Search results for: FDA adverse event reporting system

Authors: Geraldine Mc Loughlin, Mary Horgan, Rosaleen Murphy

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Childbirth is a life-changing event, a psychological transition for the mother that must be viewed in a social context. Much has been written and documented regarding the preparation for birth and the immediate postnatal period, but the full psychological impact on the mother is not clear. One aspect of the transition process is Identity. Depending on a person’s worldview, the concept of identity is viewed differently; the nature of reality and how they construct knowledge influence these perspectives. Becoming a mother is not just an event but a process that time and experience will help to shape the understanding of the woman. To explore the emotional and psychological aspects of first-time mother’s experience during the transition to new motherhood. To identify factors affecting women’s identities in the period of 36 weeks gestation to 12 weeks postpartum. Interpretative Phenomenological Analysis (IPA) was used. It explores how these women make sense of and give meaning to their experiences. IPA is underpinned by 3 key principles: phenomenology, hermeneutics and idiographics. A purposeful sample of 10 women was recruited for this longitudinal study, to enable data to be collected during the transition to motherhood. Individual identity was interpreted and viewed as developing in response to changing contexts, such as the birth event becoming a parent, enabling one to construct one’s own sense of a meaningful life. Women effectively differentiated themselves from their personal and social identities and took responsibility for their actions. Identity is culturally and socially shaped and experienced, though not experienced similarly by all women. The individualized perspective on identity recognizes that (a) social influences are seen as external to the individual and (b) the view that social influences are, in fact, internalized by the individual.

Keywords: motherhood, transition, identity, IPA

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Authors: Muhammed Ordu, Eren Demir, Chris Tofallis

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Over the past decade, the non-elective admissions in the UK have increased significantly. Taking into account limited resources (i.e. beds), the related service managers are obliged to manage their resources effectively due to the non-elective admissions which are mostly admitted to inpatient specialities via A&E departments. Geriatric medicine is one of specialities that have long length of stay for the non-elective admissions. This study aims to develop a discrete event simulation model to understand how possible increases on non-elective demand over the next 12 months affect the bed occupancy rate and to determine required number of beds in a geriatric medicine speciality in a UK hospital. In our validated simulation model, we take into account observed frequency distributions which are derived from a big data covering the period April, 2009 to January, 2013, for the non-elective admission and the length of stay. An experimental analysis, which consists of 16 experiments, is carried out to better understand possible effects of case studies and scenarios related to increase on demand and number of bed. As a result, the speciality does not achieve the target level in the base model although the bed occupancy rate decreases from 125.94% to 96.41% by increasing the number of beds by 30%. In addition, the number of required beds is more than the number of beds considered in the scenario analysis in order to meet the bed requirement. This paper sheds light on bed management for service managers in geriatric medicine specialities.

Keywords: bed management, bed occupancy rate, discrete event simulation, geriatric medicine, non-elective admission

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Authors: Nazari Maryam, Gorji Saman

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For most competitions, athletes usually engage in a process called rapid weight loss (RWL) and subsequent rapid weight gain (RWG) in the days preceding the event. Besides the perfection of performance, weight regulation mediates a self-image of being “a real athlete” which is mentally important as a part of the pre-competition preparation. This feeling enhances the focus and commitment of the athlete. There is a large body of evidence that weight loss, particularly in combat sports, results in several health benefits. However, intentional weight loss beyond normal levels might have unknown negative special effects on the immune system. As the results show, a high prevalence (50%) of RWL is happening among combat athletes. It seems that energy deprivation and intense exercise to reach RWL results in altered blood cell distribution through modification of body composition that, in turn, changes B and T-Lymphocyte and/or CD4 T-Helper response. Moreover, it may diminish IgG antibody levels and modulate IgG glycosylation after this course. On the other hand, some studies show suppression of signaling and regulation of IgE antibody and chemokine production are responsible for immunodeficiency following a period of low-energy availability. Some researchers hypothesize that severe glutamine depletion, which occurs during exercise and calorie restriction, is responsible for this immune system weakness. However, supplementation by this amino acid is not prescribed yet. Therefore, weight loss is achieved not only through chronic strategies (body fat losses) but also through acute manipulations prior to competition should be supervised by a sports nutritionist to minimize side effects on the immune system and other body systems.

Keywords: athletes, immune system, rapid weight loss, weight loss strategies

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Authors: Kanika Saxena, Sunita Balani

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Purpose - The aim of the study is to compare the reported sustainability activities in areas of emission, water management and gender equality, currently undertaken by the seven major pharmaceutical companies. Methodology: The published corporate sustainability activity reports for the year 2017 for seven pharmaceutical companies have been studied. The two main criteria for the inclusion of pharmaceutical companies in this study are that they are globally recognized and active in the field of sustainability reporting. Company’s actions and initiatives have been grouped under three categories: (i) Emissions (ii) Water management (iii) Gender Equality in terms of employee workforce. Findings: Based on the sustainability reports, quantification and grading of the companies showed interesting results. Johnson & Johnson and Bayer are leading their activities under emissions and water management categories. The number of activities under emission and water management in case of Eli Lily, Roche, Sanofi, Pfizer and GlaxoSmithKline were 19, 16, 16, 11 and 6 respectively. Johnson & Johnson and Eli Lily are leading in taking the initiatives to curb the problem of emissions as compared with other 5 companies. Under the category of gender equality in terms of employee workforce, Eli Lily is leading the group of sampled companies with 47% of women employee workforce globally followed by Sanofi with 46.2% (42.2% of managers) female employees. It has also been observed that in some of the reports, gender diversification in the workforce has not been mentioned though the total number of employees were mentioned. Conclusion: This study could serve as the informative material for future in-depth industry-specific studies in order to find out the participation of the pharmaceutical companies in the reporting of the sustainability activities especially in reference to emission, water management and gender equality in the workforce. In addition to it, this can be helpful as a reference point for other companies in the pharmaceutical sector who are yet to explore the field of sustainability initiatives and reporting. Due to the limited scope of this study, only seven major players of the pharmaceutical sector who are active in the field of sustainability have been considered.

