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  1. Deviation from the physiological glucocorticoid dynamics (circadian and underlying ultradian rhythmicity) is a common characteristic of various neuropsychiatric and endocrine disorders as well as glucocorticoi...

    Authors: Konstantinos Kalafatakis, Georgina M. Russell, Catherine J. Harmer, Marcus R. Munafo, Nicky Marchant, Aileen Wilson, Jonathan C. W. Brooks, Ngoc J. Thai, Stuart G. Ferguson, Kirsty Stevenson, Claire Durant, Kristin Schmidt and Stafford L. Lightman
    Citation: Trials 2016 17:44
  2. Analysis of trial documentation has revealed that some industry-funded trials may be done more for marketing purposes than scientific endeavour. We aimed to define characteristics of drug trials that appear to...

    Authors: Virginia Barbour, Druin Burch, Fiona Godlee, Carl Heneghan, Richard Lehman, Rafael Perera, Joseph S. Ross and Sara Schroter
    Citation: Trials 2016 17:31
  3. Authors: Dylan R. Morris, Margaret A. Cunningham, Anna A. Ahimastos, Bronwyn A. Kingwell, Elise Pappas, Michael Bourke, Christopher M. Reid, Theo Stijnen, Ronald L. Dalman, Oliver O. Aalami, Jan H. Lindeman, Paul E. Norman, Philip J. Walker, Robert Fitridge, Bernie Bourke, Anthony E. Dear…
    Citation: Trials 2016 17:43

    The original article was published in Trials 2015 16:274

  4. Authors: Toni Zhong, Claire Temple-Oberle, Stefan O. P. Hofer, Brett Beber, John Semple, Mitchell Brown, Sheina Macadam, Peter Lennox, Tony Panzarella, Colleen McCarthy and Nancy Baxter
    Citation: Trials 2016 17:39

    The original article was published in Trials 2013 14:356

  5. Physical exercise reduces glucose levels and glucose variability in patients with type 2 diabetes. Acute inspiratory muscle exercise has been shown to reduce these parameters in a small group of patients with ...

    Authors: ASO Schein, APS Correa, Karina Rabello Casali and Beatriz D. Schaan
    Citation: Trials 2016 17:38
  6. ‘Home-grown’ school feeding programmes are complex interventions with the potential to link the increased demand for school feeding goods and services to community-based stakeholders, including smallholder far...

    Authors: Aulo Gelli, Edoardo Masset, Gloria Folson, Anthoni Kusi, Daniel K. Arhinful, Felix Asante, Irene Ayi, Kwabena M. Bosompem, Kristie Watkins, Lutuf Abdul-Rahman, Rosanna Agble, Getrude Ananse-Baden, Daniel Mumuni, Elisabetta Aurino, Meena Fernandes and Lesley Drake
    Citation: Trials 2016 17:37
  7. Uncorrected refractive errors are the commonest cause of visual impairment in children, with myopia being the most frequent type. Myopia usually starts around 9 years of age and progresses throughout adolescen...

    Authors: Priya Morjaria, Kaushik Murali, Jennifer Evans and Clare Gilbert
    Citation: Trials 2016 17:36
  8. Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitmen...

    Authors: Emily Harrop, John Kelly, Gareth Griffiths, Angela Casbard and Annmarie Nelson
    Citation: Trials 2016 17:35
  9. Approximately 20 % of all patients with colorectal cancer are diagnosed as having Stage IV cancer; 80 % of these present with unresectable metastatic lesions. It is controversial whether chemotherapy with or w...

    Authors: Chang Woo Kim, Jeong-Heum Baek, Gyu-Seog Choi, Chang Sik Yu, Sung Bum Kang, Won Cheol Park, Bong Hwa Lee, Hyeong Rok Kim, Jae Hwan Oh, Jae-Hwang Kim, Seung-Yong Jeong, Jung Bae Ahn and Seung Hyuk Baik
    Citation: Trials 2016 17:34
  10. Childhood obesity is a concern in Australia and across the world. Community-based weight management programs are an important response to address childhood obesity. However, the scientific literature suggests ...

