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  1. Study protocol

    The Kusamala Program for primary caregivers of children 6–59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial

    Severe acute malnutrition (SAM) is associated with high mortality rates and impairments in growth and development in children that do survive. There are complex nutritional, health, and behavioural risk factor...

    Allison I. Daniel, Meta van den Heuvel, Wieger P. Voskuijl, Melissa Gladstone, Mike Bwanali, Isabel Potani, Celine Bourdon, Jenala Njirammadzi and Robert H. J. Bandsma

    Trials 2017 18:550

    Published on: 17 November 2017

  2. Study protocol

    Trial to Incentivise Adherence for Diabetes (TRIAD): study protocol for a randomised controlled trial

    Many people with diabetes have suboptimal glycaemic control due to not being adherent to their treatment regimen. Behavioural economic theory suggests that the lack of adherence results from the disconnect bet...

    Marcel Bilger, Mitesh Shah, Ngiap Chuan Tan, Kaye Louise Howard, Hui Yan Xu, Ecosse Luc Lamoureux and Eric Andrew Finkelstein

    Trials 2017 18:551

    Published on: 17 November 2017

  3. Study protocol

    Concomitant, sequential, and 7-day triple therapy in first-line treatment of Helicobacter pylori infection in Korea: study protocol for a randomized controlled trial

    Most international guidelines recommend triple-therapy regimens consisting of a proton pump inhibitor, clarithromycin, and amoxicillin/metronidazole for at least 7 days for the eradication of Helicobacter pylori....

    Hyuk Lee, Beom Jin Kim, Sang Gyun Kim, Jin Il Kim, Il Ju Choi, Yong Chan Lee, Jae G. Kim and Jae J. Kim

    Trials 2017 18:549

    Published on: 17 November 2017

  4. Study protocol

    Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial

    Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women—20–25% with severe symptoms. Clinical practice gui...

    Chantale Dumoulin, Mélanie Morin, Marie-Hélène Mayrand, Michel Tousignant and Michal Abrahamowicz

    Trials 2017 18:544

    Published on: 16 November 2017

  5. Study protocol

    Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): study protocol for a randomised controlled trial

    An abdominal aortic aneurysm (AAA) is a focal dilation of the abdominal aorta and is associated with a risk of fatal rupture. Experimental studies suggest that myo-inositol may exert beneficial effects on AAAs...

    Sophie E. Rowbotham, Jenna L. Pinchbeck, Georgina Anderson, Bernie Bourke, Michael Bourke, T. Christian Gasser, Rene Jaeggi, Jason S. Jenkins, Corey S. Moran, Susan K. Morton, Christopher M. Reid, Ramesh Velu, Lisan Yip, Joseph V. Moxon and Jonathan Golledge

    Trials 2017 18:547

    Published on: 16 November 2017

  6. Research

    Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial

    Research in public health emergencies requires trials to be set up in readiness for activation at short notice and in anticipation of limited timelines for patient recruitment. We conducted a simulated activat...

    Wei Shen Lim, Garry Meakin, Clare Brittain, Thomas Bewick and Lelia Duley

    Trials 2017 18:546

    Published on: 16 November 2017

  7. Study protocol

    Allogeneic mesenchymal stem cell as induction therapy to prevent both delayed graft function and acute rejection in deceased donor renal transplantation: study protocol for a randomized controlled trial

    Using kidneys from deceased donors is an available strategy to meet the growing need of grafts. However, higher incidences of delayed graft function (DGF) and acute rejection exert adverse effects on graft out...

    Qipeng Sun, Liangqing Hong, Zhengyu Huang, Ning Na, Xuefeng Hua, Yanwen Peng, Ming Zhao, Ronghua Cao and Qiquan Sun

    Trials 2017 18:545

    Published on: 16 November 2017

  8. Research

    The marketing plan and outcome indicators for recruiting and retaining parents in the HomeStyles randomized controlled trial

    Despite the critical importance of successful recruitment and retention to study integrity, reporting of recruitment and retention strategies along with factors associated with successful recruitment and reten...

