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https://www.readbyqxmd.com/read/28228148/the-effect-of-melatonin-on-depressive-symptoms-anxiety-circadian-and-sleep-disturbances-in-patients-after-acute-coronary-syndrome-medacis-study-protocol-for-a-randomized-controlled-trial
#1
Michael Tvilling Madsen, Anders Isbrand, Ulla Overgaard Andersen, Lars Juel Andersen, Mustafa Taskiran, Erik Simonsen, Ismail Gögenur
BACKGROUND: Depression following acute coronary syndrome (ACS) constitutes a serious and debilitating problem. Approximately one in five patients will develop significant depression following ACS and less severe depressive symptoms are even more frequent. Furthermore, anxiety symptoms and sleep-wake disturbances are frequent. The objective of the MEDACIS trial is to investigate whether prophylactic treatment with melatonin has a preventive effect on depression, depressive and anxiety symptoms, sleep, and circadian disturbances following ACS...
February 23, 2017: Trials
https://www.readbyqxmd.com/read/28228162/efficacy-and-safety-of-indacaterol-glycopyrronium-fixed-dose-combination-in-mild-to-moderate-copd-patients-symptomatic-on-tiotropium-in-korea-study-protocol-for-a-randomized-controlled-trial
#2
Chin Kook Rhee, Hye Yun Park, Jeong-Woong Park, Ji-Hyun Lee, Tae-Hyung Kim, Sei Won Lee, Ji Ye Jung, Song Kim, Yong Il Hwang, Ki-Suck Jung
BACKGROUND: Long-acting bronchodilator monotherapy (long-acting β2-agonist [LABA] or long-acting muscarinic antagonist [LAMA]) is extensively used for treatment of patients with chronic obstructive pulmonary disease (COPD) with mild-to-moderate airflow limitation. However, a substantial number of patients remain symptomatic despite treatment with a single bronchodilator, necessitating a change in therapy. METHODS: This 12-week, randomized, multicenter, open-label, phase IV study aims to show that the once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 μg fixed-dose LABA/LAMA combination results in an improved lung function in symptomatic patients with mild-to-moderate COPD who switch from once-daily tiotropium 18 μg...
February 22, 2017: Trials
https://www.readbyqxmd.com/read/28228151/unravelling-effectiveness-of-a-nurse-led-behaviour-change-intervention-to-enhance-physical-activity-in-patients-at-risk-for-cardiovascular-disease-in-primary-care-study-protocol-for-a-cluster-randomised-controlled-trial
#3
Heleen Westland, Irene D Bos-Touwen, Jaap C A Trappenburg, Carin D Schröder, Niek J de Wit, Marieke J Schuurmans
BACKGROUND: Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease...
February 22, 2017: Trials
https://www.readbyqxmd.com/read/28222805/use-of-activity-tracking-in-major-visceral-surgery-the-enhanced-perioperative-mobilization-epm-trial-study-protocol-for-a-randomized-controlled-trial
#4
Steffen Wolk, Theresa Meißner, Sebastian Linke, Benjamin Müssle, Ann Wierick, Andreas Bogner, Dorothée Sturm, Nuh N Rahbari, Marius Distler, Jürgen Weitz, Thilo Welsch
BACKGROUND: Enhanced recovery after surgery (ERAS) programs are aimed at minimizing postoperative stress and accelerating postoperative recovery by implementing multiple perioperative principles. "Early mobilization" is one such principle, but the quality of assessment and monitoring is poor, and evidence of improved outcome is lacking. Activity trackers allow precise monitoring and automatic feedback to the patients to enhance their motivation for early mobilization. The aim of the study is to monitor and increase the postoperative mobilization of patients by giving them continuous automatic feedback in the form of a step count using activity-tracking wristbands...
February 21, 2017: Trials
https://www.readbyqxmd.com/read/28222779/magnetic-resonance-imaging-for-cerebral-lesions-during-minimal-invasive-mitral-valve-surgery-study-protocol-for-a-randomized-controlled-trial
#5
Cristina Barbero, Davide Ricci, Erik Cura Stura, Augusto Pellegrini, Giovanni Marchetto, Suad ElQarra, Massimo Boffini, Roberto Passera, Maria Consuelo Valentini, Mauro Rinaldi
BACKGROUND: Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp...
