Search results for: dispute resolution
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 1521

Search results for: dispute resolution

1101 Multi-scale Geographic Object-Based Image Analysis (GEOBIA) Approach to Segment a Very High Resolution Images for Extraction of New Degraded Zones. Application to The Region of Mécheria in The South-West of Algeria

Authors: Bensaid A., Mostephaoui T., Nedjai R.

Abstract:

A considerable area of Algerian lands are threatened by the phenomenon of wind erosion. For a long time, wind erosion and its associated harmful effects on the natural environment have posed a serious threat, especially in the arid regions of the country. In recent years, as a result of increases in the irrational exploitation of natural resources (fodder) and extensive land clearing, wind erosion has particularly accentuated. The extent of degradation in the arid region of the Algerian Mécheriadepartment generated a new situation characterized by the reduction of vegetation cover, the decrease of land productivity, as well as sand encroachment on urban development zones. In this study, we attempt to investigate the potential of remote sensing and geographic information systems for detecting the spatial dynamics of the ancient dune cords based on the numerical processing of PlanetScope PSB.SB sensors images by September 29, 2021. As a second step, we prospect the use of a multi-scale geographic object-based image analysis (GEOBIA) approach to segment the high spatial resolution images acquired on heterogeneous surfaces that vary according to human influence on the environment. We have used the fractal net evolution approach (FNEA) algorithm to segment images (Baatz&Schäpe, 2000). Multispectral data, a digital terrain model layer, ground truth data, a normalized difference vegetation index (NDVI) layer, and a first-order texture (entropy) layer were used to segment the multispectral images at three segmentation scales, with an emphasis on accurately delineating the boundaries and components of the sand accumulation areas (Dune, dunes fields, nebka, and barkhane). It is important to note that each auxiliary data contributed to improve the segmentation at different scales. The silted areas were classified using a nearest neighbor approach over the Naâma area using imagery. The classification of silted areas was successfully achieved over all study areas with an accuracy greater than 85%, although the results suggest that, overall, a higher degree of landscape heterogeneity may have a negative effect on segmentation and classification. Some areas suffered from the greatest over-segmentation and lowest mapping accuracy (Kappa: 0.79), which was partially attributed to confounding a greater proportion of mixed siltation classes from both sandy areas and bare ground patches. This research has demonstrated a technique based on very high-resolution images for mapping sanded and degraded areas using GEOBIA, which can be applied to the study of other lands in the steppe areas of the northern countries of the African continent.

Keywords: land development, GIS, sand dunes, segmentation, remote sensing

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1100 Case Study Approach Using Scenario Analysis to Analyze Unabsorbed Head Office Overheads

Authors: K. C. Iyer, T. Gupta, Y. M. Bindal

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Head office overhead (HOOH) is an indirect cost and is recovered through individual project billings by the contractor. Delay in a project impacts the absorption of HOOH cost allocated to that particular project and thus diminishes the expected profit of the contractor. This unabsorbed HOOH cost is later claimed by contractors as damages. The subjective nature of the available formulae to compute unabsorbed HOOH is the difficulty that contractors and owners face and thus dispute it. The paper attempts to bring together the rationale of various HOOH formulae by gathering contractor’s HOOH cost data on all of its project, using case study approach and comparing variations in values of HOOH using scenario analysis. The case study approach uses project data collected from four construction projects of a contractor in India to calculate unabsorbed HOOH costs from various available formulae. Scenario analysis provides further variations in HOOH values after considering two independent situations mainly scope changes and new projects during the delay period. Interestingly, one of the findings in this study reveals that, in spite of HOOH getting absorbed by additional works available during the period of delay, a few formulae depict an increase in the value of unabsorbed HOOH, neglecting any absorption by the increase in scope. This indicates that these formulae are inappropriate for use in case of a change to the scope of work. Results of this study can help both parties in deciding on an appropriate formula more objectively, considering the events on a project causing the delay and contractor's position in respect of obtaining new projects.

Keywords: absorbed and unabsorbed overheads, head office overheads, scenario analysis, scope variation

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1099 Derivation of Bathymetry from High-Resolution Satellite Images: Comparison of Empirical Methods through Geographical Error Analysis

Authors: Anusha P. Wijesundara, Dulap I. Rathnayake, Nihal D. Perera

Abstract:

Bathymetric information is fundamental importance to coastal and marine planning and management, nautical navigation, and scientific studies of marine environments. Satellite-derived bathymetry data provide detailed information in areas where conventional sounding data is lacking and conventional surveys are inaccessible. The two empirical approaches of log-linear bathymetric inversion model and non-linear bathymetric inversion model are applied for deriving bathymetry from high-resolution multispectral satellite imagery. This study compares these two approaches by means of geographical error analysis for the site Kankesanturai using WorldView-2 satellite imagery. Based on the Levenberg-Marquardt method calibrated the parameters of non-linear inversion model and the multiple-linear regression model was applied to calibrate the log-linear inversion model. In order to calibrate both models, Single Beam Echo Sounding (SBES) data in this study area were used as reference points. Residuals were calculated as the difference between the derived depth values and the validation echo sounder bathymetry data and the geographical distribution of model residuals was mapped. The spatial autocorrelation was calculated by comparing the performance of the bathymetric models and the results showing the geographic errors for both models. A spatial error model was constructed from the initial bathymetry estimates and the estimates of autocorrelation. This spatial error model is used to generate more reliable estimates of bathymetry by quantifying autocorrelation of model error and incorporating this into an improved regression model. Log-linear model (R²=0.846) performs better than the non- linear model (R²=0.692). Finally, the spatial error models improved bathymetric estimates derived from linear and non-linear models up to R²=0.854 and R²=0.704 respectively. The Root Mean Square Error (RMSE) was calculated for all reference points in various depth ranges. The magnitude of the prediction error increases with depth for both the log-linear and the non-linear inversion models. Overall RMSE for log-linear and the non-linear inversion models were ±1.532 m and ±2.089 m, respectively.