    Carol Byrd-Bredbenner, Colleen Delaney, Jennifer Martin-Biggers, Mallory Koenings and Virginia Quick

    Trials 2017 18:540

    Published on: 15 November 2017

  9. Study protocol

    The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs

    Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been dis...

    Maïté Garrouste-Orgeas, Cécile Flahault, Léonor Fasse, Stéphane Ruckly, Nora Amdjar-Badidi, Laurent Argaud, Julio Badie, Amélie Bazire, Naike Bige, Eric Boulet, Lila Bouadma, Cédric Bretonnière, Bernard Floccard, Alain Gaffinel, Xavier de Forceville, Hubert Grand…

    Trials 2017 18:542

    Published on: 15 November 2017

  10. Study protocol

    Preventing enduring behavioural problems in young children through early psychological intervention (Healthy Start, Happy Start): study protocol for a randomized controlled trial

    Behavioural problems are common in early childhood, and can result in enduring costs to the individual and society, including an increased risk of mental and physical illness, criminality, educational failure ...

    Paul G. Ramchandani, Christine O’Farrelly, Daphne Babalis, Marian J. Bakermans-Kranenburg, Sarah Byford, Ellen S. R. Grimas, Jane E. Iles, Marinus H. van IJzendoorn, Julia McGinley, Charlotte M. Phillips, Alan Stein, Jane Warwick, Hillary C. Watt and Stephen Scott

    Trials 2017 18:543

    Published on: 15 November 2017

  11. Study protocol

    Intramuscular oxytocin versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery (LabOR trial): study protocol for a randomised controlled trial

    Primary postpartum haemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. The most common cause of primary PPH is uterine atony. Atonic PPH rates are increasing in develo...

    Nita Adnan, Fiona Boland and Deirdre J. Murphy

    Trials 2017 18:541

    Published on: 15 November 2017

  12. Study protocol

    Trial of Acute Femoral Fracture Fixation (TrAFFix): study protocol for a randomised controlled feasibility trial

    Distal femoral fractures are a source of considerable morbidity and best treatment is currently uncertain. The Trial of Acute Femoral Fracture Fixation (TrAFFix) is a randomised, parallel-group feasibility stu...

    Xavier L. Griffin, Matthew L. Costa, Juul Achten, Melina Dritsaki, Janis Baird and Nicholas Parsons

    Trials 2017 18:538

    Published on: 14 November 2017

  13. Study protocol

    Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial

    The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcom...

    Allison G. Harvey, Lu Dong, Jason Y. Lee, Nicole B. Gumport, Steven D. Hollon, Sophia Rabe-Hesketh, Kerrie Hein, Kirsten Haman, Mary E. McNamara, Claire Weaver, Armando Martinez, Haruka Notsu, Garret Zieve and Courtney C. Armstrong

    Trials 2017 18:539

    Published on: 14 November 2017

  14. Study protocol

    Comparison of the efficacy and safety of FP-1201-lyo (intravenously administered recombinant human interferon beta-1a) and placebo in the treatment of patients with moderate or severe acute respiratory distress syndrome: study protocol for a randomized controlled trial

    Acute respiratory distress syndrome (ARDS) results in vascular leakage, inflammation and respiratory failure. There are currently no approved pharmacological treatments for ARDS and standard of care involves t...

    Geoff Bellingan, David Brealey, Jordi Mancebo, Alain Mercat, Nicolò Patroniti, Ville Pettilä, Michael Quintel, Jean-Louis Vincent, Mikael Maksimow, Markku Jalkanen, Ilse Piippo and V. Marco Ranieri

    Trials 2017 18:536

    Published on: 13 November 2017

  15. Study protocol

    INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial

    Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribu...

    Praveen Sharma, Paul Cockwell, Thomas Dietrich, Charles Ferro, Natalie Ives and Iain L. C. Chapple

    Trials 2017 18:535

    Published on: 13 November 2017

  16. Study protocol

    Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial

    Genital infection with Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection, especially among young women. Mostly asymptomatic, it can lead, if untreated, to pelvic inflammatory ...

