Search results for: FDA adverse event reporting system
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 19543

Search results for: FDA adverse event reporting system

19153 Pulsed Laser Single Event Transients in 0.18 μM Partially-Depleted Silicon-On-Insulator Device

Authors: MeiBo, ZhaoXing, LuoLei, YuQingkui, TangMin, HanZhengsheng

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The Single Event Transients (SETs) were investigated on 0.18μm PDSOI transistors and 100 series CMOS inverter chain using pulse laser. The effect of different laser energy and device bias for waveform on SET was characterized experimentally, as well as the generation and propagation of SET in inverter chain. In this paper, the effects of struck transistors type and struck locations on SETs were investigated. The results showed that when irradiate NMOSFETs from 100th to 2nd stages, the SET pulse width measured at the output terminal increased from 287.4 ps to 472.9 ps; and when irradiate PMOSFETs from 99th to 1st stages, the SET pulse width increased from 287.4 ps to 472.9 ps. When struck locations were close to the output of the chain, the SET pulse was narrow; however, when struck nodes were close to the input, the SET pulse was broadening. SET pulses were progressively broadened up when propagating along inverter chains. The SET pulse broadening is independent of the type of struck transistors. Through analysis, history effect induced threshold voltage hysteresis in PDSOI is the reason of pulse broadening. The positive pulse observed by oscilloscope, contrary to the expected results, is because of charging and discharging of capacitor.

Keywords: single event transients, pulse laser, partially-depleted silicon-on-insulator, propagation-induced pulse broadening effect

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19152 Country Experience on Regulation of Traditional Medicine in Eritrea

Authors: Liya Abraham

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Eritrea is located along the Red Sea, north of the Horn of Africa, between Djibouti and Sudan and has a population of about 3.2 million as of 2010. It has six administrative regions; Anseba, Debub, Debubawi K’eyih Bahri, Gash-Barka, Ma'akel, and Semenawi K’eyih Bahri. Eritrea has got its independence in 1991 after 30 years war of liberation. The country is blessed with various medicinal flora and fauna, and marine and terrestrial biodiversity. Traditional Medicine (TM) has been an integral part of the Eritrean culture for centuries. So far, more than 19 TM modalities have been recognized, and are broadly categorized as; herbal, procedure-based and spiritual. Despite the availability of modern medicine to the majority of the population, TM is still widely practiced. The rationale behind widespread use is accessibility, affordability and cultural acceptability. Hence, TM is of great contribution to the Eritrean health care system. As a matter of fact, harnessing the potential contribution of effective and safe TM in order to attain Universal Health Coverage (UHC) has been emphasized in the WHO TM strategy 2014-2023. The Eritrean TM, however, was operating without regulation and reliable scientific justification behind its safety and efficacy. Thus, the Ministry of Health (MoH), in recognition of the role of TM in primary healthcare and safeguard public health, established a regulatory body for TM so-called as Traditional Medicine Unit (TMU) in 2012. The mission of the unit is to ensure rational TM use through an integrated health service delivery system and contribute to the country’s economic and social development. The unit has established its national TM policy in 2017. The activities of the unit are guided by the National TM Advisory Committee (TMAC), responsible for the provision of technical assistance and advisory role. Moreover, the Legal Framework and Code of Ethics and Practice which provide a legal basis for the regulation of TM have also been drafted. In recognition of the importance of TM research and development, the unit launched a nationwide TM survey in 2017 and had surveyed two zones (Gash-Barka and Debub). The findings of the survey were subjected to a research dissemination workshop and publication in international journals. Furthermore, TM-related adverse events reporting tool (Green Form) aiming to guide regulatory interventions and researches have been established by the unit, and ever since reports are flowing. The unit has also been offering training to THPs, pharmacy students and health care professionals regarding TM and its regulatory activities. In addition, as part of the establishment of the national medicinal plants' database and herbal monograph, more than 329 and 30 medicinal plants, have been compiled respectively. In conclusion, TM is still widely accepted and practiced in Eritrea. The TMU ever since its establishment is endeavoring to ensure the safety and efficacy of the TM, and its integration in the mainstream health service delivery system.

Keywords: efficacy, regulation, safety, traditional medicine, traditional medicine unit, universal health coverage

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19151 The Use of Social Media Sarcasm as a Response to Media-Coverage of Iran’s Unprecedented Attack on Israel

Authors: Afif J Arabi

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On April 15, 2024, Iran announced its unprecedented military attack by sending waves of more than 300 drones and ballistic missiles toward Israel. The Attack lasted approximately five hours and was a widely covered, distributed, and followed media event. Iran’s military action against Israel was a long-awaited action across the Middle East since the early days of the October 7th war on Gaza and after a long history of verbal threats. While people in many Arab countries stayed up past midnight in anticipation of watching the disastrous results of this unprecedented attack, voices on traditional and social media alike started to question the timed public announcement of the attack, which gave Israel at least a two-hour notice to prepare its defenses. When live news coverage started showing that nearly all the drones and missiles were intercepted by Israel – with help from the U.S. and other countries – and no deaths were reported, the social media response to this media event turned toward sarcasm, mockery, irony, and humor. Social media users posted sarcastic pictures, jokes, and comments mocking the Iranian offensive. This research examines this unique media event and the sarcastic response it generated on social media. The study aims to investigate the causes leading to media sarcasm in militarized political conflict, the social function of such generated sarcasm, and the role of social media as a platform for consuming frustration, dissatisfaction, and outrage passively through various media products. The study compares the serious traditional media coverage of the event with the humorous social media response among Arab countries. The research uses an eclectic theoretical approach using framing theory as a paradigm for understanding and investigating communication social functionalism theory in media studies to examine sarcasm. Social functionalism theory is a sociological perspective that views society as a complex system whose parts work together to promote solidarity and stability. In the context of media and sarcasm, this theory would suggest that sarcasm serves specific functions within society, such as reinforcing social norms, providing a means for social critique, or functioning as a safety valve for expressing social tension.; and a qualitative analysis of specific examples including responses of SM commentators to such manifestations of political criticism. The preliminary findings of this study point to a heightened dramatization of the televised event and a widespread belief that this attack was a staged show incongruent with Iran’s official enmity and death threats toward Israel. The social media sarcasm reinforces Arab’s view of Iran and Israel as mutual threats. This belief stems from the complex dynamics, historical context, and regional conflict surrounding these three nations: Iran, Israel, and Arabs.

