Search results for: decentralized trials

Authors: Marc Bachelet, Abhijit Kumar Chatterjee, José Manuel Avila

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Data quality is a key component of any data-driven organization. Without data quality, organizations cannot effectively make data-driven decisions, which often leads to poor business performance. Therefore, it is important for an organization to ensure that the data they use is of high quality. This is where the concept of data mesh comes in. Data mesh is an organizational and architectural decentralized approach to data management that can help organizations improve the quality of data. The concept of data mesh was first introduced in 2020. Its purpose is to decentralize data ownership, making it easier for domain experts to manage the data. This can help organizations improve data quality by reducing the reliance on centralized data teams and allowing domain experts to take charge of their data. This paper intends to discuss how a set of elements, including data mesh, are tools capable of increasing data quality. One of the key benefits of data mesh is improved metadata management. In a traditional data architecture, metadata management is typically centralized, which can lead to data silos and poor data quality. With data mesh, metadata is managed in a decentralized manner, ensuring accurate and up-to-date metadata, thereby improving data quality. Another benefit of data mesh is the clarification of roles and responsibilities. In a traditional data architecture, data teams are responsible for managing all aspects of data, which can lead to confusion and ambiguity in responsibilities. With data mesh, domain experts are responsible for managing their own data, which can help provide clarity in roles and responsibilities and improve data quality. Additionally, data mesh can also contribute to a new form of organization that is more agile and adaptable. By decentralizing data ownership, organizations can respond more quickly to changes in their business environment, which in turn can help improve overall performance by allowing better insights into business as an effect of better reports and visualization tools. Monitoring and analytics are also important aspects of data quality. With data mesh, monitoring, and analytics are decentralized, allowing domain experts to monitor and analyze their own data. This will help in identifying and addressing data quality problems in quick time, leading to improved data quality. Data culture is another major aspect of data quality. With data mesh, domain experts are encouraged to take ownership of their data, which can help create a data-driven culture within the organization. This can lead to improved data quality and better business outcomes. Finally, the paper explores the contribution of AI in the coming years. AI can help enhance data quality by automating many data-related tasks, like data cleaning and data validation. By integrating AI into data mesh, organizations can further enhance the quality of their data. The concepts mentioned above are illustrated by AEKIDEN experience feedback. AEKIDEN is an international data-driven consultancy that has successfully implemented a data mesh approach. By sharing their experience, AEKIDEN can help other organizations understand the benefits and challenges of implementing data mesh and improving data quality.

Keywords: data culture, data-driven organization, data mesh, data quality for business success

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Authors: Hadi O. Tohme

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This study is a review on the effectiveness of new physiotherapy techniques with external sensory stimulus compared to standard physiotherapy in the daily activities of patients with Parkinson's disease. Twenty studies from 1996 to 2015 were analyzed and discussed in this review, using the rehabilitation strategy with external sensory stimulus evaluating walking, freezing episodes, balance, transfers, and daily activities of parkinsonian patients. The study highlights the effectiveness of the variety of rehabilitation with cueing strategy used in the treatment of Parkinson's disease. Based on the literature review completed, there is a need for more specific trials with better treatment strategies to support the most appropriate choice of physiotherapy intervention using external sensory stimulus to the type and frequency of this stimulus. In addition, no trials examined the long-term benefits of the physiotherapy intervention with the external sensory stimulus. In order to determine if, or how long the improvements due to the external sensory stimulus physiotherapy intervention can last, long-term follow-up should be performed.

Keywords: cueing strategy, external sensory stimulus, parkinson disease, rehabilitation for parkinson, sensory attention focused exercises, sensory strategy reeducation

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Authors: Matthew Heidman, Susan Dallabrida, Analice Costa

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Background:Accuracy of caregiver reported outcomes is essential for infant growth and tolerability study success. Crying/fussiness, stool consistencies, and other gastrointestinal characteristics are important parameters regarding tolerability, and inter-caregiver reporting can see a significant amount of subjectivity and vary greatly within a study, compromising data. This study sought to elucidate how caregiver reported questions related to stool frequency are answered before and after a short amount of training and how training impacts caregivers’ understanding, and how they would answer the question. Methods:A digital survey was issued for 90 daysin the US (n=121) and 30 days in Mexico (n=88), targeting respondents with children ≤4 years of age. Respondents were asked a question in two formats, first without a line of training text and second with a line of training text. The question set was as follows, “If your baby had stool in his/her diaper and you changed the diaper and 10 min later there was more stool in the diaper, how many stools would you report this as?” followed by the same question beginning with “If you were given the instruction that IF there are at least 5 minutes in between stools, then it counts as two (2) stools…”.Four response items were provided for both questions, 1) 2 stools, 2) 1stool, 3) it depends on how much stool was in the first versus the second diaper, 4) There is not enough information to be able to answer the question. Response frequencies between questions were compared. Results: Responses to the question without training saw some variability in the US, with 69% selecting “2 stools”,11% selecting “1 stool”, 14% selecting “it depends on how much stool was in the first versus the second diaper”, and 7% selecting “There is not enough information to be able to answer the question” and in Mexico respondents selected 9%, 78%, 13%, and 0% respectively. However, responses to the question after training saw more consolidation in the US, with 85% of respondents selecting“2 stools,” representing an increase in those selecting the correct answer. Additionally in Mexico, with 84% of respondents selecting “1 episode” representing an increase in the those selecting the correct response. Conclusions: Caregiver reported outcomes are critical for infant growth and tolerability studies, however, they can be highly subjective and see a high variability of responses without guidance. Training is critical to standardize all caregivers’ perspective regarding how to answer questions accurately in order to provide an accurate dataset.

