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  1. Research

    The pancreatic surgery registry (StuDoQ|Pancreas) of the German Society for General and Visceral Surgery (DGAV) – presentation and systematic quality evaluation

    Pancreatic resections are among the most complex procedures in visceral surgery. While mortality has decreased substantially over the past decades, morbidity remains high. The volume-outcome correlation in pan...

    Ulrich F. Wellner, Carsten Klinger, Kai Lehmann, Heinz Buhr, Edmund Neugebauer and Tobias Keck

    Trials 2017 18:163

    Published on: 5 April 2017

  2. Study protocol

    Short message service (SMS)-based intervention targeting alcohol consumption among university students: study protocol of a randomized controlled trial

    Despite significant health risks, heavy drinking of alcohol among university students is a widespread problem; excessive drinking is part of the social norm. A growing number of studies indicate that short mes...

    Kristin Thomas, Marcus Bendtsen, Catharina Linderoth, Nadine Karlsson, Preben Bendtsen and Ulrika Müssener

    Trials 2017 18:156

    Published on: 4 April 2017

  3. Study protocol

    Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

    New targeted therapies and improved treatment strategies have dramatically improved the outcomes of patients with rheumatoid arthritis (RA). However, it is unknown whether different early aggressive interventi...

    Daniel Glinatsi, Marte S. Heiberg, Anna Rudin, Dan Nordström, Espen A. Haavardsholm, Bjorn Gudbjornsson, Mikkel Østergaard, Till Uhlig, Gerdur Grondal, Kim Hørslev-Petersen, Ronald van Vollenhoven and Merete L. Hetland

    Trials 2017 18:161

    Published on: 4 April 2017

  4. Study protocol

    A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial

    Worldwide, alcohol abuse is a burgeoning problem. Abstinence is key to allow recovery of physical and mental health as well as quality of life, but treatment for alcohol dependence is associated with high rela...

    Amy McAndrew, Will Lawn, Tobias Stevens, Lilla Porffy, Brigitta Brandner and Celia J. A. Morgan

    Trials 2017 18:159

    Published on: 4 April 2017

  5. Study protocol

    Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy – the COOP Study: study protocol for a cluster randomised controlled trial

    Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are l...

    Rita Romskaug, Espen Molden, Jørund Straand, Hege Kersten, Eva Skovlund, Kaisu H Pitkala and Torgeir Bruun Wyller

    Trials 2017 18:158

    Published on: 4 April 2017

  6. Study protocol

    Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial

    Up to 60% of patients with bipolar disorder (BD) have a history of traumatic events, which is associated with greater episode severity, higher risk of comorbidity and higher relapse rates. Trauma-focused treat...

    Ana Moreno-Alcázar, Joaquim Radua, Ramon Landín-Romero, Laura Blanco, Mercè Madre, Maria Reinares, Mercè Comes, Esther Jiménez, Jose Manuel Crespo, Eduard Vieta, Victor Pérez, Patricia Novo, Marta Doñate, Romina Cortizo, Alicia Valiente-Gómez, Walter Lupo…

    Trials 2017 18:160

    Published on: 4 April 2017

  7. Study protocol

    The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial

    Mobile health (mHealth) presents one of the potential solutions to maximize health worker impact and efficiency in an effort to reach the Sustainable Development Goals 3.1 and 3.2, particularly in sub-Saharan ...

    Hannah Brown Amoakoh, Kerstin Klipstein-Grobusch, Mary Amoakoh-Coleman, Irene Akua Agyepong, Gbenga A. Kayode, Charity Sarpong, Diederick E. Grobbee and Evelyn K. Ansah

    Trials 2017 18:157

    Published on: 4 April 2017

  8. Study protocol

    Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial

    Metastatic bone disease is a common and severe complication in patients with advanced cancer. Radiotherapy (RT) has long been established as an effective local treatment for metastatic bone disorder. This stud...

    Stefan Ezechiel Welte, Joachim Wiskemann, Friederike Scharhag-Rosenberger, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Eva Meyerhof, Tanja Sprave, Nils H. Nicolay, Jürgen Debus and Harald Rief

    Trials 2017 18:155

    Published on: 31 March 2017

  9. Research

    Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial

    To evaluate the antiplaque effects of an alcohol-free mouthrinse containing essential oils—Listerine Zero (LZ)—and an alcohol-based essential oils mouthrinse (EO+) compared with a positive control of 0.20% chl...

    Enrico Marchetti, Simona Tecco, Eleonora Caterini, Fabio Casalena, Vincenzo Quinzi, Antonella Mattei and Giuseppe Marzo

    Trials 2017 18:154

    Published on: 31 March 2017

  10. Study protocol

    Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial

    Constipation is common in adults and up to 20% of the population report this symptom. Chronic constipation (CC), usually defined as more than 6 months of symptoms, is less common but results in 0.5 million UK ...

