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Randomised controlled trials

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https://www.readbyqxmd.com/read/29909400/effects-of-electroacupuncture-on-bladder-and-bowel-function-in-patients-with-transverse-myelitis-a-prospective-observational-study
#1
Jiani Wu, Yanjun Cheng, Zongshi Qin, Xiaoxu Liu, Zhishun Liu
OBJECTIVE: To preliminarily explore the effect of electroacupuncture (EA) on bladder and bowel dysfunction in patients with transverse myelitis. METHODS: Sixteen participants were treated with EA at bilateral BL32, BL33, and BL35 once a day, five times a week for the first 4 weeks, and once every other day, three times a week for the following 4 weeks. Patients were then followed up for 6 months. Bladder and bowel function, and the safety of EA, were assessed...
June 16, 2018: Acupuncture in Medicine: Journal of the British Medical Acupuncture Society
https://www.readbyqxmd.com/read/29909374/the-command-trial-of-cognitive-therapy-for-harmful-compliance-with-command-hallucinations-ctch-a-qualitative-study-of-acceptability-and-tolerability-in-the-uk
#2
Max Birchwood, Laura Mohan, Alan Meaden, Nick Tarrier, Shon Lewis, Til Wykes, Linda M Davies, Graham Dunn, Emmanuelle Peters, Maria Michail
OBJECTIVES: To explore service user experiences of a 9-month cognitive behavioural therapy for command hallucinations in the context of a randomised controlled trial including their views on acceptability and tolerability of the intervention. DESIGN: Qualitative study using semistructured interviews. SETTING: The study took place across three sites: Birmingham, Manchester and London. Interviews were carried out at the sites where therapy took place which included service bases and participants' homes...
June 15, 2018: BMJ Open
https://www.readbyqxmd.com/read/29908991/mage-a3-immunotherapeutic-as-adjuvant-therapy-for-patients-with-resected-mage-a3-positive-stage-iii-melanoma-derma-a-double-blind-randomised-placebo-controlled-phase-3-trial
#3
Brigitte Dreno, John F Thompson, Bernard Mark Smithers, Mario Santinami, Thomas Jouary, Ralf Gutzmer, Evgeny Levchenko, Piotr Rutkowski, Jean-Jacques Grob, Sergii Korovin, Kamil Drucis, Florent Grange, Laurent Machet, Peter Hersey, Ivana Krajsova, Alessandro Testori, Robert Conry, Bernard Guillot, Wim H J Kruit, Lev Demidov, John A Thompson, Igor Bondarenko, Jaroslaw Jaroszek, Susana Puig, Gabriela Cinat, Axel Hauschild, Jelle J Goeman, Hans C van Houwelingen, Fernando Ulloa-Montoya, Andrea Callegaro, Benjamin Dizier, Bart Spiessens, Muriel Debois, Vincent G Brichard, Jamila Louahed, Patrick Therasse, Channa Debruyne, John M Kirkwood
BACKGROUND: Despite newly approved treatments, metastatic melanoma remains a life-threatening condition. We aimed to evaluate the efficacy of the MAGE-A3 immunotherapeutic in patients with stage IIIB or IIIC melanoma in the adjuvant setting. METHODS: DERMA was a phase 3, double-blind, randomised, placebo-controlled trial done in 31 countries and 263 centres. Eligible patients were 18 years or older and had histologically proven, completely resected, stage IIIB or IIIC, MAGE-A3-positive cutaneous melanoma with macroscopic lymph node involvement and an Eastern Cooperative Oncology Group performance score of 0 or 1...
