Search results for: monitoring radar
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3239

Search results for: monitoring radar

929 Performance Analysis of Pumps-as-Turbine Under Cavitating Conditions

Authors: Calvin Stephen, Biswajit Basu, Aonghus McNabola

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Market liberalization in the power sector has led to the emergence of micro-hydropower schemes that are dependent on the use of pumps-as-turbines in applications that were not suitable as potential hydropower sites in earlier years. These applications include energy recovery in water supply networks, sewage systems, irrigation systems, alcohol breweries, underground mining and desalination plants. As a result, there has been an accelerated adoption of pumpsas-turbine technology due to the economic advantages it presents in comparison to the conventional turbines in the micro-hydropower space. The performance of this machines under cavitation conditions, however, is not well understood as there is a deficiency of knowledge in literature focused on their turbine mode of operation. In hydraulic machines, cavitation is a common occurrence which needs to be understood to safeguard them and prolong their operation life. The overall purpose of this study is to investigate the effects of cavitation on the performance of a pumps-as-turbine system over its entire operating range. At various operating speeds, the cavitating region is identified experimentally while monitoring the effects this has on the power produced by the machine. Initial results indicate occurrence of cavitation at higher flow rates for lower operating speeds and at lower flow rates at higher operating speeds. This implies that for cavitation free operation, low speed pumps-as-turbine must be used for low flow rate conditions whereas for sites with higher flow rate conditions high speed turbines should be adopted. Such a complete understanding of pumps-as-turbine suction performance can aid avoid cavitation induced failures hence improved reliability of the micro-hydropower plant.

Keywords: cavitation, micro-hydropower, pumps-as-turbine, system design

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928 Malaria Management among Dispensers in Drug Retail Outlets in Buea Community: An Assessment of Knowledge of Malaria and Antimalarial Drug Prescription and Dispensing Practices

Authors: Marcelus U. Ajonina, Deodata B. Ngonga, Kenric B. Ware, Carine K. Nfor

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Background: Lack of knowledge of rational use of antimalarial drugs among dispensers is a serious problem, especially in areas of intense transmission, thus increasing the risk of resistance and adverse drug reactions. This study was aimed at assessing the knowledge of malaria as well as perception and dispensing practices of antimalarials among vendors in Buea community. Methods: A community-based cross-sectional survey of a random sample of 140 drug vendors living within the Buea community was conducted between March and June 2017. A questionnaire was designed to obtain information from drug vendors on the general knowledge of malaria as well as dispensing practices. Data were analyzed using SPSS Statistics 20.0 and were considered significant at p ≤ 0.05. Results: Knowledge of malaria symptoms, transmission, and prevention was reasonable among 55.8% (77) of the respondents. Only 33.6% (47) of the respondents could attribute the cause of malaria to protozoan of genus Plasmodium species. Of the 140 vendors, 115 (82.7%) prescribe antimalarial drugs. The knowledge of the national protocol was malaria case management among dispensers was 35.0%. Vendors in hospital/community pharmacies were 2.4 times (OR = 3.14, 95% CI: 4.14 - 8.74, p < 0.001) more knowledgeable about malaria treatment protocol than those of in drugstores. The prevalence of self-prescription of antimalarials was 39.3%. Self-prescription was significantly higher in drugstores than hospital/community pharmacies (p=0.004). In all, 56 (40.6%) of vendors showed good practices regarding antimalarial drug dispensing with the majority (51.7%) from community pharmacies (OR=2.27,95% CI: 1.13-4.56). Conclusion: Findings reveal moderate knowledge of malaria but poor prescription and dispensing practices of antimalarial drugs among vendors, thus indicating a need for routine monitoring and evaluation to prevent the emergence of resistant strains to current efficacious antimalarials.

Keywords: antimalarials, drug retail outlets, dispensing, drug resistance, prescription

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927 Comfort Needs and Energy Practices in Low-Income, Tropical Housing from a Socio-Technical Perspective

Authors: Tania Sharmin

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Energy use, overheating and thermal discomfort in low-income tropical housing remains an under-researched area. This research attempts to explore these aspects in the Loving Community, a housing colony created for former leprosy patients and their families in Ahmedabad in India. The living conditions in these households and working practices of the inhabitants in terms of how the building and its internal and external spaces are used, will be explored through interviews and monitoring which will be based on a household survey and a focus group discussion (FGD). The findings from the study will provide a unique and in-depth account of how the relocation of the affected households to the new, flood-resistant and architecturally-designed buildings may have affected the dwellers’ household routines (health and well-being, comfort, satisfaction and working practices) and overall living conditions compared to those living in poorly-designed, existing low-income housings. The new houses were built under an innovative building project supported by De Montfort University Leicester (DMU)’s Square Mile India project. A comparison of newly-built and existing building typologies will reveal how building design can affect people’s use of space and energy use. The findings will be helpful to design healthier, energy efficient and socially acceptable low-income housing in future, thus addressing United Nation’s sustainable development goals on three aspects: 3 (health and well-being), 7 (energy) and 11 (safe, resilient and sustainable human settlements). This will further facilitate knowledge exchange between policy makers, developers, designers and occupants focused on strategies to increase stakeholders’ participation in the design process.

Keywords: thermal comfort, energy use, low-income housing, tropical climate

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926 Enhancing Digi-Parenting Strategies to Mitigate Children’s Cyber-Aggression

Authors: Misha Teimouri

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Our world has been transformed by the use of the internet and the constant flow of information. While this transmission has its benefits, it has also added significant challenges to family relations, primarily in the field of parenting and children's digital lives. Screens, speed, and connectedness are the words that characterize the lives of today's digital generation; it's as if the entire world is in their pockets at all times. Parents attempt to regulate and control their children's internet use in the hopes of maximizing the advantages and minimizing the disadvantages of their children's internet use; however, given that children spend more time online, particularly ever since the pandemic, children's cyber-aggression has become an issue for them. Children may externalize their behavior online, bully others, send anger/hatred/resist messages, share violent and bloody content, and engage in sexting. These types of online aggression make parenting more difficult, especially for digital immigrant parents compared to digital native parents. In response to these challenges, this study investigated the level of cyber aggression among children, as well as the effects of digi-parenting (active, monitoring, restrictive, and warm and supportive) on children's cyber-aggression (sexual, verbal, visual) as victims or aggressors. The study also determined whether there were any differences in parenting styles between digital natives (DN) and digital immigrants. In accordance with the study, boys and older children are more likely to engage in cyber aggression as aggressors, whereas girls and younger children are more likely to engage as victims. Warmth and supportive digiparenting have a greater impact on children's cyber-aggression (sexual, verbal, and visual) as victims or aggressors. This study also found that, when compared to DI parents, DN parents are more successful at digi-parenting and reducing their children's exposure to cyber-aggression.

