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  1. 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

    Content type: Study protocol

    Published on:

  2. 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

    Content type: Study protocol

    Published on:

  3. Post-stroke depression (PSD) is a common complication after stroke which hinders functional recovery and return to social participation of stroke patients. Efficacy of conventional drug therapies for patients ...

    Authors: Jiming Tao, Lingjun Kong, Min Fang, Qingguang Zhu, Shuaipan Zhang, Sicong Zhang, Jiajia Wu, Chunlei Shan, Ling Feng, Qingjuan Guo and Zhiwei Wu

    Citation: Trials 2021 22:504

    Content type: Study protocol

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  4. Opioids are still widely prescribed to long-term pain patients although they are no longer recommended for long-term treatments due to poor evidence for long-term efficacy, risks of serious side effects, and t...

    Authors: Grelz Henrik, Midlöv Patrik, Håkansson Anders, Jakobsson Ulf, Rivano Fischer Marcelo and Ringqvist Åsa

    Citation: Trials 2021 22:503

    Content type: Study protocol

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  5. 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

    Content type: Methodology

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  6. The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack ...

    Authors: Laura L. Oakley, Deepa R, Arthur Namara, Biswamitra Sahu, Iliatha Papachristou Nadal, Yamuna Ana, Helen Coombe, Eugene Oteng-Ntim, Janet Seeley, Moffat Nyirenda, Giridhar Babu and Sanjay Kinra

    Citation: Trials 2021 22:501

    Content type: Study protocol

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  7. 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

    Content type: Study protocol

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  8. Patient and public involvement is increasingly common in trials, but its quality remains variable in a lot of settings. Many key decisions in trials involve numbers, but patients are rarely involved in those d...

    Authors: Beatriz Goulao, Hanne Bruhn, Marion Campbell, Craig Ramsay and Katie Gillies

    Citation: Trials 2021 22:499

    Content type: Research

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  9. 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

    Content type: Study protocol

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  10. 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

    Content type: Update

    Published on:

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

  11. Hypertension is a prevalent chronic disease worldwide that remains poorly controlled. Recent studies support the concept that the gut microbiota is involved in the development of hypertension and that dietary ...

    Authors: Dakota Rhys-Jones, Rachel E. Climie, Paul A. Gill, Hamdi A. Jama, Geoffrey A. Head, Peter R. Gibson, David M. Kaye, Jane G. Muir and Francine Z. Marques

    Citation: Trials 2021 22:496

    Content type: Study protocol

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  12. TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/...

    Authors: Moira Kelly, Liz Steed, Ratna Sohanpal, Hilary Pinnock, Amy Barradell, Clarisse Dibao-Dina, Kristie-Marie Mammoliti, Vari Wileman, Vickie Rowland, Sian Newton, Anna Moore and Stephanie Taylor

    Citation: Trials 2021 22:495

    Content type: Study protocol

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  13. Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and ap...

    Authors: Primus Che Chi, Esther Awuor Owino, Irene Jao, Fredrick Olewe, Bernhards Ogutu, Philip Bejon, Melissa Kapulu, Dorcas Kamuya and Vicki Marsh

    Citation: Trials 2021 22:494

    Content type: Research

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  14. Contextual effects (i.e., placebo response) refer to all health changes resulting from administering an apparently inactive treatment. In a randomized clinical trial (RCT), the overall treatment effect (i.e., the...

    Authors: Sigurlaug H. Hafliðadóttir, Carsten B. Juhl, Sabrina M. Nielsen, Marius Henriksen, Ian A. Harris, Henning Bliddal and Robin Christensen

    Citation: Trials 2021 22:493

    Content type: Review

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  15. Tactile maneuvers stimulating spontaneous respiratory activity in preterm infants are recommended since birth, but data on how and how often these maneuvers are applied in clinical practice are unknown. In the...

    Authors: Alessia Di Polito, Arianna Del Vecchio, Milena Tana, Patrizia Papacci, Anna Laura Vento, Benedetta Campagnola, Sefora Celona, Laura Cricenti, Ilaria Bastoni, Chiara Tirone, Alessandra Lio, Claudia Aurilia, Anthea Bottoni, Angela Paladini, Francesco Cota, Paola Emilia Ferrara…

    Citation: Trials 2021 22:492

    Content type: Study protocol

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  16. Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D...

    Authors: Xiaohui Guo, Meiling Xuan, Huan Zheng, Shumin Qin, Haomeng Wu, Shaogang Huang and Zehuai Wen

    Citation: Trials 2021 22:491

    Content type: Study protocol

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  17. A variety of household chores expose women to a variety of biomechanical and psychosocial risk factors. A result of this is many housewives with musculoskeletal disorders. Given the interactive effects of thes...

