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  1. Many people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and funct...

    Authors: Hui-Ju Young, Tapan Mehta, Yumi Kim, Sangeetha Padalabalanarayanan, Chia-Ying Chiu, James H. Rimmer and Mohanraj Thirumalai
    Citation: Trials 2021 22:551
  2. The primary objective is to evaluate the efficacy of camostat to prevent respiratory deterioration in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.

    Authors: Sarah Halford, Susan Wan, Ilaria Dragoni, Julie Silvester, Bobojon Nazarov, Daniel Anthony, Suzie Anthony, Emma Ladds, John Norrie and Kevin Dhaliwal
    Citation: Trials 2021 22:550

    The Correction to this article has been published in Trials 2022 23:336

  3. Arterial hypertension has a direct association with endothelial dysfunction and major cardiovascular events. There is evidence showing the benefits of aerobic exercise on flow-mediated dilation (FMD) in hypert...

    Authors: Gustavo Waclawovsky, Liliana Fortini Cavalheiro Boll, Salvador Gomes Neto, Maria Claudia Costa Irigoyen and Alexandre M. Lehnen
    Citation: Trials 2021 22:548
  4. Randomised controlled trials (RCTs) for surgical interventions have often proven difficult with calls for innovative approaches. The Imperial Prostate (IP4) Comparative Health Research Outcomes of Novel Surger...

    Authors: Emily Day, A. Toby Prevost, Matthew R. Sydes, Deepika Reddy, Taimur T. Shah, Mathias Winkler, Tim Dudderidge, John Staffurth, Stuart McCracken, Vincent Khoo, Puja Jadav, Natalia Klimowska-Nassar, Thiagarajah Sasikaran, Hashim U. Ahmed and Francesca Fiorentino
    Citation: Trials 2021 22:547
  5. High-dose intravenous vitamin C directly scavenges and decreases the production of harmful reactive oxygen species (ROS) generated during ischemia/reperfusion after a cardiac arrest. The aim of this study is t...

    Authors: Sander Rozemeijer, Harm-Jan de Grooth, Paul W. G. Elbers, Armand R. J. Girbes, Corstiaan A. den Uil, Eric A. Dubois, Evert-Jan Wils, Thijs C. D. Rettig, Arthur R. H. van Zanten, Roel Vink, Bas van den Bogaard, Rob J. Bosman, Heleen M. Oudemans-van Straaten and Angélique M. E. de Man
    Citation: Trials 2021 22:546
  6. Proton pump inhibitor (PPI) is effective for the treatment of nonerosive gastroesophageal reflux (NERD), but long-term use of PPI is prone to have complications and recurrence after withdrawal. Traditional Chi...

    Authors: Xiaosi Zhang, Yuan Cheng, Xiaohong Li, Xiang Tan, Lei Shi, Xiaojun Shi, Xiancui Zhang, Chun’e Xie and Junxiang Li
    Citation: Trials 2021 22:545
  7. The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and inform...

    Authors: Lydia O’ Sullivan, Laura Feeney, Rachel K. Crowley, Prasanth Sukumar, Eilish McAuliffe and Peter Doran
    Citation: Trials 2021 22:544
  8. One key pathological finding in giant cell arteritis (GCA) is the presence of interferon-gamma and interleukin (IL)-17 producing T helper (Th) 1 and Th17 cells in affected arteries. There is anecdotal evidence...

    Authors: Nils Venhoff, Wolfgang A. Schmidt, Peter Lamprecht, Hans-Peter Tony, Christine App, Christian Sieder, Carolin Legeler, Claudia Jentzsch and Jens Thiel
    Citation: Trials 2021 22:543
  9. The Sustainable Development Goals (SDGs) highlight the importance of investments in early childhood care and education (ECCE) and youth development. Given Pakistan’s large young population, and gender and urba...

    Authors: Aisha K. Yousafzai, Christopher R. Sudfeld, Emily E. Franchett, Saima Siyal, Karima Rehmani, Shelina Bhamani, Quanyi Dai, Chin R. Reyes, Günther Fink and Liliana A. Ponguta
    Citation: Trials 2021 22:542
  10. In 1979, Marvin Zelen proposed a new design for randomized clinical trials intended to facilitate clinicians’ and patients’ participation. The defining innovation of Zelen’s proposal was random assignment of t...

