Search results for: experimental results

Authors: Samar Saadeldin Abdelmotalab Omer, Ikram Mohammed Eltayeb Elsiddig, Amna Beshir Medani Ahmed, Saad Mohammed Hussein Ayoub

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Many herbal medicinal products are considered as potential hypocholesterolemic agents with encouraging safety profiles, however, only a limited amount of clinical research exists to support their efficacy. The present study was designed to compare the antihypercholesterolaemic and antioxidant activities of the crude ethanolic extracts of Citrus reticulata peel, Zingiber officinale rhizome, and Sesamum indicum seeds. Forty-five rats were used throughout the experiment, which were divided into nine groups, five rats in each as follows; normal control group (normal rats fed with standard normal diet), rats fed hypercholesterolemic diet consisting of 1% cholesterol and 10% saturated animal fat, which were further divided into eight groups; hypercholesterolemic control group (rats only fed hypercholesterolemic diet), groups 3,4,5,6,7, and 8 were given Citrus reticulata, Zingiber officinale, and Sesamum indicum ethanolic extracts at doses of (250mg/kg and 500mg/kg, respectively) orally; and group 9 rats were given atorvastatin (0.18mg/kg) orally as a reference antihypercholesterolaemic drug. Blood samples were obtained four weeks following treatment from the retro-orbital venous plexus after fasting overnight from all groups and the lipid profile (serum total cholesterol (TC), high-density-lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), and triglycerides levels) was measured and the risk ratio (TC/HDL-C) was assessed. The antioxidant activity of the three plant extracts was determined using DPPH free-radical assay. Results of in vivo and in vitro antihypercholesterolaemic and antioxidant assay, respectively, revealed that the three extracts possess comparable antioxidant and anti-hypercholesterolaemic activities.

Keywords: anti hypercholesterolemic effects, antioxidant activity, HDL, LDL, TC, TGs, citrus reticulata, sesamum indicum, zingiber officinale

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Authors: Murat Can Pehlivanoglu

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Historically, gender equality has been mainly defended in the legal arenas of constitutional law and employment law. However, social and economic progress has required corporate law to provide gender equality on corporate boards. Recently, following the trend in Europe, the State of California (United States) enacted a law requiring that every publicly traded corporation based in California should have women on its board of directors. Still, the legal, social and economic implications of this law are yet to be discovered. The contractarian view of corporate law is predominant in the U.S. jurisprudence. However, gender quota law may not be justified through contractarian theory grounds. Therefore, the conformity of gender quota law with the general principles of U.S. corporate law remains questionable, and the immunity of close corporations from the scope of gender quota legislation provides support for the discrepancy. The methodology employed in this paper in the discussion of the rule’s conformity with corporate law is doctrinal, and American case law and legal scholarship are the basis for this discussion. This paper uses the aforementioned California law as sample legislation to evaluate the gender quota laws’ conformity with the contractarian theory of corporate law. It chooses California law as the sample due to its newness and the presence of pending shareholder lawsuits against it. Also, since California is home to global companies, the effect of such law is expected to be wider. As alternative theories laid down by corporate law may already be activated to provide gender equality on boards of publicly traded corporations, enacting a specific gender quota law would not be justified by an allegedly present statutory deficiency based on contractarian theory. However, this theoretical reality would not enable shareholders to succeed in their lawsuits against such law on corporate law grounds, and investors will have limited options against its results. This will eventually harm the integrity of the marketplace. Through the analysis of the contractarian theory of corporate law and California gender quota law, the major finding of this paper is that the contractarian theory of corporate law does not permit mandating board room equality through corporate law. In conclusion, it expresses that the issue should be dealt with through separate legislation with a different remedial structure, to preserve the traditional rationale of corporate law in U.S. law.

Keywords: board of directors, gender equality, gender quota, publicly traded corporations

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Authors: Ruiyi Zhang, Wanglin Yan

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Strict land-use plan is issued based on city planning act for controlling urbanization and conserving semi-natural landscape. And the agrarian land resource in the suburbs has indispensable socio-economic value and contributes to the sustainability of the regional environment. However, the agrarian hinterland of metropolitan is witnessing severe farmland conversion and abandonment, while the contribution of land-use planning to farmland conservation remains unclear in those areas. Hypothetically, current land-use plan contributes to farmland loss. So, this research investigated the relationship between farmland loss and land-use planning at municipality level to provide base data for zoning in the metropolitan suburbs, and help to develop a sustainable land-use plan that will conserve the agrarian hinterland. As data and methods, 1) Farmland data of Census of Agriculture and Forestry for 2005 to 2015 and population data of 2015 and 2018 were used to investigate spatial distribution feathers of farmland loss in Tokyo Metropolitan District (TMD) for two periods: 2005-2010;2010-2015. 2) And the samples were divided by four urbanization facts. 3) DID data and zoning data for 2006 to 2018 were used to specify urbanization level of zones for describing land-use plan. 4) Then we conducted multiple regression between farmland loss, both abandonment and conversion amounts, and the described land-use plan in each of the urbanization scenario and in each period. As the results, the study reveals land-use plan has unignorable relation with farmland loss in the metropolitan suburbs at ward-city-town-village level. 1) The urban promotion areas planned larger than necessity and unregulated urbanization promote both farmland conversion and abandonment, and the effect weakens from inner suburbs to outer suburbs. 2) And the effect of land-use plan on farmland abandonment is more obvious than that on farmland conversion. The study advocates that, optimizing land-use plan will hopefully help the farmland conservation in metropolitan suburbs, which contributes to sustainable regional policy making.

Keywords: Agrarian land resource, land-use planning, urbanization level, multiple regression

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Authors: Eiman Alqattan

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Kuwaiti criminal justice system’s responses to allegations of sexual violence against women during the pre-trial process, suggesting that the system in Kuwait is affected by an ethos that is male dominated and patriarchal, and which results in prejudicial, unfair, and unequal treatment of female victims of serious sexual offenses. Data derived from qualitative semi-structured face-to-face interviews with four main groups of criminal justice system personnel in Kuwait (prosecutors, police investigators, police officers, and investigators) reveal the characteristics of a complaint of sexual violence that contribute to cases being either sent to court or dismissed. This proposed paper will suggest that Arab cultural views of women appear to influence and even shape the views, perceptions, and conduct of the interviewed Kuwaiti criminal justice system personnel regarding complaints of sexual violence made by citizens. Data from the interviews show how the image of the ‘modest woman’ that exists within Arabic cultural views and norms greatly contributes to shaping the characteristics of what the majority of the interviewed officials considered to be a ‘credible’ allegation of sexual violence. In addition, it is clear that the interviewees’ definitions of ‘modesty’ varied. Yet the problem is not only about the stereotypical perceptions of complainants or the consequences of those perceptions on the decision to send the case to court. These perceptions also affected the behaviours of criminal justice system personnel towards citizen complainants. When complainants’ allegations were questioned, investigators went as far as abusing the women verbally or physically, often in order to force them to withdraw the so-called ‘false’ complaint in order to protect the ‘real’ victim: the ‘innocent defendant’. The proposed presentation will discuss these police approaches to women and the techniques used in assessing the credibility of their accusations, including how they differ depending on whether the complainant was under or over 21 years old.

