Normal Conditions Of Use Research Articles

Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population.

Closed-loop spinal cord stimulation (CL-SCS) is a recently introduced system that records evoked compound action potentials (ECAPs) from the spinal cord elicited by each stimulation pulse and uses this information to automatically adjust the stimulation strength in real time, known as ECAP-controlled SCS. This innovative system compensates for fluctuations in the distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a predetermined target level. This data collection study was designed to assess the performance of the first CL-SCS system in a real-world setting under normal conditions of use in multiple European centers. The study analyzes and presents clinical outcomes and electrophysiological and device data and compares these findings with those reported in earlier pre-market studies of the same system. This prospective, multicenter, observational study was conducted in 13 European centers and aimed to gather electrophysiological and device data. The study focused on the real-world application of this system in treating chronic pain affecting the trunk and/or limbs, adhering to standard conditions of use. In addition to collecting and analyzing basic demographic information, the study presents data from the inaugural patient cohort permanently implanted at multiple European centers. A significant decrease in pain intensity was observed for overall back or leg pain scores (verbal numerical rating score [VNRS]) between baseline (mean ± standard error of the mean [SEM]; n = 135; 8.2 ± 0.1), 3 months (n = 93; 2.3 ± 0.2), 6 months (n = 82; 2.5 ± 0.3), and 12 months (n = 76; 2.5 ± 0.3). Comparison of overall pain relief (%) to the AVALON and EVOKE studies showed no significant differences at 3 and 12 months between the real-world data release (RWE; 71.3%; 69.6%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies. Further investigation was undertaken to objectively characterize the physiological parameters of SCS therapy in this cohort using the metrics of percent time above ECAP threshold (%), dose ratio, and dose accuracy (µV), according to previously described methods. Results showed that a median of 90% (40.7-99.2) of stimuli were above the ECAP threshold, with a dose ratio of 1.3 (1.1-1.4) and dose accuracy of 4.4µV (0.0-7.1), based on data from 236, 230, and 254 patients, respectively. Thus, across all three metrics, the majority of patients had objective therapy metrics corresponding to the highest levels of pain relief in previously reported studies (usage over threshold > 80%, dose ratio > 1.2, and error < 10µV). In conclusion, this study provides valuable insights into the real-world application of the ECAP-controlled CL-SCS system, highlighting its potential for maintaining effective pain relief and objective neurophysiological therapy metrics at levels seen in randomized control trials, and potential for quantifying patient burden associated with SCS system use via patient-device interaction metrics. In the Netherlands, the study is duly registered on the International Clinical Trials Registry Platform (Trial NL7889). In Germany, the study is duly registered as NCT05272137 and in the United Kingdom as ISCRTN27710516 and has been reviewed by the ethics committee in both countries.

Effectiveness and safety of AROMAFORCE® junior cough syrup in pediatric patients with acute upper respiratory conditions

Aim: The purpose of this study was to evaluate the effectiveness and safety of Aromaforce® Junior Cough Syrup (AJCS) in treating acute upper respiratory tract infection-related coughs in children, and it served as a post-marketing clinical follow-up. Methods: Prospective, multicenter, open-label, controlled clinical investigation conducted under normal conditions of use to evaluate the antitussive effectiveness of a mucilage-based syrup in pediatric patients (aged 2 to 12 years) as compared to increased hydration measures (control group), with a 1-week follow-up. Likert severity scores were used to evaluate coughs and related symptom severity. Results: The results demonstrate that AJCS effectively reduces cough severity, including daytime and night-time cough, and the number of times the child was woken up, particularly within the first three days, surpassing the effectiveness of hydration measures. The results of the degree of satisfaction with AJCS show that the majority of physicians and parents had positive feedback. Furthermore, the safety analysis confirms the syrup's non-toxic nature in children. However, the initial differences in baseline characteristics between the study and control groups, with the study group exhibiting higher combined cough scores, limit the strength of the evidence. Conclusions: This study provides further evidence supporting the efficacy and safety of AJCS in the treatment of cough associated with acute upper respiratory tract infections in children. Further randomized studies may provide further evidence of the efficacy and safety of AJCS.

