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  1. This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.

    Authors: Michael Teut, Ute Hirschberg, Rainer Luedtke, Cristoph Schnegg, Joern Dahler, Henning Albrecht and Claudia M Witt
    Citation: Trials 2010 11:80
  2. The use of Clinical Data Management Systems (CDMS) has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at in...

    Authors: Wolfgang Kuchinke, Christian Ohmann, Qin Yang, Nader Salas, Jens Lauritsen, Francois Gueyffier, Alan Leizorovicz, Carmen Schade-Brittinger, Michael Wittenberg, Zoltán Voko, Siobhan Gaynor, Margaret Cooney, Peter Doran, Aldo Maggioni, Andrea Lorimer, Ferràn Torres…
    Citation: Trials 2010 11:79
  3. Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evalua...

    Authors: Barbara Farrell, Sara Kenyon and Haleema Shakur
    Citation: Trials 2010 11:78
  4. In the course of producing the 2009 NHS Evidence - skin disorders Annual Evidence Update on Acne Vulgaris, 25 randomised controlled trials were examined. From these, at least 12 potentially serious problems of...

    Authors: John R Ingram, Douglas JC Grindlay and Hywel C Williams
    Citation: Trials 2010 11:77
  5. Traditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when eva...

    Authors: Charity D Evans, Dean T Eurich, Jeff G Taylor, Alfred J Remillard, Yvonne M Shevchuk and David F Blackburn
    Citation: Trials 2010 11:76
  6. Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is know...

    Authors: Ling Wang, Yulin Li, Jing Li, Mingming Zhang, Lin Xu, Wenming Yuan, Gang Wang and Sally Hopewell
    Citation: Trials 2010 11:75
  7. Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable inte...

    Authors: Neale R Chumbler, Dorian K Rose, Patricia Griffiths, Patricia Quigley, Nancy McGee-Hernandez, Katherine A Carlson, Phyllis Vandenberg, Miriam C Morey, Jon Sanford and Helen Hoenig
    Citation: Trials 2010 11:74
  8. Quality of residential care for people with severe dementia is in urgent need of improvement. One reason for this may be the assumption that people with severe dementia are unaware of what is happening to them...

    Authors: Linda Clare, Robert T Woods, Rhiannon Whitaker, Barbara A Wilson and Murna Downs
    Citation: Trials 2010 11:73
  9. The challenge of Bipolar Disorder (BD) treatment is due to the complexity of the disease. Current guidelines represent an effort to help clinicians in their everyday practice but still have limitations, specia...

    Authors: Rodolfo N Campos, Luis F Costa, Danielle S Bio, Márcio G Soeiro de Souza, Carla RL Garcia, Frederico N Demétrio, Doris H Moreno and Ricardo A Moreno
    Citation: Trials 2010 11:72
  10. A recent Cochrane Review demonstrated the remarkable lack of reliable clinical trials of migraine treatments for children, especially for the two most prescribed preventative treatments in the UK, Propranolol and...

    Authors: Paul Silcocks, Diane Whitham and William Patrick Whitehouse
    Citation: Trials 2010 11:71
  11. Anemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are commonly used to increase ...

    Authors: Giovanni FM Strippoli
    Citation: Trials 2010 11:70
  12. Acute infectious diseases are major causes of short periods of days off from work, day care and school. These diseases are mainly caused by viruses and hands have a key role in their transmission. Thus, hypoth...

    Authors: Carita Savolainen-Kopra, Jaason Haapakoski, Piia A Peltola, Thedi Ziegler, Terttu Korpela, Pirjo Anttila, Ali Amiryousefi, Pentti Huovinen, Markku Huvinen, Heikki Noronen, Pia Riikkala, Merja Roivainen, Petri Ruutu, Juha Teirilä, Erkki Vartiainen and Tapani Hovi
    Citation: Trials 2010 11:69
  13. The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical pr...

