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Purpose: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. Materials and Methods: We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event. Results: There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown. Conclusions: The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices. [ABSTRACT FROM AUTHOR]

It was previously reported that diols dissolved in water (pH 8, EPPS buffer) react with benzoyl methyl phosphate (BMP) in the presence of lanthanide ions to form monobenzoyl esters. We have investigated the possibility of extending this process to include formation of esters of monosaccharides in water from lanthanide-catlayzed reactions with BMP. The combination of methyl-α-D-glucopyranoside and BMP in the presence of lanthanum trichloride gave selective monoacylation of the 2- and 6-hydroxyl groups in a ratio of 2:1. The likely mechanism involves preferential bisbidentate coordination of BMP and the diol to lanthanide ion (which explains how an ester forms when water is in enormous excess) followed by base-catalyzed intramolecular acyl transfer. The method should be generally applicable where a selective acylation reaction in water as solvent is desirable. [ABSTRACT FROM AUTHOR]

The results of a quality review of 89 of the 101 environmental statements (ESs) pertaining to the British forest sector over the period 1988-1998 are presented. The methodology was based on the Environmental Statement Review Package, modified for the forest sector. The standard of ESs was generally poor, only one being wholly acceptable. The ESs presented limited useful additional information to decision makers. A fundamental, recurrent issue was the failure to adequately scope assessments, leading to unfocused baseline data collection, inadequate identification of impacts, and inappropriate or inadequate determination of impact significance. Given that wholesale amendments to environmental impact assessment (EIA) legislation are unlikely in the near future, it is up to the Forestry Commission (as the competent authority) to bring about improvements in the quality of ESs. This may be achieved by providing further guidelines on the EIA process, particularly screening and scoping, and by introducing a consistent UK-wide ES review system for forestry projects. [ABSTRACT FROM AUTHOR]

Oxo-stabilised phosphonium ylides are found to form crystalline hydrogen-bonded adducts with aromatic carboxylic acids, as confirmed by X-ray diffraction. There is also strong hydrogen bonding in solution as indicated by 13C NMR spectroscopy and this confirmed adduct formation with acetic acid, benzamide, thiobenzamide, benzyl alcohol, benzenesulfinic acid and diphenylphosphinic acid. The X-ray structure of the benzamide adduct was also determined, showing a hydrogen-bonded dimeric structure. A bis(stabilised ylide) was also prepared and is found to form a complex hydrogen-bonded adduct with benzoic acid, ethanol and water. [ABSTRACT FROM AUTHOR]

Early analyses revealed that dark web marketplaces (DWMs) started offering COVID-19 related products (e.g., masks and COVID-19 tests) as soon as the COVID-19 pandemic started, when these goods were in shortage in the traditional economy. Here, we broaden the scope and depth of previous investigations by considering how DWMs responded to an ongoing pandemic after the initial shock. Our dataset contains listings from 194 DWMs collected until July 2021. We start by focusing on vaccines. We find 248 listings offering approved vaccines, like Pfizer/BioNTech and AstraZeneca, as well as vendors offering fabricated proofs of vaccination and COVID-19 passports. Then, we consider COVID-19 related products. We show that, as the regular economy has become able to satisfy the demand of these goods, DWMs have decreased their offer. Next, we analyse the profile of vendors of COVID-19 related products and vaccines. We find that most of them are specialized in a single type of listings and are willing to ship worldwide. Finally, we consider a broader set of listings mentioning COVID-19, in order to assess the general impact of the pandemic on the broader activity of DWMs. Among 10,330 such listings, we show that recreational drugs are the most affected among traditional DWMs product, with COVID-19 mentions steadily increasing since March 2020. We anticipate that our results will be of interest to researchers, practitioners, and law enforcement agencies focused on the study and safeguard of public health. [ABSTRACT FROM AUTHOR]

Whilst virtualization was once restricted to large-scale computing platforms, it is now widely deployed on modern embedded computing systems. This has been driven by the availability of hardware support which alleviates the performance penalties incurred by traditional software virtualization technologies. In the domain of hard real-time systems, specialist virtualization technology which respects restricted timing requirements and constraints can be deployed to allow sharing of processors. However, other aspects of the embedded system (I/O, memory, and communication) are harder to analyze. In this paper, we argue that in order to support real-time virtualization on modern embedded systems, additional system-wide hardware support is required. We propose BlueVisor, an analyzable and scalable hardware hypervisor for many-core embedded systems, which enables time-predictable CPU, memory, and I/O virtualization, as well as supporting a fast interrupt handler, and inter-VM communication. We describe the design and implementation of the real-time hypervisor, and demonstrate how a BlueVisor-based virtualization system can be leveraged to meet real-time requirements with significant improvement in system performance, and with a low-performance cost when executing different types of software. [ABSTRACT FROM AUTHOR]