Preliminary Survey of Exposure to Indoor Radon in al-Farabi Kazakh National University, Kazakhstan

Radon is a major source of naturally occurring radioactivity, and its measurement is considered extremely important in radiation protection, given its association with lung cancer. This pilot study aimed to estimate the annual effective dose received by students and staff based on monitoring data on the concentration of radon in the buildings of al-Farabi Kazakh National University (Almaty, Republic of Kazakhstan), based on the distance to the tectonic fault. The measurements were recorded daily from February 2021 to September 2022 using a RAMON-02 radiometer (SOLO LLP, Almaty, Kazakhstan). All measurements were taken from the basement to the top floor under normal conditions of use. The average accumulated concentrations of radon in the studied buildings ranged from 16.34 to 78.33 Bq/m3, which is below the maximum level of 100 Bq/m3 established by the World Health Organization (WHO) and the legislation of the Republic of Kazakhstan (200 Bq/m3). Relatively high values were recorded in the basement of the Faculty of Physics and Technology building (282.0 Bq/m3 in winter, 1742.0 Bq/m3 in spring, 547.7 Bq/m3 in summer, and 550.7 Bq/m3 in autumn), which is located closest to the tectonic fault and poorly ventilated. In almost all rooms (94%), radon levels were within the WHO-recommended reference level. The averaged results show the influence of the distance to the fault on the average indoor radon levels. The annual effective dose of radon for university students and staff ranged from 1.09 mSv/year to 1.53 mSv/year. The excess lifetime risk of developing cancer ranged from 0.44% to 0.61%.

Analytical approaches for the evaluation of data deficient simulated leachable compounds in ENDS products: a case study.

Leachable investigations are routinely undertaken across a range of sectors (e.g., pharmaceuticals, medical devices, etc.) to determine whether chemicals from a container closure system transfer into a product under normal conditions of use. For Electronic Nicotine Delivery Systems (ENDS) the container closure system includes all materials in contact with the e-liquid that is aerosolized and subsequently inhaled by the user. Currently, there is no guidance for conducting leachable studies for ENDS products, however, there are relevant guidance documents for orally inhaled drug products that can be applied to an ENDS container closure system. We present a case study of the analytical investigation of two leachable compounds identified in simulated leachable studies using aged JUULpods filled with unflavored e-liquid (PG/VG/nicotine/benzoic acid). Both compounds had limited toxicological information and were considered data deficient. A qualitative analysis of the aerosol collected from aged commercial JUULpods (Virginia Tobacco and Menthol), using a similar analytical method (LC-MS/MS) used in the simulated leachable studies, showed no trace or detectable levels of either leachable compound. Therefore, this qualitative analysis did not provide semi-quantitative values for the data-deficient leachable compounds necessary to support toxicological risk assessment. Further, no commercial authentic standards or reasonable synthetic route were available due to the molecular size and structural complexity of the compounds. Instead, method limits were established using an alternative approach to standard ICH guidelines. The experimentally determined method limit of quantitation, using spiked samples of simulated leachable e-liquid, provided conservative semi-quantitative values for each data deficient leachable compound in the aerosol that enabled a transfer efficiency from e-liquid to aerosol to be estimated. The transfer efficiency of each leachable compound was experimentally determined to be less than 2% based on the limit of quantitation, which then could be used to define a relevant exposure limit for the toxicological risk assessment. This work details a novel analytical approach for determining the transfer efficiency of data deficient leachable compounds from ENDS container closure systems into the ENDS aerosol to support toxicological health risk assessments.

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain.

