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Rct neurology

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
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
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
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
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
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)
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...
2016: Trials
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
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
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
Si Zhang, Yuan Fang, Bo Wen Cai, Jian Guo Xu, Chao You
BACKGROUND: Craniopharyngiomas are the most common benign histological tumours to involve the hypothalamo-pituitary region in childhood. Cystic craniopharyngiomas account for more than 90% of the tumours. The optimal treatment of cystic craniopharyngioma remains controversial. Radical resection is the treatment of choice in patients with favourable tumour localisation. When the tumour localisation is unfavourable, a gross-total or partial resection followed by radiotherapy is the main treatment option in adults...
2016: Cochrane Database of Systematic Reviews
Gerald B Fogarty, Angela Hong, Vinai Gondi, Bryan Burmeister, Kari Jacobsen, Serigne Lo, Elizabeth Paton, Brindha Shivalingam, John F Thompson
Every year 170,000 patients are diagnosed with brain metastases (BMs) in the United States. Traditionally, adjuvant whole brain radiotherapy (AWBRT) has been offered following local therapy with neurosurgery (NSx) and/or stereotactic radiosurgery (SRS) to BMs. The aim is to increase intracranial control, thereby decreasing symptoms from intracranial progression and a neurological death. There is a rapidly evolving change in the radiation treatment of BMs happening around the world. AWBRT is now being passed over in favour of repeat scanning at regular intervals and more local therapies as more BMs appear radiologically, BMs that may never become symptomatic...
2016: BMC Cancer
Peter Markus Spieth, Anne Sophie Kubasch, Ana Isabel Penzlin, Ben Min-Woo Illigens, Kristian Barlinn, Timo Siepmann
Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials...
2016: Neuropsychiatric Disease and Treatment
Lakshmanan Arunachalam, Iain A Hunter, Shane Killeen
OBJECTIVE: To determine the nature and frequency of distorted presentation or "spin" (ie, specific reporting strategies which highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes in surgical journals. BACKGROUND: Multiple reports have suggested that interpretation of RCT results in medical journals can be distorted by authors of published reports...
June 1, 2016: Annals of Surgery
Damon C Scales, Eyal Golan, Ruxandra Pinto, Steven C Brooks, Martin Chapman, Craig M Dale, Draga Jichici, Gordon D Rubenfeld, Laurie J Morrison
RATIONALE: Predictions about neurological prognosis that are based on early clinical findings after out-of-hospital cardiac arrest (OHCA) are often inaccurate, and may lead to premature decisions to withdraw life-sustaining treatments (WLST) in patients who might otherwise survive with good neurological outcomes. OBJECTIVE: To improve adherence to recommendations for appropriate neurological prognostication after OHCA and reduce deaths from premature decisions to WLST...
April 26, 2016: American Journal of Respiratory and Critical Care Medicine
Marianne Leruez-Ville, Idir Ghout, Laurence Bussières, Julien Stirnemann, Jean-François Magny, Sophie Couderc, Laurent J Salomon, Tiffany Guilleminot, Philippe Aegerter, Guillaume Benoist, Norbert Winer, Olivier Picone, François Jacquemard, Yves Ville
BACKGROUND: Congenital infection with human cytomegalovirus is a major cause of morbidity and mortality. A randomized controlled trial showed that high-dosage valacyclovir prevents cytomegalovirus disease in transplant recipients. Fetuses showing ultrasound features of infection are at high risk of being symptomatic at or before birth. In a pilot study, oral administration of high-dosage valacyclovir to mothers significantly decreased viral load and produced therapeutic concentrations in the blood of infected fetuses...
October 2016: American Journal of Obstetrics and Gynecology
Monish M Maharaj, Jarred A Hogan, Kevin Phan, Ralph J Mobbs
OBJECTIVE: Current recommendations for traumatic spinal cord injury treatment recommend immediate transfer to a spinal injury unit (SIU) where available following patient stabilisation. Although transfer is dependent on a variety of factors, the largest review was unable to justify implementation of such units on the basis of insufficient and lack of quality data in favour of care at the SIU as opposed to non-SIU centres. Our study sought to investigate: are subspecialty spinal injury units (SIUs) able to provide superior care compared with traditional trauma/rehab units? Is the standard of care of acute spinal cord injured patients to be managed in SIU's? METHOD: A literature search was conducted across five major databases using the key terms: "spinal cord injury" AND "Spinal Injury Unit" OR "spinal rehabilitation" OR "spinal injury centre" OR "specialist care" OR "care requirements...
June 2016: European Spine Journal
Kieron Sweeney, Nicholas Silver, Mohsen Javadpour
INTRODUCTION: Subarachnoid haemorrhage (SAH) may arise spontaneously or as a result of trauma. Spontaneous SAH accounts for about 5% of all strokes. Ruptured aneurysms are the cause of 85% of spontaneous SAH. The most characteristic clinical feature is sudden-onset severe headache. Other features include vomiting, photophobia, and focal neurological deficit or seizures, or both. As the headache may have insidious onset in some cases, or may even be absent, a high degree of suspicion is required to diagnose SAH with less typical presentations...
March 17, 2016: Clinical Evidence
Rosa M Angulo-Barroso, Ming Li, Denise C C Santos, Yang Bian, Julie Sturza, Yaping Jiang, Niko Kaciroti, Blair Richards, Betsy Lozoff
BACKGROUND AND OBJECTIVE: Insufficient iron levels for optimal fetal and infant development is a concern during pregnancy and infancy. The goal of this study was to assess the effects of iron supplementation in pregnancy and/or infancy on motor development at 9 months. METHODS: The study was a randomized controlled trial (RCT) of infancy iron supplementation linked to an RCT of pregnancy iron supplementation, conducted in Hebei, China. A total of 1482 infants were randomly assigned to receive placebo (n = 730) or supplemental iron (n = 752) from 6 weeks to 9 months...
April 2016: Pediatrics
Amir Azarhomayoun, Roger Chou, Saeedeh Shirdel, Maziar Moradi Lakeh, Alexander R Vaccaro, Vafa Rahimi-Movaghar
STUDY DESIGN: A systematic review. OBJECTIVE: The aim of this study was to compare the effects of sequestrectomy versus conventional microdiscectomy for lumbar disc herniation (LDH). SUMMARY OF BACKGROUND DATA: Open surgery for LDH can be performed by sequestrectomy (removal of disc fragments) or conventional discectomy (removal of disc fragments and disc). Sequestrectomy might be associated with a higher risk of recurrence but less low back pain (LBP) after surgery...
December 2015: Spine
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