Keywords: infant nutrition, clinical trial optimization, stool reporting, decentralized clinical trials

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Authors: Zhipeng Yan, Janice Wing-Tung Kwong, Ching-Lung Lai

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Background: Advanced melanoma accounts for the majority of skin cancer death due to its poor prognosis. Nivolumab and ipilimumab are monoclonal antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocytes antigen 4 (CTLA-4). Nivolumab and ipilimumab combination therapy has been proven to be effective for advanced melanoma. This systematic review and meta-analysis are to evaluate its clinical efficacy and adverse events. Method: A systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) on 21 June 2020. Search keywords were nivolumab, ipilimumab, melanoma, and randomised controlled trials. Clinical trials fulfilling the inclusion criteria were selected to evaluate the efficacy of combination therapy in terms of prolongation of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The odd ratios and distributions of grade 3 or above adverse events were documented. Subgroup analysis was performed based on PD-L1 expression-status and BRAF-mutation status. Results: Compared with nivolumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR in combination therapy were 0.64 (95% CI, 0.48-0.85; p=0.002), 0.84 (95% CI, 0.74-0.95; p=0.007) and 1.76 (95% CI, 1.51-2.06; p < 0.001), respectively. Compared with ipilimumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR were 0.46 (95% CI, 0.37-0.57; p < 0.001), 0.54 (95% CI, 0.48-0.61; p < 0.001) and 6.18 (95% CI, 5.19-7.36; p < 0.001), respectively. In combination therapy, the odds ratios of grade 3 or above adverse events were 4.71 (95% CI, 3.57-6.22; p < 0.001) compared with nivolumab monotherapy, and 3.44 (95% CI, 2.49-4.74; p < 0.001) compared with ipilimumab monotherapy, respectively. High PD-L1 expression level and BRAF mutation were associated with better clinical outcomes in patients receiving combination therapy. Conclusion: Combination therapy is effective for the treatment of advanced melanoma. Adverse events were common but manageable. Better clinical outcomes were observed in patients with high PD-L1 expression levels and positive BRAF-mutation.

Keywords: nivolumab, ipilimumab, advanced melanoma, systematic review, meta-analysis

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Authors: Denis Obrul, Borut Žalik

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We present an extendable online real-time tracking platform that can be used to track a wide variety of location-aware devices. These can range from GPS devices mounted inside a vehicle, closed and secure systems such as Teltonika and to mobile phones running multiple platforms. Special consideration is given to decentralized approach, security and flexibility. A number of different use cases are presented as a proof of concept.

Keywords: real-time, online, gps, tracking, web application

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Authors: Svetlana Missina, Anatoliy Shipilov, Alexandr Vavaev

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The purpose of the present study was to investigate the relationship between sprint and vertical jump performance in elite female football players. Twenty four professional female football players (age, 18.6±3.1 years; height, 168.3±6.3 cm, body mass 61.6±7.4 kg; mean±SD) were tested for 30-m sprint time, 10-m sprint time and vertical countermovement (CMJ) and squat (SJ) jumps height. Participants performed three countermovement jumps and three squat jumps for maximal height on a force platform. Mean values of three trials were used in statistical analysis. The displacement of center of mass (COM) during flight phase (e.g. jump height) was calculated using the vertical velocity of the COM at the moment of take-off. 30-m and 10-m sprint time were measured using OptoGait optical system. The best of three trials were used for analysis. A significant negative correlation was found between 30-m sprint time and CMJ, SJ height (r = -0.85, r = -0.79 respectively), between 10-m sprint time and CMJ, SJ height (r = -0.73, r = -0.8 respectively), and step frequency was significantly related to CMJ peak power (r = -0.57). Our study indicates that there is strong correlation between sprint and jump performance in elite female football players, thus vertical jump test can be considered as a good sprint and agility predictor in female football.

Keywords: agility, female football players, sprint performance, vertical jump height

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Authors: Mai Ashraf Talaat

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Objectives: The aim of this review article is to assess the success of dental implants in breast cancer patients receiving bisphosphonate therapy and to evaluate the risk of developing bisphosphonate-related osteonecrosis of the jaw following dental implant surgery. Materials and Methods: A thorough search was conducted, with no time or language restriction, using: PubMed, PubMed Central, Web of Science, and ResearchGate electronic databases. Medical Subject Headings (MeSH) terms such as “bisphosphonate”, “dental implant”, “bisphosphonate-related osteonecrosis of the jaw (BRONJ)”, “osteonecrosis”, “breast cancer, MRONJ”, and their related entry terms were used. Eligibility criteria included studies and clinical trials that evaluated the impact of bisphosphonates on dental implants. Conclusion: Breast cancer patients undergoing bisphosphonate therapy may receive dental implants. However, the risk of developing BRONJ and implant failure is high. Risk factors such as the type of BP received, the route of administration, and the length of treatment prior to surgery should be considered. More randomized controlled trials with long-term follow-ups are needed to draw more evidence-based conclusions.

Keywords: dental implants, breast cancer, bisphosphonates, osteonecrosis, bisphosphonate-related osteonecrosis of the jaw

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Authors: Sheikh Omar Sillah

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Introduction: Monitoring is an important means of ensuring the smooth implementation and quality of clinical trials. For many years, traditional site monitoring approaches have been critical in detecting data errors but not optimal in identifying fabricated and implanted data as well as non-random data distributions that may significantly invalidate study results. The objective of this paper was to provide recommendations based on best statistical monitoring practices for detecting data-integrity issues suggestive of fabrication and implantation early in the study conduct to allow implementation of meaningful corrective and preventive actions. Methodology: Electronic bibliographic databases (Medline, Embase, PubMed, Scopus, and Web of Science) were used for the literature search, and both qualitative and quantitative studies were sought. Search results were uploaded into Eppi-Reviewer Software, and only publications written in the English language from 2012 were included in the review. Gray literature not considered to present reproducible methods was excluded. Results: A total of 18 peer-reviewed publications were included in the review. The publications demonstrated that traditional site monitoring techniques are not efficient in detecting data anomalies. By specifying project-specific parameters such as laboratory reference range values, visit schedules, etc., with appropriate interactive data monitoring, statistical monitoring can offer early signals of data anomalies to study teams. The review further revealed that statistical monitoring is useful to identify unusual data patterns that might be revealing issues that could impact data integrity or may potentially impact study participants' safety. However, subjective measures may not be good candidates for statistical monitoring. Conclusion: The statistical monitoring approach requires a combination of education, training, and experience sufficient to implement its principles in detecting data anomalies for the statistical aspects of a clinical trial.

