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  1. Prolonged need for intensive care is associated with neuromuscular weakness, termed Intensive Care Unit Acquired Weakness. Those affected suffer from severe functional impairment that can persist for years. Fi...

    Authors: Sabrina Eggmann, Martin L. Verra, Gere Luder, Jukka Takala and Stephan M. Jakob
    Citation: Trials 2016 17:403
  2. Children with chronic kidney disease (CKD), requiring dialysis or kidney transplantation, have a mortality rate of up to 30-fold higher than the general aged-matched population, and severely impaired quality o...

    Authors: Allison Tong, Susan Samuel, Michael Zappitelli, Allison Dart, Susan Furth, Allison Eddy, Jaap Groothoff, Nicholas J. A. Webb, Hui-Kim Yap, Detlef Bockenhauer, Aditi Sinha, Stephen I. Alexander, Stuart L. Goldstein, Debbie S. Gipson, Camilla S. Hanson, Nicole Evangelidis…
    Citation: Trials 2016 17:401
  3. The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (S...

    Authors: Phyllis J. Goodman, Catherine M. Tangen, Amy K. Darke, Kathryn B. Arnold, JoAnn Hartline, Monica Yee, Karen Anderson, Allison Caban-Holt, William G. Christen, Patricia A. Cassano, Peter Lance, Eric A. Klein, John J. Crowley, Lori M. Minasian and Frank L. Meyskens
    Citation: Trials 2016 17:400
  4. Delirium is a very common and distressing neuropsychiatric syndrome in palliative care. Increasing age, the presence of dementia and advanced cancer are well-known predisposing risk factors for delirium develo...

    Authors: Shirley Harvey Bush, Nathalie Lacaze-Masmonteil, Marie Theresa McNamara-Kilian, Alistair Richard MacDonald, Sallyanne Tierney, Franco Momoli, Meera Agar, David Christopher Currow and Peter Gerard Lawlor
    Citation: Trials 2016 17:399
  5. Tuberous sclerosis complex (TSC) is a genetic disorder affecting about 1 in 6000 people and is characterised by the development of tumours in many organs, including the skin and kidneys, and by a range of neur...

    Authors: Elizabeth Randell, Rachel McNamara, D. Mark Davies, Eleri Owen-Jones, Nigel Kirby, Lianna Angel, Cheney Drew, Rebecca Cannings-John, Michelle Smalley, Anurag Saxena, Emer McDermott, Laura Stockwell, Petrus J. de Vries, Kerry Hood and Julian R. Sampson
    Citation: Trials 2016 17:398
  6. Aging is associated with decreased muscle mass and functional capacity, which in turn decrease quality of life. The number of citizens over the age of 65 years in the Western world will increase by 50 % over t...

    Authors: Rasmus Leidesdorff Bechshøft, Søren Reitelseder, Grith Højfeldt, Josué Leonardo Castro-Mejía, Bekzod Khakimov, Hajar Fauzan Bin Ahmad, Michael Kjær, Søren Balling Engelsen, Susanne Margrete Bølling Johansen, Morten Arendt Rasmussen, Aske Juul Lassen, Tenna Jensen, Nina Beyer, Anja Serena, Frederico Jose Armando Perez-Cueto, Dennis Sandris Nielsen…
    Citation: Trials 2016 17:397
  7. Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on...

    Authors: Jill Russell, Lee Berney, Stephen Stansfeld, Doris Lanz, Sally Kerry, Tarani Chandola and Kamaldeep Bhui
    Citation: Trials 2016 17:396
  8. Some degree of cognitive decline after surgery occurs in as many as one quarter of elderly surgical patients, and this decline is associated with increased morbidity and mortality. Cognition may be affected ac...

    Authors: David R. Skvarc, Olivia M. Dean, Linda K. Byrne, Laura J. Gray, Kathryn Ives, Stephen E. Lane, Matthew Lewis, Cameron Osborne, Richard Page, Douglas Stupart, Alyna Turner, Michael Berk and Andrew J. Marriott
    Citation: Trials 2016 17:395
  9. The indications for a cochlear implant (CI) have been extended to include patients with some residual hearing. Shorter and thinner atraumatic electrodes have been designed to preserve the residual hearing in t...

