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https://www.readbyqxmd.com/read/28431952/evaluation-of-patient-preparedness-for-surgery-a-randomized-controlled-trial
#1
Kristie A Greene, Allison M Wyman, Lauren A Scott, Stuart Hart, Lennox Hoyte, Renee Bassaly
BACKGROUND: Patient preparedness for pelvic reconstructive surgery has important implications for patient satisfaction and perception of improvement after surgery. The ideal method in which to optimally prepare patients for surgery has not been determined. OBJECTIVE: To evaluate the impact of a preoperative patient education video on patient preparedness prior to sacrocolpopexy as measured by a preoperative preparedness questionnaire (PPQ). STUDY DESIGN: We performed a single-blind, randomized stratified clinical trial at a single academic center evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient preparedness...
April 18, 2017: American Journal of Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28431226/the-impact-of-automatic-devices-for-capillary-blood-collection-on-efficiency-and-pain-response-in-newborns-a-randomized-controlled-trial
#2
G Sorrentino, M Fumagalli, S Milani, I Cortinovis, A Zorz, G Cavallaro, F Mosca, L Plevani
BACKGROUND: The heel stick is the method of choice in most neonatal units for capillary blood sampling, and it represents the most common event among all painful procedures performed on newborns. The type and design of heel stick device and the clinical procedure to collect a blood sample may have an impact on newborn pain response as well. OBJECTIVE: To compare the pain response and efficiency of different automated devices for capillary blood collection in newborns...
April 11, 2017: International Journal of Nursing Studies
https://www.readbyqxmd.com/read/28430671/elevated-production-of-nociceptive-cc-chemokines-and-se-selectin-in-patients-with-low-back-pain-and-the-effects-of-spinal-manipulation-a-non-randomized-clinical-trial
#3
Julita A Teodorczyk-Injeyan, Marion McGregor, John J Triano, H Stephen Injeyan
BACKGROUND: The involvement of inflammatory components in the pathophysiology of low back pain is poorly understood. It has been suggested that spinal manipulative therapy (SMT) may exert anti-inflammatory effects. PURPOSE: To determine the involvement of inflammation-associated chemokines (CC series) in the pathogenesis of non-specific low back pain and to evaluate the effect of SMT on that process. METHODS: Patients presenting with non-radicular, non-specific low back pain (minimum pain score 3 on 10 point visual analogue scale, VAS) were recruited according to stringent inclusion criteria...
April 19, 2017: Clinical Journal of Pain
https://www.readbyqxmd.com/read/28427472/optimising-conservative-management-of-chronic-low-back-pain-study-protocol-for-a-randomised-controlled-trial
#4
Katherine J Simson, Clint T Miller, Jon Ford, Andrew Hahne, Luana Main, Timo Rantalainen, Wei-Peng Teo, Megan Teychenne, David Connell, Guy Trudel, Guoyan Zheng, Gary Thickbroom, Daniel L Belavy
BACKGROUND: Lower back pain is a global health issue affecting approximately 80% of people at some stage in their life. The current literature suggests that any exercise is beneficial for reducing back pain. However, as pain is a subjective evaluation and physical deficits are evident in low back pain, using it as the sole outcome measure to evaluate superiority of an exercise protocol for low back pain treatment is insufficient. The overarching goal of the current clinical trial is to implement two common, conservative intervention approaches and examine their impact on deficits in chronic low back pain...
April 20, 2017: Trials
https://www.readbyqxmd.com/read/28427321/in-silico-assessment-of-biomedical-products-the-conundrum-of-rare-but-not-so-rare-events-in-two-case-studies
#5
Marco Viceconti, Claudio Cobelli, Tarek Haddad, Adam Himes, Boris Kovatchev, Mark Palmer
In silico clinical trials, defined as "The use of individualized computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention," have been proposed as a possible strategy to reduce the regulatory costs of innovation and the time to market for biomedical products. We review some of the the literature on this topic, focusing in particular on those applications where the current practice is recognized as inadequate, as for example, the detection of unexpected severe adverse events too rare to be detected in a clinical trial, but still likely enough to be of concern...
