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Randomised control trial

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https://www.readbyqxmd.com/read/29352723/which-hiv-infected-adults-with-high-cd4-t-cell-counts-benefit-most-from-immediate-initiation-of-antiretroviral-therapy-a-post-hoc-subgroup-analysis-of-the-start-trial
#1
Jean-Michel Molina, Birgit Grund, Fred Gordin, Ian Williams, Mauro Schechter, Marcello Losso, Matthew Law, Ernest Ekong, Noluthando Mwelase, Athanasios Skoutelis, Martin J Wiselka, Linos Vandekerckhove, Thomas Benfield, David Munroe, Jens D Lundgren, James D Neaton
BACKGROUND: Immediate initiation of antiretroviral therapy (ART) in asymptomatic adults with CD4 counts higher than 500 cells per μL, as recommended, might not always be possible in resource-limited settings. We aimed to identify subgroups of individuals who would benefit most from immediate treatment. METHODS: The START trial was a randomised controlled trial in asymptomatic, HIV-positive adults previously untreated with ART. Participants with CD4 counts higher than 500 cells per μL were randomly assigned to receive immediate ART or to defer ART until CD4 counts were lower than 350 cells per μL...
January 15, 2018: Lancet HIV
https://www.readbyqxmd.com/read/29352704/treatment-of-adult-chronic-indeterminate-chagas-disease-with-benznidazole-and-three-e1224-dosing-regimens-a-proof-of-concept-randomised-placebo-controlled-trial
#2
Faustino Torrico, Joaquim Gascon, Lourdes Ortiz, Cristina Alonso-Vega, María-Jesús Pinazo, Alejandro Schijman, Igor C Almeida, Fabiana Alves, Nathalie Strub-Wourgaft, Isabela Ribeiro
BACKGROUND: Chagas disease is a major neglected vector-borne disease. In this study, we investigated the safety and efficacy of three oral E1224 (a water-soluble ravuconazole prodrug) regimens and benznidazole versus placebo in adult chronic indeterminate Chagas disease. METHOD: In this proof-of-concept, double-blind, randomised phase 2 clinical trial, we recruited adults (18-50 years) with confirmed diagnosis of Trypanosoma cruzi infection from two outpatient units in Bolivia...
January 15, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29352578/a-physiotherapist-led-exercise-and-education-program-for-preventing-recurrence-of-low-back-pain-a-randomised-controlled-pilot-trial
#3
Matthew L Stevens, Chung-Wei C Lin, Mark J Hancock, Trish Wisby-Roth, Jane Latimer, Chris G Maher
BACKGROUND: Before beginning a large and complex trial it is considered good practice to run a pilot study to assess the feasibility and acceptability so that quality is maintained and resources are not wasted. OBJECTIVE: To assesses the feasibility and acceptability of procedures for TOPS: Trial Of Prevention Strategies for low back pain. DESIGN: Randomised controlled pilot trial. METHODS: This is a trial of an 8 week, physiotherapist-led group exercise and education program for preventing recurrence of low back pain (LBP) in those recently recovered from LBP...
September 1, 2017: Physiotherapy
https://www.readbyqxmd.com/read/29352477/benzodiazepines-for-antipsychotic-induced-tardive-dyskinesia
#4
REVIEW
Hanna Bergman, Paranthaman S Bhoopathi, Karla Soares-Weiser
BACKGROUND: Tardive dyskinesia (TD) is a disfiguring movement disorder, often of the orofacial region, frequently caused by using antipsychotic drugs. A wide range of strategies have been used to help manage TD, and for those who are unable to have their antipsychotic medication stopped or substantially changed, the benzodiazepine group of drugs have been suggested as a useful adjunctive treatment. However, benzodiazepines are very addictive. OBJECTIVES: To determine the effects of benzodiazepines for antipsychotic-induced tardive dyskinesia in people with schizophrenia, schizoaffective disorder, or other chronic mental illnesses...
January 20, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29351865/interventions-to-support-effective-communication-between-maternity-care-staff-and-women-in-labour-a-mixed-methods-systematic-review
#5
Yan-Shing Chang, Kirstie Coxon, Anayda Gerarda Portela, Marie Furuta, Debra Bick
OBJECTIVES: the objectives of this review were (1) to assess whether interventions to support effective communication between maternity care staff and healthy women in labour with a term pregnancy could improve birth outcomes and experiences of care; and (2) to synthesize information related to the feasibility of implementation and resources required. DESIGN: a mixed-methods systematic review. SETTING AND PARTICIPANTS: studies which reported on interventions aimed at improving communication between maternity care staff and healthy women during normal labour and birth, with no apparent medical or obstetric complications, and their family members were included...
