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Impactful clinical trials

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https://www.readbyqxmd.com/read/29165723/the-impact-of-hyperosmolarity-on-long-term-outcome-in-patients-presenting-with-severe-hyperglycemic-crisis-a-population-based-study
#1
Ivan Kruljac, Miroslav Ćaćić, Petra Ćaćić, Lora Stanka Kirigin Biloš, Davor Kust, Božidar Perić, Maja Filipović-Grčić, Gorana Mirošević, Vedran Ostojić, Mario Štefanović, Milan Vrkljan
Aims We compared characteristics of patients with hyperglycemic hyperosmolar state (HHS) and patients with severe hyperglycemia without the signs of hyperosmolarity and ketoacidosis; analyzed long-term all-cause mortality and potential prognostic factors. Methods The studied population included 261 749 adults. HHS was diagnosed in patients with plasma glucose >33.0 mmol/L, ketonuria <1+, and serum osmolarity >320 mmol/L. Patients with plasma glucose >33.0 mmol/L, ketonuria <1+ and serum osmolarity <320 mmol/L were considered as controls (nHHS)...
November 17, 2017: Experimental and Clinical Endocrinology & Diabetes
https://www.readbyqxmd.com/read/29165173/health-and-well-being-benefits-of-spending-time-in-forests-systematic-review
#2
Byeongsang Oh, Kyung Ju Lee, Chris Zaslawski, Albert Yeung, David Rosenthal, Linda Larkey, Michael Back
BACKGROUND: Numerous studies have reported that spending time in nature is associated with the improvement of various health outcomes and well-being. This review evaluated the physical and psychological benefits of a specific type of exposure to nature, forest therapy. METHOD: A literature search was carried out using MEDLINE, PubMed, ScienceDirect, EMBASE, and ProQuest databases and manual searches from inception up to December 2016. Key words: "Forest" or "Shinrin -Yoku" or "Forest bath" AND "Health" or "Wellbeing"...
October 18, 2017: Environmental Health and Preventive Medicine
https://www.readbyqxmd.com/read/29165094/potential-risks-and-mitigation-strategies-during-the-conduct-of-a-clinical-trial-an-industry-perspective
#3
Seema Bhagat, Vaibhavi Kapatkar, Sagar Katare, Ashish Mane, Colette Pinto, Kedar Pawar, Agam Shah, Hanmant Barkate
BACKGROUND: Every phase of a clinical trial should be designed in compliance with good clinical practices by following all relevant regulatory guidelines. Patient safety, data integrity and ethics are an integral part of a successful clinical trial which must be considered. Therefore risk monitoring is an essential tool to identify the risks associated with conduct of any trial. This article is a result of extensive research conducted by a reputed pharmaceutical company to identify the potential stages of risks associated with the conduct phase of trial that could impact the overall quality and safety of a trial...
November 19, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/29164637/internal-pilot-design-for-balanced-repeated-measures
#4
Xinrui Zhang, Keith E Muller, Maureen M Goodenow, Yueh-Yun Chi
Repeated measures are common in clinical trials and epidemiological studies. Designing studies with repeated measures requires reasonably accurate specifications of the variances and correlations to select an appropriate sample size. Underspecifying the variances leads to a sample size that is inadequate to detect a meaningful scientific difference, while overspecifying the variances results in an unnecessarily large sample size. Both lead to wasting resources and placing study participants in unwarranted risk...
November 21, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/29164035/a-clinical-practice-guideline-for-the-management-of-patients-with-degenerative-cervical-myelopathy-recommendations-for-patients-with-mild-moderate-and-severe-disease-and-nonmyelopathic-patients-with-evidence-of-cord-compression
#5
Michael G Fehlings, Lindsay A Tetreault, K Daniel Riew, James W Middleton, Bizhan Aarabi, Paul M Arnold, Darrel S Brodke, Anthony S Burns, Simon Carette, Robert Chen, Kazuhiro Chiba, Joseph R Dettori, Julio C Furlan, James S Harrop, Langston T Holly, Sukhvinder Kalsi-Ryan, Mark Kotter, Brian K Kwon, Allan R Martin, James Milligan, Hiroaki Nakashima, Narihito Nagoshi, John Rhee, Anoushka Singh, Andrea C Skelly, Sumeet Sodhi, Jefferson R Wilson, Albert Yee, Jeffrey C Wang
Study Design: Guideline development. Objectives: The objective of this study is to develop guidelines that outline how to best manage (1) patients with mild, moderate, and severe myelopathy and (2) nonmyelopathic patients with evidence of cord compression with or without clinical symptoms of radiculopathy. Methods: Five systematic reviews of the literature were conducted to synthesize evidence on disease natural history; risk factors of disease progression; the efficacy, effectiveness, and safety of nonoperative and surgical management; the impact of preoperative duration of symptoms and myelopathy severity on treatment outcomes; and the frequency, timing, and predictors of symptom development...
