A hand-washing community-based educational intervention to reduce abscess incidence among people who inject drugs: a cluster randomised controlled clinical trial protocol (the HAWA... by Liam Balhan, Marion Aubert, Cynthia Lacoux, Nina Grau, Joachim Levy, Marie-Lou Stefanowski, Lola Perreaut, Luis Sagaon-Teyssier, Sylvie Deuffic-Burban, Anthony Cousien, David Michels, Marie Costa, Perrine Roux

“…The primary outcome is the reduction in abscess prevalence between M0 and M6, which will be compared between the control and intervention arms, and measured from observed (photographs) and self-declared (SSTI questionnaire) data. …”
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Ambroxol as a disease-modifying treatment to reduce the risk of cognitive impairment in GBA-associated Parkinson’s disease: a multicentre, randomised, double-blind, placebo-control... by Matteo Gastaldi, Diego Franciotta, Mario Cirillo, Sara Prioni, Micol Avenali, Fabrizio Esposito, Chiara Reale, Valentina Leta, Enza Maria Valente, Anna Pichiecchio, Barbara Garavaglia, Roberto Eleopra, Marina Grisoli, Roberto Cilia, Luigi Romito, Maria Grazia Bruzzone, Alessandro Tessitore, Ilaria Palmieri, Giada Cuconato, Fabiana Colucci, Pierfrancesco Mitrotti, Rosita De Micco, Marco Fusar Poli, Silvia Cerri, Mario Stanziano, Ana Bacila, Valentina Franco, Cristina Ghezzi, Antonio Emanuele Elia, Grazia Devigili, Nico Golfrè Andreasi, Federico Cazzaniga, Caterina Galandra, Giancarlo Germani, Gerardo Ongari, Marta Picascia, Mattia Verri, Federica Di Nardo, Simone Aloisio, Mattia Siciliano, Paolo Amami, Sylvie Piacentini, Fabio Moda

“…The study is conducted according to good clinical practice and the Declaration of Helsinki. The trial findings will be published in peer-reviewed journals and presented at conferences.Trial registration numbers NCT05287503, EudraCT 2021-004565-13.…”
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Rationale and design of the theRapeutic effects of peroneal nerve functionAl electrical stimuLation for Lower extremitY in patients with convalescent poststroke hemiplegia (RALLY)... by Shuji Matsumoto, Megumi Shimodozono, Tomokazu Noma

“…In addition, its efficacy in patients with a non-Western life style has not been evaluated.Methods and analysis This is a randomised, controlled, open-label multicentre study, comparing rehabilitation with and without FES. …”
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A multicentre, randomised controlled clinical trial evaluating the effect of the adsorptive filter oXiris on haemodynamics in abdominal septic shock patients requiring continuous r... by Yuan Gao, Biao Zhu, Jing Gao, Zhongwei Zhang, Yugang Zhuang, Jianxiao Chen, Yongchao Liu, Mingli Zhu

“…The study plans to recruit 192 participants from intensive care units, who will be randomly assigned to either the intervention group (oXiris set) or the control group (ST 150 set). The primary endpoint is the reduction in norepinephrine equivalence following the initiation of CRRT. …”
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Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster rand... by Reinhold Kilian, Harald Baumeister, Yannik Terhorst, Johannes Knauer, Paula Philippi, Selina Kallinger, Sandro Eiler, Tamara Waldmann, Morten Moshagen, Martina Bader

“…This study aims to evaluate the effectiveness and cost-effectiveness of such a platform for depression and anxiety (RehaCAT+) compared with the standard diagnostic system (RehaCAT) in cardiological and orthopaedic health clinics in routine care.Methods and analysis A two-arm, pragmatic, cluster-randomised controlled trial will be conducted. Twelve participating rehabilitation clinics in Germany will be randomly assigned to a control (RehaCAT) or experimental group (RehaCAT+) in a 1:1 design. …”
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The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous in... by Jonathan Carapetis, Tom Snelling, Mark A Jones, Julie A Marsh, Bianca Fleur Middleton, Claire S Waddington, Margaret Danchin, Carly McCallum, Sarah Gallagher, Ross Andrews, Carl Kirkwood, Nigel Cunliffe

