Search results for: compliance regime
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 1438

Search results for: compliance regime

118 Monitoring of Educational Achievements of Kazakhstani 4th and 9th Graders

Authors: Madina Tynybayeva, Sanya Zhumazhanova, Saltanat Kozhakhmetova, Merey Mussabayeva

Abstract:

One of the leading indicators of the education quality is the level of students’ educational achievements. The processes of modernization of Kazakhstani education system have predetermined the need to improve the national system by assessing the quality of education. The results of assessment greatly contribute to addressing questions about the current state of the educational system in the country. The monitoring of students’ educational achievements (MEAS) is the systematic measurement of the quality of education for compliance with the state obligatory standard of Kazakhstan. This systematic measurement is independent of educational organizations and approved by the order of the Minister of Education and Scienceof Kazakhstan. The MEAS was conducted in the regions of Kazakhstanfor the first time in 2022 by the National Testing Centre. The measurement does not have legal consequences either for students or for educational organizations. Students’ achievements were measured in three subject areas: reading, mathematics and science literacy. MEAS was held for the first time in April this year, 105 thousand students from 1436 schools of Kazakhstan took part in the testing. The monitoring was accompanied by a survey of students, teachers, and school leaders. The goal is to identify which contextual factors affect learning outcomes. The testing was carried out in a computer format. The test tasks of MEAS are ranked according to the three levels of difficulty: basic, medium, and high. Fourth graders are asked to complete 30 closed-type tasks. The average score of the results is 21 points out of 30, which means 70% of tasks were successfully completed. The total number of test tasks for 9th grade students – 75 questions. The results of ninth graders are comparatively lower, the success rate of completing tasks is 63%. MEAS participants did not reveal a statistically significant gap in results in terms of the language of instruction, territorial status, and type of school. The trend of reducing the gap in these indicators is also noted in the framework of recent international studies conducted across the country, in particular PISA for schools in Kazakhstan. However, there is a regional gap in MOES performance. The difference in the values of the indicators of the highest and lowest scores of the regions was 11% of the success of completing tasks in the 4th grade, 14% in the 9thgrade. The results of the 4th grade students in reading, mathematics, and science literacy are: 71.5%, 70%, and 66.9%, respectively. The results of ninth-graders in reading, mathematics, and science literacy are 69.6%, 54%, and 60.8%, respectively. From the surveys, it was revealed that the educational achievements of students are considerably influenced by such factors as the subject competences of teachers, as well as the school climate and motivation of students. Thus, the results of MEAS indicate the need for an integrated approach to improving the quality of education. In particular, the combination of improving the content of curricula and textbooks, internal and external assessment of the educational achievements of students, educational programs of pedagogical specialties, and advanced training courses is required.

Keywords: assessment, secondary school, monitoring, functional literacy, kazakhstan

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117 Double Liposomes Based Dual Drug Delivery System for Effective Eradication of Helicobacter pylori

Authors: Yuvraj Singh Dangi, Brajesh Kumar Tiwari, Ashok Kumar Jain, Kamta Prasad Namdeo

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The potential use of liposomes as drug carriers by i.v. injection is limited by their low stability in blood stream. Firstly, phospholipid exchange and transfer to lipoproteins, mainly HDL destabilizes and disintegrates liposomes with subsequent loss of content. To avoid the pain associated with injection and to obtain better patient compliance studies concerning various dosage forms, have been developed. Conventional liposomes (unilamellar and multilamellar) have certain drawbacks like low entrapment efficiency, stability and release of drug after single breach in external membrane, have led to the new type of liposomal systems. The challenge has been successfully met in the form of Double Liposomes (DL). DL is a recently developed type of liposome, consisting of smaller liposomes enveloped in lipid bilayers. The outer lipid layer of DL can protect inner liposomes against various enzymes, therefore DL was thought to be more effective than ordinary liposomes. This concept was also supported by in vitro release characteristics i.e. DL formation inhibited the release of drugs encapsulated in inner liposomes. DL consists of several small liposomes encapsulated in large liposomes, i.e., multivesicular vesicles (MVV), therefore, DL should be discriminated from ordinary classification of multilamellar vesicles (MLV), large unilamellar vesicles (LUV), small unilamellar vesicles (SUV). However, for these liposomes, the volume of inner phase is small and loading volume of water-soluble drugs is low. In the present study, the potential of phosphatidylethanolamine (PE) lipid anchored double liposomes (DL) to incorporate two drugs in a single system is exploited as a tool to augment the H. pylori eradication rate. Preparation of DL involves two steps, first formation of primary (inner) liposomes by thin film hydration method containing one drug, then addition of suspension of inner liposomes on thin film of lipid containing the other drug. The success of formation of DL was characterized by optical and transmission electron microscopy. Quantitation of DL-bacterial interaction was evaluated in terms of percent growth inhibition (%GI) on reference strain of H. pylori ATCC 26695. To confirm specific binding efficacy of DL to H. pylori PE surface receptor we performed an agglutination assay. Agglutination in DL treated H. pylori suspension suggested selectivity of DL towards the PE surface receptor of H. pylori. Monotherapy is generally not recommended for treatment of a H. pylori infection due to the danger of development of resistance and unacceptably low eradication rates. Therefore, combination therapy with amoxicillin trihydrate (AMOX) as anti-H. pylori agent and ranitidine bismuth citrate (RBC) as antisecretory agent were selected for the study with an expectation that this dual-drug delivery approach will exert acceptable anti-H. pylori activity.

Keywords: Helicobacter pylorI, amoxicillin trihydrate, Ranitidine Bismuth citrate, phosphatidylethanolamine, multi vesicular systems

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116 Segmentation along the Strike-slip Fault System of the Chotts Belt, Southern Tunisia

Authors: Abdelkader Soumaya, Aymen Arfaoui, Noureddine Ben Ayed, Ali Kadri

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The Chotts belt represents the southernmost folded structure in the Tunisian Atlas domain. It is dominated by inherited deep extensional E-W trending fault zones, which are reactivated as strike-slip faults during the Cenozoic compression. By examining the geological maps at different scales and based on the fieldwork data, we propose new structural interpretations for the geometries and fault kinematics in the Chotts chain. A set of ENE-WSW right-lateral en echelon folds, with curved shapes and steeply inclined southern limbs, is visible in the map view of this belt. These asymmetric tight anticlines are affected by E-W trending fault segments linked by local bends and stepovers. The revealed kinematic indicators along one of these E-W striated faults (Tafferna segment), such as breccias and gently inclined slickenlines (N094, 80N, 15°W pitch angles), show direct evidence of dextral strike-slip movement. The calculated stress tensors from corresponding faults slip data reveal an overall strike-slip tectonic regime with reverse component and NW-trending sub-horizontal σ1 axis ranking between N130 to N150. From west to east, we distinguished several types of structures along the segmented dextral fault system of the Chotts Range. The NE-SW striking fold-thrust belt (~25 km-long) between two continuously linked E-W fault segments (NW of Tozeur town) has been suggested as a local restraining bend. The central part of the Chotts chain is occupied by the ENE-striking Ksar Asker anticlines (Taferna, Torrich, and Sif Laham), which are truncated by a set of E-W strike-slip fault segments. Further east, the fault segments of Hachichina and Sif Laham connected across the NW-verging asymmetric fold-thrust system of Bir Oum Ali, which can be interpreted as a left-stepping contractional bend (~20 km-long). The oriental part of the Chotts belt corresponds to an array of subparallel E-W oriented fault segments (i.e., Beidha, Bouloufa, El Haidoudi-Zemlet El Beidha) with similar lengths (around 10 km). Each of these individual separated segments is associated with curved ENE-trending en echelon right-stepping anticlines. These folds are affected by a set of conjugate R and R′ shear-type faults indicating a dextral strike-lip motion. In addition, the relay zones between these E-W overstepping fault segments define local releasing stepovers dominated by NW-SE subsidiary faults. Finally, the Chotts chain provides well-exposed examples of strike-slip tectonics along E-W distributed fault segments. Each fault zone shows a typical strike-slip architecture, including parallel fault segments connecting via local stepovers or bends. Our new structural interpretations for this region reveal a great influence of the E-W deep fault segments on regional tectonic deformations and stress field during the Cenozoic shortening.

