Search results for: stages of disease
Commenced in January 2007
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Edition: International
Paper Count: 5545

Search results for: stages of disease

355 Controlling the Release of Cyt C and L- Dopa from pNIPAM-AAc Nanogel Based Systems

Authors: Sulalit Bandyopadhyay, Muhammad Awais Ashfaq Alvi, Anuvansh Sharma, Wilhelm R. Glomm

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Release of drugs from nanogels and nanogel-based systems can occur under the influence of external stimuli like temperature, pH, magnetic fields and so on. pNIPAm-AAc nanogels respond to the combined action of both temperature and pH, the former being mostly determined by hydrophilic-to-hydrophobic transitions above the volume phase transition temperature (VPTT), while the latter is controlled by the degree of protonation of the carboxylic acid groups. These nanogels based systems are promising candidates in the field of drug delivery. Combining nanogels with magneto-plasmonic nanoparticles (NPs) introduce imaging and targeting modalities along with stimuli-response in one hybrid system, thereby incorporating multifunctionality. Fe@Au core-shell NPs possess optical signature in the visible spectrum owing to localized surface plasmon resonance (LSPR) of the Au shell, and superparamagnetic properties stemming from the Fe core. Although there exist several synthesis methods to control the size and physico-chemical properties of pNIPAm-AAc nanogels, yet, there is no comprehensive study that highlights the dependence of incorporation of one or more layers of NPs to these nanogels. In addition, effective determination of volume phase transition temperature (VPTT) of the nanogels is a challenge which complicates their uses in biological applications. Here, we have modified the swelling-collapse properties of pNIPAm-AAc nanogels, by combining with Fe@Au NPs using different solution based methods. The hydrophilic-hydrophobic transition of the nanogels above the VPTT has been confirmed to be reversible. Further, an analytical method has been developed to deduce the average VPTT which is found to be 37.3°C for the nanogels and 39.3°C for nanogel coated Fe@Au NPs. An opposite swelling –collapse behaviour is observed for the latter where the Fe@Au NPs act as bridge molecules pulling together the gelling units. Thereafter, Cyt C, a model protein drug and L-Dopa, a drug used in the clinical treatment of Parkinson’s disease were loaded separately into the nanogels and nanogel coated Fe@Au NPs, using a modified breathing-in mechanism. This gave high loading and encapsulation efficiencies (L Dopa: ~9% and 70µg/mg of nanogels, Cyt C: ~30% and 10µg/mg of nanogels respectively for both the drugs. The release kinetics of L-Dopa, monitored using UV-vis spectrophotometry was observed to be rather slow (over several hours) with highest release happening under a combination of high temperature (above VPTT) and acidic conditions. However, the release of L-Dopa from nanogel coated Fe@Au NPs was the fastest, accounting for release of almost 87% of the initially loaded drug in ~30 hours. The chemical structure of the drug, drug incorporation method, location of the drug and presence of Fe@Au NPs largely alter the drug release mechanism and the kinetics of these nanogels and Fe@Au NPs coated with nanogels.

Keywords: controlled release, nanogels, volume phase transition temperature, l-dopa

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354 Classical Improvisation Facilitating Enhanced Performer-Audience Engagement and a Mutually Developing Impulse Exchange with Concert Audiences

Authors: Pauliina Haustein

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Improvisation was part of Western classical concert culture and performers’ skill sets until early 20th century. Historical accounts, as well as recent studies, indicate that improvisatory elements in the programme may contribute specifically towards the audiences’ experience of enhanced emotional engagement during the concert. This paper presents findings from the author’s artistic practice research, which explored re-introducing improvisation to Western classical performance practice as a musician (cellist and ensemble partner/leader). In an investigation of four concert cycles, the performer-researcher sought to gain solo and chamber music improvisation techniques (both related to and independent of repertoire), conduct ensemble improvisation rehearsals, design concerts with an improvisatory approach, and reflect on interactions with audiences after each concert. Data was collected through use of reflective diary, video recordings, measurement of sound parameters, questionnaires, a focus group, and interviews. The performer’s empirical experiences and findings from audience research components were juxtaposed and interrogated to better understand the (1) rehearsal and planning processes that enable improvisatory elements to return to Western classical concert experience and (2) the emotional experience and type of engagement that occur throughout the concert experience for both performer and audience members. This informed the development of a concert model, in which a programme of solo and chamber music repertoire and improvisations were combined according to historically evidenced performance practice (including free formal solo and ensemble improvisations based on audience suggestions). Inspired by historical concert culture, where elements of risk-taking, spontaneity, and audience involvement (such as proposing themes for fantasies) were customary, this concert model invited musicians to contribute to the process personally and creatively at all stages, from programme planning, and throughout the live concert. The type of democratic, personal, creative, and empathetic collaboration that emerged, as a result, appears unique in Western classical contexts, rather finding resonance in jazz ensemble, drama, or interdisciplinary settings. The research identified features of ensemble improvisation, such as empathy, emergence, mutual engagement, and collaborative creativity, that became mirrored in audience’s responses, generating higher levels of emotional engagement, empathy, inclusivity, and a participatory, co-creative experience. It appears that duringimprovisatory moments in the concert programme, audience members started feeling more like active participants in za\\a creative, collaborative exchange and became stakeholders in a deeper phenomenon of meaning-making and narrativization. Examining interactions between all involved during the concert revealed that performer-audience impulse exchange occurred on multiple levels of awareness and seemed to build upon each other, resulting in particularly strong experiences of both performer and audience’s engagement. This impact appeared especially meaningful for audience members who were seldom concertgoers and reported little familiarity with classical music. The study found that re-introducing improvisatory elements to Western classical concert programmes has strong potential in increasing audience’s emotional engagement with the musical performance, enabling audience members to connect more personally with the individual performers, and in reaching new-to-classical-music audiences.

Keywords: artistic research, audience engagement, audience experience, classical improvisation, ensemble improvisation, emotional engagement, improvisation, improvisatory approach, musical performance, practice research

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353 Factors Influencing Family Resilience and Quality of Life in Pediatric Cancer Patients and Their Caregivers: A Cluster Analysis

Authors: Li Wang, Dan Shu, Shiguang Pang, Lixiu Wang, Bing Xiang Yang, Qian Liu

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Background: Cancer is one of the most severe diseases in childhood; long-term treatment and its side effects significantly impact the patient's physical, psychological, social functioning and quality of life while also placing substantial physical and psychological burdens on caregivers and families. Family resilience is crucial for children with cancer, helping them cope better with the disease and supporting the family in facing challenges together. As a family-level variable, family resilience requires information from multiple family members. However, to our best knowledge, there is currently no research investigating family resilience from both the perspectives of pediatric cancer patients and their caregivers. Therefore, this study aims to investigate the family resilience and quality of life of pediatric cancer patients from a patient–caregiver dyadic perspective. Methods: A total of 149 dyads of patients diagnosed with pediatric cancer patients and their principal caregivers were recruited from oncology departments of 4 tertiary hospitals in Wuhan and Taiyuan, China. All participants completed questionnaires that identified their demographic and clinical characteristics as well as assessed their family resilience and quality of life for both the patients and their caregivers. K-means cluster analysis was used to identify different clusters of family resilience based on the reports from patients and caregivers. Multivariate logistic regression and linear regression are used to analyze the factors influencing family resilience and quality of life, as well as the relationship between the two. Results: Three clusters of family resilience were identified: a cluster of high family resilience (HR), a cluster of low family resilience (LR), and a cluster of discrepant family resilience (DR). Most (67.1%) families fell into the cluster with low resilience. Characteristics such as the types of caregivers perceived social support of the patient were different among the three clusters. Compared to the LR group, families where the mother is the caregiver and where the patient has high social support are more likely to be assigned to the HR. The quality of life for caregivers was consistently highest in the HR cluster and lowest in the LR cluster. The patient's quality of life is not related to family resilience. In the linear regression analysis of the patient's quality of life, patients who are the first-born have higher quality of life, while those living with their parents have lower quality of life. The participants' characteristics were not associated with the quality of life for caregivers. Conclusions: In most families, family resilience was low. Families with maternal caregivers and patients receiving high levels of social support are more inclined to be higher levels of family resilience. Family resilience was linked to the quality of life of caregivers of pediatric cancer patients. The clinical implications of this findings suggest that healthcare and social support organizations should prioritize and support the participation of mothers in caregiving responsibilities. Furthermore, they should assist families in accessing social support to enhance family resilience. This study also emphasizes the importance of promoting family resilience for enhancing family health and happiness, as well as improving the quality of life for caregivers.

Keywords: pediatric cancer, cluster analysis, family resilience, quality of life

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352 Effects of the Natural Compound on SARS-CoV-2 Spike Protein-Mediated Metabolic Alteration in THP-1 Cells Explored by the ¹H-NMR-Based Metabolomics Approach

Authors: Gyaltsen Dakpa, K. J. Senthil Kumar, Nai-Wen Tsao, Sheng-Yang Wang

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Context: Coronavirus disease 2019 (COVID-19) is a severe respiratory illness caused by the SARS-CoV-2 virus. One of the hallmarks of COVID-19 is a change in metabolism, which can lead to increased severity and mortality. The mechanism of SARS-CoV-2-mediated perturbations of metabolic pathways has yet to be fully understood. Research Aim: This study aimed to investigate the metabolic alteration caused by SARS-CoV-2 spike protein in Phorbol 12-myristate 13-acetate (PMA)-induced human monocytes (THP-1) and to examine the regulatory effect of natural compounds like Antcins A on SARS-CoV-2 spike protein-induced metabolic alteration. Methodology: The study used a combination of proton nuclear magnetic resonance (1H-NMR) and MetaboAnalyst 5.0 software. THP-1 cells were treated with SARS-CoV-2 spike protein or control, and the metabolomic profiles of the cells were compared. Antcin A was also added to the cells to assess its regulatory effect on SARS-CoV-2 spike protein-induced metabolic alteration. Findings: The study results showed that treatment with SARS-CoV-2 spike protein significantly altered the metabolomic profiles of THP-1 cells. Eight metabolites, including glycerol-phosphocholine, glycine, canadine, sarcosine, phosphoenolpyruvic acid, glutamine, glutamate, and N, N-dimethylglycine, were significantly different between control and spike-protein treatment groups. Antcin A significantly reversed the changes in these metabolites. In addition, treatment with antacid A significantly inhibited SARS-CoV-2 spike protein-mediated up-regulation of TLR-4 and ACE2 receptors. Theoretical Importance The findings of this study suggest that SARS-CoV-2 spike protein can cause significant metabolic alterations in THP-1 cells. Antcin A, a natural compound, has the potential to reverse these metabolic alterations and may be a potential candidate for developing preventive or therapeutic agents for COVID-19. Data Collection: The data for this study was collected from THP-1 cells that were treated with SARS-CoV-2 spike protein or a control. The metabolomic profiles of the cells were then compared using 1H-NMR and MetaboAnalyst 5.0 software. Analysis Procedures: The metabolomic profiles of the THP-1 cells were analyzed using 1H-NMR and MetaboAnalyst 5.0 software. The software was used to identify and quantify the cells' metabolites and compare the control and spike-protein treatment groups. Questions Addressed: The question addressed by this study was whether SARS-CoV-2 spike protein could cause metabolic alterations in THP-1 cells and whether Antcin A can reverse these alterations. Conclusion: The findings of this study suggest that SARS-CoV-2 spike protein can cause significant metabolic alterations in THP-1 cells. Antcin A, a natural compound, has the potential to reverse these metabolic alterations and may be a potential candidate for developing preventive or therapeutic agents for COVID-19.

