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  1. Mindfulness training (MT) for parents of adolescents has been shown to improve mental health and stress-related outcomes in individuals and their families. Studies of MT among young people are mainly delivered...

    Authors: Nicolas Arnaud, Christiane Baldus, Léa Josette Laurenz, Sonja Bröning, Maja Brandt, Sabrina Kunze, Maria Austermann, Linda Zimmermann, Anne Daubmann and Rainer Thomasius

    Citation: Trials 2020 21:114

    Content type: Study protocol

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  2. Periodontal diseases are regarded as the most common diseases of mankind. The prevalence rate of periodontal disease assumes a clear growth tendency, increasing by 57.3% from 1990 to 2010. Thereby, effective p...

    Authors: Yue Yan, Yalin Zhan, Xian’e Wang and Jianxia Hou

    Citation: Trials 2020 21:113

    Content type: Study protocol

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  3. After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of th...

    Authors: A.J. Kalkdijk-Dijkstra, J.A.G. van der Heijden, H.L. van Westreenen, P.M.A. Broens, M. Trzpis, J.P.E.N. Pierie and B.R. Klarenbeek

    Citation: Trials 2020 21:112

    Content type: Study protocol

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  4. Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation...

    Authors: Adnan Al-Kaisy, Jonathan Royds, Stefano Palmisani, David Pang, Samuel Wesley, Rod S. Taylor, Andrew Cook, Sam Eldabe, Lance McCracken, Rui Duarte and Jeremy Fairbank

    Citation: Trials 2020 21:111

    Content type: Study protocol

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  5. Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupunct...

    Authors: Yin Shou, Li Hu, Cuihong Zhang, Shifen Xu, Qi Jin, Li Huang, Bingrong Li, Long Yuan, Siwei Xu, Kaiyong Zhang, Huiru Jiang and Bimeng Zhang

    Citation: Trials 2020 21:110

    Content type: Study protocol

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  6. Point OutWords is a caregiver-delivered, iPad-assisted intervention for non-verbal or minimally verbal children with autism. It aims to develop prerequisite skills for communication such as manual and oral motor ...

    Authors: Ailbhe McKinney, Kathryn L. Hotson, Alicia Rybicki, Emma J. L. Weisblatt, Claudia Días, Juliet Foster, Sofía S. Villar, Suzanne Murphy and Matthew K. Belmonte

    Citation: Trials 2020 21:109

    Content type: Study protocol

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  7. Voluntary medical male circumcision (VMMC) is a key component of combination HIV-prevention programmes. Several high-HIV-prevalence countries in sub-Saharan Africa, including Zimbabwe, are looking to scale up ...

    Authors: Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett and Simon Gregson

    Citation: Trials 2020 21:108

    Content type: Study protocol

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  8. Anxiety disorders are the most prevalent class of lifetime disorders in China, and generalized anxiety disorder (GAD) is one of the most common but frequently overlooked anxiety disorders. Conventional pharmac...

    Authors: Zhongwei Sha, Yiping Hou, Chunchun Xue, Ou Li, Zhimin Li, Huiru Wang, Wenjing Zhang and Jian Xu

    Citation: Trials 2020 21:107

    Content type: Study protocol

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  9. Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy ...

    Authors: Daniel Jost, Sabine Lemoine, Frederic Lemoine, Vincent Lanoe, Olga Maurin, Clément Derkenne, Marilyn Franchin Frattini, Maëlle Delacote, Edouard Seguineau, Anne Godefroy, Nicolas Hervault, Ludovic Delhaye, Nicolas Pouliquen, Emilie Louis-Delauriere, Julie Trichereau, Florian Roquet…

    Citation: Trials 2020 21:106

    Content type: Study protocol

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  10. Intermittent claudication (IC) caused by peripheral artery disease (PAD) is a common cardiovascular disease. Patients with IC have reduced walking capacity, restricted activity levels and mobility, and reduced...

