Search results for: regulatory intervention
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3335

Search results for: regulatory intervention

3005 Yoga Offers Protection for Premenstrual Syndrome

Authors: Katalin Gocze, Vanda A Nemes, Charlotte Briest

Abstract:

Introduction: Premenstrual syndrome (PMS) is a psychoneuroendocrinological disorder adversely affecting life-quality for over 80% of hormonally active women. PMS has a negative impact on women’s daily life in terms of work, interpersonal relationships and leisure time activities. The aim of our study was to evaluate the effects of a yoga intervention focusing on the female pelvic area. Materials and methods: 34 women (ages 18-40) with PMS (Premenstrual Syndrome Screening Tool) and no previous experience in yoga were recruited and randomly assigned to either the yoga or the control group. The intervention consisted of 90’ yoga sessions twice a week and a daily 15’ self-practice module with carefully chosen yogic exercises addressing the reproductive organs by toning the pelvic floor and opening the hips as well as relieving stress and improving concentration. Severity of symptoms of PMS was assessed at the beginning and after the 8-week-long intervention. Pre- and post-program data collection included physical and psychological parameters and the evaluation of ACOQ PMS questionnaire and daily symptom diary. Results: Age and educational background were similar in the control and intervention group with an overall mean age of 29.11±4.78 years. PSST scores significantly improved in the yoga group (p=0.002), while difference in the control group’s pre and post-program values were non-significant (p=0.38). Perception and tolerance of anxiety and stress was significantly better after the intervention (p=0.008). As for changes in physical symptoms distinct improvement was registered for breast tenderness (p=0.028) and for meteorism (p=0.015). Discussion: Yoga’s success originates from the synergic positive effects of stress relief and regular physical activity. Benefits (both mental and physical) of strategically planned, focused yoga practice are apparent even after shorter time periods and can help women with PMS manage or eliminate symptoms in order to improve their life-quality.

Keywords: life-quality, physical symptoms, premenstrual syndrome, psychological impact, yoga

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3004 The Effect of Lepidium Meyenii on Viability, Motility, and Sperm Morphology in Treatment of Infertility Among Adult Male Wistar Rats

Authors: Arefeh Sabzipour

Abstract:

In the present work, the effect of Lepidium meyenii on viability, motility, and sperm morphology in the treatment of infertility of adult male Wistar rats was evaluated. 21 male Wistar rats were adopted, fed and brought up in the same conditions to reach the weight of 230±5 g. after that, they were randomly divided into three groups, including two experimental groups and one control group, each group consisted of 7 rates. Lepidium meyenii was extracted and pulverized. Mice in the control group were treated with distilled water, and experimental groups were gavage with alcoholic juice extracted from Lepidium meyenii once a day for 10 consecutive days. After rates were killed, the testes were isolated. Different parameters includes semen volume in mice, sperm count, sperm motility, morphology, and viability, were evaluated. The results shows that sperm motility and sperm survival indices were significantly different between groups, and sperm count and sperm morphology indices were not significantly different. Sperm motility index in intervention group 1 was equal to 77.00±2.499 and was significantly higher than the one in intervention group two (70.14±3.579, P=0.018) and control group (69.43 ±7.323, P=0.018). Sperm survival index was 91.14 ± 2.410 in intervention group 1, 79.43± 5.062 in intervention group 2, and 76.71.6.651 in the control group (P<0.001). Based on the results of the present study, Lepidium meyenii had great effect on improving sperm indices of mice, especially sperm motility index and sperm survival index. Sperm count index and sperm morphology index, although increased, were not statistically significant.

Keywords: infertility, lepidium meyenii, sperm morphology, sperm survival

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3003 The Effect of Lepidium Meyenii on Viability, Motility, and Sperm Morphology in Treatment of Infertility Among Adult Male Wistar Rats

Authors: Arefeh Sabzipour

Abstract:

In the present work, the effect of Lepidium meyenii on viability, motility, and sperm morphology in the treatment of infertility of adult male Wistar rats was evaluated. 21 male Wistar rats were adopted, fed and brought up in the same conditions to reach the weight of 230±5 g. after that they were randomly divided into three groups including two experimental groups and one control group, each group consisted of 7 rates. Lepidium meyenii was extracted and pulverized. Mice in the control group were treated with distilled water and experimental groups were gavage with alcoholic juice extracted from Lepidium meyenii once a day for 10 consecutive days. After rates were killed, the testes were isolated. Different parameters includes semen volume in mice, sperm count, sperm motility, morphology, and viability were evaluated. The results shows that sperm motility and sperm survival indices were significantly different between groups and sperm count and sperm morphology indices were not significantly different. Sperm motility index in intervention group 1 was equal to 77.00±2.499 and was significantly higher than the one in intervention group two (70.14±3.579, P=0.018) and control group (69.43 ±7.323, P=0.018). Sperm survival index was 91.14 ± 2.410 in intervention group 1, 79.43± 5.062 in intervention group 2, and 76.71.6.651 in control group (P<0.001). Based on the results of the present study, Lepidium meyenii had great effect on improving sperm indices of mice, especially sperm motility index and sperm survival index. Sperm count index and sperm morphology index, although increased, were not statistically significant.

Keywords: infertility, Lepidium meyenii, sperm morphology, sperm survival

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3002 Functional Food Industry in Thailand: Perspectives from Government, Education, and Private Sector

Authors: Charintorn Suwannawong, Tananpon Yavilas, Sopida Boonaneksap, Chotika Viriyarattanasak, Chairath Tangduangdee

Abstract:

With increasing aging population and health conscious consumers, the demand for health promoting products such as functional foods, dietary supplements, and nutraceutical products has continuously increased in Thailand. Nevertheless, the strategic framework for regulatory functional food developments in Thailand is still unclear. The objective of this study was to survey stakeholders’ perspectives on three scopes, consisting of 1) the current status 2) obstacles, and 3) future trend for the development and production of functional foods in Thailand. A survey was conducted by interviewing ten experts from governmental organization, industrial sector and academic institute. The obtained results show that there is no established definition for functional foods in Thailand. There is a variety of raw materials that are capable to be potential ingredients for functional food production in Thailand and exported to global market. However, the scaling up technology into a commercial production is limited. Moreover, there is a need to establish the infrastructures, such as testing laboratory, and regulatory standards for quality control and ensuring product safety. This information is useful for government in the development of the strategic framework and policy statement on improvement of functional food industry in Thailand.

