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Bronwyn Myers, Crick Lund, Carl Lombard, John Joska, Naomi Levitt, Christopher Butler, Susan Cleary, Tracey Naledi, Peter Milligan, Dan J Stein, Katherine Sorsdahl
BACKGROUND: In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes...
March 16, 2018: Trials
Ditte Beck Jepsen, Jesper Ryg, Niklas Rye Jørgensen, Stinus Hansen, Tahir Masud
BACKGROUND: PaVOS is a randomized controlled trial (RCT) which aims to address the use of whole-body vibration exercise (WBV) in combination with parathyroid hormone 1-34 fragment teriparatide (PTH 1-34) treatment in patients with osteoporosis. PTH 1-34 is an effective but expensive anabolic treatment for osteoporosis. WBV has been found to stimulate muscle and bone growth. Animal studies have shown a beneficial effect on bone when combining PTH 1-34 with mechanical loading. A combined treatment with PTH 1-34 and WBV may potentially have beneficial effects on bone and muscles, and reduce fracture risk...
March 16, 2018: Trials
Sarah K Schäfer, Frank R Ihmig, Karen A Lara H, Frank Neurohr, Stephan Kiefer, Marlene Staginnus, Johanna Lass-Hennemann, Tanja Michael
BACKGROUND: Specific phobias are among the most common anxiety disorders. Exposure therapy is the treatment of choice for specific phobias. However, not all patients respond equally well to it. Hence, current research focuses on therapeutic add-ons to increase and consolidate the effects of exposure therapy. One potential therapeutic add-on is biofeedback to increase heart rate variability (HRV). A recent meta-analysis shows beneficial effects of HRV biofeedback interventions on stress and anxiety symptoms...
March 16, 2018: Trials
Til Wykes, Eileen Joyce, Tjasa Velikonja, Andrew Watson, Gregory Aarons, Max Birchwood, Matteo Cella, Sue Dopson, David Fowler, Kathy Greenwood, Sonia Johnson, Paul McCrone, Jesus Perez, Andrew Pickles, Clare Reeder, Diana Rose, Swaran Singh, Dominic Stringer, Matthew Taylor, Rumina Taylor, Rachel Upthegrove
BACKGROUND: Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder...
March 15, 2018: Trials
Yaseen Arabi, Fahad Al-Hameed, Karen E A Burns, Sangeeta Mehta, Sami Alsolamy, Mohammed Almaani, Yasser Mandourah, Ghaleb A Almekhlafi, Ali Al Bshabshe, Simon Finfer, Mohammed Alshahrani, Imran Khalid, Yatin Mehta, Atul Gaur, Hassan Hawa, Hergen Buscher, Zia Arshad, Hani Lababidi, Abdulsalam Al Aithan, Jesna Jose, Sheryl Ann I Abdukahil, Lara Y Afesh, Maamoun Dbsawy, Abdulaziz Al-Dawood
BACKGROUND: The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. METHODS/DESIGN: In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group...
March 15, 2018: Trials
Fred Stephen Sarfo, Osei Sarfo-Kantanka, Sheila Adamu, Vida Obese, Jennifer Voeks, Raelle Tagge, Vipin Sethi, Bruce Ovbiagele
BACKGROUND: There is an unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA). Secondary prevention guidelines recommend that antihypertensive, statin and antiplatelet therapy be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular-risk reduction. However, these goals are seldom realized in routine clinical care settings in SSA due to logistical challenges. We seek to assess whether a polypill containing fixed doses of three antihypertensive agents, a statin and antiplatelet therapy taken once daily per os for 12 months among recent stroke survivors would result in carotid intimal thickness regression compared with usual care (UC)...
March 14, 2018: Trials
Tazeen H Jafar, Ngiap Chuan Tan, John C Allen, Eric A Finkelstein, Paul Goh, Peter Moey, Joanne Hui Min Quah, Siew Wai Hwang, Juliana Bahadin, Anandan Gerard Thiagarajah, Jason Chan, Gary Kang, Agnes Koong
BACKGROUND: Hypertension is a serious public health problem in Singapore and is associated with significant morbidity and mortality from cardiovascular disease (CVD) with considerable implications for health-care resources. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering blood pressure (BP) among adults with uncontrolled hypertension in Singapore primary-care clinics. METHODS/DESIGN: The study is a cluster randomized trial in eight polyclinics in Singapore: four deliver a structured MCI and four deliver usual care...
March 14, 2018: Trials
Antonella Cotoia, Lucia Mirabella, Sabrina Altamura, Rachele Villani, Flavia Marchese, Giuseppe Ferrara, Karim Mariano, Tullo Livio, Gilda Cinnella
BACKGROUND: Sepsis caused by complicated intra-abdominal infection is associated with high mortality. Loss of endothelial barrier integrity, inflammation, and impaired cellular oxygen have been shown to be primary contributors to sepsis. To date, little is known regarding the pathway for the mobilization of endothelial progenitor cells (EPCs) from the bone marrow in sepsis whereas stromal-cell-derived factor 1a (SDF-1a) and hypoxia inducible factor 1 (HIF-1) seem to have a role in the EPC response to hypoxic microenvironments...
