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Randomised control trials

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https://www.readbyqxmd.com/read/28641363/a-phase-iii-randomized-controlled-study-on-the-efficacy-and-improved-bowel-function-of-prolonged-release-pr-oxycodone-naloxone-up-to-160-80-mg-daily-vs-oxycodone-pr
#1
D Dupoiron, A Stachowiak, O Loewenstein, A Ellery, W Kremers, B Bosse, M Hopp
BACKGROUND: Oxycodone/naloxone (OXN PR) is a prolonged-release formulation containing oxycodone and naloxone in a 2:1 ratio. This study aimed to evaluate the tolerability and efficacy of doses up to OXN160/80 mg PR compared with oxycodone prolonged-release formulation (OxyPR) in a randomised controlled trial. METHODS: Two hundred and forty-three patients were randomised to treatment with OXN PR (n = 123) or OxyPR (n = 120) during the 5-week double-blind study...
June 22, 2017: European Journal of Pain: EJP
https://www.readbyqxmd.com/read/28641353/-negative-pressure-wound-therapy-randomised-controlled-trials-from-2000-to-2015
#2
Frank Peinemann
Background Negative pressure wound therapy is believed to promote wound healing. However, the results from randomised controlled trials (RCTs) are inconsistent. Systematic reviews indicate unclear evidence, due in part to low-quality RCTs, calling for more RCTs of higher quality. Methods This study aimed to ascertain the number of RCTs as well as systematic reviews on RCTs published during the time period from 2000 to 2015. Various search strategies were used to identify studies in PubMed, Cochrane Library, Google, references lists of retrieved articles, and institutions that issue evidence reports...
June 2017: Zentralblatt Für Chirurgie
https://www.readbyqxmd.com/read/28641310/potentiating-the-effects-of-radiotherapy-in-rectal-cancer-the-role-of-aspirin-statins-and-metformin-as-adjuncts-to-therapy
#3
K J Gash, A C Chambers, D E Cotton, A C Williams, M G Thomas
BACKGROUND: Complete tumour response (pCR) to neo-adjuvant chemo-radiotherapy for rectal cancer is associated with a reduction in local recurrence and improved disease-free and overall survival, but is achieved in only 20-30% of patients. Drug repurposing for anti-cancer treatments is gaining momentum, but the potential of such drugs as adjuncts, to increase tumour response to chemo-radiotherapy in rectal cancer, is only just beginning to be recognised. METHODS: A systematic literature search was conducted and all studies investigating the use of drugs to enhance response to neo-adjuvant radiation in rectal cancer were included...
June 22, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28640930/orotracheal-intubation-in-infants-performed-with-a-stylet-versus-without-a-stylet
#4
REVIEW
Joyce E O'Shea, Jennifer O'Gorman, Aakriti Gupta, Sanjay Sinhal, Jann P Foster, Liam Af O'Connell, C Omar F Kamlin, Peter G Davis
BACKGROUND: Neonatal endotracheal intubation is a common and potentially life-saving intervention. It is a mandatory skill for neonatal trainees, but one that is difficult to master and maintain. Intubation opportunities for trainees are decreasing and success rates are subsequently falling. Use of a stylet may aid intubation and improve success. However, the potential for associated harm must be considered. OBJECTIVES: To compare the benefits and harms of neonatal orotracheal intubation with a stylet versus neonatal orotracheal intubation without a stylet...
June 22, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28640890/systematic-review-and-meta-analysis-of-initial-management-of-pneumothorax-in-adults-intercostal-tube-drainage-versus-other-invasive-methods
#5
Min Joung Kim, Incheol Park, Joon Min Park, Kyung Hwan Kim, Junseok Park, Dong Wun Shin
OBJECTIVES: The ideal invasive management as initial approach for pneumothorax (PTX) is still under debate. The purpose of this systematic review and meta-analysis was to examine the evidence for the effectiveness of intercostal tube drainage and other various invasive methods as the initial approach to all subtypes of PTX in adults. METHODS: Three databases were searched from inception to May 29, 2016: MEDLINE, EMBASE, and the Cochrane CENTRAL. Randomised controlled trials that evaluated intercostal tube drainage as the control and various invasive methods as the intervention for the initial approach to PTX in adults were included...
