Search results for: FDA adverse event reporting system
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 19997

Search results for: FDA adverse event reporting system

19667 A Simulation of Patient Queuing System on Radiology Department at Tertiary Specialized Referral Hospital in Indonesia

Authors: Yonathan Audhitya Suthihono, Ratih Dyah Kusumastuti

Abstract:

The radiology department in a tertiary referral hospital faces service operation challenges such as huge and various patient arrival, which can increase the probability of patient queuing. During the COVID-19 pandemic, it is mandatory to apply social distancing protocol in the radiology department. A strategy to prevent the accumulation of patients at one spot would be required. The aim of this study is to identify an alternative solution which can reduce the patient’s waiting time in radiology department. Discrete event simulation (DES) is used for this study by constructing several improvement scenarios with Arena simulation software. Statistical analysis is used to test the validity of the base case scenario model and to investigate the performance of the improvement scenarios. The result of this study shows that the selected scenario is able to reduce patient waiting time significantly, which leads to more efficient services in a radiology department, be able to serve patients more effectively, and thus increase patient satisfaction. The result of the simulation can be used by the hospital management to improve the operational performance of the radiology department.

Keywords: discrete event simulation, hospital management patient queuing model, radiology department services

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19666 Thermodynamic Analysis of Cascade Refrigeration System Using R12-R13, R290-R23 and R404A-23

Authors: A. D. Parekh, P. R. Tailor

Abstract:

The Montreal protocol and Kyoto protocol underlined the need of substitution of CFC’s and HCFC’s due to their adverse impact on atmospheric ozone layer which protects earth from U.V rays. The CFCs have been entirely ruled out since 1995 and a long-term basis HCFCs must be replaced by 2020. All this events motivated HFC refrigerants which are harmless to ozone layer. In this paper thermodynamic analysis of cascade refrigeration system has been done using three different refrigerant pairs R13-R12, R290-R23, and R404A-R23. Effect of various operating parameters i.e evaporator temperature, condenser temperature, temperature difference in cascade condenser and low temperature cycle condenser temperature on performance parameters viz. COP, exergetic efficiency and refrigerant mass flow ratio have been studied. Thermodynamic analysis shows that out of three refrigerant pairs R12-R13, R290-R23 and R404A-R23 the COP of R290-R23 refrigerant pair is highest.

Keywords: thermodynamic analysis, cascade refrigeration system, COP, exergetic efficiency

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19665 Simulating Elevated Rapid Transit System for Performance Analysis

Authors: Ran Etgar, Yuval Cohen, Erel Avineri

Abstract:

One of the major challenges of transportation in medium sized inner-cities (such as Tel-Aviv) is the last-mile solution. Personal rapid transit (PRT) seems like an applicable candidate for this, as it combines the benefits of personal (car) travel with the operational benefits of transit. However, the investment required for large area PRT grid is significant and there is a need to economically justify such investment by correctly evaluating the grid capacity. PRT main elements are small automated vehicles (sometimes referred to as podcars) operating on a network of specially built guideways. The research is looking at a specific concept of elevated PRT system. Literature review has revealed the drawbacks PRT modelling and simulation approaches, mainly due to the lack of consideration of technical and operational features of the system (such as headways, acceleration, safety issues); the detailed design of infrastructure (guideways, stations, and docks); the stochastic and sessional characteristics of demand; and safety regulations – all of them have a strong effect on the system performance. A highly detailed model of the system, developed in this research, is applying a discrete event simulation combined with an agent-based approach, to represent the system elements and the podecars movement logic. Applying a case study approach, the simulation model is used to study the capacity of the system, the expected throughput of the system, the utilization, and the level of service (journey time, waiting time, etc.).

Keywords: capacity, productivity measurement, PRT, simulation, transportation

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19664 Speech Perception by Monolingual and Bilingual Dravidian Speakers under Adverse Listening Conditions

Authors: S. B. Rathna Kumar, Sale Kranthi, Sandya K. Varudhini

Abstract:

The precise perception of spoken language is influenced by several variables, including the listeners’ native language, distance between speaker and listener, reverberation and background noise. When noise is present in an acoustic environment, it masks the speech signal resulting in reduction in the redundancy of the acoustic and linguistic cues of speech. There is strong evidence that bilinguals face difficulty in speech perception for their second language compared with monolingual speakers under adverse listening conditions such as presence of background noise. This difficulty persists even for speakers who are highly proficient in their second language and is greater in those who have learned the second language later in life. The present study aimed to assess the performance of monolingual (Telugu speaking) and bilingual (Tamil as first language and Telugu as second language) speakers on Telugu speech perception task under quiet and noisy environments. The results indicated that both the groups performed similar in both quiet and noisy environments. The findings of the present study are not in accordance with the findings of previous studies which strongly report poorer speech perception in adverse listening conditions such as noise with bilingual speakers for their second language compared with monolinguals.