Keywords: statistical monitoring, data anomalies, clinical trials, traditional monitoring

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Authors: Foong Kiew Ooi, Aidi Naim Mohamad Samsani, Chee Keong Chen, Mohamed Saat Ismail

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Introduction: Prolonged exercise in a hot and humid environment can result in glycogen depletion and associated with loss of body fluid. Carbohydrate contained in sports beverages is beneficial for improving sports performance and preventing dehydration. Carbohydrate contained in honey is believed can be served as an alternative form of carbohydrate for enhancing sports performance. Objective: To investigate the effectiveness of honey drink compared to sports drink as a recovery aid for running performance and physiological parameters in the heat. Method: Ten male recreational athletes (age: 22.2 ± 2.0 years, VO2max: 51.5 ± 3.7 ml.kg-1.min-1) participated in this randomized cross-over study. On each trial, participants were required to run for 1 hour in the glycogen depletion phase (Run-1), followed by a rehydration phase for 2 hours and subsequently a 20 minutes time trial performance (Run-2). During Run-1, subjects were required to run on the treadmill in the heat (31°C) with 70% relative humidity at 70 % of their VO2max. During rehydration phase, participants drank either honey drink or sports drink, or plain water with amount equivalent to 150% of body weight loss in dispersed interval (60 %, 50 % and 40 %) at 0 min, 30 min and 60 min respectively. Subsequently, time trial was performed by the participants in 20 minutes and the longest distance covered was recorded. Physiological parameters were analysed using two-way ANOVA with repeated measure and time trial performance was analysed using one-way ANOVA. Results: Result showed that Acacia honey elicited a better time trial performance with significantly longer distance compared to water trial (P<0.05). However, there was no significant difference between Acacia honey and sport drink trials (P > 0.05). Acacia honey and sports drink trials elicited 249 m (8.24 %) and 211 m (6.79 %) longer in distance compared to the water trial respectively. For physiological parameters, plasma glucose, plasma insulin and plasma free fatty acids in Acacia honey and sports drink trials were significantly higher compared to the water trial respectively during rehydration phase and time trial running performance phase. There were no significant differences in body weight changes, oxygen uptake, hematocrit, plasma volume changes and plasma cortisol in all the trials. Conclusion: Acacia honey elicited greatest beneficial effects on sports performance among the drinks, thus it has potential to be used for rehydration in athletes who train and compete in hot environment.

Keywords: honey drink, rehydration, sports performance, plasma glucose, plasma insulin, plasma cortisol

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Authors: Zhaoqi He

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Research Context: Endurance performance in hot environments is influenced by the interplay of hydration status and physiological responses. This study aims to investigate how dehydration, up to 2.11% body weight loss, affects the 3 km running performance of trained male athletes under conditions mimicking high temperatures. Methodology: In a randomized crossover design, five male athletes participated in two trials – euhydrated (EU) and dehydrated (HYPO). Both trials included a 70-minute preload run at 55-60% VO2max in 32°C and 50% humidity, followed by a 3-kilometer time trial. Fluid intake was restricted in HYPO to induce a 2.11% body weight loss. Physiological metrics, including heart rate, core temperature, and oxygen uptake, were measured, along with perceptual metrics like perceived exertion and thirst sensation. Findings: The 3-kilometer run completion times showed no significant differences between EU and HYPO trials (p=0.944). Physiological indicators, including heart rate, core temperature, and oxygen uptake, did not significantly vary (p>0.05). Thirst sensation was markedly higher in HYPO (p=0.013), confirming successful induction of dehydration. Other perceptual metrics and gastrointestinal comfort remained consistent. Conclusion: Contrary to the hypothesis, the study reveals that dehydration, inducing up to 2.11% body weight loss, does not significantly impair 3 km running performance in trained male athletes under hot conditions. Thirst sensation was notably higher in the dehydrated state, emphasizing the importance of considering perceptual factors in hydration strategies. The findings suggest that trained runners can maintain performance despite moderate dehydration, highlighting the need for nuanced hydration guidelines in hot-weather running.

Keywords: hypohydration, euhydration, hot environment, 3km running time trial, endurance performance, trained athletes, perceptual metrics, dehydration impact, physiological responses, hydration strategies

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Authors: Nkrumak Micheal Atta Ofori

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The Vocational System is a decentralized Studies System implemented in Ghana as vocation studies strategy for grassroot that focuses on providing individuals with the specific skills, knowledge, and training necessary for a particular trade, craft, profession, or occupation. This article asks how devolution of vocational studies to local level authorities produces responsive and accountable representation and sustainable vocational learning under the vocational Studies System. It focuses on two case studies: Asokore Mampong and Atwima kwanwoma Municipal. Then, the paper asks how senior high school are developing new material and social practices around the vocational studies System to rebuild their livelihoods and socio-economic wellbeing. Here, the article focusses on Kumasi District, drawing lessons for the two other cases. The article shows how the creation of representative groups under the Vocational Studies System provides the democratic space necessary for effective representation of community aspirations. However, due to elite capture, the interests of privilege few people are promoted. The state vocational training fails to devolve relevant and discretionary resources to local teachers and do not follow the prescribed policy processes of the Vocational Studies System. Hence, local teachers are unable to promote responsive and accountable representation. Rural communities continue to show great interest in the Vocational Studies System, but the interest is bias towards gaining access to vocational training schools for advancing studies. There is no active engagement of the locals in vocational training, and hence, the Vocational Studies System exists only to promote individual interest of communities. This article shows how ‘failed’ interventions can gain popular support for rhetoric and individual gains.

Keywords: vocational studies system, devolution of vocational studies, local-level authorities, senior high schools and vocational learning, community aspirations and representation

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Authors: Yee Yan Crystal Kwong

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The essence of rape is the absence of consent to sexual intercourse. Yet, the definition of consent is not absolute and allows for subjectivity. In this case, the accuracy of oral interpretation becomes very important as the narratives of events and situation, as well as the register and style of speakers would influence the juror decision making. This paper first adopts a corpus-based approach to investigate how court interpreters in Hong Kong handle expressions that refer to sexual activities. The data of this study will be based on online corpus :From legislation to translation, from translation to interpretation: The narrative of sexual offences. The corpus comprises the transcription of five separate rape trials and all of these trials were heard with the presence of an interpreter. Since there are plenty of sex-related expressions used by witnesses and defendants in the five cases, emphasis will be put on those which have an impact on the definition of rape. With an in-depth analysis of the interpreted utterances, different interpreting approaches will be identified to observe how interpreters retain the intended meanings. Interviews with experienced court interpreters will also be conducted to revisit the validity of the traditional verbatim standard. At the end of this research, various interpreting approaches will be compared and evaluated. A redefinition of interpreters' institutional role, as well as recommendations for interpreting learners will be provided.

