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  1. Study protocol

    Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial

    Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased drama...

    Qinjun Chu, Dan Shen, Long He, Hongwei Wang, Xianlan Zhao, Zhimin Chen, Yanli Wang and Wei Zhang

    Trials 2017 18:240

    Published on: 26 May 2017

  2. Study protocol

    The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial

    Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in cl...

    Michele Heisler, Jennifer Burgess, Jeffrey Cass, John F. Chardos, Alexander B. Guirguis, Sean M. Jeffery, Lorrie A. Strohecker, Adam S. Tremblay, Wen-Chih Wu and Donna M. Zulman

    Trials 2017 18:239

    Published on: 26 May 2017

  3. Study protocol

    The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial

    Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral th...

    Lemmy Schakel, Dieuwke S. Veldhuijzen, Henriët van Middendorp, Corine Prins, Simone A. Joosten, Tom H. M. Ottenhoff, Leo G. Visser and Andrea W. M. Evers

    Trials 2017 18:243

    Published on: 26 May 2017

  4. Study protocol

    Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial

    Haemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several internatio...

    James Winearls, Martin Wullschleger, Elizabeth Wake, Catherine Hurn, Jeremy Furyk, Glenn Ryan, Melita Trout, James Walsham, Anthony Holley, Jeremy Cohen, Megan Shuttleworth, Wayne Dyer, Gerben Keijzers, John F Fraser, Jeffrey Presneill and Don Campbell

    Trials 2017 18:241

    Published on: 26 May 2017

  5. Update

    Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol

    Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component...

    Chris Bonell, Anne Mathiot, Elizabeth Allen, Leonardo Bevilacqua, Deborah Christie, Diana Elbourne, Adam Fletcher, Richard Grieve, Rosa Legood, Stephen Scott, Emily Warren, Meg Wiggins and Russell M. Viner

    Trials 2017 18:238

    Published on: 25 May 2017

  6. Study protocol

    Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial

    Mobility scooters can facilitate community participation among individuals with mobility limitations. However, accidents are a serious concern with scooter use. Scooter training has been recommended to improve...

    W. Ben Mortenson, Sharon Jang, Charlie H. Goldsmith, Laura Hurd Clarke, Sandra Hobson and Richelle Emery

    Trials 2017 18:235

    Published on: 25 May 2017

  7. Study protocol

    The effect of a mindfulness-based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high-risk mental state in a Chilean sample: study protocol for a randomized controlled trial

    According to the projections of the World Health Organization, 15% of all disabilities will be associated with mental illnesses by 2020. One of the mental disorders with the largest social impacts due to high ...

    Álvaro I. Langer, Carlos Schmidt, Rocío Mayol, Marcela Díaz, Javiera Lecaros, Edwin Krogh, Aída Pardow, Carolina Vergara, Guillermo Vergara, Bernardita Pérez-Herrera, María José Villar, Alejandro Maturana and Pablo A. Gaspar

    Trials 2017 18:233

    Published on: 25 May 2017

  8. Study protocol

    Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial

    Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clin...

    Sarah Ballou, Ted J. Kaptchuk, William Hirsch, Judy Nee, Johanna Iturrino, Kathryn T. Hall, John M. Kelley, Vivian Cheng, Irving Kirsch, Eric Jacobson, Lisa Conboy, Anthony Lembo and Roger B. Davis

    Trials 2017 18:234

    Published on: 25 May 2017

  9. Study protocol

    Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial

    Pruritus (itch) is a frequent, burdensome and difficult-to-treat symptom in patients with cholestasis. Fibrates are currently under investigation for the treatment of primary biliary cholangitis in patients wi...

    Ruth Bolier, Elsemieke S. de Vries, Albert Parés, Jeltje Helder, E. Marleen Kemper, Koos Zwinderman, Ronald P. Oude Elferink and Ulrich Beuers

    Trials 2017 18:230

    Published on: 23 May 2017

  10. Study protocol

    Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS): study protocol for a randomised controlled trial

    Cerebral small vessel disease is a common cause of vascular cognitive impairment in older people, with no licensed treatment. Cerebral blood flow is reduced in small vessel disease. Tadalafil is a widely presc...

    Mathilde M. H. Pauls, Natasha Clarke, Sarah Trippier, Shai Betteridge, Franklyn A. Howe, Usman Khan, Christina Kruuse, Jeremy B. Madigan, Barry Moynihan, Anthony C. Pereira, Debbie Rolfe, Egill Rostrup, Caroline E. Haig, Thomas R. Barrick, Jeremy D. Isaacs and Atticus H. Hainsworth

    Trials 2017 18:229

    Published on: 22 May 2017

  11. Study protocol

    Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial

    Laparoscopic Roux-en-Y gastric bypass (LRYGB) is considered the gold standard in bariatric surgery, achieving durable long-term weight loss with improvement of obesity-related comorbidities. Lately, the laparo...

