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  1. Study protocol

    Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial)

    Hyponatremia is the most common electrolyte imbalance encountered in clinical practice, associated with increased mortality and length of hospital stay. However, no high-quality evidence regarding whether hype...

    Anna Lee, You Hwan Jo, Kyuseok Kim, Soyeon Ahn, Yun Kyu Oh, Huijai Lee, Jonghwan Shin, Ho Jun Chin, Ki Young Na, Jung Bok Lee, Seon Ha Baek and Sejoong Kim

    Trials 2017 18:147

    Published on: 29 March 2017

  2. Study protocol

    Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial

    Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring sy...

    Catherine Elizabeth Carr, Julian O’Kelly, Stephen Sandford and Stefan Priebe

    Trials 2017 18:149

    Published on: 29 March 2017

  3. Study protocol

    Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER — Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial

    Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50–80% of these patients and is the term used to describe constipation and faec...

    Doreen McClurg, Kirsteen Goodman, Suzanne Hagen, Fional Harris, Sean Treweek, Anton Emmanuel, Christine Norton, Maureen Coggrave, Selina Doran, John Norrie, Peter Donnan, Helen Mason and Sarkis Manoukian

    Trials 2017 18:150

    Published on: 29 March 2017

  4. Study protocol

    The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial

    The incidence of type 2 diabetes, cardiovascular diseases, and obesity has been rising dramatically; however, their pathogenesis is particularly intriguing. Recently, dysbiosis of the intestinal microbiota has...

    Nazila Kassaian, Ashraf Aminorroaya, Awat Feizi, Parvaneh Jafari and Masoud Amini

    Trials 2017 18:148

    Published on: 29 March 2017

  5. Study protocol

    Cognitive-behavioral rehabilitation vs. treatment as usual for bipolar patients: study protocol for a randomized controlled trial

    Bipolar disorder (BD) is commonly associated with cognitive and functional impairments even during remission periods, and although a growing number of studies have demonstrated the benefits of psychotherapy as...

    Bernardo Carramão Gomes, Cristiana Castanho Rocca, Gabriel Okawa Belizario and Beny Lafer

    Trials 2017 18:142

    Published on: 28 March 2017

  6. Study protocol

    Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial

    Irreversible pulpitis is a highly painful inflammatory condition of the dental pulp which represents a common dental emergency. Recommended care is partial endodontic treatment. The dental literature reports m...

    Olivia Kérourédan, Léonard Jallon, Paul Perez, Christine Germain, Jean-François Péli, Dominique Oriez, Jean-Christophe Fricain, Elise Arrivé and Raphaël Devillard

    Trials 2017 18:141

    Published on: 28 March 2017

  7. Study protocol

    Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial

    Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immu...

    Annelies A. J. Verlaet, Berten Ceulemans, Helene Verhelst, Dirk Van West, Tess De Bruyne, Luc Pieters, Huub F. J. Savelkoul and Nina Hermans

    Trials 2017 18:145

    Published on: 28 March 2017

  8. Research

    An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

    Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient nu...

    Sarah Cockayne, Caroline Fairhurst, Joy Adamson, Catherine Hewitt, Robin Hull, Kate Hicks, Anne-Maree Keenan, Sarah E. Lamb, Lorraine Green, Caroline McIntosh, Hylton B. Menz, Anthony C. Redmond, Sara Rodgers, David J. Torgerson, Wesley Vernon, Judith Watson…

    Trials 2017 18:144

    Published on: 28 March 2017

  9. Study protocol

    Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial

    Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1–2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significan...

    Christine Norton, Anton Emmanuel, Natasha Stevens, S. Mark Scott, Ugo Grossi, Sybil Bannister, Sandra Eldridge, James M. Mason and Charles H. Knowles

    Trials 2017 18:139

    Published on: 24 March 2017

  10. Research

    Poor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners

    In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs co...

    Christine L. Paul, Leon Piterman, Jonathan E. Shaw, Catherine Kirby, Kristy L. Forshaw, Jennifer Robinson, Isaraporn Thepwongsa and Robert W. Sanson-Fisher

    Trials 2017 18:137

    Published on: 23 March 2017

  11. Study protocol

    Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial

    The evidence for systemic treatments for severe childhood eczema is limited and largely based on extrapolation of data from adult studies. Current therapies are often immunosuppressant and may be associated wi...

    Susan Chan, Victoria Cornelius, Tao Chen, Suzana Radulovic, Mandy Wan, Rahi Jahan and Gideon Lack

    Trials 2017 18:136

    Published on: 22 March 2017

  12. Study protocol

    Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training? Study protocol for a randomized controlled trial

    Laparoscopic training has become an important part of surgical education. Laparoscopic Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed. Surgeons must be well trained prior to o...

