Analysis of the process of inspection in recreational craft in Spain. Suggestions for safety improvement

Inspections of pleasure boats in Spain can be carried out by collaborating entities of inspection, entities that must be authorized by the Maritime Administration. This authorization allows to perform effective inspections and technical controls of recreational crafts. Recreational crafts are subjected to surveys that are based on the registration list and on the material used in the hull. In addition, required safety equipment of the recreational boat depends on the distance that the recreational boat is authorized to navigate. Following data obtained from inspections of recreational craft, this paper aims to analyze information about hulls within dry and afloat conditions, about the equipment for rescue and safety, and about other nautical equipment; as well as to perform and improve different verifications during the inspections. All this information points to several aspects relevant for the optimization of the inspection process, the ultimate target being increasing efficiency and effectiveness, and ensuring more safety in recreational craft.

Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study.

BACKGROUND: The ongoing Ebola outbreak led to accelerated efforts to test vaccine candidates. On the basis of a request by WHO, we aimed to assess the safety and immunogenicity of the monovalent, recombinant, chimpanzee adenovirus type-3 vector-based Ebola Zaire vaccine (ChAd3-EBO-Z). METHODS: We did this randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a trial at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Participants (aged 18-65 years) were randomly assigned (2:2:1), via two computer-generated randomisation lists for individuals potentially deployed in endemic areas and those not deployed, to receive a single intramuscular dose of high-dose vaccine (5 × 10(10) viral particles), low-dose vaccine (2·5 × 10(10) viral particles), or placebo. Deployed participants were allocated to only the vaccine groups. Group allocation was concealed from non-deployed participants, investigators, and outcome assessors. The safety evaluation was not masked for potentially deployed participants, who were therefore not included in the safety analysis for comparison between the vaccine doses and placebo, but were pooled with the non-deployed group to compare immunogenicity. The main objectives were safety and immunogenicity of ChAd3-EBO-Z. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02289027. FINDINGS: Between Oct 24, 2014, and June 22, 2015, we randomly assigned 120 participants, of whom 18 (15%) were potentially deployed and 102 (85%) were non-deployed, to receive high-dose vaccine (n=49), low-dose vaccine (n=51), or placebo (n=20). Participants were followed up for 6 months. No vaccine-related serious adverse events were reported. We recorded local adverse events in 30 (75%) of 40 participants in the high-dose group, 33 (79%) of 42 participants in the low-dose group, and five (25%) of 20 participants in the placebo group. Fatigue or malaise was the most common systemic adverse event, reported in 25 (62%) participants in the high-dose group, 25 (60%) participants in the low-dose group, and five (25%) participants in the placebo group, followed by headache, reported in 23 (57%), 25 (60%), and three (15%) participants, respectively. Fever occurred 24 h after injection in 12 (30%) participants in the high-dose group and 11 (26%) participants in the low-dose group versus one (5%) participant in the placebo group. Geometric mean concentrations of IgG antibodies against Ebola glycoprotein peaked on day 28 at 51 μg/mL (95% CI 41·1-63·3) in the high-dose group, 44·9 μg/mL (25·8-56·3) in the low-dose group, and 5·2 μg/mL (3·5-7·6) in the placebo group, with respective response rates of 96% (95% CI 85·7-99·5), 96% (86·5-99·5), and 5% (0·1-24·9). Geometric mean concentrations decreased by day 180 to 25·5 μg/mL (95% CI 20·6-31·5) in the high-dose group, 22·1 μg/mL (19·3-28·6) in the low-dose group, and 3·2 μg/mL (2·4-4·9) in the placebo group. 28 (57%) participants given high-dose vaccine and 31 (61%) participants given low-dose vaccine developed glycoprotein-specific CD4 cell responses, and 33 (67%) and 35 (69%), respectively, developed CD8 responses. INTERPRETATION: ChAd3-EBO-Z was safe and well tolerated, although mild to moderate systemic adverse events were common. A single dose was immunogenic in almost all vaccine recipients. Antibody responses were still significantly present at 6 months. There was no significant difference between doses for safety and immunogenicity outcomes. This acceptable safety profile provides a reliable basis to proceed with phase 2 and phase 3 efficacy trials in Africa. FUNDING: Swiss State Secretariat for Education, Research and Innovation (SERI), through the EU Horizon 2020 Research and Innovation Programme.

