Search results for: sterility and safety in pharmaceutical development

Authors: Mohd Sabri Minhat, Nurul Adilla Mohd Subha

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The 1MWth PUSPATI TRIGA Reactor (RTP) in Malaysia Nuclear Agency has been operating more than 35 years. The existing core power control is using conventional controller known as Feedback Control Algorithm (FCA). It is technically challenging to keep the core power output always stable and operating within acceptable error bands for the safety demand of the RTP. Currently, the system could be considered unsatisfactory with power tracking performance, yet there is still significant room for improvement. Hence, a new design core power control is very important to improve the current performance in tracking and regulating reactor power by controlling the movement of control rods that suit the demand of highly sensitive of nuclear reactor power control. In this paper, the proposed Model Predictive Control (MPC) law was applied to control the core power. The model for core power control was based on mathematical models of the reactor core, MPC, and control rods selection algorithm. The mathematical models of the reactor core were based on point kinetics model, thermal hydraulic models, and reactivity models. The proposed MPC was presented in a transfer function model of the reactor core according to perturbations theory. The transfer function model-based predictive control (TFMPC) was developed to design the core power control with predictions based on a T-filter towards the real-time implementation of MPC on hardware. This paper introduces the sensitivity functions for TFMPC feedback loop to reduce the impact on the input actuation signal and demonstrates the behaviour of TFMPC in term of disturbance and noise rejections. The comparisons of both tracking and regulating performance between the conventional controller and TFMPC were made using MATLAB and analysed. In conclusion, the proposed TFMPC has satisfactory performance in tracking and regulating core power for controlling nuclear reactor with high reliability and safety.

Keywords: core power control, model predictive control, PUSPATI TRIGA reactor, TFMPC

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Authors: Tagel Gebrehiwot, Carolina Castilla

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Food insecurity and child malnutrition are among the most critical issues in Ethiopia. Accordingly, different reform programs have been carried to improve household food security. The Food Security Program (FSP) (among others) was introduced to combat the persistent food insecurity problem in the country. The FSP combines a safety net component called the Productive Safety Net Program (PSNP) started in 2005. The goal of PSNP is to offer multi-annual transfers, such as food, cash or a combination of both to chronically food insecure households to break the cycle of food aid. Food or cash transfers are the main elements of PSNP. The case for cash transfers builds on the Sen’s analysis of ‘entitlement to food’, where he argues that restoring access to food by improving demand is a more effective and sustainable response to food insecurity than food aid. Cash-based schemes offer a greater choice of use of the transfer and can allow a greater diversity of food choice. It has been proven that dietary diversity is positively associated with the key pillars of food security. Thus, dietary diversity is considered as a measure of household’s capacity to access a variety of food groups. Studies of dietary diversity among Ethiopian rural households are somewhat rare and there is still a dearth of evidence on the impact of PSNP on household dietary diversity. In this paper, we examine the impact of the Ethiopia’s PSNP on household dietary diversity and child nutrition using panel household surveys. We employed different methodologies for identification. We exploit the exogenous increase in kebeles’ PSNP budget to identify the effect of the change in the amount of money households received in transfers between 2012 and 2014 on the change in dietary diversity. We use three different approaches to identify this effect: two-stage least squares, reduced form IV, and generalized propensity score matching using a continuous treatment. The results indicate the increase in PSNP transfers between 2012 and 2014 had no effect on household dietary diversity. Estimates for different household dietary indicators reveal that the effect of the change in the cash transfer received by the household is statistically and economically insignificant. This finding is robust to different identification strategies and the inclusion of control variables that determine eligibility to become a PSNP beneficiary. To identify the effect of PSNP participation on children height-for-age and stunting we use a difference-in-difference approach. We use children between 2 and 5 in 2012 as a baseline because by then they have achieved long-term failure to grow. The treatment group comprises children ages 2 to 5 in 2014 in PSNP participant households. While changes in height-for-age take time, two years of additional transfers among children who were not born or under the age of 2-3 in 2012 have the potential to make a considerable impact on reducing the prevalence of stunting. The results indicate that participation in PSNP had no effect on child nutrition measured as height-for-age or probability of beings stunted, suggesting that PSNP should be designed in a more nutrition-sensitive way.

Keywords: continuous treatment, dietary diversity, impact, nutrition security

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Authors: Brian M. Mehling, Louis Quartararo, Marine Manvelyan, Paul Wang, Dong-Cheng Wu

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Numerous investigations suggest that Mesenchymal Stem Cells (MSCs) in general represent a valuable tool for therapy of symptoms related to chronic inflammatory diseases. Blue Horizon Stem Cell Therapy Program is a leading provider of adult and children’s stem cell therapies. Uniquely we have safely and efficiently treated more than 600 patients with documenting each procedure. The purpose of our study is primarily to monitor the immune response in order to validate the safety of intravenous infusion of human umbilical cord blood derived MSCs (UC-MSCs), and secondly, to evaluate effects on biomarkers associated with chronic inflammation. Nine patients were treated for conditions associated with chronic inflammation and for the purpose of anti-aging. They have been given one intravenous infusion of UC-MSCs. Our study of blood test markers of 9 patients with chronic inflammation before and within three months after MSCs treatment demonstrates that there is no significant changes and MSCs treatment was safe for the patients. Analysis of different indicators of chronic inflammation and aging included in initial, 24-hours, two weeks and three months protocols showed that stem cell treatment was safe for the patients; there were no adverse reactions. Moreover data from follow up protocols demonstrates significant improvement in energy level, hair, nails growth and skin conditions. Intravenously administered UC-MSCs were safe and effective in the improvement of symptoms related to chronic inflammation. Further close monitoring and inclusion of more patients are necessary to fully characterize the advantages of UC-MSCs application in treatment of symptoms related to chronic inflammation.