Keywords: functional foods, interview, perspective, Thailand

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3001 Sports Preference Intervention as a Predictor of Sustainable Participation at Risk Teenagers in Ibadan Metropolis, Ibadan Nigerian

Authors: Felix Olajide Ibikunle

Abstract:

Introductory Statement: Sustainable participation of teenagers in sports requires deliberate and concerted plans and managerial policy rooted in the “philosophy of catch them young.” At risk, teenagers need proper integration into societal aspiration: This direction will go a long way to streamline them into security breaches and attractive nuisance free lifestyles. Basic Methodology: The population consists of children between 13-19 years old. A proportionate sampling size technique of 60% was adopted to select seven zones out of 11 geo-political zones in the Ibadan metropolis. Qualitative information and interview were used to collect needed information. The majority of the teenagers were out of school, street hawkers, motor pack touts and unserious vocation apprentices. These groups have the potential for security breaches in the metropolis and beyond. Five hundred and thirty-four (534) respondents were used for the study. They were drawn from Ojoo, Akingbile and Moniya axis = 72; Agbowo, Ajibode and Apete axis = 74; Akobo, Basorun and Idi-ape axis 79; Wofun, Monatan and Iyana-Church axis = 78; Molete, Oke-ado and Oke-Bola axis = 75; Beere, Odinjo, Elekuro axis = 77; Eleyele, Ologuneru and Alesinloye axis = 79. Major Findings: Multiple regression was used to analyze the independent variables and percentages. The respondents' average age was 15.6 years old, and 100% were male. The instrument (questionnaire) used yielded; sport preference (r = 0.72), intervention (r = 0.68), and sustainable participation (r = 0.70). The relative contributions of sport preference on the participation of at risk teenagers was (F-ratio = 1.067); Intervention contribution of sport on the participation of at risk teenagers = produced (F-ratio of 12.095) was significant while, sustainable participation of at risk teenagers produced (F-ratio = 1.062) was significant. Closing Statement: The respondents’ sport preference stimulated their participation in sports. The intervention exposed at risk-teenagers to coaching, which activated their interest and participation in sports. At the same time, sustainable participation contributed positively to evolving at risk teenagers' participation in their preferred sport.

Keywords: sport, preference, intervention, teenagers, sustainable, participation and risk teenagers

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3000 Investigating the Role of Social Media in Supporting Parents and Teachers of Students with Down Syndrome: Focus on Early Intervention Services in the Kingdom of Saudi Arabia

Authors: Awatif Habeeb Al-Shamare

Abstract:

The number of social media users amongst special education teachers and parents of children with Down Syndrome (DS) is increasing annually. This is also the case in the Kingdom of Saudi Arabia (KSA). However, according to the best of the author’s knowledge, there are no qualitative studies which testify to the true nature of the interaction between teachers and parents when using social media, nor the role of social media in supporting and assisting parents and teachers with regards to the children’s educational needs in KSA. Therefore, this ongoing study aims to identify the role of social media in supporting parents and teachers of DS students, with a special emphasis on early intervention services in KSA. By bridging the knowledge gap on social media and special education in KSA and presenting socially relevant and applied information on the topic, this research provides a theoretical and practical base for the establishment of appropriate and effective programmes between the ministries of Information and Special Education in particular. A qualitative approach was selected because it was the most suitable approach for exploring the participants’ experiences, which could not be determined through scientific tests. Interviewing, chosen as the research instrument, allowed the researcher to obtain a detailed understanding of the topic linked to the study objectives. Initially, a pilot study was conducted at the Daycare Center in May 2016. Its aim was to examine and refine the methodology and assess whether the questions were understood with the potential for re-drafting them, if necessary. The main study consists of five teachers and five mothers with experience of using social media and with links to the Daycare Center. Thematic Analysis has been chosen for analysing the findings because it is a flexible method that allows themes to emerge from the data. Results of the current study are still in the initial stages, but the preliminary findings are as follows: (1) social media is an important tool in encouraging parents and teachers to access the necessary information and knowledge about, and experience in, early intervention services; (2) it acts as a support network for the parents; (3) it helps raise awareness about DS and the need for early intervention; (4) it can be used to put pressure on the government for an expansion in early intervention services, and finally (5) its use can be problematic in that parents and teachers face some difficulties and challenges when using the different platforms. It can be concluded that social media plays a significant role in the lives of teachers and parents with special needs children in KSA.

Keywords: down syndrome, early intervention services, social media, support parents and teachers

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2999 Arbitration in Foreign Investment: The Need for Equitable Treatment between the Investor and the Host State

Authors: Maria João Mimoso, Bárbara Magalhães Bravo

Abstract:

This study aims to analyse the phenomenon of arbitration as a paradigm in solving emerging controversies of foreign investment. We will present their benefits and demonstrate their contribution to greater legal certainty in economic relations. This article explores the legal relevant concepts under a strictly conceptual methodology, preparing future research to be developed under more developed comparative law methodologies. The review of national and international literature and jurisprudence will reveal the importance of arbitration in the field of international economic relations, presenting it as an alternative dispute resolution. Globalization imposes new forms of investment protection and appeals to other forms of dispute settlement, primarily to prevent, among other problems, the possible bias of the recipient country's investment tribunals. Characterization of foreign investment, its regulatory sources, their characteristics and the need for intervention of an entity capable of resolving disputes between the parties involved: State investor reception; Investor (of a nationality other than the latter); State of the investor's nationality, and sometimes a ‘subsidiary’ local foreign investor. The ICSID (International Settlement of Investment Disputes) arbitration as a means of resolving investment litigations covered by bilateral treaties (BIT) and investment contracts calls for a delimitation of these two figures in order to clarify the scope of the arbitration under the aegis of the World Bank and to make it more secure in the view of the sovereign power of the States.

Keywords: arbitration, contract, foreign, investment, disputes

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2998 Ordinary Differentiation Equations (ODE) Reconstruction of High-Dimensional Genetic Networks through Game Theory with Application to Dissecting Tree Salt Tolerance

Authors: Libo Jiang, Huan Li, Rongling Wu

Abstract:

Ordinary differentiation equations (ODE) have proven to be powerful for reconstructing precise and informative gene regulatory networks (GRNs) from dynamic gene expression data. However, joint modeling and analysis of all genes, essential for the systematical characterization of genetic interactions, are challenging due to high dimensionality and a complex pattern of genetic regulation including activation, repression, and antitermination. Here, we address these challenges by unifying variable selection and game theory through ODE. Each gene within a GRN is co-expressed with its partner genes in a way like a game of multiple players, each of which tends to choose an optimal strategy to maximize its “fitness” across the whole network. Based on this unifying theory, we designed and conducted a real experiment to infer salt tolerance-related GRNs for Euphrates poplar, a hero tree that can grow in the saline desert. The pattern and magnitude of interactions between several hub genes within these GRNs were found to determine the capacity of Euphrates poplar to resist to saline stress.