Degradation of the surface of a metasilicate glass due to atmosphere moisture

Glasses with low silica content are very susceptible to suffer pronounced degradation when exposed to room atmosphere during short times. In this work the results of the degradation of the surface of a metasilicate glass with composition 2Na2O.1CaO.3SiO2 are presented. Optical and scanning electron microscopy observations, X-ray diffraction, infrared and Raman microprobe spectroscopic measurements of the modified surface of this glass show strong evidences that it is formed essentially by a crystalline carbonate layer.

Study of the optical properties of TeO2-PbO-TiO2 glass system

We describe the preparation and some optical properties of high refractive index TeO2-PbO-TiO2 glass system. Highly homogeneous glasses were obtained by agitating the mixture during the melting process in an alumina crucible. The characterization was done by X-ray diffraction, Raman scattering, light absorption and linear refractive index measurements. The results show a change in the glass structure as the PbO content increases: the TeO4 trigonal bipyramids characteristics of TeO2 glasses transform into TeO3 trigonal pyramids. However, the measured refractive indices are almost independent of the glass composition. We show that third-order nonlinear optical susceptibilities calculated from the measured refractive indices using Lines' theoretical model are also independent of the glass composition.

Transforming Maritime Safety Culture. Evaluation of the impacts of the ISM Code on maritime safety culture in Finland

The purpose of the METKU Project (Development of Maritime Safety Culture) is to study how the ISM Code has influenced the safety culture in the maritime industry. This literature review is written as a part of the Work Package 2 which is conducted by the University of Turku, Centre for Maritime Studies. The maritime traffic is rapidly growing in the Baltic Sea which leads to a growing risk of maritime accidents. Particularly in the Gulf of Finland, the high volume of traffic causes a high risk of maritime accidents. The growing risks give us good reasons for implementing the research project concerning maritime safety and the effectiveness of the safety measures, such as the safety management systems. In order to reduce maritime safety risks, the safety management systems should be further developed. The METKU Project has been launched to examine the improvements which can be done to the safety management systems. Human errors are considered as the most important reason for maritime accidents. The international safety management code (the ISM Code) has been established to cut down the occurrence of human errors by creating a safety-oriented organizational culture for the maritime industry. The ISM Code requires that a company should provide safe practices in ship operation and a safe working environment and establish safeguards against all identified risk. The fundamental idea of the ISM Code is that companies should continuously improve safety. The commitment of the top management is essential for implementing a safety-oriented culture in a company. The ISM Code has brought a significant contribution to the progress of maritime safety in recent years. Shipping companies and ships’ crews are more environmentally friendly and more safety-oriented than 12 years ago. This has been showed by several studies which have been analysed for this literature research. Nevertheless, the direct effect and influence of the ISM Code on maritime safety could not be isolated very well. No quantitative measurement (statistics/hard data) could be found in order to present the impacts of the ISM Code on maritime safety. In this study it has been discovered that safety culture has emerged and it is developing in the maritime industry. Even though the roots of the safety culture have been established there are still serious barriers to the breakthrough of the safety management. These barriers could be envisaged as cultural factors preventing the safety process. Even though the ISM Code has been effective over a decade, the old-established behaviour which is based on the old day’s maritime culture still occurs. In the next phase of this research project, these cultural factors shall be analysed in regard to the present safety culture of the maritime industry in Finland.

