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Controlled clinical trial

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https://www.readbyqxmd.com/read/29151232/early-promising-outcome-following-arthroscopic-implantation-of-the-subacromial-balloon-spacer-for-treating-massive-rotator-cuff-tear
#1
R S M Piekaar, I C E Bouman, P M van Kampen, F van Eijk, P E Huijsmans
BACKGROUND: Massive rotator cuff tear (RCT) can result in disability and severe pain. When conservative treatment fails, surgical treatment should be considered, as various surgical options can provide relatively satisfactory results. However, choosing an optimal treatment remains controversial. A relatively new treatment for irreparable RCT is the arthroscopic implantation of a biodegradable balloon spacer into the subacromial space. Here, we examined whether placement of this balloon spacer reduces pain and improves functional outcome in patients with an irreparable RCT...
November 18, 2017: Musculoskeletal Surgery
https://www.readbyqxmd.com/read/29151225/association-between-different-dietary-polyphenol-subclasses-and-the-improvement-in-cardiometabolic-risk-factors-evidence-from-a-randomized-controlled-clinical-trial
#2
Claudia Vetrani, Marilena Vitale, Lutgarda Bozzetto, Giuseppe Della Pepa, Sara Cocozza, Giuseppina Costabile, Anna Mangione, Paola Cipriano, Giovanni Annuzzi, Angela A Rivellese
AIMS: Due to their different chemical structures and metabolism, polyphenol subclasses may have specific impact on cardiometabolic risk factors. Our aim was to evaluate whether the intake of different polyphenol subclasses is associated with clinical outcomes beneficially improved by polyphenols in a nutritional trial performed by our group (postprandial lipid response, glucose homeostasis, early insulin secretion and oxidative stress). METHODS: The present study is a secondary analysis of a nutritional intervention study with a diet naturally rich in polyphenols...
November 18, 2017: Acta Diabetologica
https://www.readbyqxmd.com/read/29151182/electrical-cardioversion-of-patients-with-implanted-pacemaker-or-cardioverter-defibrillator-results-of-a-survey-of-german-centers-and-systematic-review-of-the-literature
#3
J Lüker, A Sultan, T Plenge, J van den Bruck, C-H Heeger, S Meyer, K Mischke, R R Tilz, D Vollmann, G Nölker, B Schäffer, S Willems, D Steven
AIMS: A relevant number of patients presenting for electrical cardioversion carry a pacemaker (PM) or ICD. Case reports suggest a potential hazard of external cardioversion/defibrillation. The incidence of shock related device complications is unknown. No guidelines or recommendations by international medical societies for a cardioversion protocol of cardiovascular implantable electronic device (CIED) patients exist. We conducted a nationwide survey to gather real-world clinical data on the current clinical approach towards these patients during electrical cardioversion and to estimate the incidence of shock-related complications...
November 18, 2017: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/29151138/optical-coherence-tomography-guided-percutaneous-coronary-intervention-compared-with-other-imaging-guidance-a-meta-analysis
#4
Kayode O Kuku, Emmanuel Ekanem, Viana Azizi, Gebremedhin Melaku, Anh Bui, Yael F Meirovich, Aaphtaab Dheendsa, Solomon Beyene, Alexandre Hideo-Kajita, Michael J Lipinski, Ron Waksman, Hector M Garcia-Garcia
The use of optical coherence tomography (OCT) in PCI guidance is limited perhaps by the lack of adequately powered studies which compare its efficacy and outcomes to the other more popular imaging modalities. We therefore performed a meta-analysis to compare clinical outcomes following OCT-guided PCI with the other imaging modalities in two separate comparisons. We abstracted data from randomized control trials and observational comparative studies focusing on OCT versus either angiography- or IVUS-guided PCI outcomes identified following a systematic search (April 2006 and May 2017)...
November 18, 2017: International Journal of Cardiovascular Imaging
https://www.readbyqxmd.com/read/29151116/do-alpha-1-antagonist-medications-affect-the-success-of-semi-rigid-ureteroscopy-a-prospective-randomised-single-blind-multicentric-study
#5
Mustafa Aydın, Muhammet Fatih Kılınç, Abdulmecit Yavuz, Göksel Bayar
The objective of this study is to assess the efficacy of adjunctive silodosin therapy in improving the success rate of semi-rigid ureteroscopy for removing ureteral stones. Prospective randomised controlled clinical trial performed between July 2016 and September 2016. All the patients underwent ureteroscopic holmium lithotripsy with a YAG laser. The patients were randomised into one of three groups: those who did not use an alpha-1 blocker (AB) (Group 1, n = 50), those who used an AB for one day (Group 2, n = 50), and those who used an AB for three days (Group 3, n = 47)...