Keywords: chronic inflammatory diseases, intravenous infusion, stem cell therapy, umbilical cord blood derived mesenchymal stem cells (UC-MSCs)

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Authors: R. T. Aggangan, R. J. Cabangon

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Bamboo is getting worldwide attention over the last 20 to 30 years due to numerous uses and it is regarded as the closest material that can be used as substitute to wood. In the domestic market, high quality bamboo products are sold in high-end markets while lower quality products are generally sold to medium and low income consumers. The global market in 2006 stands at about 7 billion US dollars and was projected to increase to US$ 17 B from 2015 to 2020. The Philippines had been actively producing and processing bamboo products for the furniture, handicrafts and construction industry. It was however in 2010 that the Philippine bamboo industry was formalized by virtue of Executive Order 879 that stated that the Philippine bamboo industry development is made a priority program of the government and created the Philippine Bamboo Industry Development Council (PBIDC) to provide the overall policy and program directions of the program for all stakeholders. At present, the most extensive use of bamboo is for the manufacture of engineered bamboo for school desks for all public schools as mandated by EO 879. Also, engineered bamboo products are used for high-end construction and furniture as well as for handicrafts. Development of cheap adhesives, preservatives, and finishing chemicals from local species of plants, development of economical methods of drying and preservation, product development and processing of lesser-used species of bamboo, development of processing tools, equipment and machineries are the strategies that will be employed to reduce the price and mainstream engineered bamboo products in the local and foreign market. In addition, processing wastes from bamboo can be recycled into fuel products such as charcoal are already in use. The more exciting possibility, however, is the production of bamboo pellets that can be used as a substitute for wood pellets for heating, cooking and generating electricity.

Keywords: bamboo charcoal and light distillates, engineered bamboo, furniture and handicraft industries, housing and construction, pellets

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Authors: Mihika Shivkumar, Krishna Kumar, C. Perisamy

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3D printing is a method of manufacturing wherein materials, such as plastic or metal, are deposited in layers one on top of the other to produce a three dimensional object. 3D printing is most commonly associated with creating engineering prototypes. However, its applications in the field of human health care have been frequently disregarded. Medical applications for 3D printing are expanding rapidly and are envisaged to revolutionize health care. Medical applications for 3D printing, both present and its potential, can be categorized broadly, including: creation of customized prosthetics tissue and organ fabrication; creation of implants, and anatomical models and pharmaceutical research regarding drug dosage forms. This piece breaks down bioprinting in the healthcare sector. It focuses on the better subtle elements of every particular point, including how 3D printing functions in the present, its impediments, and future applications in the health care sector.

Keywords: bio-printing, prototype, drug delivery, organ regeneration

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Authors: M. Kuzhko, M. Gumeniuk, D. Butov, T. Tlustova, O. Denysov, T. Sprynsian

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Abstract: The objective of this work was to study the efficacy and safety of inhaled nebulized chemotherapy in the treatment of patients with newly diagnosed pulmonary tuberculosis in comparison with standard antimycobacterial therapy. Materials and methods: The study involved 68 patients aged between 20 and 70 years with newly diagnosed pulmonary tuberculosis. Patients were allocated to two groups. The first (main, n=21) group of patients received standard chemotherapy and further 0.15 g of isoniazid and rifampicin 0.15 g inhaled through a nebulizer, also they received salmeterol 50 mcg + fluticasone propionate 250 mcg at 2 breaths twice a day for 2 months. The second (control, n=47) group of patients received standard chemotherapy, consisting of orally administered isoniazid (0.3 g), rifampicin (0.6 g), pyrazinamide (2 g), ethambutol (1.2 g) with a dose reduction after the intensive phase of the therapy. The anti-TB drugs were procured through the Ukraine’s centralized national supply system. Results: Intoxication symptoms in the first group reduced following 1.39±0.18 months, whereas in the second group, intoxication symptoms reduced following 2.7±0.1 months, p<.001. Moreover, respiratory symptoms regression in the first group was observed following 1.6±0.2 months, whereas in the second group – following 2.5±0.2 months, p<0.05. Bacillary excretion period evaluated within 1 month was reduced, as it was shown by 66.6±10.5% in the main group compared to 27.6±6.5%, p<0.05, in the control group. In addition, period of cavities healing was reduced to 2.9±0.2 months in the main group compared to 3.7±0.1 months, p<0.05, in the control group. Residual radiological lung damage findings (large residual changes) were observed in 22 (23.8±9.5 %) patients of the main group versus 24 (51.0±7.2 %) patients in the control group, p<0.05. After completion of treatment scar stenosis of the bronchi II-III art. diagnosed in 3 (14.2±7.8%) patients in main group and 17 (68.0±6.8%) - control group, p<0.05. The duration of hospital treatment was 2.4±0.4 months in main group and 4.1±0.4 months in control group, p<0.05. Conclusion: Administration of of inhaled nebulized chemotherapy in patients with newly diagnosed pulmonary tuberculosis resulted in a comparatively quick reduction of disease manifestation.