Keywords: gene regulatory network, ordinary differential equation, game theory, LASSO, saline resistance

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2997 Evaluation of a Driver Training Intervention for People on the Autism Spectrum: A Multi-Site Randomized Control Trial

Authors: P. Vindin, R. Cordier, N. J. Wilson, H. Lee

Abstract:

Engagement in community-based activities such as education, employment, and social relationships can improve the quality of life for individuals with Autism Spectrum Disorder (ASD). Community mobility is vital to attaining independence for individuals with ASD. Learning to drive and gaining a driver’s license is a critical link to community mobility; however, for individuals with ASD acquiring safe driving skills can be a challenging process. Issues related to anxiety, executive function, and social communication may affect driving behaviours. Driving training and education aimed at addressing barriers faced by learner drivers with ASD can help them improve their driving performance. A multi-site randomized controlled trial (RCT) was conducted to evaluate the effectiveness of an autism-specific driving training intervention for improving the on-road driving performance of learner drivers with ASD. The intervention was delivered via a training manual and interactive website consisting of five modules covering varying driving environments starting with a focus on off-road preparations and progressing through basic to complex driving skill mastery. Seventy-two learner drivers with ASD aged 16 to 35 were randomized using a blinded group allocation procedure into either the intervention or control group. The intervention group received 10 driving lessons with the instructors trained in the use of an autism-specific driving training protocol, whereas the control group received 10 driving lessons as usual. Learner drivers completed a pre- and post-observation drive using a standardized driving route to measure driving performance using the Driving Performance Checklist (DPC). They also completed anxiety, executive function, and social responsiveness measures. The findings showed that there were significant improvements in driving performance for both the intervention (d = 1.02) and the control group (d = 1.15). However, the differences were not significant between groups (p = 0.614) or study sites (p = 0.842). None of the potential moderator variables (anxiety, cognition, social responsiveness, and driving instructor experience) influenced driving performance. This study is an important step toward improving community mobility for individuals with ASD showing that an autism-specific driving training intervention can improve the driving performance of leaner drivers with ASD. It also highlighted the complexity of conducting a multi-site design even when sites were matched according to geography and traffic conditions. Driving instructors also need more and clearer information on how to communicate with learner drivers with restricted verbal expression.

Keywords: autism spectrum disorder, community mobility, driving training, transportation

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2996 A Preliminary Outcome of the Effect of an Accumulating 10,000 Daily Steps on Blood Pressure and Diabetes in Overweight Thai Participants

Authors: Kornanong Yuenyongchaiwat, Duangnate Pepatsitipong, Panthip Sangprasert

Abstract:

High blood pressure and diabetes have been suggested as being non-communicable disease (NCDs), and there is one of the components of the definition of metabolic syndrome. Therefore, the purpose of this study was to evaluate the effect of a 12-week pedometer based community walking intervention on change in resting blood pressure and blood glucose in participants with overweight in the community setting. Method: Participants were recruited both males and females who had a sedentary lifestyle aged 35-59 years (mean aged 49.67 years). A longitudinal quasi-experimental study was designed with 35 overweight participants who had body mass index ≥ 25 kg/m2. These volunteers were assigned to the 12-week pedometer-based walking program (an accumulated at least 10,000 steps a day). Blood pressure and blood glucose were measured initially before and after 12-week intervention. Results: Systolic blood pressure and heart rate were significantly lower in 30 individuals who had accumulated 10,000 steps d-1 in the intervention group at 12 week follow-up (-13.74 mmHg and 5.3 bpm, respectively). In addition, reduction in blood glucose (-14.89 mmol) in the intervention participants was statistically significant (p < .001). A regression analysis indicated that reductions in systolic blood pressure were significantly related to the increase in steps per day. Conclusion: The accumulation of least 10,000 steps d-1 resulted in decreased resting systolic blood pressure and blood glucose in overweight participants. This has also shown that an increase in physical activity in overweight participants with sedentary lifestyle by accumulating at least 10,000 steps a day can reduce the risk of cardiovascular disease (e.g., hypertension and diabetes).

Keywords: blood glucose, blood pressure, diabetes, hypertension, physical activity, walking

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2995 Calculational-Experimental Approach of Radiation Damage Parameters on VVER Equipment Evaluation

Authors: Pavel Borodkin, Nikolay Khrennikov, Azamat Gazetdinov

Abstract:

The problem of ensuring of VVER type reactor equipment integrity is now most actual in connection with justification of safety of the NPP Units and extension of their service life to 60 years and more. First of all, it concerns old units with VVER-440 and VVER-1000. The justification of the VVER equipment integrity depends on the reliability of estimation of the degree of the equipment damage. One of the mandatory requirements, providing the reliability of such estimation, and also evaluation of VVER equipment lifetime, is the monitoring of equipment radiation loading parameters. In this connection, there is a problem of justification of such normative parameters, used for an estimation of the pressure vessel metal embrittlement, as the fluence and fluence rate (FR) of fast neutrons above 0.5 MeV. From the point of view of regulatory practice, a comparison of displacement per atom (DPA) and fast neutron fluence (FNF) above 0.5 MeV has a practical concern. In accordance with the Russian regulatory rules, neutron fluence F(E > 0.5 MeV) is a radiation exposure parameter used in steel embrittlement prediction under neutron irradiation. However, the DPA parameter is a more physically legitimate quantity of neutron damage of Fe based materials. If DPA distribution in reactor structures is more conservative as neutron fluence, this case should attract the attention of the regulatory authority. The purpose of this work was to show what radiation load parameters (fluence, DPA) on all VVER equipment should be under control, and give the reasonable estimations of such parameters in the volume of all equipment. The second task is to give the conservative estimation of each parameter including its uncertainty. Results of recently received investigations allow to test the conservatism of calculational predictions, and, as it has been shown in the paper, combination of ex-vessel measured data with calculated ones allows to assess unpredicted uncertainties which are results of specific unique features of individual equipment for VVER reactor. Some results of calculational-experimental investigations are presented in this paper.