    Authors: Samaneh Norouzi, Sedigheh Sadat Tavafian, Rosanna Cousins and Hamidreza Mokarami

    Citation: Trials 2021 22:490

    Content type: Study protocol

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  18. HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers...

    Authors: Andrew Medina-Marino, Dana Bezuidenhout, Sybil Hosek, Ruanne V. Barnabas, Millicent Atujuna, Charl Bezuidenhout, Phuti Ngwepe, Remco P.H. Peters, Francesca Little, Connie L. Celum, Joseph Daniels and Linda-Gail Bekker

    Citation: Trials 2021 22:489

    Content type: Study protocol

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  19. Vegetables as first complementary foods for infants may programme taste preferences that lead to improved vegetable intake in children. Yet few studies have investigated the impact of a ”vegetables first” appr...

    Authors: Jeanette P. Rapson, Pamela R. von Hurst, Marion M. Hetherington and Cathryn A. Conlon

    Citation: Trials 2021 22:488

    Content type: Study protocol

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  20. There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repu...

    Authors: Gareth O. Griffiths, Richard FitzGerald, Thomas Jaki, Andrea Corkhill, Helen Reynolds, Sean Ewings, Susannah Condie, Emma Tilt, Lucy Johnson, Mike Radford, Catherine Simpson, Geoffrey Saunders, Sara Yeats, Pavel Mozgunov, Olana Tansley-Hancock, Karen Martin…

    Citation: Trials 2021 22:487

    Content type: Update

    Published on:

    The Letter to this article has been published in Trials 2020 21:544

  21. Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe...

    Authors: Antonio Ojeda, Andrea Calvo, Tomas Cuñat, Ricard Mellado Artigas, Oscar Comino-Trinidad, Jorge Aliaga, Marilyn Arias, Maribel Ahuir, Carlos Ferrando and Christian Dürsteler

    Citation: Trials 2021 22:486

    Content type: Study protocol

    Published on:

  22. Stress urinary incontinence (SUI) is a subtype of urinary incontinence that occurs more commonly amongst women. The pelvic floor muscle training (PFMT) is considered the gold standard for treating SUI. Another...

    Authors: Fátima Faní Fitz, Márcia Maria Gimenez, Letícia de Azevedo Ferreira, Mayanni Magda Perreira Matias, Maria Augusta Tezelli Bortolini and Rodrigo Aquino Castro

    Citation: Trials 2021 22:484

    Content type: Study protocol

    Published on:

  23. Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. Ho...

    Authors: Na Nie, Le Chen, Tong Li, Chuanlong Zhou, Bangwei Li, Conghua Ji, Jie Zhou, Qin Chen, Qiushuang Li, Yi Liang and Jianqiao Fang

    Citation: Trials 2021 22:483

    Content type: Study protocol

    Published on:

  24. Despite the high prevalence of common mental disorders in adolescents and young adults, and their association with poor health and socio-economic outcomes throughout the lifespan, many young people do not seek...

    Authors: Rebecca J. Syed Sheriff, Matti Vuorre, Evgenia Riga, Andrew K. Przybylski, Helen Adams, Catherine J. Harmer and John R. Geddes

    Citation: Trials 2021 22:482

    Content type: Study protocol

    Published on:

  25. Opposing needling has an obvious curative effect in the treatment of post-stroke hemiplegia; however, the mechanism of the opposing needling in the treatment of post-stroke hemiplegia is still not clear. The p...

    Authors: Mindong Xu, Yinyu Zi, Jianlu Wu, Nenggui Xu, Liming Lu, Jiahui Liu, Yanling Yu, Haofeng Mo, Weifeng Wen, Xiaorong Tang, Wenjuan Fan, Yu Zhang, Churong Liu, Wei Yi and Lin Wang

    Citation: Trials 2021 22:481

    Content type: Study protocol

    Published on:

  26. Reproductive genetic carrier screening is a type of genetic testing available to those planning a pregnancy, or during their first trimester, to understand their risk of having a child with a severe genetic co...

    Authors: Ebony Richardson, Alison McEwen, Toby Newton-John, Karine Manera and Chris Jacobs

    Citation: Trials 2021 22:480

    Content type: Study protocol

    Published on:

  27. Tonsillectomy is one of the most frequently performed surgeries in children and young adults worldwide. For decades, tonsillectomy was the surgical treatment of choice for recurrent acute tonsillitis. Tonsillo...

    Authors: Orlando Guntinas-Lichius, Katharina Geißler, Thomas Asendorf, Ralf Tostmann and Jan Löhler

    Citation: Trials 2021 22:479

    Content type: Study protocol

    Published on:

  28. Sub-Saharan Africa continues to carry a high burden of communicable diseases such as TB and HIV and non-communicable diseases such as hypertension and other cardiovascular conditions. Although investment in re...

