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  1. Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. The...

    Authors: Kyeong Tae Kim, Sophie Morton, Sarah Howe, Yeong Shiong Chiew, Jennifer L. Knopp, Paul Docherty, Christopher Pretty, Thomas Desaive, Balazs Benyo, Akos Szlavecz, Knut Moeller, Geoffrey M. Shaw and J. Geoffrey Chase

    Citation: Trials 2020 21:130

    Content type: Study protocol

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  2. In acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sl...

    Authors: Henrik Fox, Andrea Hetzenecker, Stefan Stadler, Olaf Oldenburg, Okka W. Hamer, Florian Zeman, Leonhard Bruch, Mirko Seidel, Stefan Buchner and Michael Arzt

    Citation: Trials 2020 21:129

    Content type: Study protocol

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  3. The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liv...

    Authors: Kyungsun Han, Ojin Kwon, Hyo-ju Park, So-Young Jung, Changsop Yang and Chang-Gue Son

    Citation: Trials 2020 21:128

    Content type: Study protocol

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  4. The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and dur...

    Authors: Sunita Taneja, Ranadip Chowdhury, Neeta Dhabhai, Sarmila Mazumder, Ravi Prakash Upadhyay, Sitanshi Sharma, Rupali Dewan, Pratima Mittal, Harish Chellani, Rajiv Bahl, Maharaj Kishan Bhan and Nita Bhandari

    Citation: Trials 2020 21:127

    Content type: Study protocol

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  5. There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in ...

    Authors: Melissa M. Medvedev, Victor Tumukunde, Ivan Mambule, Cally J. Tann, Peter Waiswa, Ruth R. Canter, Christian H. Hansen, Elizabeth Ekirapa-Kiracho, Kenneth Katumba, Catherine Pitt, Giulia Greco, Helen Brotherton, Diana Elbourne, Janet Seeley, Moffat Nyirenda, Elizabeth Allen…

    Citation: Trials 2020 21:126

    Content type: Study protocol

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  6. Bronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors and one of the most common chronic lung diseases. It has a poor prognosis, especially in preterm infants. Ho...

    Authors: Xian Wu, Yunqiu Xia, Ou Zhou, Yan Song, Xianhong Zhang, Daiyin Tian, Qubei Li, Chang Shu, Enmei Liu, Xiaoping Yuan, Ling He, Chengjun Liu, Jing Li, Xiaohua Liang, Ke Yang, Zhou Fu…

    Citation: Trials 2020 21:125

    Content type: Study protocol

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  7. Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with ph...

    Authors: Anouk S. Schuit, Karen Holtmaat, Nienke Hooghiemstra, Femke Jansen, Birgit I. Lissenberg-Witte, Veerle M. H. Coupé and Irma M. Verdonck-de Leeuw

    Citation: Trials 2020 21:124

    Content type: Study protocol

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  8. Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascula...

    Authors: Josefin Sundh, Anders Magnuson, Scott Montgomery, Pontus Andell, Gustaf Rindler and Ole Fröbert

    Citation: Trials 2020 21:123

    Content type: Study protocol

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  9. Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for...

    Authors: Anu Kemppinen, Carol Howell, Victoria Allgar, Matthew Dodd, John Gregson, Charles Knowles, John McLaughlin, Preeti Pandya, Peter Whorwell, Elena Markaryan and Yan Yiannakou

    Citation: Trials 2020 21:122

    Content type: Study protocol

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  10. Preterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. For a singleton pregnancy, progesterone treatment is effective in prevention of preterm birth in wom...

    Authors: Ka Wang Cheung, Mimi Tin Yan Seto and Ernest Hung Yu Ng

    Citation: Trials 2020 21:121

    Content type: Study protocol

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  11. Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in u...

    Authors: Jin Ho Choi, Woo Hyun Paik, Min Su You, Kyong Joo Lee, Young Hoon Choi, Bang-sup Shin, Sang Hyub Lee, Ji Kon Ryu and Yong-Tae Kim

    Citation: Trials 2020 21:120

    Content type: Study protocol

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  12. In Nepal, the burden of noncommunicable, chronic diseases is rapidly rising, and disproportionately affecting low and middle-income countries. Integrated interventions are essential in strengthening primary ca...

    Authors: Dan Schwarz, Santosh Dhungana, Anirudh Kumar, Bibhav Acharya, Pawan Agrawal, Anu Aryal, Aaron Baum, Nandini Choudhury, David Citrin, Binod Dangal, Meghnath Dhimal, Bikash Gauchan, Tula Gupta, Scott Halliday, Biraj Karmacharya, Sandeep Kishore…

    Citation: Trials 2020 21:119

    Content type: Study protocol

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  13. Gastroesophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms....

    Authors: Yeon Hee Bhang, Kwan-Il Kim, Jaehyo Kim, Junmo Ahn, Hwan-Su Jung, Changsop Yang, Seok-Jae Ko, Youngmin Bu, Jae-Woo Park, Kyoung Sun Park, Hee-Jae Jung, Jun-Hwan Lee and Beom-Joon Lee

    Citation: Trials 2020 21:118

    Content type: Study protocol

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  14. Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acut...

    Authors: Franziska Holtdirk, Anja Mehnert, Mario Weiss, Björn Meyer and Carsten Watzl

    Citation: Trials 2020 21:117

    Content type: Study protocol

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  15. Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or heal...

    Authors: Katie Biggs, Daniel Hind, Rebecca Gossage-Worrall, Kirsty Sprange, David White, Jessica Wright, Robin Chatters, Katherine Berry, Diana Papaioannou, Mike Bradburn, Stephen J. Walters and Cindy Cooper

    Citation: Trials 2020 21:116

    Content type: Research

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  16. The startup phase of a clinical trial (CT) plays a vital role in the execution of new drug development. Hence, the aim of this study is to identify the factors responsible for delaying the CT startup phase. Fu...

    Authors: Amani Abu-Shaheen, Ahmad Al Badr, Isamme Al Fayyad, Adel Al Qutub, Eissa Ali Faqeih and Mohamad Al-Tannir

    Citation: Trials 2020 21:115

    Content type: Research

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  17. 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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  18. 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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  19. 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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  20. 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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  21. 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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  22. 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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  23. 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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  24. 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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  25. 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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  26. 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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  27. 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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  28. 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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  29. 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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  30. 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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    The Correction to this article has been published in Trials 2020 21:284

  31. 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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  32. 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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  33. 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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  34. 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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  35. 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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  36. 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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  37. 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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  38. 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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  39. 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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  40. 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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  41. 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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  42. 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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  43. 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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  44. 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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  45. 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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  46. 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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  47. 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 Flüh and Erich Schmutzhard

    Citation: Trials 2020 21:80

    Content type: Study protocol

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    The Correction to this article has been published in Trials 2020 21:172

  48. 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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  49. 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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