Keywords: inhaled nebulized chemotherapy, pulmonary tuberculosis, tuberculosis, treatment of tuberculosis

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Authors: Sourabh Jain, Sukhvir Singh Jain, Gaurav V. Jain

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Intelligent Transportation System (ITS) is the application of technology for developing a user–friendly transportation system for urban areas in developing countries. The goal of urban corridor management using ITS in road transport is to achieve improvements in mobility, safety, and the productivity of the transportation system within the available facilities through the integrated application of advanced monitoring, communications, computer, display, and control process technologies, both in the vehicle and on the road. This paper attempts to present the past studies regarding several ITS available that have been successfully deployed in urban corridors of India and abroad, and to know about the current scenario and the methodology considered for planning, design, and operation of Traffic Management Systems. This paper also presents the endeavor that was made to interpret and figure out the performance of the 27.4 Km long study corridor having eight intersections and four flyovers. The corridor consisting of 6 lanes as well as 8 lanes divided road network. Two categories of data were collected on February 2016 such as traffic data (traffic volume, spot speed, delay) and road characteristics data (no. of lanes, lane width, bus stops, mid-block sections, intersections, flyovers). The instruments used for collecting the data were video camera, radar gun, mobile GPS and stopwatch. From analysis, the performance interpretations incorporated were identification of peak hours and off peak hours, congestion and level of service (LOS) at mid blocks, delay followed by the plotting speed contours and recommending urban corridor management strategies. From the analysis, it is found that ITS based urban corridor management strategies will be useful to reduce congestion, fuel consumption and pollution so as to provide comfort and efficiency to the users. The paper presented urban corridor management strategies based on sensors incorporated in both vehicles and on the roads.

Keywords: congestion, ITS strategies, mobility, safety

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Authors: Rongrong Liu, Li Wang, Hui Xu, Jianpei Fang, Sixi Liu, Xiaolin Yin, Junbin Liang, Gaohui Yan, Yaoyun Li, Yali Zhou, Xinyu Li, Yue Li, Lei Shi, Yongrong Lai, Junjiu Huang, Xinhua Zhang

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Background: Beta-Thalassemia is caused by reduced (β+) or absent (β0) synthesis of the β-globin chains of hemoglobin. Transfusions and oral iron chelation therapy have improved the quality of life for patients with Transfusion-Dependent thalassemia (TDT). Recent advances in genome editing platforms of CRISPR-Cas9 have paved the way for induction of HbF by reactivating expression of γ-chain.Aims: We performed CRISPR-Cas9-mediated genome editing of hematopoietic stem cells to mutate HBG1/HBG2 promoter sequence, thereby representing a naturally occurring HPFH-liked mutation, producing RM-001. Here, we present an initial assessment of safety and efficacy of RM-001 in patients with TDT. Methods: Patients (6–35 y of age) with TDT receiving packed red blood cell (pRBC) transfusions of ≥100 mL/kg/y or ≥10 units/y in the previous 2 y were eligible. CD34+ cells were edited with CRISPR-Cas9 using a guide RNA specific for the binding site of BCL11A on the HBG1/2 promoter. Prior to RM-001 product infusion (day 0), patients received myeloablative conditioning with Busulfan from day-7 to day-4. Patients were monitored for AEs Hb expression.Results: Data cut as of 28 Feb 2024, 16 TDT patients have been treated with RM-001 and followed ≥3 months. 5 of these 16 patients had finished their 24 months follow up. Eleven patients have β0/β0 genotype and five patients have β0/β+ genotype. In addition to β-thalassemia, two patients had α- deletion with the genotype of --/αα. Efficacy:All patients received a single dose intravenous infusion of RM-001 cells. 5 of them had been followed 24 months or longer. All patients achieved transfusion-independent (TI, total Hb continued ≥ 9g/dL) (Figure1). Patients demonstrated sustained and clinically meaningful increases in HbF levels since 4 month post-RM-001 infusion (Figure.2). Total hemoglobin in all patients was stable at 10-12g/dL during the follow-up period. Safety:The adverse events observed after RM-001 infusion were consistent with those that are typical of Busulfan-based myeloablation. The allelic editing analysis at 6-month visit showed that the on-target allelic editing frequency in bone marrow cells was 73.44% (64.65% to 84.6%, n=13).Summary/Conclusion: This interim analysis, in which all the 19 patients age from 7.9 to 25yo met the success criteria for the trial with respect to transfusion independence, showed that autologous HBG1/2 promoter-modified CD34+ HSPCs gene therapy resulted in an adequate amount of HbF as early as 2 months after infusion led to near-normal hemoglobin levels, remained transfusion-free through the reported period without product related SAE. After RM-001 infusion, high levels of HbF proportion and on-target editing in bone marrow cells were maintained. Submitted on behalf of the RM-001 Investigators.

