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https://www.readbyqxmd.com/read/28451497/evaluation-of-adverse-events-in-total-disc-replacement-a-meta-analysis-of-fda-summary-of-safety-and-effectiveness-data
#1
Paul A Anderson, Ahmad Nassr, Bradford L Currier, Arjun S Sebastian, Paul M Arnold, Michael G Fehlings, Thomas E Mroz, K Daniel Riew
STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: The safety of new technology such as cervical total disc replacement (TDR) is of paramount importance and is best evaluated in randomized clinical trials (RCT). We compared complication risks of TDR to fusion using data from Investigational Device Exemptions. METHODS: A systematic review of FDA Summary of Safety and Effectiveness reports of the 8 approved cervical TDRs was performed...
April 2017: Global Spine Journal
https://www.readbyqxmd.com/read/28417213/retrospective-analysis-of-cervical-corpectomies-implant-related-complications-of-one-and-two-level-corpectomies-in-45-patients
#2
Sebastian Hartmann, P Kavakebi, C Wipplinger, A Tschugg, P P Girod, S Lener, C Thomé
Cervical corpectomies are increasingly used to treat degenerative, metastatic, inflammatory and traumatic multisegmental diseases. The postoperative results are thought to correlate mainly with the number of resected vertebral bodies. Thus, the aim of the study was to analyse complications and early outcome of these procedures to document the implant-related complications in order to set up a prospective clinical trial. Forty-five patients, who were treated in our department from 2011 to 2014 and who were available for a minimum follow-up of 1 year, were consecutively included in this retrospective evaluation...
April 17, 2017: Neurosurgical Review
https://www.readbyqxmd.com/read/28414164/a-pre-hospital-extracorporeal-cardio-pulmonary-resuscitation-ecpr-strategy-for-treatment-of-refractory-out-hospital-cardiac-arrest-an-observational-study-and-propensity-analysis
#3
Lionel Lamhaut, Alice Hutin, Etienne Puymirat, Jérome Jouan, Jean-Herlé Raphalen, Romain Jouffroy, Murielle Jaffry, Christelle Dagron, Kim An, Florence Dumas, Eloi Marijon, Wulfran Bougouin, Jean-Pierre Tourtier, Frédéric Baud, Xavier Jouven, Nicolas Danchin, Christian Spaulding, Pierre Carli
BACKGROUND: Out of hospital cardiac arrest (OHCA) mortality rates remain very high with poor neurological outcome in survivors. Extracorporeal cardiopulmonary resuscitation (ECPR) is one of the treatments of refractory OHCA. This study used data from the mobile intensive care unit (MOICU) as part of the emergency medical system of Paris, and included all consecutive patients treated with ECPR (including pre-hospital ECPR) from 2011 to 2015 for the treatment of refractory OHCA, comparing two historical ECPR management strategies...
April 14, 2017: Resuscitation
https://www.readbyqxmd.com/read/28349529/continuous-chest-compression-versus-interrupted-chest-compression-for-cardiopulmonary-resuscitation-of-non-asphyxial-out-of-hospital-cardiac-arrest
#4
REVIEW
Lei Zhan, Li J Yang, Yu Huang, Qing He, Guan J Liu
BACKGROUND: Out-of-hospital cardiac arrest (OHCA) is a major cause of death worldwide. Cardiac arrest can be subdivided into asphyxial and non asphyxial etiologies. An asphyxia arrest is caused by lack of oxygen in the blood and occurs in drowning and choking victims and in other circumstances. A non asphyxial arrest is usually a loss of functioning cardiac electrical activity. Cardiopulmonary resuscitation (CPR) is a well-established treatment for cardiac arrest. Conventional CPR includes both chest compressions and 'rescue breathing' such as mouth-to-mouth breathing...
March 27, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28271450/patient-important-outcomes-in-randomized-controlled-trials-in-critically-ill-patients-a-systematic-review
#5
REVIEW
Stéphane Gaudry, Jonathan Messika, Jean-Damien Ricard, Sylvie Guillo, Blandine Pasquet, Emeline Dubief, Tanissia Boukertouta, Didier Dreyfuss, Florence Tubach
BACKGROUND: Intensivists' clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients. METHODS: Literature search was conducted to identify eligible trials indexed from January to December 2013...
December 2017: Annals of Intensive Care
https://www.readbyqxmd.com/read/28214921/vitamin-d-administration-during-pregnancy-as-prevention-for-pregnancy-neonatal-and-postnatal-complications
#6
REVIEW
Carol L Wagner, Bruce W Hollis, Kalliopi Kotsa, Hana Fakhoury, Spyridon N Karras
Pregnancy represents a time of rapid bodily change, which includes physical proportions, physiology and responsibility. At this context, maternal vitamin D stores have been the objective of extensive scientific research during the last decades, focusing on their potential effects on maternal an neonatal health. A growing body of observational studies indicated that maternal hypovitaminosis D (as defined by maternal 25-hydroxyvitamin D [25(OH)D] levels <20 ng/ml or <50 nmol/l) is a significant risk factor for adverse neonatal outcomes including asthma, multiple sclerosis and other neurological disorders...