    Authors: Julie Redfern, Gemma Enright, Simon Raadsma, Margaret Allman-Farinelli, Christine Innes-Hughes, Santosh Khanal, Sarah Lukeis, Chris Rissel and Alex Gyani
    Citation: Trials 2016 17:33

    The Erratum to this article has been published in Trials 2016 17:126

  11. The National Institutes of Health (NIH) Health Care Systems Research Collaboratory (NIH Collaboratory) seeks to produce generalizable knowledge about the conduct of pragmatic research in health systems. This a...

    Authors: Karin E. Johnson, Gila Neta, Laura M. Dember, Gloria D. Coronado, Jerry Suls, David A. Chambers, Sean Rundell, David H. Smith, Benmei Liu, Stephen Taplin, Catherine M. Stoney, Margaret M. Farrell and Russell E. Glasgow
    Citation: Trials 2016 17:32
  12. Failure of the pancreatic remnant anastomosis to heal following pancreato-duodenectomy is a major cause of significant and life-threatening complications, notably a post-operative pancreatic fistula. Recently,...

    Authors: Christopher M. Halloran, Kellie Platt, Abbie Gerard, Fotis Polydoros, Derek A. O’Reilly, Dhanwant Gomez, Andrew Smith, John P. Neoptolemos, Zahir Soonwalla, Mark Taylor, Jane M. Blazeby and Paula Ghaneh
    Citation: Trials 2016 17:30
  13. Moderate to severe psoriasis is a systemic inflammatory disease associated with insulin resistance, obesity and type 2 diabetes (T2DM). Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that improves g...

    Authors: Maeve Lynch, Tomás B. Ahern, Irene Timoney, Cheryl Sweeney, Genevieve Kelly, Rosalind Hughes, Anne-Marie Tobin, Donal O’Shea and Brian Kirby
    Citation: Trials 2016 17:29
  14. Loss to follow-up in randomised controlled trials reduces statistical power and increases the potential for bias. Almost half of all trials fail to achieve their follow-up target. Statistical methods have been...

    Authors: Ona McCarthy, Rebecca S. French, Ian Roberts and Caroline Free
    Citation: Trials 2016 17:28

    The Erratum to this article has been published in Trials 2016 17:484

  15. Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to impro...

    Authors: Vichithranie W. Madurasinghe
    Citation: Trials 2016 17:27
  16. Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at a...

    Authors: Jeroan J. Allison, Hoa L. Nguyen, Duc A. Ha, Germán Chiriboga, Ha N. Ly, Hanh T. Tran, Ngoc T. Phan, Nguyen C. Vu, Minjin Kim and Robert J. Goldberg
    Citation: Trials 2016 17:26
  17. Many patients with a psychotic disorder participate poorly in society. When psychotic disorders are in partial remission, feelings of paranoia, delusions of reference, social anxiety and self-stigmatization of...

    Authors: Roos Pot-Kolder, Wim Veling, Chris Geraets and Mark van der Gaag
    Citation: Trials 2016 17:25
  18. The standard treatment pathway for locally advanced rectal cancer is neoadjuvant chemoradiotherapy (CRT) followed by surgery. Neoadjuvant CRT has been shown to decrease physical fitness, and this decrease is a...

    Authors: Lisa Loughney, Malcolm A. West, Graham J. Kemp, Harry B. Rossiter, Shaunna M. Burke, Trevor Cox, Christopher P. Barben, Michael G. Mythen, Peter Calverley, Daniel H. Palmer, Michael P. W. Grocott and Sandy Jack
    Citation: Trials 2016 17:24
  19. Annually, 2.8 million neonatal deaths occur worldwide, despite the fact that three-quarters of them could be prevented if available evidence-based interventions were used. Facilitation of community groups has ...