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Rationale and design of a comparison of angiography-derived fractional flow reserve-guided and intravascular ultrasound-guided intervention strategy for clinical outcomes in patien... by Qiang Liu, Shiqiang Li, Jinlong Zhang, Fan Jiang, Bin Yang, Jianan Wang, Jun Pu, Jun Jiang, Hao Zhou, Peng Chen, Liang Lu, Dongsheng Lu, Bon-Kwon Koo, Jinyu Huang, Lijun Guo, Xinyang Hu, Eun-Seok Shin, Shengxian Tu, Xiaoping Peng, Yibin Pan, Wenming He, Jilin Li, Zhenfeng Cheng, Jianliang Ma, Daqing Song, Yongzhen Fan, Zhaohui Meng, Lijiang Tang

“…However, whether this finding can be applied to angiography-derived FFR in significant coronary artery disease (CAD) remains unclear.Method and analysis The comparison of angiography-derived FFR-guided and IVUS-guided intervention strategies for clinical outcomes in patients with coronary artery disease (FLAVOUR II) trial is a multicentre, prospective, randomised controlled trial. A total of 1872 patients with angiographically significant CAD (stenoses of at least 50% as estimated visually through angiography) in a major epicardial coronary artery will be randomised 1:1 to receive either angiography-derived FFR-guided or IVUS-guided PCI. …”
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Clinical Trial of Sinudrain Haft Bahr Solution for Symptom Management in Mild to Moderate COVID-19 by Hamid Chegni

“…Introduction: The COVID-19 pandemic, caused by the coronavirus, has been declared a global health emergency by the World Health Organization (WHO). …”

Assessment of quality of presentation of clinical trial results in Russia in accordance with CONSORT standards by A. R. Kasimova, N. M. Guseinova

“…The results show that the reviewed Russian medical journals declare requirements and recommendations for the publication of articles in accordance with the CONSORT standards. …”
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Does mobile phone instructional video demonstrating sputum expectoration improve the sputum sample quality and quantity in presumptive pulmonary TB cases? Protocol for a prospectiv... by Siddharudha Shivalli, Amrut Hondappagol, Kibballi Madhukeshwar Akshaya, Abhay Nirgude, Narendra Varun, Raveendra Harohally Ramaiah Reddy, Burugina Nagaraja Sharath

“…It complies with the Declaration of Helsinki, local laws, and the International Council for Harmonization-good clinical practices. …”
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Vision Restoration through transorbital electrical stimulation in Optic Neuropathy in patients with significant optic atrophy due to primary open-angle glaucoma—a randomised, contr... by Katrin Lorenz, Alexander Radbruch, Hans Hoerauf, Philip Enders, Karl Mercieca, Christian van Oterendorp, Marc Brockmann, Anna Beck, Thomas Asendorf, Bettina Wabbels, Michael Schittkowski, Verena Prokosch, Johanna Pohlner, Carsten Grohmann, Lena Kröger, Jens Haueisen, Alexander Hunold, Maria Bernhard, Peter Dechent, Mathias Bähr, Andrea Antal

“…Group 3 with sham stimulation will serve as control.The calculated sample size required to achieve a statistical power of 80% for a relevant effect size and allow for dropouts was 300 (100 per group). …”
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Immediate parent-infant skin-to-skin study (IPISTOSS): study protocol of a randomised controlled trial on very preterm infants cared for in skin-to-skin contact immediately after b... by Agnes Linnér, Björn Westrup, Karoline Lode-Kolz, Stina Klemming, Siri Lillieskold, Hanne Markhus Pike, Barak Morgan, Nils Johannes Bergman, Siren Rettedal, Wibke Jonas

“…Secondary outcomes are autonomic stability, thermal control, infection control, SSC time, breastfeeding and growth, epigenetic profile, microbiome profile, infant behaviour, stress resilience, sleep integrity, cortical maturation, neurodevelopment, mother-infant attachment and attunement, and parent experience and mental health.Ethics and dissemination The study has ethical approval from the Swedish Ethical Review Authority (2017/1135-31/3, 2019–03361) and the Norwegian Regional Ethical Committee (2015/889). …”
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Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individ... by Marit E Jørgensen, Graham Finlayson, Dorte Vistisen, Jonas S Quist, Marie M Jensen, Kim K B Clemmensen, Hanne Pedersen, Natasja Bjerre, Joachim Størling, Martin B Blond, Nicolai J Wewer Albrechtsen, Jens J Holst, Signe S Torekov, Satchidananda Panda, Christina Brock, Kristine Færch