Keywords: log-linear model, multi spectral, residuals, spatial error model

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1098 Zinc Oxide Nanoparticle-Doped Poly (8-Anilino-1-Napthalene Sulphonic Acid/Nat Nanobiosensors for TB Drugs

Authors: Rachel Fanelwa Ajayi, Anovuyo Jonnas, Emmanuel I. Iwuoha

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Tuberculosis (TB) is an infectious disease caused by the bacterium (Mycobacterium tuberculosis) which has a predilection for lung tissue due to its rich oxygen supply. The mycobacterial cell has a unique innate characteristic which allows it to resist human immune systems and drug treatments; hence, it is one of the most difficult of all bacterial infections to treat, let alone to cure. At the same time, multi-drug resistance TB (MDR-TB) caused by poorly managed TB treatment, is a growing problem and requires the administration of expensive and less effective second line drugs which take much longer treatment duration than fist line drugs. Therefore, to acknowledge the issues of patients falling ill as a result of inappropriate dosing of treatment and inadequate treatment administration, a device with a fast response time coupled with enhanced performance and increased sensitivity is essential. This study involved the synthesis of electroactive platforms for application in the development of nano-biosensors suitable for the appropriate dosing of clinically diagnosed patients by promptly quantifying the levels of the TB drug; Isonaizid. These nano-biosensors systems were developed on gold surfaces using the enzyme N-acetyletransferase 2 coupled to the cysteamine modified poly(8-anilino-1-napthalene sulphonic acid)/zinc oxide nanocomposites. The morphology of ZnO nanoparticles, PANSA/ZnO nano-composite and nano-biosensors platforms were characterized using High-Resolution Transmission Electron Microscopy (HRTEM) and High-Resolution Scanning Electron Microscopy (HRSEM). On the other hand, the elemental composition of the developed nanocomposites and nano-biosensors were studied using Fourier Transform Infra-Red Spectroscopy (FTIR) and Energy Dispersive X-Ray (EDX). The electrochemical studies showed an increase in electron conductivity for the PANSA/ZnO nanocomposite which was an indication that it was suitable as a platform towards biosensor development.

Keywords: N-acetyletransferase 2, isonaizid, tuberculosis, zinc oxide

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1097 Is Hormone Replacement Therapy Associated with Age-Related Macular Degeneration? A Systematic Review and Meta-Analysis

Authors: Hongxin Zhao, Shibing Yang, Bingming Yi, Yi Ning

Abstract:

Background: A few studies have found evidence that exposure to endogenous or postmenopausal exogenous estrogens may be associated with a lower prevalence of age-related macular degeneration (AMD), but dispute over this association is ongoing due to inconsistent results reported by different studies. Objectives: To conduct a systematic review and meta-analysis to investigate the association between hormone replacement therapy (HRT) use and AMD. Methods: Relevant studies that assessed the association between HRT and AMD were searched through four databases (PubMed, Web of Science, Cochrane Library, EMBASE) and reference lists of retrieved studies. Study selection, data extraction and quality assessment were conducted by three independent reviewers. The fixed-effect meta-analyses were performed to estimate the association between HRT ever-use and AMD by pooling risk ratio (RR) or odds ratio (OR) across studies. Results: The review identified 2 prospective and 7 cross-sectional studies with 93992 female participants that reported an estimate of the association between HRT ever-use and presence of early AMD or late AMD. Meta-analyses showed that there were no statistically significant associations between HRT ever-use and early AMD (pooled RR for cohort studies was 1.04, 95% CI 0.86 - 1.24; pooled OR for cross-sectional studies was 0.91, 95% CI 0.82 - 1.01). The pooled results from cross-sectional studies also showed no statistically significant association between HRT ever-use and late AMD (OR 1.01; 95% CI 0.89 - 1.15). Conclusions: The pooled effects from observational studies published to date indicate that HRT use is associated with neither early nor late AMD. Exposure to HRT may not protect women from developing AMD.

Keywords: hormone replacement therapy, age-related macular degeneration, meta-analysis, systematic review

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1096 Detection of Triclosan in Water Based on Nanostructured Thin Films

Authors: G. Magalhães-Mota, C. Magro, S. Sério, E. Mateus, P. A. Ribeiro, A. B. Ribeiro, M. Raposo

Abstract:

Triclosan [5-chloro-2-(2,4-dichlorophenoxy) phenol], belonging to the class of Pharmaceuticals and Personal Care Products (PPCPs), is a broad-spectrum antimicrobial agent and bactericide. Because of its antimicrobial efficacy, it is widely used in personal health and skin care products, such as soaps, detergents, hand cleansers, cosmetics, toothpastes, etc. However, it has been considered to disrupt the endocrine system, for instance, thyroid hormone homeostasis and possibly the reproductive system. Considering the widespread use of triclosan, it is expected that environmental and food safety problems regarding triclosan will increase dramatically. Triclosan has been found in river water samples in both North America and Europe and is likely widely distributed wherever triclosan-containing products are used. Although significant amounts are removed in sewage plants, considerable quantities remain in the sewage effluent, initiating widespread environmental contamination. Triclosan undergoes bioconversion to methyl-triclosan, which has been demonstrated to bio accumulate in fish. In addition, triclosan has been found in human urine samples from persons with no known industrial exposure and in significant amounts in samples of mother's milk, demonstrating its presence in humans. The action of sunlight in river water is known to turn triclosan into dioxin derivatives and raises the possibility of pharmacological dangers not envisioned when the compound was originally utilized. The aim of this work is to detect low concentrations of triclosan in an aqueous complex matrix through the use of a sensor array system, following the electronic tongue concept based on impedance spectroscopy. To achieve this goal, we selected the appropriate molecules to the sensor so that there is a high affinity for triclosan and whose sensitivity ensures the detection of concentrations of at least nano-molar. Thin films of organic molecules and oxides have been produced by the layer-by-layer (LbL) technique and sputtered onto glass solid supports already covered by gold interdigitated electrodes. By submerging the films in complex aqueous solutions with different concentrations of triclosan, resistance and capacitance values were obtained at different frequencies. The preliminary results showed that an array of interdigitated electrodes sensor coated or uncoated with different LbL and films, can be used to detect TCS traces in aqueous solutions in a wide range concentration, from 10⁻¹² to 10⁻⁶ M. The PCA method was applied to the measured data, in order to differentiate the solutions with different concentrations of TCS. Moreover, was also possible to trace a curve, the plot of the logarithm of resistance versus the logarithm of concentration, which allowed us to fit the plotted data points with a decreasing straight line with a slope of 0.022 ± 0.006 which corresponds to the best sensitivity of our sensor. To find the sensor resolution near of the smallest concentration (Cs) used, 1pM, the minimum measured value which can be measured with resolution is 0.006, so the ∆logC =0.006/0.022=0.273, and, therefore, C-Cs~0.9 pM. This leads to a sensor resolution of 0.9 pM for the smallest concentration used, 1pM. This attained detection limit is lower than the values obtained in the literature.

