Search results for: Distributed Feedback (DFB)
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3189

Search results for: Distributed Feedback (DFB)

1089 Evaluation of a Higher Diploma in Mental Health Nursing Using Qualitative and Quantitative Methods: Effects on Student Behavior, Attitude and Perception

Authors: T. Frawley, G. O'Kelly

Abstract:

The UCD School of Nursing, Midwifery and Health Systems Higher Diploma in Mental Health (HDMH) nursing programme commenced in January 2017. Forty students successfully completed the programme. Programme evaluation was conducted from the outset. Research ethics approval was granted by the UCD Human Research Ethics Committee – Sciences in November 2016 (LS-E-16-163). Plan for Sustainability: Each iteration of the programme continues to be evaluated and adjusted accordingly. Aims: The ultimate purpose of the HDMH programme is to prepare registered nurses (registered children’s nurse (RCN), registered nurse in intellectual disability (RNID) and registered general nurse (RGN)) to function as effective registered psychiatric nurses in all settings which provide care and treatment for people experiencing mental health difficulties. Curriculum evaluation is essential to ensure that the programme achieves its purpose, that aims and expected outcomes are met and that required changes are highlighted for the programme’s continuing positive development. Methods: Both quantitative and qualitative methods were used in the evaluation. A series of questionnaires were used (the majority pre and post programme) to determine student perceptions of the programme, behaviour and attitudinal change from commencement to completion. These included the student assessment of learning gains (SALG); mental health knowledge schedule (MAKS); mental health clinician attitudes scale (MICA); reported and intended behaviour scale (RIBS); and community attitudes towards the mentally ill (CAMI). In addition, student and staff focus groups were conducted. Evaluation methods also incorporated module feedback. Outcome/Results: The evaluation highlighted a very positive response in relation to the achievement of programme outcomes and preparation for future work as registered psychiatric nursing. Some areas were highlighted for further development, which have been taken cognisance of in the 2019 iteration of the programme.

Keywords: learning gains, mental health, nursing, stigma

Procedia PDF Downloads 133
1088 The Relationship among Perceived Risk, Product Knowledge, Brand Image and the Insurance Purchase Intention of Taiwanese Working Holiday Youths

Authors: Wan-Ling Chang, Hsiu-Ju Huang, Jui-Hsiu Chang

Abstract:

In 2004, the Ministry of Foreign Affairs Taiwan launched ‘An Arrangement on Working Holiday Scheme’ with 15 countries including New Zealand, Japan, Canada, Germany, South Korea, Britain, Australia and others. The aim of the scheme is to allow young people to work and study English or other foreign languages. Each year, there are 30,000 Taiwanese youths applied for participating in the working holiday schemes. However, frequent accidents could cause huge medical expenses and post-delivery fee, which are usually unaffordable for most families. Therefore, this study explored the relationship among perceived risk toward working holiday, insurance product knowledge, brand image and insurance purchase intention for Taiwanese youths who plan to apply for working holiday. A survey questionnaire was distributed for data collection. A total of 316 questionnaires were collected for data analyzed. Data were analyzed using descriptive statistics, independent samples T-test, one-way ANOVA, correlation analysis, regression analysis and hierarchical regression methods of analysis and hypothesis testing. The results of this research indicate that perceived risk has a negative influence on insurance purchase intention. On the opposite, product knowledge has brand image has a positive influence on the insurance purchase intention. According to the mentioned results, practical implications were further addressed for insurance companies when developing a future marketing plan.

Keywords: insurance product knowledges, insurance purchase intention, perceived risk, working holiday

Procedia PDF Downloads 248
1087 The Impact of Technology on Media Content Regulation

Authors: Eugene Mashapa

Abstract:

The age of information has witnessed countless unprecedented technological developments, which signal the articulation of succinct technological capabilities that can match these cutting-edge technological trends. These changes have impacted patterns in the production, distribution, and consumption of media content, a space that the Film and Publication Board (FPB) is concerned with. Consequently, the FPB is keen to understand the nature and impact of these technological changes on media content regulation. This exploratory study sought to investigate how content regulators in high and middle-income economies have adapted to the changes in this space, seeking insights into innovations, technological and operational, that facilitate continued relevance during this fast-changing environment. The study is aimed at developing recommendations that could assist and inform the organisation in regulating media content as it evolves. Thus, the overall research strategy in this analysis is applied research, and the analytical model adopted is a mixed research design guided by both qualitative and quantitative research instruments. It was revealed in the study that the FPB was significantly impacted by the unprecedented technological advancements in the media regulation space. Additionally, there exists a need for the FPB to understand the current and future penetrations of 4IR technology in the industry and its impact on media governance and policy implementation. This will range from reskilling officials to align with the technological skills to developing technological innovations as well as adopting co-regulatory or self-regulatory arrangements together with content distributors, where more content is distributed in higher volumes and with increased frequency. Importantly, initiating an interactive learning process for both FPB employees and the general public can assist the regulator and improve FPB’s operational efficiency and effectiveness.

Keywords: media, regulation, technology, film and publications board

Procedia PDF Downloads 98
1086 Patient Safety Culture in Brazilian Hospitals from Nurse's Team Perspective

Authors: Carmen Silvia Gabriel, Dsniele Bernardi da Costa, Andrea Bernardes, Sabrina Elias Mikael, Daniele da Silva Ramos

Abstract:

The goal of this quantitative study is to investigate patient safety culture from the perspective of professional from the hospital nursing team.It was conducted in two Brazilian hospitals,.The sample included 282 nurses Data collection occurred in 2013, through the questionnaire Hospital Survey on Patient Safety Culture.Based on the assessment of the dimensions is stressed that, in the dimension teamwork across hospital units, 69.4% of professionals agree that when a lot of work needs to be done quickly, they work together as a team; about the dimension supervisor/ manager expectations and actions promoting safety, 70.2% agree that their supervisor overlooks patient safety problems.Related to organizational learning and continuous improvement, 56.5% agree that there is evaluation of the effectiveness of the changes after its implementation.On hospital management support for patient safety, 52.8% refer that the actions of hospital management show that patient safety is a top priority.On the overall perception of patient safety, 57.2% disagree that patient safety is never compromised due to higher amount of work to be completed.In what refers to feedback and communication about error, 57.7% refer that always and usually receive such information. Relative to communication openness, 42.9% said they never or rarely feel free to question the decisions / actions of their superiors.On frequency of event reporting, 64.7% said often and always notify events with no damages to patients..About teamwork across hospital units is noted similarity between the percentages of agreement and disagreement, as on the item there is a good cooperation among hospital units that need to work together, that indicates 41.4% and 40.5% respectively.Related to adequacy of professionals, 77.8 % disagree on the existence of sufficient amount of employees to do the job, 52.4% agree that shift changes are problematic for patients. On nonpunitive response to errors, 71.7% indicate that when an event is reported it seems that the focus is on the person.On the patient safety grade of the institution, 41.6 % classified it as very good. it is concluded that there are positive points in the safety culture, and some weaknesses as a punitive culture and impaired patient safety due to work overload .