“…Introduction The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes.Methods and analysis The REStricted Eating Time (RESET) study is a randomised controlled parallel-group open-label trial. 100 women and men with (1) overweight (body mass index (BMI)≥25 kg/m2) and prediabetes (glycated haemoglobin 39–47 mmol/mol); or (2) obesity (BMI≥30 kg/m2) will be randomised to a control group (habitual living) or TRE (self-selected 10-hours eating window within the period from 06:00 to 20:00 in a 1:1 ratio. …”
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Efficacy and safety of henagliflozin combined with continuous subcutaneous insulin infusion in the treatment of Chinese inpatients with type 2 diabetes mellitus based on a continuo... by Yingfen Qin, Yingling Wu, Zhenxing Huang

“…Therefore, we aim to conduct a prospective multicentre, randomised, controlled, study to investigate whether treatment of type 2 diabetes patients with continuous subcutaneous insulin infusion (CSII) combined with henagliflozin can reduce the time required for blood glucose control, decrease total insulin requirements, mitigate blood glucose fluctuations and enhance beta-cell function.Methods and analysis In this inpatient, open-label, multicentre, randomised, controlled trial, 200 patients with type 2 diabetes who have not received hypoglycaemic drugs will be randomly allocated at a 1:1 ratio to either the henagliflozin combined with CSII group or the CSII group. …”
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Rationale and Design of a Randomized Controlled Trial of Bivalirudin with a Prolonged High-Dose Infusion Versus Heparin Monotherapy During Primary Percutaneous Coronary Interventio... by Zhenyang Liang, Yi Li, Gregg W. Stone, Yaling Han

“…The procedures set out in this protocol are in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. …”
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ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers wi... by Kenny A Rodriguez-Wallberg, Jonas Bergh, Antonis Valachis, Per Frisk, Theodoros Foukakis, Per Ljungman, Sandra Eloranta, Hanna Pauline Nilsson, Johan Malmros, Christina Linder Stragliotto, Erika Isaksson Friman, Barbro Linderholm, Anne Andersson, Sara Harrysson, Lovisa Vennström, Helena Mörse

“…Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.Methods and analysis A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. …”
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Protocol for a multicentre, randomised, parallel-control, superiority trial comparing administration of clotting factor concentrates with a standard massive haemorrhage protocol in... by Neil Parry, Andrew Beckett, Jo Carroll, Homer Tien, Jeannie Callum, Andrew Petrosoniak, Damon Scales, Luis Teodoro da Luz, Keyvan Karkouti, Paul T Engels, Hans-Peter Hucke, Deep Grewal, Bruce Schwartz, Henry Peng

“…However, there is a knowledge gap on their use compared with the standard of care, the transfusion of plasma.Methods and analysis The factors in the initial resuscitation of severe trauma 2 trial is a multicentre, randomised, parallel-control, single-blinded, phase IV superiority trial. …”
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Methods for Domain Specification of Verification-Oriented Process Ontology by Natalia O. Garanina, Igor S. Anureev, Olesya I. Borovikova, Vladimir E. Zyubin

“…We show that the constructive method is a refinement of the declarative method. The construction of ontology of the typical elements of automatic control systems illustrates our methods: we develop a declarative description of the classes and restrictions for the specialized ontology in the Prot´eg´e system in the OWL language using the deriving rules written in the SWRL language and we construct the system of semantic markup templates which implements typical elements of automatic control systems.…”
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Knowledge, attitudes, and practices (KAP) towards airborne isolation precautions among dental students and interns: A cross-sectional study by Pavani Bellamkonda, Hina Ahmed, Gautam Singh, Manojkumar Sachidanandan, TC Harini, Abdulsalam S. Alshammari, J Suresh Babu, C Swarnalatha, Abhishek Singh Nayyar

“…The active transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) held responsible for the coronavirus disease-19 (COVID-19) pandemic, was, also, declared to occur mainly through the respiratory system. …”
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Non-inferiority and cost-effectiveness trial of isolated biceps tenotomy versus tenotomy with rotator cuff repair in patients with stage 2–3 Goutallier fatty degenerative cuff lesi... by Freek Hollman, Nienke Wolterbeek, Gie Auw Yang

“…The goal of this trial is to study function and quality-of-life of patients undergoing arthroscopic biceps tenotomy with or without an additional cuff repair and to include an economic evaluation.Methods and analysis This multicentre randomised controlled non-inferiority trial, including an economic evaluation, is designed to compare the short-term and long-term outcome of patients who underwent an arthroscopic tenotomy of the long head of the biceps tendon with or without a cuff repair. …”
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