Search results for: clinical outcome
Commenced in January 2007
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Edition: International
Paper Count: 5293

Search results for: clinical outcome

763 Epidemiological Analysis of the Patients Supplied with Foot Orthoses in Ortho-Prosthetic Center of Kosovo

Authors: Ardiana Murtezani, Ilirijana Dallku, Teuta Osmani Vllasolli, Sabit Sllamniku

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Background: The use of foot orthoses are always indicated when there are alterations of the optimal biomechanics' position of the foot. Orthotics are very effective and very suitable for the majority of patients with pain due to overload which can be related to biomechanical disorders. Aim: To assess the frequency of patients requiring foot orthoses, type of orthoses and analysis of their disease leading to the use of foot orthoses. Material and Methods: Our study included 128 patients with various foot pathologies, treated at the outpatient department of the Ortho-Prosthetic Center of Kosovo (OPCK) in Prishtina. Prospective-descriptive clinical method was used during this study. Functional status of patients was examined, and the following parameters are noted: range of motion measurements for the affected joints/lower extremities, manual test for muscular strength below the knee and foot of the affected extremity, perimeter measurements of the lower extremities, measurements of lower extremities, foot length measurement, foot width measurements and size. In order to complete the measurements the following instruments are used: plantogram, pedogram, meter and cork shoe lift appliances. Results: The majority of subjects in this study are male (60.2% vs. 39.8%), and the dominant age group was 0-9 (47.7%), 61 subjects respectively. Most frequent foot disorders were: congenital disease 60.1%, trauma cases 13.3%, consequences from rheumatologic disease 12.5%, neurologic dysfunctions 11.7%, and the less frequented are the infectious cases 1.6%. Congenital anomalies were the most frequent cases, and from this group majority of cases suffered from pes planovalgus (37.5%), eqinovarus (15.6%) and discrepancies between extremities (6.3%). Furthermore, traumatic amputations (2.3%) and arthritis (0.8%). As far as neurologic disease, subjects with cerebral palsy are represented with (3.1%), peroneal nerve palsy (2.3%) and hemiparesis (1.6%). Infectious disease osteomyelitis sequels are represented with (1.6%). Conclusion: Based on our study results, we have concluded that the use of foot orthoses for patients suffering from rheumatoid arthritis and nonspecific arthropaty was effective treatment choice, leading to decrease of pain, less deformities and improves the quality of life.

Keywords: orthoses, epidemiological analysis, rheumatoid arthritis, rehabilitation

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762 Assessment of Very Low Birth Weight Neonatal Tracking and a High-Risk Approach to Minimize Neonatal Mortality in Bihar, India

Authors: Aritra Das, Tanmay Mahapatra, Prabir Maharana, Sridhar Srikantiah

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In the absence of adequate well-equipped neonatal-care facilities serving rural Bihar, India, the practice of essential home-based newborn-care remains critically important for reduction of neonatal and infant mortality, especially among pre-term and small-for-gestational-age (Low-birth-weight) newborns. To improve the child health parameters in Bihar, ‘Very-Low-Birth-Weight (vLBW) Tracking’ intervention is being conducted by CARE India, since 2015, targeting public facility-delivered newborns weighing ≤2000g at birth, to improve their identification and provision of immediate post-natal care. To assess the effectiveness of the intervention, 200 public health facilities were randomly selected from all functional public-sector delivery points in Bihar and various outcomes were tracked among the neonates born there. Thus far, one pre-intervention (Feb-Apr’2015-born neonates) and three post-intervention (for Sep-Oct’2015, Sep-Oct’2016 and Sep-Oct’2017-born children) follow-up studies were conducted. In each round, interviews were conducted with the mothers/caregivers of successfully-tracked children to understand outcome, service-coverage and care-seeking during the neonatal period. Data from 171 matched facilities common across all rounds were analyzed using SAS-9.4. Identification of neonates with birth-weight ≤ 2000g improved from 2% at baseline to 3.3%-4% during post-intervention. All indicators pertaining to post-natal home-visits by frontline-workers (FLWs) improved. Significant improvements between baseline and post-intervention rounds were also noted regarding mothers being informed about ‘weak’ child – at the facility (R1 = 25 to R4 = 50%) and at home by FLW (R1 = 19%, to R4 = 30%). Practice of ‘Kangaroo-Mother-Care (KMC)’– an important component of essential newborn care – showed significant improvement in postintervention period compared to baseline in both facility (R1 = 15% to R4 = 31%) and home (R1 = 10% to R4=29%). Increasing trend was noted regarding detection and birth weight-recording of the extremely low-birth-weight newborns (< 1500 g) showed an increasing trend. Moreover, there was a downward trend in mortality across rounds, in each birth-weight strata (< 1500g, 1500-1799g and >= 1800g). After adjustment for the differential distribution of birth-weights, mortality was found to decline significantly from R1 (22.11%) to R4 (11.87%). Significantly declining trend was also observed for both early and late neonatal mortality and morbidities. Multiple regression analysis identified - birth during immediate post-intervention phase as well as that during the maintenance phase, birth weight > 1500g, children of low-parity mothers, receiving visit from FLW in the first week and/or receiving advice on extra care from FLW as predictors of survival during neonatal period among vLBW newborns. vLBW tracking was found to be a successful and sustainable intervention and has already been handed over to the Government.

Keywords: weak newborn tracking, very low birth weight babies, newborn care, community response

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761 Correlative Study of Serum Interleukin-18 and Disease Activity, Functional Disability and Quality of Life in Rheumatoid Arthritis Patients

Authors: Hamdy Khamis Korayem, Manal Yehia Tayel, Abeer Shawky El Hadedy, Emmanuel Kamal Aziz Saba, Shimaa Badr Abdelnaby Badr

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The aim of the current study was to demonstrate whether serum Interleukin-18 (IL-18) is increased in rheumatoid arthritis (RA) and its correlation with disease activity, functional disability and quality of life in RA patients. The study included 30 RA patients and 20 healthy normal control subjects. The RA patients were diagnosed according to the 2010 ACR/EULAR classification criteria for RA with the exclusion of those who had diabetes mellitus, endocrine disorders, associated rheumatologic diseases, viral hepatitis B or C and other diseases with increased serum IL-18 level. All patients were subjected to clinical evaluation of the musculoskeletal system. Disease activity was assessed by disease activity score 28 with 4 variables (DAS 28). Functional disability was assessed by health assessment questionnaire disability index (HAQ-DI). The quality of life was assessed by Short form-36 (SF-36) questionnaire. Radiological assessment of both hands and feet by Sharp/van der Heijde (SvH) scoring method. Laboratory parameters including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibody (ACPA) were assessed in patients and serum level of IL-18 in both patients and control subjects. There was no statistically significant difference between patient and control group as regards age and sex. Among patients, 29 % were females and the age range was between 25 to 55 years. Extra-articular manifestations were presented in 56.7% of the patients. The mean of DAS 28 score was 5.73±1.46 and that of HAQ-DI was 1.22±0.72 while that of SF-36 was 40.03±13.96. The level of serum IL-18 was significantly higher in patients than in the control subjects (P= 0.030). Serum IL-18 was correlated with ACPA among the patient group. There were no statistically significant correlations between serum IL-18 and DAS28, HAQ-DI, SF-36, total SvH score and the other laboratory results. In conclusion, IL-18 is significantly higher in RA patient than in healthy control subjects and positively correlated with ACPA level. IL-18 is associated with extra-articular manifestations. However, it is not correlated with other laboratory parameters, disease activity, functional disability, quality of life nor radiological severity.

Keywords: disease activity score, Interleukin-18, quality of life assessment, rheumatoid arthritis

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760 Consumers Attitude toward the Latest Trends in Decreasing Energy Consumption of Washing Machine

Authors: Farnaz Alborzi, Angelika Schmitz, Rainer Stamminger

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Reducing water temperatures in the wash phase of a washing programme and increasing the overall cycle durations are the latest trends in decreasing energy consumption of washing programmes. Since the implementation of the new energy efficiency classes in 2010, manufacturers seem to apply the aforementioned washing strategy with lower temperatures combined with longer programme durations extensively to realise energy-savings needed to meet the requirements of the highest energy efficiency class possible. A semi-representative on-line survey in eleven European countries (Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Romania, Spain, Sweden and the United Kingdom) was conducted by Bonn University in 2015 to shed light on consumer opinion and behaviour regarding the effects of the lower washing temperature and longer cycle duration in laundry washing on consumers’ acceptance of the programme. The risk of the long wash cycle is that consumers might not use the energy efficient Standard programmes and will think of this option as inconvenient and therefore switch to shorter, but more energy consuming programmes. Furthermore, washing in a lower temperature may lead to the problem of cross-contamination. Washing behaviour of over 5,000 households was studied in this survey to provide support and guidance for manufacturers and policy designers. Qualified households were chosen following a predefined quota: -Involvement in laundry washing: substantial, -Distribution of gender: more than 50 % female , -Selected age groups: -20–39 years, -40–59 years, -60–74 years, -Household size: 1, 2, 3, 4 and more than 4 people. Furthermore, Eurostat data for each country were used to calculate the population distribution in the respective age class and household size as quotas for the consumer survey distribution in each country. Before starting the analyses, the validity of each dataset was controlled with the aid of control questions. After excluding the outlier data, the number of the panel diminished from 5,100 to 4,843. The primary outcome of the study is European consumers are willing to save water and energy in a laundry washing but reluctant to use long programme cycles since they don’t believe that the long cycles could be energy-saving. However, the results of our survey don’t confirm that there is a relation between frequency of using Standard cotton (Eco) or Energy-saving programmes and the duration of the programmes. It might be explained by the fact that the majority of washing programmes used by consumers do not take so long, perhaps consumers just choose some additional time reduction option when selecting those programmes and this finding might be changed if the Energy-saving programmes take longer. Therefore, it may be assumed that introducing the programme duration as a new measure on a revised energy label would strongly influence the consumer at the point of sale. Furthermore, results of the survey confirm that consumers are more willing to use lower temperature programmes in order to save energy than accepting longer programme cycles and majority of them accept deviation from the nominal temperature of the programme as long as the results are good.

