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  1. Randomised controlled trials are being increasingly used to evaluate new surgical interventions. There are a number of problematic methodological issues specific to surgical trials, the most important being id...

    Authors: Nicholas R Parsons, Yuri Kulikov, Alan Girling and Damian Griffin

    Citation: Trials 2011 12:258

    Content type: Methodology

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  2. Respiratory distress syndrome remains a significant problem among premature infants. Mechanical ventilation through an endotracheal tube remains the mainstay of respiratory support but may be associated with l...

    Authors: Suresh Victor

    Citation: Trials 2011 12:257

    Content type: Study protocol

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  3. There is a need for improvement of information provision and post-treatment care for cancer survivors. A Survivorship Care Plan (SCP) is recommended by the American Institute of Medicine and the Dutch Health C...

    Authors: Lonneke V van de Poll-Franse, Kim AH Nicolaije, Maria C Vos, Johanna MA Pijnenborg, Dorry Boll, Olga Husson, Nicole PM Ezendam, Erik A Boss, Ralph HM Hermans, Karin CM Engelhart, Joke E Haartsen, Brenda M Pijlman, Harrie WH Feijen, Helena JMM Mertens, Willem E Nolting, Johannes J van Beek…

    Citation: Trials 2011 12:256

    Content type: Study protocol

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  4. The treatment results of external beam radiotherapy for intermediate and high risk prostate cancer patients are insufficient with five-year biochemical relapse rates of approximately 35%. Several randomized tr...

    Authors: Irene M Lips, Uulke A van der Heide, Karin Haustermans, Emile NJT van Lin, Floris Pos, Stefan PG Franken, Alexis NTJ Kotte, Carla H van Gils and Marco van Vulpen

    Citation: Trials 2011 12:255

    Content type: Study protocol

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  5. There are a number of gaps in the evidence base for the use of ankle-foot orthoses for stroke patients. Three dimensional motion analysis offers an ideal method for objectively obtaining biomechanical gait dat...

    Authors: Bruce Carse, Roy J Bowers, Barry C Meadows and Philip J Rowe

    Citation: Trials 2011 12:254

    Content type: Study protocol

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  6. Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information repo...

    Authors: Sally Hopewell, Allison Hirst, Gary S Collins, Sue Mallett, Ly-Mee Yu and Douglas G Altman

    Citation: Trials 2011 12:253

    Content type: Research

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  7. Intravenous recombinant tissue plasminogen activator (rtPA) is approved in Europe for use in patients with acute ischaemic stroke who meet strictly defined criteria. IST-3 sought to improve the external validi...

    Authors: Peter Sandercock, Richard Lindley, Joanna Wardlaw, Martin Dennis, Karen Innes, Geoff Cohen, Will Whiteley, David Perry, Vera Soosay, David Buchanan, Graham Venables, Anna Czlonkowska, Adam Kobayashi, Eivind Berge, Karsten Bruins Slot, Veronica Murray…

    Citation: Trials 2011 12:252

    Content type: Update

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  8. Pharmacological intervention is essential for managing the symptoms of Parkinson's disease. Adherence to medication regimens however is a major problem. Poor adherence leads to significant motor deterioration ...

    Authors: David J Daley, Katherine HO Deane, Richard J Gray, Paul F Worth, Allan B Clark, Kanagasabesan Sabanathan, Michael Pfeil and Phyo K Myint

    Citation: Trials 2011 12:251

    Content type: Study protocol

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  9. Parkinson's Disease is a degenerative neurological condition that causes movement problems and other distressing symptoms. People with Parkinson's disease gradually lose their independence and strain is placed...

    Authors: Heather Gage, Sharlene Ting, Peter Williams, Karen Bryan, Julie Kaye, Beverly Castleton, Patrick Trend and Derick Wade

    Citation: Trials 2011 12:250

    Content type: Study protocol

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  10. Angiotensin-converting enzyme inhibitors and the angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI). Based on previous clinical trials, a maximum clinical...

    Authors: Young-Rak Cho, Young-Dae Kim, Tae-Ho Park, Kyungil Park, Jong-Sung Park, Heekyung Baek, Sun-Young Choi, Kee-Sik Kim, Taek-Jong Hong, Tae-Hyun Yang, Jin-Yong Hwang, Jong-Seon Park, Seung-Ho Hur and Sang-Gon Lee

    Citation: Trials 2011 12:247

    Content type: Study protocol

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  11. Polycystic liver disease (PLD) is defined as having more than 20 liver cysts and can present as a severe and disabling condition. Most symptoms are caused by the mass effect of the liver size and include abdom...

