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https://www.readbyqxmd.com/read/27930909/fda-regulation-of-neurological-and-physical-medicine-devices-access-to-safe-and-effective-neurotechnologies-for-all-americans
#1
Leigh Anderson, Patrick Antkowiak, Aden Asefa, Amber Ballard, Tushar Bansal, Ayo Bello, Bernard Berne, Kristen Bowsher, Bennett Blumenkopf, Ian Broverman, Mohamad Bydon, Kuo Chao, Peter Como, Karlene Cork, Ann Costello, Kathryn De Laurentis, Angela DeMarco, Heather Dean, John Doucet, Bradley Dworak, Lisa Epperson, Eric Franca, Naz Ghassemian, Chandramallika Ghosh, Anupama Govindarajan, Jay Gupta, Stacie Gutowski, Robert Herrmann, Michael Hoffmann, William Heetderks, Steven Hsu, Daryl Kaufman, Erin Keegan, Gregg Kittlesen, Kevin Khuu, Hyung Lee, Larry Lo, Ian Marcus, Timothy Marjenin, Binoy Mathews, Sanjay Misra, Vivek Pinto, Vesper Ramos, Samuel Raben, Avena Russell, Devjani Saha, Joonil Seog, Christian Shenouda, Myra Smith, Xiaorui Tang, Kelliann Wachrathit, Jaime Waterhouse, Dhanya Williams, Xiaolin Zheng, Carlos Peña
The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices. The Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the nervous system. This article addresses how to navigate the FDA's regulatory landscape to successfully bring medical devices to patients.
December 7, 2016: Neuron
https://www.readbyqxmd.com/read/27929583/non-adiabatic-reactions-general-discussion
#2
Stuart C Althorpe, Nandini Ananth, Gonzalo Angulo, Raymond Dean Astumian, Vijay Beniwal, Jochen Blumberger, Peter G Bolhuis, Bernd Ensing, David R Glowacki, Scott Habershon, Sharon Hammes-Schiffer, Timothy J H Hele, Nancy Makri, David E Manolopoulos, Laura K McKemmish, Thomas F Miller Iii, William H Miller, Adrian J Mulholland, Tatiana Nekipelova, Eli Pollak, Jeremy O Richardson, Martin Richter, Priyadarshi Roy Chowdhury, Dmitry Shalashilin, Rafał Szabla
No abstract text is available yet for this article.
December 8, 2016: Faraday Discussions
https://www.readbyqxmd.com/read/27927857/novel-clinical-and-pathologic-findings-in-a-heartland-virus-associated-death
#3
Mary-Margaret A Fill, Margaret L Compton, Edward C McDonald, Abelardo C Moncayo, John R Dunn, William Schaffner, Julu Bhatnagar, Sherif R Zaki, Timothy F Jones, Wun-Ju Shieh
We describe an investigation into a Heartland Virus (HRTV)-associated death in Tennessee with novel clinical and pathologic findings. HRTV can cause rapidly fatal, widely disseminated infection with multisystem organ failure in patients without substantial comorbidities. We identified viral antigen in multiple organ tissues where it was not detected previously.
December 7, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/27925311/the-chemistry-of-a-non-interacting-vicinal-frustrated-phosphane-borane-lewis-pair
#4
Lisa-Maria Elmer, Gerald Kehr, Constantin G Daniliuc, Melanie Siedow, Hellmut Eckert, Matthias Tesch, Armido Studer, Kamille Williams, Timothy H Warren, Gerhard Erker
The dimesitylphosphinocyclopentene/HB(C6 F5 )2 -derived vicinal trans-1,2-P/B frustrated Lewis pair (FLP) 4 shows no direct phosphane-borane interaction. Toward some reagents it behaves similar to an intermolecular FLP; it cleaves dihydrogen, deprotonates terminal alkynes, and adds to organic carbonyl compounds including CO2 . It shows typical intramolecular FLP reaction modes (cooperative 1,1-additions) to mesityl azide, to carbon monoxide, and to NO. The latter reaction yields a persistent P/B FLPNO nitroxide radical, which undergoes H-atom abstraction reactions...
December 7, 2016: Chemistry: a European Journal
https://www.readbyqxmd.com/read/27923523/polysorbate-80-and-polymyxin-b-inhibit-stenotrophomonas-maltophilia-biofilm
#5
Adam M Malinowski, Bryan M McClarty, Carolyn Robinson, William Spear, Maria Sanchez, Timothy C Sparkes, Joanna S Brooke
Stenotrophomonas maltophilia is an opportunistic multiple-drug-resistant human pathogen that forms biofilms on implanted medical devices. We examined the potential inhibitory activity of polysorbate 80 and polymyxin B against S. maltophilia. A combination of subMIC polymyxin B and polysorbate 80 was the most effective inhibitor of growth and biofilm formation.