Keywords: chotts belt, tunisian atlas, strike-slip fault, stepovers, fault segments

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115 The Ethics of Physical Restraints in Geriatric Care

Authors: Bei Shan Lin, Chun Mei Lu, Ya Ping Chen, Li Chen Lu

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This study explores the ethical issues concerning the use of physical restraint in geriatric care. Physical restraint use in a medical care setting is seen as a controversial form of treatment that has occurred over decades. There is no doubt that people nowadays are living longer than previous generations. The ageing process is inevitable. Common disease such as impaired comprehension, memory loss, and trouble expressing one’s self contribute to the difficulty that these older patients have in adapting to medical institution. For these reasons, physical restraint is often used in reducing the risk of falling, managing wandering behaviour, preventing agitation, and promoting patient compliance in geriatric care. It can mean that physical restraints are considered as a common practice that is used in the care of older patients. It is most commonly used for three specific purposes, including procedural restraint, restraint to prevent falls, and behavioural restraints. Although there have been well documented instances of morbidity and mortality recognised as being potential risks associated with physical restraint use, it continues to be permitted and used in healthcare, often in the name of safety. However, there is insufficient evidence supporting the effectiveness of physical restraint use reducing injuries from falls and controlling challenging behaviour in geriatric care settings. There is barely any empirical evidence of either a scientific basis or clinical trials have evaluated the improvement in patient safety following physical restraint. In difficult clinical situations, guidelines and practical suggestions for Healthcare professionals to comply requirements can help those making appropriate decisions and to facilitate better judgement regarding physical restraint use. The following recommendations are given for physical restraint use in long-term care settings: an interdisciplinary team approach to assess, evaluate, and treat underlying diseases to determine if treatment can ease issues precipitating physical restraint use; a clearly stated purpose of treatment plan should be made after weighing up the risk of physical restraint use against the risk of without physical restraint use; a care plan for physical restraint has to include individualised treatment planning, informed consent, identification and remedial action to avoid negative consequences, regular assessment and modification, reduction and removal of risks; patients and their families must have the opportunity to consider and give voluntary informed consent prior to physical restraint utilisation; patients, family members, and Healthcare professionals should be educated on use and adverse consequences of physical restraints in order to make raise awareness of potential risks and to take appropriate steps to prevent unnecessary harm; after physical restraint removal, Healthcare professionals should discuss with patients and family members about their experience, feelings, and any anxieties regarding the treatment. Physical restraint should always be considered a last resort as deprive patient’s freedom, control, and individuality. Healthcare professionals should emphasise on providing individualized care, interdisciplinary decision-making process, and creative and collaborative alternatives to promote older patient’s rights, dignity and overall well-being as much as possible.

Keywords: ethics healthcare, geriatric care, healthcare, physical restraint

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114 The International Legal Protection of Foreign Investment Through Bilateral Investment Treaties and Double Taxation Treaties in the Context of International Investment Law and International Tax Law

Authors: Abdulmajeed Abdullah Alqarni

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This paper is devoted a study of the current frameworks applicable to foreign investments at the levels of domestic and international law, with a particular focus on the legitimate balance to be achieved between the rights of the host state and the legal protections owed to foreign investors. At the wider level of analysis, the paper attempts to map and critically examine the relationship between foreign investment and economic development. In doing so, the paper offers a study in how current discourses and practices on investment law can reconcile the competing interests of developing and developed countries. The study draws on the growing economic imperative for developing nations to create a favorable investment climate capable of attracting private foreign investment. It notes that that over the past decades, an abundance of legal standards that establish substantive and procedural protections for legal forms of foreign investments in the host countries have evolved and crystalized. The study then goes on to offer a substantive analysis of legal reforms at the domestic level in countries such as Saudi Arabia before going on to provide an in- depth and substantive examination of the most important instruments developed at the levels of international law: bilateral investment agreements and double taxation agreements. As to its methods, the study draws on case studies and from data assessing the link between double taxation and economic development. Drawing from the extant literature and doctrinal research, and international and comparative jurisprudence, the paper excavates and critically examines contemporary definitions and norms of international investment law, many of which have been given concrete form and specificity in an ever-expanding number of bilateral and multilateral investment treaties. By reconsidering the wider challenges of conflicts of law and jurisdiction, and the competing aims of the modern investment law regime, the study reflects on how bilateral investment treaties might succeed in achieving the dual aims of rights protection and economic sovereignty. Through its examination of the double taxation phenomena, the study goes on to identify key practical challenges raised by the implementation of bilateral treaties whilst also assessing the sufficiency of the domestic and international legal solutions that are proposed in response. In its final analysis, the study aims to contribute to existing scholarship by assessing contemporary legal and economic barriers to the free flow of investment with due regard for the legitimate concerns and diversity of developing nations. It does by situating its analysis of the domestic enforcement of international investment instrument in its wider historical and normative context. By focusing on the economic and legal dimensions of foreign investment, the paper also aims to offer an interdisciplinary and holistic perspective on contemporary issues and developments in investment law while offering practical reform proposals that can be used to be achieve a more equitable balance between the rights and interests of states and private entities in an increasingly trans nationalized sphere of investment regulation and treaty arbitration.

Keywords: foreign investment, bilateral investment treaties, international tax law, double taxation treaties

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113 An Investigation into Why Very Few Small Start-Ups Business Survive for Longer Than Three Years: An Explanatory Study in the Context of Saudi Arabia

Authors: Motaz Alsolaim

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Nowadays, the challenges of running a start-up can be very complex and are perhaps more difficult than at any other time in the past. Changes in technology, manufacturing innovation, and product development, combined with intense competition and market regulations are factors that have put pressure on classic ways of managing firms, thereby forcing change. As a result, the rate of closure, exit or discontinuation of start-ups and young businesses is very high. Despite the essential role of small firms in an economy, they still tend to face obstacles that exert a negative influence on their performance and rate of survival. In fact, it is not easy to determine with any certainty the reasons why small firms fail. For this reason, failure itself is not clearly defined, and its exact causes are hard to diagnose. In this current study, therefore, the barriers to survival will be covered more broadly, especially personal/entrepreneurial, enterprise and environmental factors with regard to various possible reasons for this failure, in order to determine the best solutions and make appropriate recommendations. Methodology: It could be argued that mixed methods might help to improve entrepreneurship research addressing challenges emphasis in previous studies and to achieve the triangulation. Calls for the combined use of quantitative and qualitative research were also made in the entrepreneurship field since entrepreneurship is a multi-faceted area of research. Therefore, explanatory sequential mixed method was used, using questionnaire online survey for entrepreneurs, followed by semi-structure interview. Collecting over 750 surveys and accepting 296 valid surveys, after that 13 interviews from government official seniors, businessmen successful entrepreneurs, and non-successful entrepreneurs. Findings: The first phase findings ( quantitative) shows the obstacles to survive; starting from the personal/ entrepreneurial factors such as; past work experience, lack of skills and interest, are positive factors, while; gender, age and education level of the owner are negative factors. Internal factors such as lack of marketing research and weak business planning are positive. The environmental factors; in economic perspectives; difficulty to find labors, in socio-cultural perspectives; Social restriction and traditions found to be a negative factors. In other hand, from the political perspective; cost of compliance and insufficient government plans found to be a positive factors for small business failure. From infrastructure perspective; lack of skills labor, high level of bureaucracy and lack of information are positive factors. Conclusion: This paper serves to enrich the understanding of failure factors in MENA region more precisely in SA, by minimizing the probability of failure in small-micro entrepreneurial start-up in SA, in the light of the Saudi government’s Vision 2030 plan.

Keywords: small business barriers, start-up business, entrepreneurship, Saudi Arabia

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112 Assessment of Tidal Influence in Spatial and Temporal Variations of Water Quality in Masan Bay, Korea

Authors: S. J. Kim, Y. J. Yoo

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Slack-tide sampling was carried out at seven stations at high and low tides for a tidal cycle, in summer (7, 8, 9) and fall (10), 2016 to determine the differences of water quality according to tides in Masan Bay. The data were analyzed by Pearson correlation and factor analysis. The mixing state of all the water quality components investigated is well explained by the correlation with salinity (SAL). Turbidity (TURB), dissolved silica (DSi), nitrite and nitrate nitrogen (NNN) and total nitrogen (TN), which find their way into the bay from the streams and have no internal source and sink reaction, showed a strong negative correlation with SAL at low tide, indicating the property of conservative mixing. On the contrary, in summer and fall, dissolved oxygen (DO), hydrogen sulfide (H2S) and chemical oxygen demand with KMnO4 (CODMn) of the surface and bottom water, which were sensitive to an internal source and sink reaction, showed no significant correlation with SAL at high and low tides. The remaining water quality parameters showed a conservative or a non-conservative mixing pattern depending on the mixing characteristics at high and low tides, determined by the functional relationship between the changes of the flushing time and the changes of the characteristics of water quality components of the end-members in the bay. Factor analysis performed on the concentration difference data sets between high and low tides helped in identifying the principal latent variables for them. The concentration differences varied spatially and temporally. Principal factors (PFs) scores plots for each monitoring situation showed high associations of the variations to the monitoring sites. At sampling station 1 (ST1), temperature (TEMP), SAL, DSi, TURB, NNN and TN of the surface water in summer, TEMP, SAL, DSi, DO, TURB, NNN, TN, reactive soluble phosphorus (RSP) and total phosphorus (TP) of the bottom water in summer, TEMP, pH, SAL, DSi, DO, TURB, CODMn, particulate organic carbon (POC), ammonia nitrogen (AMN), NNN, TN and fecal coliform (FC) of the surface water in fall, TEMP, pH, SAL, DSi, H2S, TURB, CODMn, AMN, NNN and TN of the bottom water in fall commonly showed up as the most significant parameters and the large concentration differences between high and low tides. At other stations, the significant parameters showed differently according to the spatial and temporal variations of mixing pattern in the bay. In fact, there is no estuary that always maintains steady-state flow conditions. The mixing regime of an estuary might be changed at any time from linear to non-linear, due to the change of flushing time according to the combination of hydrogeometric properties, inflow of freshwater and tidal action, And furthermore the change of end-member conditions due to the internal sinks and sources makes the occurrence of concentration difference inevitable. Therefore, when investigating the water quality of the estuary, it is necessary to take a sampling method considering the tide to obtain average water quality data.