A novel closed-loop spinal cord stimulation (SCS) system has recently been approved for use which records evoked compound action potentials (ECAPs) from the spinal cord and utilizes these recordings to automatically adjust the stimulation strength in real time. It automatically compensates for fluctuations in distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a determined target level. This data collection was principally designed to evaluate the performance of this first closed-loop SCS system in a 'real-world' setting under normal conditions of use in a single European center. In this prospective, single-center observational data collection, 22 patients were recruited at the outpatient pain clinic of the St. Antonius Hospital. All candidates were suffering from chronic pain in the trunk and/or limbs due to PSPS type 2 (persistent spinal pain syndrome). As standard of care, follow-up visits were completed at 3months, 6months, and 12months post-device activation. Patient-reported outcome data (pain intensity, patient satisfaction) and electrophysiological and device data (ECAP amplitude, conduction velocity, current output, pulse width, frequency, usage), and patient interaction with their controller were collected at baseline and during standard of care follow-up visits. Significant decreases in pain intensity for overall back or leg pain scores (verbal numerical rating score=VNRS) were observed between baseline [mean±SEM (standard error of the mean); n=22; 8.4±0.2)], 3months (n=12; 1.9±0.5), 6months (n=16; 2.6±0.5), and 12months (n=20; 2.0±0.5), with 85.0% of the patients being satisfied at 12months. Additionally, no significant differences in average pain relief at 3months and 12months between the real-world data (77.2%; 76.8%) and the AVALON (71.2%; 73.6%) and EVOKE (78.1%; 76.7%) studies were observed. These initial 'real-world' data on ECAP-controlled, closed-loop SCS in a real-world clinical setting appear to be promising, as they provide novel insights of the beneficial effect of ECAP-controlled, closed-loop SCS in a real-world setting. The presented results demonstrate a noteworthy maintenance of pain relief over 12months and corroborate the outcomes observed in the AVALON prospective, multicenter, single-arm study and the EVOKE double-blind, multicenter, randomized controlled trial. The data collection is registered on the International Clinical Trials Registry Platform (Trial NL7889).

Study on the effectiveness of an air treatment tool that combines filtration and photocatalysis

The microbiological quality of air in working environments is a very current topic. This study aims to evaluate the effectiveness of a machine equipped with EPA filters and photocatalytic activity. This type of treatment combines a physical action with a chemical activity. The latter occurs thanks to the production of reactive oxygen species (ROS), responsible for a marked bactericidal activity. The search for new sanitization techniques pushes companies to invest to improve the quality of work of their employees. Many tools are sold on the market, but it is important to check their actual effectiveness. Monitoring the activity of air treatments is always very complex, due to the variability and heterogeneity of airborne microorganisms. This study was conducted in a typical working environment, to better simulate normal conditions of use. To avoid potentially pathogenic contamination, microorganisms typically recountable in the air matrix were not used, but the species of bacteria Lactococcus lactis was used. These microorganisms are also naturally present in the outdoor environment and represent a population of bacteria that could potentially cause indoor air pollution. The results confirm the effectiveness of this type of treatment. It was not possible to determine the impact of the catalytic feature installed.

A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices

The recent passage of European Union (EU) Regulation 2017/745 on medical devices (MDs) has improved the classification of MDs and revised their approval process and the post-marketing evaluation of their safety and effectiveness, promoting transparency and post-marketing oversight in Europe. This new regulation can better ensure patient safety and provide new opportunities for therapeutic innovation. In addition, the new regulations include and define MDs made of substances or of combinations of substances (substance-based MDs: SBMDs). The impressive growth of the MD, including SBMDs, that have been marketed over the recent years has likely been a relevant factor fueling this change. MD regulation requires a major effort from both industry and regulatory bodies to comply with its provisions. Manufacturers should produce sufficient clinical evidence that an MD, under normal conditions of use, provides adequate performance and that the foreseeable risks and frequency of adverse events (AEs) have an acceptable minimum rate, taking into account the benefits provided. We describe how we implemented the post-marketing surveillance (PMS) system of SBMDs to properly deal with post-market monitoring and confirmation of safety and performance, including AEs and the benefit–risk evaluation, as required by the 2017/745 Regulation. The two pillars of this novel system are: 1) passive vigilance, i.e., spontaneous reporting and 2) active post-marketing clinical follow-up (PMCF) activities, which systematically gather, record, and analyze real-world data (RWD) on performance, quality, function, use, tolerability, and safety of an MD, collected through a dedicated, structured web platform. Active PMCF is achieved through a process of generation, validation, and administration of digital questionnaires to all stakeholders, i.e., patients, physicians, both general practitioners and specialists, and pharmacists. The technology, potential use, advantages, and limitations of this large source of RWD are also discussed.