Keywords: triclosan, layer-by-layer, impedance spectroscopy, electronic tongue

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1095 Crustal Scale Seismic Surveys in Search for Gawler Craton Iron Oxide Cu-Au (IOCG) under Very Deep Cover

Authors: E. O. Okan, A. Kepic, P. Williams

Abstract:

Iron oxide copper gold (IOCG) deposits constitute important sources of copper and gold in Australia especially since the discovery of the supergiant Olympic Dam deposits in 1975. They are considered to be metasomatic expressions of large crustal-scale alteration events occasioned by intrusive actions and are associated with felsic igneous rocks in most cases, commonly potassic igneous magmatism, with the deposits ranging from ~2.2 –1.5 Ga in age. For the past two decades, geological, geochemical and potential methods have been used to identify the structures hosting these deposits follow up by drilling. Though these methods have largely been successful for shallow targets, at deeper depth due to low resolution they are limited to mapping only very large to gigantic deposits with sufficient contrast. As the search for ore-bodies under regolith cover continues due to depletion of the near surface deposits, there is a compelling need to develop new exploration technology to explore these deep seated ore-bodies within 1-4km which is the current mining depth range. Seismic reflection method represents this new technology as it offers a distinct advantage over all other geophysical techniques because of its great depth of penetration and superior spatial resolution maintained with depth. Further, in many different geological scenarios, it offers a greater ‘3D mapability’ of units within the stratigraphic boundary. Despite these superior attributes, no arguments for crustal scale seismic surveys have been proposed because there has not been a compelling argument of economic benefit to proceed with such work. For the seismic reflection method to be used at these scales (100’s to 1000’s of square km covered) the technical risks or the survey costs have to be reduced. In addition, as most IOCG deposits have large footprint due to its association with intrusions and large fault zones; we hypothesized that these deposits can be found by mainly looking for the seismic signatures of intrusions along prospective structures. In this study, we present two of such cases: - Olympic Dam and Vulcan iron-oxide copper-gold (IOCG) deposits all located in the Gawler craton, South Australia. Results from our 2D modelling experiments revealed that seismic reflection surveys using 20m geophones and 40m shot spacing as an exploration tool for locating IOCG deposit is possible even when hosted in very complex structures. The migrated sections were not only able to identify and trace various layers plus the complex structures but also show reflections around the edges of intrusive packages. The presences of such intrusions were clearly detected from 100m to 1000m depth range without losing its resolution. The modelled seismic images match the available real seismic data and have the hypothesized characteristics; thus, the seismic method seems to be a valid exploration tool to find IOCG deposits. We therefore propose that 2D seismic survey is viable for IOCG exploration as it can detect mineralised intrusive structures along known favourable corridors. This would help in reducing the exploration risk associated with locating undiscovered resources as well as conducting a life-of-mine study which will enable better development decisions at the very beginning.

Keywords: crustal scale, exploration, IOCG deposit, modelling, seismic surveys

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1094 Monte Carlo Simulation of Thyroid Phantom Imaging Using Geant4-GATE

Authors: Parimalah Velo, Ahmad Zakaria

Abstract:

Introduction: Monte Carlo simulations of preclinical imaging systems allow opportunity to enable new research that could range from designing hardware up to discovery of new imaging application. The simulation system which could accurately model an imaging modality provides a platform for imaging developments that might be inconvenient in physical experiment systems due to the expense, unnecessary radiation exposures and technological difficulties. The aim of present study is to validate the Monte Carlo simulation of thyroid phantom imaging using Geant4-GATE for Siemen’s e-cam single head gamma camera. Upon the validation of the gamma camera simulation model by comparing physical characteristic such as energy resolution, spatial resolution, sensitivity, and dead time, the GATE simulation of thyroid phantom imaging is carried out. Methods: A thyroid phantom is defined geometrically which comprises of 2 lobes with 80mm in diameter, 1 hot spot, and 3 cold spots. This geometry accurately resembling the actual dimensions of thyroid phantom. A planar image of 500k counts with 128x128 matrix size was acquired using simulation model and in actual experimental setup. Upon image acquisition, quantitative image analysis was performed by investigating the total number of counts in image, the contrast of the image, radioactivity distributions on image and the dimension of hot spot. Algorithm for each quantification is described in detail. The difference in estimated and actual values for both simulation and experimental setup is analyzed for radioactivity distribution and dimension of hot spot. Results: The results show that the difference between contrast level of simulation image and experimental image is within 2%. The difference in the total count between simulation and actual study is 0.4%. The results of activity estimation show that the relative difference between estimated and actual activity for experimental and simulation is 4.62% and 3.03% respectively. The deviation in estimated diameter of hot spot for both simulation and experimental study are similar which is 0.5 pixel. In conclusion, the comparisons show good agreement between the simulation and experimental data.

Keywords: gamma camera, Geant4 application of tomographic emission (GATE), Monte Carlo, thyroid imaging

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1093 Clinch Process Simulation Using Diffuse Elements

Authors: Benzegaou Ali, Brani Benabderrahmane

Abstract:

This work describes a numerical study of the TOX–clinching process using diffuse elements. A computer code baptized SEMA "Static Explicit Method Analysis" is developed to simulate the clinch joining process. The FE code is based on an Updated Lagrangian scheme. The used resolution method is based on an explicit static approach. The integration of the elasto-plastic behavior law is realized with an algorithm of Simo and Taylor. The tools are represented by plane facets.

Keywords: diffuse elements, numerical simulation, clinching, contact, large deformation

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1092 On the Possibility of Real Time Characterisation of Ambient Toxicity Using Multi-Wavelength Photoacoustic Instrument

Authors: Tibor Ajtai, Máté Pintér, Noémi Utry, Gergely Kiss-Albert, Andrea Palágyi, László Manczinger, Csaba Vágvölgyi, Gábor Szabó, Zoltán Bozóki

Abstract:

According to the best knowledge of the authors, here we experimentally demonstrate first, a quantified correlation between the real-time measured optical feature of the ambient and the off-line measured toxicity data. Finally, using these correlations we are presenting a novel methodology for real time characterisation of ambient toxicity based on the multi wavelength aerosol phase photoacoustic measurement. Ambient carbonaceous particulate matter is one of the most intensively studied atmospheric constituent in climate science nowadays. Beyond their climatic impact, atmospheric soot also plays an important role as an air pollutant that harms human health. Moreover, according to the latest scientific assessments ambient soot is the second most important anthropogenic emission source, while in health aspect its being one of the most harmful atmospheric constituents as well. Despite of its importance, generally accepted standard methodology for the quantitative determination of ambient toxicology is not available yet. Dominantly, ambient toxicology measurement is based on the posterior analysis of filter accumulated aerosol with limited time resolution. Most of the toxicological studies are based on operational definitions using different measurement protocols therefore the comprehensive analysis of the existing data set is really limited in many cases. The situation is further complicated by the fact that even during its relatively short residence time the physicochemical features of the aerosol can be masked significantly by the actual ambient factors. Therefore, decreasing the time resolution of the existing methodology and developing real-time methodology for air quality monitoring are really actual issues in the air pollution research. During the last decades many experimental studies have verified that there is a relation between the chemical composition and the absorption feature quantified by Absorption Angström Exponent (AAE) of the carbonaceous particulate matter. Although the scientific community are in the common platform that the PhotoAcoustic Spectroscopy (PAS) is the only methodology that can measure the light absorption by aerosol with accurate and reliable way so far, the multi-wavelength PAS which are able to selectively characterise the wavelength dependency of absorption has become only available in the last decade. In this study, the first results of the intensive measurement campaign focusing the physicochemical and toxicological characterisation of ambient particulate matter are presented. Here we demonstrate the complete microphysical characterisation of winter time urban ambient including optical absorption and scattering as well as size distribution using our recently developed state of the art multi-wavelength photoacoustic instrument (4λ-PAS), integrating nephelometer (Aurora 3000) as well as single mobility particle sizer and optical particle counter (SMPS+C). Beyond this on-line characterisation of the ambient, we also demonstrate the results of the eco-, cyto- and genotoxicity measurements of ambient aerosol based on the posterior analysis of filter accumulated aerosol with 6h time resolution. We demonstrate a diurnal variation of toxicities and AAE data deduced directly from the multi-wavelength absorption measurement results.