Calcium phosphate glasses: silanation process and effect on the bioactivity behavior of Glass-PMMA composites

This article presents the results of a study of the efficiency of silanation process of calcium phosphate glasses particles and its effect on the bioactivity behavior of glasspoly( methyl methacrylate) (PMMA) composites. Two different calcium phosphate glasses: 44.5CaO-44.5P2O5-11Na2O (BV11) and 44.5CaO-44.5P2O5-6Na2O-5TiO2 (G5) were synthesized and treated with silane coupling agent. The glasses obtained were characterized by Microprobe and BET while the efficiency of silanation process was determined using Fourier Transform Infrared Spectroscopy (FTIR), X-ray Photoelectron Spectroscopy (XPS) and Thermal Analysis (DTA and TG)techniques. The content of coupling agent chemically tightly bond to the silanated glasses ascended to 1.69 6 0.02 wt % for BV11sil glass and 0.93 6 0.01 wt % for G5sil glass. The in vitro bioactivity test carried out in Simulated Body Fluid (SBF) revealed certain bioactive performance with the use of both silanated glasses in a 30% (by weight) as filler of the PMMA composites because of a superficial deposition of an apatite-like layer with low content of CO3 22 and HPO4 22 in its structure after soaking for 30 days occurred. VC 2013 Wiley Periodicals,Inc. J Biomed Mater Res Part B: Appl Biomater 00B: 000-000, 2013.

The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS)

In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g. colorants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers summited to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition.

Food Safety Testing: Rapid Molecular Methods for Chemical and Biological Hazards

The central goal of food safety policy in the European Union (EU) is to protect consumer health by guaranteeing a high level of food safety throughout the food chain. This goal can in part be achieved by testing foodstuffs for the presence of various chemical and biological hazards. The aim of this study was to facilitate food safety testing by providing rapid and user-friendly methods for the detection of particular food-related hazards. Heterogeneous competitive time-resolved fluoroimmunoassays were developed for the detection of selected veterinary residues, that is coccidiostat residues, in eggs and chicken liver. After a simplified sample preparation procedure, the immunoassays were performed either in manual format with dissociation-enhanced measurement or in automated format with pre-dried assay reagents and surface measurement. Although the assays were primarily designed for screening purposes providing only qualitative results, they could also be used in a quantitative mode. All the developed assays had good performance characteristics enabling reliable screening of samples at concentration levels required by the authorities. A novel polymerase chain reaction (PCR)-based assay system was developed for the detection of Salmonella spp. in food. The sample preparation included a short non-selective pre-enrichment step, after which the target cells were collected with immunomagnetic beads and applied to PCR reaction vessels containing all the reagents required for the assay in dry form. The homogeneous PCR assay was performed with a novel instrument platform, GenomEra^™, and the qualitative assay results were automatically interpreted based on end-point time-resolved fluorescence measurements and cut-off values. The assay was validated using various food matrices spiked with sub-lethally injured Salmonella cells at levels of 1-10 colony forming units (CFU)/25 g of food. The main advantage of the system was the exceptionally short time to result; the entire process starting from the pre-enrichment and ending with the PCR result could be completed in eight hours. In conclusion, molecular methods using state-of-the-art assay techniques were developed for food safety testing. The combination of time-resolved fluorescence detection and ready-to-use reagents enabled sensitive assays easily amenable to automation. Consequently, together with the simplified sample preparation, these methods could prove to be applicable in routine testing.

Motorways, tolls and road safety. Evidence from European Panel Data

The use of tolls is being widespread around the world. Its ability to fund infrastructure projects and to solve budget constraints have been the main rationale behind its renewed interest. However, less attention has been payed to the safety effects derived from this policy in a moment of increasing concern on road fatalities. Pricing best infrastructures shifts some drivers onto worse alternative roads usually not prepared to receive high traffic in comparable safety standards. In this paper we provide evidence of the existence of this perverse consequence by using an international European panel in a two way fixed effects estimation.