Keywords: emission, gender equality workforce, pharmaceutical, sustainability, water management

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Authors: Mamouni Mohammed Dhiya Eddine

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This work aims at studying the exploitation of high-speed networks of clusters for distributed storage. Parallel applications running on clusters require both high-performance communications between nodes and efficient access to the storage system. Many studies on network technologies led to the design of dedicated architectures for clusters with very fast communications between computing nodes. Efficient distributed storage in clusters has been essentially developed by adding parallelization mechanisms so that the server(s) may sustain an increased workload. In this work, we propose to improve the performance of distributed storage systems in clusters by efficiently using the underlying high-performance network to access distant storage systems. The main question we are addressing is: do high-speed networks of clusters fit the requirements of a transparent, efficient and high-performance access to remote storage? We show that storage requirements are very different from those of parallel computation. High-speed networks of clusters were designed to optimize communications between different nodes of a parallel application. We study their utilization in a very different context, storage in clusters, where client-server models are generally used to access remote storage (for instance NFS, PVFS or LUSTRE). Our experimental study based on the usage of the GM programming interface of MYRINET high-speed networks for distributed storage raised several interesting problems. Firstly, the specific memory utilization in the storage access system layers does not easily fit the traditional memory model of high-speed networks. Secondly, client-server models that are used for distributed storage have specific requirements on message control and event processing, which are not handled by existing interfaces. We propose different solutions to solve communication control problems at the filesystem level. We show that a modification of the network programming interface is required. Data transfer issues need an adaptation of the operating system. We detail several propositions for network programming interfaces which make their utilization easier in the context of distributed storage. The integration of a flexible processing of data transfer in the new programming interface MYRINET/MX is finally presented. Performance evaluations show that its usage in the context of both storage and other types of applications is easy and efficient.

Keywords: distributed storage, remote file access, cluster, high-speed network, MYRINET, zero-copy, memory registration, communication control, event notification, application programming interface

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Authors: Rachel M. Edelstein, John D. Van Horn, Karen M. Schmidt, Sydney N. Cushing

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As a consequence of sports-related concussions, female athletes have been documented as reporting more symptoms than their male counterparts, in addition to incurring longer periods of recovery. However, the role of sex and its potential influence on symptom reporting and recovery outcomes in concussion management has not been completely explored. The present aims to investigate the relationship between female concussion symptom severity and the presence of assessment bias. The Sport Concussion Assessment Tool 3 (SCAT3), collected by the NCAA and DoD CARE Consortium, was quantified at five different time points post-concussion. N= 1,258 NCAA athletes, n= 473 female (soccer, rugby, lacrosse, ice hockey) and n=785 male athletes (football, rugby, lacrosse, ice hockey). A polytomous Item Response Theory (IRT) Graded Response Model (GRM) was used to assess the relationship between sex and symptom reporting. Differential Item Functioning (DIF) and Differential Group Functioning (DGF) were used to examine potential group-level bias. Interactions for DIF were utilized to explore the impact of sex on symptom reporting among NCAA male and female athletes throughout and after their concussion recovery. DIF was significantly detected after B-H corrections displayed in limited items; however, one symptom, “Pressure in Head” (-0.29, p=0.04 vs -0.20, p =0.04), was statistically significant at both < 6 hours and 24-48 hours. Thus, implies that at < 6 hours, males were 29% less likely to indicate “Pressure in the Head” compared to female athletes and 20% less likely at 24-48 hours. Overall, the DGF suggested significant group differences, suggesting that male athletes might be at a higher risk for returning to play prematurely (logits = -0.38, p < 0.001). However, after analyzing the SCAT 3, a clinically relevant trend was discovered. Twelve out of the twenty-two symptoms suggest higher difficulty in female athletes within three or more of the five-time points. These symptoms include Balance Problems, Blurry Vision, Confusion, Dizziness, Don’t Feel Right, Feel in Fog, Feel Slow Down, Low Energy, Neck Pain, Sensitivity to Light, Sensitivity to Noise, Trouble Falling Asleep. Despite a lack of statistical significance, this tendency is contrary to current literature stating that males may be unclear on symptoms, but females may be more honest in reporting symptoms. Further research, which includes possible modifying socioecological factors, is needed to determine whether females may consistently experience more symptoms and require longer recovery times or if, parsimoniously, males tend to present their symptoms and readiness for play differently than females. Such research will help to improve the validity of current assumptions concerning male as compared to female head injuries and optimize individualized treatments for sports-related head injuries.

Keywords: female athlete, sports-related concussion, item response theory, concussion assessment

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Authors: Nelson Igaba, C. Onaga, S. Hlongwane

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Background: Medical Male Circumcision (MMC) is part of a comprehensive HIV prevention strategy. The quality of MMC done at Right To Care (RtC) sites is maintained by Continuous Quality Improvement (CQI) based on findings of assessments by internal and independent external assessors who evaluate such parameters as the quality of the surgical procedure, infection control, etc. There are 12 RtC MMC teams in Mpumalanga, two of which are headed by Medical Officers and 10 by Clinical Associates (Clin A). Objectives: To compare the quality (i) of care rendered at doctor headed sites (DHS) versus Clin A headed sites (CHS); (ii) of CQI assessments (external versus internal). Methodology: A retrospective review of data from RightMax™ (a novel RtC data management system) and CQI reports (external and internal) was done. CQI assessment scores of October 2015 and October 2016 were taken as the baseline and latest respectively. Four sites with 745-810 circumcisions per annum were purposively selected; the two DHS (group A) and two CHS (group B). Statistical analyses were conducted using R (2017 version). Results: There were no significant difference in latest CQI scores between the two groups (DHS and CHS) (Anova, F = 1.97, df = 1, P = 0.165); between internal and external CQI assessment scores (Anova, F = 2.251, df = 1, P = 0.139) or among the individual sites (Anova, F = 1.095, df = 2, P = 0.341). Of the total of 16 adverse events reported by the four sites in the 12 months reviewed (all were infections), there was no statistical evidence that the documented severity of the infection was different for DHS and CHS (Fisher’s exact test, p-value = 0.269). Conclusion: At RtC VMMC sites in Mpumalanga, internal and external/independent CQI assessments are comparable, and quality of care of VMMC is standardized with the performance of well-supervised clinical associates comparing well with those of medical officers.