November 18, 2017: Urolithiasis
https://www.readbyqxmd.com/read/29151054/effect-of-ephedrine-and-phenylephrine-on-brain-oxygenation-and-microcirculation-in-anaesthetised-patients-with-cerebral-tumours-study-protocol-for-a-randomised-controlled-trial
#6
Klaus Ulrik Koch, Anna Tietze, Joel Aanerud, Gorm von Öettingen, Niels Juul, Jens Christian Hedemann Sørensen, Lone Nikolajsen, Leif Østergaard, Mads Rasmussen
INTRODUCTION: During brain tumour surgery, vasopressor drugs are commonly administered to increase mean arterial blood pressure with the aim of maintaining sufficient cerebral perfusion pressure. Studies of the commonly used vasopressors show that brain oxygen saturation is reduced after phenylephrine administration, but unaltered by ephedrine administration. These findings may be explained by different effects of phenylephrine and ephedrine on the cerebral microcirculation, in particular the capillary transit-time heterogeneity, which determines oxygen extraction efficacy...
November 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/29151048/early-vasopressor-use-following-traumatic-injury-a-systematic-review
#7
Mathieu Hylands, Augustin Toma, Nicolas Beaudoin, Anne Julie Frenette, Frédérick D'Aragon, Émilie Belley-Côté, Emmanuel Charbonney, Morten Hylander Møller, Jon Henrik Laake, Per Olav Vandvik, Reed Alexander Siemieniuk, Bram Rochwerg, François Lauzier, Robert S Green, Ian Ball, Damon Scales, Srinivas Murthy, Joey S W Kwong, Gordon Guyatt, Sandro Rizoli, Pierre Asfar, François Lamontagne
OBJECTIVES: Current guidelines suggest limiting the use of vasopressors following traumatic injury; however, wide variations in practice exist. Although excessive vasoconstriction may be harmful, these agents may help reduce administration of potentially harmful resuscitation fluids. This systematic review aims to compare early vasopressor use to standard resuscitation in adults with trauma-induced shock. DESIGN: Systematic review. DATA SOURCES: We searched MEDLINE, EMBASE, ClinicalTrials...
November 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/29150995/efficacy-and-safety-of-extracranial-vein-angioplasty-in-multiple-sclerosis-a-randomized-clinical-trial
#8
Paolo Zamboni, Luigi Tesio, Stefania Galimberti, Luca Massacesi, Fabrizio Salvi, Roberto D'Alessandro, Patrizia Cenni, Roberto Galeotti, Donato Papini, Roberto D'Amico, Silvana Simi, Maria Grazia Valsecchi, Graziella Filippini
Importance: Chronic cerebrospinal venous insufficiency (CCSVI) is characterized by restricted venous outflow from the brain and spinal cord. Whether this condition is associated with multiple sclerosis (MS) and whether venous percutaneous transluminal angioplasty (PTA) is beneficial in persons with MS and CCSVI is controversial. Objective: To determine the efficacy and safety of venous PTA in patients with MS and CCSVI. Design, Setting, and Participants: We analyzed 177 patients with relapsing-remitting MS; 62 were ineligible, including 47 (26...
November 18, 2017: JAMA Neurology
https://www.readbyqxmd.com/read/29150922/prospective-evaluation-of-a-nonsurgical-device-for-rhinoplasty
#9
M A Deggeller, D Holzmann, M B Soyka
BACKGROUND: Rhinoplasty represents one of the most challenging and frequently performed procedures in plastic surgery and non-surgical rhinoplasty is rarely considered. The aim of this study was to investigate whether the Nasella Nose Former (NNF), a newly developed non-surgical rhinoplasty device, could improve objective and subjective results following surgical rhinoplasty and even correct the shape of the nose without any surgery at all. METHODOLOGY: In this prospective, monocentric, two-armed, non-blinded randomized, controlled clinical trial, a total of 43 participants were included...
November 18, 2017: Rhinology
https://www.readbyqxmd.com/read/29150886/ruxolitinib-associated-infections-a-systematic-review-and-meta-analysis
#10
Federico Lussana, Marco Cattaneo, Alessandro Rambaldi, Alessandro Squizzato
Ruxolitinib exerts immunosuppressive activity that may increase the risk of infectious complications. We performed a systematic review of the literature with the aim of estimating the risk of infections in patients treated with ruxolitinib. Studies were identified by electronic search of MEDLINE and EMBASE database. Differences in the incidence of infectious events between ruxolitinib and comparison groups were expressed as odds ratios (ORs) and 95% confidence intervals (95% CI). Five phase III randomized clinical trials (RCTs) (3 phase IIIa with their extended phase and 2 phase IIIb), 6 phase IV studies and 28 case reports were included in this systematic review...
