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  1. Study protocol

    Use of activity tracking in major visceral surgery—the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial

    Enhanced recovery after surgery (ERAS) programs are aimed at minimizing postoperative stress and accelerating postoperative recovery by implementing multiple perioperative principles. “Early mobilization” is o...

    Steffen Wolk, Theresa Meißner, Sebastian Linke, Benjamin Müssle, Ann Wierick, Andreas Bogner, Dorothée Sturm, Nuh N. Rahbari, Marius Distler, Jürgen Weitz and Thilo Welsch

    Trials 2017 18:77

    Published on: 21 February 2017

  2. Study protocol

    Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial

    Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping tec...

    Cristina Barbero, Davide Ricci, Erik Cura Stura, Augusto Pellegrini, Giovanni Marchetto, Suad ElQarra, Massimo Boffini, Roberto Passera, Maria Consuelo Valentini and Mauro Rinaldi

    Trials 2017 18:76

    Published on: 21 February 2017

  3. Research

    Sample size considerations for trials using cerebral white matter hyperintensity progression as an intermediate outcome at 1 year after mild stroke: results of a prospective cohort study

    White matter hyperintensities (WMHs) are commonly seen on in brain imaging and are associated with stroke and cognitive decline. Therefore, they may provide a relevant intermediate outcome in clinical trials. ...

    Francesca M. Chappell, Maria del Carmen Valdés Hernández, Stephen D. Makin, Kirsten Shuler, Eleni Sakka, Martin S. Dennis, Paul A. Armitage, Susana Muñoz Maniega and Joanna M. Wardlaw

    Trials 2017 18:78

    Published on: 21 February 2017

  4. Study protocol

    The KiVa antibullying program in primary schools in Chile, with and without the digital game component: study protocol for a randomized controlled trial

    Bullying is a major problem worldwide and Chile is no exception. Bullying is defined as a systematic aggressive behavior against a victim who cannot defend him or herself. Victims suffer social isolation and p...

    Jorge Gaete, Daniela Valenzuela, Cristian Rojas-Barahona, Eduardo Valenzuela, Ricardo Araya and Christina Salmivalli

    Trials 2017 18:75

    Published on: 20 February 2017

  5. Erratum

    Trials 2017 18:74

    Published on: 16 February 2017

    The original article was published in Trials 2016 17:442

  6. Study protocol

    Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial

    Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone ...

    Jodie Wiseman, Megan Simons, Roy Kimble, Robert Ware, Steven McPhail and Zephanie Tyack

    Trials 2017 18:72

    Published on: 16 February 2017

  7. Study protocol

    Vascular Impulse Technology versus elevation in the treatment of posttraumatic swelling of extremity fractures: study protocol for a randomized controlled trial

    Fractures of the extremities are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury. Patients typically require up to 7 days of inpatient bed rest and elevation t...

    Marc Schnetzke, Benedict Swartman, Isabel Bonnen, Holger Keil, Svenja Schüler, Paul A. Grützner and Jochen Franke

    Trials 2017 18:73

    Published on: 16 February 2017

  8. Commentary

    Challenges to complete and useful data sharing

    Data sharing from clinical trials is one way of promoting fair and transparent conduct of clinical trials. It would maximise the use of data and permit the exploration of additional hypotheses. On the other ha...

    Lawrence Mbuagbaw, Gary Foster, Ji Cheng and Lehana Thabane

    Trials 2017 18:71

    Published on: 14 February 2017

  9. Study protocol

    A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review

    People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest i...

    Johanna Taylor, Jan R. Böhnke, Judy Wright, Ian Kellar, Sarah L. Alderson, Tom Hughes, Richard I. G. Holt and Najma Siddiqi

    Trials 2017 18:70

    Published on: 14 February 2017

  10. Study protocol

    Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial

    Linezolid, an oxazolidinone, substantially improves treatment outcomes of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. We started a trial to test whether the use of linezolid i...

    Ji Yeon Lee, Deog Kyeom Kim, Jung-Kyu Lee, Ho Il Yoon, Ina Jeong, Eunyoung Heo, Young Sik Park, Jae Ho Lee, Sung Soo Park, Sang-Min Lee, Chang-Hoon Lee, Jinwoo Lee, Sun Mi Choi, Jong Sun Park, Joon-Sung Joh, Young-Jae Cho…

    Trials 2017 18:68

    Published on: 13 February 2017

  11. Study protocol

    Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial

    Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme ...

    Merethe K. Andersen, Line B. Pedersen, Volkert Siersma, Flemming Bro, Susanne Reventlow, Jens Søndergaard, Marius Brostrøm Kousgaard and Frans B. Waldorff

    Trials 2017 18:69

    Published on: 13 February 2017

  12. Study protocol

    Efficacy of vitamin D3 supplementation in reducing incidence of pulmonary tuberculosis and mortality among HIV-infected Tanzanian adults initiating antiretroviral therapy: study protocol for a randomized controlled trial

    HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in h...