November 14, 2016: Diagnostic Microbiology and Infectious Disease
https://www.readbyqxmd.com/read/27919027/phosphorylation-of-janus-kinase-1-jak1-by-amp-activated-protein-kinase-ampk-links-energy-sensing-to-anti-inflammatory-signaling
#6
Claire Rutherford, Claire Speirs, Jamie J L Williams, Marie-Ann Ewart, Sarah J Mancini, Simon A Hawley, Christian Delles, Benoit Viollet, Ana P Costa-Pereira, George S Baillie, Ian P Salt, Timothy M Palmer
Adenosine 5'-monophosphate-activated protein kinase (AMPK) is a pivotal regulator of metabolism at cellular and organismal levels. AMPK also suppresses inflammation. We found that pharmacological activation of AMPK rapidly inhibited the Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway in various cells. In vitro kinase assays revealed that AMPK directly phosphorylated two residues (Ser(515) and Ser(518)) within the Src homology 2 domain of JAK1. Activation of AMPK enhanced the interaction between JAK1 and 14-3-3 proteins in cultured vascular endothelial cells and fibroblasts, an effect that required the presence of Ser(515) and Ser(518) and was abolished in cells lacking AMPK catalytic subunits...
November 8, 2016: Science Signaling
https://www.readbyqxmd.com/read/27918565/centimetre-scale-micropore-alignment-in-oriented-polycrystalline-metal-organic-framework-films-via-heteroepitaxial-growth
#7
Paolo Falcaro, Kenji Okada, Takaaki Hara, Ken Ikigaki, Yasuaki Tokudome, Aaron W Thornton, Anita J Hill, Timothy Williams, Christian Doonan, Masahide Takahashi
The fabrication of oriented, crystalline films of metal-organic frameworks (MOFs) is a critical step toward their application to advanced technologies such as optics, microelectronics, microfluidics and sensing. However, the direct synthesis of MOF films with controlled crystalline orientation remains a significant challenge. Here we report a one-step approach, carried out under mild conditions, that exploits heteroepitaxial growth for the rapid fabrication of oriented polycrystalline MOF films on the centimetre scale...
December 5, 2016: Nature Materials
https://www.readbyqxmd.com/read/27911098/siga-deficiency-in-individual-small-airways-is-associated-with-persistent-inflammation-and-remodeling
#8
Vasiliy V Polosukhin, Bradley W Richmond, Rui-Hong Du, Justin M Cates, Pingsheng Wu, Hui Nian, Pierre P Massion, Lorraine B Ware, Jae Woo Lee, Alexey V Kononov, William E Lawson, Timothy S Blackwell
RATIONALE: Maintenance of a surface immune barrier is important for homeostasis in organs with mucosal surfaces that interface with the external environment; however, the role of the mucosal immune system in chronic lung diseases is incompletely understood. OBJECTIVES: We examined the relationship between secretory immunoglobulin A (SIgA) on the mucosal surface of small airways and parameters of inflammation and airway wall remodeling in chronic obstructive pulmonary disease (COPD)...
December 2, 2016: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/27894105/histone-deacetylase-inhibitors-provoke-a-tumor-supportive-phenotype-in-pancreatic-cancer-associated-fibroblasts
#9
Andrew H Nguyen, Irmina A Elliott, Nanping Wu, Cynthia Matsumura, Maria Vogelauer, Narsis Attar, Amanda Dann, Razmik Ghukasyan, Paul A Toste, Sanjeet G Patel, Jennifer L Williams, Luyi Li, David W Dawson, Caius Radu, Siavash K Kurdistani, Timothy R Donahue
Although histone deacetylase inhibitors (HDACi) are a promising class of anti-cancer drugs, thus far, they have been unsuccessful in early phase clinical trials for pancreatic ductal adenocarcinoma (PDAC). One potential reason for their poor efficacy is the tumor stroma, where cancer-associated fibroblasts (CAFs) are a prominent cell type and a source of resistance to cancer therapies. Here, we demonstrate that stromal fibroblasts contribute to the poor efficacy of HDACi's in PDAC. HDACi-treated fibroblasts show increased biological aggressiveness and are characterized by increased secretion of pro-inflammatory tumor-supportive cytokines and chemokines...