Keywords: duration, energy-saving, standard programmes, washing temperature

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759 Improving School Design through Diverse Stakeholder Participation in the Programming Phase

Authors: Doris C. C. K. Kowaltowski, Marcella S. Deliberador

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The architectural design process, in general, is becoming more complex, as new technical, social, environmental, and economical requirements are imposed. For school buildings, this scenario is also valid. The quality of a school building depends on known design criteria and professional knowledge, as well as feedback from building performance assessments. To attain high-performance school buildings, a design process should add a multidisciplinary team, through an integrated process, to ensure that the various specialists contribute at an early stage to design solutions. The participation of stakeholders is of special importance at the programming phase when the search for the most appropriate design solutions is underway. The composition of a multidisciplinary team should comprise specialists in education, design professionals, and consultants in various fields such as environmental comfort and psychology, sustainability, safety and security, as well as administrators, public officials and neighbourhood representatives. Users, or potential users (teachers, parents, students, school officials, and staff), should be involved. User expectations must be guided, however, toward a proper understanding of a response of design to needs to avoid disappointment. In this context, appropriate tools should be introduced to organize such diverse participants and ensure a rich and focused response to needs and a productive outcome of programming sessions. In this paper, different stakeholder in a school design process are discussed in relation to their specific contributions and a tool in the form of a card game is described to structure the design debates and ensure a comprehensive decision-making process. The game is based on design patterns for school architecture as found in the literature and is adapted to a specific reality: State-run public schools in São Paulo, Brazil. In this State, school buildings are managed by a foundation called Fundação para o Desenvolvimento da Educação (FDE). FDE supervises new designs and is responsible for the maintenance of ~ 5000 schools. The design process of this context was characterised with a recommendation to improve the programming phase. Card games can create a common environment, to which all participants can relate and, therefore, can contribute to briefing debates on an equal footing. The cards of the game described here represent essential school design themes as found in the literature. The tool was tested with stakeholder groups and with architecture students. In both situations, the game proved to be an efficient tool to stimulate school design discussions and to aid in the elaboration of a rich, focused and thoughtful architectural program for a given demand. The game organizes the debates and all participants are shown to spontaneously contribute each in his own field of expertise to the decision-making process. Although the game was specifically based on a local school design process it shows potential for other contexts because the content is based on known facts, needs and concepts of school design, which are global. A structured briefing phase with diverse stakeholder participation can enrich the design process and consequently improve the quality of school buildings.

Keywords: architectural program, design process, school building design, stakeholder

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758 Psychological Factors of Readiness of Defectologists to Professional Development: On the Example of Choosing an Educational Environment

Authors: Inna V. Krotova

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The study pays special attention to the definition of the psychological potential of a specialist-defectologist, which determines his desire to increase the level of his or her professional competence. The group included participants of the educational environment – an additional professional program 'Technologies of psychological and pedagogical assistance for children with complex developmental disabilities' implemented by the department of defectology and clinical psychology of the KFU jointly with the Support Fund for the Deafblind people 'Co-Unity'. The purpose of our study was to identify the psychological aspects of the readiness of the specialist-defectologist to his or her professional development. The study assessed the indicators of psychological preparedness, and its four components were taken into account: motivational, cognitive, emotional and volitional. We used valid and standardized tests during the study. As a result of the factor analysis of data received (from Extraction Method: Principal Component Analysis, Rotation Method: Varimax with Kaiser Normalization, Rotation converged in 12 iterations), there were identified three factors with maximum factor load from 24 indices, and their correlation coefficients with other indicators were taken into account at the level of reliability p ≤ 0.001 and p ≤ 0.01. Thus the system making factor was determined – it’s a 'motivation to achieve success'; it formed a correlation galaxy with two other factors: 'general internality' and 'internality in the field of achievements', as well as with such psychological indicators as 'internality in the field of family relations', 'internality in the field of interpersonal relations 'and 'low self-control-high self-control' (the names of the scales used is the same as names in the analysis methods. In conclusion of the article, we present some proposals to take into account the psychological model of readiness of specialists-defectologists for their professional development, to stimulate the growth of their professional competence. The study has practical value for all providers of special education and organizations that have their own specialists-defectologists, teachers-defectologists, teachers for correctional and ergotherapeutic activities, specialists working in the field of correctional-pedagogical activity (speech therapists) to people with special needs who need true professional support.

Keywords: psychological readiness, defectologist, professional development, psychological factors, special education, professional competence, innovative educational environment

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757 Empirical Study on Causes of Project Delays

Authors: Khan Farhan Rafat, Riaz Ahmed

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Renowned offshore organizations are drifting towards collaborative exertion to win and implement international projects for business gains. However, devoid of financial constraints, with the availability of skilled professionals, and despite improved project management practices through state-of-the-art tools and techniques, project delays have become a norm these days. This situation calls for exploring the factor(s) affecting the bonding between project management performance and project success. In the context of the well-known 3M’s of project management (that is, manpower, machinery, and materials), machinery and materials are dependent upon manpower. Because the body of knowledge inveterate on the influence of national culture on men, hence, the realization of the impact on the link between project management performance and project success need to be investigated in detail to arrive at the possible cause(s) of project delays. This research initiative was, therefore, undertaken to fill the research gap. The unit of analysis for the proposed research excretion was the individuals who had worked on skyscraper construction projects. In reverent studies, project management is best described using construction examples. It is due to this reason that the project oriented city of Dubai was chosen to reconnoiter on causes of project delays. A structured questionnaire survey was disseminated online with the courtesy of the Project Management Institute local chapter to carry out the cross-sectional study. The Construction Industry Institute, Austin, of the United States of America along with 23 high-rise builders in Dubai were also contacted by email requesting for their contribution to the study and providing them with the online link to the survey questionnaire. The reliability of the instrument was warranted using Cronbach’s alpha coefficient of 0.70. The appropriateness of sampling adequacy and homogeneity in variance was ensured by keeping Kaiser–Meyer–Olkin (KMO) and Bartlett’s test of sphericity in the range ≥ 0.60 and < 0.05, respectively. Factor analysis was used to verify construct validity. During exploratory factor analysis, all items were loaded using a threshold of 0.4. Four hundred and seventeen respondents, including members from top management, project managers, and project staff, contributed to the study. The link between project management performance and project success was significant at 0.01 level (2-tailed), and 0.05 level (2-tailed) for Pearson’s correlation. Before initiating the moderator analysis test for linearity, multicollinearity, outliers, leverage points and influential cases, test for homoscedasticity and normality were carried out which are prerequisites for conducting moderator review. The moderator analysis, using a macro named PROCESS, was performed to verify the hypothesis that national culture has an influence on the said link. The empirical findings, when compared with Hofstede's results, showed high power distance as the cause of construction project delays in Dubai. The research outcome calls for the project sponsors and top management to reshape their project management strategy and allow for low power distance between management and project personnel for timely completion of projects.