December 27, 2017: Midwifery
https://www.readbyqxmd.com/read/29351861/improving-implementation-of-evidence-based-practice-for-people-with-psychosis-through-training-the-wider-workforce-results-of-the-goals-feasibility-randomised-controlled-trial
#6
Helen Waller, Sabine Landau, Miriam Fornells-Ambrojo, Suzanne Jolley, Paul McCrone, Rikesh Halkoree, Nedah Basit, Catherine Iredale, Catherine Tunnard, Darshan Zala, Tom J K Craig, Philippa Garety
BACKGROUND AND OBJECTIVES: There is a pressing need to improve access to evidence-based practice for people with psychosis. The primary aim of this study was to assess clinical feasibility of a manualised, evidence-based CBT intervention (GOALS) targeting a personalised recovery goal, delivered by the frontline workforce, following brief training. Secondly, we aimed to conduct preliminary statistical analyses of key outcomes and costs. METHODS: The GOALS study is a feasibility randomised controlled trial (ISRCTN 73188383)...
December 21, 2017: Journal of Behavior Therapy and Experimental Psychiatry
https://www.readbyqxmd.com/read/29351792/successful-recruitment-to-trials-findings-from-the-scimitar-trial
#7
Emily Peckham, Catherine Arundel, Della Bailey, Tracy Callen, Christina Cusack, Suzanne Crosland, Penny Foster, Hannah Herlihy, James Hope, Suzy Ker, Tayla McCloud, Crystal-Bella Romain-Hooper, Alison Stribling, Peter Phiri, Ellen Tait, Simon Gilbody
BACKGROUND: Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations...
January 19, 2018: Trials
https://www.readbyqxmd.com/read/29351790/development-of-a-framework-to-improve-the-process-of-recruitment-to-randomised-controlled-trials-rcts-the-sear-screened-eligible-approached-randomised-framework
#8
Caroline Wilson, Leila Rooshenas, Sangeetha Paramasivan, Daisy Elliott, Marcus Jepson, Sean Strong, Alison Birtle, David J Beard, Alison Halliday, Freddie C Hamdy, Rebecca Lewis, Chris Metcalfe, Chris A Rogers, Robert C Stein, Jane M Blazeby, Jenny L Donovan
BACKGROUND: Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment. METHODS: Eight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study...
January 19, 2018: Trials
https://www.readbyqxmd.com/read/29351760/glycaemic-control-targets-after-traumatic-brain-injury-a-systematic-review-and-meta-analysis
#9
Jeroen Hermanides, Mark P Plummer, Mark Finnis, Adam M Deane, Jonathan P Coles, David K Menon
BACKGROUND: Optimal glycaemic targets in traumatic brain injury (TBI) remain unclear. We performed a systematic review and meta-analysis of randomised controlled trials (RCTs) comparing intensive with conventional glycaemic control in TBI requiring admission to an intensive care unit (ICU). METHODS: We systematically searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials to November 2016. Outcomes of interest included ICU and in-hospital mortality, poor neurological outcome, the incidence of hypoglycaemia and infective complications...
January 19, 2018: Critical Care: the Official Journal of the Critical Care Forum
https://www.readbyqxmd.com/read/29351594/sero-efficacy-of-vi-polysaccharide-tetanus-toxoid-typhoid-conjugate-vaccine-typbar-tcv
#10
Merryn Voysey, Andrew J Pollard
Background: Salmonella Typhi is the major cause of enteric fever in lower income countries. New conjugate vaccines show promise as public health interventions, however there are no efficacy data available from endemic areas. Methods: Data were obtained from a previously published phase 3 randomised controlled trial comparing Vi-polysaccharide tetanus-toxoid conjugate vaccine (Typbar-TCV; Bharat Biotech Intl Ltd, India): (Vi-TT) with Vi-polysaccharide (Typbar; Bharat Biotech Intl Ltd, India): (Vi-PS) in participants aged 2- 45 years...
