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  1. Trial research has predominantly focused on patient and staff understandings of trial concepts and/or motivations for taking part, rather than why treatment recommendations may or may not be followed during tr...

    Authors: Julia Lawton, Nicholas Jenkins, Julie L Darbyshire, Rury R Holman, Andrew J Farmer and Nina Hallowell

    Citation: Trials 2011 12:108

    Content type: Research

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  2. Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae. Metabolic syndrome (MetS) comprises a constellation of factors that increas...

    Authors: Alison J Dunkley, Melanie J Davies, Margaret A Stone, Nicholas A Taub, Jacqui Troughton, Thomas Yates and Kamlesh Khunti

    Citation: Trials 2011 12:107

    Content type: Research

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  3. Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both ...

    Authors: Jennifer Schumi and Janet T Wittes

    Citation: Trials 2011 12:106

    Content type: Review

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  4. Depression occurs in up to 50% of patients after stroke and limits rehabilitation and recovery. Mood disorders are also highly prevalent in carers; their mental health intertwined with the physical and mental ...

    Authors: Richard J Gray, Phyo K Myint, Frances Elender, Garry Barton, Michael Pfeil, Gill Price, Niki Wyatt, Garth Ravenhill, Ester Thomas, Jenny Jagger, Amelia Hursey, Kelly Waterfield and Sheila Hardy

    Citation: Trials 2011 12:105

    Content type: Study protocol

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  5. Prospective meta-analysis (PMA) is a collaborative research design in which individual sites perform randomized controlled trials (RCTs) and pool the data for meta-analysis. Members of the PMA collaboration ag...

    Authors: David K Turok, Eve Espey, Alison B Edelman, Pamela S Lotke, Eva H Lathrop, Stephanie B Teal, Janet C Jacobson, Sara E Simonsen and Kenneth F Schulz

    Citation: Trials 2011 12:104

    Content type: Methodology

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  6. Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent ...

    Authors: Irene Bachmann-Mettler, Claudia Steurer-Stey, Oliver Senn, Mathyas Wang, Katarina Bardheci and Thomas Rosemann

    Citation: Trials 2011 12:103

    Content type: Study protocol

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  7. We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, ...

    Authors: Alain B Labrique, Parul Christian, Rolf DW Klemm, Mahbubur Rashid, Abu Ahmed Shamim, Allan Massie, Kerry Schulze, Andre Hackman and Keith P West Jr

    Citation: Trials 2011 12:102

    Content type: Methodology

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  8. We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of ...

    Authors: Peter AG Sandercock, Maciej Niewada and Anna Członkowska

    Citation: Trials 2011 12:101

    Content type: Research

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    The Erratum to this article has been published in Trials 2012 13:24

  9. The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing...

    Authors: Charles Weijer, Jeremy M Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie C Brehaut, Allan Donner, Martin P Eccles, Antonio Gallo, Andrew D McRae, Raphael Saginur and Merrick Zwarenstein

    Citation: Trials 2011 12:100

    Content type: Research

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  10. Oropharyngeal candidasis is a common opportunistic infection seen in immunocompromised patients. Fluconazole has a broad spectrum antifungal activity including a wide variety of candida species. Aim of the presen...

    Authors: Harish M Nairy, Narayana R Charyulu, Veena A Shetty and Prabhu Prabhakara

    Citation: Trials 2011 12:99

    Content type: Research

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  11. The CONSORT Statement was developed to help authors improve the quality of reporting randomized trials. To augment the statement we published the CONSORT explanation and elaboration paper which included at lea...

    Authors: David Moher, Sally Hopewell, Kenneth F Schulz and Douglas G Altman

    Citation: Trials 2011 12:98

    Content type: Editorial

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  12. Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH). High intak...

    Authors: Christopher E Ramsden, J Douglas Mann, Keturah R Faurot, Chanee Lynch, Syed Taha Imam, Beth A MacIntosh, Joseph R Hibbeln, James Loewke, Sunyata Smith, Rebecca Coble, Chirayath Suchindran and Susan A Gaylord

    Citation: Trials 2011 12:97

    Content type: Study protocol

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  13. Several studies have showed that people with intellectual disabilities (ID) have suitable skills to undergo cognitive behavioural therapy (CBT). Case studies have reported successful use of cognitive behaviour...

