Search results for: human subjects

Authors: Joshi Rajiv, Shah Priyank, Thavkar Amit, Rohira Poonam, Mehta Suyog

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Topical formulation containing minoxidil and finasteride helps hair growth in the treatment of male androgenetic alopecia. The objective of this study is to compare the irritation potential of three conventional formulations of minoxidil 5% + finasteride 0.1% topical solution of in human patch test. The study was a single centre, double blind, non-randomized controlled study in 53 healthy adult Indian subjects. Occlusive patch test for 24 hours was performed with three formulations of minoxidil 5% + finasteride 0.1% topical solution. Products tested included aqueous based minoxidil 5% + finasteride 0.1% (AnasureTM-F, Sun Pharma, India – Brand A), lipid based minoxidil 5% + finasteride 0.1% (Brand B) and aqueous based minoxidil 5% + finasteride 0.1% (Brand C). Isotonic saline 0.9% and 1% w/w sodium lauryl sulphate were included as negative control and positive control respectively. Patches were applied and removed after 24 hours. The skin reaction was assessed and clinically scored 24 hours after the removal of the patches under constant artificial daylight source using the Draize scale (0-4 points scale for erythema/dryness//wrinkles and for oedema). Follow-up was scheduled after one week to confirm recovery for any reaction. A combined mean score up to 2.0/8.0 indicates a product is “non-irritant” and a score between 2.0/8.0 and 4.0/8.0 indicates “mildly irritant” and a score above 4.0/8.0 indicates “irritant”. The procedure of the patch test followed the principles outlined by the Bureau of Indian Standards (BIS) (IS 4011:2018; Methods of Test for safety evaluation of Cosmetics-3rd revision). Fifty three subjects with mean age 31.9 years (25 males and 28 females) participated in the study. The combined mean score ± standard deviation were: 0.06 ± 0.23 (Brand A), 0.81 ± 0.59 (Brand B), 0.38 ± 0.49 (Brand C), 2.92 ± 0.47 (positive control) and 0.0 ± 0.0 (Negative control). This means the score of Brand A (Sun Pharma product) was significantly lower than that of Brand B (p=0.001) and that of Brand C (p=0.001). The combined mean erythema score ± standard deviation were: 0.06 ± 0.23 (Brand A), 0.81 ± 0.59 (Brand B), 0.38 ± 0.49 (Brand C), 2.09 ± 0.4 (Positive control) and 0.0 ± 0.0 (Negative control). The mean erythema score of Brand A was significantly lower than Brand B (p=0.001) and that of Brand C (p=0.001). Any reaction observed at 24hours after patch removal subsided in a week. All the three topical formulations of minoxidil 5% + finasteride 0.1% were non-irritant. Brand A of minoxidil 5% + finasteride 0.1% (Sun Pharma) was found to be the least irritant than Brand B and Brand C based on the combined mean score and mean erythema score in the human patch test as per the BIS, IS 4011:2018

Keywords: erythema, finasteride, irritation, minoxidil, patch test

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Authors: Tamanda Kamwendo

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The concept of benefit sharing has been a prominent global debate in the world, gaining traction in human research ethics. Despite its prevalence, the concept of benefit sharing is not without controversy over its meaning and justification. This is due to the fact that it lacks a broadly accepted definition and many proponents discuss benefit sharing by arguing for its necessity rather than engaging in critical intellectual engagement with technical issues such as what it implies. What is clear in the literature is that the underlying premise of benefit-sharing is that research involving underprivileged and marginalized people is currently unjust and inequitable because these people are denied access to these gains; thus, benefit-sharing arrangements are required for these research projects to be just and equitable. This paper, therefore, investigates the discourses and justifications behind the concept of benefit sharing to human participants, particularly when dealing with human genomics research. Furthermore, considering that benefit sharing is generally viewed as a transaction between research organizations and research participants, it raises ethical concerns concerning the commodification of human material and undermines the sanctity of the human genome. This is predicated on the idea that research sponsors would be compelled to deliver a minimum set of possible benefits to research participants and communities in exchange for their involvement in the study. There is, therefore, need to protect benefit-sharing practices in international health research by developing a governance legal framework. A legal framework of benefit sharing will also dispel the issue of commodification of human material where human genomic research is done.

Keywords: benefit sharing, human participants, human genomic research, ethical concerns

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Authors: Sule Pallavi, Shah Priyank, Thavkar Amit, Rohira Poonam, Mehta Suyog

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Introduction: Minoxidil has been used topically for a long time to assist hair growth in the management of male androgenetic alopecia. The aim of this study was a comparative assessment of the irritation potential of three commercial formulations of minoxidil 2% topical solution in a human patch test. Methodology: The study was a non-randomized, double-blind, controlled, single-center study of 56 healthy adult Indian subjects. A 24-hour occlusive patch test was conducted with three formulations of minoxidil 2% topical solution. Products tested were aqueous-based minoxidil 2% (AnasureTM 2%, Sun Pharma, India – Brand A), alcohol-based minoxidil 2% (Brand B) and aqueous-based minoxidil 2% (Brand C). Isotonic saline 0.9% and 1% w/w sodium lauryl sulphate as a negative and positive control, respectively, were included. Patches were applied on the back, followed by removal after 24 hours. The Draize scale (0-4 points scale for erythema/dryness/wrinkles and for oedema) was used to evaluate and clinically score the skin reaction under constant artificial daylight 24 hours after the removal of the patches. The patch test was based on the principles outlined by Bureau of Indian Standards (BIS) (IS 4011:2018; Methods of Test for safety evaluation of Cosmetics-3rd revision). A mean combined score up to 2.0/8.0 indicates that a product is “non-irritant,” and a score between 2.0/8.0 and 4.0/8.0 indicates “mildly irritant” and a score above 4.0/8.0 indicates “irritant”. In case of any skin reaction that was observed, a follow-up was planned after one week to confirm recovery. Results: The 56 subjects who participated in the study had a mean age of 28.7 years (28 males and 28 females). The combined mean score ± standard deviation was: 0.09 ± 0.29 (Brand A), 0.29± 0.53 (Brand B), 0.30 ± 0.46 (Brand C), 3.25 ± 0.77 (positive control) and 0.02 ± 0.13 (negative control). This mean score of Brand A (Sun Pharma) was significantly lower than that of Brand B (p=0.016) and that of Brand C (p=0.004). The mean erythema score ± standard deviation was: 0.09 ± 0.29 (Brand A), 0.27 ± 0.49 (Brand B), 0.30 ± 0.46 (Brand C), 2.5 ± 0.66 (positive control) and 0.02 ± 0.13 (negative control). The mean erythema score of Brand A (Sun Pharma) was significantly lower than that of Brand B (p=0.019) and that of Brand C (p=0.004). Reactions that were observed 24 hours after patch removal subsided in a week’s time. Conclusion: Based on the human patch test as per the BIS, IS 4011:2018, all the three topical formulations of minoxidil 2% were found to be non-irritant. Brand A of 2% minoxidil (Sun Pharma) was found to be the least irritant than Brand B and Brand C based on the combined mean score and mean erythema score.