Keywords: digi-parenting, cyber-aggression, digital natives, digital immigrants, children's cyber-aggression (sexual, verbal, visual)

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925 Analysis, Evaluation and Optimization of Food Management: Minimization of Food Losses and Food Wastage along the Food Value Chain

Authors: G. Hafner

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A method developed at the University of Stuttgart will be presented: ‘Analysis, Evaluation and Optimization of Food Management’. A major focus is represented by quantification of food losses and food waste as well as their classification and evaluation regarding a system optimization through waste prevention. For quantification and accounting of food, food losses and food waste along the food chain, a clear definition of core terms is required at the beginning. This includes their methodological classification and demarcation within sectors of the food value chain. The food chain is divided into agriculture, industry and crafts, trade and consumption (at home and out of home). For adjustment of core terms, the authors have cooperated with relevant stakeholders in Germany for achieving the goal of holistic and agreed definitions for the whole food chain. This includes modeling of sub systems within the food value chain, definition of terms, differentiation between food losses and food wastage as well as methodological approaches. ‘Food Losses’ and ‘Food Wastes’ are assigned to individual sectors of the food chain including a description of the respective methods. The method for analyzing, evaluation and optimization of food management systems consist of the following parts: Part I: Terms and Definitions. Part II: System Modeling. Part III: Procedure for Data Collection and Accounting Part. IV: Methodological Approaches for Classification and Evaluation of Results. Part V: Evaluation Parameters and Benchmarks. Part VI: Measures for Optimization. Part VII: Monitoring of Success The method will be demonstrated at the example of an invesigation of food losses and food wastage in the Federal State of Bavaria including an extrapolation of respective results to quantify food wastage in Germany.

Keywords: food losses, food waste, resource management, waste management, system analysis, waste minimization, resource efficiency

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924 Interaction Effects of Dietary Ginger, Zingiber Officinale, on Plasma Protein Fractions in Rainbow Trout, Oncorhynchus Mykiss

Authors: Ali Taheri Mirghaed, Sara Ahani, Ashkan Zargar, Seyyed Morteza Hoseini

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Diseases are the major challenges in intensive aquaculture that cause significant annual losses. Antibiotic-therapy is a common way to control bacterial disease in fish, and oxytetracycline (OTC) is the only oral antibiotic in aquaculture approved FDA. OTC has been found to have negative effects on fish, such as oxidative stress and immune-suppression, thus, it is necessary to mitigate such effects. Medicinal herbs have various benefits on fish, including antioxidant, immunostimulant, and anti-microbial effects. Therefore, we hypothesized if dietary ginger meal (GM) interacts with dietary OTC by monitoring plasma protein fractions in rainbow trout. The study was conducted as a 2 × 2 factorial design, including diets containing 0 and 1% GM and 0 and 1.66 % OTC (corresponding to 100 mg/kg fish biomass per day). After ten days treating the fish (60 g individual weight) with these feeds, blood samples were taken from al treatments (n =3). Plasma was separated by centrifugation, and protein fractions were determined by electrophoresis. The results showed that OTC and GM had interaction effects on total protein (P<0.001), albumin (P<0.001), alpha-1 fraction (P=0.010), alpha-2 fraction (P=0.001), beta-2 fraction (P=0.014), and gamma fraction (P<0.001). Beta-1 fraction was significantly (P=0.030) affected by dietary GM. GM decreased plasma total protein, albumin, and beta-2 but increased beta-1 fraction. OTC significantly decreased total protein (P<0.001), albumin (P=0.001), alpha-2 fraction (P<0.001), beta-2 fraction (P=0.004), and gamma fraction (P<0.001) but had no significant effects on alpha-1 and beta-1 fractions. Dietary GM inhibited/suppressed the effects of dietary OTC on the plasma total protein and protein fractions. In conclusion, adding 1% GM to diet can mitigate the negative effects of dietary OTC on plasma proteins. Thus, GM may boost health of rainbow trout during the period of medication with OTC.

Keywords: ginger, plasma protein electrophoresis, dietary additive, rainbow trout

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923 Macroinvertebrates of Paravani and Saghamo Lakes, South Georgia

Authors: Bella Japoshvili, Zhanetta Shubitidze, Ani Bikashvili, Sophio Gabelashvili, Marina Gioshvili, Levan Mumladze

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Paravani and Saghamo Lakes are oligotrophic lentic systems located in Javakheti plateau (South Georgia) at 2073 m and 1996 m a.s.l. respectively. Javakheti plateau is known as a lakes region as there are located almost 60 small and medium size lakes. Paravani Lake is the biggest lake by its surface area in Georgia, 37 km 2. The Saghamo Lake is smaller and its surface area consists 4.58 km2. These two lakes are connected with Paravani River, because of this the main hydrobiological and ichthyological features are the same. More than 15-30 years were not studied macroinvertebrates of these lakes. Even the existing information is lack and very limited. The aim of our study was to identify main macroinvertebrate groups inhabiting both lakes and to compare obtaining results to existing information. Our investigation was carried out during 2014 and 2015, in 3 seasons of the year, in winter because of severe condition samples were not taken. Kick-net and Petersen grab were used for material collecting, 4 sites from Paravani Lake and 3–from Saghamo Lake were sampled. Collected invertebrates were fixed in ethanol and late taken to the laboratory, where organisms were identified to the lowest taxon possible, usually family. By our results identified 14 taxa for Paravani Lake and 12 taxa for Saghamo Lake. Our results differ from previous information; for Saghamo Lake previously 13 taxa and for Paravani Lake 12 taxa were described. The percentage of the groups also differ from existing information. Our investigation showed that in Paravani Lake most abundant are Apmhipoda, Hydrachnidae, and Hemiptera, in our samples the number of individuals for those 3 taxa was more than thousand, in each. For Saghamo Lake numerous taxon was Amphipoda-36.3%, following by Ephemeroptera-11.37%, Chironomidae-10.5% and Hydrachnidae-7.03% respectively. We also identified the dominant taxon for all studied seasons. Autumn is the period when the diversity of macroinvertebrates are higher in both lakes.