Keywords: criminal justice system, law and Arab culture, modest woman, sexual violence

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Authors: Eleni Stefanidou, Nikolaos Katsenios, Ioanna Karamichali, Aspasia Efthimiadou, Panagiotis Madesis

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The excessive use of pesticides and fertilizers has significant environmental and human health-related negative effects. In the frame of the development of sustainable agriculture practices, especially in the context of extreme environmental changes (climate change), it is important to develop alternative practices to increase productivity and biotic and abiotic stress tolerance. Beneficial bacteria, such as symbiotic bacteria in legumes (rhizobia) and symbiotic or free-living Plant Growth Promoting Rhizobacteria (PGPR), which could act as "plant probiotics", can promote plant growth and significantly increase the resistance of crops under adverse environmental conditions. In this study, we explored the symbiotic relationships between Faba bean (Vicia faba L.) cultivars with different PGPR bacteria, aiming to identify the possible influence on yield and biotic-abiotic phytoprotection benefits. Transcriptomic analysis of root and whole plant samples was executed for two Vicia faba L. cultivars (Polikarpi and Solon) treated with selected PGPR bacteria (6 treatments: B. subtilis + Rhizobium-mixture, A. chroococcum + Rhizobium-mixture, B. subtilis, A. chroococcum and Rhizobium-mixture). Preliminary results indicate a significant yield (Seed weight and Total number of pods) increase in both varieties, ranging around 25%, in comparison to the control, especially for the Solon cultivar. The increase was observed for all treatments, with the B. subtilis + Rhizobium-mixture treatment being the highest performing. The correlation of the physiological and morphological data with the transcriptome analysis revealed molecular mechanisms and molecular targets underlying the observed yield increase, opening perspectives for the use of nitrogen-fixing bacteria as a natural, more ecological enhancer of legume crop productivity.

Keywords: plant probiotics, PGPR, legumes, sustainable agriculture

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Authors: Waqas Ashraf, Yasir Nawab, Haritham Khan, Habib Awais, Shahbaz Ahmad

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Seersucker is a popular lightweight fabric widely used in men’s and women’s suiting, casual wear, children’s clothing, house robes, bed spreads and for spring and summer wear. The puckered effect generates air spaces between body and the fabric, keeping the wearer cool in hot conditions. The aim of this work was to develop knitted seersucker fabric on single cylinder weft knitting machine using plain jersey structure. Core spun cotton yarn and cotton spun yarn of same linear density were used. Core spun cotton yarn, contains cotton fiber in the sheath and elastase filament in the core. The both yarn were fed at regular interval to feeders on the machine. The loop length and yarn tension were kept constant at each feeder. The samples were then scoured and bleached. After wet processing, the fabric samples were washed and tumble dried. Parameters like loop length, stitch density and areal density were measured after conditioning these samples for 24 hours in Standard atmospheric condition. Produced sample has a regular puckering stripe along the width of the fabric with same height. The stitch density of both the flat and puckered area of relaxed fabric was found to be different .Air permeability and moisture management tests were performed. The results indicated that the knitted seersucker fabric has better wicking and moisture management properties as the flat area contact, whereas puckered area held away from the skin. Seersucker effect in knitted fabric was achieved by the difference of contraction of both sets of courses produced from different types of yarns. The seer sucker fabric produce by knitting technique is less expensive as compared to woven seer sucker fabric as there is no need of yarn preparation. The knitted seersucker fabric is more practicable for summer dresses, skirts, blouses, shirts, trousers and shorts.

Keywords: air permeability, knitted structure, moisture management, seersucker

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Authors: Chulpan Gromova, Rezeda Khairutdinova, Dina Birman

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One of the most significant issues that schools all over the world face today is the ways teachers respond to increasing diversity. The study was informed by the tripartite model of multicultural competence, with awareness of personal biases a necessary component, together with knowledge of different cultures, and skills to work with students from diverse backgrounds. The paper presents the results of qualitative descriptive studies that help to understand how school teachers in Russia treat migrant children, how they solve the problems of adaptation of migrant children. The purpose of this study was to determine: a) educational practices used by primary school teachers when working with migrant children; b) relationship between practices and attitudes of teachers. Empirical data were collected through interviews. The participants were informed that a conversation was being recorded. They were also warned that the study was voluntary, absolutely anonymous, no personal data was disclosed. Consent was received from 20 teachers. The findings were analyzed using directive content analysis (Graneheim and Lundman, 2004). The analysis was deductive according to the categories of practices and attitudes identified in the literature review and enriched inductively to identify variation within these categories. Studying practices is an essential part of preparing future teachers for working in a multicultural classroom. For language and academic support, teachers mostly use individual work. In order to create a friendly classroom climate and environment teachers have productive conversations with students, organize multicultural events for the whole school or just for an individual class. The majority of teachers have positive attitudes toward migrant children. In most cases, positive attitudes lead to high expectations for their academic achievements. Conceptual orientation of teacher attitudes toward cultural diversity is mostly pluralistic. Positive attitudes, high academic expectations and conceptual orientation toward pluralism are favorably reflected in teachers’ practice.

Keywords: intercultural education, migrant children schooling, teachers attitudes, teaching practices

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Authors: Mohana Basu, Snehamanju Basu

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Urbanization has an immense impact on the holistic development of a region. In that same context, the level of women empowerment plays a significant role in the development of any region, particularly a region belonging to a developing country. The present study investigates the status of women empowerment in the Asansol Durgapur Planning Area of the state of West Bengal, India by investigating the status of women and their access to various facilities and awareness about the various governmental and non-governmental schemes meant for their elevation. Through this study, an attempt has been to made to understand the perception of the respondents on the context of women's empowerment. The study integrates multiple sources of qualitative and quantitative data collected from various reports, field-based measurements, questionnaire survey and community based participatory appraisals. Results reveal that women of the rural parts of the region are relatively disempowered due to the various restrictions imposed on them and enjoy lower socioeconomic clout than their male counterparts in spite of the several remedial efforts taken by the government and NGOs to elevate their position in the society. A considerable gender gap still exists regarding access to education, employment and decision-making power in the family and significant differences in attitude towards women are observable in the rural and urban areas. Freedom of women primarily vary according to their age group, educational level, employment and income status and also on the degree of urbanization. Asansol Durgapur Planning Area is primarily an industrial region where huge employment generation scope exists. But these disparities are quite alarming and indicate that economic development does not always usher in socially justifiable rights and access to resources for both men and women alike in its awake. In this backdrop, this study will attempt to forward relevant suggestions which can be followed for betterment of the status of women.

