Exploring the effects of time-restricted eating on body weight and associated cardiometabolic outcomes in South African women living with HIV (TESSA): protocol for a randomised con... by Andre P Kengne, Julia H Goedecke, Jonas Salling Quist, Ole F Olesen, Kristine Færch, Dirk L Christensen, Amy E Mendham, Lorena Heckens, Fatima Hoosen, Majken Lillholm Pico, Joel Dave, Louise Groth Grunnet

“…Participants will be randomised 1:1 to the TRE group (n=76) or standard of care control group (n=76) for 12 months. The TRE group will be required to restrict their eating window to ~8–10 hours/day and will receive nutritional information sessions at baseline and at 3, 6, 9 and 12 months. …”
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Emotion regulation intervention to promote well-being through a serious game (emoWELL): a study protocol for a randomised controlled trial in Spanish emerging adults by José-Antonio Gil-Gómez, Inmaculada Montoya-Castilla, Saray Velert-Jiménez, Hugo Sanchez-Sanchez, Marian Perez-Marin

“…They will be randomly assigned to either the control or experimental group. The experimental group will complete the emoWELL serious game. …”
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Effectiveness of the Labour Inspection Authority’s regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegi... by Øivind Skare, Stein Knardahl, Anne-Marthe R Indregard, Jan Shahid Emberland, Håkon A Johannessen

“…The home-care service is one of the fastest growing occupations and a prioritised area for the NLIA, hence the present study will investigate regulatory tools in this sector.Methods and analysis The research project has been designed as a longitudinal, cluster-randomised, controlled trial and will be conducted among Norwegian home-care workers. …”
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Protocol of DEXPED trial: efficacy of intravenous dexamethasone, administered at the time of analgesic blocking of the lower limb, on postoperative pain in children: a randomised,... by Nathalie Thilly, Nicolas Vautrin, Yohann Bernard, François Wurtz, Claude Meistelman

“…This study is a monocentric, prospective, randomised, placebo-controlled, double-blinded study in a university hospital in France. …”
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Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and... by Kevin K Brown, Toby M Maher, Michael Kreuter, David J Lederer, Wim Wuyts, Nadia Verbruggen, Simone Stutvoet, Ann Fieuw, Paul Ford, Walid Abi-Saab, Marlies Wijsenbeek

“…Here we report the design of two phase III studies of the novel IPF therapy, GLPG1690.Methods and analysis Two identically designed, phase III, international, randomised, double-blind, placebo-controlled, parallel-group, multicentre studies (ISABELA 1 and 2) were initiated in November 2018. …”
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Mediating role of gut microbiota on Baduanjin for cognitive function in community-dwelling older adults with mild cognitive impairment: a study protocol for a cluster randomised co... by Guohua Zheng, Liwei Sun, Qian Geng

“…The aim of this study is to investigate the mediating effect of gut microbiome between regular Baduanjin training and improvement in cognitive function in community-dwelling older adults with MCI.Methods and analysis This is a two-arm, randomised, parallel-controlled, single-blinded trial. Four residential communities (clusters) with a total of 64 eligible participants (16 participants in each residential community) will be randomised 1:1 to either the 24-week Baduanjin exercise intervention group (60 min per session, four sessions per week) or the no specific exercise intervention control group. …”
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Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial by Paweł Krajewski, Justyna Romańska, Wojciech Margas, Joanna Seliga-Siwecka

“…Non-inferiority will be declared if the mean weight of children in the intervention group will be no worse than the mean weight of children from the control group, by a margin of −210 g.Ethics and dissemination The Bioethics Committee of the Medical University of Warsaw approved the study protocol prior to recruitment. …”
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The proximal hamstring avulsion clinical trial (PHACT)—a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: s... by Ville M Mattila, Olof Sköldenberg, Martin Eklund, Elsa Pihl, Carl Johan Hedbeck, Målfrid Holen Kristoffersen, Anne-Mari Rosenlund, Sofia Laszlo, Mida Berglöf, Eva Ribom, Karl Eriksson, Frede Frihagen, Jörg Schilcher, Greta Snellman, Mikael Skorpil, Kenneth Jonsson

“…This protocol describes the design for the proximal hamstring avulsion clinical trial (PHACT)—the first randomised controlled trial of operative versus non-operative treatment for proximal hamstring avulsions.Methods and analysis PHACT is a multicentre randomised controlled trial conducted across Sweden, Norway and Finland. …”
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Effects of preconditioning by nasal splint and mouth breathing on emergence delirium after functional endoscopic sinus surgery in Chinese adults: a study protocol for a randomised... by Xiang Li, Bin Yang, Jinbao Li, Hongjiao Xu, Zhenyuan Shen, Weiwen Li, Yachun Zhou, Jihong Jiang, Yuyu Gu, Zhi Pei

“…This study aims to test a non-invasive, non-drug treatment modality of nose clamping and mouth-breathing training before surgery to reduce ED.Methods and analysis This prospective randomised controlled trial (RCT) will include 200 patients who undergo functional endoscopic sinus surgery (FESS) at Shanghai General Hospital, China. …”
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Investigating the combined effects of statins and exercise on skeletal muscle mitochondrial content and function, cardiorespiratory fitness and quality of life in individuals with... by Simon Birk Kjær Jensen, Magni Mohr, Jacob Bejder, Nikolai B Nordsborg, Jacobina Kristiansen, Tórur Sjúrðarson, Jan Rasmussen, Helga Ellingsgaard, Steen Larsen, Sanna á Borg, Jørgen Martin Meinhardsson, Helgi Winther Olsen, Jeppe F Vigh-Larsen