    Authors: Verena Scheper, Melanie Leifholz, Heiko von der Leyen, Miriam Keller, Ute Denkena, Armin Koch, Annika Karch, Josef Miller and Thomas Lenarz
    Citation: Trials 2016 17:394
  10. Adolescence is a high-risk time for the development of mental health and substance use problems. However, fewer than one in four 16–24 year-olds with a current disorder access health services, with those exper...

    Authors: Dan I. Lubman, Bonita J. Berridge, Fiona Blee, Anthony F. Jorm, Coralie J. Wilson, Nicholas B. Allen, Lisa McKay-Brown, Jenny Proimos, Ali Cheetham and Rory Wolfe
    Citation: Trials 2016 17:393
  11. Vascular cognitive impairment, no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes that fall short of a dementia diagnosis. There is currently no treatment for VCIND. Co...

    Authors: Yi Tang, Zude Zhu, Qing Liu, Fang Li, Jianwei Yang, Fangyu Li, Yi Xing and Jianping Jia
    Citation: Trials 2016 17:392
  12. Warfarin is an oral anticoagulant medication that disrupts the liver’s production of clotting factors. While this medication is highly effective for the prevention of thromboembolic events, it also has a narro...

    Authors: Balraj S. Heran, G. Michael Allan, Lee Green, Christina Korownyk, Michael Kolber, Nicole Olivier, Mary Flesher and Scott Garrison
    Citation: Trials 2016 17:391
  13. Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. How...

    Authors: Yaseen M Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E. A. Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M. Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I. Abdukahil, Lara Y. Afesh…
    Citation: Trials 2016 17:390

    The Erratum to this article has been published in Trials 2016 17:420

  14. Duchenne muscular dystrophy (DMD) is an X-linked recessive disease that affects 1 in 3500–6000 male births. Despite broad research aiming to improve muscle function as well as heart and brain function, suffici...

    Authors: Patricia Hafner, Ulrike Bonati, Daniela Rubino, Vanya Gocheva, Thomas Zumbrunn, Nuri Gueven and Dirk Fischer
    Citation: Trials 2016 17:389
  15. Globally, burns are the fifth leading cause of non-fatal children’s injuries, and the leading cause of childhood burns is hot beverage scalds. Although there have been a number of programmes aimed at preventin...

    Authors: J. D. Burgess, C. M. Cameron, K. Watt and R. M. Kimble
    Citation: Trials 2016 17:388
  16. Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical an...

    Authors: Annet Kleiboer, Jan Smit, Judith Bosmans, Jeroen Ruwaard, Gerhard Andersson, Naira Topooco, Thomas Berger, Tobias Krieger, Cristina Botella, Rosa Baños, Karine Chevreul, Ricardo Araya, Arlinda Cerga-Pashoja, Roman Cieślak, Anna Rogala, Christiaan Vis…
    Citation: Trials 2016 17:387
  17. The OPTI-SCRIPT cluster randomised controlled trial (RCT) found that a three-phase multifaceted intervention including academic detailing with a pharmacist, GP-led medicines reviews, supported by web-based pha...

    Authors: Barbara Clyne, Janine A. Cooper, Carmel M. Hughes, Tom Fahey and Susan M. Smith
    Citation: Trials 2016 17:386
  18. Skin fibrosis is involved in a variety of pathologic conditions ranging from scar formation secondary to surgery or trauma to immune-mediated processes. Skin fibrosis is a significant international health prob...

    Authors: Derek Ho, Ekaterina Kraeva, Ted Wun, R. Rivkah Isseroff and Jared Jagdeo
    Citation: Trials 2016 17:385
  19. Septic shock has a 90-day mortality risk of up to 50 %. The hemodynamic targets, including mean arterial pressure (MAP) are not based on robust clinical data. Both severe hypotension and high doses of vasopres...