Keywords: development, disempowered, economic development, urbanization, women empowerment

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Authors: H. Zouar, I. Kassous, F. Benzert

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The relentless pace of technology development in the last two decades has pervaded much of the recent educational discourse on a nation-wide scale. The rippling echoes of the buzz that account for the myriad of advantages the new technologies bring to the pedagogical activity has inevitably transcended from the western world to the Algerian educational contexts. Attempts have been made by Algerian practitioners to heed this digital advancement and push their instructional practices forward. However, due to the still largely existing first-order barriers as exemplified in the forms of deficient institutional infrastructure and unavailability of sufficient digital materials, the results of those attempts have polarised the views of Algerian academics regarding technology integration within higher education context. Hence, this study aims at measuring the possibility of integrating technology in our classrooms in a way that conforms to the philosophy of hybrid education. It also attempts to re-consider teachers’ understanding of technology integration in our context. Furthermore, the purpose of this research is also to reveal the level of teachers’ awareness regarding the distinction between technology integration and instrumental use. In view of the nature of these aims, a mixed-methods mode of investigation has been adopted to collect both qualitative and quantitative data from different perspectives. The data collection tools comprise of an observation as well as students’ and teachers’ questionnaires. The findings show that despite the fact that the examined context is not without its technological limitations, technology integration can be successfully incorporated contingent on teachers' level of knowledge and agency. Technology integration in Algerian universities does not proceed as the bedrock theory of it entails due to issues within teachers' general understanding of utilizing technology in class. It seems that technology is a means to an end, depending on the teachers who make use of it in order to deliver lessons (PowerPoint presentation) and issue commands (Facebook posting). Teachers' ability to clearly discern between integrating technology in their practices versus employing it as an instrument of instruction needs further consideration in order to establish a solid understanding of technology integration within higher education context.

Keywords: technology integration, hybrid education, teachers' understanding, teachers' awareness, instrumental use

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Authors: Ruchi Garg

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Background: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, named after the first President of India, was established on the 10th of March, 1967 as a National Center for ophthalmic science to provide state-of-the-art patient care, expand human resources for medical education and undertake research to find solutions to eye health problems of national importance. The average number of cataract surgeries performed per month is 700 to 1000. Methods: Anticipating implementation in 50% cases hundred cases of cataract surgery were observed to study the existing system of surgical safety followed at Dr. R.P. Center and gap analysis done against the WHO surgical safety checklist for cataract surgery. A modified WHO surgical safety checklist for cataract surgery was developed and implemented in the center. Barriers in the implementation of the surgical safety checklist were also identified, and remedial measures were suggested. Results: Significant improvement was noticed in all the parameters after the introduction of the modified checklist. The additional points which were added in the modified surgical safety checklist were implemented in almost all the cases by the nursing staff. The overall mean compliance percentage before the implementation of the modified surgical safety checklist at Dr. R.P.C was 37%±10.1 (P=0.001). While after the introduction of the modified surgical safety checklist, the mean compliance has improved to 62.7%±10.3; the Wilcoxon rank sum test/Independent test is applied for each domain. Conclusions: The cataract procedure is the most common surgical procedure performed in the population in India. High volume and high turnover increase the potential for errors. Compliance with the surgical safety checklist before intervention was 32%. After intervention in the form of a focus group discussion and introduction of a modified surgical safety checklist has resulted in an increase in the compliance rate to 67%, this study revealed that changes or additional work are not happily accepted by the staff. After six months of intervention with the modified surgical safety checklist compliance rate was still high, this suggests that constant supervision and monitoring by senior staff can sustain the compliance rate.

Keywords: patient safety, hospital safety, quality, WHO surgical safety checklist

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Authors: Dmitry Aron

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Major radiation accidents carry not only the potential risks of negative consequences for public health due to exposure but also because of large-scale emergency measures were taken by authorities to protect the population, which can lead to unreasonable social and economic damage. It is technically difficult, as a rule, to assess the possible costs and damages from decisions on evacuation or resettlement of residents in the shortest possible time, since it requires specially prepared information systems containing relevant information on demographic, economic parameters and incoming data on radiation conditions. Foreign observers also face the difficulties in assessing the consequences of an accident in a foreign territory, since they usually do not have official and detailed statistical data on the territory of foreign state beforehand. Also, they can suppose the application of unofficial data from open Internet sources is an unreliable and overly labor-consuming procedure. This paper describes an approach to prompt creation of relational database that contains detailed actual data on economics, demographics and radiation situation at the Fukushima Prefecture during the Fukushima Daiichi NPP accident, received by the author from open Internet sources. This database was developed and used to assess the number of evacuated population, radiation doses, expected financial losses and other parameters of the affected areas. The costs for the areas with temporarily evacuated and long-term resettled population were investigated, and the radiological and economic effectiveness of the measures taken to protect the population was estimated. Some of the results are presented in the article. The study showed that such a tool for analyzing the consequences of radiation accidents can be prepared in a short space of time for the entire territory of Japan, and it can serve for the modeling of social and economic consequences for hypothetical accidents for any nuclear power plant in its territory.

Keywords: Fukushima, radiation accident, emergency measures, database

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Authors: Subodh Kumar, Sanjeev Kumar Sharma, Gaurav Kaushik, Pramod Avti, Phulen Sarma, Bikash Medhi, Krishan Lal Khanduja

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Background: It is well known that cigarette smoke is one of the causative factors in various lung diseases especially cancer. Carcinogens and oxidant molecules present in cigarette smoke not only damage the cellular constituents (lipids, proteins, DNA) but may also regulate the molecular pathways involved in inflammation and cancer. Continuous oxidative stress caused by the constituents of cigarette smoke leads to higher PhospholipaseA₂ (PLA₂) activity, resulting in elevated levels of secondary metabolites whose role is well defined in cancer. To reduce the burden of chronic inflammation as well as oxidative stress, and higher levels of secondary metabolites, we checked the curative potential of PLA₂ inhibitor Bromoenol Lactone (BEL) during continuous exposure of cigarette smoke condensate (CSC). Aim: To check the therapeutic potential of Bromoenol Lactone (BEL), an inhibitor of PhospholipaseA₂s, in pathways of CSC-induced changes in type I and type II alveolar epithelial cells. Methods: Effect of BEL on CSC-induced PLA2 activity were checked using colorimetric assay, cellular toxicity using cell viability assay, membrane integrity using fluorescein di-acetate (FDA) uptake assay, reactive oxygen species (ROS) levels and apoptosis markers through flow cytometry, and cellular regulation using MAPKinases levels, in lung epithelium. Results: BEL significantly mimicked CSC-induced PLA₂ activity, ROS levels, apoptosis, and kinases level whereas improved cellular viability and membrane integrity. Conclusions: Current observations revealed that BEL may be a potential therapeutic agent during Cigarette smoke-induced anomalies in lung epithelium.

