Comparison of Chest-to-Back Skin-to-Skin Contact and Chest-to-Chest Skin-to-Skin Contact on the Risk of Oxygen Desaturation and Change in Heart Rate in Low Birth Weight and/or Premature Babies: A Randomized Controlled Clinical Trial by Sisay Gere, Yemane Berhane, Alemayehu Worku

“…We used a parallel-group randomized controlled clinical trial. Peripheral arterial blood oxygen saturation (SpO2) and heart rate (HR) were measured using an OxiMaxN-600X Pulse Oximeter. …”
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To Dissect or Not to Dissect? The Surgeon’s Perspective on the Prediction of Greater Than or Equal to 4 Axillary Lymph Node Metastasis in Early-Stage Breast Cancer: A Comparative Analysis of the Per-Protocol Population of the SINODAR-ONE Clinical Trial by Corrado Tinterri, MD, Giuseppe Canavese, MD, Damiano Gentile, MD

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Statistical analysis plan for the LAST ACT clinical trial; a Leukotriene A4 hydrolase Stratified non-inferiority Trial of Adjunctive Corticosteroids for HIV-negative adults with Tuberculous meningitis [version 1; peer review: 2 approved, 1 approved with reservations] by Joseph Donovan, Dong Huu Khanh Trinh, Ronald B. Geskus, Marcel Wolbers, Guy E. Thwaites, Nguyen Thuy Thuong Thuong, Le Thanh Hoang Nhat

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Statistical analysis plan for the LAST ACT clinical trial; a Leukotriene A4 hydrolase Stratified non-inferiority Trial of Adjunctive Corticosteroids for HIV-negative adults with Tuberculous meningitis [version 2; peer review: 2 approved, 1 approved with reservations] by Joseph Donovan, Dong Huu Khanh Trinh, Ronald B. Geskus, Marcel Wolbers, Guy E. Thwaites, Nguyen Thuy Thuong Thuong, Le Thanh Hoang Nhat

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Acute effects of virtual reality exercise bike games on psychophysiological outcomes in college North-African adolescents with cerebral palsy: A randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations] by Mehdi Chlif, Amine Ghram, Makrem Soudani, Faical Farhat, Helmi Ben Saad

“…Registration Pan African Clinical Trial Registry (PACTR202308598603482; 31/08/2023). …”
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Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial by Natalia Comino-Suárez, Juan C. Moreno, Álvaro Megía-García, Antonio J. del-Ama, Diego Serrano-Muñoz, Juan Avendaño-Coy, Ángel Gil-Agudo, Mónica Alcobendas-Maestro, Esther López-López, Julio Gómez-Soriano

“…Trial registration ClinicalTrials.gov (NCT05210166).…”
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Acceptability of donor funding for clinical trials in the UK: a qualitative empirical ethics study using focus groups to elicit the views of research patient public involvement group members, research ethics committee chairs and clinical researchers by Simon Bowman, Heather Draper, Alexander Masters, Dominic Nutt, Kirstie Shearman

“…Objectives The Plutocratic Proposal is a novel method of funding early phase clinical trials where a single donor funds the entire trial and in so doing secures a place on it. …”
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Reply to comments regarding ‘efficacy of analgesia using ilioinguinal-iliohypogastric (IIIH) nerve block, transversus abdominis plane (TAP) block and diclofenac after cesarean delivery under spinal anaesthesia: A non-randomised clinical trial’ by Ranju Singh, Kavita Yadav, Pooja Singh

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Bee Venom—A Potential Complementary Medicine Candidate for SARS-CoV-2 Infections by Keneth Iceland, Kasozi, Simon Peter, Musinguzi

Subjects: “…bee venom, complementary medicine and alternative medicine, SARS-CoV-2 (2019-nCoV), pharmokinetics of bee poison, COVID-19 and complementary medicine, bee venom in clinical trials…”
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Comparing the Efficacy and Safety of Glucagon-Like Peptide 1 Receptor Agonists with Sodium-Glucose Cotransporter 2 Inhibitors for Obese Type 2 Diabetes Patients Uncontrolled on Metformin: A Systematic Review and Meta-Analysis of Randomized Clinical Trials by Lu Ding, Bang Sun, Xinhua Xiao

“…Future large longer-term follow-up clinical trials are needed to provide more evidence about the sustainable effects and safety of GLP-1RAs compared with SGLT-2is.…”
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Comparison of effects of volume-controlled equal inspiratory-to-expiratory ratio (1:1) ventilation with conventional ratio (1:2) ventilation on respiratory mechanics and hemodynamics in patients undergoing upper abdominal laparoscopic surgeries: A randomized clinical trial by Prathap Gunasekaran, Ramyavel Thangavelu, Sivakumar Segaran

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Corrigendum to “The Threshold of the Severity of Diabetic Retinopathy below Which Intensive Glycemic Control Is Beneficial in Diabetic Patients: Estimation Using Data from Large Randomized Clinical Trials” by Yuqi Liu,Juan Li, Jinfang Ma, Nanwei Tong by Yuqi Liu, Juan Li, Jinfang Ma, Nanwei Tong

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Development of a family-centred core outcome set for infants with developmental dysplasia of the hip treated with a brace by Joanna Craven, Olivia O’Malley, Daniel C. Perry