Keywords: Georgia, lakes, macroinvertebrates, monitoring

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922 Experimental Evaluation of 10 Ecotypes of Toxic and Non-Toxic Jatropha curcas as Raw Material to Produce Biodiesel in Morelos State, Mexico

Authors: Guadalupe Pérez, Jorge Islas, Mirna Guevara, Raúl Suárez

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Jatropha curcas is a perennial oleaginous plant that is currently considered an energy crop with high potential as an environmentally sustainable biofuel. During the last decades, research in biofuels has grown in tropical and subtropical regions in Latin America. However, as far we know, there are no reports on the growth and yield patterns of Jatropha curcas under the specific agro climatic scenarios of the State of Morelos, Mexico. This study presents the results of 52 months monitoring of 10 toxic and non-toxic ecotypes of Jatropha curcas (E1M, E2M, E3M, E4M, E5M, E6O, E7O, E8O, E9C, E10C) in an experimental plantation with minimum watering and fertilization resources. The main objective is to identify the ecotypes with the highest potential as biodiesel raw material in the select region, by developing experimental information. Specifically, we monitored biophysical and growth parameters, including plant survival and seed production (at the end of month 52), to study the performance of each ecotype and to establish differences among the variables of morphological growth, net seed oil content, and toxicity. To analyze the morphological growth, a statistical approach to the biophysical parameters was used; the net seed oil content -80 to 192 kg/ha- was estimated with the first harvest; and the toxicity was evaluated by examining the phorbol ester concentration (µg/L) in the oil extracted from the seeds. The comparison and selection of ecotypes was performed through a methodology developed based on the normalization of results. We identified four outstanding ecotypes (E1M, E2M, E3M, and E4M) that can be used to establish Jatropha curcas as energy crops in the state of Morelos for feasible agro-industrial production of biodiesel and other products related to the use of biomass.

Keywords: biodiesel production, Jatropha curcas, seed oil content, toxic and non-toxic ecotypes

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921 Ribosomal Protein S4 Gene: Exploring the Presence in Syrian Strain of Leishmania Tropica Genome, Sequencing it and Evaluating Immune Response of pCI-S4 DNA Vaccine

Authors: Alyaa Abdlwahab

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Cutaneous leishmaniasis represents a serious health problem in Syria; this problem has become noticeably aggravated after the civil war in the country. Leishmania tropica parasite is the main cause of cutaneous leishmaniasis in Syria. In order to control the disease, we need an effective vaccine against leishmania parasite. DNA vaccination remains one of the favorable approaches that have been used to face cutaneous leishmaniasis. Ribosomal protein S4 is responsible for important roles in Leishmania parasite life. DNA vaccine based on S4 gene has been used against infections by many species of Leishmania parasite but leishmania tropica parasite, so this gene represents a good candidate for DNA vaccine construction. After proving the existence of ribosomal protein S4 gene in a Syrian strain of Leishmania tropica (LCED Syrian 01), sequencing it and cloning it into pCI plasmid, BALB/C mice were inoculated with pCI-S4 DNA vaccine. The immune response was determined by monitoring the lesion progression in inoculated BALB/C mice for six weeks after challenging mice with Leishmania tropica (LCED Syrian 01) parasites. IL-12, IFN-γ, and IL-4 were quantified in draining lymph nodes (DLNa) of the immunized BALB/C mice by using the RT-qPCR technique. The parasite burden was calculated in the final week for the footpad lesion and the DLNs of the mice. This study proved the existence and the expression of the ribosomal protein S4 gene in Leishmania tropica (LCED Syrian 01) promastigotes. The sequence of ribosomal protein cDNA S4 gene was determined and published in Genbank; the gene size was 822 bp. Expression was also demonstrated at the level of cDNA. Also, this study revealed that pCI-S4 DNA vaccine induces TH1\TH2 response in immunized mice; this response prevents partially developing a dermal lesion of Leishmania.

Keywords: ribosomal protein S4, DNA vaccine, Leishmania tropica, BALB\c

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920 Investigating the Relationship between Service Quality and Amount of Violations in Community Pharmacies with Their Type of Ownership

Authors: Afshin Azari, Farzad Peiravian, Nazila Yousefi

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Introduction: Community pharmacies have been always played an important role in public health. Therefore, having a decent service provided by these pharmacies is of paramount importance for the healthcare system. The issue of pharmacy ownership and its possible impact on the quality of services and amount of violations has been argued for many years, and there are different opinions around this debate. Since, so far, no scientific research has been performed to investigate this issue in Iran, this study aimed to examine the differences between these two types of pharmacies ownership in terms of violations and service quality. Method: This study investigates the impact of two different kinds of pharmacy ownership (pharmacists and non-pharmacist’s ownership) on the pharmacies’ amount of violations and services quality. Pharmacies’ amount of violations was examined using “pharmacy inspection reports” between September 2018 and September 2019, in their distinguishable categories: minor, major and critical violations. Then, service quality was examined using a questionnaire from the perspective of pharmacy customers. Results: Considering violations, there was no evidence to prove a significant relationship between critical violations and major violations with the type of pharmacy ownership. However, in minor violations, the average of violations was higher in pharmacies owned by pharmacists in comparison to their non-pharmacist owned counterparts. Regarding service quality, the results showed that there is no significant relationship between the quality of service and the type of pharmacy ownership. Discussion and Conclusion: In this study, no significant relationship was found between the amount of violations and the type of pharmacy ownership. This could indicate that the pharmacy ownership would not influence the rate of violations. Considering that more inspections have been carried out in non-pharmacist owned pharmacies, it can be concluded that these pharmacies are more under control, and in fact, this monitoring has reduced violations in these pharmacies. The quality of services in the two types of pharmacies were not significantly different from each other, and this shows that non-pharmacist-owned pharmacies also try to maintain the desired level of service in competition with their competitors.

