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Sarah A Moore, Ruth Da Silva, Madelaine Balaam, Lianne Brkic, Dan Jackson, Dan Jamieson, Thomas Ploetz, Helen Rodgers, Lisa Shaw, Frederike van Wijck, Christopher Price
BACKGROUND: Loss of upper limb function affects up to 85 % of acute stroke patients. Recovery of upper limb function requires regular intensive practise of specific upper limb tasks. To enhance intensity of practice interventions are being developed to encourage patients to undertake self-directed exercise practice. Most interventions do not translate well into everyday activities and stroke patients continue to find it difficult remembering integration of upper limb movements into daily activities...
October 21, 2016: Trials
Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon
BACKGROUND: Young women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties...
October 21, 2016: Trials
Camilla T Damsgaard, Lotte Lauritzen, Hanne Hauger, Stine Vuholm, Marie N Teisen, Christian Ritz, Max Hansen, Janni Niclasen, Christian Mølgaard
BACKGROUND: Most children in Western populations do not meet recommendations for fish consumption. Oily fish is an important source of n-3 long-chain polyunsaturated fatty acids (LCPUFA), which reduce blood pressure and plasma triacylglycerol in adults and may affect cognitive development and behavior. However, to our knowledge, the potential effects of oily fish on cardiometabolic health, cognitive function, and behavior in children have not been investigated. The aim of the FiSK Junior study is to investigate the effects of oily fish consumption on cardiovascular risk markers, cognitive function, and behavior in healthy children...
October 21, 2016: Trials
Ying Zhang, Jin Sun, Yun-Jiao Zhang, Qian-Yun Chai, Kang Zhang, Hong-Li Ma, Xiao-Ke Wu, Jian-Ping Liu
BACKGROUND: Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). METHODS: The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting...
October 21, 2016: Trials
Mahnaz Ashoorkhani, Ali Bozorgi, Reza Majdzadeh, Hamed Hosseini, Ali Yoonessi, Ali Ramezankhani, Hassan Eftekhar
BACKGROUND: Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment...
October 21, 2016: Trials
Daniel Niederer, Lutz Vogt, Pia-Maria Wippert, Anne-Katrin Puschmann, Ann-Christin Pfeifer, Marcus Schiltenwolf, Winfried Banzer, Frank Mayer
BACKGROUND: Arising from the relevance of sensorimotor training in the therapy of nonspecific low back pain patients and from the value of individualized therapy, the present trial aims to test the feasibility and efficacy of individualized sensorimotor training interventions in patients suffering from nonspecific low back pain. METHODS AND STUDY DESIGN: A multicentre, single-blind two-armed randomized controlled trial to evaluate the effects of a 12-week (3 weeks supervised centre-based and 9 weeks home-based) individualized sensorimotor exercise program is performed...
October 20, 2016: Trials
Suguru Kimoto, Yasuhiko Kawai, Atsuko Gunji, Hisatomo Kondo, Taro Nomura, Tomohiko Murakami, Akito Tsuboi, Guang Hong, Shunsuke Minakuchi, Yusuke Sato, Gaku Ohwada, Tetsuya Suzuki, Katsuhiko Kimoto, Noriyuki Hoshi, Makiko Saita, Yoshikazu Yoneyama, Yohei Sato, Masakazu Morokuma, Joji Okazaki, Takeshi Maeda, Kenichiro Nakai, Tetsuo Ichikawa, Kan Nagao, Keiko Fujimoto, Hiroshi Murata, Tadafumi Kurogi, Kazuhiro Yoshida, Masahiro Nishimura, Yasuhiro Nishi, Mamoru Murakami, Toshio Hosoi, Taizo Hamada
BACKGROUND: Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users...
October 18, 2016: Trials
Frans van Workum, Stefan A W Bouwense, Misha D P Luyer, Grard A P Nieuwenhuijzen, Donald L van der Peet, Freek Daams, Ewout A Kouwenhoven, Marc J van Det, Frits J H van den Wildenberg, Fatih Polat, Suzanne S Gisbertz, Mark I van Berge Henegouwen, Joos Heisterkamp, Barbara S Langenhoff, Ingrid S Martijnse, Janneke P Grutters, Bastiaan R Klarenbeek, Maroeska M Rovers, Camiel Rosman
BACKGROUND: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE...
