Search results for: metabolic disease

Authors: Yusra Pintaningrum, Ilma Fahira Basyir, Sony Hilal Wicaksono, Vito A. Damay

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Background: Coronary artery calcium (CAC) scores play an important role in improving prognostic accuracy and can be selectively used to guide the allocation of statin therapy for atherosclerotic cardiovascular disease outcomes and potentially associated with the occurrence of MACE (Major Adverse Cardiovascular Event) and MI (Myocardial Infarction). Objective: This systematic review and meta-analysis aim to analyze the findings of a study about CAC Score and statin treatment effect on MI and MACE risk. Methods: Search for published scientific articles using the PRISMA (Preferred Reporting, Items for Systematic Reviews and Meta-Analysis) method conducted on PubMed, Cochrane Library, and Medline databases published in the last 20 years on “coronary artery calcium” AND “statin” AND “cardiovascular disease” Further systematic review and meta-analysis using RevMan version 5.4 were performed based on the included published scientific articles. Results: Based on 11 studies included with a total of 1055 participants, we performed a meta-analysis and found that individuals with CAC score > 0 increased risk ratio of MI 8.48 (RR = 9.48: 95% CI: 6.22 – 14.45) times and MACE 2.48 (RR = 3.48: 95% CI: 2.98 – 4.05) times higher than CAC score 0 individual. Statin compared against non-statin treatment showed a statistically insignificant overall effect on the risk of MI (P = 0.81) and MACE (P = 0.89) in an individual with elevated CAC score 1 – 100 (P = 0.65) and > 100 (P = 0.11). Conclusions: This study found that an elevated CAC scores individual has a higher risk of MI and MACE than a non-elevated CAC score individual. There is no significant effect of statin compared against non-statin treatment to reduce MI and MACE in elevated CAC score individuals of 1 – 100 or > 100.

Keywords: coronary artery calcium, statin, cardiovascular disease, myocardial infarction, MACE

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Authors: Isil Cakir, Mustafa Uluhan

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Elevated serum Cardiotrophin-1 (CT-1) and leptin levels are important risk factors for cardiovascular diseases (CVDs). Obstructive sleep apnea syndrome (OSAS) has been reported to increase the risk of CVDs, too. The aim of this study was to evaluate the concentrations of serum CT-1 and leptin in these patients and whether their possible association with the disease severity. Fifty newly diagnosed patients with OSAS and thirty nonapneic snoring subjects were participated in this study. The mean ages of patients and control groups were 47.40±13.30 and 43.23±10.50 years, respectively (P=0.128). Fasting serum triglyseride, total cholesterol, LDL and HDL cholesterol, also CT-1 and leptin levels were evaluated. A significant difference was found in the serum CT-1 and leptin levels between the patients and the controls:serum median CT-1 levels in patients and control groups, respectively, were 19.47 and 8.23 pg/mL (P < 0.001) and leptin levels were 2.07 and 1.29 ng/mL (P < 0.001). In severe patients group (n=39), serum median CT-1 level was found statistically significantly higher than the median level in mild/moderate patients (n=11) group. Patients CT-1 concentrations were not associated with lipoprotein levels and there was no correlation between patients’ leptin and lipid profile parameters. Two risk factors for CVDs, CT-1 and leptin, have significantly elevated and they were associated with OSAS. Furthermore, CT-1 was associated with the severity of disease. We recommend the use of increased serum CT-1 and leptin concentrations as markers of the presence and severity of OSAS.They can be used as early markers in male OSAS patients without known CVDs.

Keywords: obstructive sleep apnea syndrome, cardiotrophin-1, leptin, cardiovascular disease

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Authors: Bassma A. Abdel Haleem, Ehab K. Emam, George E. Yacoub, Ashraf M. Salem