Keywords: pharmacy ownership, quality of service, violation, community pharmacy

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919 Wearable Monitoring and Treatment System for Parkinson’s Disease

Authors: Bulcha Belay Etana, Benny Malengier, Janarthanan Krishnamoorthy, Timothy Kwa, Lieva Vanlangenhove

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Electromyography measures the electrical activity of muscles using surface electrodes or needle electrodes to monitor various disease conditions. Recent developments in the signal acquisition of electromyograms using textile electrodes facilitate wearable devices, enabling patients to monitor and control their health status outside of healthcare facilities. Here, we have developed and tested wearable textile electrodes to acquire electromyography signals from patients suffering from Parkinson’s disease and incorporated a feedback-control system to relieve muscle cramping through thermal stimulus. In brief, the textile electrodes made of stainless steel was knitted into a textile fabric as a sleeve, and their electrical characteristic, such as signal-to-noise ratio, was compared with traditional electrodes. To relieve muscle cramping, a heating element made of stainless-steel conductive yarn sewn onto a cotton fabric, coupled with a vibration system, was developed. The system integrated a microcontroller and a Myoware muscle sensor to activate the heating element as well as the vibration motor when cramping occurred. At the same time, the element gets deactivated when the muscle cramping subsides. An optimum therapeutic temperature of 35.5°C is regulated and maintained continuously by a heating device. The textile electrode exhibited a signal-to-noise ratio of 6.38dB, comparable to that of the traditional electrode’s value of 7.05 dB. For a given 9 V power supply, the rise time for the developed heating element was about 6 minutes to reach an optimum temperature.

Keywords: smart textile system, wearable electronic textile, electromyography, heating textile, vibration therapy, Parkinson’s disease

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918 Analyzing the Influence of Hydrometeorlogical Extremes, Geological Setting, and Social Demographic on Public Health

Authors: Irfan Ahmad Afip

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This main research objective is to accurately identify the possibility for a Leptospirosis outbreak severity of a certain area based on its input features into a multivariate regression model. The research question is the possibility of an outbreak in a specific area being influenced by this feature, such as social demographics and hydrometeorological extremes. If the occurrence of an outbreak is being subjected to these features, then the epidemic severity for an area will be different depending on its environmental setting because the features will influence the possibility and severity of an outbreak. Specifically, this research objective was three-fold, namely: (a) to identify the relevant multivariate features and visualize the patterns data, (b) to develop a multivariate regression model based from the selected features and determine the possibility for Leptospirosis outbreak in an area, and (c) to compare the predictive ability of multivariate regression model and machine learning algorithms. Several secondary data features were collected locations in the state of Negeri Sembilan, Malaysia, based on the possibility it would be relevant to determine the outbreak severity in the area. The relevant features then will become an input in a multivariate regression model; a linear regression model is a simple and quick solution for creating prognostic capabilities. A multivariate regression model has proven more precise prognostic capabilities than univariate models. The expected outcome from this research is to establish a correlation between the features of social demographic and hydrometeorological with Leptospirosis bacteria; it will also become a contributor for understanding the underlying relationship between the pathogen and the ecosystem. The relationship established can be beneficial for the health department or urban planner to inspect and prepare for future outcomes in event detection and system health monitoring.

Keywords: geographical information system, hydrometeorological, leptospirosis, multivariate regression

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917 Ecological impacts of Cage Farming: A Case Study of Lake Victoria, Kenya

Authors: Mercy Chepkirui, Reuben Omondi, Paul Orina, Albert Getabu, Lewis Sitoki, Jonathan Munguti

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Globally, the decline in capture fisheries as a result of the growing population and increasing awareness of the nutritional benefits of white meat has led to the development of aquaculture. This is anticipated to meet the increasing call for more food for the human population, which is likely to increase further by 2050. Statistics showed that more than 50% of the global future fish diet will come from aquaculture. Aquaculture began commercializing some decades ago; this is accredited to technological advancement from traditional to modern cultural systems, including cage farming. Cage farming technology has been rapidly growing since its inception in Lake Victoria, Kenya. Currently, over 6,000 cages have been set up in Kenyan waters, and this offers an excellent opportunity for recognition of Kenya’s government tactic to eliminate food insecurity and malnutrition, create employment and promote a Blue Economy. However, being an open farming enterprise is likely to emit large bulk of waste hence altering the ecosystem integrity of the lake. This is through increased chlorophyll-a pigments, alteration of the plankton community, macroinvertebrates, fish genetic pollution, transmission of fish diseases and pathogens. Cage farming further increases the nutrient loads leading to the production of harmful algal blooms, thus negatively affecting aquatic and human life. Despite the ecological transformation, cage farming provides a platform for the achievement of the Sustainable Development Goals of 2030, especially the achievement of food security and nutrition. Therefore, there is a need for Integrated Multitrophic Aquaculture as part of Blue Transformation for ecosystem monitoring.

Keywords: aquaculture, ecosystem, blue economy, food security

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916 Review of Strategies for Hybrid Energy Storage Management System in Electric Vehicle Application

Authors: Kayode A. Olaniyi, Adeola A. Ogunleye, Tola M. Osifeko

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Electric Vehicles (EV) appear to be gaining increasing patronage as a feasible alternative to Internal Combustion Engine Vehicles (ICEVs) for having low emission and high operation efficiency. The EV energy storage systems are required to handle high energy and power density capacity constrained by limited space, operating temperature, weight and cost. The choice of strategies for energy storage evaluation, monitoring and control remains a challenging task. This paper presents review of various energy storage technologies and recent researches in battery evaluation techniques used in EV applications. It also underscores strategies for the hybrid energy storage management and control schemes for the improvement of EV stability and reliability. The study reveals that despite the advances recorded in battery technologies there is still no cell which possess both the optimum power and energy densities among other requirements, for EV application. However combination of two or more energy storages as hybrid and allowing the advantageous attributes from each device to be utilized is a promising solution. The review also reveals that State-of-Charge (SoC) is the most crucial method for battery estimation. The conventional method of SoC measurement is however questioned in the literature and adaptive algorithms that include all model of disturbances are being proposed. The review further suggests that heuristic-based approach is commonly adopted in the development of strategies for hybrid energy storage system management. The alternative approach which is optimization-based is found to be more accurate but is memory and computational intensive and as such not recommended in most real-time applications.