November 18, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/29150857/a-randomized-double-blind-placebo-controlled-dose-finding-trial-with-lolium-perenne-peptide-immunotherapy
#11
Ralph Mösges, Elena M Kasche, Esther Raskopf, Jaswinder Singh, Lea Sohlich, Anatoli Astvatsatourov, Kija Shah-Hosseini, Sabine Pirotton, Ludo Haazen, Stephen R Durham, Thierry Legon, Gregor Zadoyan, Mohamed H Shamji
BACKGROUND: A novel subcutaneous allergen immunotherapy formulation (gpASIT+(™) ) containing Lolium perenne peptides (LPP) and having a short up-dosing phase has been developed to treat grass pollen-induced seasonal allergic rhinoconjunctivitis. We investigated peptide immunotherapy containing the hydrolysate from perennial ryegrass allergens for the optimum dose in terms of clinical efficacy, immunogenicity, and safety. METHODS: This prospective, double-blind, placebo-controlled, phase IIb, parallel, four-arm, dose-finding study randomized 198 grass pollen-allergic adults to receive placebo or cumulative doses of 70, 170, or 370 μg LPP...
November 18, 2017: Allergy
https://www.readbyqxmd.com/read/29150842/the-effect-of-6-hydroxyethyl-starch-130-0-4-on-acute-kidney-injury-in-paediatric-cardiac-surgery-a-prospective-randomised-trial
#12
H-W Oh, J-H Lee, H-C Kim, E-H Kim, I-K Song, H-S Kim, J-T Kim
We have evaluated the effect of a colloid solution on acute kidney injury in paediatric cardiac surgery. A total of 195 patients were ramdomly divided into an hydroxyethyl starch group and a control group. In the starch group, 6% hydroxyethyl starch 130/0.4 (Volulyte(®) ) was used as the primary fluid for volume resuscitation but was limited to 30 ml.kg(-1) . In the control group, only crystalloid fluid was used during the peri-operative period. The incidence of acute kidney injury, peri-operative transfusion, clinical outcomes and laboratory data were compared...
November 17, 2017: Anaesthesia
https://www.readbyqxmd.com/read/29150790/clinical-study-on-yishen-qufeng-shengshi-recipe-for-glomerular-proteinuria-patients-a-randomized-controlled-trial
#13
Qin Dai, Pei-Qing Zhang, Xiao-Qin Wang, Li-Fang Nie, Xiao-Jun Fu, Wen Peng, Yi Wang, Jun Li, Yue-Ping Bi, Xiu-Hua Mi, Min Yuan, Li-Qun He
OBJECTIVE: To explore the therapeutic effect of Yishen Qufeng Shengshi Recipe (, YQSR) in patients with glomerular proteinuria. METHODS: A total of 145 patients with glomerular proteinuria were selected and randomly assigned to the treatment group (108 cases) and the control group (37 cases) according to a random number table in a ratio of 3:1. All patients received conventional and symptomatic treatment. In addition, patients in the treatment and control groups were given YQSR (200 mL, twice per day, orally) and losartan (50 mg/d orally), respectively for 6 months...
November 17, 2017: Chinese Journal of Integrative Medicine
https://www.readbyqxmd.com/read/29150739/cell-therapy-in-stroke-cautious-steps-towards-a-clinical-treatment
#14
REVIEW
Olivier Detante, Keith Muir, Jukka Jolkkonen
In the future, stroke patients may receive stem cell therapy as this has the potential to restore lost functions. However, the development of clinically deliverable therapy has been slower and more challenging than expected. Despite recommendations by STAIR and STEPS consortiums, there remain flaws in experimental studies such as lack of animals with comorbidities, inconsistent approaches to experimental design, and concurrent rehabilitation that might lead to a bias towards positive results. Clinical studies have typically been small, lacking control groups as well as often without clear biological hypotheses to guide patient selection...
November 17, 2017: Translational Stroke Research
https://www.readbyqxmd.com/read/29150713/efficacy-of-silexan-in-subthreshold-anxiety-meta-analysis-of-randomised-placebo-controlled-trials
#15
Hans-Jürgen Möller, Hans-Peter Volz, Angelika Dienel, Sandra Schläfke, Siegfried Kasper
Subthreshold psychiatric disorders do not fully meet the diagnostic criteria of syndromal disorders but may be associated with comparable disability. To investigate the anxiolytic effect of Silexan, an active substance from lavender oil for oral administration, in patients with subthreshold anxiety, a meta-analysis that included all published trials with Silexan in this indication was performed. Three randomised, placebo-controlled trials in subthreshold anxiety disorders (anxiety disorder not otherwise specified, restlessness and agitation, mixed anxiety and depressive disorder) were included...
