Search results for: decentralized trials

Authors: H. Cano, P. Ferrer, N. Garcia, M. Popovic, J. Zapata

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Positive Reinforcement Training is a well-known methodology which has been reported frequently to be used in captive non-human primates. As a matter of fact, it is an invaluable tool for different purposes related with animal welfare, such as primate husbandry and environmental enrichment. It is also essential to perform some cognitive experiments. The main propose of this pilot study was to establish an efficient protocol to train captive olive baboons (Papio anubis). This protocol seems to be vital in the context of a larger research program in which it will be necessary to train a complete population of around 40 baboons. Baboons were studied at the Veterinary Research Farm of the University of Murcia. Temporally isolated animals were trained to perform three basic tasks. Firstly, they were required to take food prices directly from the researchers’ hands. Then a clicker sound or bridge stimulus was added each time the animal acceded to the reinforcement. Finally, they were trained to touch a target, consisted of a whip with a red ball in its end, with their hands or their nose. When the subject completed correctly this task, it was also exposed to the bridge stimulus and awarded with a food price, such as a portion of banana, orange, apple, peach or a raisin. Two protocols were tested during this experiment. In both of them, there were 6 series of 2min training periods each day. However, in the first protocol, the series consisted in 3 trials, whereas in the second one, in each series there were 5 trials. A reliable performance was obtained with only 6 days of training in the case of the 5-trials protocol. However, with the 3-trials one, 26 days of training were needed. As a result, the 5-trials protocol seems to be more effective than the 3-trials one, in order to teach these three basic tasks to olive baboons. In consequence, it will be used to train the rest of the colony.

Keywords: captive primates, olive baboon, positive reinforcement training, Papio anubis, training

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Authors: Doua AlSaad, Ahmed Awaisu, Samah Elsalem, Palli Valapila Abdulrouf, Binny Thomas, Moza AlHail

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Background: It has been suggested that pyridoxine has an anti-lactogenic effect. Studies of the efficacy of pyridoxine in suppressing lactation have reported conflicting results. The aim of this review is to evaluate the effectiveness and safety of high-dose pyridoxine in postpartum lactation inhibition. Methods: This systematic review included published trials that compared the efficacy and/or safety of pyridoxine to placebo or to other pharmacological agents for the inhibition of postpartum lactation. We searched PubMed, Embase, ScienceDirect, CINAHL, AMED, the Cochrane library, and the clinical trials registry to identify relevant literature. No limit was imposed on the year of publication of the studies, and the review included studies published until 15 January 2016. Two reviewers independently extracted data and assessed the risk of bias. Results: Seven studies were included, with a total of 1155 women, of which 471 women received pyridoxine. Three studies were randomized controlled trials, while the remaining four studies were non-randomized controlled trials. All of the included studies were relatively small (n = 18 – 482). The studies compared pyridoxine with placebo, bromocriptine, and/or stilboestrol. Pyridoxine was given orally, with a total daily dose of 450 – 600 mg for 5 to 7 days. Two trials (n = 349 participants) indicated that pyridoxine was effective in inhibiting lactation in approximately 95% of the enrolled patients. All other studies failed to demonstrate pyridoxine efficacy through either clinical assessment or prolactin level measurements. Pyridoxine safety was assessed by two trials in which no serious untoward side-effects were reported. Overall, the risk of bias for most of the studies was low to moderate. Conclusion: Current evidence supporting the effectiveness of high dose pyridoxine in the inhibition of postpartum lactation is inconsistent and insufficient. Larger randomized trials are needed to confirm the efficacy of pyridoxine in postpartum lactation inhibition. Acknowledgment: This review received a grant from the Medical Research Center of Hamad Medical Corporation in Qatar (grant number: 15100/15).

Keywords: pyridoxine, safety, effectiveness, lactation inhibition

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Authors: Achim Kampker, Kai Kreiskoether, Johannes Wagner, Sarah Fluchs

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The growing speed of innovation in related industries requires the automotive industry to adapt and increase release frequencies of new vehicle derivatives which implies a significant reduction of investments per vehicle and ramp-up times. Emerging markets in various parts of the world augment the currently dominating established main automotive markets. Local content requirements such as import tariffs on final products impede the accessibility of these micro markets, which is why in the future market exploitation will not be driven by pure sales activities anymore but rather by setting up local assembly units. The aim of this paper is to provide an overview of the concept of decentralized assembly and to discuss and critically assess some currently researched and crucial approaches in production technology. In order to determine the scope in which complementary mobile assembly can be profitable for manufacturers, a general cost model is set up and each cost driver is assessed with respect to varying levels of decentralization. One main result of the paper is that the presented approaches offer huge cost-saving potentials and are thus critical for future production strategies. Nevertheless, they still need to be further exploited in order for decentralized assembly to be profitable for companies. The optimal level of decentralization must, however, be specifically determined in each case and cannot be defined in general.