    Authors: Maj Siercke, Lise Pyndt Jørgensen, Malene Missel, Lau Caspar Thygesen, Pernille Peppercorn Blach, Henrik Sillesen and Selina Kikkenborg Berg

    Citation: Trials 2020 21:105

    Content type: Study protocol

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  11. Prescribing, monitoring and administration of medicines in care homes could be improved. Research has identified the need for one person to assume overall responsibility for the management of medicines within ...

    Authors: Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M. Poland…

    Citation: Trials 2020 21:103

    Content type: Study protocol

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  12. Hysterosalpingography (HSG) is an accepted radiologic diagnostic modality for initial infertility workup, and is generally considered uncomfortable and painful. However, the management of pain related to HSG r...

    Authors: Yi-Ling Wang, Hai-Xiang Gao, Jin-She Wang, Jing-Hui Wang, Lei Bo, Ting-Ting Zhang, Ya-Liang Dai, Lu-Lu Gao, Qiang Liu, Jun-Jun Zhang, Ju-Min Cai, Jian-Qiang Yu and Yu-Xiang Li

    Citation: Trials 2020 21:102

    Content type: Study protocol

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  13. Polycystic ovary syndrome (PCOS) affects up to 20% of women and is characterised by higher amounts of visceral fat, obesity, insulin resistance, dyslipidemia and reproductive and cardiometabolic complications....

    Authors: Amie Woodward, David Broom, Caroline Dalton, Mostafa Metwally and Markos Klonizakis

    Citation: Trials 2020 21:101

    Content type: Study protocol

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  14. Multiple sclerosis (MS) is an unpredictable, chronic neurological disease accompanied with high rates of depression and anxiety, particularly in the early stages of diagnosis. There is evidence to suggest that...

    Authors: Litza Kiropoulos, Trevor Kilpatrick, Tomas Kalincek, Leonid Cherulov, Elizabeth McDonald, Tissa Wijeratne, Jennifer Threader, Vanja Rozenblat, Neil Simpson-O’Brien, Anneke Van Der Walt and Lisa Taylor

    Citation: Trials 2020 21:100

    Content type: Study protocol

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  15. Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Despite the development of pharmacological and nonpharmacological interve...

    Authors: Chao Hsing Yeh, Cuicui Li, Ronald Glick, Elizabeth A. Schlenk, Kathryn Albers, Lorna Kwai-Ping Suen, Nada Lukkahatai, Nicole Salen, Sonaali Pandiri, Weixia Ma, Nancy Perrin, Natalia E. Morone and Paul J. Christo

    Citation: Trials 2020 21:99

    Content type: Study protocol

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  16. Cognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improve...

    Authors: Marieke Houniet-de Gier, Heleen Beckerman, Kimberley van Vliet, Hans Knoop and Vincent de Groot

    Citation: Trials 2020 21:98

    Content type: Study protocol

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  17. Antimicrobial therapy with appropriate biliary drainage is considered the standard of care for acute cholangitis, but the optimal duration of antimicrobial therapy remains unknown. Seven to 10 days of antimicr...

    Authors: Kentaro Iwata, Asako Doi, Yuichiro Oba, Hiroo Matsuo, Kei Ebisawa, Manabu Nagata, Sho Nishimura, Kenichi Yoshimura, Atsuhiro Masuda, Hideyuki Shiomi and Yuzo Kodama

    Citation: Trials 2020 21:97

    Content type: Study protocol

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  18. Although there have been multiple randomised trials in newly diagnosed Ewing sarcoma family of tumours (ESFT) and these have been conducted over many years and involved many international cooperative groups, t...

    Authors: Jennifer Anderton, Veronica Moroz, Perrine Marec-Bérard, Nathalie Gaspar, Valerie Laurence, Javier Martín-Broto, Ana Sastre, Hans Gelderblom, Cormac Owens, Sophie Kaiser, Melissa Fernández-Pinto, Nicola Fenwick, Abigail Evans, Sandra Strauss, Jeremy Whelan, Keith Wheatley…

    Citation: Trials 2020 21:96

    Content type: Study protocol

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  19. Fractures of the distal radius are one of the most common osteoporotic fractures in elderly men and women. These fractures are a particular health concern amongst the elderly, who are at risk of fragility frac...