Keywords: equipment integrity, fluence, displacement per atom, nuclear power plant, neutron activation measurements, neutron transport calculations

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2994 Determination of Aflatoxins in Edible-Medicinal Plant Samples by HPLC with Fluorescence Detector and KOBRA-Cell

Authors: Isil Gazioglu, Abdulselam Ertas

Abstract:

Aflatoxins (AFs) are secondary toxic metabolites of Aspergillus flavus and A. parasiticus. AFs can be absorbed through the skin. Potent carcinogens like AFs should be completely absent from cosmetics, this can be achieved by careful quality control of the raw plant materials. Regulatory limits for aflatoxins have been established in many countries, and reliable testing methodology is needed to implement and enforce the regulatory limits. In this study, ten medicinal plant samples (Bundelia tournefortti, Capsella bursa-pastoris, Carduus tenuiflorus, Cardaria draba, Malva neglecta, Malvella sharardiana, Melissa officinalis, Sideritis libanotica, Stakys thirkei, Thymus nummularius) were investigated for aflatoxin (AF) contaminations by employing an HPLC assay for the determination of AFB1, B2, G1 and G2. The samples were extracted with 70% (v/v) methanol in water before further cleaned up with an immunoaffinity column and followed by the detection of AFs by using an electrochemically post-column derivatization with Kobra-Cell and fluorescence detector. The extraction procedure was optimized in order to obtain the best recovery. The method was successfully carried out with all medicinal plant samples. The results revealed that five (50%) of samples were contaminated with AFs. The association between particular samples and the AF contaminated could not be determined due to the low frequency of positive samples.

Keywords: aflatoxin B1, HPLC-FLD, KOBRA-Cell, mycotoxin

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2993 Young Social Beings: An Investigation into the Social Interactions and Relationships of a Year Five Class

Authors: A. Sewell

Abstract:

The paper reports a research project which investigated the social interactions of nine to ten-year-olds in a mainstream primary school. The project implemented an adaption of a whole class, behavioural intervention known as 'The Good Behaviour Game (TGBG)'. TGBG is an evidence-based intervention traditionally used to reduce low-level disruptive behaviours in a classroom setting. TGBG was adapted to encourage pupil’s engagement in pro-social behaviour during lessons. A mixed methods research design was employed to evaluate intervention effects and pupil’s perceptions of their social interactions and relationships with others. Single-case research design was used to evaluate behaviour change, and Personal Construct Psychology (PCP) repertory grids were used to explore pupil’s perceptions. The findings demonstrated that TGBG could be successfully adapted to positively influence pupil’s engagement in pro-social behaviours. The findings from the PCP repertory grid interviews revealed the complexities of how children construct their social interactions and relationships with others, and how an understanding of these could be used to design better social skills interventions. It is concluded that TGBG is a cost-effective, simple to implement intervention for promoting positive social interactions and relationships at the whole class level. The paper presents the aims, design, findings, and conclusions of the study in further detail and relates limitations and potential future extensions of the research. The outcomes have direct application and relevance for practitioners interested in children’s social development and how to promote positive outcomes in this critical aspect of childhood.

Keywords: social skills, social development, social competency, the good behaviour game

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2992 Language Development and Learning about Violence

Authors: Karen V. Lee

Abstract:

The background and significance of this study involves research about a music teacher discovering how language development and learning can help her overcome harmful and lasting consequences from sexual violence. Education about intervention resources from language development that helps her cope with consequences influencing her career as teacher. Basic methodology involves the qualitative method of research as theoretical framework where the author is drawn into a deep storied reflection about political issues surrounding teachers who need to overcome social, psychological, and health risk behaviors from violence. Sub-themes involve available education from learning resources to ensure teachers receive social, emotional, physical, spiritual, and intervention resources that evoke visceral, emotional responses from the audience. Major findings share how language development and learning provide helpful resources to victims of violence. It is hoped the research dramatizes an episodic yet incomplete story that highlights the circumstances surrounding the protagonist’s life. In conclusion, the research has a reflexive storied framework that embraces harmful and lasting consequences from sexual violence. The reflexive story of the sensory experience critically seeks verisimilitude by evoking lifelike and believable feelings from others. Thus, the scholarly importance of using language development and learning for intervention resources can provide transformative aspects that contribute to social change. Overall, the circumstance surrounding the story about sexual violence is not uncommon in society. Language development and learning supports the moral mission to help teachers overcome sexual violence that socially impacts their professional lives as victims.

Keywords: intervention, language development and learning, sexual violence, story

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2991 Educational Challenges: Cultural Behaviours, Psychopathology and Psychological Intervention

Authors: Sandra Figueiredo, Alexandra Pereira, Ana Oliveira, Idia Brito, Ivaniltan Jones, Joana Moreira, Madalena Silva, Maria Paraíba, Milene Silva, Tânia Pinho

Abstract:

In the present society, we are facing behaviours mainly in young individuals that might be considered trends of culture or psychopathology. Both contexts are challenges for Education, Psychology and Health. This paper examines nine case studies specifically in Educational Psychology with the main goal to identify and define phenomena contexts in school culture, the psychopathology involved and to present a psychological intervention for each case. The research was conducted by university students in the period of March 2017-June 2017, in Portugal, and the childhood was focused. The case studies explored the cyberbullying; the bullying - victims and bullies’ perspectives; the obsessive compulsive disorder; perception and inclusion of children from homoparental families; inclusion of foreign students in the higher education system; blindness and the inclusion in physical curricular activities; influence of doc-reality and media in attitudes and self-esteem; and the morningness and eveningness types learning in the same school timetables. The university students were supervised during their research analysis and two methods were available for the intervention research study: the meta-analysis and the empirical study. In the second phase, the pedagogical intervention was designed for the different educational contexts in analysis, especially concerning the school environments. The evidence of literature and the empirical studies showed new trends of school’ behaviours and educational disturbances that require further research and effective (and adequate to age, gender, nationality and culture) pedagogical instruments. Respecting the instruments, on the one hand, to identify behaviors, habits or pathologies and highlight the role and training of teachers, psychologists and health professionals, on the other hand, to promote the early intervention and to enhance healthy child development and orientation of the families. To respond to both milestones, this paper present nine pedagogical techniques and measures that will be discussed on their impact concerning advances for the psychological and educational intervention, centered in the individual and in the new generations of family’ cultures.