Keywords: automotive assembly, e-mobility, production technology, release capability, small series assembly

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Authors: Saeed M. Alshahrani

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This research integrated blockchain technology to reform medical records management in healthcare informatics. It was aimed at resolving the limitations of centralized systems by establishing a secure, decentralized, and user-centric platform. The system was architected with a sophisticated three-tiered structure, integrating advanced cryptographic methodologies, consensus algorithms, and the Fast Healthcare Interoperability Resources (HL7 FHIR) standard to ensure data security, transaction validity, and semantic interoperability. The research has profound implications for healthcare delivery, patient care, legal compliance, operational efficiency, and academic advancements in blockchain technology and healthcare IT sectors. The methodology adapted in this research comprises of Preliminary Feasibility Study, Literature Review, Design and Development, Cryptographic Algorithm Integration, Modeling the data and testing the system. The research employed a permissioned blockchain with a Practical Byzantine Fault Tolerance (PBFT) consensus algorithm and Ethereum-based smart contracts. It integrated advanced cryptographic algorithms, role-based access control, multi-factor authentication, and RESTful APIs to ensure security, regulate access, authenticate user identities, and facilitate seamless data exchange between the blockchain and legacy healthcare systems. The research contributed to the development of a secure, interoperable, and decentralized system for managing medical records, addressing the limitations of the centralized systems that were in place. Future work will delve into optimizing the system further, exploring additional blockchain use cases in healthcare, and expanding the adoption of the system globally, contributing to the evolution of global healthcare practices and policies.

Keywords: healthcare informatics, blockchain, medical records management, decentralized architecture, data security, cryptographic algorithms

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Authors: Fuqiang Wang, Jun Liu, Liyan Cai

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This paper investigates the coordination of the conflicting two-stage low carbon supply chain consisting of upstream and downstream manufacturers. The conflict means that the upstream manufacturer takes action for carbon emissions reduction under carbon trading mechanism while the downstream manufacturer’s production cost rises. It assumes for the Stackelberg game that the upstream manufacturer plays as a leader and the downstream manufacturer does as a follower. Four kinds of the situation of decentralized decision making, centralized decision-making, the production cost sharing contract and the carbon emissions reduction revenue sharing contract under decentralized decision making are considered. The backward induction approach is adopted to solve the game. The results show that the more intense the conflict is, the lower the efficiency of carbon emissions reduction and the higher the retail price is. The optimal investment of the decentralized supply chain under the two contracts is unchanged and still lower than that of the centralized supply chain. Both the production cost sharing contract and the carbon emissions reduction revenue sharing contract cannot coordinate the supply chain, because that the sharing cost or carbon emissions reduction sharing revenue will transfer through the wholesale price mechanism. As a result, it requires more complicated contract forms to coordinate such a supply chain.

Keywords: cap-and-trade mechanism, carbon emissions reduction, conflict, supply chain coordination

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Authors: Laila Akbarali

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In the small scale study, an attempt is made to explore the structure and administrative relationships adopted by Multi Campus Universities [MCU] in UK and Pakistan and how these universities deal with some selected issues with respect to student related functions. For this study, literature on multi-site, divisionalized and other complex organizations related to business and Industry was consulted and an attempt was made to empirically test the normative models in the literature with respect to centralized , deconcentrated and decentralized structures. A questionnaire was used to gather data for this study. Purposive sampling was used. The findings of this study are somewhat different for UK and Pakistan. Contrary to a substantial body of organization theory, the results show that deconcentrated and decentralized universities in the UK are prone to delays in decision making and tend not to sensitive to local needs. In Pakistan on the other hand, deconcentrated and decentralized universities are more sensitive to local needs and there are less delays in decision making. The findings suggest that distance and reporting relationships could perhaps be responsible for the contradiction. The results also suggest that there is better coordination when the subsidiary campus sub-registrar reports to the registrar. The findings also highlight, that in both contexts, leadership at the campus level remains an issue. The results suggest that there may be factors other than structure that allow universities to keep their identity intact. The study highlights that MCU are inclined to use Information Technology and develop broad policies within which they allow their campuses to operate.

Keywords: administrative relationships, Multi-Campus, organization structure, registrar

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Authors: Tambe Daniel Atem

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Background: Clinical Research is an organized research on human beings intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy. The significance of the study is to educate the global health and life science graduates in Clinical Research in depth to perform better as it involves testing drugs on human beings. Objectives: to provide an overall understanding of the scientific approach to the evaluation of new and existing medical interventions and to apply ethical and regulatory principles appropriate to any individual research. Methodology: It is based on – Primary data analysis and Secondary data analysis. Primary data analysis: means the collection of data from journals, the internet, and other online sources. Secondary data analysis: a survey was conducted with a questionnaire to interview the Clinical Research Professionals to understand the need of training to perform clinical trials globally. The questionnaire consisted details of the professionals working with the expertise. It also included the areas of clinical research which needed intense training before entering into hardcore clinical research domain. Results: The Clinical Trials market worldwide worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the U.K, and they form one-third of the total research and development staff. There are more than 2,50,000 vacant positions globally with salary variations in the regions for a Clinical Research Coordinator. R&D cost on new drug development is estimated at US$ 70-85 billion. The cost of doing clinical trials for a new drug is US$ 200-250 million. Due to an increase trained Clinical Research Professionals India has emerged as a global hub for clinical research. The Global Clinical Trial outsourcing opportunity in India in the pharmaceutical industry increased to more than $2 billion in 2014 due to increased outsourcing from U.S and Europe to India. Conclusion: Assessment of training need is recommended for newer Clinical Research Professionals and trial sites, especially prior the conduct of larger confirmatory clinical trials.