Keywords: SARS-CoV-2-spike, ¹H-NMR, metabolomics, antcin-A, taiwanofungus camphoratus

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351 Identifying Protein-Coding and Non-Coding Regions in Transcriptomes

Authors: Angela U. Makolo

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Protein-coding and Non-coding regions determine the biology of a sequenced transcriptome. Research advances have shown that Non-coding regions are important in disease progression and clinical diagnosis. Existing bioinformatics tools have been targeted towards Protein-coding regions alone. Therefore, there are challenges associated with gaining biological insights from transcriptome sequence data. These tools are also limited to computationally intensive sequence alignment, which is inadequate and less accurate to identify both Protein-coding and Non-coding regions. Alignment-free techniques can overcome the limitation of identifying both regions. Therefore, this study was designed to develop an efficient sequence alignment-free model for identifying both Protein-coding and Non-coding regions in sequenced transcriptomes. Feature grouping and randomization procedures were applied to the input transcriptomes (37,503 data points). Successive iterations were carried out to compute the gradient vector that converged the developed Protein-coding and Non-coding Region Identifier (PNRI) model to the approximate coefficient vector. The logistic regression algorithm was used with a sigmoid activation function. A parameter vector was estimated for every sample in 37,503 data points in a bid to reduce the generalization error and cost. Maximum Likelihood Estimation (MLE) was used for parameter estimation by taking the log-likelihood of six features and combining them into a summation function. Dynamic thresholding was used to classify the Protein-coding and Non-coding regions, and the Receiver Operating Characteristic (ROC) curve was determined. The generalization performance of PNRI was determined in terms of F1 score, accuracy, sensitivity, and specificity. The average generalization performance of PNRI was determined using a benchmark of multi-species organisms. The generalization error for identifying Protein-coding and Non-coding regions decreased from 0.514 to 0.508 and to 0.378, respectively, after three iterations. The cost (difference between the predicted and the actual outcome) also decreased from 1.446 to 0.842 and to 0.718, respectively, for the first, second and third iterations. The iterations terminated at the 390th epoch, having an error of 0.036 and a cost of 0.316. The computed elements of the parameter vector that maximized the objective function were 0.043, 0.519, 0.715, 0.878, 1.157, and 2.575. The PNRI gave an ROC of 0.97, indicating an improved predictive ability. The PNRI identified both Protein-coding and Non-coding regions with an F1 score of 0.970, accuracy (0.969), sensitivity (0.966), and specificity of 0.973. Using 13 non-human multi-species model organisms, the average generalization performance of the traditional method was 74.4%, while that of the developed model was 85.2%, thereby making the developed model better in the identification of Protein-coding and Non-coding regions in transcriptomes. The developed Protein-coding and Non-coding region identifier model efficiently identified the Protein-coding and Non-coding transcriptomic regions. It could be used in genome annotation and in the analysis of transcriptomes.

Keywords: sequence alignment-free model, dynamic thresholding classification, input randomization, genome annotation

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350 Nursing Students’ Learning Effects of Online Visits for Mothers Rearing Infants during the COVID-19 Pandemic

Authors: Saori Fujimoto, Hiromi Kawasaki, Mari Murakami, Yoko Ueno

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Background: Coronavirus disease (COVID-19) has been spreading throughout the world. In Japan, many nursing universities have conducted online clinical practices to secure students’ learning opportunities. In the field of women’s health nursing, even after the pandemic ended, it will be worthwhile to utilize online practice in declining birthrate and reducing the burden of mothers. This study examined the learning effects of conducting online visits for mothers with infants during the COVID-19 pandemic by nursing students to enhance the students’ ability to carry out the online practice even in ordinary times effectively. Methods: Students were divided into groups of three, and information on the mothers was assessed, and the visits were planned. After role-play was conducted by the students and teachers, an online visit was conducted. The analysis target was the self-evaluation score of nine students who conducted online visits in June 2020 and had consented to participate. The evaluation contents included three items for assessment, two items for planning, one item for ethical consideration, five items for nursing practice, and two items for evaluation. The self-evaluation score ranged from 4 (‘Can do with a little advice’) to 1 (‘Can’t do with a little advice’). A univariate statistical analysis was performed. This study was approved by the Ethical Committee for Epidemiology of Hiroshima University. Results: The items with the highest mean (standard deviation) scores were ‘advocates for the dignity and the rights of mothers’ (3.89 (0.31)) and ‘communication behavior needed to create a trusting relationship’ (3.89 (0.31)).’ Next were the ‘individual nursing practice tailored to mothers (3.78 (0.42))’ and ‘review own practice and work on own task (3.78 (0.42)).’ The mean (standard deviation) of the items by type were as follows: three assessment items, 3.26 (0.70), two planning items, 3.11 (0.49), one ethical consideration item, 3.89 (0.31), five nursing practice items, 3.56 (0.54), and two evaluation items, 3.67 (0.47). Conclusion: The highest self-evaluations were for ‘advocates for the dignity and the rights of mothers’ and ‘communication behavior needed to create a trusting relationship.’ These findings suggest that the students were able to form good relationships with the mothers by improving their ability to effectively communicate and by presenting a positive attitude, even when conducting health visits online. However, the self-evaluation scores for assessment and planning were lower than those of ethical consideration, nursing practice, and evaluation. This was most likely due to a lack of opportunities and time to gather information and the need to modify and add plans in a short amount of time during one online visit. It is necessary to further consider the methods used in conducting online visits from the following viewpoints: methods of gathering information and the ability to make changes through multiple visits.

Keywords: infants, learning effects, mothers, online visit practice

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349 Evaluation of Antidiabetic Activity of a Combination Extract of Nigella Sativa & Cinnamomum Cassia in Streptozotocin Induced Type-I Diabetic Rats

Authors: Ginpreet Kaur, Mohammad Yasir Usmani, Mohammed Kamil Khan

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Diabetes mellitus is a disease with a high global burden and results in significant morbidity and mortality. In India, the number of people suffering with diabetes is expected to rise from 19 to 57 million in 2025. At present, interest in herbal remedies is growing to reduce the side effects associated with conventional dosage form like oral hypoglycemic agents and insulin for the treatment of diabetes mellitus. Our aim was to investigate the antidiabetic activities of combinatorial extract of N. sativa & C. cassia in Streptozotocin induced type-I Diabetic Rats. Thus, the present study was undertaken to screen postprandial glucose excursion potential through α- glucosidase inhibitory activity (In Vitro) and effect of combinatorial extract of N. sativa & C. cassia in Streptozotocin induced type-I Diabetic Rats (In Vivo). In addition changes in body weight, plasma glucose, lipid profile and kidney profile were also determined. The IC50 values for both extract and Acarbose was calculated by extrapolation method. Combinatorial extract of N. sativa & C. cassia at different dosages (100 and 200 mg/kg orally) and Metformin (50 mg/kg orally) as the standard drug was administered for 28 days and then biochemical estimation, body weights and OGTT (Oral glucose tolerance test) were determined. Histopathological studies were also performed on kidney and pancreatic tissue. In In-Vitro the combinatorial extract shows much more inhibiting effect than the individual extracts. The results reveals that combinatorial extract of N. sativa & C. cassia has shown significant decrease in plasma glucose (p<0.0001), total cholesterol and LDL levels when compared with the STZ group The decreasing level of BUN and creatinine revealed the protection of N. sativa & C. cassia extracts against nephropathy associated with diabetes. Combination of N. sativa & C. cassia significantly improved glucose tolerance to exogenously administered glucose (2 g/kg) after 60, 90 and 120 min interval on OGTT in high dose streptozotocin induced diabetic rats compared with the untreated control group. Histopathological studies shown that treatment with N. sativa & C. cassia extract alone and in combination restored pancreatic tissue integrity and was able to regenerate the STZ damaged pancreatic β cells. Thus, the present study reveals that combination of N. sativa & C. cassia extract has significant α- glucosidase inhibitory activity and thus has great potential as a new source for diabetes treatment.