    Authors: Gregory E. Simon, Susan M. Shortreed and Lynn L. DeBar
    Citation: Trials 2021 22:541
  11. To compare the efficacy of chlorhexidine–alcohol and povidone–iodine as preoperative antiseptic skin preparation for prevention of surgical site infection (SSI) after cesarean delivery (CD).

    Authors: Athokpam Lenin Luwang, Pradip Kumar Saha, Minakshi Rohilla, Pooja Sikka, Lekha Saha and Vikas Gautam
    Citation: Trials 2021 22:540
  12. Many shift workers suffer from sleep issues, which negatively affect quality of life and performance. Scientifically evaluated, structured programs for prevention and treatment are scarce. We developed an anon...

    Authors: Lukas Retzer, Monika Feil, Richard Reindl, Kneginja Richter, Robert Lehmann, Mark Stemmler and Elmar Graessel
    Citation: Trials 2021 22:539
  13. Authors: Ulrich Reininghaus, Annelie Klippel, Henrietta Steinhart, Thomas Vaessen, Martine van Nierop, Wolfgang Viechtbauer, Tim Batink, Zuzana Kasanova, Evelyne van Aubel, Ruud van Winkel, Machteld Marcelis, Therese van Amelsvoort, Mark van der Gaag, Lieuwe de Haan and Inez Myin-Germeys
    Citation: Trials 2021 22:538

    The original article was published in Trials 2019 20:769

  14. Interest in the application of machine learning (ML) to the design, conduct, and analysis of clinical trials has grown, but the evidence base for such applications has not been surveyed. This manuscript review...

    Authors: E. Hope Weissler, Tristan Naumann, Tomas Andersson, Rajesh Ranganath, Olivier Elemento, Yuan Luo, Daniel F. Freitag, James Benoit, Michael C. Hughes, Faisal Khan, Paul Slater, Khader Shameer, Matthew Roe, Emmette Hutchison, Scott H. Kollins, Uli Broedl…
    Citation: Trials 2021 22:537

    The Correction to this article has been published in Trials 2021 22:593

  15. Acupuncture is effective for reducing the symptoms of neck pain (NP). However, the underlying mechanisms are not fully elucidated. Based on evaluating the efficacy of two acupuncture prescriptions for treating...

    Authors: Zhen Gao, Tao Yin, Lei Lan, Dehua Li, Ruirui Sun, Guodong Ha, Caili Jiang, Xin Shao, Zhaoxuan He, Laixi Ji and Fang Zeng
    Citation: Trials 2021 22:536
  16. Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the inte...

    Authors: D. Reynaud, N. Bouscaren, V. Lenclume and M. Boukerrou
    Citation: Trials 2021 22:535
  17. Recent studies point to a lower number and reduced severity of cases in higher altitude cities with decreased oxygen concentration. Specific literature has shown several benefits of physical training, so, in t...

    Authors: Átila Alexandre Trapé, Marta Camacho-Cardenosa, Alba Camacho-Cardenosa, Eugenio Merellano-Navarro, Jhennyfer Aline Lima Rodrigues, Elisangela Aparecida da Silva Lizzi, Carlos Arterio Sorgi, Marcelo Papoti and Javier Brazo-Sayavera
    Citation: Trials 2021 22:534
  18. Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive beh...

    Authors: Anna L. MacKinnon, Joshua W. Madsen, Ashley Dhillon, Elizabeth Keys, Gerald F. Giesbrecht, Tyler Williamson, Amy Metcalfe, Tavis Campbell, Kelly J. Mrklas and Lianne Tomfohr-Madsen
    Citation: Trials 2021 22:532
  19. Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF) was a pragmatic, cluster randomized trial assessing the effectiveness of a clinical decision support (CDS) tool in...