February 18, 2017: Reviews in Endocrine & Metabolic Disorders
https://www.readbyqxmd.com/read/28173775/evaluation-and-implementation-of-highly-challenging-balance-training-in-clinical-practice-for-people-with-parkinson-s-disease-protocol-for-the-hibalance-effectiveness-implementation-trial
#7
Breiffni Leavy, Lydia Kwak, Maria Hagströmer, Erika Franzén
BACKGROUND: If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented...
February 7, 2017: BMC Neurology
https://www.readbyqxmd.com/read/28051764/the-use-of-fibrin-sealant-during-non-emergency-surgery-a-systematic-review-of-evidence-of-benefits-and-harms
#8
Steven J Edwards, Fay Crawford, Michelle Helena van Velthoven, Andrea Berardi, George Osei-Assibey, Mariana Bacelar, Fatima Salih, Victoria Wakefield
BACKGROUND: Fibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use. OBJECTIVES: To systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults. DATA SOURCES: Electronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015...
December 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27965377/twenty-year-follow-up-of-kangaroo-mother-care-versus-traditional-care
#9
Nathalie Charpak, Rejean Tessier, Juan G Ruiz, Jose Tiberio Hernandez, Felipe Uriza, Julieta Villegas, Line Nadeau, Catherine Mercier, Francoise Maheu, Jorge Marin, Darwin Cortes, Juan Miguel Gallego, Dario Maldonado
BACKGROUND AND OBJECTIVES: Kangaroo mother care (KMC) is a multifaceted intervention for preterm and low birth weight infants and their parents. Short- and mid-term benefits of KMC on survival, neurodevelopment, breastfeeding, and the quality of mother-infant bonding were documented in a randomized controlled trial (RCT) conducted in Colombia from 1993 to 1996. The aim of the present study was to evaluate the persistence of these results in young adulthood. METHODS: From 2012 to 2014, a total of 494 (69%) of the 716 participants of the original RCT known to be alive were identified; 441 (62% of the participants in the original RCT) were re-enrolled, and results for the 264 participants weighing ≤1800 g at birth were analyzed...
January 2017: Pediatrics
https://www.readbyqxmd.com/read/27913539/prevention-of-central-nervous-system-sequelae-in-sickle-cell-disease-without-evidence-from-randomized-controlled-trials-the-case-for-a-team-based-learning-collaborative
#10
Michael R DeBaun, Allison A King
Since 1998, the National Institutes of Health has funded 5 randomized controlled trials (RCTs) for primary and secondary prevention of strokes in children with sickle cell anemia (SCA). In a systematic fashion, these trials have significantly advanced the care of children with SCA. In the absence of an RCT, clinicians are often compelled to make decisions at the bedside, based on experience, observational studies, and principles of hematology. We will provide an initial example that describes how a team-based, learning collaborative developed a multisite standard care protocol with a low budget (<$10 000 per year) to overcome the intrinsic limitations of advancing the care of neurologic complications in sickle cell disease (SCD)...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27759881/endodontic-procedures-for-retreatment-of-periapical-lesions
#11
REVIEW
Massimo Del Fabbro, Stefano Corbella, Patrick Sequeira-Byron, Igor Tsesis, Eyal Rosen, Alessandra Lolato, Silvio Taschieri
BACKGROUND: When primary root canal therapy fails, periapical lesions can be retreated with or without surgery. Root canal retreatment is a non-surgical procedure that involves removal of root canal filling materials from the tooth, followed by cleaning, shaping and obturating of the canals. Root-end resection is a surgical procedure that involves exposure of the periapical lesion through an osteotomy, surgical removal of the lesion, removal of part of the root-end tip, disinfection and, commonly, retrograde sealing or filling of the apical portion of the remaining root canal...
October 19, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27697876/community-based-rehabilitation-training-after-stroke-protocol-of-a-pilot-randomised-controlled-trial-retrain
#12
Sarah G Dean, Leon Poltawski, Anne Forster, Rod S Taylor, Anne Spencer, Martin James, Rhoda Allison, Shirley Stevens, Meriel Norris, Anthony I Shepherd, Raff Calitri
INTRODUCTION: The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design...
October 3, 2016: BMJ Open
https://www.readbyqxmd.com/read/27572719/pharmacological-treatments-for-friedreich-ataxia
#13
REVIEW
Mary Kearney, Richard W Orrell, Michael Fahey, Ruth Brassington, Massimo Pandolfo
BACKGROUND: Friedreich ataxia is a rare inherited autosomal recessive neurological disorder, characterised initially by unsteadiness in standing and walking, slowly progressing to wheelchair dependency usually in the late teens or early twenties. It is associated with slurred speech, scoliosis, and pes cavus. Heart abnormalities cause premature death in 60% of people with the disorder. There is no easily defined clinical or biochemical marker and no known treatment. This is the second update of a review first published in 2009 and previously updated in 2012...