October 18, 2016: Trials
Cindy X Guo, Raiju J Babu, Joanna M Black, William R Bobier, Carly S Y Lam, Shuan Dai, Tina Y Gao, Robert F Hess, Michelle Jenkins, Yannan Jiang, Lionel Kowal, Varsha Parag, Jayshree South, Sandra Elfride Staffieri, Natalie Walker, Angela Wadham, Benjamin Thompson
BACKGROUND: Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults...
October 18, 2016: Trials
Kylee Trevillion, Jill Domoney, Andrew Pickles, Debra Bick, Sarah Byford, Margaret Heslin, Jeannette Milgrom, Rachel Mycroft, Carmine Pariante, Elizabeth Ryan, Myra Hunter, Louise Michele Howard
BACKGROUND: Depression is a common antenatal mental disorder and is associated with an increased risk of adverse effects on the fetus and significant morbidity for the mother; if untreated it can also continue into the post-natal period and affect mother-infant interactions. There has been little research evaluating the effectiveness or cost-effectiveness of antenatal psychological interventions for antenatal depression, particularly for mild to moderate disorders. International guidelines recommend a stepped care approach starting with Guided Self Help, and the aim of this exploratory trial is to investigate Guided Self Help modified for pregnancy...
October 18, 2016: Trials
Lianne M Tomfohr-Madsen, Tavis S Campbell, Gerald F Giesbrecht, Nicole L Letourneau, Linda E Carlson, Joshua W Madsen, Sona Dimidjian
BACKGROUND: Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy...
October 13, 2016: Trials
Andrew Skeggs, Tricia McKeever, Lelia Duley, Eleanor Mitchell, Lucy Bradshaw, Kevin Mortimer, Samantha Walker, Steve Parrott, Andrew Wilson, Ian Pavord, Chris Brightling, Mike Thomas, David Price, Graham Devereux, Bernard Higgins, Tim Harrison, Rebecca Haydock
BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan...
October 13, 2016: Trials
Eleanor I Walsh, Emma L Turner, J Athene Lane, Jenny L Donovan, David E Neal, Freddie C Hamdy, Richard M Martin
BACKGROUND: Sociodemographic characteristics are associated with participating in cancer screening and trials. We compared the characteristics of those responding with those not responding to a single invitation for prostate-specific antigen (PSA) testing for prostate cancer as part of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP). METHODS: Age, rurality and deprivation among 197,763 men from 271 cluster-randomised primary care centres in the UK were compared between those responding (n = 90,300) and those not responding (n = 100,953) to a prostate cancer testing invitation...
October 13, 2016: Trials
Jesús Villar, Javier Belda, Jesús Blanco, Fernando Suarez-Sipmann, José Manuel Añón, Lina Pérez-Méndez, Carlos Ferrando, Dácil Parrilla, Raquel Montiel, Ruth Corpas, Elena González-Higueras, David Pestaña, Domingo Martínez, Lorena Fernández, Marina Soro, Miguel Angel García-Bello, Rosa Lidia Fernández, Robert M Kacmarek
BACKGROUND: Patient-ventilator asynchrony is a common problem in mechanically ventilated patients with acute respiratory failure. It is assumed that asynchronies worsen lung function and prolong the duration of mechanical ventilation (MV). Neurally Adjusted Ventilatory Assist (NAVA) is a novel approach to MV based on neural respiratory center output that is able to trigger, cycle, and regulate the ventilatory cycle. We hypothesized that the use of NAVA compared to conventional lung-protective MV will result in a reduction of the duration of MV...
October 13, 2016: Trials
Erin Davis, Carlo Marra, John-Michael Gamble, Jamie Farrell, Joe Lockyer, J Mark FitzGerald, Waseem Abu-Ashour, Charlie Gillis, John Hawboldt
BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are often nonadherent with medications and have poor inhaler technique. Community pharmacists can help to improve health-related quality of life and overall outcomes in patients with COPD. We aim to measure the effectiveness of a systematic, pharmacist-driven intervention on patients with diagnosed COPD. METHODS/DESIGN: This pragmatic, parallel-group, cluster randomized controlled trial is designed to determine the effectiveness of a multifactorial, pharmacist-led intervention on medication adherence, inhaler technique, health-related quality of life, health care resource utilization including COPD exacerbations, and use of medications...
