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  1. Study protocol

    Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland’s public sector health system: study protocol for a stepped-wedge randomized trial

    There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and ...

    Fiona J. Walsh, Till Bärnighausen, Wim Delva, Yvette Fleming, Gavin Khumalo, Charlotte L. Lejeune, Sikhathele Mazibuko, Charmaine Khudzie Mlambo, Ria Reis, Donna Spiegelman, Mandisa Zwane and Velephi Okello

    Trials 2017 18:383

    Published on: 18 August 2017

  2. Study protocol

    High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial

    The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in p...

    Pazit Levinger, Jeremy Dunn, Nancy Bifera, Michael Butson, George Elias and Keith D. Hill

    Trials 2017 18:384

    Published on: 18 August 2017

  3. Study protocol

    Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials

    People with anxiety disorders represent a significant part of a general practitioner’s patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of i...

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

    Trials 2017 18:382

    Published on: 16 August 2017

  4. Methodology

    Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial

    In a cluster randomised crossover (CRXO) design, a sequence of interventions is assigned to a group, or ‘cluster’ of individuals. Each cluster receives each intervention in a separate period of time, forming ‘...

    Sarah J. Arnup, Joanne E. McKenzie, Karla Hemming, David Pilcher and Andrew B. Forbes

    Trials 2017 18:381

    Published on: 15 August 2017

  5. Study protocol

    Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial

    Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment “default.” Current treatment guidelines recommend that providers (1) ask patients if they are will...

    Babalola Faseru, Edward F. Ellerbeck, Delwyn Catley, Byron J. Gajewski, Taneisha S. Scheuermann, Theresa I. Shireman, Laura M. Mussulman, Niaman Nazir, Terry Bush and Kimber P. Richter

    Trials 2017 18:379

    Published on: 14 August 2017

  6. Research

    The impact of active stakeholder involvement on recruitment, retention and engagement of schools, children and their families in the cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP): a school-based intervention to prevent obesity

    Recruitment and retention of participants is crucial for statistical power and internal and external validity and participant engagement is essential for behaviour change. However, many school-based interventi...

    J. Lloyd, C. McHugh, J. Minton, H. Eke and K. Wyatt

    Trials 2017 18:378

    Published on: 14 August 2017

  7. Research

    A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) – one-year results of a pre-maturely terminated study

    The indications for conservative “best medical treatment” (BMT) versus additional renal artery stenting are a matter of ongoing debate. The RADAR study aimed to evaluate the impact of percutaneous renal artery...

    Thomas Zeller, Hans Krankenberg, Andrejs Erglis, Erwin Blessing, Torsten Fuss, Dierk Scheinert, Ralf Weser, Beatrix B. Doerr, Wilfrid D. Yollo and Joerg Radermacher

    Trials 2017 18:380

    Published on: 14 August 2017

  8. Study protocol

    The influence of 3 months of physical exercises and verbal stimulation on functional efficiency and use of free time in an older population under institutional care: study protocol for a randomized controlled trial

    In recent years, there has been a significant change in the demographics of developed countries, including an increase in the number of older people. This aging population and the associated need for medical c...

    Agnieszka Wiśniowska-Szurlej, Agnieszka Ćwirlej-Sozańska, Anna Wilmowska-Pietruszyńska, Natalia Milewska and Bernard Sozański

    Trials 2017 18:376

    Published on: 11 August 2017

  9. Study protocol

    Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial

    Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis and/or hyperdistention of the lungs. Recent studies show benefits of lung...

    Zoltán Ruszkai, Erika Kiss, Ildikó László, Fanni Gyura, Erika Surány, Péter Töhötöm Bartha, Gergely Péter Bokrétás, Edit Rácz, István Buzogány, Zoltán Bajory, Erzsébet Hajdú and Zsolt Molnár

    Trials 2017 18:375

    Published on: 11 August 2017

  10. Study protocol

    A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

    An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) ...

    Louise K. Hoeffding, Maria Haahr Nielsen, Morten A. Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K. Kjær, Kristoffer Sølvsten Burgdorf and Trine Schow

    Trials 2017 18:371

    Published on: 10 August 2017

  11. Study protocol

    Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial

    The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention pro...

    Lide Arenaza, María Medrano, María Amasene, Beatriz Rodríguez-Vigil, Ignacio Díez, Manuel Graña, Ignacio Tobalina, Edurne Maiz, Edurne Arteche, Eider Larrarte, Inge Huybrechts, Catherine L. Davis, Jonatan R. Ruiz, Francisco B. Ortega, Javier Margareto and Idoia Labayen

    Trials 2017 18:372

    Published on: 10 August 2017

  12. Study protocol

    The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study

    In patients with peripheral arterial disease (PAD), walking improvements are often limited by early pain onset due to vascular claudication. It would thus appear interesting to develop noninvasive therapeutic ...

