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  1. Research

    The use of randomisation-based efficacy estimators in non-inferiority trials

    In a non-inferiority (NI) trial, analysis based on the intention-to-treat (ITT) principle is anti-conservative, so current guidelines recommend analysing on a per-protocol (PP) population in addition. However,...

    David Gillespie, Daniel Farewell, Peter Barrett-Lee, Angela Casbard, Anthony Barney Hawthorne, Chris Hurt, Nick Murray, Chris Probert, Rachel Stenson and Kerenza Hood

    Trials 2017 18:117

    Published on: 9 March 2017

  2. Study protocol

    Rituximab versus azathioprine as therapy for maintenance of remission for anti-neutrophil cytoplasm antibody-associated vasculitis (RITAZAREM): study protocol for a randomized controlled trial

    Rituximab is effective as therapy for induction of remission in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). However, the effect of rituximab is not sustained, and subsequent relaps...

    Seerapani Gopaluni, Rona M. Smith, Michelle Lewin, Carol A. McAlear, Kim Mynard, Rachel B. Jones, Ulrich Specks, Peter A. Merkel and David R. W. Jayne

    Trials 2017 18:112

    Published on: 7 March 2017

  3. Study protocol

    Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial

    Acupressure therapy may be potentially beneficial in improving postoperative symptoms like postoperative nausea and vomiting (PONV), pain and sleep disorder and improving postoperative quality of recovery. The...

    Eric Noll, Shivam Shodhan, Maria Cecilia Madariaga, Christopher R. Page, Diane Santangelo, Xiaojun Guo, Ehab Al Bizri, Aurora D. Pryor, Jamie Romeiser and Elliott Bennett-Guerrero

    Trials 2017 18:110

    Published on: 7 March 2017

  4. Study protocol

    Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

    Patients with germline mutations in a tumour suppressor gene called CYLD develop multiple, disfiguring, hair follicle tumours on the head and neck. The prognosis is poor, with up to one in four mutation carriers ...

    Amy Cranston, Deborah D. Stocken, Elaine Stamp, David Roblin, Julia Hamlin, James Langtry, Ruth Plummer, Alan Ashworth, John Burn and Neil Rajan

    Trials 2017 18:111

    Published on: 7 March 2017

  5. Research

    The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study

    There is increasing evidence that low levels of physical activity and diets low in fruit and vegetables and high in meat and dairy products are risk factors for prostate cancer disease progression. The Prostat...

    Ellie Shingler, Lucy Hackshaw-McGeagh, Luke Robles, Raj Persad, Anthony Koupparis, Edward Rowe, Constance Shiridzinomwa, Amit Bahl, Richard M. Martin and J. Athene Lane

    Trials 2017 18:106

    Published on: 7 March 2017

  6. Study protocol

    First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial

    Salivary gland hypofunction and xerostomia are major complications following radiotherapy for head and neck cancer and may lead to debilitating oral disorders and impaired quality of life. Currently, only symp...

    Christian Grønhøj, David H. Jensen, Peter V. Glovinski, Siri Beier Jensen, Allan Bardow, Roberto S. Oliveri, Lena Specht, Carsten Thomsen, Sune Darkner, Katalin Kiss, Anne Fischer-Nielsen and Christian von Buchwald

    Trials 2017 18:108

    Published on: 7 March 2017

  7. Study protocol

    Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial

    Manual acupuncture (MA) manipulations are one of the key factors influencing acupuncture effects in traditional Chinese medicine theory. Different MA manipulations contain different stimulating parameters, thu...

    Shou-hai Hong, Sha-sha Ding, Fei Wu, Ying Bi, Fu Xu, Yi-jia Wan and Li-hua Xuan

    Trials 2017 18:102

    Published on: 6 March 2017

  8. Study protocol

    Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

    Peripheral arterial disease (PAD) has a population prevalence of 4.6% with intermittent claudication (IC) presenting as one of the earliest and most common symptoms. PAD has detrimental effects on patients’ wa...

    Thomas Cayton, Amy E. Harwood, George E. Smith, Joshua P. Totty, Daniel Carradice and Ian C. Chetter

    Trials 2017 18:104

    Published on: 6 March 2017

  9. Study protocol

    Mobile Exergaming for Health—Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus—study protocol for a randomized controlled trial

    Exergaming is a novel approach to increase motivation for regular physical activity (PA) among sedentary individuals such as patients with type 2 diabetes mellitus (T2DM). Because existing exergames do not off...