Keywords: lipid levels, OGTT, diabetes, herbs, glucosidase

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348 Socioeconomic Burden of Life Long Disease: A Case of Diabetes Care in Bangladesh

Authors: Samira Humaira Habib

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Diabetes has profound effects on individuals and their families. If diabetes is not well monitored and managed, then it leads to long-term complications and a large and growing cost to the health care system. Prevalence and socioeconomic burden of diabetes and relative return of investment for the elimination or the reduction of the burden are much more important regarding its cost burden. Various studies regarding the socioeconomic cost burden of diabetes are well explored in developed countries but almost absent in developing countries like Bangladesh. The main objective of the study is to estimate the total socioeconomic burden of diabetes. It is a prospective longitudinal follow up study which is analytical in nature. Primary and secondary data are collected from patients who are undergoing treatment for diabetes at the out-patient department of Bangladesh Institute of Research & Rehabilitation in Diabetes, Endocrine & Metabolic Disorders (BIRDEM). Of the 2115 diabetic subjects, females constitute around 50.35% of the study subject, and the rest are male (49.65%). Among the subjects, 1323 are controlled, and 792 are uncontrolled diabetes. Cost analysis of 2115 diabetic patients shows that the total cost of diabetes management and treatment is US$ 903018 with an average of US$ 426.95 per patient. In direct cost, the investigation and medical treatment at hospital along with investigation constitute most of the cost in diabetes. The average cost of a hospital is US$ 311.79, which indicates an alarming warn for diabetic patients. The indirect cost shows that cost of productivity loss (US$ 51110.1) is higher among the all indirect item. All constitute total indirect cost as US$ 69215.7. The incremental cost of intensive management of uncontrolled diabetes is US$ 101.54 per patient and event-free time gained in this group is 0.55 years and the life years gain is 1.19 years. The incremental cost per event-free year gained is US$ 198.12. The incremental cost of intensive management of the controlled group is US$ 89.54 per patient and event-free time gained is 0.68 years, and the life year gain is 1.12 years. The incremental cost per event-free year gained is US$ 223.34. The EuroQoL difference between the groups is found to be 64.04. The cost-effective ratio is found to be US$ 1.64 cost per effect in case of controlled diabetes and US$ 1.69 cost per effect in case of uncontrolled diabetes. So management of diabetes is much more cost-effective. Cost of young type 1 diabetic patient showed upper socioeconomic class, and with the increase of the duration of diabetes, the cost increased also. The dietary pattern showed macronutrients intake and cost are significantly higher in the uncontrolled group than their counterparts. Proper management and control of diabetes can decrease the cost of care for the long term.

Keywords: cost, cost-effective, chronic diseases, diabetes care, burden, Bangladesh

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347 Aerobic Training Combined with Nutritional Guidance as an Effective Strategy for Improving Aerobic Fitness and Reducing BMI in Inactive Adults

Authors: Leif Inge Tjelta, Gerd Lise Nordbotten, Cathrine Nyhus Hagum, Merete Hagen Helland

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Overweight and obesity can lead to numerous health problems, and inactive people are more often overweight and obese compared to physically active people. Even a moderate weight loss can improve cardiovascular and endocrine disease risk factors. The aim of the study was to examine to what extent overweight and obese adults starting up with two weekly intensive running sessions had an increase in aerobic capacity, reduction in BMI and waist circumference and changes in body composition after 33 weeks of training. An additional aim was to see if there were differences between participants who, in addition to training, also received lifestyle modification education, including practical cooking (nutritional guidance and training group (NTG =32)) compared to those who were not given any nutritional guidance (training group (TG=40)). 72 participants (49 women), mean age of 46.1 ( ± 10.4) were included. Inclusion Criteria: Previous untrained and inactive adults in all age groups, BMI ≥ 25, desire to become fitter and reduce their BMI. The two weekly supervised training sessions consisted of 10 min warm up followed by 20 to 21 min effective interval running where the participants’ heart rate were between 82 and 92% of hearth rate maximum. The sessions were completed with ten minutes whole body strength training. Measures of BMI, waist circumference (WC) and 3000m running time were performed at the start of the project (T1), after 15 weeks (T2) and at the end of the project (T3). Measurements of fat percentage, muscle mass, and visceral fat were performed at T1 and T3. Twelve participants (9 women) from both groups, who all scored around average on the 3000 m pre-test, were chosen to do a VO₂max test at T1 and T3. The NTG were given ten theoretical sessions (80 minutes each) and eight practical cooking sessions (140 minutes each). There was a significant reduction in bout groups for WC and BMI from T1 to T2. There was not found any further reduction from T2 to T3. Although not significant, NTG reduced their WC more than TG. For both groups, the percentage reduction in WC was similar to the reduction in BMI. There was a decrease in fat percentage in both groups from pre-test to post-test, whereas, for muscle mass, a small, but insignificant increase was observed for both groups. There was a decrease in 3000m running time for both groups from T1 to T2 as well as from T2 to T3. The difference between T2 and T3 was not statistically significant. The 12 participants who tested VO₂max had an increase of 2.86 ( ± 3.84) mlkg⁻¹ min⁻¹ in VO₂max and 3:02 min (± 2:01 min) reduction in running time over 3000 m from T1 until T3. There was a strong, negative correlation between the two variables. The study shows that two intensive running session in 33 weeks can increase aerobic fitness and reduce BMI, WC and fat percent in inactive adults. Cost guidance in addition to training will give additional effect.

Keywords: interval training, nutritional guidance, fitness, BMI

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346 Using Health Literacy and Medico-Legal Guidance to Improve Restorative Dentistry Patient Information Leaflets

Authors: Hasneet K. Kalsi, Julie K. Kilgariff

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Introduction: Within dentistry, the process for gaining informed consent has become more complex. To consent for treatment, patients must understand all reasonable treatment options and associated risks and benefits. Consenting is therefore deeply embedded in health literacy. Patients attending for dental consultation are often presented with an array of information and choices, yet studies show patients recall less than half of the information provided immediately after. Appropriate and comprehensible patient information leaflets (PILs) may be useful aid memories. In 2016 the World Health Organisation set improving health literacy as a global priority. Soon after, Scotland’s 2017-2025 Making it Easier: A Health Literacy Action Plan followed. This project involved the review of Restorative PILs used within Dundee Dental Hospital to assess the Content and Readability. Method: The current PIL on Root Canal Treatment (RCT) was created in 2011. This predates the Montgomery vs. NHS Lanarkshire case, a ruling which significantly impacted dental consenting processes, as well as General Dental Council’s (GDC’s) Standards for the Dental Team and Faculty of General Dental Practice’s Good Practice Guidance on Clinical Examination and Record-Keeping. Current evidence-based guidance, including that stipulated by the GDC, was reviewed. A 20-point Essential Content Checklist was designed to conform to best practice guidance for valid consenting processes. The RCT leaflet was scored against this to ascertain if the content was satisfactory. Having ensured the content satisfied medicolegal requirements, health literacy considerations were reviewed regarding readability. This was assessed using McLaughlin’s Simple Measure of Gobbledygook (SMOG) formula, which identifies school stages that would have to be achieved to comprehend the PIL. The sensitivity of the results to alternative readability methods were assessed. Results: The PIL was not sufficient for modern consenting processes and reflected a suboptimal level of health literacy. Evaluation of the leaflet revealed key content was missing, including information pertaining to risks and benefits. Only five points out of the 20-point checklist were present. The readability score was 16, equivalent to a level 2 in National Adult Literacy Standards/Scottish Credit and Qualification Framework Level 5; 62% of Scottish adults are able to read to this standard. Discussion: Assessment of the leaflet showed it was no longer fit for purpose. Reasons include a lack of pertinent information, a text-heavy leaflet lacking flow, and content errors. The SMOG score indicates a high level of comprehension is required to understand this PIL, which many patients may not possess. A new PIL, compliant with medicolegal and health literacy guidance, was designed with patient-driven checklists, notes spaces for annotations/ questions and areas for clinicians to highlight important case-specific information. It has been tested using the SMOG formula. Conclusion: PILs can be extremely useful. Studies show that interactive use can enhance their effectiveness. PILs should reflect best practice guidance and be understood by patients. The 2020 leaflet designed and implemented aims to fulfill the needs of a modern healthcare system and its service users. It embraces and embeds Scotland’s Health Literacy Action Plan within the consenting process. A review of further leaflets using this model is ongoing.

Keywords: consent, health literacy, patient information leaflet, restorative dentistry

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345 Effect of Reminiscence Therapy on the Sleep Quality of the Elderly Living in Nursing Homes

Authors: Güler Duru Aşiret

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Introduction: Poor sleep quality is a common problem among the older people living in nursing homes. Our study aimed at assessing the effect of individual reminiscence therapy on the sleep quality of the elderly living in nursing homes. Methods: The study had 22 people in the intervention group and 24 people in the control group. The intervention group had reminiscence therapy once a week for 12 weeks in the form of individual sessions of 25-30 minutes. In our study, we first determined the dates suitable for the intervention group and researcher and planned the date and time of individual reminiscence therapies, which would take 12 weeks. While preparing this schedule, we considered subjects’ time schedules for their regular visits to health facilities and the arrival of their visitors. At this stage, the researcher informed the participants that their regular attendance in sessions would affect the intervention outcome. One topic was discussed every week. Weekly topics included: introduction in the first week; childhood and family life, school days, starting work and work life (a day at home for housewives), a fun day out of home, marriage (friendship for the singles), plants and animals they loved, babies and children, food and cooking, holidays and travelling, special days and celebrations, assessment and closure, in the following weeks respectively. The control group had no intervention. Study data was collected by using an introductory information form and the Pittsburgh Sleep Quality Index (PSQI). Results: In our study, participants’ average age was 76.02 ± 7.31. 58.7% of them were male and 84.8% were single. All of them had at least one chronic disease. 76.1% did not need help for performing their daily life activities. The length of stay in the institution was 6.32 ± 3.85 years. According to the participants’ descriptive characteristics, there was no difference between groups. While there was no statistically significant difference between the pretest PSQI median scores (p > 0.05) of both groups, PSQI median score had a statistically significant decrease after 12 weeks of reminiscence therapy (p < 0.05). There was no statistically significant change in the median scores of the subcomponents of sleep latency, sleep duration, sleep efficiency, sleep disturbance and use of sleep medication before and after reminiscence therapy. After the 12-weeks reminiscence therapy, there was a statistically significant change in the median scores for the PSQI subcomponents of subjective sleep quality (p<0.05). Conclusion: Our study found that reminiscence therapy increased the sleep quality of the elderly living in nursing homes. Acknowledgment: This study (project no 2017-037) was supported by the Scientific Research Projects Coordination Unit of Aksaray University. We thank the elderly subjects for their kind participation.