Keywords: social functionalism, social media sarcasm, Television news framing, live militarized conflict coverage, iran, israel, communication theory

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19150 Socioeconomic Burden of Life Long Disease: A Case of Diabetes Care in Bangladesh

Authors: Samira Humaira Habib

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Diabetes has profound effects on individuals and their families. If diabetes is not well monitored and managed, then it leads to long-term complications and a large and growing cost to the health care system. Prevalence and socioeconomic burden of diabetes and relative return of investment for the elimination or the reduction of the burden are much more important regarding its cost burden. Various studies regarding the socioeconomic cost burden of diabetes are well explored in developed countries but almost absent in developing countries like Bangladesh. The main objective of the study is to estimate the total socioeconomic burden of diabetes. It is a prospective longitudinal follow up study which is analytical in nature. Primary and secondary data are collected from patients who are undergoing treatment for diabetes at the out-patient department of Bangladesh Institute of Research & Rehabilitation in Diabetes, Endocrine & Metabolic Disorders (BIRDEM). Of the 2115 diabetic subjects, females constitute around 50.35% of the study subject, and the rest are male (49.65%). Among the subjects, 1323 are controlled, and 792 are uncontrolled diabetes. Cost analysis of 2115 diabetic patients shows that the total cost of diabetes management and treatment is US$ 903018 with an average of US$ 426.95 per patient. In direct cost, the investigation and medical treatment at hospital along with investigation constitute most of the cost in diabetes. The average cost of a hospital is US$ 311.79, which indicates an alarming warn for diabetic patients. The indirect cost shows that cost of productivity loss (US$ 51110.1) is higher among the all indirect item. All constitute total indirect cost as US$ 69215.7. The incremental cost of intensive management of uncontrolled diabetes is US$ 101.54 per patient and event-free time gained in this group is 0.55 years and the life years gain is 1.19 years. The incremental cost per event-free year gained is US$ 198.12. The incremental cost of intensive management of the controlled group is US$ 89.54 per patient and event-free time gained is 0.68 years, and the life year gain is 1.12 years. The incremental cost per event-free year gained is US$ 223.34. The EuroQoL difference between the groups is found to be 64.04. The cost-effective ratio is found to be US$ 1.64 cost per effect in case of controlled diabetes and US$ 1.69 cost per effect in case of uncontrolled diabetes. So management of diabetes is much more cost-effective. Cost of young type 1 diabetic patient showed upper socioeconomic class, and with the increase of the duration of diabetes, the cost increased also. The dietary pattern showed macronutrients intake and cost are significantly higher in the uncontrolled group than their counterparts. Proper management and control of diabetes can decrease the cost of care for the long term.

Keywords: cost, cost-effective, chronic diseases, diabetes care, burden, Bangladesh

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19149 Discovering Event Outliers for Drug as Commercial Products

Authors: Arunas Burinskas, Aurelija Burinskiene

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On average, ten percent of drugs - commercial products are not available in pharmacies due to shortage. The shortage event disbalance sales and requires a recovery period, which is too long. Therefore, one of the critical issues that pharmacies do not record potential sales transactions during shortage and recovery periods. The authors suggest estimating outliers during shortage and recovery periods. To shorten the recovery period, the authors suggest using average sales per sales day prediction, which helps to protect the data from being downwards or upwards. Authors use the outlier’s visualization method across different drugs and apply the Grubbs test for significance evaluation. The researched sample is 100 drugs in a one-month time frame. The authors detected that high demand variability products had outliers. Among analyzed drugs, which are commercial products i) High demand variability drugs have a one-week shortage period, and the probability of facing a shortage is equal to 69.23%. ii) Mid demand variability drugs have three days shortage period, and the likelihood to fall into deficit is equal to 34.62%. To avoid shortage events and minimize the recovery period, real data must be set up. Even though there are some outlier detection methods for drug data cleaning, they have not been used for the minimization of recovery period once a shortage has occurred. The authors use Grubbs’ test real-life data cleaning method for outliers’ adjustment. In the paper, the outliers’ adjustment method is applied with a confidence level of 99%. In practice, the Grubbs’ test was used to detect outliers for cancer drugs and reported positive results. The application of the Grubbs’ test is used to detect outliers which exceed boundaries of normal distribution. The result is a probability that indicates the core data of actual sales. The application of the outliers’ test method helps to represent the difference of the mean of the sample and the most extreme data considering the standard deviation. The test detects one outlier at a time with different probabilities from a data set with an assumed normal distribution. Based on approximation data, the authors constructed a framework for scaling potential sales and estimating outliers with Grubbs’ test method. The suggested framework is applicable during the shortage event and recovery periods. The proposed framework has practical value and could be used for the minimization of the recovery period required after the shortage of event occurrence.

Keywords: drugs, Grubbs' test, outlier, shortage event

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19148 Downtime Estimation of Building Structures Using Fuzzy Logic

Authors: M. De Iuliis, O. Kammouh, G. P. Cimellaro, S. Tesfamariam

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Community Resilience has gained a significant attention due to the recent unexpected natural and man-made disasters. Resilience is the process of maintaining livable conditions in the event of interruptions in normally available services. Estimating the resilience of systems, ranging from individuals to communities, is a formidable task due to the complexity involved in the process. The most challenging parameter involved in the resilience assessment is the 'downtime'. Downtime is the time needed for a system to recover its services following a disaster event. Estimating the exact downtime of a system requires a lot of inputs and resources that are not always obtainable. The uncertainties in the downtime estimation are usually handled using probabilistic methods, which necessitates acquiring large historical data. The estimation process also involves ignorance, imprecision, vagueness, and subjective judgment. In this paper, a fuzzy-based approach to estimate the downtime of building structures following earthquake events is proposed. Fuzzy logic can integrate descriptive (linguistic) knowledge and numerical data into the fuzzy system. This ability allows the use of walk down surveys, which collect data in a linguistic or a numerical form. The use of fuzzy logic permits a fast and economical estimation of parameters that involve uncertainties. The first step of the method is to determine the building’s vulnerability. A rapid visual screening is designed to acquire information about the analyzed building (e.g. year of construction, structural system, site seismicity, etc.). Then, a fuzzy logic is implemented using a hierarchical scheme to determine the building damageability, which is the main ingredient to estimate the downtime. Generally, the downtime can be divided into three main components: downtime due to the actual damage (DT1); downtime caused by rational and irrational delays (DT2); and downtime due to utilities disruption (DT3). In this work, DT1 is computed by relating the building damageability results obtained from the visual screening to some already-defined components repair times available in the literature. DT2 and DT3 are estimated using the REDITM Guidelines. The Downtime of the building is finally obtained by combining the three components. The proposed method also allows identifying the downtime corresponding to each of the three recovery states: re-occupancy; functional recovery; and full recovery. Future work is aimed at improving the current methodology to pass from the downtime to the resilience of buildings. This will provide a simple tool that can be used by the authorities for decision making.