Keywords: conservative mixing, end-member, factor analysis, flushing time, high and low tide, latent variables, non-conservative mixing, slack-tide sampling, spatial and temporal variations, surface and bottom water

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111 Photonic Dual-Microcomb Ranging with Extreme Speed Resolution

Authors: R. R. Galiev, I. I. Lykov, A. E. Shitikov, I. A. Bilenko

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Dual-comb interferometry is based on the mixing of two optical frequency combs with slightly different lines spacing which results in the mapping of the optical spectrum into the radio-frequency domain for future digitizing and numerical processing. The dual-comb approach enables diverse applications, including metrology, fast high-precision spectroscopy, and distance range. Ordinary frequency-modulated continuous-wave (FMCW) laser-based Light Identification Detection and Ranging systems (LIDARs) suffer from two main disadvantages: slow and unreliable mechanical, spatial scan and a rather wide linewidth of conventional lasers, which limits speed measurement resolution. Dual-comb distance measurements with Allan deviations down to 12 nanometers at averaging times of 13 microseconds, along with ultrafast ranging at acquisition rates of 100 megahertz, allowing for an in-flight sampling of gun projectiles moving at 150 meters per second, was previously demonstrated. Nevertheless, pump lasers with EDFA amplifiers made the device bulky and expensive. An alternative approach is a direct coupling of the laser to a reference microring cavity. Backscattering can tune the laser to the eigenfrequency of the cavity via the so-called self-injection locked (SIL) effect. Moreover, the nonlinearity of the cavity allows a solitonic frequency comb generation in the very same cavity. In this work, we developed a fully integrated, power-efficient, electrically driven dual-micro comb source based on the semiconductor lasers SIL to high-quality integrated Si3N4 microresonators. We managed to obtain robust 1400-1700 nm combs generation with a 150 GHz or 1 THz lines spacing and measure less than a 1 kHz Lorentzian withs of stable, MHz spaced beat notes in a GHz band using two separated chips, each pumped by its own, self-injection locked laser. A deep investigation of the SIL dynamic allows us to find out the turn-key operation regime even for affordable Fabry-Perot multifrequency lasers used as a pump. It is important that such lasers are usually more powerful than DFB ones, which were also tested in our experiments. In order to test the advantages of the proposed techniques, we experimentally measured a minimum detectable speed of a reflective object. It has been shown that the narrow line of the laser locked to the microresonator provides markedly better velocity accuracy, showing velocity resolution down to 16 nm/s, while the no-SIL diode laser only allowed 160 nm/s with good accuracy. The results obtained are in agreement with the estimations and open up ways to develop LIDARs based on compact and cheap lasers. Our implementation uses affordable components, including semiconductor laser diodes and commercially available silicon nitride photonic circuits with microresonators.

Keywords: dual-comb spectroscopy, LIDAR, optical microresonator, self-injection locking

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110 Archaeoseismological Evidence for a Possible Destructive Earthquake in the 7th Century AD at the Ancient Sites of Bulla Regia and Chemtou (NW Tunisia): Seismotectonic and Structural Implications

Authors: Abdelkader Soumaya, Noureddine Ben Ayed, Ali Kadri, Said Maouche, Hayet Khayati Ammar, Ahmed Braham

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The historic sites of Bulla Regia and Chemtou are among the most important archaeological monuments in northwestern Tunisia, which flourished as large, wealthy settlements during the Roman and Byzantine periods (2nd to 7th centuries AD). An archaeoseismological study provides the first indications about the impact of a possible ancient strong earthquake in the destruction of these cities. Based on previous archaeological excavation results, including numismatic evidence, pottery, economic meltdown and urban transformation, the abrupt ruin and destruction of the cities of Bulla Regia and Chemtou can be bracketed between 613 and 647 AD. In this study, we carried out the first attempt to use the analysis of earthquake archaeological effects (EAEs) that were observed during our field investigations in these two historic cities. The damage includes different types of EAEs: folds on regular pavements, displaced and deformed vaults, folded walls, tilted walls, collapsed keystones in arches, dipping broken corners, displaced-fallen columns, block extrusions in walls, penetrative fractures in brick-made walls and open fractures on regular pavements. These deformations are spread over 10 different sectors or buildings and include 56 measured EAEs. The structural analysis of the identified EAEs can indicate an ancient destructive earthquake that probably destroyed the Bulla Regia and Chemtou archaeological sites. We then analyzed these measurements using structural geological analysis to obtain the maximum horizontal strain of the ground (e.g., S ₕₘₐₓ) on each building-oriented damage. After the collection and analysis of these strain datasets, we proceed to plot the orientation of Sₕₘₐₓ trajectories on the map of the archaeological site (Bulla Regia). We concluded that the obtained Sₕₘₐₓ trajectories within this site could then be related to the mean direction of ground motion (oscillatory movement of the ground) triggered by a seismic event, as documented for some historical earthquakes across the world. These Sₕₘₐₓ orientations closely match the current active stress field, as highlighted by some instrumental events in northern Tunisia. In terms of the seismic source, we strongly suggest that the reactivation of a neotectonic strike-slip fault trending N50E must be responsible for this probable historic earthquake and the recent instrumental seismicity in this area. This fault segment, affecting the folded quaternary deposits south of Jebel Rebia, passes through the monument of Bulla Regia. Stress inversion of the observed and measured data along this fault shows an N150 - 160 trend of Sₕₘₐₓ under a transpressional tectonic regime, which is quite consistent with the GPS data and the state of the current stress field in this region.

Keywords: NW Tunisia, archaeoseismology, earthquake archaeological effect, bulla regia - Chemtou, seismotectonic, neotectonic fault

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109 Training in Communicational Skills in Students of Medicine: Differences in Bilingualism

Authors: Naiara Ozamiz Etcebarria, Sonia Ruiz De Azua Garcia, Agurtzane Ortiz Jauregi, Virginia Guillen Cañas

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Introduction: The most relevant competencies of a health professional are an adequate communication capacity, which will influence the satisfaction of professionals and patients, therapeutic compliance, conflict prevention, clinical outcomes´ improvement and efficiency of health services. The ability of Active listening , empathy, assertiveness and social skills, are important abilities to develop in all professions in which there is a relationship with other people. In the field of health, it is even more important to have adequate qualities so that the treatment with the patient will be adequate and satisfactory. We conducted a research with students of third year in the Degree of Medicine with the objectives: - to know how the active listening, empathy, assertiveness and social skills of students are. - to know if there are differences according to different demographic variables, such as sex, language, age, number of siblings and interest in the subject. Material and Methods: The students of the Third year in the Degree of Medicine (N = 212) participated voluntarily. Sociodemographic data were collected. Descriptive and comparative analysis of the averages of the students with respect to active listening, empathy, assertiveness and social skills were performed. Once the questionnaires were collected, they were entered into the SPSS 21 database. Four communicational aspects were evaluated: The active listening questionnaire, the TECA empathy questionnaire, the ACDA questionnaire and the EHS questionnaire Social Skills Scale. The active listening questionnaire assesses these factors: Listening without interruption and less contradiction, Listening with 100% attention, Listening beyond words, Listening encouraging the other to go deeper. The TECA questionnaire of cognitive and affective empathy evaluates: Adoption of perspectives, Emotional Comprehension, Emphasizing stress, Empathic joy. The EHS questionnaire Social Skills Scale: Self-expression in social situations, Defending one's own rights as a consumer, Expressing anger or dissatisfaction, Refusing to do and cutting interactions off, Making requests, Initiating positive interactions with the other sex. The ACDA questionnaire Assertiveness Assessment Scale evaluates self-assertiveness and heteroaservitivity. Applicability: To train these skills is so important for clinical practice of medical students and these capabilities that can be measured in a longitudinal way time. Ethical-legal aspects: The data were anonymous. The study was approved by the Ethics Committee. Results: The students of the Third year in the Degree of Medicine (34.4% Basque speakers and 65.6% Spanish speakers) with average age 20.93, (27.8% men and 72.2% women). There are no differences in social skills between men and women. The Basque speaker students of are more heteroactive (ACDA) than Spanish students. Active listening has a high correlation with social skills, especially with self-expression in social situations. Listening without interruption has a high correlation with self-expression in social situations and initiating positive interactions with the opposite sex. Adoption of perspectives presents a high correlation with auto- assertiveness. Emotional understanding presents a high correlation with positive interactions with the opposite sex. Empathic joy correlates with self-assertiveness, self-expression in social situations, and initiating positive interactions with the opposite sex.