August 30, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27559457/clinical-factors-for-prognosis-and-treatment-guidance-of-spinal-cord-astrocytoma
#14
Toshitaka Seki, Kazutoshi Hida, Shunsuke Yano, Takeshi Aoyama, Izumi Koyanagi, Toru Sasamori, Shuji Hamauch, Kiyohiro Houkin
STUDY DESIGN: Retrospective study. PURPOSE: To obtain information useful in establishing treatment guidelines by evaluating baseline clinical features and treatment outcomes of patients with spinal cord astrocytoma (SCA). OVERVIEW OF LITERATURE: The optimal management of SCA remains controversial, and there are no standard guidelines. METHODS: The study included 20 patients with low-grade and 13 with high-grade SCA surgically treated between 1989 and 2014...
August 2016: Asian Spine Journal
https://www.readbyqxmd.com/read/27553811/optimal-management-of-leptomeningeal-carcinomatosis-in-breast-cancer-patients-a-systematic-review
#15
REVIEW
Shaan Dudani, Sasha Mazzarello, John Hilton, Brian Hutton, Lisa Vandermeer, Ricardo Fernandes, Mohammed F K Ibrahim, Stephanie Smith, Habeeb Majeed, Khalid Al-Baimani, Jean-Michel Caudrelier, Risa Shorr, Mark Clemons
The incidence of leptomeningeal carcinomatosis in breast cancer patients (LC-BC) is increasing. Despite significantly affecting patient quality of life (QoL) and overall survival (OS), little is known about its optimal management. A systematic review of treatment strategies for LC-BC was performed. EMBASE, Ovid Medline, Pubmed, and the Cochrane Central Register of Controlled Trials were searched from 1946 to 2015 for trials reporting on treatments for LC-BC. All treatment modalities and study types were considered...
December 2016: Clinical Breast Cancer
https://www.readbyqxmd.com/read/27495048/a-meta-analysis-for-efficacy-and-safety-evaluation-of-transcatheter-left-atrial-appendage-occlusion-in-patients-with-nonvalvular-atrial-fibrillation
#16
REVIEW
Zhonghai Wei, Xinlin Zhang, Han Wu, Jun Xie, Qing Dai, Lian Wang, Biao Xu
OBJECTIVES: This meta-analysis was conducted to evaluate the efficacy and safety of transcatheter left atrial appendage (LAA) occlusion in patients with nonvalvular atrial fibrillation. METHODS: The randomized controlled trials (RCT) or observational studies with any transcatheter LAA occlusion devices were searched in PubMed, Embase, and Cochrane library from inception to November 2015. The incidence rates from individual studies were combined to evaluate the procedural efficacy and safety, including all-cause death, cardiac/neurological death, stroke, transient ischemic attack (TIA), thrombosis, hemorrhagic complications, and pericardial effusion/tamponade...
August 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27473269/melatonin-in-youth-n-of-1-trials-in-a-stimulant-treated-adhd-population-mynap-study-protocol-for-a-randomized-controlled-trial
#17
Salima Punja, Catherine J Nikles, Hugh Senior, Geoffrey Mitchell, Christopher H Schmid, Helen Heussler, Manisha Witmans, Sunita Vohra
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a common neurological disorder affecting 5 % of children worldwide. A prevalent problem for children with ADHD is initial insomnia. The gold standard treatment to manage ADHD symptoms is stimulant medications, which may exacerbate the severity of existing initial insomnia. Currently, no gold standard treatment option exists for initial insomnia for these children. Melatonin, a hormone and a popular natural health product, is commonly provided to children by parents and recommended by healthcare providers, but high quality pediatric evidence is lacking...
July 29, 2016: Trials
https://www.readbyqxmd.com/read/27463686/peculiarities-of-neurological-disorders-and-study-designs
#18
REVIEW
Ettore Beghi, Elisabetta Pupillo, Giorgia Giussani
BACKGROUND: Neurological disorders are heterogeneous clinical conditions with variable course and outcome. SUMMARY: The basic aspects of the commonest neurological disorders are addressed along with the proposed structure of randomized clinical trials (RCTs). Dementing disorders, including Alzheimer's disease (AD), are clinical conditions in which altered cognitive functions are associated with behavioral and personality changes. Parkinson's disease (PD) is a multisystem disorder characterized by motor dysfunction associated with dysautonomia, sleep and olfactory disturbances, cognitive changes, and depression...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463525/the-basic-structure-of-a-randomized-clinical-trial
#19
Ettore Beghi
BACKGROUND: According to the Directive 2001/20/EC of the European Union, a clinical trial is any investigation in human subjects intended to (1) discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of one or more investigational medicinal product(s), (2) identify any adverse reactions to one or more investigational medicinal product(s), (3) and/or study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy...
2016: Frontiers of Neurology and Neuroscience
https://www.readbyqxmd.com/read/27463091/general-overview-conclusions-and-future-directions
#20
REVIEW
Ettore Beghi, Giancarlo Logroscino
BACKGROUND: The traditional design of the randomized clinical trial (RCT) is challenged by the peculiarities of the genotype and phenotype of neurological disorders. SUMMARY: RCTs are intended to verify the net effect of an investigational treatment on the outcome of a disease. This implies the inclusion of strictly homogeneous sample of patients that represent only in part the full disease spectrum. For this reason, pragmatic trials on representative samples of the general population are welcome...
2016: Frontiers of Neurology and Neuroscience
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