Keywords: cigarette smoke condensate, phospholipase A₂, oxidative stress, alveolar epithelium, bromoenol lactone

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Authors: Natarajan Tirupattur Srinivasan

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Quantum mechanics( QM) and (special) relativity (SR) have indeed revolutionized the very thinking of physicists, and the spectacular successes achieved over a century due to these two theories are mind-boggling. However, there is still a strong disquiet among some physicists. While the mathematical structure of these two theories has been established beyond any doubt, their physical interpretations are still being contested by many. Even after a hundred years of their existence, we cannot answer a very simple question, “What is an electron”? Physicists are struggling even now to come to grips with the different interpretations of quantum mechanics with all their ramifications. However, it is indeed strange that the (special) relativity theory of Einstein enjoys many orders of magnitude of “acceptance”, though both theories have their own stocks of weirdness in the results, like time dilation, mass increase with velocity, the collapse of the wave function, quantum jump, tunnelling, etc. Here, in this paper, it would be shown that by postulating an intrinsic internal motion to these enigmatic electrons, one can build a fairly consistent picture of reality, revealing a very simple picture of nature. This is also evidenced by Schrodinger’s ‘Zitterbewegung’ motion, about which so much has been written. This leads to a helical trajectory of electrons when they move in a laboratory frame. It will be shown that the helix is a three-dimensional wave having all the characteristics of our familiar 2D wave. Again, the helix, being a geodesic on an imaginary cylinder, supports ‘quantization’, and its representation is just the complex exponentials matching with the wave function of quantum mechanics. By postulating the instantaneous velocity of the electrons to be always ‘c’, the velocity of light, the entire relativity comes alive, and we can interpret the ‘time dilation’, ‘mass increase with velocity’, etc., in a very simple way. Thus, this model unifies both QM and SR without the need for a counterintuitive postulate of Einstein about the constancy of the velocity of light for all inertial observers. After all, if the motion of an inertial frame cannot affect the velocity of light, the converse that this constant also cannot affect the events in the frame must be true. But entire relativity is about how ‘c’ affects time, length, mass, etc., in different frames.

Keywords: quantum reconstruction, special theory of relativity, quantum mechanics, zitterbewegung, complex wave function, helix, geodesic, Schrodinger’s wave equations

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Authors: Aliya Sekenova, Vyacheslav Ogay

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The derivation of human induced pluripotent stem cells (iPSCs) from somatic cells by direct reprogramming opens wide perspectives in the regenerative medicine. It means the possibility to develop the personal and, consequently, any immunologically compatible cells for applications in cell-based therapy. The purpose of our study was to develop the technology for the production of NK cells from T cell-derived induced pluripotent stem cells (TiPSCs) for subsequent application in adoptive cancer immunotherapy. Methods: In this study iPSCs were derived from peripheral blood T cells using Sendai virus vectors expressing Oct4, Sox2, Klf4 and c-Myc. Pluripotent characteristics of TiPSCs were examined and confirmed with alkaline phosphatase staining, immunocytochemistry and RT-PCR analysis. For NK cell differentiation, embryoid bodies (EB) formed from (TiPSCs) were cultured in xenogeneic serum-free medium containing human serum, IL-3, IL-7, IL-15, SCF, FLT3L without using M210-B4 and AFT-024 stromal feeder cells. After differentiation, NK cells were characterized with immunofluorescence analysis, flow cytometry and cytotoxicity assay. Results: Here, we for the first time demonstrate that TiPSCs can effectively differentiate into functionally active NK cells without M210-B4 and AFT-024 xenogeneic stroma cells. Immunofluorescence and flow cytometry analysis showed that EB-derived cells can differentiate into a homogeneous population of NK cell expressing high levels of CD56, CD45 and CD16 specific markers. Moreover, these cells significantly express killing activation receptors such as NKp44 and NKp46. In the comparative analysis, we observed that NK cells derived using feeder-free culture system have more high killing activity against K-562 tumor cells, than NK cells derived by feeder-dependent method. Thus, we think that our obtained data will be useful for the development of large-scale production of NK cells for translation into cancer immunotherapy.

Keywords: induced pluripotent stem cells, NK cells, T cells, cell diffentiation, feeder cell-free culture system

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Authors: Yusuf E. Mustapha, Inioluwa A Akindoyeni, Oluwatoyin G. Ezekiel, Ifeoluwa O. Awogbindin, Ebenezer O. Farombi

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Background: Parkinson's disease (PD) is the most prevalent motor disorder. Available therapies are palliative with no effect on disease progression. Kolaviron (KV), a natural anti-inflammatory and antioxidant agent, has been reported to possess neuroprotective effects in Parkinsonian flies and rats. Objective: The present study investigates the neuroprotective effect of KV, focusing on the DJ1/Nrf2 signaling pathway. Methodology: All-trans retinoic acid (ATRA, 10 mg/kg, i.p.) was used to inhibit Nrf2. Murine model of PD was established with four doses of MPTP (20 mg/kg i.p.) at 2 hours interval. MPTP mice were pre-treated with either KV (200 mg/kg/day p.o), ATRA, or both conditions for seven days before PD induction. Motor behaviour was evaluated, and markers of oxidative stress/damage and its regulators were assessed with immunofluorescence and ELISA techniques. Results: MPTP-treated mice covered less distance with reduced numbers of anticlockwise rotations, heightened freezing, and prolonged immobility when compared to control. However, KV significantly attenuated these deficits. Pretreatment of MPTP mice with KV upregulated Nrf2 expression beyond MPTP level with a remarkable reduction in Keap1 expression and marked elevation of DJ-1 level, whereas co-administration with ATRA abrogated these effects. KV treatment restored MPTP-mediated depletion of endogenous antioxidant, striatal oxidative stress, oxidative damage, and inhibition of acetylcholinesterase activity. However, ATRA treatment potentiated acetylcholinesterase inhibition and attenuated the protective effect of KV on the level of nitric oxide and activities of catalase and superoxide dismutase. Conclusion: Kolaviron protects Parkinsonian mice by stabilizing and activating the Nrf2 signaling pathway. Thus, kolaviron can be explored as a pharmacological lead in PD management.