Background: Influenza surveillance systems vary widely between countries and there is no framework to evaluate national surveillance systems in terms of data generation and dissemination. This study aimed to develop and test a comparative framework for European influenza surveillance.Methods: Surveillance systems were evaluated qualitatively in five European countries (France, Germany, Italy, Spain, and the United Kingdom) by a panel of influenza experts and researchers from each country. Seven surveillance sub-systems were defined: non-medically attended community surveillance, virological surveillance, community surveillance, outbreak surveillance, primary care surveillance, hospital surveillance, mortality surveillance). These covered a total of 19 comparable outcomes of increasing severity, ranging from non-medically attended cases to deaths, which were evaluated using 5 comparison criteria based on WHO guidance (granularity, timing, representativeness, sampling strategy, communication) to produce a framework to compare the five countries.Results: France and the United Kingdom showed the widest range of surveillance sub-systems, particularly for hospital surveillance, followed by Germany, Spain, and Italy. In all countries, virological, primary care and hospital surveillance were well developed, but non-medically attended events, influenza cases in the community, outbreaks in closed settings and mortality estimates were not consistently reported or published. The framework also allowed the comparison of variations in data granularity, timing, representativeness, sampling strategy, and communication between countries. For data granularity, breakdown per risk condition were available in France and Spain, but not in the United Kingdom, Germany and Italy. For data communication, there were disparities in the timeliness and accessibility of surveillance data.Conclusions: This new framework can be used to compare influenza surveillance systems qualitatively between countries to allow the identification of structural differences as well as to evaluate adherence to WHO guidance. The framework may be adapted for other infectious respiratory diseases. [ABSTRACT FROM AUTHOR]

Background: Several lines of evidence support a role for CCL2 (monocyte chemotactic protein-1) and its receptor CCR2 in the development of atherosclerosis. The aim of the present study was to determine the association of the CCR2 Val64Ile polymorphism with the development of coronary artery disease in the WOSCOPS study sample set. Findings: A total of 443 cases and 1003 controls from the West of Scotland Coronary Prevention Study (WOSCOPS) were genotyped for the Val64Ile polymorphism in the CCR2 gene. Genotype frequencies were compared between cases and controls. The CCR2 Val64Ile polymorphism was found not to be associated with coronary events in this study population (odds ratio 1.15, 95% CI 0.82-1.61, p = 0.41). Conclusions: This case-control study does not support an association of the CCR2 Val64Ile polymorphism with coronary artery disease in the WOSCOPS sample set and does not confirm a possible protective role for CCR2 Val64Ile in the development of coronary artery disease. [ABSTRACT FROM AUTHOR]

A massive hexanucleotide repeat expansion mutation (HREM) in C9ORF72 has recently been linked to amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). Here we describe the frequency, origin and stability of this mutation in ALS+/−FTD from five European cohorts (total n=1347). Single-nucleotide polymorphisms defining the risk haplotype in linked kindreds were genotyped in cases (n=434) and controls (n=856). Haplotypes were analysed using PLINK and aged using DMLE+. In a London clinic cohort, the HREM was the most common mutation in familial ALS+/−FTD: C9ORF72 29/112 (26%), SOD1 27/112 (24%), TARDBP 1/112 (1%) and FUS 4/112 (4%) and detected in 13/216 (6%) of unselected sporadic ALS cases but was rare in controls (3/856, 0.3%). HREM prevalence was high for familial ALS+/−FTD throughout Europe: Belgium 19/22 (86%), Sweden 30/41 (73%), the Netherlands 10/27 (37%) and Italy 4/20 (20%). The HREM did not affect the age at onset or survival of ALS patients. Haplotype analysis identified a common founder in all 137 HREM carriers that arose around 6300 years ago. The haplotype from which the HREM arose is intrinsically unstable with an increased number of repeats (average 8, compared with 2 for controls, P<10−8). We conclude that the HREM has a single founder and is the most common mutation in familial and sporadic ALS in Europe. [ABSTRACT FROM AUTHOR]

We identified two novel mouse mutants with abnormal head-shaking behavior and neural tube defects during the course of independent ENU mutagenesis experiments. The heterozygous and homozygous mutants exhibit defects in the orientation of sensory hair cells in the organ of Corti, indicating a defect in planar cell polarity. The homozygous mutants exhibit severe neural tube defects as a result of failure to initiate neural tube closure. We show that these mutants, spin cycle and crash, carry independent missense mutations within the coding region of Celsr1, encoding a large protocadherin molecule [1]. Celsr1 is one of three mammalian homologs of Drosophila flamingo/starry night, which is essential for the planar cell polarity pathway in Drosophila together with frizzled, dishevelled, prickle, strabismus/van gogh, and rhoA . The identification of mouse mutants of Celsr1 provides the first evidence for the function of the Celsr family in planar cell polarity in mammals and further supports the involvement of a planar cell polarity pathway in vertebrate neurulation. [Copyright &y& Elsevier]

Presents information on a study which demonstrated a mutant mouse model for cerebellar ataxia that develops Purkinje cell loss in a stereotypical region-specific manner. Histology and immunohistochemistry; Identification of robotic mice which develop region-specific Purkinje cell loss; Neurodegenerative changes in the robotic cerebellum.

A quiz concerning a mathematical problems on a trip to the zoo.