2017: PloS One
https://www.readbyqxmd.com/read/28636752/comparison-of-effect-sizes-between-enriched-and-non-enriched-trials-of-analgesics-for-chronic-musculoskeletal-pain-a-systematic-review
#6
Tie P Yamato, Chris G Maher, Bruno T Saragiotto, Christina Abdel Shaheed, Anne M Moseley, Chung-Wei Christine Lin, Bart Koes, Andrew J McLachlan
OBJECTIVE: To investigate the use of an enriched study design on the estimates of treatment effect in analgesic trials for chronic musculoskeletal pain METHODS: Database searches were conducted from 2004 to 2014. We included randomised placebo-controlled trials evaluating pain medications for chronic musculoskeletal pain. Methodological quality was assessed using the PEDro scale. The estimates of treatment effect on pain and adverse events were compared between enriched and non-enriched designs...
June 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28635352/a-randomized-controlled-trial-comparing-two-types-of-retractors-at-caesarean-delivery
#7
Abbey J Hardy-Fairbanks, Todd Mackenzie, Martin McCarthy, Marlene B Goldman, Michele R Lauria
The aim of this study was to determine if the use of a self-retaining, symmetrical retractor (OB/Mobius(®)) during caesarean delivery is associated with differences in post-operative pain experience. Consenting women undergoing caesarean delivery were randomly assigned to OB/Mobius(®) versus conventional retraction instruments. Women were blinded to retractor type and filled out surgical pain surveys each post-operative day. Additional outcome variables were collected through a provider survey and chart review...
June 21, 2017: Journal of Obstetrics and Gynaecology: the Journal of the Institute of Obstetrics and Gynaecology
https://www.readbyqxmd.com/read/28634899/primary-prevention-of-food-allergy
#8
REVIEW
Rachel L Peters, Melanie R Neeland, Katrina J Allen
PURPOSE OF REVIEW: This article summarises recent developments on the prevention of food allergy in terms of the 5 D's of the development of food allergy: dry skin, diet, dogs, dribble, and vitamin D. RECENT FINDINGS: While several advances have improved our understanding of the development of food allergy, few preventive strategies have been implemented beyond changes in infant feeding guidelines. These now state that the introduction of allergenic solids such as peanuts should occur in the first year of life...
August 2017: Current Allergy and Asthma Reports
https://www.readbyqxmd.com/read/28634703/isoperistaltic-versus-antiperistaltic-side-to-side-anastomosis-after-right-laparoscopic-hemicolectomy-for-cancer-isovanti-trial-study-protocol-for-a-randomised-clinical-trial
#9
N Ibañez, J Abrisqueta, J Luján, Q Hernández, P Parrilla
BACKGROUND: It is believed that loosing ileocecal valve is well tolerated in patients who do not have short bowel syndrome or Crohn disease. From the hypothesis of colonic peristalsis and transit is regulated by that ileocecal valvular mechanism, we try to find out if the creation of a new pseudo-valvular mechanism as antiperistaltic anastomosis could be considered after right hemicolectomy can cause any short- or long-term changes in gastrointestinal habits. PURPOSE: The purpose of the study at primary endpoint is to compare early (occurring within 30 days of surgery) and late (occurring during the follow-up) postoperative complications between both groups The purpose of the study at secondary endpoint is to compare intraoperative and postoperative events between experimental and control groups in terms of operating time, first oral tolerance day, first flatus and faeces, length of hospital stay and orocecal transit; comparing rates of gastrointestinal life quality and comparing mortality rates between both groups...
June 21, 2017: International Journal of Colorectal Disease
https://www.readbyqxmd.com/read/28634587/exercise-metabolism-in-nonobese-patients-with-type-2-diabetes-following-the-acute-restoration-of-normoglycaemia
#10
Christopher J Gaffney, Peter Mansell, Francis B Stephens, Ian A Macdonald, Kostas Tsintzas
This study investigated how acute restoration of normoglycaemia affected energy metabolism during exercise in nonobese patients with type 2 diabetes. Six subjects (mean ± SEM) aged 56.2 ± 2.7 years, with a BMI of 24.5 ± 1.5 kg/m(2) and a VO2 peak of 28.7 ml/kg/min, attended the lab on two randomised occasions for a four-hour resting infusion of insulin or saline, followed by 30 minutes cycling at 50% VO2 peak. During the 4 h resting infusion, there was a greater (P < 0.0001) reduction in blood glucose in insulin treatment (INS) (from 11...
