Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with rese... by Orlaith Doherty, Conor White, Nanna Brix Finnerup, Eimear Smith, Mark Pollock, Nathan Kirwan, Olive Lennon, Catherine Blake

“…Methods This is a phase 2 single-blinded, randomised feasibility study. It will test the feasibility and acceptability of exoskeleton-based walking 3 times per week for 12 weeks (intervention), as a mechanistic-based intervention for NP after SCI. …”
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Safety and Intranasal Retention of a Broad-Spectrum Anti-SARS-CoV-2 Monoclonal Antibody SA55 Nasal Spray in Healthy Volunteers: A Phase I Clinical Trial by Chaoying Hu, Yibo Zhou, Xing Meng, Jianhua Li, Jinxia Chen, Zhifang Ying, Xiaoliang Sunney Xie, Yaling Hu, Yunlong Cao, Ronghua Jin

“…Methods: This phase I, dose-escalation clinical trial combined an open-label design with a randomized, controlled, double-blind design. Healthy participants aged 18–65 years were enrolled and received a single dose of the SA55 nasal spray (1 mg or 2 mg) or multiple doses of SA55 nasal spray/placebo for 7 days (1 or 2 mg/dose, 3 or 6 doses/day). …”
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Large language models for pretreatment education in pediatric radiation oncology: A comparative evaluation study by Dominik Wawrzuta, Aleksandra Napieralska, Katarzyna Ludwikowska, Laimonas Jaruševičius, Anastasija Trofimoviča-Krasnorucka, Gints Rausis, Agata Szulc, Katarzyna Pędziwiatr, Kateřina Poláchová, Justyna Klejdysz, Marzanna Chojnacka

“…Finally, a multi-institutional group of nine pediatric radiotherapy experts conducted a blind review of responses, assessing reliability, concision, and comprehensibility. …”
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Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding by Fátima Higuera-de-la-Tijera, Alfredo I. Servín-Caamaño, Francisco Salas-Gordillo, José L. Pérez-Hernández, Juan M. Abdo-Francis, Jaime Camacho-Aguilera, Sai N. Alla, Fiacro Jiménez-Ponce

“…Methods. A randomized, double-blind, placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT02158182) which included cirrhotic patients with variceal bleeding, without minimal or clinical hepatic encephalopathy at admission. …”
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Zinc absorption from maize-based meals enriched with edible house crickets: a randomized crossover stable-isotope study in Kenyan pre-school children by Nikolin Hilaj, Tele Boit, Pauline Andang’o, Christophe Zeder, Martin N. Mwangi, Marijke Hummel, Ornella Necochea Velazco, Joop J. A. van Loon, Marcel Dicke, Michael B. Zimmermann, Alida Melse-Boonstra

“…We investigated zinc absorption from house crickets (Acheta domesticus) in a single-center and single-blinded cross-over study with children aged 24–36 months old in Kenya from September-November 2021. …”
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Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled t... by Xun Xu, Tianwei Qian, Hao Zhou, Weijun Wang, Ying Fan, Lin Xue, Xia Wu, Qiaoyun Gong, Luyao Ye

“…This study aims to evaluate the efficacy and safety of vitrectomy combined with lens capsule flap transplantation in the treatment of HMMHRD.Methods and analysis This single-centre, single-blind, prospective, randomised clinical trial will include 54 patients with HMMHRD who will first undergo phacoemulsification and intraocular lens implantation and then vitrectomy combined with lens capsule flap transplantation (experimental group) or ILM tamponade (control group). …”
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Usefulness of Magnetoinertial Wearable Devices in Neurorehabilitation of Children with Cerebral Palsy by Marco Iosa, Manuela de Sanctis, Aurora Summa, Elena Bergamini, Daniela Morelli, Giuseppe Vannozzi

“…Children with CP were randomly divided in two groups: in the first group (CPI), MIMU-based parameters were used by therapists for planning patient-tailored rehabilitation programs, whereas in the second group (CPB), therapists were blind to the MIMU-based assessment results. Both CPI and CPB were tested before and after the relevant neurorehabilitation program. …”
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Standardization and validation of a novel reverse transcriptase polymerase chain reaction method for detecting virulent strains of the infectious bursal disease virus by Vladimir Longa-Bobadilla, Phillip Ormeño-Vásquez, Manuel Criollo-Orozco, Luis Tataje-Lavanda, Katherine Huamán-Gutierrez, Ángela Montalván, Mirko Zimic, Manolo Fernández-Sanchez, Manolo Fernández-Díaz