Keywords: quality of health care, health services evaluation, safety culture, patient safety, nursing team

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1085 Segmenting 3D Optical Coherence Tomography Images Using a Kalman Filter

Authors: Deniz Guven, Wil Ward, Jinming Duan, Li Bai

Abstract:

Over the past two decades or so, Optical Coherence Tomography (OCT) has been used to diagnose retina and optic nerve diseases. The retinal nerve fibre layer, for example, is a powerful diagnostic marker for detecting and staging glaucoma. With the advances in optical imaging hardware, the adoption of OCT is now commonplace in clinics. More and more OCT images are being generated, and for these OCT images to have clinical applicability, accurate automated OCT image segmentation software is needed. Oct image segmentation is still an active research area, as OCT images are inherently noisy, with the multiplicative speckling noise. Simple edge detection algorithms are unsuitable for detecting retinal layer boundaries in OCT images. Intensity fluctuation, motion artefact, and the presence of blood vessels also decrease further OCT image quality. In this paper, we introduce a new method for segmenting three-dimensional (3D) OCT images. This involves the use of a Kalman filter, which is commonly used in computer vision for object tracking. The Kalman filter is applied to the 3D OCT image volume to track the retinal layer boundaries through the slices within the volume and thus segmenting the 3D image. Specifically, after some pre-processing of the OCT images, points on the retinal layer boundaries in the first image are identified, and curve fitting is applied to them such that the layer boundaries can be represented by the coefficients of the curve equations. These coefficients then form the state space for the Kalman Filter. The filter then produces an optimal estimate of the current state of the system by updating its previous state using the measurements available in the form of a feedback control loop. The results show that the algorithm can be used to segment the retinal layers in OCT images. One of the limitations of the current algorithm is that the curve representation of the retinal layer boundary does not work well when the layer boundary is split into two, e.g., at the optic nerve, the layer boundary split into two. This maybe resolved by using a different approach to representing the boundaries, such as b-splines or level sets. The use of a Kalman filter shows promise to developing accurate and effective 3D OCT segmentation methods.

Keywords: optical coherence tomography, image segmentation, Kalman filter, object tracking

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1084 Utilizing Laser Cutting Method in Men's' Custom-Made Casualwear

Authors: M A. Habit, S. A. Syed-Sahil, A. Bahari

Abstract:

Abstract—Laser cutting is a method of manufacturing process that uses laser in order to cut materials. It provides and ensures extreme accuracy which has a clean cut effect, CO2 laser dominate this application due to their good- quality beam combined with high output power. It comes with a small scale and it has a limitation in cutting sizes of materials, therefore it is more appropriate for custom- made products. The same laser cutting machine is also capable in cutting fine material such as fine silk, cotton, leather, polyester, etc. Lack of explorations and knowledge besides being unaware about this technology had caused many of the designers not to use this laser cutting method in their collections. The objectives of this study are: 1) To identify the potential of laser cutting technique in Custom-Made Garments for men’s casual wear: 2) To experiment the laser cutting technique in custom made garments: 3) To offer guidelines and formula for men’s custom- made casualwear designs with aesthetic value. In order to achieve the objectives, this research has been conducted by using mixed methods which are interviews with two (2) local experts in the apparel manufacturing industries and interviews via telephone with five (5) local respondents who are local emerging fashion designers, the questionnaires were distributed to one hundred (100) respondents around Klang Valley, in order to gain the information about their understanding and awareness regarding laser cutting technology. The experiment was conducted by using natural and man- made fibers. As a conclusion, all of the objectives had been achieved in producing custom-made men’s casualwear and with the production of these attires it will help to educate and enhance the innovation in fine technology. Therefore, there will be a good linkage and collaboration between the design experts and the manufacturing companies.

Keywords: custom-made, fashion, laser cut, men’s wear

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1083 Power Angle Control Strategy of Virtual Synchronous Machine: A Novel Approach to Control Virtual Synchronous Machine

Authors: Shishir Lamichhane, Saurav Dulal, Bibek Gautam, Madan Thapa Magar, Indraman Tamrakar

Abstract:

Renewable energies such as wind turbines and solar photovoltaic have gained significance as a result of global environmental pollution and energy crises. These sources of energy are converted into electrical energy and delivered to end-users through the utility system. As a result of the widespread use of power electronics-based grid-interfacing technologies to accommodate renewable sources of energy, the prevalence of converters has expanded as well. As a result, the power system's rotating inertia is decreasing, endangering the utility grid's stability. The use of Virtual Synchronous Machine (VSM) technology has been proposed to overcome the grid stability problem due to low rotating inertia. The grid-connected inverter used in VSM can be controlled to emulate inertia, which replicates the external features of a synchronous generator. As a result, the rotating inertia is increased to support the power system's stability. A power angle control strategy is proposed in this paper and its model is simulated in MATLAB/Simulink to study the effects of parameter disturbances on the active power and frequency for a VSM. The system consists of a synchronous generator, which is modeled in such a way that the frequency drops to an unacceptable region during transient conditions due to a lack of inertia when VSM is not used. Then, the suggested model incorporating VSM emulates rotating inertia, injecting a controllable amount of energy into the grid during frequency transients to enhance transient stability.

