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  1. Study protocol

    The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial

    The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit c...

    Marcela Perdomo Rodrigues, Luciana Kaercher John dos Santos, Flavio Danni Fuchs, Sandra Costa Fuchs and Leila Beltrami Moreira

    Trials 2017 18:347

    Published on: 21 July 2017

  2. Study protocol

    Effectiveness and cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children (The BEEP trial): protocol for a randomised controlled trial

    Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a ...

    Joanne R. Chalmers, Rachel H. Haines, Eleanor J. Mitchell, Kim S. Thomas, Sara J. Brown, Matthew Ridd, Sandra Lawton, Eric L. Simpson, Michael J. Cork, Tracey H. Sach, Lucy E. Bradshaw, Alan A. Montgomery, Robert J. Boyle and Hywel C. Williams

    Trials 2017 18:343

    Published on: 21 July 2017

  3. Study protocol

    Collaborative care for depression in general practice: study protocol for a randomised controlled trial

    Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provide...

    Ursula Ødum Brinck-Claussen, Nadja Kehler Curth, Annette Sofie Davidsen, John Hagel Mikkelsen, Marianne Engelbrecht Lau, Merete Lundsteen, Claudio Csillag, Kaj Sparle Christensen, Carsten Hjorthøj, Merete Nordentoft and Lene Falgaard Eplov

    Trials 2017 18:344

    Published on: 21 July 2017

  4. Study protocol

    Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial

    Depression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to...

    Jane Gunn, Caroline Wachtler, Susan Fletcher, Sandra Davidson, Cathrine Mihalopoulos, Victoria Palmer, Kelsey Hegarty, Amy Coe, Elizabeth Murray, Christopher Dowrick, Gavin Andrews and Patty Chondros

    Trials 2017 18:342

    Published on: 20 July 2017

  5. Study protocol

    Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial

    People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. However, many patients mismanage their medicatio...

    Kelly L. Hayward, Jennifer H. Martin, W. Neil Cottrell, Antara Karmakar, Leigh U. Horsfall, Preya J. Patel, David D. Smith, Katharine M. Irvine, Elizabeth E. Powell and Patricia C. Valery

    Trials 2017 18:339

    Published on: 20 July 2017

  6. Study protocol

    Effect of insulin therapy and dietary adjustments on safety and performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized controlled trial

    Despite the reduction in glycemic derangement in patients with type 1 diabetes mellitus (T1D) through dietary and therapeutic adjustments implemented before, during and after continuous exercise, evidence for ...

    Javier Calvo-Marín, Gabriel Torrealba-Acosta, Matthew Campbell, Jesse Gaboury, Ajmol Ali and Chih Hao Chen-Ku

    Trials 2017 18:338

    Published on: 20 July 2017

  7. Research

    Birth weight differences between those offered financial voucher incentives for verified smoking cessation and control participants enrolled in the Cessation in Pregnancy Incentives Trial (CPIT), employing an intuitive approach and a Complier Average Causal Effects (CACE) analysis

    The Cessation in Pregnancy Incentives Trial (CPIT), which offered financial incentives for smoking cessation during pregnancy showed a clinically and statistically significant improvement in cessation. However...

    Alex McConnachie, Caroline Haig, Lesley Sinclair, Linda Bauld and David M. Tappin

    Trials 2017 18:337

    Published on: 20 July 2017

  8. Study protocol

    Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

    Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves u...

    Helen Rodgers, Lisa Shaw, Helen Bosomworth, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L. Cohen, Jesse Dawson, Janet Eyre, Tracy Finch, Gary A. Ford, Jennifer Hislop, Steven Hogg, Denise Howel, Niall Hughes, Hermano Igo Krebs…

    Trials 2017 18:340

    Published on: 20 July 2017

  9. Commentary

    Blockchain technology for improving clinical research quality

    Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key...

    Mehdi Benchoufi and Philippe Ravaud

    Trials 2017 18:335

    Published on: 19 July 2017

  10. Study protocol

    The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients’ adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial

    Despite a variety of efficient and cost-effective antihypertensive medication, hypertension remains a serious health and economic burden. High consumption of cardiovascular drugs in the Slovak Republic does re...