September 2017: Global Spine Journal
https://www.readbyqxmd.com/read/29163732/a-comparison-of-the-effects-and-side-effects-of-oral-betahistine-with-injectable-promethazine-in-the-treatment-of-acute-peripheral-vertigo-in-emergency
#6
Hassan Motamed, Meisam Moezzi, Ali Dalir Rooyfard, Kambiz Ahmadi Angali, Zahra Izadi
Background: Vertigo is an illusion of rotation that is caused by the asymmetry of neurological function of the right and left vestibular nuclei. The aim of this study was to compare the efficacy and side effects of oral betahistine with injectable promethazine in treatment of acute peripheral vertigo. Methods: In this double-blind clinical trial study, the patients with acute peripheral vertigo were assigned in the two groups: receiving promethazine intramuscularly at a dose of 25 mg (group A) and receiving 8 mg betahistine tablets (group B) and the severity of their vertigo was evaluated on the visual analog scale (VAS) scoring system...
December 2017: Journal of Clinical Medicine Research
https://www.readbyqxmd.com/read/29163644/evaluation-of-amprolium-and-toltrazuril-efficacy-in-controlling-natural-intestinal-rabbit-coccidiosis
#7
A El-Ghoneimy, I El-Shahawy
This trial was undertaken with the objective to evaluate the efficacy of amprolium, toltrazuril and their combination in rabbits naturally infected with Eimeria species (32 × 10(3) ± 4.63 oocysts per gram (OPG) of faeces). Thirty-six rabbits (11 weeks old with average body weight (BW) 2000 ± 75 g), were randomly allocated into six groups (six kits each), namely, negative untreated and was retained as negative control (group 1), infected and kept untreated (group 2), treated with single oral dose of amprolium at 50 mg/kg BW for 5 days (group 3), received toltrazuril at 5 mg/kg BW for 2 days (group 4), treated orally with toltrazuril at 2...
2017: Iranian journal of veterinary research
https://www.readbyqxmd.com/read/29163061/cyclodextrins-and-iatrogenic-hearing-loss-new-drugs-with-significant-risk
#8
REVIEW
Mark A Crumling, Kelly A King, R Keith Duncan
Cyclodextrins are a family of cyclic oligosaccharides with widespread usage in medicine, industry and basic sciences owing to their ability to solubilize and stabilize guest compounds. In medicine, cyclodextrins primarily act as a complexing vehicle and consequently serve as powerful drug delivery agents. Recently, uncomplexed cyclodextrins have emerged as potent therapeutic compounds in their own right, based on their ability to sequester and mobilize cellular lipids. In particular, 2-hydroxypropyl-β-cyclodextrin (HPβCD) has garnered attention because of its cholesterol chelating properties, which appear to treat a rare neurodegenerative disorder and to promote atherosclerosis regression related to stroke and heart disease...
2017: Frontiers in Cellular Neuroscience
https://www.readbyqxmd.com/read/29162557/self-management-and-clinical-decision-support-for-patients-with-complex-chronic-conditions-through-the-use-of-smartphone-based-telemonitoring-randomized-controlled-trial-protocol
#9
Emily Seto, Patrick Ware, Alexander G Logan, Joseph A Cafazzo, Kenneth R Chapman, Phillip Segal, Heather J Ross
BACKGROUND: The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology...
November 21, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/29162460/physical-exercise-in-cirrhotic-patients-towards-prehabilitation-on-waiting-list-for-liver-transplantation-a-systematic-review-and-meta-analysis
#10
Raffaele Brustia, Eric Savier, Olivier Scatton
BACKGROUND: Early survival after Liver Transplantation (LT) is reduced among sarcopenic patients. Despite, Adapted Physical Activity (APA) before LT is rarely proposed for the risk to impair portal hypertension and its resulting complications. OBJECTIVES: To assess the effects of APA program in adults affected by End Stage Liver Disease (ESLD) on hospital stay, 1-year mortality and morbidity after LT, adverse events (Primary outcomes). Secondary outcomes were changes in VO2 peak, muscle morphology, 6minutes walking distance test (6MWD), Body Mass Index (BMI), MELD, CHILD score and Hepatic Venous Pressure Gradient (HVPG)...