    Authors: Melissa Chrispijn and Joost PH Drenth

    Citation: Trials 2011 12:246

    Content type: Study protocol

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  12. Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been sug...

    Authors: Ulrike Heger, Sabine Voss, Phillip Knebel, Colette Doerr-Harim, Jens Neudecker, Christoph Schuhmacher, Eugen Faist, Markus K Diener, Meinhard Kieser, Christoph M Seiler and Markus W Büchler

    Citation: Trials 2011 12:245

    Content type: Study protocol

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  13. Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have side effects and poor adherence. Qigong has bee...

    Authors: Ji-Eun Park, Yan Liu, Taeseob Park, Sanghoon Hong, Jung-Eun Kim, Tae-Hun Kim, Ae-Ran Kim, So-Young Jung, Hyoju Park and Sun-Mi Choi

    Citation: Trials 2011 12:244

    Content type: Study protocol

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  14. In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway the greater saphenous vein continues to be the most commonly used bypas...

    Authors: Antonio Campanella, Laura Bergamasco, Luigia Macri, Sofia Asioli, Roger Devotini, Serenella Scipioni, Silvana Barbaro, Pietro Rispoli and Mauro Rinaldi

    Citation: Trials 2011 12:243

    Content type: Study protocol

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  15. The childhood obesity epidemic is one of the foremost UK health priorities. Childhood obesity tracks into adult life and places individuals at considerable risk for diabetes, cardiovascular disease, liver dise...

    Authors: Deborah Christie, Lee Hudson, Anne Mathiot, Tim J Cole, Saffron Karlsen, Anthony Kessel, Sanjay Kinra, Steve Morris, Irwin Nazareth, Ulla Sovio, Ian CK Wong and Russell M Viner

    Citation: Trials 2011 12:242

    Content type: Study protocol

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  16. Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practic...

    Authors: Marc Cohen, Shefton Parker, David Taylor, De Villiers Smit, Michael Ben-Meir, Peter Cameron and Charlie Xue

    Citation: Trials 2011 12:241

    Content type: Study protocol

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  17. Myocardial infarction causes irreversible loss of cardiomyocytes and may lead to loss of ventricular function, morbidity and mortality. Infarct size is a major prognostic factor and reduction of infarct size h...

    Authors: Martijn Scholte, Leo Timmers, Flip JP Bernink, Robert N Denham, Aernout M Beek, Otto Kamp, Michaela Diamant, Anton JG Horrevoets, Hans WM Niessen, Weena JY Chen, Albert C van Rossum, Niels van Royen, Pieter A Doevendans and Yolande Appelman

    Citation: Trials 2011 12:240

    Content type: Study protocol

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  18. Bacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation.

    Authors: Leticia Krauss-Silva, Maria Elizabeth L Moreira, Mariane B Alves, Alcione Braga, Karla G Camacho, Maria Rosa R Batista, Antonio Almada-Horta, Maria R Rebello and Fernando Guerra

    Citation: Trials 2011 12:239

    Content type: Research

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  19. Russia has particularly low life expectancy for an industrialised country, with mortality at working ages having fluctuated dramatically over the past few decades, particularly among men. Alcohol has been iden...

    Authors: Elizabeth Allen, Olga Polikina, Lyudmila Saburova, Jim McCambridge, Diana Elbourne, Sergey Pakriev, Nadezhda Nekrasova, Maxim Vasilyev, Keith Tomlin, Alexey Oralov, Artyom Gil, Martin McKee, Nikolay Kiryanov and David A Leon

    Citation: Trials 2011 12:238

    Content type: Research

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  20. Progress towards MDG4 in South Africa will depend largely on scaling up effective prevention against mother to child transmission (PMTCT) of HIV and also addressing neonatal mortality. This imperative drives i...

    Authors: Mark Tomlinson, Tanya Doherty, Debra Jackson, Joy E Lawn, Petrida Ijumba, Mark Colvin, Lungiswa Nkonki, Emmanuelle Daviaud, Ameena Goga, David Sanders, Carl Lombard, Lars Åke Persson, Thoko Ndaba, Gail Snetro and Mickey Chopra

    Citation: Trials 2011 12:236

    Content type: Study protocol

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  21. Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sha...

    Authors: Bruce F Walker, Barrett Losco, Brenton R Clarke, Jeff Hebert, Simon French and Norman J Stomski

    Citation: Trials 2011 12:235

    Content type: Study protocol

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  22. Early graft dysfunction due to preservation/reperfusion injury represents a dramatic event after liver transplantation. Enhancement of donor organ criteria, in order to cope with the ever increasing donor shor...