Keywords: monolingual, bilingual, second language, speech perception, quiet, noise

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19663 Adverse Impacts of Poor Wastewater Management Practices on Water Quality in Gebeng Industrial Area, Pahang, Malaysia

Authors: I. M. Sujaul, M. A. Sobahan, A. A. Edriyana, F. M. Yahaya, R. M. Yunus

Abstract:

This study was carried out to investigate the adverse effect of industrial waste water on surface water quality in Gebeng industrial estate, Pahang, Malaysia. Surface water was collected from 6 sampling stations. Physico-chemical parameters were characterized based on in-situ and ex-situ analysis according to standard methods by American Public Health Association (APHA). Selected heavy metals were determined by using Inductively Coupled Plasma Mass Spectrometry (ICP MS). The result reveled that the concentration of heavy metals such as Pb, Cu, Cd, Cr and Hg were high in samples. The result showed that the value of Pb and Hg were higher in the wet season in comparison to dry season. According to Malaysia National Water Quality Standard (NWQS) and Water Quality Index (WQI) all the sampling station were categorized as class IV (highly polluted). The present study reveled that the adverse effects of careless disposal of wastes and directly discharge of effluents affected on surface water quality. Therefore, the authorities should implement the laws to ensure the proper practices of waste water management for environmental sustainability around the study area.

Keywords: water, heavy metals, water quality index, Gebeng

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19662 The Event of the World in Martin Heidegger’s Early Hermeneutical Phenomenology

Authors: Guelfo Carbone

Abstract:

The paper focuses on Heidegger’s 1919-1920 early research in order to point out his hermeneutical phenomenology of the life-world, arguing that the concept of world (Welt) is the main philosophical trigger for the phenomenology of factical life. Accordingly, the argument of the paper is twofold: First, the phenomenological hermeneutics of facticity is preceded both chronologically and philosophically by an original phenomenological investigation of the life-world, in which the world is construed as the context of the givenness of life. Second, the phenomenology of life-world anticipates the question of being (Seinsfrage), but it also follows it, once this latter is shattered, the question of world as event remaining at the very core of Heidegger’s last meditations on the dominion of technology and the post-metaphysical abode of human beings on earth.

Keywords: Heidegger, hermeneutics, life-world, phenomenology

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19661 Increasing Access to Upper Limb Reconstruction in Cervical Spinal Cord Injury

Authors: Michelle Jennett, Jana Dengler, Maytal Perlman

Abstract:

Background: Cervical spinal cord injury (SCI) is a devastating event that results in upper limb paralysis, loss of independence, and disability. People living with cervical SCI have identified improvement of upper limb function as a top priority. Nerve and tendon transfer surgery has successfully restored upper limb function in cervical SCI but is not universally used or available to all eligible individuals. This exploratory mixed-methods study used an implementation science approach to better understand these factors that influence access to upper limb reconstruction in the Canadian context and design an intervention to increase access to care. Methods: Data from the Canadian Institute for Health Information’s Discharge Abstracts Database (CIHI-DAD) and the National Ambulatory Care Reporting System (NACRS) were used to determine the annual rate of nerve transfer and tendon transfer surgeries performed in cervical SCI in Canada over the last 15 years. Semi-structured interviews informed by the consolidated framework for implementation research (CFIR) were used to explore Ontario healthcare provider knowledge and practices around upper limb reconstruction. An inductive, iterative constant comparative process involving descriptive and interpretive analyses was used to identify themes that emerged from the data. Results: Healthcare providers (n = 10 upper extremity surgeons, n = 10 SCI physiatrists, n = 12 physical and occupational therapists working with individuals with SCI) were interviewed about their knowledge and perceptions of upper limb reconstruction and their current practices and discussions around upper limb reconstruction. Data analysis is currently underway and will be presented. Regional variation in rates of upper limb reconstruction and trends over time are also currently being analyzed. Conclusions: Utilization of nerve and tendon transfer surgery to improve upper limb reconstruction in Canada remains low. There are a complex array of interrelated individual-, provider- and system-level barriers that prevent individuals with cervical SCI from accessing upper limb reconstruction. In order to offer equitable access to care, a multi-modal approach addressing current barriers is required.

Keywords: cervical spinal cord injury, nerve and tendon transfer surgery, spinal cord injury, upper extremity reconstruction

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19660 A Fuzzy TOPSIS Based Model for Safety Risk Assessment of Operational Flight Data

Authors: N. Borjalilu, P. Rabiei, A. Enjoo

Abstract:

Flight Data Monitoring (FDM) program assists an operator in aviation industries to identify, quantify, assess and address operational safety risks, in order to improve safety of flight operations. FDM is a powerful tool for an aircraft operator integrated into the operator’s Safety Management System (SMS), allowing to detect, confirm, and assess safety issues and to check the effectiveness of corrective actions, associated with human errors. This article proposes a model for safety risk assessment level of flight data in a different aspect of event focus based on fuzzy set values. It permits to evaluate the operational safety level from the point of view of flight activities. The main advantages of this method are proposed qualitative safety analysis of flight data. This research applies the opinions of the aviation experts through a number of questionnaires Related to flight data in four categories of occurrence that can take place during an accident or an incident such as: Runway Excursions (RE), Controlled Flight Into Terrain (CFIT), Mid-Air Collision (MAC), Loss of Control in Flight (LOC-I). By weighting each one (by F-TOPSIS) and applying it to the number of risks of the event, the safety risk of each related events can be obtained.