    Authors: Joanna M. Nemis-White, Laura M. Hamilton, Sarah Shaw, James H. MacKillop, Ratika Parkash, Shurjeel H. Choudhri, Antonio Ciaccia, Feng Xie, Lehana Thabane and Jafna L. Cox
    Citation: Trials 2021 22:531

    The Correction to this article has been published in Trials 2022 23:547

  20. Systemic lupus erythematosus (SLE) is an autoimmune disease that can involve multiple organs or systems. Lupus nephritis (LN) is associated with high mortality and morbidity. However, plenty of patients do not...

    Authors: Qingran Yan, Fang Du, Yuening Kang, Ping Ye, Xiaodong Wang, Jianhua Xu, Jianping Tang, Niansong Wang, Gengru Jiang, Zhijun Li, Xuan Wang, Qin Xue, Xinfang Huang, Xiaoyan Zhang, Ying Zhou, Min Dai…
    Citation: Trials 2021 22:530
  21. Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and ...

    Authors: Victoria Hodgetts-Morton, Catherine A. Hewitt, Laura Jones, Lisa Leighton, Nicole Pilarski, Eleanor Molloy, Kim Hinshaw, Jane Norman, Jason Waugh, Sarah Stock, Jim Thornton, Philip Toozs-Hobson, Tracey Johnston, Arri Coomarasamy, Shakila Thangaratinam, Ben Mol…
    Citation: Trials 2021 22:529
  22. Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and d...

    Authors: Russell E. Glasgow, Christopher E. Knoepke, David Magid, Gary K. Grunwald, Thomas J. Glorioso, Joy Waughtal, Joel C. Marrs, Sheana Bull and P. Michael Ho
    Citation: Trials 2021 22:528
  23. Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to the resorption of alveolar bone. The initial strategy for treating periodontal diseas...

    Authors: Carly A. R. Zanatta, Peter C. Fritz, Elena M. Comelli and Wendy E. Ward
    Citation: Trials 2021 22:527
  24. A healthy lifestyle can help prevent diseases that impair quality of life and lead to premature death. The Techniker health insurance fund offers a comprehensive online health program to support users in achievin...

    Authors: Iris Tinsel, Gloria Metzner, Christian Schlett, Matthias Sehlbrede, Martina Bischoff, Robin Anger, Judith Brame, Daniel König, Ramona Wurst, Reinhard Fuchs, Peter Lindinger, Rainer Bredenkamp and Erik Farin-Glattacker
    Citation: Trials 2021 22:526
  25. Atrial fibrillation is a cardiac arrhythmia commonly encountered in a primary care setting. Current screening is limited to pulse palpation and ECG confirmation when an irregular pulse is found. Paroxysmal atr...

    Authors: Simon Gabriël Beerten, Tine Proesmans and Bert Vaes
    Citation: Trials 2021 22:525
  26. Lumbar spinal stenosis (LSS) is a common degenerative condition associated with old age. Its incidence continues to increase with the rapidly aging population in China. Treatment for LSS usually begins with co...

    Authors: Akram Osman, Wei Hu, Jianhua-Sun, Jing Li, Xiao Luo, Nianrong Han, Ehsan Abduhani and Zhenqiang Liu
    Citation: Trials 2021 22:524
  27. A drive to improve functional outcomes for patients undergoing total knee arthroplasty (TKA) has led to alternative alignment being used. Functional alignment (FA) uses intraoperative soft tissue tension to de...

    Authors: Richard Steer, Beth Tippett, R. Nazim Khan, Dermot Collopy and Gavin Clark
    Citation: Trials 2021 22:523
  28. Community-based diabetes prevention programs varied widely in effectiveness, and the intervention strategy consisting of lifestyle interventions, stepwise addition of metformin, and financial incentives has no...

    Authors: Kar-Fu Yeung, Mihir Gandhi, Amanda Yun Rui Lam, Selly Julianty, Alvin Yeow Meng Chia, Gilbert Choon Seng Tan, Su-Yen Goh, Emily Tse Lin Ho, Angela Fang Yung Koh, Gavin Siew Wei Tan, Eugene Jin Wen Shum, Eric A. Finkelstein, Tazeen H. Jafar, Yee Leong Teoh, Rob M. van Dam, Clare Whitton…
    Citation: Trials 2021 22:522
  29. Adverse drug events (ADE) represent one of the main causes of admission to emergency department (ED). Their detection, documentation, and reporting are essential to avoid readmission.

