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  1. Throughout the last decade, tuberculosis (TB) treatment success has not surpassed 90%, the global target. The impact of mobile health interventions (MHIs) on TB treatment outcomes is unknown, especially in low...

    Authors: Dathan Mirembe Byonanebye, Hope Mackline, Christine Sekaggya-Wiltshire, Agnes N. Kiragga, Mohammed Lamorde, Elizabeth Oseku, Rachel King and Rosalind Parkes-Ratanshi

    Citation: Trials 2021 22:391

    Content type: Study protocol

    Published on:

  2. Medication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contrib...

    Authors: Sam Kosari, Jane Koerner, Mark Naunton, Gregory M. Peterson, Ibrahim Haider, Emily Lancsar, David Wright, Theo Niyonsenga and Rachel Davey

    Citation: Trials 2021 22:390

    Content type: Study protocol

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  3. South Africa has achieved drug-susceptible TB (DS-TB) treatment success of only 77% among people with new and previously treated TB. Alternative approaches are required to improve medication adherence and trea...

    Authors: Noriah Maraba, Catherine Orrell, Candice M. Chetty-Makkan, Kavindhran Velen, Rachel Mukora, Liesl Page-Shipp, Pren Naidoo, M. Thulani Mbatha, Katherine L. Fielding and Salome Charalambous

    Citation: Trials 2021 22:389

    Content type: Study protocol

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  4. Therapeutic exercise is recommended as a core treatment for hip osteoarthritis (HOA). Whilst it is widely accepted that exercise can improve pain and disability, optimal type and dose of exercise are yet to be...

    Authors: Louise C. Burgess, Thomas W. Wainwright, Khara A. James, Johan von Heideken and Maura D. Iversen

    Citation: Trials 2021 22:388

    Content type: Review

    Published on:

  5. Nowadays, because of the increasing incidence, the prevention and control of myopia has become an urgent issue. In China, auricular acupressure has been commonly used in the clinical treatment of myopia in chi...

    Authors: Rong Han, Xie-he Kong, Feng Zhao, Yan-ting Yang, Xiao-qing Dong, Li Zeng, Zhi Chen, Yue Zhao, Guang Yang, Jue Hong, Xing-tao Zhou and Xiao-peng Ma

    Citation: Trials 2021 22:387

    Content type: Study protocol

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  6. Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID a...

    Authors: Wei Peng, Xiaojuan Hong, Yaru Huangfu, Zhao Sun, Wei Shen, Fen Feng, Liang Gong, Zhifu Shen, Baojun Guo, Leixiao Zhang, Yanan Wang, Ying Zhao, Tianmin Zhu, Youping Hu and Siyi Yu

    Citation: Trials 2021 22:386

    Content type: Study protocol

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  7. Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL). It is often accompanied by arthralgia, stiff...

    Authors: Mengyu Wang, Wen Fu, Lingcui Meng, Jia Liu, Lihua Wu, Yingjun Peng and Ziping Li

    Citation: Trials 2021 22:385

    Content type: Study protocol

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  8. Postoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. It has been shown to be preventable with prophylactic ami...

    Authors: Heather A. Smith, Salmaan Kanji, Diem T. T. Tran, Calum Redpath, Dean Ferguson, Tori Lenet, Greg Sigler, Sebastien Gilbert, Donna Maziak, Patrick Villeneuve, Sudhir Sundaresan and Andrew J. E. Seely

    Citation: Trials 2021 22:384

    Content type: Study protocol

    Published on:

  9. Borderline personality disorder (BPD) is a high prevalence and serious mental health disorder that has historically challenged the finite resources of health services. Despite empirical evidence supporting str...

    Authors: Judy A. Pickard, Adam Finch, Elizabeth Huxley, Michelle L. Townsend, Stephanie Deuchar, Kate L. Lewis, Jason Pratt and Brin F. S. Grenyer

    Citation: Trials 2021 22:383

    Content type: Study protocol

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  10. As COVID-19 is spreading, new psychological health problems are suspected to be emerging among pregnant women. Higher maternal mental health distress, including perinatal anxiety, depression, and COVID-19-spec...