Keywords: active listening, assertiveness, communicational skills, empathy, students of medicine

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108 New Findings on the Plasma Electrolytic Oxidation (PEO) of Aluminium

Authors: J. Martin, A. Nominé, T. Czerwiec, G. Henrion, T. Belmonte

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The plasma electrolytic oxidation (PEO) is a particular electrochemical process to produce protective oxide ceramic coatings on light-weight metals (Al, Mg, Ti). When applied to aluminum alloys, the resulting PEO coating exhibit improved wear and corrosion resistance because thick, hard, compact and adherent crystalline alumina layers can be achieved. Several investigations have been carried out to improve the efficiency of the PEO process and one particular way consists in tuning the suitable electrical regime. Despite the considerable interest in this process, there is still no clear understanding of the underlying discharge mechanisms that make possible metal oxidation up to hundreds of µm through the ceramic layer. A key parameter that governs the PEO process is the numerous short-lived micro-discharges (micro-plasma in liquid) that occur continuously over the processed surface when the high applied voltage exceeds the critical dielectric breakdown value of the growing ceramic layer. By using a bipolar pulsed current to supply the electrodes, we previously observed that micro-discharges are delayed with respect to the rising edge of the anodic current. Nevertheless, explanation of the origin of such phenomena is still not clear and needs more systematic investigations. The aim of the present communication is to identify the relationship that exists between this delay and the mechanisms responsible of the oxide growth. For this purpose, the delay of micro-discharges ignition is investigated as the function of various electrical parameters such as the current density (J), the current pulse frequency (F) and the anodic to cathodic charge quantity ratio (R = Qp/Qn) delivered to the electrodes. The PEO process was conducted on Al2214 aluminum alloy substrates in a solution containing potassium hydroxide [KOH] and sodium silicate diluted in deionized water. The light emitted from micro-discharges was detected by a photomultiplier and the micro-discharge parameters (number, size, life-time) were measured during the process by means of ultra-fast video imaging (125 kfr./s). SEM observations and roughness measurements were performed to characterize the morphology of the elaborated oxide coatings while XRD was carried out to evaluate the amount of corundum -Al203 phase. Results show that whatever the applied current waveform, the delay of micro-discharge appearance increases as the process goes on. Moreover, the delay is shorter when the current density J (A/dm2), the current pulse frequency F (Hz) and the ratio of charge quantity R are high. It also appears that shorter delays are associated to stronger micro-discharges (localized, long and large micro-discharges) which have a detrimental effect on the elaborated oxide layers (thin and porous). On the basis of the results, a model for the growth of the PEO oxide layers will be presented and discussed. Experimental results support that a mechanism of electrical charge accumulation at the oxide surface / electrolyte interface takes place until the dielectric breakdown occurs and thus until micro-discharges appear.

Keywords: aluminium, micro-discharges, oxidation mechanisms, plasma electrolytic oxidation

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107 From Shelf to Shell - The Corporate Form in the Era of Over-Regulation

Authors: Chrysthia Papacleovoulou

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The era of de-regulation, off-shore and tax haven jurisdictions, and shelf companies has come to an end. The usage of complex corporate structures involving trust instruments, special purpose vehicles, holding-subsidiaries in offshore haven jurisdictions, and taking advantage of tax treaties is soaring. States which raced to introduce corporate friendly legislation, tax incentives, and creative international trust law in order to attract greater FDI are now faced with regulatory challenges and are forced to revisit the corporate form and its tax treatment. The fiduciary services industry, which dominated over the last 3 decades, is now striving to keep up with the new regulatory framework as a result of a number of European and international legislative measures. This article considers the challenges to the company and the corporate form as a result of the legislative measures on tax planning and tax avoidance, CRS reporting, FATCA, CFC rules, OECD’s BEPS, the EU Commission's new transparency rules for intermediaries that extends to tax advisors, accountants, banks & lawyers who design and promote tax planning schemes for their clients, new EU rules to block artificial tax arrangements and new transparency requirements for financial accounts, tax rulings and multinationals activities (DAC 6), G20's decision for a global 15% minimum corporate tax and banking regulation. As a result, states are found in a race of over-regulation and compliance. These legislative measures constitute a global up-side down tax-harmonisation. Through the adoption of the OECD’s BEPS, states agreed to an international collaboration to end tax avoidance and reform international taxation rules. Whilst the idea was to ensure that multinationals would pay their fair share of tax everywhere they operate, an indirect result of the aforementioned regulatory measures was to attack private clients-individuals who -over the past 3 decades- used the international tax system and jurisdictions such as Marshal Islands, Cayman Islands, British Virgin Islands, Bermuda, Seychelles, St. Vincent, Jersey, Guernsey, Liechtenstein, Monaco, Cyprus, and Malta, to name but a few, to engage in legitimate tax planning and tax avoidance. Companies can no longer maintain bank accounts without satisfying the real substance test. States override the incorporation doctrine theory and apply a real seat or real substance test in taxing companies and their activities, targeting even the beneficial owners personally with tax liability. Tax authorities in civil law jurisdictions lift the corporate veil through the public registries of UBO Registries and Trust Registries. As a result, the corporate form and the doctrine of limited liability are challenged in their core. Lastly, this article identifies the development of new instruments, such as funds and private placement insurance policies, and the trend of digital nomad workers. The baffling question is whether industry and states can meet somewhere in the middle and exit this over-regulation frenzy.

Keywords: company, regulation, TAX, corporate structure, trust vehicles, real seat

Procedia PDF Downloads 114
106 Knowledge Based Software Model for the Management and Treatment of Malaria Patients: A Case of Kalisizo General Hospital

Authors: Mbonigaba Swale

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Malaria is an infection or disease caused by parasites (Plasmodium Falciparum — causes severe Malaria, plasmodium Vivax, Plasmodium Ovale, and Plasmodium Malariae), transmitted by bites of infected anopheles (female) mosquitoes to humans. These vectors comprise of two types in Africa, particularly in Uganda, i.e. anopheles fenestus and Anopheles gambaie (‘example Anopheles arabiensis,,); feeds on man inside the house mainly at dusk, mid-night and dawn and rests indoors and makes them effective transmitters (vectors) of the disease. People in both urban and rural areas have consistently become prone to repetitive attacks of malaria, causing a lot of deaths and significantly increasing the poverty levels of the rural poor. Malaria is a national problem; it causes a lot of maternal pre-natal and antenatal disorders, anemia in pregnant mothers, low birth weights for the newly born, convulsions and epilepsy among the infants. Cumulatively, it kills about one million children every year in sub-Saharan Africa. It has been estimated to account for 25-35% of all outpatient visits, 20-45% of acute hospital admissions and 15-35% of hospital deaths. Uganda is the leading victim country, for which Rakai and Masaka districts are the most affected. So, it is not clear whether these abhorrent situations and episodes of recurrences and failure to cure from the disease are a result of poor diagnosis, prescription and dosing, treatment habits and compliance of the patients to the drugs or the ethical domain of the stake holders in relation to the main stream methodology of malaria management. The research is aimed at offering an alternative approach to manage and deal absolutely with problem by using a knowledge based software model of Artificial Intelligence (Al) that is capable of performing common-sense and cognitive reasoning so as to take decisions like the human brain would do to provide instantaneous expert solutions so as to avoid speculative simulation of the problem during differential diagnosis in the most accurate and literal inferential aspect. This system will assist physicians in many kinds of medical diagnosis, prescribing treatments and doses, and in monitoring patient responses, basing on the body weight and age group of the patient, it will be able to provide instantaneous and timely information options, alternative ways and approaches to influence decision making during case analysis. The computerized system approach, a new model in Uganda termed as “Software Aided Treatment” (SAT) will try to change the moral and ethical approach and influence conduct so as to improve the skills, experience and values (social and ethical) in the administration and management of the disease and drugs (combination therapy and generics) by both the patient and the health worker.

Keywords: knowledge based software, management, treatment, diagnosis

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105 Encapsulation of Venlafaxine-Dowex® Resinate: A Once Daily Multiple Unit Formulation

Authors: Salwa Mohamed Salah Eldin, Howida Kamal Ibrahim

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Introduction: Major depressive disorder affects high proportion of the world’s population presenting cost load in health care. Extended release venlafaxine is more convenient and could reduce discontinuation syndrome. The once daily dosing also reduces the potential for adverse events such as nausea due to reduced Cmax. Venlafaxine is an effective first-line agent in the treatment of depression. A once daily formulation was designed to enhance patient compliance. Complexing with a resin was suggested to improve loading of the water soluble drug. The formulated systems were thoroughly evaluated in vitro to prove superiority to previous trials and were compared to the commercial extended release product in experimental animals. Materials and Methods: Venlafaxine-resinates were prepared using Dowex®50WX4-400 and Dowex®50WX8-100 at drug to resin weight ratio of 1: 1. The prepared resinates were evaluated for their drug content, particle shape and surface properties and in vitro release profile in gradient pH. The release kinetics and mechanism were evaluated. Venlafaxine-Dowex® resinates were encapsulated using O/W solvent evaporation technique. Poly-ε-caprolactone, Poly(D, L-lactide-co-glycolide) ester, Poly(D, L-lactide) ester and Eudragit®RS100 were used as coating polymers alone and in combination. Drug-resinate microcapsules were evaluated for morphology, entrapment efficiency and in-vitro release profile. The selected formula was tested in rabbits using a randomized, single-dose, 2-way crossover study against Effexor-XR tablets under fasting condition. Results and Discussion: The equilibrium time was 30 min for Dowex®50WX4-400 and 90 min for Dowex®50WX8-100. The percentage drug loaded was 93.96 and 83.56% for both resins, respectively. Both drug-Dowex® resintes were efficient in sustaining venlafaxine release in comparison to the free drug (up to 8h.). Dowex®50WX4-400 based venlafaxine-resinate was selected for further encapsulation to optimize the release profile for once daily dosing and to lower the burst effect. The selected formula (coated with a mixture of Eudragit RS and PLGA in a ratio of 50/50) was chosen by applying a group of mathematical equations according to targeted values. It recorded the minimum burst effect, the maximum MDT (Mean dissolution time) and a Q24h (percentage drug released after 24 hours) between 95 and 100%. The 90% confidence intervals for the test/reference mean ratio of the log-transformed data of AUC0–24 and AUC0−∞ are within (0.8–1.25), which satisfies the bioequivalence criteria. Conclusion: The optimized formula could be a promising extended release form of the water soluble, short half lived venlafaxine. Being a multiple unit formulation, it lowers the probability of dose dumping and reduces the inter-subject variability in absorption.