    Authors: Ville Pettilä, Tobias Merz, Erika Wilkman, Anders Perner, Sari Karlsson, Theis Lange, Johanna Hästbacka, Peter Buhl Hjortrup, Anne Kuitunen, Stephan M. Jakob and Jukka Takala
    Citation: Trials 2016 17:384
  20. Open globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsati...

    Authors: Jessica W. Lo, Catey Bunce, David Charteris, Philip Banerjee, Rachel Phillips and Victoria R. Cornelius
    Citation: Trials 2016 17:383
  21. Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively re...

    Authors: Simone Regina Posser, Carine Cristina Callegaro, Marina Beltrami-Moreira and Leila Beltrami Moreira
    Citation: Trials 2016 17:382
  22. Muscles get smaller and weaker as we age and become more vulnerable to atrophy when physical activity is reduced or removed. This research is designed to investigate the potentially protective effects of two s...

    Authors: Oliver J. Perkin, Rebecca L. Travers, Javier T. Gonzalez, James E. Turner, Fiona Gillison, Cassie Wilson, Polly M. McGuigan, Dylan Thompson and Keith A. Stokes
    Citation: Trials 2016 17:381
  23. Transcranial direct current stimulation (tDCS) is a promising new technique to optimize the effect of regular Speech and Language Therapy (SLT) in the context of aphasia rehabilitation. The present study focus...

    Authors: Kerstin Spielmann, W. Mieke E. van de Sandt-Koenderman, Majanka H. Heijenbrok-Kal and Gerard M. Ribbers
    Citation: Trials 2016 17:380
  24. Use of antiplatelet therapy shortly before stroke due to spontaneous primary intracerebral haemorrhage (ICH) is associated with higher case fatality in comparison to ICH without prior antithrombotic drug use. ...

    Authors: M. Irem Baharoglu, Rustam Al-Shahi Salman, Charlotte Cordonnier, Rob J. de Haan and Yvo B. W. E. M. Roos
    Citation: Trials 2016 17:379
  25. Morbidity and mortality following initial survival of cardiac arrest remain high despite great efforts to improve resuscitation techniques and post-resuscitation care, in part due to the ischemia-reperfusion i...

    Authors: Anna Sina P. Meyer, Sisse R. Ostrowski, Jesper Kjaergaard, Pär I. Johansson and Christian Hassager
    Citation: Trials 2016 17:378
  26. Probiotics are live microorganisms that may confer health benefits when ingested. Randomized trials suggest that probiotics significantly decrease the incidence of ventilator-associated pneumonia (VAP) and the...

    Authors: Deborah J. Cook, Jennie Johnstone, John C. Marshall, Francois Lauzier, Lehana Thabane, Sangeeta Mehta, Peter M. Dodek, Lauralyn McIntyre, Joe Pagliarello, William Henderson, Robert W. Taylor, Rodrigo Cartin-Ceba, Eyal Golan, Margaret Herridge, Gordon Wood, Daniel Ovakim…
    Citation: Trials 2016 17:377
  27. Patient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a se...

    Authors: Annabelle South, Bec Hanley, Mitzy Gafos, Ben Cromarty, Richard Stephens, Kate Sturgeon, Karen Scott, William J. Cragg, Conor D. Tweed, Jacqueline Teera and Claire L. Vale
    Citation: Trials 2016 17:376

    The Erratum to this article has been published in Trials 2016 17:440

  28. Attention-deficit/hyperactivity disorder (ADHD) is a common neurological disorder affecting 5 % of children worldwide. A prevalent problem for children with ADHD is initial insomnia. The gold standard treatmen...

    Authors: Salima Punja, Catherine J. Nikles, Hugh Senior, Geoffrey Mitchell, Christopher H. Schmid, Helen Heussler, Manisha Witmans and Sunita Vohra
    Citation: Trials 2016 17:375
  29. Early identification of participants at risk of run-in failure (RIF) may present opportunities to improve trial efficiency and generalizability.