Intensities of 4f-4f transitions in glass materials

In this article we review some of the basic aspects of rare earth spectroscopy applied to vitreous materials. The characteristics of the intra-atomic free ion and ligand field interactions, as well as the formalisms of the forced electric dipole and dynamic coupling mechanisms of 4f-4f intensities, are outlined. The contribution of the later mechanism to the 4f-4f intensities is critically discussed, a point that has been commonly overlooked in the literature of rare earth doped glasses. The observed correlation between the empirical intensity parameter W2 and the covalence of the ion first coordination shell is discussed accordingly to the theoretical predictions.

Thermal-Hydraulic Studies on the Safety Of VVER-440 Type Nuclear Power Plants

This thesis includes several thermal hydraulic analyses related to the Loviisa WER 440 nuclear power plant units. The work consists of experimental studies, analysis of the experiments, analysis of some plant transits and development of a calculational model for calculation of boric acid concentrations in the reactor. In the first part of the thesis, in the case of won of boric acid solution behaviour during long term cooling period of LOCAs, experiments were performed in scaled down test facilities. The experimental data together with the results of RELAPS/MOD3 simulations were used to develop a model for calculations of boric acid concentrations in the reactor during LOCAs. The results of calculations showed that margins to critical concentrations that would lead to boric acid crystallization were large, both in the reactor core and in the lower plenum. This was mainly caused by the fact that water in the primary cooling circuit includes borax (Na)BsO,.IOHZO), which enters the reactor when ECC water is taken from the sump and greatly increases boric acid solubility in water. In the second part, in the case of simulation of horizontal steam generators, experiments were performed with PACTEL integral test loop to simulate loss of feedwater transients. The PACTEL experiments, as well as earlier REWET III natural circulation tests, were analyzed with RELAPS/MOD3 Version Sm5 code. The analysis showed that the code was capable of simulating the main events during the experiments. However, in the case of loss of secondary side feedwater the code was not completely capable to simulate steam superheating in the secondary side of the steam generators. The third part of the work consists of simulations of Loviisa VVER reactor pump trip transients with RELAPSlMODI Eur, RELAPS/MOD3 and CATHARE codes. All three codes were capable to simulate the two selected pump trip transients and no significant differences were found between the results of different codes. Comparison of the calculated results with the data measured in the Loviisa plant also showed good agreement.

A evolução dos reagentes químicos comerciais através dos rótulos e frascos

This work presents an evolution profile of labels and containers of commercial chemicals employed in laboratories since 1870. Most chemicals were made in Germany before the Second World War, after which many other manufacturers arrived on the Brazilian market. North-american products were dominant in the 1940s, but Brazilian chemicals have increased their participation along time. Labels presented increasingly more information, from originally simple names of the compounds at the beginning of the XXth century to the data presented today such as chemical formulae, safety regards and detailed chemical analysis. The raw material for container manufacturing also changed: glass was dominant until the 1950s, but nowadays plastic flasks are preferred whenever possible. Cork covers were replaced by screw caps. The diversity of commercial products also sharply increased with time, especially after the 1950s, following the many new and specific applications of chemicals for research and commercial purposes.

Intravitreal docosahexaenoic acid in a rabbit model: preclinical safety assessment

Purpose The purpose of the present study was to evaluate the retinal toxicity of a single dose of intravitreal docosahexaenoic acid (DHA) in rabbit eyes over a short-term period. Methods Sixteen New Zealand albino rabbits were selected for this pre-clinical study. Six concentrations of DHA (Brudy Laboratories, Barcelona, Spain) were prepared: 10 mg/50 µl, 5 mg/50 µl, 2'5 mg/50 µl, 50 µg/50 µl, 25 µg/50 µl, and 5 µg/50 µl. Each concentration was injected intravitreally in the right eye of two rabbits. As a control, the vehicle solution was injected in one eye of four animals. Retinal safety was studied by slit-lamp examination, and electroretinography. All the rabbits were euthanized one week after the intravitreal injection of DHA and the eyeballs were processed to morphologic and morphometric histological examination by light microscopy. At the same time aqueous and vitreous humor samples were taken to quantify the concentration of omega-3 acids by gas chromatography. Statistical analysis was performed by SPSS 21.0. Results Slit-lamp examination revealed an important inflammatory reaction on the anterior chamber of the rabbits injected with the higher concentrations of DHA (10 mg/50 µl, 5 mg/50 µl, 2'5 mg/50 µ) Lower concentrations showed no inflammation. Electroretinography and histological studies showed no significant difference between control and DHA-injected groups except for the group injected with 50 µg/50 µl. Conclusions Our results indicate that administration of intravitreal DHA is safe in the albino rabbit model up to the maximum tolerated dose of 25 µg/50 µl. Further studies should be performed in order to evaluate the effect of intravitreal injection of DHA as a treatment, alone or in combination, of different retinal diseases.