November 18, 2017: Clinics and Research in Hepatology and Gastroenterology
https://www.readbyqxmd.com/read/29162080/modifications-to-advanced-core-decompression-for-treatment-of-avascular-necrosis-of-the-femoral-head
#11
Stefan Landgraeber, Sebastian Warwas, Tim Claßen, Marcus Jäger
BACKGROUND: "Advanced Core Decompression" (ACD) is a new technique for treatment of osteonecrosis of the femoral head (ONFH) that includes removal of the necrotic tissue using a percutaneous expandable reamer followed by refilling of the drill hole and the defect with an injectable, hard-setting, composite calcium sulphate (CaSO4)-calcium phosphate (CaPO4) bone graft substitute. As autologous bone has been shown to be superior to all other types of bone grafts, the aim of the study is to present and evaluate a modified technique of ACD with impaction of autologous bone derived from the femoral neck into the necrotic defect...
November 21, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/29162066/effect-of-sivelestat-sodium-in-patients-with-acute-lung-injury-or-acute-respiratory-distress-syndrome-a-meta-analysis-of-randomized-controlled-trials
#12
Shenglan Pu, Daoxin Wang, Daishun Liu, Yan Zhao, Di Qi, Jing He, Guoqi Zhou
BACKGROUND: Sivelestat is widely used in treating acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), although the clinical efficacy of sivelestat remains controversial. This study aimed to evaluate the impact of sivelestat in patients with ALI/ARDS. METHODS: Electronic databases, PubMed, Embase, and the Cochrane Library, were searched to identify trials through April 2017. Randomized controlled trials (RCTs) were included irrespective of blinding or language that compared patients with and without sivelestat therapy in ALI/ARDS...
November 21, 2017: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/29161839/the-potential-impact-of-a-prophylactic-vaccine-for-ebola-in-sierra-leone
#13
Erin N Bodine, Connor Cook, Mikayla Shorten
The 2014 outbreak of Ebola virus disease (EVD) in West Africa was multinational and of an unprecedented scale primarily affecting the countries of Guinea, Liberia, and Sierra Leone. One of the qualities that makes EVD of high public concern is its potential for extremely high mortality rates (up to 90%). A prophylactic vaccine for ebolavirus (rVSV-ZEBOV) has been developed, and clinical trials show near-perfect efficacy. We have developed an ordinary differential equations model that simulates an EVD epidemic and takes into account (1) transmission through contact with infectious EVD individuals and deceased EVD bodies, (2) the heterogeneity of the risk of becoming infected with EVD, and (3) the increased survival rate of infected EVD patients due to greater access to trained healthcare providers...
April 1, 2018: Mathematical Biosciences and Engineering: MBE
https://www.readbyqxmd.com/read/29161424/clinical-impact-of-implantable-cardioverter-defibrillator-in-primary-prevention-of-total-mortality-in-non-ischaemic-cardiomyopathy-results-from-a-meta-analysis-of-prospective-randomized-clinical-trials
#14
Jorge Romero, Juan Carlos Díaz, Michael Grushko, Renato Quispe, David Briceno, Ricardo Avendano, Anjani Golive, Ileana Pina, Andrea Natale, Mario J Garcia, Ulrich P Jorde, Luigi Di Biase
Aim: Primary prophylactic implantable cardioverter defibrillators (ICDs) have demonstrated a clear all-cause mortality benefit in patients with ischaemic cardiomyopathy, with less compelling evidence supporting its use in patients with non-ischaemic cardiomyopathy (NICM). We performed a meta-analysis of randomized controlled trials (RCTs) evaluating the role of ICD for reduction in total mortality in NICM patients. Methods and results: An electronic search on PubMed, the Cochrane Library, and EMBASE databases was performed to identify the RCTs evaluating the role of prophylactic ICD placement in NICM patients...
November 17, 2017: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/29161417/bolus-weekly-vitamin-d3-supplementation-impacts-gut-and-airway-microbiota-in-adults-with-cystic-fibrosis-a-double-blind-randomized-placebo-controlled-clinical-trial
#15
Mansi Kanhere, Jiabei He, Benoit Chassaing, Thomas R Ziegler, Jessica A Alvarez, Elizabeth A Ivie, Li Hao, John Hanfelt, Andrew T Gewirtz, Vin Tangpricha
Background: Disruption of gut microbiota may exacerbate severity of cystic fibrosis (CF). Vitamin D deficiency is a common co-morbidity in patients with CF that may influence composition of the gut microbiota. Objectives: Compare microbiota of vitamin D sufficient and insufficient CF patients, and assess impact of a weekly high-dose vitamin D3 bolus regimen on gut and airway microbiome in adults with CF and vitamin D insufficiency (25(OH)D <30 ng/mL). Design: Forty-one subjects with CF were classified into two groups - vitamin D insufficient (n=23) and vitamin D sufficient (n=18)...