Keywords: erythema, irritation, minoxidil, patch test

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Authors: Anatoly Krivinsh

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The results of dissertation research "Preventing and combating corruption in public procurement" are presented in this publication. The study was conducted 2011 till 2013 in a Member State of the European Union, in the Republic of Latvia. Goal of the thesis is to explore corruption prevention and combating issues in public procurement sphere, to identify the prevalence rates, determinants and contributing factors and prevention opportunities in Latvia. In the first chapter the author analyses theoretical aspects of understanding corruption in public procurement, with particular emphasis on corruption definition problem, its nature, causes and consequences. A separate section is dedicated to the public procurement concept, mechanism and legal framework. In the first part of this work the author presents cognitive methodology of corruption in public procurement field, based on which the author has carried out an analysis of corruption situation in public procurement in Republic of Latvia. In the second chapter of the thesis, the author analyzes the problem of corruption in public procurement, including its historical aspects, typology and classification of corruption subjects involved, corruption risk elements in public procurement and their identification. During the development of the second chapter author's practical experience in public procurements was widely used. The third and fourth chapter deals with issues related to the prevention and combating corruption in public procurement, namely the operation of the concept, principles, methods and techniques, subjects in Republic of Latvia, as well as an analysis of foreign experience in preventing and combating corruption. The fifth chapter is devoted to the corruption prevention and combating perspectives and their assessment. In this chapter the author has made the evaluation of corruption prevention and combating measures efficiency in Republic of Latvia, assessment of anti-corruption legislation development stage in public procurement field in Latvia.

Keywords: prevention of corruption, public purchases, good governance, human rights

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Authors: Azin Karami, Bahareh Heydari

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There is a difference between national sovereignty ( national security guarantee) and human rights standards (human security guarantee). Under the pretext of providing security for the majority, Governments violate human rights standards and lead to populism. This paper illustrates despite the human rights standards of non-citizens, they mostly confront different practical and social realities. (a large gap between the reality and the truth). This paper has focused on one of vulnerable irregular non-citizens immigrants from Mediterranean . In addition, it has considered challenges of the basic and primary human rights standards of this group. It shows how government policies affect the flow of irregular immigration. This paper is based upon UN data about Mediterranean immigrants and polls answered by 68 people who intended to migrate from Mediterranean (28 female and 40 male people, the average age of 30 to 40). The model is supposed to be a convenient one to present objective, real evidence of irregular immigrants and discusses the challenges that this group of immigrants confront them .This paper shows clear concept of immigrants.

Keywords: human rights, human security, national sovereignty, irregular immigrants

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Authors: Young Nam Jo, Moon Jeong Kang, Hong Hee Yoo

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Most human vibration models have been modeled as a multibody system consisting of some rigid bodies and spring-dampers. These models are developed for certain posture and conditions. So, the models cannot be used in vibration analysis in various posture and conditions. The purpose of this study is to develop a human vibration model that represent human vibration characteristics under various conditions by employing a musculoskeletal model. To do this, the human vibration model is developed based on biomechanical models. In addition, muscle models are employed instead of spring-dampers. Activations of muscles are controlled by PD controller to maintain body posture under vertical vibration is applied. Each gain value of the controller is obtained to minimize the difference of apparent mass and acceleration transmissibility between experim ent and analysis by using an optimization method.

Keywords: human vibration analysis, hill type muscle model, PD control, whole-body vibration

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Authors: Rashmi Tomar, A. Srinivasan, Nayan K. Mohanty, Arun K. Jain

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Phthalates have been used as additives in industrial products since the 1930s, and are universally considered to be ubiquitous environmental contaminants. The general population is exposed to phthalates through consumer products, as well as diet and medical treatments. Animal studies showing the existence of an association between some phthalates and testicular toxicity have generated public and scientific concern about the potential adverse effects of environmental changes on male reproductive health. Unprecedented declines in fertility rates and semen quality have been reported during the last half of the 20th century in developed countries and increasing interest exists on the potential relationship between exposure to environmental contaminants, including phthalates, and human male reproductive health Studies. Phthalates may be associated with altered endocrine function and adverse effects on male reproductive development and function, but human studies are limited. The aim of the present study was detection of phthalate compounds, estimation of their metabolites in infertile & fertile male. Blood and urine samples were collected from 150 infertile patients & 75 fertile volunteers recruited through Department of Urology, Safdarjung Hospital, New Delhi. Blood have been collected in separate glass tubes from the antecubital vein of the patients, serum have been separate and estimate the phthalate level in serum samples by Gas Chromatography / Mass Spectrometry using NIOSH / OSHA detailed protocol. Urine of Infertile & Fertile Subjects was collected & extracted using solid phase extraction method, analysis by HPLC. In conclusion, to the best of our knowledge the present study based on human is first to show the presence of phthalate in human serum samples and their metabolites in urine samples. Significant differences were observed between several phthalates in infertile and fertile healthy individuals.

Keywords: Gas Chromatography, HPLC, male infertility, phthalates, serum, toxicity, urine

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Authors: B. González-Yebra, B. Flores-Nieto, P. Aguilar-Salinas, M. Preciado Puga, A. L. González Yebra

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The monitoring of populations occupationally exposed to organic solvents has been an important issue for several shoe factories for years since the International Agency for Research on Cancer (IARC) has advised on the potential carcinogenic risk of chemicals related to occupations. In order to detect if exposition to organic solvents used in some Mexican shoe factories contributes to oral carcinogenesis, we performed monitoring in three factories. Occupational exposure was determined by using monitors 3M. Organic solvents were assessed by gas chromatography. Then, we recruited 30 shoe workers (30.2 ± 8.4 years) and 10 unexposed subjects (43.3 ± 11.2 years) for the micronuclei (MN) test and immunodetection of some cancer biomarkers (ki-67, p16, caspase-3) in scraped oral epithelial cells. Monitored solvents detected were acetone, benzene, hexane, methyl ethyl ketone, and toluene in acceptable levels according to Official Mexican Norm. We found by MN test higher incidence of nuclear abnormalities (karyorrhexis, pycnosis, karyolysis, condensed chromatin, and macronuclei) in the exposed group than the non-exposed group. On the other hand, we found, a negative expression for Ki-67 and p16 in exfoliated epithelial cells from exposed and non-exposed to organic solvents subjects. Only caspase-3 shown positive patter of expression in 9/30 (30%) exposed subjects, and we detected high karyolysis incidence in caspase-3 subjects (p = 0.021). The absence of expression of proliferation markers p16 and ki-67 and presence of apoptosis marker caspase-3 are indicating the absence of malignancy in oral epithelial cells and low risk for oral cancer. It is a fact that the MN test is a very effective method to detect nuclear abnormalities in exfoliated buccal cells from subjects that have been exposed to organic solvents in the shoe industry. However, in order to improve this tool and predict cancer risk is it is mandatory to implement complementary tests as other biomarkers that can help to detect malignancy in individuals occupationally exposed.

