Search results for: regulatory compliance

Authors: Mohamed A. Etman, Mona G. Abd-Elnasser, Mohamed A. Shams-Eldin, Aly H. Nada

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Orally disintegrating tablets (ODTs) are gaining importance as new drug delivery systems and emerged as one of the popular and widely accepted dosage forms, especially for the pediatric and geriatric patients. Their advantages such as administration without water, anywhere, anytime lead to their suitability to geriatric and pediatric patients. They are also suitable for the mentally ill, the bed-ridden and patients who do not have easy access to water. The benefits, in terms of patient compliance, rapid onset of action, increased bioavailability, and good stability make these tablets popular as a dosage form of choice in the current market. These dosage forms dissolve or disintegrate in the oral cavity within a matter of seconds without the need of water or chewing. Desloratadine is a tricyclic antihistaminic, which has a selective and peripheral H1-antagonist action. It is an antagonist at histamine H1 receptors, and an antagonist at all subtypes of the muscarinic acetylcholine receptor. Desloratadine is the major metabolite of loratadine. Twelve different placebos ODT were prepared (F1-F12) using different functional excipients. They were evaluated for their compressibility, hardness and disintegration time. All formulations were non sticky except four formulations; namely (F8, F9, F10, F11). All formulations were compressible with the exception of (F2). Variable disintegration times were found ranging between 20 and 120 seconds. It was found that (F12) showed the least disintegration time (20 secs) without showing any sticking which could be due to the use of high percentage of superdisintegrants. Desloratadine showed bitter taste when formulated as ODT without any treatment. Therefore, different techniques were tried in order to mask its bitter taste. Using Eudragit EPO resulted in complete masking of the bitter taste of the drug and increased the acceptability to volunteers. The compressible non sticky formulations (F1, F3, F4, F5, F6, F7 and F12) were subjected to further evaluation tests after addition of coated desloratadine, including weight uniformity, wetting time, and friability testing.. Fairly good weight uniformity values were observed in all the tested formulations. F12 exhibiting the shortest wetting time (14.7 seconds) and consequently the lowest (20 seconds) disintegration time. Dissolution profile showed that 100% desloratadine release was attained after only 2.5 minutes from the prepared ODT (F12) with dissolution efficiency of 95%.

Keywords: Desloratadine, orally disintegrating tablets (ODTs), formulations, taste masking

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Authors: Dolores Sucozhañay, Gustavo Pacheco, Paul Vanegas

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In the context of sustainable development and the transition towards a sustainable circular economy (CE), evaluating the social dimension remains a challenge. Therefore, developing a respective methodology is highly important. First, the change of the economic model may cause significant social effects, which today remain unaddressed. Second, following the current level of globalization, CE implementation requires targeting global material cycles and causes social impacts on potentially vulnerable social groups. A promising methodology is the Social Life Cycle Assessment (SLCA), which embraces the philosophy of life cycle thinking and provides complementary information to environmental and economic assessments. In this context, the present work uses the updated Social Life Cycle Assessment (SLCA) Guidelines 2020 to assess the social performance of the recycling system of Cuenca, Ecuador, to exemplify a social assessment method. Like many other developing countries, Ecuador heavily depends on the work of informal waste pickers (recyclers), who, even contributing to a CE, face harsh socio-economic circumstances, including inappropriate working conditions, social exclusion, exploitation, etc. Under a Reference Scale approach (Type 1), 12 impact subcategories were assessed through 73 site-specific inventory indicators, using an ascending reference scale ranging from -2 to +2. Findings reveal a social performance below compliance levels with local and international laws, basic societal expectations, and practices in the recycling sector; only eight and five indicators present a positive score. In addition, a social hotspot analysis depicts collection as the most time-consuming lifecycle stage and the one with the most hotspots, mainly related to working hours and health and safety aspects. This study provides an integrated view of the recyclers’ contributions, challenges, and opportunities within the recycling system while highlighting the relevance of assessing the social dimension of CE practices. It also fosters an understanding of the social impact of CE operations in developing countries, highlights the need for a close north-south relationship in CE, and enables the connection among the environmental, economic, and social dimensions.

Keywords: SLCA, circular economy, recycling, social impact assessment

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Authors: Ramin Mehdiabadi

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Background: Breast cancer remains the most prevalent cancer diagnosis and the leading cause of cancer death among women globally, representing 11.7% of new cases and 6.9% of deaths. While the incidence and mortality of major cancers are declining in developed regions like the United States and Western Europe, underdeveloped and developing countries exhibit an increasing trend, attributed to lifestyle factors such as smoking, physical inactivity, and high-calorie diets. Objective: This study explores the intricate relationship between the mammalian transcription factor forkhead box (FoxM1) and the microRNA miR-216b-5p in various subtypes of breast cancer, aiming to deepen the understanding of their roles in tumorigenesis, metastasis, and drug resistance. Methods: Breast cancer subtypes were categorized based on key biomarkers: estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2. These include luminal A, luminal B, HER2 enriched, triple-negative, and normal-like subtypes. We focused on analyzing the expression levels of FoxM1 and miR-216b-5p, given the known role of FoxM1 in cell proliferation and its implications in cancer pathologies such as lung, gastric, and breast cancers. Concurrently, miR-216b-5p's function as a tumor suppressor was evaluated to ascertain its regulatory effects on FoxM1. Results: Preliminary data indicate a nuanced interplay between FoxM1 and miR-216b-5p, suggesting a potential inverse relationship that varies across breast cancer subtypes. This relationship underscores the dual role of these biomarkers in modulating cancer progression and response to treatments. Conclusion: The findings advocate for the potential of miR-216b-5p to serve as a prognostic biomarker and a therapeutic target, particularly in subtypes where FoxM1 is prominently expressed. Understanding these molecular interactions provides crucial insights into the personalized treatment strategies and could lead to more effective therapeutic interventions in breast cancer management. Implications: The study highlights the importance of molecular profiling in breast cancer treatment and emphasizes the need for targeted therapeutic approaches in managing diverse cancer subtypes, particularly in varying global contexts where lifestyle factors significantly impact cancer dynamics.

Keywords: breast cancer, gene expression, FoxM1, microRNA

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Authors: Shwu-Ling Peng, Chiung-Man Tsai, Chia-Jui Weng

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Chronic micro-inflammation is a hallmark of many aging-related neurodegenerative and metabolic syndrome-driven diseases. In high glucose (HG) environment, reactive oxygen species (ROS) is generated and the ROS induced inflammation, cytokines secretion, DNA damage, and cell cycle arrest to lead to cellular senescence. Water chestnut shell (WCS) is a plant hull which containing polyphenolic compounds and showed antioxidant and anticancer activities. Orchid, which containing a natural polysaccharide compound, possesses many physiological activities including anti-inflammatory and neuroprotective effects. These agricultural plants might be able to reduce oxidative stress and inflammation. This study was used HG-induced human normal dermal fibroblasts (HG-HNDFs) as an in vitro model to disclose the effects of water extract of Phalaenopsis orchid flower (WEPF) and ethanol extract of water chestnut shell (EEWCS) on the anti-aging and their underlying molecular mechanisms. The toxicity of extracts on human normal dermal fibroblasts (HNDFs) was determined by MTT method. The senescence of cells was assayed by β-galactosidase (SA-β-gal) kit. ROS and nitrate production was analyzed by Intracellular ROS contents and ELISA, respectively. Western blotting was used to detect the proteins in cells. The results showed that the exposure of HNDFs to HG (30 mM) for 72 h were caused cellular senescence and arrested cells at G0/G1 phase. Indeed, the treatment of HG-HNDFs with WEPF (200 μg/ml) and EEWCS (10 μg/ml) significantly released cell cycle arrest and promoted cell proliferation. The G1/S phase transition regulatory proteins such as protein retinoblastoma (pRb), p53, and p16ᴵᴺᴷ⁴ᵃ depressed by WEPF and EEWCS were also observed. Additionally, the treatment of WEPF and EEWCS increased the activity of HO-1 through upregulating Nrf2 as well as decreased the ROS and NO of HG-HNDFs. Therefore, the senescence marker protein-30 (SMP30) in cells was diminished. In conclusion, the WEPF and EEWCS might inhibit HG-induced aging of HNDFs by reducing oxidative stress and free radicals.