    Authors: Sarah Naja, Rowaida Elyamani, Mohamad Chehab, Mohamed Siddig, Abdullah Al Ibrahim, Tagreed Mohamad, Rajvir Singh and Iheb Bougmiza

    Citation: Trials 2021 22:382

    Content type: Study protocol

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  11. After the SARS-CoV-2 pandemic took hold in the UK, the ActWELL trial team’s plans to present the trial results to participants and other stakeholders had to change. Instead of face-face events, three online ev...

    Authors: Hanne Bruhn, Annie S. Anderson, Amy Hickman, E. Jane Macaskill and Shaun Treweek

    Citation: Trials 2021 22:381

    Content type: Letter

    Published on:

    The Research to this article has been published in Trials 2020 21:484

  12. Sub-Saharan Africa is a subcontinent with a proud cultural richness and diversity, yet inexplicably also a region with severe health care challenges and inequity. To challenge this health equity gap and reduce...

    Authors: Martin Heine, Lidwine B. Mokkink, Chanel van Zyl, Wayne Derman and Susan Hanekom

    Citation: Trials 2021 22:380

    Content type: Review

    Published on:

  13. Accelerometers and other wearable devices are increasingly being used in clinical trials to provide an objective measure of the impact of an intervention on physical activity. Missing data are ubiquitous in th...

    Authors: Mia S. Tackney, Derek G. Cook, Daniel Stahl, Khalida Ismail, Elizabeth Williamson and James Carpenter

    Citation: Trials 2021 22:379

    Content type: Methodology

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  14. Intrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy. There are two promising endoscopic treatment strategies in the case of leaks: the placement of self-expanding meta...

    Authors: Michael Tachezy, Seung-Hun Chon, Isabel Rieck, Marcus Kantowski, Hildegard Christ, Karl Karstens, Florian Gebauer, Tobias Goeser, Thomas Rösch, Jakob R. Izbicki and Christiane J. Bruns

    Citation: Trials 2021 22:377

    Content type: Study protocol

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  15. Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintai...

    Authors: Gernot Marx, Kai Zacharowski, Carole Ichai, Karim Asehnoune, Vladimír Černý, Rolf Dembinski, Ricard Ferrer Roca, Dietmar Fries, Zsolt Molnar, Peter Rosenberger, Manuel Sanchez-Sanchez, Tobias Schürholz, Tamara Dehnhardt, Sonja Schmier, Elke von Kleist, Ute Brauer…

    Citation: Trials 2021 22:376

    Content type: Study protocol

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  16. Clinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to m...

    Authors: Sarai Mirjam Keestra, Florence Rodgers, Daphne Lenz, Rhiannon Osborne, Till Bruckner and Sean Lee

    Citation: Trials 2021 22:375

    Content type: Letter

    Published on:

  17. In common with many South East Asian countries, Malaysia is endemic for dengue. Dengue control in Malaysia is currently based on reactive vector management within 24 h of a dengue case being reported. Preventi...

    Authors: Mitra Saadatian-Elahi, Neal Alexander, Tim Möhlmann, Carole Langlois-Jacques, Remco Suer, Nazni Wasi Ahmad, Rose Nani Mudin, Farah Diana Ariffin, Frederic Baur, Frederic Schmitt, Jason H. Richardson, Muriel Rabilloud and Nurulhusna Ab Hamid

    Citation: Trials 2021 22:374

    Content type: Study protocol

    Published on:

  18. Fidelity in complex behavioural interventions is underexplored and few comprehensive or detailed fidelity studies report on specific procedures for monitoring fidelity. Using Bellg’s popular Treatment Fidelity...

    Authors: Liane R. Ginsburg, Matthias Hoben, Adam Easterbrook, Ruth A. Anderson, Carole A. Estabrooks and Peter G. Norton

    Citation: Trials 2021 22:372

    Content type: Methodology

    Published on:

  19. Chemoprophylactics against emerging epidemic and pandemic infectious diseases offer potential for prevention but require efficacy and safety analysis before widespread use can be recommended. Chemoprophylaxis ...

    Authors: Lakshmi Manoharan, Piero Olliaro, Peter W. Horby and Conall H. Watson

    Citation: Trials 2021 22:370

    Content type: Review

    Published on:

  20. Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and weight-be...