Keywords: Garcinia kola, Kolaviron, Parkinson Disease, Nrf2, behavioral incompetence, neurodegeneration

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Authors: Neuma Chaveiro, Juliana Guimarães Faria

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Introduction: The thematic that guides this study is teacher training for the teaching of sign language in a perspective of bilingual education – specifically aimed at Brazilian public schools that offer inclusive education, and that have, among its students, deaf children who use Brazilian Sign Language as a means of communication and expression. In the Teacher Training Course for Letters/Libras at the Universidade Federal de Goiás/UFG, we developed a bilingual education project for the deaf, linked to PIBID (Institutional Scholarship for Teaching Initiation Program), funded by the Brazilian Federal Government through CAPES (Coordination for the Improvement of Higher Education Personnel). Goals: to provide the education of higher education teachers to work in public schools in basic education and to insert students from the UFG’s Letters/Libras course in the school’s daily life, giving them the opportunity for the creation and participation in methodological experiences and of teaching practices in order to overcome the problems identified in the teaching-learning process of deaf students, in a bilingual perspective, associating Libras (Brazilian Sign Language) and Portuguese. Methodology: qualitative approach and research-action, prioritizing action – reflection – action of the people involved. The Letters-Libras PIBID of the College of Letters/UFG, in this qualitative context, is guided by the assumptions of investigation-action to contribute to the education of the Libras teacher. Results: production of studies and researches in the area of education, professionalization and teaching practice for the degree holder in Letters: Libras; b) studies, research and training in bilingual education; c) clarification and discussion of the myths that permeate the reality of users of sign languages; d) involving students in the development of didactic materials for bilingual education. Conclusion: the PIBID Project Letters/Libras allows, both to the basic education school and to the teachers in training for the teaching of Libras, an integrated and collective work partnership, with discussions and changes in relation to bilingual education for the deaf and the teaching of Libras.

Keywords: deaf, sign language, teacher training, educacion

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Authors: Hela Ghali, Oumayma Ben Amor, Salwa Khefacha, Mohamed Ben Rejeb, Sirine Frigui, Meriam Tourki Dhidah, Lamine Dhidah, Houyem Said Laatiri

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Background: Blood exposure accidents are the most common problem in hospitals that threaten healthcare professionals with a high risk of infectious complications which weighs heavily on health systems worldwide. Paramedics are the highest risk group due to the nature of their daily activities. We aimed to determine knowledge and attitudes about the management of blood-exposure accidents among nurses and technicians in two pediatric departments. Materials/Methods: This is a cross-sectional descriptive study conducted on March 2017, carried out with the care staff of the pediatric ward of the Farhat Hached Teaching Hospital of Sousse and pediatric surgery of the Fattouma Bourguiba University Hospital in Monastir, using a pre- tested and self-administered questionnaire. Data entry and analysis were performed using Excel software. Results: The response rate was 85.1%. A female predominance (82.5%) was reported among respondents with a sex ratio of 0.21. 80% of the participants were under 35 years old. Seniority of less than 10 years was found in 77.5% of respondents. Only 22.5% knew the definition of a blood- exposure accident. 100% and 95% of participants reported the relative risk, respectively, to hepatitis and AIDS viruses. However, only 15% recognized the severity factors of a blood-exposure accident. Hygiene compliance was the most important dimension for almost the entire population for the prevention. On the other hand, only 12.5% knew the meaning of 'standard precautions' and ¼ considered them necessary for at-risk patients only. 40% reported being exposed at least once, among them, 87.5% used betadine, and 77.5% said that anti-infectious chemoprophylaxis is necessary regardless of the patient's serological status. However, 52.5% did not know the official reporting circuit of management of blood-exposure accident in their institutions. Conclusion: For better management of risks in hospitals and an improvement of the safety of the care, a reinforcement of the sensibilization of the caregivers with regard to the risks of blood exposure accident is necessary, while developing their knowledge to act in security.

Keywords: attitudes, blood-exposure accident, knowledge, pediatric department

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Authors: Jéssica Ferreira Rodrigues, Júlio Silvio De Sousa Bueno Filho, Vanessa Rios De Souza, Ana Carla Marques Pinheiro

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This study aimed to evaluate the implications of the block size and testing order on efficiency and precision of preference estimation for Dulce de leche samples. Efficiency was defined as the inverse of the average variance of pairwise comparisons among treatments. Precision was defined as the inverse of the variance of treatment means (or effects) estimates. The experiment was originally designed to test 16 treatments as a series of 8 Sudoku 16x16 designs being 4 randomized independently and 4 others in the reverse order, to yield balance in testing order. Linear mixed models were assigned to the whole experiment with 112 testers and all their grades, as well as their partially balanced subgroups, namely: a) experiment with the four initial EU; b) experiment with EU 5 to 8; c) experiment with EU 9 to 12; and b) experiment with EU 13 to 16. To record responses we used a nine-point hedonic scale, it was assumed a mixed linear model analysis with random tester and treatments effects and with fixed test order effect. Analysis of a cumulative random effects probit link model was very similar, with essentially no different conclusions and for simplicity, we present the results using Gaussian assumption. R-CRAN library lme4 and its function lmer (Fit Linear Mixed-Effects Models) was used for the mixed models and libraries Bayesthresh (default Gaussian threshold function) and ordinal with the function clmm (Cumulative Link Mixed Model) was used to check Bayesian analysis of threshold models and cumulative link probit models. It was noted that the number of samples tested in the same session can influence the acceptance level, underestimating the acceptance. However, proving a large number of samples can help to improve the samples discrimination.

Keywords: acceptance, block size, mixed linear model, testing order, testing order

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Authors: Vedat Uyak

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Seasonal variations of trihalomethanes (THMs) and haloacetic acids (HAAs) concentrations were investigated within three distribution systems of a coastal city of Istanbul, Turkey. Moreover, total trihalomethanes and other organics concentration were also analyzed. The investigation was based on an intensive 16 month (2009-2010) sampling program, undertaken during the spring, summer, fall and winter seasons. Four THM (chloroform, dichlorobromomethane, chlorodibromomethane, bromoform), and nine HAA (the most commonly occurring one being dichloroacetic acid (DCAA) and trichloroacetic acid (TCAA); other compounds are monochloroacetic acid (MCAA), monobromoacetic acid (MBAA), dibromoacetic acid (DBAA), tribromoacetic acid (TBAA), bromochloroacetic acid (BCAA), bromodichloroacetic acid (BDCAA) and chlorodibromoacetic acid (CDBAA)) species and other water quality and operational parameters were monitored at points along the distribution system between the treatment plant and the system’s extremity. The effects of coastal water sources, seasonal variation and spatial variation were examined. The results showed that THMs and HAAs concentrations vary significantly between treated waters and water at the distribution networks. When water temperature exceeds 26°C in summer, the THMs and HAAs levels are 0.8 – 1.1, and 0.4 – 0.9 times higher than treated water, respectively. While when water temperature is below 12°C in the winter, the measured THMs and HAAs concentrations at the system’s extremity were very rarely higher than 100 μg/L, and 60 μg/L, respectively. The highest THM concentrations occurred in the Buyukcekmece distribution system, with an average total HAA concentration of 92 μg/L. Moreover, the lowest THM levels were observed in the Omerli distribution network, with a mean concentration of 7 μg/L. For HAA levels, the maximum concentrations again were observed in the Buyukcekmece distribution system, with an average total HAA concentration of 57 μg/l. High spatial and seasonal variation of disinfection by-products in the drinking water of Istanbul was attributed of illegal wastewater discharges to water supplies of Istanbul city.