March 12, 2018: Trials
Megan Rose Stafford, Mick Cooper, Michael Barkham, Jeni Beecham, Peter Bower, Karen Cromarty, Andrew J B Fugard, Charlie Jackson, Peter Pearce, Rebekah Ryder, Cathy Street
BACKGROUND: One in ten children in Britain have been identified as experiencing a diagnosable mental health disorder. School-based humanistic counselling (SBHC) may help young people identify, address, and overcome psychological distress. Data from four pilot trials suggest that SBHC may be clinically effective. However, a fully powered randomised controlled trial (RCT) is needed to provide a robust test of its effectiveness, to assess its cost-effectiveness, and to determine the process of change...
March 9, 2018: Trials
Wes Onland, Maruschka P Merkus, Debbie H Nuytemans, Marijke C Jansen-van der Weide, Rebecca Holman, Anton H van Kaam
BACKGROUND: Bronchopulmonary dysplasia (BPD) is the most common complication of preterm birth with short-term and long-term adverse consequences. Although the glucocorticoid dexamethasone has been proven to be beneficial for the prevention of BPD, there are concerns about an increased risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. The aim of the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) trial is to assess the efficacy and safety of postnatal hydrocortisone administration for the reduction of death or BPD in ventilator-dependent preterm infants...
March 9, 2018: Trials
Suneetha Kadiyala, Audrey Prost, Helen Harris-Fry, Meghan O'Hearn, Ronali Pradhan, Shibananth Pradhan, Naba Kishore Mishra, Suchitra Rath, Nirmala Nair, Shibanand Rath, Prasantha Tripathy, Sneha Krishnan, Peggy Koniz-Booher, Heather Danton, Diana Elbourne, Joanna Sturgess, Emma Beaumont, Hassan Haghparast-Bidgoli, Jolene Skordis-Worrall, Satyanarayan Mohanty, Avinash Upadhay, Elizabeth Allen
BACKGROUND: Maternal and child undernutrition have adverse consequences for pregnancy outcomes and child morbidity and mortality, and they are associated with low educational attainment, economic productivity as an adult, and human wellbeing. 'Nutrition-sensitive' agriculture programs could tackle the underlying causes of undernutrition. METHODS/DESIGN: This study is a four-arm cluster randomised controlled trial in Odisha, India. Interventions are as follows: (1) an agricultural extension platform of women's groups viewing and discussing videos on nutrition-sensitive agriculture (NSA) practices, and follow-up visits to women at home to encourage the adoption of new practices shown in the videos; (2) women's groups viewing and discussing videos on NSA and nutrition-specific practices, with follow-up visits; and (3) women's groups viewing and discussing videos on NSA and nutrition-specific practices combined with a cycle of Participatory Learning and Action meetings, with follow-up visits...
March 9, 2018: Trials
Yun Dong, Dax Steins, Shanbin Sun, Fei Li, James D Amor, Christopher J James, Zhidao Xia, Helen Dawes, Hooshang Izadi, Yi Cao, Derick T Wade
BACKGROUND: Practicing activities improves recovery after stroke, but many people in hospital do little activity. Feedback on activity using an accelerometer is a potential method to increase activity in hospital inpatients. This study's goal is to investigate the effect of feedback, enabled by a Smart watch, on daily physical activity levels during inpatient stroke rehabilitation and the short-term effects on simple functional activities, primarily mobility. METHODS/DESIGN: A randomized controlled trial will be undertaken within the stroke rehabilitation wards of the Second Affiliated hospital of Anhui University of Traditional Chinese Medicine, Hefei, China...
March 9, 2018: Trials
Gilles Defer, Florian Le Caignec, Sophie Fedrizzi, François Montastruc, Damien Chevanne, Jean-Jacques Parienti, Laure Peyro-Saint-Paul
BACKGROUND: The reporting of adverse drug reactions (ADR) by patients represents an interesting challenge in the field of pharmacovigilance, but the reporting system is not adequately implemented in France. In 2015, only 20 MS patients in France reported ADR due to first-line disease-modifying drugs (DMD), while more than 3000 patients were initiated on DMD. The aim of this study is to validate a proof-of-concept as to whether the use of a mobile application (App) increases ADR reporting among patients with relapsing-remitting multiple sclerosis (RR-MS) receiving DMD...