Keywords: agricultural plant extract, anti-aging, high glucose, Phalaenopsis orchid flower, water chestnut shell

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Authors: Peyton M. Provenzano

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This paper draws primarily upon the framework of necropolitics and presents California as itself a former frontier, colony, and late-modern settler society. The convergence of these successive and overlapping regimes of state terror is actualized and traceable through an analysis of historical and contemporary police practices. At the behest of the Spanish Crown and with the assistance of the Spanish military, the Catholic Church led the original expedition to colonize California. The indigenous populations of California were subjected to brutal practices of confinement and enslavement at the missions. After the annex of California by the United States, the western-most territory became an infamous frontier where new settlers established vigilante militias to enact violence against indigenous populations to protect their newly stolen land. Early mining settlements sought to legitimize and fund vigilante violence by wielding the authority of rudimentary democratic structures. White settlers circulated petitions for funding to establish a volunteer company under California’s Militia Law for ‘protection’ against the local indigenous populations. The expansive carceral practices of Los Angelinos at the turn of the 19th century exemplify the way in which California solidified its regime of exclusion as a white settler society. Drawing on recent scholarship that queers the notion of biopower and names police as street-level sovereigns, the police murder of Kayla Moore is understood as the latest manifestation of a carceral regime of exclusion and genocide. Kayla Moore was an African American transgender woman living with a mental health disability that was murdered by Berkeley police responding to a mental health crisis call in 2013. The intersectionality of Kayla’s identity made her hyper-vulnerable to state-sanctioned violence. Kayla was a victim not only of the explicitly racial biopower of police, nor the regulatory state power of necropolitics but of the ‘asphyxia’ that was intended to invisibilize both her life and her murder.

Keywords: asphyxia, biopower, california, carceral state, genocide, necropolitics, police, police violence

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Authors: Seba Mohanty, Jitendra Mahakud

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Capital ratio is one of the major indicators of the stability of the commercial banks. Pertinent to its pervasive importance, over the years the regulators, policy makers focus on the maintenance of the particular level of capital ratio to minimize the solvency and liquidation risk. In this context, it is very much important to identify the relationship between capital and risk and find out the factors which determine the capital ratios of commercial banks. The study examines the relationship between capital and risk of the commercial banks operating in India. Other bank specific variables like bank size, deposit, profitability, non-performing assets, bank liquidity, net interest margin, loan loss reserves, deposits variability and regulatory pressure are also considered for the analysis. The period of study is 1997-2015 i.e. the period of post liberalization. To identify the impact of financial crisis and implementation of Basel II on capital ratio, we have divided the whole period into two sub-periods i.e. 1997-2008 and 2008-2015. This study considers all the three types of commercial banks, i.e. public sector, the private sector and foreign banks, which have continuous data for the whole period. The main sources of data are Prowess data base maintained by centre for monitoring Indian economy (CMIE) and Reserve Bank of India publications. We use simultaneous equation model and more specifically Two Stage Least Square method to find out the relationship between capital and risk. From the econometric analysis, we find that capital and risk affect each other simultaneously, and this is consistent across the time period and across the type of banks. Moreover, regulation has a positive significant impact on the ratio of capital to risk-weighted assets, but no significant impact on the banks risk taking behaviour. Our empirical findings also suggest that size has a negative impact on capital and risk, indicating that larger banks increase their capital less than the other banks supported by the too-big-to-fail hypothesis. This study contributes to the existing body of literature by predicting a strong relationship between capital and risk in an emerging economy, where banking sector plays a majority role for financial development. Further this study may be considered as a primary study to find out the macro economic factors which affecting risk and capital in India.

Keywords: capital, commercial bank, risk, simultaneous equation model

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Authors: Esmael Makarian, Ayub Elyasi, Fatemeh Saberi, Olusegun Stanley Tomomewo

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Geothermal reservoirs (GTRs) have garnered global recognition as a sustainable energy source. The Thermo-Hydro-Mechanical-Chemical (THMC) integration coupling proves to be a practical and effective method for optimizing production in GTRs. The study outcomes demonstrate that THMC coupling serves as a versatile and valuable tool, offering in-depth insights into GTRs and enhancing their operational efficiency. This is achieved through temperature analysis and pressure changes and their impacts on mechanical properties, structural integrity, fracture aperture, permeability, and heat extraction efficiency. Moreover, THMC coupling facilitates potential benefits assessment and risks associated with different geothermal technologies, considering the complex thermal, hydraulic, mechanical, and chemical interactions within the reservoirs. However, THMC-coupling utilization in GTRs presents a multitude of challenges. These challenges include accurately modeling and predicting behavior due to the interconnected nature of processes, limited data availability leading to uncertainties, induced seismic events risks to nearby communities, scaling and mineral deposition reducing operational efficiency, and reservoirs' long-term sustainability. In addition, material degradation, environmental impacts, technical challenges in monitoring and control, accurate assessment of resource potential, and regulatory and social acceptance further complicate geothermal projects. Addressing these multifaceted challenges is crucial for successful geothermal energy resources sustainable utilization. This paper aims to illuminate the challenges and opportunities associated with THMC coupling in enhanced geothermal systems. Practical solutions and strategies for mitigating these challenges are discussed, emphasizing the need for interdisciplinary approaches, improved data collection and modeling techniques, and advanced monitoring and control systems. Overcoming these challenges is imperative for unlocking the full potential of geothermal energy making a substantial contribution to the global energy transition and sustainable development.

Keywords: geothermal reservoirs, THMC coupling, interdisciplinary approaches, challenges and opportunities, sustainable utilization

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Authors: Xiaobo Wang, Zhen-Yu Chen

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Higher plasma total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) are independent risk factors of cardiovascular disease while high-density lipoprotein cholesterol (HDL-C) is protective. Vitamin D is well-known for its regulatory role in calcium homeostasis. Its potential important role in cardiovascular disease has recently attracted much attention. This study was conducted to investigate effects of different dosage of calcitriol on plasma lipoprotein profile and the underlying mechanism. Sixty male Syrian Golden hamsters were randomly divided into 6 groups: no-cholesterol control (NCD), high-cholesterol control (HCD), groups with calcitriol supplementation at 10/20/40/80ng/kg body weight (CA, CB, CC, CD), respectively. Calcitriol in medium-chain triacylglycerol (MCT) oil was delivered to four experimental groups via oral gavage every other day, while NCD and HCD received MCT oil in the equivalent amount. NCD hamsters were fed with non-cholesterol diet while other five groups were maintained on diet containing 0.2% cholesterol to induce a hypercholesterolemic condition. The treatment lasts for 6 weeks followed by sample collection after hamsters sacrificed. Four experimental groups experienced a reduction in average food intake around 11% compared to HCD with slight decrease in body weight (not exceeding 10%). This reduction reflects on the deceased relative weights of testis, epididymal and perirenal adipose tissue in a dose-dependent manner. Plasma calcitriol levels were measured and was corresponding to oral gavage. At the end of week 6, lipoprotein profiles were improved with calcitriol supplementation with TC, non-HDL-C and plasma triglyceride (TG) decreased in a dose-dependent manner (TC: r=0.373, p=0.009, non-HDL-C: r=0.479, p=0.001, TG: r=0.405, p=0.004). Since HDL-C of four experiment groups showed no significant difference compared to HCD, the ratio of nHDL-C to HDL-C and HDL-C to TC had been restored in a dose-dependent manner. For hamsters receiving the highest level of calcitriol (80ng/kg) showed a reduction of TC by 11.5%, nHDL-C by 24.1% and TG by 31.25%. Little difference was found among six groups on the acetylcholine-induced endothelium-dependent relaxation or contraction of thoracic aorta. To summarize, calcitriol supplementation in hamster at maximum 80ng/kg body weight for 6 weeks lead to an overall improvement in plasma lipoprotein profile with decreased TC and TG level. The molecular mechanism of its effects is under investigation.