Keywords: nursing, older people, reminiscence therapy, sleep

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344 [Keynote Speech]: Evidence-Based Outcome Effectiveness Longitudinal Study on Three Approaches to Reduce Proactive and Reactive Aggression in Schoolchildren: Group CBT, Moral Education, Bioneurological Intervention

Authors: Annis Lai Chu Fung

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While aggression had high stability throughout developmental stages and across generations, it should be the top priority of researchers and frontline helping professionals to develop prevention and intervention programme for aggressive children and children at risk of developing aggressive behaviours. Although there is a substantial amount of anti-bullying programmes, they gave disappointingly small effect sizes. The neglectful practical significance could be attributed to the overly simplistic categorisation of individuals involved as bullies or victims. In the past three decades, the distinction between reactive and proactive aggression has been well-proved. As children displaying reactively aggressive behaviours have distinct social-information processing pattern with those showing proactively aggressive behaviours, it is critical to identify the unique needs of the two subtypes accordingly when designing an intervention. The onset of reactive aggression and proactive aggression was observed at earliest in 4.4 and 6.8 years old respectively. Such findings called for a differential early intervention targeting these high-risk children. However, to the best of the author’s knowledge, the author was the first to establish an evidence-based intervention programme against reactive and proactive aggression. With the largest samples in the world, the author, in the past 10 years, explored three different approaches and their effectiveness against aggression quantitatively and qualitatively with longitudinal design. The three approaches presented are (a) cognitive-behavioral approach, (b) moral education, with Chinese marital arts and ethics as the medium, and (c) bioneurological measures (omega-3 supplementation). The studies adopted a multi-informant approach with repeated measures before and after the intervention, and follow-up assessment. Participants were recruited from primary and secondary schools in Hong Kong. In the cognitive-behavioral approach, 66 reactive aggressors and 63 proactive aggressors, aged from 11 to 17, were identified from 10,096 secondary-school children with questionnaire and subsequent structured interview. Participants underwent 10 group sessions specifically designed for each subtype of aggressor. Results revealed significant declines in aggression levels from the baseline to the follow-up assessment after 1 year. In moral education through the Chinese martial arts, 315 high-risk aggressive children, aged 6 to 12 years, were selected from 3,511 primary-school children and randomly assigned into four types of 10-session intervention group, namely martial-skills-only, martial-ethics-only, both martial-skills-and-ethics, and physical fitness (placebo). Results showed only the martial-skills-and-ethics group had a significant reduction in aggression after treatment and 6 months after treatment comparing with the placebo group. In the bioneurological approach, 218 children, aged from 8 to 17, were randomly assigned to the omega-3 supplement group and the placebo group. Results revealed that compared with the placebo group, the omega-3 supplement group had significant declines in aggression levels at the 6-month follow-up assessment. All three approaches were effective in reducing proactive and reactive aggression. Traditionally, intervention programmes against aggressive behaviour often adapted the cognitive and/or behavioural approach. However, cognitive-behavioural approach for children was recently challenged by its demanding requirement of cognitive ability. Traditional cognitive interventions may not be as beneficial to an older population as in young children. The present study offered an insightful perspective in aggression reduction measures.

Keywords: intervention, outcome effectiveness, proactive aggression, reactive aggression

Procedia PDF Downloads 221
343 Comparative Histological, Immunohistochemical and Biochemical Study on the Effect of Vit. C, Vit. E, Gallic Acid and Silymarin on Carbon Tetrachloride Model of Liver Fibrosis in Rats

Authors: Safaa S. Hassan, Mohammed H. Elbakry, Safwat A. Mangoura, Zainab M. Omar

Abstract:

Background: Liver fibrosis is the main reason for increased mortality in chronic liver disease. It has no standard treatment. Antioxidants from a variety of sources are capable of slowing or preventing oxidation of other molecules. Aim: to evaluate the hepatoprotective effect of vit. C, vit. E and gallic acid in comparison to silymarin in the rat model of carbon tetrachloride induced liver fibrosis and their possible mechanisms of action. Material& Methods: A total number of 60 adult male albino rats 160-200gm were divided into six equal groups; received subcutaneous (s.c) injection for 8 weeks. Group I: as control. Group II: received 1.5 mL/kg of CCL4 .Group III: CCL4 and co- treatment with silymarin 100mg/kg p.o. daily. Group IV: CCL4 and co-treatment with vit. C 50mg/kg p.o. daily. Group V: CCL4 and co-treatment with vit. E 200mg/kg. p.o. Group VI: CCL4 and co-treatment with Gallic acid 100mg/kg. p.o. daily. Liver was processed for histological and immunohistochemical examination. Levels of AST, ALT, ALP, reduced GSH, MDA, SOD and hydroxyproline concentration were measured and evaluated statistically. Results: Light and electron microscopic examination of liver of group II exhibited foci of altered cells with dense nuclei and vacuolated, granular cytoplasm, mononuclear cell infiltration in portal areas, profuse collagen fiber deposits were found around portal tract, more intense staining α-SMA-positive cells occupied most of the liver fibrosis tissue, electron lucent areas in the cytoplasm of the hepatocytes, margination of nuclear chromatin. Treatment by any of the antioxidants variably reduced the hepatic structural changes induced by CCL4. Biochemical analysis showed that carbon tetrachloride significantly increased the levels of serum AST, ALT, ALP, hepatic malondialdehyde and hydroxyproline content. Moreover, it decreased the activities of superoxide dismutase and glutathione. Treatment with silymarin, gallic acid, vit. C and vit. E decreased significantly the AST, ALT, and ALP levels in plasma, MDA and hydroxyproline and increased the activities of SOD and glutathione in liver tissue. The effect of administration of CCl4 was improved with the used antioxidants in variable degrees. The most efficient antioxidant was silymarin followed by gallic acid and vit. C then vit. E. It is possibly due to their antioxidant effect, free radical scavenging properties and the reduction of oxidant dependent activation and proliferation of HSCs. Conclusion: So these antioxidants can be a promising drugs candidate for ameliorating liver fibrosis better than the use of the drugs and their side effects.

Keywords: antioxidant, ccl4, gallic acid, liver fibrosis

Procedia PDF Downloads 271
342 Correlations between Folate, Homocysteine Levels, and Markers of Brain Atrophy in Elderly Male and Female Rats

Authors: Fatimah A. Alhomaid, Nadia H. Mahmoud, Maha A. Al-Qaraawi

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The present study was designed to induce hyperhomocysteinemia (HHcy) in elderly male and female rats. Also,to evaluate, the effect of (HHcy) as a risk factor for cerebrovascular disease and brain atrophy and folate supplementation on serum levels of Hcy, total cholesterol, low density lipoprotein cholesterol (LDLc), high density lipoprotein cholesterol (HDLc), triglycerides, pyridoxal phosphate , folate also, histopathological examination of brain and cerebrovascular vessels In this work 50 male and 50 female elderly albino rats were used and divided into five groups. The first group served as control, the second and third group received two different dose of L-methionine, the fourth and fifth group received fortified diet with folate powder plus L-methionine. Our results showed that homocysteine levels in male and female rats that received low and high dose of methionine were higher than in the control group, while the levels of folate significantly decreased in male rats only. Induced hyperhomocysteinemia in elderly male and female rats led to significant increase in serum level of cholesterol, LDLc and triglycerides but serum level of HDLc were significantly lower in methionine treated male and female rats than in control. Our results showed that a strong positive correlation between all these parameters and homocysteine except HDLc levels which correlate negatively to Hcy levels. Administration of folate to methionine treated male rats led to insignificant changes in the level of cholesterol when compared to control group but this level was found to be significantly decrease in female rats received small dose of methionine. When the level of cholesterol compared to the same dose of methionine treated group we found a significant decrease in both male and female rats. LDLc and triglycerides level significantly decrease in male rats only versus the control rats, while when compared to low and high dose of methionine a significant decreased occurs. A significant increase in serum level of HDLc in male and female rats when compared to both control and methionine treated groups. In male and female rats supplemented with folate we found an increased serum levels of folate when compared to rats received both dose of methionine. The levels of pyridoxal phosphate significantly decreased in all treated rats compared to the control group and its level were increased with supplementation of folate versus the rats received small and large dose of methionine. It can be concluded that hyperhomocysteinemia may be an additional risk factor for cerebrovascular atherosclesosis and brain atrophy in elderly people and diatery supplementation with folate blocking the activity of homocysteine and may be considered as a therapeutic possibility.

Keywords: hyperhomocysteinemia, brain atrophy, cerebrovascular, L-methionine, pyridoxal phosphate

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341 Interdisciplinary Evaluations of Children with Autism Spectrum Disorder in a Telehealth Arena

Authors: Janice Keener, Christine Houlihan

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Over the last several years, there has been an increase in children identified as having Autism Spectrum Disorder (ASD). Specialists across several disciplines: mental health and medical professionals have been tasked with ensuring accurate and timely evaluations for children with suspected ASD. Due to the nature of the ASD symptom presentation, an interdisciplinary assessment and treatment approach best addresses the needs of the whole child. During the unprecedented COVID-19 Pandemic, clinicians were faced with how to continue with interdisciplinary assessments in a telehealth arena. Instruments that were previously used to assess ASD in-person were no longer appropriate measures to use due to the safety restrictions. For example, The Autism Diagnostic Observation Schedule requires examiners and children to be in very close proximity of each other and if masks or face shields are worn, they render the evaluation invalid. Similar issues arose with the various cognitive measures that are used to assess children such as the Weschler Tests of Intelligence and the Differential Ability Scale. Thus the need arose to identify measures that are able to be safely and accurately administered using safety guidelines. The incidence of ASD continues to rise over time. Currently, the Center for Disease Control estimates that 1 in 59 children meet the criteria for a diagnosis of ASD. The reasons for this increase are likely multifold, including changes in diagnostic criteria, public awareness of the condition, and other environmental and genetic factors. The rise in the incidence of ASD has led to a greater need for diagnostic and treatment services across the United States. The uncertainty of the diagnostic process can lead to an increased level of stress for families of children with suspected ASD. Along with this increase, there is a need for diagnostic clarity to avoid both under and over-identification of this condition. Interdisciplinary assessment is ideal for children with suspected ASD, as it allows for an assessment of the whole child over the course of time and across multiple settings. Clinicians such as Psychologists and Developmental Pediatricians play important roles in the initial evaluation of autism spectrum disorder. An ASD assessment may consist of several types of measures such as standardized checklists, structured interviews, and direct assessments such as the ADOS-2 are just a few examples. With the advent of telehealth clinicians were asked to continue to provide meaningful interdisciplinary assessments via an electronic platform and, in a sense, going to the family home and evaluating the clinical symptom presentation remotely and confidently making an accurate diagnosis. This poster presentation will review the benefits, limitations, and interpretation of these various instruments. The role of other medical professionals will also be addressed, including medical providers, speech pathology, and occupational therapy.