Keywords: thalassemian, genetherapy, CRISPR/Cas9, HbF

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Authors: Areej Isam Barham

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The implementation of Japanese lesson study approach in the mathematics classroom has been grown worldwide as a model of professional development for teachers. In Qatar, the implementation of IMPULS-QU lesson study program aimed to establish a robust organizational improvement model of professional development for mathematics teachers in Qatar schools. This study describes the implementation of a lesson study model at Al-Markhyia Independent Primary School through different stages; and discusses how the planning process, the research lesson, and the post discussion participates in providing teachers and researchers with a successful research lesson for teacher professional development. The research followed a case study approach in one mathematics classroom. Two teachers and one professional development specialist participated the planning process. One teacher conducted the research lesson study by introducing a problem solving related to the concept of the ‘Mean’ in a mathematics class, 21 students in grade 6 participated in solving the mathematic problem, 11 teachers, 4 professional development specialists, and 4 mathematics professors observed the research lesson. All previous participants except the students participated in a pre and post-lesson discussion within this research. This study followed a qualitative research approach by analyzing the collected data through different stages in the research lesson study. Observation, field notes, and semi-structured interviews conducted to collect data to achieve the research aims. One feature of this lesson study research is that this research describes the implementation for a lesson study as a new experience for one mathematics teacher and 21 students after 3 years of conducting IMPULS-QU project in Al-Markhyia school. The research describes various stages through the implementation of this lesson study model starting from the planning process and ending by the post discussion process. Findings of the study also address the impact of lesson study approach in teaching mathematics for the development of teachers from their point views. Results of the study show the benefits of using lesson study from the point views of participated teachers, theory perceptions about the essential features of lesson study, and their needs for future development. The discussion of the study addresses different features and issues related to the implementation of IMPULS-QU lesson study model in the mathematics classroom. In the light of the study, the research presents recommendations and suggestions for future professional development.

Keywords: lesson study, mathematics education, mathematics teaching experience, teacher professional development

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Authors: Yeganeh Attari, Gudmund Reidar Eiksund, Hans Peter Jostad

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In Geotechnical practice, there is no standard method recognized by the industry to account for the reduction of safety factor of a slope as an effect of soil displacement and pore pressure build-up during pile installation. Pile driving disturbs causes large strains and generates excess pore pressures in a zone that can extend many diameters from the installed pile, resulting in a decrease of the shear strength of the surrounding soil. This phenomenon may cause slope failure. Moreover, dissipation of excess pore pressure set-up may cause weakening of areas outside the volume of soil remoulded during installation. Because of complex interactions between changes in mean stress and shearing, it is challenging to predict installation induced pore pressure response. Furthermore, it is a complex task to follow the rate and path of pore pressure dissipation in order to analyze slope stability. In cohesive soils it is necessary to implement soil models that account for strain softening in the analysis. In the literature, several cases of slope failure due to pile driving activities have been reported, for instance, a landslide in Gothenburg that resulted in a slope failure destroying more than thirty houses and Rigaud landslide in Quebec which resulted in loss of life. Up to now, several methods have been suggested to predict the effect of pile driving on total and effective stress, pore pressure changes and their effect on soil strength. However, this is still not well understood or agreed upon. In Norway, general approaches applied by geotechnical engineers for this problem are based on old empirical methods with little accurate theoretical background. While the limitations of such methods are discussed, this paper attempts to capture the reduction in the factor of safety of a slope during pile driving, using coupled Finite Element analysis and cavity expansion method. This is demonstrated by analyzing a case of slope failure due to pile driving in Norway.

Keywords: cavity expansion method, excess pore pressure, pile driving, slope failure

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Authors: Abdullah Abu-Tineh, Youmen Chaaban

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This study examines the development of a professional development (PD) model for teacher growth and learning that is embedded into the school context. The School based Support Program (SBSP), designed for the Qatari context, targets the practices, knowledge and skills of both school leadership and teachers in an attempt to improve student learning outcomes. Key aspects of the model include the development of learning communities among teachers, strong leadership that supports school improvement activities, and the use of research-based PD to improve teacher practices and student achievement. This paper further presents findings from an evaluation of this PD program. Based on an adaptation of Guskey’s evaluation of PD models, 100 teachers at the participating schools were selected for classroom observations and 40 took part in in-depth interviews to examine changed classroom practices. The impact of the PD program on student learning was also examined. Teachers’ practices and their students’ achievement in English, Arabic, mathematics and science were measured at the beginning and at the end of the intervention.

Keywords: initiative, professional development, school based support Program (SBSP), school reform

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Authors: Ahmad Javid Habib, Tetsuo Kidokoro

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There is an increasing demand for developing urban land to provide better living conditions for all citizens in Afghanistan. Most of the development will involve the acquisition of land. And the current land acquisition method practiced by central government is expropriation, which is a cash-based transaction method that imposes heavy fiscal burden on local municipalities and central government, and it does not protect ownership rights and social equity of landowners besides it relocates the urban poor to remote areas with limited access to jobs and public services. The questionnaire analysis, backed by observations of different case studies in countries where land readjustment is used as a collaborative land development tool indicates that the method plays a key role in valuing landowners’ rights, giving other community members and stakeholders the opportunity to collaboratively implement urban development projects. The practice of the method is reducing the heavy fiscal burden on the local and central governments and is a better option to deal with the current development challenges in Afghanistan.

Keywords: collaboration, land readjustment, master plan, expropriation

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Authors: G. K. Abdigalieva, Z. N. Ismagambetova, T. H. Gabitov, K. A. Biazdikova, A. A. Mukhanbet , B. E. Moldagaliyev, Saira Shamahay

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In the article was shown attitude to contemporary traditional culture and cultural heritage preservation issues and features of further development of a culture. Concerning innovation, appeal to cultural heritage, ability of reception of a culture and cultural diffusion in the process of globalization, it is offered further positive development of Kazakhstan’s based human experience and achieved with time. System of traditions is considered as a phenomenon which describes unity, harmony and stability of social body. Contradictions of contemporary culture and civilization, processes of tradition and innovation, cultural changes, and creativities are considered as second side of a society development. Innovation is analyzed as a method of renewal of a culture, tradition and innovation are considered as universal feature of any culture.