Non-resorbable glass fibre-reinforced composite with porous surface as bone substitute material: Experimental studies in vitro and in vivo focused on bone-implant interface

The development of load-bearing osseous implant with desired mechanical and surface properties in order to promote incorporation with bone and to eliminate risk of bone resorption and implant failure is a very challenging task. Bone formation and resoption processes depend on the mechanical environment. Certain stress/strain conditions are required to promote new bone growth and to prevent bone mass loss. Conventional metallic implants with high stiffness carry most of the load and the surrounding bone becomes virtually unloaded and inactive. Fibre-reinforced composites offer an interesting alternative to metallic implants, because their mechanical properties can be tailored to be equal to those of bone, by the careful selection of matrix polymer, type of fibres, fibre volume fraction, orientation and length. Successful load transfer at bone-implant interface requires proper fixation between the bone and implant. One promising method to promote fixation is to prepare implants with porous surface. Bone ingrowth into porous surface structure stabilises the system and improves clinical success of the implant. The experimental part of this work was focused on polymethyl methacrylate (PMMA) -based composites with dense load-bearing core and porous surface. Three-dimensionally randomly orientated chopped glass fibres were used to reinforce the composite. A method to fabricate those composites was developed by a solvent treatment technique and some characterisations concerning the functionality of the surface structure were made in vitro and in vivo. Scanning electron microscope observations revealed that the pore size and interconnective porous architecture of the surface layer of the fibre-reinforced composite (FRC) could be optimal for bone ingrowth. Microhardness measurements showed that the solvent treatment did not have an effect on the mechanical properties of the load-bearing core. A push-out test, using dental stone as a bone model material, revealed that short glass fibre-reinforced porous surface layer is strong enough to carry load. Unreacted monomers can cause the chemical necrosis of the tissue, but the levels of leachable resisidual monomers were considerably lower than those found in chemically cured fibre-reinforced dentures and in modified acrylic bone cements. Animal experiments proved that surface porous FRC implant can enhance fixation between bone and FRC. New bone ingrowth into the pores was detected and strong interlocking between bone and the implant was achieved.

Targeted vs. standard treatment against Helicobacter pylori: safety assessment clinical trial

Helicobacter pylori (H. pylori) is a gram negative bacteria that represents a considerable global burden in the world and is related to many gastrointestinal diseases (peptic ulcer, gastric MALT lymphoma or gastric cancer). Currently the triple standard therapy is less used as there is an increase of the clarithromycin resistance. Therefore patients have to receive several lines of treatment with the consequence of adverse events and the possibility to interrupt the treatment. This is why the main objective is to determine if making a culture and antibiogram to do a targeted treatment cause less adverse events with the same eradication than making an empirical treatment to eradicate H. pylori. The secondary objective is to determine the prevalence of resistance to clarithromycin in the province of GironaThis is a multicentre clinical trial without blinding; patients are selected by non-probabilistic sampling, with a total sample of 868 patients randomized in two equal groups of 434 patients in each group. The study will last 2 years. The endpoints will be to evaluate the adverse events and eradication of each group of patients. Also it will be evaluated the resistance to clarithromycin