Keywords: adverse events, Right to Care, male medical circumcision, continuous quality improvement

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Authors: Chau-Kuang Chen, Juanita Buford, Colette Davis, Raisha Allen, John Hughes, James Tyus, Dexter Samuels

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During the post-Civil War era, the city of Nashville, Tennessee, had the highest mortality rate in the country. The elevated death and disease among ex-slaves were attributable to the unavailability of healthcare. To address the paucity of healthcare services, the College, an institution with the mission of educating minority professionals and serving the under served population, was established in 1876. This study was designed to assess if the College has accomplished its mission of serving under served communities and contributed to the elimination of health disparities in the United States. The study objective was to quantify the impact of socioeconomic status and adverse health outcomes on primary care professionals serving disadvantaged communities, which, in turn, was significantly associated with a health professional shortage score partly designated by the U.S. Department of Health and Human Services. Various statistical methods were used to analyze the alumni data in years 1975 – 2013. K-means cluster analysis was utilized to identify individual medical and dental graduates into the cluster groups of the practice communities (Disadvantaged or Non-disadvantaged Communities). Discriminant analysis was implemented to verify the classification accuracy of cluster analysis. The independent t test was performed to detect the significant mean differences for clustering and criterion variables between Disadvantaged and Non-disadvantaged Communities, which confirms the “content” validity of cluster analysis model. Chi-square test was used to assess if the proportion of cluster groups (Disadvantaged vs Non-disadvantaged Communities) were consistent with that of practicing specialties (primary care vs. non-primary care). Finally, the partial least squares (PLS) path model was constructed to explore the “construct” validity of analytics model by providing the magnitude effects of socioeconomic status and adverse health outcome on primary care professionals serving disadvantaged community. The social ecological theory along with statistical models mentioned was used to establish the relationship between medical and dental graduates (primary care professionals serving disadvantaged communities) and their social environments (socioeconomic status, adverse health outcome, health professional shortage score). Based on social ecological framework, it was hypothesized that the impact of socioeconomic status and adverse health outcomes on primary care professionals serving disadvantaged communities could be quantified. Also, primary care professionals serving disadvantaged communities related to a health professional shortage score can be measured. Adverse health outcome (adult obesity rate, age-adjusted premature mortality rate, and percent of people diagnosed with diabetes) could be affected by the latent variable, namely socioeconomic status (unemployment rate, poverty rate, percent of children who were in free lunch programs, and percent of uninsured adults). The study results indicated that approximately 83% (3,192/3,864) of the College’s medical and dental graduates from 1975 to 2013 were practicing in disadvantaged communities. In addition, the PLS path modeling demonstrated that primary care professionals serving disadvantaged community was significantly associated with socioeconomic status and adverse health outcome (p < .001). In summary, the majority of medical and dental graduates from the College provide primary care services to disadvantaged communities with low socioeconomic status and high adverse health outcomes, which demonstrate that the College has fulfilled its mission.

Keywords: disadvantaged community, K-means cluster analysis, PLS path modeling, primary care

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Authors: Fang Ye, Han Yu, Yibing Li

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Radio interference is one of the major concerns in using the global positioning system (GPS) for civilian and military applications. Interference signals are produced not only through all electronic systems but also illegal jammers. Among different types of interferences, continuous wave (CW) interference has strong adverse impacts on the quality of the received signal. In this paper, we make more detailed analysis for CW interference effects on GPS signal quality. Based on the C/A code spectrum lines, the influence of CW interference on the acquisition performance of GPS receivers is further analysed. This influence is supported by simulation results using GPS software receiver. As the most important user parameter of GPS receivers, the mathematical expression of bit error probability is also derived in the presence of CW interference, and the expression is consistent with the Monte Carlo simulation results. The research on CW interference provides some theoretical gist and new thoughts on monitoring the radio noise environment and improving the anti-jamming ability of GPS receivers.

Keywords: GPS, CW interference, acquisition performance, bit error probability, Monte Carlo

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Authors: Maryam Bahreini, Mostafa Talebi Garekani, Fatemeh Rasooli, Atefeh Abdollahi

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Introduction: Procedural sedation and analgesia have been desirable to handle painful procedures. The trend to find the agent with more efficacy and less complications is still controversial; thus, many sedative regimens have been studied. This study tried to assess the effectiveness and adverse effects of thiopental sodium-fentanyl with the known medication, ketamine-propofol for procedural sedation in the emergency department. Methods: Consenting patients were enrolled in this randomized double-blind trial to receive either 1:1 ketamine-propofol (KP) or thiopental-fentanyl (TF) 1:1 mg: Mg proportion on a weight-based dosing basis to reach the sedation level of American Society of Anesthesiologist class III/IV. The respiratory and hemodynamic complications, nausea and vomiting, recovery agitation, patient recall and satisfaction, provider satisfaction and recovery time were compared. The study was registered in Iranian randomized Control Trial Registry (Code: IRCT2015111325025N1). Results: 96 adult patients were included and randomized, 47 in the KP group and 49 in the TF group. 2.1% in the KP group and 8.1 % in the TF group experienced transient hypoxia leading to performing 4.2 % versus 8.1 % airway maneuvers for 2 groups, respectively; however, no statistically significant difference was observed between 2 combinations, and there was no report of endotracheal placement or further admission. Patient and physician satisfaction were significantly higher in the KP group. There was no difference in respiratory, gastrointestinal, cardiovascular and psychiatric adverse events, recovery time and patient recall of the procedure between groups. The efficacy and complications were not related to the type of procedure or patients’ smoking or addiction trends. Conclusion: Ketamine-propofol and thiopental-fentanyl combinations were effectively comparable although KP resulted in higher patient and provider satisfaction. It is estimated that thiopental fentanyl combination can be as potent and efficacious as ketofol with relatively similar incidence of adverse events in procedural sedation.