Keywords: court interpreting, interpreters, legal translation, slangs

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Authors: Hadriana Bansi, Elizabeth Wina, Toto Toharmat

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Acacia villosa is thornless shrub legume which contents high crude protein. However, the utilization of A. villosa as ruminant feed is limited by its secondary compounds. The aim of this article is to find out the maximum of substitution A. villosa in sheep ration. The nutritional evaluation consisted of in vitro two stages, in vivo, and in vitro gas production trials. The secondary compounds of A. villosa also were analyzed. Evaluating digestibility of increasing level of substitution A. villosa replacing Pennisetum purpureum was using in vitro two stages. The substitution of 30% A. villosa was compared to 100% P. purpureum by in vitro gas production technique and in vivo digestibility. The results of two stages in vitro showed that total phenol, condensed tannin, and non-protein amino acid (NPAA) were high. Substitution 15% A. villosa reached the highest digestibility for both dry matter (DM) and crude protein (CP) which were 67% and 86% respectively, but it was shown that DM and CP digestibility of substitution 30% of A. villosa was still high which were 61.82% and 75-67% respectively. The pattern of gas production showed that first 8 hours total gas production substitution of 30% A. villosa was higher than 100% P. purpureum and declined after 10 hours incubation. In vivo trials showed that substitution of 30% A. villosa significantly increased CP intake, CP digestibility, and nitrogen retention. It can be concluded that substitution A. villosa until 30% still gave the good impact even though it has high secondary compounds.

Keywords: Acacia villosa, digestibility, gas production, secondary compounds

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Authors: Bijad Alqahtani, Graham Arnold, Weijie Wang

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Background—Tai Chi Chuan (TCC) is a type of traditional Chinese martial art and is considered a benefiting physical fitness. Advanced techniques of motion analysis have been routinely used in the clinical assessment. However, so far, little research has been done on the biomechanical assessment of TCC players in terms of gait and balance using motion analysis. Objectives—The aim of this study was to investigate whether TCC improves the lower limb conditions and balance ability using the state of the art motion analysis technologies, i.e. motion capture system, electromyography and force platform. Methods—Twenty TCC (9 male, 11 female) with age between (42-77) years old and weight (56.2-119 Kg), and eighteen Non-TCC participants (7 male, 11 female), weight (50-110 Kg) with age (43- 78) years old at the matched age as a control group were recruited in this study. Their gait and balance were collected using Vicon Nexus® to obtain the gait parameters, and kinematic parameters of hip, knee, and ankle joints in three planes of both limbs. Participants stood on force platforms to perform a single leg balance test. Then, they were asked to walk along a 10 m walkway at their comfortable speed. Participants performed 5 trials of single-leg balance for the dominant side. Also, the participants performed 3 trials of four square step balance and 10 trials of walking. From the recorded trials, three good ones were analyzed using the Vicon Plug-in-Gait model to obtain gait parameters, e.g. walking speed, cadence, stride length, and joint parameters, e.g. joint angle, force, moments, etc. Result— The temporal-spatial variables of TCC subjects were compared with the Non-TCC subjects, it was found that there was a significant difference (p < 0.05) between the groups. Moreover, it was observed that participants of TCC have significant differences in ankle, hip, and knee joints’ kinematics in the sagittal, coronal, and transverse planes such as ankle angle (19.90±19.54 deg) for TCC while (15.34±6.50 deg) for Non-TCC, and knee angle (14.96±6.40 deg) for TCC while (17.63±5.79 deg) for Non-TCC in the transverse plane. Also, the result showed that there was a significant difference between groups in the single-leg balance test, e.g. maintaining single leg stance time in the TCC participants showed longer duration (20.85±10.53 s) in compared to Non-TCC people group (13.39±8.78 s). While the result showed that there was no significant difference between groups in the four square step balance. Conclusion—Our result showed that there are significant differences between Tai Chi Chuan and Non-Tai Chi Chuan participants in the various aspects of gait analysis and balance test, as a consequence of these findings some of biomechanical parameters such as joints kinematics, gait parameters and single leg stance balance test, the Tai Chi Chuan could improve the lower limb conditions and could reduce a risk of fall for the elderly with ageing.

Keywords: gait analysis, kinematics, single leg stance, Tai Chi Chuan

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Authors: Flex Anim

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The financial system is a decentralized studies system that was put into place in Ghana as a grassroots financial studies approach. Its main goal is to give people the precise knowledge, abilities, and training required for a given trade, business, profession, or occupation. In this essay, the question of how the financial studies system's devolution to local businesses results in responsible and responsive representation as well as long-term company learning is raised. It centers on two case studies, Asekwa Municipal and Oforikrom. The next question posed by the study is how senior high school students are rebuilding their livelihoods and socioeconomic well-being by creating new curriculum and social practices related to the finance and business studies system. The paper here concentrates on Kumasi District and makes inferences for the other two examples. The paper demonstrates how the financial studies system's establishment of representative groups creates the democratic space required for the successful representation of community goals. Nonetheless, the interests of a privileged few are advanced as a result of elite capture. The state's financial and business training programs do not adhere to the financial studies system's established policy procedures and do not transfer pertinent and discretionary resources to local educators. As a result, local educators are unable to encourage representation that is accountable and responsive. The financial studies system continues to pique the interest of rural areas, but this desire is skewed toward getting access to financial or business training institutions for higher education. Since the locals are not actively involved in financial education, the financial studies system serves just to advance the interests of specific populations. This article explains how rhetoric and personal benefits can be supported by the public even in the case of "failed" interventions.