    Authors: Thomas Minor, Carolin Pütter, Anja Gallinat, Claudia Ose, Gernot Kaiser, Andre Scherag, Jürgen Treckmann and Andreas Paul

    Citation: Trials 2011 12:234

    Content type: Study protocol

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  23. Large clinical trials databases, developed over the course of a comprehensive clinical trial programme, represent an invaluable resource for clinical researchers. Data mining projects sponsored by industry tha...

    Authors: Roy Jones, David Wilkinson, Oscar L Lopez, Jeffrey Cummings, Gunhild Waldemar, Richard Zhang, Joan Mackell and Serge Gauthier

    Citation: Trials 2011 12:233

    Content type: Research

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  24. Shared Decision Making (SDM) is regarded as the best practice model for the communicative challenge of decision making about treatment or diagnostic options. However, randomized controlled trials focusing the ...

    Authors: Friedemann Geiger, Katrin Liethmann, Frauke Hoffmann, Jutta Paschedag and Jürgen Kasper

    Citation: Trials 2011 12:232

    Content type: Study protocol

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  25. An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts f...

    Authors: Leonard E Egede, Joni L Strom, Jyotika Fernandes, Rebecca G Knapp and Adebola Rojugbokan

    Citation: Trials 2011 12:231

    Content type: Study protocol

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  26. Current treatments for Alzheimer's disease and related disorders (ADRD) are symptomatic and can only temporarily slow down ADRD. Future possibilities of care rely on multi-target drugs therapies that address s...

    Authors: Cédric Annweiler, Bruno Fantino, Elsa Parot-Schinkel, Samuel Thiery, Jennifer Gautier and Olivier Beauchet

    Citation: Trials 2011 12:230

    Content type: Study protocol

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  27. Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the l...

    Authors: Anne M Eskes, Fleur E Brölmann, Louise AA Gerbens, Dirk T Ubbink and Hester Vermeulen

    Citation: Trials 2011 12:229

    Content type: Study protocol

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  28. Traumatic brain injury (TBI) is a main cause of severe prolonged disability of young patients. Hospital acquired pneumonia (HAP) add to the morbidity and mortality of traumatic brain-injured patients. In one s...

    Authors: Karim Asehnoune, Antoine Roquilly and Véronique Sebille

    Citation: Trials 2011 12:228

    Content type: Study protocol

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  29. Frequent rehospitalisations and poorer survival chances in heart failure (HF) patients may partly be explained by poor medication adherence. There are multiple medication-related reasons for suboptimal adheren...

    Authors: Dionne Kessing, Johan Denollet, Jos Widdershoven and Nina Kupper

    Citation: Trials 2011 12:227

    Content type: Study protocol

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  30. Lumbar disc herniation is a common and costly problem. Moxibustion is employed to relieve symptoms and might therefore act as a therapeutic alternative. Many studies have already reported encouraging results i...

    Authors: Mingren Chen, Rixin Chen, Jun Xiong, Fan Yi, Zhenhai Chi and Bo Zhang

    Citation: Trials 2011 12:226

    Content type: Study protocol

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  31. Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older...

    Authors: Natasha Mitchell, Catherine Hewitt, Joy Adamson, Steve Parrott, David Torgerson, David Ekers, John Holmes, Helen Lester, Dean McMillan, David Richards, Karen Spilsbury, Christine Godfrey and Simon Gilbody

    Citation: Trials 2011 12:225

    Content type: Study protocol

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  32. Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on t...

    Authors: Conor Doyle, Pradeep Panda, Ellen Van de Poel, Ralf Radermacher and David M Dror

    Citation: Trials 2011 12:224

    Content type: Study protocol

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  33. Systemic inflammation in response to a femur fracture and the additional fixation is associated with inflammatory complications, such as acute respiratory distress syndrome and multiple organ dysfunction syndr...

    Authors: Marjolein Heeres, Tjaakje Visser, Karlijn JP van Wessem, Anky HL Koenderman, Paul FW Strengers, Leo Koenderman and Luke PH Leenen

    Citation: Trials 2011 12:223

    Content type: Study protocol

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  34. Severe gait disturbances in idiopathic Parkinson's disease (PD) are observed in up to 80% of all patients in advanced disease stages with important impact on quality of life. There is an unmet need for further...

    Authors: Daniel Weiss, Tobias Wächter, Christoph Meisner, Melanie Fritz, Alireza Gharabaghi, Christian Plewnia, Sorin Breit and Rejko Krüger

    Citation: Trials 2011 12:222

    Content type: Study protocol

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  35. Neovascular age-related macular degeneration is the leading cause of irreversible blindness in people 50 years of age or older in the developed world. As in other chronic diseases, several effective treatments...