Clinical studies in Chinese subjects investigating the tolerance and soothing efficacy of a cream and balm containing 4-t-butylcyclohexanol on the sensitivity of facial skin.

Asian subjects are particularly prone to skin sensitivity. We developed a facial cream and balm containing 4-t-butylcyclohexanol to provide skin comfort and a soothing effect for sensitive skin. Assess the dermatological and ophthalmological tolerance and efficacy in improving skin sensitivity of face cream and balm under normal conditions of use by a population known to be particularly prone to this problem. In a monocentric non-randomized open trial, the cream or balm was applied twice daily to the face, neck, and eye contour of 33 stinger subjects with hypersensitive skin (22-63 years old). Assessments included dermatological and ophthalmological physical and functional signs on Day 1 (D1), D8, and D22, and cosmetic acceptability, cutaneous sensitivity according to a stinging test and the sensitive scale, and the soothing efficacy according to a questionnaire on D22. The cream and balm were very well tolerated. Immediately after application, subjects reported a reduction in the skin's hypersensitivity (93.9% of subjects for the cream and 81.8% for the balm), skin redness (90.9% of subjects for the cream and 87.9% for the balm), sensations of tightness (93.9% for the cream and 97.0% for the balm), and discomfort sensations (93.9% for the cream and 87.9% for the balm). After 21 days, the application of the cream and balm decreased the stinging scores by 65% and 41%, respectively, with 94% and 77% of subjects showing an improvement, respectively. The sensitivity scale questionnaire indicated that the cream and balm significantly and profoundly decreased all negative signs, for example, irritability, stinging, general discomfort, redness, and dryness on D22 compared to D1. On D22, all 15 parameters recorded were improved by 89%-100% by the cream and by 74%-100% by the balm. The majority (90.9% and 96.8% of subjects using the cream and balm, respectively) of the subjects noticed positive changes in their skin condition after using the product for 21 days. The cream and balm were very well-tolerated. This study demonstrated that both products controlled and markedly reduced skin hypersensitivity in Asian subjects, with an immediate and lasting skin soothing and repairing effect over 21 days.

Criminal legal meaning of "dangerous product" according to the legislation of Ukraine

The paper examines the criminal-legal meaning of the term «dangerous product» under the legislation of Ukraine. The Criminal Code of Ukraine defines dangerous products as products that do not meet the requirements for product safety established by normative legal acts. The Law of Ukraine «On the Protection of Consumer Rights» uses the terms «product safety» and «adequate quality of goods, work or services». The term «product» covers any product (goods), work or service that is manufactured, performed or provided to meet public needs. Product safety means the absence of any risk to the life, health, property of the consumer and the natural environment under normal conditions of use, storage, transportation, manufacture and disposal of products. The proper quality of goods, work or services is a property of products that meets the requirements established for this category of products in regulatory acts and the terms of the contract with the consumer. The Law of Ukraine «On the Protection of Consumer Rights» also obliges to put into circulation and sell products for which regulatory and legal acts, including technical regulations, establish requirements regarding safety for life, health, property of consumers and the natural environment. The most acceptable, according to scientists, is the definition of products, which includes food and non-food products, as well as works and services. Dangerous products are products that, under normal conditions of use, pose a risk to the life and health of people, the property of consumers (users), as well as to the natural environment. The application of criminal liability in case of violation of the property rights of consumers in connection with the sale to them of products of inadequate quality (substandard products) is inappropriate.

Estimation of the lifespan distribution of gold nanoparticles stabilized with lipoic acid by accelerated degradation tests and wiener process

Accelerated degradation tests (ADT) are widely used in the manufacturing industry to obtain information on the reliability of components and materials, by degrading the lifespan of the product by applying an acceleration factor that damage to the material. The main objective is to obtain fast information which is modeled to estimate the characteristics of the material life under normal conditions of use and to save time and expenses. The purpose of this work is to estimate the lifespan distribution of gold nanoparticles stabilized with lipoic acid (GNPs@LA) through accelerated degradation tests applying sodium chloride (NaCl) as an acceleration factor. For this, the synthesis of GNPs@LA was carried out, a constant stress ADT (CSADT) was applied, and the non-linear Wiener process was proposed with random effects, error measures, and different covariability for the adjustment of the degradation signals. The information obtained with the test and analysis allows us to obtain the life distribution in GNPs@LA, the results make it possible to determine the guaranteed time for possible commercialization and successful application based on the stability of the material. In addition, for the evaluation and selection of the model, the Akaike and Bootstrapping criteria were used.