Keywords: clinical research, clinical trials, clinical research professionals

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Authors: Matthieu-P. Schapranow

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Recruitment of participants for clinical trials requires the screening of a big number of potential candidates, i.e. the testing for trial-specific inclusion and exclusion criteria, which is a time-consuming and complex task. Today, a significant amount of time is spent on identification of adequate trial participants as their selection may affect the overall study results. We introduce a unique patient eligibility metric, which allows systematic ranking and classification of candidates based on trial-specific filter criteria. Our web application enables real-time analysis of patient data and assessment of candidates using freely definable inclusion and exclusion criteria. As a result, the overall time required for identifying eligible candidates is tremendously reduced whilst additional degrees of freedom for evaluating the relevance of individual candidates are introduced by our contribution.

Keywords: in-memory technology, clinical trials, screening, eligibility metric, data analysis, clustering

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Authors: Senait Belay Adugna, Mirutse Giday, Tsegahun Manyazewal

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Background: The emergence and resurgence of zoonotic diseases have continued to be a major threat to global health and the economy. Developing countries are particularly vulnerable due to agricultural expansions and the domestication of animals by humans. Scientifically sound clinical trials are important to find better ways to prevent, diagnose, and treat zoonotic diseases, while there is a lack of evidence to inform the clinical trials’ capacity and practice in countries highly affected by the diseases. This study aimed to investigate researchers’ perceptions and experiences in conducting clinical trials on zoonotic diseases in Ethiopia. Methods: This study employed a descriptive, qualitative study design. It included major academic and research institutions in Ethiopia that had active engagements in veterinary and public health research. It included the National Veterinary Institute, the National Animal Health Diagnostic and Investigation Center, the College of Veterinary Medicine at Addis Ababa University, the Ethiopian Public Health Institute, the Armauer Hansen Research Institute, and the College of Health Sciences at Addis Ababa University. In-depth interviews were conducted with 14 senior researcher investigators in the institutions who hold a proven exhibit primarily leading research activities or research units. Data were collected from October 2019 to April 2020. Data analysis was undertaken using open code 4.03 for qualitative data analysis. Results: Five major themes, with 18 sub-themes, emerged from the in-depth interview in connection. These were: challenges in the prevention, control, and treatment of zoonotic diseases; One Health approach to mitigate zoonotic diseases; personal and institutional experiences in conducting clinical trials on zoonotic diseases; barriers in conducting clinical trials towards zoonotic diseases; and strategies that promote conducting clinical trials on zoonotic diseases. Conducting clinical trials on zoonotic diseases in Ethiopia is hampered by a lack of clearly articulated ethics and regulatory frameworks, trial experts, financial resources, and good governance. Conclusions: In Ethiopia, conducting clinical trials on zoonotic diseases deserves due attention. Strengthening institutional and human resources capacity is a precondition to harnessing effective implementation of clinical trials on zoonotic diseases in the country. In Ethiopia, where skilled human resource is scarce, the One Health approach has the potential to form multidisciplinary teams to systematically improve clinical trials capacity and outcomes in the country.

Keywords: Ethiopia, clinical triak, zoonoses, disease

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Authors: Medani Prasad Rijal

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The study outlines the impacts of decentralized forest policy on natural Sal (shorea robusta) forests in the Terai region of Nepal. The government has implemented community forestry program to manage the forest resources and improve the livelihood of local people collectively. The forest management authorities such as conserve, manage, develop and use of forest resources were shifted to the local communities, however, the ownership right of the forestland retained by the government. Local communities took the decision on harvesting, distribution, and sell of forest products by fixing the prices independently. The local communities were putting the low value of forest products and distributed among the user households on the name of collective decision. The decision of low valuation is devaluating the worth of forest products. Therefore, the study hypothesized that decision-making capacities are equally prominent next to the decentralized policy and program formulation. To accomplish the study, individual to group level discussions and questionnaire survey methods were applied with executive committee members and user households. The study revealed that the local intuition called Community Forest User Group (CFUG) committee normally took the decisions on consensus basis. Considering to the access and affording capacity of user households having poor economic backgrounds, low pricing mechanism of forest products has been practiced, even though the Sal timber is far expensive in the local market. The local communities thought that low pricing mechanism is accessible to all user households from poor to better off households. However, the analysis of forest products distribution opposed the assumption as most of the Sal timber, which is the most valuable forest product of community forest only purchased by the limited households of better economic conditions. Since the Terai region is heterogeneous by socio-economic conditions, better off households always have higher affording capacity and possibility of taking higher timber benefits because of low price mechanism. On the other hand, the minimum price rate of forest products has poor contribution in community fund collection. Consequently, it has poor support to carry out poverty alleviation activities to poor people. The local communities have been fixed Sal timber price rate around three times cheaper than normal market price, which is a strong evidence of forest product devaluation itself. Finally, the study concluded that the capacity building of local executives as the decision-makers of natural Sal forests is equally indispensable next to the policy and program formulation for effective decentralized forest management. Unilateral decentralized forest policy may devaluate the forest products rather than devolve of power to the local communities and empower to them.