    Authors: Ramy Khojaly, Ruairí Mac Niocaill, Muhammad Shahab, Matthew Nagle, Colm Taylor, Fiachra E. Rowan and May Cleary

    Citation: Trials 2021 22:369

    Content type: Study protocol

    Published on:

  21. The Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper de...

    Authors: Jennifer L. Bell, Samir Gupta, Edmund Juszczak, Pollyanna Hardy and Louise Linsell

    Citation: Trials 2021 22:368

    Content type: Update

    Published on:

    The Study protocol to this article has been published in BMC Pediatrics 2021 21:100

  22. Patients with chronic obstructive pulmonary disease (COPD) present pulmonary and extrapulmonary impairments. The strategies used to mitigate these impairments are pulmonary rehabilitation programs (PRP). Howev...

    Authors: Marcela Maria Carvalho da Silva, Juliano Ferreira Arcuri and Valéria Amorim Pires Di Lorenzo

    Citation: Trials 2021 22:367

    Content type: Study protocol

    Published on:

  23. AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth ‘voices’). A digital simulation (avatar) of the voice is created and used in a three-way dialogue between...

    Authors: Philippa Garety, Clementine J. Edwards, Thomas Ward, Richard Emsley, Mark Huckvale, Paul McCrone, Mar Rus-Calafell, Miriam Fornells-Ambrojo, Andrew Gumley, Gillian Haddock, Sandra Bucci, Hamish McLeod, Amy Hardy, Emmanuelle Peters, Inez Myin-Germeys and Thomas Craig

    Citation: Trials 2021 22:366

    Content type: Study protocol

    Published on:

  24. High level of perceived stress may result in negative effects both psychologically and physically on individuals and may predispose onset of mental disorders such as depression, anxiety, and posttraumatic stre...

    Authors: Jingsong Wu, Mengyu Han, Youze He, Xiaoting Xie, Jian Song and Xiujuan Geng

    Citation: Trials 2021 22:365

    Content type: Study protocol

    Published on:

  25. Muscle strength decreases as kidney failure progresses. Low muscle strength affects more than 50% of hemodialysis patients and leads to daily life activities impairment. In the general population, numerous stu...

    Authors: Stanislas Bataille, Nathalie Pedinielli, Elisa Carreno, Mathilde Prezelin-Reydit, Philippe Chauveau, Guillaume Jean, Thomas Robert, Mickaël Bobot, Guillaume Seret, Elisabeth Jouve, Frederic Lavainne, Marianne Serveaux, Laurence Vrigneaud and Stéphanie Gentile

    Citation: Trials 2021 22:364

    Content type: Study protocol

    Published on:

  26. The primary objective is to evaluate the comparative effectiveness of COVID-19 specific monoclonal antibodies (mABs) with US Food and Drug Administration (FDA) Emergency Use Authorization (EUA), alongside UPMC...

    Authors: David T. Huang, Erin K. McCreary, J. Ryan Bariola, Richard J. Wadas, Kevin E. Kip, Oscar C. Marroquin, Stephen Koscumb, Kevin Collins, Judith A. Shovel, Mark Schmidhofer, Mary Kay Wisniewski, Colleen Sullivan, Donald M. Yealy, Meredith Axe, David A. Nace, Ghady Haidar…

    Citation: Trials 2021 22:363

    Content type: Letter

    Published on:

  27. Fetal growth restriction (FGR) affects 7–10% of all pregnancies resulting in a higher risk of perinatal morbidity and mortality, long-term disabilities, and cognitive impairment. Due to its multifactorial etio...

    Authors: Francesca Crovetto, Fàtima Crispi, Roger Borras, Cristina Paules, Rosa Casas, Andrés Martín-Asuero, Angela Arranz, Eduard Vieta, Ramon Estruch and Eduard Gratacós

    Citation: Trials 2021 22:362

    Content type: Study protocol

    Published on:

  28. There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the r...

    Authors: Hanne Bruhn, Elle-Jay Cowan, Marion K. Campbell, Lynda Constable, Seonaidh Cotton, Vikki Entwistle, Rosemary Humphreys, Karen Innes, Sandra Jayacodi, Peter Knapp, Annabelle South and Katie Gillies

    Citation: Trials 2021 22:361

    Content type: Research

    Published on:

  29. Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of seasonal malaria chemoprophylaxis (SMC), an intervention aimed at reducing m...