June 13, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29908990/development-and-validation-of-response-markers-to-predict-survival-and-pleurodesis-success-in-patients-with-malignant-pleural-effusion-promise-a-multicohort-analysis
#4
Ioannis Psallidas, Nikolaos I Kanellakis, Stephen Gerry, Marie Laëtitia Thézénas, Philip D Charles, Anastasia Samsonova, Herbert B Schiller, Roman Fischer, Rachelle Asciak, Robert J Hallifax, Rachel Mercer, Melissa Dobson, Tao Dong, Ian D Pavord, Gary S Collins, Benedikt M Kessler, Harvey I Pass, Nick Maskell, Georgios T Stathopoulos, Najib M Rahman
BACKGROUND: The prevalence of malignant pleural effusion is increasing worldwide, but prognostic biomarkers to plan treatment and to understand the underlying mechanisms of disease progression remain unidentified. The PROMISE study was designed with the objectives to discover, validate, and prospectively assess biomarkers of survival and pleurodesis response in malignant pleural effusion and build a score that predicts survival. METHODS: In this multicohort study, we used five separate and independent datasets from randomised controlled trials to investigate potential biomarkers of survival and pleurodesis...
June 13, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29908871/an-overview-on-personalisation-of-radiotherapy-prescriptions-in-locally-advanced-non-small-cell-lung-cancer-are-we-there-yet
#5
REVIEW
Sarah Barrett, Gerard G Hanna, Laure Marignol
Standard of care radiotherapy in LA-NSCLC is 60-66 Gy in 30-33 fractions. However outcomes for these patients are poor with 5-year survival in the range of 10-20%. Randomised controlled trials have shown that dose escalation in a linear fashion does not improve outcomes for all patients, thus there is a need to tailor the prescription to the individual patient. This review assesses the strategies published to personalise the radiation therapy dose prescription in LA-NSCLC. A systematic and scoping search of the literature was performed to identify studies that met the inclusion criteria...
June 13, 2018: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29908853/exercise-programs-may-be-effective-in-preventing-a-new-episode-of-neck-pain-a-systematic-review-and-meta-analysis
#6
Tarcisio F de Campos, Chris G Maher, Daniel Steffens, Joel T Fuller, Mark J Hancock
QUESTION: What is the effectiveness of interventions that aim to prevent a new episode of neck pain? DESIGN: Systematic review and meta-analysis of randomised, controlled trials. PARTICIPANTS: People without neck pain at study entry. INTERVENTION: Any intervention aiming to prevent a future episode of neck pain. OUTCOME MEASURES: New episode of neck pain. RESULTS: Five trials including a total of 3852 individuals met the inclusion criteria...
June 13, 2018: Journal of Physiotherapy
https://www.readbyqxmd.com/read/29908670/safety-and-efficacy-of-upadacitinib-in-patients-with-active-rheumatoid-arthritis-refractory-to-biologic-disease-modifying-anti-rheumatic-drugs-select-beyond-a-double-blind-randomised-controlled-phase-3-trial
#7
Mark C Genovese, Roy Fleischmann, Bernard Combe, Stephen Hall, Andrea Rubbert-Roth, Ying Zhang, Yijie Zhou, Mohamed-Eslam F Mohamed, Sebastian Meerwein, Aileen L Pangan
BACKGROUND: Phase 2 studies with upadacitinib, a selective Janus kinase 1 (JAK1) inhibitor, have shown safety and efficacy in the treatment of patients with active rheumatoid arthritis. We did this study to further assess the safety and efficacy of upadacitinib in patients with an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs). METHODS: We did this double-blind, randomised controlled phase 3 trial at 153 sites in 26 countries. Patients were aged 18 years or older, had active rheumatoid arthritis and previous inadequate response or intolerance to bDMARDs, and were receiving concomitant background conventional synthetic DMARDS (csDMARDs)...
June 12, 2018: Lancet
https://www.readbyqxmd.com/read/29908669/safety-and-efficacy-of-upadacitinib-in-patients-with-rheumatoid-arthritis-and-inadequate-response-to-conventional-synthetic-disease-modifying-anti-rheumatic-drugs-select-next-a-randomised-double-blind-placebo-controlled-phase-3-trial
#8
Gerd R Burmester, Joel M Kremer, Filip Van den Bosch, Alan Kivitz, Louis Bessette, Yihan Li, Yijie Zhou, Ahmed A Othman, Aileen L Pangan, Heidi S Camp
BACKGROUND: Upadacitinib is a selective inhibitor of Janus kinase 1 and was efficacious in phase 2 studies in patients with moderate-to-severe rheumatoid arthritis. We aimed to assess the efficacy of upadacitinib in patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). METHODS: This study is a double-blind, placebo-controlled trial at 150 sites in 35 countries. We enrolled patients aged 18 years or older with active rheumatoid arthritis for 3 months or longer, who had received csDMARDs for at least 3 months with a stable dose for at least 4 weeks before study entry, and had an inadequate response to at least one of the following csDMARDs: methotrexate, sulfasalazine, or leflunomide...