    Authors: Anja Frei, Katja Woitzek, Mathyas Wang, Ulrike Held and Thomas Rosemann

    Citation: Trials 2011 12:221

    Content type: Study protocol

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  36. Despite the growing emphasis on the inclusion of ethnic minority patients in research, there is little published on the recruitment of these populations especially to randomised, community based, lifestyle int...

    Authors: Anne Douglas, Raj S Bhopal, Ruby Bhopal, John F Forbes, Jason MR Gill, Julia Lawton, John McKnight, Gordon Murray, Naveed Sattar, Anu Sharma, Jaakko Tuomilehto, Sunita Wallia, Sarah H Wild and Aziz Sheikh

    Citation: Trials 2011 12:220

    Content type: Research

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  37. Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habits without organic disease. Many patients seek alternative IBS treatments because o...

    Authors: Seok-Jae Ko, Bongha Ryu, Jinsung Kim, Beom-Gi Hong, Inkwon Yeo, Beom-Joon Lee, Jin-Moo Lee and Jae-Woo Park

    Citation: Trials 2011 12:219

    Content type: Study protocol

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  38. Evidence demonstrates that measures are needed to optimise therapy and improve administration of medicines in care homes for older people. The aim of this study is to determine the clinical and cost effectiven...

    Authors: James Desborough, Julie Houghton, John Wood, David Wright, Richard Holland, Tracey Sach, Sue Ashwell and Val Shaw

    Citation: Trials 2011 12:218

    Content type: Study protocol

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  39. Surgical site infection (SSI) is a common complication following abdominal surgery. It is associated with considerable morbidity and mortality, and its management results in significant cost to health services...

    Authors: Thomas D Pinkney, David C Bartlett, William Hawkins, Tony Mak, Haney Youssef, Kaori Futaba, Gareth Harrison, Adrian Gheorghe, Jennifer M Bradbury, Melanie J Calvert, George Dowswell, Laura Magill, Val Redman, Sue Wilson, David Leaper and Dion G Morton

    Citation: Trials 2011 12:217

    Content type: Study protocol

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  40. Low back pain (LBP) is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for l...

    Authors: Paolo Buselli, Roberto Bosoni, Gabriella Busè, Paola Fasoli, Elide La Scala, Rita Mazzolari, Federica Zanetti and Sara Messina

    Citation: Trials 2011 12:216

    Content type: Study protocol

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  41. Late onset neonatal sepsis (LOS) with the mortality of 17 to 27% is still a serious disease. Meropenem is an antibiotic with wide antibacterial coverage. The advantage of it over standard of care could be its ...

    Authors: Irja Lutsar, Ursula MT Trafojer, Paul T Heath, Tuuli Metsvaht, Joseph Standing, Susanna Esposito, Vincent Meiffredy de Cabre, Clarissa Oeser and Jean-Pierre Aboulker

    Citation: Trials 2011 12:215

    Content type: Study protocol

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  42. Approximately 70,000 patients/year undergo surgery for repair of a fractured hip in the United Kingdom. This is associated with 30-day mortality of 9% and survivors have a considerable length of acute hospital...

    Authors: Matthew D Wiles, William JD Whiteley, Chris G Moran and Iain K Moppett

    Citation: Trials 2011 12:213

    Content type: Study protocol

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  43. ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data qualit...

    Authors: Lukasz J Krzych, Belinda Lees, Fiona Nugara, Winston Banya, Andrzej Bochenek, Jo Cook, David Taggart and Marcus D Flather

    Citation: Trials 2011 12:212

    Content type: Research

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  44. Acu-point specificity is a key issue in acupuncture. To date there has not been any satisfactory trial which can ratify the specific effect of acupuncture. This trial will evaluate the specific effect of BL33 ...

    Authors: Yang Wang, Zhishun Liu, Jinna Yu, Yulong Ding and Xuan Liu

    Citation: Trials 2011 12:211

    Content type: Study protocol

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  45. Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard t...

    Authors: Mark Rochester, James Armitage, Mark Sanders and Paula Christmas

    Citation: Trials 2011 12:210

    Content type: Study protocol

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  46. Urban South-Asian's are predisposed to early onset of type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). There is an urgent need for country specific primary prevention strategies to address the...

    Authors: Mahen Wijesuriya, Martin Gulliford, Laksha Vasantharajah, Giancarlo Viberti, Luigi Gnudi and Janaka Karalliedde

    Citation: Trials 2011 12:209

    Content type: Study protocol

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