    Authors:
    Citation: Trials 2010 11:68
  14. Screening for abdominal aortic aneurysm (AAA) of men aged 65-74 years reduces the AAA-related mortality and is generally considered cost effective. Despite of this only a few national health care services have...

    Authors: Nikolaj Grøndal, Rikke Søgaard, Eskild W Henneberg and Jes S Lindholt
    Citation: Trials 2010 11:67
  15. Our objective was to report on the design and essentials of the Etoricoxib protocol- Preemptive and Postoperative Analgesia (EPPA) Trial, investigating whether preemptive analgesia with cox-2 inhibitors is more e...

    Authors: Johannes Fleckenstein, Sybille Kramer, Martin Offenbächer, Gabriel Schober, Herbert Plischke, Matthias Siebeck, Thomas Mussack, Rudolf Hatz, Lukas Lehmeyer, Philip M Lang, Bernhard Heindl, Peter Conzen and Dominik Irnich
    Citation: Trials 2010 11:66
  16. The subject of death and bereavement in the context of randomised controlled trials in neonatal or paediatric intensive care is under-researched. The objectives of this phase of the Bereavement and RAndomised ...

    Authors: Claire Snowdon, Sheila E Harvey, Peter Brocklehurst, Robert C Tasker, Martin P Ward Platt, Elizabeth Allen and Diana Elbourne
    Citation: Trials 2010 11:65
  17. Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration...

    Authors: Zhao-Xiang Bian and Tai-Xiang Wu
    Citation: Trials 2010 11:64
  18. There is scope to improve the quality of life (QOL) of people with dementia living in residential care facilities (RCF). The DIRECT study will determine if delivery of education to General Practitioners (GPs) ...

    Authors: Christopher D Beer, Barbara Horner, Osvaldo P Almeida, Samuel Scherer, Nicola T Lautenschlager, Nick Bretland, Penelope Flett, Frank Schaper and Leon Flicker
    Citation: Trials 2010 11:63
  19. The standard of care for colorectal peritoneal carcinomatosis is evolving from chemotherapy to cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with disease limit...

    Authors: Robert T Ripley, Jeremy L Davis, Clinton D Kemp, Seth M Steinberg, Mary Ann Toomey and Itzhak Avital
    Citation: Trials 2010 11:62
  20. Statins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and effica...

    Authors: Petr Ostadal, David Alan, Jiri Vejvoda, Jiri Kukacka, Milan Macek, Petr Hajek, Martin Mates, Milan Kvapil, Jiri Kettner, Martin Wiendl, Ondrej Aschermann, Josef Slaby, Frantisek Holm, Peter Telekes, David Horak, Peter Blasko…
    Citation: Trials 2010 11:61
  21. Associated with a tripling in obesity since 1970, type 2 diabetes mellitus (T2DM) in children has risen 9-10 fold. There is a critical need of protocols for trials to prevent T2DM in children.

    Authors: Lorrene D Ritchie, Sushma Sharma, Joanne P Ikeda, Rita A Mitchell, Aarthi Raman, Barbara S Green, Mark L Hudes and Sharon E Fleming
    Citation: Trials 2010 11:60
  22. To evaluate the use and reporting of adjusted analysis in randomised controlled trials (RCTs) and compare the quality of reporting before and after the revision of the CONSORT Statement in 2001.

    Authors: Ly-Mee Yu, An-Wen Chan, Sally Hopewell, Jonathan J Deeks and Douglas G Altman
    Citation: Trials 2010 11:59
  23. Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths amo...

    Authors: Betty R Kirkwood, Alexander Manu, Charlotte Tawiah-Agyemang, Guus ten Asbroek, Thomas Gyan, Benedict Weobong, R Eric Lewandowski, Seyi Soremekun, Samuel Danso, Catherine Pitt, Kara Hanson, Seth Owusu-Agyei and Zelee Hill
    Citation: Trials 2010 11:58
  24. Chest pain is a common presenting complaint in the emergency department (ED). Despite the frequency with which clinicians evaluate patients with chest pain, accurately determining the risk of acute coronary sy...