Keywords: Autism Spectrum Disorder Assessments, Interdisciplinary Evaluations , Tele-Assessment with Autism Spectrum Disorder, Diagnosis of Autism Spectrum Disorder

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340 Reducing Falls in Memory Care through Implementation of the Stopping Elderly Accidents, Deaths, and Injuries Program

Authors: Cory B. Lord

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Falls among the elderly population has become an area of concern in healthcare today. The negative impacts of falls lead to increased morbidity, mortality, and financial burdens for both patients and healthcare systems. Falls in the United States is reported at an annual rate of 36 million in those aged 65 and older. Each year, one out of four people in this age group will suffer a fall, with 20% of these falls causing injury. The setting for this Doctor of Nursing Practice (DNP) project was a memory care unit in an assisted living community, as these facilities house cognitively impaired older adults. These communities lack fall prevention programs; therefore, the need exists to add to the body of knowledge to positively impact this population. The objective of this project was to reduce fall rates through the implementation of the Center for Disease Control and Prevention (CDC) STEADI (stopping elderly accidents, deaths, and injuries) program. The DNP project performed was a quality improvement pilot study with a pre and post-test design. This program was implemented in the memory care setting over 12 weeks. The project included an educational session for staff and a fall risk assessment with appropriate resident referrals. The three aims of the DNP project were to reduce fall rates among the elderly aged 65 and older who reside in the memory care unit, increase staff knowledge of STEADI fall prevention measures after an educational session, and assess the willingness of memory care unit staff to adopt an evidence-based a fall prevention program. The Donabedian model was used as a guiding conceptual framework for this quality improvement pilot study. The fall rate data for 12 months before the intervention was evaluated and compared to post-intervention fall rates. The educational session comprised of a pre and post-test to assess staff knowledge of the fall prevention program and the willingness of staff to adopt the fall prevention program. The overarching goal was to reduce falls in the elderly population who live in memory care units. The results of the study showed, on average that the fall rate during the implementation period of STEADI (μ=6.79) was significantly lower when compared to the prior 12 months (μ= 9.50) (p=0.02, α = 0.05). The mean staff knowledge scores improved from pretest (μ=77.74%) to post-test (μ=87.42%) (p=0.00, α= 0.05) after the education session. The results of the willingness to adopt a fall prevention program were scored at 100%. In summation, implementing the STEADI fall prevention program can assist in reducing fall rates for residents aged 65 and older who reside in a memory care setting.

Keywords: dementia, elderly, falls, STEADI

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339 Immunomodulatory Role of Heat Killed Mycobacterium indicus pranii against Cervical Cancer

Authors: Priyanka Bhowmik, Subrata Majumdar, Debprasad Chattopadhyay

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Background: Cervical cancer is the third major cause of cancer in women and the second most frequent cause of cancer related deaths causing 300,000 deaths annually worldwide. Evasion of immune response by Human Papilloma Virus (HPV), the key contributing factor behind cancer and pre-cancerous lesions of the uterine cervix, makes immunotherapy a necessity to treat this disease. Objective: A Heat killed fraction of Mycobacterium indicus pranii (MIP), a non-pathogenic Mycobacterium has been shown to exhibit cytotoxic effects on different cancer cells, including human cervical carcinoma cell line HeLa. However, the underlying mechanisms remain unknown. The aim of this study is to decipher the mechanism of MIP induced HeLa cell death. Methods: The cytotoxicity of Mycobacterium indicus pranii against HeLa cells was evaluated by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. Apoptosis was detected by annexin V and Propidium iodide (PI) staining. The assessment of reactive oxygen species (ROS) generation and cell cycle analysis were measured by flow cytometry. The expression of apoptosis associated genes was analyzed by real time PCR. Result: MIP could inhibit the proliferation of HeLa cell in a time and dose dependent manner but caused minor damage to normal cells. The induction of apoptosis was confirmed by the cell surface presentation of phosphatidyl serine, DNA fragmentation, and mitochondrial damage. MIP caused very early (as early as 30 minutes) transcriptional activation of p53, followed by a higher activation (32 fold) at 24 hours suggesting prime importance of p53 in MIP-induced apoptosis in HeLa cell. The up regulation of p53 dependent pro-apoptotic genes Bax, Bak, PUMA, and Noxa followed a lag phase that was required for the transcriptional p53 program. MIP also caused the transcriptional up regulation of Toll like receptor 2 and 4 after 30 minutes of MIP treatment suggesting recognition of MIP by toll like receptors. Moreover, MIP caused the inhibition of expression of HPV anti apoptotic gene E6, which is known to interfere with p53/PUMA/Bax apoptotic cascade. This inhibition might have played a role in transcriptional up regulation of PUMA and subsequently apoptosis. ROS was generated transiently which was concomitant with the highest transcription activation of p53 suggesting a plausible feedback loop network of p53 and ROS in the apoptosis of HeLa cells. Scavenger of ROS, such as N-acetyl-L-cysteine, decreased apoptosis suggesting ROS is an important effector of MIP induced apoptosis. Conclusion: Taken together, MIP possesses full potential to be a novel therapeutic agent in the clinical treatment of cervical cancer.

Keywords: cancer, mycobacterium, immunity, immunotherapy.

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338 Anti-Apoptotic Effect of Pueraria tuberosa in Rats with Streptozotocin Induced Diabetic Nephropathy

Authors: Rashmi Shukla, Yamini Bhusan Tripathi

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Diabetic nephropathy (DN) is characterized as diabetic kidney disease which involves many pathways e.g. hyperactivated protein kinase c (PKC), polyol pathway, excess production of advanced glycation end product (AGEs) & free radical accumulation etc. All of them results to hypoxia followed by apoptosis of podocytes, glomerulosclerosis, extracellular matrix (ECM) accumulation and fibrosis resulting to irreversible changes in kidney. This is continuously rising worldwide and there are not enough specific drugs, to retard its progress. Due to increasing side effects of allopathic drugs, interest in herbal remedies is growing. Earlier, we have reported that PTY-2 (a phytomedicine, derived from Pueraria tuberosa Linn.) inhibits the accumulation of extracellular matrix (ECM) through activation of MMP-9. Present study exhibited the therapeutic potential of Pueraria tuberosa in the prevention of podocytes apoptosis and modulation of nephrin expression in streptozotocin (STZ) induced DN rats. DN rats were produced by maintaining persistent hyperglycemia for 8 weeks by intra-peritoneal injection of 55 mg/kg streptozotocin (STZ). These rats were randomly divided in 2 groups, i.e. DN control, and DN+ water extract of Pueraria tuberosa (PTW). One group of age-matched normal rats served as non-diabetic control (group-1), The STZ induced DN rats (group-2) and DN+PTW treated rats (group-3). The PTW was orally administered (0.3g/kg) daily to group-2 rats and drug vector (1 ml of 10% tween 20) in control rats. The treatments were continued for 20 days and blood and urine samples were collected. Rats were then sacrificed to investigate the expression Bcl2, Bax and nephroprotective protein i.e. nephrin in kidney glomerulus. The effect of PTW was evaluated, we have found that the PTW significantly(p < .001) reversed the raised serum urea, serum creatinine, urine protein and improved the creatinine clearance in STZ induce diabetic nephropathy in rats and also significantly(p < .001) prevented the rise in urine albumin excretion. The Western blot analysis of kidney tissue homogenate showed increased expression of Bcl2 in PTW treated rats. The RT-PCR showed the increased expression and accumulation of nephrin mRNA. The confocal photomicrographs also supported the reduction of Bax and a simultaneous increase in Bcl2 and nephrin in glomerular podocytes. Hence, our finding suggests that the nephroprotective role of PTW is mediated via restoration of nephrin thus prevents the podocytes apoptosis and ameliorates diabetic nephropathy. The clinical trial of PTW would prove to be a potential food supplement/ drug of alternative medicine for patients with diabetic nephropathy in early stage.

Keywords: Pueraria tuberosa, diabetic nephropathy, anti-apoptosis, nephrin

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337 Environmental Fate and Toxicity of Aged Titanium Dioxide Nano-Composites Used in Sunscreen

Authors: Danielle Slomberg, Jerome Labille, Riccardo Catalano, Jean-Claude Hubaud, Alexandra Lopes, Alice Tagliati, Teresa Fernandes

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In the assessment and management of cosmetics and personal care products, sunscreens are of emerging concern regarding both human and environmental health. Organic UV blockers in many sunscreens have been evidenced to undergo rapid photodegradation, induce dermal allergic reactions due to skin penetration, and to cause adverse effects on marine systems. While mineral UV-blockers may offer a safer alternative, their fate and impact and resulting regulation are still under consideration, largely related to the potential influence of nanotechnology-based products on both consumers and the environment. Nanometric titanium dioxide (TiO₂) UV-blockers have many advantages in terms of sun protection and asthetics (i.e., transparency). These UV-blockers typically consist of rutile nanoparticles coated with a primary mineral layer (silica or alumina) aimed at blocking the nanomaterial photoactivity and can include a secondary organic coating (e.g., stearic acid, methicone) aimed at favouring dispersion of the nanomaterial in the sunscreen formulation. The nanomaterials contained in the sunscreen can leave the skin either through a bathing of everyday usage, with subsequent release into rivers, lakes, seashores, and/or sewage treatment plants. The nanomaterial behaviour, fate and impact in these different systems is largely determined by its surface properties, (e.g. the nanomaterial coating type) and lifetime. The present work aims to develop the eco-design of sunscreens through the minimisation of risks associated with nanomaterials incorporated into the formulation. All stages of the sunscreen’s life cycle must be considered in this aspect, from its manufacture to its end-of-life, through its use by the consumer to its impact on the exposed environment. Reducing the potential release and/or toxicity of the nanomaterial from the sunscreen is a decisive criterion for its eco-design. TiO₂ UV-blockers of varied size and surface coating (e.g., stearic acid and silica) have been selected for this study. Hydrophobic TiO₂ UV-blockers (i.e., stearic acid-coated) were incorporated into a typical water-in-oil (w/o) formulation while hydrophilic, silica-coated TiO₂ UV-blockers were dispersed into an oil-in-water (o/w) formulation. The resulting sunscreens were characterised in terms of nanomaterial localisation, sun protection factor, and photo-passivation. The risk to the direct aquatic environment was assessed by evaluating the release of nanomaterials from the sunscreen through a simulated laboratory aging procedure. The size distribution, surface charge, and degradation state of the nano-composite by-products, as well as their nanomaterial concentration and colloidal behaviour were determined in a variety of aqueous environments (e.g., seawater and freshwater). Release of the hydrophobic nanocomposites into the aqueous environment was driven by oil droplet formation while hydrophilic nano-composites were readily dispersed. Ecotoxicity of the sunscreen by-products (from both w/o and o/w formulations) and their risk to marine organisms were assessed using coral symbiotes and tropical corals, evaluating both lethal and sublethal toxicities. The data dissemination and provided risk knowledge from the present work will help guide regulation related to nanomaterials in sunscreen, provide better information for consumers, and allow for easier decision-making for manufacturers.