“…Genetic analysis will be conducted to assess the role of genetic polymorphisms in individual responses to statins and exercise.Ethics and dissemination The trial has received ethical approval from the Faroe Islands Ethical Committee (2024-10) and adheres to the Declaration of Helsinki and General Data Protection Regulation (GDPR). …”
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Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomi... by Jie Li, Yajie Liu, Min Zhang, Haoyang Sun, Yingying Zhu, XinGuang Yang, Dong Pan, Yamei Tang, Hongbiao Hou, Xiongjun He, Yongteng Xu, Huiyuan Peng, Kaifeng Li, Yanting Chen, Baixuan He, Hongxing Zhou

“…Eligible participants are 1:1 randomly assigned to the experimental group and the control group. Participants in the experimental group will receive intra-arterial alteplase (0.225 mg/kg and a maximum dose of 20 mg) after MT and standard medical treatment, while those in the control group will receive standard medical treatment alone after the procedure. …”
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Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – su... by Najib Rahman, Babu Naidu, Eihab O Bedawi, Zaigham Saghir, Uffe Bodtger, Bo Martin Bibby, Christian B Laursen, Thomas Decker Christensen, Morten Bendixen, Søren Helbo Skaarup, Jens-Ulrik Jensen, Rene Horsleben Petersen, Merete Christensen, Peter Licht, Kirsten Neckelmann, Lars B Møller, Morten Hornemann Borg, Sten Langfeldt, Stefan M W Harders

“…The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. …”
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The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonat... by Anne Greenough, Thomas Schaible, Neil Patel, Dick Tibboel, Arno van Heijst, Theodore Dassios, Joost van Rosmalen, Viviana Arreo, Yogen Singh, Karel Allegaert, Suzan Cochius-den Otter, Florian Kipfmueller, Maria Dolores Elorza, Ana Sanchez, Leopoldo Martinez, Carlos Labrandero, Pertierra Cortada, Jordi Clotet Caba, Marta Aguar, Ana Gimeno, Raquel Escrig, Irma Capolupo, Pietro Bagolan, Fabrizio Ciralli, Genny Raffaeli, Giacomo Cavallaro, Valentina Condò, Paul D. Losty, Marie Horan, Nimish V. Subhedar, Emma E. Williams, Jennifer B. Brandt, Alexandra Kreissl, Berndt Urlesberger, Carmen Mesas Burgos, Björn Frenckner, Björn Larrson, Carla Pinto, Joana Saldaha, Anne Debeer, Anne Smits, Ragnhild Emblem, Richard Keijzer, Yassar Elsayed, David Tingay, Ulrike Kraemer

“…The principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act and the national rules and regulations on personal data protection will be used. …”
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Effectiveness of containment strategies and local cognition to control vehicular traffic volume in Dhaka, Bangladesh during COVID-19 pandemic: Use of Google Map based real-time tra... by Niaz Mahmud Zafri, Sadia Afroj, Mohammad Ashraf Ali, Md Musleh Uddin Hasan, Md Hamidur Rahman

“…<h4>Background</h4>To prevent the viral transmission from higher infected to lower infected area, controlling the vehicular traffic, consequently public movement on roads is crucial. …”
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Administrative law challenges of post-clearance audit in Serbia by Cucić Vuk

“…The backbone of this system consists of customs declarations filed by the importers/exporters, selective control at the border, based on risk assessment, and the post-clearance audit (PCA) of the accepted customs declarations. …”
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Antitrust Private Enforcement and the Binding Effect of Public Enforcement Decisions by Miguel Sousa Ferro

“…It tackles decisions declaring antitrust infringements adopted by the European Commission and by national competition authorities, as well as commitment decisions and decisions declaring infringements of merger control and State aid rules. …”
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Risk of evolution driven population-wide emergence of mpox: The paradoxic effect of moderate interventions by F. Nedényi, J.M. Benke, M. Szalai, G. Röst

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Environmental surveillance of SARS-CoV-2 for outbreak detection in hospital: A single centre prospective study by Hania Siddiqui, Alexandra M.A. Hicks, Aaron Hinz, Prachi Ray, Jennie Johnstone, Derek R. MacFadden, Jason A. Moggridge, Michael Fralick

“…Objective: To determine whether results from the environmental detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) from floor swabs could be provided to the Infection Prevention and Control (IPAC) team in near real-time. Methods: We conducted a 9-week prospective study at a rehabilitation hospital in Toronto, Canada. …”
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Ultrasound-guided thoracic paravertebral injection of dexamethasone palmitate combined with ropivacaine for the treatment of thoracic herpes zoster-related pain: protocol for a pro... by Liu Wang, Shengrong Xu, Zongbin Jiang, Ruilin He

“…Patients will be randomly assigned in a 1:1 ratio to the intervention group (thoracic paravertebral injections of DXP combined with ropivacaine and antiviral therapy) or the control group (antiviral therapy). Assessments will include pain intensity, quality of life, sleep quality, inflammatory markers, and adverse events.Ethics and registrationThis study strictly adheres to the 2013 SPIRIT Statement and the Declaration of Helsinki and has been approved by the Ethics Committee of the Second Affiliated Hospital of Guangxi Medical University (Approval Number: 2024-KY(0505)). …”
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Protocol: Filgotinib in addition to methotrexate versus filgotinib monotherapy in patients with rheumatoid arthritis with an inadequate response to methotrexate: A multicenter, pro... by Mitsuhiro Akiyama, Toshihiko Hidaka, Motohide Kaneko, Satoshi Ito, Hiroaki Taguchi, Tomonori Ishii, Shuji Asai, Shintaro Hirata, Kei Ikeda, Katsuya Suzuki, Naoki Kato, Yuko Kaneko

“…<h4>Ethics and dissemination</h4>The study has received approval from the Certified Review Board of Keio University Hospital (N20230002) and adheres to the principles outlined in the Declaration of Helsinki and good clinical practice standards. …”
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