Keywords: community forestry program, decentralized forest policy, Nepal, Sal forests, Terai

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Authors: Obi Olor, Asu-Nnandi Judith, Ishiekwen Bridget

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Regardless of the settled perception that the substitution of saturated fats for starches or unsaturated fats builds low-density lipoprotein (LDL) cholesterol in people, in animal models, the relationship of saturated fat intake to the hazard of atherosclerotic cardiovascular ailment in people remains controversial. Clinical trials that supplanted immersed fat with polyunsaturated fat have, for the most part, demonstrated a lessening in CVD occasions, albeit a few reviews demonstrated no impacts. An autonomous relationship of soaked fat admission with CVD chance has not reliably appeared in planned epidemiologic reviews, albeit some have confirmed an expanded hazard in youthful people and in ladies. Substitution of soaked fat by polyunsaturated or monounsaturated fat reduces LDL and HDL cholesterol. Given the differing qualities of these cardio-protective eating methodologies and their healthy parts, one of the needs in research should be to attempt more near trials. These trials decide persistent worthiness, consequences for surrogate markers of hazard, and which at last affects morbidity and mortality.

Keywords: cardiovascular disease, dietary saturated fat, saturated fat, unsaturated fat

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Authors: Claire Biasco, Thaier Hayajneh

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A smart city is the integration of digital technologies in urban environments to enhance the quality of life. Smart cities capture real-time information from devices, sensors, and network data to analyze and improve city functions such as traffic analysis, public safety, and environmental impacts. Current smart cities face controversy due to their reliance on real-time data tracking and surveillance. Internet of Things (IoT) devices and blockchain technology are converging to reshape smart city infrastructure away from its centralized model. Connecting IoT data to blockchain applications would create a peer-to-peer, decentralized model. Furthermore, blockchain technology powers the ability for IoT device data to shift from the ownership and control of centralized entities to individuals or communities with Decentralized Autonomous Organizations (DAOs). In the context of smart cities, DAOs can govern cyber-physical systems to have a greater influence over how urban services are being provided. This paper will explore how the core components of a smart city now apply to DAOs. We will also analyze different definitions of DAOs to determine their most important aspects in relation to smart cities. Both categorizations will provide a solid foundation to conduct a cybersecurity assessment of DAOs in smart cities. It will identify the benefits and risks of adopting DAOs as they currently operate. The paper will then provide several mitigation methods to combat cybersecurity risks of DAO integrations. Finally, we will give several insights into what challenges will be faced by DAO and blockchain spaces in the coming years before achieving a higher level of maturity.

Keywords: blockchain, IoT, smart city, DAO

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Authors: Karima Qayumi, Alex Norta

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The rapid generation of high volume and a broad variety of data from the application of new technologies pose challenges for the generation of business-intelligence. Most organizations and business owners need to extract data from multiple sources and apply analytical methods for the purposes of developing their business. Therefore, the recently decentralized data management environment is relying on a distributed computing paradigm. While data are stored in highly distributed systems, the implementation of distributed data-mining techniques is a challenge. The aim of this technique is to gather knowledge from every domain and all the datasets stemming from distributed resources. As agent technologies offer significant contributions for managing the complexity of distributed systems, we consider this for next-generation data-mining processes. To demonstrate agent-based business intelligence operations, we use agent-oriented modeling techniques to develop a new artifact for mining massive datasets.

Keywords: agent-oriented modeling (AOM), business intelligence model (BIM), distributed data mining (DDM), multi-agent system (MAS)

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Authors: Elham Azimzadeh, Hamidollah Hassanlouei, Hadi Nobari, Georgian Badicu, Jorge Pérez-Gómez, Luca Paolo Ardigò

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Children with cerebral palsy (CP) have weak physical abilities and their limitations may have an effect on performing everyday motor activities. One of the most important and common debilitating factors in CP is the malfunction in the upper extremities to perform motor skills and there is strong evidence that task-specific training may lead to improve general upper limb function among this population. However, augmented feedback enhances the acquisition and learning of a motor task. Practice conditions may alter the difficulty, e.g., the reduced frequency of PG could be more challenging for this population to learn a motor task. So, the purpose of this study was to investigate the effect of physical guidance (PG) on learning a tracking task in children with cerebral palsy (CP). Twenty-five independently ambulant children with spastic hemiplegic CP aged 7-15 years were assigned randomly to five groups. After the pre-test, experimental groups participated in an intervention for eight sessions, 12 trials during each session. The 0% PG group received no PG; the 25% PG group received PG for three trials; the 50% PG group received PG for six trials; the 75% PG group received PG for nine trials; and the 100% PG group, received PG for all 12 trials. PG consisted of placing the experimenter's hand around the children's hand, guiding them to stay on track and complete the task. Learning was inferred by acquisition and delayed retention tests. The tests involved two blocks of 12 trials of the tracking task without any PG being performed by all participants. They were asked to make the movement as accurate as possible (i.e., fewer errors) and the number of total touches (errors) in 24 trials was calculated as the scores of the tests. The results showed that the higher frequency of PG led to more accurate performance during the practice phase. However, the group that received 75% PG had significantly better performance compared to the other groups in the retention phase. It is concluded that the optimal frequency of PG played a critical role in learning a tracking task in children with CP and likely this population may benefit from an optimal level of PG to get the appropriate amount of information confirming the challenge point framework (CPF), which state that too much or too little information will retard learning a motor skill. Therefore, an optimum level of PG may help these children to identify appropriate patterns of motor skill using extrinsic information they receive through PG and improve learning by activating the intrinsic feedback mechanisms.

