Preferences of people with type 2 diabetes for telemedical lifestyle programmes in Germany: protocol of a discrete choice experiment by Veronika Gontscharuk, Andrea Icks, Michael Roden, Markus Vomhof, Sandra Grobosch, Jana Sommer, Jan Dyczmons

“…When implementing new programmes into standard care, considering patients’ preferences may increase the success of the participants. …”
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Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study by Samir Jaber, Karim Asehnoune, Fanny Feuillet, Mickael Vourc’h, Donatien Huard, Gabrielle Baud, Arthur Guichoux, Marielle Surbled, Melanie Tissot, Anne Chiffoleau, Christophe Guitton

“…Intent-to-treat and per-protocol analysis are planned for the primary outcome.Ethics and dissemination The study project has been approved by an independent ethics committee. …”
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Effects of minocycline on patients with acute anterior circulation ischaemic stroke undergoing intravenous thrombectomy (MIST-A): the study protocol for a multicentre, prospective,... by Xiao Zhang, Li Yao, Jingjing Zhao, Hao Zhu, Bin Wang, Huiping Zhang, Wen Jiang, Dong Wei, Wen Liu, Zhongqing Sun, Weiwang Li, Xiangjun Yuan, Xingshun Ma, Junpeng Meng, Yi Jia, Na Qin

“…These patients will be randomly divided into two groups: one receiving minocycline in addition to standard care and the other receiving only standard care. …”
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Serial Paediatrics Omics Tracking in Myalgic Encephalomyelitis (SPOT-ME): protocol paper for a multidisciplinary, observational study of clinical and biological markers of paediatr... by Adam Scheinberg, Natalie Thomas, Katherine Huang, Paul R Gooley, Elisha K Josev, Tracey Chau, Darcy Tantanis, Sarah J Knight, Christopher W Armstrong

“…Findings from this study will be disseminated through peer-reviewed journal publications and presentations at relevant conferences. …”
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Intraperitoneal paclitaxel for patients with primary malignant peritoneal mesothelioma: a phase I/II dose escalation and safety study—INTERACT MESO by Job P van Kooten, Jacobus W A Burger, Cornelis Verhoef, Joachim G J V Aerts, Eva V E Madsen, Alexandra R M Brandt-Kerkhof, Stijn L W Koolen, Ron H J Mathijssen, Michelle V Dietz, Niels A D Guchelaar

“…Through this PAC, 8–16 weekly cycles of intraperitoneal chemotherapy will be administered.Ethics and dissemination The Central Committee on Research Involving Human Subjects (CCMO, The Hague, The Netherlands) and the Medical Research Ethics Committee (METC, Rotterdam, The Netherlands) have granted permission to carry out this study protocol. …”
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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

“…Results will be published via peer-reviewed journals.Trial registration number DRKS00027447…”
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PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol by Alex Burdorf, Jasper V Been, Frank J Van Lenthe, Nienke W Boderie, Johannes LW van Kippersluis, Diarmaid T Ó Ceallaigh, Márta K Radó

“…Effectiveness will be determined by intention-to-treat analysis.Ethics and dissemination The Erasmus MC Medical Ethics Committee decided that according to the Dutch Human Research Law (WMO), the protocol required no formal ethical approval. …”
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A maChine and deep Learning Approach to predict pulmoNary hyperteNsIon in newbornS with congenital diaphragmatic Hernia (CLANNISH): Protocol for a retrospective study. by Ilaria Amodeo, Giorgio De Nunzio, Genny Raffaeli, Irene Borzani, Alice Griggio, Luana Conte, Francesco Macchini, Valentina Condò, Nicola Persico, Isabella Fabietti, Stefano Ghirardello, Maria Pierro, Benedetta Tafuri, Giuseppe Como, Donato Cascio, Mariarosa Colnaghi, Fabio Mosca, Giacomo Cavallaro

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RadBone: bone toxicity following pelvic radiotherapy – a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecologica... by Janelle Yorke, Sarah O’Connell, Sally Taylor, Karen Johnson, Robert G Bristow, Martin Eden, Kate Haslett, John Moore, Rohit Kochhar, Victoria Chatzimavridou Grigoriadou, Lisa H Barraclough, Ivona Baricevic-Jones, Zoe Merchant, Thomas Westwood, Anthony David Whetton, Claire E Higham

“…Clinical effectiveness and bone turnover markers will be evaluated as secondary outcomes.Ethics and dissemination This study has been approved by the Greater Manchester East Research Ethics Committee (Reference: 20/NW/0410, November 2020). …”
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IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers by Sunita Mathur, John Muscedere, David M Maslove, Miranda Hunt, John Gordon Boyd, Stephanie Sibley, Tracy Boyd, Michelle Tryon, Natasha Arianne Jawa, Michaela Hanley, Robin Westphal, Afolasade Fakolade

“…The control group will receive standard of care in the ICU and follow-up with their PCP. …”
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Effect of environmental enrichment on relapse rates in patients with severe alcohol use disorder: protocol for a randomised controlled trial by Lila Barillot, Claudia Chauvet, Marc Besnier, Nematollah Jaafari, Marcello Solinas, Armand Chatard