Keywords: biomarkers, oral cancer, organic solvents, shoe industries

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Authors: Andreas Aceranti, Simonetta Vernocchi, Marco Colorato, Guido Bighiani, Lorenzo Moretti

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Internalized homo/biphobia refers to a set of negative feelings (feelings of guilt, contempt, anger, a sense of inferiority) that nonheterosexuals may feel towards themselves. We studied 22 young males struggling with their bisexuality or homosexuality. All have come to psychoanalysis/counselling because something was “not going right in their lives.” Even though they were all involved in heterosexual relations, they felt that the relationship was not satisfactory, and even tried having affairs with other women, they felt unsatisfied. All revealed that even though they felt sexually attracted to women, they fell in love with other men. When we investigated the main resistances, the answers were almost the same fearing rejection: four from their mates; six from their parents; eight both from mates and parents; the other four were unable to accept the “deviation for religious reasons.” During the sessions, we educated them about sexual orientation and affection, and we spent much time educating them about the normality of sexual orientation. We found out that the majority (20 subjects) were totally ignorant about sexual orientation and had evaluated themselves only on prejudice or religious approaches. After many sessions, 18 subjects stopped coming to sessions as they felt at peace with themselves. Interestingly the four patients who still come to therapy and are still struggling with themselves are the four subjects with religious issues. Based on our experience, the most destructive aspect of sexual orientation acceptance is the lack of education. Prejudice and religion, unfortunately, still play a big role in self-acceptance.

Keywords: prejudice, homophobia, sexual orientation, biphobia, acceptance, ignorance

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Authors: B. Vadiraj, S. N. Omkar, B. Kapil Bharadwaj, Yash Vardhan Gupta

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During manned exploration of space, missions will require astronaut crewmembers to perform Extra Vehicular Activities (EVAs) for a variety of tasks. These EVAs take place after long periods of operations in space, and in and around unique vehicles, space structures and systems. Considering the remoteness and time spans in which these vehicles will operate, EVA system operations should utilize common worksites, tools and procedures as much as possible to increase the efficiency of training and proficiency in operations. All of the preparations need to be carried out based on studies of astronaut motions. Until now, development and training activities associated with the planned EVAs in Russian and U.S. space programs have relied almost exclusively on physical simulators. These experimental tests are expensive and time consuming. During the past few years a strong increase has been observed in the use of computer simulations due to the fast developments in computer hardware and simulation software. Based on this idea, an effort to develop a computational simulation system to model human dynamic motion for EVA is initiated. This study focuses on the simulation of an astronaut moving the orbital replaceable units into the worksites or removing them from the worksites. Our physics-based methodology helps fill the gap in quantitative analysis of astronaut EVA by providing a multisegment human arm model. Simulation work described in the study improves on the realism of previous efforts, incorporating joint stops to account for the physiological limits of range of motion. To demonstrate the utility of this approach human arm model is simulated virtually using ADAMS/LifeMOD® software. Kinematic mechanism for the astronaut’s task is studied from joint angles and torques. Simulation results obtained is validated with numerical simulation based on the principles of Newton-Euler method. Torques determined using mathematical model are compared among the subjects to know the grace and consistency of the task performed. We conclude that due to uncertain nature of exploration-class EVA, a virtual model developed using multibody dynamics approach offers significant advantages over traditional human modeling approaches.

Keywords: extra vehicular activity, biomechanics, inverse kinematics, human body modeling

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Authors: Adeleke Omolade

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The study investigated the impacts of capital goods' import and human capital on the economic growth of the Sub Sahahra Africa (SSA). 30 countries were used in the Panel- ARDL analysis where economic growth is the dependent variables and capital goods' import, human capital, primary export, investment exchange rate, among others were used as the independent variables. The result from the panel analysis indicates that capital goods' import will significantly and positively influence economic growth but human capital fails to have significant positive impact on economic growth of the SSA. Earlier the trend analysis and the correlation results have shown that there is a weak association between capital goods' import and human capital in the SSA. The results offer an expository analysis that reveals that the quality of the human capital is very germane to the effective utilization of capital goods' import for the purpose of growth in a primary goods' export dominated region like the SSA.

Keywords: capital goods import, economic growth, human capital, Sub-Sahara Africa

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Authors: Himanshu Dehra

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This paper presents a paradigm for characterization and checking of human noise behavior. The definitions of ‘Noise’ and ‘Noise Behavior’ are devised. The concept of characterization and examining of Noise Behavior is obtained from the proposed paradigm of Psychoacoustics. The measurement of human noise behavior is discussed through definitions of noise sources and noise measurements. The noise sources, noise measurement equations and noise filters are further illustrated through examples. The theory and significance of solar energy acoustics is presented for life and its activities. Human comfort and health are correlated with human brain through physiological responses and noise protection. Examples of heat stress, intense heat, sweating and evaporation are also enumerated.

Keywords: human brain, noise behavior, noise characterization, noise filters, physiological responses, psychoacoustics

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Authors: Agnieszka Leszczynska

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Flexibility and agility constitute the most dominant features of modern human resource management systems. The former pertains to procedures, practices and competences of human resources, and the latter to the procedures and practices’ effectiveness in dealing with changing conditions in the surrounding environment. The purpose of the paper is to present the relations between the flexibility and agility of human resources and achieving sustainable competitiveness. Based upon hitherto research, we develop a conceptual model that links the constructs together. The conducted study is of theoretical and conceptual nature. Critical literature analysis and the synthesis method were applied. A premise was made that the three dimensions of HR (Human Resources) flexibility (employee skill flexibility, employee behaviour flexibility, and HR practice flexibility) and HR agility affect competitiveness, by increasing the flexibility, creativity of human resources, and improving quality performance, and exert an impact upon the quality of life of employees and social relations. In particular, the agility and flexibility of human resources contribute to the growth of adaptability and strategic orientation, which directly affects the organization's competitiveness. The research results will help to better understand the impact of flexibility and agility related to the HRM (Human Resources Management) system upon the implementation of the concept of sustainable development in the organization.