February 21, 2017: Trials
https://www.readbyqxmd.com/read/28222778/sample-size-considerations-for-trials-using-cerebral-white-matter-hyperintensity-progression-as-an-intermediate-outcome-at-1%C3%A2-year-after-mild-stroke-results-of-a-prospective-cohort-study
#6
Francesca M Chappell, Maria Del Carmen Valdés Hernández, Stephen D Makin, Kirsten Shuler, Eleni Sakka, Martin S Dennis, Paul A Armitage, Susana Muñoz Maniega, Joanna M Wardlaw
BACKGROUND: White matter hyperintensities (WMHs) are commonly seen on in brain imaging and are associated with stroke and cognitive decline. Therefore, they may provide a relevant intermediate outcome in clinical trials. WMH can be measured as a volume or visually on the Fazekas scale. We investigated predictors of WMH progression and design of efficient studies using WMH volume and Fazekas score as an intermediate outcome. METHODS: We prospectively recruited 264 patients with mild ischaemic stroke and measured WMH volume, Fazekas score, age and cardiovascular risk factors at baseline and 1 year...
February 21, 2017: Trials
https://www.readbyqxmd.com/read/28219403/the-kiva-antibullying-program-in-primary-schools-in-chile-with-and-without-the-digital-game-component-study-protocol-for-a-randomized-controlled-trial
#7
Jorge Gaete, Daniela Valenzuela, Cristian Rojas-Barahona, Eduardo Valenzuela, Ricardo Araya, Christina Salmivalli
BACKGROUND: Bullying is a major problem worldwide and Chile is no exception. Bullying is defined as a systematic aggressive behavior against a victim who cannot defend him or herself. Victims suffer social isolation and psychological maladjustment, while bullies have a higher risk for conduct problems and substance use disorders. These problems appear to last over time. The KiVa antibullying program has been evaluated in Finland and other European countries, showing preventive effects on victimization and self-reported bullying...
February 20, 2017: Trials
https://www.readbyqxmd.com/read/28209175/effectiveness-of-topical-silicone-gel-and-pressure-garment-therapy-for-burn-scar-prevention-and-management-in-children-study-protocol-for-a-randomised-controlled-trial
#8
Jodie Wiseman, Megan Simons, Roy Kimble, Robert Ware, Steven McPhail, Zephanie Tyack
BACKGROUND: Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently, no definitive, high-quality evidence is available for the effectiveness of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population...
February 16, 2017: Trials
https://www.readbyqxmd.com/read/28209169/vascular-impulse-technology-versus-elevation-in-the-treatment-of-posttraumatic-swelling-of-extremity-fractures-study-protocol-for-a-randomized-controlled-trial
#9
Marc Schnetzke, Benedict Swartman, Isabel Bonnen, Holger Keil, Svenja Schüler, Paul A Grützner, Jochen Franke
BACKGROUND: Fractures of the extremities are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury. Patients typically require up to 7 days of inpatient bed rest and elevation to reduce swelling to an acceptable level for operative treatment with internal fixation. Alternatively, an intermittent pneumatic compression device, such as the Vascular Impulse Technology (VIT) system, can be used at the injured extremity to reduce the posttraumatic swelling...
February 16, 2017: Trials
https://www.readbyqxmd.com/read/28209167/erratum-to-the-effectiveness-of-the-peer-delivered-thinking-healthy-plus-thpp-programme-for-maternal-depression-and-child-socio-emotional-development-in-pakistan-study-protocol-for-a-three-year-cluster-randomized-controlled-trial
#10
Elizabeth L Turner, Siham Sikander, Omer Bangash, Ahmed Zaidi, Lisa Bates, John Gallis, Nima Ganga, Karen O'Donnell, Atif Rahman, Joanna Maselko
No abstract text is available yet for this article.