Keywords: causes of construction project delays, construction industry, construction management, power distance

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756 Cardiac Protective Effect of Olive Oil against Ischemia Reperfusion- Induced Cardiac Arrhythmias in Isolated Diabetic Rat Hearts

Authors: Ishfaq A. Bukhari, Bassem Yousef Sheikh, Abdulrahman Almotrefi, Osama Yousaf, Amer Mahmood

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Olive oil is the primary source of fat in the Mediterranean diet which is associated with a low mortality for cardiovascular disease. Olive oil is rich in monounsaturated fatty acids, and has been reported for variety of beneficial cardiovascular effects including blood pressure lowering, anti-platelet, anti-diabetic and anti-inflammatory effects. Growing number evidences from preclinical and clinical studies have shown that olive oil improves insulin resistance, decrease vessels stiffness and prevent thromboembolism. We evaluated the effects of olive against streptozotocin-induced physiological disorders in the animal models of diabetes and ischemia and reperfusion (I/R)- induced cardiac arrhythmias. Diabetes was induced in male rats with a single intraperitoneal injection of streptozotocin (60 mg/kg), rats were treated for two months with olive oil (1 ml/kg p.o). Control animals received saline. Blood glucose, body weight were monitored every 14 days. At the end of the treatment rats were sacrificed hearts were isolated for mounting on langedorff’s apparatus. The blood glucose and body weight was not significantly different in the control and olive treated animals. The control diabetic animals exhibited 100% incidence of I/R –induced ventricular fibrillation which was reduced to 0% with olive oil, treatment. The duration of ventricular fibrillation reduced from 98.8± 2.3 (control) to 0 seconds in the olive oil treated group. Diltiazem, a calcium channel blocker (1 µm/L) showed similar results and protected the I/R-induced cardiac disorders. The biochemical analysis of the cardiac tissues showed that diabetes and I/R produce marked pathological changes in the cardiomyocytes including decreased glutathione (GSH) and increased oxidative stress (Malondialdehyde; MDA). Pretreatment of animals with olive oil (1 ml/kg p.o) increased GSH and MDA levels. Olive oil also improved the diabetic-induced histopathological changes in the cardiomyocytes. These finding indicates that olive possesses cardiac protective properties. Further studies are under way in our lab to explore the mechanism of the cardio-protective effect of olive oil.

Keywords: diabeties, ischemia-reperfusion, olive oil, rats heart

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755 A Non-Invasive Neonatal Jaundice Screening Device Measuring Bilirubin on Eyes

Authors: Li Shihao, Dieter Trau

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Bilirubin is a yellow substance that is made when the body breaks down old red blood cells. High levels of bilirubin can cause jaundice, a condition that makes the newborn's skin and the white part of the eyes look yellow. Jaundice is a serial-killer in developing countries in Southeast Asia such as Myanmar and most parts of Africa where jaundice screening is largely unavailable. Worldwide, 60% of newborns experience infant jaundice. One in ten will require therapy to prevent serious complications and lifelong neurologic sequelae. Limitations of current solutions: - Blood test: Blood tests are painful may largely unavailable in poor areas of developing countries, and also can be costly and unsafe due to the insufficient investment and lack of access to health care systems. - Transcutaneous jaundice-meter: 1) can only provide reliable results to caucasian newborns, due to skin pigmentations since current technologies measure bilirubin by the color of the skin. Basically, the darker the skin is, the harder to measure, 2) current jaundice meters are not affordable for most underdeveloped areas in Africa like Kenya and Togo, 3) fat tissue under the skin also influences the accuracy, which will give overestimated results, 4) current jaundice meters are not reliable after treatment (phototherapy) because bilirubin levels underneath the skin will be reduced first, while overall levels may be quite high. Thus, there is an urgent need for a low-cost non-invasive device, which can be effective not only for caucasian babies but also Asian and African newborns, to save lives at the most vulnerable time and prevent any complications like brain damage. Instead of measuring bilirubin on skin, we proposed a new method to do the measurement on the sclera, which can avoid the difference of skin pigmentations and ethnicities, due to the necessity for the sclera to be white regardless of racial background. This is a novel approach for measuring bilirubin by an optical method of light reflection off the white part of the eye. Moreover, the device is connected to a smart device, which can provide a user-friendly interface and the ability to record the clinical data continuously A disposable eye cap will be provided avoiding contamination and fixing the distance to the eye.

Keywords: Jaundice, bilirubin, non-invasive, sclera

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754 Sialic Acid Profile and Sialidase Activity in HIV-Infected Individuals

Authors: Hadiza Abdullahi

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Sialic Acids and sialidases have been implicated in many disease states particularly bacterial and viral infections which are common opportunist infections of HIV disease. Their role in HIV/AIDS is contemplated. A study was carried out to determine Sialic Acid profile and Sialidase Activity in HIV infected and Apparently Healthy individuals, and also determine the relationship between the sialic acid levels and sialidase activity. Blood samples were collected from 200 subjects (150 HIV infected individuals and 50 apparently healthy individuals divided into four groups- HIV ART Naïve, HIV Stable (on ART but have been stable with no clinical episodes), HIV-OI (on ART with opportunistic infections), and Apparently Healthy). Complete Blood Count, Erythrocyte Surface Sialic Acid (ESSA), Free Serum Sialic Acid (FSSA) concentrations and Sialidase activity were determined for all 200 subjects. Analysis of variance (ANOVA) was used to compare the results of the different groups of HIV infected individuals as well as controls. The mean haemoglobin (HGB), Packed Cell Volume (PCV) and Red Blood Cells (RBC) concentrations were significantly lower (P ≤ 0.05) in the HIV groups compared with the apparently healthy groups. Anaemia and neutropaenia were the most common heamatological abnormalities observed in this study with highest prevalence of anaemia found in the ART naive group. The mean FSSA was 0.4±0.4mg/ml. There was a significant difference (p ≤ 0.05) between some groups. The highest levels of FSSA was observed in the HIV ART naïve (0.65±0.5mg/ml). The mean ESSA value for the study population was 0.54±0.35mg/ml with no significant difference (p ≤ 0.05) between groups. The mean sialidase activity values were 0.52±0.1 µmol/min/µl, 0.40±0.1 µmol/min/µl, 0.45±0.1 µmol/min/µl and 0.41±0.1 µmol/min/µl for the HIV ART naïve, HIV stable, HIV/OIs and apparently healthy groups respectively. No significant difference (p ≤ 0.05) was found between groups and also in gender and age. The finding in this study of higher mean sialidase activity and FSSA levels in the ART naïve HIV group compared with other groups indicate that the virus and other opportunistic pathogens may be sialidase producers in vivo which cleave off sialic acids from erythrocytes surface, leading to high levels of FSSA, anaemia and neutropaenia seen in this group. The higher ESSA concentration found in the HIV stable group along with lowest FSSA concentration in the group suggests the presence of sialyltransferases.

Keywords: erythrocyte surface sialic acid, free serum sialic acid, HIV, sialidase

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753 Efficacy and Safety of Electrical Vestibular Stimulation on Adults with Symptoms of Insomnia: A Double-Blind, Randomized, Sham-Controlled Trial

Authors: Teris Cheung, Joyce Yuen Ting Lam, Kwan Hin Fong, Calvin Pak-Wing Cheng, Julie Sittlington, Yu-Tao Xiang, Tim Man Ho Li

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Insomnia is one of the most common health problems in the general population. Insomnia can be acute, intermittent, and become chronic, often due to comorbidity with other physical and mental health conditions. Although there are conventional pharmaceutical and psychotherapeutic treatments to treat symptoms of insomnia, however; there is no robust and novel randomized controlled trial (RCT) using transdermal neurostimulation on individuals with insomnia symptoms. This gives us the impetus to execute the first nationwide RCT. Aim: To evaluate the efficacy of Electrical Vestibular Stimulation (VeNS) on individuals with insomnia in Hong Kong. Design: This study was a two-armed, double blinded, randomized, sham-controlled trial. Sampling: 60 community-dwelling adults aged 18 and 60 years with moderate insomnia symptoms or above (Insomnia Severity Index > 14) were recruited. All subjects were computerized randomized into either the active VeNS group or the sham VeNS group on a 1:1 ratio. Intervention: All participants received a home-use VeNS device and used 30-min VeNS sessions during five consecutive days across a 4-week period (total treatment hours: 10). Baseline measurements and post-VeNS evaluation of the psychological outcomes, including 1) insomnia severity, 2) sleep quality, and 3) quality of life were investigated. The short-and long-term sustainability of the VeNS intervention was assessed immediately after poststim and at a 1-month and 3-month follow-up period. Data analysis: A mixed GEE model was used to analyze the repeated measures data. Missing data were managed by multiple imputations. The level of significance was set to p < 0.05. Significance of the study: This is the first trial to examine the efficacy and safety of VeNS among adults with insomnia symptoms in Hong Kong. Findings that emerged were used to determine whether this VeNS device can be considered a self-help technological device to reduce the severity of insomnia in the community setting and to reduce the global disease burden. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04452981.