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Background: Obesity is an increasingly common problem in childhood. Childhood obesity is considered the main risk factor for the development of metabolic syndrome (MetS) (diabetes type 2, dyslipidemia, and hypertension). Recent studies estimated that among children with obesity 30-60% will develop MetS. Visceral fat thickness is a valuable predictor of the development of MetS. Computed tomography and dual-energy X-ray absorptiometry are the main techniques to assess visceral fat. However, they carry the risk of radiation exposure and are expensive procedures. Consequently, they are seldom used in the assessment of visceral fat in children. Some studies explored the potential of ultrasound as a substitute to assess visceral fat in the elderly and found promising results. Given the vulnerability of children to radiation exposure, we sought to evaluate ultrasound as a safer and more cost-efficient alternative for measuring visceral fat in obese children. Additionally, we assessed the correlation between visceral fat and obesity indicators such as insulin resistance. Methods: A cross-sectional study was conducted on 46 children with obesity (aged 6–16 years). Their visceral fat was evaluated by ultrasound. Subcutaneous fat thickness (SFT), i.e., the measurement from the skin-fat interface to the linea alba, and visceral fat thickness (VFT), i.e., the thickness from the linea alba to the aorta, were measured and correlated with anthropometric measures, fasting lipid profile, homeostatic model assessment for insulin resistance (HOMA-IR) and liver enzymes (ALT). Results: VFT assessed via ultrasound was found to strongly correlate with the BMI, HOMA-IR with AUC for VFT as a predictor of insulin resistance of 0.858 and cut off point of >2.98. VFT also correlates positively with serum triglycerides and serum ALT. VFT correlates negatively with HDL. Conclusions: Ultrasound, a safe and cost-efficient technique, could be a useful tool for measuring the abdominal fat thickness in children with obesity. Ultrasound-measured VFT could be an appropriate prognostic factor for insulin resistance, hypertriglyceridemia, and elevated liver enzymes in obese children.

Keywords: metabolic syndrome, pediatric obesity, sonography, visceral fat

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Authors: M. Mydlárová Blaščáková, J. Bernasovská, J. Poráčová, I. Boroňová

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Obesity is frequent attendant phenomenon of patients with endocrinological disease. Between BMI and endocrinological diseases is close correlation. In thesis we focused on the allocation of hormone concentration – PTH and TSH, CHOL a mineral element Ca in a blood serum. The examined group was formed by 100 respondents (women) aged 36 – 83 years, who were divided into two groups – control group (CG), group with diagnosed endocrine disease (DED). The concentration of PTH and TSH, Ca and CHOL was measured through the medium of analyzers Cobas e411 (Japan); Cobas Integra 400 (Switzerland). At individuals was measured body weight as well as stature and thereupon from those data we enumerated BMI. On the basis of Student T-test in biochemical parameter of PTH and Ca we found out significantly meaningful difference (p<0,05) between CG and DED. In CG we made a founding the association between BMI and PTH by means of correlation analysis.

Keywords: biochemical markers, hormones, obesity, women

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Authors: Suhaib Radi, Ibrahim Basem Nafadi, Abdullah Ahmed Alsulami, Nawaf Faisal Halabi, Abdulrhman Abdullah Alsubhi, Sami Wesam Maghrabi, Waleed Saad Alshehri

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Background: Kidney stones greatly affect individuals. The range of these effects regarding multiple kidney stone factors (size, presence of obstruction, and modality of treatment) in stone formers with and without diabetes has not been well explored in the literature to the best of the author's knowledge. Our goal is to investigate this unexplored correlation between diabetes and kidney stones by conducting a Cohort retrospective study to precisely evaluate the effects of this condition and the existence of complications in adult individuals with diabetes in Saudi Arabia in comparison to a non-diabetic control group. Methodology: This is a retrospective cohort study aiming to evaluate the range of effects of kidney stones in stone formers in a group of adults diagnosed with type 2 diabetes mellitus and adults without diabetes between 2017 and 2019 in Jeddah, Saudi Arabia. An IRB approval has been granted for this study. The data was analyzed using SPSS. The data was collected from the 1st of December 2022 until the 1st of March 2023. Results: A total of 254 individuals diagnosed with kidney stones were included, 127 of whom were adult individuals with type 2 diabetes, and 127 were non-diabetics. Our study shows that the individuals affected with diabetes were more likely to have larger kidney stones in comparison to individuals without diabetes (13.12 mm vs. 10.53 mm, p-value = 0.03). Moreover, individuals with hypertension and dyslipidemia also had significantly larger stones. On the other hand, no significant difference was found in the presence of obstruction and modality of treatment between the two groups. Conclusion: This study done in Saudi Arabia found that individuals with kidney stones who concurrently had diabetes formed larger kidney stones, and they were also found to have other comorbidities such as HTN, dyslipidemia, obesity, and renal disease. The significance of these findings could assist in the future of primary and secondary prevention of renal stones.