Keywords: disinfection byproducts, drinking water, trihalomethanes, haloacetic acids, seasonal variation

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Authors: Davod Ahmadi, Narges Ebadi, Ethan Wang, Hugo Melgar-Quiñonez

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Compared to the other Least Developed Countries (LDCs), major countries in sub-Saharan Africa (SSA) have limited access to the clean water. People in this region, and more specifically females, suffer from acute water scarcity problems. They are compelled to spend too much of their time bringing water for domestic use like drinking and washing. Apart from domestic use, water through affecting agriculture and livestock contributes to the food security status of people in vulnerable regions like SSA. Livestock needs water to grow, and agriculture requires enormous quantities of water for irrigation. The main objective of this study is to explore the association between access to water and individuals’ food security status. Data from 2017 Gallup World Poll (GWP) for SSA were analyzed (n=35,000). The target population in GWP is the entire civilian, non-institutionalized, aged 15 and older population. All samples selection is probability based and nationally representative. The Gallup surveys an average of 1,000 samples of individuals per country. Three questions related to water (i.e., water quality, availability of water for crops and availability of water for livestock) were used as the exposure variables. Food Insecurity Experience Scale (FIES) was used as the outcome variable. FIES measures individuals’ food security status, and it is composed of eight questions with simple dichotomous responses (1=Yes and 0=No). Different statistical analyses such as descriptive, crosstabs and binary logistic regression, form the basis of this study. Results from descriptive analyses showed that more than 50% of the respondents had no access to enough water for crops and livestock. More than 85% of respondents were categorized as “food insecure”. Findings from cross-tabulation analyses showed that food security status was significantly associated with water quality (0.135; P=0.000), water for crops (0.106; P=0.000) and water for livestock (0.112; P=0.000). In regression analyses, the probability of being food insecure increased among people who expressed no satisfaction with water quality (OR=1.884 (OR=1.768-2.008)), not enough water for crops (OR=1.721 (1.616-1.834)) and not enough water for livestock (OR=1.706 (1.819)). In conclusion, it should note that water access affects food security status in SSA.

Keywords: water access, agriculture, livestock, FIES

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Authors: Kana Matsuyanagi

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Anorexia Nervosa (AN) is a psychiatric disorder characterized by a relentless pursuit of thinness and strict restriction of food. The current therapeutic approaches for AN predominantly revolve around outpatient psychotherapies, which create significant financial barriers for the majority of affected patients, hindering their access to treatment. Nonetheless, AN exhibit one of the highest mortality and relapse rates among psychological disorders, underscoring the urgent need to provide patients with an affordable self-treatment tool, enabling those unable to access conventional medical intervention to address their condition autonomously. To this end, a neurofeedback software, termed RelaxNeuron, was developed with the objective of providing an economical and portable means to aid individuals in self-managing AN. Electroencephalography (EEG) was chosen as the preferred modality for RelaxNeuron, as it aligns with the study's goal of supplying a cost-effective and convenient solution for addressing AN. The primary aim of the software is to ameliorate the negative emotional responses towards food stimuli and the accompanying aberrant eye-tracking patterns observed in AN patient, ultimately alleviating the profound fear towards food an elemental symptom and, conceivably, the fundamental etiology of AN. The core functionality of RelaxNeuron hinges on the acquisition and analysis of EEG signals, alongside an electrocardiogram (ECG) signal, to infer the user's emotional state while viewing dynamic food-related imagery on the screen. Moreover, the software quantifies the user's performance in accurately tracking the moving food image. Subsequently, these two parameters undergo further processing in the subsequent algorithm, informing the delivery of either negative or positive feedback to the user. Preliminary test results have exhibited promising outcomes, suggesting the potential advantages of employing RelaxNeuron in the treatment of AN, as evidenced by its capacity to enhance emotional regulation and attentional processing through repetitive and persistent therapeutic interventions.

Keywords: Anorexia Nervosa, fear conditioning, neurofeedback, BCI

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Authors: Isaac Diaka, Matsui Kenichi

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Ghana’s rice production has increased mainly because of increased cultivated areas. On this point, scholars who promoted crop production increase for food security have overlooked the fact that its per-acre yield has not increased. Also, Ghana’s domestic rice production has not contributed much to domestic rice consumption especially in major cities where consumers tend to rely on imported rice from Asia. Considering these points, the paper seeks to understand why smallholder rice farmers have not been able to increase per acre rice yield. It also examines smallholder rice farmers’ rice yield improvement needs, and the relationship that exist between rice farmers’ socioeconomic factors and their yield levels by rice varieties. The study adopted a simple random sampling technique to select 154 rice farmers for a questionnaire survey between October and November 2020. The data was analyzed by performing a correlation analysis, an independent t-test, and Kendall’s coefficient of concordance. The results showed that 58.4% of the respondents cultivated popular high-yield varieties like AGRA and Jasmine. The rest used local varieties. Regarding respondents’ yield differentials, AGRA and Jasmine had an average yield of 2.6 mt/ha, which is higher than that of local varieties (1.6mt/ha). The study found untimely availability of improved seed varieties and high cost of inputs some of the major reasons affecting yield in the area. For respondents’ yield improvement needs, Kendall’s coefficient of concordance showed that access to improved varieties, irrigation infrastructure, and row planting were respondents’ major technological needs. As to their non-technological needs, the respondents needed timely information about rice production, access to credit support options, and extension services. The correlation analysis revealed that farm size and off-farm income exhibited a positive and negative association towards respondents’ yield level, respectively. This paper then discusses recommendations for providing with improved rice production technologies to farmers.

Keywords: Ghana, rice, smallholder farmers, yield improvement.