Keywords: biodegradable polymers, cation-exchange resin, microencapsulation, venlafaxine hcl

Procedia PDF Downloads 375
104 Attitudes, Knowledge and Perceptions towards Cervical Cancer Messages among Female University Students

Authors: Anne Nattembo

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Cervical cancer remains a major public health problem in developing countries, especially in Africa. Effective cervical cancer prevention communication requires identification of behaviors, attitudes and increasing awareness of a given population; thus this study focused on investigating awareness, attitudes, and behavior among female university students towards cervical cancer messages. The study objectives sought to investigate the communication behavior of young adults towards cervical cancer, to understand female students recognition of cervical cancer as a problem, to identify the frames related to cervical cancer and their impact towards audience communication and participation behaviors, to identify the factors that influence behavioral intentions and level of involvement towards cervical cancer services and to make recommendations on how to improve cervical cancer communication towards female university students. The researcher obtained data using semi-structured interviews and focus group discussions targeting 90 respondents. The semi-structured in-depth interviews were carried out through one-on-one discussions basis using a set of prepared questions among 53 respondents. All interviews were audio-tape recorded. Each interview was directly typed into Microsoft Word. 4 focus group discussions were conducted with a total of 37 respondents; 2 female only groups with 10 respondents in one and 9 respondents in another, 1 mixed with 12 participants 5 of whom were male, and 1 male only group with 6 participants. The key findings show that the participants preferred to receive and access cervical cancer information from doctors although they were mainly receiving information from the radio. In regards to the type of public the respondents represent, majority of the respondents were non-publics in the sense that they did not have knowledge about cervical cancer, had low levels of involvement and had high constraint recognition their cervical cancer knowledge levels. The researcher identified the most salient audience frames among female university students towards cervical cancer and these included; death, loss, and fear. These frames did not necessarily make cervical cancer an issue of concern among the female university students but rather an issue they distanced themselves from as they did not perceive it as a risk. The study also identified the constraints respondents face in responding to cervical cancer campaign calls-to-action which included; stigma, lack of knowledge and access to services as well as lack of recommendation from doctors. In regards to sex differences, females had more knowledge about cervical cancer than the males. In conclusion the study highlights the importance of interpersonal communication in risk or health communication with a focus on health providers proactively sharing cervical cancer prevention information with their patients. Health provider’s involvement in cervical cancer is very important in influencing behavior and compliance of cervical cancer calls-to-action. The study also provides recommendations for designing effective cervical cancer campaigns that will positively impact on the audience such as packaging cervical cancer messages that also target the males as a way of increasing their involvement and more campaigns to increase awareness of cervical cancer as well as designing positive framed messages to counter the negative audience frames towards cervical cancer.

Keywords: cervical cancer communication, health communication, university students, risk communication

Procedia PDF Downloads 207
103 Informalization and Feminization of Labour Force in the Context of Globalization of Production: Case Study of Women Migrant Workers in Kinfra Apparel Park of India

Authors: Manasi Mahanty

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In the current phase of globalization, the mobility of capital facilitates outsourcing and subcontracting of production processes to the developing economies for cheap and flexible labour force. In such process, the globalization of production networks operates at multi-locational points within the nation. Under the new quota regime in the globalization period, the Indian manufacturing exporters came under the influence of corporate buyers and large retailers from the importing countries. As part of such process, the garment manufacturing sector is expected to create huge employment opportunities and to expand the export market in the country. While following these, expectations, the apparel and garment industries mostly target to hire female migrant workers with a purpose of establishing more flexible industrial relations through the casual nature of employment contract. It leads to an increasing women’s participation in the labour market as well as the rise in precarious forms of female paid employment. In the context, the main objective of the paper is to understand the wider dynamics of globalization of production and its link with informalization, feminization of labour force and internal migration process of the country. For this purpose, the study examines the changing labour relations in the KINFRA Apparel Park at Kerala’s Special Economic Zone which operates under the scheme ‘Apparel Parks for Export’ (APE) of the Government of India. The present study was based on both quantitative and qualitative analysis. In the first, the secondary sources of data were collected from the source location (SEAM centre) and destination (KINFRA Park). The official figures and data were discussed and analyzed in order to find out the various dimensions of labour relations under globalization of production. In the second, the primary survey was conducted to make a comparative analysis of local and migrant female workers. The study is executed by taking 100 workers in total. The local workers comprised of 53% of the sample whereas the outside state workers were 47%. Even personal interviews with management staff, and workers were also made for collecting the information regarding the organisational structure, nature, and mode of recruitment, work environment, etc. The study shows the enormous presence of rural women migrant workers in KINFRA Apparel Park. A Public Private Partnership (PPP) arranged migration system is found as Skills for Employment in Apparel Manufacturing (SEAM) from where young women and girls are being sent to work in garment factories of Kerala’s KINFRA International Apparel Park under the guise of an apprenticeship based recruitment. The study concludes that such arrangements try to avoid standard employment relationships and strengthen informalization, casualization and contractualization of work. In this process, the recruitment of women migrant workers is to be considered as best option for the employers of private industries which could be more easily hired and fired.

Keywords: female migration, globalization, informalization, KINFRA apparel park

Procedia PDF Downloads 315
102 The Effect of Online Analyzer Malfunction on the Performance of Sulfur Recovery Unit and Providing a Temporary Solution to Reduce the Emission Rate

Authors: Hamid Reza Mahdipoor, Mehdi Bahrami, Mohammad Bodaghi, Seyed Ali Akbar Mansoori

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Nowadays, with stricter limitations to reduce emissions, considerable penalties are imposed if pollution limits are exceeded. Therefore, refineries, along with focusing on improving the quality of their products, are also focused on producing products with the least environmental impact. The duty of the sulfur recovery unit (SRU) is to convert H₂S gas coming from the upstream units to elemental sulfur and minimize the burning of sulfur compounds to SO₂. The Claus process is a common process for converting H₂S to sulfur, including a reaction furnace followed by catalytic reactors and sulfur condensers. In addition to a Claus section, SRUs usually consist of a tail gas treatment (TGT) section to decrease the concentration of SO₂ in the flue gas below the emission limits. To operate an SRU properly, the flow rate of combustion air to the reaction furnace must be adjusted so that the Claus reaction is performed according to stoichiometry. Accurate control of the air demand leads to an optimum recovery of sulfur during the flow and composition fluctuations in the acid gas feed. Therefore, the major control system in the SRU is the air demand control loop, which includes a feed-forward control system based on predetermined feed flow rates and a feed-back control system based on the signal from the tail gas online analyzer. The use of online analyzers requires compliance with the installation and operation instructions. Unfortunately, most of these analyzers in Iran are out of service for different reasons, like the low importance of environmental issues and a lack of access to after-sales services due to sanctions. In this paper, an SRU in Iran was simulated and calibrated using industrial experimental data. Afterward, the effect of the malfunction of the online analyzer on the performance of SRU was investigated using the calibrated simulation. The results showed that an increase in the SO₂ concentration in the tail gas led to an increase in the temperature of the reduction reactor in the TGT section. This increase in temperature caused the failure of TGT and increased the concentration of SO₂ from 750 ppm to 35,000 ppm. In addition, the lack of a control system for the adjustment of the combustion air caused further increases in SO₂ emissions. In some processes, the major variable cannot be controlled directly due to difficulty in measurement or a long delay in the sampling system. In these cases, a secondary variable, which can be measured more easily, is considered to be controlled. With the correct selection of this variable, the main variable is also controlled along with the secondary variable. This strategy for controlling a process system is referred to as inferential control" and is considered in this paper. Therefore, a sensitivity analysis was performed to investigate the sensitivity of other measurable parameters to input disturbances. The results revealed that the output temperature of the first Claus reactor could be used for inferential control of the combustion air. Applying this method to the operation led to maximizing the sulfur recovery in the Claus section.

Keywords: sulfur recovery, online analyzer, inferential control, SO₂ emission

Procedia PDF Downloads 53
101 A Hybrid of BioWin and Computational Fluid Dynamics Based Modeling of Biological Wastewater Treatment Plants for Model-Based Control

Authors: Komal Rathore, Kiesha Pierre, Kyle Cogswell, Aaron Driscoll, Andres Tejada Martinez, Gita Iranipour, Luke Mulford, Aydin Sunol

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Modeling of Biological Wastewater Treatment Plants requires several parameters for kinetic rate expressions, thermo-physical properties, and hydrodynamic behavior. The kinetics and associated mechanisms become complex due to several biological processes taking place in wastewater treatment plants at varying times and spatial scales. A dynamic process model that incorporated the complex model for activated sludge kinetics was developed using the BioWin software platform for an Advanced Wastewater Treatment Plant in Valrico, Florida. Due to the extensive number of tunable parameters, an experimental design was employed for judicious selection of the most influential parameter sets and their bounds. The model was tuned using both the influent and effluent plant data to reconcile and rectify the forecasted results from the BioWin Model. Amount of mixed liquor suspended solids in the oxidation ditch, aeration rates and recycle rates were adjusted accordingly. The experimental analysis and plant SCADA data were used to predict influent wastewater rates and composition profiles as a function of time for extended periods. The lumped dynamic model development process was coupled with Computational Fluid Dynamics (CFD) modeling of the key units such as oxidation ditches in the plant. Several CFD models that incorporate the nitrification-denitrification kinetics, as well as, hydrodynamics was developed and being tested using ANSYS Fluent software platform. These realistic and verified models developed using BioWin and ANSYS were used to plan beforehand the operating policies and control strategies for the biological wastewater plant accordingly that further allows regulatory compliance at minimum operational cost. These models, with a little bit of tuning, can be used for other biological wastewater treatment plants as well. The BioWin model mimics the existing performance of the Valrico Plant which allowed the operators and engineers to predict effluent behavior and take control actions to meet the discharge limits of the plant. Also, with the help of this model, we were able to find out the key kinetic and stoichiometric parameters which are significantly more important for modeling of biological wastewater treatment plants. One of the other important findings from this model were the effects of mixed liquor suspended solids and recycle ratios on the effluent concentration of various parameters such as total nitrogen, ammonia, nitrate, nitrite, etc. The ANSYS model allowed the abstraction of information such as the formation of dead zones increases through the length of the oxidation ditches as compared to near the aerators. These profiles were also very useful in studying the behavior of mixing patterns, effect of aerator speed, and use of baffles which in turn helps in optimizing the plant performance.