    Authors: Paul Sondo, Marc Christian Tahita, Toussaint Rouamba, Karim Derra, Bérenger Kaboré, Cheick Saïd Compaoré, Florence Ouédraogo, Eli Rouamba, Hamidou Ilboudo, Estelle Aïssa Bambara, Macaire Nana, Edmond Yabré Sawadogo, Hermann Sorgho, Athanase Mwinessobaonfou Somé, Innocent Valéa, Prabin Dahal…

    Citation: Trials 2021 22:360

    Content type: Study protocol

    Published on:

  30. Sedentary behaviour (SB) and low levels of physical activity (PA) are predictors of morbidity and mortality. Tertiary employees spend a considerable amount of their daily time seated and new efficient strategi...

    Authors: Terry Guirado, Lore Metz, Bruno Pereira, Audrey Bergouignan, David Thivel and Martine Duclos

    Citation: Trials 2021 22:359

    Content type: Study protocol

    Published on:

  31. Chronic pain is naturally aversive and often distressing for patients. Pain coping and self-regulatory skills have been shown to effectively reduce pain-related distress and other symptoms. In this trial, the ...

    Authors: Maisa S. Ziadni, Steven R. Anderson, Lluvia Gonzalez-Castro and Beth D. Darnall

    Citation: Trials 2021 22:358

    Content type: Study protocol

    Published on:

  32. Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5.7% to 26.6% of women and 2.2% to 9.7% of men, characterized by hypersensitivity of the central and peripheral nervous system affe...

    Authors: A. Carralero-Martínez, M. A. Muñoz Pérez, R. Pané-Alemany, L. Blanco-Ratto, S. Kauffmann and I. Ramírez-García

    Citation: Trials 2021 22:356

    Content type: Study protocol

    Published on:

  33. The risk of tuberculosis (TB) is high among people with HIV (PWH). Heavy alcohol drinking independently increases TB risk and approximately 25% of PWH globally engage in heavy drinking. While isoniazid (INH) prev...

    Authors: Sara Lodi, Nneka I. Emenyonu, Kara Marson, Dalsone Kwarisiima, Robin Fatch, Michael G. McDonell, Debbie M. Cheng, Harsha Thirumurthy, Monica Gandhi, Carol S. Camlin, Winnie R. Muyindike, Judith A. Hahn and Gabriel Chamie

    Citation: Trials 2021 22:355

    Content type: Study protocol

    Published on:

  34. There is a growing number of randomized controlled trials (RCTs) evaluating interventions to prevent or treat delirium in the intensive care unit (ICU). Efforts to improve the conduct of delirium RCTs are unde...

    Authors: Elizabeth Colantuoni, Mounica Koneru, Narjes Akhlaghi, Ximin Li, Mohamed D. Hashem, Victor D. Dinglas, Karin J. Neufeld, Michael O. Harhay and Dale M. Needham

    Citation: Trials 2021 22:354

    Content type: Review

    Published on:

  35. Obesity and type 2 diabetes mellitus are reaching epidemic proportions. In morbidly obese patients, bariatric operations lead to sustained weight loss and relief of comorbidities in the majority of patients. L...

    Authors: Marko Kraljević, Romano Schneider, Bettina Wölnerhanssen, Marco Bueter, Tarik Delko and Ralph Peterli

    Citation: Trials 2021 22:352

    Content type: Study protocol

    Published on:

  36. This trial aimed to evaluate the effects of a protective ventilation strategy on oxygenation/pulmonary indexes in patients undergoing robot-assisted radical prostatectomy (RARP) in the steep Trendelenburg posi...

    Authors: Jianwei Zhou, Chuanguang Wang, Ran Lv, Na Liu, Yan Huang, Wu Wang, Lina Yu and Junran Xie

    Citation: Trials 2021 22:351

    Content type: Research

    Published on:

  37. Ventriculoperitoneal shunt (VPS) placement is one of the most frequent neurosurgical procedures and the operation is performed in a highly standardised manner under maintenance of highest infection precautions...

    Authors: Severina Leu, Florian Halbeisen, Luigi Mariani and Jehuda Soleman

    Citation: Trials 2021 22:350

    Content type: Study protocol

    Published on:

  38. In this study, we will investigate the effect of hydroxychloroquine on the prevention of novel coronavirus disease (COVID-19) in cancer patients being treated.