    Authors: Judy R. Rees, Leila A. Mott, Elizabeth L. Barry, John A. Baron, Jane C. Figueiredo, Douglas J. Robertson, Robert S. Bresalier and Janet L. Peacock
    Citation: Trials 2016 17:374
  30. Adaptive designs have been increasingly used in the pharmaceutical and device industries, but adoption within the academic setting has been less widespread — particularly for confirmatory phase trials. We soug...

    Authors: William J. Meurer, Laurie Legocki, Samkeliso Mawocha, Shirley M. Frederiksen, Timothy C. Guetterman, William Barsan, Roger Lewis, Donald Berry and Michael Fetters
    Citation: Trials 2016 17:373
  31. The high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventi...

    Authors: Itxaso González-Ortega, Enrique Echeburúa, Adriana García-Alocén, Patricia Vega and Ana González-Pinto
    Citation: Trials 2016 17:372
  32. People with bipolar disorder often show difficulties with cognitive functioning, and though these difficulties are identified as important targets for intervention, few treatment options are available. Prelimi...

    Authors: Rebecca Strawbridge, Jessica Fish, Rozmin Halari, John Hodsoll, Clare Reeder, Karine Macritchie, Paul McCrone, Til Wykes and Allan H. Young
    Citation: Trials 2016 17:371
  33. Dementia is very common in Down syndrome (trisomy 21) adults. Statins may slow brain amyloid β (Aβ, coded on chromosome 21) deposition and, therefore, delay Alzheimer disease onset. One prospective cohort stud...

    Authors: Sally-Ann Cooper, Temitope Ademola, Muriel Caslake, Elizabeth Douglas, Jonathan Evans, Nicola Greenlaw, Caroline Haig, Angela Hassiotis, Andrew Jahoda, Alex McConnachie, Jill Morrison, Howard Ring, John Starr, Ciara Stiles, Chammy Sirisena and Frank Sullivan
    Citation: Trials 2016 17:370
  34. Chronic pain in older people is highly prevalent, often underestimated, and associated with adverse outcomes. Most available analgesic drugs are often either ineffective or not tolerated, with many side effect...

    Authors: Maura Marcucci, Federico Germini, Anna Coerezza, Luca Andreinetti, Lorenzo Bellintani, Alessandro Nobili, Paolo Dionigi Rossi and Daniela Mari
    Citation: Trials 2016 17:369
  35. Women with highly penetrant BRCA mutations have a 55–60 % lifetime risk for breast cancer and a 16–59 % lifetime risk of developing ovarian cancer. However, penetrance differs interindividually, indicating that e...

    Authors: Marion Kiechle, Christoph Engel, Anika Berling, Katrin Hebestreit, Stephan C. Bischoff, Ricarda Dukatz, Michael Siniatchkin, Katharina Pfeifer, Sabine Grill, Maryam Yahiaoui-Doktor, Ellen Kirsch, Uwe Niederberger, Ute Enders, Markus Löffler, Alfons Meindl, Kerstin Rhiem…
    Citation: Trials 2016 17:368
  36. Most positive psychology interventions conducted in the West have been focused on the individual. Family relationships are highly valued in the Chinese collectivist culture, and it is of interest to know wheth...

    Authors: Henry C. Y. Ho, Moses Mui, Alice Wan, Yin-lam Ng, Sunita M. Stewart, Carol Yew, Tai Hing Lam and Sophia S. Chan
    Citation: Trials 2016 17:367
  37. Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses h...

    Authors: Kirsty Roberts, John Macleod, Chris Metcalfe, Joanne Simon, Jeremy Horwood, William Hollingworth, Sharon Marlowe, Fiona H. Gordon, Peter Muir, Barbara Coleman, Peter Vickerman, Graham I. Harrison, Cherry-Ann Waldron, William Irving and Matthew Hickman
    Citation: Trials 2016 17:366
  38. The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared...

    Authors: Áine Aventin, Maria Lohan, Lisa Maguire and Mike Clarke
    Citation: Trials 2016 17:365
  39. This descriptive study aimed to investigate adolescents’ motivations for participating in a randomised controlled trial (RCT), to explore the understanding that the young people had regarding a number of aspec...