Keywords: battery state estimation, hybrid electric vehicle, hybrid energy storage, state of charge, state of health

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915 Comparison of Radiation Dosage and Image Quality: Digital Breast Tomosynthesis vs. Full-Field Digital Mammography

Authors: Okhee Woo

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Purpose: With increasing concern of individual radiation exposure doses, studies analyzing radiation dosage in breast imaging modalities are required. Aim of this study is to compare radiation dosage and image quality between digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM). Methods and Materials: 303 patients (mean age 52.1 years) who studied DBT and FFDM were retrospectively reviewed. Radiation dosage data were obtained by radiation dosage scoring and monitoring program: Radimetrics (Bayer HealthCare, Whippany, NJ). Entrance dose and mean glandular doses in each breast were obtained in both imaging modalities. To compare the image quality of DBT with two-dimensional synthesized mammogram (2DSM) and FFDM, 5-point scoring of lesion clarity was assessed and the better modality between the two was selected. Interobserver performance was compared with kappa values and diagnostic accuracy was compared using McNemar test. The parameters of radiation dosages (entrance dose, mean glandular dose) and image quality were compared between two modalities by using paired t-test and Wilcoxon rank sum test. Results: For entrance dose and mean glandular doses for each breasts, DBT had lower values compared with FFDM (p-value < 0.0001). Diagnostic accuracy did not have statistical difference, but lesion clarity score was higher in DBT with 2DSM and DBT was chosen as a better modality compared with FFDM. Conclusion: DBT showed lower radiation entrance dose and also lower mean glandular doses to both breasts compared with FFDM. Also, DBT with 2DSM had better image quality than FFDM with similar diagnostic accuracy, suggesting that DBT may have a potential to be performed as an alternative to FFDM.

Keywords: radiation dose, DBT, digital mammography, image quality

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914 Assets Integrity Management in Oil and Gas Production Facilities through Corrosion Mitigation and Inspection Strategy: A Case Study of Sarir Oilfield

Authors: Iftikhar Ahmad, Youssef Elkezza

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Sarir oilfield is in North Africa. It has facilities for oil and gas production. The assets of the Sarir oilfield can be divided into five following categories, namely: (i) well bore and wellheads; (ii) vessels such as separators, desalters, and gas processing facilities; (iii) pipelines including all flow lines, trunk lines, and shipping lines; (iv) storage tanks; (v) other assets such as turbines and compressors, etc. The nature of the petroleum industry recognizes the potential human, environmental and financial consequences that can result from failing to maintain the integrity of wellheads, vessels, tanks, pipelines, and other assets. The importance of effective asset integrity management increases as the industry infrastructure continues to age. The primary objective of assets integrity management (AIM) is to maintain assets in a fit-for-service condition while extending their remaining life in the most reliable, safe, and cost-effective manner. Corrosion management is one of the important aspects of successful asset integrity management. It covers corrosion mitigation, monitoring, inspection, and risk evaluation. External corrosion on pipelines, well bores, buried assets, and bottoms of tanks is controlled with a combination of coatings by cathodic protection, while the external corrosion on surface equipment, wellheads, and storage tanks is controlled by coatings. The periodic cleaning of the pipeline by pigging helps in the prevention of internal corrosion. Further, internal corrosion of pipelines is prevented by chemical treatment and controlled operations. This paper describes the integrity management system used in the Sarir oil field for its oil and gas production facilities based on standard practices of corrosion mitigation and inspection.

Keywords: assets integrity management, corrosion prevention in oilfield assets, corrosion management in oilfield, corrosion prevention, inspection activities

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913 Critical Vision Innovation and Creativity in the Architecture and Urbanism of the Land in Islam between Traditionalism and Positivism

Authors: Wafeek Mohamed Ibrahim Mohamed

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In the era of globalization and openness informational. Anyone who thinks about innovation in the earth population in Islam in our contemporary reality, he will find that it is not destined to its civilized extension to last. The purpose of the research is a trial to reach a realistic vision for creative, innovative and intellectual thought for the earth population in Islam as an instrument to Confrontation and observe the changes that have affected in the architecture of the land during different eras. Through knowing the controls of the ruling legitimacy(that served as definitions and laws which formulate its features) and using customs, traditions, and conventions as a telescope for the earth population in Islam, It explained the impact of them on features of creative formation for the architecture of the land in our contemporary reality. The study shows a modern vision to identify innovation in the earth population in Islam. As well as reformulating its mental image and monitoring its changes in Islamic heritage cities. This will be done through a two main branches: firstly, set forth a theory represented in studying creative concepts which formulate the population of the earth in Islam. Such as initiative and responsibility for reviving the dead land, the lane [alley] as formation unit and social solidarity,… Etc.. The second branch is preparing a practical, critical vision for innovative conceptual thought for the architecture of the land of Islam, through studying the development of a traditional Islamic city., The conceptual thought of making the birth festival ["Al-Refaee"] and its emulation for governing roles in the traditional city building. The research concludes The necessity of forming the suggested a creative vision for identifying how to re-form the conceptual for our contemporary population of the earth. It poses an important question which is how to return to creativity in the architecture of the land of Islam in our built environments.

Keywords: innovation and creation, architecture, the land in Islam, criticism of design

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912 The Impact of Temporal Impairment on Quality of Experience (QoE) in Video Streaming: A No Reference (NR) Subjective and Objective Study

Authors: Muhammad Arslan Usman, Muhammad Rehan Usman, Soo Young Shin

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Live video streaming is one of the most widely used service among end users, yet it is a big challenge for the network operators in terms of quality. The only way to provide excellent Quality of Experience (QoE) to the end users is continuous monitoring of live video streaming. For this purpose, there are several objective algorithms available that monitor the quality of the video in a live stream. Subjective tests play a very important role in fine tuning the results of objective algorithms. As human perception is considered to be the most reliable source for assessing the quality of a video stream, subjective tests are conducted in order to develop more reliable objective algorithms. Temporal impairments in a live video stream can have a negative impact on the end users. In this paper we have conducted subjective evaluation tests on a set of video sequences containing temporal impairment known as frame freezing. Frame Freezing is considered as a transmission error as well as a hardware error which can result in loss of video frames on the reception side of a transmission system. In our subjective tests, we have performed tests on videos that contain a single freezing event and also for videos that contain multiple freezing events. We have recorded our subjective test results for all the videos in order to give a comparison on the available No Reference (NR) objective algorithms. Finally, we have shown the performance of no reference algorithms used for objective evaluation of videos and suggested the algorithm that works better. The outcome of this study shows the importance of QoE and its effect on human perception. The results for the subjective evaluation can serve the purpose for validating objective algorithms.