June 12, 2018: Lancet
https://www.readbyqxmd.com/read/29908389/development-and-validation-of-a-clinical-prediction-tool-to-estimate-the-individual-risk-of-depressive-relapse-or-recurrence-in-individuals-with-recurrent-depression
#9
Nicola S Klein, Gea A Holtman, Claudi L H Bockting, Martijn W Heymans, Huibert Burger
OBJECTIVES: Many studies examined predictors of depressive relapse/recurrence but no simple tool based on well-established risk factors is available that estimates the risk within an individual. We developed and validated such a prediction tool in remitted recurrently depressed individuals. METHODS: The tool was developed using data (n = 235) from a pragmatic randomised controlled trial in remitted recurrently depressed participants and externally validated using data (n = 209) from a similar randomised controlled trial of remitted recurrently depressed participants using maintenance antidepressants...
June 8, 2018: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/29908336/positive-reinforcement-targeting-abstinence-in-substance-misuse-praise-study-protocol-for-a-cluster-rct-process-evaluation-of-contingency-management
#10
N Metrebian, T Weaver, S Pilling, J Hellier, S Byford, J Shearer, L Mitcheson, M Astbury, P Bijral, N Bogdan, O Bowden-Jones, E Day, J Dunn, E Finch, S Forshall, A Glasper, G Morse, S Akhtar, J Bajaria, C Bennett, E Bishop, V Charles, C Davey, R Desai, C Goodfellow, F Haque, N Little, H McKechnie, J Morris, F Mosler, J Mutz, R Pauli, D Poovendran, E Slater, J Strang
There are approximately 256,000 heroin and other opiate users in England of whom 155,000 are in treatment for heroin (or opiate) addiction. The majority of people in treatment receive opiate substitution treatment (OST) (methadone and buprenorphine). However, OST suffers from high attrition and persistent heroin use even whilst in treatment. Contingency management (CM) is a psychological intervention based on the principles of operant conditioning. It is delivered as an adjunct to existing evidence based treatments to amplify patient benefit and involves the systematic application of positive reinforcement (financial or material incentives) to promote behaviours consistent with treatment goals...
June 13, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29908039/no-neurodevelopmental-benefit-of-cerebral-oximetry-in-the-first-randomised-trial-in-preterm-infants-during-the-first-days-of-life-safeboosc-ii
#11
Anne M Plomgaard, Thomas Alderliesten, Frank van Bel, Manon Benders, Olivier Claris, Malaika Cordeiro, Eugene Dempsey, Monica Fumagalli, Christian Gluud, Simon Hyttel-Sorensen, Petra Lemmers, Adelina Pellicer, Gerhard Pichler, Gorm Greisen
AIM: Cerebral hypoxia has been associated with neurodevelopmental impairment. We studied whether reducing cerebral hypoxia in extremely preterm infants during the first 72 hours of life affected neurological outcomes at two years of corrected age. METHODS: In 2012-2013 the phase II randomised Safeguarding the Brains of our Smallest Children trial compared visible cerebral near infrared spectroscopy (NIRS) monitoring in an intervention group and blinded NIRS monitoring in a control group...
