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  1. 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. 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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  12. 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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  13. 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

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  14. 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:

  15. 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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  16. 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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  17. 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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  18. 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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  19. 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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  20. 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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  21. 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

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  22. 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

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  23. 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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  24. 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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  25. 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

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  26. 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

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  27. 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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  28. School interventions such as the Incredible Years Classroom Dinosaur Programme targets pupil behaviour across whole classrooms, yet for some children a more intense approach is needed. The Incredible Years Therap...

    Authors: Tracey Bywater, Judy Hutchings, Christopher Whitaker, Ceri Evans and Laura Parry

    Citation: Trials 2011 12:39

    Content type: Study protocol

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  29. 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

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  30. Chronic obstructive pulmonary disease (COPD) is a common disease, associated with cardiovascular disease. Many patients use (long-acting) bronchodilators, whilst they continue smoking alongside. We hypothesise...

    Authors: WD van Dijk, PTJ Scheepers, R Cremers, JWM Lenders, W Klerx, C van Weel, TRJ Schermer and Y Heijdra

    Citation: Trials 2011 12:37

    Content type: Methodology

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  31. Cognitive behaviour therapy (CBT) is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited ev...

    Authors: Paul Willner, Andrew Jahoda, John Rose, Biza Stenfert-Kroese, Kerenza Hood, Julia K Townson, Jacqueline Nuttall, David Gillespie and David Felce

    Citation: Trials 2011 12:36

    Content type: Study protocol

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  32. Up to 85% of patients with schizophrenia demonstrate cognitive dysfunction in at least one domain. Cognitive dysfunction plays a major role in functional outcome. It is hypothesized that addition of cognitive ...

    Authors: Lone Vesterager, Torben Ø Christensen, Birthe B Olsen, Gertrud Krarup, Hysse B Forchhammer, Marianne Melau, Christian Gluud and Merete Nordentoft

    Citation: Trials 2011 12:35

    Content type: Study protocol

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  33. Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection...

    Authors: Thorsten Löffler, Christoph M Seiler, Inga Rossion, Thomas Kijak, Oliver Thomusch, Renè Hodina, Matthias Krüger, Thomas Simon, Thomas Bruckner, Meinhard Kieser, Markus W Büchler and Jürgen Weitz

    Citation: Trials 2011 12:34

    Content type: Study protocol

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  34. Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function. However, the improvement of left ventricular s...

    Authors: Hyun-Jae Kang, Min-Kyung Kim, Myung-Gon Kim, Dong-Ju Choi, Jung-Han Yoon, Young-Bae Park and Hyo-Soo Kim

    Citation: Trials 2011 12:33

    Content type: Study protocol

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  35. In unipolar, and bipolar affective disorders, there is a high risk of relapse that increases as the number of episodes increases. Naturalistic follow-up studies suggest that the progressive development of the ...

    Authors: Lars Vedel Kessing, Hanne Vibe Hansen, Ellen Margrethe Christensen, Henrik Dam, Christian Gluud and Jørn Wetterslev

    Citation: Trials 2011 12:32

    Content type: Study protocol

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  36. Serum phosphate is an independent predictor of cardiovascular morbidity and mortality in patients with chronic kidney disease and the general population. There is accumulating evidence that phosphate promotes ...

    Authors: Colin D Chue, Jonathan N Townend, Richard P Steeds and Charles J Ferro

    Citation: Trials 2011 12:30

    Content type: Study protocol

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  37. Research has shown that current claims settlement process can have a negative impact on psychological and physical recovery of personal injury (PI) victims. One of the explanations for the negative impact on h...

    Authors: Nieke A Elbers, Arno J Akkermans, Pim Cuijpers and David J Bruinvels

    Citation: Trials 2011 12:29

    Content type: Study protocol

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  38. The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation wa...

    Authors: David R Ellard, Stephanie JC Taylor, Suzanne Parsons and Margaret Thorogood

    Citation: Trials 2011 12:28

    Content type: Study protocol

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  39. Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortali...