Keywords: adverse effects, conscious sedation, fentanyl, propofol, ketamine, safety, thiopental

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Authors: Zsanett Bahor, Cristina Nunes-Fonseca, Gillian L. Currie, Emily S. Sena, Lindsay D.G. Thomson, Malcolm R. Macleod

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Psychosis is ranked as the third most disabling medical condition in the world by the World Health Organization. Despite a substantial amount of research in recent years, available treatments are not universally effective and have a wide range of adverse side effects. Since many clinical drug candidates are identified through in vivo modelling, a deeper understanding of these models, and their strengths and limitations, might help us understand reasons for difficulties in psychosis drug development. To provide an unbiased summary of the preclinical psychosis literature we performed a systematic electronic search of PubMed for publications modelling a psychotic disorder in vivo, identifying 14,721 relevant studies. Double screening of 11,000 publications from this dataset so far established 2403 animal studies of psychosis, with the most common model being schizophrenia (95%). 61% of these models are induced using pharmacological agents. For all the models only 56% of publications test a therapeutic treatment. We propose a systematic review of these studies to assess the prevalence of reporting of measures to reduce risk of bias, and a meta-analysis to assess the internal and external validity of these animal models. Our findings are likely to be relevant to future preclinical studies of psychosis as this generation of strong empirical evidence has the potential to identify weaknesses, areas for improvement and make suggestions on refinement of experimental design. Such a detailed understanding of the data which inform what we think we know will help improve the current attrition rate between bench and bedside in psychosis research.

Keywords: animal models, psychosis, systematic review, schizophrenia

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Authors: Patience Muchini, Electdom Matandiroya, Emmanuel Mashonjowa

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A ground-end manifestation of space weather phenomena is known as geomagnetically induced currents (GICs). GICs flow along the electric power transmission cables connecting the transformers and between the grounding points of power transformers during significant geomagnetic storms. Geomagnetically induced currents have been studied in other regions and have been noted to affect the power grid network. In Zimbabwe, grid failures have been experienced, but it is yet to be proven if these failures have been due to GICs. The purpose of this paper is to characterize geomagnetically induced currents with a power grid network. This paper analyses data collected, which is geomagnetic data, which includes the Kp index, DST index, and the G-Scale from geomagnetic storms and also analyses power grid data, which includes reactive power, relay tripping, and alarms from high voltage substations and then correlates the data. This research analysis was first theoretically analyzed by studying geomagnetic parameters and then experimented upon. To correlate, MATLAB was used as the basic software to analyze the data. Latitudes of the substations were also brought into scrutiny to note if they were an impact due to the location as low latitudes areas like most parts of Zimbabwe, there are less severe geomagnetic variations. Based on theoretical and graphical analysis, it has been proven that there is a slight relationship between power system failures and GICs. Further analyses can be done by implementing measuring instruments to measure any currents in the grounding of high-voltage transformers when geomagnetic storms occur. Mitigation measures can then be developed to minimize the susceptibility of the power network to GICs.

Keywords: adverse space weather, DST index, geomagnetically induced currents, KP index, reactive power

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Authors: Onyebuchi Mogbo, Abdulsalam Mohammed, Salsabila Wali

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This research discusses the design and modeling of an amphibious building. The amphibious building is a house with the function of floating during a flood event. Over the years, houses have been built to resist flood events some of which have failed. The floating house is designed to work with nature and not against it. In the event of a flood, the house will rise with the increasing water level and protect the house from sinking. For the design and modeling of this house an estimated cost of N250, 000, approximately $700, will be needed. It is expected that the house will rise when lightweight materials are incorporated in the design, and the concrete dock (in form of a hollow box) carrying the entire house in its hollow space is well designed. When there is flooding the water will fill up the concrete dock, and the house will rise upwards with vertical guides preventing it from moving side to side or out of its boundary. Architectural and Structural designs will be used in this project.

Keywords: amphibious building, flood, housing, design and modelling

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Authors: Y. Bai, M. Bodlak, V. Frolov, S. Huber, V. Jary, I. Konorov, D. Levit, J. Novy, D. Steffen, O. Subrt, M. Virius

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Modern experiments in high energy physics impose great demands on the reliability, the efficiency, and the data rate of Data Acquisition Systems (DAQ). This contribution focuses on the development and deployment of the new communication library DIALOG for the intelligent, FPGA-based Data Acquisition System (iFDAQ) of the COMPASS experiment at CERN. The iFDAQ utilizing a hardware event builder is designed to be able to readout data at the maximum rate of the experiment. The DIALOG library is a communication system both for distributed and mixed environments, it provides a network transparent inter-process communication layer. Using the high-performance and modern C++ framework Qt and its Qt Network API, the DIALOG library presents an alternative to the previously used DIM library. The DIALOG library was fully incorporated to all processes in the iFDAQ during the run 2016. From the software point of view, it might be considered as a significant improvement of iFDAQ in comparison with the previous run. To extend the possibilities of debugging, the online monitoring of communication among processes via DIALOG GUI is a desirable feature. In the paper, we present the DIALOG library from several insights and discuss it in a detailed way. Moreover, the efficiency measurement and comparison with the DIM library with respect to the iFDAQ requirements is provided.

Keywords: data acquisition system, DIALOG library, DIM library, FPGA, Qt framework, TCP/IP

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Authors: Josine Beek, S. Agten, R. Del Pozo, B. Balis

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The objective of the present study was to compare the safety of intramuscular administration of Zuprevo® (tildipirosin, 40 mg/mL) with Draxxin® (tulathromycin, 100 mg/mL) in the treatment of swine respiratory disease at weaning age. The trial was carried out in two farrow-to-finish farms with 300 sows (farm A) and 500 sows (farm B) in a batch-production system. Farm A had no history of respiratory problems, whereas farm B had a history of respiratory outbreaks with increased mortality ( > 2%) in the nursery. Both farms were positive to Pasteurella multocida, Bordetella bronchiseptica, Actinobacillus pleuropneumoniae and Haemophilus parasuis. From each farm, one batch of piglets was included (farm A: 644 piglets; farm B: 963 piglets). One day before weaning (day 0; 18-21 days of age), piglets were identified by an individual ear tag and randomly assigned to a treatment group. At day 0, Group 1 was treated with a single intramuscular injection with Zuprevo® (tildipirosin, 40 mg/mL; 1 mL/10 kg) and group 2 with Draxxin® (tulathromycin, 100 mg/mL; 1 mL/40 kg). For practical reasons, dosage of the product was adjusted according to three weight categories: < 4 kg, 4-6 kg and > 6 kg. Within each farm, piglets of both groups were comingled at weaning and subsequently managed and located in the same facilities and with identical environmental conditions. Our study involved the period from day 0 until 10 weeks of age. Safety of treatment was evaluated by 1) visual examination for signs of discomfort directly after treatment and after 15 min, 1 h and 24 h and 2) mortality rate within 24 h after treatment. Efficacy of treatment was evaluated based on mortality rate from day 0 until 10 weeks of age. Each piglet that died during the study period was necropsied by the herd veterinarian to determine the probable cause of death. Data were analyzed using binary logistic regression and differences were considered significant if p < 0.05. The pig was the experimental unit. In total, 848 piglets were treated with tildipirosin and 759 piglets with tulathromycin. In farm A, one piglet with retarded growth ( < 1 kg at 18 days of age) showed an adverse reaction after injection of tildipirosin: lateral recumbence and dullness for ± 30 sec. The piglet recovered after 1-2 min. This adverse reaction was probably due to overdosing (12 mg/kg). No adverse effect of treatment was observed in any other piglet. There was no mortality within 24 h after treatment. No significant difference was found in mortality rate between both groups from day 0 until 10 weeks of age. In farm A, overall mortality rate was 0.3% (2/644). In farm B, mortality rate was 0.2% (1/502) in group 1 (tildipirosin) and 0.9% (4/461) in group 2 (tulathromycin)(p=0.60). The necropsy of piglets that died during the study period revealed no macroscopic lesions of the respiratory tract. In conclusion, Zuprevo® (tildipirosin, 40 mg/mL) was shown to be a safe and efficacious alternative to Draxxin® (tulathromycin, 100 mg/mL) for the early treatment of swine respiratory disease at weaning age.