Keywords: agility, human resource, sustainable competitiveness, sustainable development

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Authors: Irena Kostovska, Katerina Tosheska Trajkovska, Svetlana Cekovska, Julijana Brezovska Kavrakova, Hristina Ampova, Sonja Topuzovska, Ognen Kostovski, Goce Spasovski, Danica Labudovic

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Background: Proteinuria is an important feature of secondary nephropathies. The quantitative and qualitative analysis of proteinuria plays an important role in determining the types of proteinuria (glomerular, tubular and mixed), in the diagnosis and prognosis of secondary nephropathies. The damage of the glomerular basement membrane is responsible for a proteinuria characterized by the presence of large amounts of protein with high molecular weights such as albumin (69 kilo Daltons-kD), transferrin (78 kD) and immunoglobulin G (150 kD). An insufficiency of proximal tubular function is the cause of a proteinuria characterized by the presence of proteins with low molecular weight (LMW), such as retinol binding protein (21 kD) and α1-microglobulin (31 kD). In some renal diseases, a mixed glomerular and tubular proteinuria is frequently seen. Sodium dodecyl sulphate polyacrylamide gel electrophoresis (SDS-PAGE) is the most widely used method of analyzing urine proteins for clinical purposes. The main aim of the study is to determine the type of proteinuria in the most common secondary nephropathies such as diabetic, hypertensive nephropathy and preeclampsia. Material and methods: In this study were included 90 subjects: subjects with diabetic nephropathy (n=30), subjects with hypertensive nephropahty (n=30) and pregnant women with preeclampsia (n=30). We divided all subjects according to UM/CR into three subgroups: macroalbuminuric (UM/CR >300 mg/g), microalbuminuric (UM/CR 30-300 mg/g) and normolabuminuric (UM/CR<30 mg/g). In all subjects, we measured microalbumin and creatinine in urine with standard biochemical methods. Separation of urinary proteins was performed by SDS-PAGE, in several stages: linear gel preparation (4-22%), treatment of urinary samples before their application on the gel, electrophoresis, gel fixation, coloring with Coomassie blue, and identification of the separated protein fractions based on standards with exactly known molecular weight. Results: According to urinary microalbumin/creatinin ratio in group of subject with diabetic nephropathy, nine patients were macroalbuminuric, while 21 subject were microalbuminuric. In group of subjects with hypertensive nephropathy, we found macroalbuminuria (n=4), microalbuminuria (n=20) and normoalbuminuria (n=6). All pregnant women with preeclampsia were macroalbuminuric. Electrophoretic separation of urinary proteins showed that in macroalbuminric patients with diabetic nephropathy 56% have mixed proteinuria, 22% have glomerular proteinuria and 22% have tubular proteinuria. In subgroup of subjects with diabetic nephropathy and microalbuminuria, 52% have glomerular proteinuria, 8% have tubular proteinuria, and 40% of subjects have normal electrophoretic findings. All patients with maroalbuminuria and hypertensive nephropathy have mixed proteinuria. In subgroup of patients with microalbuminuria and hypertensive nephropathy, we found: 32% with mixed proteinuria, 27% with normal findings, 23% with tubular, and 18% with glomerular proteinuria. In all normoalbuminruic patiens with hypertensive nephropathy, we detected normal electrophoretic findings. In group of subjects pregnant women with preeclampsia, we found: 81% with mixed proteinuria, 13% with glomerular, and 8% with tubular proteinuria. Conclusion: By SDS PAGE method, we detected that in patients with secondary nephropathies the most common type of proteinuria is mixed proteinuria, indicating both loss of glomerular permeability and tubular function. We can conclude that SDS PAGE is high sensitive method for detection of renal impairment in patients with secondary nephropathies.

Keywords: diabetic nephropathy, preeclampsia, hypertensive nephropathy, SDS PAGE

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Authors: Premalatha B. S., Shenoy A. M.

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Background: Rehabilitation of swallowing is as vital as speech in surgically treated head and neck cancer patients to maintain nutritional support, enhance wound healing and improve quality of life. Aspiration following supraglottic laryngectomy is very common, and rehabilitation of the same is crucial which requires involvement of speech therapist in close contact with head and neck surgeon. Objectives: To examine the functions of swallowing outcomes after intensive therapy in supraglottic laryngectomy. Materials: Thirty-nine supra glottic laryngectomees were participated in the study. Of them, 36 subjects were males and 3 were females, in the age range of 32-68 years. Eighteen subjects had undergone standard supra glottis laryngectomy (Group1) for supraglottic lesions where as 21 of them for extended supraglottic laryngectomy (Group 2) for base tongue and lateral pharyngeal wall lesion. Prior to surgery visit by speech pathologist was mandatory to assess the sutability for surgery and rehabilitation. Dysphagia rehabilitation started after decannulation of tracheostoma by focusing on orientation about anatomy, physiological variation before and after surgery, which was tailor made for each individual based on their type and extent of surgery. Supraglottic diet - Soft solid with supraglottic swallow method was advocated to prevent aspiration. The success of intervention was documented as number of sessions taken to swallow different food consistency and also percentage of subjects who achieved satisfactory swallow in terms of number of weeks in both the groups. Results: Statistical data was computed in two ways in both the groups 1) to calculate percentage (%) of subjects who swallowed satisfactorily in the time frame of less than 3 weeks to more than 6 weeks, 2) number of sessions taken to swallow without aspiration as far as food consistency was concerned. The study indicated that in group 1 subjects of standard supraglottic laryngectomy, 61% (n=11) of them were successfully rehabilitated but their swallowing normalcy was delayed by an average 29th post operative day (3-6 weeks). Thirty three percentages (33%) (n=6) of the subjects could swallow satisfactorily without aspiration even before 3 weeks and only 5 % (n=1) of the needed more than 6 weeks to achieve normal swallowing ability. Group 2 subjects of extended SGL only 47 %( n=10) of them could achieved satisfactory swallow by 3-6 weeks and 24% (n=5) of them of them achieved normal swallowing ability before 3 weeks. Around 4% (n=1) needed more than 6 weeks and as high as 24 % (n=5) of them continued to be supplemented with naso gastric feeding even after 8-10 months post operative as they exhibited severe aspiration. As far as type of food consistencies were concerned group 1 subject could able to swallow all types without aspiration much earlier than group 2 subjects. Group 1 needed only 8 swallowing therapy sessions for thickened soft solid and 15 sessions for liquids whereas group 2 required 14 sessions for soft solid and 17 sessions for liquids to achieve swallowing normalcy without aspiration. Conclusion: The study highlights the importance of dysphagia intervention in supraglottic laryngectomees by speech pathologist.