    Florent Besnier, Jean-Michel Sénard, Vincent Grémeaux, Mélanie Riédel, Damien Garrigues, Thibaut Guiraud and Marc Labrunée

    Trials 2017 18:373

    Published on: 10 August 2017

  13. Study protocol

    Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study)

    Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating g...

    Bilal Alkhaffaf, Anne-Marie Glenny, Jane M. Blazeby, Paula Williamson and Iain A. Bruce

    Trials 2017 18:370

    Published on: 9 August 2017

  14. Study protocol

    To evaluate if increased supervision and support of South African Government health workers’ home visits improves maternal and child outcomes: study protocol for a randomized control trial

    Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in res...

    Mary Jane Rotheram-Borus, Karl Le Roux, Ingrid M. Le Roux, Joan Christodoulou, Christina Laurenzi, Nokwanele Mbewu and Mark Tomlinson

    Trials 2017 18:368

    Published on: 7 August 2017

  15. Study protocol

    Effectiveness of a low-fructose and/or low-sucrose diet in decreasing insulin resistance (DISFRUTE study): study protocol for a randomized controlled trial

    Research published to date on the relationship between insulin resistance (IR) and fructose consumption is scarce, has used different methods, and has yielded sometimes contradictory results. This study aims t...

    Santiago Domínguez Coello, Lourdes Carrillo Fernández, Jesús Gobierno Hernández, Manuel Méndez Abad, Carlos Borges Álamo, José Antonio García Dopico, Armando Aguirre Jaime and Antonio Cabrera de León

    Trials 2017 18:369

    Published on: 7 August 2017

  16. Study protocol

    Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial

    Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short perio...

    Richard A. Van Dorn, Sarah L. Desmarais, Candalyn B. Rade, Elizabeth N. Burris, Gary S. Cuddeback, Kiersten L. Johnson, Stephen J. Tueller, Megan L. Comfort and Kim T. Mueser

    Trials 2017 18:365

    Published on: 4 August 2017

  17. Study protocol

    Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial

    Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies),...

    John Hustedt, Dyna Doum, Vanney Keo, Sokha Ly, BunLeng Sam, Vibol Chan, Neal Alexander, John Bradley, Didot Budi Prasetyo, Agus Rachmat, Shafique Muhammad, Sergio Lopes, Rithea Leang and Jeffrey Hii

    Trials 2017 18:367

    Published on: 4 August 2017

  18. Study protocol

    Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study

    Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England...

    Aliki Tsichlaki, Kevin O’Brien, Ama Johal, Zoe Z. Marshman, Philip P. Benson, Fiorella B. Colonio Salazar and Padhraig S. Fleming

    Trials 2017 18:366

    Published on: 4 August 2017

  19. Study protocol

    Measurement, Education and Tracking in Integrated Care (METRIC): use of a culturally adapted education tool versus standard education to increase engagement in depression treatment among Hispanic patients: study protocol for a randomized control trial

    Significant mental health disparities exist for Hispanic populations, especially with regard to depression treatment. Stigma and poor communication between patients and their providers result in low use of ant...

    Katherine Sanchez, Brittany H. Eghaneyan, Michael O. Killian, Leopoldo Cabassa and Madhukar H. Trivedi

    Trials 2017 18:363

    Published on: 3 August 2017

  20. Study protocol

    Measuring the effect of nurse practitioner (NP)-led care on health-related quality of life in adult patients with atrial fibrillation: study protocol for a randomized controlled trial

    Atrial fibrillation (AF) is a common arrhythmia associated with significant morbidity, mortality, and healthcare resource use. The prevalence of AF is increasing with a growing and aging population, and timely...

    Marcie J. Smigorowsky, Colleen M. Norris, Micheal Sean McMurtry and Ross T. Tsuyuki

    Trials 2017 18:364

    Published on: 3 August 2017

  21. Study protocol

    Pulsed radiofrequency or anterior neurectomy for anterior cutaneous nerve entrapment syndrome (ACNES) (the PULSE trial): study protocol of a randomized controlled trial

    Some patients with chronic abdominal pain suffer from an anterior cutaneous nerve entrapment syndrome (ACNES). This somewhat illusive syndrome is thought to be caused by the entrapment of end branches of the i...

    Robbert C. Maatman, Monique A. H. Steegers, Oliver B. A. Boelens, Toine C. Lim, Hans J. van den Berg, Sandra A. S. van den Heuvel, Marc R. M. Scheltinga and Rudi M. H. Roumen

    Trials 2017 18:362

    Published on: 2 August 2017

  22. Study protocol

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

    Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick sk...

    Daniel I. Schlessinger, Sanjana Iyengar, Arianna F. Yanes, Jill K. Henley, Hovik J. Ashchyan, Anastasia O. Kurta, Payal M. Patel, Umar A. Sheikh, Matthew J. Franklin, Courtney C. Hanna, Brian R. Chen, Sarah G. Chiren, Jochen Schmitt, Stefanie Deckert, Karina C. Furlan, Emily Poon…

    Trials 2017 18:359

    Published on: 1 August 2017

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