Keywords: antibiotic treatment, safety, swine respiratory disease, tildipirosin

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Authors: Andreas Jede, Frank Teuteberg

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Cloud computing (CC) has already gained overall appreciation in research and practice. Whereas the willingness to integrate cloud services in various IT environments is still unbroken, the previous CC procurement processes run mostly in an unorganized and non-standardized way. In practice, a sufficiently specific, yet applicable business process for the important acquisition phase is often lacking. And research does not appropriately remedy this deficiency yet. Therefore, this paper introduces a field-tested approach for CC procurement. Based on an extensive literature review and augmented by expert interviews, we designed a model that is validated and further refined through an in-depth real-life case study. For the detailed process description, we apply the event-driven process chain notation (EPC). The gained valuable insights into the case study may help CC research to shift to a more socio-technical area. For practice, next to giving useful organizational instructions we will provide extended checklists and lessons learned.

Keywords: cloud procurement process, IT-organization, event-driven process chain, in-depth case study

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Authors: Nayoma Ranawaka

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The demand for the high quality internationally comparable financial information has been increased than ever with the expansion of economic activities beyond its national boundaries. Thus, the necessity of converging accounting practices across the world is now continuously discussed with greater emphasis. The global convergence to International Financial Reporting Standards has been one of the main objectives of the International Accounting Standards Setting Board (IASB) since its establishment in 2001. Accordingly, Sri Lanka has adopted IFRSs in 2012. Among the other standards as a newly introduced standard by the IASB, IFRS 13 plays a pivotal role as it deals with the Fair Value Accounting (FVA). Therefore, it is valuable to obtain knowledge about the consequences of implementing IFRS 13 in Sri Lanka and compare results across nations. According to the IFRS Jurisdictional provision of Sri Lanka, Institute of Chartered Accountants of Sri Lanka has taken official steps to adopt IFRS 13 by introducing SLFRS 13 with de jure convergence. Then this study was identified the de facto convergence of the SLFRS 13 in measuring the Fair Value of Financial Instruments in the Sri Lankan context. Accordingly, the objective of this study is to explore the consequences to financial reporting by implementing SLFRS 13 on measuring the financial instruments. In order to achieve the objective of the study expert interview and in-depth interviews with the interviewees from the selected three case studies and their independent auditor were carried out using customized three different interview guides. These three cases were selected from three different industries; Banking, Manufacturing and Finance. NVivo version 10 was used to analyze the data collected through in-depth interviews. Then the content analysis was carried out and conclusions were derived based on the findings. Contribution to the knowledge by this study can be identified in different aspects. Findings of this study facilitate accounting practitioners to get an overall picture of application of fair value standard in measuring the financial instruments and to identify the challenges and barriers to the adoption process. Further, assist auditors in carrying out their audit procedures to check the level of compliance to the fair value standard in measuring the financial instruments. Moreover, this would enable foreign investors in assessing the reliability of the financial statements of their target investments as a result of SLFRS 13 in measuring the FVs of the FIs. The findings of the study could be used to open new avenues of thinking for policy formulators to provide the necessary infrastructure to eliminate disparities exists among different regulatory bodies to facilitate full convergence and thereby growth of the economy. Further, this provides insights to the dynamics of FVA implementation that are also relevant for other developing countries.

Keywords: convergence, fair value, financial instruments, IFRS 13

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Authors: Tien-Ching Yao, Ching-Ching Lu

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Understanding human language processing is one of the main challenges of current cognitive neuroscience. The aims of the present study were to use a sentence decision task combined with event-related potentials to investigate the psychological reality of "cross-sentence patterns." Therefore, we take the math word problems the experimental materials and use the ERPs' P600 component to verify. In this study, the experimental material consisted of 200 math word problems with three different conditions were used ( multiplication word problems、division word problems type 1、division word problems type 2 ). Eighteen Mandarin native speakers participated in the ERPs study (14 of whom were female). The result of the grand average waveforms suggests a later posterior positivity at around 500ms - 900ms. These findings were tested statistically using repeated measures ANOVAs at the component caused by the stimulus type of different questions. Results suggest that three conditions present significant (P < 0.05) on the Mean Amplitude, Latency, and Peak Amplitude. The result showed the characteristic timing and posterior scalp distribution of a P600 effect. We interpreted these characteristic responses as the psychological reality of "cross-sentence patterns." These results provide insights into the sentence processing issues in linguistic theory and psycholinguistic models of language processing and advance our understanding of how people make sense of information during language comprehension.