Keywords: dysphagia management, supraglotic diet, supraglottic laryngectomy, supraglottic swallow

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Authors: Xin Chen

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Pre-industrial old-world human cultural diversity and societal complexity exhibits remarkable geographic regularities. Along the latitudinal axis from the equator to the arctic, a descending trend of human ethno-cultural diversity is found to be in coincidence with a descending trend of biological diversity. Along the same latitudinal axis, the pre-industrial human societal complexity shows to peak at the intermediate latitude. It is postulated that human cultural diversity and societal complexity are strongly influenced by collective learning, and that collective learning is positively related to human population size, social interactions, and environmental challenges. Under such postulations the relationship between collective learning and important geographical-environmental factors, including climate and biodiversity/bio-productivity is examined. A hypothesis of intermediate bio-productivity is formulated to account for those latitudinal patterns of pre-industrial human societal complexity.

Keywords: cultural diversity, soetal complexity, latitudinal patterns, biodiversity, bio-productivity, collective learning

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Authors: Ana Luiza Casasanta Garcia, Maria Del Carmen Cortizo

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From the classic contractualist and early declarations of modern rights, discussions on policies for the protection and promotion of human rights were highlighted in an attempt to ensure the realization of human dignity and its values, which are (re) negotiated according to the needs evidenced in each historical and contextual moment. Aiming at guaranteeing human rights to Brazilian citizens, created in 2009 and updated in 2010, the Third National Human Rights Program (PNDH III) in force highlights guidelines and recommendations to guarantee human rights, among them, to guarantee the rights of women in Brazil. Based on this document, this article aims to locate historically and culturally the understanding of human rights related to the rights of women in Brazilian territory, from the analysis of the guiding axes of women's rights of the PNDH III. In methodological terms, the qualitative approach and documentary research were used to analyze the data according to the critical discourse analysis. As a result, it has been found that the process of building and maintaining the guarantee of women's human rights needs a reformulation that also shows a social revolution. This is justified by the fact that even with the provision in the PNDH III that, in order to guarantee the rights of women, it is necessary, for example, to adapt the Penal Code to the decriminalization of abortion and the professionalization of prostitution, these points are still very controversial and are not put into practice by the State. Finally, the importance of the critique of politics and the current system of production of understandings in favor of this social transformation is emphasized.

Keywords: human rights of women, social transformation, national human rights program III, public politics

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Authors: Uche A. Nnawulezi

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This study evolved from the need to look at and evaluate the difficulties in the domestication of International Laws and Human Rights Laws in Nigeria. Essentially, the paper-based its examination on documentary evidence and depended much on secondary sources, for example, textbooks, journals, articles, periodicals and research reports emanating from suggestions of international law experts, jurists and human rights lawyers on the development challenges in domesticating international laws and human rights laws in Nigeria. These data were analyzed by the application of content analysis and careful observation of the current municipal laws which has posed great challenges in the domestication of International laws. This paper might follow the historical backdrop of the practices in the use of International law in Nigeria and should likewise consider the challenges inherent in these practices. The paper suggests that a sustainable domestication of International Laws and its application in Nigerian courts will ensure a better enforcement of human rights within the domestic jurisdiction.

Keywords: international law, human rights, domestication, challenges

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Authors: Tooba Sabir, Namra Sabir, Mohammad Amjad Sabir

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The human-environment relationship has been projected since the beginning of literary tradition i.e. pastoral tradition, however, the interest of critics, writers and poets, in this view, has been developed, since the last couple of decades because of the increasing scope of environmental studies and growing environmental issues. One such novel, that projects human-environment relationship, is ‘The Alchemist.’ It is Paulo Coelho’s one of the most read novels. It holds a central theme that the universe conspires to help a person achieve his destiny, projecting anthropocentrism and human domination by centralizing human and devaluing the intrinsic worth of ecosystem. However, ecocritical analysis of the text reveals that the novel contains, at several instances, ecocentrism as well e.g. ‘everything on earth is being continuously transformed because earth is alive.’ This portrays ecosphere as living and dynamic entity rather than a mere instrument for human to achieve his destiny. The idea that the universe shares the same language projects unity of nature showing the relationship between human and non-human aspects of the environment as one being and not separate or superior to one another. It depicts human as a part of the environment and not the lord of the world. Therefore, it can be concluded that the novel oscillates between both the ecocentric and the anthropocentric phenomena. It is not suggested, however, that one phenomenon should be valued over the other but that the complexities of both the phenomena should be recognized, acknowledged and valued in order to encourage the interactions between literature and environment.

Keywords: anthropocentrism, ecocentrism, ecocritical analysis, human-environment relationship

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Authors: Salima Taleb, Kafila Boulaba, Ahlem Yousfi, Nada Taleb, Difallah Basma

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Introduction: Obesity is recognized as a cardiovascular risk factor. It is associated with cardio-metabolic diseases. Its prevalence is increasing significantly in both rich and poor countries. However, there are obese people who have no metabolic disturbance. So we think obesity is not always a risk factor for an abnormal metabolic profile that increases the risk of cardiometabolic problems. However, there is no definition that allows us to identify the individual group Metabolically Healthy but Obese (MHO). Objective: The objective of this study is to evaluate the relationship between MHO and some factors associated with it. Methods: A longitudinal study is a prospective cohort study of 600 participants aged ≥18 years. Metabolic status was assessed by the following parameters: blood pressure, fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. Body Mass Index (BMI) was calculated as weight (in kg) divided by height (m2), BMI = Weight/(Height)². According to the BMI value, our population was divided into four groups: underweight subjects with BMI <18.5 kg/m2, normal weight subjects with BMI = 18.5–24.9 kg/m², overweight subjects with BMI=25–29.9 kg/m², and obese subjects who have (BMI ≥ 30 kg/m²). A value of P < 0.05 was considered significant. Statistical processing was done using the SPSS 25 software. Results: During this study, 194 (32.33%) were identified as MHO among 416 (37%) obese individuals. The prevalence of the metabolically unhealthy phenotype among normal-weight individuals was (13.83%) vs. (37%) in obese individuals. Compared with metabolically healthy normal-weight individuals (10.93%), the prevalence of diabetes was (30.60%) in MHO, (20.59%) in metabolically unhealthy normal weight, and (52.29%) for metabolically unhealthy obese (p = 0.032). Blood pressure was significantly higher in MHO individuals than in metabolically healthy normal-weight individuals and in metabolically unhealthy obese than in metabolically unhealthy normal weight (P < 0.0001). Familial coronary artery disease does not appear to have an effect on the metabolic status of obese and normal-weight patients (P = 0.544). However, waist circumference appears to have an effect on the metabolic status of individuals (P < 0.0001). Conclusion: This study showed a high prevalence of metabolic profile disruption in normal-weight subjects and a high rate of overweight and/or obese people who are metabolically healthy. To understand the physiological mechanism related to these metabolic statuses, a thorough study is needed.