Keywords: resilience, restoration, downtime, community resilience, fuzzy logic, recovery, damage, built environment

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19147 Sensing to Respond & Recover in Emergency

Authors: Alok Kumar, Raviraj Patil

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The ability to respond to an incident of a disastrous event in a vulnerable area is very crucial an aspect of emergency management. The ability to constantly predict the likelihood of an event along with its severity in an area and react to those significant events which are likely to have a high impact allows the authorities to respond by allocating resources optimally in a timely manner. It provides for measuring, monitoring, and modeling facilities that integrate underlying systems into one solution to improve operational efficiency, planning, and coordination. We were particularly involved in this innovative incubation work on the current state of research and development in collaboration. technologies & systems for a disaster.

Keywords: predictive analytics, advanced analytics, area flood likelihood model, area flood severity model, level of impact model, mortality score, economic loss score, resource allocation, crew allocation

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19146 Application of GPRS in Water Quality Monitoring System

Authors: V. Ayishwarya Bharathi, S. M. Hasker, J. Indhu, M. Mohamed Azarudeen, G. Gowthami, R. Vinoth Rajan, N. Vijayarangan

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Identification of water quality conditions in a river system based on limited observations is an essential task for meeting the goals of environmental management. The traditional method of water quality testing is to collect samples manually and then send to laboratory for analysis. However, it has been unable to meet the demands of water quality monitoring today. So a set of automatic measurement and reporting system of water quality has been developed. In this project specifies Water quality parameters collected by multi-parameter water quality probe are transmitted to data processing and monitoring center through GPRS wireless communication network of mobile. The multi parameter sensor is directly placed above the water level. The monitoring center consists of GPRS and micro-controller which monitor the data. The collected data can be monitor at any instant of time. In the pollution control board they will monitor the water quality sensor data in computer using Visual Basic Software. The system collects, transmits and processes water quality parameters automatically, so production efficiency and economy benefit are improved greatly. GPRS technology can achieve well within the complex environment of poor water quality non-monitored, and more specifically applicable to the collection point, data transmission automatically generate the field of water analysis equipment data transmission and monitoring.

Keywords: multiparameter sensor, GPRS, visual basic software, RS232

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19145 Implementation of a Web-Based Clinical Outcomes Monitoring and Reporting Platform across the Fortis Network

Authors: Narottam Puri, Bishnu Panigrahi, Narayan Pendse

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Background: Clinical Outcomes are the globally agreed upon, evidence-based measurable changes in health or quality of life resulting from the patient care. Reporting of outcomes and its continuous monitoring provides an opportunity for both assessing and improving the quality of patient care. In 2012, International Consortium Of HealthCare Outcome Measurement (ICHOM) was founded which has defined global Standard Sets for measuring the outcome of various treatments. Method: Monitoring of Clinical Outcomes was identified as a pillar of Fortis’ core value of Patient Centricity. The project was started as an in-house developed Clinical Outcomes Reporting Portal by the Fortis Medical IT team. Standard sets of Outcome measurement developed by ICHOM were used. A pilot was run at Fortis Escorts Heart Institute from Aug’13 – Dec’13.Starting Jan’14, it was implemented across 11 hospitals of the group. The scope was hospital-wide and major clinical specialties: Cardiac Sciences, Orthopedics & Joint Replacement were covered. The internally developed portal had its limitations of report generation and also capturing of Patient related outcomes was restricted. A year later, the company provisioned for an ICHOM Certified Software product which could provide a platform for data capturing and reporting to ensure compliance with all ICHOM requirements. Post a year of the launch of the software; Fortis Healthcare has become the 1st Healthcare Provider in Asia to publish Clinical Outcomes data for the Coronary Artery Disease Standard Set comprising of Coronary Artery Bypass Graft and Percutaneous Coronary Interventions) in the public domain. (Jan 2016). Results: This project has helped in firmly establishing a culture of monitoring and reporting Clinical Outcomes across Fortis Hospitals. Given the diverse nature of the healthcare delivery model at Fortis Network, which comprises of hospitals of varying size and specialty-mix and practically covering the entire span of the country, standardization of data collection and reporting methodology is a huge achievement in itself. 95% case reporting was achieved with more than 90% data completion at the end of Phase 1 (March 2016). Post implementation the group now has one year of data from its own hospitals. This has helped identify the gaps and plan towards ways to bridge them and also establish internal benchmarks for continual improvement. Besides the value created for the group includes: 1. Entire Fortis community has been sensitized on the importance of Clinical Outcomes monitoring for patient centric care. Initial skepticism and cynicism has been countered by effective stakeholder engagement and automation of processes. 2. Measuring quality is the first step in improving quality. Data analysis has helped compare clinical results with best-in-class hospitals and identify improvement opportunities. 3. Clinical fraternity is extremely pleased to be part of this initiative and has taken ownership of the project. Conclusion: Fortis Healthcare is the pioneer in the monitoring of Clinical Outcomes. Implementation of ICHOM standards has helped Fortis Clinical Excellence Program in improving patient engagement and strengthening its commitment to its core value of Patient Centricity. Validation and certification of the Clinical Outcomes data by an ICHOM Certified Supplier adds confidence to its claim of being leaders in this space.

Keywords: clinical outcomes, healthcare delivery, patient centricity, ICHOM

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19144 The Opportunities and Challenges of Adopting International Financial Reporting Standards in Saudi Capital Market

Authors: Abdullah Almulhim

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The International Accounting Standards Board (IASB) was established in 2001 to develop International Financial Reporting Standards (IFRS) that bring transparency, accountability, and efficiency to financial markets around the world. In addition, the IFRS provide a unified accounting language, which is especially important in the era of globalization. However, the establishment of a single set of high-quality international accounting standards is a matter of growing importance, as participants in the increasingly integrated world capital market demand comparability and transparency of financial reporting worldwide. Saudi Arabia became the 149th member of the World Trade Organization (WTO) on 11 December 2005, which has increased the need to convert to IFRS. Currently, the Saudi Arabian Monetary Authority (SAMA) requires banks and insurance companies in Saudi Arabia to report under IFRS Standards. However, until the end of 2016, SOCPA standards were applied to all other companies, listed and unlisted. From 2017, listed Saudi companies would be required to report under IFRS Standards as adopted by SOCPA effective 2017. This paper is to investigate the expected benefits gained and highlight the challenges faced by adopting IFRS by the listed companies in the Saudi Stock Exchange. Questionnaires were used as the main method of data collection. They were distributed to listed companies in the Saudi Capital Market. Data obtained through the questionnaires have been imported into SPSS statistical software for analysis. The expected results of this study will show the benefits of adopting IFRS by Saudi Listed Companies. However, this study will investigate the challenges faced by adopting IFRS by the listed companies in the Saudi Arabian Stock Market. Findings will be discussed later upon completion of initial analysis.