Keywords: financial studies system, financial studies' devolution, local government, senior high schools and financial education, as well as community goals and representation

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Authors: Hamza I. Isa, Gezina C. H. Ferreira, Jan E. Crafford, Christoffel J. Botha

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Moraea pallida Bak. (yellow tulip) poisoning is the most important plant-induced cardiac glycoside toxicosis in South Africa. Cardiac glycoside poisonings collectively account for about 33 and 10 % mortalities due to plants, in large and small stock respectively, in South Africa. The toxic principle is 1α, 2α-epoxyscillirosidine, a bufadienolide. The aim of the study was to investigate the potential to develop a vaccine against epoxyscillirosidine. Epoxyscillirosidine and the related bufadienolides proscillaridin and bufalin, which are commercially available, were conjugated to the carrier proteins [Hen ovalbumin (OVA), bovine serum albumin (BSA) and keyhole limpet haemocyanin (KLH)], rendering them immunogenic. Adult male New Zealand White rabbits were immunized. In Trials 1 and 2, rabbits (n=6) were, each assigned to two groups. Experimental animals (n=3; n=4) were vaccinated with epoxyscillirosidine-OVA conjugate, while the control (n=3; n=2) were vaccinated with OVA, using Freund’s complete and incomplete and Montanide adjuvants, for Trials 1 and 2, respectively. In Trial 3, rabbits (n=15), randomly allocated to 5 equal groups (I, II, III, IV and V), were vaccinated with proscillaridin-BSA, bufalin-BSA, epoxyscillirosidine-KLH, epoxyscillirosidine-BSA conjugates, and BSA respectively, using Montanide as adjuvant. Vaccination was on Days 0, 21 and 42. Additional vaccinations were done on Day 56 and 63 for Trial 1. Vaccination was by intradermal injection of 0.4 ml of the immunogen (4 mg/ml [Trial 1] and 8 mg/ml for Trials 2 and Trial 3, respectively). Blood was collected pre-vaccination and at 3 week intervals following each vaccination. Antibody response was determined using an indirect ELISA. There was poor immune response associated with the dose (0.4 mg per rabbit) and adjuvant used in Trial 1. Antibodies were synthesized against the conjugate administered in Trial 2. For Trail 3, antibodies against the immunogens were successfully raised in rabbits with epoxyscillirosidine-KLH inducing the highest immune response. The antibodies raised against proscillaridin and bufalin cross-reacted with epoxyscillirosidine when used as antigen in the ELISA. The study successfully demonstrated the synthesis of antibodies against the bufadienolide conjugates administered. The cross-reactivity of proscillaridin and bufalin with epoxyscillirosidine could potentially be utilized as alternative to epoxyscillirosidine in future studies to prevent yellow tulp poisoning by vaccination.

Keywords: antibodies , bufadienolides, cross-reactivity, epoxyscillirosidine, Moraea pallida, poisoning

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Authors: Yaxian Chen, Yeonhee Park

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Driven by evolving FDA recommendations, modern clinical trials demand innovative designs that strike a balance between statistical rigor and ethical considerations. Covariate-adjusted response-adaptive (CARA) designs bridge this gap by utilizing patient attributes and responses to skew treatment allocation in favor of the treatment that is best for an individual patient’s profile. However, existing CARA designs for survival outcomes often hinge on specific parametric models, constraining their applicability in clinical practice. In this article, we address this limitation by introducing a CARA design for survival outcomes (CARAS) based on the Cox model and a variance estimator. This method addresses issues of model misspecification and enhances the flexibility of the design. We also propose a group sequential overlapweighted log-rank test to preserve type I error rate in the context of group sequential trials using extensive simulation studies to demonstrate the clinical benefit, statistical efficiency, and robustness to model misspecification of the proposed method compared to traditional randomized controlled trial designs and response-adaptive randomization designs.

Keywords: cox model, log-rank test, optimal allocation ratio, overlap weight, survival outcome

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Authors: Petr Konvalina, Jan Moudry

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As organic farmers are searching foregoing crops for horticultural crops, there is possible to choice neglected wheat species and also have a new market and sale opportunities. Concerning wheat, there are landraces so called hulled wheat species (einkorn, emmer wheat, spelt) comprising parts of collections of the world gene banks. The advantage of this wheat species are small demands on growing conditions and also droughtiness in conditions of changing climate. Our paper aims at presenting the results of the study and the assessment of spring wheat forms, four einkorn cultivars, eight emmer wheat cultivars, seven spelt wheat cultivars in particular, as compared to modern bread wheat variety. Small-plot trials were established at two different localities within the Czech Republic and Austria in 2009 and 2012. The results of the trials show that some varieties were inclined to lodging. On the other hand, they were resistant to common wheat diseases (mildew, brown rust). Hulls served as barriers and obstacles against the DON grain contamination. The yield rate was lower. The grains were characterized by a high proportion of protein in grain (up to 18.1 %). However, they may be difficult to use for common baking. Moreover, new food products demonstrating a different technological quality of the hulled wheat species have to be launched on the market. They will be suitable for regional marketing.

Keywords: organic farming, hulled wheat species, einkorn, emmer, spelt

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Authors: A. Mech

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Repetitive transcranial magnetic stimulation has proven to be a valuable treatment option for patients who have failed to respond to multiple courses of antidepressant medication. In fact, the American Psychiatric Association recommends TMS after one failed treatment course of antidepressant medication. Genetic testing has proven valuable for pharmacokinetic variables, which, if understood, could lead to more efficient dosing of psychotropic medications to improve outcomes. Pharmacodynamic testing can identify biomarkers, which, if addressed, can improve patients' outcomes in antidepressant therapy. Monotherapy treatment of major depressive disorder with methylated B vitamin treatment has been shown to be safe and effective in patients with MTHFR polymorphisms without waiting for multiple trials of failed medication treatment for depression. Such treatment has demonstrated remission rates similar to antidepressant clinical trials. Combining pharmacodynamics testing with repetitive TMS treatment with NeuroStar has shown promising potential for enhancing remission rates and durability of treatment. In this study, a retrospective chart review (ongoing) of patients who obtained repetitive TMS treatment enhanced by dietary supplementation guided by Pharmacodynamic testing, displayed a greater remission rate (90%) than patients treated with only NeuroStar TMS (62%).