    Christopher R. Sudfeld, Ferdinand Mugusi, Said Aboud, Tumaini J. Nagu, Molin Wang and Wafaie W. Fawzi

    Trials 2017 18:66

    Published on: 10 February 2017

  13. Study protocol

    The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial

    The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activit...

    Barnaby Young, Sapna Sadarangani, Haur Sen Yew, Chee Fu Yung, Yee Sin Leo, Mark I-Cheng Chen and Annelies Wilder-Smith

    Trials 2017 18:67

    Published on: 10 February 2017

  14. Study protocol

    Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial

    Early hospital readmission of patients after discharge is a public health problem. One major cause of hospital readmission is dysfunctions in integrated pathways between community and hospital care that can ca...

    Pierre Renaudin, Karine Baumstarck, Aurélie Daumas, Marie-Anne Esteve, Stéphane Gayet, Pascal Auquier, Michel Tsimaratos, Patrick Villani and Stéphane Honore

    Trials 2017 18:65

    Published on: 9 February 2017

  15. Study protocol

    The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial

    It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social ch...

    Agneta Malmgren Fänge, Steven M. Schmidt, Maria H. Nilsson, Gunilla Carlsson, Anna Liwander, Caroline Dahlgren Bergström, Paolo Olivetti, Per Johansson and Carlos Chiatti

    Trials 2017 18:63

    Published on: 9 February 2017

  16. Research

    Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study

    The ending of a clinical trial may be challenging, particularly if staff are required to withdraw the investigated treatment(s); however, this aspect of trial work is surprisingly under-researched. To address ...

    Julia Lawton, David White, David Rankin, Jackie Elliott, Carolin Taylor, Cindy Cooper, Simon Heller and Nina Hallowell

    Trials 2017 18:61

    Published on: 7 February 2017

  17. Study protocol

    App-based serious gaming for training of chest tube insertion: study protocol for a randomized controlled trial

    Chest tube insertion is a standard intervention for management of various injuries of the thorax. Quick and accurate execution facilitates efficient therapy without further complications. Here, we propose a ne...

    Mirco Friedrich, Christian Bergdolt, Patrick Haubruck, Thomas Bruckner, Karl-Friedrich Kowalewski, Beat Peter Müller-Stich, Michael C. Tanner and Felix Nickel

    Trials 2017 18:56

    Published on: 6 February 2017

  18. Study protocol

    A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial

    People with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits. Rather than being merely a consequence of symptom-related physical impairments...

    Eleonora Volpato, Paolo Banfi and Francesco Pagnini

    Trials 2017 18:59

    Published on: 6 February 2017

  19. Study protocol

    Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial

    Liver resection is the only potentially curative treatment for colorectal liver metastases (LM). It is considered a safe procedure, but is often associated with blood loss during liver transection. Blood trans...

    Aurélien Dupré, David Pérol, Ellen Blanc, Patrice Peyrat, Valéria Basso, Yao Chen, Jérémy Vincenot, Anthony Kocot, David Melodelima and Michel Rivoire

    Trials 2017 18:57

    Published on: 6 February 2017

  20. Study protocol

    The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial

    Intramuscular injections of botulinum toxin A (BoNT-A) have been a cornerstone in the treatment of spasticity for the last 20 years. In Norway, the treatment is now offered to two out of three children with sp...

    Siri Merete Brændvik, Karin Roeleveld, Guro Lillemoen Andersen, Anne Elisabeth Ross Raftemo, Kjersti Ramstad, Jasmina Majkic-Tajsic, Torarin Lamvik, Bendik Lund, Turid Follestad and Torstein Vik

    Trials 2017 18:58

    Published on: 6 February 2017

  21. Study protocol

    The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial

    Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevente...

    Maureen Markle-Reid, Jenny Ploeg, Kimberly D. Fraser, Kathryn Ann Fisher, Noori Akhtar-Danesh, Amy Bartholomew, Amiram Gafni, Andrea Gruneir, Sandra P. Hirst, Sharon Kaasalainen, Caralyn Kelly Stradiotto, John Miklavcic, Carlos Rojas-Fernandez, Cheryl A. Sadowski, Lehana Thabane, Jean A. C. Triscott…

    Trials 2017 18:55

    Published on: 6 February 2017

  22. Letter

    The COMET Initiative database: progress and activities update (2015)

    This letter describes the substantial activity on the Core Outcome Measure in Effectiveness Trials (COMET) website in 2015, updating our earlier progress reports for the period from the launch of the COMET web...

    E. Gargon, P. R. Williamson, D. G. Altman, J. M. Blazeby, S. Tunis and M. Clarke

    Trials 2017 18:54

    Published on: 3 February 2017

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