    Authors: Angela Hassiotis, Marc Serfaty, Kiran Azam, Andre Strydom, Sue Martin, Charles Parkes, Robert Blizard and Michael King

    Citation: Trials 2011 12:95

    Content type: Study protocol

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  14. Acute lower respiratory infections are the commonest cause of morbidity and potentially preventable mortality in Indigenous infants. Infancy is also a critical time for post-natal lung growth and development. ...

    Authors: Anne B Chang, Keith Grimwood, Andrew V White, Carolyn Maclennan, Theo P Sloots, Alan Sive, Gabrielle B McCallum, Ian M Mackay and Peter S Morris

    Citation: Trials 2011 12:94

    Content type: Study protocol

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  15. The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment opti...

    Authors: Cristina Firanescu, Paul NM Lohle, Jolanda de Vries, Caroline A Klazen, Job R Juttmann, William Clark and Willem Jan van Rooij

    Citation: Trials 2011 12:93

    Content type: Study protocol

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  16. The effects of variations in exercise training on Left ventricular (LV) remodeling in patients shortly after Myocardial Infarction (MI) are important but poorly understood.

    Authors: Mark Haykowsky, Jessica Scott, Ben Esch, Don Schopflocher, Jonathan Myers, Ian Paterson, Darren Warburton, Lee Jones and Alexander M Clark

    Citation: Trials 2011 12:92

    Content type: Research

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  17. Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/...

    Authors: Ildikó Gágyor, Jutta Bleidorn, Karl Wegscheider, Eva Hummers-Pradier and Michael M Kochen

    Citation: Trials 2011 12:91

    Content type: Research

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  18. Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost...

    Authors: Richard G Kyle, Bill Culbard, Josie Evans, Nicola M Gray, Dolapo Ayansina and Gill Hubbard

    Citation: Trials 2011 12:89

    Content type: Study protocol

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  19. Postnatal depression (PND) can be experienced by 13% of women who give birth, and such women often exhibit disabling symptoms, which can have a negative effect on the mother and infant relationship, with signi...

    Authors: Isabela Caramlau, Jane Barlow, Sukhdev Sembi, Kirstie McKenzie-McHarg and Chris McCabe

    Citation: Trials 2011 12:88

    Content type: Study protocol

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  20. In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the ...

    Authors: Ling Zhao, Fu-wen Zhang, Ying Li, Xi Wu, Hui Zheng, Lin-hao Cheng and Fan-rong Liang

    Citation: Trials 2011 12:87

    Content type: Research

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  21. Data from a randomized multinational phase 3 trial of 320 adults with acute myeloid leukemia (AML) demonstrated that maintenance therapy with 3-week cycles of histamine dihydrochloride plus low-dose interleuki...

    Authors: Marc Buyse, Pierre Squifflet, Kathryn J Lucchesi, Mats L Brune, Sylvie Castaigne and Jacob M Rowe

    Citation: Trials 2011 12:86

    Content type: Research

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  22. A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limit...

    Authors: Christian Ohmann, Wolfgang Kuchinke, Steve Canham, Jens Lauritsen, Nader Salas, Carmen Schade-Brittinger, Michael Wittenberg, Gladys McPherson, John McCourt, Francois Gueyffier, Andrea Lorimer and Ferràn Torres

    Citation: Trials 2011 12:85

    Content type: Research

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  23. Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed re...

    Authors: Christoph Bartl, Dirk Stengel, Thomas Bruckner, Inga Rossion, Steffen Luntz, Christoph Seiler and Florian Gebhard

    Citation: Trials 2011 12:84

    Content type: Study protocol

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  24. In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been sug...

    Authors: Kyu Seok Kim and Yoon-Bum Kim

    Citation: Trials 2011 12:82

    Content type: Study protocol

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  25. The pace of novel medical treatments and approaches to therapy has accelerated in recent years. Unfortunately, many potential therapeutic advances do not fulfil their promise when subjected to randomized contr...

    Authors: Patrick Royston, Friederike M-S Barthel, Mahesh KB Parmar, Babak Choodari-Oskooei and Valerie Isham

    Citation: Trials 2011 12:81

    Content type: Research

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  26. The environmental impact of research increasingly needs to be taken into account in design and execution. This makes good financial sense. However, it is especially in the research world as one of the key reas...

    Authors: David C Pencheon

    Citation: Trials 2011 12:80

    Content type: Commentary

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  27. Acute lung injury complicates approximately 25-30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with beta agonists may prevent the development of acute lung injury by decr...