Keywords: damping constant, inertia–constant, ROCOF, transient stability, distributed sources

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1082 Mercury (Hg) Concentration in Fish Marketed in the São Luís Fish Market (MA) and Potential Exposure of Consumers

Authors: Luiz Drude de Lacerda, Kevin Luiz Cordeiro Ferrer do Carmo, Victor Lacerda Moura, Rayone Wesley Santos de Oliveira, Moisés Fernandes Bezerra

Abstract:

Fish is a food source well recognized for its health benefits. However, the consumption of fish, especially carnivorous species, is the main path of human exposure to Hg, a widely distributed pollutant on the planet and that accumulates along food chains. Studies on the impacts on public health by fish intake show existing toxic risks even when at low concentrations. This study quantifies, for the first time, the concentrations of Hg in muscle tissue of the nine most commercialized fish species in the fish market of São Luís (MA) in north Brazil and estimates the consequent human exposure through consumption. Concentrations varied according to trophic level, with the highest found in the larger carnivorous species; the Yellow hake (Cynoscion acoupa) (296.4 ± 241.2 ng/g w.w) and the Atlantic croaker (Micropogonias undulatus) (262.8 ± 89.1 ng/g w.w.), whereas the lowest concentrations were recorded in iliophagous Mullets (Mugil curema) (20.5 ± 9.6 ng/g w.w.). Significant correlations were observed between Hg concentrations and individual length in only two species: the Flaming catfish (Bagre marinus) and the Atlantic bumper (Chloroscombrus crysurus). Given the relatively uniform size of individuals of the other species and/or the small number of samples, this relationship was not found for the other species. The estimated risk coefficients, despite the relatively low concentrations of Hg, suggest that yellow hake and Whitemouth croaker (Micropogonias furnieri), fish most consumed by the local population, present some risk to human health (> 1) HQ and THQ, depending on the frequency of their consumption.

Keywords: contamination, fish, human exposure, risk assessment

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1081 A System Dynamics Approach for Assessing Policy Impacts on Closed-Loop Supply Chain Efficiency: A Case Study on Electric Vehicle Batteries

Authors: Guannan Ren, Thomas Mazzuchi, Shahram Sarkani

Abstract:

Electric vehicle battery recycling has emerged as a critical process in the transition toward sustainable transportation. As the demand for electric vehicles continues to rise, so does the need to address the end-of-life management of their batteries. Electric vehicle battery recycling benefits resource recovery and supply chain stability by reclaiming valuable metals like lithium, cobalt, nickel, and graphite. The reclaimed materials can then be reintroduced into the battery manufacturing process, reducing the reliance on raw material extraction and the environmental impacts of waste. Current battery recycling rates are insufficient to meet the growing demands for raw materials. While significant progress has been made in electric vehicle battery recycling, many areas can still improve. Standardization of battery designs, increased collection and recycling infrastructures, and improved efficiency in recycling processes are essential for scaling up recycling efforts and maximizing material recovery. This work delves into key factors, such as regulatory frameworks, economic incentives, and technological processes, that influence the cost-effectiveness and efficiency of battery recycling systems. A system dynamics model that considers variables such as battery production rates, demand and price fluctuations, recycling infrastructure capacity, and the effectiveness of recycling processes is created to study how these variables are interconnected, forming feedback loops that affect the overall supply chain efficiency. Such a model can also help simulate the effects of stricter regulations on battery disposal, incentives for recycling, or investments in research and development for battery designs and advanced recycling technologies. By using the developed model, policymakers, industry stakeholders, and researchers may gain insights into the effects of applying different policies or process updates on electric vehicle battery recycling rates.

Keywords: environmental engineering, modeling and simulation, circular economy, sustainability, transportation science, policy

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1080 An Efficient Tool for Mitigating Voltage Unbalance with Reactive Power Control of Distributed Grid-Connected Photovoltaic Systems

Authors: Malinwo Estone Ayikpa

Abstract:

With the rapid increase of grid-connected PV systems over the last decades, genuine challenges have arisen for engineers and professionals of energy field in the planning and operation of existing distribution networks with the integration of new generation sources. However, the conventional distribution network, in its design was not expected to receive other generation outside the main power supply. The tools generally used to analyze the networks become inefficient and cannot take into account all the constraints related to the operation of grid-connected PV systems. Some of these constraints are voltage control difficulty, reverse power flow, and especially voltage unbalance which could be due to the poor distribution of single-phase PV systems in the network. In order to analyze the impact of the connection of small and large number of PV systems to the distribution networks, this paper presents an efficient optimization tool that minimizes voltage unbalance in three-phase distribution networks with active and reactive power injections from the allocation of single-phase and three-phase PV plants. Reactive power can be generated or absorbed using the available capacity and the adjustable power factor of the inverter. Good reduction of voltage unbalance can be achieved by reactive power control of the PV systems. The presented tool is based on the three-phase current injection method and the PV systems are modeled via an equivalent circuit. The primal-dual interior point method is used to obtain the optimal operating points for the systems.

Keywords: Photovoltaic system, Primal-dual interior point method, Three-phase optimal power flow, Voltage unbalance

Procedia PDF Downloads 328
1079 Automated Natural Hazard Zonation System with Internet-SMS Warning: Distributed GIS for Sustainable Societies Creating Schema and Interface for Mapping and Communication

Authors: Devanjan Bhattacharya, Jitka Komarkova

Abstract:

The research describes the implementation of a novel and stand-alone system for dynamic hazard warning. The system uses all existing infrastructure already in place like mobile networks, a laptop/PC and the small installation software. The geospatial dataset are the maps of a region which are again frugal. Hence there is no need to invest and it reaches everyone with a mobile. A novel architecture of hazard assessment and warning introduced where major technologies in ICT interfaced to give a unique WebGIS based dynamic real time geohazard warning communication system. A never before architecture introduced for integrating WebGIS with telecommunication technology. Existing technologies interfaced in a novel architectural design to address a neglected domain in a way never done before–through dynamically updatable WebGIS based warning communication. The work publishes new architecture and novelty in addressing hazard warning techniques in sustainable way and user friendly manner. Coupling of hazard zonation and hazard warning procedures into a single system has been shown. Generalized architecture for deciphering a range of geo-hazards has been developed. Hence the developmental work presented here can be summarized as the development of internet-SMS based automated geo-hazard warning communication system; integrating a warning communication system with a hazard evaluation system; interfacing different open-source technologies towards design and development of a warning system; modularization of different technologies towards development of a warning communication system; automated data creation, transformation and dissemination over different interfaces. The architecture of the developed warning system has been functionally automated as well as generalized enough that can be used for any hazard and setup requirement has been kept to a minimum.