October 13, 2016: Trials
Karen L Barker, David Beard, Andrew Price, Francine Toye, Martin Underwood, Avril Drummond, Gary Collins, Susan Dutton, Helen Campbell, Nicola Kenealy, Jon Room, Sarah E Lamb
BACKGROUND: The number of knee arthroplasties performed each year is steadily increasing. Although the outcome is generally favourable, up to 15 % fail to achieve a satisfactory clinical outcome which may indicate that the existing model of rehabilitation after surgery may not be the most efficacious. Given the increasing number of knee arthroplasties, the relative limited physiotherapy resources available and the increasing age and frailty of patients receiving arthroplasty surgery, it is important that we concentrate our rehabilitation resources on those patients who most need help to achieve a good outcome...
October 13, 2016: Trials
Valery S Effoe, Jeffrey A Katula, Julienne K Kirk, Carolyn F Pedley, Linda Y Bollhalter, W Mark Brown, Margaret R Savoca, Stedman T Jones, Janet Baek, Alain G Bertoni
BACKGROUND: The use of the electronic medical record (EMR) system in recruitment in clinical trials has the potential for providing a very reliable and cost-effective recruiting methodology which may improve participant recruitment in clinical trials. We examined a recruitment approach centered on the use of the EMR, as well as other traditional methods, in the Lifestyle Intervention for Treatment of Diabetes (LIFT Diabetes) trial. METHODS: LIFT Diabetes is a randomized controlled trial designed to investigate the effects of two contrasting interventions on cardiovascular disease risk: a community-based intensive lifestyle program aimed at achieving weight loss and a clinic-based enhanced diabetes self-management program...
October 13, 2016: Trials
Norbert J Tripolt, Felix Aberer, Regina Riedl, Barbara Hutz, Jasmin Url, Gudrun Dimsity, Andreas Meinitzer, Tatjana Stojakovic, Ronald Hödl, Marianne Brodmann, Franz Hafner, Harald Sourij
BACKGROUND: Patients with type 2 diabetes (T2DM) are at increased risk for macrovascular events as well as for microvascular complications. There is evidence that in patients with coronary artery disease (CAD), about 35 % suffer from manifest T2DM. Early glucose-lowering intervention in subjects with T2DM has been demonstrated to be beneficial in terms of cardiovascular risk reduction. But thus far, no data are available regarding investigating the impact of linagliptin treatment in patients with early diabetes on cardiovascular endpoints or surrogate parameters...
October 13, 2016: Trials
Adwoa Hughes-Morley, Bridget Young, Roelie J Hempel, Ian T Russell, Waquas Waheed, Peter Bower
BACKGROUND: Trials increasingly experience problems in recruiting participants. Understanding the causes of poor recruitment is critical to developing solutions. We interviewed people who had declined a trial of an innovative psychological therapy for depression (REFRAMED) about their response to the trial invitation, in order to understand their decision and identify ways to improve recruitment. METHODS: Of 214 people who declined the trial, 35 (16 %) gave permission to be contacted about a qualitative study to explore their decision...
October 12, 2016: Trials
Janis Baird, Mary Barker, Nicholas C Harvey, Wendy Lawrence, Christina Vogel, Megan Jarman, Rufia Begum, Tannaze Tinati, Pamela Mahon, Sofia Strommer, Taylor Rose, Hazel Inskip, Cyrus Cooper
BACKGROUND: The nutritional status and health of mothers influence the growth and development of infants during pregnancy and postnatal life. Interventions that focus on improving the nutritional status and lifestyle of mothers have the potential to optimise the development of the fetus as well as improve the health of mothers themselves. Improving the diets of women of childbearing age is likely to require complex interventions that are delivered in a socially and culturally appropriate context...
October 12, 2016: Trials
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