Keywords: behaviour, culture trends, educational intervention, psychopathology, obsessive compulsive disorder, cyberbullying, bullying, homoparental families, sleep influence, blindness and sports at school, inclusion of foreign students, media influence in behaviour

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2990 Feasibility Study of Women’s Participation in the Renovation of the Worn-Out Texture: A Case Study Investigation of the Worn-Out Urban Texture of the Tehran Helal-Ahmar Region

Authors: Bahram Siavashpor, Zeynab Haji Abdolhadi

Abstract:

The issue of the worn out textures is one of the urban community challenges in which, undoubtedly, the intervention is impossible without the social involvement. Some believe that in the worn out areas the most important intervention challenge is the social issues, and the most important social issue, in the intervention in the worn out areas, is how to attract public participation. Participation by itself has a widespread literature and despite relative acceptance, it should be said that planners, managers and designers are not always successful in attracting public participation. If participation means the intervention of all the residents in the neighborhood, women’s community forms half of these residents, but they are neglected in the participatory planning. It is important to know that to what extent the presence of women’s community in the related participation to the worn out textures affects the success of the projects. The present study hypotheses emphasize the effectiveness of women than men in involvement of the renovation and reforming projects. A case study was selected to investigate this hypothesis in order to test it through doing a questionnaire and visiting the place. Tehran Helal Ahmar region located in district 11 has 2740 households in which 51% are men and 49% women. The statistical population consists of 150 men and women of this area selected randomly. In the present study, interview technique with the executives was used as well as questionnaire along collecting the related research. The hypothesis analysis was carried out through SPSS and Excel software, in which two tests ‘Man-Whitney’ and ‘chi-square’ were used. The results indicate that women are empowered in the participation and renovation of the area, but it is necessary to rectify men’s attitude towards women’s ability in terms of women participation.

Keywords: renovation, social involvement, women’s participation, worn out texture

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2989 The Use of the Mediated Learning Experience in Response of Special Needs Education

Authors: Maria Luisa Boninelli

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This study wants to explore the effects of a mediated intervention program in a primary school. The participants where 120 students aged 8-9, half of them Italian and half immigrants of first or second generation. The activities consisted on the cognitive enhancement of the participants through Feuerstein’s Instrumental Enrichment, (IE) and on an activity centred on body awareness and mediated learning experience. Given that there are limited studied on learners in remedial schools, the current study intented to hypothesized that participants exposed to mediation would yiel a significant improvement in cognitive functioning. Hypothesis One proposed that, following the intervention, improved Q1vata scores of the participants would occur in each of the groups. Hypothesis two postulated that participants within the Mediated Learning Experience would perform significantly better than those group of control. For the intervention a group of 60 participants constituted a group of Mediation sample and were exposed to Mediated Learning Experience through Enrichment Programm. Similiary the other 60 were control group. Both the groups have students with special needs and were exposed to the same learning goals. A pre-experimental research design, in particular a one-group pretest-posttest approach was adopted. All the participants in this study underwent pretest and post test phases whereby they completed measures according to the standard instructions. During the pretest phase, all the participants were simultaneously exposed to Q1vata test for logical and linguistic evaluation skill. During the mediation intervention, significant improvement was demonstrated with the group of mediation. This supports Feuerstein's Theory that initial poor performance was a result of a lack of mediated learning experience rather than inherent difference or deficiencies. Furthermore the use of an appropriate mediated learning enabled the participants to function adequately.

Keywords: cognitive structural modifiability, learning to learn, mediated learning experience, Reuven Feuerstein, special needs

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2988 Comparative Outcomes of Percutaneous Coronary Intervention in Smokers versus Non Nonsmokers Patients: Observational Studies

Authors: Pratima Tatke, Archana Avhad, Bhanu Duggal, Meeta Rajivlochan, Sujata Saunik, Pradip Vyas, Nidhi Pandey, Aditee Dalvi, Jyothi Subramanian

Abstract:

Background: Smoking is well established risk factor for the development and progression of coronary artery disease. It is strongly related to morbidity and mortality from cardiovascular causes. The aim of this study is to observe effect of smoking status on percutaneous coronary intervention(PCI) after 1 year. Methods: 2527 patients who underwent PCI at different hospital of Maharashtra(India) from 2012 to 2015 under the health insurance scheme which is launched by Health department, Government of Maharashtra for below poverty line(BPL) families which covers cardiology. Informed consent of patients was taken .They were followed by telephonic survey after 6months to 1year of PCI . Outcomes of interest included myocardial infarction, restenosis, cardiac rehospitalization, death, and a composite of events after PCI. Made group of two non smokers-1861 and smokers (including patients who quit at time of PCI )-659. Results: Statistical Analysis using Pearson’s chi square test revealed that there was trend seen of increasing incidence of death, Myocardial infarction and Restenosis in smokers than non smokers .Smokers had a greater death risk compared to nonsmoker; 5.7% and 5.1% respectively p=0.518. Also Repeat procedures (2.1% vs. 1.5% p=0.222), breathlessness (17.8% vs. 18.20% p=0.1) and Myocardial Infarction (7.3% vs. 10%) high in smoker than non smokers. Conclusion: Major adverse cardiovascular events (MACE) were observed even after successful PCI in smokers. Patients undergoing percutaneous coronary intervention should be encouraged to stop smoking.

Keywords: coronary artery diseases, major adverse cardiovascular events, percutaneous coronary intervention, smoking

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2987 Comparison of Quality of Life One Year after Bariatric Intervention: Systematic Review of the Literature with Bayesian Network Meta-Analysis

Authors: Piotr Tylec, Alicja Dudek, Grzegorz Torbicz, Magdalena Mizera, Natalia Gajewska, Michael Su, Tanawat Vongsurbchart, Tomasz Stefura, Magdalena Pisarska, Mateusz Rubinkiewicz, Piotr Malczak, Piotr Major, Michal Pedziwiatr

Abstract:

Introduction: Quality of life after bariatric surgery is an important factor when evaluating the final result of the treatment. Considering the vast surgical options, we tried to globally compare available methods in terms of quality of following the surgery. The aim of the study is to compare the quality of life a year after bariatric intervention using network meta-analysis methods. Material and Methods: We performed a systematic review according to PRISMA guidelines with Bayesian network meta-analysis. Inclusion criteria were: studies comparing at least two methods of weight loss treatment of which at least one is surgical, assessment of the quality of life one year after surgery by validated questionnaires. Primary outcomes were quality of life one year after bariatric procedure. The following aspects of quality of life were analyzed: physical, emotional, general health, vitality, role physical, social, mental, and bodily pain. All questionnaires were standardized and pooled to a single scale. Lifestyle intervention was considered as a referenced point. Results: An initial reference search yielded 5636 articles. 18 studies were evaluated. In comparison of total score of quality of life, we observed that laparoscopic sleeve gastrectomy (LSG) (median (M): 3.606, Credible Interval 97.5% (CrI): 1.039; 6.191), laparoscopic Roux en-Y gastric by-pass (LRYGB) (M: 4.973, CrI: 2.627; 7.317) and open Roux en-Y gastric by-pass (RYGB) (M: 9.735, CrI: 6.708; 12.760) had better results than other bariatric intervention in relation to lifestyle interventions. In the analysis of the physical aspects of quality of life, we notice better results in LSG (M: 3.348, CrI: 0.548; 6.147) and in LRYGB procedure (M: 5.070, CrI: 2.896; 7.208) than control intervention, and worst results in open RYGB (M: -9.212, CrI: -11.610; -6.844). Analyzing emotional aspects, we found better results than control intervention in LSG, in LRYGB, in open RYGB, and laparoscopic gastric plication. In general health better results were in LSG (M: 9.144, CrI: 4.704; 13.470), in LRYGB (M: 6.451, CrI: 10.240; 13.830) and in single-anastomosis gastric by-pass (M: 8.671, CrI: 1.986; 15.310), and worst results in open RYGB (M: -4.048, CrI: -7.984; -0.305). In social and vital aspects of quality of life, better results were observed in LSG and LRYGB than control intervention. We did not find any differences between bariatric interventions in physical role, mental and bodily aspects of quality of life. Conclusion: The network meta-analysis revealed that better quality of life in total score one year after bariatric interventions were after LSG, LRYGB, open RYGB. In physical and general health aspects worst quality of life was in open RYGB procedure. Other interventions did not significantly affect the quality of life after a year compared to dietary intervention.

Keywords: bariatric surgery, network meta-analysis, quality of life, one year follow-up

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2986 Intensive Crosstalk between Autophagy and Intracellular Signaling Regulates Osteosarcoma Cell Survival Response under Cisplatin Stress

Authors: Jyothi Nagraj, Sudeshna Mukherjee, Rajdeep Chowdhury

Abstract:

Autophagy has recently been linked with cancer cell survival post drug insult contributing to acquisition of resistance. However, the molecular signaling governing autophagic survival response is poorly explored. In our study, in osteosarcoma (OS) cells cisplatin shock was found to activate both MAPK and autophagy signaling. An activation of JNK and autophagy acted as pro-survival strategy, while ERK1/2 triggered apoptotic signals upon cisplatin stress. An increased sensitivity of the cells to cisplatin was obtained with simultaneous inhibition of both autophagy and JNK pathway. Furthermore, we observed that the autophagic stimulation upon drug stress regulates other developmentally active signaling pathways like the Hippo pathway in OS cells. Cisplatin resistant cells were thereafter developed by repetitive drug exposure followed by clonal selection. Basal levels of autophagy were found to be high in resistant cells to. However, the signaling mechanism leading to autophagic up-regulation and its regulatory effect differed in OS cells upon attaining drug resistance. Our results provide valuable clues to regulatory dynamics of autophagy that can be considered for development of improved therapeutic strategy against resistant type cancers.

Keywords: JNK, autophagy, drug resistance, cancer

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2985 School Administrators’ Perspectives on Child Neglect and Abuse and Intervention Methods

Authors: Eylem G. Cengiz, Ersin Çilek, Gözde Başkaya, Havva Nur Taş

Abstract:

It is possible to define the abuse and neglect of the child as a social problem. Such adverse experiences of the child are witnessed by wider social circles as well as his or her immediate environment. The most effective institution among these social circles is the school. The awareness of teachers, administrators, and even auxiliary personnel on this issue can act as a protective and preventive buffer because teachers have the opportunity to be with children every day and constantly observe them; therefore, they can notice the physical and mental changes in students. Furthermore, school administrators have an undeniable role in recognizing and responding to the risk of neglect and abuse. This study aims to evaluate the awareness of school administrators on the risk factors, clues, and ways of intervention towards abuse and neglect through the scenarios given to them. Data were collected from 37 primary, secondary, and high school administrators working in various provinces of Turkey through descriptive and scenario-based questions to determine their general knowledge of the concepts of neglect and abuse and their general tendencies towards practice. Descriptive questions were evaluated with content analysis, and scenario-based questions were evaluated with numerical qualitative data analysis. Concepts and themes were tried to be reached by content analysis from the descriptive data collected. When the results are evaluated in general, it is striking that the concept of child abuse means only sexual abuse for some school administrators. There is an important uncertainty for school administrators in the content of the idea of neglect. When the views on the causes of neglect and abuse are examined, the family factor was seen as the primary source of both neglect and abuse. In addition, among the prevention strategies applied by school administrators, intervention for the family -interviewing and informing- was recommended by only 9 (29%) out of 31 administrators. When the responses to the physical, emotional, and sexual abuse scenarios are examined, it is revealed that the administrators generally realize the abuse but fail to develop an appropriate/whole intervention method. The research results show that school administrators' awareness should be increased. Although administrators have sensitivity towards children, they should be empowered to recognize all types of neglect and abuse and develop appropriate intervention tools.

Keywords: assessment child abuse and neglect, child abuse, child neglect, school administrators

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2984 Possibilities of Building Regional Migration Governance due to the Venezuelan Diaspora in Ibero-America (2015-2018)

Authors: Jonathan Palatz Cedeño

Abstract:

The paper will seek to examine the scope and limitations of the process of construction of ordinary and extraordinary migration regulatory tools of the countries of Latin America, due to the Venezuelan diaspora in Ibero-America (2015-2018). The analysis methodology will be based on a systematic presentation of the existing advances in the subject under a qualitative approach, in which the results are detailed. We hold that an important part of the Latin American countries that used to be the emitters of migrants have had to generate, with greater or lesser success both nationally and regionally, ordinary and extraordinary migration regulatory tools to respond to the rapid intensification of the current Venezuelan migratory flows. This fact beyond implementing policies for the reception and integration of this population marks a new moment that represents a huge challenge both for the receiving States and for the young Ibero-American institutional migration system. Therefore, we can say that measures to adopt reception and solidarity policies, despite being supported by organs of the multilateral system such as UNHCR and IOM, are not found as guidelines for national and regional action, at the expense of the reactions of the respective public opinions and the influence of what to do of the neighboring countries in the face of the problem.