    Authors: Ronald Man Yeung WONG, Wing-Tung HO, Ning TANG, Chi Yin TSO, Wai Kit Raymond Ng, Simon Kwoon-Ho CHOW and Wing-Hoi CHEUNG

    Citation: Trials 2020 21:95

    Content type: Study protocol

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  20. Chemotherapy-related fatigue (CRF) is a common symptom in non-small cell lung cancer (NSCLC) patients. A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in ...

    Authors: Zhiwei Xiao, Leihao Hu, Jietao Lin, Liming Lu, Xuewu Huang, Xiaoshu Zhu, Chiahshean Teo and Lizhu Lin

    Citation: Trials 2020 21:94

    Content type: Study protocol

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  21. This trial addresses the global problem of chronic venous leg ulcers (CVLUs), wounds that cause significant infirmity for an estimated 9.7 million people annually, mainly older adults with comorbidities. Advan...

    Authors: Jodi C. McDaniel, Jamie Rausch and Alai Tan

    Citation: Trials 2020 21:93

    Content type: Study protocol

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  22. The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RC...

    Authors: Nick Daneman, Asgar H. Rishu, Ruxandra Pinto, Yaseen Arabi, Emilie P. Belley-Cote, Robert Cirone, Mark Downing, Deborah J. Cook, Richard Hall, Shay McGuinness, Lauralyn McIntyre, John Muscedere, Rachael Parke, Steven Reynolds, Benjamin A. Rogers, Yahya Shehabi…

    Citation: Trials 2020 21:92

    Content type: Research

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  23. Colorectal cancer (CRC) screening rates remain suboptimal, particularly in low-income and underserved populations. Mailed fecal immunochemical testing (FIT) may overcome common barriers to screening; however, ...

    Authors: Elizabeth A. O’Connor, William M. Vollmer, Amanda F. Petrik, Beverly B. Green and Gloria D. Coronado

    Citation: Trials 2020 21:91

    Content type: Research

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  24. Tumour necrosis factor inhibitors (TNFi) are effective in the treatment of patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). However, these drugs c...

    Authors: Celia A. J. Michielsens, Nadine Boers, Nathan den Broeder, Mark H. Wenink, Aatke van der Maas, Elien A. M. Mahler, Michelle L. M. Mulder, Désirée van der Heijde, Frank H. J. van den Hoogen, Lise M. Verhoef and Alfons A. den Broeder

    Citation: Trials 2020 21:90

    Content type: Study protocol

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  25. A substantial proportion of breast cancer patients develop metastatic disease, with over 450,000 deaths globally per year. Bone is the most common first site of metastatic disease accounting for 40% of all fir...

    Authors: Rob Coleman, Janet Brown, Emma Rathbone, Louise Flanagan, Amber Reid, Jessica Kendall, Sacha Howell, Chris Twelves, Carlo Palmieri, Anjana Anand, Iain MacPherson and Sarah Brown

    Citation: Trials 2020 21:89

    Content type: Study protocol

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  26. Current guidelines recommend that every person with Parkinson’s disease (PD) should have access to Parkinson’s disease nurse specialist (PDNS) care. However, there is little scientific evidence of the cost-eff...

    Authors: Danique L. M. Radder, Herma H. Lennaerts, Hester Vermeulen, Thies van Asseldonk, Cathérine C. S. Delnooz, Rob H. Hagen, Marten Munneke, Bastiaan R. Bloem and Nienke M. de Vries

    Citation: Trials 2020 21:88

    Content type: Study protocol

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  27. Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus...

    Authors: Nagy A. Mekhail, Charles E. Argoff, Rod S. Taylor, Christian Nasr, David L. Caraway, Bradford E. Gliner, Jeyakumar Subbaroyan and Elizabeth S. Brooks

    Citation: Trials 2020 21:87

    Content type: Study protocol

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  28. There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we wi...