Keywords: cholesterol, vitamin D, calcitriol, hamster

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Authors: Farzana Esmailkassam, Usakorn Kunanuvat, Zahraa Mohammed Ali

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Objective: The key barrier in Clozapine treatment of treatment-resistant schizophrenia (TRS) includes frequent bloods draws to monitor neutropenia, the main drug side effect. WBC and ANC monitoring must occur throughout treatment. Accurate WBC and ANC counts are necessary for clinical decisions to halt, modify or continue clozapine treatment. The CSAN Pronto point-of-care (POC) analyzer generates white blood cells (WBC) and absolute neutrophils (ANC) through image analysis of capillary blood. POC monitoring offers significant advantages over central laboratory testing. This study evaluated the performance of the CSAN Pronto against the Beckman DxH900 Hematology laboratory analyzer. Methods: Forty venous samples (EDTA whole blood) with varying concentrations of WBC and ANC as established on the DxH900 analyzer were tested in duplicates on three CSAN Pronto analyzers. Additionally, both venous and capillary samples were concomitantly collected from 20 volunteers and assessed on the CSAN Pronto and the DxH900 analyzer. The analytical performance including precision using liquid quality controls (QCs) as well as patient samples near the medical decision points, and linearity using a mix of high and low patient samples to create five concentrations was also evaluated. Results: In the precision study for QCs and whole blood, WBC and ANC showed CV inside the limits established according to manufacturer and laboratory acceptability standards. WBC and ANC were found to be linear across the measurement range with a correlation of 0.99. WBC and ANC from all analyzers correlated well in venous samples on the DxH900 across the tested sample ranges with a correlation of > 0.95. Mean bias in ANC obtained on the CSAN pronto versus the DxH900 was 0.07× 109 cells/L (95% L.O.A -0.25 to 0.49) for concentrations <4.0 × 109 cells/L, which includes decision-making cut-offs for continuing clozapine treatment. Mean bias in WBC obtained on the CSAN pronto versus the DxH900 was 0.34× 109 cells/L (95% L.O.A -0.13 to 0.72) for concentrations <5.0 × 109 cells/L. The mean bias was higher (-11% for ANC, 5% for WBC) at higher concentrations. The correlations between capillary and venous samples showed more variability with mean bias of 0.20 × 109 cells/L for the ANC. Conclusions: The CSAN pronto showed acceptable performance in WBC and ANC measurements from venous and capillary samples and was approved for clinical use. This testing will facilitate treatment decisions and improve clozapine uptake and compliance.

Keywords: absolute neutrophil counts, clozapine, point of care, white blood cells

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Authors: G. Blanco-Lizana, C. García-Fernández, J. A. Sánchez

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Growth is a productive trait regulated by a large and complex gene network with very different effect. Some of they (candidate genes) have a higher effect and are excellent resources to search in them polymorphisms correlated with differences in growth rates. This study was focused on the identification of single nucleotide polymorphism (SNP) in MyoD-1 and MyoD-2 genes, members of the family of myogenic regulatory genes with a key role in the differentiation and development of muscular tissue.(MFRs), and its evaluation as potential markers in genetic selection programs for growth in gilthead sea bream (Sparus aurata). Through a sequencing in 30 seabream (classified as unrelated by microsatellite markers) of 1.968bp in MyoD-1 gene [AF478568 .1] and 1.963bp in MyoD-2 gene [AF478569.1], three SNPs were identified in each gene (SaMyoD-1 D2100A (D indicate a deletion) SaMyoD-1 A2143G and SaMyoD-1 A2404G and SaMyoD-2_A785C, SaMyoD-2_C1982T and SaMyoD-2_A2031T). The relationships between SNPs and body weight were evaluated by SNP genotyping of 53 breeders from two broodstocks (A:18♀-9♂; B:16♀-10♂) and 389 offspring divided into two groups (slow- and fast-growth) with significant differences in growth at 18 months of development (A18Slow: N=107, A18Fast: N=103, B18Slow: N=92 and B18Fast: N=87) (Borrell et al., 2011). Haplotype and diplotype were reconstructed from genotype data by Phase 2.1 software. Differences among means of different diplotypes were calculated by one-way ANOVA followed by post-hoc Tukey test. Association analysis indicated that single SNP did not show significant effect on body weight. However, when the analysis is carried out considering haplotype data it was observed that the DGG haplotipe of MyoD-1 gen and CCA haplotipe of MyoD- 2gen were associated to with lower body weight. This haplotype combination always showed the lowest mean body weight (P<0.05) in three (A18Slow, A18Fast & B18Slow) of the four groups tested. Individuals with DGG haplotipe of MyoD-1 gen have a 25,5% and those with CCA haplotipe of MyoD- 2gen showed 14-18% less on mean body weight. Although further studies are need to validate the role of these 3 SNPs as marker for body weight, the polymorphism-trait association established in this work create promising expectations on the use of these variants as genetic tool for future giltead seabream breeding programs.

Keywords: growth, MyoD-1 and MyoD-2 genes, selective breeding, SNP-haplotype

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Authors: Maria Antonieta Erna Castillo Holly

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During the last decade, data analysis, strategic decision making, and the use of artificial intelligence (AI) tools in Latin American agriculture have been a challenge. In some countries, the availability, quality, and reliability of historical data, in addition to the current data recording methodology in the field, makes it difficult to use information systems, complete data analysis, and their support for making the right strategic decisions. This is something essential in Agriculture 4.0. where the increase in the global demand for fresh agricultural products of tropical origin, during all the seasons of the year requires a change in the production model and greater agility in the responses to the consumer market demands of quality, quantity, traceability, and sustainability –that means extensive data-. Having quality information available and updated in real-time on what, how much, how, when, where, at what cost, and the compliance with production quality standards represents the greatest challenge for sustainable and profitable agriculture in the region. The objective of this work is to present a methodological proposal for the collection of georeferenced data from the protected agriculture sector, specifically in production units (UP) with tall structures (Greenhouses), initially for Venezuela, taking the state of Mérida as the geographical framework, and horticultural products as target crops. The document presents some background information and explains the methodology and tools used in the 3 phases of the work: diagnosis, data collection, and analysis. As a result, an evaluation of the process is carried out, relevant data and dashboards are displayed, and the first satellite maps integrated with layers of information in a geographic information system are presented. Finally, some improvement proposals and tentatively recommended applications are added to the process, understanding that their objective is to provide better qualified and traceable georeferenced data for subsequent analysis of the information and more agile and accurate strategic decision making. One of the main points of this study is the lack of quality data treatment in the Latin America area and especially in the Caribbean basin, being one of the most important points how to manage the lack of complete official data. The methodology has been tested with horticultural products, but it can be extended to other tropical crops.

Keywords: greenhouses, protected agriculture, data analysis, geographic information systems, Venezuela

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Authors: Natalia Carolina Encalada Castillo

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As part of an intended radical policy change compared to former administrations in Ecuador, the transformation of the institutionality of international cooperation during the period of President Rafael Correa was considered as a key element for the construction of the state of 'Good Living'. This intention led to several regulatory changes in the reception of cooperation for development, and even the departure of some foreign cooperation agencies. Moreover, Ecuador launched the initiative to become a donor of cooperation towards other developing countries through the ‘South-South Cooperation’ approach. All these changes were institutionalized through the Ecuadorian System of International Cooperation as a new framework to establish rules and policies that guarantee a sovereign management of foreign aid. Therefore, this research project has been guided by two questions: What were the factors that motivated the transformation of the institutionality of international cooperation in Ecuador from 2007 to 2017? and, what were the implications of this transformation in terms of the international role of the country? This paper seeks to answer these questions through Role Theory within a Constructivist meta-theoretical perspective, considering that in this case, changes at the institutional level in the field of cooperation, responded not only to material motivations but also to interests built on the basis of a specific state identity. The latter was only possible to affirm through specific roles such as ‘sovereign recipient of cooperation’ as well as ‘donor of international cooperation’. However, the performance of these roles was problematic as they were not easily accepted by the other actors in the international arena or in the domestic level. In terms of methodology, these dynamics are analyzed in a qualitative way mainly through interpretive analysis of the discourse of high-level decision-makers from Ecuador and other cooperation actors. Complementary to this, document-based research of relevant information as well as interviews have been conducted. Finally, it is concluded that even if material factors such as infrastructure needs, trade and investment interests, as well as reinforcement of state control and monitoring of cooperation flows, motivated the institutional transformation of international cooperation in Ecuador; the essential basis of these changes was the search for a new identity for the country to be projected in the international arena. This identity started to be built but continues to be unstable. Therefore, it is important to potentiate the achievements of the new international cooperation policies, and review their weaknesses, so that non-reimbursable cooperation funds received as well as ‘South-South cooperation’ actions, contribute effectively to national objectives.