Keywords: challenges, IAS, IFRS, opportunities, Saudi, SOCPA

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19143 Minerals of Canola (Brassica napus) as Affected by Water Stress and Applied Calcium

Authors: Rizwan Alam, Ikhtiar Khan, Aqib Iqbal

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Plants are naturally exposed to a wide variety of environmental stresses. The stresses may be biotic or/and abiotic. These environmental stresses have adverse effects on photosynthesis, water relation and nutrients uptake of plants. Fertilization of plants with exogenous minerals can enhance the drought tolerance in plants. In this experiment, canola (Brassica napus) was treated with solutions of calcium nitrate in different concentrations before the imposition of drought stress for 10 days. It was observed that drought stress decreased the tissue-K, Ca and K/Ca ratio of canola seedlings. The tissue-carbon and nitrogen contents were also depressed by the drought stress. Application of calcium nitrate, however, could alleviate the adverse effects of drought stress by showing a positive effect on all the aforementioned parameters.

Keywords: Brassica napus, calcium, carbon, potassium

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19142 Inter-Departmental Survey to Check the Impact of Bio-Safety Training Sessions among Lab Employees

Authors: Noorulaine Maqsood, Saeed Khan

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Background: Concern regarding incident reporting and bio-safety training in clinical laboratories in Pakistan has increased remarkably in the last few years due to rapid increase in diagnosis and research on infectious organisms. In order to ensure the safety of employees, this issue needs to be addressed immediately. Bio-safety training sessions and lectures are necessary for the protection of laboratory workers in order to ensure safe practices and minimize the count of incident reporting in the lab. Objective: To carry out an inter-departmental survey in lab regarding the awareness of bio-safety practices among lab employees before and after conducting bio-safety training sessions. Methodology: We conducted a 30 questions survey of laboratory workers in June 2013 (before training session) to gather information related to bio-safety awareness. Afterwards, we conducted another survey after training sessions and workshops related to bio-safety. Result: The survey regarding bio-safety level showed that before the training session 32% of the participants were aware of bio-safety level being used in their lab whereas after the session this percentage increased to 72%. 48% of the participants had information about the proper usage of PPE which increased to 76%. Awareness regarding proper management of hazardous waste increased from 32% to 64%. The incident reporting practice, sample handling and hand hygiene awareness was previously reported to be 40%, 65%, and 52% that increased to 80%, 85% and 88% respectively after the training session was completed. Conclusion: The first survey results showed lack of awareness that suggest nearly all senior scientists, faculty, medical technologist, lab attendant and housekeeping staff working in laboratories are required to have bio-safety training, and required inspection at least twice a year by a bio-safety officer and also required to renew their bio-safety training. After the training session, significant changes in awareness level and attitude of the participants regarding biosafety practices were observed. Therefore, such bio-safety sessions should be carried out regularly in clinical laboratories.

Keywords: biosafety practices, clinical laboratory, Pakistan, survey

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19141 A Semantic and Concise Structure to Represent Human Actions

Authors: Tobias Strübing, Fatemeh Ziaeetabar

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Humans usually manipulate objects with their hands. To represent these actions in a simple and understandable way, we need to use a semantic framework. For this purpose, the Semantic Event Chain (SEC) method has already been presented which is done by consideration of touching and non-touching relations between manipulated objects in a scene. This method was improved by a computational model, the so-called enriched Semantic Event Chain (eSEC), which incorporates the information of static (e.g. top, bottom) and dynamic spatial relations (e.g. moving apart, getting closer) between objects in an action scene. This leads to a better action prediction as well as the ability to distinguish between more actions. Each eSEC manipulation descriptor is a huge matrix with thirty rows and a massive set of the spatial relations between each pair of manipulated objects. The current eSEC framework has so far only been used in the category of manipulation actions, which eventually involve two hands. Here, we would like to extend this approach to a whole body action descriptor and make a conjoint activity representation structure. For this purpose, we need to do a statistical analysis to modify the current eSEC by summarizing while preserving its features, and introduce a new version called Enhanced eSEC or (e2SEC). This summarization can be done from two points of the view: 1) reducing the number of rows in an eSEC matrix, 2) shrinking the set of possible semantic spatial relations. To achieve these, we computed the importance of each matrix row in an statistical way, to see if it is possible to remove a particular one while all manipulations are still distinguishable from each other. On the other hand, we examined which semantic spatial relations can be merged without compromising the unity of the predefined manipulation actions. Therefore by performing the above analyses, we made the new e2SEC framework which has 20% fewer rows, 16.7% less static spatial and 11.1% less dynamic spatial relations. This simplification, while preserving the salient features of a semantic structure in representing actions, has a tremendous impact on the recognition and prediction of complex actions, as well as the interactions between humans and robots. It also creates a comprehensive platform to integrate with the body limbs descriptors and dramatically increases system performance, especially in complex real time applications such as human-robot interaction prediction.

Keywords: enriched semantic event chain, semantic action representation, spatial relations, statistical analysis

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19140 Unpacking Chilean Preservice Teachers’ Beliefs on Practicum Experiences through Digital Stories

Authors: Claudio Díaz, Mabel Ortiz

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An EFL teacher education programme in Chile takes five years to train a future teacher of English. Preservice teachers are prepared to learn an advanced level of English and teach the language from 5th to 12th grade in the Chilean educational system. In the context of their first EFL Methodology course in year four, preservice teachers have to create a five-minute digital story that starts from a critical incident they have experienced as teachers-to-be during their observations or interventions in the schools. A critical incident can be defined as a happening, a specific incident or event either observed by them or involving them. The happening sparks their thinking and may make them subsequently think differently about the particular event. When they create their digital stories, preservice teachers put technology, teaching practice and theory together to narrate a story that is complemented by still images, moving images, text, sound effects and music. The story should be told as a personal narrative, which explains the critical incident. This presentation will focus on the creation process of 50 Chilean preservice teachers’ digital stories highlighting the critical incidents they started their stories. It will also unpack preservice teachers’ beliefs and reflections when approaching their teaching practices in schools. These beliefs will be coded and categorized through content analysis to evidence preservice teachers’ most rooted conceptions about English teaching and learning in Chilean schools. The findings seem to indicate that preservice teachers’ beliefs are strongly mediated by contextual and affective factors.