“…Conclusion: Our novel RT-PCR procedure has been demonstrated to be helpful in selectively amplifying the consensus sequence of the VP5 gene, indicating that this novel RT-PCR procedure constitutes an important and useful tool to execute initial discrimination of field-retrieved samples containing and not containing virulent strains of this virus before deciding to execute a blindly and more costly sequencing procedure of all the samples together.…”
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Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlle... by Jan Kottner, Monira El Genedy-Kalyoncu, Alexandra Fastner, Bettina Völzer, Kathrin Raeder, Konrad Neumann, Nils Axel Lahmann

“…Therefore, the overall aim of this exploratory trial is to compare the effects of three skin protection strategies to estimate effect sizes of the recently published core outcomes in IAD research.Methods and analysis A pragmatic three-arm, assessor-blinded, randomised controlled, exploratory trial with parallel group design will be performed, comparing film-forming and lipophilic skin protecting leave-on products for IAD prevention with standard incontinence care alone. …”
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Effect of Zhan Zhuang Qigong on upper limb static tremor and aerobic exercise capacity in patients with mild-to-moderate Parkinson’s disease: study protocol for a randomised contro... by Hang Su, Xiaoyu Jiang, Limin Wang, Linlin Zhang, Qing Wang, Xihua Liu, Xiaoming Xi, Yuxiao Chen, Xinjie Qu, Haihao Cao, Wenyu Sun, Guoming Chen, Huifen Liu, Jiahui Jiang, Hongyan Bi

“…Studies have indicated that aerobic and resistance exercises alleviate PD movement disorders and improve aerobic capacity, but the effects of Qigong on PD static tremor and aerobic capacity remain unknown.Methods and analysis Objective To observe the effects of Zhan Zhuang Qigong on upper limb static tremor and aerobic capacity in patients with PD, we established a rigorous randomised, parallel-controlled, assignment hidden, evaluator-blinded protocol.Methods Seventy-two patients with PD, at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, were recruited and randomly divided into a control (n=36) and experimental group (n=36). …”
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Efficacy of the Foodbot Factory digital curriculum-based nutrition education intervention in improving children’s nutrition knowledge, attitudes and behaviours in elementary school... by Wendy Lou, Michael Farkouh, JoAnne Arcand, Jacqueline Marie Brown, Saman Tahir, Beatriz Franco-Arellano, Ann LeSage, Janette Hughes, Bill Kapralos, Ellen Vogel, Claire Tugault-Lafleur

“…Pilot data have demonstrated that Foodbot Factory can significantly improve children’s nutrition knowledge, but it has not yet been evaluated in classrooms.Methods and analysis A single-blinded cluster randomised controlled trial was designed in 2022 by a research team based at Ontario Tech University to determine the efficacy of the Foodbot Factory intervention in improving children’s nutrition knowledge, attitudes and behaviours. 32 grade 4 and 4/5 classrooms in Ontario will be randomised to receive (1) the Foodbot Factory intervention or (2) a control nutrition education intervention using conventional materials (eg, activity sheets). …”
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Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial by Robert Clarke, Emma J Crosbie, Basil G Issa, John Belcher, Helen Clarke, Anthony Howell, Michelle Harvie, Hannah Harrison, Cheryl Lombardelli, Suzanne Krizak, Katharine Sellers, Yit Y Lim, Caroline Parkin, Shruthi Patel, Anthony J Maxwell, Julie Wisely, Sacha J Howell

“…This study aims to examine the cellular and molecular changes in breast and endometrial tissue in high-risk women following TDR-induced weight loss, as well as longer-term adherence to a 12-month TDR weight loss intervention.Methods and analysis PROBE-TDR (PRevention Of Breast and Endometrial cancer using Total Diet Replacement) is a prospective, non-blinded, randomised controlled trial of 47 women at increased risk of breast and/or endometrial cancer. …”
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Efficacy and Tolerance of Vascular Electrical Stimulation Therapy in the Management of Vaso-Occlusive Crises in Patients with Sickle Cell Disease: A Phase II Single-Centre Randomiz... by Renée-Paule Botti, Sie Saïda Bokoum, Etienne L’Hermite, Dohoma Alexis Silue, Boidy Kouakou, Sarah Anastasie Bognini, Serge Arnaud Agoua, Edgar Mandeng Ma Linwa, Roméo Ayemou, Kouassi Gustave Koffi

“…We conducted a phase II, single blinded, randomized, controlled, triple-arm, comparative trial. …”
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Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol by Andrew Xanthopoulos, Eleni Kapreli, Garyfallia Pepera, Konstantinos I Gourgoulianis, Varsamo Antoniou, Gregory Giamouzis, Constantinos Davos, Ladislav Batalik, Vasileios Stavrou, John Skoularigis