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Authors: Etukudo, M. Mbosowo, Nyananyo, L. Bio, Negbenebor, A. Charles

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An aqueous extract of palm bunch ash from Elaeis guineensis Jacq., equilibrated with water was used to assess the growth and minerals composition of Amaranthus hybridus L. in agricultural soil of Abak, Akwa Ibom State, nigeria. Various concentrations, 0 (control), 10, 20, 30, 40, and 50% of palm bunch extract per 4kg of sandy-loam soil were used for the study. Chemical characteristics of the extract, Growth parameters (Plant height, root length, fresh weight, dry weight and moisture content), leaf minerals composition (Nitrogen, phosphorus, potassium, calcium and magnesium) of the crop and soil chemical composition before and after harvest (pH, organic matter, nitrogen, phosphorus, potassium, calcium and magnesium) were examined. The results showed that palm bunch ash extract significantly (P < 0.05) increased the soil pH at all levels of treatments compared to the control. Similarly, the soil and leaf minerals component (N, P, K. Ca, and Mg) of the crop increased with increase in the concentration of palm bunch extract, except at 40 and 50% for leaf minerals composition, Soil organic matter, nitrogen and phosphorus J(before and after harvest). In addition, The plant height, Root length, fresh weight, dry weight and moisture content of the crop increased significantly (P < 0.05) with increase in the concentration of the extract, Except at 30, 40 and 50% where these growth parameters decreased in relation to the control treatment. Therefore, this study suggests that palm bunch ash extract could be utilized at lower concentration as a nutrient supplement for both Amaranthus hubridus L. and soil medium, most especially in the tropical soils of the Niger Delta region of Nigeria.

Keywords: Amaranthus hybridus L., growth, leaf minerals composition, palm bunch ash extract

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Authors: Mengjia Zhi, Xingmei Wei, Xiang Gao, Shiyang Liu, Zhiran Huang, Li Yang, Jing Sun

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Background: To understand the consumption trend of opioid analgesics and the consumption adequacy of opioid analgesic treatment for moderate to severe pain in China, as well as the pain control level of China with international perspective. Importance: To author’s best knowledge, this is the first study in China to measure the adequacy of opioid analgesic treatment for moderate to severe pain considering disease pattern and with the standardized pain treatment guideline. Methods: A retrospective analysis was carried out to show the consumption frequency (daily defined doses, DDDs) of opioid analgesics and its trend in China from 2006 to 2016. Adequacy of consumption measure (ACM) was used to measure the number of needed morphine equivalents and the overall adequacy of opioid analgesic treatment of moderate to severe pain in China, and compared with international data. Results: The consumption frequency of opioid analgesics (DDDs) in China increased from 13,200,000 DDDs in 2006 to 44,200,000 DDDs in 2016, and showed an increasing trend. The growth rate was faster at first, especially in 2013, then slowed down, decreased slightly in 2015. The ACM of China increased from 0.0032 in 2006 to 0.0074 in 2016, with an overall trend of growth. The ACM level of China has been always a very poor level during 2006-2016. Conclusion: The consumption of opioid analgesics for the treatment of moderate to severe pain in China has always been inadequate. There is a huge gap between China and the international level. There are many reasons behind this problem, which lie in different aspects, including medical staff, patients and the public, health systems and social & cultural aspects. It is necessary to strengthen the training and education of medical staff and the patients, to use mass media to disseminate scientific knowledge of pain management, to encourage communications between doctors and patients, to improve regulatory system for the controlled medicines and the overall health systems, and to balance the regulatory goal for avoidance of abuse, and the social goal of meeting the increasing needs of the people for better life.

Keywords: opioid analgesics, adequate consumption measure, pain control, China

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Authors: Floyd Misheck Mwanza, Paul Boniface Majura

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The paper looked at highways/ roadside waste generation, disposal and the consequent environmental impacts. The dramatic increase in vehicular and paved roads in the recent past in Zambia, has given rise to the indiscriminate disposal of litter that now poses a threat to health and the environment. Primary data was generated by carrying out oral interviews and field observations for holistic and in–depth assessment of the environment and the secondary data was obtained from desk review method, information on effects of roadside wastes on environment were obtained from relevant literatures. The interviews were semi structured and a purposive sampling method was adopted and analyzed descriptively. The results of the findings showed that population growth and unplanned road expansion has exceeded the expected limit in recent time with resultant poor system of roadside wastes disposal. Roadside wastes which contain both biodegradable and non-biodegradable roadside wastes are disposed at the shoulders of major highways in temporary dumpsites and are never collected by a road development agency (RDA). There is no organized highway to highway or street to street collection of the wastes in Zambia by the key organization the RDA. The study revealed that roadside disposal of roadside wastes has serious impacts on the environment. Some of these impacts include physical nuisance of the wastes to the environment, the waste dumps also serve as hideouts for rodents and snakes which are dangerous. Waste are blown around by wind making the environment filthy, most of the wastes are also been washed by overland flow during heavy downpour to block drainage channels and subsequently lead to flooding of the environment. Most of the non- biodegradable wastes contain toxic chemicals which have serious implications on the environmental sustainability and human health. The paper therefore recommends that Government/ RDA should come up with proper orientation and environmental laws should be put in place for the general public and also to provide necessary facilities and arrange for better methods of collection of wastes.

Keywords: biodegradable, disposal, environment, impacts

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Authors: Corinne Kowalski, Lea de Jong, Rainer Sauerborn, Niamh Herlihy, Anneliese Depoux, Jale Tosun

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Climate change is considered one of the biggest threats to human health of the 21st century. The link between climate change and health has received relatively little attention in the media, in research and in policy-making. A long term and broad overview of how health is represented in the legislation on climate change is missing in the legislative literature. It is unknown if or how the argument for health is referred in legal clauses addressing climate change, in national and European legislation. Integrating scientific based evidence into policies regarding the impacts of climate change on health could be a key step to inciting the political and societal changes necessary to decelerate global warming. This may also drive the implementation of new strategies to mitigate the consequences on health systems. To provide an overview of this issue, we are analyzing the Global Climate Legislation Database provided by the Grantham Research Institute on Climate Change and the Environment. This institution was established in 2008 at the London School of Economics and Political Science. The database consists of (updated as of 1st January 2015) legislations on climate change in 99 countries around the world. This tool offers relevant information about the state of climate related policies. We will use the database to systematically analyze the 829 identified legislations to identify how health is represented as a relevant aspect of climate change legislation. We are conducting explorative research of national and supranational legislations and anticipate health to be addressed in various forms. The goal is to highlight how often, in what specific terms, which aspects of health or health risks of climate change are mentioned in various legislations. The position and recurrence of the mention of health is also of importance. Data will be extracted with complete quotation of the sentence which mentions health, which will allow for second qualitative stage to analyze which aspects of health are represented and in what context. This study is part of an interdisciplinary project called 4CHealth that confronts results of the research done on scientific, political and press literature to better understand how the knowledge on climate change and health circulates within those different fields and whether and how it is translated to real world change.