Keywords: culture, civilization, innovation, tradition, reality, customs, social relations, morality, values

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Authors: Fu Jiayan, Wang Zhu, Sun Jiaojiao

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Mixed-use development is one of the most important trends in new island house transformation along southeast coastal area in China. Unique island geographical environment and profound fishing village culture coexist for a long time in this. With artistic creation for the purpose of the "live-work" houses are in a large number of emergence, however, still lack of systematic strategy. Based on space effect from marine resources to regional human settlements, this article teases out the evolution regularity of island settlement context and architectural form, then, puts forward the formation mechanism and construction model of art island houses. Thereby, to further explore space design method and site creation strategy of mixed-use development.

Keywords: mixed-use, island house, art creation, Southeast Coastal Area of Chinese

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Authors: Somyoung Shin, Donghun Jeong, Yeoil Yun

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South Korea continuously installed tunnels in consideration of the safety and operation efficiency, and the number of installed tunnels has doubled over the past ten years. The tunnel section is designed based on the guidelines, but the tunnel entrance becomes narrow due to dark adaptation and pressure. In fact, around 13% of traffic in expressways of Japan happens at the entrance, leading to congestion and rear-ends collision accidents. Therefore, this study aims to analyze the stability from the expansion of the shoulder width in the tunnel entrance by applying a virtual reality driving simulator in order to reduce the accidents that happen in the tunnel entrance. To compare the driving stability based on the changes in the width of the right shoulder under the same condition, a virtual reality driving simulator is used to conduct an experiment on 30 subjects in their 20s to 60s and to provide a more practical virtual reality driving environment, and an experiment map is designed based on actual roads as the background to conduct the experiment. The right shoulder is classified into 2.5m and 3.0m based on the design guidelines of the expressways and the road structure installation regulations. The experimenters' experiment order is decided randomly. As a result of analyzing the average speed, it was displayed as 100.73km/h when the shoulder width was 2.5m and 101.69km/h when the shoulder width was 3.0m and as a result of conducting t-test analysis, the p-value appeared as more than 0.05 in the significance level of 95%, so it was statistically insignificant. Also, as a result of analyzing the speed deviation between the average driving speed of the analyzed interval and the average driving speed upon entering the tunnel, it was displayed as 3.06km/h when the shoulder width was 2.5m and 1.87km/h when the shoulder width was 3.0m and as a result of conducting t-test analysis, the p-value appeared as less than 0.05 in the significance level of 95%, so it was statistically significant. This means that when the shoulder width is 3.0m, there is stability in terms of the driving stability compared to when it is 2.5m. Therefore, it is considered that when new roads are constructed in Korea, the right shoulder width should be installed as 3.0m to enhance the driving stability.

Keywords: driving stability, shoulder width, tunnel, virtual reality driving simulator

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Authors: Gampel Alexander, Mazzuchi Thomas, Sarkani Shahram

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The cybersecurity landscape is constantly evolving, and organizations must adapt to the changing threat environment to protect their assets. The implementation of the NIST Risk Management Framework (RMF) has become critical in ensuring the security and safety of industrial control and automation systems. However, cybersecurity professionals are facing challenges in implementing RMF, leading to systems operating without authorization and being non-compliant with regulations. The current approach to RMF implementation based on business practices is limited and insufficient, leaving organizations vulnerable to cyberattacks resulting in the loss of personal consumer data and critical infrastructure details. To address these challenges, this research proposes a Model-Based Systems Engineering (MBSE) approach to implementing cybersecurity controls and assessing risk through the RMF process. The study emphasizes the need to shift to a modeling approach, which can streamline the RMF process and eliminate bloated structures that make it difficult to receive an Authorization-To-Operate (ATO). The study focuses on the practical application of MBSE in industrial control and automation systems to improve the security and safety of operations. It is concluded that MBSE can be used to solve the implementation challenges of the NIST RMF process and improve the security of industrial control and automation systems. The research suggests that MBSE provides a more effective and efficient method for implementing cybersecurity controls and assessing risk through the RMF process. The future work for this research involves exploring the broader applicability of MBSE in different industries and domains. The study suggests that the MBSE approach can be applied to other domains beyond industrial control and automation systems.

Keywords: authorization-to-operate (ATO), industrial control systems (ICS), model-based system’s engineering (MBSE), risk management framework (RMF)

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Authors: Linda Kauškale, Ineta Geipele

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Due to the rapidly changing external environment, portfolio management strategies became closely interconnected with real estate industry development and macroeconomic development tendencies. The aim of the research is to analyze sustainable real estate market development influencing factors, with particular focus on its economic and management aspects that influences real estate investment decisions as well. Scientific literature and article analysis, data analysis, expert evaluation, and other quantitative and qualitative research methods were used in the research. Developed real estate market sustainability model and index analysis approach can be applied by investors and real estate companies in real estate asset management and can help in risk minimization activities in international entrepreneurship. Future research directions have been identified in the research as well.