    Javier Rodrigo De La Garza, Karl-Friedrich Kowalewski, Mirco Friedrich, Mona Wanda Schmidt, Thomas Bruckner, Hannes Götz Kenngott, Lars Fischer, Beat-Peter Müller-Stich and Felix Nickel

    Trials 2017 18:134

    Published on: 21 March 2017

  13. Commentary

    The possibility of critical realist randomised controlled trials

    Some realists have criticised randomised controlled trials for their inability to explain the causal relations that they identify; to take into account the influence of the social context of the interventions ...

    Sam Porter, Tracey McConnell and Joanne Reid

    Trials 2017 18:133

    Published on: 21 March 2017

  14. Study protocol

    Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study protocol for a randomised controlled trial

    PRESSURE 2 is a randomised evaluation of the clinical and cost effectiveness of two types of pressure relieving mattress for the prevention of pressure ulcers. The primary endpoint is the time to development o...

    Elizabeth McGinnis, Sarah Brown, Howard Collier, Phil Faulks, Rachael Gilberts, Clare Greenwood, Valerie Henderson, Delia Muir, Andrea Nelson, Jane Nixon, Isabelle Smith, Nikki Stubbs, Kay Walker, Lyn Wilson and Susanne Coleman

    Trials 2017 18:132

    Published on: 20 March 2017

  15. Study protocol

    Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health (“NiPPeR”): study protocol for a randomised controlled trial

    Improved maternal nutrition and glycaemic control before and during pregnancy are thought to benefit the health of the mother, with consequent benefits for infant body composition and later obesity risk. Mater...

    Keith M. Godfrey, Wayne Cutfield, Shiao-Yng Chan, Philip N. Baker and Yap-Seng Chong

    Trials 2017 18:131

    Published on: 20 March 2017

  16. Study protocol

    Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial

    China has the largest burden of primary angle-closure glaucoma (PACG) worldwide. The mechanism of the angle closure is complex and includes pupillary block and non-pupillary block. Currently, opinion is that l...

    Shida Chen, Jianhua Lv, Sujie Fan, Hong Zhang, Lin Xie, Ling Xu, Bing Jiang, Huipin Yuan, Yuanbo Liang, Shuning Li, Pingyan Chen, Xiulan Zhang and Ningli Wang

    Trials 2017 18:130

    Published on: 17 March 2017

  17. Study protocol

    A prospective, randomised, placebo-controlled, double-masked, three-armed, multicentre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma – the STRONG study: study protocol for a randomised controlled trial

    Neovascular glaucoma (NVG) is rare, comprising only 3.9% of all glaucoma cases. The most common cause of NVG is ischaemic central retinal vein occlusion (iCRVO). NVG frequently results in blindness and painful...

    Katrin Lorenz, Yvonne Scheller, Katharina Bell, Franz Grus, Katharina A. Ponto, Felix Bock, Claus Cursiefen, Jens Flach, Marta Gehring, Tunde Peto, Rufino Silva, Yossi Tal and Norbert Pfeiffer

    Trials 2017 18:128

    Published on: 16 March 2017

  18. Study protocol

    Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial

    Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystallo...

    Matthew W. Semler, Wesley H. Self, Li Wang, Daniel W. Byrne, Jonathan P. Wanderer, Jesse M. Ehrenfeld, Joanna L. Stollings, Avinash B. Kumar, Antonio Hernandez, Oscar D. Guillamondegui, Addison K. May, Edward D. Siew, Andrew D. Shaw, Gordon R. Bernard and Todd W. Rice

    Trials 2017 18:129

    Published on: 16 March 2017

  19. Study protocol

    Frailty Related to Anesthesia guided by the Index “bispectraL” (FRAIL) study: study protocol for a randomized controlled trial

    Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medic...

    Morgan Le Guen, Marie Herr, Antoine Bizard, Caroline Bichon, Nathalie Boichut, Thierry Chazot, Ngai Liu, Joel Ankri and Marc Fischler

    Trials 2017 18:127

    Published on: 16 March 2017

  20. Study protocol

    Addition of Propranolol in Resistant Arterial hypertension Treatment (APROPRIATE study): study protocol for a randomized double-blind placebo-controlled trial

    Resistant hypertension is defined as an uncontrolled blood pressure despite treatment at best-tolerated doses with at least three antihypertensive agents including a diuretic. It is an emerging public health p...

    G. R. Constantine, P. Ranasinghe, P. Weeratunga, C. Weeraratne, P. Galappatthy, S. Rajapakse, U. Senarath and P. Katulanda

    Trials 2017 18:124

    Published on: 14 March 2017

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