Keywords: language processing, sentence comprehension, event-related potentials, cross-sentence patterns

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Authors: Grace Scaplehorn, Muhammad Adeel Akhtar, Jane Gibson

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Background: Canoe Slalom entails the skilful navigation of a carbon composite canoe or kayak through a series of 18-25 hanging gates, strategically positioned along the course, either upstream or downstream, amidst currents of whitewater rapids in natural and man-made river settings. Athletes compete individually in timed trials, competing for the fastest course time, typically around 80 to 120 seconds. In the new discipline of Kayak Cross, descents of the course are initiated by groups of four athletes freefalling simultaneously from a starting platform situated 3m above the river. Kayak Cross athletes, in contrast to Canoe Slalom, can make physical contact with suspended gates without incurring time penalties and are required to perform a kayak roll half way down the course. The Canoe Slalom World Championships were held at Lee Valley Whitewater Centre, London, from 19th to 24th September 2023. The event comprised 299 international athletes competing for 10 World Championship titles in Canoe/Kayak Slalom events (Olympic Debut Munich 1972), and the new Kayak Cross discipline (Olympic Debut Paris 2024). The inaugural appearance of Kayak Cross at the World Championships occurred in 2017, in Pau, France. There is limited literature surrounding Kayak Cross and the incidence of athlete injuries compared to traditional Canoe Slalom, hence it was felt important to undertake this review to address the perception that the event is dangerous. Aim: The study aimed to quantify and collate data collected from athletes presenting to the event medical centre. Methods: Athletes’ details were collected at initial assessments from the start of the practice period (16th–18th September) and throughout the event. Demographics such as age, sex and nationality were recorded along with presenting complaints, treatment, medication administered and outcome. Specifically, injuries were then sub-classified into body regions. The data does not include athletes who sought medical attention from their own governing body’s medical team. Results: During the 8-day period, there were 11 individual presentations to the medical centre, 3.7% of the athlete population (n=299). The mean age was 23.9 years (n=7), 6 were male (n=10). The most common presentation was minor injury (n=9), with 6 being musculoskeletal and 3 comprising skin damage, followed by insect sting/allergy (n=1) and pain relief requests (n=1). Five presentations were event-related, all being musculoskeletal injuries; 2 shoulder/arm, 1 head/neck, 1 hand/wrist and 1 other (data was not recorded). Of these injuries, the only intervention was 2 cases of 400mg Ibuprofen, which was given to both shoulder/arm injuries. Four of the 11 presentations were pre-existing injuries, which had been exacerbated due to increased intensity of practice. Two patients were advised to return for review, with 100% compliance. There were no unplanned re-presentations, and no emergency transfers to secondary care. Both the Kayak Cross and Canoe Slalom competitions resulted in 1 new event-related athlete presentation each. Conclusion: The event resulted in a negligible incidence of presentations at the medical centre, for both Kayak Cross and Canoe Slalom. This data holds significance in informing risk assessments and medical protocols necessary for the organisation of canoe slalom events.

Keywords: canoe slalom, kayak cross, athlete injuries, event injuries

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Authors: Byung Keun Yang, Jae Eun Ku, Young Seon Joo, Je Sung You, Sung Phil Chung, Hahn Shick Lee

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The purpose of this study is to review the evidence comparing the efficacy and safety between L-carnitine and extracorporeal elimination therapy in the management of acute valproic acid L-carnitine vs Extracorporeal Elimination for Acute Valproic acid Intoxication. PubMed, Embase, Cochrane library, Web of Science, KoreaMed, KMbase, and KISS were searched, using the terms carnitine and valproic acid. All studies, regardless of design, reporting efficacy or safety endpoints were included. Reference citations from identified publications were reviewed. Both English and Korean languages were included. Two authors extracted primary data elements including poisoning severity, presenting features, clinical management, and outcomes. Thirty two articles including 33 cases were identified. Poisoning severity was classified as 3 mild, 11 moderate, and 19 severe cases. Nine cases were treated with L-carnitine while 24 cases received extracorporeal therapy without L-carnitine. All patients except one expired patient treated with hemodialysis recovered clinically and no adverse effects were noted. A case report comparing two patients who ingested the same amount of valproic acid showed increased ICU stay (3 vs. 11 days) in case of delayed extracorporeal therapy. Published evidence comparing L-carnitine with extracorporeal therapy is limited. Based on the available evidence, it is reasonable to consider L-carnitine for patients with acute valproic acid overdose. In case of severe poisoning, extracorporeal therapy would also be considered in the early phase of treatment.

Keywords: carnitine, overdose, poisoning, renal dialysis, valproic acid

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Authors: Ehsan Ahmed Yahia

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Introduction: The nursing role in nutrition screening and assessing hospitalized patients is important. Malnutrition is a common and costly problem, particularly among hospitalized patients, and can have an adverse effect on the healing process. The study's goal is to assess the prevalence of malnutrition among adult hospitalized orthopedic patients and to detect the barriers to the nutrition screening process. Aim of the study: This study aimed to (a) assess the prevalence of malnutrition in hospitalized orthopedic patients and (b) evaluate the relationship between malnutrition and selected clinical outcomes. Material and Methods: This prospective field study was conducted for three months between 03/2022 and 06/2022 in the selected orthopedic departments in a teaching hospital affiliated withCairo University, Egypt. with a total number of one hundred twenty (120) patients. Patients' assessment included checking for malnutrition using the Nutritional Risk Screening Questionnaire. Patients at risk for malnourishment were defined as NRS score ≥ 3. Clinical outcomes under consideration included 1) length of hospitalization, 2) mobilization after surgery and conservative treatment, and 3) rate of adverse events. Results: This study found that malnutrition is a significant problem among patients hospitalized in an orthopedic ward. The prevalence of malnutrition was the highest in patients with lumbar spine and pelvis fractures, followed by the proximal femur and proximal humerus fractures. Patients at risk for malnutrition had significantly prolonged hospitalization, delayed postoperative mobilization, and increased incidence of adverse events.27.8% of the study sample were at risk for malnutrition. The highest prevalence of malnourishment was found in Septic Surgery with 32%, followed by Traumatology with 19.6% and Arthroplasty with 15.3%. A higher prevalence of malnutrition was detected among patients with typical fractures, such as lumbar spine and pelvis (46.7%), proximal femur (34.4%), and proximal humeral (23.7%) fractures. Additionally, patients at risk for malnutrition showed prolonged hospitalization (14.7 ± 11.1 vs. 21.2 ± 11.7 days), delayed postoperative mobilization (2.3 ± 2.9 vs. 4.1 ± 4.9 days), and delayed to mobilize after conservative treatment (1.1 ± 2.7 vs. 1.8 ± 1.9 days). A significant statistical correlation of NRS with individual parameters (Spearman's rank correlation, p < 0.05) was observed. The rate of adverse incidents in patients at risk for malnutrition was significantly higher than that of patients with a regular nutritional status (37.2% vs. 21.1%, p < 0.001). Conclusions: Our results indicate that the prevalence of malnutrition in surgical patients is significant. The nutritional status of patients with typical fractures is especially at risk. Prolonged hospitalization, delayed postoperative mobilization, and delayed mobilization after conservative treatment is significantly associated with malnutrition. In addition, the incidence of adverse events in patients at risk for malnutrition is significantly higher.

