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  1. 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

    Published on:

  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. 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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  12. 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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  13. 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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  14. 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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  15. 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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  16. 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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  17. 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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  18. 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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  19. 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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  20. 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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  21. 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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  22. 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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  23. 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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  24. 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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  25. 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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  26. 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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  27. 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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  28. Many studies have suggested a relationship between metabolic abnormalities and impaired fetal growth with the development of non-transmissible chronic diseases in the adulthood. Moreover, it has been proposed ...

    Authors: Robinson Ramírez-Vélez, Miryam Romero, Isabella Echeverri, José Guillermo Ortega, Mildrey Mosquera, Blanca Salazar, Sandra Lorena Girón, Wilmar Saldarriaga, Ana Cecilia Aguilar de Plata and Julio Cesar Mateus

    Citation: Trials 2011 12:60

    Content type: Study protocol

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  29. Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have n...

    Authors: Jorge Vas, Manuela Modesto, Inmaculada Aguilar, Koldo Santos-Rey, Nicolás Benítez-Parejo and Francisco Rivas-Ruiz

    Citation: Trials 2011 12:59

    Content type: Study protocol

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  30. 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

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  31. Clavicle fractures account for around 4% of all fractures and up to 44% of fractures of the shoulder girdle. Fractures of the middle third (or mid-shaft) account for approximately 80% of all clavicle fractures...

    Authors: Umile Giuseppe Longo, Sughran Banerjee, Julie Barber, Andrew Chambler, Carlos Cobiella, Steven Corbett, Mark Crowther, Steven Drew, Andrea Francis, Marcus Lee, Nicholas Garlick, Iain Packham, Yemi Pearse, Andrew Richards, Chris Roberts, Duncan Tennent…

    Citation: Trials 2011 12:57

    Content type: Study protocol

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  32. Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include anti...

    Authors: Ahmed A Khattab, Stephan Windecker, Peter Jüni, David Hildick-Smith, Dariusz Dudek, Henning R Andersen, Reda Ibrahim, Gerhard Schuler, Antony S Walton, Andreas Wahl, Heinrich P Mattle and Bernhard Meier

    Citation: Trials 2011 12:56

    Content type: Study protocol

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  33. The EdAL (Ed ucació en Al imentació) study is a long-term, nutrition educational, primary-school-based program designed to prevent obesity by promoting a healthy lifestyle that includes dietary recommendations an...

    Authors: Montse Giralt, Rosa Albaladejo, Lucia Tarro, David Moriña, Victoria Arija and Rosa Solà

    Citation: Trials 2011 12:54

    Content type: Study protocol

    Published on:

  34. Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated...

    Authors: Flávio D Fuchs, Sandra C Fuchs, Leila B Moreira, Miguel Gus, Antônio C Nóbrega, Carlos E Poli-de-Figueiredo, Décio Mion, Luiz Bortolotto, 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 12:53

    Content type: Study protocol

    Published on:

  35. Sedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE) is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 gu...

    Authors: P Knebel, K Schwan, T Bruckner, CM Seiler, K Plaschke, K Streitberger, A Schaible and C Bopp

    Citation: Trials 2011 12:52

    Content type: Study protocol

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  36. Hip replacement surgery is increasingly common due to an ageing population, and rising levels of obesity. The provision of excellent pain relief with minimal side effects is important in order to facilitate pa...

    Authors: Rachel J Kearns, Alan JR Macfarlane, Keith J Anderson and John Kinsella

    Citation: Trials 2011 12:51

    Content type: Study protocol

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  37. Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical ...

    Authors: MK Campbell, VA Entwistle, BH Cuthbertson, ZC Skea, AG Sutherland, AM McDonald, JD Norrie, RV Carlson and S Bridgman

    Citation: Trials 2011 12:50

    Content type: Research

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  38. Depression is common and can have devastating effects on the life of adolescents. Psychological interventions are the first-line for treating or preventing depression among adolescents. This proposal aims to e...