Keywords: geospatial, web-based GIS, geohazard, warning system

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1078 An Investigation into the Current Implementation of Design-Build Contracts in the Kingdom of Saudi Arabia

Authors: Ibrahim A. Alhammad, Suleiman A. Al-Otaibi, Khalid S. Al-Gahtani, Naïf Al-Otaibi, Abdulaziz A. Bubshait

Abstract:

In the last decade, the use of project delivery system of design build engineering contracts is increasing in North America due to the reasons of reducing the project duration and minimizing costs. The shift from traditional approach of Design-Bid-Build to Design-Build contracts have been attributed to many factors such as evolution of the regulatory and legal frameworks governing the engineering contracts and improvement in integrating design and construction. The aforementioned practice of contracting is more appropriate in North America; yet, it may not be the case in Saudi Arabia where the traditional approach of construction contracting remains dominant. The authors believe there are number of factors related to the gaps in the level of sophistication of the engineering and management of the construction projects in both countries. A step towards improving the Saudi construction practice by adopting the new trend of construction contracting, this paper identifies the reasons why Design/Build form of contracting are not frequently utilized. A field survey, which includes the questionnaire addressing the research problem, is distributed to three main parties of the construction contracts: clients, consultants, and contractors. The analyzed collected data were statistically sufficient to finding the reasons of not adopting the new trend of good practice of deign build approach in Saudi Arabia. In addition, the reasons are: (1) lack of regulation and legal framework; (2) absence of clear criteria of the owner for the trade-off between competing contractors, (3) and lack of experience, knowledge and skill.

Keywords: design built projects, Saudi Arabia, GCC, mega projects

Procedia PDF Downloads 215
1077 Efficacy of Vitamins A, C and E on the Growth Performance of Broiler Chickens Subjected to Heat Stress

Authors: Desierin Rodrin, Magdalena Alcantara, Cristina Olo

Abstract:

The increase in environmental temperatures brought about by climate change impacts negatively the growth performance of broilers that may be solved by manipulating the diet of the animals. Hence, this study was conducted to evaluate the effects of different vitamin supplements on the growth performance of broiler chickens subjected to ambient (31°C) and heat stress (34°C) temperatures. The treatments were: I- Control (no vitamin supplement), II- Vitamin A (4.5 mg/kg of feed), III- Vitamin C (250 mg/kg of feed), IV- Vitamin E (250 mg/kg of feed), V- Vitamin C and E (250 mg/kg of feed and 250 mg/kg of feed), VI- Vitamin A and E (4.5 mg/kg of feed and 250 mg/kg of feed), VII- Vitamin A and C (4.5 mg/kg of feed and 250 mg/kg of feed), and VIII- Vitamin A, C and E (4.5 mg/kg of feed, 250 mg/kg of feed and 250 mg/kg of feed). The birds (n=240) were distributed randomly into eight treatments replicated three times, with each replicates having five birds. Ambient temperature was maintained using a 25 watts bulb for every 20 birds, while heat stress condition was sustained at 34°C for about 9 hours daily by using a 50 watts bulb per 5 birds. The interaction of vitamin supplements and temperatures did not significantly (P>0.05) affected body weight, average daily gain, feed consumption and feed conversion efficiency throughout the growing period. Similarly, supplementation of different vitamins did not improve (P>0.05) the overall production performance of birds throughout the rearing period. Birds raised in heat stress (34°C) condition had significantly lower ((P<0.05) body weight, average daily gain, and feed consumption compared to birds raised in ambient temperature at weeks 3, 4 and 5 of rearing. Supplementation of vitamins A, C, and E in the diet of broilers did not alleviate the effect of heat stress in the growth performance of broilers.

Keywords: broiler growth performance, heat stress, vitamin supplementation, vitamin A, vitamin C, vitamin E

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1076 Toxic Ingredients Contained in Our Cosmetics

Authors: El Alia Boularas, H. Bekkar, H. Larachi, H. Rezk-kallah

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Introduction: Notwithstanding cosmetics are used in life every day, these products are not all innocuous and harmless, as they may contain ingredients responsible for allergic reactions and, possibly, for other health problems. Additionally, environmental pollution should be taken into account. Thus, it is time to investigate what is ‘hidden behind beauty’. Aims: 1.To investigate prevalence of 13 chemical ingredients in cosmetics being object of concern, which the Algerians use regularly. 2.To know the profile of questioned consumers and describe their opinion on cosmetics. Methods: The survey was carried out in year 2013 over a period of 3 months, among Algerian Internet users having an e-mail address or a Facebook account.The study investigated 13 chemical agents showing health and environmental problems, selected after analysis of the recent studies published on the subject, the lists of national and international regulatory references on chemical hazards, and querying the database Skin Deep presented by the Environmental Working Group. Results: 300 people distributed all over the Algerian territory participated in the survey, providing information about 731 cosmetics; 86% aged from 20 to 39 years, with a sex ratio=0,27. A percentage of 43% of the analyzed cosmetics contained at least one of the 13 toxic ingredients. The targeted ingredient that has been most frequently reported was ‘perfume’ followed by parabens and PEG.85% of the participants declared that cosmetics ‘can contain toxic substances’, 27% asserted that they verify regularly the list of ingredients when they buy cosmetics, 61% said that they try to avoid the toxic ingredients, among whom 24 % were more vigilant on the presence of parabens, 95% were in favour of the strengthening of the Algerian laws on cosmetics. Conclusion: The results of the survey provide the indication of a widespread presence of toxic chemical ingredients in personal care products that Algerians use daily.

Keywords: Algerians consumers, cosmetics, survey, toxic ingredients

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1075 A Literature Review: The Anti-Obesity Effect of Epigallocathecin-3-Gallate of Camellia sinensis (Green Tea) Extraction as a Potential Adjuvant Therapy for Management Obesity

Authors: Nunuy Nuraeni, Vera Amalia Lestari, Atri Laranova, Viena Nissa Mien Fadhillah, Mutia, Muhammad Ikhlas Abdian Putra

Abstract:

Introduction: Obesity is a common disease with high prevalence especially in developing countries including Indonesia. The obesitygenic lifestyle such as excessive intake of food, sedentary lifestyle is the major environmental etiologies of obesity. Obesity is also as one of burden disease with high morbidity due to its complication, such as diabetes mellitus and hypertension. The objective of this literature review is to know how the Epigallocathecin-3-Gallate of Green tea or Camellia sinensis effect as anti-obesity agent and reduce the complication of obesity. Material and Methods: This study based on the secondary data analysis complemented by primary data collection from several journal and textbook. We identified the effect of Epigallocathecin-3-Gallate of Green tea or Camellia sinensis as adjuvant therapy for management obesity and to prevent the complications of obesity. Results: Based on the result, Green tea or Camellia sinensis contain Epigallocathecin-3-Gallate (EGCG) that has anti-obesity effect such as induce apoptosis, inhibit adipogenesis, increasing lipolytic activity, increasing fat oxidation and thermogenesis. Discussion: EGCG are naturally distributed in green tea, that contains a biological activity that has a potential effect to treat obesity. Conclusion: EGCG are capable to treat obesity. By consuming EGCG can prevent obesity in normal health person and prevent complication in patient with obesity.