February 16, 2017: Trials
https://www.readbyqxmd.com/read/28196540/challenges-to-complete-and-useful-data-sharing
#11
LETTER
Lawrence Mbuagbaw, Gary Foster, Ji Cheng, Lehana Thabane
Data sharing from clinical trials is one way of promoting fair and transparent conduct of clinical trials. It would maximise the use of data and permit the exploration of additional hypotheses. On the other hand, the quality of secondary analyses cannot always be ascertained, and it may be unfair to investigators who have expended resources to collect data to bear the additional burden of sharing. As the discussion on the best modalities of sharing data evolves, some of the practical issues that may arise need to be addressed...
February 14, 2017: Trials
https://www.readbyqxmd.com/read/28196512/a-core-outcome-set-for-evaluating-self-management-interventions-in-people-with-comorbid-diabetes-and-severe-mental-illness-study-protocol-for-a-modified-delphi-study-and-systematic-review
#12
Johanna Taylor, Jan R Böhnke, Judy Wright, Ian Kellar, Sarah L Alderson, Tom Hughes, Richard I G Holt, Najma Siddiqi
BACKGROUND: People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health...
February 14, 2017: Trials
https://www.readbyqxmd.com/read/28193288/accreditation-in-general-practice-in-denmark-study-protocol-for-a-cluster-randomized-controlled-trial
#13
Merethe K Andersen, Line B Pedersen, Volkert Siersma, Flemming Bro, Susanne Reventlow, Jens Søndergaard, Marius Brostrøm Kousgaard, Frans B Waldorff
BACKGROUND: Accreditation is used increasingly in health systems worldwide. However, there is a lack of evidence on the effects of accreditation, particularly in general practice. In 2016 a mandatory accreditation scheme was initiated in Denmark, and during a 3-year period all practices, as default, should undergo accreditation according to the Danish Healthcare Quality Program. The aim of this study is primarily to evaluate the effects of a mandatory accreditation scheme. METHODS/DESIGN: The study is conducted as a cluster-randomized controlled trial among 1252 practices (clusters) with 2211 general practitioners in Denmark...
February 13, 2017: Trials
https://www.readbyqxmd.com/read/28193240/substitution-of-ethambutol-with-linezolid-during-the-intensive-phase-of-treatment-of-pulmonary-tuberculosis-study-protocol-for-a-prospective-multicenter-randomized-open-label-phase-ii-trial
#14
Ji Yeon Lee, Deog Kyeom Kim, Jung-Kyu Lee, Ho Il Yoon, Ina Jeong, Eunyoung Heo, Young Sik Park, Jae Ho Lee, Sung Soo Park, Sang-Min Lee, Chang-Hoon Lee, Jinwoo Lee, Sun Mi Choi, Jong Sun Park, Joon-Sung Joh, Young-Jae Cho, Yeon Joo Lee, Se Joong Kim, Young Ran Hwang, Hyeonjeong Kim, Jongeun Ki, Hyungsook Choi, Jiyeon Han, Heejung Ahn, Seokyung Hahn, Jae-Joon Yim
BACKGROUND: Linezolid, an oxazolidinone, substantially improves treatment outcomes of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. We started a trial to test whether the use of linezolid instead of ethambutol could increase the rate of sputum culture conversion as of 8 weeks of treatment in patients with drug-susceptible tuberculosis. METHODS/DESIGN: This is a phase II, multicenter, randomized study with three arms. We are enrolling patients with pulmonary tuberculosis without rifampicin resistance screened by the Xpert MTB/RIF® assay...
February 13, 2017: Trials
https://www.readbyqxmd.com/read/28183335/efficacy-of-vitamin-d3-supplementation-in-reducing-incidence-of-pulmonary-tuberculosis-and-mortality-among-hiv-infected-tanzanian-adults-initiating-antiretroviral-therapy-study-protocol-for-a-randomized-controlled-trial
#15
Christopher R Sudfeld, Ferdinand Mugusi, Said Aboud, Tumaini J Nagu, Molin Wang, Wafaie W Fawzi
BACKGROUND: HIV-infected adults initiating antiretroviral therapy (ART) in sub-Saharan Africa continue to experience high rates of morbidity and mortality during the initial months of treatment. Observational studies in high-income and resource-limited settings indicate that HIV-infected adults with low vitamin D levels may be at increased risk of mortality, HIV disease progression, and incidence of pulmonary tuberculosis (TB). As a result, vitamin D3 supplementation may improve survival and treatment outcomes for HIV-infected adults initiating ART...