Keywords: beliefs, digital stories, preservice teachers, practicum

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19139 Decision Support System for Hospital Selection in Emergency Medical Services: A Discrete Event Simulation Approach

Authors: D. Tedesco, G. Feletti, P. Trucco

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The present study aims to develop a Decision Support System (DSS) to support the operational decision of the Emergency Medical Service (EMS) regarding the assignment of medical emergency requests to Emergency Departments (ED). In the literature, this problem is also known as “hospital selection” and concerns the definition of policies for the selection of the ED to which patients who require further treatment are transported by ambulance. The employed research methodology consists of the first phase of revision of the technical-scientific literature concerning DSSs to support the EMS management and, in particular, the hospital selection decision. From the literature analysis, it emerged that current studies are mainly focused on the EMS phases related to the ambulance service and consider a process that ends when the ambulance is available after completing a request. Therefore, all the ED-related issues are excluded and considered as part of a separate process. Indeed, the most studied hospital selection policy turned out to be proximity, thus allowing to minimize the transport time and release the ambulance in the shortest possible time. The purpose of the present study consists in developing an optimization model for assigning medical emergency requests to the EDs, considering information relating to the subsequent phases of the process, such as the case-mix, the expected service throughput times, and the operational capacity of different EDs in hospitals. To this end, a Discrete Event Simulation (DES) model was created to evaluate different hospital selection policies. Therefore, the next steps of the research consisted of the development of a general simulation architecture, its implementation in the AnyLogic software and its validation on a realistic dataset. The hospital selection policy that produced the best results was the minimization of the Time To Provider (TTP), considered as the time from the beginning of the ambulance journey to the ED at the beginning of the clinical evaluation by the doctor. Finally, two approaches were further compared: a static approach, which is based on a retrospective estimate of the TTP, and a dynamic approach, which is based on a predictive estimate of the TTP determined with a constantly updated Winters model. Findings reveal that considering the minimization of TTP as a hospital selection policy raises several benefits. It allows to significantly reduce service throughput times in the ED with a minimum increase in travel time. Furthermore, an immediate view of the saturation state of the ED is produced and the case-mix present in the ED structures (i.e., the different triage codes) is considered, as different severity codes correspond to different service throughput times. Besides, the use of a predictive approach is certainly more reliable in terms of TTP estimation than a retrospective approach but entails a more difficult application. These considerations can support decision-makers in introducing different hospital selection policies to enhance EMSs performance.

Keywords: discrete event simulation, emergency medical services, forecast model, hospital selection

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19138 Compliance of Systematic Reviews in Ophthalmology with the PRISMA Statement

Authors: Seon-Young Lee, Harkiran Sagoo, Reem Farwana, Katharine Whitehurst, Alex Fowler, Riaz Agha

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Background/Aims: Systematic reviews and meta-analysis are becoming increasingly important way of summarizing research evidence. Researches in ophthalmology may represent further challenges, due to their potential complexity in study design. The aim of our study was to determine the reporting quality of systematic reviews and meta-analysis in ophthalmology with the PRISMA statement, by assessing the articles published between 2010 and 2015 from five major journals with the highest impact factor. Methods: MEDLINE and EMBASE were used to search systematic reviews published between January 2010 and December 2015, in 5 major ophthalmology journals: Progress in Retinal and Eye Research, Ophthalmology, Archives of Ophthalmology, American Journal of Ophthalmology, Journal of the American Optometric Association. Screening, identification, and scoring of articles were performed independently by two teams, followed by statistical analysis including the median, range, and 95% CIs. Results: 115 articles were involved. The median PRISMA score was 15 of 27 items (56%), with a range of 5-26 (19-96%) and 95% CI 13.9-16.1 (51-60%). Compliance was highest in items related to the description of rationale (item 3,100%) and inclusion of a structured summary in the abstract (item 2, 90%), while poorest in indication of review protocol and registration (item 5, 9%), specification of risk of bias affecting the cumulative evidence (item 15, 24%) and description of clear objectives in introduction (item 4, 26%). Conclusion: The reporting quality of systematic reviews and meta-analysis in ophthalmology need significant improvement. While the use of PRISMA criteria as a guideline before journal submission is recommended, additional research identifying potential barriers may be required to improve the compliance to the PRISMA guidelines.

Keywords: systematic reviews, meta-analysis, research methodology, reporting quality, PRISMA, ophthalmology

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19137 Pattern and Risk Factors of Menstrual Regulation Service Use among Ever-married Women in Bangladesh: Evidence from a Nationally Representative Cross-sectional Study

Authors: Md. Rashed Aalm, Md. Nuruzzaman Khan, Yothin Sawangdee

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Background: Around 47% of the total pregnancies are unintended in Bangladesh, which lead to several adverse consequences, including maternal and child mortality. Use of menstrual regulation (MR) can help women to reduce unintended pregnancy related adverse consequences. We explored the prevalence and determinants of MR services among ever-married women in Bangladesh. Methods: Total of 14,346 ever-married women data were analysed from the 2017 Bangladesh Demographic and Health Survey. Our study variable was use or non-use of MR services. Individual, household, and community level factors were the explanatory factors. Multilevel mixed-effect Poisson regression model was used to determine the factors associated with MR services in Bangladesh. Results: Nearly 7% of the total women in Bangladesh use MR services. Use of MR services was found higher among women who were aged 20-30 ages (IRR 1.60, 95% CI: 1.17–2.17), who were overweight (IRR 1.43, 95% CI: 1.13–1.81), had at least 1 child (IRR 2.97, 95% CI: 2.34– 3.77) or > 2 children (IRR 3.22, 95% CI: 2.45–4.20), and the birth preceding birth interval was(2 – 4) years (IRR 1.56, 95% CI: 1.13–2.15). Around 1.39 times (95% CI: 1.11–1.73) higher likelihood of MR was found among women whose husbands were engage with business. At the community level, MR service was found lower among the women who resided in the community with higherilliteracy (IRR 0.67, 95% CI: 0.42–0.96) and the Mymensingh division (IRR 0.39, 95% CI: 0.31–0.91). Conclusion: Use of MR service is comparatively low, which indicate a significant proportion of unintended pregnancy continued toward life-birth. This could be responsible for higher adverse maternal and child health outcomes in Bangladesh. Initiatives should be taken to ensure MR services is available when women need this service.