    Authors: Meghan A Pierce, Erik P Hess, Jeffrey A Kline, Nilay D Shah, Maggie Breslin, Megan E Branda, Laurie J Pencille, Brent R Asplin, David M Nestler, Annie T Sadosty, Ian G Stiell, Henry H Ting and Victor M Montori
    Citation: Trials 2010 11:57
  25. Chronic (systolic) heart failure (CHF) represents a clinical syndrome with high individual and societal burden of disease. Multifaceted interventions like case management are seen as promising ways of improvin...

    Authors: Frank Peters-Klimm, Stephen Campbell, Katja Hermann, Cornelia U Kunz, Thomas Müller-Tasch and Joachim Szecsenyi
    Citation: Trials 2010 11:56
  26. Almost all of the 820,000 people in the UK with dementia will experience Behavioural and Psychological Symptoms of Dementia (BPSD). However, research has traditionally focused on treating cognitive symptoms, t...

    Authors: Arlinda Cerga-Pashoja, David Lowery, Rahul Bhattacharya, Mark Griffin, Steve Iliffe, James Lee, Claire Leonard, Sue Ricketts, Lyn Strother, Fiona Waters, Craig W Ritchie and James Warner
    Citation: Trials 2010 11:53
  27. Outcome reporting bias (ORB) occurs when variables are selected for publication based on their results. This can impact upon the results of a meta-analysis, biasing the pooled treatment effect estimate.

    Authors: Kerry Dwan, Carrol Gamble, Ruwanthi Kolamunnage-Dona, Shabana Mohammed, Colin Powell and Paula R Williamson
    Citation: Trials 2010 11:52
  28. Thrombolysis with intravenous rt-PA is currently the only approved acute therapy for ischemic stroke. Re-occlusion after initial recanalization occurs in up to 34% in patients treated with rt-PA, probably caus...

    Authors: SM Zinkstok, M Vermeulen, J Stam, RJ de Haan and YB Roos
    Citation: Trials 2010 11:51
  29. Furosemide is commonly prescribed in critically ill patients with acute kidney injury (AKI). Existing data from observational studies and small clinical trials have significant limitations and have reported co...

    Authors: Sean M Bagshaw, R T Noel Gibney, Finlay A McAlister and Rinaldo Bellomo
    Citation: Trials 2010 11:50
  30. The process for data collection in multicenter trials may be troublesome and expensive. We report our experience with the spreadsheet function in Googledocs for this purpose.

    Authors: Jacob Rosenberg, Nadia Abdelaal Henriksen and Lars Nannestad Jørgensen
    Citation: Trials 2010 11:49
  31. Generalised anxiety disorder (GAD) is a high prevalence, chronic psychiatric disorder which commonly presents early in the lifespan. Internet e-health applications have been found to be successful in reducing ...

    Authors: Helen Christensen, Adam J Guastella, Andrew J Mackinnon, Kathleen M Griffiths, Claire Eagleson, Philip J Batterham, Kanupriya Kalia, Justin Kenardy, Kylie Bennett and Ian B Hickie
    Citation: Trials 2010 11:48
  32. A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of t...

    Authors: Markus K Diener, Thomas Bruckner, Pietro Contin, Christopher Halloran, Matthias Glanemann, Hans Jürgen Schlitt, Joachim Mössner, Meinhard Kieser, Jens Werner, Markus W Büchler and Christoph M Seiler
    Citation: Trials 2010 11:47
  33. Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recogni...

    Authors: Elisa Aguirre, Aimee Spector, Juanita Hoe, Ian T Russell, Martin Knapp, Robert T Woods and Martin Orrell
    Citation: Trials 2010 11:46
  34. Editors from a number of medical journals lay out principles for journals considering publication of Comparative Effectiveness Research (CER). In order to encourage dissemination of this editorial, this articl...