January 17, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29351310/healthy-ageing-at-work-efficacy-of-group-interventions-on-the-mental-health-of-nurses-aged-45-and-older-results-of-a-randomised-controlled-trial
#11
Imad Maatouk, Andreas Müller, Peter Angerer, Renate Schmook, Christoph Nikendei, Kirsten Herbst, Melanie Gantner, Wolfgang Herzog, Harald Gündel
OBJECTIVE: This multicentre, randomised controlled trial (RCT) aimed to evaluate the efficacy of a small-group intervention promoting successful ageing at work in older nurses (aged ≥45). METHOD: A sample of 115 nurses aged ≥45 from 4 trial sites in Germany were randomly assigned to either the intervention group (IG), that received a small-group intervention of seven weekly sessions of 120 min with a booster session after six weeks or to a wait-list control condition (WLC)...
2018: PloS One
https://www.readbyqxmd.com/read/29351295/effects-of-a-population-based-person-centred-and-integrated-care-service-on-health-wellbeing-and-self-management-of-community-living-older-adults-a-randomised-controlled-trial-on-embrace
#12
Sophie L W Spoorenberg, Klaske Wynia, Ronald J Uittenbroek, Hubertus P H Kremer, Sijmen A Reijneveld
OBJECTIVE: To evaluate the effects of the population-based, person-centred and integrated care service 'Embrace' at twelve months on three domains comprising health, wellbeing and self-management among community-living older people. METHODS: Embrace supports older adults to age in place. A multidisciplinary team provides care and support, with intensity depending on the older adults' risk profile. A randomised controlled trial was conducted in fifteen general practices in the Netherlands...
2018: PloS One
https://www.readbyqxmd.com/read/29350565/safety-and-efficacy-of-denosumab-in-osteoporotic-patients-previously-treated-with-other-medications-a-systematic-review-and-meta-analysis
#13
Andreas Fontalis, Kenanidis Eustathios, Efthymia Prousali, Potoupnis Michael, Tsiridis Eleftherios
Denosumab is a monoclonal antibody that received approval by the FDA for the treatment of osteoporosis in 2010. Available higher level research evidence concerns the treatment of patients that have not received any anti-osteoporotic medication in the past. Further investigation is warranted, since clinicians often face the challenge of administering the most efficacious drug in patients, pretreated with other medications. Areas Covered: We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of denosumab compared to other active anti-osteoporotic agents in patients formerly receiving other treatments...
January 19, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29350536/diagnostic-accuracy-of-functional-imaging-and-biochemical-tests-for-patients-presenting-with-chest-pain-to-the-emergency-department-a-systematic-review-and-meta-analysis
#14
Mario Iannaccone, Sebastiano Gili, Ovidio De Filippo, Salvatore D'Amico, Marco Gagliardi, Maurizio Bertaina, Silvia Mazzilli, Sara Rettegno, Federica Bongiovanni, Paolo Gatti, Fabrizio Ugo, Giacomo G Boccuzzi, Salvatore Colangelo, Silvia Prato, Claudio Moretti, Maurizio D'Amico, Patrizia Noussan, Roberto Garbo, David Hildick-Smith, Fiorenzo Gaita, Fabrizio D'Ascenzo
BACKGROUND: Non-invasive ischaemia tests and biomarkers are widely adopted to rule out acute coronary syndrome in the emergency department. Their diagnostic accuracy has yet to be precisely defined. METHODS: Medline, Cochrane Library CENTRAL, EMBASE and Biomed Central were systematically screened (start date 1 September 2016, end date 1 December 2016). Prospective studies (observational or randomised controlled trial) comparing functional/imaging or biochemical tests for patients presenting with chest pain to the emergency department were included...
January 1, 2018: European Heart Journal. Acute Cardiovascular Care
https://www.readbyqxmd.com/read/29350249/efficacy-of-phloroglucinol-for-treatment-of-abdominal-pain-a-systematic-review-of-literature-and-meta-analysis-of-randomised-controlled-trials-versus-placebo
#15
REVIEW
Clara Blanchard, Denis Pouchain, Paul Vanderkam, Marie-Christine Perault-Pochat, Rémy Boussageon, Hélène Vaillant-Roussel
AIM: Phloroglucinol is a musculotropic anti-spasmodic drug. It is frequently prescribed in many European countries with a considerable cost for health services. The purpose of this study was to review the existing randomised controlled trials (RCT) comparing the efficacy of phloroglucinol treating abdominal pain versus placebo. METHODS: A literature search was carried out up to May 2017 to select RCT comparing the effect of phloroglucinol versus placebo with intensity of abdominal pain as an endpoint...