2017: Journal of Diabetes Research
https://www.readbyqxmd.com/read/28634259/effectiveness-of-an-online-support-programme-supr-for-older-hearing-aid-users-study-protocol-for-a-cluster-randomised-controlled-trial
#11
Janine Fj Meijerink, Marieke Pronk, Bernadette Paulissen, Birgit I Witte, Bregje van der Wouden, Vera Jansen, Sophia E Kramer
BACKGROUND: An educational SUpport PRogramme called SUPR has been developed for hearing aid users (HAUs) and their communication partners (CPs) offering care beyond hearing aid fitting. SUPR teaches its users communication strategies, hearing aid handling skills and personal adjustment to hearing impairment. METHODS/DESIGN: Using a cluster randomised controlled trial design, 70 Dutch hearing aid dispenser practices were randomised into hearing aid fitting (care as usual, 34 practices) and hearing aid fitting including SUPR (36 practices)...
June 20, 2017: BMJ Open
https://www.readbyqxmd.com/read/28633702/impact-of-isoniazid-preventive-therapy-on-the-evaluation-of-long-term-effectiveness-of-infant-mva85a-vaccination
#12
E W Bunyasi, A K K Luabeya, M Tameris, H Geldenhuys, H Mulenga, B S Landry, T J Scriba, B-M Schmidt, W A Hanekom, H Mahomed, H McShane, M Hatherill
SETTING: South Africa. OBJECTIVE: To evaluate the long-term effectiveness of infant modified vaccinia Ankara virus-expressing antigen 85A (MVA85A) vaccination against tuberculosis (TB). DESIGN: We analysed data from a double-blind randomised placebo-controlled Phase 2b MVA85A infant TB vaccine trial (2009-2012), with extended post-trial follow-up (2012-2014). Isoniazid preventive therapy (IPT) was provided by public health services according to national guidelines...
July 1, 2017: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/28633650/effects-of-tolvaptan-in-patients-with-acute-heart-failure-a-systematic-review-and-meta-analysis
#13
Chunbin Wang, Bo Xiong, Lin Cai
BACKGROUND: Acute heart failure, which requires urgent evaluation and treatment, is a leading cause for admission to the emergency department. The aim of this meta-analysis was to evaluate the effects of tolvaptan on acute heart failure and compare them with the effects of conventional therapy or placebo. METHODS: The electronic databases PubMed, EMBASE, and the Cochrane Controlled Trial registry were searched from their starting dates to October 24, 2016. Two authors independently read the trials and extracted related information from the included studies...
June 20, 2017: BMC Cardiovascular Disorders
https://www.readbyqxmd.com/read/28633609/modelling-and-sample-size-reestimation-for-longitudinal-count-data-with-incomplete-follow-up
#14
Thomas Asendorf, Robin Henderson, Heinz Schmidli, Tim Friede
We consider modelling and inference as well as sample size estimation and reestimation for clinical trials with longitudinal count data as outcomes. Our approach is general but is rooted in design and analysis of multiple sclerosis trials where lesion counts obtained by magnetic resonance imaging are important endpoints. We adopt a binomial thinning model that allows for correlated counts with marginal Poisson or negative binomial distributions. Methods for sample size planning and blinded sample size reestimation for randomised controlled clinical trials with such outcomes are developed...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28632910/withdrawn-hypnosis-for-children-undergoing-dental-treatment
#15
REVIEW
Sharifa Al-Harasi, Paul F Ashley, David R Moles, Susan Parekh, Val Walters
BACKGROUND: Managing children is a challenge that many dentists face. Many non-pharmacological techniques have been developed to manage anxiety and behavioural problems in children, such us: 'tell, show & do', positive reinforcement, modelling and hypnosis. The use of hypnosis is generally an overlooked area, hence the need for this review. OBJECTIVES: This systematic review attempted to answer the question: What is the effectiveness of hypnosis (with or without sedation) for behaviour management of children who are receiving dental care in order to allow successful completion of treatment?Null hypothesis: Hypnosis has no effect on the outcome of dental treatment of children...