    Jeanne Tamarelle, Anne C. M. Thiébaut, Bénédicte Sabin, Cécile Bébéar, Philippe Judlin, Arnaud Fauconnier, Delphine Rahib, Layidé Méaude-Roufai, Jacques Ravel, Servaas A. Morré, Bertille de Barbeyrac and Elisabeth Delarocque-Astagneau

    Trials 2017 18:534

    Published on: 13 November 2017

  17. Study protocol

    Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial

    Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested...

    Jing-Wen Yang, Li-Wen Zhang, Guang-Xia Shi, Yi Du, Jun Wang, Jing-Jie Zhao, Yan Cao, Jian-Feng Tu, Shuai Zhang, Cheng Tan, San-San Chen and Cun-Zhi Liu

    Trials 2017 18:537

    Published on: 13 November 2017

  18. Research

    Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains

    There continues to be debate about what constitutes a pragmatic trial and how it is distinguished from more traditional explanatory trials. The NIH Pragmatic Trials Collaborative Project, which includes five t...

    Paula Darby Lipman, Kirsty Loudon, Leanora Dluzak, Rachael Moloney, Donna Messner and Catherine M. Stoney

    Trials 2017 18:532

    Published on: 10 November 2017

  19. Study protocol

    Adjunctive use of physostigmine salicylate (Anticholium®) in perioperative sepsis and septic shock: study protocol for a randomized, double-blind, placebo-controlled, monocentric trial (Anticholium® per Se)

    Severe sepsis and septic shock remain a major challenge, even in modern intensive care. In Germany, about 68,000 patients die annually because of septic diseases, characterized by a complex systemic inflammato...

    Johannes B. Zimmermann, Nadine Pinder, Thomas Bruckner, Monika Lehmann, Johann Motsch, Thorsten Brenner, Torsten Hoppe-Tichy, Stefanie Swoboda, Markus A. Weigand and Stefan Hofer

    Trials 2017 18:530

    Published on: 10 November 2017

  20. Study protocol

    Platelet inhibition during ticagrelor monotherapy versus ticagrelor plus aspirin in patients with coronary artery disease (TEMPLATE study): study protocol for a randomised controlled trial

    Dual antiplatelet therapy (DAPT) with aspirin (ASP) and a P2Y12 blocker is currently standard care after percutaneous coronary intervention (PCI) with stent insertion, and aims to inhibit platelet function in ord...

    Sarah Baos, Wendy Underwood, Lucy Culliford, Barnaby C. Reeves, Chris A. Rogers, Ruth Bowles, Tom Johnson, Andreas Baumbach and Andrew Mumford

    Trials 2017 18:529

    Published on: 9 November 2017

  21. Study protocol

    Efficacy of Banha-sasim-tang on functional dyspepsia classified as excess pattern: study protocol for a randomized controlled trial

    Functional dyspepsia (FD) refers to the presence of one or more gastrointestinal symptoms including postprandial fullness, epigastric pain, burning, and early satiety without an organic explanation for chronic...

    Yun Hee Kim, Jun Young Kim, So Young Jung, O-Jin Kwon, Jun-Hwan Lee and Chang-Gue Son

    Trials 2017 18:525

    Published on: 9 November 2017

  22. Study protocol

    A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol

    The at-risk mental state (ARMS) describes individuals at high risk of developing schizophrenia or psychosis. The use of antipsychotics in this population is not supported, because most individuals with ARMS ar...

    Inti Qurashi, Imran B. Chaudhry, Ameer B. Khoso, Sana Farooque, Steve Lane, Mohammad Omair Husain, Simon Chu, Jane Sarginson, Munir Hamarani, Haider A. Naqvi, Bushra Razzaque, Fareed A. Minhas, Alison R. Yung, J. F. W. Deakin and Nusrat Husain

    Trials 2017 18:524

    Published on: 9 November 2017

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