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  1. Study protocol

    Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial

    Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for...

    Eldré W. Beukes, David M. Baguley, Peter M. Allen, Vinaya Manchaiah and Gerhard Andersson

    Trials 2017 18:186

    Published on: 21 April 2017

  2. Study protocol

    The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial

    Vitamin B12 deficiency is one of the most common micronutrient deficiencies and is associated with poor cognitive development and growth. Vitamin B12 is crucial for normal cell division and differentiation, and i...

    Tor A. Strand, Manjeswori Ulak, Ram K. Chandyo, Ingrid Kvestad, Mari Hysing, Merina Shrestha, Sudha Basnet, Suman Ranjitkar, Laxman Shrestha and Prakash S. Shrestha

    Trials 2017 18:187

    Published on: 21 April 2017

  3. Study protocol

    Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial

    Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side effects in patients with cancer. The introduction and development of antiemetic drugs have significantly improved ...

    Qi-wei Li, Ming-wei Yu, Guo-wang Yang, Xiao-min Wang, Huan Wang, Chen-xi Zhang, Na Xue, Wei-ru Xu, Qi Fu, Zhong Yang and Lin Yang

    Trials 2017 18:185

    Published on: 20 April 2017

  4. Study protocol

    A multicenter randomized controlled trial of surgery alone or surgery with atrial natriuretic peptide in lung cancer surgery: study protocol for a randomized controlled trial

    Postoperative cancer recurrence is a major problem following curative surgery. In a previous retrospective study of lung cancer surgery, we reported that administration of atrial natriuretic peptide (ANP) duri...

    Takashi Nojiri, Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Kikuko Ohshima, Yasushi Shintani, Meinoshin Okumura and Kenji Kangawa

    Trials 2017 18:183

    Published on: 20 April 2017

  5. Study protocol

    Optimising conservative management of chronic low back pain: study protocol for a randomised controlled trial

    Lower back pain is a global health issue affecting approximately 80% of people at some stage in their life. The current literature suggests that any exercise is beneficial for reducing back pain. However, as p...

    Katherine J. Simson, Clint T. Miller, Jon Ford, Andrew Hahne, Luana Main, Timo Rantalainen, Wei-Peng Teo, Megan Teychenne, David Connell, Guy Trudel, Guoyan Zheng, Gary Thickbroom and Daniel L. Belavy

    Trials 2017 18:184

    Published on: 20 April 2017

  6. Study protocol

    Research Exploring Physical Activity in Care Homes (REACH): study protocol for a randomised controlled trial

    As life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home se...

    Anne Forster, Jennifer Airlie, Karen Birch, Robert Cicero, Bonnie Cundill, Alison Ellwood, Mary Godfrey, Liz Graham, John Green, Claire Hulme, Rebecca Lawton, Vicki McLellan, Nicola McMaster and Amanda Farrin

    Trials 2017 18:182

    Published on: 19 April 2017

  7. Study protocol

    Optimizing veteran-centered prostate cancer survivorship care: study protocol for a randomized controlled trial

    Although prostate cancer is the most common cancer among veterans receiving care in the Veterans Health Administration (VA), more needs to be done to understand and improve survivorship care for this large pop...

    Ted A. Skolarus, Tabitha Metreger, Soohyun Hwang, Hyungjin Myra Kim, Robert L. Grubb, Jeffrey R. Gingrich and Sarah T. Hawley

    Trials 2017 18:181

    Published on: 18 April 2017

  8. Study protocol

    A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) – the UNBLOCS trial: a study protocol for a randomised controlled trial

    Transurethral resection of the prostate (TURP) has been the standard operation for benign prostatic obstruction (BPO) for 40 years, with approximately 25,000 procedures performed annually, and has remained lar...

    Jo Worthington, Hilary Taylor, Paul Abrams, Sara T. Brookes, Nikki Cotterill, Sian M. Noble, Tobias Page, K. Satchi Swami, J. Athene Lane and Hashim Hashim

    Trials 2017 18:179

    Published on: 17 April 2017

  9. Study protocol

    Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial

    Prior studies in critically ill patients suggest the supra-physiologic chloride concentration of 0.9% (“normal”) saline may be associated with higher risk of renal failure and death compared to physiologically...

    Wesley H. Self, Matthew W. Semler, Jonathan P. Wanderer, Jesse M. Ehrenfeld, Daniel W. Byrne, Li Wang, Leanne Atchison, Matthew Felbinger, Ian D. Jones, Stephan Russ, Andrew D. Shaw, Gordon R. Bernard and Todd W. Rice

    Trials 2017 18:178

    Published on: 13 April 2017

  10. Study protocol

    Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial

    Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse ...

    Sung-Phil Kim, Joo-Hee Kim, Bo-Kyung Kim, Hyeong-Jun Kim, In Chul Jung, Jung Hyo Cho, Jung-Eun Kim, Mi-Kyung Kim, O-Jin Kwon, Ae-Ran Kim, Hyo-Ju Park and Bok-Nam Seo

    Trials 2017 18:177

    Published on: 13 April 2017

  11. Research

    Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

    Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome report...

    Anna N. Millar, Amrit Daffu-O’Reilly, Carmel M. Hughes, David P. Alldred, Garry Barton, Christine M. Bond, James A. Desborough, Phyo K. Myint, Richard Holland, Fiona M. Poland and David Wright

    Trials 2017 18:175

    Published on: 12 April 2017

  12. Study protocol

    PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial

    Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the interventio...