Keywords: metabolically health, obesity, factors associated, cardiovascular diseases

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Authors: C. Román, M. Guevara, P. Salas, D. Duclap, J. Houenou, C. Poupon, J. F. Mangin, P. Guevara

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Diffusion Magnetic Resonance Imaging (dMRI) allows the non-invasive study of human brain white matter. From diffusion data, it is possible to reconstruct fiber trajectories using tractography algorithms. Our previous work consists in an automatic method for the identification of short association bundles of the superficial white matter (SWM), based on a whole brain inter-subject hierarchical clustering applied to a HARDI database. The method finds representative clusters of similar fibers, belonging to a group of subjects, according to a distance measure between fibers, using a non-linear registration (DTI-TK). The algorithm performs an automatic labeling based on the anatomy, defined by a cortex mesh parcelated with FreeSurfer software. The clustering was applied to two independent groups of 37 subjects. The clusters resulting from both groups were compared using a restrictive threshold of mean distance between each pair of bundles from different groups, in order to keep reproducible connections. In the left hemisphere, 48 reproducible bundles were found, while 43 bundles where found in the right hemisphere. An inter-hemispheric bundle correspondence was then applied. The symmetric horizontal reflection of the right bundles was calculated, in order to obtain the position of them in the left hemisphere. Next, the intersection between similar bundles was calculated. The pairs of bundles with a fiber intersection percentage higher than 50% were considered similar. The similar bundles between both hemispheres were fused and symmetrized. We obtained 30 common bundles between hemispheres. An atlas was created with the resulting bundles and used to segment 78 new subjects from another HARDI database, using a distance threshold between 6-8 mm according to the bundle length. Finally, a laterality index was calculated based on the bundle volume. Seven bundles of the atlas presented right laterality (IP_SP_1i, LO_LO_1i, Op_Tr_0i, PoC_PoC_0i, PoC_PreC_2i, PreC_SM_0i, y RoMF_RoMF_0i) and one presented left laterality (IP_SP_2i), there is no tendency of lateralization according to the brain region. Many factors can affect the results, like tractography artifacts, subject registration, and bundle segmentation. Further studies are necessary in order to establish the influence of these factors and evaluate SWM laterality.

Keywords: dMRI, hierarchical clustering, lateralization index, tractography

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Authors: Yuliya Kovalenko

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Given the social nature of people, it is interesting to explore strategies of responding to psycho-traumatic situations in individuals of different ethnic and religious identity. This would allow to substantially expand the idea of human behavior in general, and coping behavior, in particular. This paper investigated the weighted impact of ethnic and religious identities on the patterns of coping behavior. This cross-cultural research empirically revealed intergroup differences in coping strategies and behavior in the samples of young students and teachers of different ethnic identities (Egyptians N=216 and Ukrainians N=109) and different religious identities (Egyptian Muslims N=147 and Christians, including Egyptian Christians N=68 and Ukrainian Christians N = 109). The empirical data were obtained using the questionnaires SACS and COPE. Statistical analysis and interpretation of the results were performed with IBM SPSS-23.0. It was found that, compared to the religious identity, the ethnic identity of the subjects appeared more predictive of coping behavior. It was shown that the constant exchange of information and the unity of biological and social contributed to a more homogeneous picture in the society where Christians and Muslims were integrated into a single cultural space. It was concluded that depending on their ethnic identity, individuals would form a specific hierarchy of coping strategies resulting in a specific pattern of coping with certain stressors. The Egyptian subjects revealed the following pattern of coping with various kinds of academic stress: 'seeking social support', 'problem solving', 'adapting', 'seeking information'. The coping pattern demonstrated by the Ukrainian subjects could be presented as 'seeking information', 'adapting', 'seeking social support', 'problem solving'. There was a tendency in the group of Egyptians to engage in more collectivist coping strategies (with the predominant coping strategy 'religious coping'), in contrast to the Ukrainians who displayed more individualistic coping strategies (with 'planning' and 'active coping' as the mostly used coping strategies). At the same time, it was obvious that Ukrainians should not be unambiguously attributed to the individualistic coping behavior due to their reliance on 'seeking social support' and 'social contact'. The final conclusion was also drawn from the peculiarities of developing religious identity, including religiosity, in Egyptians (formal religious education of both Muslims and Christians) and Ukrainians (more spontaneous process): Egyptians seem to learn to resort to the religious coping, which could be an indication that, in principle, it is possible and necessary to train individuals in desirable coping behavior.

Keywords: coping behavior, cross-cultural research, ethnic and religious identity, hierarchical pattern of coping

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Authors: Ashutosh Biswas, Poonam Coushic, Kalpana Baruah, Paras Singla, A. C. Dhariwal, Pawana Murthy