Keywords: kidney stone, type 2 DM, metabolic syndrome, lithotripsy

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Authors: Ajay Gogia, Svs Deo, Dn Sharma, Atul Batra, Ashutash Mishra

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Background and Aims: Breast cancer in women aged less than 25 years (defined as very young breast cancer, VYBC) is rare and accounts for 0.25% of all breast cancer in the West. There is no data available on VYBC from developing countries. The aim of this study was to analyze the clinical, pathological, and prognostic factors and outcomes in VYBC. Methods: This retrospective analysis was performed on 80 patients aged 25 years or less (screened 8000 files of female BC) who were registered at All India Institute of Medical Sciences (AIIMS), New Delhi, India, over a 15-year period between 2011 and 2023. Results: The median age was 21.5 years (range 16-25). A positive family history (siblings and parents) was elicited in 30% of cases, and breast cancer gene (BRCA1/2) mutation was found in 33% of cases patients. Ten patients (12.5%) patients have pregnancy-associated breast cancer (BC detected during pregnancy or 1 year after postpartum period). The TNM stage distribution was Stage I was 0, stage II -30%, stage III –60% and Stage IV -10 %patients. Seventy percent of tumors were high grade, and 90% had pathological node-positive disease. Estrogen, Progesterone, and human epidermal growth factor receptor 2 (HER2)/neu positivity were 25%,25% and 35%, respectively. Triple-negative breast cancer constituted 40% of patients. With a median follow-up of 42 months, 3 years, relapse-free survival (nonmetastatic disease), progression-free survival (metastatic disease) and overall survival were 30%, 15% and 50%, respectively. Conclusions: Very young women constituted 1% of all breast cancer cases. Advanced disease at presentation and high-risk pathological features result in poor outcomes. One-third of VYBCs are associated with BRCA mutation, which requires genetic counseling and risk reduction surgery if required. Due to the aggressive behavior of BC in this age group, need early diagnosis and prompt treatment

Keywords: very young, breast cancer, outcome, developing country, India

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Authors: Nikhil A. Gavhane, Sachin Shah, Ishant S. Mahajan, Pawan D. Bahekar

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Introduction: Millions of people are affected with dengue fever every year, which drives up healthcare expenses in many low-income countries. Organ failure and other serious symptoms may result. Another worldwide public health problem is sickle cell anaemia, which is most prevalent in Africa, the Caribbean, and Europe. Dengue epidemics have reportedly occurred in locations with a high frequency of sickle cell disease, compounding the health problems in these areas. Aims and Objectives: This study examines dengue infection in sickle cell disease-afflicted pre-schoolers. Method:This Retrospective cohort study examined paediatric patients. Young people with sickle cell disease (SCD), dengue infection, and a control group without SCD or dengue were studied. Data on demographics, SCD consequences, medical treatments, and laboratory findings were gathered to analyse the influence of SCD on dengue severity and clinical outcomes, classified as severe or non-severe by the 2009 WHO classification. Using fever or admission symptoms, the research estimated acute illness duration. Result: Table 1 compares haemoglobin genotype-based dengue episode features in SS, SC, and controls. Table 2 shows that severe dengue cases are older, have longer admission delays, and have particular symptoms. Table 3's multivariate analysis indicates SS genotype's high connection with severe dengue, multiorgan failure, and acute pulmonary problems. Table 4 relates severe dengue to greater white blood cell counts, anaemia, liver enzymes, and reduced lactate dehydrogenase. Conclusion: This study is valuable but confined to hospitalised dengue patients with sickle cell illness. Small cohorts limit comparisons. Further study is needed since findings contradict predictions.

Keywords: dengue, chills, headache, severe myalgia, vomiting, nausea, prostration

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Authors: Randa M. Ali, Naguiba F. Loutfy, Osama M. Awad

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Background: Leishmaniasis is a worldwide disease, affecting 88 countries, it is estimated that about 350 million people are at risk of leishmaniasis. Overall prevalence is 12 million people with annual mortality of about 60,000. Annual incidence is 1,500,000 cases of cutaneous leishmaniasis (CL) worldwide and half million cases of visceral Leishmaniasis (VL). Objectives: The objective of this study was to assess primary health care physicians knowledge (PHP) and attitude about leishmaniasis and to assess awareness of local inhabitants about the disease and its vector in four areas in west Alexandria, Egypt. Methods: This study was a cross sectional survey that was conducted in four PHC units in west Alexandria. All physicians currently working in these units during the study period were invited to participate in the study, only 20 PHP completed the questionnaire. 60 local inhabitant were selected randomly from the four areas of the study, 15 from each area; Data was collected through two different specially designed questionnaires. Results: 11(55%) percent of the physicians had satisfactory knowledge, they answered more than 9 (60%) questions out of a total 14 questions about leishmaniasis and sandfly. The second part of the questionnaire is concerned with attitude of the primary health care physicians about leishmaniasis, 17 (85%) had good attitude and 3 (15%) had poor attitude. The second questionnaire showed that the awareness of local inhabitants about leishmaniasis and sandly as a vector of the disease is poor and needs to be corrected. Most of the respondents (90%) had not heard about leishmaniasis, Only 3 (5%) of the interviewed inhabitants said they know sandfly and its role in transmission of leishmaniasis. Conclusions: knowledge and attitudes of physicians are acceptable. However, there is, room for improvement and could be done through formal training courses and distribution of guidelines. In addition to raising the awareness of primary health care physicians about the importance of early detection and notification of cases of lesihmaniasis. Moreover, health education for raising awareness of the public regarding the vector and the disease is necessary because related studies have demonstrated that if the inhabitants do not perceive mosquitoes to be responsible for diseases such as malaria they do not take enough measures to protect themselves against the vector.