Keywords: alteration, environmental fate, sunscreens, titanium dioxide nanoparticles

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336 Scenario of Some Minerals and Impact of Promoter Hypermethylation of DAP-K Gene in Gastric Carcinoma Patients of Kashmir Valley

Authors: Showkat Ahmad Bhat, Iqra Reyaz, Falaque ul Afshan, Ahmad Arif Reshi, Muneeb U. Rehman, Manzoor R. Mir, Sabhiya Majid, Sonallah, Sheikh Bilal, Ishraq Hussain

Abstract:

Background: Gastric cancer is the fourth most common cancer and the second leading cause of worldwide cancer-related deaths, with a wide variation in incidence rates across different geographical areas. The current view of cancer is that a malignancy arises from a transformation of the genetic material of a normal cell, followed by successive mutations and by chain of alterations in genes such as DNA repair genes, oncogenes, Tumor suppressor genes. Minerals are necessary for the functioning of several transcriptional factors, proteins that recognize certain DNA sequences and have been found to play a role in gastric cancer. Material Methods:The present work was a case control study and its aim was to ascertain the role of minerals and promoter hypermethylation of CpG islands of DAP-K gene in Gastric cancer patients among the Kashmiri population. Serum was extracted from all the samples and mineral estimation was done by AAS from serum, DNA was also extracted and was modified using bisulphite modification kit. Methylation-specific PCR was used for the analysis of the promoter hypermethylation status of DAP-K gene. The epigenetic analysis revealed that unlike other high risk regions, Kashmiri population has a different promoter hypermethylation profile of DAP-K gene and has different mineral profile. Results: In our study mean serum copper levels were significantly different for the two genders (p<0.05), while as no significant differences were observed for iron and zinc levels. In Methylation-specific PCR the methylation status of the promoter region of DAP-K gene was as 67.50% (27/40) of the gastric cancer tissues showed methylated DAP-K promoter and 32.50% (13/40) of the cases however showed unmethylated DAP-K promoter. Almost all 85% (17/20) of the histopathologically confirmed normal tissues showed unmethylated DAP-K promoter except only in 3 cases where DAP-K promoter was found to be methylated. The association of promoter hypermethylation with gastric cancer was evaluated by χ2 (Chi square) test and was found to be significant (P=0.0006). Occurrence of DAP-K methylation was found to be unequally distributed in males and females with more frequency in males than in females but the difference was not statistically significant (P =0.7635, Odds ratio=1.368 and 95% C.I=0.4197 to 4.456). When the frequency of DAP-K promoter methylation was compared with clinical staging of the disease, DAP-K promoter methylation was found to be certainly higher in Stage III/IV (85.71%) compared to Stage I/ II (57.69%) but the difference was not statistically significant (P =0.0673). These results suggest that DAP-K aberrant promoter hypermethylation in Kashmiri population contributes to the process of carcinogenesis in Gastric cancer and is reportedly one of the commonest epigenetic changes in the development of Gastric cancer.

Keywords: gastric cancer, minerals, AAS, hypermethylation, CpG islands, DAP-K gene

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335 Elimination of Mother to Child Transmission of HIV/AIDS: A Study of the Knowledge, Attitudes and Perceptions of Healthcare Workers in Abuja Nigeria

Authors: Ezinne K. Okoro, Takahiko Katoh, Yoko Kawamura, Stanley C. Meribe

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HIV infection in children is largely as a result of vertical transmission (mother to child transmission [MTCT]). Thus, elimination of mother to child transmission of HIV/AIDS is critical in eliminating HIV infection in children. In Nigeria, drawbacks such as; limited pediatric screening, limited human capital, insufficient advocacy and poor understanding of ART guidelines, have impacted efforts at combating the disease, even as treatment services are free. Prevention of Mother to Child Transmission (PMTCT) program relies on health workers who not only counsel pregnant women on first contact but can competently provide HIV-positive pregnant women with accurate information about the PMTCT program such as feeding techniques and drug adherence. In developing regions like Nigeria where health care delivery faces a lot of drawbacks, it becomes paramount to address these issues of poor PMTCT coverage by conducting a baseline assessment of the knowledge, practices and perceptions related to HIV prevention amongst healthcare workers in Nigeria. A descriptive cross-sectional study was conducted amongst 250 health workers currently employed in health facilities in Abuja, Nigeria where PMTCT services were offered with the capacity to carry out early infant diagnosis testing (EID). Data was collected using a self-administered, pretested, structured questionnaire. This study showed that the knowledge of PMTCT of HIV was poor (30%) among healthcare workers who offer this service day-to-day to pregnant women. When PMTCT practices were analyzed in keeping with National PMTCT guidelines, over 61% of the respondents reported observing standard practices and the majority (58%) had good attitudes towards caring for patients with HIV/AIDS. Although 61% of the respondents reported being satisfied with the quality of service being rendered, 63% reported not being satisfied with their level of knowledge. Predictors of good knowledge were job designation and level of educational attainment. Health workers who were more satisfied with their working conditions and those who had worked for a longer time in the PMTCT service were more likely to observe standard PMTCT practices. With over 62% of the healthcare workers suggesting that more training would improve the quality of service being rendered, this is a strong pointer to stakeholders to consider a ‘healthcare worker-oriented approach’ when planning and conducting PMTCT training for healthcare workers. This in turn will increase pediatric ARV coverage, the knowledge and effectiveness of the healthcare workers in carrying out appropriate PMTCT interventions and culminating in the reduction/elimination of HIV transmission to newborns.

Keywords: attitudes, HIV/AIDS, healthcare workers, knowledge, mother to child transmission, Nigeria, perceptions

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334 Curcumin Nanomedicine: A Breakthrough Approach for Enhanced Lung Cancer Therapy

Authors: Shiva Shakori Poshteh

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Lung cancer is a highly prevalent and devastating disease, representing a significant global health concern with profound implications for healthcare systems and society. Its high incidence, mortality rates, and late-stage diagnosis contribute to its formidable nature. To address these challenges, nanoparticle-based drug delivery has emerged as a promising therapeutic strategy. Curcumin (CUR), a natural compound derived from turmeric, has garnered attention as a potential nanomedicine for lung cancer treatment. Nanoparticle formulations of CUR offer several advantages, including improved drug delivery efficiency, enhanced stability, controlled release kinetics, and targeted delivery to lung cancer cells. CUR exhibits a diverse array of effects on cancer cells. It induces apoptosis by upregulating pro-apoptotic proteins, such as Bax and Bak, and downregulating anti-apoptotic proteins, such as Bcl-2. Additionally, CUR inhibits cell proliferation by modulating key signaling pathways involved in cancer progression. It suppresses the PI3K/Akt pathway, crucial for cell survival and growth, and attenuates the mTOR pathway, which regulates protein synthesis and cell proliferation. CUR also interferes with the MAPK pathway, which controls cell proliferation and survival, and modulates the Wnt/β-catenin pathway, which plays a role in cell proliferation and tumor development. Moreover, CUR exhibits potent antioxidant activity, reducing oxidative stress and protecting cells from DNA damage. Utilizing CUR as a standalone treatment is limited by poor bioavailability, lack of targeting, and degradation susceptibility. Nanoparticle-based delivery systems can overcome these challenges. They enhance CUR’s bioavailability, protect it from degradation, and improve absorption. Further, Nanoparticles enable targeted delivery to lung cancer cells through surface modifications or ligand-based targeting, ensuring sustained release of CUR to prolong therapeutic effects, reduce administration frequency, and facilitate penetration through the tumor microenvironment, thereby enhancing CUR’s access to cancer cells. Thus, nanoparticle-based CUR delivery systems promise to improve lung cancer treatment outcomes. This article provides an overview of lung cancer, explores CUR nanoparticles as a treatment approach, discusses the benefits and challenges of nanoparticle-based drug delivery, and highlights prospects for CUR nanoparticles in lung cancer treatment. Future research aims to optimize these delivery systems for improved efficacy and patient prognosis in lung cancer.