May 2017: Proceedings of the Institution of Mechanical Engineers. Part H, Journal of Engineering in Medicine
https://www.readbyqxmd.com/read/28426857/spectacle-wear-among-children-in-a-school-based-program-for-ready-made-vs-custom-made-spectacles-in-india-a-randomized-clinical-trial
#6
Priya Morjaria, Jenifer Evans, Kaushik Murali, Clare Gilbert
Importance: Uncorrected refractive errors are the most common cause of visual impairment in children despite correction being highly cost-effective. Objective: To determine whether less expensive ready-made spectacles produce rates of spectacle wear at 3 to 4 months comparable to those of more expensive custom-made spectacles among eligible school-aged children. Design, Setting, and Participants: This noninferiority, double-masked, randomized clinical trial recruited children aged 11 to 15 years from January 12 through July 31, 2015, from government schools in urban and periurban areas surrounding Bangalore, India...
April 20, 2017: JAMA Ophthalmology
https://www.readbyqxmd.com/read/28426137/hydroxyurea-hydroxycarbamide-for-sickle-cell-disease
#7
REVIEW
Sarah J Nevitt, Ashley P Jones, Jo Howard
BACKGROUND: Sickle cell disease (SCD) is one of the most common inherited diseases worldwide. It is associated with lifelong morbidity and a reduced life expectancy. Hydroxyurea (hydroxycarbamide), an oral chemotherapeutic drug, ameliorates some of the clinical problems of SCD, in particular that of pain, by raising fetal haemoglobin. This is an update of a previously published Cochrane Review. OBJECTIVES: To assess the effects of hydroxyurea therapy in people with SCD (all genotypes), of any age, regardless of setting...
April 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28423223/implementation-and-preliminary-effectiveness-of-a-real-time-pain-management-smartphone-app-for-adolescents-with-cancer-a-multicenter-pilot-clinical-study
#8
Lindsay A Jibb, Bonnie J Stevens, Paul C Nathan, Emily Seto, Joseph A Cafazzo, Donna L Johnston, Vanessa Hum, Jennifer N Stinson
BACKGROUND: Pain in adolescents with cancer (12-18 years) is common and negatively impacts health-related quality of life (HRQL). The Pain Squad+ smartphone app, which provides adolescents with real-time pain self-management support, was developed to address this issue. This study evaluated the implementation of the app to inform a future randomized controlled trial (RCT) and obtain treatment effect estimates for pain intensity, pain interference, HRQL, and self-efficacy. PROCEDURE: A one-group baseline/poststudy design with 40 adolescents recruited from two pediatric tertiary care centers was used...
April 19, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28423145/brief-behavioral-therapy-for-pediatric-anxiety-and-depression-in-primary-care-a-randomized-clinical-trial
#9
V Robin Weersing, David A Brent, Michelle S Rozenman, Araceli Gonzalez, Megan Jeffreys, John F Dickerson, Frances L Lynch, Giovanna Porta, Satish Iyengar
Importance: Anxiety and depression affect 30% of youth but are markedly undertreated compared with other mental disorders, especially in Hispanic populations. Objective: To examine whether a pediatrics-based behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health care. Design, Setting, and Participants: This 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8...
April 19, 2017: JAMA Psychiatry
https://www.readbyqxmd.com/read/28421567/early-biomarker-response-and-patient-preferences-to-oral-and-intramuscular-vitamin-b12-substitution-in-primary-care-a-randomised-parallel-group-trial
#10
Corina Metaxas, Deborah Mathis, Cyrill Jeger, Kurt Eduard Hersberger, Isabelle Arnet, Philipp Walter
BACKGROUND: Vitamin B12 (VB12) deficiency can be treated with oral high-dose substitution or intramuscular (i.m.) injection of VB12. Whenever alternative routes of administration exist, patient preferences should be considered when choosing the treatment. We aimed to assess outpatient preferences towards oral or IM VB12 substitution and confirm noninferiority of early biomarker response with oral treatment, in a typical primary care population. METHODS: Prospective randomised nonblinded parallel-group trial...