November 16, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29161116/corticosteroid-therapy-for-critically-ill-patients-with-the-middle-east-respiratory-syndrome
#16
Yaseen M Arabi, Yasser Mandourah, Fahad Al-Hameed, Anees A Sindi, Ghaleb A Al Mekhlafi, Mohamed A Hussein, Jesna Jose, Ruxandra Pinto, Awad Al-Omari, Ayman Kharaba, Abdullah Almotairi, Kasim Al Khatib, Basem Alraddadi, Sarah Shalhoub, Ahmed Abdulmomen, Ismael Qushmaq, Ahmed Mady, Othman Solaiman, Abdulsalam M Al-Aithan, Rajaa Al-Raddadi, Ahmed Ragab, Hanan H Balkhy, Abdulrahman Al Harthy, Ahmad M Deeb, Hanan Al Mutairi, Abdulaziz Al-Dawood, Laura Merson, Frederick G Hayden, Robert A Fowler
RATIONALE: Corticosteroid therapy is commonly used among critically ill patients with the Middle East Respiratory Syndrome (MERS), but its impact on outcomes is uncertain. Analyses of observational studies often do not account for patients' clinical condition at the time of corticosteroid therapy initiation. OBJECTIVES: To investigate the association of corticosteroid therapy on mortality and on MERS coronavirus RNA clearance in critically ill patients with MERS...
November 21, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29159857/methylphenidate-for-children-and-adolescents-with-autism-spectrum-disorder
#17
REVIEW
Nancy Sturman, Laura Deckx, Mieke L van Driel
BACKGROUND: Children with autistic spectrum disorder (ASD) frequently present with inattention, impulsivity and hyperactivity, which are the cardinal symptoms of attention deficit hyperactivity disorder (ADHD). The effectiveness of methylphenidate, a commonly used ADHD treatment, is therefore of interest in these children. OBJECTIVES: To assess the effects of methylphenidate for symptoms of ADHD (inattention, impulsivity and hyperactivity) and ASD (impairments in social interaction and communication, and repetitive, restricted or stereotypical behaviours) in children and adolescents aged 6 to 18 years with ASD...
November 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29159776/non-pharmacological-interventions-in-patients-with-spinal-cord-compression-a-systematic-review
#18
REVIEW
María Paniagua-Collado, Omar Cauli
Spinal cord compression is a complex and challenging condition that greatly affects the quality of life. Non-pharmacological techniques have only been studied to a very lesser extent; although they are evidence to be beneficial. We performed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) analysis of the scientific literature in several databases (Medline, Cochrane, Scopus, Cuiden, Pubmed, Lilacs and Embase); using the following keywords: spinal cord compression, spine compression, mobilization, positioning, brace and bracing...
November 20, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/29159599/delayed-gastric-emptying-following-laparoscopic-repair-of-very-large-hiatus-hernias-impairs-quality-of-life
#19
David S Liu, Chek Tog, Hou K Lim, Peter Stiven, Sarah K Thompson, David I Watson, Ahmad Aly
BACKGROUND: Delayed gastric emptying (DGE) following hiatus hernia surgery may affect a substantial number of patients with adverse clinical consequences. Here, we aim to evaluate the impact of DGE following laparoscopic repair of very large hiatus hernias on patients' quality of life, gastrointestinal symptomatology, and daily function. METHODS: Analysis of data collected from a multicenter prospective randomised trial of patients who underwent laparoscopic mesh versus sutured repair of very large hiatus hernias (>50% of stomach in chest)...
November 20, 2017: World Journal of Surgery
https://www.readbyqxmd.com/read/29159267/long-term-impact-of-intensive-lifestyle-intervention-on-cognitive-function-assessed-with-the-national-institutes-of-health-toolbox-the-look-ahead-study
#20
Kathleen M Hayden, Laura D Baker, George Bray, Raymond Carvajal, Kathryn Demos-McDermott, Andrea L Hergenroeder, James O Hill, Edward Horton, John M Jakicic, Karen C Johnson, Rebecca H Neiberg, Stephen R Rapp, Thomas A Wadden, Michael E Miller
Introduction: This study sought to determine whether 10 years of assignment to intensive lifestyle intervention (ILI) relative to diabetes support and education leads to better cognition. We examine intervention effects overall and among clinical subgroups, and report correlations between computer-administered and interviewer-administered cognitive batteries. Methods: The Action for Health in Diabetes (Look AHEAD) was a 16-site randomized controlled trial with overweight/obese individuals (aged 45-76) who had type 2 diabetes...
2018: Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring
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