Evaluation of the Transition-to-Practice Arrangements for Novice Perioperative Nurses: Protocol for a Mixed Methods Study by Nick Nijkamp, Pauline Calleja, Ashlyn Sahay, Leanne Jack

“…Following this, Human Research Ethics Committee approval was sought for phases 1 and 2, and recruitment began. …”
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Strategic Coupling and Its Impact on the Survival of Taiwan-Invested Enterprises in Chinese Mainland: A Configuration-Based Perspective by Sun Jiping, Wei Suqiong, You Xiaojun, Chen Jindong

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Observational study protocol: the faecal microbiome in the acute stage of new-onset paediatric type 1 diabetes in an Irish cohort by Eugene Dempsey, Catherine Stanton, Paul Ross, Colin Patrick Hawkes, Aonghus Lavelle, Carol-Anne O’Shea, Elaine Catherine Kennedy, Fiona Catherine Ross

“…Through this initial exploratory study, we aim to identify specific microbial biomarkers which may be used as future interventional targets throughout the various stages of T1D progression.Ethics and dissemination This study has been approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. …”
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Impact of a synchronous prophylactic treatment of the anterior accessory saphenous vein on the recurrent varicose vein rate in patients undergoing thermal ablation of an insufficie... by Lorenz Uhlmann, Christine Fink, Karsten Hartmann, Thomas Mattausch, Hans-Christian Wenzel, Phillip Zollmann, Jürgen Veltman, Thomas Weiler, Guido Lengfellner, Lars Müller, Markus Stücker, Felizitas Pannier, Carmen Dietrich, Tobias Hirsch

“…Additionally, it will be clarified whether patients benefit from a preventive ablation of a sufficient AASV.Methods and analysis This is a multicentre, prospective, controlled, exploratory clinical study in 1150 patients with a medical indication for EVLA of a refluxing great saphenous vein. …”
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Protocol for a first-in-human feasibility study of T regulatory cells (TR004) for inflammatory bowel disease using (ex vivo) Treg expansion (TRIBUTE) by Jennifer Clough, Peter Irving, A Toby Prevost, Graham M Lord, Joana Vasconcelos, James B Canavan, Beverley Rodger, D Macallan

“…Participants receive a single dose of autologous ex vivo-expanded Tregs and will be followed up to week 21 to collect safety and exploratory efficacy data. Additional safety monitoring will occur at 1 and 2 years post-dose. …”
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Cadaveric simulation versus standard training for postgraduate trauma and orthopaedic surgical trainees: protocol for the CAD:TRAUMA study multicentre randomised controlled educati... by Damian Griffin, Hannah K James, Giles T R Pattison, Joanne D Fisher

“…A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. …”
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Effect of oxytocin nasal spray pretreatment on postoperative acute stress disorder in patients with accidental traumatic fracture: a single-centre prospective randomised controlled... by Ling Ren, Qingqing Huang, Hengdi Zhang, Jingzheng Zeng, Yi Wen, Haifeng Shu, Gu Gong

“…Secondary outcomes include patient resilience, anxiety, depression and pain scores on postoperative days 1–3. The exploratory results include the concentrations of stress response indicators such as malondialdehyde, cortisol and superoxide dismutase in the saliva before the first intervention and on days 1–3 after surgery.Ethics and dissemination The trial was approved by the clinical research ethics committee of the General Hospital of the Western Theater Command (identifier: 2024EC3-ky014). …”
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Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pa... by Phillip Knebel, Thilo Hackert, Markus W Büchler, Thomas Bruckner, Peter Sauer, Markus K Diener, Christine Tjaden, Ulla Klaiber, Pascal Probst, Eike Martin, Steffen Luntz

“…For safety analysis, rates of adverse events (AEs) and serious AEs will be calculated with 95% CIs for group comparisons.Ethics, funding and dissemination PREBOTPilot has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4043654) and the Ethics Committee of Heidelberg University (reference number AFmo-523/2019). …”
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Exploring SLEEPINESS through home monitoring with ultra-long-term subcutaneous EEG and ecological momentary assessment in sleepy treatment naïve obstructive sleep apnea patients st... by Mathias Sarkez-Knudsen, Martin Ballegaard, Martin Ballegaard, Henning Piilgaard, Esben Ahrens, Martin Christian Hemmsen, Tobias Søren Andersen, Jakob Eyvind Bradram, Preben Homøe, Preben Homøe