“…This study will investigate the efficacy, efficiency, safety and cost-effectiveness of a telerehabilitation programme based on objective exercise telemonitoring and evaluation of cardiorespiratory fitness.Methods and analysis A supervised, parallel-group, single-blind randomised controlled trial will be conducted. …”
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Efficacy and safety of edoxaban in patients with chronic thromboembolic pulmonary hypertension: protocol for a multicentre, randomised, warfarin-controlled, parallel group trial -... by Keiichi Fukuda, Satoshi Yasuda, Hiroyuki Tsutsui, Toyoaki Murohara, Kohtaro Abe, Koichiro Tatsumi, Junji Kishimoto, Yu Taniguchi, Yuichi Tamura, Koji Todaka, Shun Minatsuki, Kazuya Hosokawa, Yuko Kobayakawa, Takumi Inami, Nobutaka Ikeda

“…The present trial seeks to evaluate whether edoxaban is non-inferior to warfarin in preventing worsening of CTEPH.Methods and analysis The KABUKI trial (is an investigator-initiated, multicentre, phase 3, randomised, single-blind, parallel-group, warfarin-controlled, non-inferiority trial to evaluate the efficacy and safety of edoxaban versus warfarin (vitamin K Antagonist) in subjects with chronic thromBoembolic pUlmonary hypertension taking warfarin (vitamin K antagonIst) at baseline) is designed to prove the non-inferiority of edoxaban to warfarin in terms of efficacy and safety in patients with CTEPH.Ethics and dissemination This study is approved by the Institutional Review Board of each participating institution. …”
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Comparison of Efficacy and Safety of Lispro and Aspart Evaluated by Continuous Glucose Monitoring System in Patients with Newly Diagnosed Type 2 Diabetes by Bing-li Liu, Guo-ping Yin, Feng-fei Li, Yun Hu, Jin-dan Wu, Mao-yuan Chen, Lei Ye, Xiao-fei Su, Jian-hua Ma

“…Methods. This is a single-blind randomized controlled trial. A total of 110 patients with newly diagnosed T2DM and with hemoglobin A1c (HbA1c%) above 9% was hospitalized and randomly divided into two groups: group Asp (NovoRapid group) and group Lis (Prandilin group). …”
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Clinical Profile and Outcome in Patients with Coronary Slow Flow Phenomenon by Xiaogang Zhu, Hua Shen, Fei Gao, Sijing Wu, Qian Ma, Shuo Jia, Ziwei Zhao, Shan Tong, Zhihao Zhang, Yujie Zhou

“…Two teams (clinical center and core lab) were blind to patient data for the assessment of coronary angiograph using corrected thrombolysis in myocardial infarction (TIMI) frame count (CTFC). …”
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Development and Videographic Evaluation of a Vascular Access Simulation-Based Curriculum for Surgical and Medical Trainees by Alaska Pendleton, MD, MPH, Tiffany R. Bellomo, MD, Srihari K. Lella, MD, Kristen Jogerst, MD, Ada Stefanescu, MD, MSc, Douglas Drachman, MD, Nikolaos Zacharias, MD, Anahita Dua, MD, MBA, MSc

“…All recordings were reviewed and scored by 2 blinded, independent investigators. Results:. Twenty-six participants completed the curriculum with pre- and postcurriculum recordings. …”
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Comparison of glycosylated fibronectin versus soluble fms-like tyrosine kinase/placental growth factor ratio testing for the assessment of pre-eclampsia: protocol for a multicentre... by Marcus Green, Chao Wang, Sarah Fisher, Amarnath Bhide, Ramesh Ganapathy, Basky Thilaganathan, Nouran Elbarbary

“…The clinical team will be blinded to the results of the GlyFn test but not that of the sFlt/PlGF test. …”
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Magnetic resonance imaging -based radiomics of the pituitary gland is highly predictive of precocious puberty in girls: a pilot study by Michele Maddalo, Maddalena Petraroli, Francesca Ormitti, Alice Fulgoni, Margherita Gnocchi, Marco Masetti, Eugenia Borgia, Benedetta Piccolo, Emanuela C. Turco, Viviana D. Patianna, Nicola Sverzellati, Susanna Esposito, Susanna Esposito, Caterina Ghetti, Maria E. Street, Maria E. Street

“…Two readers (R1, R2) blindly segmented the pituitary gland on MRI studies for RFs and performed a manual estimation of the pituitary volume. …”
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