    Authors: Martin Underwood, Sandra Eldridge, Sallie Lamb, Rachel Potter, Bartley Sheehan, Anne-Marie Slowther, Stephanie Taylor, Margaret Thorogood and Scott Weich

    Citation: Trials 2011 12:27

    Content type: Study protocol

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  40. In certain diseases clinical experts may judge that the intervention with the best prospects is the addition of two treatments to the standard of care. This can either be tested with a simple randomized trial ...

    Authors: Marcel Wolbers, Dorothee Heemskerk, Tran Thi Hong Chau, Nguyen Thi Bich Yen, Maxine Caws, Jeremy Farrar and Jeremy Day

    Citation: Trials 2011 12:26

    Content type: Methodology

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  41. Tuberculous meningitis is the most severe form of tuberculosis. Mortality for untreated tuberculous meningitis is 100%. Despite the introduction of antibiotic treatment for tuberculosis the mortality rate for ...

    Authors: Dorothee Heemskerk, Jeremy Day, Tran Thi Hong Chau, Nguyen Huy Dung, Nguyen Thi Bich Yen, Nguyen Duc Bang, Laura Merson, Piero Olliaro, Thomas Pouplin, Maxine Caws, Marcel Wolbers and Jeremy Farrar

    Citation: Trials 2011 12:25

    Content type: Study protocol

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  42. By tradition colloid solutions have been used to obtain fast circulatory stabilisation in shock, but high molecular weight hydroxyethyl starch (HES) may cause acute kidney failure in patients with severe sepsi...

    Authors: Anders Perner, Nicolai Haase, Jørn Wetterslev, Anders Åneman, Jyrki Tenhunen, Anne Berit Guttormsen, Gudmundur Klemenzson, Frank Pott, Karen Doris Bødker, Per Martin Bådstøløkken, Asger Bendtsen, Peter Søe-Jensen, Hamid Tousi, Morten Bestle, Malgorzata Pawlowicz, Robert Winding…

    Citation: Trials 2011 12:24

    Content type: Study protocol

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  43. Most guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, but the clinical benefit of this strategy has not been demonstrated compared with the simp...

    Authors: Michel M Lièvre, Philippe Moulin, Charles Thivolet, Michel Rodier, Vincent Rigalleau, Alfred Penfornis, Alain Pradignac and Michel Ovize

    Citation: Trials 2011 12:23

    Content type: Research

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  44. African Americans experience significant tobacco-related health disparities despite the fact that over half of African American smokers are light smokers (use ≤10 cigarettes per day). African Americans have be...

    Authors: Lisa Sanderson Cox, Babalola Faseru, Matthew S Mayo, Ron Krebill, Tricia S Snow, Carrie A Bronars, Nicole L Nollen, Won S Choi, Kolawole S Okuyemi, Gary A Salzman, Neal L Benowitz, Rachel F Tyndale and Jasjit S Ahluwalia

    Citation: Trials 2011 12:22

    Content type: Research

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  45. For critically ill patients treated in intensive care units (ICU), two feeding strategies are currently being advocated, one by American/Canadian and the other by European expert guidelines. These guidelines d...

    Authors: Michaël P Casaer, Greet Hermans, Alexander Wilmer and Greet Van den Berghe

    Citation: Trials 2011 12:21

    Content type: Study protocol

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  46. The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurren...

    Authors: A Marjolein Schrijver, Michel MPJ Reijnen, Jacques A van Oostayen, Rudolf PJ Tutein Nolthenius, Pieter HM van der Valk, Arjan WJ Hoksbergen, Rutger J Lely, Bram Fioole, Dammis Vroegindeweij, Marc van Leersum and Jean-Paul PM de Vries

    Citation: Trials 2011 12:20

    Content type: Study protocol

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  47. Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we w...

    Authors: Subhadra Evans, Laura Cousins, Jennie CI Tsao, Saskia Subramanian, Beth Sternlieb and Lonnie K Zeltzer

    Citation: Trials 2011 12:19

    Content type: Study protocol

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  48. The prevalence of mood difficulties in persons with diabetes is approximately twice that in the general population, affecting the health outcomes and patients' quality of life in an undesirable way. Although s...

    Authors: Mirjana Pibernik-Okanović, Dea Ajduković, Marijana Vučić Lovrenčić and Norbert Hermanns

    Citation: Trials 2011 12:17

    Content type: Study protocol

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