    Authors: Leif Eriksson, Tran Q. Huy, Duong M. Duc, Katarina Ekholm Selling, Dinh P. Hoa, Nguyen T. Thuy, Nguyen T. Nga, Lars-Åke Persson and Lars Wallin
    Citation: Trials 2016 17:23
  20. By changing the paradigm of neonatal intensive care and integrating parents into the care team, the ‘family integrated care’ (FICare) model developed in Canada ensures that infants receive more consistent care...

    Authors: Mingyan Hei, Xiangyu Gao, Xirong Gao, Shaohan Nong, Aimin Zhang, Qianshen Zhang and Shoo K. Lee
    Citation: Trials 2016 17:22
  21. Therapeutic use of an unauthorised drug (or of an authorised drug for an unauthorised indication) for patients with a life-threating disease is permitted outside a clinical trial as an Expanded Access Programm...

    Authors: Antonella Iudicello, Lucia Alberghini, Giulia Benini and Paola Mosconi
    Citation: Trials 2016 17:21
  22. Long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) are the main malaria prevention interventions in Ethiopia. There is conflicting evidence that the combined application of both interven...

    Authors: Wakgari Deressa, Eskindir Loha, Meshesha Balkew, Alemayehu Hailu, Taye Gari, Oljira Kenea, Hans J. Overgaard, Teshome Gebremichael, Bjarne Robberstad and Bernt Lindtjørn
    Citation: Trials 2016 17:20
  23. The ECRAN (European Communication on Research Awareness Needs) project was initiated in 2012, with support from the European Commission, to improve public knowledge about the importance of independent, multina...

    Authors: Paola Mosconi, Gerd Antes, Giorgio Barbareschi, Amanda Burls, Jacques Demotes-Mainard, Iain Chalmers, Cinzia Colombo, Silvio Garattini, Christian Gluud, Gill Gyte, Catherine Mcllwain, Matt Penfold, Nils Post, Roberto Satolli, Maria Rosa Valetto, Brian West…
    Citation: Trials 2016 17:19
  24. Previous psychological and pharmacological interventions have primarily focused on depression disorders in populations with cardiovascular diseases (CVDs) and the efficacy of anxiety disorder interventions is ...

    Authors: Phillip J. Tully, Deborah A. Turnbull, John D. Horowitz, John F. Beltrame, Terina Selkow, Bernhard T. Baune, Elizabeth Markwick, Shannon Sauer-Zavala, Harald Baumeister, Suzanne Cosh and Gary A. Wittert
    Citation: Trials 2016 17:18
  25. Recruitment to clinical trials can be challenging and slower than anticipated. This prospective patient survey aimed to investigate the proportion of patients approached about a trial who agree to participate,...

    Authors: Sing Yu Moorcraft, Cheryl Marriott, Clare Peckitt, David Cunningham, Ian Chau, Naureen Starling, David Watkins and Sheela Rao
    Citation: Trials 2016 17:17
  26. Children are increasingly being diagnosed with primary hypertension. The absence of comparative effectiveness research of antihypertensive medications in children has contributed to considerable differences in...

    Authors: Joyce P. Samuel, Joshua A. Samuels, Lauren E. Brooks, Cynthia S. Bell, Claudia Pedroza, Donald A. Molony and Jon E. Tyson
    Citation: Trials 2016 17:16
  27. Asthma affects more than 5 million patients in the United Kingdom. Nearly 500,000 of these patients have severe asthma with severe symptoms and frequent exacerbations that are inadequately controlled with avai...

    Authors: Will Storrar, Carole Fogg, Tom Brown, Paddy Dennison, Ly-Mee Yu, Ann Dewey, Ramon Luengo-Fernandez, Tara Dean, Najib Rahman, Adel Mansur, Peter H. Howarth, Peter Bradding and Anoop J. Chauhan
    Citation: Trials 2016 17:15
  28. Laparoscopy training has become an integral part of surgical education. Suturing and knot tying is a basic, yet inherent part of many laparoscopic operations, and should be mastered prior to operating on patie...