    Authors: Harold C Sox, Mark Helfand, Jeremy Grimshaw, Kay Dickersin, David Tovey, J André Knottnerus and Peter Tugwell
    Citation: Trials 2010 11:45
  35. The gap between the level of care recommended by evidence-based clinical practice guidelines and the actual care delivered to patients in practice has been well established. The Canadian Diabetes Association (...

    Authors: Baiju R Shah, Onil Bhattacharyya, Catherine Yu, Muhammad Mamdani, Janet A Parsons, Sharon E Straus and Merrick Zwarenstein
    Citation: Trials 2010 11:44
  36. We assessed the prevalence, and potential impact of, trials of pharmacological agents for acute stroke that were completed but not published in full. Failure to publish trial data is to be deprecated as it set...

    Authors: Lorna M Gibson, Miriam Brazzelli, Brenda M Thomas and Peter AG Sandercock
    Citation: Trials 2010 11:43
  37. Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream whi...

    Authors: Mara Ozolins, Hywel C Williams, Sarah J Armstrong and Fiona J Bath-Hextall
    Citation: Trials 2010 11:42
  38. Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher lev...

    Authors: Brian H Cuthbertson, Marion K Campbell, Stephen A Stott, Luke Vale, John Norrie, John Kinsella, Jonathan Cook, Julie Brittenden and Adrian Grant
    Citation: Trials 2010 11:41
  39. Each year, worldwide about 530,000 women die from causes related to pregnancy and childbirth. Of the deaths 99% are in low and middle income countries. Obstetric haemorrhage is the leading cause of maternal mo...

    Authors: Haleema Shakur, Diana Elbourne, Metin Gülmezoglu, Zarko Alfirevic, Carine Ronsmans, Elizabeth Allen and Ian Roberts
    Citation: Trials 2010 11:40
  40. Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely co...

    Authors: Joanna McGregor, Caroline Brooks, Padmaja Chalasani, Jude Chukwuma, Hayley Hutchings, Ronan A Lyons and Keith Lloyd
    Citation: Trials 2010 11:39
  41. Insufficient blood pressure control is a frequent problem despite the existence of effective treatment. Insufficient adherence to self-monitoring as well as to therapy is a common reason. Blood pressure self-m...

    Authors: Claudia Steurer-Stey, Marco Zoller, Corinne Chmiel Moshinsky, Oliver Senn and Thomas Rosemann
    Citation: Trials 2010 11:38
  42. Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressan...

    Authors: Natalie McGauran, Beate Wieseler, Julia Kreis, Yvonne-Beatrice Schüler, Heike Kölsch and Thomas Kaiser
    Citation: Trials 2010 11:37
  43. Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" C...

    Authors: Karen J Sherman, Daniel C Cherkin, Andrea J Cook, Rene J Hawkes, Richard A Deyo, Robert Wellman and Partap S Khalsa
    Citation: Trials 2010 11:36
  44. African Americans with Type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to American Whites. Poor outcomes in African Am...

    Authors: Leonard E Egede, Joni L Strom, Valerie L Durkalski, Patrick D Mauldin and William P Moran
    Citation: Trials 2010 11:35
  45. Tinnitus is the perception of hearing a sound for which there is no external acoustic source. It is often associated with sudden, temporary hearing loss and has a clear impact on a patient's quality of life. D...

    Authors: Nam-Kwen Kim, Dong-Hyo Lee, Jung-Hun Lee, Yong-Leol Oh, In-Hwan Yoon, Eun-Sung Seo and Chung-Ho Lee
    Citation: Trials 2010 11:34
  46. Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the u...

    Authors: Hywel C Williams
    Citation: Trials 2010 11:33
  47. Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains o...

    Authors: Patrick Jahn, Maria Kitzmantel, Petra Renz, Ene Kukk, Oliver Kuss, Anette Thoke-Colberg, Ingrid Horn and Margarete Landenberger
    Citation: Trials 2010 11:29

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