Keywords: objective evaluation, subjective evaluation, quality of experience (QoE), video quality assessment (VQA)

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911 Corporate Governance Development in Mongolia: The Role of Professional Accountants

Authors: Ernest Nweke

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The work of Professional Accountants and Corporate governance are synonymous and cannot be divorced from each other. Organizations, profit and non-profit alike cannot implement sound corporate practices without inputs from Professional Accountants. In today’s dynamic corporate world, good corporate governance practice is a sine qua non. More so, following the corporate failures of the past decades like Enron and WorldCom, governments around the world, including Mongolia are becoming more proactive in ensuring sound corporate governance mechanisms. In the past fifteen years, the Mongolian government has taken several measures to establish and strengthen internal corporate governance structures in firms. This paper highlights the role of professional accountants and auditors play in ensuring that good corporate governance mechanisms are entrenched in listed companies in Mongolia. Both primary and secondary data are utilized in this research. In collection of primary data, Delphi method was used, securing responses from only knowledgeable senior employees, top managers, and some CEOs. Using this method, a total of 107 top-level company employees and executives randomly selected from 22 companies were surveyed; maximum of 5 and minimum of 4 from each company. These companies cut across several sectors. It was concluded that Professional Accountants play key roles in setting and maintaining firm governance. They do this by ensuring full compliance with all the requirements of good and sound corporate governance, establishing reporting, monitoring and evaluating standards, assisting in the setting up of proper controls, efficient and effective audit systems, sound fraud risk management and putting in place an overall vision for the enterprise. Companies with effective corporate governance mechanisms are usually strong and fraud-resilient. It was also discovered that companies with big 4 audit firms tend to have better governance structures in Mongolia.

Keywords: accountants, corporate disclosure, corporate failure, corporate governance

Procedia PDF Downloads 251
910 Heavy Metal Contents in Vegetable Oils of Kazakhstan Origin and Life Risk Assessment

Authors: A. E. Mukhametov, M. T. Yerbulekova, D. R. Dautkanova, G. A. Tuyakova, G. Aitkhozhayeva

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The accumulation of heavy metals in food is a constant problem in many parts of the world. Vegetable oils are widely used, both for cooking and for processing in the food industry, meeting the main dietary requirements. One of the main chemical pollutants, heavy metals, is usually found in vegetable oils. These chemical pollutants are carcinogenic, teratogenic and immunotoxic, harmful to consumption and have a negative effect on human health even in trace amounts. Residues of these substances can easily accumulate in vegetable oil during cultivation, processing and storage. In this article, the content of the concentration of heavy metal ions in vegetable oils of Kazakhstan production is studied: sunflower, rapeseed, safflower and linseed oil. Heavy metals: arsenic, cadmium, lead and nickel, were determined in three repetitions by the method of flame atomic absorption. Analysis of vegetable oil samples revealed that the largest lead contamination (Pb) was determined to be 0.065 mg/kg in linseed oil. The content of cadmium (Cd) in the largest amount of 0.009 mg/kg was found in safflower oil. Arsenic (As) content was determined in rapeseed and safflower oils at 0.003 mg/kg, and arsenic (As) was not detected in linseed and sunflower oil. The nickel (Ni) content in the largest amount of 0.433 mg/kg was in linseed oil. The heavy metal contents in the test samples complied with the requirements of regulatory documents for vegetable oils. An assessment of the health risk of vegetable oils with a daily consumption of 36 g per day shows that all samples of vegetable oils produced in Kazakhstan are safe for consumption. But further monitoring is needed, since all these metals are toxic and their harmful effects become apparent only after several years of exposure.

Keywords: vegetable oil, sunflower oil, linseed oil, safflower oil, toxic metals, food safety, rape oil

Procedia PDF Downloads 112
909 Activity-Based Safety Assessment of Real Estate Projects in Western India

Authors: Patel Parul, Harsh Ganvit

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The construction industry is the second highest industry after agriculture provides employment in India. In developing countries like India, many construction projects are coming up to meet the demand. On the one hand, construction projects are increasing; on the other hand still, construction companies are struggling with many problems. One of the major problems is to ensure safe working conditions at the construction site. Due to a lack of safety awareness and ignorance of safety aspects, many fatal accidents are very common at the construction site in India. One of the key success factors for construction projects is “Accident-Free Construction Projects”. The construction projects can be divided into various categories like Infrastructure projects, industrial construction and real estate construction. Real estate projects are mainly comprised of commercial and residential projects. In the construction industry, private sectors play a huge role in urban and rural development and also contribute significantly to the growth of the nation. Infrastructure and Industrial projects are mainly executed by well-qualified construction contractors. For such projects, ensuring safety at construction projects is inevitable and probably one of the major clauses of contract documents as well. These projects are monitored from time to time by national agencies and researchers, too. However, Real estate projects are rarely monitored for safety aspects. No systematic contract system is followed for these projects. Safety is the most neglected aspect of these projects. In the current research projects, an attempt is made to carry out safety auditing for about 75 real estate projects. The objective of this work is to collect the activity-based safety survey of real estate projects in western India. The analysis of activity-based safety implementation for real estate projects is discussed in the present work. The activities are divided into three categories based on the data collected. The findings of this work will help local monitoring authorities to implement a safety management plan for real estate projects.

Keywords: construction safety, safety assessment, activity-based safety, real estate projects

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908 Radon-222 Concentration and Potential Risk to Workers of Al-Jalamid Phosphate Mines, North Province, Saudi Arabia

Authors: El-Said. I. Shabana, Mohammad S. Tayeb, Maher M. T. Qutub, Abdulraheem A. Kinsara

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Usually, phosphate deposits contain 238U and 232Th in addition to their decay products. Due to their different pathways in the environment, the 238U/232Th activity concentration ratio usually found to be greater than unity in phosphate sediments. The presence of these radionuclides creates a potential need to control exposure of workers in the mining and processing activities of the phosphate minerals in accordance with IAEA safety standards. The greatest dose to workers comes from exposure to radon, especially 222Rn from the uranium series, and has to be controlled. In this regard, radon (222Rn) was measured in the atmosphere (indoor and outdoor) of Al-Jalamid phosphate-mines working area using a portable radon-measurement instrument RAD7, in a purpose of radiation protection. Radon was measured in 61 sites inside the open phosphate mines, the phosphate upgrading facility (offices and rooms of the workers, and in some open-air sites) and in the dwellings of the workers residence-village that lies at about 3 km from the mines working area. The obtained results indicated that the average indoor radon concentration was about 48.4 Bq/m3. Inside the upgrading facility, the average outdoor concentrations were 10.8 and 9.7 Bq/m3 in the concentrate piles and crushing areas, respectively. It was 12.3 Bq/m3 in the atmosphere of the open mines. These values are comparable with the global average values. Based on the average values, the annual effective dose due to radon inhalation was calculated and risk estimates have been done. The average annual effective dose to workers due to the radon inhalation was estimated by 1.32 mSv. The potential excess risk of lung cancer mortality that could be attributed to radon, when considering the lifetime exposure, was estimated by 53.0x10-4. The results have been discussed in detail.