March 9, 2018: Trials
Alina Striha, A John Ashcroft, Anna Hockaday, David A Cairns, Karen Boardman, Gwen Jacques, Cathy Williams, John A Snowden, Mamta Garg, Jamie Cavenagh, Kwee Yong, Mark T Drayson, Roger Owen, Mark Cook, Gordon Cook
BACKGROUND: Multiple myeloma (MM) is a plasma cell tumour with an approximate annual incidence of 4500 in the UK. Therapeutic options for patients with MM have changed in the last decade with the arrival of proteasome inhibitors and immunomodulatory drugs. Despite these options, almost all patients will relapse post first-line autologous stem cell transplantation (ASCT). First relapse management (second-line treatment) has evolved in recent years with an expanding portfolio of novel agents, driving response rates influencing the durability of response...
March 7, 2018: Trials
Yuchi Wu, Lihong Yang, Lingli Li, Xiuqing Wu, Zhicong Zhong, Zhiren He, Hongyan Ma, Lixin Wang, Zhaoyu Lu, Cun Cai, Daixin Zhao, Xiangxin Meng, Airong Qi, Aicheng Yang, Guobin Su, Xinfeng Guo, Xusheng Liu, Chuan Zou, Qizhan Lin
BACKGROUND: Patients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. Previously we applied auricular acupressure therapy (AAT) for MHD patients with insomnia and yielded favorable results. AAT probably improves sleep quality by stimulating the vagus nerve and inhibiting sympathetic overactivity. However, the efficacy of AAT for insomnia in this population is still lacking. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia...
March 7, 2018: Trials
Mariana Brussoni, Takuro Ishikawa, Christina Han, Ian Pike, Anita Bundy, Guy Faulkner, Louise C Mâsse
BACKGROUND: Children's risky play is associated with a variety of positive developmental, physical and mental health outcomes, including greater physical activity, self-confidence and risk-management skills. Children's opportunities for risky play have eroded over time, limited by parents' fears and beliefs about risk, particularly among mothers. We developed a digital tool and in-person Risk-reframing (RR) workshop to reframe parents' perceptions of risk and change parenting behaviours...
March 7, 2018: Trials
Farid Froghi, Rahul Koti, Kurinchi Gurusamy, Susan Mallett, Douglas Thorburn, Linda Selves, Sarah James, Jeshika Singh, Manuel Pinto, Christine Eastgate, Margaret McNeil, Helder Filipe, Fatima Jichi, Nick Schofield, Daniel Martin, Brian Davidson
BACKGROUND: Patients with liver cirrhosis undergoing liver transplantation have a hyperdynamic circulation which persists into the early postoperative period making accurate assessment of fluid requirements challenging. Goal-directed fluid therapy (GDFT) has been shown to reduce morbidity and mortality in a number of surgery settings. The impact of GDFT in patients undergoing liver transplantation is unknown. A feasibility trial was designed to determine patient and clinician support for recruitment into a randomised controlled trial of GDFT following liver transplantation, adherence to a GDFT protocol, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate the efficacy of GDFT in patients undergoing liver transplantation...
March 7, 2018: Trials
Vitor Barreto Paravidino, Mauro Felippe Felix Mediano, Inácio Crochemore M Silva, Andrea Wendt, Fabrício Boscolo Del Vecchio, Fabiana Alves Neves, Bruno de Souza Terra, Erika Alvarenga Corrêa Gomes, Anibal Sanchez Moura, Rosely Sichieri
BACKGROUND: Physical exercise interventions have been extensively advocated for the treatment of obesity; however, clinical trials evaluating the effectiveness of exercise interventions on weight control show controversial results. Compensatory mechanisms through a decrease in energy expenditure and/or an increase in caloric consumption is a possible explanation. Several physiological mechanisms involved in the energy balance could explain compensatory mechanisms, but the influences of physical exercise on these adjustments are still unclear...
March 7, 2018: Trials
Heather Burroughs, Bernadette Bartlam, Mo Ray, Tom Kingstone, Tom Shepherd, Reuben Ogollah, Janine Proctor, Waquas Waheed, Peter Bower, Peter Bullock, Karina Lovell, Simon Gilbody, Della Bailey, Stephanie Butler-Whalley, Carolyn Chew-Graham
BACKGROUND: Anxiety and depression are common among older people, with up to 20% reporting such symptoms, and the prevalence increases with co-morbid chronic physical health problems. Access to treatment for anxiety and depression in this population is poor due to a combination of factors at the level of patient, practitioner and healthcare system. There is evidence to suggest that older people with anxiety and/or depression may benefit both from one-to-one interventions and group social or educational activities, which reduce loneliness, are participatory and offer some activity...
March 7, 2018: Trials
Tai-Wa Liu, Gabriel Y F Ng, Shamay S M Ng
BACKGROUND: The consequences of falls are devastating for patients with stroke. Balance problems and fear of falling are two major challenges, and recent systematic reviews have revealed that habitual physical exercise training alone cannot reduce the occurrence of falls in stroke survivors. However, recent trials with community-dwelling healthy older adults yielded the promising result that interventions with a cognitive behavioral therapy (CBT) component can simultaneously promote balance and reduce the fear of falling...
March 7, 2018: Trials
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