Keywords: menstrual regulation, pattern, risk, maternal health, Bangladesh

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19136 IT-Based Global Healthcare Delivery System: An Alternative Global Healthcare Delivery System

Authors: Arvind Aggarwal

Abstract:

We have developed a comprehensive global healthcare delivery System based on information technology. It has medical consultation system where a virtual consultant can give medical consultation to the patients and Doctors at the digital medical centre after reviewing the patient’s EMR file consisting of patient’s history, investigations in the voice, images and data format. The system has the surgical operation system too, where a remote robotic consultant can conduct surgery at the robotic surgical centre. The instant speech and text translation is incorporated in the software where the patient’s speech and text (language) can be translated into the consultant’s language and vice versa. A consultant of any specialty (surgeon or Physician) based in any country can provide instant health care consultation, to any patient in any country without loss of time. Robotic surgeons based in any country in a tertiary care hospital can perform remote robotic surgery, through patient friendly telemedicine and tele-surgical centres. The patient EMR, financial data and data of all the consultants and robotic surgeons shall be stored in cloud. It is a complete comprehensive business model with healthcare medical and surgical delivery system. The whole system is self-financing and can be implemented in any country. The entire system uses paperless, filmless techniques. This eliminates the use of all consumables thereby reduces substantial cost which is incurred by consumables. The consultants receive virtual patients, in the form of EMR, thus the consultant saves time and expense to travel to the hospital to see the patients. The consultant gets electronic file ready for reporting & diagnosis. Hence time spent on the physical examination of the patient is saved, the consultant can, therefore, spend quality time in studying the EMR/virtual patient and give his instant advice. The time consumed per patient is reduced and therefore can see more number of patients, the cost of the consultation per patients is therefore reduced. The additional productivity of the consultants can be channelized to serve rural patients devoid of doctors.

Keywords: e-health, telemedicine, telecare, IT-based healthcare

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19135 An Appraisal of Mitigation and Adaptation Measures under Paris Agreement 2015: Developing Nations' Pie

Authors: Olubisi Friday Oluduro

Abstract:

The Paris Agreement 2015, the result of negotiations under the United Nations Framework Convention on Climate Change (UNFCCC), after Kyoto Protocol expiration, sets a long-term goal of limiting the increase in the global average temperature to well below 2 degrees Celsius above pre-industrial levels, and of pursuing efforts to limiting this temperature increase to 1.5 degrees Celsius. An advancement on the erstwhile Kyoto Protocol which sets commitments to only a limited number of Parties to reduce their greenhouse gas (GHGs) emissions, it includes the goal to increase the ability to adapt to the adverse impacts of climate change and to make finance flows consistent with a pathway towards low GHGs emissions. For it achieve these goals, the Agreement requires all Parties to undertake efforts towards reaching global peaking of GHG emissions as soon as possible and towards achieving a balance between anthropogenic emissions by sources and removals by sinks in the second half of the twenty-first century. In addition to climate change mitigation, the Agreement aims at enhancing adaptive capacity, strengthening resilience and reducing the vulnerability to climate change in different parts of the world. It acknowledges the importance of addressing loss and damage associated with the adverse of climate change. The Agreement also contains comprehensive provisions on support to be provided to developing countries, which includes finance, technology transfer and capacity building. To ensure that such supports and actions are transparent, the Agreement contains a number reporting provisions, requiring parties to choose the efforts and measures that mostly suit them (Nationally Determined Contributions), providing for a mechanism of assessing progress and increasing global ambition over time by a regular global stocktake. Despite the somewhat global look of the Agreement, it has been fraught with manifold limitations threatening its very existential capability to produce any meaningful result. Considering these obvious limitations some of which were the very cause of the failure of its predecessor—the Kyoto Protocol—such as the non-participation of the United States, non-payment of funds into the various coffers for appropriate strategic purposes, among others. These have left the developing countries largely threatened eve the more, being more vulnerable than the developed countries, which are really responsible for the climate change scourge. The paper seeks to examine the mitigation and adaptation measures under the Paris Agreement 2015, appraise the present situation since the Agreement was concluded and ascertain whether the developing countries have been better or worse off since the Agreement was concluded, and examine why and how, while projecting a way forward in the present circumstance. It would conclude with recommendations towards ameliorating the situation.

Keywords: mitigation, adaptation, climate change, Paris agreement 2015, framework

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19134 Effect of Internal Control Weaknesses and Audit Opinion to the Findings of State Losses

Authors: Wiji Wijaya

Abstract:

The aim of this research is to examine the effect of internal control weaknesses and audit opinion on the state’s loss findings of audit compliance to the regulation in public sector. The samples of this research consisted of 175 local government financial statements in the area of Central Java Province at 2009 until 2013. Area sampling design was used to select the financial statements. This study using quantitative descriptive statistical analysis and regression was run for data analysis and hypothesis examination. Result of this study indicated that internal control weaknesses and audit opinion contributes a positive influence which is significant to the state’s loss findings of audit compliance to the regulation. The internal control weaknesses that affect the state's loss finding are weakness control system of accounting and reporting with the value of the critical ratio 0.010 p 2.613 ; weakness budget execution control system with critical ratio value of 3.421 p 0.001 and weaknesses internal control structure with critical ratio value of 2.246 p 0.026 . While the audit opinion with a critical ratio value of 4.401 p 0.000. The implications of this research so that policy makers at the local government should give more attention to the implementation and improvement of internal control system.

Keywords: audit compliance findings, state’s loss, audit opinion, internal control, local government

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19133 Estimate Robert Gordon University's Scope Three Emissions by Nearest Neighbor Analysis

Authors: Nayak Amar, Turner Naomi, Gobina Edward

Abstract:

The Scottish Higher Education Institutes must report their scope 1 & 2 emissions, whereas reporting scope 3 is optional. Scope 3 is indirect emissions which embodies a significant component of total carbon footprint and therefore it is important to record, measure and report it accurately. Robert Gordon University (RGU) reported only business travel, grid transmission and distribution, water supply and transport, and recycling scope 3 emissions. This study estimates the RGUs total scope 3 emissions by comparing it with a similar HEI in scale. The scope 3 emission reporting of sixteen Scottish HEI was studied. Glasgow Caledonian University was identified as the nearest neighbour by comparing its students' full time equivalent, staff full time equivalent, research-teaching split, budget, and foundation year. Apart from the peer, data was also collected from the Higher Education Statistics Agency database. RGU reported emissions from business travel, grid transmission and distribution, water supply, and transport and recycling. This study estimated RGUs scope 3 emissions from procurement, student-staff commute, and international student trip. The result showed that RGU covered only 11% of the scope 3 emissions. The major contributor to scope 3 emissions were procurement (48%), student commute (21%), international student trip (16%), and staff commute (4%). The estimated scope 3 emission was more than 14 times the reported emissions. This study has shown the relative importance of each scope 3 emissions source, which gives a guideline for the HEIs, on where to focus their attention to capture maximum scope 3 emissions. Moreover, it has demonstrated that it is possible to estimate the scope 3 emissions with limited data.