Keywords: photoacoustic spectroscopy, absorption Angström exponent, toxicity, Ames-test

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1091 Suitable Site Selection of Small Dams Using Geo-Spatial Technique: A Case Study of Dadu Tehsil, Sindh

Authors: Zahid Khalil, Saad Ul Haque, Asif Khan

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Decision making about identifying suitable sites for any project by considering different parameters is difficult. Using GIS and Multi-Criteria Analysis (MCA) can make it easy for those projects. This technology has proved to be an efficient and adequate in acquiring the desired information. In this study, GIS and MCA were employed to identify the suitable sites for small dams in Dadu Tehsil, Sindh. The GIS software is used to create all the spatial parameters for the analysis. The parameters that derived are slope, drainage density, rainfall, land use / land cover, soil groups, Curve Number (CN) and runoff index with a spatial resolution of 30m. The data used for deriving above layers include 30-meter resolution SRTM DEM, Landsat 8 imagery, and rainfall from National Centre of Environment Prediction (NCEP) and soil data from World Harmonized Soil Data (WHSD). Land use/Land cover map is derived from Landsat 8 using supervised classification. Slope, drainage network and watershed are delineated by terrain processing of DEM. The Soil Conservation Services (SCS) method is implemented to estimate the surface runoff from the rainfall. Prior to this, SCS-CN grid is developed by integrating the soil and land use/land cover raster. These layers with some technical and ecological constraints are assigned weights on the basis of suitability criteria. The pairwise comparison method, also known as Analytical Hierarchy Process (AHP) is taken into account as MCA for assigning weights on each decision element. All the parameters and group of parameters are integrated using weighted overlay in GIS environment to produce suitable sites for the Dams. The resultant layer is then classified into four classes namely, best suitable, suitable, moderate and less suitable. This study reveals a contribution to decision-making about suitable sites analysis for small dams using geospatial data with minimal amount of ground data. This suitability maps can be helpful for water resource management organizations in determination of feasible rainwater harvesting structures (RWH).

Keywords: Remote sensing, GIS, AHP, RWH

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1090 Bee Colony Optimization Applied to the Bin Packing Problem

Authors: Kenza Aida Amara, Bachir Djebbar

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We treat the two-dimensional bin packing problem which involves packing a given set of rectangles into a minimum number of larger identical rectangles called bins. This combinatorial problem is NP-hard. We propose a pretreatment for the oriented version of the problem that allows the valorization of the lost areas in the bins and the reduction of the size problem. A heuristic method based on the strategy first-fit adapted to this problem is presented. We present an approach of resolution by bee colony optimization. Computational results express a comparison of the number of bins used with and without pretreatment.

Keywords: bee colony optimization, bin packing, heuristic algorithm, pretreatment

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1089 A Case Report: The Role of Gut Directed Hypnotherapy in Resolution of Irritable Bowel Syndrome in a Medication Refractory Pediatric Male Patient

Authors: Alok Bapatla, Pamela Lutting, Mariastella Serrano

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Background: Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with altered bowel habits in the absence of an underlying organic cause. Although the exact etiology of IBS is not fully understood, one of the leading theories postulates a pathology within the Brain-Gut Axis that leads to an overall increase in gastrointestinal sensitivity and pejorative changes in gastrointestinal motility. Research and clinical practice have shown that Gut Directed Hypnotherapy (GDH) has a beneficial clinical role in improving Mind-Gut control and thereby comorbid conditions such as anxiety, abdominal pain, constipation, and diarrhea. Aims: This study presents a 17-year old male with underlying anxiety and a one-year history of IBS-Constipation Predominant Subtype (IBS-C), who has demonstrated impressive improvement of symptoms following GDH treatment following refractory trials with medications including bisacodyl, senna, docusate, magnesium citrate, lubiprostone, linaclotide. Method: The patient was referred to a licensed clinical psychologist specializing in clinical hypnosis and cognitive-behavioral therapy (CBT), who implemented “The Standardized Hypnosis Protocol for IBS” developed by Dr. Olafur S. Palsson, Psy.D at the University of North Carolina at Chapel Hill. The hypnotherapy protocol consisted of a total of seven weekly 45-minute sessions supplemented with a 20-minute audio recording to be listened to once daily. Outcome variables included the GAD-7, PHQ-9 and DCI-2, as well as self-ratings (ranging 0-10) for pain (intensity and frequency), emotional distress about IBS symptoms, and overall emotional distress. All variables were measured at intake prior to administration of the hypnosis protocol and at the conclusion of the hypnosis treatment. A retrospective IBS Questionnaire (IBS Severity Scoring System) was also completed at the conclusion of the GDH treatment for pre-and post-test ratings of clinical symptoms. Results: The patient showed improvement in all outcome variables and self-ratings, including abdominal pain intensity, frequency of abdominal pain episodes, emotional distress relating to gut issues, depression, and anxiety. The IBS Questionnaire showed a significant improvement from a severity score of 400 (defined as severe) prior to GDH intervention compared to 55 (defined as complete resolution) at four months after the last session. IBS Questionnaire subset questions that showed a significant score improvement included abdominal pain intensity, days of pain experienced per 10 days, satisfaction with bowel habits, and overall interference of life affected by IBS symptoms. Conclusion: This case supports the existing research literature that GDH has a significantly beneficial role in improving symptoms in patients with IBS. Emphasis is placed on the numerical results of the IBS Questionnaire scoring, which reflects a patient who initially suffered from severe IBS with failed response to multiple medications, who subsequently showed full and sustained resolution

Keywords: pediatrics, constipation, irritable bowel syndrome, hypnotherapy, gut-directed hypnosis

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1088 Policy Effectiveness in the Situation of Economic Recession

Authors: S. K. Ashiquer Rahman

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The proper policy handling might not able to attain the target since some of recessions, e.g., pandemic-led crises, the variables shocks of the economics. At the level of this situation, the Central bank implements the monetary policy to choose increase the exogenous expenditure and level of money supply consecutively for booster level economic growth, whether the monetary policy is relatively more effective than fiscal policy in altering real output growth of a country or both stand for relatively effective in the direction of output growth of a country. The dispute with reference to the relationship between the monetary policy and fiscal policy is centered on the inflationary penalty of the shortfall financing by the fiscal authority. The latest variables socks of economics as well as the pandemic-led crises, central banks around the world predicted just about a general dilemma in relation to increase rates to face the or decrease rates to sustain the economic movement. Whether the prices hang about fundamentally unaffected, the aggregate demand has also been hold a significantly negative attitude by the outbreak COVID-19 pandemic. To empirically investigate the effects of economics shocks associated COVID-19 pandemic, the paper considers the effectiveness of the monetary policy and fiscal policy that linked to the adjustment mechanism of different economic variables. To examine the effects of economics shock associated COVID-19 pandemic towards the effectiveness of Monetary Policy and Fiscal Policy in the direction of output growth of a Country, this paper uses the Simultaneous equations model under the estimation of Two-Stage Least Squares (2SLS) and Ordinary Least Squares (OLS) Method.