    Elodie Crétel-Durand, Emilie Nouguerède, Hervé Le Caer, Frédérique Rousseau, Frédérique Retornaz, Olivier Guillem, Anne-Laure Couderc, Laurent Greillier, Emmanuelle Norguet, Maud Cécile, Rabia Boulahssass, Francoise Le Caer, Sandrine Tournier, Chantal Butaud, Pierre Guillet, Sophie Nahon…

    Trials 2017 18:174

    Published on: 12 April 2017

  13. Study protocol

    MYPLAN –mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial

    Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time.

    Kate Andreasson, Jesper Krogh, Per Bech, Hanne Frandsen, Niels Buus, Barbara Stanley, Ad Kerkhof, Merete Nordentoft and Annette Erlangsen

    Trials 2017 18:171

    Published on: 11 April 2017

  14. Study protocol

    Abelmoschus manihot – a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial

    IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-conv...

    Ping Li, Yi-zhi Chen, Hong-li Lin, Zhao-hui Ni, Yong-li Zhan, Rong Wang, Hong-tao Yang, Jing-ai Fang, Nian-song Wang, Wen-ge Li, Xue-feng Sun and Xiang-mei Chen

    Trials 2017 18:170

    Published on: 11 April 2017

  15. Study protocol

    Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial

    Uncooperative children may need to receive dental treatment under sedation, which is indicated when nonpharmacological behavior guidance is unsuccessful. There are randomized controlled trials (RCTs) comparing...

    Heloisa Sousa Gomes, Analya Rodrigues Miranda, Karolline Alves Viana, Aline Carvalho Batista, Paulo Sucasas Costa, Anelise Daher, Geovanna de Castro Morais Machado, Joji Sado-Filho, Liliani Aires Candido Vieira, Patrícia Corrêa-Faria, Marie Therese Hosey and Luciane Rezende Costa

    Trials 2017 18:172

    Published on: 11 April 2017

  16. Study protocol

    Prospective clinical study of rehabilitation interventions with multisensory interactive training in patients with cerebral infarction: study protocol for a randomised controlled trial

    Multisensory interactive training has an increasingly prominent role in stroke rehabilitation. Currently, there is insufficient evidence to demonstrate its efficacy on gait improvement, upper limb and lower li...

    Wai Leung Ambrose Lo, Yu Rong Mao, Le Li, Ai Hua Lin, Jiang Li Zhao, Ling Chen, Qiang Lin, Hai Li and Dong Feng Huang

    Trials 2017 18:173

    Published on: 11 April 2017

  17. Study protocol

    Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

    Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intra...

    Thijs de Rooij, Jony van Hilst, Jantien A. Vogel, Hjalmar C. van Santvoort, Marieke T. de Boer, Djamila Boerma, Peter B. van den Boezem, Bert A. Bonsing, Koop Bosscha, Peter-Paul Coene, Freek Daams, Ronald M. van Dam, Marcel G. Dijkgraaf, Casper H. van Eijck, Sebastiaan Festen, Michael F. Gerhards…

    Trials 2017 18:166

    Published on: 8 April 2017

  18. Study protocol

    Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial

    Uncorrected refractive errors are the commonest cause of visual loss in children despite spectacle correction being highly cost-effective. Many affected children do not benefit from correction as a high propor...

    Priya Morjaria, Andrew Bastawrous, Gudlavalleti Venkata Satyanarayana Murthy, Jennifer Evans and Clare Gilbert

    Trials 2017 18:168

    Published on: 8 April 2017

  19. Methodology

    Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses

    Engagement is essential in trials research but is rarely embedded across all stages of the research continuum. The development, use, effectiveness and value of engagement in trials research is poorly researche...

    Lauralie Richard, Donella Piper, Wayne Weavell, Rosemary Callander, Rick Iedema, John Furler, David Pierce, Kali Godbee, Jane Gunn and Victoria J. Palmer

    Trials 2017 18:169

    Published on: 8 April 2017

  20. Study protocol

    The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial

    Psychotic disorders affect up to 3% of the population and are often chronic and disabling. Innovation in the pharmacological treatment of psychosis has remained stagnant in recent decades. In order to improve ...

    Alex Ryan, Andrea Baker, Frances Dark, Sharon Foley, Anne Gordon, Sean Hatherill, Stephen Stathis, Sukanta Saha, George Bruxner, Martin Beckman, Drew Richardson, Michael Berk, Olivia Dean, John McGrath, Cadence Working Group and James Scott

    Trials 2017 18:165

    Published on: 7 April 2017

  21. Research

    Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study

    Recruitment to randomised prevention trials is challenging, not least for intracerebral haemorrhage (ICH) associated with antithrombotic drug use. We investigated reasons for not recruiting apparently eligible...

    Amy E. Maxwell, Mary Joan MacLeod, Anu Joyson, Sharon Johnson, Hawraman Ramadan, Ruth Bellfield, Anthony Byrne, Caroline McGhee, Anthony Rudd, Fiona Price, Evangelos Vasileiadis, Melinda Holden, Jonathan Hewitt, Michael Carpenter, Ann Needle, Stacey Valentine…

    Trials 2017 18:162

    Published on: 5 April 2017

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