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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Study protocol

    The Ghent Psychotherapy Study (GPS) on the differential efficacy of supportive-expressive and cognitive behavioral interventions in dependent and self-critical depressive patients: study protocol for a randomized controlled trial

    Major depressive disorder is a leading cause of disease burden worldwide, indicating the importance of effective therapies. Outcome studies have shown overall efficacy of different types of psychotherapy acros...

    Reitske Meganck, Mattias Desmet, Claudi Bockting, Ruth Inslegers, Femke Truijens, Melissa De Smet, Rosa De Geest, Kimberly Van Nieuwenhove, Vicky Hennissen, Goedele Hermans, Tom Loeys, Ufuoma Angelica Norman, Chris Baeken and Stijn Vanheule

    Trials 2017 18:126

    Published on: 14 March 2017

  14. Research

    Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment

    Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions...

    Lee J. Middleton, Jane P. Daniels, Annalise Weckesser and Siladitya Bhattacharya

    Trials 2017 18:121

    Published on: 11 March 2017

  15. Study protocol

    The Benefits of Early Book Sharing (BEBS) for child cognitive and socio-emotional development in South Africa: study protocol for a randomised controlled trial

    Children in low and middle-income countries (LMICs) are at risk for problems in their cognitive, social and behavioural development. Factors such as a lack of cognitive stimulation, harsh parenting practices, ...

    Nicholas Dowdall, Peter J. Cooper, Mark Tomlinson, Sarah Skeen, Frances Gardner and Lynne Murray

    Trials 2017 18:118

    Published on: 9 March 2017

  16. Study protocol

    Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial

    Our prospective pilot study of acupuncture affecting insulin sensitivity on polycystic ovary syndrome (PCOS) combined with insulin resistance (IR) showed that acupuncture had a significant effect on improving ...

    Juan Li, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Zhenxing Hu, Xiaoguang Shao, Haiyan Wang, Meifang Li, Maohua Lai, Changcai Xie, Nianjun Su, Chuyi Yu, Jia Liu, Taixiang Wu and Hongxia Ma

    Trials 2017 18:115

    Published on: 9 March 2017

  17. Study protocol

    Treatment with L-citrulline in patients with post-polio syndrome: study protocol for a single-center, randomised, placebo-controlled, double-blind trial

    Post-polio syndrome (PPS) is a condition that affects polio survivors years after recovery from an initial acute infection by the Poliomyelitis virus. Most often, patients who suffered from polio start to expe...

    Simone Schmidt, Vanya Gocheva, Thomas Zumbrunn, Daniela Rubino-Nacht, Ulrike Bonati, Dirk Fischer and Patricia Hafner

    Trials 2017 18:116

    Published on: 9 March 2017

  18. Research

    Minimum number of clusters and comparison of analysis methods for cross sectional stepped wedge cluster randomised trials with binary outcomes: A simulation study

    Stepped wedge cluster randomised trials frequently involve a relatively small number of clusters. The most common frameworks used to analyse data from these types of trials are generalised estimating equations...

    Daniel Barker, Catherine D’Este, Michael J. Campbell and Patrick McElduff

    Trials 2017 18:119

    Published on: 9 March 2017

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