April 19, 2017: Swiss Medical Weekly
https://www.readbyqxmd.com/read/28420766/project-accrue-exploring-options-to-increase-awareness-of-aids-malignancy-consortium-clinical-trials-in-north-carolina
#11
Anissa I Vines, Cathy L Melvin, Jaimie C Hunter, Veronica A Carlisle
BACKGROUND Longer lifespans conferred by antiretroviral therapy result in more time exposed to cancer risk for people living with HIV/AIDS (PLWHA). Given limited diversity in AIDS Malignancy Consortium (AMC) clinical trials, there is need for new approaches to educate PLWHA in order to improve awareness and participation in AMC trials.METHODS With input from a community advisory board, Project ACCRUE (AMC Clinical Trials at Carolina Ramp Up Enrollment) conducted a key informant interview with service providers; online organizational surveys of AMC trial awareness and resource needs; and "lunch and learn" educational sessions, including pre- and post-intervention knowledge assessments...
March 2017: North Carolina Medical Journal
https://www.readbyqxmd.com/read/28420664/the-uk-cardiac-and-vascular-surgery-interventional-anaemia-response-caviar-study-protocol-for-an-observational-cohort-study-to-determine-the-impact-and-effect-of-preoperative-anaemia-management-in-cardiac-and-vascular-surgical-patients
#12
Marisa Chau, Toby Richards, Caroline Evans, Anna Butcher, Timothy Collier, Andrew Klein
INTRODUCTION: Preoperative anaemia is linked to poor postsurgical outcome, longer hospital stays, greater risk of complications and mortality. Currently in the UK, some sites have developed anaemia clinics or pathways that use intravenous iron to correct iron deficiency anaemia prior to surgery as their standard of care. Although intravenous iron has been observed to be effective in a variety of patient settings, there is insufficient evidence in its use in cardiac and vascular patients...
April 18, 2017: BMJ Open
https://www.readbyqxmd.com/read/28420604/a-digital-tool-to-promote-alcohol-and-drug-use-screening-brief-intervention-and-referral-to-treatment-skill-translation-a-mobile-app-development-and-randomized-controlled-trial-protocol
#13
Derek D Satre, Khanh Ly, Maria Wamsley, Alexa Curtis, Jason Satterfield
BACKGROUND: Translation of knowledge and skills from classroom settings to clinical practice is a major challenge in healthcare training, especially for behavioral interventions. For example, screening, brief intervention, and referral to treatment (SBIRT) is a highly-promoted approach to identifying and treating individuals at risk for alcohol or drug problems, yet effective, routine use of SBIRT has lagged. OBJECTIVE: The objective of this paper is to describe the development, pilot testing, and trial protocol of a mobile app based on the theory of planned behavior (TPB) to promote SBIRT skill translation and application...
April 18, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28420441/autologous-bone-marrow-derived-cell-transplantation-in-decompensated-alcoholic-liver-disease-what-is-the-impact-on-liver-histology-and-gene-expression-patterns
#14
Nicolas Lanthier, Nathalie Lin-Marq, Laura Rubbia-Brandt, Sophie Clément, Nicolas Goossens, Laurent Spahr
BACKGROUND: Liver stem cell therapy (SCT) has been suggested as a promising means to improve liver regeneration in advanced liver disease. However, data from trials are heterogeneous, with no systematic histological evaluation. The aim of this study is to specifically analyze the effect of autologous SCT on liver regeneration and on gene expression changes. METHODS: Individuals in the randomized controlled trial of SCT in alcoholic hepatitis with paired liver biopsies were included (n = 58)...
April 18, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/28420417/do-images-of-a-personalised-future-body-shape-help-with-weight-loss-a-randomised-controlled-study
#15
Gemma Ossolinski, Moyez Jiwa, Alexandra McManus, Richard Parsons
BACKGROUND: This randomised controlled study evaluated a computer-generated future self-image as a personalised, visual motivational tool for weight loss in adults. METHODS: One hundred and forty-five people (age 18-79 years) with a Body Mass Index (BMI) of at least 25 kg/m(2) were randomised to receive a hard copy future self-image at recruitment (early image) or after 8 weeks (delayed image). Participants received general healthy lifestyle information at recruitment and were weighed at 4-weekly intervals for 24 weeks...
April 18, 2017: Trials
https://www.readbyqxmd.com/read/28420367/rationale-and-methods-of-the-ifightdepression-study-a-double-blind-randomized-controlled-trial-evaluating-the-efficacy-of-an-internet-based-self-management-tool-for-moderate-to-mild-depression
#16
Azucena Justicia, Matilde Elices, Ana Isabel Cebria, Diego J Palao, Jesús Gorosabel, Dolors Puigdemont, Javier de Diego-Adeliño, Andrea Gabilondo, Alvaro Iruin, Ulrich Hegerl, Víctor Pérez
BACKGROUND: During the last decade online interventions have emerged as a promising approach for patients with mild/moderate depressive symptoms, reaching at large populations and representing cost-effective alternatives. The main objective of this double-blind, randomized controlled trial is to examine the efficacy of an internet-based self-management tool (iFightDepression) for mild to moderate depression as an add-on to treatment as usual (TAU) versus internet-based psychoeducation plus TAU...