Keywords: Ecuador, international cooperation, Role Theory, state identity

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Authors: Muhammad Fatahillah Akbar

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Criminal Procedural Law is established to protect the society from the abuse of authority. To achieve that purpose, the criminal procedural law shall be established in accordance with the laws of human right and the protection of the society. One of the mechanisms to protect human rights and to ensure the compliance of authorities in criminal procedural law is pre-trial mechanism. In many countries, there are various mechanisms of pre-trial. In the recent cases in Indonesia, pre-trial has been an interesting issue. The issue is also addressed by the Constitutional Court Decision Number 21/PUU-XII/2014 which enhance the competence of pre-trial which includes the suspect determination and the legality of seizure and search. Before that decision, some pre-trial decisions have made landmark decision by enhancing the competence of pre-trial, such as the suspect determination case in Budi Gunawan Case and legality of the investigation in Hadi Purnomo Case. These pre-trial cases occurred because the society needs protection even though it is not provided by written legislations, in this matter, The Indonesian Criminal Procedural Code (KUHAP). For instance, a person can be a suspect for unlimited time because the Criminal Procedural Code does not regulate the limit of investigation, so the suspect enactment shall be able to be challenged to protect human rights. Before the Constitutional Court Decision Suspect Determination cannot be challenged so that the society is not fully protected. The Constitutional Court Decision has provided more protections. Nowadays, investigators shall be more careful in conducting the investigation. However, those decisions, including the Constitutional Court Decision are not sufficient for society to be protected by abuse of authority. For example, on 7 March 2017, a single judge, in a Pre-Trial, at the Surabaya District Court, decided that the investigation was unlawful and shall be terminated. This is not regulated according to the Code and also any decisions in pre-trial. It can be seen that the reform of pre-trial is necessary. Hence, this paper aims to examine how pre-trial shall be developed in the future to provide wide access for society to have social justice in criminal justice system. The question will be answered by normative, historical, and comparative approaches. Firstly, the paper will examine the history of pre-trial in Indonesia and also landmark decisions on pre-trial. Then, the lessons learned from other countries regarding to the pre-trial mechanism will be elaborated to show how pre-trial shall be developed and what the competences of a pre-trial are. The focus of all discussions shall be on how the society is protected and provided access to legally complain to the authority. At the end of the paper, the recommendation to reform the pre-trial mechanism will be suggested.

Keywords: pre-trial, criminal procedural law, society

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Authors: Sheillah Hlamalani Mboweni, Lufuno Makhado

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Background: The increasing number of people who tested HIV positive and who demand antiretroviral therapy (ART) prompted the National Department of Health to adopt WHO recommendations of task shifting where Professional Nurses(PNs) initiate ART rather than doctors in the hospital. This resulted in the decentralization of services to primary health care(PHC), generating a need to capacitate PNs on NIMART. After years of training, the impact of NIMART was assessed where it was established that even though there was an increased number who accessed ART, the quality of care is of serious concern. The study aims to answer the following question: What are the challenges influencing NIMART implementation in primary health care. Objectives: This study explores challenges influencing NIMART training and implementation and makes recommendations to improve patient and HIV program outcomes. Methods: A qualitative explorative program evaluation research design. The study was conducted in the rural districts of North West province. Purposive sampling was used to sample PNs trained on NIMART. FGDs were used to collect data with 6-9 participants and data was analysed using ATLAS ti. Results: Five FGDs, n=28 PNs and three program managers were interviewed. The study results revealed two themes: inadequacy in NIMART training and the health care system challenges. Conclusion: The deficiency in NIMART training and health care system challenges is a public health concern as it compromises the quality of HIV management resulting in poor patients’ outcomes and retard the goal of ending the HIV epidemic. These should be dealt with decisively by all stakeholders. Recommendations: The national department of health should improve NIMART training and HIV management: standardization of NIMART training curriculum through the involvement of all relevant stakeholders skilled facilitators, the introduction of pre-service NIMART training in institutions of higher learning, support of PNs by district and program managers, plan on how to deal with the shortage of staff, negative attitude to ensure compliance to guidelines. There is a need to develop a conceptual framework that provides guidance and strengthens NIMART implementation in PHC facilities.

Keywords: antiretroviral therapy, nurse initiated management of retroviral therapy, primary health care, professional nurses

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Authors: Ozcan Yavas, Berrak Erol Nalbur, Sermin Gunarslan

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A materiality matrix is a tool that organizations use to prioritize their activities and adapt to the increasing sustainability requirements in recent years. For the materiality index to move from business models to the sustainability business model stage, it must be done with all partners in the raw material, supply, production, product, and end-of-life product stages. Within the scope of this study, the Materiality Matrix was used to transform the business model into a sustainability business model and to create a sustainability roadmap in a factory producing electric buses. This matrix determines the necessary roadmap for all stakeholders to participate in the process, especially in sectors that produce sustainable products, such as the electric vehicle sector, and to act together with the cradle-to-cradle approach of sustainability roadmaps. Global Reporting Initiative analysis was used in the study conducted with 1150 stakeholders within the scope of the study, and 43 questions were asked to the stakeholders under the main headings of 'Legal Compliance Level,' 'Environmental Strategies,' 'Risk Management Activities,' 'Impact of Sustainability Activities on Products and Services,' 'Corporate Culture,' 'Responsible and Profitable Business Model Practices' and 'Achievements in Leading the Sector' and Economic, Governance, Environment, Social and Other. The results of the study aimed to include five 1st priority issues and four 2nd priority issues in the sustainability strategies of the organization in the short and medium term. When the studies carried out in the short term are evaluated in terms of Sustainability and Environmental Risk Management, it is seen that the studies are still limited to the level of legal legislation (60%) and individual studies in line with the strategies (20%). At the same time, the stakeholders expect the company to integrate sustainability activities into its business model within five years (35%) and to carry out projects to become the first company that comes to mind with its success leading the sector (20%). Another result obtained within the study's scope is identifying barriers to implementation. It is seen that the most critical obstacles identified by stakeholders with climate change and environmental impacts are financial deficiency and lack of infrastructure in the dissemination of sustainable products. These studies are critical for transitioning to sustainable business models for the electric vehicle sector to achieve the EU Green Deal and CBAM targets.