Keywords: cerebral palsy, challenge point framework, motor learning, physical guidance, tracking task

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Authors: S. Sambath, P. Palanivel

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Research conducted in the last few decades has proven that an inclusion of Distributed Genaration (DG) into distribution systems considerably lowers the level of power losses and the power quality improved. Moreover, the choice of DG is even more attractive since it provides not only benefits in power loss minimisation, but also a wide range of other advantages including environment, economic, power qualities and technical issues. This paper is an intent to quantify and analyse the impact of distributed generation (DG) in Tamil Nadu, India to examine what the benefits of decentralized generation would be for meeting rural loads. We used load flow analysis to simulate and quantify the loss reduction and power quality enhancement by having decentralized generation available line conditions for actual rural feeders in Tamil Nadu, India. Reactive and voltage profile was considered. This helps utilities to better plan their system in rural areas to meet dispersed loads, while optimizing the renewable and decentralised generation sources.

Keywords: distributed generation, distribution system, load flow analysis, optimal location, power quality

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Authors: Derick Shi-Chen Ou, Liang-Yu Chen

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Background: Acupuncture, a potential alternative, and complementary therapy revealed insufficient evidence in depression treatment. The efficacy of acupuncture treatment was still uncertainty. To evaluate the effect of acupuncture in treating depression, the randomized controlled trials (RCTs) were examined. Methods: RCTs of the acupuncture therapy in treating major depression were searched from MEDLINE from 2007 to 2017. Keywords used for searching strategy included acupuncture, acupoint, and major depressive disorder. Results: Among the nine RCTs, four studies demonstrated great improvement in acupuncture treatment and five studies revealed the effectiveness of acupuncture intervention in medication. General trends suggest that acupuncture treatment is as effective as antidepressants with minimal side effects. Conclusion: Despite the promising results from the RCTs, there are still a variety of limitations, including small sample size, imprecise enrollment criteria, difficulties with blinding, randomization, short duration of study and lack of longitudinal follow-up. Therefore, the evidence that acupuncture as an alternative therapy for depression is inconclusive. More rigorously designed RCTs should be conducted in the future.

Keywords: acupuncture, major depressive disorders, randomized clinical trials, antidepressants

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Authors: Merey M. Sarsengeldin, Alexandr S. Kolokhmatov, Galiya Seidaliyeva, Alexandr Ozerov, Sanim T. Imatayeva

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This series of interdisciplinary studies is an attempt to investigate and develop a scalable model of fair socioeconomic relations on the base of blockchain using positive psychology techniques and Machine Learning algorithms for data analytics. In this particular study, we use hyperinteraction approach and intuition to investigate their influence on 'wisdom of crowds' via created mobile application which was created for the purpose of this research. Along with the public blockchain and private Decentralized Autonomous Organization (DAO) which were elaborated by us on the base of Ethereum blockchain, a model of fair financial relations of members of DAO was developed. We developed a smart contract, so-called, Fair Price Protocol and use it for implementation of model. The data obtained from mobile application was analyzed by ML algorithms. A model was tested on football matches.

Keywords: blockchain, Naïve Bayes algorithm, hyperinteraction, intuition, wisdom of crowd, decentralized autonomous organization

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Authors: Dhiraj Neupane

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Decentralized policy and practices have largely concentrated on the transformation of decision-making authorities from central to local institutions (or people) in the developing world. Such policy and practices always aimed for the equitable and efficient management of resources in the line of poverty reduction. The transformation of forest decision-making autonomy has also glorified as the best forest management alternatives to maximize the forest benefits and improve the livelihood of local people living nearby the forests. However, social heterogeneity and poor decision-making capacity of local institutions (or people) pose a nexus while managing the resources and sharing the forest benefits among the user households despite the policy objectives. The situation is severe in the lowland of Nepal, where forest resources have higher economic potential and user households have heterogeneous socio-economic conditions. The study discovered that utilizing the power of decision-making autonomy, user households were putting low values of timber considering the equitable access of timber to all user households as it is the most valuable product of community forest. Being the society is heterogeneous by socio-economic conditions, households of better economic conditions were always taking higher amount of forest benefits. The low valuation of timber has negative consequences on equitable benefit sharing and poor support to livelihood improvement of user households. Moreover, low valuation has possibility to increase the local demands of timber and increase the human pressure on forests.