Keywords: IS-LM framework, pandemic. Economics variables shocks, simultaneous equations model, output growth

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1087 Explicit Chain Homotopic Function to Compute Hochschild Homology of the Polynomial Algebra

Authors: Zuhier Altawallbeh

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In this paper, an explicit homotopic function is constructed to compute the Hochschild homology of a finite dimensional free k-module V. Because the polynomial algebra is of course fundamental in the computation of the Hochschild homology HH and the cyclic homology CH of commutative algebras, we concentrate our work to compute HH of the polynomial algebra.by providing certain homotopic function.

Keywords: hochschild homology, homotopic function, free and projective modules, free resolution, exterior algebra, symmetric algebra

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1086 Philippine Foreign Policy in the West Philippine Sea after the 2012 Scarborough Standoff: Implications for National Security

Authors: Rhisan Mae Enriquez-Morales

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The primary concern of this study is to answer the question: How does the Philippine government formulate its foreign policy with respect to its territorial claims over areas in the West Philippine Sea after the Scarborough standoff in April 2012? Specifically, the study seeks to provide understanding on the political process in the formulation of foreign policy relating to the Philippine claims in the West Philippine Sea after the 2012 Scarborough Standoff, by looking into the relationship of bureaucracies and how it influences the decision-making process. Secondly, this study aims to determine the long and short term foreign policies of the Philippines with respect to its territorial claims over the West Philippine Sea. Lastly, this study seeks to determine the implication of Philippine foreign policy in settling the West Philippine Sea dispute on the country’s national security. The Bureaucratic Politics Model (BPM) in Foreign Policy Analysis (FPA) is the framework utilized in this study, which focuses primarily on the relationship of bureaucracies in the formulation of foreign policy and how these agencies influence the process of foreign policy formulation. The findings of this study reveal that: first, the Philippines foreign policy in the West Philippine Sea continues to develop to address current developments in the WPS. Second, as the government requires demilitarization there is a shift from traditional to non-traditional security approach. This shift caused inconvenience from the defense sector particularly the Navy thinking that they are being deprived of their traditional roles. Lastly, the Philippine government’s greater emphasis on internal security operation implies the need to reassess its security concerns and look into territorial security.

Keywords: bureaucratic politics model, foreign policy analysis, security, West Philippine sea

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1085 Automatic Vertical Wicking Tester Based on Optoelectronic Techniques

Authors: Chi-Wai Kan, Kam-Hong Chau, Ho-Shing Law

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Wicking property is important for textile finishing and wears comfort. Good wicking properties can ensure uniformity and efficiency of the textiles treatment. In view of wear comfort, quick wicking fabrics facilitate the evaporation of sweat. Therefore, the wetness sensation of the skin is minimised to prevent discomfort. The testing method for vertical wicking was standardised by the American Association of Textile Chemists and Colorists (AATCC) in 2011. The traditional vertical wicking test involves human error to observe fast changing and/or unclear wicking height. This study introduces optoelectronic devices to achieve an automatic Vertical Wicking Tester (VWT) and reduce human error. The VWT can record the wicking time and wicking height of samples. By reducing the difficulties of manual judgment, the reliability of the vertical wicking experiment is highly increased. Furthermore, labour is greatly decreased by using the VWT. The automatic measurement of the VWT has optoelectronic devices to trace the liquid wicking with a simple operation procedure. The optoelectronic devices detect the colour difference between dry and wet samples. This allows high sensitivity to a difference in irradiance down to 10 μW/cm². Therefore, the VWT is capable of testing dark fabric. The VWT gives a wicking distance (wicking height) of 1 mm resolution and a wicking time of one-second resolution. Acknowledgment: This is a research project of HKRITA funded by Innovation and Technology Fund (ITF) with title “Development of an Automatic Measuring System for Vertical Wicking” (ITP/055/20TP). Author would like to thank the financial support by ITF. Any opinions, findings, conclusions or recommendations expressed in this material/event (or by members of the project team) do not reflect the views of the Government of the Hong Kong Special Administrative Region, the Innovation and Technology Commission or the Panel of Assessors for the Innovation and Technology Support Programme of the Innovation and Technology Fund and the Hong Kong Research Institute of Textiles and Apparel. Also, we would like to thank the support and sponsorship from Lai Tak Enterprises Limited, Kingis Development Limited and Wing Yue Textile Company Limited.

Keywords: AATCC method, comfort, textile measurement, wetness sensation

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1084 'Antibody Exception' under Dispute and Waning Usage: Potential Influence on Patenting Antibodies

Authors: Xiangjun Kong, Dongning Yao, Yuanjia Hu

Abstract:

Therapeutic antibodies have become the most valuable and successful class of biopharmaceutical drugs, with a huge market potential and therapeutic advantages. Antibody patents are, accordingly, extremely important. As the technological limitation of the early stage of this field, the U. S. Patent and Trademark Offices (USPTO) have issued guidelines that suggest an exception for patents claiming a genus of antibodies that bind to a novel antigen, even in the absence of any experimental antibody production. This 'antibody exception' allowed for a broad scope on antibody claims, and led a global trend to patent antibodies without antibodies. Disputes around the pertinent patentability and written description issues remain particularly intense. Yet the validity of such patents had not been overtly challenged until Centocor v. Abbott, which restricted the broad scope of antibody patents and hit the brakes on the 'antibody exception'. The courts tend to uphold the requirement for adequate description of antibodies in the patent specifications, to avoid overreaching antibody claims. Patents following the 'antibody exception' are at risk of being found invalid for inadequately describing what they have claimed. However, the relation between the court and USPTO guidelines remains obscure, and the waning of the 'antibody exception' has led to further disputes around antibody patents. This uncertainty clearly affects patent applications, antibody innovations, and even relevant business performance. This study will give an overview of the emergence, debate, and waning usage of the 'antibody exception' in a number of enlightening cases, attempting to understand the specific concerns and the potential influence of antibody patents. We will then provide some possible strategies for antibody patenting, under the current considerations on the 'antibody exception'.