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Efficacy and safety of glycyrrhizic acid and essential phospholipids (Phosphogliv) combination for alcoholic liver disease: results of the double-blind randomized placebo-controlled multicenter post-registration (phase IV) clinical trial «Jaguar» (PHG-M2/P03-12) by I. G. Bakulin, N. A. Bokhan, P. O. Bogomolov, N. I. Geyvandova, M. V. Matsiyevich, M. A. Vinnikova, V. G. Morozov, O. M. Khromtsova, G. S. Soldatova, O. Yu. Shiryayev, R. D. Ilyuk, K. V. Rybakova, A. G. Katkovskaya, S. V. Teplykh, A. A. Bagretsova, M. V. Krasnova, Ye. V. Alekseyeva, A. V. Anipchenko, Ye. V. Baskakov

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Adaptive clinical trial of AZD7442 and SARS-CoV-2 vaccination in immunosuppressed patients highly vulnerable to infection with SARS-CoV-2 virus (RAPID-PROTECTION): protocol for a multicentre, interventional open-label, randomised controlled trial by Ernest Choy, Kerenza Hood, Emma Thomas-Jones, Eleanor Barnes, Keith Wilson, Christian H Ottensmeier, Debbie Harris, Adrian Hill, Mark Tuthill, Richard Adams, Catherine Porter, Katie Ewer, Sian Griffin, Rebecca Tangney, Joanne Euden, Shirley Pringle, Lawrence Raisanen, Ruby Ray, Lisette Sheena Nixon, Melanie Varley, Craig Bodman, Paola Cicconi, Vivien Dagley, Steven Knapper

“…AZD7442 (Evusheld) is a long-acting monoclonal antibody treatment that has been shown in clinical trials to prevent SARS-CoV-2 infection for up to a year after a single dose. …”
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Study protocol for virtual leisure investigating the effect of virtual reality-delivered stress reduction, entertainment and distraction on the use of coercion and need-based medication and patient satisfaction at a closed psychiatric intensive care unit - a mixed-methods pilot clinical trial by Julie Midtgaard, Lars Clemmensen, Louise Birkedal Glenthøj, Gry Jørgensen, Kristina Ballestad Gundersen, Lisa Charlotte Smith, Stephane Bouchard, Christina Plambøck Thomsen, Louise Turgut

“…Virtual reality (VR) may help overcome these challenges.Methods and analysis The study is a mixed-methods clinical trial with a target sample of 124 patients hospitalised at a closed psychiatric ward in the capital region of Denmark. …”
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Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2): study protocol for a phase 2, prospective, multicentre, open-label, multiarm, biomarker-directed, signal-seeking, umbrella, clinical trial for recurrent IDH mutant, grade 2/3 glioma by Marshall Pitz, Eng-Siew Koh, Elizabeth H Barnes, Lucille Sebastian, Mandy L Ballinger, David M Thomas, Christopher O'Callaghan, John Simes, Hui K Gan, Sonia Yip, Hao-Wen Sim, Desma Spyridopoulos, Richard De Abreu Lourenco, Cynthia Hawkins, Kristen McParland, Benjamin Kong, Subotheni Thavaneswaran, Patrick J Wheeler

“…This study aims to improve outcomes by molecular profiling of patients at relapse, then matching them with the best available drug based on their molecular profile, maximising the chances of patient benefit while simultaneously testing multiple novel drugs.Methods and analysis Low & Anaplastic Grade Glioma Umbrella Study of MOlecular Guided TherapieS (LUMOS-2) will be an international, phase 2, multicentre, open-label, biomarker-directed, umbrella clinical trial for recurrent isocitrate dehydrogenase mutant, histologically grade 2/3 gliomas. …”
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Safety, Tolerability, and Immunogenicity of the Invaplex_AR-Detox <i>Shigella</i> Vaccine Co-Administered with the dmLT Adjuvant in Dutch and Zambian Adults: Study Protocol for a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase Ia/b Clinical Trial by Geert V. T. Roozen, Nsofwa Sukwa, Masuzyo Chirwa, Jessica A. White, Marcus Estrada, Nicole Maier, Kevin R. Turbyfill, Renee M. Laird, Akamol E. Suvarnapunya, Aicha Sayeh, Flavia D’Alessio, Candice Marion, Laura Pattacini, Marie-Astrid Hoogerwerf, Rajagopal Murugan, Manuela Terrinoni, Jan R. Holmgren, Sodiomon B. Sirima, Sophie Houard, Michelo Simuyandi, Meta Roestenberg

“…Trial registration: EU CT number: 2023-506394-35-02, ClinicalTrials.gov identifier: NCT05961059.…”
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Describing randomization in trials included in systematic reviews in orthopaedic surgery by Matthew Tang, Kimberley K. Lun, Adriane M. Lewin, Ian A. Harris

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Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology de... by Barbara A Friedland, Holly Gundacker, Sharon L Achilles, Beatrice A Chen, Craig Hoesley, Barbra A Richardson, Clifton W Kelly, Jeanna Piper, Sherri Johnson, Brid Devlin, John Steytler, Kyle Kleinbeck, Bindi Dangi, Chantél Friend, Mei Song, Barbara Mensch, Ariane van der Straten, Cindy Jacobson, Craig W Hendrix, Jill Brown, Diana Blithe, Sharon L Hiller, MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network

“…Trial registration: Clinical Trial Registration: MTN-030/IPM 041: ClinicalTrials.gov NCT02855346; MTN-044/IPM 053/CCN019: ClinicalTrials.gov NCT03467347.…”
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