    Authors: Cyril Breuker, Marie Faucanié, Marion Laureau, Damien Perier, Véronique Pinzani, Grégory Marin, Mustapha Sebbane and M. Villiet
    Citation: Trials 2021 22:521
  30. Randomised controlled trials in reproductive medicine are often subject to outcome truncation, where the study outcomes are only defined in a subset of the randomised cohort. Examples include birthweight (meas...

    Authors: Jack Wilkinson, Jonathan Y. Huang, Antonia Marsden, Michael O. Harhay, Andy Vail and Stephen A. Roberts
    Citation: Trials 2021 22:520
  31. Silver diamine fluoride (SDF) and sodium fluoride (NaF) are widely used for caries management. The objectives of this study are (i) to compare the caries-arresting and caries-preventive effects of SDF and NaF ...

    Authors: Sherry Shiqian Gao, Faith Miaomiao Zheng, Kitty Jieyi Chen, Duangporn Duangthip, Edward Chin Man Lo and Chun Hung Chu
    Citation: Trials 2021 22:519
  32. Sarcopenia is accompanied by a decline in muscle mass, muscle strength, and muscle function. Resistance training is the most potential training method for the prevention and treatment of sarcopenia. However, t...

    Authors: Nan Chen, Xiangfeng He, Guoyun Zhao, Linqian Lu, Barbara E. Ainsworth, Yu Liu and Xie Wu
    Citation: Trials 2021 22:518
  33. Diabetic foot osteomyelitis (DFO) poses a major disease burden. It can generally be treated with long-term antibacterial therapy. International guidelines recommend to base antibacterial therapy choices on per...

    Authors: Meryl Cinzía Tila Tamara Gramberg, Rimke Sabine Lagrand, Louise Willy Elizabeth Sabelis, Martin den Heijer, Vincent de Groot, Max Nieuwdorp, Willemijn Kortmann, Elske Sieswerda and Edgar Josephus Gerardus Peters
    Citation: Trials 2021 22:517
  34. Despite being in clinical remission, many people with inflammatory bowel disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to te...

    Authors: Christine Norton, Jonathan Syred, Sally Kerry, Micol Artom, Louise Sweeney, Ailsa Hart, Wladyslawa Czuber-Dochan, Stephanie J. C. Taylor, Borislava Mihaylova, Chris Roukas, Qasim Aziz, Laura Miller, Richard Pollok, Sonia Saxena, Imogen Stagg, Helen Terry…
    Citation: Trials 2021 22:516
  35. Safe, more efficacious treatments are needed to address the considerable morbidity and mortality associated with pulmonary tuberculosis (TB). However, the current practice in TB therapeutics trials is to use c...

    Authors: N. K. Hills, J. Lyimo, P. Nahid, R. M. Savic, C. Lienhardt and P. P. J. Phillips
    Citation: Trials 2021 22:515
  36. The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentat...

    Authors: Sara Mahmoodi, Mojtaba Yousefi, Omid Sadeghi, Ali Mahmoodabadi, Mohammadreza Sadriirani, Zahra Hosseinzade, Abdolhossein Jahanbakhsh, Seyed Bahman Panahande, Zaker Saeedinejad, Jan Mohamad Malekzadeh, Mohsen Naghmachi and Azizollah Pourmahmoudi
    Citation: Trials 2021 22:514
  37. Financial incentives are an effective way of helping women to stop smoking during pregnancy. Unfortunately, most women who stop smoking at this time return to smoking within 12 months of the infant’s birth. Th...

    Authors: M. Ussher, C. Best, S. Lewis, J. McKell, T. Coleman, S. Cooper, S. Orton and L. Bauld
    Citation: Trials 2021 22:512
  38. Survival after out-of-hospital cardiac arrest (OHCA) is poor and dependent on high-quality cardiopulmonary resuscitation. Resuscitative endovascular balloon occlusion of the aorta (REBOA) may be advantageous i...

