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  1. IMI2-PainCare-BioPain-RCT3 is one of four similarly designed clinical studies aiming at profiling a set of functional biomarkers of drug effects on the nociceptive system that could serve to accelerate the fut...

    Authors: André Mouraux, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Giulia Di Stefano, Nanna Brix Finnerup, Luis Garcia-Larrea, Marcus Goetz, Anna Kostenko, Bernhard Pelz, Esther Pogatzki-Zahn, Karin Schubart, Alexandre Stouffs, Andrea Truini, Irene Tracey…

    Citation: Trials 2021 22:404

    Content type: Study protocol

    Published on:

  2. Almost all Aboriginal children in remote communities have persistent bilateral otitis media affecting hearing and learning throughout early childhood and school years, with consequences for social and educatio...

    Authors: Kelvin Kong, Alan Cass, Amanda Jane Leach, Peter Stanley Morris, Amy Kimber, Jiunn-Yih Su and Victor Maduabuchi Oguoma

    Citation: Trials 2021 22:403

    Content type: Study protocol

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  3. Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we ...

    Authors: Alice MacLachlan, Karen Crawford, Shona Shinwell, Catherine Nixon and Marion Henderson

    Citation: Trials 2021 22:402

    Content type: Research

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  4. Up to two-thirds of dementia care is provided by family caregivers who often experience high burden, little support and adverse health outcomes. Enabling and supporting family caregivers to provide care at hom...

    Authors: Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann and Wolfgang Hoffmann

    Citation: Trials 2021 22:401

    Content type: Study protocol

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  5. Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly inc...

    Authors: Elvira Maranesi, Roberta Bevilacqua, Mirko Di Rosa, Giuseppe Pelliccioni, Valentina Di Donna, Riccardo Luzi, Micaela Morettini, Agnese Sbrollini, Elisa Casoni, Nadia Rinaldi, Renato Baldoni, Fabrizia Lattanzio, Laura Burattini and Giovanni R. Riccardi

    Citation: Trials 2021 22:400

    Content type: Study protocol

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  6. As it has been recorded in ancient Chinese classics, Yanglingquan (GB34) and Dannangxue (EX-LE6) are two important acupoints that can regulate the function of the gallbladder. Acupuncture at these two acupoint...

    Authors: Ning Sun, Yuan-Fang Zhou, Jie Zhou, Wen-Wei Zuo, Xiang-Yin Ye, Xiao-Dong Deng, Zheng-Jie Li, Shi-Rui Cheng, Yu-Zhu Qu, Jun Zhou, Rui-Rui Sun and Fan-Rong Liang

    Citation: Trials 2021 22:399

    Content type: Study protocol

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  7. Degenerative lumbar instability (DLI) is a common disease that causes low back pain (LBP) in clinic. It is difficult to completely recover from DLI, and it occurs repeatedly, which seriously affects the qualit...

    Authors: Rui Xie, Long Liang, Kaiming Li, Jie Yu, Minshan Feng, Jiawen Zhan, Xu Wei, Kexin Yang, Zhefeng Jin, He Yin, Xin Chen, Xunlu Yin, Zhiwei Liu, Wenkang Dai and Liguo Zhu

    Citation: Trials 2021 22:398

    Content type: Study protocol

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  8. For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (deci...

    Authors: Indrani S. Bhattacharya, Joanne S. Haviland, Lesley Turner, Hilary Stobart, Ada Balasopoulou, Liba Stones, Anna M. Kirby, Cliona C. Kirwan, Charlotte E. Coles and Judith M. Bliss

    Citation: Trials 2021 22:397

    Content type: Research

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  9. To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise t...

    Authors: Lasse K. Harris, Søren T. Skou, Carsten B. Juhl, Madalina Jäger and Alessio Bricca

    Citation: Trials 2021 22:396

    Content type: Review

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  10. Exome sequencing (ES) has probable utility for shortening the diagnostic odyssey of children with suspected genetic disorders. This report describes the design and methods of a study evaluating the potential o...

    Authors: Brooke S. Staley, Laura V. Milko, Margaret Waltz, Ida Griesemer, Lonna Mollison, Tracey L. Grant, Laura Farnan, Myra Roche, Angelo Navas, Alexandra Lightfoot, Ann Katherine M. Foreman, Julianne M. O’Daniel, Suzanne C. O’Neill, Feng-Chang Lin, Tamara S. Roman, Alicia Brandt…

    Citation: Trials 2021 22:395

    Content type: Study protocol

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  11. There remains no effective intervention capable of reversing most cases of dementia. Current research is focused on prevention by addressing risk factors that are shared between cardiovascular disease and deme...

    Authors: Renata L. Krüger, Cameron M. Clark, Adrienna M. Dyck, Todd J. Anderson, Fiona Clement, Patrick J. Hanly, Heather M. Hanson, Michael D. Hill, David B. Hogan, Jayna Holroyd-Leduc, R. Stewart Longman, Meghan McDonough, G. Bruce Pike, Jean M. Rawling, Tolulope Sajobi and Marc J. Poulin

    Citation: Trials 2021 22:394

    Content type: Study protocol

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  12. Bone grafting is an important surgical procedure to restore missing bone in patients with alveolar cleft lip/palate, aiming to stabilize either sides of the maxillary segments by inducing new bone formation, a...

    Authors: S. A. Alkaabi, D. S. Natsir Kalla, G. A. Alsabri, A. Fauzi, A. Tajrin, W. E. G. Müller, H. C. Schröder, X. G. Wang, T. Forouzanfar, M. N. Helder and M. Ruslin

    Citation: Trials 2021 22:393

    Content type: Study protocol

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  13. Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention i...

    Authors: Francesco Cresi, Federica Chiale, Elena Maggiora, Silvia Maria Borgione, Mattia Ferroglio, Federica Runfola, Giulia Maiocco, Chiara Peila, Enrico Bertino and Alessandra Coscia

    Citation: Trials 2021 22:392

    Content type: Study protocol

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  14. 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

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  15. 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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  16. 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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  17. 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

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  18. 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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  19. 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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  20. 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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  21. 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:

  22. 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

    Published on:

  23. 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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  24. 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

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

  25. 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:

  26. 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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  27. 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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  28. 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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  29. 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:

  30. 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

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  31. 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

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  32. 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:

  33. 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

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  34. 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

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

  35. 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:

  36. 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

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  37. 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

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  38. 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

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  39. 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:

  40. 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:

  41. 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

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  42. 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

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  43. 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

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  44. 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:

  45. 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:

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