Keywords: lung cancer, curcumin, nanomedicine, nanoparticle-based drug delivery

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333 Evaluation of Antimicrobial and Anti-Inflammatory Activity of Doani Sidr Honey and Madecassoside against Propionibacterium Acnes

Authors: Hana Al-Baghaoi, Kumar Shiva Gubbiyappa, Mayuren Candasamy, Kiruthiga Perumal Vijayaraman

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Acne is a chronic inflammatory disease of the sebaceous glands characterized by areas of skin with seborrhea, comedones, papules, pustules, nodules, and possibly scarring. Propionibacterium acnes (P. acnes), plays a key role in the pathogenesis of acne. Their colonization and proliferation trigger the host’s inflammatory response leading to the production of pro-inflammatory cytokines such as interleukin-8 (IL-8) and tumour necrosis factor-α (TNF-α). The usage of honey and natural compounds to treat skin ailments has strong support in the current trend of drug discovery. The present study was carried out evaluate antimicrobial and anti-inflammatory potential of Doani Sidr honey and its fractions against P. acnes and to screen madecassoside alone and in combination with fractions of honey. The broth dilution method was used to assess the antibacterial activity. Also, ultra structural changes in cell morphology were studied before and after exposure to Sidr honey using transmission electron microscopy (TEM). The three non-toxic concentrations of the samples were investigated for suppression of cytokines IL 8 and TNF α by testing the cell supernatants in the co-culture of the human peripheral blood mononuclear cells (hPBMCs) heat killed P. acnes using enzyme immunoassay kits (ELISA). Results obtained was evaluated by statistical analysis using Graph Pad Prism 5 software. The Doani Sidr honey and polysaccharide fractions were able to inhibit the growth of P. acnes with a noteworthy minimum inhibitory concentration (MIC) value of 18% (w/v) and 29% (w/v), respectively. The proximity of MIC and MBC values indicates that Doani Sidr honey had bactericidal effect against P. acnes which is confirmed by TEM analysis. TEM images of P. acnes after treatment with Doani Sidr honey showed completely physical membrane damage and lysis of cells; whereas non honey treated cells (control) did not show any damage. In addition, Doani Sidr honey and its fractions significantly inhibited (> 90%) of secretion of pro-inflammatory cytokines like TNF α and IL 8 by hPBMCs pretreated with heat-killed P. acnes. However, no significant inhibition was detected for madecassoside at its highest concentration tested. Our results suggested that Doani Sidr honey possesses both antimicrobial and anti-inflammatory effects against P. acnes and can possibly be used as therapeutic agents for acne. Furthermore, polysaccharide fraction derived from Doani Sidr honey showed potent inhibitory effect toward P. acnes. Hence, we hypothesize that fraction prepared from Sidr honey might be contributing to the antimicrobial and anti-inflammatory activity. Therefore, this polysaccharide fraction of Doani Sidr honey needs to be further explored and characterized for various phytochemicals which are contributing to antimicrobial and anti-inflammatory properties.

Keywords: Doani sidr honey, Propionibacterium acnes, IL-8, TNF alpha

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332 Severe Infestation of Laspeyresia Koenigana Fab. and Alternaria Leaf Spot on Azadirachta Indica (Neem)

Authors: Shiwani Bhatnagar, K. K. Srivastava, Sangeeta Singh, Ameen Ullah Khan, Bundesh Kumar, Lokendra Singh Rathore

Abstract:

From the instigation of the world medicinal plants are treated as part and parcel of human society to fight against diseases. Azadirachta indica (Neem) a herbal plant has been used as an Indian traditional medicine since ages and its products are acknowledged to solve agricultural, forestry and public health related problems, owing to its beneficial medicinal properties. Each part of the neem tree is known for its medicinal property. Bark & leaf extracts of neem have been used to control leprosy, respiratory disorders, constipation and also as blood purifier and a general health tonic. Neem is still regarded as ' rural community dispensary' in India or a tree for solving medical problems. Use of Neem as pesticides for the management of insect pest of agriculture crops and forestry has been seen as a shift in the use of synthetic pesticides to ecofriendly botanicals. Neem oil and seed extracts possess germicidal and anti-bacterial properties which when sprayed on the plant helps in protecting them from foliage pests. Azadirachtin, the main active ingredient found in neem tree, acts as an insect repellent and antifeedant. However the young plants are susceptible to many insect pest and foliar diseases. Recently, in the avenue plantation, planted by Arid Forest Research Institute, Jodhpur, around the premises of IIT Jodhpur, two years old neem plants were found to be severely infested with tip borer Laspeyresia koenigana (Family: Eucosmidae). The adult moth of L. koenigana lays eggs on the tender shoots and the young larvae tunnel into the shoot and feed inside. A small pinhole can be seen at the entrance point, from where the larva enters in to the stem. The severely attached apical shoots exhibit profuse gum exudation resulting in development of a callus structure. The internal feeding causes the stem to wilt and the leaves to dry up from the tips resulting in growth retardation. Alternaria Leaf spot and blight symptoms were also recorded on these neem plants. For the management of tip borer and Alternaria Leaf spot, foliar spray of monocrotophos @0.05% and Dithane M-45 @ 0.15% and powermin @ 2ml/lit were found efficient in managing the insect pest and foliar disease problem. No Further incidence of pest/diseases was noticed.

Keywords: azadirachta indica, alternaria leaf spot, laspeyresia koenigana, management

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331 High Throughput Virtual Screening against ns3 Helicase of Japanese Encephalitis Virus (JEV)

Authors: Soma Banerjee, Aamen Talukdar, Argha Mandal, Dipankar Chaudhuri

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Japanese Encephalitis is a major infectious disease with nearly half the world’s population living in areas where it is prevalent. Currently, treatment for it involves only supportive care and symptom management through vaccination. Due to the lack of antiviral drugs against Japanese Encephalitis Virus (JEV), the quest for such agents remains a priority. For these reasons, simulation studies of drug targets against JEV are important. Towards this purpose, docking experiments of the kinase inhibitors were done against the chosen target NS3 helicase as it is a nucleoside binding protein. Previous efforts regarding computational drug design against JEV revealed some lead molecules by virtual screening using public domain software. To be more specific and accurate regarding finding leads, in this study a proprietary software Schrödinger-GLIDE has been used. Druggability of the pockets in the NS3 helicase crystal structure was first calculated by SITEMAP. Then the sites were screened according to compatibility with ATP. The site which is most compatible with ATP was selected as target. Virtual screening was performed by acquiring ligands from databases: KinaseSARfari, KinaseKnowledgebase and Published inhibitor Set using GLIDE. The 25 ligands with best docking scores from each database were re-docked in XP mode. Protein structure alignment of NS3 was performed using VAST against MMDB, and similar human proteins were docked to all the best scoring ligands. The low scoring ligands were chosen for further studies and the high scoring ligands were screened. Seventy-three ligands were listed as the best scoring ones after performing HTVS. Protein structure alignment of NS3 revealed 3 human proteins with RMSD values lesser than 2Å. Docking results with these three proteins revealed the inhibitors that can interfere and inhibit human proteins. Those inhibitors were screened. Among the ones left, those with docking scores worse than a threshold value were also removed to get the final hits. Analysis of the docked complexes through 2D interaction diagrams revealed the amino acid residues that are essential for ligand binding within the active site. Interaction analysis will help to find a strongly interacting scaffold among the hits. This experiment yielded 21 hits with the best docking scores which could be investigated further for their drug like properties. Aside from getting suitable leads, specific NS3 helicase-inhibitor interactions were identified. Selection of Target modification strategies complementing docking methodologies which can result in choosing better lead compounds are in progress. Those enhanced leads can lead to better in vitro testing.

Keywords: antivirals, docking, glide, high-throughput virtual screening, Japanese encephalitis, ns3 helicase

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330 Molecular Detection of mRNA bcr-abl and Circulating Leukemic Stem Cells CD34+ in Patients with Acute Lymphoblastic Leukemia and Chronic Myeloid Leukemia and Its Association with Clinical Parameters

Authors: B. Gonzalez-Yebra, H. Barajas, P. Palomares, M. Hernandez, O. Torres, M. Ayala, A. L. González, G. Vazquez-Ortiz, M. L. Guzman

Abstract:

Leukemia arises by molecular alterations of the normal hematopoietic stem cell (HSC) transforming it into a leukemic stem cell (LSC) with high cell proliferation, self-renewal, and cell differentiation. Chronic myeloid leukemia (CML) originates from an LSC-leading to elevated proliferation of myeloid cells and acute lymphoblastic leukemia (ALL) originates from an LSC development leading to elevated proliferation of lymphoid cells. In both cases, LSC can be identified by multicolor flow cytometry using several antibodies. However, to date, LSC levels in peripheral blood (PB) are not established well enough in ALL and CML patients. On the other hand, the detection of the minimal residue disease (MRD) in leukemia is mainly based on the identification of the mRNA bcr-abl gene in CML patients and some other genes in ALL patients. There is no a properly biomarker to detect MDR in both types of leukemia. The objective of this study was to determine mRNA bcr-abl and the percentage of LSC in peripheral blood of patients with CML and ALL and identify a possible association between the amount of LSC in PB and clinical data. We included in this study 19 patients with Leukemia. A PB sample was collected per patient and leukocytes were obtained by Ficoll gradient. The immunophenotype for LSC CD34+ was done by flow cytometry analysis with CD33, CD2, CD14, CD16, CD64, HLA-DR, CD13, CD15, CD19, CD10, CD20, CD34, CD38, CD71, CD90, CD117, CD123 monoclonal antibodies. In addition, to identify the presence of the mRNA bcr-abl by RT-PCR, the RNA was isolated using TRIZOL reagent. Molecular (presence of mRNA bcr-abl and LSC CD34+) and clinical results were analyzed with descriptive statistics and a multiple regression analysis was performed to determine statistically significant association. In total, 19 patients (8 patients with ALL and 11 patients with CML) were analyzed, 9 patients with de novo leukemia (ALL = 6 and CML = 3) and 10 under treatment (ALL = 5 and CML = 5). The overall frequency of mRNA bcr-abl was 31% (6/19), and it was negative in ALL patients and positive in 80% in CML patients. On the other hand, LSC was determined in 16/19 leukemia patients (%LSC= 0.02-17.3). The Novo patients had higher percentage of LSC (0.26 to 17.3%) than patients under treatment (0 to 5.93%). The amount of LSC was significantly associated with the amount of LSC were: absence of treatment, the absence of splenomegaly, and a lower number of leukocytes, negative association for the clinical variables age, sex, blasts, and mRNA bcr-abl. In conclusion, patients with de novo leukemia had a higher percentage of circulating LSC than patients under treatment, and it was associated with clinical parameters as lack of treatment, absence of splenomegaly and a lower number of leukocytes. The mRNA bcr-abl detection was only possible in the series of patients with CML, and molecular detection of LSC could be identified in the peripheral blood of all leukemia patients, we believe the identification of circulating LSC may be used as biomarker for the detection of the MRD in leukemia patients.