Keywords: decentralized forest policy, Nepal, poverty, social heterogeneity, Terai

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Authors: Caio E. G. Reis, Jose G. Dórea, Teresa H. M. da Costa

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Objective: Epidemiological data shows an inverse association of coffee consumption with risk of type 2 diabetes mellitus. However, the clinical effects of coffee consumption on the glucose metabolism biomarkers remain controversial. Thus, this paper reviews clinical trials that evaluated the effects of coffee consumption on glucose metabolism. Research Design and Methods: We identified studies published until December 2014 by searching electronic databases and reference lists. We included randomized clinical trials which the intervention group received caffeinated and/or decaffeinated coffee and the control group received water or placebo treatments and measured biomarkers of glucose metabolism. The Jadad Score was applied to evaluate the quality of the studies whereas studies that scored ≥ 3 points were considered for the analyses. Results: Seven clinical trials (total of 237 subjects) were analyzed involving adult healthy, overweight and diabetic subjects. The studies were divided in short-term (1 to 3h) and long-term (2 to 16 weeks) duration. The results for short-term studies showed that caffeinated coffee consumption may increase the area under the curve for glucose response, while for long-term studies caffeinated coffee may improve the glycemic metabolism by reducing the glucose curve and increasing insulin response. These results seem to show that the benefits of coffee consumption occur in the long-term as has been shown in the reduction of type 2 diabetes mellitus risk in epidemiological studies. Nevertheless, until the relationship between long-term coffee consumption and type 2 diabetes mellitus is better understood and any mechanism involved identified, it is premature to make claims about coffee preventing type 2 diabetes mellitus. Conclusion: The findings suggest that caffeinated coffee may impairs glucose metabolism in short-term but in the long-term the studies indicate reduction of type 2 diabetes mellitus risk. More clinical trials with comparable methodology are needed to unravel this paradox.

Keywords: coffee, diabetes mellitus type 2, glucose, insulin

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Authors: Kohkan Shamsi

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Background: MRI and PET are now extensively utilized in Alzheimer's disease (AD) trials for patient eligibility, efficacy assessment, and safety evaluations but including imaging in AD trials impacts site selection process, patient recruitment, and patient retention. Methods: PET/MRI are performed at baseline and at multiple follow-up timepoints. This requires prospective site imaging qualification, evaluation of phantom data, training and continuous monitoring of machines for acquisition of standardized and consistent data. This also requires prospective patient/caregiver training as patients must go to multiple facilities for imaging examinations. We will share our experience form one of the largest AD programs. Lesson learned: Many neurological diseases have a similar presentation as AD or could confound the assessment of drug therapy. The inclusion of wrong patients has ethical and legal issues, and data could be excluded from the analysis. Centralized eligibility evaluation read process will be discussed. Amyloid related imaging abnormalities (ARIA) were observed in amyloid-β trials. FDA recommended regular monitoring of ARIA. Our experience in ARIA evaluations in large phase III study at > 350 sites will be presented. Efficacy evaluation: MRI is utilized to evaluate various volumes of the brain. FDG PET or amyloid PET agents has been used in AD trials. We will share our experience about site and central independent reads. Imaging logistic issues that need to be handled in the planning phase will also be discussed as it can impact patient compliance thereby increasing missing data and affecting study results. Conclusion: imaging must be prospectively planned to include standardizing imaging methodologies, site selection process and selecting assessment criteria. Training should be transparently conducted and documented. Prospective patient/caregiver awareness of imaging requirement is essential for patient compliance and reduction in missing imaging data.

Keywords: Alzheimer's disease, ARIA, MRI, PET, patient recruitment, retention

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Authors: Vadim Makarov, Stewart T.Cole

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PBTZ169 is novel drug candidate with high efficacy in animals models, and its combination treatment of PBTZ169 with BDQ and pyrazinamide was shown to be more efficacious than the standard treatment for tuberculosis in a mouse model. The target of PBTZ169 is famous DprE1, an essential enzyme in cell wall biosynthesis. The crystal structure of the DprE1-PBTZ169 complex reveals formation of a semimercaptal adduct with Cys387 in the active site and explains the irreversible inactivation of the enzyme. Furthermore, this drug candidate demonstrated during preclinical research ‘drug like’ properties what made it an attractive drug candidate to treat tuberculosis in humans. During first clinical trials several cohorts of the healthy volunteers were treated by the single doses of PBTZ169 as well as two weeks repeated treatment was chosen for two maximal doses. As expected PBTZ169 was well tolerated, and no significant toxicity effects were observed during the trials. The study of the metabolism shown that human metabolism of PBTZ169 is very different from microbial or animals compound transformation. So main pathway of microbial, mice and less rats metabolism connected with reduction processes, but human metabolism mainly connected with oxidation processes. Due to this difference we observed several metabolites of PBTZ169 in humans with antitubercular activity, and now we can conclude that animal antituberculosis activity of PBTZ169 is a result not only activity of the drug itself, but it is a result of the sum activity of the drug and its metabolites. Direct antimicrobial plasma activity was studied, and such activity was observed for 24 hours after human treatment for some doses. This data gets high chance for good efficacy of PBTZ169 in human for treatment TB infection. Second phase of clinical trials was started summer of 2017 and continues to the present day. Available data will be presented.

Keywords: clinical trials, DprE1, PBTZ169, metabolism

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Authors: Sameh Eldaly, Rola Essam

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Objective: The purpose of this study was to determine the benefits of low-level laser therapy for Athletic Achilles Tendinopathy. Data sources: Search strategies were conducted on 2 Randomized control trial and one pilot study. Results: three trials (103 participants) were analyzed. Laser therapy associated to eccentric exercises, when compared to eccentric exercises and placebo, had low to very low certainty of evidence in pain and function assessment. Conclusion: those three trials evidenced low to very low effect of LLLT, and the results are insufficient to support the routine use LLLT for Achilles tendinopathy.