    Authors: Jonathan D. Hendrie, Felix Nickel, Thomas Bruckner, Karl-Friedrich Kowalewski, Carly R. Garrow, Maisha Mantel, Philipp Romero and Beat P. Müller-Stich
    Citation: Trials 2016 17:14
  29. Globally, most strokes occur in low- and middle-income countries, such as India, with many affected people having no or limited access to rehabilitation services. Western models of stroke rehabilitation are of...

    Authors: Mohammed Alim, Richard Lindley, Cynthia Felix, Dorcas Beulah Chandramathy Gandhi, Shweta Jain Verma, Deepak Kumar Tugnawat, Anuradha Syrigapu, Craig Stuart Anderson, Ramaprabhu Krishnappa Ramamurthy, Peter Langhorne, Gudlavalleti Venkata Satyanarayana Murthy, Bindiganavale Ramaswamy Shamanna, Maree Lisa Hackett, Pallab Kumar Maulik, Lisa Anne Harvey, Stephen Jan…
    Citation: Trials 2016 17:13
  30. The decision to conduct a randomized controlled trial (RCT) in a field raises ethical as well as scientific issues. From the clinical equipoise literature, future trials are justifiable if there is ”honest, pr...

    Authors: Fiona Webster, Charles Weijer, Laura Todd, Jeremy M. Grimshaw, Andrea P. Marshall, Deborah Cook, Graeme MacLennan, Brian H. Cuthbertson and Jill J. Francis
    Citation: Trials 2016 17:12
  31. Severe limb ischaemia is defined by ischaemic rest/night pain, tissue loss, or both, secondary to arterial insufficiency and is increasingly caused by infra-popliteal (below the knee) disease, mainly as a resu...

    Authors: Matthew A. Popplewell, Huw Davies, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Samir Mehta, Lazaros Andronis, Tracy Roberts, Jon Deeks and Andrew Bradbury
    Citation: Trials 2016 17:11
  32. Epicardial adipose tissue (EAT) is a newly discovered independent risk factor for coronary atherosclerosis. There is a scarcity of information on the reduction of EAT volume to reduce atherosclerosis risk. Cor...

    Authors: Ying Zhou, Feng Tian, Jing Wang, Jun-Jie Yang, Tao Zhang, Jing Jing and Yun-Dai Chen
    Citation: Trials 2016 17:10
  33. The World Health Organization predicts that by 2030 diabetes will be the seventh leading cause of death in the world. Multiple studies have tried to determine if cinnamon is an effective treatment for diabetes...

    Authors: Paul Crawford, Chuong Thai, Joshua Obholz, Jeffrey Schievenin, Mark True, Sachin A. Shah, John Hallgren, Jill Clark and Danny Sharon
    Citation: Trials 2016 17:9
  34. Patients with testicular germ cell cancer (GCC) have a high cure rate; however, cancer-related fatigue is the most common complication among patients with GCC undergoing treatment with chemotherapy. Although e...

    Authors: Antonio Ignacio Cuesta-Vargas, Francisco Carabantes, Zaira Caracuel, Inmaculada Conejo and Emilio Alba
    Citation: Trials 2016 17:8
  35. Pragmatic cluster-randomised trials should seek to make unbiased estimates of effect and be reported according to CONSORT principles, and the study population should be representative of the target population....

    Authors: James R. Hargreaves, Elizabeth Fearon, Calum Davey, Andrew Phillips, Valentina Cambiano and Frances M. Cowan
    Citation: Trials 2016 17:6
  36. Acute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these patients. Wh...

    Authors: Nicolien J. Schepers, Olaf J. Bakker, Marc G. H. Besselink, Thomas L. Bollen, Marcel G. W. Dijkgraaf, Casper H. J. van Eijck, Paul Fockens, Erwin J. M. van Geenen, Janneke van Grinsven, Nora D. L. Hallensleben, Bettina E. Hansen, Hjalmar C. van Santvoort, Robin Timmer, Marie-Paule G. F. Anten, Clemens J. M. Bolwerk, Foke van Delft…
    Citation: Trials 2016 17:5
  37. Mindfulness-based interventions, modified and shortened versions of meditation teachings, have proved to be effective in the improvement of quality of life in many clinical conditions, including chronic diseas...