Keywords: indexes, investment decisions, real estate market, sustainability

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Authors: Malki Nadia Fatima Zahra, Kellal Cheimaa, Brahimi Houria

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Aim of the study is to show the role of total Quality Management on firm performance; the research relied on the views of sample managers working in the Marinel pharmaceutical company. The research aims to achieve many objectives, including increasing awareness of the concepts of Total Quality Management on Firm Performance, especially in the manufacturing firm, providing a future vision of the possibility of success, and the actual application of the Principles of Total Quality Management in the manufacturing company. The research adopted a default model was built after a review and analysis of the literature review in the context of one hypothesis main points at the origin of a group of sub-hypotheses. The research presented a set of conclusions, and the most important of these conclusions was there is a relationship between the Principles of TQM and Firm Performance.

Keywords: total quality management, TQM dimension, firm performance, strategies

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Authors: Awangku Hassanal Bahar Pengiran Bagul

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Ecotourism has been the signature tourism activity for Sabah since the 90s, and it has become a model of sustainable tourism development for Malaysia due to its ability to enhance conservation activities and local community development. This paper outlines the experience in developing indicators for the success of the local community participation of an ecotourism site, Sukau, in Sabah. The research was qualitative in nature and employed case study as its methodology. The outcome of this research suggested that Sukau has a mixed success with local community participation for the ecotourism activity. The community is in need of coaching and capacity building to intensify the ecotourism activity However, the ecotourism has successfully promoted conservation at its surrounding area.

Keywords: community, ecotourism, rural development, success, sustainable tourism

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Authors: S. H. Park, D. W. You

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This study is about to the field survey and repair works in a marine approach-bride. In order to evaluate the stability of the ground and the structure, field surveys such as exterior inspection, non-destructive inspection, measurement, and geophysical exploration are carried out. Numerical analysis is conducted to investigate the cause of the abutment displacement at the same time. In addition, repair works are practiced to the region damaged with intent to sustain long-term safety.

Keywords: field survey, expansion joint, repair, maintenance

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Authors: Yifat Koren Carmi, Abed Agbarya, Hazem Khamaisi, Raymond Farah, Yelena Shechtman, Roman Korobochka, Jacob Gopas, Jamal Mahajna

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Ovarian cancer (OC), the second most common form of gynecological malignancy, has a poor prognosis and is frequently identified in its late stages. The recommended treatment for OC typically includes a platinum-based chemotherapy, like carboplatin. Nonetheless, OC treatment has proven challenging due to toxicity and development of acquired resistance to therapy. Chemoresistance is a significant obstacle to a long-lasting response in OC patients, believed to arise from alterations within the cancer cells as well as within the tumor microenvironments (TME). Malignant ascites is a presenting feature in more than one-third of OC patients. It serves as a reservoir for a complex mixture of soluble factors, metabolites, and cellular components, providing a pro-inflammatory and tumor-promoting microenvironment for the OC cells. Malignant ascites is also associated with metastasis and chemoresistance. In an attempt to elucidate the role of TME in chemoresistance of OC, we monitored the ability of soluble factors derived from ascites fluids to affect platinum sensitivity of OC cells. This research, compared ascites fluids from non-malignant cirrhotic patients to those from OC patients in terms of their ability to alter the platinum sensitivity of OC cells. Our findings indicated that exposure to OC ascites induces platinum chemoresistance on OC cells in 11 out of 13 cases (85%). In contrast, 75% of cirrhosis ascites (3 out of 4) failed to confer platinum chemoresistance to OC cells. Cytokine array analysis revealed that IL-6, and to a lesser extent HGF were enriched in OC ascites, whereas IL-22 was enriched in cirrhosis ascites. Pharmaceutical inhibitors that target the IL-6/JAK signaling pathway were mildly effective in overcoming the platinum chemoresistance induced by malignant ascites. In contrast, Crizotinib an HGF/c-MET inhibitor, and 2-hydroxyestradiol (2HE2) were effective in restoring platinum chemoresistance to OC. Our findings demonstrate the importance of OC ascites in supporting platinum chemoresistance as well as the potential of a combination therapy with Crizotinib and the estradiol metabolite 2HE2 to regain OC cells chemosensitivity.

Keywords: ovarian cancer, platinum chemoresistance, malignant ascites, tumor microenvironment, IL-6, 2-hydroxyestradiol, HGF, crizotinib

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Authors: Ozge Celik, Elvan Ender

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With rapidly increasing population growth and industrial revolution in the 1950s, in Turkey migration began to the cities from the countryside. Along the rapid growth of urban population has started to bring many problems. Depending on the uncontrolled urban development, concerns about the protection of natural values has increased day by day. As a result of disturbance on the natural environment, human health has started to be under threat. After all, much urban planning approaches outspread that protecting natural resources by respect to human health and troubleshooting problems emerging with anthropogenic effects. Smart growth concept is one of the chosen methods to resolve the problems in Turkey. In this paper, smart growth concept idea and its criteria will be explained while ecological planning and urban planning problems will be mentioned in Turkey according to the need of concept. Studies, consisting of practical and theoretical smart growth ideas, shows that ecological landscape planning is not included in the urban development process in Turkey. The main idea is to initiate urban development plans considering social and cultural structures of cultural assets and also natural values.