November 24, 2016: Oncotarget
https://www.readbyqxmd.com/read/27893987/transdisciplinary-approaches-enhance-the-production-of-translational-knowledge
#10
REVIEW
Timothy H Ciesielski, Melinda C Aldrich, Carmen J Marsit, Robert A Hiatt, Scott M Williams
The primary goal of translational research is to generate and apply knowledge that can improve human health. Although research conducted within the confines of a single discipline has helped us to achieve this goal in many settings, this unidisciplinary approach may not be optimal when disease causation is complex and health decisions are pressing. To address these issues, we suggest that transdisciplinary approaches can facilitate the progress of translational research, and we review publications that demonstrate what these approaches can look like...
November 10, 2016: Translational Research: the Journal of Laboratory and Clinical Medicine
https://www.readbyqxmd.com/read/27892705/modeling-the-degradation-kinetics-of-ascorbic-acid
#11
Micha Peleg, Mark D Normand, William R Dixon, Timothy R Goulette
Most published reports on ascorbic acid (AA) degradation during food storage and heat preservation suggest that it follows first-order kinetics. Deviations from this pattern include Weibullian decay, and exponential drop approaching finite non-zero retention. Almost invariably, the degradation rate constant's temperature-dependence followed the Arrhenius equation, and hence the simpler exponential model too. A formula and freely downloadable interactive Wolfram Demonstration to convert the Arrhenius model's energy of activation, Ea, to the exponential model's c parameter, or vice versa, are provided...
November 28, 2016: Critical Reviews in Food Science and Nutrition
https://www.readbyqxmd.com/read/27889601/microcystin-lr-induced-liver-injury-in-mice-and-in-primary-human-hepatocytes-is-caused-by-oncotic-necrosis
#12
Benjamin L Woolbright, C David Williams, Hongmin Ni, Sean C Kumer, Timothy Schmitt, Bartholomew Kane, Hartmut Jaeschke
Microcystins are a group of toxins produced by freshwater cyanobacteria. Uptake of microcystin-leucine arginine (MC-LR) by organic anion transporting polypeptide 1B2 in hepatocytes results in inhibition of protein phosphatase 1A and 2A, and subsequent cell death. Studies performed in primary rat hepatocytes demonstrate prototypical apoptosis after MC-LR exposure; however, no study has directly tested whether apoptosis is critically involved in vivo in the mouse, or in human hepatocytes. MC-LR (120 μg/kg) was administered to C57BL/6J mice and cell death was evaluated by alanine aminotransferase (ALT) release, caspase-3 activity in the liver, and histology...
November 23, 2016: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/27889410/multiple-states-of-environmental-regulation-in-well-mixed-model-biospheres
#13
Arwen E Nicholson, David M Wilkinson, Hywel T P Williams, Timothy M Lenton
The Gaia hypothesis postulates that life influences Earth's feedback mechanisms to form a self regulating system. This provokes the question: how can global self-regulation evolve? Most models demonstrating environmental regulation involving life have relied on alignment between local selection and global regulation. In these models environment-improving individuals or communities spread to outcompete environment degrading individuals/communities, leading to global regulation, but this depends on local differences in environmental conditions...
November 23, 2016: Journal of Theoretical Biology
https://www.readbyqxmd.com/read/27887877/a-discrete-stage-structured-model-of-california-newt-population-dynamics-during-a-period-of-drought
#14
Marjorie T Jones, William R Milligan, Lee B Kats, Thomas L Vandergon, Rodney L Honeycutt, Robert N Fisher, Courtney L Davis, Timothy A Lucas
We introduce a mathematical model for studying the population dynamics under drought of the California newt (Taricha torosa), a species of special concern in the state of California. Since 2012, California has experienced a record-setting drought, and multiple studies predict drought conditions currently underway will persist and even increase in severity. Recent declines and local extinctions of California newt populations in Santa Monica Mountain streams motivate our study of the impact of drought on newt population sizes...
November 22, 2016: Journal of Theoretical Biology
https://www.readbyqxmd.com/read/27881567/importance-of-assessing-cardiorespiratory-fitness-in-clinical-practice-a-case-for-fitness-as-a-clinical-vital-sign-a-scientific-statement-from-the-american-heart-association
#15
Robert Ross, Steven N Blair, Ross Arena, Timothy S Church, Jean-Pierre Després, Barry A Franklin, William L Haskell, Leonard A Kaminsky, Benjamin D Levine, Carl J Lavie, Jonathan Myers, Josef Niebauer, Robert Sallis, Susumu S Sawada, Xuemei Sui, Ulrik Wisløff
Mounting evidence has firmly established that low levels of cardiorespiratory fitness (CRF) are associated with a high risk of cardiovascular disease, all-cause mortality, and mortality rates attributable to various cancers. A growing body of epidemiological and clinical evidence demonstrates not only that CRF is a potentially stronger predictor of mortality than established risk factors such as smoking, hypertension, high cholesterol, and type 2 diabetes mellitus, but that the addition of CRF to traditional risk factors significantly improves the reclassification of risk for adverse outcomes...