Keywords: improved remission rate, major depressive disorder, pharmacodynamic testing, rTMS outcomes

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Authors: Naser Shagerdi Esmaeli, Mohsen Hamidpour

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Purposes: The activation of coagulation in patients with cancer contributes significantly to morbidity and mortality rates and may play a fundamental role in the host response to growing tumor’s. Patients with cancer are clearly at high risk for the development of venous thromboembolism (VTE), particularly during chemotherapy and surgery. This situation is aggravated by the use of venous access catheters and possibly growth factors. Methods: Data derived from large, randomized, controlled trials have been used to determine the true incidence of this complication of cancer and its treatment. The incidence based on the analyses of these randomized controlled trials varies from 1% for limited stage patients with breast cancer treated with tamoxifen to 60% for patients with any type of cancer who are subjected to orthopedic surgery and do not receive prophylactic therapy. Results: In view of the morbidity and mortality attributable to VTE in cancer, widespread utilization of prophylactic anticoagulation therapy, which has proven safe and effective in a variety of situations, should be considered. While migratory thrombophlebitis is a clear indicator of an underlying neoplasm, the risk of cancer in patients with the more typical form of VTE has been the subject of intense debate over recent years. Conclusion: Some investigators have suggested that the relative risk of being diagnosed with occult cancer within six months of an episode of VTE (particularly recurrent VTE) could be up to 10-fold. However, the cost-effectiveness of aggressive screening for cancer in patients with VTE has not yet been defined adequately.

Keywords: venous thromboembolism, malignancy, cancer, tumor, heparin

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Authors: Thomas Weber, Nina Strobel, Thomas Kohne, Eberhard Abele

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In context of the energy transition in Germany, the importance of so-called virtual power plants in the energy supply continues to increase. The progressive dismantling of the large power plants and the ongoing construction of many new decentralized plants result in great potential for optimization through synergies between the individual plants. These potentials can be exploited by mathematical optimization algorithms to calculate the optimal application planning of decentralized power and heat generators and storage systems. This also includes linear or linear mixed integer optimization. In this paper, procedures for reducing the number of decision variables to be calculated are explained and validated. On the one hand, this includes combining n similar installation types into one aggregated unit. This aggregated unit is described by the same constraints and target function terms as a single plant. This reduces the number of decision variables per time step and the complexity of the problem to be solved by a factor of n. The exact operating mode of the individual plants can then be calculated in a second optimization in such a way that the output of the individual plants corresponds to the calculated output of the aggregated unit. Another way to reduce the number of decision variables in an optimization problem is to reduce the number of time steps to be calculated. This is useful if a high temporal resolution is not necessary for all time steps. For example, the volatility or the forecast quality of environmental parameters may justify a high or low temporal resolution of the optimization. Both approaches are examined for the resulting calculation time as well as for optimality. Several optimization models for virtual power plants (combined heat and power plants, heat storage, power storage, gas turbine) with different numbers of plants are used as a reference for the investigation of both processes with regard to calculation duration and optimality.

Keywords: CHP, Energy 4.0, energy storage, MILP, optimization, virtual power plant

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Authors: Raheel Shakoor Siddiqui, Shahbaz Malik, Manikandar Srinivas Cheruvu, Sanjay Narayana Murthy, Livio DiMascio

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Background: elderly traumatic hip fracture patients frequently present to trauma services globally. Rising low energy falls amongst an osteoporotic aging population is the commonest cause for injury. Hip fractures in this population are a major cause for severe pain, morbidity and mortality. The term hip fracture is interchangeable with neck of femur fracture, fractured neck of femur or proximal femur fracture. Hip fracture pain management protocols and guidelines suggest conventional analgesia, nerve block and opioid based treatment as rescue analgesia. There is a current global opioid crisis with overuse, abuse and dependence. Adverse opioid related complications in vulnerable elderly patients further adds to morbidity and mortality. Systematic reviews in literature have evidenced superiority of multimodal analgesia in osteoarthritic primary joint replacements compared to opioids however, this has not yet been conducted for elderly traumatic hip fracture patients. Aims: The primary aim of this systematic review is to provide standardised evidence following Cochrane and PRISMA guidance in determining advantages of perioperative multimodal analgesia over conventional opioid based treatments in elderly traumatic hip fractures. Methods: 5 databases were searched from January 2000-2023 which identified 8 randomised controlled trials and 446 total participants. These trials met defined PICOS eligibility criteria of patient mean age ≥ 65 years presenting with a unilateral traumatic fractured neck of femur for operative intervention. Analgesic intervention with perioperative multimodal analgesia has been compared to conventional opioid based analgesia. Outcomes of interest include, primarily, the change in postoperative opioid consumption within a 0-30 postoperative period and secondarily, the change in postoperative adverse events and complications. A qualitative synthesis has been performed due to clinical heterogenicity and variance amongst trials. Results: GRADE evidence of moderate quality supports perioperative multimodal analgesia leads to a reduction in postoperative opioid consumption however, low quality evidence supports a reduction of adverse effects and complications. Conclusion: Perioperative multimodal analgesia whether used preoperative, intraoperative and/or postoperative leads to a reduction in postoperative opioid consumption for elderly traumatic hip fracture patients. This review recommends the use of perioperative multimodal analgesia as part of hip fracture pain protocols however, caution and clinical judgement should be used as the risk of adverse effects may not be lower.