Keywords: Venezuela, migration, migration policies and governance, Venezuelan diaspora

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2983 Effects of Cranberry Juice Enriched with n-3 PUFA Consumption in Adjunct with Non-Surgical Periodontal Therapy on Glycemic Control, Antioxidant Status and Periodontal indices in Type 2 Diabetes Patients with Periodontitis

Authors: A. Zare Javid, H. Babaee, E. Ashrafzadeh, H. Yousefimanesh, M. Zakerkish, K. Ahmadi Angali, M. Ravanbakhsh

Abstract:

Introduction: Type 2 diabetes mellitus and periodontal disease hold a physiologically relationship. Periodontal disease, a common widespread chronic disease, is considered as an important complication in diabetes mellitus. The prevalence and severity of periodontal disease are increased among diabetic patients. A balanced nutrition may improve either diabetes or periodontal disease by controlling one of them. The aim of this study was to evaluate the effects of cranberry juice enriched with n-3 PUFA and their individual consumption on glycemic control and antioxidant status in diabetic patients with periodontal disease. Methods: In this randomized clinical trial 41 diabetic patients (35 – 65 y) with chronic adult periodontal disease were recruited from Endocrinology Clinic of Golestan Hospital in Ahvaz city, Iran. Subjects were randomly assigned to four groups as follow: one control group (n=12) and three intervention groups as receiving 1 g n-3 PUFA capsule (n=10), 400 ml cranberry juice (n=9), 400 ml cranberry juice enriched with 1g n-3 PUFA (n=10) for 8 weeks. Non-surgical periodontal therapy was provided for all patients during study. Fasting blood glucose, glycated hemoglobin, plasma and saliva TAOC and MDA, pocket depth and bleeding on probing were measured at baseline and post intervention. Results: There was a significant reduction in glycated hemoglobin observed in intervention groups of receiving n-3 PUFA and cranberry enriched with n-3 PUFA (11 %, P = 0.01 and 7 %, P = 0.01, respectively). The intervention group receiving n-3 PUFA had significantly lower glycated hemoglobin compared with control group. There was no significant difference found in FBS between and within groups. Furthermore, there was a significant increase in plasma TAOC only in cranberry enriched with n-3 PUFA group. Moreover, plasma MDA significantly decreased in intervention groups of receiving cranberry and cranberry enriched with n-3 PUFA. A significant increase was observed in TAOC of salvia in cranberry enriched with n-3 PUFA group compared to control group .The intervention group receiving cranberry enriched with n-3 PUFA had significantly lower MDA of salvia compared with control group. Pocket depth were significantly decreased in all groups, however, bleeding on probing didn’t significantly changed in patients post intervention. Conclusion: It is suggested that consumption of cranberry juice enriched with n-3 PUFA as a nutritional approach in adjunct with non-surgical periodontal therapy may help to improve glycosylated hemogolobin and TAOC in salvia and plasma in diabetic patients with periodontal disease.

Keywords: antioxidant, cranberry, oxidant status, periodontal disease, type 2 diabetes mellitus

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2982 Entertainment-Education for the Prevention & Intervention of Eating Disorders in Adolescents

Authors: Tracey Lion-Cachet

Abstract:

Eating disorders typically manifest in adolescence and are notoriously difficult to treat. There are two notable reasons for this. Firstly, research consistently demonstrates that early intervention is a critical mediator of prognosis, with early intervention leading to a better prognosis. However, because eating disorders do not originate as full-syndrome diagnoses but rather as prodromal cases, they often go undetected; by the time symptoms meet diagnostic criteria, they have become recalcitrant. Another interrelated issue is motivation to change. Research demonstrates that in the early stages of an eating disorder, adolescents are highly resistant to change, and motivation increases only once symptoms have shifted from egosyntonic to egodystonic in nature. The purpose of this project was to design a prevention model based on the social psychology paradigm of Entertainment-Education, which embeds messages within the genre of film as a means of affecting change. The resulting project was a narrative screenplay targeting teenagers/young adults from diverse backgrounds. The goals of the project were to create a film script that, if ultimately made into a film, could serve to: 1) interrupt symptom progression and improve prognosis through early intervention; 2) incorporate techniques from third-wave cognitive behavioral treatment models, acceptance and commitment therapy (ACT) and rational recovery (RR), with a focus on the effects of mindfulness as a means of informing recovery; 3) target issues to do with motivation to change by shifting the perception of eating disorders from culturally specific psychiatric illnesses to habit-based brain wiring issues. Nine licensed clinicians were asked to evaluate two excerpts taken from the final script. They subsequently provided feedback on a Likert-scale, which assessed whether the script had achieved its goals. Overall, evaluators agreed that the project’s etiological and intervention models have the potential to inspire change and serve as an effective means of prevention and treatment of eating disorders. However, one-third of the evaluators did not find the content developmentally appropriate. This is a notable limitation to the study and will need to be addressed in the larger script before the final project can potentially be targeted to a teenage and young adult audience.

Keywords: adolescents, eating disorders, pediatrics, entertainment-education, mindfulness-based intervention, prevention

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2981 Effect of Non-Invasive Electrical Stimulation on Partial Hearing Loss: Pilot Study

Authors: Geetanjali Saggar

Abstract:

Background: Partial hearing loss is the inability to hear effectively as a normal hearing individual whose hearing threshold is 20 dB or better in both ears. Individuals with partial hearing loss may benefit from non-invasive electrical stimulation as a method of therapy and possible intervention. Objective: The project aims to assess and relate the efficacy of electrical stimulation on individuals with partial hearing loss. The study's goal was to evaluate the different sorts of non-invasive electrical stimulation in tinnitus and hearing loss in order to build the framework for future research. Method: In this pilot study, a total of five patients of age group above 50 years were selected with partial hearing loss. The electrical modality of Repetitive Transcranial Magnetic Stimulation (RTMS) was used among the patients and was evaluated using gold questionnaires- HHIA and APHAB for hearing at intervals of 0-7-14 days. The statistical data was analyzed by SPSS software-16. Results: There were not much significant changes in the hearing of the patients when non-invasive electrical modality was applied as an intervention in the partial hearing loss condition. However, there was minimal change in the daily functioning of the patient with the application of intervention. Conclusion: This study concluded that non-invasive electrical stimulation had minimal to no effect on the partial hearing of the patients.