Keywords: adjuvant therapy, anti-obesity effect, complication, epigallocathecin-3-gallate, obesity

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1074 The Availability Degree of Transformational Leadership Dimensions among Heads of Scientific Departments in the Education Faculty at King Saud University

Authors: Yahya Al-Gabri

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This study aimed to identify the availability degree of transformational leadership dimensions among heads of scientific departments in the Education Faculty at King Saud University. It also aimed to identify the degree of opinions divergence of the study sample on the availability degree of transformational leadership dimensions among the department heads according to the variable of scientific rank. The researcher used the descriptive approach. The study sample consisted of (34) members of education faculty which chosen randomly. To collect the data, the researcher developed a questionnaire consisting of (47) items distributed on four areas after ensuring validity and reliability. Results showed that the degree of practicing the dimensions of transformational leadership by the heads of scientific departments was medium and the mean was (3.21). The dimension of Individualized consideration came first and had a high degree of availability with a mean of (3.31) and the dimension of idealized influence came secondly and had a medium degree (near of high) of availability with a mean of (3.25), also and the dimension of inspirational motivation came thirdly and had a medium degree of availability with a mean of (3.16), whereas the dimension of intellectual stimulation came finally and had a medium degree of availability with a mean of (3.13). The study also showed that there are no statistically significant differences at the level of significance (0.05) in the availability degree of transformational leadership dimensions among the heads of scientific departments at the Faculty of Education according to the scientific rank variable. Finally, the researcher made a number of recommendations and suggestions.

Keywords: transformational leadership, heads of scientific departments, individualized consideration, idealized influence, inspirational motivation, intellectual stimulation

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1073 SEM Detection of Folate Receptor in a Murine Breast Cancer Model Using Secondary Antibody-Conjugated, Gold-Coated Magnetite Nanoparticles

Authors: Yasser A. Ahmed, Juleen M Dickson, Evan S. Krystofiak, Julie A. Oliver

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Cancer cells urgently need folate to support their rapid division. Folate receptors (FR) are over-expressed on a wide range of tumor cells, including breast cancer cells. FR are distributed over the entire surface of cancer cells, but are polarized to the apical surface of normal cells. Targeting of cancer cells using specific surface molecules such as folate receptors may be one of the strategies used to kill cancer cells without hurting the neighing normal cells. The aim of the current study was to try a method of SEM detecting FR in a murine breast cancer cell model (4T1 cells) using secondary antibody conjugated to gold or gold-coated magnetite nanoparticles. 4T1 cells were suspended in RPMI medium witth FR antibody and incubated with secondary antibody for fluorescence microscopy. The cells were cultured on 30mm Thermanox coverslips for 18 hours, labeled with FR antibody then incubated with secondary antibody conjugated to gold or gold-coated magnetite nanoparticles and processed to scanning electron microscopy (SEM) analysis. The fluorescence microscopy study showed strong punctate FR expression on 4T1 cell membrane. With SEM, the labeling with gold or gold-coated magnetite conjugates showed a similar pattern. Specific labeling occurred in nanoparticle clusters, which are clearly visualized in backscattered electron images. The 4T1 tumor cell model may be useful for the development of FR-targeted tumor therapy using gold-coated magnetite nano-particles.

Keywords: cancer cell, nanoparticles, cell culture, SEM

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1072 Portable Cardiac Monitoring System Based on Real-Time Microcontroller and Multiple Communication Interfaces

Authors: Ionel Zagan, Vasile Gheorghita Gaitan, Adrian Brezulianu

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This paper presents the contributions in designing a mobile system named Tele-ECG implemented for remote monitoring of cardiac patients. For a better flexibility of this application, the authors chose to implement a local memory and multiple communication interfaces. The project described in this presentation is based on the ARM Cortex M0+ microcontroller and the ADAS1000 dedicated chip necessary for the collection and transmission of Electrocardiogram signals (ECG) from the patient to the microcontroller, without altering the performances and the stability of the system. The novelty brought by this paper is the implementation of a remote monitoring system for cardiac patients, having a real-time behavior and multiple interfaces. The microcontroller is responsible for processing digital signals corresponding to ECG and also for the implementation of communication interface with the main server, using GSM/Bluetooth SIMCOM SIM800C module. This paper translates all the characteristics of the Tele-ECG project representing a feasible implementation in the biomedical field. Acknowledgment: This paper was supported by the project 'Development and integration of a mobile tele-electrocardiograph in the GreenCARDIO© system for patients monitoring and diagnosis - m-GreenCARDIO', Contract no. BG58/30.09.2016, PNCDI III, Bridge Grant 2016, using the infrastructure from the project 'Integrated Center for research, development and innovation in Advanced Materials, Nanotechnologies, and Distributed Systems for fabrication and control', Contract No. 671/09.04.2015, Sectoral Operational Program for Increase of the Economic Competitiveness co-funded from the European Regional Development Fund.