    Authors: Gavin D Perkins, Daniel Park, Derek Alderson, Matthew W Cooke, Fang Gao, Simon Gates, Sarah E Lamb, Dipesh Mistry and David R Thickett

    Citation: Trials 2011 12:79

    Content type: Study protocol

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  28. Recruitment to randomised controlled trials (RCTs) with very different treatment arms is often difficult. The ProtecT (Prostate testing for cancer and Treatment) study successfully used qualitative research me...

    Authors: Sangeetha Paramasivan, Robert Huddart, Emma Hall, Rebecca Lewis, Alison Birtle and Jenny L Donovan

    Citation: Trials 2011 12:78

    Content type: Research

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  29. The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant) is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxet...

    Authors: Tracey W Tsang, Michael R Kohn, Daniel F Hermens, Simon D Clarke, C Richard Clark, Daryl Efron, Noel Cranswick, Chris Lamb and Leanne M Williams

    Citation: Trials 2011 12:77

    Content type: Methodology

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  30. The prevalence of mental illness in young people is the highest of any age group, with the onset of depression, anxiety and substance use peaking between 18 and 24 years. Effective treatments that target sub-t...

    Authors: Alexandra G Parker, Sarah E Hetrick, Anthony F Jorm, Alison R Yung, Patrick D McGorry, Andrew Mackinnon, Bridget Moller and Rosemary Purcell

    Citation: Trials 2011 12:76

    Content type: Study protocol

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  31. Internet based self-help for panic disorder (PD) has proven to be effective. However, studies so far have focussed on treating a full-blown disorder. Panic symptoms that do not meet DSM-IV criteria are more pr...

    Authors: Wouter van Ballegooijen, Heleen Riper, Annemieke van Straten, Jeannet Kramer, Barbara Conijn and Pim Cuijpers

    Citation: Trials 2011 12:75

    Content type: Study protocol

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  32. Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently li...

    Authors: Alison M McDonald, Shaun Treweek, Haleema Shakur, Caroline Free, Rosemary Knight, Chris Speed and Marion K Campbell

    Citation: Trials 2011 12:74

    Content type: Review

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  33. In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the ...

    Authors: Olaf J Bakker, Hjalmar C van Santvoort, Sandra van Brunschot, Usama Ahmed Ali, Marc G Besselink, Marja A Boermeester, Thomas L Bollen, Koop Bosscha, Menno A Brink, Cornelis H Dejong, Erwin J van Geenen, Harry van Goor, Joos Heisterkamp, Alexander P Houdijk, Jeroen M Jansen, Thom M Karsten…

    Citation: Trials 2011 12:73

    Content type: Study protocol

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  34. The Danish OPUS I trial randomized 547 patients with first-episode psychosis to a two-year early-specialised assertive treatment programme (OPUS) versus standard treatment. The two years OPUS treatment had sig...

    Authors: Marianne Melau, Pia Jeppesen, Anne Thorup, Mette Bertelsen, Lone Petersen, Christian Gluud, Gertrud Krarup and Merete Nordentoft

    Citation: Trials 2011 12:72

    Content type: Study protocol

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  35. Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed t...

    Authors: Hyo-Jung Kwon, Jong-In Kim, Myeong Soo Lee, Jun-Yong Choi, Sungkeel Kang, Jie-Yoon Chung, Young-Jin Kim, Seung-Hoon Lee, Sanghoon Lee, Dongwoo Nam, Yong-Suk Kim, Jae-Dong Lee and Do-Young Choi

    Citation: Trials 2011 12:71

    Content type: Study protocol

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  36. Swine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more s...

    Authors: Karen EA Burns, Clarence Chant, Orla Smith, Brian Cuthbertson, Robert Fowler, Deborah J Cook, Peter Kruger, Steve Webb, Jamal Alhashemi, Guillermo Dominguez-Cherit, Carlos Zala, Gordon D Rubenfeld and John C Marshall

    Citation: Trials 2011 12:70

    Content type: Study protocol

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  37. It has been suggested that the use of adjunctive hyperbaric oxygen therapy improves the healing of diabetic foot ulcers, and decreases the risk of lower extremity amputations. A limited number of studies have ...

    Authors: Daria O'Reilly, Ron Linden, Ludwik Fedorko, Jean-Eric Tarride, Wilhelmine Giffening Jones, James M Bowen and Ron Goeree

    Citation: Trials 2011 12:69

    Content type: Study protocol

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  38. It is known that repetitive, skilled, functional movement is beneficial in driving functional reorganisation of the brain early after stroke. This study will investigate a) whether pedalling an upright, static...

