
January 2025
Center of Excellence in Probiotics, Srinakharinwirot University, Bangkok, Thailand.
Modern treatment, a healthy diet, and physical activity routines lower the risk factors for metabolic syndrome; however, this condition is associated with all-cause and cardiovascular mortality worldwide. This investigation involved a randomized controlled trial, double-blind, parallel study. Fifty-eight participants with risk factors of metabolic syndrome according to the inclusion criteria were randomized into two groups and given probiotics (Lacticaseibacillus paracasei MSMC39-1 and Bifidobacterium animalis TA-1) (n = 31) or a placebo (n = 27).
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