Keywords: HEI, university, emission calculations, scope 3 emissions, emissions reporting

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19132 Intellectual Capital Disclosure: A Study of Australia and Sri Lanka

Authors: Puwanenthiren Pratheepkanth

Abstract:

This study considers whether national development level influences a firm’s voluntary intellectual capital disclosure (ICD) provided by a sample of 100 Australian and 100 Sri Lankan firms in terms of a two-years during 2015-16. This two-nation study uses a content analysis and literature-review analysis to provide an understanding of the underlying forces and issues. It was found that Australian firms tend to rely heavily on external structure disclosures (with particular attention to brands, customer loyalty, and research collaborations), but Sri Lankan relatively larger firms prefer intellectual property disclosures and the smaller firms tend to be as adept at external structure as their Australian counterparts. It was also found that the nature of a firm tends to trump the nurture of the development level of the country in which the firm is embedded. While a wider diffusion of better ICD methodology under International Financial Reporting Standard (IFRS) could improve the cost-effectiveness of financial reporting and generally increase efficiency, this is unlikely to occur until competition is more of a spur.

Keywords: developed countries, developing countries, content analysis, intellectual capital disclosure

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19131 Safety and Feasibility of Distal Radial Balloon Aortic Valvuloplasty - The DR-BAV Study

Authors: Alexandru Achim, Tamás Szűcsborus, Viktor Sasi, Ferenc Nagy, Zoltán Jambrik, Attila Nemes, Albert Varga, Călin Homorodean, Olivier F. Bertrand, Zoltán Ruzsa

Abstract:

Aim: Our study aimed to establish the safety and the technical success of distal radial access for balloon aortic valvuloplasty (DR-BAV). The secondary objective was to determine the effectiveness and appropriate role of DR-BAV within half year follow-up. Methods: Clinical and angiographic data from 32 consecutive patients with symptomatic aortic stenosis were evaluated in a prospective pilot single-center study. Between 2020 and 2021, the patients were treated utilizing dual distal radial access with 6-10F compatible balloons. The efficacy endpoint was divided into technical success (successful valvuloplasty balloon inflation at the aortic valve and absence of intra- or periprocedural major complications), hemodynamic success (a reduction of the mean invasive gradient >30%), and clinical success (an improvement of at least one clinical category in the NYHA classification). The safety endpoints were vascular complications (major and minor Valve Academic Research Consortium (VARC)-2 bleeding, diminished or lost arterial pulse or the presence of any pseudo-aneurysm or arteriovenous fistula during the clinical follow-up) and major adverse events, MAEs (the composite of death, stroke, myocardial infarction, and urgent major aortic valve replacement or implantation during the hospital stay and or at one-month follow-up). Results: 32 patients (40 % male, mean age 80 ± 8,5) with severe aortic valve stenosis were included in the study and 4 patients were excluded. Technical success was achieved in all patients (100%). Hemodynamic success was achieved in 30 patients (93,75%). Invasive max and mean gradients were reduced from 73±22 mm Hg and 49±22 mm Hg to 49±19 mm Hg and 20±13 mm Hg, respectively (p = <.001). Clinical success was achieved in 29 patients (90,6%). In total, no major adverse cardiac or cerebrovascular event nor vascular complications (according to VARC 2 criteria) occurred during the intervention. All-cause death at 6 months was 12%. Conclusion: According to our study, dual distal radial artery access is a safe and effective option for balloon aortic valvuloplasty in patients with severe aortic valve stenosis and can be performed in all patients with sufficient lumen diameter. Future randomized studies are warranted to investigate whether this technique is superior to other approaches.

Keywords: mean invasive gradient, distal radial access for balloon aortic valvuloplasty (DR-BAV), aortic valve stenosis, pseudo-aneurysm, arteriovenous fistula, valve academic research consortium (VARC)-2

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19130 Efficacy and Safety of COVID-19 Vaccination in Patients with Multiple Sclerosis: Looking Forward to Post-COVID-19

Authors: Achiron Anat, Mathilda Mandel, Mayust Sue, Achiron Reuven, Gurevich Michael

Abstract:

Introduction: As coronavirus disease 2019 (COVID-19) vaccination is currently spreading around the world, it is of importance to assess the ability of multiple sclerosis (MS) patients to mount an appropriate immune response to the vaccine in the context of disease-modifying treatments (DMT’s). Objectives: Evaluate immunity generated following COVID-19 vaccination in MS patients, and assess factors contributing to protective humoral and cellular immune responses in MS patients vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) virus infection. Methods: Review our recent data related to (1) the safety of PfizerBNT162b2 COVID-19 mRNA vaccine in adult MS patients; (2) the humoral post-vaccination SARS-CoV2 IgG response in MS vaccinees using anti-spike protein-based serology; and (3) the cellular immune response of memory B-cells specific for SARS-CoV-2 receptor-binding domain (RBD) and memory T-cells secreting IFN-g and/or IL-2 in response to SARS-CoV2 peptides using ELISpot/Fluorospot assays in MS patients either untreated or under treatment with fingolimod, cladribine, or ocrelizumab; (4) covariate parameters related to mounting protective immune responses. Results: COVID-19 vaccine proved safe in MS patients, and the adverse event profile was mainly characterised by pain at the injection site, fatigue, and headache. Not any increased risk of relapse activity was noted and the rate of patients with acute relapse was comparable to the relapse rate in non-vaccinated patients during the corresponding follow-up period. A mild increase in the rate of adverse events was noted in younger MS patients, among patients with lower disability, and in patients treated with DMTs. Following COVID-19 vaccination protective humoral immune response was significantly decreased in fingolimod- and ocrelizumab- treated MS patients. SARS-CoV2 specific B-cell and T-cell cellular responses were respectively decreased. Untreated MS patients and patients treated with cladribine demonstrated protective humoral and cellular immune responses, similar to healthy vaccinated subjects. Conclusions: COVID-19 BNT162b2 vaccine proved as safe for MS patients. No increased risk of relapse activity was noted post-vaccination. Although COVID-19 vaccination is new, accumulated data demonstrate differences in immune responses under various DMT’s. This knowledge can help to construct appropriate COVID-19 vaccine guidelines to ensure proper immune responses for MS patients.