Keywords: sustainability business model, materiality matrix, electricity bus, carbon neutrality, sustainability management

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Authors: Nurul Hidayat

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Based on the data from the Indonesian Tax Authority, the contribution of self-employed taxpayers in Indonesia is just approximately 1-2 percent of total tax revenues during 2013 - 2015. This phenomenon requires greater attention to understand what factors that may affect it. The fact that Indonesia has the most prominent Muslim population in the world makes it important to analyze whether there potentially exists a correlation between Islamic religiosity and low tax contribution. The low level of tax contribution may provide an initial indication of low tax morale and tax compliance. This study will extend the existing literature by investigating the influence of Islamic religiosity as a moderating effect on the relationship between the perceptions of government legitimacy and tax morale among self-employed taxpayers. There are some factors to consider when taking into account the issue of Islamic religiosity and its relationship with tax morale in this study. Firstly, in Islam, there is a debate surrounding the lawfulness of tax. Some argue that Muslims should not have to pay tax; while others argue that the imposition of the tax is legitimate in circumstances. These views may have an impact on government legitimacy and tax morale. Secondly, according to Islamic sharia, Islam recognizes another compulsory payment, i.e. zakat, which to some extent has similar characteristics to tax. According to Indonesian Income Tax Law, zakat payment has just been accommodated as a deduction from taxable income. As a comparison, Malaysia treats zakat as a tax rebate. The treatment of zakat only as a taxable income deduction may also lead to a conflicting issue regarding the perception of tax fairness that possibly erode the perception of government legitimacy and tax morale. Based on the considerations above, perceptions of government legitimacy become important to influence the willingness of people to pay tax while the level of Islamic religiosity has a potential moderator effect on that correlation. In terms of measuring the relationship among the variables, this study utilizes mixed-quantitative and qualitative methods. The quantitative methods use surveys to approximately 400 targeted taxpayers while the qualitative methods employ in-depth interviews with 12 people, consist of experts, Islamic leaders and selected taxpayers. In particular, the research is being conducted in Indonesia, the country with the largest Muslim population in the world which has not fully implemented Islamic law as state law. The result indicates that Islamic religiosity becomes a moderating effect on the way taxpayers perceived government legitimacy that finally influences on tax morale. The findings of this study are supportive for the improvement of tax regulations by specifically considering tax deductions for zakat.

Keywords: Islamic religiosity, tax morale, government legitimacy, zakat

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Authors: Seyedahmad Hosseini, Mohammadjavad Sotoudeheian

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Introduction: Allergic asthma is a heterogeneous immuno-inflammatory disease based on Th-2-mediated inflammation. Histopathologic abnormalities of the airways characteristic of asthma include epithelial damage and subepithelial collagen deposition. Objectives: Human bronchial epithelial cell genome expression of TNF‑α, IL‑6, ICAM‑1, VCAM‑1, nuclear factor (NF)‑κB signaling pathways up-regulate during inflammatory cascades. Moreover, immunofluorescence assays confirmed the nuclear translocation of NF‑κB p65 during inflammatory responses. An absolute LDH leakage assays suggestedLPS-inducedcells injury, and the associated mechanisms are co-incident events. LPS-induced phosphorylation of ERKand JNK causes inflammation in epithelial cells through inhibition of ERK and JNK activation and NF-κB signaling pathway. Furthermore, the inhibition of NF-κB mRNA expression and the nuclear translocation of NF-κB lead to anti-inflammatory events. Likewise, activation of SUMF2 which inhibits IL-13 and reduces Th2-cytokines, NF-κB, and IgE levels to ameliorate asthma. On the other hand, TNFα-induced mucus production reduced NF-κB activation through inhibition of the activation status of Rac1 and IκBα phosphorylation. In addition, bradykinin B2 receptor (B2R), which mediates airway remodeling, regulates through NF-κB. Bronchial B2R expression is constitutively elevated in allergic asthma. In addition, certain NF-κB -dependent chemokines function to recruit eosinophils in the airway. Besides, bromodomain containing 4 (BRD4) plays a significant role in mediating innate immune response in human small airway epithelial cells as well as transglutaminase 2 (TG2), which is detectable in saliva. So, the guanine nucleotide-binding regulatory protein α-subunit, Gα16, expresses a κB-driven luciferase reporter. This response was accompanied by phosphorylation of IκBα. Furthermore, expression of Gα16 in saliva markedly enhanced TNF-α-induced κB reporter activity. Methods: The applied method to form NF-κB activation is the electromobility shift assay (EMSA). Also, B2R-BRD4-TG2 complex detection by immunoassay method within saliva with EMSA of NF-κB activation may be a novel biomarker for asthma diagnosis and follow up. Conclusion: This concept introduces NF-κB signaling pathway as potential asthma biomarkers and promising targets for the development of new therapeutic strategies against asthma.

Keywords: NF-κB, asthma, saliva, T-helper

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Authors: Lottie Lane

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It is habitually assumed and stated that the World Bank should engage and comply with international human rights standards. However, the basis for holding the Bank to such standards is unclear. Most advocates of the idea invoke aspects of international law to argue that the Bank has existing obligations to act in compliance with human rights standards. The Bank itself, however, does not appear to accept such arguments, despite having endorsed the importance of human rights for a considerable length of time. A substantial challenge is that under the current international human rights law framework, the World Bank is considered a non-state actor, and as such, has no direct human rights obligations. In the absence of clear legal duties for the Bank, it is necessary to look at the tools available beyond the international human rights framework to encourage the Bank to comply with human rights standards. This article critically examines several bases for arguing that the Bank should comply and engage with human rights through its policies and practices. Drawing on the Bank’s own ‘good governance’ approach as well as the United Nations’ ‘human rights-based-approach’ to development, a new basis is suggested. First, the relationship between the World Bank and human rights is examined. Three perspectives are considered: (1) the legal position – what the status of the World Bank is under international human rights law, and whether it can be said to have existing legal human rights obligations; (2) the Bank’s own official position – how the Bank envisages its relationship with and role in the protection of human rights; and (3) the relationship between the Bank’s policies and practices and human rights (including how its attitudes are reflected in its policies and how the Bank’s operations impact human rights enjoyment in practice). Here, the article focuses on two examples – the (revised) 2016 Environmental and Social Safeguard Policies and the 2012 case-study regarding Gambella, Ethiopia. Both examples are widely considered missed opportunities for the Bank to actively engage with human rights. The analysis shows that however much pressure is placed on the Bank to improve its human rights footprint, it is extremely reluctant to do so explicitly, and the legal bases available are insufficient for requiring concrete, ex ante action by the Bank. Instead, the Bank’s own ‘good governance’ approach to development – which it has been advocating since the 1990s – can be relied upon. ‘Good governance’ has been used and applied by many actors in many contexts, receiving numerous different definitions. This article argues that human rights protection can now be considered a crucial component of good governance, at least in the context of development. In doing so, the article explains the relationship and interdependence between the two concepts, and provides three rationales for the Bank to take a ‘human rights-based approach’ to good governance. Ultimately, this article seeks to look beyond international human rights law and take a governance approach to provide a convincing basis upon which to argue that the World Bank should comply with human rights standards.

Keywords: World Bank, international human rights law, good governance, human rights-based approach

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Authors: Margot Whitfield, Andrea Ducent, Marie Catherine Rombaut, Katia Iassinovskaia, Deborah Fels

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Learning how to create inclusive media, such as closed captioning (CC) and audio description (AD), in North America is restricted to the private sector, proprietary company-based training. We are delivering (through synchronous and asynchronous online learning) the first Canadian post-secondary, practice-based continuing education course package in inclusive media for broadcast production and processes. Despite the prevalence of CC and AD taught within the field of translation studies in Europe, North America has no comparable field of study. This novel approach to audio visual translation (AVT) education develops evidence-based methodology innovations, stemming from user study research with blind/low vision and Deaf/hard of hearing audiences for television and theatre, undertaken at Ryerson University. Knowledge outcomes from the courses include a) Understanding how CC/AD fit within disability/regulatory frameworks in Canada. b) Knowledge of how CC/AD could be employed in the initial stages of production development within broadcasting. c) Writing and/or speaking techniques designed for media. d) Hands-on practice in captioning re-speaking techniques and open source technologies, or in AD techniques. e) Understanding of audio production technologies and editing techniques. The case study of the curriculum development and deployment, involving first-time online course delivery from academic and practitioner-based instructors in introductory Captioning and Audio Description courses (CDIM 101 and 102), will compare two different instructors' approaches to learning design, including the ratio of synchronous and asynchronous classroom time and technological engagement tools on meeting software platform such as breakout rooms and polling. Student reception of these two different approaches will be analysed using qualitative thematic and quantitative survey analysis. Thus far, anecdotal conversations with students suggests that they prefer synchronous compared with asynchronous learning within our hands-on online course delivery method.