Keywords: achilles tendinopathy, evidence-based, low-level laser therapy, review

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Authors: Azeddine Ghodbane, David Bensoussan, Maher Hammami

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An innovative approach for controlling unstable and invertible systems has demonstrated superior performance compared to conventional controllers. It has been successfully applied to a levitation system and drone control. Simulations have yielded satisfactory performances when applied to a satellite antenna controller. This design method, based on sensitivity analysis, has also been extended to handle multivariable unstable and invertible systems that exhibit dominant diagonal characteristics at high frequencies, enabling decentralized control. Furthermore, this control method has been expanded to the realm of adaptive control. In this study, we introduce an alternative adaptive architecture that enhances both time and frequency performance, helpfully mitigating the effects of disturbances from the input plant and external disturbances affecting the output. To facilitate superior performance in both the time and frequency domains, we have developed user-friendly interactive design methods using the GeoGebra platform.

Keywords: control theory, decentralized control, sensitivity theory, input-output stability theory, robust multivariable feedback control design

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Authors: John McDowall, Crysta Derham

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Broaden and build theory of emotion describes how experiencing positive emotions, such as happiness, broadens our ‘thought-action repertoire’ leading us to be more likely to go out and act on our positive emotions. This results in the building of new relationships, resources and skills, which we can draw on in times of need throughout life. In contrast, the experience of negative emotion is thought to narrow our ‘thought-action repertoire’, leading to specific actions to aid in survival. Three experiments aimed to explore the effect of briefly presented schematic faces (happy, sad, and neutral) on attentional scope using the flanker task. Based on the broaden and build theory it was hypothesised that there would be an increase in reaction time in trials primed with a happy face due to a broadening of attention, leading to increased flanker interference. A decrease in reaction time was predicted for trials primed with a sad face, due to a narrowing of attention leading to less flanker interference. Results lended partial support to the broaden and build hypothesis, with reaction times being slower following happy primes in incongruent flanker trials. Recent research is discussed in regards to potential mediators of the relationship between emotion and attention.

Keywords: emotion, attention, broaden and build, flanker task

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Authors: Antonia Stergiou

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Background: Due to the developmental trajectory of executive function in preschool age, the majority of existing studies investigating the association between acute physical activity and cognitive control have focused on adolescents and adult population. Aim- The aim of this study was to investigate the possible effects of physical activity on the inhibitory control of pre-school children. Methods: This is a prospectively designed study that was conducted in a primary school in Bristol in June 2015. The total number of subjects was n=61 and 20 trials of a modified Eriksen Flanker Task were completed before and after a 30-minutes session of moderate exercise (including both 5 minutes of warm up and cool down). For each test a pre- and post-test assessment took place that included both congruent and incongruent trials. The congruent trials were considered as the control condition and the incongruent trials as those that measure inhibitory control (experimental condition). At the end of the assessment, the participants were instructed to choose the face that described their current feelings between three options (happy, neutral, sad). Results: There was a trend for increased accuracy following moderate exercise, but there was statistical significance (p > .05). However, there was statistically significant improvement in the reaction time following the same type of exercise (p = .005). Face board assessment revealed positive emotions after 30 minutes of moderate exercise. Conclusions: The current study supports findings from previous studies related to the benefits of physical activity on the children’s inhibitory control and provides evidence of those benefits in even younger ages. Further research should take place considering each child individually. Implementation of those findings could result in an improved curriculum in schools with additional time spent on physical education courses.

Keywords: cognitive control, inhibition, physical activity, pre-school children

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Authors: K. Hariohm, V. Prakash, J. Saravana Kumar

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Introduction and Rationale: Increased scope of Physiotherapy (PT) practice also has contributed to research in the field of PT. It is essential to determine the production and quality of the clinical trials from India since, it may reflect the scientific growth of the profession. These trends can be taken as a baseline to measure our performance and also can be used as a guideline for the future trials. Objective: To quantify and analyze qualitatively the RCT’s from India from the period 2000-2013’ May, and classify data for the information process. Methods: Studies were searched in the Medline database using the key terms “India”, “Indian”, “Physiotherapy”. Clinical trials only with PT authors were included. Trials out of scope of PT practice and on animals were excluded. Retrieved valid articles were analyzed for published year, type of participants, area of study, PEDro score, outcome measure domains of impairment, activity, participation; ‘a priori’ sample size calculation, region, and explanation of the intervention. Result: 45 valid articles were retrieved from the year 2000-2013’ May. The majority of articles were done on symptomatic participants (81%). The frequencies of conditions repeated more were low back pain (n-7) and diabetes (n-4). PEDro score with mode 5 and upper limit of 8 and lower limit 4 was found. 97.2% of studies measure the outcome at the impairment level, 34% in activity level, and 27.8% in participation level. 29.7% of studies did ‘a priori’ sample size calculation. Correlation of year trend and PEDro score found to be not significant (p>.05). Individual PEDro item analysis showed, randomization (100%), concealment (33%) baseline (76%), blinding-subject, therapist, assessor (9.1%, 0%, 10%), follow-up (89%) ITT (15%), statistics between groups (100%), measures of variance (88 %). Conclusion: The trend shows an upward slope in terms of RCTs published from India which is a good indicator. The qualitative analysis showed some gaps in the clinical trial design, which can be expected to be, fulfilled by the future researchers.