January 19, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29349868/workplace-alcohol-harm-reduction-intervention-in-australia-cluster-non-randomised-controlled-trial
#16
Ken Pidd, Ann Roche, Jacqui Cameron, Nicole Lee, Linda Jenner, Vinita Duraisingam
INTRODUCTION AND AIMS: The workplace holds substantial potential as an alcohol harm reduction and prevention setting. Few studies have rigorously examined strategies to reduce workplace alcohol-related harm. Hence, an in-situ 3 year trial of a comprehensive alcohol harm reduction intervention in Australian manufacturing workplaces was undertaken. DESIGN AND METHODS: Informed by a gap analysis, a multi-site trial was undertaken. Three manufacturing industry companies, located at four separate worksites, with a minimum of 100 employees were recruited through a local industry network...
January 18, 2018: Drug and Alcohol Review
https://www.readbyqxmd.com/read/29349674/extracorporeal-life-support-in-cardiogenic-shock-indications-and-management-in-current-practice
#17
REVIEW
C L Meuwese, F Z Ramjankhan, S A Braithwaite, N de Jonge, M de Jong, M P Buijsrogge, J G D Janssen, C Klöpping, J H Kirkels, D W Donker
Veno-arterial extracorporeal life support (VA-ECLS) provides circulatory and respiratory stabilisation in patients with severe refractory cardiogenic shock. Although randomised controlled trials are lacking, the use of VA-ECLS is increasing and observational studies repeatedly have shown treatment benefits in well-selected patients. Current clinical challenges in VA-ECLS relate to optimal management of the individual patient on extracorporeal support given its inherent complexity. In this review article we will discuss indications, daily clinical management and complications of VA-ECLS in cardiogenic shock refractory to conventional treatment strategies...
January 18, 2018: Netherlands Heart Journal
https://www.readbyqxmd.com/read/29349644/does-statin-benefits-patients-with-heart-failure-undergoing-percutaneous-coronary-intervention-findings-from-the-melbourne-interventional-group-registry
#18
Ken Lee Chin, Rory Wolfe, Christopher M Reid, Andrew Tonkin, Ingrid Hopper, Angela Brennan, Nick Andrianopoulos, Stephen J Duffy, David Clark, Andrew Ajani, Danny Liew
PURPOSE: The effectiveness of statins in improving clinical outcomes among patients with heart failure (HF) undergoing percutaneous coronary intervention (PCI) is unclear. We examined the association between use of statins and clinical outcomes in patients with HF included in the Melbourne Interventional Group registry. METHODS: Patients were followed from 30 days to 1 year post-PCI for a primary composite outcome of all-cause mortality and hospitalisation for cardiovascular (CV) causes...
January 18, 2018: Cardiovascular Drugs and Therapy
https://www.readbyqxmd.com/read/29349285/a-smart-phone-intervention-to-address-mental-health-stigma-in-the-construction-industry-a-two-arm-randomised-controlled-trial
#19
A Milner, P C F Law, C Mann, T Cooper, K Witt, A D LaMontagne
Background: High levels of self-stigma are associated with a range of adverse mental health, treatment, and functional outcomes. This prospective study examined the effects of an electronic mental health stigma reduction intervention on self-stigma (self-blame, shame, and help-seeking inhibition) among male construction workers in Australia. Method: Male construction workers (N = 682) were randomly assigned to receive either the intervention condition or the wait list control over a six-week period...
April 2018: SSM—Population Health
https://www.readbyqxmd.com/read/29347991/the-benefits-and-tolerance-of-exercise-in-myasthenia-gravis-mgex-study-protocol-for-a-randomised-controlled-trial
#20
Simone Birnbaum, Jean-Yves Hogrel, Raphael Porcher, Pierre Portero, Bernard Clair, Bruno Eymard, Sophie Demeret, Guillaume Bassez, Marcela Gargiulo, Estelle Louët, Sonia Berrih-Aknin, Asmaa Jobic, Philippe Aegerter, Philippe Thoumie, Tarek Sharshar
BACKGROUND: Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG...
January 18, 2018: Trials
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