Keywords: malnutrition, nutritional risk screening, surgery, nursing, orthopedic nurse

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Authors: Minjeong Kim, Seungchul Lee, Iman Janghorban Esfahani, Jeong Tai Kim, ChangKyoo Yoo

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A trajectory of set-point of ventilation control systems plays an important role for efficient ventilation inside subway stations since it affects the level of indoor air pollutants and ventilation energy consumption. To maintain indoor air quality (IAQ) at a comfortable range with lower ventilation energy consumption, the optimal trajectory of the ventilation control system needs to be determined. The concentration of air pollutants inside the station shows a diurnal variation in accordance with the variations in the number of passengers and subway frequency. To consider the diurnal variation of IAQ, an iterative dynamic programming (IDP) that searches for a piecewise control policy by separating whole duration into several stages is used. When outdoor air is contaminated by pollutants, it enters the subway station through the ventilation system, which results in the deteriorated IAQ and adverse effects on passenger health. In this study, to consider the influence of outdoor air quality (OAQ), a new performance index of the IDP with the passenger health risk and OAQ is proposed. This study was carried out for an underground subway station at Seoul Metro, Korea. The optimal set-points of the ventilation control system are determined every 3 hours, then, the ventilation controller adjusts the ventilation fan speed according to the optimal set-point changes. Compared to manual ventilation system which is operated irrespective of the OAQ, the IDP-based ventilation control system saves 3.7% of the energy consumption. Compared to the fixed set-point controller which is operated irrespective of the IAQ diurnal variation, the IDP-based controller shows better performance with a 2% decrease in energy consumption, maintaining the comfortable IAQ range inside the station.

Keywords: indoor air quality, iterative dynamic algorithm, outdoor air information, ventilation control system

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Authors: Ofuan James Ilaboya, Okhae J. Ibhadode

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The objective of this paper is to theoretically examine the truism of the “true and fair view” in the context of financial reporting. The paper examines the concepts such as true, fair, true and fair view, problems of true and fair view, the origin/history of true and fair view, review of attributes and key issues relating to true and fair view. The methodological approach adopted in this paper is library-based research, focusing on the review of relevant and related extant literature. The findings based on the review of relevant and related literature is suggestive of the fact that the true and fair concept in financial reporting environment is contentious. The study concludes that given the circumstances as chronicled on this paper, it is evident that the truism of the true and fair view of the auditor’s opinion is under serious threat. The way forward may be for the auditor to certify the accuracy and the correctness of the financial statement. While this position being canvassed here may help to substantially bridge the age-long expectation gap, it may as well require an upward review of the current audit fee structure in order to be able to operationalize the onerous task of certifying the accuracy and correctness of the financial statement. This position is contentious and will require a robust consideration which is not within the purview of the present review.

Keywords: fiduciary duty, financial statement, true and correct, true and fair

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Authors: Eda Orhun

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Purpose: This paper analyzes a target firm’s decision to voluntarily disclose information during a takeover event and the effect of such disclosures on the outcome of the takeover. Such voluntary disclosures especially in the form of earnings forecasts made around takeover events may affect shareholders’ decisions about the target firm’s value and in return takeover result. This study aims to shed light on this question. Design/methodology/approach: The paper tries to understand the role of voluntary disclosures by target firms during a takeover event in the likelihood of takeover success both theoretically and empirically. A game-theoretical model is set up to analyze the voluntary disclosure decision of a target firm to inform the shareholders about its real worth. The empirical implication of model is tested by employing binary outcome models where the disclosure variable is obtained by identifying the target firms in the sample that provide positive news by issuing increasing management earnings forecasts. Findings: The model predicts that a voluntary disclosure of positive information by the target decreases the likelihood that the takeover succeeds. The empirical analysis confirms this prediction by showing that positive earnings forecasts by target firms during takeover events increase the probability of takeover failure. Overall, it is shown that information dissemination through voluntary disclosures by target firms is an important factor affecting takeover outcomes. Originality/Value: This study is the first to the author's knowledge that studies the impact of voluntary disclosures by the target firm during a takeover event on the likelihood of takeover success. The results contribute to information economics, corporate finance and M&As literatures.

Keywords: takeovers, target firm, voluntary disclosures, earnings forecasts, takeover success

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Authors: C. Pacheco, A. Cipriano

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A new concept of response system is proposed for filling the gap that exists in reducing vulnerability during immediate response to natural disasters. Real Time Early Response Systems (RTERSs) incorporate real time information as feedback data for closing control loop and for generating real time situation assessment. A review of the state of the art works that fit the concept of RTERS is presented, and it is found that they are mainly focused on manmade disasters. At the same time, in response phase of natural disaster management many works are involved in creating early warning systems, but just few efforts have been put on deciding what to do once an alarm is activated. In this context a RTERS arises as a useful tool for supporting people in their decision making process during natural disasters after an event is detected, and also as an innovative context for applying well-known automation technologies and automatic control concepts and tools.

Keywords: disaster management, emergency response system, natural disasters, real time

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Authors: Zeynep Şahin, Züleyha Yılmaz, Fikret Çankaya

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In today's business world, in which it is difficult to survive, the economic life of products, services or knowledge is considerably reduced. Competitors produce similar products or extra-featured ones instantly. In this environment, the contribution of companies to the social and economic environment is a preferred criterion by consumers alongside products or services. Therefore, consumers need to obtain more detailed information about companies. Besides, this drastic change in the market encourages companies to become sustainable. Sustainable business means the company puts consumed products back. Corporate sustainability, corresponds to sustainability at the level of the company, and gives equal importance to company growth and profitability together with environmental and social issues. The BIST Sustainability Index started to be calculated by the Istanbul Stock Exchange (BIST) in 2014 to evaluate the sustainability performance of companies in Turkey. The main objective of this study is to present the importance of sustainability reports in Turkey. To this aim, the performances of 15 companies in the BIST Sustainability Index were compared the periods before and after entering the index. On the other hand, sustainability reporting practices should be encouraged to increase studies on this issue. In this context, to remain on the agenda of the issue is a further objective of this study. To achieve these objectives, the financial data of the companies in the period before and after entering to the BIST Sustainability Index were analyzed using t-test in Statistical Package for the Social Sciences (SPSS) package. The results of the study showed that no significant difference between the performances of the companies in terms of the net profit margin, the return on assets and equity capital in these periods could be found. Therefore, it can be said that insufficient importance is given to sustainability issues in Turkey. The reasons for this situation might be considered as a lack of awareness due to the recent introduction and calculation of the index. It is expected that the awareness of firms and investors about sustainability will increase, and that they will demonstrate the necessary importance to this issue over time.