Keywords: F-topsis, fuzzy set, flight data monitoring (FDM), flight safety

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19659 Represent Light and Shade of Old Beijing: Construction of Historical Picture Display Platform Based on Geographic Information System (GIS)

Authors: Li Niu, Jihong Liang, Lichao Liu, Huidi Chen

Abstract:

With the drawing of ancient palace painter, the layout of Beijing famous architect and the lens under photographers, a series of pictures which described whether emperors or ordinary people, whether gardens or Hutongs, whether historical events or life scenarios has emerged into our society. These precious resources are scattered around and preserved in different places Such as organizations like archives and libraries, along with individuals. The research combined decentralized photographic resources with Geographic Information System (GIS), focusing on the figure, event, time and location of the pictures to map them with geographic information in webpage and to display them productively. In order to meet the demand of reality, we designed a metadata description proposal, which is referred to DC and VRA standards. Another essential procedure is to formulate a four-tier classification system to correspond with the metadata proposals. As for visualization, we used Photo Waterfall and Time Line to display our resources in front end. Last but not the least, leading the Web 2.0 trend, the research developed an artistic, friendly, expandable, universal and user involvement platform to show the historical and culture precipitation of Beijing.

Keywords: historical picture, geographic information system, display platform, four-tier classification system

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19658 Architectural Adaptation for Road Humps Detection in Adverse Light Scenario

Authors: Padmini S. Navalgund, Manasi Naik, Ujwala Patil

Abstract:

Road hump is a semi-cylindrical elevation on the road made across specific locations of the road. The vehicle needs to maneuver the hump by reducing the speed to avoid car damage and pass over the road hump safely. Road Humps on road surfaces, if identified in advance, help to maintain the security and stability of vehicles, especially in adverse visibility conditions, viz. night scenarios. We have proposed a deep learning architecture adaptation by implementing the MISH activation function and developing a new classification loss function called "Effective Focal Loss" for Indian road humps detection in adverse light scenarios. We captured images comprising of marked and unmarked road humps from two different types of cameras across South India to build a heterogeneous dataset. A heterogeneous dataset enabled the algorithm to train and improve the accuracy of detection. The images were pre-processed, annotated for two classes viz, marked hump and unmarked hump. The dataset from these images was used to train the single-stage object detection algorithm. We utilised an algorithm to synthetically generate reduced visible road humps scenarios. We observed that our proposed framework effectively detected the marked and unmarked hump in the images in clear and ad-verse light environments. This architectural adaptation sets up an option for early detection of Indian road humps in reduced visibility conditions, thereby enhancing the autonomous driving technology to handle a wider range of real-world scenarios.

Keywords: Indian road hump, reduced visibility condition, low light condition, adverse light condition, marked hump, unmarked hump, YOLOv9

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19657 The Effect of Manure Loaded Biochar on Soil Microbial Communities

Authors: T. Weber, D. MacKenzie

Abstract:

The script in this paper describes the use of advanced simulation environment using electronic systems (microcontroller, operational amplifiers, and FPGA). The simulation was used for non-linear dynamic systems behaviour with required observer structure working with parallel real-time simulation based on state-space representation. The proposed deposited model was used for electrodynamic effects including ionising effects and eddy current distribution also. With the script and proposed method, it is possible to calculate the spatial distribution of the electromagnetic fields in real-time and such systems. For further purpose, the spatial temperature distribution may also be used. With upon system, the uncertainties and disturbances may be determined. This provides the estimation of the more precise system states for the required system and additionally the estimation of the ionising disturbances that arise due to radiation effects in space systems. The results have also shown that a system can be developed specifically with the real-time calculation (estimation) of the radiation effects only. Electronic systems can take damage caused by impacts with charged particle flux in space or radiation environment. TID (Total Ionising Dose) of 1 Gy and Single Effect Transient (SET) free operation up to 50 MeVcm²/mg may assure certain functions. Single-Event Latch-up (SEL) results on the placement of several transistors in the shared substrate of an integrated circuit; ionising radiation can activate an additional parasitic thyristor. This short circuit between semiconductor-elements can destroy the device without protection and measurements. Single-Event Burnout (SEB) on the other hand, increases current between drain and source of a MOSFET and destroys the component in a short time. A Single-Event Gate Rupture (SEGR) can destroy a dielectric of semiconductor also. In order to be able to react to these processes, it must be calculated within a shorter time that ionizing radiation and dose is present. For this purpose, sensors may be used for the realistic evaluation of the diffusion and ionizing effects of the test system. For this purpose, the Peltier element is used for the evaluation of the dynamic temperature increases (dT/dt), from which a measure of the ionization processes and thus radiation will be detected. In addition, the piezo element may be used to record highly dynamic vibrations and oscillations to absorb impacts of charged particle flux. All available sensors shall be used to calibrate the spatial distributions also. By measured value of size and known location of the sensors, the entire distribution in space can be calculated retroactively or more accurately. With the formation, the type of ionisation and the direct effect to the systems and thus possible prevent processes can be activated up to the shutdown. The results show possibilities to perform more qualitative and faster simulations independent of space-systems and radiation environment also. The paper gives additionally an overview of the diffusion effects and their mechanisms.