Keywords: trauma, orthopaedics, hip, fracture, neck of femur fracture, analgesia, multimodal analgesia, opioid

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Authors: Arkadiusz P. Wójcik, Tetsuya Sato, Shin-Ichiro Shima, Mateusz Malanowski

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Over the last decades, new technologies have significantly changed the way information is transmitted and stored. Renewable energy sources have become prevalent and affordable. Cooperation of the Information and Communication Technology industry and Renewable Energy industry makes it possible to create a next generation, decentralized power grid. In this context, the study seeks to identify the wider benefits to the local Japanese economy as a result of the development of a decentralised electricity market. Our general approach aims to integrate an economic analysis (monetary appraisal of costs and benefits to society) with externalities that are not quantifiable in monetary terms (e.g. social impact, environmental impact). The study also highlights opportunities and sets out recommendations for the citizens of the island and the local government. The simulation is the scientific basis for economic impact analysis. Various types of sources of energy have been taken into account: residential wind farm, residential wind turbine, solar farm, residential solar panels and private solar farms. Analysis of local geographic and economic conditions allowed creating a customized business model. Very often farmers on Awaji Island are using crop cycle. During each cycle, one part of the field is resting and replenishing nutrients. In the next year another part of the field is resting. Portable solar panels could be freely set up in this part of the field. At the end of the crop cycle, portable solar panels would be moved to the next resting part. Because of spacious area, for a single household 500 square meters of portable solar panels has been proposed and simulated. The devised simulation shows that the Rate of Return on Investment for solar panels, which are on the island, could reach up to 37.21%. Supposing that about 20% of households install solar panels they could produce 49.11% of the electric energy consumed by households on the island. The analysis shows that rest of the energy supply can be produced by currently existing one huge solar farm and two wind farms to meet 97.59% of demand on electricity for households on the island. Although there are more than 7,000 agricultural fields on the island, young people tend to avoid agricultural work and prefer to move from the island to big cities, live there in little mansions and work until late night. The business model proposed in this study could increase farmer’s monthly income by ¥200,000 - ¥300,000 (1,600 euro – 2,400 euro). Young people could work less and have a higher standard of living than in a city. Creation of a decentralized electricity market can unlock significant benefits in other industries (e.g. electric vehicles), providing a welcome boost to economic growth, jobs and quality of life.

Keywords: digital twin, Matlab, model-based systems engineering, simulink, smart grid, systems engineering

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Authors: Ladda Her, Juntip Kanjanasilp, Ratree Sawangjit, Nathorn Chaiyakunapruk

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Cough is the common symptom of the respiratory tract infections or non-infections; the duration of cough indicates a classification and severity of disease. Herbal medicines can be used as the alternative to drugs for relief of cough symptoms from acute and chronic disease. Eucalyptus was used for reducing cough with evidences suggesting it has an active role in reduction of airway inflammation. The present study aims to evaluate efficacy and safety of eucalyptus for relief of cough symptom in respiratory disease. Method: The Cochrane Library, MEDLINE (PubMed), Scopus, CINAHL, Springer, Science direct, ProQuest, and THAILIS databases. From its inception until 01/02/2019 for randomized control trials. We follow for the efficacy and safety of eucalyptus for reducing cough. Methodological quality was evaluated by using the Cochrane risk of bias tool; two reviewers in our team screened eligibility and extracted data. Result: Six studies were included for the review and five studies were included in the meta-analysis, there were 1.911 persons including children (n: 1) and adult (n: 5) studies; for study in children and adult were between 1 and 80 years old, respectively. Eucalyptus was used as mono herb (n: 2) and in combination with other herbs form (n: 4). All of the studies with eucalyptus were compared for efficacy and safety with placebo or standard treatment, Eucalyptus dosage form in studies included capsules, spray, and syrup. Heterogeneity was 32.44 used random effect model (I² = 1.2%, χ² = 1.01; P-value = 0.314). The efficacy of eucalyptus was showed a reduced cough symptom statistically significant (n = 402, RR: 1.40, 95%CI [1.19, 1.65], P-value < 0.0001) when compared with placebo. Adverse events (AEs) were reported mild to moderate intensity with mostly gastrointestinal symptom. The methodological quality of the included trials was overall poor. Conclusion: Eucalyptus appears to be beneficial and safe for relieving in respiratory diseases focus on cough frequency. The evidence was inconclusive due to limited quality trial. Well-designed trials for evaluating the effectiveness in humans, the effectiveness for reducing cough symptom in human is needed. Eucalyptus had safety as monotherapy or in combination with other herbs.

Keywords: cough, eucalyptus, cineole, herbal medicine, systematic review, meta-analysis

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Authors: Onder Aldemir, Ercan Ceyhan

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The research was conducted to determine effects of salt concentrations on emergence and seedling development of chickpea genotypes. Trials were performed during the year of 2013 on the laboratory and greenhouse of Agricultural Faculty, Selcuk University. Emergency trial was set up according to ‘Randomized Plots Design’ by two factors and four replications; greenhouse trial was also set up according to ‘Randomized Plots Design’ by two factors with three replications. The chickpea genotypes; CA119, CA132, CA149, CA150, CA215, CA222, CA235, CA261, Bozkır and Gokce were used as material for both of the trials. Effects of the five doses of salt concentrations (control, 30 mM, 60 mM, 90 mM and 120 mM) on the ratio of emergency, speed of emergency, average time for emergency, index of sensibility, length of shoot and root, fresh weight of shoot and root, dry weight of shoot and root, index of salt tolerance were evaluated. Responses of the chickpea genotypes for salt concentrations were found different. Comparing to the control, all of the investigated characteristics on the chickpea genotypes showed significant reduction by depending on the increasing salt level. According to the effects of salt application, the chickpea genotypes Gokce, CA215 and CA222 were the most tolerant in respect to plant dry weights while the chickpea genotypes CA149 and CA150 were the most sensitive.

Keywords: chickpea, emergence, salt tolerant, seedling development

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Authors: Madeline Foster

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Since the COVID-19 pandemic, telehealth usage for the delivery of psychotherapy has surged. The evidence base evaluating the success of telehealth interventions continues to grow, with both benefits as well as potential risks identified. This study compared two recent randomized clinical trials (RCTs) from Sweden that looked at the effectiveness of Cognitive Behavioral Therapy (CBT) delivered via telehealth (TH) versus face-to-face (FTF) for individuals with Obsessive Compulsive Disorder (OCD). The papers had mixed results. The first paper by Aspvall and colleagues compared the effect of a therapist-supported, internet-delivered stepped-care CBT program for children and adolescents aged 7 to 17 with face-to-face CBT (2021). In Aspvall’s study, the control scored a mean Y-BOCS of 10.57 and the TH intervention group scored a mean Y-BOCS of 11.57. The mean difference (0.91) met the criteria for noninferiority (p = 0.03). The second study by Lundström and colleagues also compared therapist-supported, internet-based CBT with FTF CBT for the treatment of those with DSM-5-diagnosed OCD. Conversely, while Lundström’s study reported improved symptoms across all groups, at follow up the difference in symptom severity between FTF and TH was clinically significant, with 77% of FTF participants responding to treatment compared to only 45% of TH participants. Due to the methodological limitations of Lundström’s study, it was concluded that Aspvall’s paper made a stronger scientific argument.