Keywords: adults, insomnia, neuromodulation, rct, vestibular stimulation

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752 Measuring Enterprise Growth: Pitfalls and Implications

Authors: N. Šarlija, S. Pfeifer, M. Jeger, A. Bilandžić

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Enterprise growth is generally considered as a key driver of competitiveness, employment, economic development and social inclusion. As such, it is perceived to be a highly desirable outcome of entrepreneurship for scholars and decision makers. The huge academic debate resulted in the multitude of theoretical frameworks focused on explaining growth stages, determinants and future prospects. It has been widely accepted that enterprise growth is most likely nonlinear, temporal and related to the variety of factors which reflect the individual, firm, organizational, industry or environmental determinants of growth. However, factors that affect growth are not easily captured, instruments to measure those factors are often arbitrary, causality between variables and growth is elusive, indicating that growth is not easily modeled. Furthermore, in line with heterogeneous nature of the growth phenomenon, there is a vast number of measurement constructs assessing growth which are used interchangeably. Differences among various growth measures, at conceptual as well as at operationalization level, can hinder theory development which emphasizes the need for more empirically robust studies. In line with these highlights, the main purpose of this paper is twofold. Firstly, to compare structure and performance of three growth prediction models based on the main growth measures: Revenues, employment and assets growth. Secondly, to explore the prospects of financial indicators, set as exact, visible, standardized and accessible variables, to serve as determinants of enterprise growth. Finally, to contribute to the understanding of the implications on research results and recommendations for growth caused by different growth measures. The models include a range of financial indicators as lag determinants of the enterprises’ performances during the 2008-2013, extracted from the national register of the financial statements of SMEs in Croatia. The design and testing stage of the modeling used the logistic regression procedures. Findings confirm that growth prediction models based on different measures of growth have different set of predictors. Moreover, the relationship between particular predictors and growth measure is inconsistent, namely the same predictor positively related to one growth measure may exert negative effect on a different growth measure. Overall, financial indicators alone can serve as good proxy of growth and yield adequate predictive power of the models. The paper sheds light on both methodology and conceptual framework of enterprise growth by using a range of variables which serve as a proxy for the multitude of internal and external determinants, but are unlike them, accessible, available, exact and free of perceptual nuances in building up the model. Selection of the growth measure seems to have significant impact on the implications and recommendations related to growth. Furthermore, the paper points out to potential pitfalls of measuring and predicting growth. Overall, the results and the implications of the study are relevant for advancing academic debates on growth-related methodology, and can contribute to evidence-based decisions of policy makers.

Keywords: growth measurement constructs, logistic regression, prediction of growth potential, small and medium-sized enterprises

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751 Comparison of the Efficacy of Ketamine-Propofol versus Thiopental Sodium-Fentanyl in Procedural Sedation in the Emergency Department: A Randomized Double-Blind Clinical Trial

Authors: Maryam Bahreini, Mostafa Talebi Garekani, Fatemeh Rasooli, Atefeh Abdollahi

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Introduction: Procedural sedation and analgesia have been desirable to handle painful procedures. The trend to find the agent with more efficacy and less complications is still controversial; thus, many sedative regimens have been studied. This study tried to assess the effectiveness and adverse effects of thiopental sodium-fentanyl with the known medication, ketamine-propofol for procedural sedation in the emergency department. Methods: Consenting patients were enrolled in this randomized double-blind trial to receive either 1:1 ketamine-propofol (KP) or thiopental-fentanyl (TF) 1:1 mg: Mg proportion on a weight-based dosing basis to reach the sedation level of American Society of Anesthesiologist class III/IV. The respiratory and hemodynamic complications, nausea and vomiting, recovery agitation, patient recall and satisfaction, provider satisfaction and recovery time were compared. The study was registered in Iranian randomized Control Trial Registry (Code: IRCT2015111325025N1). Results: 96 adult patients were included and randomized, 47 in the KP group and 49 in the TF group. 2.1% in the KP group and 8.1 % in the TF group experienced transient hypoxia leading to performing 4.2 % versus 8.1 % airway maneuvers for 2 groups, respectively; however, no statistically significant difference was observed between 2 combinations, and there was no report of endotracheal placement or further admission. Patient and physician satisfaction were significantly higher in the KP group. There was no difference in respiratory, gastrointestinal, cardiovascular and psychiatric adverse events, recovery time and patient recall of the procedure between groups. The efficacy and complications were not related to the type of procedure or patients’ smoking or addiction trends. Conclusion: Ketamine-propofol and thiopental-fentanyl combinations were effectively comparable although KP resulted in higher patient and provider satisfaction. It is estimated that thiopental fentanyl combination can be as potent and efficacious as ketofol with relatively similar incidence of adverse events in procedural sedation.

Keywords: adverse effects, conscious sedation, fentanyl, propofol, ketamine, safety, thiopental

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750 Medical Authorizations for Cannabis-Based Products in Canada: Sante Cannabis Data on Patient’s Safety and Treatment Profiles

Authors: Rihab Gamaoun, Cynthia El Hage, Laura Ruiz, Erin Prosk, Antonio Vigano

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Introduction: Santé Cannabis (SC), a Canadian medical cannabis-specialized group of clinics based in Montreal and in the province of Québec, has served more than 5000 patients seeking cannabis-based treatment prescription for medical indications over the past five years. Within a research frame, data on the use of medical cannabis products from all the above patients were prospectively collected, leading to a large real-world database on the use of medical cannabis. The aim of this study was to gather information on the profiles of both patients and prescribed medical cannabis products at SC clinics and to assess the safety of medical cannabis among Canadian patients. Methods: Using a retrospective analysis of the database, records of 2585 patients who were prescribed medical cannabis products for therapeutic purposes between 01-November 2017 and 04-September 2019 were included. Patients’ demographics, primary diagnosis, route of administration, and chemovars recorded at the initial visits were investigated. Results: At baseline: 9% of SC patients were female, with a mean age of 57 (SD= 15.8, range= [18-96]); Cannabis products were prescribed mainly for patients with a diagnosis of chronic pain (65.9% of patients), cancer (9.4%), neurological disorders (6.5%), mood disorders (5.8 %) and inflammatory diseases (4.1%). Route of administration and chemovars of prescribed cannabis products were the following: 96% of patients received cannabis oil (51% CBD rich, 42.5% CBD:THC); 32.1% dried cannabis (21.3% CBD:THC, 7.4% THC rich, 3.4 CBD rich), and 2.1% oral spray cannabis (1.1% CBD:THC, 0.8% CBD rich, 0.2% THC rich). Most patients were prescribed simultaneously, a combination of products with different administration routes and chemovars. Safety analysis is undergoing. Conclusion: Our results provided initial information on the profile of medical cannabis products prescribed in a Canadian population and the experienced adverse events over the past three years. The Santé Cannabis database represents a unique opportunity for comparing clinical practices in prescribing and titrating cannabis-based medications across different centers. Ultimately real-world data, including information about safety and effectiveness, will help to create standardized and validated guidelines for choosing dose, route of administration, and chemovars types for the cannabis-based medication in different diseases and indications.

Keywords: medical cannabis, real-world data, safety, pharmacovigilance

Procedia PDF Downloads 108
749 Turn-Taking and Leading Roles in Early Cognition: Interaction of Social Cognition and Language in Development

Authors: Zsuzsanna Schnell, Francesca Ervas

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Background: Our study aims to clarify how language fosters further cognitive development and how we eventually arrive at the complex human specific skill of pragmatic competence and reveal what levels of mentalization and theory of mind are in place before language. Method: Our experimental pragmatic investigation maps the interaction of mentalization and pragmatic competence. We map the different levels of mentalization that empower different levels of pragmatic meaning construction and evaluate the results with statistical analysis (MannWhitney and ANOVA). Analyzing the comprehension of literal and non-compositional (figurative) utterances, we apply linguistic trials, among them metaphor-, irony-, irony with surface cue-, humor- and the recognition of maxim infringements trial in neurotypical (NT) preschoolers with a coherent and comparative methodology. Results: The findings reveal the relationship and direction of interaction between Language and theory of mind. On the one hand social-cognitive skills enhance, facilitate and provide a basis for language acquisition, and in return linguistic structures (DeVilliers 2000, 2007) provide a framework for further development of mentalizing skills. Conclusions: Findings confirm that this scaffolding becomes a mutually supportive system where language and social cognition develops in interaction. Certain stages in ToM development serve as a precursor of understanding grammatically complex sentences, like embedded phrases which mirror embedded mental states; which, in turn, facilitates the development of pragmatic competence, thus, the social use of language, integrating social, cognitive, linguistic and psychological factors in discourse. Future implications: Our investigation functions as a differential-diagnostic measure, with typically developing results thus serve as a baseline in further empirical research for atypical cases. This enables the study of populations where language and ToM development is disturbed, reveals how language and ToM are acquired and interact, and gives an insight into what this has to do with clinical symptoms. This in turn can reveal the causal link to the syndrome at hand, which can set directions for therapeutic development and training.