    Authors: Tonya M. Esterhuizen, Guowei Li, Taryn Young, Jie Zeng, Rhoderick Machekano and Lehana Thabane

    Citation: Trials 2021 22:478

    Content type: Research

    Published on:

  29. The control of the dynamic functional leg alignment (dFLA) and biomechanical load are important joint-related aspects regarding the development of osteoarthritis (OA). Research on level walking with feedback o...

    Authors: Klaus Widhalm, Sebastian Durstberger and Peter Putz

    Citation: Trials 2021 22:477

    Content type: Study protocol

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  30. Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus fa...

    Authors: Wen Zhang, Qin Xie, Xiaoming Xu, Shuting Sun, Tian Fan, Xinxin Wu, Yao Qu, Jinhua Che, Tingrong Huang, Huacheng Li, You Zheng, Chao Jiang, Bangjiang Fang and Shuang Zhou

    Citation: Trials 2021 22:476

    Content type: Study protocol

    Published on:

  31. A previously performed phase III trial on 112 subjects investigating prophylactic nimodipine treatment in vestibular schwannoma (VS) surgery showed no clear beneficial effects on preservation of facial and coc...

    Authors: Christian Scheller, Christian Strauss, Sandra Leisz, Pia Hänel, Ariane Klemm, Simone Kowoll, Iris Böselt, Torsten Rahne and Andreas Wienke

    Citation: Trials 2021 22:475

    Content type: Study protocol

    Published on:

  32. Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide and the commonest of non-communicable diseases (NCDs) in Nepal. Risk factors like indoor and outdoor air pollution, ...

    Authors: Tara Ballav Adhikari, Dinesh Neupane, Arjun Karki, Arne Drews, Brendan Cooper, Marieann Högman, Torben Sigsgaard and Per Kallestrup

    Citation: Trials 2021 22:474

    Content type: Study protocol

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  33. Endometriosis (EMS) can be implanted everywhere, especially in pelvic organs. EMS can be asymptomatic, but it can result in pelvic pain and infertility by inducing local inflammation and pelvic adhesion. The p...

    Authors: Hyunji Lim, Soo Jin Park, Haerin Paik, Jaehee Mun, Eun Ji Lee, Seungmee Lee, Whasun Lim, Gwonhwa Song, Seung-Hyuk Shim, Chae Hyeong Lee, Ga Won Yim and Hee Seung Kim

    Citation: Trials 2021 22:473

    Content type: Study protocol

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  34. Prospective registration of clinical trials is an ethical, scientific, and legal requirement that serves several functions, including minimising research wastage and publication bias. Sub-Saharan Africa (SSA) ...

    Authors: Bassey Edem, Chukwuemeka Onwuchekwa, Oghenebrume Wariri, Esin Nkereuwem, Oluwatosin O. Nkereuwem and Victor Williams

    Citation: Trials 2021 22:472

    Content type: Research

    Published on:

  35. Surgical site infection is the most common complication of abdominal surgery, with a global impact on patients and health systems. There are no tools to identify wound infection that are validated for use in t...

    Authors:

    Citation: Trials 2021 22:471

    Content type: Study protocol

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  36. Knee osteoarthritis (OA) is a common painful and disabling condition that affects older individuals. Proprioceptive training programs in the form of kinesthesia, balance and agility (KBA) exercises have been r...

    Authors: Aysha I. Adhama, Mukadas O. Akindele and Aminu A. Ibrahim

    Citation: Trials 2021 22:470

    Content type: Study protocol

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  37. Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal eros...

    Authors: Kristin Helene Skullerud, Petter Gjersvik, Are Hugo Pripp, Erik Qvigstad and Anne Lise Ording Helgesen

    Citation: Trials 2021 22:469

    Content type: Study protocol

    Published on:

  38. Early interventions benefit the mental health, academic performance and productivity of children and adolescents throughout their life. The present study protocol will evaluate the effectiveness of the Elos 2....

    Authors: Marília Mariano, Anderson Ribeiro da Silva, Jacqueline L. S. Lima, Nícolas Tenedine de Pinho, Hugo Cogo-Moreira, Márcia H. S. Melo, Jair J. Mari, Zila M. Sanchez and Sheila C. Caetano

    Citation: Trials 2021 22:468

    Content type: Study protocol

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  39. Total hip (THR) and total knee replacements (TKR) are two highly successful orthopaedic procedures that reduce pain for people with osteoarthritis. Previous evidence suggests that physical activity, at best, r...

    Authors: Alexander Ooms, Susan J. Dutton, Scott Parsons, Beth Fordham, Caroline Hing, Sarah Lamb and Toby Smith

    Citation: Trials 2021 22:467

    Content type: Update

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  40. Coronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD with poor prognosis and high mortality. Although there are various interv...