“…Results will be disseminated through presentations, peer-reviewed journals and seminar conferences. All information on ethical considerations and open science practices can be accessed at https://osf.io/b57uj/Trial registration number NCT05577741.…”
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Rationale and design for the thoracic Paravertebral Adjunctive Dexamethasone Palmitate Reducing chronic pain After cardiac surgery (PANDORA) trial: a parallel-group, double-blinded... by Jing Zhao, Hui Zhang, Ziyu Zheng, Baobao Gao, Lini Wang, Chong Lei, Hailong Dong, Taoyuan Zhang, Jiao Gao, Lihong Hou

“…The nature and intensity of pain will be evaluated with a Brief Pain Inventory Short Form (BPI-SF) questionnaire.Ethics and dissemination The trial was approved by the Ethics Committee of Xijing Hospital, the First Affiliated Hospital of Air Force Military Medical University (KY20232194-C-1). …”
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Comparative CT with stress manoeuvres for diagnosing distal isolated tibiofibular syndesmotic injury in acute ankle sprain: a protocol for an accuracy- test prospective study by João Carlos Rodrigues, Mario Lenza, Laercio Alberto Rosemberg, Durval do Carmo Santos Barros, Mario Ferretti, Alexandre Leme Godoy Santos, Marcelo Pires Prado, José Felipe Marion Alloza, Renato Amaral Masagão, Adham do Amaral e Castro, Marco Kawamura Demange

“…Sensitivity, specificity, area under the receiver operating characteristic curve and likelihood analyses will compare the diagnostic accuracies of the strategies.Ethics and dissemination The Internal Review Board and the Einstein Ethics Committee approved this study (registered number 62100016.5.0000.0071). …”
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The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vert... by Avril Drummond, Opinder Sahota, Simon Bishop, Dritan Pasku, Apostolos Fakis, Anastasios Bastounis, Chia Wei Tan, Maribel Cameron, Yuriy Arlachov, Michal Czernicki

“…Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data.Ethics and dissemination Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). …”
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Evaluation of in-office tooth whitening treatment with violet LED: protocol for a randomised controlled clinical trial by Lara Jansiski Motta, Anna Carolina Ratto Tempestini Horliana, Sandra Kalil Bussadori, Maria Fernanda Setúbal Destro Rodrigues, Ana Eliza Castanho Garrini dos Santos, Marcelo Mendes Pinto, Dácio Antonio Pantano Junior, Aldo Brugnera Jr, Fátima Antonia Aparecida Zanin

“…The findings will be published in a peer-reviewed journal.Trial registration number NCT03192852; Pre-results.…”
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Randomised, placebo-controlled, double-blinded, four-way crossover trial to demonstrate the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for adrenal in... by Judith Cohen, Miguel Debono, Kathleen Baster, Richard J Ross, Charlotte J Elder, Kathryn L Date, Sharon L Caunt, Jane Fearnside, Trevor N Johnson, Rosie N Taylor

“…In addition, the proportion of participants for which Nasacthin produces a rise above a preset serum cortisol threshold at 30 min will be determined, with the negative per cent agreement with the SST calculated using the SST as the reference standard.Ethics and dissemination The study and its amendments have been reviewed and approved by South Central–Hampshire A Research Ethics Committee. …”
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Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehe... by Ulrich Mansmann, Claudia Spies, Ursula Marschall, Reinhard Busse, Christine Adrion, Bjoern Weiss, Nicolas Paul, Elke Berger, Jörg Caumanns, Simone Rosseau

“…The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient’s ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.Ethics and dissemination This protocol was approved by the ethics committee of the Charité—Universitätsmedizin, Berlin, Germany (EA1/006/18). …”
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Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitud... by Danielle Mazza, Angela Taft, Kevin McGeechan, Kathleen Mcnamee, Natalie Amos, Kirsten I Black, Cathy J Watson, Marion Haas, Jeffrey F Peipert, Jayne Lucke

“…We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.Discussion Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and dissemination The ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. …”
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Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-labe... by Ying Zhu, Jianwei Zhou, Zhigang Zhang, Jiaojiao Zhang, Jing Fei, Xiaoqing Zhu

“…The findings will contribute to the growing body of evidence in support of the incorporation of immunotherapy into the treatment paradigm for ovarian cancer, thus facilitating the development of more personalised and efficacious therapeutic modalities.Ethics and dissemination This trial has received ethical approval from the Institutional Ethics Committee of the Second Affiliated Hospital of the Medical College of Zhejiang University. …”
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Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, sin... by Arjan Vissink, K Hakki Karagozoglu, Tim Forouzanfar, Henk S Brand, Derk Hendrik Jan Jager, Marco Helder, Joseph Bot, Otto Kamp, Seunghee Cha, Gary Weisman, Imke Bartelink

“…Finally, salivary gland topographical alterations will be evaluated by US.Ethics and dissemination Ethical approval for this study was obtained from the Medical Ethics Committee of the Amsterdam University Medical Centre, Amsterdam, The Netherlands (NL68283.029.19). data will be presented at national and international conferences and published in a peer-reviewed journal. …”
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