Keywords: theory of mind, language development, mentalization, language philosophy, experimental pragmatics

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748 Change through Stillness: Mindfulness Meditation as an Intervention for Men with Self-Perceived Problematic Pornography Use

Authors: Luke Sniewski, Pante Farvid, Phil Carter, Rita Csako

Abstract:

Background and Aims: Self-Perceived Problematic Porn Use (SPPPU) refers to individuals who identify as or perceive themselves to be addicted to porn. These individuals feel they are unable to regulate their porn consumption and experience adverse consequences as a result of their use in everyday life. To the author’s best knowledge, this research represents the first study to intervene with pornography use with mindfulness meditation, and aims to investigate the experiences and challenges of men with SPPPU as they engage in a mindfulness meditation intervention. As meditation is commonly characterized by sitting and observing one’s internal experience with non-reaction and acceptance, the study’s principal hypothesis was that consistent practice of meditation would develop the participant’s capacity to respond to cravings, urges, and unwanted thoughts in less reactive, more productive ways. Method: This 12-mixed method research utilised Single Case Experimental Design (SCED) methodology, with a standard AB design. Each participant was randomly assigned to an initial baseline time period between 2 to 5 weeks before learning the meditation technique and practicing it for the remainder of the 12-week study. The pilot study included 3 participants, while the intervention study included 12. The meditation technique used for the study involved a 15-minute guided breathing exercise in the morning, along with a 15-minute guided concentration meditation in the evening. Results: At the time of submission, only pilot study results were available. Results from the pilot study indicate an improved capacity for self-awareness of the uncomfortable mental and emotional states that drove their participants’ pornography use. Statistically significant reductions were also observed in daily porn use, total weekly time spent viewing porn, as well as lowered Pornography Craving Questionnaire (PCQ) and Problematic Pornography Use Scale (PPUS) scores. Conclusion: Pilot study results suggest that meditation could serve as a complementary tool for health professionals to provide clients in conjunction with therapeutic interventions. Study limitations, directions for future research, and clinical implications to be discussed as well.

Keywords: meditation, behavioural change, pornography, mindfulness

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747 Clinical Outcomes of Toric Implantable Collamer Lens (T-ICL) and Toric Implantable Phakic Contact Lens (IPCL) for Correction of High Myopia with Astigmatism: Comparative Study

Authors: Mohamed Salah El-Din Mahmoud, Heba Radi Atta Allah

Abstract:

Background: Our study assesses the safety profile and efficacy of toric Implantable Collamer Lens (T-ICL) and toric implantable phakic contact lens (IPCL) for the correction of high myopia with astigmatism. Methods: A prospective interventional randomized comparative study included 60 myopic eyes divided into 2 groups, group A including 30 eyes that were implanted with T-ICL, and group B including 30 eyes that were implanted with toric IPCL. The refractive results, visual acuity, corneal endothelial cell count, and intraocular pressure (IOP) were evaluated at baseline and at 1, 6, and 9 months post-surgery. Any complications either during or after surgery were assessed. Results: A significant reduction in both spherical and cylindrical refractive errors with good predictability was reported in both groups compared with preoperative values. Regarding the predictability, In T-ICL group (A), the median spherical and cylindrical errors were significantly improved from (-10 D & -4.5 D) pre-operatively to (-0.25 D & - 0.3 D) at the end of 9 months follow up period. Similarly, in the toric IPCL group (B), the median spherical and cylindrical errors were significantly improved from (-11 D & -4.5 D) pre-operatively to (-0.25 D & - 0.3 D) at the end of 9 months follow up period. A statistically significant improvement of UCDVA at 9 months postoperatively was found in both groups, as median preoperative Log Mar UCDVA was 1.1 and 1.3 in groups A and B respectively, which was significantly improved to 0.2 in both groups at the end of follow-up period. Regarding IOP, no significant difference was found between both groups, either pre-operatively or during the postoperative period. Regarding the endothelial count, no significant differences were found during the pre-operative and postoperative follow-up periods between the two groups. Fortunately, no intra or postoperative complications as cataract, keratitis or lens decentration had occurred. Conclusions: Toric IPCL is a suitable alternative to T-ICL for the management of high myopia with astigmatism, especially in developing countries, as it is cheaper and easier for implantation than T-ICL. However, data over longer follow-up periods are needed to confirm its safety and stability.

Keywords: T-ICL, Toric IPCL, IOP, corneal endothelium

Procedia PDF Downloads 148
746 The Effect of Bihemisferic Transcranial Direct Current Stimulation Therapy on Upper Extremity Motor Functions in Stroke Patients

Authors: Dilek Cetin Alisar, Oya Umit Yemisci, Selin Ozen, Seyhan Sozay

Abstract:

New approaches and treatment modalities are being developed to make patients more functional and independent in stroke rehabilitation. One of these approaches is transcranial direct stimulation therapy (tDCS), which aims to improve the hemiplegic upper limb function of stroke patients. tDCS therapy is not in the routine rehabilitation program; however, the studies about tDCS therapy on stroke rehabilitation was increased in recent years. Evaluate the effect of tDCS treatment on upper extremity motor function in patients with subacute stroke was aimed in our study. 32 stroke patients (16 tDCS group, 16 sham groups) who were hospitalized for rehabilitation in Başkent University Physical Medicine and Rehabilitation Clinic between 01.08.2016-20.01-2018 were included in the study. The conventional upper limb rehabilitation program was used for both tDCS and control group patients for 3 weeks, 5 days a week, for 60-120 minutes a day. In addition to the conventional stroke rehabilitation program in the tDAS group, bihemispheric tDCS was administered for 30 minutes daily. Patients were evaluated before treatment and after 1 week of treatment. Functional independence measure self-care score (FIM), Brunnstorm Recovery Stage (BRS), and Fugl-Meyer (FM) upper extremity motor function scale were used. There was no difference in demographic characteristics between the groups. There were no significant differences between BRS and FM scores in two groups, but there was a significant difference FIM score (p=0.05. FIM, BRS, and FM scores are significantly in the tDCS group, when before therapy and after 1 week of therapy, however, no difference is found in the shame group (p < 0,001). When FBS and FM scores were compared, there were statistical significant differences in tDCS group (p < 0,001). In conclusion, this randomized double-blind study showed that bihemispheric tDCS treatment was found to be superior to upper extremity motor and functional enhancement in addition to conventional rehabilitation methods in subacute stroke patients. In order for tDCS therapy to be used routinely in stroke rehabilitation, there is a need for more comprehensive, long-termed, randomized controlled clinical trials in order to find answers to many questions, such as the duration and intensity of treatment.

Keywords: cortical stimulation, motor function, rehabilitation, stroke

Procedia PDF Downloads 127
745 Visual Preferences of Elementary School Children with Autism Spectrum Disorder: An Experimental Study

Authors: Larissa Pliska, Isabel Neitzel, Michael Buschermöhle, Olga Kunina-Habenicht, Ute Ritterfeld

Abstract:

Visual preferences, which can be assessed using eye tracking technologies, are considered one of the defining hallmarks of Autism Spectrum Disorder (ASD). Specifically, children with ASD show a decreased preference for social images rather than geometric images compared to typically developed (TD) children. Such differences are already prevalent at a very early age and indicate the severity of the disorder: toddlers with ASD who preferred geometric images when confronted with social and geometric images showed higher ASD symptom severity than toddlers with ASD who showed higher social attention. Furthermore, the complexity of social pictures (one child playing vs. two children playing together) as well as the mode of stimulus presentation (video or image), are not decisive for the marker. The average age of diagnosis for ASD in Germany is 6.5 years, and visual preference data on this age group is missing. In the present study, we therefore investigated whether visual preferences persist into school age. We examined the visual preferences of 16 boys aged 6 to 11 with ASD and unimpaired cognition as well as TD children (1:1 matching based on children's age and the parent's level of education) within an experimental setting. Different stimulus presentation formats (images vs. videos) and different levels of stimulus complexity were included. Children with and without ASD received pairs of social and non-social images and video stimuli on a screen while eye movements (i.e., eye position and gaze direction) were recorded. For this specific use case, KIZMO GmbH developed a customized, native iOS app (KIZMO Face-Analyzer) for use on iPads. Neither the format of stimulus presentation nor the complexity of the social images had a significant effect on the visual preference of children with and without ASD in this study. Despite the tendency for a difference between the groups for the video stimuli, there were no significant differences. Overall, no statistical differences in visual preference occurred between boys with and without ASD, suggesting that gaze preference in these groups is similar at primary school age. One limitation is that the children with ASD were already receiving Autism-specific intervention. The potential of a visual preference task as an indicator of ASD can be emphasized. The article discusses the clinical relevance of this marker in elementary school children.