Keywords: antibody exception, antibody patent, USPTO (U. S. Patent and Trademark Offices) guidelines, written description requirement

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1083 Optimising Transcranial Alternating Current Stimulation

Authors: Robert Lenzie

Abstract:

Transcranial electrical stimulation (tES) is significant in the research literature. However, the effects of tES on brain activity are still poorly understood at the surface level, the Brodmann Area level, and the impact on neural networks. Using a method like electroencephalography (EEG) in conjunction with tES might make it possible to comprehend the brain response and mechanisms behind published observed alterations in more depth. Using a method to directly see the effect of tES on EEG may offer high temporal resolution data on the brain activity changes/modulations brought on by tES that correlate to various processing stages within the brain. This paper provides unpublished information on a cutting-edge methodology that may reveal details about the dynamics of how the human brain works beyond what is now achievable with existing methods.

Keywords: tACS, frequency, EEG, optimal

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1082 Invisible Aircraft Using Plasma Display

Authors: C. Ramamoorthy, R. Ranga Raj

Abstract:

In olden days the Ramayana epic depicts the usage of invisible and fuel less aircraft named pushpavimana. The change of color in the reptile family chameleon paves way for the concept of color change phenomenon available in nature. In present scenario the aircrafts are visible so it is easily identified. So there are too many problems from the threatening. Research is still going on about this problem by using Liquid Crystal Display (LCD). Objective of this paper is to find much better to use the concept of invisible aircraft using plasma display through Couple Charged Device camera (CCD), which has a high resolution and can be used for many purposes like spying, defense, etc. Moreover it is cost wise cheap then, escaping the foe viewing.

Keywords: CCD camera, chameleon, invisible, plasma display

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1081 A Geosynchronous Orbit Synthetic Aperture Radar Simulator for Moving Ship Targets

Authors: Linjie Zhang, Baifen Ren, Xi Zhang, Genwang Liu

Abstract:

Ship detection is of great significance for both military and civilian applications. Synthetic aperture radar (SAR) with all-day, all-weather, ultra-long-range characteristics, has been used widely. In view of the low time resolution of low orbit SAR and the needs for high time resolution SAR data, GEO (Geosynchronous orbit) SAR is getting more and more attention. Since GEO SAR has short revisiting period and large coverage area, it is expected to be well utilized in marine ship targets monitoring. However, the height of the orbit increases the time of integration by almost two orders of magnitude. For moving marine vessels, the utility and efficacy of GEO SAR are still not sure. This paper attempts to find the feasibility of GEO SAR by giving a GEO SAR simulator of moving ships. This presented GEO SAR simulator is a kind of geometrical-based radar imaging simulator, which focus on geometrical quality rather than high radiometric. Inputs of this simulator are 3D ship model (.obj format, produced by most 3D design software, such as 3D Max), ship's velocity, and the parameters of satellite orbit and SAR platform. Its outputs are simulated GEO SAR raw signal data and SAR image. This simulating process is accomplished by the following four steps. (1) Reading 3D model, including the ship rotations (pitch, yaw, and roll) and velocity (speed and direction) parameters, extract information of those little primitives (triangles) which is visible from the SAR platform. (2) Computing the radar scattering from the ship with physical optics (PO) method. In this step, the vessel is sliced into many little rectangles primitives along the azimuth. The radiometric calculation of each primitive is carried out separately. Since this simulator only focuses on the complex structure of ships, only single-bounce reflection and double-bounce reflection are considered. (3) Generating the raw data with GEO SAR signal modeling. Since the normal ‘stop and go’ model is not available for GEO SAR, the range model should be reconsidered. (4) At last, generating GEO SAR image with improved Range Doppler method. Numerical simulation of fishing boat and cargo ship will be given. GEO SAR images of different posture, velocity, satellite orbit, and SAR platform will be simulated. By analyzing these simulated results, the effectiveness of GEO SAR for the detection of marine moving vessels is evaluated.

Keywords: GEO SAR, radar, simulation, ship

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1080 Acoustic Analysis of Psycho-Communication Disorders within Moroccan Students

Authors: Brahim Sabir

Abstract:

Psycho-Communication disorders negatively affect the academic curriculum for students in higher education. Thus, understanding these disorders, their causes and effects will give education specialists a tool for the decision, which will lead to the resolution of problems related to the integration of students with Psycho-Communication disorders. It is in this context that a statistical study was conducted, targeting the population object of study, namely Moroccan students. Pathological voice samples were recorded and analyzed acoustically with PRAAT software, in order to build a model that will be the basis for the objective diagnostic.

Keywords: psycho-communication disorders, acoustic analysis, PRAAT

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1079 Reflecting Socio-Political Needs in Education Policy-Making: An Exploratory Study of Vietnam's Key Education Reforms (1945-2017)

Authors: Linh Tong

Abstract:

This paper aims to contribute to the understanding of key education reforms in Vietnam from 1945 to 2017, which reflects an evolution of socio-political needs of the Socialist Republic of Vietnam throughout this period. It explores the contextual conditions, motivations and ambitions influencing the formation of the education reforms in Vietnam. It also looks, from an applied practical perspective, at the influence of politics on education policy-making. The research methodology includes a content analysis of curriculum designs proposed by the Ministry of Education and Training, relevant resolutions and executive orders passed by the National Assembly and the Prime Minister, as well as interviews with experts and key stakeholders. The results point to a particular configuration of factors which have been inspiring the shape and substance of these reforms and which have most certainly influenced their implementation. This configuration evolves from the immediate needs to erase illiteracy and cultivate socialist economic model at the beginning of Vietnam’s independence in 1945-1975, to a renewed urge to adopt market-oriented economy in 1986 and cautiously communicate with the outside world until 2000s, and to currently a demonstrated desire to fully integrate into the global economy and tackle with rising concerns about national security (the South China Sea Dispute), environmental sustainability, construction of a knowledge economy, and a rule-of-law society. Overall, the paper attempts to map Vietnam’s socio-political needs with the changing sets of goals and expected outcomes in teaching and learning methodologies and practices as introduced in Vietnamese key education reforms.