    Zuzana Haramiova, Michal Stasko, Martin Hulin, Tomas Tesar, Magdalena Kuzelova and Donald M. Morisky

    Trials 2017 18:334

    Published on: 18 July 2017

  11. Study protocol

    STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial

    To evaluate the effect of a smoking-, alcohol- or combined-cessation intervention starting shortly before surgery and lasting 6 weeks on overall complications after radical cystectomy. Secondary objectives are...

    Susanne Vahr Lauridsen, Thordis Thomsen, Peter Thind and Hanne Tønnesen

    Trials 2017 18:329

    Published on: 17 July 2017

  12. Study protocol

    Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial

    South Africa recently phased out access to free formula milk in the public sector in support of breastfeeding for women living with HIV. Few women living with HIV in South Africa choose breastfeeding and among...

    Moleen Zunza, Mark F. Cotton, Lawrence Mbuagbaw, Richard Lester and Lehana Thabane

    Trials 2017 18:331

    Published on: 17 July 2017

  13. Research

    Resource implications of preparing individual participant data from a clinical trial to share with external researchers

    Demands are increasingly being made for clinical trialists to actively share individual participant data (IPD) collected from clinical trials using responsible methods that protect the confidentiality and priv...

    Catrin Tudur Smith, Sarah Nevitt, Duncan Appelbe, Richard Appleton, Pete Dixon, Janet Harrison, Anthony Marson, Paula Williamson and Elizabeth Tremain

    Trials 2017 18:319

    Published on: 17 July 2017

  14. Study protocol

    A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS])

    Tranexamic acid prevents blood clots from breaking down and reduces bleeding. However, it is uncertain whether tranexamic acid is effective in traumatic brain injury. The CRASH-3 trial is a randomised controll...

    Abda Mahmood, Ian Roberts and Haleema Shakur

    Trials 2017 18:330

    Published on: 17 July 2017

  15. Research

    Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)

    Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure ...

    Julia Wade, Daisy Elliott, Kerry N. L. Avery, Daisy Gaunt, Grace J. Young, Rebecca Barnes, Sangeetha Paramasivan, W Bruce Campbell, Jane M. Blazeby, Alison J Birtle, Rob C. Stein, David J Beard, Alison W Halliday and Jenny L. Donovan

    Trials 2017 18:327

    Published on: 17 July 2017

  16. Study protocol

    Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial

    Low back pain causes more global disability than any other condition. Once the acute pain becomes chronic, about two-thirds of sufferers will not fully recover after 1–2 years. There is a paucity of effective ...

    Christoph Schnelle, Steffen Messerschmidt, Eunice J. Minford, Kate Greenaway-Twist, Maxine Szramka, Marianna Masiorski, Michelle Sheldrake and Mark Jones

    Trials 2017 18:328

    Published on: 17 July 2017

  17. Study protocol

    Twin–Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set

    Twin–Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery...

    Asma Khalil, Helen Perry, James Duffy, Keith Reed, Ahmet Baschat, Jan Deprest, Kurt Hecher, Liesbeth Lewi, Enrico Lopriore and Dick Oepkes

    Trials 2017 18:325

    Published on: 14 July 2017

  18. Study protocol

    The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial

    Lack of trust in parental support is a transdiagnostic risk factor for the development of psychological problems throughout the lifespan. Research suggests that children’s cognitive attachment representations ...

    Martine W. F. T. Verhees, Eva Ceulemans, Marian J. Bakermans-Kranenburg, Marinus H. van IJzendoorn, Simon de Winter and Guy Bosmans

    Trials 2017 18:326

    Published on: 14 July 2017

  19. Update

    A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update

    Temporal changes in the placebo arm of randomized controlled trials (RCTs) have not been thoroughly investigated, despite the fact that results of RCTs depend on the comparison between arms.

    Karolina A. Wartolowska, Stephen Gerry, Benjamin G. Feakins, Gary S. Collins, Jonathan Cook, Andrew Judge and Andrew J. Carr

    Trials 2017 18:323

    Published on: 12 July 2017

  20. Study protocol

    Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

    Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinical...

    Daniel I. Schlessinger, Sanjana Iyengar, Arianna F. Yanes, Sarah G. Chiren, Victoria Godinez-Puig, Brian R. Chen, Anastasia O. Kurta, Jochen Schmitt, Stefanie Deckert, Karina C. Furlan, Emily Poon, Todd V. Cartee, Ian A. Maher, Murad Alam and Joseph F. Sobanko

    Trials 2017 18:321

    Published on: 12 July 2017

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