    Marko Kraljević, Tarik Delko, Thomas Köstler, Elena Osto, Thomas Lutz, Sarah Thommen, Raoul A. Droeser, Lincoln Rothwell, Daniel Oertli and Urs Zingg

    Trials 2017 18:226

    Published on: 22 May 2017

  12. Study protocol

    Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial

    Cancer survivors have to deal with a wide range of physical symptoms, psychological, social and existential concerns, and lifestyle issues related to cancer and its treatment. Therefore, it is essential that t...

    Anja van der Hout, Cornelia F. van Uden-Kraan, Birgit I. Witte, Veerle M. H. Coupé, Femke Jansen, C. René Leemans, Pim Cuijpers, Lonneke V. van de Poll-Franse and Irma M. Verdonck-de Leeuw

    Trials 2017 18:228

    Published on: 22 May 2017

  13. Research

    Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis

    Implementing the treatment arm of a clinical trial often requires changes to healthcare practices. Barriers to such changes may undermine the delivery of the treatment making it more likely that the trial will...

    Justin Presseau, Brittany Mutsaers, Ahmed A. Al-Jaishi, Janet Squires, Christopher W. McIntyre, Amit X. Garg, Manish M. Sood and Jeremy M. Grimshaw

    Trials 2017 18:227

    Published on: 22 May 2017

  14. Study protocol

    BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial

    Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries a...

    Benjamin D. Hunt, Matthew A. Popplewell, Huw Davies, Lewis Meecham, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Catherine Hewitt, Lazaros Andronis, Jonathan J. Deeks and Andrew Bradbury

    Trials 2017 18:224

    Published on: 19 May 2017

  15. Study protocol

    A multimodal day treatment program for multi-problem young adults: study protocol for a randomized controlled trial

    Effective interventions for young adults with severe, multiple problems – such as psychosocial and psychiatric problems, delinquency, unemployment and substance use – are scarce but urgently needed in order to...

    Marie-Jolette A. Luijks, Floor Bevaart, Josjan Zijlmans, Laura van Duin, Reshmi Marhe, Theo A. H. Doreleijers, Henning Tiemeier, Jessica J. Asscher and Arne Popma

    Trials 2017 18:225

    Published on: 19 May 2017

  16. Study protocol

    Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial

    According to the Global Diabetes Plan, a unified health system with preventive and educational strategies is essential to proper diabetes care and primary settings should be the main site of care. In Brazil, t...

    Ana Marina Moreira, Roberta Marobin, Dimitris Varvaki Rados, Camila Bergonsi de Farias, Sabrina Coelli, Bárbara Luiza Bernardi, Lívia de Almeida Faller, Laura Ferraz dos Santos, Ana Maria Matzenbacher, Natan Katz, Erno Harzheim and Sandra Pinho Silveiro

    Trials 2017 18:222

    Published on: 18 May 2017

  17. Study protocol

    The SITLESS project: exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: study protocol for a randomised controlled trial

    Older adults are the fastest growing segment of the world‘s population. Recent evidence indicates that excessive sitting time is harmful to health, independent of meeting the recommended moderate to vigorous p...

    Maria Giné-Garriga, Laura Coll-Planas, Míriam Guerra, Àlex Domingo, Marta Roqué, Paolo Caserotti, Michael Denkinger, Dietrich Rothenbacher, Mark A. Tully, Frank Kee, Emma McIntosh, Carme Martín-Borràs, Guillermo R. Oviedo, Javier Jerez-Roig, Marta Santiago, Oriol Sansano…

    Trials 2017 18:221

    Published on: 18 May 2017

  18. Study protocol

    Does the use of the Informed Healthcare Choices (IHC) primary school resources improve the ability of grade-5 children in Uganda to assess the trustworthiness of claims about the effects of treatments: protocol for a cluster-randomised trial

    The ability to appraise claims about the benefits and harms of treatments is crucial for informed health care decision-making. This research aims to enable children in East African primary schools (the cluster...

    Allen Nsangi, Daniel Semakula, Andrew D. Oxman, Matthew Oxman, Sarah Rosenbaum, Astrid Austvoll-Dahlgren, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim and Nelson K. Sewankambo

    Trials 2017 18:223

    Published on: 18 May 2017

  19. Research

    HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

    A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered. This paper reports on...

    Noor Heim, Henk F. van Stel, Roelof G. Ettema, Roos C. van der Mast, Sharon K. Inouye and Marieke J. Schuurmans

    Trials 2017 18:220

    Published on: 17 May 2017

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