Keywords: computational fluid dynamics, flow-sheet simulation, kinetic modeling, process dynamics

Procedia PDF Downloads 177
100 South-Mediterranean Oaks Forests Management in Changing Climate Case of the National Park of Tlemcen-Algeria

Authors: K. Bencherif, M. Bellifa

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The expected climatic changes in North Africa are the increase of both intensity and frequencies of the summer droughts and a reduction in water availability during growing season. The exiting coppices and forest formations in the national park of Tlemcen are dominated by holm oak, zen oak and cork oak. These opened-fragmented structures don’t seem enough strong so to hope durable protection against climate change. According to the observed climatic tendency, the objective is to analyze the climatic context and its evolution taking into account the eventual behaving of the oak species during the next 20-30 years on one side and the landscaped context in relation with the most adequate sylvicultural models to choose and especially in relation with human activities on another side. The study methodology is based on Climatic synthesis and Floristic and spatial analysis. Meteorological data of the decade 1989-2009 are used to characterize the current climate. An another approach, based on dendrochronological analysis of a 120 years sample Aleppo pine stem growing in the park, is used so to analyze the climate evolution during one century. Results on the climate evolution during the 50 years obtained through climatic predictive models are exploited so to predict the climate tendency in the park. Spatially, in each forest unit of the Park, stratified sampling is achieved so to reduce the degree of heterogeneity and to easily delineate different stands using the GPS. Results from precedent study are used to analyze the anthropogenic factor considering the forecasts for the period 2025-2100, the number of warm days with a temperature over 25°C would increase from 30 to 70. The monthly mean temperatures of the maxima’s (M) and the minima’s (m) would pass respectively from 30.5°C to 33°C and from 2.3°C to 4.8°C. With an average drop of 25%, precipitations will be reduced to 411.37 mm. These new data highlight the importance of the risk fire and the water stress witch would affect the vegetation and the regeneration process. Spatial analysis highlights the forest and the agricultural dimensions of the park compared to the urban habitat and bare soils. Maps show both fragmentation state and forest surface regression (50% of total surface). At the level of the park, fires affected already all types of covers creating low structures with various densities. On the silvi cultural plan, Zen oak form in some places pure stands and this invasion must be considered as a natural tendency where Zen oak becomes the structuring specie. Climate-related changes have nothing to do with the real impact that South-Mediterranean forests are undergoing because human constraints they support. Nevertheless, hardwoods stand of oak in the national park of Tlemcen will face up to unexpected climate changes such as changing rainfall regime associated with a lengthening of the period of water stress, to heavy rainfall and/or to sudden cold snaps. Faced with these new conditions, management based on mixed uneven aged high forest method promoting the more dynamic specie could be an appropriate measure.

Keywords: global warming, mediterranean forest, oak shrub-lands, Tlemcen

Procedia PDF Downloads 370
99 A Randomized Active Controlled Clinical Trial to Assess Clinical Efficacy and Safety of Tapentadol Nasal Spray in Moderate to Severe Post-Surgical Pain

Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

Procedia PDF Downloads 218
98 Gender, Agency, and Health: An Exploratory Study Using an Ethnographic Material for Illustrative Reasons

Authors: S. Gustafsson

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The aim of this paper is to explore the connection between gender, agency, and health on personal and social levels over time. The use of gender as an analytical tool for health research has been shown to be useful to explore thoughts and ideas that are taken for granted, which have relevance for health. The paper highlights the following three issues. There are multiple forms of femininity and masculinity. Agency and social structure are closely related and referred to in this paper as 'gender agency'. Gender is illuminated as a product of history but also treated as a social factor and a producer of history. As a prominent social factor in the process of shaping living conditions, gender is highlighted as being significant for understanding health. To make health explicit as a dynamic and complex concept and not merely the opposite of disease requires a broader alliance with feminist theory and a post-Bourdieusian framework. A personal story, included with other ethnographic material about women’s networking in rural Sweden, is used as an empirical illustration. Ethnographic material was chosen for its ability to illustrate historical, local, and cultural ways of doing gendered and capitalized health. New concepts characterize ethnography, exemplified in this study by 'processes of transformation'. The semi-structured interviews followed an interview guide drafted with reference to the background theory of gender. The interviews lasted about an hour and were recorded and transcribed verbatim. The transcribed interviews and the author’s field notes formed the basis for the writing up of this paper. Initially, the participants' interests in weaving, sewing, and various handicrafts became obvious foci for networking activities and seemed at first to shape compliance with patriarchy, which generally does the opposite of promoting health. However, a significant event disrupted the stability of this phenomenon. What was permissible for the women began to crack and new spaces opened up. By exploiting these new spaces, the participants found opportunities to try out alternatives to emphasized femininity. Over time, they began combining feminized activities with degrees of masculinity, as leadership became part of the activities. In response to this, masculine enactment was gradually transformed and became increasingly gender neutral. As the tasks became more gender neutral the activities assumed a more formal character and the women stretched the limits of their capacity by enacting gender agency, a process the participants referred to as 'personal growth' and described as health promotion. What was described in terms of 'personal growth' can be interpreted as the effects of a raised status. Participation in women’s networking strengthened the participants’ structural position. More specifically, it was the gender-neutral position that was rewarded. To clarify the connection between gender, agency, and health on personal and social levels over time the concept processes of transformation is used. This concept is suggested as a dynamic equivalent to habitus. Health is thus seen as resulting from situational access to social recognition, prestige, capital assets and not least, meanings of gender.

Keywords: a cross-gender bodily hexis, gender agency, gender as analytical tool, processes of transformation

Procedia PDF Downloads 135
97 Confidence Envelopes for Parametric Model Selection Inference and Post-Model Selection Inference

Authors: I. M. L. Nadeesha Jayaweera, Adao Alex Trindade

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In choosing a candidate model in likelihood-based modeling via an information criterion, the practitioner is often faced with the difficult task of deciding just how far up the ranked list to look. Motivated by this pragmatic necessity, we construct an uncertainty band for a generalized (model selection) information criterion (GIC), defined as a criterion for which the limit in probability is identical to that of the normalized log-likelihood. This includes common special cases such as AIC & BIC. The method starts from the asymptotic normality of the GIC for the joint distribution of the candidate models in an independent and identically distributed (IID) data framework and proceeds by deriving the (asymptotically) exact distribution of the minimum. The calculation of an upper quantile for its distribution then involves the computation of multivariate Gaussian integrals, which is amenable to efficient implementation via the R package "mvtnorm". The performance of the methodology is tested on simulated data by checking the coverage probability of nominal upper quantiles and compared to the bootstrap. Both methods give coverages close to nominal for large samples, but the bootstrap is two orders of magnitude slower. The methodology is subsequently extended to two other commonly used model structures: regression and time series. In the regression case, we derive the corresponding asymptotically exact distribution of the minimum GIC invoking Lindeberg-Feller type conditions for triangular arrays and are thus able to similarly calculate upper quantiles for its distribution via multivariate Gaussian integration. The bootstrap once again provides a default competing procedure, and we find that similar comparison performance metrics hold as for the IID case. The time series case is complicated by far more intricate asymptotic regime for the joint distribution of the model GIC statistics. Under a Gaussian likelihood, the default in most packages, one needs to derive the limiting distribution of a normalized quadratic form for a realization from a stationary series. Under conditions on the process satisfied by ARMA models, a multivariate normal limit is once again achieved. The bootstrap can, however, be employed for its computation, whence we are once again in the multivariate Gaussian integration paradigm for upper quantile evaluation. Comparisons of this bootstrap-aided semi-exact method with the full-blown bootstrap once again reveal a similar performance but faster computation speeds. One of the most difficult problems in contemporary statistical methodological research is to be able to account for the extra variability introduced by model selection uncertainty, the so-called post-model selection inference (PMSI). We explore ways in which the GIC uncertainty band can be inverted to make inferences on the parameters. This is being attempted in the IID case by pivoting the CDF of the asymptotically exact distribution of the minimum GIC. For inference one parameter at a time and a small number of candidate models, this works well, whence the attained PMSI confidence intervals are wider than the MLE-based Wald, as expected.