Keywords: autism spectrum disorder, eye tracking, hallmark, visual preference

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744 User-Centered Design in the Development of Patient Decision Aids

Authors: Ariane Plaisance, Holly O. Witteman, Patrick Michel Archambault

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Upon admission to an intensive care unit (ICU), all patients should discuss their wishes concerning life-sustaining interventions (e.g., cardiopulmonary resuscitation (CPR)). Without such discussions, interventions that prolong life at the cost of decreasing its quality may be used without appropriate guidance from patients. We employed user-centered design to adapt an existing decision aid (DA) about CPR to create a novel wiki-based DA adapted to the context of a single ICU and tailored to individual patient’s risk factors. During Phase 1, we conducted three weeks of ethnography of the decision-making context in our ICU to identify clinician and patient needs for a decision aid. During this time, we observed five dyads of intensivists and patients discussing their wishes concerning life-sustaining interventions. We also conducted semi-structured interviews with the attending intensivists in this ICU. During Phase 2, we conducted three rounds of rapid prototyping involving 15 patients and 11 other allied health professionals. We recorded discussions between intensivists and patients and used a standardized observation grid to collect patients’ comments and sociodemographic data. We applied content analysis to field notes, verbatim transcripts and the completed observation grids. Each round of observations and rapid prototyping iteratively informed the design of the next prototype. We also used the programming architecture of a wiki platform to embed the GO-FAR prediction rule programming code that we linked to a risk graphics software to better illustrate outcome risks calculated. During Phase I, we identified the need to add a section in our DA concerning invasive mechanical ventilation in addition to CPR because both life-sustaining interventions were often discussed together by physicians. During Phase II, we produced a context-adapted decision aid about CPR and mechanical ventilation that includes a values clarification section, questions about the patient’s functional autonomy prior to admission to the ICU and the functional decline that they would judge acceptable upon hospital discharge, risks and benefits of CPR and invasive mechanical ventilation, population-level statistics about CPR, a synthesis section to help patients come to a final decision and an online calculator based on the GO-FAR prediction rule. Even though the three rounds of rapid prototyping led to simplifying the information in our DA, 60% (n= 3/5) of the patients involved in the last cycle still did not understand the purpose of the DA. We also identified gaps in the discussion and documentation of patients’ preferences concerning life-sustaining interventions (e.g.,. CPR, invasive mechanical ventilation). The final version of our DA and our online wiki-based GO-FAR risk calculator using the IconArray.com risk graphics software are available online at www.wikidecision.org and are ready to be adapted to other contexts. Our results inform producers of decision aids on the use of wikis and user-centered design to develop DAs that are better adapted to users’ needs. Further work is needed on the creation of a video version of our DA. Physicians will also need the training to use our DA and to develop shared decision-making skills about goals of care.

Keywords: ethnography, intensive care units, life-sustaining therapies, user-centered design

Procedia PDF Downloads 354
743 Intervening between Family Functioning and Depressive Symptoms: Effect of Deprivation of Liberty, Self-Efficacy and Differentiation of Self

Authors: Jasna Hrncic

Abstract:

Poor family relations predict depression, but also to other mental health issues. Mediating effect of self-efficacy and differentiation of self and moderating effect of decreased accessibility and/or success of other adaptive and defensive mechanisms for overcoming social disadvantages could explain depression as a specific outcome of dysfunctional family relations. The present study analyzes the mediation effect of self-efficacy and differentiation of self from poor family functioning to depressive symptoms and the moderation effect of deprivation of liberty on the listed mediation effect. Deprivation of liberty has, as a general consequence, a decreased accessibility and/or success of many adaptive and defensive mechanisms. It is hypothesized that: 1) self-efficacy and differentiation of self will mediate between family functioning and depressiveness in the total sample, and 2) deprivation of liberty will moderate the stated relations. Cross-sectional study was conducted among 323 male juveniles in Serbia divided in three groups: 98 adolescents deprived of their liberty due to antisocial behavior (incarcerated antisocial group - IAG), 121 adolescents with antisocial behavior in their natural setting (antisocial control group - CAG) and 105 adolescents in general population (general control group - CGG). The CAG was included along with GCG to control the possible influence that comorbidity of antisocial behavior and depressiveness could have on results. Instruments for family relations assessment were: for a whole family of origin the emotional exchange scale and individuation scale from GRADIR by Knezevic, and for a relationship with mother PCS-YSR and CRPBI by barber, and intimacy, rejection, sacrifice, punishment, demands, control and internal control by Opacic and Kos. Differentiation of self (DOS) is measured by emotional self scale (Opacic), self-efficacy (SE) by general incompetence scale by Bezinovic, and depression by BDI (Back), CES-D (Radloff) and D6R (Momirovic). Two-path structural equation modeling based on most commonly reported fit indices, showed that the mediation model had unfavorable fit to our data for total sample [(χ2 (1, N = 324) = 13.73); RMSEA= .20 (90% CI= [.12, .30]); CFI= .98; NFI= .97; AIC=31.73]. Path model provided an adequate fit to the data only for AIG - and not to the data from ACG and GCG. SE and DOS mediated the relationship between PFF and depressiveness. Test of the indirect effects revealed that 23.85% of PFF influences on depressiveness is mediated by these two mediators (the quotient of mediated effect = .24). Test of specific indirect effects showed that SE mediates 22.17%, while DOS mediates 1.67% of PFF influence on depressiveness. Lack of expected mediation effect could be explained by missing other potential mediators (i.e., relationship with that father, social skills, self-esteem) and lower variability of both predictor and criterion variable due to their low levels on the whole sample and on control subsamples. Results suggested that inaccessibility and/or successfulness of other adaptive and defensive mechanisms for overcoming social disadvantages has a strong impact on the mediation effect of self/efficacy and differentiation of self from poor family functioning to depressive symptoms. Further researches could include other potential mediators and a sample of clinically depressed people.

Keywords: antisocial behavior, mediating effect, moderating effect, natural setting, incarceration

Procedia PDF Downloads 117
742 Legislating for Public Participation and Environmental Justice: Whether It Solves or Prevent Disputes

Authors: Deborah A. Hollingworth

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The key tenets associated with ‘environmental justice’, were first articulated in a global context in Principle 10 of the United Nations Declaration on Environment and Development at Rio de Janeiro in 1992 (the Rio Declaration). The elements can be conflated to require: public participation in decision-making; the provision of relevant information to those affected about environmental hazards issues; access to judicial and administrative proceeding; and the opportunity for redress where remedy where required. This paper examines the legislative and regulatory arrangements in place for the implementation these elements in a number of industrialised democracies, including Australia. Most have, over time made regulatory provision for these elements – even if they are not directly attributed Principle 10 or the notion of environmental justice. The paper proposes, that of these elements the most critical to the achievement of good environmental governance, is a legislated recognition and role of public participation. However, the paper considers that notwithstanding sound legislative and regulatory practices, environmental regulators frequently struggle, where there is a complex decision-making scenario or long-standing enmity between a community and industry to achieve effective engagement with the public. This study considers the dilemma confronted by environmental regulators to given meaningful effect to the principles enshrined in Principle 10 – that even when the legislative expression of Principle 10 is adhered to – does not prevent adverse outcomes. In particular, it considers, as a case study a prominent environmental incident in 2014 in Australia in which an open-cut coalmine located in the regional township of Morwell caught fire during bushfire season. The fire, which took 45 days to be extinguished had a significant and adverse impact on the community in question, but compounded a complex, and sometime antagonistic history between the mine and township. The case study exemplifies the complex factors that will often be present between industry, the public and regulatory bodies, and which confound the concept of environmental justice, and the elements of enshrined in the Principle 10 of the Rio Declaration. The study proposes that such tensions and complex examples will commonly be the reality of communities and regulators. However, to give practical effect to outcomes contemplated by Principle 10, the paper considers that regulators will may consider public intervention more broadly as including early interventions and formal opportunities for “conferencing” between industry, community and regulators. These initiatives help to develop a shared understanding and identification of issues. It is proposed that although important, options for “alternative dispute resolution” are not sufficiently preventative, as they come into play when a dispute has arise. Similarly “restorative justice” programs, while important once an incident or adverse environmental outcome has occurred, are post event and therefore necessarily limited. The paper considers the examples of how public participation at the outset – at the time of a proposal, before issues arise or eventuate to ensure, is demonstrably the most effective way for building commonality and an agreed methodology for working to resolve issues once they occur.