Keywords: climate change, explorative research, health, policies

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Authors: Endalew Jibat, Feyera Senbeta, Tesfaye Zeleke, Fitsum Hagos

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Water governance considers multi-sector participation beyond the state; and for sustainable use of water resources, appropriate laws, policies, regulations, and institutions needs to be developed and put in place. Water policy, a critical and integral instrument of water governance, guided water use schemes and ensures equitable water distribution among users. The Ethiopian Central Rift Valley (CRV) is wealthy of water resources, but these water resources are currently under severe strain owing to an imbalance in human-water interactions. The main aim of the study was to examine the state of water resources governance in the CRV of Ethiopia, and the impact of the Ethiopian Water Resources Management Policy on water governance. Key informant interviews (KII), focused group discussions, and document reviews were used to gather data for the study. The NVivo 11 program was used to organize, code, and analyze the data. The results revealed that water resources governance practices such as water allocation and apportionment, comprehensive and integrated water management plans, water resources protection, and conservation activities were rarely implemented. Water resources management policy mechanisms were not fully put in place. Lack of coherence in water policy implementation, absence of clear roles and responsibilities of stakeholders, absence of transparency and accountability in irrigation water service delivery, and lack of meaningful participation of key actors in water governance decision-making were the primary shortcomings observed. Factors such as over-abstraction, deterioration of buffer zone, and chemical erosion from surrounding farming have contributed to the reduction in water volume and quality in the CRV. These challenges have influenced aquatic ecosystem services and threaten the livelihoods of the surrounding communities. Hence, reforms relating to policy coherence and enforcement, stakeholder involvement, water distribution strategies, and the application of water governance principles must be given more emphasis.

Keywords: water resources, irrigation, governance, water allocation, governance principles, stakeholders engagement, central rift valley

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Authors: Mahmood Shamshiri

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While visual sensation is the key gate for human-being to understand the world, visual impairment is one of the common cause of disability around the world. There is no doubt about the importance of eye sight in daily life among people, even it is understood the best gift of God to human-beings in many societies. Blind people are admitted to hospital for different health issues. Nurses and other health professionals who provide care for this group of patients need to understand their patients. Understanding the lived experience of blind people helps nurses to expand their knowledge regarding blind patients in order to provide a holistic care and improve the quality of care for blind patients. This phenomenological inquiry aimed to describe the meaning of discipline in daily life of blind people admitted in hospital. An interpretive phenomenology underpinned the philosophical approach of the study. While the interpretive phenomenology played as an umbrella role in the overall point of the study, the six methodical activities which introduced by van Manen helped the researchers to conduct the study. ‘Disciplined care for disciplined patients’ was the main theme emerged from dialogues of blind patients about their daily life in the hospital. Almost all of participants called themselves as disciplined people. The theme ‘disciplined care for disciplined patients’ appeared from four sub-themes including discipline through careful touching and listening, discipline as the ideal way of existence, discipline the preferred way of being independent, desire to take disciplined and detailed care, reactions to the undisciplined caring culture. This phenomenological inquiry to the experiences of patients with blindness in hospital revealed that they commonly are disciplined people and want to be cared in well-organized caring environment. Furthermore, they need to be familiar with the new caring environment. Well-organized and familiar environment help blind patients to increase the level of independency. In addition, blind patients prefer a detail informed and disciplined caring culture. Health professionals have to consider the concept of disciplined care in order to provide a holistic and comprehensive competent care.

Keywords: disciplined people, disciplined care, lived experience, patient with blindness

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Authors: M. Miljkovic, A. Urakpo, M. Simic-Koumoutsaris

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Benefit-risk assessment (BRA) is a valuable tool that takes place in multiple stages during a medicine's lifecycle, and this assessment can be conducted in a variety of ways. The aim was to summarize current BRA methods used during approval decisions and in post-approval settings and to see possible future directions. Relevant reviews, recommendations, and guidelines published in medical literature and through regulatory agencies over the past five years have been examined. BRA implies the review of two dimensions: the dimension of benefits (determined mainly by the therapeutic efficacy) and the dimension of risks (comprises the safety profile of a drug). Regulators, industry, and academia have developed various approaches, ranging from descriptive textual (qualitative) to decision-analytic (quantitative) models, to facilitate the BRA of medicines during the product lifecycle (from Phase I trials, to authorization procedure, post-marketing surveillance and health technology assessment for inclusion in public formularies). These approaches can be classified into the following categories: stepwise structured approaches (frameworks); measures for benefits and risks that are usually endpoint specific (metrics), simulation techniques and meta-analysis (estimation techniques), and utility survey techniques to elicit stakeholders’ preferences (utilities). All these approaches share the following two common goals: to assist this analysis and to improve the communication of decisions, but each is subject to its own specific strengths and limitations. Before using any method, its utility, complexity, the extent to which it is established, and the ease of results interpretation should be considered. Despite widespread and long-time use, BRA is subject to debate, suffers from a number of limitations, and currently is still under development. The use of formal, systematic structured approaches to BRA for regulatory decision-making and quantitative methods to support BRA during the product lifecycle is a standard practice in medicine that is subject to continuous improvement and modernization, not only in methodology but also in cooperation between organizations.

Keywords: benefit-risk assessment, benefit-risk profile, product lifecycle, quantitative methods, structured approaches

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Authors: R. Fardid, R. Coppes

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Introduction: In mediastinal radiotherapy and to a lesser extend also in total-body irradiation (TBI) radiation exposure may lead to development of cardiac diseases. Radiation-induced heart disease is dose-dependent and it is characterized by a loss of cardiac function, associated with progressive heart cells degeneration. We aimed to determine the in-vivo radiation effects on fibronectin, ColaA1, ColaA2, galectin and TGFb1 gene expression levels in left ventricle heart tissues of rats after irradiation. Material and method: Four non-treatment adult Wistar rats as control group (group A) were selected. In group B, 4 adult Wistar rats irradiated to 20 Gy single dose of 150 Mev proton beam locally in heart only. In heart plus lung irradiate group (group C) 4 adult rats was irradiated by 50% of lung laterally plus heart radiation that mentioned in before group. At 8 weeks after radiation animals sacrificed and left ventricle heart dropped in liquid nitrogen for RNA extraction by Absolutely RNA® Miniprep Kit (Stratagen, Cat no. 400800). cDNA was synthesized using M-MLV reverse transcriptase (Life Technologies, Cat no. 28025-013). We used Bio-Rad machine (Bio Rad iQ5 Real Time PCR) for QPCR testing by relative standard curve method. Results: We found that gene expression of fibronectin in group C significantly increased compared to control group, but it was not showed significant change in group B compared to group A. The levels of gene expressions of Cola1 and Cola2 in mRNA did not show any significant changes between normal and radiation groups. Changes of expression of galectin target significantly increased only in group C compared to group A. TGFb1 expressions in group C more than group B showed significant enhancement compared to group A. Conclusion: In summary we can say that 20 Gy of proton exposure of heart tissue may lead to detectable damages in heart cells and may distribute function of them as a component of heart tissue structure in molecular level.

Keywords: gene expression, heart damage, proton irradiation, radiotherapy

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