June 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28632180/preview-prevention-of-diabetes-through-lifestyle-intervention-and-population-studies-in-europe-and-around-the-world-design-methods-and-baseline-participant-description-of-an-adult-cohort-enrolled-into-a-three-year-randomised-clinical-trial
#16
Mikael Fogelholm, Thomas Meinert Larsen, Margriet Westerterp-Plantenga, Ian Macdonald, J Alfredo Martinez, Nadka Boyadjieva, Sally Poppitt, Wolfgang Schlicht, Gareth Stratton, Jouko Sundvall, Tony Lam, Elli Jalo, Pia Christensen, Mathijs Drummen, Elizabeth Simpson, Santiago Navas-Carretero, Teodora Handjieva-Darlenska, Roslyn Muirhead, Marta P Silvestre, Daniela Kahlert, Laura Pastor-Sanz, Jennie Brand-Miller, Anne Raben
Type-2 diabetes (T2D) is one of the fastest growing chronic diseases worldwide. The PREVIEW project has been initiated to find the most effective lifestyle (diet and physical activity) for the prevention of T2D, in overweight and obese participants with increased risk for T2D. The study is a three-year multi-centre, 2 × 2 factorial, randomised controlled trial. The impact of a high-protein, low-glycaemic index (GI) vs. moderate protein, moderate-GI diet in combination with moderate or high-intensity physical activity on the incidence of T2D and the related clinical end-points are investigated...
June 20, 2017: Nutrients
https://www.readbyqxmd.com/read/28631933/a-salt-reduction-smartphone-app-supports-lower-salt-food-purchases-for-people-with-cardiovascular-disease-findings-from-the-saltswitch-randomised-controlled-trial
#17
Helen Eyles, Rebecca McLean, Bruce Neal, Yannan Jiang, Robert N Doughty, Rachael McLean, Cliona Ni Mhurchu
Background SaltSwitch is an innovative smartphone application (app) that enables shoppers to scan the barcode of a packaged food and receive an immediate, interpretive, traffic light nutrition label on the screen, along with suggestions for lower salt alternatives. Our aim was to determine the effectiveness of SaltSwitch to support people with cardiovascular disease to make lower salt food choices. Design Six-week, two-arm, parallel, randomised controlled trial in Auckland, New Zealand (2 weeks baseline and 4 weeks intervention)...
January 1, 2017: European Journal of Preventive Cardiology
https://www.readbyqxmd.com/read/28631809/anabolic-steroids-for-treating-pressure-ulcers
#18
REVIEW
Cho Naing, Maxine A Whittaker
BACKGROUND: Pressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localised injury to the skin or underlying tissue, or both. The ulcers usually arise over a bony prominence, and are recognised as a common medical problem affecting people confined to a bed or wheelchair for long periods of time. Anabolic steroids are used as off-label drugs (drugs which are used without regulatory approval) and have been used as adjuvants to usual treatment with dressings, debridement, nutritional supplements, systemic antibiotics and antiseptics, which are considered to be supportive in healing of pressure ulcers...
June 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28631805/drug-therapy-for-chronic-idiopathic-axonal-polyneuropathy
#19
REVIEW
Janna Warendorf, Alexander Fje Vrancken, Ivo N van Schaik, Richard Ac Hughes, Nicolette C Notermans
BACKGROUND: Chronic idiopathic axonal polyneuropathy (CIAP) is an insidiously progressive sensory or sensorimotor polyneuropathy that affects elderly people. Although severe disability or handicap does not occur, CIAP reduces quality of life. CIAP is diagnosed in 10% to 25% of people referred for evaluation of polyneuropathy. There is a need to gather and review emerging evidence on treatments, as the number of people affected is likely to increase in ageing populations. This is an update of a review first published in 2004 and previously updated in 2006, 2008, 2011 and 2013...
June 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28631745/achieving-assessor-accuracy-on-the-international-standards-for-neurological-classification-of-spinal-cord-injury
#20
A J Armstrong, J M Clark, D T Ho, C J Payne, S Nolan, L M Goodes, L A Harvey, R Marshall, M P Galea, S A Dunlop
STUDY DESIGN: A retrospective audit of assessor accuracy using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) in three multicentre randomised controlled trials (SCIPA: Spinal Cord Injury and Physical Activity) spanning 2010-2014 with standards revised in 2011. OBJECTIVES: To investigate assessor accuracy of neurological classification after spinal cord injury. SETTING: Australia and New Zealand...
June 20, 2017: Spinal Cord
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