Keywords: ecological landscape planning, smart growth, Turkey, urban development

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Authors: Alpana Meena

Abstract:

Background: Tuberculosis is one of the major causes of death in south-east nations. Anti-TB–induced hepatotoxicity (AIH) is associated with a mortality of 6%–12%. The risk is increased when the drugs are combined. Reintroduction of anti-tuberculosis drugs in patients with AIH has never been studied systematically. The present study was planned to see the clinical profile of patients of AIH and the response to reintroduction of therapy. Methods: The trial was conducted in the Department of Medicine, Maulana Azad Medical College and associated Lok Nayak Hospital, on 32 patients with extra-pulmonary tuberculosis who developed AIH. Patients were randomly allocated into 3 groups. In group 1- Isoniazid (INH) and Rifampicin (RIF) were given at full dosages (weight calculated) from day 1. In group 2- RIF was given at maximum dosage from day 1 and INH at maximum dosage from day 8. In group 3- INH was given at maximum dosage from day 1 and RIF at maximum dosage from day 8. Pyrazinamide was added when above regimens were tolerated. Results: The mean age of presentation was 29.37±13.497 years. The incidence was found to be highest in patients with tubercular meningitis (41%) followed by abdominal, pericardial, disseminated, spinal, and lymph nodes. The mean latent period for development of AIH was 7.84 days ± 6.149 days and the median normalization days for LFT’s was 8.81 ± 4.22 days (3-21). In the study, 21% patients had recurrence of AIH with majority of patients having tolerated the reintroduction of drugs. Pyrazinamide was introduced after establishing isoniazid and rifampicin safety, thus emphasizing the role of gradual reintroduction of ATT to avoid the combined effects of hepatotoxicity. Conclusion: To conclude, the recurrence rate of hepatotoxicity was not statistically significant between the three groups studied (p > 0.05), and thus all 3 hepatotoxic drugs can be reintroduced safely in patients developing AIH.

Keywords: anti-tubercular therapy induced hepatotoxicity, extra-pulmonary tuberculosis, reintroduction regimens, risk factors

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Authors: Asavasereerat K., Teacharsripaitoon T., Tungyingyong P., Charupongrat S., Noppiboon S. Hochareon L., Kitsuban P.

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Third generation of vaccines is based on gene therapy where DNA is introduced into patients. The antigenic or therapeutic proteins encoded from transgenes DNA triggers an immune-response to counteract various diseases. Moreover, DNA vaccine offers the customization of its ability on protection and treatment with high stability. The production of DNA vaccines become of interest. According to USFDA guidance for industry, the recommended limits for impurities from host cell are lower than 1%, and the active conformation homogeneity supercoiled DNA, is more than 80%. Thus, the purification strategy using two-steps chromatography has been established and verified for its robustness. Herein, pVax1/lacZ, a pre-approved USFDA DNA vaccine backbone, was used and transformed into E. coli strain DH5α. Three purification process parameters including sample-loading flow rate, the salt concentration in washing and eluting buffer, were studied and the experiment was designed using response surface method with central composite face-centered (CCF) as a model. The designed range of selected parameters was 10% variation from the optimized set point as a safety factor. The purity in the percentage of supercoiled conformation obtained from each chromatography step, AIEX and HIC, were analyzed by HPLC. The response data were used to establish regression model and statistically analyzed followed by Monte Carlo simulation using SAS JMP. The results on the purity of the product obtained from AIEX and HIC are between 89.4 to 92.5% and 88.3 to 100.0%, respectively. Monte Carlo simulation showed that the pVAX1/lacZ purification process is robust with confidence intervals of 0.90 in range of 90.18-91.00% and 95.88-100.00%, for AIEX and HIC respectively.

Keywords: AIEX, DNA vaccine, HIC, puification, response surface method, robustness

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Authors: Christina Kalogirou

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The object of this research is to explore the views of Greek Second Chance Schools’ (SCS) graduates regarding their personal, social, professional and educational development after graduation. SCS are addressed to adults who had failed to complete their studies in the nine-year compulsory education. Furthermore, the research focuses on their motives as well as on any possible achievement of transformative processes. The quantitative survey involved in total 426 graduates while in the qualitative survey participated 38 persons, all of whom graduated in the period 2010-2012 from 27 schools throughout the country. The survey was conducted by filling in a structured questionnaire and by carrying out semi-structured interviews. As regards the results, the respondents decided to attend the SCS primarily to acquire knowledge while most of them feel that they managed to meet their goals. Also, graduates recognize that studying in SCS contributed primarily in their social and personal development. In addition, an encouraging fact is that some of the graduates recognize the transformative processes which they experienced during their studies in SCS.

Keywords: Adults Education, Motives of Attendance, Personal-Social-Professional-Educational Development, Transformative Processes, Quantitative and Qualitative Survey

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Authors: Francesca Giliberto

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Heritage and culture, in general, plays a central role in addressing the complexity and broad variety of global development challenges, ranging from environmental degradation and refugee and humanitarian crisis to extreme poverty, food insecurity, persisting inequalities, and unsustainable urbanisation, just to mention some examples. Nevertheless, the potential of harnessing heritage to address global challenges has remained largely under-represented and underestimated in the most recent international development agenda adopted by the United Nations in 2015 (2030 Agenda). Among the 17 sustainable development goals (SDGs) and 169 associated targets established, only target 11.4 explicitly mentions heritage, stating that efforts should be strengthened “to protect and safeguard the world’s cultural and natural heritage in order to make our cities safe, resilient, and sustainable”. However, this global target continues to reflect a rather limited approach to heritage for development. This paper will provide a critical reflection on the contribution that using (tangible and intangible) heritage in international research can make to tackling global challenges and supporting the achievement of all the SDGs. It will present key findings and insights from the heritage strand of PRAXIS, a research project from the University of Leeds, which focuses on Arts and Humanities research across 300+ projects funded through the Global Challenges Research Fund and Newton Fund. In particular, this paper will shed light on successful practices and lessons learned from 87 research projects funded through the Global Challenges Research Fund and Newton Fund portfolios in 49 countries eligible for Official Development Assistance (ODA) between 2014 and 2021. Research data were collected through a desk assessment of project data available on UKRI Gateway to Research, online surveys, and qualitative interviews with research principal investigators and partners. The findings of this research provide evidence of how heritage and heritage research can foster innovative, interdisciplinary, inclusive, and transformative sustainable development and the achievement of the SDGs in ODA countries and beyond. This paper also highlights current challenges and research gaps that still need to be overcome to rethink current approaches and transform our development models to be more integrated, human-centred, and sustainable.