    Authors: Jostein Rødseth Brede, Arne Kristian Skulberg, Marius Rehn, Kjetil Thorsen, Pål Klepstad, Ida Tylleskär, Bjørn Farbu, Jostein Dale, Trond Nordseth, Rune Wiseth and Andreas Jørstad Krüger
    Citation: Trials 2021 22:511
  39. Cognitive biases play an important role in the development and maintenance of emotional disorders, such as depression and anxiety. Novel procedures, known as Cognitive Bias Modification (CBM), aim to reduce th...

    Authors: Inés Nieto and Carmelo Vazquez
    Citation: Trials 2021 22:510
  40. Preterm birth accounts for approximately 11% of all livebirths globally. Due to improvements in perinatal care, more than 95% of these infants now survive into adulthood. Research has indicated a robust associ...

    Authors: Wolfgang Mitterer, Christoph Binder, Anya Blassnig-Ezeh, Lorenz Auer-Hackenberg, Angelika Berger, Burkhard Simma, Martin Wald, Martin Lee and Ursula Kiechl-Kohlendorfer
    Citation: Trials 2021 22:509
  41. Although Alzheimer’s disease affects around 800,000 people in the UK and costs almost £23 billion per year, currently licenced treatments only offer modest benefit at best. Seizures, which are more common in p...

    Authors: Arjune Sen, Mary Akinola, Xin You Tai, Mkael Symmonds, Gabriel Davis Jones, Sergio Mura, Joanne Galloway, Angela Hallam, Jane Y. C. Chan, Ivan Koychev, Chris Butler, John Geddes, Rohan Van Der Putt, Sian Thompson, Sanjay G. Manohar, Eleni Frangou…
    Citation: Trials 2021 22:508
  42. Enamel white spot lesions (WSLs), characterized by an opaque, matt, and chalky white appearance of enamel, are a sign of incipient caries. WSLs are common in orthodontic practice and can affect both the oral h...

    Authors: Danchen Qin, Yunlei Wang, Colin Levey, Peter Ngan, Hong He and Fang Hua
    Citation: Trials 2021 22:507
  43. Spinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict...

    Authors: Jennifer A. Rabbitts, Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray and Tonya M. Palermo
    Citation: Trials 2021 22:506

    The Correction to this article has been published in Trials 2021 22:646

  44. In the context of the COVID-19 pandemic, lockdown and social distancing measures are applied to prevent the spread of the virus. It is well known that confinement and social isolation can have a negative impac...

    Authors: Emma Gabrielle Dupuy, Florent Besnier, Christine Gagnon, Thomas Vincent, Catherine-Alexandra Grégoire, Caroll-Ann Blanchette, Kathia Saillant, Nadia Bouabdallaoui, Josep Iglesies-Grau, Marie Payer, Marie-France Marin, Sylvie Belleville, Martin Juneau, Paolo Vitali, Mathieu Gayda, Anil Nigam…
    Citation: Trials 2021 22:505
  45. Use of a person’s name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient’s name) versus a ...

    Authors: Lucy Cureton, Ioana R. Marian, Vicki S. Barber, Adwoa Parker, David J. Torgerson and Sally Hopewell
    Citation: Trials 2021 22:502
  46. The lockdown associated with the COVID-19 pandemic is likely to impact people’s mental health, especially those from economically disadvantaged and vulnerable sections of society. Mental health can be affected...

    Authors: Saju Madavanakadu Devassy, Komal Preet Allagh, Anuja Maria Benny, Lorane Scaria, Natania Cheguvera and I. P. Sunirose
    Citation: Trials 2021 22:500
  47. New Zealand Greenshell™ mussels (GSM; Perna canaliculus) have recently been shown to decrease cartilage degradation in a rat model of induced metabolic osteoarthritis (MetOA). However, this effect has not been in...

    Authors: Maryam Abshirini, Jane Coad, Frances M. Wolber, Pamela von Hurst, Matthew R. Miller, Hong Sabrina Tian and Marlena C. Kruger
    Citation: Trials 2021 22:498
  48. Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, wh...

    Authors: Sophie Juul, Sebastian Simonsen, Stig Poulsen, Susanne Lunn, Per Sørensen, Anthony Bateman and Janus Christian Jakobsen
    Citation: Trials 2021 22:497

    The Study protocol to this article has been published in Trials 2019 20:196

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