Metal Marking Behavior and Testing of Porcelain Tableware.

The term “metal marking” is widely used to define the common phenomenon of tableware glazes being damaged by metallic cutlery. Appearing as unaesthetic gray marks and scratches resulting from normal conditions of use, these defects deeply affect the performance of ceramic products, especially in intensive environments, such as in the hospitality industry. The scope of this article is to establish a comprehensive review of the phenomenon, focusing on the physical and chemical mechanisms involved in the process, and their interactions and consequences. It also intends to list the different methods normally followed to avoid or at least reduce this defect, in order to enhance the durability of porcelain dishware. This manuscript also provides a review of the different testing methods developed and used by the tableware industry and technical centers to quantify the ability of porcelain tableware to produce metal marks. To face the current lack of any international or at least national standard testing procedure that would permit a reliable comparison of products, a new metal marking test developed at the Technological Center for Ceramic and Glass (CTCV) is presented as an alternative to common tests normally based on knives as a marking tool.

Are carbon water filters safe for private wells? Evaluating the occurrence of microbial indicator organisms in private well water treated by point-of-use activated carbon block filters.

Point-of-use (POU) water treatment is highly relevant to private well users vulnerable to chemical contamination, but uncertainty remains around the effects of activated carbon based POU devices on the microbial quality of the treated water. In this study, under-sink activated carbon block water filters were installed in 17 homes relying on private well water in North Carolina. The influent and effluent water in each home was evaluated for bacterial and viral microbial indicator organisms monthly for five months. Multiple logistic regression was used to identify water quality and water usage variables that were significant predictors of each indicator organism occurring in the filter effluent. The odds of total coliforms occurring in the effluent decreased by 84% with each 1-log10 increase in the influent HPC (p<0.05), suggesting a protective effect by native heterotrophic bacteria, but increased by over 50 times with low cumulative water use (p<0.05). The filters were not protective against coliphages in the influent and viral shedding may occur after periods of increased virus concentrations in the raw well water. Specific bacteria were also found to increase in the effluent, causing a shift in the bacterial community composition, although potential opportunistic pathogens were detected in both the influent and the effluent. Overall, under normal conditions of use, the filters tested in this study did not represent a significant additional risk for well users beyond the existing exposures from undisinfected well water alone.

Presence of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) in Food Contact Materials (FCM) and Its Migration to Food.

Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are synthetic chemical compounds widely used in different industry fields including food contact materials (FCM), providing resistance to fat and humidity, and non-stick properties. PFAS enter into the food chain directly from the intake of contaminated food or indirectly from the migration of the FCM into the food. This exposure published in different research highlights a public health concern. Therefore, it is necessary to perform analysis of the content of different FCM and evaluate the migration from the FCM under normal conditions of use and storage. This bibliographical review proves that different perfluoroalkyl and polyfluoroalkyl compounds are detected in fast food packaging, microwave popcorn bags, and frying pans, among others. Furthermore, it shows the conditions or factors that favor the migration of the PFAS from the FCM into the food.

Evaluation of the Efficacy of Lacer HaliTM Treatment on the Management of Halitosis: A Randomized Double-Blind Clinical Trial.