February 10, 2017: Trials
https://www.readbyqxmd.com/read/28183326/the-immune-response-to-6-monthly-versus-annual-standard-dose-inactivated-trivalent-influenza-vaccination-in-older-people-study-protocol-for-a-randomised-clinical-trial
#16
Barnaby Young, Sapna Sadarangani, Haur Sen Yew, Chee Fu Yung, Yee Sin Leo, Mark I-Cheng Chen, Annelies Wilder-Smith
BACKGROUND: The seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activity. This study aims to assess the effect of a trivalent inactivated influenza vaccine (IIV3) booster at 180 days on haemagglutination-inhibition (HI) antibody titres for each of the influenza strains present in the administered vaccine in older people aged 65 years or above in Singapore...
February 10, 2017: Trials
https://www.readbyqxmd.com/read/28183355/transcranial-magnetic-stimulation-for-tinnitus-using-the-tinnitus-functional-index-to-predict-benefit-in-a-randomized-controlled-trial
#17
LETTER
Sarah M Theodoroff, Susan E Griest, Robert L Folmer
BACKGROUND: Identifying characteristics associated with transcranial magnetic stimulation (TMS) benefit would offer insight as to why some individuals experience tinnitus relief following TMS treatment, whereas others do not. The purpose of this study was to use the Tinnitus Functional Index (TFI) and its subscales to identify specific factors associated with TMS treatment responsiveness. METHODS: Individuals with bothersome tinnitus underwent 2000 pulses of 1-Hz TMS for 10 consecutive business days...
February 9, 2017: Trials
https://www.readbyqxmd.com/read/28183347/application-of-incident-command-structure-to-clinical-trial-management-in-the-academic-setting-principles-and-lessons-learned
#18
Penny S Reynolds, Mary J Michael, Bruce D Spiess
BACKGROUND: Clinical trial success depends on appropriate management, but practical guidance to trial organisation and planning is lacking. The Incident Command System (ICS) is the 'gold standard' management system developed for managing diverse operations in major incident and public health arenas. It enables effective and flexible management through integration of personnel, procedures, resources, and communications within a common hierarchical organisational structure. Conventional ICS organisation consists of five function modules: Command, Planning, Operations, Logistics, and Finance/Administration...
February 9, 2017: Trials
https://www.readbyqxmd.com/read/28183323/the-tech-home-study-a-technological-intervention-to-reduce-caregiver-burden-for-informal-caregivers-of-people-with-dementia-study-protocol-for-a-randomized-controlled-trial
#19
Agneta Malmgren Fänge, Steven M Schmidt, Maria H Nilsson, Gunilla Carlsson, Anna Liwander, Caroline Dahlgren Bergström, Paolo Olivetti, Per Johansson, Carlos Chiatti
BACKGROUND: It is estimated that global dementia rates will more than triple by 2050 and result in a staggering economic burden on families and societies. Dementia carries significant physical, psychological and social challenges for individuals and caregivers. Informal caregiving is common and increasing as more people with dementia are being cared for at home instead of in nursing homes. Caregiver burden is associated with lower perceived health, lower social coherence, and increased risk of morbidity and mortality...
February 9, 2017: Trials
https://www.readbyqxmd.com/read/28183322/impact-of-a-pharmacist-led-medication-review-on-hospital-readmission-in-a-pediatric-and-elderly-population-study-protocol-for-a-randomized-open-label-controlled-trial
#20
Pierre Renaudin, Karine Baumstarck, Aurélie Daumas, Marie-Anne Esteve, Stéphane Gayet, Pascal Auquier, Michel Tsimaratos, Patrick Villani, Stéphane Honore
BACKGROUND: Early hospital readmission of patients after discharge is a public health problem. One major cause of hospital readmission is dysfunctions in integrated pathways between community and hospital care that can cause adverse drug events. Furthermore, the French ENEIS 2 study showed that 1.3% of hospital stays originated from serious adverse drug events in 2009. Pharmacy-led medication reviews at hospital transitions are an effective means of decreasing medication discrepancies when conducted at admission or discharge...
February 9, 2017: Trials
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