    Authors: H. Rahimi, A. Allahyari, S. Ataei Azimi, M. Kamandi, Z. Mozaheb, F. Zemorshidi, M. Khadem-Rezaiyan, A. Bary, M. Seddigh-Shamsi and M. Moeini Nodeh

    Citation: Trials 2021 22:349

    Content type: Update

    Published on:

    The Letter to this article has been published in Trials 2020 21:575

  39. To date, hip arthroplasty is one of the most commonly performed surgical procedures, with growing worldwide demand. In recent decades, major progress made in terms of surgical technique, biomechanics, and trib...

    Authors: Martina Rocchi, Cesare Stagni, Marco Govoni, Alessandro Mazzotta, Leonardo Vivarelli, Antonella Orlandi Magli, Mariada Perrone, Maria Grazia Benedetti and Dante Dallari

    Citation: Trials 2021 22:348

    Content type: Study protocol

    Published on:

  40. Evidence generated from partnering with parents to design and conduct research together may be used to refine, adjust, and modify future research approaches. This study aimed to describe the initial approaches...

    Authors: Leigh M. Vanderloo, Shelley M. Vanderhout, Erika Tavares, Jonathon Maguire, Sharon Straus and Catherine S. Birken

    Citation: Trials 2021 22:347

    Content type: Methodology

    Published on:

  41. Up to three quarters of surgical patients receive inadequate pain relief, with 40% of patients reporting severe pain following knee replacement, which may indicate the current pain relief strategies using opia...

    Authors: Jamie R. Stokes, Ariel Wang, Lisa Poulton, Ines Rombach, Hemant Pandit and Ruth Knight

    Citation: Trials 2021 22:346

    Content type: Update

    Published on:

    The Study protocol to this article has been published in Trials 2019 20:732

  42. The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The ...

    Authors: Ben M. Eyck, Berend J. van der Wilk, Bo Jan Noordman, Bas P. L. Wijnhoven, Sjoerd M. Lagarde, Henk H. Hartgrink, Peter Paul L. O. Coene, Jan Willem T. Dekker, Michail Doukas, Ate van der Gaast, Joos Heisterkamp, Ewout A. Kouwenhoven, Grard A. P. Nieuwenhuijzen, Jean-Pierre E. N. Pierie, Camiel Rosman, Johanna W. van Sandick…

    Citation: Trials 2021 22:345

    Content type: Update

    Published on:

    The Study protocol to this article has been published in BMC Cancer 2018 18:142

  43. Depression is a highly prevalent mental disorder with major public health effects globally. It impairs the quality of life and reduces the ability to work and function, leading to increasing costs of sick leav...

    Authors: Johanna Roponen, Anu Ruusunen, Pilvikki Absetz, Timo Partonen, Virpi Kuvaja-Köllner, Mika Hujo and Outi Nuutinen

    Citation: Trials 2021 22:344

    Content type: Study protocol

    Published on:

  44. Currently, there are no approved treatments for early disease stages of COVID-19 and few strategies to prevent disease progression after infection with SARS-CoV-2. The objective of this study is to evaluate th...

    Authors: Verena Keitel, Björn Jensen, Torsten Feldt, Johannes C. Fischer, Johannes G. Bode, Christiane Matuschek, Edwin Bölke, Wilfried Budach, Christian Plettenberg, Kathrin Scheckenbach, Detlef Kindgen-Milles, Jörg Timm, Lisa Müller, Henrike Kolbe, Andreas Stöhr, Christian Calles…

    Citation: Trials 2021 22:343

    Content type: Letter

    Published on:

  45. The general objective of this study is to test the hypothesis that administration of convalescent plasma from donors with previous diagnosis of severe COVID-19 pneumonia is safe and associated with a decrease ...

    Authors: Alonso Soto, Fiorella Krapp, Alex Vargas, Lucía Cabrejos, Enrique Argumanis, Patricia L. García, Karina Altamirano, Martín Montes, Pamela R. Chacón-Uscamaita and Patricia J. García

    Citation: Trials 2021 22:342

    Content type: Letter

    Published on:

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