    Authors: Cesare Cavalera, Francesco Pagnini, Marco Rovaris, Laura Mendozzi, Luigi Pugnetti, Massimo Garegnani and Enrico Molinari
    Citation: Trials 2016 17:4
  38. Knee osteoarthritis (KOA) is a major public health issue causing chronic disability as well as a burden on healthcare resources. In China, a herbal drug tablet has been used as an effective and conventional th...

    Authors: Xue-Wei Cao, Da Guo, Jin-Wen Liu, Wei Niu, Jun Liu, Jian-Ke Pan, Hui Xie, Wen-Wei Ouyang and Ding-Kun Lin
    Citation: Trials 2016 17:3
  39. Erosive lichen planus affecting the vulva (ELPV) is a relatively rare, chronic condition causing painful raw areas in the vulvovaginal region. Symptoms are pain and burning, which impact upon daily living. The...

    Authors: Rosalind C. Simpson, Ruth Murphy, Daniel J. Bratton, Matthew R. Sydes, Sally Wilkes, Helen Nankervis, Shelley Dowey and Kim S. Thomas
    Citation: Trials 2016 17:2
  40. Depression is a global health challenge. Prevention is highlighted as a priority to reduce its prevalence. Although effective preventive interventions exist, the efficacy and coverage can be improved. One prop...

    Authors: Lorna Cook and Edward Watkins
    Citation: Trials 2016 17:1
  41. Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms s...

    Authors: Rachel Stephenson, Sonya Carnell, Nicola Johnson, Robbie Brown, Jennifer Wilkinson, Anthony Mundy, Steven Payne, Nick Watkin, James N’Dow, Andrew Sinclair, Rowland Rees, Stewart Barclay, Jonathan A. Cook, Beatriz Goulao, Graeme MacLennan, Gladys McPherson…
    Citation: Trials 2015 16:600
  42. Childhood anemia is highly prevalent worldwide. Improving the hemoglobin level of preschool age children could yield substantial benefits in cognitive and psychosocial development and overall health. While evi...

    Authors: Arun S. Shet, Merrick Zwarenstein, Maya Mascarenhas, Arvind Risbud, Salla Atkins, Neil Klar and Maria Rosaria Galanti
    Citation: Trials 2015 16:599
  43. The incidence of biliary complications following liver transplantation (LT) remains high, ranging from 10 to 50 % of patients, especially when the diameter of the bile duct is smaller than 7 mm. Biliary recons...

    Authors: Claire Goumard, Marine Cachanado, Astrid Herrero, Géraldine Rousseau, Federica Dondero, Philippe Compagnon, Emmanuel Boleslawski, Jean Yves Mabrut, Ephrem Salamé, Olivier Soubrane, Tabassome Simon and Olivier Scatton
    Citation: Trials 2015 16:598
  44. The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring ...

    Authors: Nicola L. Harman, Elizabeth J. Conroy, Steff C. Lewis, Gordon Murray, John Norrie, Matt R. Sydes, J. Athene Lane, Douglas G. Altman, Colin Baigent, Judith M. Bliss, Marion K. Campbell, Diana Elbourne, Stephen Evans, Peter Sandercock and Carrol Gamble
    Citation: Trials 2015 16:597
  45. Catheter-related bladder discomfort (CRBD) is common in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, we will enroll male patient...

    Authors: Jing-yi Li and Ren Liao
    Citation: Trials 2015 16:596
  46. Depression appears to be more enduring amongst people with intellectual disabilities, suggesting that it is a more chronic problem or more poorly managed in this population. This is not helped by a lack of evi...

    Authors: Andrew Jahoda, Craig Melville, Sally-Ann Cooper, Richard Hastings, Andrew Briggs, Dave Dagnan, Chris Hatton, Alex McConnachie, Chris Williams and Robert S. P. Jones
    Citation: Trials 2015 16:595

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