    Authors: Nick Midgley, Danny Isaacs, Katharina Weitkamp and Mary Target
    Citation: Trials 2016 17:364
  40. Most women with breast cancer experience a progressive weight gain during and after treatment. Obesity is associated with an increased risk of recurrence, contralateral breast cancer, and death. Physical activ...

    Authors: Patrizia Gnagnarella, Daniele Dragà, Federica Baggi, Maria Claudia Simoncini, Annarita Sabbatini, Ketti Mazzocco, Fabio Domenico Bassi, Gabriella Pravettoni and Patrick Maisonneuve
    Citation: Trials 2016 17:363
  41. Accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Around 10–30 % of young injured children will go on to develop post-traumatic stress disor...

    Authors: Alexandra C. De Young, Ann-Christin Haag, Justin A. Kenardy, Roy M. Kimble and Markus A. Landolt
    Citation: Trials 2016 17:362
  42. A major challenge in treating acute asthma exacerbations is the need to open constricted airways rapidly enough to reestablish ventilation and allow delivery of conventional medication to diseased airways. The...

    Authors: Francis H. Y. Green, Richard Leigh, Morenike Fadayomi, Gurkeet Lalli, Andrea Chiu, Grishma Shrestha, Sharif G. ElShahat, David Evan Nelson, Tamer Y. El Mays, Cora A. Pieron and John H. Dennis
    Citation: Trials 2016 17:361
  43. Gastroschisis research is limited in quality by the presence of significant heterogeneity in outcome measure reporting (PloS One 10(1):e0116908, 2015). Using core outcome sets in research is one proposed metho...

    Authors: Benjamin Allin, Andrew Ross, Sean Marven, Nigel J Hall and Marian Knight
    Citation: Trials 2016 17:360
  44. Tong Luo Hua Shi (TLHS) is a new formulation of the traditional Tibetan medicine Wu-wei-gan-lu that has been used for the treatment of rheumatoid arthritis (RA) for hundreds of years in China. This study aimed...

    Authors: Wei Liu, Yuan-Hao Wu, Si-Yuan Hu, Cheng-Liang Zhong, Ming-Li Gao, Dong-Wu Liu, Hai-Yun Wang, Mu-Zhi Chen, Yue-Jin Song, Ben-Zha-Xi Yang, Qing-Shan Zheng, Hua Yao, Xue-Bing Qi and Gang Li
    Citation: Trials 2016 17:359
  45. In the UK, urinary tract infections (UTIs) are the most common bacterial infection presented by women in primary care. Recurrent urinary tract infections (RUTIs) are defined as three episodes of UTI in the las...

    Authors: Andrew Flower, Kim Harman, George Lewith, Michael Moore, Felicity L. Bishop, Beth Stuart and Nicholas Lampert
    Citation: Trials 2016 17:358
  46. About half of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. More than one-third (37.9 %) of daily smokers have attempted to quit but failed. Nicotine replacement therap...

    Authors: Yee Tak Derek Cheung, Jessica Pui Kei Leung, Chelsia Ka Ching Cheung, William Ho Cheung Li, Man Ping Wang and Tai Hing Lam
    Citation: Trials 2016 17:355
  47. The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but th...

    Authors: Jie-shu You, Jian-ping Chen, Jessie S.M. Chan, Ho-fun Lee, Mei-kuen Wong, Wing-Fai Yeung and Li-xing Lao
    Citation: Trials 2016 17:354
  48. Cognitive behavior therapy for psychosis (CBTp) is an effective intervention for people who hear distressing voices (auditory hallucinations). However, there continues to be a problem of poor access to CBTp. C...

    Authors: Cassie M. Hazell, Mark Hayward, Kate Cavanagh, Anna-Marie Jones and Clara Strauss
    Citation: Trials 2016 17:351
  49. The gut microbiome is increasingly recognized as a contributor to disease states. Patients with type 1 diabetes (DM1) have distinct gut microbiota in comparison to non-diabetic individuals, and it has been lin...

    Authors: Josephine Ho, Raylene A. Reimer, Manpreet Doulla and Carol Huang
    Citation: Trials 2016 17:347

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