    Christoph Höchsmann, Steffen P. Walz, Juliane Schäfer, Jussi Holopainen, Henner Hanssen and Arno Schmidt-Trucksäss

    Trials 2017 18:103

    Published on: 6 March 2017

  10. Study protocol

    Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study

    Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce p...

    Moira H. D. Bruintjes, Andries E. Braat, Albert Dahan, Gert-Jan Scheffer, Luuk B. Hilbrands, Frank C. H. d’Ancona, Rogier A. R. T. Donders, Cornelis J. H. M. van Laarhoven and Michiel C. Warlé

    Trials 2017 18:99

    Published on: 4 March 2017

  11. Study protocol

    School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial

    Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. Howev...

    Bente Storm Mowatt Haugland, Solfrid Raknes, Aashild Tellefsen Haaland, Gro Janne Wergeland, Jon Fauskanger Bjaastad, Valborg Baste, Joe Himle, Ron Rapee and Asle Hoffart

    Trials 2017 18:100

    Published on: 4 March 2017

  12. Study protocol

    Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial

    Radiation therapy (RT) of bone metastases provides an important treatment approach in palliative care treatment concepts. As a consequence of treatment, the extent of radiation-induced toxicity is a crucial fe...

    Eva Meyerhof, Tanja Sprave, Stefan Ezechiel Welte, Nils H. Nicolay, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Jürgen Debus and Harald Rief

    Trials 2017 18:98

    Published on: 3 March 2017

  13. Study protocol

    A mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial

    Sedentary behaviour (e.g. television viewing, sitting time) tracks over time and is associated with adverse health and developmental outcomes across the lifespan. Young children (5 years or younger) spend up t...

    Katherine L. Downing, Jo Salmon, Trina Hinkley, Jill A. Hnatiuk and Kylie D. Hesketh

    Trials 2017 18:97

    Published on: 3 March 2017

  14. Erratum

    Erratum to: START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a clusterrandomised controlled trial

    Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M. Freitag, Robert L. Trestman and Christina Stadler

    Trials 2017 18:95

    Published on: 2 March 2017

    The original article was published in Trials 2016 17:568

  15. Update

    Promoting Recruitment using Information Management Efficiently (PRIME): statistical analysis plan for a stepped wedge cluster randomised trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

    Promoting Recruitment using Information Management Efficiently (PRIME) is a stepped wedge, cluster randomised trial-within-a-trial of a complex intervention to help sites in the United Kingdom to attain their ...

    Richard A. Parker, Christopher J. Weir, Amy E. Maxwell and Rustam Al-Shahi Salman

    Trials 2017 18:94

    Published on: 1 March 2017

  16. Study protocol

    Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

    Research into methods to boost recruitment has been identified as the highest priority for randomised controlled trial (RCT) methodological research in the United Kingdom. Slow recruitment delays the delivery ...

    Amy E. Maxwell, Martin Dennis, Anthony Rudd, Christopher J. Weir, Richard A. Parker and Rustam Al-Shahi Salman

    Trials 2017 18:22

    Published on: 1 March 2017

  17. Study protocol

    A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial

    NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centr...

    David Saxon, Kate Ashley, Lindsey Bishop-Edwards, Janice Connell, Phillippa Harrison, Sally Ohlsen, Gillian E. Hardy, Stephen Kellett, Clara Mukuria, Toni Mank, Peter Bower, Mike Bradburn, John Brazier, Robert Elliott, Lynne Gabriel, Michael King…

    Trials 2017 18:93

    Published on: 1 March 2017

  18. Study protocol

    The effectiveness of a skin care program for the prevention of contact dermatitis in health care workers (the Healthy Hands Project): study protocol for a cluster randomized controlled trial

    Health care workers (HCW) are at high risk for developing occupational hand dermatitis (HD) due to frequent exposure to ‘wet work’. Amongst HCWs, nurses are at highest risk, with an estimated point prevalence ...

    Maryam Soltanipoor, Sanja Kezic, Judith K. Sluiter and Thomas Rustemeyer

    Trials 2017 18:92

    Published on: 28 February 2017

  19. Study protocol

    Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

    Proximal humeral fractures are common in older patients. The majority are minimally displaced and are associated with good outcomes after nonoperative treatment. Poorer outcomes are associated with displaced, ...

    Geoffrey C. S. Smith, Ed Bateman, Ben Cass, Maurizio Damiani, Wade Harper, Hugh Jones, David Lieu, Jeff Petchell, Minas Petrelis, Kalman Piper, Doron Sher, Christopher J. Smithers, John Trantalis, Sindy Vrancic and Ian A. Harris

    Trials 2017 18:91

    Published on: 28 February 2017

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