Keywords: RCT, PEDro, physical therapy, rehabilitation

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Authors: Ben Hadj Hassen Sameh, Gaillard Corentin, Andrew Parker, Kristine Krug

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Perceptual decisions about sequences of sensory stimuli often show serial dependence. The behavioural choice on one trial is often affected by the choice on previous trials. We investigated whether the neuronal signals in extrastriate visual area V5/MT on preceding trials might influence choice on the current trial and thereby reveal the neuronal mechanisms of sequential choice effects. We analysed data from 30 single neurons recorded from V5/MT in three Rhesus monkeys making sequential choices about the direction of rotation of a three-dimensional cylinder. We focused exclusively on the responses of neurons that showed significant choice-related firing (mean choice probability =0.73) while the monkey viewed perceptually ambiguous stimuli. Application of a wavelet transform to the choice-related firing revealed differences in the frequency band of neuronal activity that depended on whether the previous trial resulted in a correct choice for an unambiguous stimulus that was in the neuron’s preferred direction (low alpha and high beta and gamma) or non-preferred direction (high alpha and low beta and gamma). To probe this in further detail, we applied a regularized linear decoder to predict the choice for an ambiguous trial by referencing the neuronal activity of the preceding unambiguous trial. Neuronal activity on a previous trial provided a significant prediction of the current choice (61% correc, 95%Cl~52%t), even when limiting analysis to preceding trials that were correct and rewarded. These findings provide a potential neuronal signature of sequential choice effects in the primate visual cortex.

Keywords: perception, decision making, attention, decoding, visual system

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Authors: Emad Kouhestani

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Background: Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, as an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. Method: A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane, and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, or cumulative opioid consumption, adverse events) following the administration of pregabalin in patients undergoing ACL reconstruction. Result: Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75 mg and 150 mg of oral pregabalin were used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1 hour before anesthesia induction and 12 hours after. One study used daily pregabalin 7 days before and 7 days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in the pregabalin group compared with the placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. Conclusion: The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample sizes and longer follow-up periods are required.

Keywords: pregabalin, anterior cruciate ligament, postoperative pain, clinical trial

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Authors: Clarisse Umutoni, Augustine Ayantunde, Matthew Turner, Germain J. Sawadogo

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Decentralized governance of natural resources is considered one of the key strategies for promoting sustainable management of natural resources at local level. The rationale behind decentralization of natural resources is that local populations are both better situated and more highly motivated than outside agencies to manage the resources in an ecologically and economically sustainable manner. Effective decentralized natural resource management requires strong local natural resource institutions. Therefore, strengthening local institutions governing natural resource management is essential to promoting strong participation of local communities in managing their resources. This paper investigated the existing local institutions (rules, norms and or local conventions) governing the management of natural resources and forms of community participation in the development of these natural resource institutions. Group discussions and individual interviews were conducted to collect data. Our findings showed significant variation within the study sites regarding the level of knowledge of existing local rules and norms governing the management of natural resources by the respondents. The results also show that participation was dominated by a small group of individuals, often community leaders and elites. The results suggest that women are marginalized. In general, factors which influence the level of participation include; age, year of residence in the community, gender and education level. This study also highlights the strengths of local natural resource institutions especially if enforced. Presently, the big challenge that faces the institutions governing natural resource use in the study area is the system of representativeness in the community in the development of local rules and norms as community leaders and household heads often dominate, which does not encourage active participation of community members. Therefore, for effective implementation of local natural resource institutions, the interest of key natural resource users should be taken into account. It is also important to promote rules and norms that attempt to protect or strengthen women’s access to natural resources in the community.

Keywords: decentralization, land use plan, local institutions, Mali

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Authors: Christoph Speer

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Decentralized ventilation systems should combine a small and economical design with high aerodynamic and thermal efficiency. The Counter Flow Heat Recovery Fan (CHRF) provides the ability to meet these requirements by using only one cross flow fan with a large number of blades to generate both airflows and which simultaneously acts as a regenerative counter flow heat exchanger. The successful development of the first laboratory prototype has shown the potential of this ventilation system. Occurring condensate on the surfaces of the fan blades during the cold and dry season can be recovered through the characteristic mode of operation. Hence the CHRF provides the possibility to avoid the need for frost protection and condensate drain. Through the implementation of system-specific solutions for flow balancing and summer bypass the required functionality is assured. The scalability of the CHRF concept allows the use in renovation as well as in new buildings from single-room devices through to systems for office buildings. High aerodynamic and thermal efficiency and the lower number of required mechatronic components should enable a reduction in investment as well as operating costs. The rotor is the key component of the system, the requirements and possible implementation variants are presented.

Keywords: CHRF, counter flow heat recovery fan, decentralized ventilation system, renovation

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