Keywords: environmental justice, alternative dispute resolution, domestic environmental law, international environmental law

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741 A New Obesity Index Derived from Waist Circumference and Hip Circumference Well-Matched with Other Indices in Children with Obesity

Authors: Mustafa M. Donma, Orkide Donma

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Anthropometric obesity indices such as waist circumference (WC), indices derived from anthropometric measurements such as waist-to-hip ratio (WHR), and indices created from body fat mass composition such as trunk-to-leg fat ratio (TLFR) are commonly used for the evaluation of mild or severe forms of obesity. Their clinical utilities are being compared using body mass index (BMI) percentiles to classify obesity groups. The best of them is still being investigated to make a clear-cut discrimination between healthy normal individuals (N-BMI) and overweight or obese (OB) or morbid obese patients. The aim of this study is to derive a new index, which best suits the purpose for the discrimination of children with N-BMI from OB children. A total of eighty-three children participated in the study. Two groups were constituted. The first group comprised 42 children with N-BMI, and the second group was composed of 41 OB children, whose age- and sex- adjusted BMI percentile values vary between 95 and 99. The corresponding values for the first group were between 15 and 85. This classification was based upon the tables created by World Health Organization. The institutional ethics committee approved the study protocol. Informed consent forms were filled by the parents of the participants. Anthropometric measurements were taken and recorded following a detailed physical examination. Within this context, weight, height (Ht), WC, hip C (HC), neck C (NC) values were taken. Body mass index, WHR, (WC+HC)/2, WC/Ht, (WC/HC)/Ht, WC*NC were calculated. Bioelectrical impedance analysis was performed to obtain body’s fat compartments in terms of total fat, trunk fat, leg fat, arm fat masses. Trunk-to-leg fat ratio, trunk-to-appendicular fat ratio (TAFR), (trunk fat+leg fat)/2 ((TF+LF)/2) were calculated. Fat mass index (FMI) and diagnostic obesity notation model assessment-II (D2I) index values were calculated. Statistical analysis of the data was performed. Significantly increased values of (WC+HC)/2, (TF+LF)/2, D2I, and FMI were observed in OB group in comparison with those of N-BMI group. Significant correlations were calculated between BMI and WC, (WC+HC)/2, (TF+LF)/2, TLFR, TAFR, D2I as well as FMI both in N-BMI and OB groups. The same correlations were obtained for WC. (WC+HC)/2 was correlated with TLFR, TAFR, (TF+LF)/2, D2I, and FMI in N-BMI group. In OB group, the correlations were the same except those with TLFR and TAFR. These correlations were not present with WHR. Correlations were observed between TLFR and BMI, WC, (WC+HC)/2, (TF+LF)/2, D2I as well as FMI in N-BMI group. Same correlations were observed also with TAFR. In OB group, correlations between TLFR or TAFR and BMI, WC as well as (WC+HC)/2 were missing. None was noted with WHR. From these findings, it was concluded that (WC+HC)/2, but not WHR, was much more suitable as an anthropometric obesity index. The only correlation valid in both groups was that exists between (WC+HC)/2 and (TF+LF)/2. This index was suggested as a link between anthropometric and fat-based indices.

Keywords: children, hip circumference, obesity, waist circumference

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740 A Retrospective Study on the Spectrum of Infection and Emerging Antimicrobial Resistance in Type 2 Diabetes Mellitus

Authors: Pampita Chakraborty, Sukumar Mukherjee

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People with diabetes mellitus are more susceptible to developing infections, as high blood sugar levels can weaken the patient's immune system defences. People with diabetes are more adversely affected when they get an infection than someone without the disease, because you have weakened immune defences in diabetes. People who have minimally elevated blood sugar levels experience worse outcomes with infections. Diabetic patients in hospitals do not necessarily have a higher mortality rate due to infections, but they do face longer hospitalisation and recovery times. A study was done in a tertiary care unit in eastern India. Patients with type 2 diabetes mellitus infection were recruited in the study. A total of 520 cases of Type 2 Diabetes Mellitus were recorded out of which 200 infectious cases was included in the study. All subjects underwent detailed history & clinical examination. Microbiological samples were collected from respective site of the infection for microbial culture and antibiotic sensitivity test. Out of the 200 infectious cases urinary tract infection(UTI) was found in majority of the cases followed by diabetic foot ulcer (DFU), respiratory tract infection(RTI) and sepsis. It was observed that Escherichia coli was the most commonest pathogen isolated from UTI cases and Staphylococcus aureus was predominant in foot ulcers followed by other organisms. Klebsiella pneumonia was the major organism isolated from RTI and Enterobacter aerogenes was commonly observed in patients with sepsis. Isolated bacteria showed differential sensitivity pattern against commonly used antibiotics. The majority of the isolates were resistant to several antibiotics that are usually prescribed on an empirical basis. These observations are important, especially for patient management and the development of antibiotic treatment guidelines. It is recommended that diabetic patients receive pneumococcal and influenza vaccine annually to reduce morbidity and mortality. Appropriate usage of antibiotics based on local antibiogram pattern can certainly help the clinician in reducing the burden of infections.

Keywords: antimicrobial resistance, diabetic foot ulcer, respiratory tract infection, urinary tract infection

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739 Modulation of the Innate Immune Response in Bovine Udder Tissue by Epigenetic Modifiers

Authors: Holm Zerbe, Laura Macias, Hans-Joachim Schuberth, Wolfram Petzl

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Mastitis is among the most important production diseases in cows. It accounts for large parts of antimicrobial drug use in the dairy industry worldwide. Due to the imminent normative to reduce the use of antimicrobial drugs in livestock, new ways for therapy and prophylaxis of mastitis are needed. Recently epigenetic regulation of inflammation by chromatin modifications has increasingly drawn attention. Currently, some epigenetic modifiers have already been approved for the use in humans, however little is known about their actions in the bovine system. The aim of our study was to investigate whether three selected epigenetic modifiers (Vitamin D3, SAHA and S2101) influence the initial immune response towards mastitis pathogens in bovine udder tissue in vitro. Tissue explants of the teat cistern and udder parenchyma were collected from 21 cows and were incubated for 36 hours in the absence and presence of epigenetic modifiers. Additionally, the tissue was stimulated with heat-inactivated particles of Escherichia coli and Staphylococcus aureus, which are regarded as two of the most important mastitis pathogens. After incubation, the explants were tested by RT-qPCR for transcript abundances of immune-related candidate genes. Gene expression was validated in culture supernatants by an AlphaLISA assay. Furthermore, the culture supernatants were analyzed for their chemotactic capacity through a chemotaxis assay. Statistical analysis of data was performed with the program ‘R’ version 3.2.3. Vitamin D3 had no effect on the immune response of udder tissue in vitro after stimulation with mastitis pathogens. The epigenetic modifiers SAHA and S2101 however significantly blocked the pathogen-induced upregulation of CXCL8, TNFα, S100A9 and LAP (P < 0.05). The regulation of IL10 was not affected by treatment with SAHA and S2101. Transcript abundances for CXCL8 were reflected by IL8 contents and chemotactic activity in culture supernatants. In conclusion, these data show the potential of epigenetic modifiers (SAHA and S2101) to block overshooting inflammation in the udder. Thus epigenetic modifiers may serve in future as immune modulators for the treatment and/or prophylaxis of clinical mastitis. (Funded by Deutsche Forschungsgemeinschaft PE 1495/2-1).

Keywords: mastitis, cattle, epigenetics, immunomodulation

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738 Analytical Performance of Cobas C 8000 Analyzer Based on Sigma Metrics

Authors: Sairi Satari

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Introduction: Six-sigma is a metric that quantifies the performance of processes as a rate of Defects-Per-Million Opportunities. Sigma methodology can be applied in chemical pathology laboratory for evaluating process performance with evidence for process improvement in quality assurance program. In the laboratory, these methods have been used to improve the timeliness of troubleshooting, reduce the cost and frequency of quality control and minimize pre and post-analytical errors. Aim: The aim of this study is to evaluate the sigma values of the Cobas 8000 analyzer based on the minimum requirement of the specification. Methodology: Twenty-one analytes were chosen in this study. The analytes were alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), Amylase, aspartate transaminase (AST), total bilirubin, calcium, chloride, cholesterol, HDL-cholesterol, creatinine, creatinine kinase, glucose, lactate dehydrogenase (LDH), magnesium, potassium, protein, sodium, triglyceride, uric acid and urea. Total error was obtained from Clinical Laboratory Improvement Amendments (CLIA). The Bias was calculated from end cycle report of Royal College of Pathologists of Australasia (RCPA) cycle from July to December 2016 and coefficient variation (CV) from six-month internal quality control (IQC). The sigma was calculated based on the formula :Sigma = (Total Error - Bias) / CV. The analytical performance was evaluated based on the sigma, sigma > 6 is world class, sigma > 5 is excellent, sigma > 4 is good and sigma < 4 is satisfactory and sigma < 3 is poor performance. Results: Based on the calculation, we found that, 96% are world class (ALT, albumin, ALP, amylase, AST, total bilirubin, cholesterol, HDL-cholesterol, creatinine, creatinine kinase, glucose, LDH, magnesium, potassium, triglyceride and uric acid. 14% are excellent (calcium, protein and urea), and 10% ( chloride and sodium) require more frequent IQC performed per day. Conclusion: Based on this study, we found that IQC should be performed frequently for only Chloride and Sodium to ensure accurate and reliable analysis for patient management.