Keywords: Tele-ECG, real-time cardiac monitoring, electrocardiogram, microcontroller

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1071 The Effect of Artificial Intelligence on Civil Engineering Outputs and Designs

Authors: Mina Youssef Makram Ibrahim

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Engineering identity contributes to the professional and academic sustainability of female engineers. Recognizability is an important factor that shapes an engineer's identity. People who are deprived of real recognition often fail to create a positive identity. This study draws on Hornet’s recognition theory to identify factors that influence female civil engineers' sense of recognition. Over the past decade, a survey was created and distributed to 330 graduate students in the Department of Civil, Civil and Environmental Engineering at Iowa State University. Survey items include demographics, perceptions of a civil engineer's identity, and factors that influence recognition of a civil engineer's identity, such as B. Opinions about society and family. Descriptive analysis of survey responses revealed that perceptions of civil engineering varied significantly. The definitions of civil engineering provided by participants included the terms structure, design and infrastructure. Almost half of the participants said the main reason for studying Civil Engineering was their interest in the subject, and the majority said they were proud to be a civil engineer. Many study participants reported that their parents viewed them as civil engineers. Institutional and operational treatment was also found to have a significant impact on the recognition of women civil engineers. Almost half of the participants reported feeling isolated or ignored at work because of their gender. This research highlights the importance of recognition in developing the identity of women engineers.

Keywords: civil service, hiring, merit, policing civil engineering, construction, surveying, mapping, pile civil service, Kazakhstan, modernization, a national model of civil service, civil service reforms, bureaucracy civil engineering, gender, identity, recognition

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1070 Effect of Temperature on the Properties of Cement Paste Modified with Nanoparticles

Authors: Karine Pimenta Teixeira, Jessica Flores, Isadora PerdigãO Rocha, Leticia De Sá Carneiro, Mahsa Kamali, Ali Ghahremaninezhad

Abstract:

The advent of nanotechnology has enabled innovative solutions towards improving the behavior of infrastructure materials. Nanomaterials have the potential to revolutionize the construction industry by improving the performance and durability of construction materials, as well as imparting new functionalities to these materials. Due to variability in the environmental temperature during mixing and curing of cementitious materials in practice, it is important to understand how curing temperature influences the behavior of cementitious materials. In addition, high temperature curing is relevant in applications such as oil well cement and precast industry. Knowledge of the influence of temperature on the performance of cementitious materials modified with nanoparticles is important in the nanoengineering of cementitious materials in applications such as oil well cement and precast industry. This presentation aims to investigate the influence of temperature on the hydration, mechanical properties and durability of cementitious materials modified with TiO2 nanoparticles. It was found that temperature improved the early hydration. The cement pastes cured at high temperatures showed an increase in the compressive strength at early age but the strength gain decreased at late ages. The electrical resistivity of the cement pastes cured at high temperatures was shown to decrease more noticeably at late ages compared to that of the room temperature cured cement paste. SEM examination indicated that hydration product was more uniformly distributed in the microstructure of the cement paste cured at room temperature compared to the cement pastes cured at high temperature.

Keywords: cement paste, nanoparticles, temperature, hydration

Procedia PDF Downloads 315
1069 Hidden Truths of Advertising: An Unspoken Fact in Making Ethical Diffusions

Authors: Mustafa Hyder, Shamaila Burney, Roohi Mumtaz

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The aim of this study is to determine the consequences of silent or hidden messages and their effectiveness in deteriorating or altering our ethical norms and values. The study also focuses the repercussions of subconscious messages and possibilities of ethical diffusion in our society. The research based on the question that what are the different factors that motivate advertisers to include subliminal messages and how much these unspoken truths affecting our ethical values silently. What are the causes and effects of the subliminal messages in general and the level of ethical diffusion and its acceptance? The concept of advertising is to promote and highlight the salient features of the products and services, a company offers. Advertising is the best option nowadays to convey the related information to the consumers so that they attracted more towards the products or services proposed. The other thing advertisers concentrate, is the psychological characteristics using to persuade consumers choice. Using skills and tactics of advertising to promote a product in such a way that it creates a sensation, controversy or brand consciousness among the consumers or customers. The purpose to have increase purchase or to gain popularity in comparison to their competitors, they sometimes use such tactics and techniques, which is highly unethical and immoral for any society. These kinds of stuff used very smartly within the ads that only the conscious mind subconsciously catches the meaning of those glittery images, posters, phrases, tag lines and non-verbal clues. This study elucidates the subliminal advertising their repercussions and impact on consumer’s behaviour in our society with the help of few ads embedded subliminally and the trends of profitability. The methods used to accomplish our research are based on qualitative research along with the research articles, books and feedback from focused groups regarding the topic. The basic objective of this study was that, there is no significant change in the behaviour and attitude observed. These messages capture very short-term life on the viewer’s subconscious mind but in long run people get used to it and hence not only have the diffusion power but also has the high level of acceptance as well that reflects mostly through their social behaviours and attitudes.

Keywords: ethical diffusion, subconscious, subliminal advertising, unspoken facts

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1068 Qf-Pcr as a Rapid Technique for Routine Prenatal Diagnosis of Fetal Aneuploidies

Authors: S. H. Atef

Abstract:

Background: The most common chromosomal abnormalities identified at birth are aneuploidies of chromosome 21, 18, 13, X and Y. Prenatal diagnosis of fetal aneuploidies is routinely done by traditional cytogenetic culture, a major drawback of this technique is the long period of time required to reach a diagnosis. In this study, we evaluated the QF-PCR as a rapid technique for prenatal diagnosis of common aneuploidies. Method:This work was carried out on Sixty amniotic fluid samples taken from patients with one or more of the following indications: Advanced maternal age (3 case), abnormal biochemical markers (6 cases), abnormal ultrasound (12 cases) or previous history of abnormal child (39 cases).Each sample was tested by QF-PCR and traditional cytogenetic. Aneuploidy screenings were performed amplifying four STRs on chromosomes 21, 18, 13, two pseudoautosomal,one X linked, as well as the AMXY and SRY; markers were distributed in two multiplex QFPCR assays (S1 and S2) in order to reduce the risk of sample mishandling. Results: All the QF-PCR results were successful, while there was two culture failures, only one of them was repeated. No discrepancy was seen between the results of both techniques. Fifty six samples showed normal patterns, three sample showed trisomy 21, successfully detected by both techniques and one sample showed normal pattern by QF-PCR but could not be compared to the cytogenetics due to culture failure, the pregnancy outcome of this case was a normal baby. Conclusion: Our study concluded that QF-PCR is a reliable technique for prenatal diagnosis of the common chromosomal aneuploidies. It has the advantages over the cytogenetic culture of being faster with the results appearing within 24-48 hours, simpler, doesn't need a highly qualified staff, less prone to failure and more cost effective.