Background: Halitosis of oral origin is very common in the general population. Due to their antimicrobial properties, chlorhexidine-based products are widely used in the management of this condition, but these are associated with reversible side effects. In this study we evaluated the efficacy of Lacer HaliTM mouthrinse and toothpaste in subjects with intraoral halitosis after several applications under normal conditions of use. Methods: In this randomized clinical trial with mouth rinse and toothpaste, single-center, double-blinded, parallel participants were assigned to an experimental group (Lacer HaliTM,, n = 20), a positive control group (HalitaTM, n = 20), and a placebo group (n = 20). The active duration of the study was 18 days. The clinical follow-up evaluations were performed at five time points (T0, T1, T2, T3, and T4). The intensity of halitosis was evaluated by organoleptic measurement and the portable gas chromatograph OralChromaTM. The data were analyzed using generalized mixed linear models. Results: Sixty patients completed the study. Lacer HaliTM, in comparison with HalitaTM, did not show statistically significant differences at any time during the study except for the levels of hydrogen sulfide and total volatile sulfur compounds at 15 days, where HalitaTM was better. Compared to the placebo treatment, Lacer HaliTM, was significantly more efficient, in terms of both the organoleptic evaluations at 8 days and the levels of hydrogen sulfide. Conclusions: Lacer HaliTM is an alternative to chlorhexidine-based toothpaste and mouthwashes in the management of halitosis.

Peut-on utiliser des triptans dans la crise de migraine chez la femme enceinte ?

Despite the widespread use of triptans in the treatment of migraine during pregnancy, questions relating to their vasoconstrictive properties have been raised following recent reports of rare fetal deaths and intrauterine growth restrictions. However, to date, analysis of these data does not allow to conclude to a direct effect of triptans, which remain a second line treatment of migraine attacks during pregnancy at any term and under normal conditions of use.

Lactobacillus reuteri DSM 17938 as a Novel Topical Cosmetic Ingredient: A Proof of Concept Clinical Study in Adults with Atopic Dermatitis.

Atopic Dermatitis (AD) is a chronically relapsing skin condition characterized by dry, itchy, and inflamed skin where sufferers can frequently be subject to infections. Probiotics are known to be potent immune-modulators, and live Lactobacillus reuteri DSM 17938 has shown to be anti-inflammatory but also to possess antimicrobial and barrier function properties. This study aimed to investigate and compare two investigational ointment products (topical probiotic and control) for cutaneous acceptability, safety, and efficacy under normal conditions of use, in adult subjects with atopic dermatitis. The products were applied twice daily for 8 weeks, and cutaneous acceptability, SCORAD index, local SCORAD, and adverse events were evaluated after 4 and 8 weeks of treatment. At the end of the observations, it was demonstrated that both the probiotic-containing and probiotic-free ointments were both cutaneously acceptable and safe. It importantly showed a statistically and clinically significant improvement of the SCORAD index and local SCORAD in adult subjects with AD after 4 and 8 weeks of continuous use. In conclusion, we show evidence that the probiotic product, containing live L. reuteri DSM 17938 as an extra ingredient, is safe and promising as a novel topical cosmetic ointment and with further testing could be a standard topical product for the management of atopic dermatitis or other disorders associated with the skin.

A preservative with bleaching and emulsifying effects

In cosmetic products, additives are substances that aren’t consumed as main ingredients, actually, they are added to these products in the processes of preparation, packaging or storage in order to make them safer, improve their appearance, help to present a stable, attractive and easier to apply the product, without being stricken by environmental conditions [1, 2]. The protection and quality of toiletries or medicine products are important elements in regards to the health of the consumers. Adding preservatives to the formulations helps the cosmetic manufacturer achieve the first objective of products i.e. meeting the requirements of the users while being safe under normal conditions of use. Despite advances in manufacturing conditions (raw materials with exhaustive bacteriological controls and manufacturing in sterile areas), and the containers used (single-dose ampoules, opaque and hermetic bottles which are used for precise amount), there is still the possibility of colonizing cosmetics without a preservative in their composition. Principally adding extra compounds as emulsifier and blanching agent causes more noxious compounds in the products, which should be avoided. Hence, it is desirable that some components of the formulation fulfill this function [3]. In our study, a combination of sodium thiosulfate and Citric acid contains emulsifiers and bleaching substances. When this mixture was added to Azadirachta indica (Neem) gum or Acacia Senegal (Gum Arabic), besides the above-mentioned properties, turned these gums into a thickener and stabilizer agent. This formulation can prevent the spreading of microorganisms. It will be shown from the findings and results that this formula can be used as a preservative agent in the cosmetic and pharmaceutical industry with significant emulsifying and bleach potential. The rare side effect of this additive is mild skin hypersensitivity reaction only in sensitive individuals. Objective: The purpose of the study was to develop a powerful preservative based on synthetic and natural ingredients, with bleaching and emulsifying effects.