Keywords: inclusive media theory, broadcasting practices, AVT post secondary education, respeaking, audio description, learning design, virtual education

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Authors: Magdalena Smoktunowicz, Renata Wawrzyniak, Malgorzata Waleron, Krzysztof Waleron

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Pectobacterium spp. were previously classified into the Erwinia genus founded in 1917 to unite at that time all Gram-negative, fermentative, nonsporulating and peritrichous flagellated plant pathogenic bacteria. After work of Waldee (1945), on Approved Lists of Bacterial Names and bacteriology manuals in 1980, they were described either under the species named Erwinia or Pectobacterium. The Pectobacterium genus was formally described in 1998 of 265 Pectobacterium strains. Currently, there are 21 species of Pectobacterium bacteria, including Pectobacterium betavasculorum since 2003, which caused soft rot on sugar beet tubers. Based on the biochemical experiments carried out for this, it is known that these bacteria are gram-negative, catalase-positive, oxidase-negative, facultatively anaerobic, using gelatin and causing symptoms of soft rot on potato and sugar beet tubers. The mere fact of growing on sugar beet may indicate a metabolism characteristic only for this species. Metabolomics, broadly defined as the biology of the metabolic systems, which allows to make comprehensive measurements of metabolites. Metabolomics, in combination with genomics, are complementary tools for the identification of metabolites and their reactions, and thus for the reconstruction of metabolic networks. The aim of this study was to apply the GC-MS-based untargeted metabolomics to study the metabolism of P. betavasculorum in different growing conditions. The metabolomic profiles of biomass and biomass media were determined. For sample preparation the following protocol was used: extraction with 900 µl of methanol: chloroform: water mixture (10: 3: 1, v: v) were added to 900 µl of biomass from the bottom of the tube and up to 900 µl of nutrient medium from the bacterial biomass. After centrifugation (13,000 x g, 15 min, 4oC), 300µL of the obtained supernatants were concentrated by rotary vacuum and evaporated to dryness. Afterwards, two-step derivatization procedure was performed before GC-MS analyses. The obtained results were subjected to statistical calculations with the use of both uni- and multivariate tests. The obtained results were evaluated using KEGG database, to asses which metabolic pathways are activated and which genes are responsible for it, during the metabolism of given substrates contained in the growing environment. The observed metabolic changes, combined with biochemical and physiological tests, may enable pathway discovery, regulatory inference and understanding of the homeostatic abilities of P. betavasculorum.

Keywords: GC-MS chromatograpfy, metabolomics, metabolism, pectobacterium strains, pectobacterium betavasculorum

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Authors: H. Jeries, N. Volkova, C. G. Iglesias, M. Najjar, M. Rosenblat, M. Aviram, T. Hayek

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Background: Synthetic forms of glucocorticoids (e.g., prednisone, prednisolone) are anti-inflammatory drugs which are widely used in clinical practice. The role of glucocorticoids (GCs) in cardiovascular diseases including atherosclerosis is highly controversial, and their impact on macrophage foam cell formation is still unknown. Our aim was to investigate the effects of prednisone or its active metabolite, prednisolone, on macrophage oxidative stress and lipid metabolism using in-vivo, ex-vivo and in-vitro systems. Methods: The in-vivo study included C57BL/6 mice which were intraperitoneally injected with prednisone or prednisolone (5mg/kg) for 4 weeks, followed by lipid metabolism analyses in the mice aorta, and in peritoneal macrophages (MPM). In the ex-vivo study, we analyzed the effect of serum samples obtained from 9 healthy volunteers before or after treatment with oral prednisone (20mg for 5 days), on J774A.1 macrophage atherogenicity. In-vitro studies were conducted using J774A.1 macrophages, human monocyte derived macrophages (HMDM) and fibroblasts. Cells were incubated with increasing concentrations (0-200 ng/ml) of prednisone or prednisolone, followed by determination of cellular oxidative status, triglyceride and cholesterol metabolism. Results: Prednisone or prednisolone treatment resulted in a significant reduction in triglycerides and mainly in cholesterol cellular accumulation in MPM or in J774A.1 macrophages incubated with human serum. Similar resulted were noted in HMDM or in J774A.1 macrophages which were directly incubated with the GCs. These effects were associated with GCs inhibitory effect on triglycerides and cholesterol biosynthesis rates, throughout downregulation of diacylglycerol acyltransferase1 (DGAT1) expression, and of the sterol regulatory element binding protein (SREBP2) and HMGCR expression, respectively. In parallel to prednisone or prednisolone induced reduction in macrophage triglyceride content, paraoxonase 2 (PON2) expression was significantly upregulated. GCs-induced reduction of cellular triglyceride and cholesterol mass was mediated by the GCs receptors on macrophages since the GCs receptor antagonist (RU 486) abolished these effects. In fibroblasts, unlike macrophages, prednisone or prednisolone showed no anti-atherogenic effects. Conclusions: Prednisone or prednisolone are anti-atherogenic since they protected macrophages from lipid accumulation and foam cell formation.

Keywords: atherosclerosis, cholesterol, foam cell, macrophage, prednisone, prednisolone, triglycerides

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Authors: Sidra Suleman, Maliha Suleman, Jinesh Shah

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Maxillary canines play a crucial role in occlusion and aesthetics. Successful management of impacted canines requires early identification and intervention to prevent complications such as resorption of adjacent teeth and cystic changes. Although removal of the deciduous canine can encourage normal eruption of its successor, this is not always successful. Some patients may require surgical exposure and bonding of a gold chain to mobilise and align the canine, which can take up to 3 years. As this procedure has various risks, patients need to be appropriately consented to. Failure of such treatment commonly occurs due to inadequate anchorage or failure of the gold chain attachment, but in some cases, this is due to ankylosis. Aim: The aim of this study was to determine the incidence of ankylosis of unerupted maxillary ectopic canines following surgical exposure and orthodontic alignment at the Maxillofacial and Orthodontic Department, Royal Stoke University Hospital (RSUH), United Kingdom. Methodology: Patients treated from January 1, 2017, to December 31, 2019, were retrospectively studied. Electronic records with post-treatment follow-up at 3-6 months and 12-15 months were extracted and analysed. Patients were excluded based on three criteria, non-compliance with orthodontic treatment post-surgery, presence of canine transposition, and external orthodontic treatment. Sample: Overall, 159 suitable patients were selected from the 171 patients identified. Surgical exposure and gold chain bonding was carried out for a total of 206 maxillary canines, with the pattern of impaction being 159 (77.2 %) palatal, 46 (22.3%) buccal, and 1 (0.49%) in line of the arch. The sample consisted of 57 (35.8%) males and 102 (64.2%) females between the age range of 10 to 32 years, with the mean age being 15 years. The procedures were carried out under general anaesthesia for all but three patients, with two cases being repeats. Closed exposure was carried out for 189 (91.7%) canines. Results: The incidence of ankylosis from this study was 0.97%. In total, two patients had upper left canine ankylosis, which was identified at their 12-15 months orthodontic follow-up. Both patients were males, one having closed exposure at age 15 and the other having open exposure at age 19. Conclusions: Although this data shows that there is a low risk of ankylosis (0.97%), it highlights the difficulty in predicting which patients may be affected, and thus, a thorough pre-treatment assessment and careful observation during treatment is necessary. Future studies involving larger cohorts are warranted to further analyse factors affecting outcomes.