Keywords: model selection inference, generalized information criteria, post model selection, Asymptotic Theory

Procedia PDF Downloads 65
96 Integrating the Principles of Sustainability and Corporate Social Responsibility (CSR): By Engaging the India Inc. With Sustainable Development Goals (SDGs)

Authors: Radhika Ralhan

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With the formalization of 2030, Global Agenda for Sustainable Development nations have instantaneously geared up their efforts towards the implementation of a comprehensive list of global goals. The criticality of Sustainable Development Goals (SDGs) is imperative, as it will define the course and pace of development for the next 15 years. This development will entail transformational shifts towards a green and inclusive growth. Leadership, investments and technology will constitute as key ingredients of this transformational shift and governance will emerge as a one of the most significant driver of the global 2030 agenda. Corporate Governance is viewed as one of the key force to accelerate the momentum of SDGs and initiate these transformational shifts. Many senior level leaders have reinstated their conviction that adopting a triple bottom line approach will play an imperative role in transforming the entire industrial sector. In the Indian context, the above occurrence bears an intriguing facet, as the framing of SDGs in the global scenario coincided with the emergence of mandatory Corporate Social Responsibility (CSR) Rules in India at national level. As one of the leading democracies in the world, India is among few countries to formally mandate companies to spend 2% from their CSR funds under Section 135 of The New Companies Act 2013. The overarching framework of SDGs correlates to the areas of CSR interventions as mentioned in the Schedule VII of Section 135. As one of the legitimate stakeholders, business leaders have expressed their commitments to their respective governments, to reorient the entire fabric of their companies to scale up global priorities. This is explicitly seen in the case of India where leading business entities have converged national government priorities of Clean India, Make in India and Skill India by actively participating in the campaigns and incorporating these programmes within the ambit of their CSR policies. However, the CSR Act has received mixed responses with associated concerns such as the onus of doing what the government has to do, mandatory reporting mechanisms, policy disclosures, personnel handling CSR portfolios etc. The overall objective of the paper, therefore, rests in analyzing the discourse of CSR and the perspectives of Indian Inc. in imbibing the principles of SDGs within their business polices and operations. Through primary and secondary research analysis, the paper attempts to outline the diverse challenges that are being faced by Indian businesses while establishing the business case of sustainable responsibility. Some of the principal questions that paper addresses are: What are the SDG priorities for India Inc. as per their respective industry sectors? How can corporate policies imbibe the SDGs principles? How can the global concerns in form of SDGs align with the national CSR mandate and development issues? What initiatives have been undertaken by the companies to integrate their long term business strategy and sustainability? The paper will also reinstate an approach or a way forward that will enable businesses to proceed beyond compliance and accentuate the principles of responsibility and transparency within their operational framework.

Keywords: corporate social responsibility, CSR, India Inc., section 135, new companies act 2013, sustainable development goals, SDGs, sustainability, corporate governance

Procedia PDF Downloads 230
95 E-Governance: A Key for Improved Public Service Delivery

Authors: Ayesha Akbar

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Public service delivery has witnessed a significant improvement with the integration of information communication technology (ICT). It not only improves management structure with advanced technology for surveillance of service delivery but also provides evidence for informed decisions and policy. Pakistan’s public sector organizations have not been able to produce some good results to ensure service delivery. Notwithstanding, some of the public sector organizations in Pakistan has diffused modern technology and proved their credence by providing better service delivery standards. These good indicators provide sound basis to integrate technology in public sector organizations and shift of policy towards evidence based policy making. Rescue-1122 is a public sector organization which provides emergency services and proved to be a successful model for the provision of service delivery to save human lives and to ensure human development in Pakistan. The information about the organization has been received by employing qualitative research methodology. The information is broadly based on primary and secondary sources which includes Rescue-1122 website, official reports of organizations; UNDP (United Nation Development Program), WHO (World Health Organization) and by conducting 10 in-depth interviews with the high administrative staff of organizations who work in the Lahore offices. The information received has been incorporated with the study for the better understanding of the organization and their management procedures. Rescue-1122 represents a successful model in delivering the services in an efficient way to deal with the disaster management. The management of Rescue has strategized the policies and procedures in such a way to develop a comprehensive model with the integration of technology. This model provides efficient service delivery as well as maintains the standards of the organization. The service delivery model of rescue-1122 works on two fronts; front-office interface and the back-office interface. Back-office defines the procedures of operations and assures the compliance of the staff whereas, front-office equipped with the latest technology and good infrastructure handles the emergency calls. Both ends are integrated with satellite based vehicle tracking, wireless system, fleet monitoring system and IP camera which monitors every move of the staff to provide better services and to pinpoint the distortions in the services. The standard time of reaching to the emergency spot is 7 minutes, and during entertaining the case; driver‘s behavior, traffic volume and the technical assistance being provided to the emergency case is being monitored by front-office. Then the whole information get uploaded to the main dashboard of Lahore headquarter from the provincial offices. The latest technology is being materialized by Rescue-1122 for delivering the efficient services, investigating the flaws; if found, and to develop data to make informed decision making. The other public sector organizations of Pakistan can also develop such models to integrate technology for improving service delivery and to develop evidence for informed decisions and policy making.

Keywords: data, e-governance, evidence, policy

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94 Modern Technology-Based Methods in Neurorehabilitation for Social Competence Deficit in Children with Acquired Brain Injury

Authors: M. Saard, A. Kolk, K. Sepp, L. Pertens, L. Reinart, C. Kööp

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Introduction: Social competence is often impaired in children with acquired brain injury (ABI), but evidence-based rehabilitation for social skills has remained undeveloped. Modern technology-based methods create effective and safe learning environments for pediatric social skills remediation. The aim of the study was to implement our structured model of neuro rehab for socio-cognitive deficit using multitouch-multiuser tabletop (MMT) computer-based platforms and virtual reality (VR) technology. Methods: 40 children aged 8-13 years (yrs) have participated in the pilot study: 30 with ABI -epilepsy, traumatic brain injury and/or tic disorder- and 10 healthy age-matched controls. From the patients, 12 have completed the training (M = 11.10 yrs, SD = 1.543) and 20 are still in training or in the waiting-list group (M = 10.69 yrs, SD = 1.704). All children performed the first individual and paired assessments. For patients, second evaluations were performed after the intervention period. Two interactive applications were implemented into rehabilitation design: Snowflake software on MMT tabletop and NoProblem on DiamondTouch Table (DTT), which allowed paired training (2 children at once). Also, in individual training sessions, HTC Vive VR device was used with VR metaphors of difficult social situations to treat social anxiety and train social skills. Results: At baseline (B) evaluations, patients had higher deficits in executive functions on the BRIEF parents’ questionnaire (M = 117, SD = 23.594) compared to healthy controls (M = 22, SD = 18.385). The most impaired components of social competence were emotion recognition, Theory of Mind skills (ToM), cooperation, verbal/non-verbal communication, and pragmatics (Friendship Observation Scale scores only 25-50% out of 100% for patients). In Sentence Completion Task and Spence Anxiety Scale, the patients reported a lack of friends, behavioral problems, bullying in school, and social anxiety. Outcome evaluations: Snowflake on MMT improved executive and cooperation skills and DTT developed communication skills, metacognitive skills, and coping. VR, video modelling and role-plays improved social attention, emotional attitude, gestural behaviors, and decreased social anxiety. NEPSY-II showed improvement in Affect Recognition [B = 7, SD = 5.01 vs outcome (O) = 10, SD = 5.85], Verbal ToM (B = 8, SD = 3.06 vs O = 10, SD = 4.08), Contextual ToM (B = 8, SD = 3.15 vs O = 11, SD = 2.87). ToM Stories test showed an improved understanding of Intentional Lying (B = 7, SD = 2.20 vs O = 10, SD = 0.50), and Sarcasm (B=6, SD = 2.20 vs O = 7, SD = 2.50). Conclusion: Neurorehabilitation based on the Structured Model of Neurorehab for Socio-Cognitive Deficit in children with ABI were effective in social skills remediation. The model helps to understand theoretical connections between components of social competence and modern interactive computerized platforms. We encourage therapists to implement these next-generation devices into the rehabilitation process as MMT and VR interfaces are motivating for children, thus ensuring good compliance. Improving children’s social skills is important for their and their families’ quality of life and social capital.

Keywords: acquired brain injury, children, social skills deficit, technology-based neurorehabilitation

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93 Leveraging Advanced Technologies and Data to Eliminate Abandoned, Lost, or Otherwise Discarded Fishing Gear and Derelict Fishing Gear

Authors: Grant Bifolchi

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As global environmental problems continue to have highly adverse effects, finding long-term, sustainable solutions to combat ecological distress are of growing paramount concern. Ghost Gear—also known as abandoned, lost or otherwise discarded fishing gear (ALDFG) and derelict fishing gear (DFG)—represents one of the greatest threats to the world’s oceans, posing a significant hazard to human health, livelihoods, and global food security. In fact, according to the UN Food and Agriculture Organization (FAO), abandoned, lost and discarded fishing gear represents approximately 10% of marine debris by volume. Around the world, many governments, governmental and non-profit organizations are doing their best to manage the reporting and retrieval of nets, lines, ropes, traps, floats and more from their respective bodies of water. However, these organizations’ ability to effectively manage files and documents about the environmental problem further complicates matters. In Ghost Gear monitoring and management, organizations face additional complexities. Whether it’s data ingest, industry regulations and standards, garnering actionable insights into the location, security, and management of data, or the application of enforcement due to disparate data—all of these factors are placing massive strains on organizations struggling to save the planet from the dangers of Ghost Gear. In this 90-minute educational session, globally recognized Ghost Gear technology expert Grant Bifolchi CET, BBA, Bcom, will provide real-world insight into how governments currently manage Ghost Gear and the technology that can accelerate success in combatting ALDFG and DFG. In this session, attendees will learn how to: • Identify specific technologies to solve the ingest and management of Ghost Gear data categories, including type, geo-location, size, ownership, regional assignment, collection and disposal. • Provide enhanced access to authorities, fisheries, independent fishing vessels, individuals, etc., while securely controlling confidential and privileged data to globally recognized standards. • Create and maintain processing accuracy to effectively track ALDFG/DFG reporting progress—including acknowledging receipt of the report and sharing it with all pertinent stakeholders to ensure approvals are secured. • Enable and utilize Business Intelligence (BI) and Analytics to store and analyze data to optimize organizational performance, maintain anytime-visibility of report status, user accountability, scheduling, management, and foster governmental transparency. • Maintain Compliance Reporting through highly defined, detailed and automated reports—enabling all stakeholders to share critical insights with internal colleagues, regulatory agencies, and national and international partners.