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Burden of Dengue in Northern India Ashutosh Biswas, Poonam Coushic, Kalpana Baruah, Paras Singla, AC Dhariwal, Pawana Murthy. All India Institute of Medical Sciences, NVBDCP,WHO New Delhi, India Aim: This study was conducted to estimate the burden of dengue in capital region of India. Methodology:Seropositivity of Dengue for IgM Ab, NS1 Ag and IgG Ab were performed among the blood donors’ samples from blood bank, those who were coming to donate blood for the requirement of blood for the admitted patients in hospital. Blood samplles were collected through out the year to estimate seroprevalance of dengue with or without outbreak season. All the subjects were asymptomatic at the time of blood donation. Results: A total of 1558 donors were screened for the study. On the basis of inclusion/ exclusion criteria, we enrolled 1531subjects for the study.Twenty seven donors were excluded from the study, out of which 6 were detected HIV +ve, 11 were positive for HBsAg and 10 were found positive for HCV.Mean age was 30.51 ± 7.75 years.Of 1531subjects, 18 (1.18%) had a past history of typhoid fever, 28 (1.83%) had chikungunya fever, 9 (0.59%) had malaria and 43 subjects (2.81%) had a past history of symptomatic dengue infection.About 2.22% (34) of subjects were found to have sero-positive for NS1 Ag with a peak point prevalence of 7.14% in the month of October and sero-positive of IgM Ab was observed about 5.49% (84)with a peak point prevalence of 14.29% in the month of October. Sero-prevalnce of IgGwas detected in about 64.21% (983) of subjects. Conclusion: Acute asymptomatic dengue (NS1 Ag+ve) was observed in 7.14%, as the subjects were having no symptoms at the time of sampling. This group of subjects poses a potential public health threat for transmitting dengue infection through blood transfusion (TTI) in the community as evident by presence of active viral infection due to NS1Ag +VE. Therefore a policy may be implemented in the blood bank for testing NS1 Ag to look for active dengue infection for preventing dengue transmission through blood transfusion (TTI). Acute or Subacute dengue infection ( IgM Ab+ve) was observed from 5.49% to 14.29% which is a peak point prevalence in the month of October. About 64.21% of the population were immunized by natural dengue infection ( IgG Ab+ve) in theNorthern province of India. This might be helpful for implementing the dengue vaccine in a region. Blood samples in blood banks should be tested for dengue before transfusion to any other person to prevent transfusion transmitted dengue infection as we estimated upto 7.14% positivity of NS1 Ag in our study which indicates presence of dengue virus in blood donors’ samples.

Keywords: Dengue Burden, Seroprevalance, Asymptomatic dengue, Dengue transmission through blood transfusion

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Authors: Begum Rokeya, Rahelee Zinnat, Fatema Jebunnesa, Israt Ara Hossain, A. Rahman

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Background and Aims: Arsenic in drinking water is a global environmental health problem, and the exposure may increase dyslipidemia and cerebrovascular diseases mortalities, most likely through causing atherosclerosis. However, the mechanism of lipid metabolism, atherosclerosis formation, arsenic exposure and impact in pregnancy is still unclear. Recent epidemiological evidences indicate close association between inorganic arsenic exposure via drinking water and Dyslipidemia. However, the exact mechanism of this arsenic-mediated increase in atherosclerosis risk factors remains enigmatic. We explore the association of the effect of arsenic on serum lipid profile in pregnant subjects. Methods: A total 200 pregnant mother screened in this study from arsenic exposed area. Our study group included 100 exposed subjects were cases and 100 Non exposed healthy pregnant were controls requited by a cross-sectional study. Clinical and anthropometric measurements were done by standard techniques. Lipidemic status was assessed by enzymatic endpoint method. Urinary As was measured by inductively coupled plasma-mass spectrometry and adjusted with specific gravity and Arsenic exposure was assessed by the level of urinary arsenic level > 100 μg/L was categorized as arsenic exposed and < 100 μg/L were categorized as non-exposed. Multivariate logistic regression and Student’s t - test was used for statistical analysis. Results: Systolic and diastolic blood pressure both were significantly higher in the Arsenic exposed pregnant subjects compared to the Non-exposed group (p<0.001). Arsenic exposed subjects had 2 times higher chance of developing hypertensive pregnancy (Odds Ratio 2.2). In parallel to the findings in Ar exposed subjects showed significantly higher proportion of triglyceride and total cholesterol and low density of lipo protein when compare to non- arsenic exposed pregnant subjects. Significant correlation of urinary arsenic level was also found with SBP, DBP, TG, T chol and serum LDL-Cholesterol. On multivariate logistic regression showed urinary arsenic had a positive association with DBP, SBP, Triglyceride and LDL-c. Conclusion: In conclusion, arsenic exposure may induce dyslipidemia like atherosclerosis through modifying reverse cholesterol transport in cholesterol metabolism. For decreasing atherosclerosis related mortality associated with arsenic, preventing exposure from environmental sources in early life is an important element.

Keywords: Arsenic Exposure, Dyslipidemia, Gestational Diabetes Mellitus, Serum lipid profile

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Authors: Def Primal, Sasanty Kusumaningtyas, Ermita I. Ibrahim

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Purpose: The main objective of this study is to determine the pes planus plantaris (flat foot) condition can contribute to the disturbance of postural stability in basketball athletes in static and dynamic activities. Methods: This cross-sectional quantitative analytical retrospective study on 47 subjects of basketball student-athletes identified the foot arch index by extensive footprint area and AMTI (Advanced Mechanical Technology Inc.) Force flat-form (force plate) determined their postural stability. Subjects were conducted in three activities (static, dynamic vertical jump, and dynamic loading response) for ground reaction force (GRF) resultant vectors towards the vertical plane of body mass (W). Results Analytical results obtained that 80.9% of subjects had pes planus plantaris. It shows no significant differences in pes planus plantaris incidence in both sexes subject (p>0.005); however, there are differences in athlete’s exercise period aspect. Athlete students who have practiced strictly for more than four years’ experience over 50% of pes planus plantaris; furthermore, a long period of exercise was believed to stimulate pes planus. The average value of GRF vectors of pes planus plantaris subjects on three different basketball movements shows a significant correlation to postural stability. Conclusions Pes planus plantaris affected almost basketball athletes regarding the length and intensity of exercise performed. The condition significantly contributes to postural stability disturbance on a static condition, dynamic vertical jump, and dynamic vertical jump loading response.

Keywords: pes planus plantaris, flatfoot, ground reaction force, static and dynamic stability

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Authors: Eva Kotlánová

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After recession that began in 2007 in the United States and subsequently spilled over the Europe we could expect recovery of economic growth. According to the last estimation of economic progress of European countries, this recovery is not strong enough. Among others, it will depend on economic policy, where and in which way, the economic indicators will proceed. Economic theories postulate that the economic subjects prefer stably, continual economic policy without repeated and strong fluctuations. This policy is perceived as support of economic growth. Mostly in crises period, when the government must cope with consequences of recession, the economic policy becomes unpredictable for many subjects and economic policy uncertainty grows, which have negative influence on economic growth. The aim of this paper is to use panel regression to prove or disprove this hypothesis on the example of five largest European economies in the period 2008–2012.