June 16, 2018: Acta Paediatrica
https://www.readbyqxmd.com/read/29908037/alpha-blockers-as-medical-expulsive-therapy-for-ureteral-stones-a-cochrane-systematic-review
#12
Thijs Campschroer, Xiaoye Zhu, Robin W M Vernooij, M T W Tycho Lock
OBJECTIVES: To assess the effects of alpha-blockers compared to standard therapy or placebo for ureteral stones 1 cm and less confirmed by imaging in adult patients presenting with symptoms of ureteral stone disease. PATIENTS AND METHODS: We performed a systematic search in multiple databases and grey literature with no restrictions on the language of publication or publication status, up until November 2017. We included randomised controlled trials evaluating ureteral stone passage in adult patients, that compared alpha-blockers with standard therapy or placebo...
June 16, 2018: BJU International
https://www.readbyqxmd.com/read/29907614/human-milk-as-a-protective-factor-for-bronchopulmonary-dysplasia-a-systematic-review-and-meta-analysis
#13
Jinglan Huang, Li Zhang, Jun Tang, Jing Shi, Yi Qu, Tao Xiong, Dezhi Mu
OBJECTIVE: To summarise current evidence evaluating the effects of human milk on the risk of bronchopulmonary dysplasia (BPD) in preterm infants. DESIGN: We searched for studies on human milk and BPD in English and Chinese databases on 26 July 2017. Furthermore, the references of included studies were also screened. The inclusion criteria in this meta-analysis were the following: (1) preterm infants (<37 weeks); (2) human milk; (3) comparing with formula feeding; (4) the outcome included BPD; and (5) the type of study was randomised controlled trial (RCT) or cohort study...
June 15, 2018: Archives of Disease in Childhood. Fetal and Neonatal Edition
https://www.readbyqxmd.com/read/29907576/effectiveness-of-acupuncture-in-postpartum-depression-a-systematic-review-and-meta-analysis
#14
Shanshan Li, Weiqiang Zhong, Wen Peng, Gaofeng Jiang
OBJECTIVE: To assess the clinical effectiveness of acupuncture in the treatment of postpartum depression (PPD). METHODS: The following electronic databases were systematically searched: PubMed, Cochrane Library, SCI, Elsevier SDOL, China National Knowledge, Wan Fang database and Chinese Science and Technology Periodical Database. Only randomised controlled trials (RCTs) of acupuncture for PPD were considered. Primary outcomes were the Hamilton Rating Scale for Depression (HAMD) or the Edinburgh Postnatal Depression Scale (EPDS) scores and effective rate...
June 15, 2018: Acupuncture in Medicine: Journal of the British Medical Acupuncture Society
https://www.readbyqxmd.com/read/29907335/trial-protocol-the-use-of-mindfulness-based-intervention-for-improving-bracing-compliance-for-adolescent-idiopathic-scoliosis-patients-protocol-for-a-randomised-controlled-trial
#15
Benjamin Hon Kei Yip, Xue Li, Christine Hiu Yan Leung, Ting Gao, Vincent Chi Ho Chung, Fiona Wai Ping Yu, Tsz Ping Lam, Jack Chun Yiu Cheng, Samuel Yeung Shan Wong
INTRODUCTION: Adolescent idiopathic scoliosis (AIS) is the most prevalent deforming orthopaedic condition; it causes significant disability when spinal curves progress beyond 45deg. Bracing is the primary treatment prescribed for adolescents with an immature skeleton who have spinal curves between 25 and 45deg. New evidence suggests that compliance with bracing significantly decreases the progression of high-risk curves to the threshold for surgery. Nonetheless, bracing is a stressful experience...
June 12, 2018: Journal of Physiotherapy
https://www.readbyqxmd.com/read/29907153/comparison-of-two-low-fat-diets-differing-in-protein-and-carbohydrate-on-psychological-wellbeing-in-adults-with-obesity-and-type-2-diabetes-a-randomised-clinical-trial
#16
Nerylee Ann Watson, Kathryn Ann Dyer, Jonathan David Buckley, Grant David Brinkworth, Alison Mary Coates, Gaynor Parfitt, Peter Ranald Charles Howe, Manny Noakes, Karen Joy Murphy
BACKGROUND: Although higher-protein diets (HP) can assist with weight loss and glycemic control, their effect on psychological wellbeing has not been established. The objective of this study was to compare the effects of a HP and a higher-carbohydrate diet (HC), combined with regular exercise, on psychological wellbeing both during weight loss (WL) and weight maintenance phases (WM). METHODS: In a parallel RCT, 61 adults with T2D (mean ± SD: BMI 34.3 ± 5...