April 19, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28420323/study-protocol-insight-46-a-neuroscience-sub-study-of-the-mrc-national-survey-of-health-and-development
#17
Christopher A Lane, Thomas D Parker, Dave M Cash, Kirsty Macpherson, Elizabeth Donnachie, Heidi Murray-Smith, Anna Barnes, Suzie Barker, Daniel G Beasley, Jose Bras, David Brown, Ninon Burgos, Michelle Byford, M Jorge Cardoso, Ana Carvalho, Jessica Collins, Enrico De Vita, John C Dickson, Norah Epie, Miklos Espak, Susie M D Henley, Chandrashekar Hoskote, Michael Hutel, Jana Klimova, Ian B Malone, Pawel Markiewicz, Andrew Melbourne, Marc Modat, Anette Schrag, Sachit Shah, Nikhil Sharma, Carole H Sudre, David L Thomas, Andrew Wong, Hui Zhang, John Hardy, Henrik Zetterberg, Sebastien Ourselin, Sebastian J Crutch, Diana Kuh, Marcus Richards, Nick C Fox, Jonathan M Schott
BACKGROUND: Increasing age is the biggest risk factor for dementia, of which Alzheimer's disease is the commonest cause. The pathological changes underpinning Alzheimer's disease are thought to develop at least a decade prior to the onset of symptoms. Molecular positron emission tomography and multi-modal magnetic resonance imaging allow key pathological processes underpinning cognitive impairment - including β-amyloid depostion, vascular disease, network breakdown and atrophy - to be assessed repeatedly and non-invasively...
April 18, 2017: BMC Neurology
https://www.readbyqxmd.com/read/28419890/pragmatic-trial-of-a-study-navigator-model-nau-vs-ambassador-model-n-to-increase-enrollment-to-health-research-among-community-members-who-use-illicit-drugs
#18
Linda B Cottler, Catherine W Striley, Amy L Elliott, Abigail E Zulich, Evan Kwiatkowski, David R Nelson
BACKGROUND: Although drug use is common in the population, drug users are sometimes excluded from research without justification. Two models of individualized study matching were compared for effectiveness in enrolling people who "endorsed current drug use" and those who "did not" into appropriate research. METHODS: Participants in the NIDA-funded Transformative Approach to Reduce Research Disparities Towards Drug Users study (Navigation Study) were recruited through a Clinical and Translational Science Award (CTSA) community engagement model...
April 4, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28419518/public-preferences-on-written-informed-consent-for-low-risk-pragmatic-clinical-trials-in-spain
#19
Rafael Dal-Ré, Antonio J Carcas, Xavier Carné, David Wendler
AIMS: Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to significantly improve medical care. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the U.S. public endorses written consent for low risk pRCTs. This study was designed to assess whether this view is specific to the US. METHODS: Cross-sectional, probability-based survey, with a 2x2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night...
April 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419124/a-randomised-controlled-trial-of-losartan-as-an-anti-fibrotic-agent-in-non-alcoholic-steatohepatitis
#20
Stuart McPherson, Nina Wilkinson, Dina Tiniakos, Jennifer Wilkinson, Alastair D Burt, Elaine McColl, Deborah D Stocken, Nick Steen, Jane Barnes, Nicola Goudie, Stephen Stewart, Yvonne Bury, Derek Mann, Quentin M Anstee, Christopher P Day
INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is a common liver disease worldwide. Experimental and small clinical trials have demonstrated that angiotensin II blockers (ARB) may be anti-fibrotic in the liver. The aim of this randomised controlled trial was to assess whether treatment with Losartan for 96 weeks slowed, halted or reversed the progression of fibrosis in patients with non-alcoholic steatohepatitis (NASH). METHODS: Double-blind randomised-controlled trial of Losartan 50 mg once a day versus placebo for 96 weeks in patients with histological evidence of NASH...
2017: PloS One
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