Keywords: ankylosis, ectopic, maxillary canines, orthodontics

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Authors: Kalidas Sarma

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Fraud is a social problem changing with social change and it has a regional and global impact. Introduction of private domain in higher education along with public institutions has led to commercialization of higher education which encourages unprecedented mushrooming of private institutions resulting in fraudulent activities in higher educational institutions in Assam, India. Presently, fraud has been noticed in in-service promotion, fake entry qualification by teachers in different levels of work-place by using fake master degrees, master of philosophy and doctor of philosophy degree certificates. The aim and objective of the study are to identify grey areas in maintenance of quality in higher educational institutions in Assam and also to draw the contour for planning and implementation. This study is based on both primary and secondary data collected through questionnaire and seeking information through Right to Information Act 2005. In Assam, there are 301 undergraduate and graduate colleges distributed in 27 (Twenty seven) administrative districts with 11000 (Eleven thousand) college teachers. Total 421 (Four hundred twenty one) college teachers from the 14 respondent colleges have been taken for analysis. Data collected has been analyzed by using 'Hypertext Pre-processor' (PhP) application with My Sequel Structure Query Language (MySQL) and Google Map Application Programming Interface (APIs). Graph has been generated by using open source tool Chart.js. Spatial distribution maps have been generated with the help of geo-references of the colleges. The result shows: (i) the violation of University Grants Commission's (UGCs) Regulation for the awards of M. Phil/Ph.D. clearly exhibits. (ii) There is a gap between apex regulatory bodies of higher education at national and as well as state level to check fraud. (iii) Mala fide 'No Objection Certificate' (NOC) issued by the Government of Assam have played pivotal role in the occurrence of fraudulent practices in higher educational institutions of Assam. (iv) Violation of verdict of the Hon'ble Supreme Court of India regarding territorial jurisdiction of Universities for the awards of Ph.D. and M. Phil degrees in distance mode/study centre is also a responsible factor for the spread of these academic frauds in Assam and other states. The challenges and mitigation of these issues have been discussed.

Keywords: Assam, fraud, higher education, mitigation

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Authors: Alissa Lefebre

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It might seem intuitive to hope for a fast decision on the patent grant. After all, a granted patent provides you with a monopoly position, which allows you to obstruct others from using your technology. However, this does not take into account the strategic advantages one can obtain from keeping their patent applications pending. First, you have the financial advantage of postponing certain fees, although many applicants would probably agree that this is not the main benefit. As the scope of the patent protection is only decided upon at the grant, the pendency period introduces uncertainty amongst rivals. This uncertainty entails not knowing whether the patent will actually get granted and what the scope of protection will be. Consequently, rivals can only depend upon limited and uncertain information when deciding what technology is worth pursuing. One way to keep patent applications pending, is the use of divisional applications. These applicants can be filed out of a parent application as long as that parent application is still pending. This allows the applicant to pursue (part of) the content of the parent application in another application, as the divisional application cannot exceed the scope of the parent application. In a fast-moving and complex market such as the tele- and digital communications, it might allow applicants to obtain an actual monopoly position as competitors are discouraged to pursue a certain technology. Nevertheless, this practice also has downsides to it. First of all, it has an impact on the workload of the examiners at the patent office. As the number of patent filings have been increasing over the last decades, using strategies that increase this number even more, is not desirable from the patent examiners point of view. Secondly, a pending patent does not provide you with the protection of a granted patent, thus not only create uncertainty for the rivals, but also for the applicant. Consequently, the European patent office (EPO) has come up with a “raising the bar initiative” in which they have decided to tackle the strategic use of divisional applications. Over the past years, two rules have been implemented. The first rule in 2010 introduced a time limit, upon which divisional applications could only be filed within a 24-month limit after the first communication with the patent office. However, after carrying-out a user feedback survey, the EPO abolished the rule again in 2014 and replaced it by a fee mechanism. The fee mechanism is still in place today, which might be an indication of a better result compared to the first rule change. This study tests the impact of these rules on the strategic use of divisional applications in the tele- and digital communication industry and provides empirical evidence on their success. Upon using three different survival models, we find overall evidence that divisional applications prolong the pendency time and that only the second rule is able to tackle the strategic patenting and thus decrease the pendency time.

Keywords: divisional applications, regulatory changes, strategic patenting, EPO

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Authors: Shalini Shawari Matharage

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The worldwide refugee challenge has arisen as a critical concern, with millions of individuals fleeing their home countries owing to conflict, persecution, and human rights violations. Since the establishment of an international framework in 1951 for tackling the humanitarian needs of refugees and asylum seekers, many developed and developing countries have adopted a refugee admittance framework into their national immigration policy and steadily changed their domestic legislation to assist the resettlement of refugees. However, many developed nations have put forth strict limitations on refugee admission in the midst of the continuing refugee crisis, claiming factors including national sovereignty, security of their borders, and national economy. Two such developed nations that have been restrictive on refugees is Japan and the United Kingdom. Despite their contrasting histories, migration methods, and viewpoints on diversity in modern society, the two notably developed nations have taken similar restrictive approaches in refugee policy in the recent years. This study attempts to investigate the underlying causes that led these countries to adopt strict refugee policies and how those policies have affected their compliance with international human rights responsibilities. The study employs a head-to-head methodology to examine the structural inequities in Japan and the United Kingdom's refugee policies. Using data from the UNHCR Refugee Data Finder, official government policy proposals, statements, and academic works, the study evaluates the contemporary refugee legislations, fundamental causes, and subsequent implications. The study illustrates a combination of economic, security, and demographic issues, as well as political rigidity and negative public perceptions, as major determinants of the two countries' restrictive refugee policies. The findings shed light on the restrictive actions taken by Japan and the UK, raising concerns about potential breaches in obligations to their commitments to international law and human rights obligations. Understanding the underlying issues influencing these policies allows lawmakers and activists to establish more compassionate refugee policies that adhere to international human rights and protect vulnerable individuals fleeing persecution. Ultimately, this study aims to contribute to the development of sensible refugee policies that uphold human rights and humanitarian values.

Keywords: immigration, Japan, refugee policy, united kingdom

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Authors: Krzysztof J. Czarnocki, F. Silveira, E. Czarnocka, K. Szaniawska

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Research background: Problems related to the occupational health and decreasing level of safety occur commonly in the construction industry. Important factor in the occupational safety in construction industry is scaffold use. All scaffolds used in construction, renovation, and demolition shall be erected, dismantled and maintained in accordance with safety procedure. Increasing demand for new construction projects unfortunately still is linked to high level of occupational accidents. Therefore, it is crucial to implement concrete actions while dealing with scaffolds and risk assessment in construction industry, the way on doing assessment and liability of assessment is critical for both construction workers and regulatory framework. Unfortunately, professionals, who tend to rely heavily on their own experience and knowledge when taking decisions regarding risk assessment, may show lack of reliability in checking the results of decisions taken. Purpose of the article: The aim was to indicate crucial parameters that could be modeling with Risk Assessment Model (RAM) use for improving both building enterprise productivity and/or developing potential and safety climate. The developed RAM could be a benefit for predicting high-risk construction activities and thus preventing accidents occurred based on a set of historical accident data. Methodology/Methods: A RAM has been developed for assessing risk levels as various construction process stages with various work trades impacting different spheres of enterprise activity. This project includes research carried out by teams of researchers on over 60 construction sites in Poland and Portugal, under which over 450 individual research cycles were carried out. The conducted research trials included variable conditions of employee exposure to harmful physical and chemical factors, variable levels of stress of employees and differences in behaviors and habits of staff. Genetic modeling tool has been used for developing the RAM. Findings and value added: Common types of trades, accidents, and accident causes have been explored, in addition to suitable risk assessment methods and criteria. We have found that the initial worker stress level is more direct predictor for developing the unsafe chain leading to the accident rather than the workload, or concentration of harmful factors at the workplace or even training frequency and management involvement.

