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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Research

    The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials

    When designing and analysing clinical trials, using previous relevant information, perhaps in the form of evidence syntheses, can reduce research waste. We conducted the INVEST (INVestigating the use of Eviden...

    Gemma L. Clayton, Isabelle L. Smith, Julian P. T. Higgins, Borislava Mihaylova, Benjamin Thorpe, Robert Cicero, Kusal Lokuge, Julia R. Forman, Jayne F. Tierney, Ian R. White, Linda D. Sharples and Hayley E. Jones

    Trials 2017 18:219

    Published on: 15 May 2017

  13. Research

    A feasibility randomised controlled trial of extended brief intervention for alcohol misuse in adults with mild to moderate intellectual disabilities living in the community; The EBI-LD study

    Extended brief interventions (EBIs) are effective in targeting alcohol misuse in the general population. However, little is known of the effects of EBI in adults with intellectual (also known as learning) disa...

    Christos Kouimtsidis, Alessandro Bosco, Katrina Scior, Gianluca Baio, Rachael Hunter, Vittoria Pezzoni, Eileen Mcnamara and Angela Hassiotis

    Trials 2017 18:216

    Published on: 12 May 2017

  14. Study protocol

    Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial

    Depression has become one of the leading contributors to the global disease burden. Evidence-based treatments for depression are available, but access to them is still limited in some instances. As technology ...

    Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentagotai, Vlad Mureşan and Rareș Boian

    Trials 2017 18:215

    Published on: 12 May 2017

  15. Study protocol

    Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element: study protocol for a randomised controlled trial

    Fatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). Although fatigue increases during periods of inflammation, for some patients it persists when di...

    Micol Artom, Wladyslawa Czuber-Dochan, Jackie Sturt and Christine Norton

    Trials 2017 18:213

    Published on: 11 May 2017

  16. Study protocol

    The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial

    Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative ph...

    Aron Onerup, Eva Angenete, David Bock, Mats Börjesson, Monika Fagevik Olsén, Elin Grybäck Gillheimer, Stefan Skullman, Sven-Egron Thörn, Eva Haglind and Hanna Nilsson

    Trials 2017 18:212

    Published on: 8 May 2017

  17. Study protocol

    Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial

    Denture-related erythematous stomatitis (DES) is a chronic biofilm-mediated disease, affecting one in every three complete denture wearers. Antifungals are the treatment most commonly prescribed by oral health...

    Raphael F. de Souza, Muhammad Faheem Khiyani, Carolina A. L. Chaves, Jocelyne Feine, Jean Barbeau, Ramón Fuentes, Eduardo Borie, Luciana C. Crizostomo, Claudia H. Silva-Lovato, Pierre Rompre and Elham Emami

    Trials 2017 18:211

    Published on: 5 May 2017

  18. Study protocol

    Effect of supervised exercise in groups on psychological well-being among pregnant women at risk of depression (the EWE Study): study protocol for a randomized controlled trial

    Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well d...

    Lotte Broberg, Mette Backhausen, Peter Damm, Per Bech, Ann Tabor and Hanne Kristine Hegaard

    Trials 2017 18:210

    Published on: 5 May 2017

  19. Study protocol

    The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial

    Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services fo...

    Jill Murphy, Charles H. Goldsmith, Wayne Jones, Pham Thi Oanh and Vu Cong Nguyen

    Trials 2017 18:209

    Published on: 5 May 2017

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