June 15, 2018: Nutrition Journal
https://www.readbyqxmd.com/read/29907128/protecting-adolescents-in-low-and-middle-income-countries-from-interpersonal-violence-pro-youth-trial-study-protocol-for-a-cluster-randomized-controlled-trial-of-the-strengthening-families-programme-10-14-familias-fuertes-in-panama
#17
Anilena Mejia, Richard Emsley, Eleonora Fichera, Wadih Maalouf, Jeremy Segrott, Rachel Calam
BACKGROUND: Interpersonal violence can significantly reduce adolescents' opportunities for becoming happy and healthy adults. Central America is the most violent region in the world and it is estimated that adolescents are involved in 82% of all homicides in this region. Family skills training programmes have been designed to prevent interpersonal violence in adolescents. Several studies in high-income countries suggest they are effective. However, there are no published trials assessing effectiveness of these programmes in low- and middle-income countries (LMIC)...
June 15, 2018: Trials
https://www.readbyqxmd.com/read/29907111/changes-in-biomarkers-in-equine-synovial-fluid-two-weeks-after-intra-articular-hyaluronan-treatment-a-randomised-double-blind-clinical-trial
#18
Tytti M Niemelä, Riitta-Mari Tulamo, Kaisa Aaltonen, Satu M Sankari, Anna K Hielm-Björkman
BACKGROUND: Inflammatory and degenerative activity inside the joint can be studied in vivo via analysis of synovial fluid (SF) biomarkers, which are molecular markers of inflammatory processes and tissue turnover. The aim of this study was to investigate the response of selected biomarkers in the SF after an intra-articular (IA) high-molecular-weight non-animal stabilized hyaluronic acid (NASHA) treatment. Our hypothesis was that prostaglandin E2 (PGE2 ), substance P, aggrecan chondroitin sulfate 846 epitope (CS846), and carboxypeptide of type II collagen (CPII) concentrations in SF would decrease more in the NASHA than in the placebo group...
June 15, 2018: BMC Veterinary Research
https://www.readbyqxmd.com/read/29906580/posterior-lumbar-interbody-fusion-vs-dynamic-hybrid-instrumentation-a-prospective-randomised-clinical-trial
#19
C Herren, M Simons, J Bredow, S Oikonomidis, L Westermann, R Sobottke, M J Scheyerer, M Pishnamaz, P Eysel, K Zarghooni, J Franklin, J Siewe
PURPOSE: The purpose of this study was to assess the radiological and clinical outcomes following lumbar fusion intervention and to compare both, the established posterior lumbar interbody fusion (PLIF)-technique and the dynamic hybrid instrumentation ('topping off'). METHODS: In this prospective randomised trial all patients presented with degenerative changes to the lumbar spine (L2-S1) were included and randomised in two groups: patients who underwent the 360°-fusion procedure in PLIF-technique (1, control group) and those patients who underwent fusion surgery with additional hybrid instrumentation (DTO, Zimmer, Inc...
June 12, 2018: World Neurosurgery
https://www.readbyqxmd.com/read/29906322/dressings-and-topical-agents-for-treating-venous-leg-ulcers
#20
REVIEW
Gill Norman, Maggie J Westby, Amber D Rithalia, Nikki Stubbs, Marta O Soares, Jo C Dumville
BACKGROUND: Venous leg ulcers are open skin wounds on the lower leg which can be slow to heal, and are both painful and costly. The point prevalence of open venous leg ulcers in the UK is about 3 cases per 10,000 people, and many people experience recurrent episodes of prolonged ulceration. First-line treatment for venous leg ulcers is compression therapy, but a wide range of dressings and topical treatments are also used. This diversity of treatments makes evidence-based decision-making challenging, and a clear and current overview of all the evidence is required...
June 15, 2018: Cochrane Database of Systematic Reviews
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