Keywords: ghost gear, ALDFG, DFG, abandoned, lost or otherwise discarded fishing gear, data, technology

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92 Music Piracy Revisited: Agent-Based Modelling and Simulation of Illegal Consumption Behavior

Authors: U. S. Putro, L. Mayangsari, M. Siallagan, N. P. Tjahyani

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National Collective Management Institute (LKMN) in Indonesia stated that legal music products were about 77.552.008 unit while illegal music products were about 22.0688.225 unit in 1996 and this number keeps getting worse every year. Consequently, Indonesia named as one of the countries with high piracy levels in 2005. This study models people decision toward unlawful behavior, music content piracy in particular, using agent-based modeling and simulation (ABMS). The classification of actors in the model constructed in this study are legal consumer, illegal consumer, and neutral consumer. The decision toward piracy among the actors is a manifestation of the social norm which attributes are social pressure, peer pressure, social approval, and perceived prevalence of piracy. The influencing attributes fluctuate depending on the majority of surrounding behavior called social network. There are two main interventions undertaken in the model, campaign and peer influence, which leads to scenarios in the simulation: positively-framed descriptive norm message, negatively-framed descriptive norm message, positively-framed injunctive norm with benefits message, and negatively-framed injunctive norm with costs message. Using NetLogo, the model is simulated in 30 runs with 10.000 iteration for each run. The initial number of agent was set 100 proportion of 95:5 for illegal consumption. The assumption of proportion is based on the data stated that 95% sales of music industry are pirated. The finding of this study is that negatively-framed descriptive norm message has a worse reversed effect toward music piracy. The study discovers that selecting the context-based campaign is the key process to reduce the level of intention toward music piracy as unlawful behavior by increasing the compliance awareness. The context of Indonesia reveals that that majority of people has actively engaged in music piracy as unlawful behavior, so that people think that this illegal act is common behavior. Therefore, providing the information about how widespread and big this problem is could make people do the illegal consumption behavior instead. The positively-framed descriptive norm message scenario works best to reduce music piracy numbers as it focuses on supporting positive behavior and subject to the right perception on this phenomenon. Music piracy is not merely economical, but rather social phenomenon due to the underlying motivation of the actors which has shifted toward community sharing. The indication of misconception of value co-creation in the context of music piracy in Indonesia is also discussed. This study contributes theoretically that understanding how social norm configures the behavior of decision-making process is essential to breakdown the phenomenon of unlawful behavior in music industry. In practice, this study proposes that reward-based and context-based strategy is the most relevant strategy for stakeholders in music industry. Furthermore, this study provides an opportunity that findings may generalize well beyond music piracy context. As an emerging body of work that systematically constructs the backstage of law and social affect decision-making process, it is interesting to see how the model is implemented in other decision-behavior related situation.

Keywords: music piracy, social norm, behavioral decision-making, agent-based model, value co-creation

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91 Growth Mechanism and Sensing Behaviour of Sn Doped ZnO Nanoprisms Prepared by Thermal Evaporation Technique

Authors: Sudip Kumar Sinha, Saptarshi Ghosh

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While there’s a perpetual buzz around zinc oxide (ZnO) superstructures for their unique optical features, the versatile material has been constantly utilized to manifest tailored electronic properties through rendition of distinct morphologies. And yet, the unorthodox approach of implementing the novel 1D nanostructures of ZnO (pristine or doped) for volatile sensing applications has ample scope to accommodate new unconventional morphologies. In the last two decades, solid-state sensors have attracted much curiosity for their relevance in identifying pollutant, toxic and other industrial gases. In particular gas sensors based on metal oxide semiconducting (wide Eg) nanomaterials have recently attracted intensive attention owing to their high sensitivity and fast response and recovery time. These materials when exposed to air, the atmospheric O2 dissociates and get absorb on the surface of the sensors by trapping the outermost shell electrons. Finally a depleted zone on the surface of the sensors is formed, that enhances the potential barrier height at grain boundary . Once a target gas is exposed to the sensor, the chemical interaction between the chemisorbed oxygen and the specific gas liberates the trapped electrons. Therefore altering the amount of adsorbate is a considerable approach to improve the sensitivity of any target gas/vapour molecule. Likewise, this study presents a spontaneous but self catalytic creation of Sn-doped ZnO hexagonal nanoprisms on Si (100) substrates through thermal evaporation-condensation method, and their subsequent deployment for volatile sensing. In particular, the sensors were utilized to detect molecules of ethanol, acetone and ammonia below their permissible exposure limits which returned sensitivities of around 85%, 80% and 50% respectively. The influence of Sn concentration on the growth, microstructural and optical properties of the nanoprisms along with its role in augmenting the sensing parameters has been detailed. The single-crystalline nanostructures have a typical diameter ranging from 300 to 500 nm and a length that extends up to few micrometers. HRTEM images confirmed the hexagonal crystallography for the nanoprisms, while SAED pattern asserted the single crystalline nature. The growth habit is along the low index <0001>directions. It has been seen that the growth mechanism of the as-deposited nanostructures are directly influenced by varying supersaturation ratio, fairly high substrate temperatures, and specified surface defects in certain crystallographic planes, all acting cooperatively decide the final product morphology. Room temperature photoluminescence (PL) spectra of this rod like structures exhibits a weak ultraviolet (UV) emission peak at around 380 nm and a broad green emission peak in the 505 nm regime. An estimate of the sensing parameters against dispensed target molecules highlighted the potential for the nanoprisms as an effective volatile sensing material. The Sn-doped ZnO nanostructures with unique prismatic morphology may find important applications in various chemical sensors as well as other potential nanodevices.

Keywords: gas sensor, HRTEM, photoluminescence, ultraviolet, zinc oxide

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90 Scientific and Regulatory Challenges of Advanced Therapy Medicinal Products

Authors: Alaa Abdellatif, Gabrièle Breda

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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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89 Optimizing Data Transfer and Processing in Multi-Cloud Environments for Big Data Workloads

Authors: Gaurav Kumar Sinha

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In an era defined by the proliferation of data and the utilization of cloud computing environments, the efficient transfer and processing of big data workloads across multi-cloud platforms have emerged as critical challenges. This research paper embarks on a comprehensive exploration of the complexities associated with managing and optimizing big data in a multi-cloud ecosystem.The foundation of this study is rooted in the recognition that modern enterprises increasingly rely on multiple cloud providers to meet diverse business needs, enhance redundancy, and reduce vendor lock-in. As a consequence, managing data across these heterogeneous cloud environments has become intricate, necessitating innovative approaches to ensure data integrity, security, and performance.The primary objective of this research is to investigate strategies and techniques for enhancing the efficiency of data transfer and processing in multi-cloud scenarios. It recognizes that big data workloads are characterized by their sheer volume, variety, velocity, and complexity, making traditional data management solutions insufficient for harnessing the full potential of multi-cloud architectures.The study commences by elucidating the challenges posed by multi-cloud environments in the context of big data. These challenges encompass data fragmentation, latency, security concerns, and cost optimization. To address these challenges, the research explores a range of methodologies and solutions. One of the key areas of focus is data transfer optimization. The paper delves into techniques for minimizing data movement latency, optimizing bandwidth utilization, and ensuring secure data transmission between different cloud providers. It evaluates the applicability of dedicated data transfer protocols, intelligent data routing algorithms, and edge computing approaches in reducing transfer times.Furthermore, the study examines strategies for efficient data processing across multi-cloud environments. It acknowledges that big data processing requires distributed and parallel computing capabilities that span across cloud boundaries. The research investigates containerization and orchestration technologies, serverless computing models, and interoperability standards that facilitate seamless data processing workflows.Security and data governance are paramount concerns in multi-cloud environments. The paper explores methods for ensuring data security, access control, and compliance with regulatory frameworks. It considers encryption techniques, identity and access management, and auditing mechanisms as essential components of a robust multi-cloud data security strategy.The research also evaluates cost optimization strategies, recognizing that the dynamic nature of multi-cloud pricing models can impact the overall cost of data transfer and processing. It examines approaches for workload placement, resource allocation, and predictive cost modeling to minimize operational expenses while maximizing performance.Moreover, this study provides insights into real-world case studies and best practices adopted by organizations that have successfully navigated the challenges of multi-cloud big data management. It presents a comparative analysis of various multi-cloud management platforms and tools available in the market.

Keywords: multi-cloud environments, big data workloads, data transfer optimization, data processing strategies

Procedia PDF Downloads 44