Keywords: stem cells, leukemia, biomarkers, flow cytometry

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329 Case Study about Women Driving in Saudi Arabia Announced in 2018: Netnographic and Data Mining Study

Authors: Majdah Alnefaie

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The ‘netnographic study’ and data mining have been used to monitor the public interaction on Social Media Sites (SMSs) to understand what the motivational factors influence the Saudi intentions regarding allowing women driving in Saudi Arabia in 2018. The netnographic study monitored the publics’ textual and visual communications in Twitter, Snapchat, and YouTube. SMSs users’ communications method is also known as electronic word of mouth (eWOM). Netnography methodology is still in its initial stages as it depends on manual extraction, reading and classification of SMSs users text. On the other hand, data mining is come from the computer and physical sciences background, therefore it is much harder to extract meaning from unstructured qualitative data. In addition, the new development in data mining software does not support the Arabic text, especially local slang in Saudi Arabia. Therefore, collaborations between social and computer scientists such as ‘netnographic study’ and data mining will enhance the efficiency of this study methodology leading to comprehensive research outcome. The eWOM communications between individuals on SMSs can promote a sense that sharing their preferences and experiences regarding politics and social government regulations is a part of their daily life, highlighting the importance of using SMSs as assistance in promoting participation in political and social. Therefore, public interactions on SMSs are important tools to comprehend people’s intentions regarding the new government regulations in the country. This study aims to answer this question, "What factors influence the Saudi Arabians' intentions of Saudi female's car-driving in 2018". The study utilized qualitative method known as netnographic study. The study used R studio to collect and analyses 27000 Saudi users’ comments from 25th May until 25th June 2018. The study has developed data collection model that support importing and analysing the Arabic text in the local slang. The data collection model in this study has been clustered based on different type of social networks, gender and the study main factors. The social network analysis was employed to collect comments from SMSs owned by governments’ originations, celebrities, vloggers, social activist and news SMSs accounts. The comments were collected from both males and females SMSs users. The sentiment analysis shows that the total number of positive comments Saudi females car driving was higher than negative comments. The data have provided the most important factors influenced the Saudi Arabians’ intention of Saudi females car driving including, culture and environment, freedom of choice, equal opportunities, security and safety. The most interesting finding indicted that women driving would play a role in increasing the individual freedom of choice. Saudi female will be able to drive cars to fulfill her daily life and family needs without being stressed due to the lack of transportation. The study outcome will help Saudi government to improve woman quality of life by increasing the ability to find more jobs and studies, increasing income through decreasing the spending on transport means such as taxi and having more freedom of choice in woman daily life needs. The study enhances the importance of using use marketing research to measure the public opinions on the new government regulations in the country. The study has explained the limitations and suggestions for future research.

Keywords: netnographic study, data mining, social media, Saudi Arabia, female driving

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328 The Role of Community Beliefs and Practices on the Spread of Ebola in Uganda, September 2022

Authors: Helen Nelly Naiga, Jane Frances Zalwango, Saudah N. Kizito, Brian Agaba, Brenda N Simbwa, Maria Goretti Zalwango, Richard Migisha, Benon Kwesiga, Daniel Kadobera, Alex Ario Riolexus, Sarah Paige, Julie R. Harris

Abstract:

Background: Traditional community beliefs and practices can facilitate the spread of Ebola virus during outbreaks. On September 20, 2022, Uganda declared a Sudan Virus Disease (SVD) outbreak after a case was confirmed in Mubende District. During September–November 2022, the outbreak spread to eight additional districts. We investigated the role of community beliefs and practices in the spread of SUDV in Uganda in 2022. Methods: A qualitative study was conducted in Mubende, Kassanda, and Kyegegwa districts in February 2023. We conducted nine focus group discussions (FGDs) and six key informant interviews (KIIs). FGDs included SVD survivors, household members of SVD patients, traditional healers, religious leaders, and community leaders. Key informants included community, political, and religious leaders, traditional healers, and health workers. We asked about community beliefs and practices to understand if and how they contributed to the spread of SUDV. Interviews were recorded, translated, transcribed, and analyzed thematically. Results: Frequently-reported themes included beliefs that the community deaths, later found to be due to SVD, were the result of witchcraft or poisoning. Key informants reported that SVD patients frequently first consulted traditional healers or spiritual leaders before seeking formal healthcare, and noted that traditional healers treated patients with signs and symptoms of SVD without protective measures. Additional themes included religious leaders conducting laying-on-of-hands prayers for SVD patients and symptomatic contacts, SVD patients and their symptomatic contacts hiding in friends’ homes, and exhumation of SVD patients originally buried in safe and dignified burials, to enable traditional burials. Conclusion: Multiple community beliefs and practices likely promoted SVD outbreak spread during the 2022 outbreak in Uganda. Engaging traditional and spiritual healers early during similar outbreaks through risk communication and community engagement efforts could facilitate outbreak control. Targeted community messaging, including clear biological explanations for clusters of deaths and information on the dangers of exhuming bodies of SVD patients, could similarly facilitate improved control in future outbreaks in Uganda.

Keywords: Ebola, Sudan virus, outbreak, beliefs, traditional

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327 Delivering Safer Clinical Trials; Using Electronic Healthcare Records (EHR) to Monitor, Detect and Report Adverse Events in Clinical Trials

Authors: Claire Williams

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Randomised controlled Trials (RCTs) of efficacy are still perceived as the gold standard for the generation of evidence, and whilst advances in data collection methods are well developed, this progress has not been matched for the reporting of adverse events (AEs). Assessment and reporting of AEs in clinical trials are fraught with human error and inefficiency and are extremely time and resource intensive. Recent research conducted into the quality of reporting of AEs during clinical trials concluded it is substandard and reporting is inconsistent. Investigators commonly send reports to sponsors who are incorrectly categorised and lacking in critical information, which can complicate the detection of valid safety signals. In our presentation, we will describe an electronic data capture system, which has been designed to support clinical trial processes by reducing the resource burden on investigators, improving overall trial efficiencies, and making trials safer for patients. This proprietary technology was developed using expertise proven in the delivery of the world’s first prospective, phase 3b real-world trial, ‘The Salford Lung Study, ’ which enabled robust safety monitoring and reporting processes to be accomplished by the remote monitoring of patients’ EHRs. This technology enables safety alerts that are pre-defined by the protocol to be detected from the data extracted directly from the patients EHR. Based on study-specific criteria, which are created from the standard definition of a serious adverse event (SAE) and the safety profile of the medicinal product, the system alerts the investigator or study team to the safety alert. Each safety alert will require a clinical review by the investigator or delegate; examples of the types of alerts include hospital admission, death, hepatotoxicity, neutropenia, and acute renal failure. This is achieved in near real-time; safety alerts can be reviewed along with any additional information available to determine whether they meet the protocol-defined criteria for reporting or withdrawal. This active surveillance technology helps reduce the resource burden of the more traditional methods of AE detection for the investigators and study teams and can help eliminate reporting bias. Integration of multiple healthcare data sources enables much more complete and accurate safety data to be collected as part of a trial and can also provide an opportunity to evaluate a drug’s safety profile long-term, in post-trial follow-up. By utilising this robust and proven method for safety monitoring and reporting, a much higher risk of patient cohorts can be enrolled into trials, thus promoting inclusivity and diversity. Broadening eligibility criteria and adopting more inclusive recruitment practices in the later stages of drug development will increase the ability to understand the medicinal products risk-benefit profile across the patient population that is likely to use the product in clinical practice. Furthermore, this ground-breaking approach to AE detection not only provides sponsors with better-quality safety data for their products, but it reduces the resource burden on the investigator and study teams. With the data taken directly from the source, trial costs are reduced, with minimal data validation required and near real-time reporting enables safety concerns and signals to be detected more quickly than in a traditional RCT.

Keywords: more comprehensive and accurate safety data, near real-time safety alerts, reduced resource burden, safer trials

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326 Management Problems in a Patient With Long-term Undiagnosed Permanent Hypoparathyroidism

Authors: Babarina Maria, Andropova Margarita

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Introduction: Hypoparathyroidism (HypoPT) is a rare endocrine disorder with an estimated prevalence of 0.25 per 1000 individuals. The most common cause of HypoPT is the loss of active parathyroid tissue following thyroid or parathyroid surgery. Sometimes permanent postoperative HypoPT occures, manifested by hypocalcemia in combination with low levels of PTH during 6 months or more after surgery. Cognitive impairments in patients with hypocalcemia due to chronic HypoPT are observed, and this can lead to problems and challenges in everyday living: memory loss and impaired concentration, that may be the cause of poor compliance. Clinical case: Patient K., 66 years old, underwent thyroidectomy in 2013 (at the age of 55) because of papillary thyroid cancer T1NxMx, histopathology findings confirmed the diagnosis. 5 years after the surgery, she was followed up on an outpatient basis, TSH levelsonly were monitored, and the dose of levothyroxine was adjusted. In 2018 due to, increasing complaints include tingling and cramps in the arms and legs, memory loss, sleep disorder, fatigue, anxiety, hair loss, muscle pain, tachycardia, positive Chvostek, and Trousseau signs were diagnosed during examination, also in blood analyses: total Ca 1.86 mmol/l (2.15-2.55), Ca++ 0.96 mmol/l (1.12-1.3), P 1.55 mmol/l (0.74-1.52), Mg 0.79 mmol/l (0.66-1.07) - chronic postoperative HypoPT was diagnosed. Therapy was initiated: alfacalcidol 0.5 mcg per day, calcium carbonate 2000 mg per day, cholecalciferol 1000 IU per day, magnesium orotate 3000 mg per day. During the case follow-up, hypocalcemia, hyperphosphatemia persisted, hypercalciuria15.7 mmol/day (2.5-6.5) was diagnosed. Dietary recommendations were given because of the high content of phosphorus rich foods, and therapy was adjusted: the dose of alfacalcidol was increased to 2.5 mcg per day, and the dose of calcium carbonate was reduced to 1500 mg per day. As part of the screening for complications of hypoPT, data for cataracts, Fahr syndrome, nephrocalcinosis, and kidney stone disease were not obtained. However, HypoPT compensation was not achieved, and therefore hydrochlorothiazide 25 mg was initiated, the dose of alfacalcidol was increased to 3 mcg per day, calcium carbonate to 3000 mg per day, magnesium orotate and cholecalciferol were continued at the same doses. Therapeutic goals were achieved: calcium phosphate product <4.4 mmol2/l2, there were no episodes of hypercalcemia, twenty-four-hour urinary calcium excretion was significantly reduced. Conclusion: Timely prescription, careful explanation of drugs usage rules, and monitoring and maintaining blood and urine parameters within the target contribute to the prevention of HypoPT complications development and life-threatening events.

Keywords: hypoparathyroidism, hypocalcemia, hyperphosphatemia, hypercalciuria

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