“…Ethical approval from the Region Zealand Ethics Committee on 13/09/2021 (SJ939, EMN-2021-06803). The study will be conducted in accordance with local legislation and institutional requirements and comply with the Declaration of Helsinki and the General Data Protection Regulation (GDPR).…”
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Co-producing a safe mobility and falls informatics platform to drive meaningful quality improvement in the hospital setting: a mixed-methods protocol for the insightFall study by Ben Glampson, Clare Leon-Villapalos, Erik Mayer, Rachael Lear, Phoebe Averill, Catalina Carenzo, Rachel Tao, Robert Latchford

“…The data to be included in the informatics platform will be curated from electronic health records and incident reports within an existing secure data environment, with appropriate data access approvals and controls. Exploratory analysis of a preliminary static dataset will examine the variety (structured/unstructured), veracity (accuracy/completeness) and value (clinical utility) of the data. …”
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Exercise medicine as adjunct therapy during RADIation for CAncer of the prostaTE to improve treatment efficacy – protocol for the ERADICATE study: a phase II randomised controlled... by Oliver Schumacher, Robert U. Newton, Colin Tang, Raphael Chee, Sjoerd B. Vos, Ronny S. Low, David Joseph, Dennis R. Taaffe, Daniel A. Galvão

“…Survival outcomes will be assessed as exploratory endpoints. Study measurements will be conducted at baseline (i.e., prior to commencing EBRT), immediately after completion of EBRT, and during follow-up at 3 months as well as 2 years and 5 years post treatment. …”
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At-Home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial by Jing Zhao, Akitomo Yasunaga, Andrew T Kaczynski, Hyuntae Park, Yufeng Luo, Jiuling Li, Ai Shibata, Kaori Ishii, Shohei Yano, Koichiro Oka, Mohammad Javad Koohsari

“…Changes in active and sedentary behaviors will also be used to determine the impacts of VR exergames on metabolic syndrome. ResultsThe ethics committee of Guangzhou University, China, approved this study on September 25, 2024. …”
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A randomized, placebo-controlled, cross-over trial of ketamine in Rett syndrome by Kathleen Campbell, Jeffrey L. Neul, David N. Lieberman, Elizabeth Berry-Kravis, Tim A. Benke, Cary Fu, Alan Percy, Bernhard Suter, David Morris, Randall L. Carpenter, Eric D. Marsh, Jana von Hehn

“…An independent safety monitoring committee evaluated safety and approved proceeding to the next dose cohort. …”
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Rationale and design of a randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated phase 2a study to investigate the efficacy and safety of elobixibat i... by Atsushi Nakajima, Takeharu Yamanaka, Koji Yamamoto, Yasushi Honda, Kento Imajo, Masato Yoneda, Yuji Ogawa, Takaomi Kessoku, Takashi Kobayashi, Anna Ozaki, Satoru Saito, Michihiro Iwaki, Yusuke Saigusa, Haruki Usuda, Koichiro Wada

“…The primary study endpoint will be the absolute LDL-C level change at week 16 after treatment initiation. The exploratory endpoint will include absolute changes in the liver fat fraction as measured by MRI-PDFF. …”
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Development and validation of a tool for advising primiparous women during early labour: study protocol for the GebStart Study by Mechthild M Gross, Susanne Grylka-Baeschlin, Antonia N Mueller, Jessica Pehlke-Milde

“…Analyses will be performed using Stata V.17.Ethics and dissemination Ethical approval was obtained by the Ethics Committees Zurich and Northwestern and Central Switzerland (BASEC-Nr. 2021-00687). …”
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Can screening for degenerative cervical myelopathy (SCREEN-DCM) be effectively undertaken based on signs, symptoms and known risk factors? Rationale and research protocol for a pro... by Benjamin Davies, Mark Kotter, Granit Molliqaj, Enrico Tessitore, Karl Schaller, Teresa Somma, Aria Nouri, Renato Gondar, Joseph S Cheng, Paolo Cappabianca, Alexandre Lavé, Gianpaolo Jannelli, Allan Martin, Justin Virojanapa, Carmen L A Vleggeert-Lankamp, Valerie ter Wengel, Torstein Meling

“…Patients with positive MRIs will be consulted and receive assessment via modified Japanese Orthopedic Association and Neck Disability Index scores, and subsequent clinical management will be based on practice guidelines. An exploratory multivariate analysis of the effectiveness and efficiency of this proposed screening test will be evaluated after positively screening 50 patients for DCM.Ethics and dissemination This study has received research ethics approval from the Swiss Association of Research Ethics Committees (ID: 2020-02785). …”
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