Keywords: QF-PCR, traditional cytogenetic fetal aneuploidies, trisomy 21, prenatal diagnosis

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1067 Development of Hierarchically Structured Tablets with 3D Printed Inclusions for Controlled Drug Release

Authors: Veronika Lesáková, Silvia Slezáková, František Štěpánek

Abstract:

Drug dosage forms consisting of multi-unit particle systems (MUPS) for modified drug release provide a promising route for overcoming the limitation of conventional tablets. Despite the conventional use of pellets as units for MUP systems, 3D printed polymers loaded with a drug seem like an interesting candidate due to the control over dosing that 3D printing mechanisms offer. Further, 3D printing offers high flexibility and control over the spatial structuring of a printed object. The final MUPS tablets include PVP and HPC as granulate with other excipients, enabling the compaction process of this mixture with 3D printed inclusions, also termed minitablets. In this study, we have developed the multi-step production process for MUPS tablets, including the 3D printing technology. The MUPS tablets with incorporated 3D printed minitablets are a complex system for drug delivery, providing modified drug release. Such structured tablets promise to reduce drug fluctuations in blood, risk of local toxicity, and increase bioavailability, resulting in an improved therapeutic effect due to the fast transfer into the small intestine, where particles are evenly distributed. Drug loaded 3D printed minitablets were compacted into the excipient mixture, influencing drug release through varying parameters, such as minitablets size, matrix composition, and compaction parameters. Further, the mechanical properties and morphology of the final MUPS tablets were analyzed as many properties, such as plasticity and elasticity, can significantly influence the dissolution profile of the drug.

Keywords: 3D printing, dissolution kinetics, drug delivery, hot-melt extrusion

Procedia PDF Downloads 88
1066 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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1065 Comparison of the Hospital Patient Safety Culture between Bulgarian, Croatian and American: Preliminary Results

Authors: R. Stoyanova, R. Dimova, M. Tarnovska, T. Boeva, R. Dimov, I. Doykov

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Patient safety culture (PSC) is an essential component of quality of healthcare. Improving PSC is considered a priority in many developed countries. Specialized software platform for registration and evaluation of hospital patient safety culture has been developed with the support of the Medical University Plovdiv Project №11/2017. The aim of the study is to assess the status of PSC in Bulgarian hospitals and to compare it to that in USA and Croatian hospitals. Methods: The study was conducted from June 01 to July 31, 2018 using the web-based Bulgarian Version of the Hospital Survey on Patient Safety Culture Questionnaire (B-HSOPSC). Two hundred and forty-eight medical professionals from different hospitals in Bulgaria participated in the study. To quantify the differences of positive scores distributions for each of the 42 HSOPSC items between Bulgarian, Croatian and USA samples, the x²-test was applied. The research hypothesis assumed that there are no significant differences between the Bulgarian, Croatian and US PSCs. Results: The results revealed 14 significant differences in the positive scores between the Bulgarian and Croatian PSCs and 15 between the Bulgarian and the USA PSC, respectively. Bulgarian medical professionals provided less positive responses to 12 items compared with Croatian and USA respondents. The Bulgarian respondents were more positive compared to Croatians on the feedback and communication of medical errors (Items - C1, C4, C5) as well as on the employment of locum staff (A7) and the frequency of reported mistakes (D1). Bulgarian medical professionals were more positive compared with their USA colleagues on the communication of information at shift handover and across hospital units (F5, F7). The distribution of positive scores on items: ‘Staff worries that their mistakes are kept in their personnel file’ (RA16), ‘Things ‘fall between the cracks’ when transferring patients from one unit to another’ (RF3) and ‘Shift handovers are problematic for patients in this hospital’ (RF11) were significantly higher among Bulgarian respondents compared with Croatian and US respondents. Conclusions: Significant differences of positive scores distribution were found between Bulgarian and USA PSC on one hand and between Bulgarian and Croatian on the other. The study reveals that distribution of positive responses could be explained by the cultural, organizational and healthcare system differences.

Keywords: patient safety culture, healthcare, HSOPSC, medical error

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1064 Improving Cleanability by Changing Fish Processing Equipment Design

Authors: Lars A. L. Giske, Ola J. Mork, Emil Bjoerlykhaug

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The design of fish processing equipment greatly impacts how easy the cleaning process for the equipment is. This is a critical issue in fish processing, as cleaning of fish processing equipment is a task that is both costly and time consuming, in addition to being very important with regards to product quality. Even more, poorly cleaned equipment could in the worst case lead to contaminated product from which consumers could get ill. This paper will elucidate how equipment design changes could improve the work for the cleaners and saving money for the fish processing facilities by looking at a case for product design improvements. The design of fish processing equipment largely determines how easy it is to clean. “Design for cleaning” is the new hype in the industry and equipment where the ease of cleaning is prioritized gets a competitive advantage over equipment in which design for cleaning has not been prioritized. Design for cleaning is an important research area for equipment manufacturers. SeaSide AS is doing continuously improvements in the design of their products in order to gain a competitive advantage. The focus in this paper will be conveyors for internal logistic and a product called the “electro stunner” will be studied with regards to “Design for cleaning”. Often together with SeaSide’s customers, ideas for new products or product improvements are sketched out, 3D-modelled, discussed, revised, built and delivered. Feedback from the customers is taken into consideration, and the product design is revised once again. This loop was repeated multiple times, and led to new product designs. The new designs sometimes also cause the manufacturing processes to change (as in going from bolted to welded connections). Customers report back that the concrete changes applied to products by SeaSide has resulted in overall more easily cleaned equipment. These changes include, but are not limited to; welded connections (opposed to bolted connections), gaps between contact faces, opening up structures to allow cleaning “inside” equipment, and generally avoiding areas in which humidity and water may gather and build up. This is important, as there will always be bacteria in the water which will grow if the area never dries up. The work of creating more cleanable design is still ongoing, and will “never” be finished as new designs and new equipment will have their own challenges.