    Authors: Ricardo Araya, Alan A Montgomery, Rosemarie Fritsch, David Gunnell, Paul Stallard, Sian Noble, Vania Martinez, Sergio Barroilhet, Paul Vohringer, Viviana Guajardo, Felix Cova, Jorge Gaete, Alejandro Gomez and Graciela Rojas

    Citation: Trials 2011 12:49

    Content type: Study protocol

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  39. The Biostatistics and Methodological Innovation Working (BMIW) Group is one of several working groups within the CANadian Network and Centre for Trials INternationally (CANNeCTIN). This programme received fund...

    Authors: Lehana Thabane, George Wells, Richard Cook, Robert Platt, Janice Pogue, Eleanor Pullenayegum, David Matthews, Tara McCready, Philip J Devereaux, John A Cairns and Salim Yusuf

    Citation: Trials 2011 12:48

    Content type: Commentary

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  40. Participation in cognitive stimulation therapy (CST) may reduce the rate of cognitive decline in people with Alzheimer's disease (AD), however it is unclear if the training of carers to deliver activities is s...

    Authors: Mandy R Vidovich, Josephine Shaw, Leon Flicker and Osvaldo P Almeida

    Citation: Trials 2011 12:47

    Content type: Study protocol

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  41. Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been...

    Authors: Jorge H Ramírez, Roger M Arce and Adolfo Contreras

    Citation: Trials 2011 12:46

    Content type: Study protocol

    Published on:

  42. Previous interventions to increase physical activity and reduce cardiovascular risk factors have been targeted at individuals with established disease; less attention has been given to intervention among indiv...

    Authors: Robert J Petrella, Kuni Aizawa, Kevin Shoemaker, Tom Overend, Len Piche, Mauricio Marin, Sheree Shapiro and Sophie Atkin

    Citation: Trials 2011 12:45

    Content type: Study protocol

    Published on:

  43. Heart failure(HF) and atrial fibrillation(AF) frequently coexist in the same patient and are associated with increased mortality and frequent hospitalizations. As the concomitance of AF and HF is often associa...

    Authors: Giovanni Luca Botto, Giuseppe Boriani, Stefano Favale, Maurizio Landolina, Giulio Molon, Claudio Tondo, Mauro Biffi, Giuseppe Grandinetti, Paolo De Filippo, Giovanni Raciti and Luigi Padeletti

    Citation: Trials 2011 12:44

    Content type: Study protocol

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  44. Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remed...

    Authors: Ubiratan C Adler, Stephanie Krüger, Michael Teut, Rainer Lüdtke, Iris Bartsch, Lena Schützler, Friedericke Melcher, Stefan N Willich, Klaus Linde and Claudia M Witt

    Citation: Trials 2011 12:43

    Content type: Study protocol

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  45. What study participants think about the nature of a study has been hypothesised to affect subsequent behaviour and to potentially bias study findings. In this trial we examine the impact of awareness of study ...

    Authors: Kypros Kypri, Jim McCambridge, Amanda Wilson, John Attia, Paschal Sheeran, Steve Bowe and Tina Vater

    Citation: Trials 2011 12:42

    Content type: Study protocol

    Published on:

  46. Current projections indicate that there will be a significant increase in the number of people with dementia in Ireland, from approximately 40,000 at present to 100,000 by 2036. Psychosocial interventions, suc...

    Authors: Eamon O'Shea, Declan Devane, Kathy Murphy, Adeline Cooney, Dympna Casey, Fionnuala Jordan, Andrew Hunter and Edel Murphy

    Citation: Trials 2011 12:41

    Content type: Study protocol

    Published on:

  47. Low therapeutic adherence to medication is very common. Clinical effectiveness is related to dose rate and route of administration and so poor therapeutic adherence can reduce the clinical benefit of treatment...

    Authors: Pilar Barnestein-Fonseca, José Leiva-Fernández, Francisca Vidal-España, Antonio García-Ruiz, Daniel Prados-Torres and Francisca Leiva-Fernández

    Citation: Trials 2011 12:40

    Content type: Study protocol

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  48. Diabetes has already become a threat to the nation and the individual due to its high prevalence rates and high medical expenses. Therefore, preventing diabetes at an earlier stage is very important. Despite a...

    Authors: Sunju Park, Jeong-Su Park, Hoyeon Go, Bo-Hyoung Jang, Yongcheol Shin and Seong-Gyu Ko

    Citation: Trials 2011 12:38

    Content type: Study protocol

    Published on:

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