    Authors: Xiaofen Ruan, Yiping Li, Yuanlong Sun, Meijun Jia, Xiaowen Xu, Li Huo, Wei Song, Yili Yao and Xiaolong Wang

    Citation: Trials 2021 22:466

    Content type: Study protocol

    Published on:

  41. The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information ...

    Authors: Emily C. O’Brien, Sudha R. Raman, Alicia Ellis, Bradley G. Hammill, Lisa G. Berdan, Tyrus Rorick, Salim Janmohamed, Zachary Lampron, Adrian F. Hernandez and Lesley H. Curtis

    Citation: Trials 2021 22:465

    Content type: Research

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  42. Preclinical studies demonstrated that glucagon-like peptide 1 (GLP-1) is locally synthesized in taste bud cells and that GLP-1 receptor exists on the gustatory nerves in close proximity to GLP-1-containing tas...

    Authors: Mojca Jensterle, Simona Ferjan, Tadej Battelino, Jernej Kovač, Saba Battelino, Dušan Šuput, Andrej Vovk and Andrej Janež

    Citation: Trials 2021 22:464

    Content type: Study protocol

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  43. Protocols involving intensive practice have shown positive outcomes. Constraint induced movement therapy (CIT) appears to be one of the best options for better outcomes in upper limb rehabilitation, but we sti...

    Authors: Elaine Menezes-Oliveira, Gabriela da Silva Matuti, Clarissa Barros de Oliveira, Simone Ferreira de Freitas, Catia Miyuki Kawamura, José Augusto Fernandes Lopes and Ricardo Mario Arida

    Citation: Trials 2021 22:463

    Content type: Study protocol

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  44. With the expanded utilization of transcatheter aortic valve implantation (TAVI) to younger and lower surgical risk patients with severe aortic stenosis (AS), optimal medical therapy after TAVI procedure has be...

    Authors: Yan Biao Liao, Congying Xia, Yiheng Cheng, Qiao Li, Xin Wei, Yuanweixiang Ou, Fei Chen, Yijian Li, Qi Liu, Tianyuan Xiong, Zhengang Zhao, Yong Peng, Jiafu Wei, Yuan Feng and Mao Chen

    Citation: Trials 2021 22:462

    Content type: Study protocol

    Published on:

  45. Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challeng...

    Authors: Arabella Scantlebury, Catriona McDaid, Stephen Brealey, Elizabeth Cook, Hemant Sharma, Arun Ranganathan and Joy Adamson

    Citation: Trials 2021 22:461

    Content type: Research

    Published on:

  46. Hypoxia is one of the life-threatening complications of endotracheal intubation. Supplemental oxygen and ventilation play a vital role in preventing hypoxia. Bag-valve mask (BVM) ventilation is frequently used...

    Authors: Yili Dai, Jiayuan Dai, Joseph Harold Walline, Yangyang Fu, Huadong Zhu, Jun Xu and Xuezhong Yu

    Citation: Trials 2021 22:460

    Content type: Study protocol

    Published on:

  47. The COVID-19 pandemic has altered the research landscape for clinical trials, requiring thoughtful consideration regarding how to handle the risks and benefits of continuing them.

    Authors: Marian Fitzgibbon, Lara Blumstein, Linda Schiffer, Mirjana A. Antonic, Andrew McLeod, Roxanne Dakers, Leo Restrepo, Elizabeth A. Boots, Jennifer C. Sanchez-Flack, Lisa Tussing-Humphreys and Melissa Lamar

    Citation: Trials 2021 22:459

    Content type: Commentary

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  48. The ‘Melatonin for Anxiety prior to General anaesthesia In Children’ (MAGIC) trial was designed to compare midazolam and melatonin as pre-medications for anxious children (aged five to fourteen), undergoing da...

    Authors: Jennifer Kettle, Chris Deery, Robert Bolt, Diana Papaioannou and Zoe Marshman

    Citation: Trials 2021 22:458

    Content type: Research

    Published on:

  49. Stroke results in neurologic impairments and aerobic deconditioning that contribute to limited walking capacity which is a major barrier post-stroke. Current exercise recommendations and stroke rehabilitation ...

    Authors: Allison Miller, Darcy S. Reisman, Sandra A. Billinger, Kari Dunning, Sarah Doren, Jaimie Ward, Henry Wright, Erin Wagner, Daniel Carl, Myron Gerson, Oluwole Awosika, Jane Khoury, Brett Kissela and Pierce Boyne

    Citation: Trials 2021 22:457

    Content type: Study protocol

    Published on:

  50. Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors o...

    Authors: Markus Harboe Olsen, Britt Morthorst, Anne Katrine Pagsberg, Michella Heinrichsen, Bo Møhl, Lotte Rubæk, Johan Bjureberg, Olivia Simonsson, Jane Lindschou, Christian Gluud and Janus Christian Jakobsen

    Citation: Trials 2021 22:456

    Content type: Update

    Published on:

    The Study Protocol to this article has been published in Pilot and Feasibility Studies 2021 7:44

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