Keywords: telehealth, Sweden, RCT, cognitive-behavioral therapy, obsessive-compulsive disorder

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Authors: Freitas Vania Moreira, Rodrigues B. B., Araujo M.B., Silva D. R., Sousa A. C., Araujo K. P., Pimentel R. R., Cares J. E., Junqueira N. T. V.

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The Pitahayas are cactus native from America and abundant in arid regions. The cultivation is based mainly on the following species: Hylocereus undatus, H. polyrhizus, H. setaceus and H. megalanthus, being H. undatus the most cultivated in Brazil. The pitahaya cultivation is recent in Brazil and is concentrated in São Paulo. Meloidogyne enterolobii is of unknown origin being distributed in several countries. This nematode has recently been detected in Brazil causing damage in several crops. Similarly, M. incognita is a widely distributed pathogen in Brazil. The objective of this study is to evaluate the following accesses of pitahaya to M. enterolobii: CPAC- Py H. hundatus 01, 02, 03, 04, 05, 06, 07 and 08; CPAC - Py H. costaricense 8A; CPAC - Py Selenicereus setaceus 17 and CPAC - Py S. megalantus 22. And the following accesses to M. incognita: CPAC- Py H. hundatus 05; CPAC - Py H. costaricense 8A; CPAC - Py S. setaceus 17 and CPAC - Py S. megalantus 22. According to the results, CPAC – Py H. hundatus 01, 02, 03, 04 and 07 were considered resistant. While CPAC - Py 05 and 08 was susceptible. CPAC-Py 06 also was considered susceptible, because there was the reaction of susceptibility in one of the trials. Given this wide diversity in H. hundatus and being this species the most cultivated in Brazil it is suggested to work more with this material in Embrapa Cerrados. CPAC - Py H. costaricense 8A behaved as susceptible in one of the trials. CPAC - Py S. setaceus 17 and CPAC – Py S. megalantus 22 were considered highly susceptible. The susceptibility of S. megalantus is widely described in the literature. In relation to M. incognita, there were differences between the results in both experiments, but all behaved as susceptible in at least one of the tests.

Keywords: pitaya, meloidogyne, fruit, resistance

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Authors: Yasser F. Hassan

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In this paper, a proposed model of cellular automata is studied by means of fractional integral function. A cellular automaton is a decentralized computing model providing an excellent platform for performing complex computation with the help of only local information. The paper discusses how using fractional integral function for representing cellular automata memory or state. The architecture of computing and learning model will be given and the results of calibrating of approach are also given.

Keywords: fractional integral, cellular automata, memory, learning

Procedia PDF Downloads 387

Authors: David Muyise

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Mixed Integer Programming (MIP) is an approach that involves the optimization of a range of decision variables in order to minimize or maximize a particular objective function. The main objective of this study was to apply the MIP approach to optimize the deployment of waste plastic to fuel oil processing plants in Uganda. The processing plants are meant to reduce plastic pollution by pyrolyzing the waste plastic into a cleaner fuel that can be used to power diesel/paraffin engines, so as (1) to reduce the negative environmental impacts associated with plastic pollution and also (2) to curb down the energy gap by utilizing the fuel oil. A programming model was established and tested in two case study applications that are, small-scale applications in rural towns and large-scale deployment across major cities in the country. In order to design the supply chain, optimal decisions on the types of waste plastic to be processed, size, location and number of plants, and downstream fuel applications were concurrently made based on the payback period, investor requirements for capital cost and production cost of fuel and electricity. The model comprises qualitative data gathered from waste plastic pickers at landfills and potential investors, and quantitative data obtained from primary research. It was found out from the study that a distributed system is suitable for small rural towns, whereas a decentralized system is only suitable for big cities. Small towns of Kalagi, Mukono, Ishaka, and Jinja were found to be the ideal locations for the deployment of distributed processing systems, whereas Kampala, Mbarara, and Gulu cities were found to be the ideal locations initially utilize the decentralized pyrolysis technology system. We conclude that the model findings will be most important to investors, engineers, plant developers, and municipalities interested in waste plastic to fuel processing in Uganda and elsewhere in developing economy.

Keywords: mixed integer programming, fuel oil plants, optimisation of waste plastics, plastic pollution, pyrolyzing

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Authors: Husham Bayazed

Abstract:

A growing number of studies indicate that atherosclerotic coronary artery disease (CAD) has a complex pathogenesis that extends beyond cholesterol intimal infiltration. The atherosclerosis process may involve an immune micro-environmental condition driven by local activation of the adaptive and innate immunity arrays, resulting in the formation of atherosclerotic plaques. Therefore, despite the wide usage of lipid-lowering agents, these devastating coronary diseases are not averted either at primary or secondary prevention levels. Many trials have recently shown an interest in the immune targeting of the inflammatory process of atherosclerotic plaques, with the promised improvement in atherosclerotic cardiovascular disease outcomes. This recently includes the immune-modulatory drug “Canakinumab” as an anti-interleukin-1 beta monoclonal antibody in addition to "Colchicine,” which's established as a broad-effect drug in the management of other inflammatory conditions. Recent trials and studies highlight the importance of inflammation and immune reactions in the pathogenesis of atherosclerosis and plaque formation. This provides an insight to discuss and extend the therapies from old lipid-lowering drugs (statins) to anti-inflammatory drugs (colchicine) and new targeted immune-modulatory therapies like inhibitors of IL-1 beta (canakinumab) currently under investigation.

Keywords: atherosclerotic plagues, immune microenvironment, lipid-lowering agents, and immunomodulatory drugs

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