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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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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The activity of a herbal medicinal product of Phyllanthus niruri and Silybum marianum powdered extracts (Heptex®) in patients with apparent risk factors for nonalcoholic steatohepatitis: a phase II, multicentered, randomized, double-blind, placebo-controlled clinical trial by Mohamed Kamal Shaker, Mohamed Hassany, Basem Eysa, AbdulMoneim Adel, Ahmed Zidan, Shahnaz Mohamed

“…Methods This was a phase II, randomized, double-blind, placebo-controlled, three-arm, interventional clinical trial. Patients were randomized in a 1:1:1 ratio to receive placebo, low dose (one capsule) of Heptex®, or high dose (two capsules) of Heptex®. …”
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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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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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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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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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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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Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Bip... by Madison T. Baxter, Christopher C. Conlin, Aditya Bagrodia, Tristan Barrett, Hauke Bartsch, Anja Brau, Matthew Cooperberg, Anders M. Dale, Arnaud Guidon, Michael E. Hahn, Mukesh G. Harisinghani, Juan F. Javier-DesLoges, Sophia C. Kamran, Christopher J. Kane, Joshua M. Kuperman, Daniel J.A. Margolis, Paul M. Murphy, Nabih Nakrour, Michael A. Ohliger, Rebecca Rakow-Penner, Ahmed Shabaik, Jeffry P. Simko, Clare M. Tempany, Natasha Wehrli, Sean A. Woolen, Jingjing Zou, Tyler M. Seibert

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Current Application and Meta-analysis of Traditional Chinese Medicine emotional nursing for colorectal cancer patients' psycho-somatic rehabilitation after radical surgery (中医情志护理在... by SUN Lingyun (孙凌云), PENG Rongyan (彭蓉晏), LIU Jiaxi (刘稼玺), YAN Yunzi (闫蕴孜), YANG Yufei (杨宇飞), ZHAO Nan (赵楠)

Subjects: “…randomized-controlled clinical trials…”
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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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