November 17, 2017: European Archives of Psychiatry and Clinical Neuroscience
https://www.readbyqxmd.com/read/29150470/platelet-rich-plasma-in-achilles-tendon-healing-2-path-2-trial-protocol-for-a-multicentre-participant-and-assessor-blinded-parallel-group-randomised-clinical-trial-comparing-platelet-rich-plasma-prp-injection-versus-placebo-injection-for-achilles-tendon-rupture
#16
Joseph Alsousou, David J Keene, Philippa A Hulley, Paul Harrison, Susan Wagland, Christopher Byrne, Michael Maia Schlüssel, Susan J Dutton, Sarah E Lamb, Keith Willett
BACKGROUND: Achilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies...
November 16, 2017: BMJ Open
https://www.readbyqxmd.com/read/29150377/urgent-versus-post-stabilisation-antiretroviral-treatment-in-hospitalised-hiv-infected-children-in-kenya-push-a-randomised-controlled-trial
#17
Irene N Njuguna, Lisa M Cranmer, Vincent O Otieno, Cyrus Mugo, Hellen M Okinyi, Sarah Benki-Nugent, Barbra Richardson, Joshua Stern, Elizabeth Maleche-Obimbo, Dalton C Wamalwa, Grace C John-Stewart
BACKGROUND: Urgent antiretroviral therapy (ART) among hospitalised HIV-infected children might accelerate recovery or worsen outcomes associated with immune reconstitution. We aimed to compare urgent versus post-stabilisation ART among hospitalised HIV-infected children in Kenya. METHODS: In this unmasked randomised controlled trial, we randomly assigned (1:1) HIV-infected, ART-naive children aged 0-12 years who were eligible for treatment to receive ART within 48 h (urgent group) or in 7-14 days (post-stabilisation group) at four hospitals in Kenya (two in Nairobi and two in western Kenya)...
November 14, 2017: Lancet HIV
https://www.readbyqxmd.com/read/29150209/exploring-the-relationship-between-polio-type-2-serum-neutralizing-antibodies-and-intestinal-immunity-using-data-from-two-randomized-controlled-trials-of-new-bopv-ipv-immunization-schedules
#18
Ananda S Bandyopadhyay, Edwin J Asturias, Miguel O'Ryan, M Steven Oberste, William Weldon, Ralf Clemens, Ricardo Rüttimann, John F Modlin, Chris Gast
BACKGROUND: Inactivated polio vaccine (IPV) is now the only source of routine type 2 protection. The relationship, if any, between vaccine-induced type 2 humoral and intestinal immunity is poorly understood. METHODS: Two clinical trials in five Latin American countries of mixed or sequential bOPV-IPV schedules in 1640 infants provided data on serum neutralizing antibodies (NAb) and intestinal immunity, assessed as viral shedding following oral mOPV2 challenge. Analyses with generalized additive and quantile regression models examined the relationships between prechallenge NAb titers and proportion, duration and titers (magnitude) of viral shedding...
November 14, 2017: Vaccine
https://www.readbyqxmd.com/read/29150198/comparative-effectiveness-of-extended-release-naltrexone-versus-buprenorphine-naloxone-for-opioid-relapse-prevention-x-bot-a-multicentre-open-label-randomised-controlled-trial
#19
Joshua D Lee, Edward V Nunes, Patricia Novo, Ken Bachrach, Genie L Bailey, Snehal Bhatt, Sarah Farkas, Marc Fishman, Phoebe Gauthier, Candace C Hodgkins, Jacquie King, Robert Lindblad, David Liu, Abigail G Matthews, Jeanine May, K Michelle Peavy, Stephen Ross, Dagmar Salazar, Paul Schkolnik, Dikla Shmueli-Blumberg, Don Stablein, Geetha Subramaniam, John Rotrosen
BACKGROUND: Extended-release naltrexone (XR-NTX), an opioid antagonist, and sublingual buprenorphine-naloxone (BUP-NX), a partial opioid agonist, are pharmacologically and conceptually distinct interventions to prevent opioid relapse. We aimed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX. METHODS: We initiated this 24 week, open-label, randomised controlled, comparative effectiveness trial at eight US community-based inpatient services and followed up participants as outpatients...
November 14, 2017: Lancet
https://www.readbyqxmd.com/read/29150176/studies-on-in-vitro-hypoglycemic-effects-of-root-bark-of-caesalpinia-bonducella
#20
F J Sayyed, G H Wadkar
OBJECTIVE: The present investigation was undertaken to assess the hypoglycemic potential of ethanolic (ECB) and aqueous extracts (ACB) of root bark of Caesalpinia bonducella using various in vitro techniques. METHOD: The ethanolic and aqueous extracts of root bark of C. bonducella were studied for their effects on glucose adsorption capacity, in vitro glucose diffusion, in-vitro amylolysis kinetics and glucose transport across membrane of yeast cells. RESULT: It was observed that the extracts under study adsorbed glucose and the adsorption of glucose increased remarkably with an increase in glucose concentration...
November 14, 2017: Annales Pharmaceutiques Françaises
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