    Authors: Emma Lidington, Sophie E McGrath, Jillian Noble, Susannah Stanway, Amanda Lucas, Kabir Mohammed, Winette van der Graaf and Olga Husson

    Citation: Trials 2020 21:86

    Content type: Study protocol

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  29. Youth depression is highly prevalent and is related to impairments in academic, social and behavioural functioning. Evidence-based treatments are available, but many young people do not respond or sufficiently...

    Authors: D. J. Hallford, A. M. Carmichael, D. W. Austin, K. Takano, F. Raes and M. Fuller-Tyszkiewicz

    Citation: Trials 2020 21:85

    Content type: Study protocol

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  30. Phase III trials often require large sample sizes, leading to high costs and delays in clinical decision-making. Group sequential designs can improve trial efficiency by allowing for early stopping for efficac...

    Authors: Elizabeth G. Ryan, Nigel Stallard, Ranjit Lall, Chen Ji, Gavin D. Perkins and Simon Gates

    Citation: Trials 2020 21:84

    Content type: Methodology

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  31. Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor functio...

    Authors: Niccolò Butti, Emilia Biffi, Chiara Genova, Romina Romaniello, Davide Felice Redaelli, Gianluigi Reni, Renato Borgatti and Cosimo Urgesi

    Citation: Trials 2020 21:82

    Content type: Study protocol

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  32. High-flow nasal cannula (HFNC) oxygen therapy has been widely used in critically ill patients. Despite the effectiveness of HFNC as a treatment, optimal methods to withdraw HFNC after recovery from preexisting...

    Authors: Min Chul Kim, Yeon Joo Lee, Jong Sun Park, Young-Jae Cho, Ho Il Yoon, Choon-Taek Lee, Jae Ho Lee and Eun Sun Kim

    Citation: Trials 2020 21:81

    Content type: Study protocol

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  33. Traumatic brain injury is a leading cause of death and disability worldwide. The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial.

    Authors: Frank Tegtmeier, Reinhard Schinzel, Ronny Beer, Diederik Bulters, Jean-Yves LeFrant, Joan Sahuquillo, Andreas Unterberg, Peter Andrews, Antonio Belli, Javier Ibanez, Alfonso Lagares, Michael Mokry, Harald Willschke, Charlotte Flühe and Erich Schmutzhard

    Citation: Trials 2020 21:80

    Content type: Study protocol

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  34. Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, sy...

    Authors: L. L. Laslett, B. Antony, A. E. Wluka, C. Hill, L. March, H. I. Keen, P. Otahal, F. M. Cicuttini and G. Jones

    Citation: Trials 2020 21:79

    Content type: Study protocol

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  35. The prevention of catheter-related complications is nowadays an important topic of research. Flushing catheters is considered an important clinical procedure in preventing malfunction and several complications...

    Authors: Pedro Parreira, Liliana B. Sousa, Inês A. Marques, Paulo Santos-Costa, Luciene M. Braga, Arménio Cruz and Anabela Salgueiro-Oliveira

    Citation: Trials 2020 21:78

    Content type: Study protocol

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  36. Acupoint selection is a key factor in the treatment of diseases and has not been well studied. The aim of this trial is to explore the differences in efficacy between compatible acupoints and a single acupoint...

    Authors: Le Guo, Xin Huang, Li-Juan Ha, Jing-Zhou Zhang, Jia Mi, Ping-Hui Sun, Xi-Ying Han, Ying Wang, Jing-Lin Hu, Fu-Chun Wang and Tie Li

    Citation: Trials 2020 21:77

    Content type: Study protocol

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  37. The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy...

    Authors: Raine Sihvonen, Roope Kalske, Martin Englund, Aleksandra Turkiewicz, Pirjo Toivonen, Simo Taimela and Teppo L. N. Järvinen

    Citation: Trials 2020 21:76

    Content type: Study protocol

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  38. Coronary microvascular disease (CMVD) can be described as one of the cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculatory lesions, often presenting a...