Keywords: curriculum development, knowledge society, national security, politics of education policy-making, Vietnam's education reforms

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1078 Digital Holographic Interferometric Microscopy for the Testing of Micro-Optics

Authors: Varun Kumar, Chandra Shakher

Abstract:

Micro-optical components such as microlenses and microlens array have numerous engineering and industrial applications for collimation of laser diodes, imaging devices for sensor system (CCD/CMOS, document copier machines etc.), for making beam homogeneous for high power lasers, a critical component in Shack-Hartmann sensor, fiber optic coupling and optical switching in communication technology. Also micro-optical components have become an alternative for applications where miniaturization, reduction of alignment and packaging cost are necessary. The compliance with high-quality standards in the manufacturing of micro-optical components is a precondition to be compatible on worldwide markets. Therefore, high demands are put on quality assurance. For quality assurance of these lenses, an economical measurement technique is needed. For cost and time reason, technique should be fast, simple (for production reason), and robust with high resolution. The technique should provide non contact, non-invasive and full field information about the shape of micro- optical component under test. The interferometric techniques are noncontact type and non invasive and provide full field information about the shape of the optical components. The conventional interferometric technique such as holographic interferometry or Mach-Zehnder interferometry is available for characterization of micro-lenses. However, these techniques need more experimental efforts and are also time consuming. Digital holography (DH) overcomes the above described problems. Digital holographic microscopy (DHM) allows one to extract both the amplitude and phase information of a wavefront transmitted through the transparent object (microlens or microlens array) from a single recorded digital hologram by using numerical methods. Also one can reconstruct the complex object wavefront at different depths due to numerical reconstruction. Digital holography provides axial resolution in nanometer range while lateral resolution is limited by diffraction and the size of the sensor. In this paper, Mach-Zehnder based digital holographic interferometric microscope (DHIM) system is used for the testing of transparent microlenses. The advantage of using the DHIM is that the distortions due to aberrations in the optical system are avoided by the interferometric comparison of reconstructed phase with and without the object (microlens array). In the experiment, first a digital hologram is recorded in the absence of sample (microlens array) as a reference hologram. Second hologram is recorded in the presence of microlens array. The presence of transparent microlens array will induce a phase change in the transmitted laser light. Complex amplitude of object wavefront in presence and absence of microlens array is reconstructed by using Fresnel reconstruction method. From the reconstructed complex amplitude, one can evaluate the phase of object wave in presence and absence of microlens array. Phase difference between the two states of object wave will provide the information about the optical path length change due to the shape of the microlens. By the knowledge of the value of the refractive index of microlens array material and air, the surface profile of microlens array is evaluated. The Sag of microlens and radius of curvature of microlens are evaluated and reported. The sag of microlens agrees well within the experimental limit as provided in the specification by the manufacturer.

Keywords: micro-optics, microlens array, phase map, digital holographic interferometric microscopy

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1077 Study of Mixing Conditions for Different Endothelial Dysfunction in Arteriosclerosis

Authors: Sara Segura, Diego Nuñez, Miryam Villamil

Abstract:

In this work, we studied the microscale interaction of foreign substances with blood inside an artificial transparent artery system that represents medium and small muscular arteries. This artery system had channels ranging from 75 μm to 930 μm and was fabricated using glass and transparent polymer blends like Phenylbis(2,4,6-trimethylbenzoyl) phosphine oxide, Poly(ethylene glycol) and PDMS in order to be monitored in real time. The setup was performed using a computer controlled precision micropump and a high resolution optical microscope capable of tracking fluids at fast capture. Observation and analysis were performed using a real time software that reconstructs the fluid dynamics determining the flux velocity, injection dependency, turbulence and rheology. All experiments were carried out with fully computer controlled equipment. Interactions between substances like water, serum (0.9% sodium chloride and electrolyte with a ratio of 4 ppm) and blood cells were studied at microscale as high as 400nm of resolution and the analysis was performed using a frame-by-frame observation and HD-video capture. These observations lead us to understand the fluid and mixing behavior of the interest substance in the blood stream and to shed a light on the use of implantable devices for drug delivery at arteries with different Endothelial dysfunction. Several substances were tested using the artificial artery system. Initially, Milli-Q water was used as a control substance for the study of the basic fluid dynamics of the artificial artery system. However, serum and other low viscous substances were pumped into the system with the presence of other liquids to study the mixing profiles and behaviors. Finally, mammal blood was used for the final test while serum was injected. Different flow conditions, pumping rates, and time rates were evaluated for the determination of the optimal mixing conditions. Our results suggested the use of a very fine controlled microinjection for better mixing profiles with and approximately rate of 135.000 μm3/s for the administration of drugs inside arteries.

Keywords: artificial artery, drug delivery, microfluidics dynamics, arteriosclerosis

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1076 Demonstration of Logical Inconsistency in the Discussion of the Problem of Evil

Authors: Mohammad Soltani Renani

Abstract:

The problem of evil is one of the heated battlegrounds of the idea of theism and its critics. Since time immemorial and in various philosophical schools and religions, the belief in an Omniscient, Omnipotent, and Absolutely Good God has been considered inconsistent with the existence of the evil in the universe. The theist thinkers have generally adopted one of the following four ways for answering this problem: denial of the existence of evil or considering it to be relative, privation theory of evil, attribution of evil to something other than God, and depiction of an alternative picture of God. Defense or criticism of these alternative answers have given rise to an extensive and unending dispute. However, evaluation of the presupposition and context upon/in which a question is raised precedes offering an answer to it. This point in the discussion of the problem of evil is of paramount importance for both parties, i.e., questioners and answerers, that the attributes of knowledge, power, love, good-will, among others, can be supposed to be infinite only in the essence of the attributed and the domain of potentiality but what can be realized in the domain of actuality is always finite. Therefore, infinite nature of Divine Attributes and realization of evil belong to two spheres. Divine Attributes are infinite (absolute) in Divine Essence, but when they are created, each one becomes bounded by the other. This boundedness is a result of the state of being surrounded of the attributes by each other in finite world of possibility. Evil also appears in this limited world. This inconsistency leads to the collapse of the problem of evil from within: the place of infinity of the Divine Attributes, in the words of Muslim mystics, lies in the Holiest Manifestation [Feyze Aqdas] while evil emerges in the Holy Manifestation where the Divine Attributes become bounded by each other. This idea is neither a new answer to the problem of evil nor a defense of theism; rather it reveals a logical inconsistency in the discussion of the problem of evil.

Keywords: problem of evil, infinity of divine attributes, boundedness of divine attributes, holiest manifestation, holy manifestation

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1075 DEMs: A Multivariate Comparison Approach

Authors: Juan Francisco Reinoso Gordo, Francisco Javier Ariza-López, José Rodríguez Avi, Domingo Barrera Rosillo

Abstract:

The evaluation of the quality of a data product is based on the comparison of the product with a reference of greater accuracy. In the case of MDE data products, quality assessment usually focuses on positional accuracy and few studies consider other terrain characteristics, such as slope and orientation. The proposal that is made consists of evaluating the similarity of two DEMs (a product and a reference), through the joint analysis of the distribution functions of the variables of interest, for example, elevations, slopes and orientations. This is a multivariable approach that focuses on distribution functions, not on single parameters such as mean values or dispersions (e.g. root mean squared error or variance). This is considered to be a more holistic approach. The use of the Kolmogorov-Smirnov test is proposed due to its non-parametric nature, since the distributions of the variables of interest cannot always be adequately modeled by parametric models (e.g. the Normal distribution model). In addition, its application to the multivariate case is carried out jointly by means of a single test on the convolution of the distribution functions of the variables considered, which avoids the use of corrections such as Bonferroni when several statistics hypothesis tests are carried out together. In this work, two DEM products have been considered, DEM02 with a resolution of 2x2 meters and DEM05 with a resolution of 5x5 meters, both generated by the National Geographic Institute of Spain. DEM02 is considered as the reference and DEM05 as the product to be evaluated. In addition, the slope and aspect derived models have been calculated by GIS operations on the two DEM datasets. Through sample simulation processes, the adequate behavior of the Kolmogorov-Smirnov statistical test has been verified when the null hypothesis is true, which allows calibrating the value of the statistic for the desired significance value (e.g. 5%). Once the process has been calibrated, the same process can be applied to compare the similarity of different DEM data sets (e.g. the DEM05 versus the DEM02). In summary, an innovative alternative for the comparison of DEM data sets based on a multinomial non-parametric perspective has been proposed by means of a single Kolmogorov-Smirnov test. This new approach could be extended to other DEM features of interest (e.g. curvature, etc.) and to more than three variables

Keywords: data quality, DEM, kolmogorov-smirnov test, multivariate DEM comparison

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1074 An Assessment into Impact of Regional Conflicts upon Socio-Political Sustainability in Pakistan

Authors: Syed Toqueer Akhter, Muhammad Muzaffar Abbas

Abstract:

Conflicts in Pakistan are a result of a configuration of factors, which are directly related to the system of the state, the unstable regional setting, and the geo-strategic location of Pakistan at large. This paper examines the impact of regional conflict onto the socio-political sustainability of Pakistan. The magnitude of the spillover from a conflicted region is similar in size of the equivalent increase in domestic conflict. Pakistan has gone at war three times with India; the border with India is named as the tensest borderlines of the world. Disagreements with India and lack of dispute settlement mechanisms have negatively effected the peace in the region, influx of illegal weapons and refugees from Afghanistan as an outcome of 9/11 incidence, have exasperated the criticality of levels of internal conflict in Pakistan. Our empirical findings are based on the data collected on regional conflict levels, regional trade, global trade, comparative defence capabilities of the region in contrast to Pakistan and the government regime (Autocratic, Democratic) over 1972-2007. It has been proposed in this paper that the intent of domestic conflict is associated with the conflict in the region, regional trade, global trade and the government regime of Pakistan. The estimated model (OLS) implies that domestic conflict is effected positively and significantly with long term impact of conflict in the region. Also, if defence capabilities of the region are better than that of Pakistan it effects domestic conflict positively and significantly. Conflict in neighbouring countries are found as a source of domestic conflict in Pakistan, whereas the regional trade as well as type of government regimes in Pakistan lowered the intensity of domestic conflict significantly, while globalized trade imply risk of domestic conflict to be reduced but not significantly.

Keywords: conflict, regional trade, socio-politcal instability

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1073 Resolving Problems Experienced by Involving Patients in the Development of Pharmaceutical Products at Post-Launch Stage of Pharmaceutical Product Development

Authors: Clara T. Fatoye, April Betts, Abayomi Odeyemi, Francis A. Fatoye, Isaac O. Odeyemi

Abstract:

Background: The post-launch stage is the last stage in the development of a pharmaceutical product. It is important to involve patients in the development of pharmaceutical products at the post-launch stage, as patients are the end-users of pharmaceutical products. It is expected that involving them might ensure an effective working relationship among the various stakeholders. However, involving patients in the development of pharmaceutical products comes with its problems. Hence, this study examined how to resolve problems experienced by involving patients in the developments of pharmaceutical products’ at post-launch consisting of Positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and Formulary Submission (R&FS). Methods: A questionnaire was used for the present study. It was administered at the ISPOR Glasgow 2017 to 104 participants, all of which were professionals from Market access (MA) and health economics and outcomes research (HEOR) backgrounds. They were asked how the issues experienced by patients can be resolved. Participants responded under six domains as follows: communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was carried out to identify strategies to resolve issues experienced by patients at the post-launch stage. Results: Three (3) factors cut across at POPP, DOPP, and R&FS that is (external factors, communication and QoL). The first resolution method was an external factor that is, the relationship with stakeholders and policymakers. Communication was also identified as a resolution method that can help to resolve problems experienced by patients at the post-launch stage. The third method was QoL as perceived by the patients based on professionals’ opinions. Other strategies that could be used to resolve problems experienced were the effectiveness of pharmaceutical products at the DOPP level and cost at R&FS. Conclusion: The study showed that focusing on external factors, communication, and patients’ QoL are methods for resolving issues experienced by involving patients at the post-launch stage of pharmaceutical product development. Hence, effective working relationships between patients, policymakers and stakeholders may help to resolve problems experienced at the post-launch stage. Healthcare policymakers are to be aware of these findings as they may help them to put appropriate strategies in place to enhance the involvement of patients in pharmaceutical product development at the post-launch stage, thereby improving the health outcomes of the patients.

Keywords: patients, pharmaceutical products, post-launch stage, quality of life, QoL

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1072 Statistical Pattern Recognition for Biotechnological Process Characterization Based on High Resolution Mass Spectrometry

Authors: S. Fröhlich, M. Herold, M. Allmer

Abstract:

Early stage quantitative analysis of host cell protein (HCP) variations is challenging yet necessary for comprehensive bioprocess development. High resolution mass spectrometry (HRMS) provides a high-end technology for accurate identification alongside with quantitative information. Hereby we describe a flexible HRMS assay platform to quantify HCPs relevant in microbial expression systems such as E. Coli in both up and downstream development by means of MVDA tools. Cell pellets were lysed and proteins extracted, purified samples not further treated before applying the SMART tryptic digest kit. Peptides separation was optimized using an RP-UHPLC separation platform. HRMS-MSMS analysis was conducted on an Orbitrap Velos Elite applying CID. Quantification was performed label-free taking into account ionization properties and physicochemical peptide similarities. Results were analyzed using SIEVE 2.0 (Thermo Fisher Scientific) and SIMCA (Umetrics AG). The developed HRMS platform was applied to an E. Coli expression set with varying productivity and the corresponding downstream process. Selected HCPs were successfully quantified within the fmol range. Analysing HCP networks based on pattern analysis facilitated low level quantification and enhanced validity. This approach is of high relevance for high-throughput screening experiments during upstream development, e.g. for titer determination, dynamic HCP network analysis or product characterization. Considering the downstream purification process, physicochemical clustering of identified HCPs is of relevance to adjust buffer conditions accordingly. However, the technology provides an innovative approach for label-free MS based quantification relying on statistical pattern analysis and comparison. Absolute quantification based on physicochemical properties and peptide similarity score provides a technological approach without the need of sophisticated sample preparation strategies and is therefore proven to be straightforward, sensitive and highly reproducible in terms of product characterization.

Keywords: process analytical technology, mass spectrometry, process characterization, MVDA, pattern recognition

Procedia PDF Downloads 239