Keywords: global challenges, heritage, international research, sustainable development

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Authors: Salami Ayobami Taofeek, Ajayi Adeola

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Rural tourism entrepreurship is a tourist industry which revolutionizes businesses and prompting economic development across the globe. It encompasses huge range activities, natural or man-made attractions, amenities and facilities, transportation, marketing and information systems. It is also an important export for 83% of the developing countries and the main export for one third of them. In 2000, developing countries recorded 142.6 million international arrivals an increase of 95% compared to the figures of 1990. However, only developing countries with effective natural and man-made tourism supporting and enhancing infrastructure have been able to develop their tourism sector and seize the attendance advantages. Rural areas of Nigeria possess some distinctive peculiarities which can be transformed into attractive tourist centers. In spite of all these, rural tourism areas are still faced with myriad problems which include poor finance inadequate awareness and education, lack of progress in developing the rural of progress in developing the rural tourism potentials inadequate legislation, insecurity, entrepreneurial inertness, over-dependent on oil among others. This paper focuses on the impact and challenges of rural tourism entrepreneurship as strategy for economic development in Nigeria. It reviews literature rural tourism, tourism entrepreneurship potentials and classifications of Nigerians tourism potential’s destinations. The paper concludes that Nigeria Government should encourage rural based tourism entrepreneurship development by addressing the challenges facing rural tourism entrepreneurship in the country.

Keywords: entrepreneurship, economic development, rural tourism, tourism destinations tourism potentials

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Authors: Matthew I. Bellgard

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The field of bioinformatics has made, and continues to make, substantial progress and contributions to life science research and development. However, this paper contends that a systems approach integrates bioinformatics activities for any project in a defined manner. The application of critical control points in this bioinformatics systems approach may be useful to identify and evaluate points in a pathway where specified activity risk can be reduced, monitored and quality enhanced.

Keywords: bioinformatics, food security, personalized medicine, systems approach

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Authors: S. P. Rana

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Objectives: For the manufacture of a very thin strip or a strip with a high-quality finish, the stainless steel sheet that is called billet is re-rolled in re-rolling mill to make stainless steel sheet of 18 gauges. The rolls of re-rolling mill exert tremendous pressure over the sheet and there is likely chance of breaking of stainless steel strip from the sheet. The objective of the study was to minimise the number of accidents in steel re-rolling mills due to ejection of stainless steel strip and to minimize the pollution caused by the pickling process used in these units. Methods: Looking into the high rate of frequency and severity of accidents as well as pollution hazard in re-rolling and pickling mills, it becomes essential to make necessary arrangements for prevention of accidents in such type of industry. The author carried out survey/inspections of a large number of re-rolling and pickling mills and allied units. During the course of inspection, the working of these steel re-rolling and pickling mills was closely studied and monitored. A number of accidents involving re-rolling mills were investigated and subsequently remedial measures to prevent the occurrence of such accidents were suggested. Assessment of occupational safety and health system of these units was carried out and compliance level of the statutory requirements was checked. The workers were medically examined and monitored to ascertain their health conditions. Results: Proper use of safety gadgets by workers, machine guarding and regular training brought down the risk to an acceptable level and discharged effluent pollution was brought down to permissible limits. The fatal accidents have been reduced by 83%. Conclusions: Effective enforcement and implementation of the directions/suggestions given to the managements of such units brought down the no. of accidents to a rational level. The number of fatal accidents has reduced by 83% during the study period. The effective implementation of pollution control device curtailed the pollution level to an acceptable level.

Keywords: re-rolling mill, hazard, accident, health hazards

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Authors: Chien-Liang Chao, Yun-Sheng Lin

Abstract:

Secondary metabolites are applied in the human life of the Chinese herbal medicine. Many drugs are originally extracted from natural products with combination of pharmaceutical and chemical studies. Crude extract of the leaves from Zamia furfureace L. has been shown to exhibit anticancer activities. The first chemical investigation of this plant was carried out by our group. In this study, four known compounds were isolated from Zamia furfureace L. with three lignins (Sesamin (1), Wodeshiol (2) and Paulownin (3)), and one dipeptide (Aurantiamide acetate (4)). The structures of these compounds were analyzed through the 1D-NMR(1H-NMR,13C-NMR)、2D-NMR(COSY、HMQC、HMBC、NOESY) spectroscopic analysis, and by comparison of variety of physical data (IR, mass spectrometry, ultraviolet, optical rotation). Among them, Aurantiamide acetate (4) exhibited weak cytotoxic activity against human gastric cancer cells.

Keywords: Zamia furfureace L., AGS, sesamin, Aurantiamide acetate, secondary metabolites

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