Overview of the light-duty vehicles tailpipe emissions regulations in the European Union: status and upcoming type-approval and market surveillance schema

In order to curb pollutant emissions from light-duty vehicles in the European Union, a set of complex regulations have been ap-proved in the recent years (2016-2018) including more stringent emissions tests, independent in-service conformity checks, and a novel type-approval framework which includes market surveillance provisions to complement the type-approval requirements. Tailpipe emissions will need to meet stringent emission limits before entering the market at type-approval and at the end of the production line, as well as during their normal life under normal conditions of use. This contribution aims at providing a comprehensive but synthetic analysis of the current regulatory context in the EU.

Observational assessment of safety in seroquel (OASIS): a specialist cohort event monitoring (SCEM) study in England.

Background:This study was designed to monitor the short-term (up to 12 weeks) use and safety of quetiapine (Seroquel) extended release (XL) and quetiapine immediate release (IR) prescribed to patients with a clinical diagnosis of schizophrenia, and/or manic episodes associated with bipolar disorder by psychiatrists under normal conditions of use.Methods:A Specialist Cohort Event Monitoring (SCEM) study was conducted in England February 2010–April 2013. This observational cohort study recruited patients prescribed quetiapine XL within the secondary care setting by psychiatrists. A reference cohort of quetiapine IR users was also recruited. Baseline and 12 week observational data were collected from psychiatrists who abstracted information from medical records onto bespoke questionnaires. Data were collected on demographics, indication, past medical history, prescribing information and events of interest. Summary descriptive statistics were calculated.Results:The final cohort consisted of 869 eligible patients; 646 XL users and 223 IR users. The majority of XL and IR users were female (56.2% and 55.6%, respectively), with a median age of 40 (interquartile range [IQR]: 29, 49) and 39 (IQR: 28, 50) years, respectively. The most frequent indication for treatment was Manic episodes associated with Bipolar Affective disorder (53.4% XL and 49.8% IR). Median index dose was 200 mg/day (IQR: 100, 300) for XL users and 50 mg/day (IQR: 50, 100) for IR users, while median final maintenance dose was 400mg/day (IQR: 250, 600) and 300 mg/day (IQR: 100, 400), respectively. The most frequently reported event of interest in both cohorts was sedation (n = 151, 23.9% XL cohort and n = 49, 23.0% IR cohort).Conclusion:Utilisation of quetiapine XL appeared to be in line with prescribing guidelines in terms of dose, and commonly reported events of interest were in concordance with the known safety profile. Overall, this SCEM study provided important information on the safety and utilisation of quetiapine XL in the secondary care setting in England.

DETECÇÃO DE DANOS EM VIGAS DE ALUMÍNIO USANDO O MÉTODO DAS CURVATURAS MODAIS

As estruturas civis estão susceptíveis à deterioração mesmo sob condições normais de uso. Dependendo da severidade dos danos, a capacidade resistente da estrutura pode ficar comprometida. Assim, quando houver dúvida quanto a sua integridade é de extrema importância que a detecção dos danos ocorra o mais breve possível. O objetivo desta pesquisa foi investigar a aplicação do método das curvaturas modais na detecção de danos em vigas de alumínio. Foi encontrada grande dificuldade para localizar os defeitos usando o método original proposto por Pandey et al. (1991). A partir das curvaturas modais foi calculado um Índice de Danificação (ID) o qual mostrou-se mais sensível e preciso do que o método original. Concluiu-se que o método das curvaturas modais associado ao cálculo do ID tem potencial para a detecção de danos em vigas, porém, verificou-se a necessidade de amostrar sinais em uma banda de frequências mais larga a fim de identificar um número maior de modos de flexão e, desta forma, melhorar a sensibilidade na localização dos defeitos.