Keywords: sigma matrics, analytical performance, total error, bias

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737 Preliminary Report on the Assessment of the Impact of the Kinesiology Taping Application versus Placebo Taping on the Knee Joint Position Sense

Authors: Anna Hadamus, Patryk Wasowski, Anna Mosiolek, Zbigniew Wronski, Sebastian Wojtowicz, Dariusz Bialoszewski

Abstract:

Introduction: Kinesiology Taping is a very popular physiotherapy method, often used for healthy people, especially athletes, in order to stimulate the muscles and improve their performance. The aim of this study was to determine the effect of the muscle application of Kinesiology Taping on the joint position sense in active motion. Material and Methods: The study involved 50 healthy people - 30 men and 20 women, mean age was 23.2 years (range 18-30 years). The exclusion criteria were injuries and operations of the knee, which could affect the test results. The participants were divided randomly into two equal groups. The first group consisted of individuals with the applied Kinesiology Taping muscle application (KT group), whereas in the rest of the individuals placebo application from red adhesive tape was used (placebo group). Both applications were to enhance the effects of quadriceps muscle activity. Joint position sense (JPS) was evaluated in this study. Error of Active Reproduction of the Joint Position (EARJP) of the knee was measured in 45° flexion. The test was performed prior to applying the patch, with the applied application, then 24 hours after wearing, and after removing the tape. The interval between trials was not less than 30 minutes. Statistical analysis was performed using Statistica 12.0. We calculated distribution characteristics, Wilcoxon test, Friedman‘s ANOVA and Mann-Whitney U test. Results. In the KT group and the placebo group average test score of JPS before applying application KT were 3.48° and 5.16° respectively, after its application it was 4.84° and 4.88°, then after 24 hours of experiment JPS was 5.12° and 4.96°, and after application removal we measured 3.84° and 5.12° respectively. Differences over time in any of the groups were not statistically significant. There were also no significant differences between the groups. Conclusions: 1. Applying Kinesiology Taping to quadriceps muscle had no significant effect on the knee joint proprioception. Its use in order to improve sensorimitor skills seems therefore to be unreasonable. 2. No differences between applications of KT and placebo indicates that the clinical effect of stretch tape is minimal or absent. 3. The results are the basis for the continuation of prospective, randomized trials of numerous study groups.

Keywords: joint position sense, kinesiology taping, kinesiotaping, knee

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736 Proniosomes as a Carrier for Ocular Drug Delivery

Authors: Rawia M. Khalil, Ghada Abd-Elbary, Mona Basha, Ghada E. A. Awad, Hadeer A. Elhashemy

Abstract:

Background: Bacterial infections of the eye are the clinical conditions responsible for ocular morbidity and blindness. Conjunctivitis is an inflammation of the conjunctiva, due to Staphylococcus aureus. Lomefloxacin HCl (LXN) is a third generation flouroquinolone antibiotic with a broad spectrum against wide range of bacteria and very effective against Staph infections especially in conjunctiva (conjunctivitis). The present study aims to develop and evaluate novel ocular proniosomal gels of Lomefloxacin Hcl (LXN); in order to improve its ocular bioavailability for the management of bacterial conjunctivitis. Materials and methods: Proniosomes were prepared by coacervation phase separation method using different types of nonionic surfactants (Span 60,40,20,Tween 20,40,60,80,Brij 35,98,72) solely and as mixtures with Span® 60. The formed gels were characterized for entrapment efficiency, vesicle size and in vitro drug release. The optimum proniosomal gel; P-LXN 7 were characterized for pH measurement, transmission electron microscopy (TEM) and differential scanning calorimetry (DSC) as well as Stability study and microbiological evaluation .The results revealed that only Span 60 was able to form stable LXN proniosomal gel when used individually while the other nonionic surfactants formed gels only in combination with Span 60 at different ratios. The optimum proniosomal gel; P-LXN 7 (Span60:Tween60, 9:1) appeared as spherical shaped vesicles having high entrapment efficiency (>80 %), appropriate vesicle size (187 nm) as well as controlled drug release over 12h. DSC confirmed the amorphous nature and the uniformity of LXN inclusion within the vesicles. Physical stability study did not show any significant changes in appearance or entrapment efficiency or vesicle size after storage for 3 months at 4°C. Ocular irritancy test revealed that P-LXN 7 was safe, well tolerable and suitable for ocular delivery. In vivo antibacterial activity of P-LXN 7 evaluated using the susceptibility test and topical therapy of induced ocular conjunctivitis confirmed the enhanced antibacterial therapeutic efficacy of the LXN-proniosomal gel compared to the commercially available LXN eye drops; Orchacin®. Conclusions: Our results suggest that proniosomal gels could provide a promising carrier of LXN for efficient ocular treatment of bacterial conjunctivitis.

Keywords: bacterial conjunctivitis, lomefloxacin HCl, ocular drug delivery, proniosomes

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735 Cytology Is a Promising Tool for the Diagnosis of High-Grade Serous Ovarian Carcinoma from Ascites

Authors: Miceska Simona, Škof Erik, Frković Grazio Snježana, Jeričević Anja, Smrkolj Špela, Cvjetićanin Branko, Novaković Srdjan, Grčar Kuzmanov Biljana, Kloboves-Prevodnik Veronika

Abstract:

Objectives: High-grade serous ovarian cancer (HGSOC) is characterized by the dissemination of the tumor cells (TC) in the peritoneal cavity forming malignant ascites at the time of diagnosis or recurrence. Still, cytology itself has been underutilized as a modality for the diagnosis of HGSOC from ascites, and histological examination from the tumor tissue is yet the only validated method used. The objective of this study was to evaluate the reliability of cytology in the diagnosis of HGSOC in relation to the histopathological examination. Methods: The study included 42 patients with histologically confirmed HGSOC, accompanied by malignant ascites. To confirm the malignancy of the TC in the ascites and to define their immunophenotype, immunohistochemical reaction (IHC) of the following antigens: Calretinin, MOC, WT1, PAX8, p53, p16 & Ki-67 was evaluated on ascites cytospins and tissue blocks. For complete cytological determination of HGSOC, BRCA 1/2 gene mutation was determined from ascites, tissue block, and blood. BRCA1/2 mutation from blood was performed to define the type of mutation, somatic vs germline. Results: Among 42 patients, the immunophenotype of HGSOC from ascites was confirmed in 36 cases (86%). For more profound analysis, the patients were divided in 3 groups regarding the number of TC present in the ascites: patients with less than 10% TC, 10% TC, and more than 10% TC. From all included patients, in the group with less than 10% TC, there were 10 cases, and only 5 of them(50%) showed HGSOC phenotype; 12 cases had equally 10% of TC, and 11 cases (92%) showed HGSOC phenotype; 20 cases had more than 10% TC and all of them (100%) confirmed the HGSOC immunophenotype from ascites. Only 33 patients were eligible for further BRCA1/2 analysis. Eleven BRCA1/2 mutations were detected from thetissue block: 6 germline and 5 somatic. In 2 cases with less than 10% TC, BRCA1/2 mutation was not detected; 4 cases had 10% TC, and 2 of them (50%) confirmed the mutation; 4 cases had more than 10% TC, and all showed 100% reliability with the tumor tissue. Conclusions: Cytology is a highly reliable method for determining the immunophenotype of HGSOC and BRCA1/2 mutation if more than 10% of tumor cells are present in the ascites. This may present an additional non-invasive clinical approach for fast and effective diagnose in the future, especially in inoperable conditions or relapses.

Keywords: cytology, ascites, high-grade serous ovarian cancer, immunophenotype, BRCA1/2

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734 Let’s talk about it! Increasing Advance Directives and End-of-Life Planning Awareness & Acceptance in Multi-Cultural Population with Low Health Literacy in a Faith-Based Setting

Authors: Tonya P. Bowers

Abstract:

Background: The community/patient-focused quality improvement (QI) project has resolved a clinical problem using a quantitative design evaluating behavior change practices in a convenience sample from a multi-cultural congregation in a faith-based setting. AD is a legal document that speaks for the patient when they are unable to speak for themselves. The AD provides detailed information regarding critical medical decisions on behalf of the patient if they’re unable to make decisions themselves. The goal of an AD is to improve EOL care renderings that align with the patient’s desires. The AD diminishes anxiety and stress associated with making difficult EOL care decisions for patients and their families. Method: The project has two intervention strategies: pre-intervention and post-intervention formative surveys and a final summative survey. Most of the data collection takes place during implementation. The Let’s Talk About It Program utilized an online meeting platform for presentation. Participants were asked to complete informed consent and surveys via an online portal. Education included slide presentation, Advance Directive demonstration, video clips, discussions and 1:1 assistance with AD completion with a project manager. Results: Considering the overwhelming likelihood responses where 87.5% identified they “definitely would” hold an End-Of-Life conversation with their healthcare provider or family, and 81.25% indicated their likelihood that they “definitely would” complete an advance directive. In addition, the final summative post-intervention survey (n-14) also demonstrated an overwhelming 93% positive response. Which undoubtedly demonstrates favorable outcomes for the project. Conclusion: the Let’s Talk About It Program demonstrated effectiveness in improving participants' attitudes and acceptance towards Advance Directives and expanding End-of-Life care discussions. Emphasis on program sustainment within the church is imperative in fostering continued awareness and improved health outcomes for the local community with low health literacy.

Keywords: advance directive, end of life, advance care planning, palliative care, low health literacy, faith-based

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