Keywords: economic crises in Europe, economic policy, uncertainty, panel analysis regression

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Authors: Andreas Aceranti, Guido Bighiani, Francesca Crotto, Marco Colorato, Stefania Zaghi, Marino Zanetti, Simonetta Vernocchi

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The management of eye parameters such as convergence, accommodation, and miosis is very complex; in fact, both the neurovegetative system and the complex Oculocephalgiria system come into play. We have found the effectiveness of the "highvelocity low amplitude" technique directed on C7-T1 (where the cilio-spinal nucleus of the budge is located) in improving the convergence parameter through the measurement of the point of maximum convergence. With this research, we set out to investigate whether the improvement obtained through the High Velocity Low Amplitude maneuver lasts over time, carrying out a pre-manipulation measurement, one immediately after manipulation and one month after manipulation. We took a population of 30 subjects with both refractive and non-refractive problems. Of the 30 patients tested, 27 gave a positive result after the High Velocity Low Amplitude maneuver, giving an improvement in the point of maximum convergence. After a month, we retested all 27 subjects: some further improved the result, others kept, and three subjects slightly lost the gain obtained. None of the re-tested patients returned to the point of maximum convergence starting pre-manipulation. This result opens the door to a multidisciplinary approach between ophthalmologists and osteopaths with the aim of addressing oculomotricity and convergence deficits that increasingly afflict our society due to the massive use of devices and for the conduct of life in closed and restricted environments.

Keywords: point of maximum convergence, HVLA, improvement in PPC, convergence

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Authors: Gheida J. Shahrour, Martin J. Russell

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The 3D body movement signals captured during human-human conversation include clues not only to the content of people’s communication but also to their culture and personality. This paper is concerned with automatic extraction of this information from body movement signals. For the purpose of this research, we collected a novel corpus from 27 subjects, arranged them into groups according to their culture. We arranged each group into pairs and each pair communicated with each other about different topics. A state-of-art recognition system is applied to the problems of person, culture, and topic recognition. We borrowed modeling, classification, and normalization techniques from speech recognition. We used Gaussian Mixture Modeling (GMM) as the main technique for building our three systems, obtaining 77.78%, 55.47%, and 39.06% from the person, culture, and topic recognition systems respectively. In addition, we combined the above GMM systems with Support Vector Machines (SVM) to obtain 85.42%, 62.50%, and 40.63% accuracy for person, culture, and topic recognition respectively. Although direct comparison among these three recognition systems is difficult, it seems that our person recognition system performs best for both GMM and GMM-SVM, suggesting that inter-subject differences (i.e. subject’s personality traits) are a major source of variation. When removing these traits from culture and topic recognition systems using the Nuisance Attribute Projection (NAP) and the Intersession Variability Compensation (ISVC) techniques, we obtained 73.44% and 46.09% accuracy from culture and topic recognition systems respectively.

Keywords: person recognition, topic recognition, culture recognition, 3D body movement signals, variability compensation

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Authors: Pouira Askary

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Indeed, in our globalized world which is facing with various international crises, the transnational corporations and other business enterprises have the capacity to foster economic well-being, development, technological improvement and wealth, as well as causing adverse impacts on human rights. The UN Human Rights Council declared that although the primary responsibility to protect human rights lie with the State but the transnational corporations and other business enterprises have also a responsibility to respect and protect human rights in the framework of corporate social responsibility. In 2011, the Human Rights Council endorsed the Guiding Principles on Business and Human Rights, a set of guidelines that define the key duties and responsibilities of States and business enterprises with regard to business-related human rights abuses. In UN’s view, the Guiding Principles do not create new legal obligations but constitute a clarification of the implications of existing standards, including under international human rights law. In 2014 the UN Human Rights Council decided to establish a working group on transnational corporations and other business enterprises whose mandate shall be to elaborate an international legally binding instrument to regulate, in international human rights law, the activities of transnational corporations and other business enterprises. Extremely difficult task for the working group to codify a legally binding document to regulate the behavior of corporations on the basis of the norms of international law! Concentration of this paper is on the origins of those human rights applicable on business enterprises. The research will discuss that the social and ethical roots of the CSR are much more institutionalized and elaborated than the legal roots. Therefore, the first step is to determine whether and to what extent corporations, do have an ethical responsibility to respect human rights and if so, by which means this ethical and social responsibility is convertible to legal commitments.

Keywords: CSR, ethics, international law, human rights, development, sustainable business

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Authors: Endang Lukitaningsih, Fathul Jannah, Arief R. Hakim, Ratna D. Puspita, Zullies Ikawati

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Rifampicin is a semisynthetic antibiotic derivative of rifamycin B produced by Streptomyces mediterranei. RIF has been used worldwide as first line drug-prescribed throughout tuberculosis therapy. This study aims to develop and to validate an HPLC method couple with a UV detection for determination of rifampicin in spiked human plasma and its application for bioequivalence study. The chromatographic separation was achieved on an RP-C18 column (LachromHitachi, 250 x 4.6 mm., 5μm), utilizing a mobile phase of phosphate buffer/acetonitrile (55:45, v/v, pH 6.8 ± 0.1) at a flow of 1.5 mL/min. Detection was carried out at 337 nm by using spectrophotometer. The developed method was statistically validated for the linearity, accuracy, limit of detection, limit of quantitation, precise and specifity. The specifity of the method was ascertained by comparing chromatograms of blank plasma and plasma containing rifampicin; the matrix and rifampicin were well separated. The limit of detection and limit of quantification were 0.7 µg/mL and 2.3 µg/mL, respectively. The regression curve of standard was linear (r > 0.999) over a range concentration of 20.0 – 100.0 µg/mL. The mean recovery of the method was 96.68 ± 8.06 %. Both intraday and interday precision data showed reproducibility (R.S.D. 2.98% and 1.13 %, respectively). Therefore, the method can be used for routine analysis of rifampicin in human plasma and in bioequivalence study. The validated method was successfully applied in pharmacokinetic and bioequivalence study of rifampicin tablet in a limited number of subjects (under an Ethical Clearance No. KE/FK/6201/EC/2015). The mean values of Cmax, Tmax, AUC(0-24) and AUC(o-∞) for the test formulation of rifampicin were 5.81 ± 0.88 µg/mL, 1.25 hour, 29.16 ± 4.05 µg/mL. h. and 29.41 ± 4.07 µg/mL. h., respectively. Meanwhile for the reference formulation, the values were 5.04 ± 0.54 µg/mL, 1.31 hour, 27.20 ± 3.98 µg/mL.h. and 27.49 ± 4.01 µg/mL.h. From bioequivalence study, the 90% CIs for the test formulation/reference formulation ratio for the logarithmic transformations of Cmax and AUC(0-24) were 97.96-129.48% and 99.13-120.02%, respectively. According to the bioequivamence test guidelines of the European Commission-European Medicines Agency, it can be concluded that the test formulation of rifampicin is bioequivalence with the reference formulation.

Keywords: validation, HPLC, plasma, bioequivalence

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