Keywords: covid-19, vaccination, multiple sclerosis, IgG

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19129 West Nile Virus Outbreaks in Canada under Expected Climate Conditions

Authors: Jalila Jbilou, Salaheddine El Adlouni, Pierre Gosselin

Abstract:

Background: West Nile virus is increasingly an important public health issue in North America. In Canada, WVN was officially reported in Toronto and Montréal for the first time in 2001. During the last decade, several WNV events have been reported in several Canadian provinces. The main objective of the present study is to update the frequency of the climate conditions favorable to WNV outbreaks in Canada. Method: Statistical frequency analysis has been used to estimate the return period for climate conditions associated with WNV outbreaks for the 1961–2050 period. The best fit is selected through the Akaike Information Criterion, and the parameters are estimated using the maximum likelihood approach. Results: Results show that the climate conditions related to the 2002 event, for Montreal and Toronto, are becoming more frequent. For Saskatoon, the highest DD20 events recorded for the last few decades were observed in 2003 and 2007. The estimated return periods are 30 years and 70 years, respectively. Conclusion: The emergence of WNV was related to extremely high DD values in the summer. However, some exceptions may be related to several factors such as virus persistence, vector migration, and also improved diagnosis and reporting levels. It is clear that such climate conditions have become much more common in the last decade and will likely continue to do so over future decades.

Keywords: West Nile virus, climate, North America, statistical frequency analysis, risk estimation, public health, modeling, scenario, temperature, precipitation

Procedia PDF Downloads 326
19128 Accelerated Structural Reliability Analysis under Earthquake-Induced Tsunamis by Advanced Stochastic Simulation

Authors: Sai Hung Cheung, Zhe Shao

Abstract:

Recent earthquake-induced tsunamis in Padang, 2004 and Tohoku, 2011 brought huge losses of lives and properties. Maintaining vertical evacuation systems is the most crucial strategy to effectively reduce casualty during the tsunami event. Thus, it is of our great interest to quantify the risk to structural dynamic systems due to earthquake-induced tsunamis. Despite continuous advancement in computational simulation of the tsunami and wave-structure interaction modeling, it still remains computationally challenging to evaluate the reliability (or its complement failure probability) of a structural dynamic system when uncertainties related to the system and its modeling are taken into account. The failure of the structure in a tsunami-wave-structural system is defined as any response quantities of the system exceeding specified thresholds during the time when the structure is subjected to dynamic wave impact due to earthquake-induced tsunamis. In this paper, an approach based on a novel integration of the Subset Simulation algorithm and a recently proposed moving least squares response surface approach for stochastic sampling is proposed. The effectiveness of the proposed approach is discussed by comparing its results with those obtained from the Subset Simulation algorithm without using the response surface approach.

Keywords: response surface model, subset simulation, structural reliability, Tsunami risk

Procedia PDF Downloads 351
19127 Effect of Addition and Reduction of Sharia Index Constituents

Authors: Rosyidah, Permata Wulandari

Abstract:

We investigate the price effect of addition and deletions from the Indonesia Sharia Stock Index (ISSI) and Jakarta Islamic Index (JII). Using event study methodology, we measure abnormal returns for firms over the period June 2019 - to December 2021. Through the sample of 107 additions and 95 deletions, we find evidence to support the theory of Muslim country investment behavior. We find that additions to the Islamic index led to a significant positive stock market reaction and deletions to the Islamic index led to a negative stock market reaction on Jakarta Islamic Index (JII) and there is no significant reaction of addition and deletion on Indonesia Sharia Stock Index (ISSI).

Keywords: abnormal return, abnormal volume, event study, index changes, sharia index

Procedia PDF Downloads 107
19126 Instructional Information Resources

Authors: Parveen Kumar

Abstract:

This article discusses institute information resources. Information, in its most restricted technical sense, is a sequence of symbols that can be interpreted as message information can be recorded as signs, or transmitted as signals. Information is any kind of event that affects the state of a dynamic system. Conceptually, information is the message being conveyed. This concept has numerous other meanings in different contexts. Moreover, the concept of information is closely related to notions of constraint, communication, control, data, form, instruction, knowledge, meaning, mental stimulus, pattern, perception, representation, and especially entropy.

Keywords: institutions, information institutions, information services for mission-oriented institute, pattern

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19125 Civil Liability for Digital Crimes

Authors: Pál Mészáros

Abstract:

The aim of this research topic is to examine civil law consequences caused by crimes committed in the digital space. During the commission of certain crimes, not only the rights of one person are violated, but also the rights of an entire institution, for example, if the information system of a university is attacked. The consequences of these crimes committed in the digital space may also be that the victim himself is liable to other third parties, for example, in the event that health data comes into the possession of unauthorized persons, and it can be proved that the service provider's IT system was inadequate. An interesting question may also be the civil liability of credit institutions if someone becomes a victim of fraud but is not expected from him/her to notice the fraud. In such a case, the liability of the credit institution may arise if they do not respond in time in the case of unauthorized bank transactions. Based on the above, the main topic of the research is the civil liability of the victim, or another person or company related to the victim in the case of damages caused by crimes.

Keywords: civil liability, digital crimes, transfer of responsibility, civil law

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19124 Patient Support Program in Pharmacovigilance: Foster Patient Confidence and Compliance

Authors: Atul Khurana, Rajul Rastogi, Hans-Joachim Gamperl

Abstract:

The pharmaceutical companies are getting more inclined towards patient support programs (PSPs) which assist patients and/or healthcare professionals (HCPs) in more desirable disease management and cost-effective treatment. The utmost objective of these programs is patient care. The PSPs may include financial assistance to patients, medicine compliance programs, access to HCPs via phone or online chat centers, etc. The PSP has a crucial role in terms of customer acquisition and retention strategies. During the conduct of these programs, Marketing Authorisation Holder (MAH) may receive information related to concerned medicinal products, which is usually reported by patients or involved HCPs. This information may include suspected adverse reaction(s) during/after administration of medicinal products. Hence, the MAH should design PSP to comply with regulatory reporting requirements and avoid non-compliance during PV inspection. The emergence of wireless health devices is lowering the burden on patients to manually incorporate safety data, and building a significant option for patients to observe major swings in reference to drug safety. Therefore, to enhance the adoption of these programs, MAH not only needs to aware patients about advantages of the program, but also recognizes the importance of time of patients and commitments made in a constructive manner. It is indispensable that strengthening the public health is considered as the topmost priority in such programs, and the MAH is compliant to Pharmacovigilance (PV) requirements along with regulatory obligations.

Keywords: drug safety, good pharmacovigilance practice, patient support program, pharmacovigilance

Procedia PDF Downloads 287