    Authors: Zhuang Jieqin, Liu Shuling, Cai Hairong, Dai Xingzhen, Chen Yanhong, Jin Zilin and Chen Bojun

    Citation: Trials 2020 21:75

    Content type: Study protocol

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  39. The success of a clinical trial depends on its recruitment of eligible patients; therefore, the recruitment period requires special attention. We hypothesized that with a new approach focused on continuous inf...

    Authors: Annika Rühle, Florian Oehme, Björn-Christian Link, Jürg Metzger, Henning Fischer, Michael Stickel, Dimitri E. Delagrammaticas, Reto Babst and Frank J. P. Beeres

    Citation: Trials 2020 21:74

    Content type: Research

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  40. This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for sel...

    Authors: J. S. S. P. Ferreira, R. H. Cruvinel Junior, E. Q. Silva, J. L. Veríssimo, R. L. Monteiro, D. S. Pereira, E. Y. Suda, C. D. Sartor and I. C. N. Sacco

    Citation: Trials 2020 21:73

    Content type: Study protocol

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  41. Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency condition. There is a wide range of different approaches to this condition, with very little supporting evidence, lead...

    Authors: Simon Craig, Franz E. Babl, Stuart R. Dalziel, Charmaine Gray, Colin Powell, Khalid Al Ansari, Mark D. Lyttle, Damian Roland, Javier Benito, Roberto Velasco, Julia Hoeffe, Diana Moldovan, Graham Thompson, Suzanne Schuh, Joseph J. Zorc, Maria Kwok…

    Citation: Trials 2020 21:72

    Content type: Study protocol

    Published on:

  42. Acute diarrhoea is a common cause of illness and death among children in low- to middle-income settings. World Health Organization guidelines for the clinical management of acute watery diarrhoea in children f...

    Authors:

    Citation: Trials 2020 21:71

    Content type: Study protocol

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  43. After publication of our article [1] the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study.

    Authors: O. Diaz-Cambronero, G. Mazzinari, C. L. Errando, M. J. Schultz, B. Flor Lorente, N. García-Gregorio, M. Vila Montañés, Daniel Robles-Hernández, L. E. Olmedilla Arnal, A. Martín-De-Pablos, A. Marqués Marí and M. P. Argente Navarro

    Citation: Trials 2020 21:70

    Content type: Correction

    Published on:

    The original article was published in Trials 2019 20:190

  44. The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands. Hand functional exercise is the premise of alleviating hand dysfunction, and th...

    Authors: Zeng-Qiao Zhang, Kun-Peng Li, Jing He, Li-Ming Jiang, Wu Wang, Xiao-Shen Hu and Wei Feng

    Citation: Trials 2020 21:69

    Content type: Study protocol

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  45. Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke r...

    Authors: Kris McGill, Catherine M. Sackley, Jon Godwin, Jodie McGarry and Marian C. Brady

    Citation: Trials 2020 21:68

    Content type: Review

    Published on:

  46. Equipoise and role conflict have been previously identified as important factors in professionals’ engagement with trials, inducing behaviours which can impact on recruitment. We explored these phenomena as po...

    Authors: Ruth I. Hart, Nina Hallowell, Jeni Harden, Angela B. Jesudason and Julia Lawton

    Citation: Trials 2020 21:67

    Content type: Research

    Published on:

  47. Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more acces...

    Authors: Stephanie S. Leone, Suzanne Lokman, Brigitte Boon, Agnes van der Poel, Filip Smit, Moniek Zijlstra-Vlasveld and Odile Smeets

    Citation: Trials 2020 21:64

    Content type: Study protocol

    Published on:

  48. Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider’s histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney...

    Authors: Daniela Kniepeiss, Philipp Houben, Philipp Stiegler, Andrea Berghold, Regina Riedl, Judith Kahn and Peter Schemmer

    Citation: Trials 2020 21:62

    Content type: Study protocol

    Published on:

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