Keywords: non-invasive, hearing loss, transcranial magnetic stimulation, partial deafness, transcranial direct current stimulation, tinnitus

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2980 Effect of Automatic Self Transcending Meditation on Perceived Stress and Sleep Quality in Adults

Authors: Divya Kanchibhotla, Shashank Kulkarni, Shweta Singh

Abstract:

Chronic stress and sleep quality reduces mental health and increases the risk of developing depression and anxiety as well. There is increasing evidence for the utility of meditation as an adjunct clinical intervention for conditions like depression and anxiety. The present study is an attempt to explore the impact of Sahaj Samadhi Meditation (SSM), a category of Automatic Self Transcending Meditation (ASTM), on perceived stress and sleep quality in adults. The study design was a single group pre-post assessment. Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI) were used in this study. Fifty-two participants filled PSS, and 60 participants filled PSQI at the beginning of the program (day 0), after two weeks (day 16) and at two months (day 60). Significant pre-post differences for the perceived stress level on Day 0 - Day 16 (p < 0.01; Cohen's d = 0.46) and Day 0 - Day 60 (p < 0.01; Cohen's d = 0.76) clearly demonstrated that by practicing SSM, participants experienced reduction in the perceived stress. The effect size of the intervention observed on the 16th day of assessment was small to medium, but on the 60th day, a medium to large effect size of the intervention was observed. In addition to this, significant pre-post differences for the sleep quality on Day 0 - Day 16 and Day 0 - Day 60 (p < 0.05) clearly demonstrated that by practicing SSM, participants experienced improvement in the sleep quality. Compared with Day 0 assessment, participants demonstrated significant improvement in the quality of sleep on Day 16 and Day 60. The effect size of the intervention observed on the 16th day of assessment was small, but on the 60th day, a small to medium effect size of the intervention was observed. In the current study we found out that after practicing SSM for two months, participants reported a reduction in the perceived stress, they felt that they are more confident about their ability to handle personal problems, were able to cope with all the things that they had to do, felt that they were on top of the things, and felt less angered. Participants also reported that their overall sleep quality improved; they took less time to fall asleep; they had less disturbances in sleep and less daytime dysfunction due to sleep deprivation. The present study provides clear evidence of the efficacy and safety of non-pharmacological interventions such as SSM in reducing stress and improving sleep quality. Thus, ASTM may be considered a useful intervention to reduce psychological distress in healthy, non-clinical populations, and it can be an alternative remedy for treating poor sleep among individuals and decreasing the use of harmful sedatives.

Keywords: automatic self transcending meditation, Sahaj Samadhi meditation, sleep, stress

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2979 Fall Prevention: Evidence-Based Intervention in Exercise Program Implementation for Keeping Older Adults Safe and Active

Authors: Jennifer Holbein, Maritza Wiedel

Abstract:

Background: Aging is associated with an increased risk of falls in older adults, and as a result, falls have become public health crises. However, the incidence of falls can be reduced through healthy aging and the implementation of a regular exercise and strengthening program. Public health and healthcare professionals authorize the use of evidence‐based, exercise‐focused fall interventions, but there are major obstacles to translating and disseminating research findings into healthcare practices. The purpose of this study was to assess the feasibility of an intervention, A Matter of Balance, in terms of demand, acceptability, and implementation into current exercise programs. Subjects: Seventy-five participants from rural communities, above the age of sixty, were randomized to an intervention or attention-control of the standardized senior fitness test. Methods: Subject completes the intervention, which combines two components: (1) motivation and (2) fall-reducing physical activities with protocols derived from baseline strength and balanced assessments. Participants (n=75) took part in the program after completing baseline functional assessments as well as evaluations of their personal knowledge, health outcomes, demand, and implementation interventions. After 8-weeks of the program, participants were invited to complete follow-up assessments with results that were compared to their baseline functional analyses. Out of all the participants in the study who complete the initial assessment, approximately 80% are expected to maintain enrollment in the implemented prescription. Furthermore, those who commit to the program should show mitigation of fall risk upon completion of their final assessment.

Keywords: aging population, exercise, falls, functional assessment, healthy aging

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2978 Accountants and Anti-Money Laundering Compliance in the Real Estate Sector

Authors: Mark E. Lokanan, Liz Lee

Abstract:

This paper aims to examine the role of accountants as gatekeepers in anti-money laundering compliance in real estate transactions. The paper seeks to answer questions on ways in which accountants are involved in real estate transactions and mandatory compliance with regulatory authorities in Canada. The data for the study came from semi-structured interviews with accountants, lawyers, and government officials. Preliminary results reveal that there is a conflict between accountants’ obligation to disclose and loyalty to their clients. Accountants often do not see why they are obligated to disclose their clients' information to government agencies. The importance of the client in terms of the amount of revenue contributed to the accounting firm also plays a significant role in accountants' reporting decision-making process. Although the involvement of accountants in real estate purchase and sale transactions is limited to lawyers or notaries, they are often involved in designing financing schemes, which may involve money laundering activities. The paper is of wider public policy interests to both accountants and regulators. It is hard not to see Chartered Professional Accountant (CPA) Canada and government regulators using the findings to better understand the decision-making processes of accountants in their reporting practices to regulatory authorities.

Keywords: money laundering, real estate, disclosure, legislation, compliance

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2977 Scientific and Regulatory Challenges of Advanced Therapy Medicinal Products

Authors: Alaa Abdellatif, Gabrièle Breda

Abstract:

Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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2976 Acceptability of the Carers-ID Intervention for Family Carers of People with Intellectual Disabilities

Authors: Mark Linden, Michael Brown, Lynne Marsh, Maria Truesdale, Stuart Todd, Nathan Hughes, Trisha Forbes, Rachel Leonard

Abstract:

Background: Family carers of people with intellectual disabilities (ID) face ongoing challenges in accessing services and often experience poor mental health. Online support programmes may prove effective in addressing the mental health and well-being needs of family carers. This study sought to test the acceptability of a newly developed online support programme for carers of people with intellectual disabilities called Carers-ID. Methods A sequential mixed-methods explanatory design was utilised. An adapted version of the Acceptability of Health Apps among Adolescents (AHAA) Scale was distributed to family carers who had viewed the Carers-ID.com intervention. Following this, participants were invited to take part in an online interview. Interview questions focused on participants’ experiences of using the programme and its acceptability. Qualitative and quantitative data were analysed separately and then brought together through the triangulation protocol developed by Farmer et al (2006). Findings: Seventy family carers responded to the acceptability survey, whilst 10 took part in interviews. Six themes were generated from interviews with family carers. Based on our triangulation, four areas of convergence were identified, these included, programme usability and ease, attitudes towards the programme, perceptions of effectiveness, and programme relatability. Conclusions: In order to be acceptable, online interventions for carers of people with ID need to be accessible, understandable and easy to use, as carers time is precious. Further research is needed to investigate the effectiveness of online interventions for family carers, specifically considering which carers the intervention works for, and for whom it may not.

Keywords: intellectual disability, family carer, acceptability study, online intervention

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