Keywords: dosimetry, environmental monitoring, phosphate deposits, radiation protection, radon

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907 The Promotion of a Risk Culture: a Descriptive Study of Ghanaian Banks

Authors: Gerhard Grebe, Johan Marx

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The aim of the study is to assess the state of operational risk management and the adoption of an appropriate risk culture in Ghanaian banks. The Bank of Ghana (BoG) joined the Basel Consultative Group (BCG) of the Basel Committee on Bank Supervision (BCBS) in 2021 and is proceeding with the implementation of the Basel III international regulatory framework for banks. The BoG’s Directive about risk management encourages, inter alia, the creation of an appropriate risk culture by Ghanaian banks. However, it is not evident how the risk management staff of Ghanaian banks experience the risk culture and the implementation of operational risk management in the banks where they are employed. Ghana is a developing economy, and it is addressing challenges with its organisational culture. According to Transparency International, successive Ghanaian governments claim to be fighting corruption, but little success has been achieved so far. This points to a possible lack of accountability, transparency, and integrity in the environment in which Ghanaian banks operate and which could influence their risk culture negatively. Purposive sampling was used for the survey, and the questionnaire was completed byGhanaian bank personnel who specializesin operational risk management, risk governance, and compliance, bank supervision, risk analyses, as well as the implementation of the operational risk management requirements of the Basel regulatory frameworks. The respondents indicated that they are fostering a risk culture and implementing monitoring and reporting procedures; the three lines of defence (3LOD); compliance; internal auditing; disclosure of operational risk information; and receiving guidance from the bank supervisor in an attempt to improve their operational risk management practices. However, the respondents reported the following challenges with staff members who are not inside the risk management departments(in order of priority), namelydemonstrating a risk culture, training and development; communication; reporting and disclosure; roles and responsibilities; performance appraisal; and technological and environmental barriers. Recommendations to address these challenges are provided

Keywords: ghana, operational risk, risk culture, risk management

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906 Blue Whale Body Condition from Photographs Taken over a 14-Year Period in the North East Pacific: Annual Variations and Connection to Measures of Ocean Productivity

Authors: Rachel Wachtendonk, John Calambokidis, Kiirsten Flynn

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Large marine mammals can serve as an indicator of the overall state of the environment due to their long lifespan and apex position in marine food webs. Reductions in prey, driven by changes in environmental conditions can have resounding impacts on the trophic system as a whole; this can manifest in reduced fat stores that are visible on large whales. Poor health can lead to reduced survivorship and fitness, both of which can be detrimental to a recovering population. A non-invasive technique was used for monitoring blue whale health and for seeing if it changes with ocean conditions. Digital photographs of blue whales taken in the NE Pacific by Cascadia Research and collaborators from 2005-2018 (n=3,545) were scored for overall body condition based on visible vertebrae and body shape on a scale of 0-3 where a score of 0 indicated best body condition and a score of 3 indicated poorest. The data was analyzed to determine if there were patterns in the health of whales across years and whether overall poor health was related to oceanographic conditions and predictors of prey abundance on the California coast. The year was a highly significant factor in body condition (Chi-Square, p<0.001). The proportion of whales showing poor body condition (scores 2 & 3) overall was 33% but by year varied widely from a low of 18% (2008) to a high of 55% (2015). The only two years where >50% of animals had poor body condition were 2015 and 2017 (no other year was above 45%). The 2015 maximum proportion of whales in poor body condition coincide with the marine heat wave that affected the NE Pacific 2014-16 and impacted other whale populations. This indicates that the scoring method was an effective way to evaluate blue whale health and how they respond to a changing ocean.

Keywords: blue whale, body condition, environmental variability, photo-identification

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905 Synthesis of Nanoparticles and Thin Film of Cu₂ZnSnS₄ by Hydrothermal Method and Its Application as Congo Red Photocatalyst

Authors: Paula Salazar, Rodrigo Henríquez, Pablo Zerega

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The textile, food and pharmaceutical industries are expanding daily worldwide, and they are located within the most polluting industries due to the fact that wastewater is discharged into watercourses with high concentrations of dyes and traces of drugs. Many of these compounds are stable to light and biodegradation, being considered as emerging organic contaminants. Advanced oxidation processes (AOPs) emerge as an effective alternative for the removal and elimination of this type of contaminants. Heterogeneous photocatalysis has been extensively studied as it is an efficient, low-cost and durable method. As the main photocatalyst, TiO₂ has been used for the degradation of a large number of dyes and drugs. The disadvantage of TiO₂ is its absorption in the UV region of the solar spectrum. On the other hand, quaternary chalcogenides based on Cu₂SnZnX₄ (X = S, Se) are a possible alternative due to their narrow bandgap (ca. between 0.8 to 1.5 eV depending on the phase considered), low cost, an abundance of its constituent elements in the earth's crust and its low toxicity. The objective of this research was to synthesize Cu₂SnZnS₄ (CZTS) through of a low-cost hydrothermal method and evaluate it as a potential photo-catalyst in the photo-degradation process of Congo Red. The synthesis of the nanoparticle in suspension and film onto fluorine-doped tin oxide coated glass (FTO) was carried out using a mixture of: 2 mmol CuCl₂, 1 mmol ZnCl₂, 1 mmol SnCl₂ and 4 mmol CH4N₂S in a Teflon reactor at 180⁰C for 72 h. Characterization was performed through scanning electron microscopy (SEM), X-ray diffraction (XRD) and UV VIS spectroscopy. Photo-degradation monitoring was carried out employing a UV VIS spectrophotometer. The results show that photodegradation of 55% of the dye can be obtained after 4h of exposure to polychromatic light, it should be noted that the Congo Red dye is being studied for the first time.