November 21, 2016: Circulation
https://www.readbyqxmd.com/read/27878078/cool-habitats-support-darker-and-bigger-butterflies-in-australian-tropical-forests
#16
Shuang Xing, Timothy C Bonebrake, Chin Cheung Tang, Evan J Pickett, Wenda Cheng, Sasha E Greenspan, Stephen E Williams, Brett R Scheffers
Morphology mediates the relationship between an organism's body temperature and its environment. Dark organisms, for example, tend to absorb heat more quickly than lighter individuals, which could influence their responses to temperature. Therefore, temperature-related traits such as morphology may affect patterns of species abundance, richness, and community assembly across a broad range of spatial scales. In this study, we examined variation in color lightness and body size within butterfly communities across hot and cool habitats in the tropical woodland-rainforest ecosystems of northeast Queensland, Australia...
November 2016: Ecology and Evolution
https://www.readbyqxmd.com/read/27876163/process-control-charts-in-infection-prevention-make-it-simple-to-make-it-happen
#17
Timothy L Wiemken, Stephen P Furmanek, Ruth M Carrico, William A Mattingly, Annuradha K Persaud, Brian E Guinn, Robert R Kelley, Julio A Ramirez
BACKGROUND: Quality improvement is central to Infection Prevention and Control (IPC) programs. Challenges may occur when applying quality improvement methodologies like process control charts, often due to the limited exposure of typical IPs. Because of this, our team created an open-source database with a process control chart generator for IPC programs. The objectives of this report are to outline the development of the application and demonstrate application using simulated data. METHODS: We used Research Electronic Data Capture (REDCap Consortium, Vanderbilt University, Nashville, TN), R (R Foundation for Statistical Computing, Vienna, Austria), and R Studio Shiny (R Foundation for Statistical Computing) to create an open source data collection system with automated process control chart generation...
November 18, 2016: American Journal of Infection Control
https://www.readbyqxmd.com/read/27871729/an-integrative-tinnitus-model-based-on-sensory-precision
#18
REVIEW
William Sedley, Karl J Friston, Phillip E Gander, Sukhbinder Kumar, Timothy D Griffiths
Tinnitus is a common disorder that often complicates hearing loss. Its mechanisms are incompletely understood. Current theories proposing pathophysiology from the ear to the cortex cannot individually - or collectively - explain the range of experimental evidence available. We propose a new framework, based on predictive coding, in which spontaneous activity in the subcortical auditory pathway constitutes a 'tinnitus precursor' which is normally ignored as imprecise evidence against the prevailing percept of 'silence'...
December 2016: Trends in Neurosciences
https://www.readbyqxmd.com/read/27867912/central-neurocytoma-a-review-of-clinical-management-and-histopathologic-features
#19
REVIEW
Seung J Lee, Timothy T Bui, Cheng Hao Jacky Chen, Carlito Lagman, Lawrance K Chung, Sabrin Sidhu, David J Seo, William H Yong, Todd L Siegal, Minsu Kim, Isaac Yang
Central neurocytoma (CN) is a rare, benign brain tumor often located in the lateral ventricles. CN may cause obstructive hydrocephalus and manifest as signs of increased intracranial pressure. The goal of treatment for CN is a gross total resection (GTR), which often yields excellent prognosis with a very high rate of tumor control and survival. Adjuvant radiosurgery and radiotherapy may be considered to improve tumor control when GTR cannot be achieved. Chemotherapy is also not considered a primary treatment, but has been used as a salvage therapy...
October 2016: Brain Tumor Research and Treatment
https://www.readbyqxmd.com/read/27866956/accuracy-and-completeness-of-drug-information-in-wikipedia-medication-monographs
#20
Timothy Reilly, William Jackson, Victoria Berger, Danielle Candelario
OBJECTIVES: The primary objective of this study was to determine the accuracy and completeness of drug information on Wikipedia and Micromedex compared with U.S. Food and Drug Administration-approved U.S. product inserts. METHODS: The top 10 brand and top 10 generic medications from the 2012 Institute for Health Informatics' list of top 200 drugs were selected for evaluation. Wikipedia medication information was evaluated and compared with Micromedex in 7 sections of drug information; the U...
November 17, 2016: Journal of the American Pharmacists Association: JAPhA
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