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  1. Study protocol

    Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT’ID study protocol for using a Delphi process and face-to-face meetings to establish consensus

    The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. lou...

    Kathryn Fackrell, Harriet Smith, Veronica Colley, Brian Thacker, Adele Horobin, Haúla F. Haider, Alain Londero, Birgit Mazurek and Deborah A. Hall

    Trials 2017 18:388

    Published on: 23 August 2017

  2. Study protocol

    Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial

    The additional value of perioperative antibiotic prophylaxis in preventing infectious complications after emergency cholecystectomy for acute cholecystitis is a much-debated subject in the surgical community. ...

    Charlotte S. Loozen, Hjalmar C. van Santvoort, Antoinette A. W. van Geloven, Grard A. P. Nieuwenhuijzen, Philip R. de Reuver, Mark H. G. Besselink, Bart Vlaminckx, Johannes C. Kelder, Catherijne A. J. Knibbe and Djamila Boerma

    Trials 2017 18:390

    Published on: 23 August 2017

  3. Study protocol

    Assessment of ibrutinib plus rituximab in front-line CLL (FLAIR trial): study protocol for a phase III randomised controlled trial

    Treatment of chronic lymphocytic leukaemia (CLL) has seen a substantial improvement over the last few years. Combination immunochemotherapy, such as fludarabine, cyclophosphamide and rituximab (FCR), is now st...

    Laura Collett, Dena R. Howard, Talha Munir, Lucy McParland, Jamie B. Oughton, Andy C. Rawstron, Anna Hockaday, Claire Dimbleby, David Phillips, Kathryn McMahon, Claire Hulme, David Allsup, Adrian Bloor and Peter Hillmen

    Trials 2017 18:387

    Published on: 22 August 2017

  4. Study protocol

    Oral hygiene in intensive care unit patients with photodynamic therapy: study protocol for randomised controlled trial

    In intensive care units (ICUs), nosocomial infections are prevalent conditions and they have been related to high mortality indexes. Some studies have suggested that inefficient oral hygiene and ventilator-ass...

    Gabriela Alves Da Collina, Anna Carolina Ratto Tempestini-Horliana, Daniela de Fátima Teixeira da Silva, Priscila Larcher Longo, Maria Luisa Faria Makabe and Christiane Pavani

    Trials 2017 18:385

    Published on: 22 August 2017

  5. Study protocol

    Cardioprotective effect of Platycodon grandiflorum in patients with early breast cancer receiving anthracycline-based chemotherapy: study protocol for a randomized controlled trial

    Anthracyclines, alone or in combination with other drugs, are among the most effective chemotherapeutic agents to treat breast cancer both in the adjuvant and neoadjuvant setting. Unfortunately, anthracycline-...

    Wei Hao, Sheng Liu, Yuenong Qin, Chenping Sun, Liying Chen, Chunyu Wu and Yijia Bao

    Trials 2017 18:386

    Published on: 22 August 2017

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

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