Keywords: CZTS, hydrothermal, photocatalysis, dye

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904 Determination of Viscosity and Degree of Hydrogenation of Liquid Organic Hydrogen Carriers by Cavity Based Permittivity Measurement

Authors: I. Wiemann, N. Weiß, E. Schlücker, M. Wensing

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A very promising alternative to compression or cryogenics is the chemical storage of hydrogen by liquid organic hydrogen carriers (LOHC). These carriers enable high energy density and allow, at the same time, efficient and safe storage under ambient conditions without leakage losses. Another benefit of this storage medium is the possibility of transporting it using already available infrastructure for the transport of fossil fuels. Efficient use of LOHC is related to precise process control, which requires a number of sensors in order to measure all relevant process parameters, for example, to measure the level of hydrogen loading of the carrier. The degree of loading is relevant for the energy content of the storage carrier and simultaneously represents the modification in the chemical structure of the carrier molecules. This variation can be detected in different physical properties like permittivity, viscosity, or density. E.g., each degree of loading corresponds to different viscosity values. Conventional measurements currently use invasive viscosity measurements or near-line measurements to obtain quantitative information. This study investigates permittivity changes resulting from changes in hydrogenation degree (chemical structure) and temperature. Based on calibration measurements, the degree of loading and temperature of LOHC can thus be determined by comparatively simple permittivity measurements in a cavity resonator. Subsequently, viscosity and density can be calculated. An experimental setup with a heating device and flow test bench was designed. By varying temperature in the range of 293,15 K -393,15 K and flow velocity up to 140 mm/s, corresponding changes in the resonation frequency were determined in the hundredths of the GHz range. This approach allows inline process monitoring of hydrogenation of the liquid organic hydrogen carrier (LOHC).

Keywords: hydrogen loading, LOHC, measurement, permittivity, viscosity

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903 The Safety Profile of Vilazodone: A Study on Post-Marketing Surveillance

Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

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Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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902 Application of the Critical Decision Method for Monitoring and Improving Safety in the Construction Industry

Authors: Juan Carlos Rubio Romero, Francico Salguero Caparros, Virginia Herrera-Pérez

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No one is in the slightest doubt about the high levels of risk involved in work in the construction industry. They are even higher in structural construction work. The Critical Decision Method (CDM) is a semi-structured interview technique that uses cognitive tests to identify the different disturbances that workers have to deal with in their work activity. At present, the vision of safety focused on daily performance and things that go well for safety and health management is facing the new paradigm known as Resilience Engineering. The aim of this study has been to describe the variability in formwork labour on concrete structures in the construction industry and, from there, to find out the resilient attitude of workers to unexpected events that they have experienced during their working lives. For this purpose, a series of semi-structured interviews were carried out with construction employees with extensive experience in formwork labour in Spain by applying the Critical Decision Method. This work has been the first application of the Critical Decision Method in the field of construction and, more specifically, in the execution of structures. The results obtained show that situations categorised as unthought-of are identified to a greater extent than potentially unexpected situations. The identification during these interviews of both expected and unexpected events provides insight into the critical decisions made and actions taken to improve resilience in daily practice in this construction work. From this study, it is clear that it is essential to gain more knowledge about the nature of the human cognitive process in work situations within complex socio-technical systems such as construction sites. This could lead to a more effective design of workplaces in the search for improved human performance.

Keywords: resilience engineering, construction industry, unthought-of situations, critical decision method

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901 Review of the Road Crash Data Availability in Iraq

Authors: Abeer K. Jameel, Harry Evdorides

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Iraq is a middle income country where the road safety issue is considered one of the leading causes of deaths. To control the road risk issue, the Iraqi Ministry of Planning, General Statistical Organization started to organise a collection system of traffic accidents data with details related to their causes and severity. These data are published as an annual report. In this paper, a review of the available crash data in Iraq will be presented. The available data represent the rate of accidents in aggregated level and classified according to their types, road users’ details, and crash severity, type of vehicles, causes and number of causalities. The review is according to the types of models used in road safety studies and research, and according to the required road safety data in the road constructions tasks. The available data are also compared with the road safety dataset published in the United Kingdom as an example of developed country. It is concluded that the data in Iraq are suitable for descriptive and exploratory models, aggregated level comparison analysis, and evaluation and monitoring the progress of the overall traffic safety performance. However, important traffic safety studies require disaggregated level of data and details related to the factors of the likelihood of traffic crashes. Some studies require spatial geographic details such as the location of the accidents which is essential in ranking the roads according to their level of safety, and name the most dangerous roads in Iraq which requires tactic plan to control this issue. Global Road safety agencies interested in solve this problem in low and middle-income countries have designed road safety assessment methodologies which are basing on the road attributes data only. Therefore, in this research it is recommended to use one of these methodologies.

Keywords: road safety, Iraq, crash data, road risk assessment, The International Road Assessment Program (iRAP)

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900 Predictors of Post-marketing Regulatory Actions Concerning Hepatotoxicity

Authors: Salwa M. Almomen, Mona A. Almaghrabi, Saja M. Alhabardi, Adel A. Alrwisan

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Background: Hepatotoxicity is a major reason for medication withdrawal from the markets. Unfortunately, serious adverse hepatic effects can occur after marketing with limited indicators during clinical development. Therefore, finding possible predictors for hepatotoxicity might guide the monitoring program of various stakeholders. Methods: We examined the clinical review documents for drugs approved in the US from 2011 to 2016 to evaluate their hepatic safety profile. Predictors: we assessed whether these medications meet Hy’s Law with hepatotoxicity grade ≥ 3, labeled hepatic adverse effects at approval, or accelerated approval status. Outcome: post-marketing regulatory action related to hepatotoxicity, including product withdrawal or updates to warning, precaution, or adverse effects sections. Statistical analysis: drugs were included in the analysis from the time of approval until the end of 2019 or the first post-marketing regulatory action related to hepatotoxicity, whichever occurred first. The hazard ratio (HR) was estimated using Cox-regression analysis. Results: We included 192 medications in the study. We classified 48 drugs as having grade ≥ 3 hepatotoxicities, 43 had accelerated approval status, and 74 had labeled information about hepatotoxicity prior to marketing. The adjusted HRs for post-marketing regulatory action for products with grade ≥ 3 hepatotoxicity was 0.61 (95% confidence interval [CI], 0.17-2.23), 0.92 (95%CI, 0.29-2.93) for a drug approved via accelerated approval program, and was 0.91 (95%CI, 0.33-2.56) for drugs with labeled hepatotoxicity information at approval time. Conclusion: This study does not provide conclusive evidence on the association between post-marketing regulatory action and grade ≥ 3 hepatotoxicity, accelerated approval status, or availability of labeled information at approval due to sampling size and channeling bias.

Keywords: accelerated approvals, hepatic adverse effects, drug-induced liver injury, hepatotoxicity predictors, post-marketing withdrawal

Procedia PDF Downloads 134