Keywords: cattle, biochar, manure, microbial activity

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19656 The Liberal Tension of the Adversarial Criminal ‎Procedure

Authors: Benjamin Newman

Abstract:

The picture of an adverse contest between two parties has often been used as an archetypal description of the Anglo-American adversarial criminal trial. However, in actuality, guilty pleas and plea-bargains have been dominating the procedure for over the last half-a-century. Characterised by two adverse parties, the court adjudicative system in the Anglo-American world adhere to the adversarial procedure, and while further features have been attributed and the values that are embedded within the procedure vary, it is a system that we have no adequate theory. Damaska had argued that the adversarial conflict-resolution mode of administration of justice stems from a liberal laissez-faire concept of a value neutral liberal state. Having said that, the court’s neutrality has been additionally rationalised in light of its liberal end as a safeguard from the state’s coercive force. Both conceptions of the court’s neutrality conflict in cases where the by-standing role disposes of its liberal duty in safeguarding the individual. Such is noticeable in plea bargains, where the defendant has the liberty to plead guilty, despite concerns over wrongful convictions and deprivation of liberty. It is an inner liberal tension within the notion of criminal adversarialism, between the laissez-faire mode which grants autonomy to the parties and the safeguarding liberal end of the trial. Langbein had asserted that the adversarial system is a criminal procedure for which we have no adequate theory, and it is by reference to political and moral theories that the research aims to articulate a normative account. The paper contemplates on the above liberal-tension, and by reference to Duff’s ‘calling-to-account’ theory, argues that autonomy is of inherent value to the criminal process, being considered a constitutive element in the process of being called to account. While the aspiration is that the defendant’s guilty plea should be genuine, the guilty-plea decision must be voluntary if it is to be considered a performative act of accountability. Thus, by valuing procedural autonomy as a necessary element within the criminal adjudicative process, it assimilates a liberal procedure, whilst maintaining the liberal end by holding the defendant to account.

Keywords: liberal theory, adversarial criminal procedure, criminal law theory, liberal perfectionism, political liberalism

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19655 The Event of Extreme Precipitation Occurred in the Metropolitan Mesoregion of the Capital of Para

Authors: Natasha Correa Vitória Bandeira, Lais Cordeiro Soares, Claudineia Brazil, Luciane Teresa Salvi

Abstract:

The intense rain event that occurred between February 16 and 18, 2018, in the city of Barcarena in Pará, located in the North region of Brazil, demonstrates the importance of analyzing this type of event. The metropolitan mesoregion of Belem was severely punished by rains much above the averages normally expected for that time of year; this phenomenon affected, in addition to the capital, the municipalities of Barcarena, Murucupi and Muruçambá. Resulting in a great flood in the rivers of the region, whose basins were affected with great intensity of precipitation, causing concern for the local population because in this region, there are located companies that accumulate ore tailings, and in this specific case, the dam of any of these companies, leaching the ore to the water bodies of the Murucupi River Basin. This article aims to characterize this phenomenon through a special analysis of the distribution of rainfall, using data from atmospheric soundings, satellite images, radar images and data from the GPCP (Global Precipitation Climatology Project), in addition to rainfall stations located in the study region. The results of the work demonstrated a dissociation between the data measured in the meteorological stations and the other forms of analysis of this extreme event. Monitoring carried out solely on the basis of data from pluviometric stations is not sufficient for monitoring and/or diagnosing extreme weather events, and investment by the competent bodies is important to install a larger network of pluviometric stations sufficient to meet the demand in a given region.

Keywords: extreme precipitation, great flood, GPCP, ore dam

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19654 Neural Correlates of Arabic Digits Naming

Authors: Fernando Ojedo, Alejandro Alvarez, Pedro Macizo

Abstract:

In the present study, we explored electrophysiological correlates of Arabic digits naming to determine semantic processing of numbers. Participants named Arabic digits grouped by category or intermixed with exemplars of other semantic categories while the N400 event-related potential was examined. Around 350-450 ms after the presentation of Arabic digits, brain waves were more positive in anterior regions and more negative in posterior regions when stimuli were grouped by category relative to the mixed condition. Contrary to what was found in other studies, electrophysiological results suggested that the production of numerals involved semantic mediation.

Keywords: Arabic digit naming, event-related potentials, semantic processing, number production

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19653 Entrepreneurial Venture Creation through Anchor Event Activities: Pop-Up Stores as On-Site Arenas

Authors: Birgit A. A. Solem, Kristin Bentsen

Abstract:

Scholarly attention in entrepreneurship is currently directed towards understanding entrepreneurial venture creation as a process -the journey of new economic activities from nonexistence to existence often studied through flow- or network models. To complement existing research on entrepreneurial venture creation with more interactivity-based research of organized activities, this study examines two pop-up stores as anchor events involving on-site activities of fifteen participating entrepreneurs launching their new ventures. The pop-up stores were arranged in two middle-sized Norwegian cities and contained different brand stores that brought together actors of sub-networks and communities executing venture creation activities. The pop-up stores became on-site arenas for the entrepreneurs to create, maintain, and rejuvenate their networks, at the same time as becoming venues for temporal coordination of activities involving existing and potential customers in their venture creation. In this work, we apply a conceptual framework based on frequently addressed dilemmas within entrepreneurship theory (discovery/creation, causation/effectuation) to further shed light on the broad aspect of on-site anchor event activities and their venture creation outcomes. The dilemma-based concepts are applied as an analytic toolkit to pursue answers regarding the nature of anchor event activities typically found within entrepreneurial venture creation and how these anchor event activities affect entrepreneurial venture creation outcomes. Our study combines researcher participation with 200 hours of observation and twenty in-depth interviews. Data analysis followed established guidelines for hermeneutic analysis and was intimately intertwined with ongoing data collection. Data was coded and categorized in NVivo 12 software, and iterated several times as patterns were steadily developing. Our findings suggest that core anchor event activities typically found within entrepreneurial venture creation are; a concept- and product experimentation with visitors, arrangements to socialize (evening specials, auctions, and exhibitions), store-in-store concepts, arranged meeting places for peers and close connection with municipality and property owners. Further, this work points to four main entrepreneurial venture creation outcomes derived from the core anchor event activities; (1) venture attention, (2) venture idea-realization, (3) venture collaboration, and (4) venture extension. Our findings show that, depending on which anchor event activities are applied, the outcomes vary. Theoretically, this study offers two main implications. First, anchor event activities are both discovered and created, following the logic of causation, at the same time as being experimental, based on “learning by doing” principles of effectuation during the execution. Second, our research enriches prior studies on venture creation as a process. In this work, entrepreneurial venture creation activities and outcomes are understood through pop-up stores as on-site anchor event arenas, particularly suitable for interactivity-based research requested by the entrepreneurship field. This study also reveals important managerial implications, such as that entrepreneurs should allow themselves to find creative physical venture creation arenas (e.g., pop-up stores, showrooms), as well as collaborate with partners when discovering and creating concepts and activities based on new ideas. In this way, they allow themselves to both strategically plan for- and continually experiment with their venture.

Keywords: anchor event, interactivity-based research, pop-up store, entrepreneurial venture creation

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19652 Labview-Based System for Fiber Links Events Detection

Authors: Bo Liu, Qingshan Kong, Weiqing Huang

Abstract:

With the rapid development of modern communication, diagnosing the fiber-optic quality and faults in real-time is widely focused. In this paper, a Labview-based system is proposed for fiber-optic faults detection. The wavelet threshold denoising method combined with Empirical Mode Decomposition (EMD) is applied to denoise the optical time domain reflectometer (OTDR) signal. Then the method based on Gabor representation is used to detect events. Experimental measurements show that signal to noise ratio (SNR) of the OTDR signal is improved by 1.34dB on average, compared with using the wavelet threshold denosing method. The proposed system has a high score in event detection capability and accuracy. The maximum detectable fiber length of the proposed Labview-based system can be 65km.

Keywords: empirical mode decomposition, events detection, Gabor transform, optical time domain reflectometer, wavelet threshold denoising

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19651 Case Study of the Impact of Sport Tourism Event on Local Residents in Cameroon: The African Cup of Nations

Authors: Zita Fomukong Andam

Abstract:

The decision on where to host sport events does not depend on the national politicians or specific international sport event bodies but also involves the residents of the hosting country. Sport tourism is one of the fast growing industries in the world. Cameroonians consider sport as a point of unity and growth within the country. It has a huge variety of sporting activities like swimming, canoe racing, tug of war and most especially soccer well known as football. The football national team made an impact in 1990 at the FIFA world cup. They also won the African Nations Cup five times. Being the winner of the 2017 African Cup of Nations, they are to host the 2019 African cup of Nations. The purpose of this research is to analyse the impacts of sport tourism event in Cameroon and specifically examine how this event influences the residents. A deep research discourse conducted with randomly selected 300 inbound residents and 200 Cameroonian residents living abroad. Survey questionnaires, interviews and direct observations were carried out as a method of collecting data. The results showed that sport events brings a lot of prestige and honor to the country; generate revenues to the country’s economy and particularly to the local businesses. On the other hand, the results showed that the local residents lose their intimacy, privacy, and their daily life routine is affected. In addition to this, they face negative social inequalities and environmental impacts. Understanding these results the national government and international bodies might be able to contribute to future studies and propose efficient measures to maximize the positive benefits and minimize the negative benefits.

Keywords: sport Tourism, economic impact, resident altitude, african Cup of nations

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19650 Predictors of Post-marketing Regulatory Actions Concerning Hepatotoxicity

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

Abstract:

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

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19649 Effect on Tolerability and Adverse Events in Participants Receiving Naltrexone/Bupropion and Antidepressant Medication, Including SSRIs, in a Large Randomized Double-Blind Study

Authors: Kye Gilder, Kevin Shan, Amy Halseth, Steve Smith

Abstract:

This study assessed the effect of prolonged-release naltrexone 32 mg/bupropion 360 mg (NB) on cardiovascular (CV) events in overweight/obese participants at elevated CV risk. Participants must lose ≥2% body weight at 16 wks, without a sustained increase in blood pressure, to continue drug. Only serious adverse events (SAE) and adverse events leading to discontinuation of study drug (AELDSD) were collected. The study was terminated early after second interim analysis with 50% of all CV events. Data on CV endpoints has been published. Current analyses focused on AEs in participants on antidepressants at baseline, as these individuals were excluded from Phase 3 trials. Intent-to-treat (ITT) population (placebo [PBO] N=4450, NB N=4455) was 54.5% female, 83.5% white, mean age of 61 yrs, mean BMI 37.3 kg/m2, 22.8% with a history of depression, 23.1% on antidepressants, including 15.4% on an SSRI. SAEs in participants receiving antidepressants was similar between NB (10.7%) and PBO (9.9%) and also similar to overall population (9.5% NB, 8.1% PBO). SAEs in those on SSRIs were similar, 10.1% NB and PBO 9.4%. For those on SSRIs or other antidepressants, AELDSDs were similar to overall population and were primarily GI disorders. Obesity increases the risk of developing depression. For participants taking NB and antidepressants, including SSRIs, there is a similar AE profile as the overall population and data revealed no evidence of an additional health risk with combined use.

Keywords: antidepressant, Contrave, Mysimba, obesity, pharmacotherapy

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19648 Environment-Specific Political Risk Discourse, Environmental Reputation, and Stock Price Crash Risk

Authors: Sohanur Rahman, Elisabeth Sinnewe, Larelle (Ellie) Chapple, Sarah Osborne

Abstract:

Greater political attention to global climate change exposes firms to a higher level of political uncertainty, which can lead to adverse capital market consequences. However, a higher level of discourse on environment-specific political risk (EPR) between management and investors can mitigate information asymmetry, followed by less stock price crash risk. This study examines whether EPR discourse in discourse in the earnings conference calls (ECC) reduces firm-level stock price crash risk in the US market. This research also explores if adverse disclosures via media channels further moderates the association between EPR on crash risk. Employing a dataset of 28,933 firm-year observations from 2002 to 2020, the empirical analysis reveals that EPR discourse in ECC reduces future stock price crash risk. However, adverse disclosures via media channels can offset the favourable effect of EPR discourse on crash risk. The results are robust to the potential endogeneity concern in a quasi-natural experiment setting.

Keywords: earnings conference calls, environment, environment-specific political risk discourse, environmental disclosures, information asymmetry, reputation risk, stock price crash risk

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19647 Anomaly: A Case of Babri Masjid Dispute

Authors: Karitikeya Sonker

Abstract:

Religion as a discrete system through its lawful internal working produces an output in the form of realised spatial order with its social logic and a social order with its spatial logic. Thus, it appears to exhibit its duality of spatial and trans-spatial. The components of this system share a relevance forming a collective. This shared relevance creates meaning forming a group where all collectives share one identity. This group with its new social order and its spatial logic revive the already existing spatial order. These religious groups do so having a tendency to expand resulting in the production of space in a situation of encounter where they have found relevance. But an encounter without a lawful internal working of a discrete system results in anomaly because groups do not find relevance due to the absence of collective identity. Events happen all around. One of the main reasons we could say that something became an event is because of conflict. Conflict not in its definitive sense but any occurrence that happens because of an intervention that creates an event worth remembering. The unfolding of such events creates Cities and Urban spaces which exhibit their duality of spatial and trans-spatial by behaving as a discrete system. This system through its lawful internal working produces an output in the form of realized spatial order with its social logic and a social order with spatial logic. The components of this system form a collective through a shared a relevance. This shared relevance creates meaning forming a group where all collectives share one identity. This group with its new social order and its spatial logic revives the already existing spatial order. These groups do so having a tendency to expand resulting in the production of space in a situation of encounter where they have found relevance. But an encounter without a lawful internal working of the discrete system results in anomaly because groups do not find relevance due to the absence of collective identity. This paper makes an effort to explore one such even in the case of Babri Mosque and Ramjanmabhumi, Ayodhya to explain the anomaly as transposition of social and spatial. The paper through the case studies makes an attempt to generate an equation explaining the two different situations of religious encounters, former reviving the social and spatial order and the other resulting in anomaly. Through the case study, it makes an attempt to generate an equation explaining the two different situations of religious encounters, former reviving the social and spatial order and the other resulting in anomaly.

Keywords: Babri Masjid, Ayodhya, conflict, religion

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19646 Is Materiality Determination the Key to Integrating Corporate Sustainability and Maximising Value?

Authors: Ruth Hegarty, Noel Connaughton

Abstract:

Sustainability reporting has become a priority for many global multinational companies. This is associated with ever-increasing expectations from key stakeholders for companies to be transparent about their strategies, activities and management with regard to sustainability issues. The Global Reporting Initiative (GRI) encourages reporters to only provide information on the issues that are really critical in order to achieve the organisation’s goals for sustainability and manage its impact on environment and society. A key challenge for most reporting organisations is how to identify relevant issues for sustainability reporting and prioritise those material issues in accordance with company and stakeholder needs. A recent study indicates that most of the largest companies listed on the world’s stock exchanges are failing to provide data on key sustainability indicators such as employee turnover, energy, greenhouse gas emissions (GHGs), injury rate, pay equity, waste and water. This paper takes an indepth look at the approaches used by a select number of international sustainability leader corporates to identify key sustainability issues. The research methodology involves performing a detailed analysis of the sustainability report content of up to 50 companies listed on the 2014 Dow Jones Sustainability Indices (DJSI). The most recent sustainability report content found on the GRI Sustainability Disclosure Database is then compared with 91 GRI Specific Standard Disclosures and a small number of GRI Standard Disclosures. Preliminary research indicates significant gaps in the information disclosed in corporate sustainability reports versus the indicator content specified in the GRI Content Index. The following outlines some of the key findings to date: Most companies made a partial disclosure with regard to the Economic indicators of climate change risks and infrastructure investments, but did not focus on the associated negative impacts. The top Environmental indicators disclosed were energy consumption and reductions, GHG emissions, water withdrawals, waste and compliance. The lowest rates of indicator disclosure included biodiversity, water discharge, mitigation of environmental impacts of products and services, transport, environmental investments, screening of new suppliers and supply chain impacts. The top Social indicators disclosed were new employee hires, rates of injury, freedom of association in operations, child labour and forced labour. Lesser disclosure rates were reported for employee training, composition of governance bodies and employees, political contributions, corruption and fines for non-compliance. The reporting on most other Social indicators was found to be poor. In addition, most companies give only a brief explanation on how material issues are defined, identified and ranked. Data on the identification of key stakeholders and the degree and nature of engagement for determining issues and their weightings is also lacking. Generally, little to no data is provided on the algorithms used to score an issue. Research indicates that most companies lack a rigorous and thorough methodology to systematically determine the material issues of sustainability reporting in accordance with company and stakeholder needs.

Keywords: identification of key stakeholders, material issues, sustainability reporting, transparency

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19645 Modifying Hawking Radiation in 2D-Approximated Schwarzschild Black Holes near the Event Horizon

Authors: Richard Pincak

Abstract:

Starting from a 4D spacetime model using a partially negative dimensional product manifold (PNDP-manifold), which emerges as a 2D spacetime, we developed an analysis of tidal forces and Hawking radiation near the event horizon of a Schwarzchild black hole. The modified 2D metric, incorporating the effects of the four-dimensional Weyl tensor, with the dilatonic field and the newly derived time relation \(2\alpha t = \ln \epsilon\), can enable a deeper understanding of quantum gravity. The analysis shows how the modified Hawking temperature and distribution of emitted particles are affected by additional fields, providing potential observables for future experiments.

Keywords: black holes, Hawking radiation, Weyl tensor, information paradox

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19644 Heat: A Healthy Eating Programme

Authors: Osagbai Joshua Eriki, Ngozi Agunwamba, Alice Hill, Lorna Almond, Maniya Duffy, Devashini Naidoo, David Ho, Raman Deo

Abstract:

Aims: To evaluate the baseline eating pattern in a psychiatric hospital through quantifying purchases of food and drink items at the hospital shop and to implement a traffic light healthy eating labeling system. Method: A electronic till with reporting capabilities was purchased. A two-week period of baseline data collection was conducted. Thereafter, a system for labeling items based on the nutritional value of the food items at the hospital shop was implemented. Green labeling represented the items with the lowest calories and red the most. Further data was collated on the number and types of items purchased by patients according to the category, and the initial effectiveness of the system was evaluated. Result: Despite the implementation of the traffic light system, the red category had the highest number of items purchased by patients, highlighting the importance of promoting healthy eating choices. However, the study also showed that the system was effective in promoting healthy options, as the number of items purchased from the green category increased during the study period. Conclusion: The implementation of a traffic light labeling system for items sold at the hospital shop offers a promising approach to promoting healthy eating habits and choices. This is likely to contribute to a toolkit of measures when considering the multifactorial challenges that obesity and weight issues pose for long-stay psychiatric inpatients

Keywords: mental health, nutrition, food, healthy

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19643 Designing a Waste Management System for an Urban Area in Sri Lanka

Authors: R. A. C. K. Gunathilaka, P. T. D. Peiris, O. S. M. Jayawardane, S. M. A. I. Kulathunga

Abstract:

Waste management is one of the predominant aspects of resource utilization and sustainability. The absence of a proper waste management system may lead to adverse troubles and catastrophic tragedies ultimately. Sri Lanka has faced different predicaments for a long time due to the unavailability of a systematic manner in the waste management process. The main objective of this research is to design an efficient waste management system for an urban area in Sri Lanka. The research was dispersed into three categories as biodegradable, non-biodegradable, and hazardous waste. Different waste materials were researched for each category by probing the entire process from the beginning to final disposal for perceiving the prevailing problems in the waste management system. The distinctive segment of this research is comparing efficient foreign waste management strategies with efficacious approaches on increasing public commitment to uncovering cognizable ways of implementing such a system in the Sri Lankan context. Waste management systems in Singapore, Japan, Malaysia, USA, Maldives, and China incorporated their exemplary plan of action on tackling the waste problem in diverse sectors were studied. Ultimately, three coherent models were proposed for each category pertaining to the concepts of circular economy and lean manufacturing from the inception to the final disposal of the waste. This research also includes concealed financial opportunities regarding waste management.