Keywords: cleaning, design, equipment, fish processing, innovation

Procedia PDF Downloads 233
1063 Effect of Dietary Melissa officinalis Leaves Supplementation on Lipid Oxidation of Broiler Breast Fillets During Refrigerated Storage

Authors: Khosro Ghazvinian, Touba Khodaeian

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To improve the oxidative stability of meat products, the use of dietary form of antioxidants can extend the shelf life and acceptability of muscle food during exposition or storage condition. As shown, this method is more effective than adding direct preservatives due to uniform incorporation of dietary additives into sub cellular membrane and therefore, they can properly inhibit the oxidative reaction at their localized sites. Furthermore, postmortem addition of antioxidants to meat cannot directly inhibit the oxidation in membrane phospholipids. Therefore, this study was designed to evaluate the effects of feed supplementation with Melissa officinalis leaves on lipid peroxidation of chicken breast fillets during refrigerated storage. In this study, 72 one-day old Ross 308 broilers distributed in four groups with six replicates (3 chickens each) were fed a basal diet (CONT) or basal diet supplemented with 5, 10, and 15 gr/Kg M.officinalis, for 6 weeks. Following slaughter, fillets from breast were stored at 4 °C in the dark for 12 days, and lipid oxidation was assessed on the basis of thiobarbituric acid reactive substances (TBARS) formed. Results showed that incorporation of M.officinalis in broiler diets delayed lipid oxidation in raw breast meat during refrigerated storage comparative with CONT(p<0.05). In this regard, TBARS levels of breast samples containing higher concentrations (10 and 15 gr/Kg) of M. officinalis (625.43 and 504.32 µg/kg MDA equivalents, respectively )were significantly lower than those of control and 5g/kg samples (872.75 and 841.32 µg/kg MDA equivalents, respectively) (p<0.05). Therefore, M. officinalis might be utilized in novel applications as a nutritional supplement or a functional food component.

Keywords: breast fillet, lipid oxidation, Melissa officinalis, TBARS assay

Procedia PDF Downloads 264
1062 A Quinary Coding and Matrix Structure Based Channel Hopping Algorithm for Blind Rendezvous in Cognitive Radio Networks

Authors: Qinglin Liu, Zhiyong Lin, Zongheng Wei, Jianfeng Wen, Congming Yi, Hai Liu

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The multi-channel blind rendezvous problem in distributed cognitive radio networks (DCRNs) refers to how users in the network can hop to the same channel at the same time slot without any prior knowledge (i.e., each user is unaware of other users' information). The channel hopping (CH) technique is a typical solution to this blind rendezvous problem. In this paper, we propose a quinary coding and matrix structure-based CH algorithm called QCMS-CH. The QCMS-CH algorithm can guarantee the rendezvous of users using only one cognitive radio in the scenario of the asynchronous clock (i.e., arbitrary time drift between the users), heterogeneous channels (i.e., the available channel sets of users are distinct), and symmetric role (i.e., all users play a same role). The QCMS-CH algorithm first represents a randomly selected channel (denoted by R) as a fixed-length quaternary number. Then it encodes the quaternary number into a quinary bootstrapping sequence according to a carefully designed quaternary-quinary coding table with the prefix "R00". Finally, it builds a CH matrix column by column according to the bootstrapping sequence and six different types of elaborately generated subsequences. The user can access the CH matrix row by row and accordingly perform its channel, hoping to attempt rendezvous with other users. We prove the correctness of QCMS-CH and derive an upper bound on its Maximum Time-to-Rendezvous (MTTR). Simulation results show that the QCMS-CH algorithm outperforms the state-of-the-art in terms of the MTTR and the Expected Time-to-Rendezvous (ETTR).

Keywords: channel hopping, blind rendezvous, cognitive radio networks, quaternary-quinary coding

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1061 Green Computing: Awareness and Practice in a University Information Technology Department

Authors: Samson Temitope Obafemi

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The fact that ICTs is pervasive in today’s society paradoxically also calls for the need for green computing. Green computing generally encompasses the study and practice of using Information and Communication Technology (ICT) resources effectively and efficiently without negatively affecting the environment. Since the emergence of this innovation, manufacturers and governmental bodies such as Energy Star and the United State of America’s government have obviously invested many resources in ensuring the reality of green design, manufacture, and disposal of ICTs. However, the level of adherence to green use of ICTs among users have been less accounted for especially in developing ICT consuming nations. This paper, therefore, focuses on examining the awareness and practice of green computing among academics and students of the Information Technology Department of Durban University of Technology, Durban South Africa, in the context of green use of ICTs. This was achieved through a survey that involved the use of a questionnaire with four sections: (a) demography of respondents, (b) Awareness of green computing, (c) practices of green computing, and (d) attitude towards greener computing. One hundred and fifty (150) questionnaires were distributed, one hundred and twenty (125) were completed and collected for data analysis. Out of the one hundred and twenty-five (125) respondents, twenty-five percent (25%) were academics while the remaining seventy-five percent (75%) were students. The result showed a higher level of awareness of green computing among academics when compared to the students. Green computing practices are also shown to be highly adhered to among academics only. However, interestingly, the students were found to be more enthusiastic towards greener computing in the future. The study, therefore, suggests that the awareness of green computing should be further strengthened among students from the curriculum point of view in order to improve on the greener use of ICTs in universities especially in developing countries.

Keywords: awareness, green computing, green use, information technology

Procedia PDF Downloads 183
1060 Botulism Clinical Experience and Update

Authors: Kevin Yeo, Christine Hall, Babinchak Tim

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BAT® [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] anti-toxin is a mixture of equine immune globulin fragments indicated for the treatment of symptomatic botulism in adult and pediatric patients. The effectiveness of BAT anti-toxin is based on efficacy studies conducted in animal models. A general explanation of the pivotal animal studies, post market surveillance and outcomes of an observational patient registry for patients treated with BAT product distributed in the USA is briefly discussed. Overall it took 20 animal studies for two well-designed and appropriately powered pivotal efficacy studies – one in which the effectiveness of BAT was assessed against all 7 serotypes in the guinea pig, and the other where efficacy is confirmed in the Rhesus macaque using Serotype A. Clinical Experience for BAT to date involves approximately 600 adult and pediatric patients with suspected botulism. In pre-licensure, patient data was recorded under the US CDC expanded access program (259 adult and pediatric patients between 10 days to 88 years of age). In post licensure, greater than 350 patients to date have received BAT and been followed up by enhanced expanded access program. The analysis of the post market surveillance data provided a unique opportunity to demonstrate clinical benefit in the field study required by the animal rule. While the animal rule is applied because human efficacy studies are not ethical or feasible, a post-marketing requirement is to conduct a study to evaluate safety and clinical benefit when circumstances arise and demonstrate the favourable benefit-risk profile that supported licensure.

Keywords: botulism, threat, clinical benefit, observational patient registry

Procedia PDF Downloads 177