    Christopher Emmett, Helen Close, James Mason, Shiva Taheri, Natasha Stevens, Sandra Eldridge, Christine Norton, Charles Knowles and Yan Yiannakou

    Trials 2017 18:151

    Published on: 31 March 2017

  11. Study protocol

    Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial

    Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. In the ambulatory setting, this practice is particularl...

    Dennis H. Murphree, Theresa N. Kinard, Nandita Khera, Curtis B. Storlie, Che Ngufor, Sudhindra Upadhyaya, Jyotishman Pathak, Emma Fortune, Eapen K. Jacob, Rickey E. Carter, Karl A. Poterack and Daryl J. Kor

    Trials 2017 18:153

    Published on: 31 March 2017

  12. Study protocol

    Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial

    Bacillus Calmette-Guérin (BCG) vaccination may have nonspecific effects, i.e., effects on childhood morbidity and mortality that go beyond its effect on the risk of childhood tuberculosis (TB). Though the avai...

    Victoria Nankabirwa, James K. Tumwine, Olive Namugga, Thorkild Tylleskär, Grace Ndeezi, Bjarne Robberstad, Mihai G. Netea and Halvor Sommerfelt

    Trials 2017 18:152

    Published on: 31 March 2017

  13. Study protocol

    Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial)

    Hyponatremia is the most common electrolyte imbalance encountered in clinical practice, associated with increased mortality and length of hospital stay. However, no high-quality evidence regarding whether hype...

    Anna Lee, You Hwan Jo, Kyuseok Kim, Soyeon Ahn, Yun Kyu Oh, Huijai Lee, Jonghwan Shin, Ho Jun Chin, Ki Young Na, Jung Bok Lee, Seon Ha Baek and Sejoong Kim

    Trials 2017 18:147

    Published on: 29 March 2017

  14. Study protocol

    Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial

    Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring sy...

    Catherine Elizabeth Carr, Julian O’Kelly, Stephen Sandford and Stefan Priebe

    Trials 2017 18:149

    Published on: 29 March 2017

  15. Study protocol

    Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER — Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial

    Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50–80% of these patients and is the term used to describe constipation and faec...

    Doreen McClurg, Kirsteen Goodman, Suzanne Hagen, Fional Harris, Sean Treweek, Anton Emmanuel, Christine Norton, Maureen Coggrave, Selina Doran, John Norrie, Peter Donnan, Helen Mason and Sarkis Manoukian

    Trials 2017 18:150

    Published on: 29 March 2017

  16. Study protocol

    The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial

    The incidence of type 2 diabetes, cardiovascular diseases, and obesity has been rising dramatically; however, their pathogenesis is particularly intriguing. Recently, dysbiosis of the intestinal microbiota has...

    Nazila Kassaian, Ashraf Aminorroaya, Awat Feizi, Parvaneh Jafari and Masoud Amini

    Trials 2017 18:148

    Published on: 29 March 2017

  17. Study protocol

    Cognitive-behavioral rehabilitation vs. treatment as usual for bipolar patients: study protocol for a randomized controlled trial

    Bipolar disorder (BD) is commonly associated with cognitive and functional impairments even during remission periods, and although a growing number of studies have demonstrated the benefits of psychotherapy as...

    Bernardo Carramão Gomes, Cristiana Castanho Rocca, Gabriel Okawa Belizario and Beny Lafer

    Trials 2017 18:142

    Published on: 28 March 2017

  18. Study protocol

    Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial

    Irreversible pulpitis is a highly painful inflammatory condition of the dental pulp which represents a common dental emergency. Recommended care is partial endodontic treatment. The dental literature reports m...

    Olivia Kérourédan, Léonard Jallon, Paul Perez, Christine Germain, Jean-François Péli, Dominique Oriez, Jean-Christophe Fricain, Elise Arrivé and Raphaël Devillard

    Trials 2017 18:141

    Published on: 28 March 2017

  19. Study protocol

    Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial

    Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immu...

    Annelies A. J. Verlaet, Berten Ceulemans, Helene Verhelst, Dirk Van West, Tess De Bruyne, Luc Pieters, Huub F. J. Savelkoul and Nina Hermans

    Trials 2017 18:145

    Published on: 28 March 2017

  20. Research

    An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

    Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient nu...

    Sarah Cockayne, Caroline Fairhurst, Joy Adamson, Catherine Hewitt, Robin Hull, Kate Hicks, Anne-Maree Keenan, Sarah E. Lamb, Lorraine Green, Caroline McIntosh, Hylton B. Menz, Anthony C. Redmond, Sara Rodgers, David J. Torgerson, Wesley Vernon, Judith Watson…

    Trials 2017 18:144

    Published on: 28 March 2017

  21. Study protocol

    Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial

    Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1–2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significan...

    Christine Norton, Anton Emmanuel, Natasha Stevens, S. Mark Scott, Ugo Grossi, Sybil Bannister, Sandra Eldridge, James M. Mason and Charles H. Knowles

    Trials 2017 18:139

    Published on: 24 March 2017

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