    Authors: Nicola J Hancock, Lee Shepstone, Philip Rowe, Phyo Kyaw Myint and Valerie Pomeroy

    Citation: Trials 2011 12:68

    Content type: Study protocol

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  39. Young women in sub-Saharan Africa bear a disproportionate burden of HIV infection compared to men but have limited options to reduce their HIV risk. Microbicides could fill an important HIV prevention gap for ...

    Authors: Quarraisha Abdool Karim, Ayesha BM Kharsany, Janet A Frohlich, Cheryl Baxter, Nonhlanhla Yende, Leila E Mansoor, Koleka P Mlisana, Silvia Maarschalk, Natasha Arulappan, Anneke Grobler, Sengeziwe Sibeko, Zaheen Omar, Tanuja N Gengiah, Mukelisiwe Mlotshwa, Natasha Samsunder and Salim S Abdool Karim

    Citation: Trials 2011 12:67

    Content type: Research

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  40. AmBisome® is an efficacious, safe anti-leishmanial treatment. There is growing interest in its use, either as a single dose or in combination treatments. In East Africa, the minimum optimal single-dosage has not ...

    Authors: Tansy Edwards, Raymond Omollo, Eltahir AG Khalil, Sisay Yifru, Brima Musa, Ahmed Musa, Monique Wasunna, Peter G Smith, Catherine Royce, Sally Ellis, Manica Balasegaram and Asrat Hailu

    Citation: Trials 2011 12:66

    Content type: Study protocol

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  41. Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to...

    Authors: Flávio D Fuchs, Sandra C Fuchs, Leila B Moreira, Miguel Gus, Antônio C Nóbrega, Carlos E Poli-de-Figueiredo, Décio Mion, Luiz Bortoloto, Fernanda Consolim-Colombo, Fernando Nobre, Eduardo Barbosa Coelho, José F Vilela-Martin, Heitor Moreno Jr, Evandro José Cesarino, Roberto Franco, Andréa Araujo Brandão…

    Citation: Trials 2011 12:65

    Content type: Study protocol

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  42. The trial on endovascular management of unruptured intracranial aneurysms (TEAM), a prospective randomized trial comparing coiling and conservative management, initiated in September 2006, was stopped in June ...

    Authors: Jean Raymond, Tim E Darsaut and Andrew J Molyneux

    Citation: Trials 2011 12:64

    Content type: Research

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  43. Chronic heart failure (CHF) is a chronic debilitating condition with economic consequences, mostly because of frequent hospitalisations. Physical activity and adequate self-management capacity are important ri...

    Authors: Hui Y Du, Phillip J Newton, Robert Zecchin, Robert Denniss, Yenna Salamonson, Bronwyn Everett, David C Currow, Peter S Macdonald and Patricia M Davidson

    Citation: Trials 2011 12:63

    Content type: Study protocol

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  44. No treatments are currently available that slow, stop, or reverse disease progression in established multiple sclerosis (MS). The Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) trial tests the safety an...

    Authors: Peter Connick, Madhan Kolappan, Rickie Patani, Michael A Scott, Charles Crawley, Xiao-Ling He, Karen Richardson, Kelly Barber, Daniel J Webber, Claudia AM Wheeler-Kingshott, Daniel J Tozer, Rebecca S Samson, David L Thomas, Ming-Qing Du, Shi L Luan, Andrew W Michell…

    Citation: Trials 2011 12:62

    Content type: Methodology

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  45. Participants in trials evaluating preventive interventions such as screening are on average healthier than the general population. To decrease this 'healthy volunteer effect' (HVE) women were randomly invited ...

    Authors: Matthew Burnell, Aleksandra Gentry-Maharaj, Andy Ryan, Sophia Apostolidou, Mariam Habib, Jatinderpal Kalsi, Steven Skates, Mahesh Parmar, Mourad W Seif, Nazar N Amso, Keith Godfrey, David Oram, Jonathan Herod, Karin Williamson, Howard Jenkins, Tim Mould…

    Citation: Trials 2011 12:61

    Content type: Research

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  46. Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponso...

    Authors: Alessandro Montedori, Maria Isabella Bonacini, Giovanni Casazza, Maria Laura Luchetta, Piergiorgio Duca, Francesco Cozzolino and Iosief Abraha

    Citation: Trials 2011 12:58

    Content type: Research

    Published on:

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