Keywords: sustainability reporting, sustainability index, firm performance, BIST sustainability index

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Authors: Jianguo Chen, Fenggang Zang, Yu Yang, Liangang Zheng

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Reactor Pressure Vessel (RPV) is an important security barrier in nuclear power plant. Crack like defects may be produced on RPV during the whole operation lifetime due to the harsh operation condition and irradiation embrittlement. During the severe loss of coolant accident, thermal shock happened as the injection of emergency cooling water into RPV, which results in re-pressurization of the vessel and very high tension stress on the vessel wall, this event called Pressurized Thermal Shock (PTS). Crack on the vessel wall may propagate even penetrate the vessel, so the safety of the RPV would undergo great challenge. Many assumptions in structure integrity evaluation make the result of deterministic fracture mechanics very conservative, which affect the operation lifetime of the plant. Actually, many parameters in the evaluation process, such as fracture toughness and nil-ductility transition temperature, have statistical distribution characteristics. So it is necessary to assess the structural integrity of RPV subjected to PTS event by means of Probabilistic Fracture Mechanics (PFM). Structure integrity evaluation methods of RPV subjected to PTS event are summarized firstly, then evaluation method based on probabilistic fracture mechanics are presented by considering the probabilistic characteristics of material and structure parameters. A comprehensive analysis example is carried out at last. The results show that the probability of crack penetrates through wall increases gradually with the growth of fast neutron irradiation flux. The results give advice for reactor life extension.

Keywords: fracture toughness, integrity evaluation, pressurized thermal shock, probabilistic fracture mechanics, reactor pressure vessel

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Authors: Brenden M. Shutt, Lubjana Beshaj, Paul L. Goethals, Ambrose Kam

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Communication security is of particular interest to military data networks. A relatively novel approach to network security is blockchain, a cryptographically secured distribution ledger with a decentralized consensus mechanism for data transaction processing. Recent advances in blockchain technology have proposed new techniques for both data validation and trust management, as well as different frameworks for managing dataflow. The purpose of this work is to test the feasibility of different blockchain architectures as applied to military command and control networks. Various architectures are tested through discrete-event simulation and the feasibility is determined based upon a blockchain design’s ability to maintain long-term stable performance at industry standards of throughput, network latency, and security. This work proposes a consortium blockchain architecture with a computationally inexpensive consensus mechanism, one that leverages a Proof-of-Identity (PoI) concept and a reputation management mechanism.

Keywords: blockchain, consensus mechanism, discrete-event simulation, fog computing

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Authors: Mohd Taufiq bin Azmy, Yahaya Hassan, Shubashini Gnanasan, Loganathan Fahrni

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Inappropriate prescribing in older patients has been associated with resource utilization and adverse drug events (ADE) such as hospitalization, morbidity and mortality. Globally, there is a lack of published data on ADE induced by inappropriate prescribing. Our study is specific to an older population and is aimed at identifying risk factors for ADE and to develop a model that will link ADE to inappropriate prescribing. The design of the study was prospective whereby computerized medical records of 302 hospitalized elderly aged 65 years and above in 3 public hospitals in Malaysia (Hospital Serdang, Hospital Selayang and Hospital Sungai Buloh) were studied over a 7 month period from September 2013 until March 2014. Potentially inappropriate medications and potential prescribing omissions were determined using the published and validated START-STOPP criteria. Patients who had at least one inappropriate medication were included in Phase II of the study where ADE were identified by local expert consensus panel based on the published and validated Naranjo ADR probability scale. The panel also assessed whether ADE were causal or contributory to current hospitalization. The association between inappropriate prescribing and ADE (hospitalization, mortality and adverse drug reactions) was determined by identifying whether or not the former was causal or contributory to the latter. Rate of ADE avoidability was also determined. Our findings revealed that the prevalence of potential inappropriate prescribing was 58.6%. A total of ADEs were detected in 31 of 105 patients (29.5%) when STOPP criteria were used to identify potentially inappropriate medication; All of the 31 ADE (100%) were considered causal or contributory to admission. Of the 31 ADEs, 28 (90.3%) were considered avoidable or potentially avoidable. After adjusting for age, sex, comorbidity, dementia, baseline activities of daily living function, and number of medications, the likelihood of a serious avoidable ADE increased significantly when a potentially inappropriate medication was prescribed (odds ratio, 11.18; 95% confidence interval [CI], 5.014 - 24.93; p < .001). The medications identified by STOPP criteria, are significantly associated with avoidable ADE in older people that cause or contribute to urgent hospitalization but contributed less towards morbidity and mortality. Findings of the study underscore the importance of preventing inappropriate prescribing.

Keywords: adverse drug events, appropriate prescribing, health services research

Procedia PDF Downloads 396

Authors: Ching-Yi Wang

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The purpose of this study is to explore strategies for integrate Minhsiung environments and cultural resources for Infernal Lord Festival. Minhsiung Infernal Lord Festival is one of the famous religious event in Chia-Yi County, Taiwan. This religious event and the life of local residents are inseparable. Minhsiung Infernal Lord Festival has a rich cultural ceremonies meaning and sentiment of local concern. This study apply field study, document analysis and interviews to analyze Minhsiung Township’s featured attractions and folklore events. The research results reveal the difficulties and strategies while incorporating culture elements into culture tourism. This study hopes to provide innovative techniques for the purpose of prolonging the feasibility of future development of the tradition folk culture.

Keywords: Taiwan folk culture, Minhsiung Infernal Lord Festival, religious tourism, folklore, cultural tourism

Procedia PDF Downloads 338