Keywords: circular economy, efficient waste management system, lean manufacturing, sustainability, urban area

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19642 Analysis of Drought Flood Abrupt Alternation Events and there Impacts in Kenya

Authors: Betty Makena, Tsegaye Tadesse, Mark Svoboda

Abstract:

Global warming has intensified the frequency and intensity of extreme climate disasters and led to unpredictable weather conditions. Consequently, rapid shifts between drought and floods, known as Drought-Flood Abrupt Alteration (DFAA), have become increasingly common. DFAA results in superimposed impacts of drought and floods within a short period, exacerbating the effects of the floods or drought event. Current disaster management plans often overlook DFAA events, as they primarily focus on either floods or drought. Therefore, effectively identifying DFAA events is crucial for developing effective mitigation strategies. This study aims to identify historical DFAA events in Kenya using the Long Cycle Drought-Flood Abrupt Alteration Index (LDFAI). The research will analyze the spatial distribution, temporal variation, and intensity of DFAA events from 1990 to 2023, as well as their socio-economic impacts. Understanding these events is important to develop more effective strategies to address the impacts of DFAA events. Findings from this study will inform decision making to develop coping strategies to mitigate the adverse effects of DFAA in Kenya.

Keywords: abrupt, alteration, drought, floods

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19641 Modeling SET Effect on Charge Pump Phase Locked Loop

Authors: Varsha Prasad, S. Sandya

Abstract:

Cosmic Ray effects in microelectronics such as single event effect (SET) and total dose ionization (TID) have been of major concern in space electronics since 1970. Advanced CMOS technologies have demonstrated reduced sensitivity to TID effect. However, charge pump Phase Locked Loop is very much vulnerable to single event transient effect. This paper presents an SET analysis model, where the SET is modeled as a double exponential pulse. The time domain analysis reveals that the settling time of the voltage controlled oscillator (VCO) depends on the SET pulse strength, setting the time constant and the damping factor. The analysis of the proposed SET analysis model is confirmed by the simulation results.

Keywords: charge pump, phase locked loop, SET, VCO

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19640 Role of Radiologic Technologist Specialist in Plain Image Interpretation of Adults in the Middle East: A Radiologist’s Perspective

Authors: Awad Mohamed Elkhadir, Rajab M. Ben Yousef

Abstract:

Background/Aim: Radiological technologists are medical professionals who perform diagnostic imaging tests such as X-rays, magnetic resonance imaging (MRI) scans, and computer tomography (CT) scans. Despite the recognition of image interpretation by British radiologists, it is still considered a problem in the Arab world. This study evaluates the perceptions of radiologists in the Middle East concerning the plain image interpretation of adults by radiologic technologist specialists. Methods: This is a cross-sectional study that follows a quantitative approach. A close-ended questionnaire was distributed among 103 participants who were radiologists by profession from various hospitals in Saudi Arabia and Sudan. The gathered data was then analyzed through Statistical Package for Social Sciences (SPSS). Results: The results showed that 29% recognized the Radiologic Technologist Specialist (RTS) role of writing image reports, while 61% did not. A total of 38% of participants believed that RTS image interpretation would help diagnose unreported radiographs. 47% of the sample responded that the workload and stress on radiologists would reduce by allowing reporting for RTS, while 37% did not. Lastly, 43% believe that image interpretation by RTS can be introduced into the Middle East in the future. Conclusion: The study's findings reveal that the combination of image reporting and radiography improves the care of the patients. The study's outcomes also show that the burden of the medical practitioners reduces due to image reporting of the radiographers. Further researches need to be conducted in the Arab World to obtain and measure the associated factors of the desired criteria.

Keywords: Arab world, image interpretation, radiographer, radiologist, Saudi Arabia, Sudan

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19639 A Content Analysis of Us Media Framing of Conflict: Effects on Global Journalism and Its Social Consequences

Authors: Lee Artz

Abstract:

This presentation outlines US media frames of recent interventions in Iraq, Afghanistan, and Syria and their impact on global media and public discourse. A content analysis of sources, descriptors, and contexts of leading US media (AP, New York Times, Fox News) finds that news coverage highlights terrorism, justifies military action, and downplays the human costs. These media frames that normalize intervention also omit coverage of the environmental consequences of war, with scant or no reporting on pollution, destruction and contamination of agricultural infrastructures and the difficulty of any environmentally sustainable recovery. A content analysis of leading European and Middle East media (Daily Mail, Le Monde, Deutsch Welle, Al Jazeera) indicates that they have adopted the same reporting practices, frames, and techniques resulting in a hybrid, yet homogeneous, increasingly global news environment that does a disservice to the public interest and democracy.

Keywords: conflict, environment, media framing, public interest

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19638 Convergence with IFRS: Evidence from Financial Statements

Authors: M. S. Turan, Dimple

Abstract:

Due to implementation of IFRS by several developed and developing countries, India has no option other than to converge their accounting standards with IFRS. There are over 10,000 listed companies required to implement IFRS in India. IFRS based financial information presented by a company is different from the same information provided by Indian GAAPs. In this study, we have brought out and analyzed the effect of IFRS reporting on the financial statements of selected companies. The results reveal that convergence with IFRS brought prominent positive variations in the values of quick ratio, debt/equity ratio, proprietary ratio and net profit ratio, while negative variation is brought in the values of current ratio, debt to total assets ratio, operating profit ratio, return on capital employed and return on shareholders’ equity ratios. It also presents significant changes in the values of items of balance sheet, profit and loss account and cash flow statement.

Keywords: IFRS, reporting standards, convergence process, results

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