Keywords: safety climate, occupational health, civil engineering, productivity

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Authors: Madhura Yadav

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Urban redevelopment planning initiatives in developing countries have been largely criticised due to top-down planning approach and lack of involvement of the targeted beneficiaries which have led to a challenging situation which is contrary to the perceived needs of beneficiaries. Urban renewal projects improve the lives of people and meaningful participation of community plays a pivotal role. Public perceptions on satisfaction and participation have been given less priority in the investigation, which hinders effective planning and implementation of urban renewal projects. Moreover, challenges of community participation in urban renewal projects are less documented, particularly in relation to public participation and satisfaction. There is a need for new paradigm shift focusing on community participatory approach in urban renewal projects. The over 125-year-old Bhendi Bazar in Mumbai, India is the country’s first ever cluster redevelopment project, popularly known as Bhendi Bazaar redevelopment and it will be one of the largest projects for urban rejuvenation of one of Mumbai’s oldest and dying inner city areas. The project is led by the community trust, inputs were taken from various stakeholders, including residents, commercial tenants and expert consultants to shape the master plan and design of the project. The project started in 2016 but there is a significant delay in implementing the project. The study aimed at studying and assessing public perceptions on satisfaction and the relationship between community participation and community satisfaction in Bhendi Bazaar of Mumbai, India. Furthermore, the study will outline the challenges and problems of community participation in urban renewal projects and it suggests recommendations for the future. The qualitative and quantitative methods such as reconnaissance survey, key informant interviews, focus group discussions, walking interviews, a narrative inquiry is used for analysis of data. Preliminary findings revealed that all tenants are satisfied for the redevelopment of an area but the willingness of residential tenants to move in transit accommodation has made the projects successful and reductant of some residential and commercial tenants, regulatory provisions rising to face challenges in implementation. Experiences from the case study can help to understand dynamics behind public participation and government. At the same time, they serve as an inspiration and learning opportunity for future projects to ensure that they are sustainable not only from an economic standpoint but also, a social perspective.

Keywords: urban renewal, Bhendi Bazaar, community participation, satisfaction, social perspective

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Authors: Naira Hakobyan, Shant Bagratyan

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This paper explores the phenomenon of management of innovations from the standpoint of work motivation. The main purpose of the theoretical research is to reveal the role of management of innovations to overcome the destructive work motivation and anomie. Systematization of the theoretical approaches and the literary sources indicates connections between destructive forms of work motivation and anomie. These connections allow an understanding of the role of innovations dedicated to decrease the motivational destructiveness of the employees. It is important to note that, in general, the presence of destructive motivation among employees can lead to work anomie. At the same time, issues related to the influence of destructive motivation on innovative processes in the management of an organization are not sufficiently studied. Exploring the factors leading to destructive work motivation and anomie manages toolkit and innovative ways of solution of the motivational destructiveness. The relevance of this scientific issue is that motivational destructiveness and work anomie are widespread phenomena in modern society. It means that previous forms of management become unusable and the way to introduce the innovations seems unclear for the employees. Investigation of the phenomenon of management of innovations is carried out in the following logical sequence: firstly, the issues of destructive work motivation and leadership are considered, and then the key points of work anomie are presented. Finally, there are explored the modern trends in the management of innovations aimed at overcoming motivational destructiveness and work anomie. The issue of management of innovations is explored by two levels: external-social and internal-organizational levels. Considering the phenomenon of management of innovations, the motivational role of the innovations is emphasized. The object of the research is the phenomenon of management of innovations in the context of overcoming motivational and anomic destructiveness. The paper presents the results of the theoretical analysis of the main factors of destructive motivation and work anomie among employees: an excessive dependence of employees on the manager, ignorance of one’s own work functions or unreasonable change by the manager, prevalence of formalism in assessing work comparing with the content and quality of work, lack of adaptive interaction among employees and low self-esteem of work activity. The paper theoretically proves that unclearly formulated innovative strategies for the development of the organization, lack of feedback from the manager to employees regarding the discussion of innovative technologies, non-compliance of working conditions with declared norms and standards, and formalism in management of innovations lead to destructiveness in a management system. The results of the research can be useful for managers, sociologists, economists, and psychologists.

Keywords: management of innovations, destructive motivation, work anomie, leadership, workaholism

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Authors: Raj Chavan

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The City of Jal serves a population of approximately 3,500 people, including 2,100 permanent inhabitants and 1,400 oil and gas sector workers and RV park occupants. Over the past three years, Jal's population has increased by about 70 percent, mostly due to the oil and gas industry. The City anticipates that the population will exceed 4,200 by 2020, necessitating the construction of a new wastewater treatment plant (WWTP) because the old plant (aerated lagoon system) cannot accommodate such rapid population expansion without major renovations or replacement. Adhering to discharge permit restrictions has been challenging due to aging infrastructure and equipment replacement needs, as well as increasing nutrient loading to the wastewater collecting system from the additional oil and gas residents' recreational vehicles. The WWTP has not been able to maintain permit discharge standards for total nitrogen of less than 20 mg N/L and other characteristics in recent years. Based on discussions with the state's environmental department, it is likely that the future permit renewal would impose stricter conditions. Given its location in the dry, western part of the country, the City must rely on its meager groundwater supplies and scant annual precipitation. The city's groundwater supplies will be depleted sooner than predicted due to rising demand from the growing population for drinking, leisure, and other industrial uses (fracking). The sole type of reuse the city was engaging in (recreational reuse for a golf course) had to be put on hold because of an effluent water compliance issue. As of right now, all treated effluent is evaporated. The city's long-term goal is to become a zero-waste community that sends all of its treated wastewater effluent either to the golf course, Jal Lake, or the oil and gas industry for reuse. Hydraulic fracturing uses a lot of water, but if the oil and gas industry can use recycled water, it can reduce its impact on freshwater supplies. The City's goal of 100% reuse has been delayed by the difficulties of meeting the constraints of the regular discharge permit due to the large rise in influent loads and the aging infrastructure. The City of Jal plans to build a new WWTP that can keep up with the city's rapid population increase due to the oil and gas industry. Several treatment methods were considered in light of the City's needs and its long-term goals, but MBR was ultimately chosen recommended since it meets all of the permit's requirements while also providing 100 percent beneficial reuse. This talk will lay out the plan for the city to reach its goal of 100 percent reuse, as well as the various avenues for funding the small community that have been considered.

Keywords: membrane bioreactor, nitrogent, reuse, small community

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Authors: Yiu K. C. Jacky, Tang S. K. Eric, W. Y. Tsang, C. Y. Li, C. K. Leung

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Objectives : (1) To enhance the competence of nurses on using IPMOE for drug administration; (2) To ensure the transition on implementation of IPMOE in safer and smooth way hospital-wide. Methodology: (1) Well-structured Governance: To make provision for IPMOE implementation, multidisciplinary governance structure at Corporate and Local levels are well established. (2) Staff Engagement: A series of staff engagement events were conducted including Staff Forum, IPMOE Hospital Visit, Kick-off Ceremony and establishment of IPMOE Webpage for familiarizing the forthcoming implementation with frontline staff. (3) Well-organized training program: from Workshop to Workplace Two different IPMOE training programs were tailor-made which aimed at introducing the core features of administration module. Fifty-five identical training classes and six train-the-trainer workshops were organized at 2-3Q 2015. Lending Scheme on IPMOE hardware for hands-on practicing was launched and further extended the training from workshop to workplace. (4) Standard Guidelines and Workflow: the related workflow and guidelines are developed which facilitates users to acquire the competence towards IPMOE and fully familiarize with the standardized contingency plan. (5) Facilities and Equipment: The installations of IPMOE hardware were promptly arranged for rollout. Besides, IPMOE training venue was well-established for staff training. (6) Risk Management Strategy: UCH Medication Safety Forum is organized in December 2015 for sharing “Tricks & Tips” on IPMOE which further disseminate at webpage for arousal of medication safety. Hospital-wide annual audit on drug administration was planned to figure out the compliance and deliberate the rooms for improvement. Results: Through the comprehensive training plan, over 1,000 UCH nurses attended the training program with positive feedback. They agreed that their competence on using IPMOE was enhanced. By the end of November 2015, 28 wards (over 1,000 Inpatient-bed) involving departments of M&G, SUR, O&T and O&G have been successfully rolled out IPMOE in 5-month. A smooth and safe transition of implementation of IPMOE was achieved. Eventually, we all get prepared for embedding IPMOE into daily nursing and work altogether for medication safety at UCH.

Keywords: drug administration, inpatient medication order entry system, medication safety, nursing informatics

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