Keywords: leishmaniasis, PHP, knowledge, attitude, local inhabitants

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Authors: Jenee Gooden, Kevin Vasquez-monterroso, Lady Paula Dejesus, Sandra Wainwright, Daniel Kim, Mackenzie Walker

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Introduction: Pyoderma gangrenosum (PG) is a rare, rapidly progressive, neutrophilic ulcerative colitis condition with an incidence of 3 to 10 cases per year ¹ ². Due to the similar appearance, PG is often misdiagnosed as a diabetic ulcer in diabetic patients. Though they may clinically appear similar in appearance, the treatment protocol and diagnostic criteria differ. Also, end-stage renal disease (ESRD) is often a condition seen in diabetic patients, which can have a significant impact on wound healing due to the wide range of uremic toxins³. This case study demonstrates a multidisciplinary team and multimodal treatment approach by podiatric surgery, general surgery, rheumatology, infectious disease, interventional cardiology, wound care and hyperbaric medicine for an uncontrolled diabetic with pyoderma gangrenosum of a significant circumferential wound, covering almost the entire right lower extremity. Methods:56 y.o male presents with multiple PG ulcerations, including the chest, right posterior lower extremity and sacrum. All ulcerations were previously managed by the same wound care specialist. His chief complaint was worsening PG ulcerations accompanied by a fever of 103 °F . This case study focuses on the wound to his RLE. Past medical history significant for diabetes mellitus type 2 with hemoglobin A1c of 10% and end stage renal disease (ESRD) on hemodialysis. A multidisciplinary team approach by podiatric surgery, general surgery, rheumatology, infectious disease, interventional cardiology, wound care and hyperbaric medicine was successfully used to perform right lower extremity limb salvage. The patient was managed by rheumatology for the continuation of prior medication, as well as the mutual agreement with wound care for the addition of dapsone. A coronary CT angiogram was performed by interventional cardiology, but no significant disease was noted, and no further vascular workup was necessary. Multiple surgical sharp wide excisional debridements with application of allografts and split thickness skin grafts for the circumferential ulceration that encompassed almost the entire right lower extremity were performed by both podiatric surgery and general surgery. Wound cultures and soft tissue biopsies were performed, and infectious disease managed antibiotic therapy. Hyperbaric oxygen therapy and wound vac therapy by wound care were also completed as adjunct management. Results: Prevention of leg amputation by limb salvage of the RLE was accomplished by a multidisciplinary team approach, with the wound size decreasing over a total of 29 weeks from 600 cm² to 12.0 x 3.5 x 0.2 cm. Our multidisciplinary team included podiatric surgery, general surgery, rheumatology, infectious disease, interventional cardiology, wound care and hyperbaric medicine. Discussion: Wound healing, in general, can have its challenges, and those challenges are only magnified when accompanied by multiple systemic illnesses. Though the negative impact of diabetes on wound healing is well known, the compound impact of being a diabetic with ESRD and having pyoderma gangrenosum is not. This case demonstrates the necessity for a multidisciplinary team approach with a wide array of treatment modalities to optimize wound healing and perform limb salvage with prevention of lower extremity amputation.

Keywords: diabetes, podiatry, pyoderma gangrenosum, end stage renal disease

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Authors: Popy Bora, L. C. Bora, A. Bhattacharya, Sehnaz S. Ahmed

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Microbial bioagents, viz., Pseudomonas fluorescens, Bacillus subtilis, and Trichoderma viride were assessed for their ability to suppress grey blight caused by Pestalotiopsis theae, a major disease of tea crop in Assam. The expression of defense-related phytochemicals due to the application of these bioagents was also evaluated. The individual bioagents, as well as their combinations, were screened for their bioefficacy against P. theae in vitro using nutrient agar (NA) as basal medium. The treatment comprising a combination of the three bioagents, P. fluorescens, B. subtilis, and T. viride showed significantly the highest inhibition against the pathogen. Bioformulation of effective bioagent combinations was further evaluated under field condition, where significantly highest reduction of grey blight (90.30%), as well as the highest increase in the green leaf yield (10.52q/ha), was recorded due to application of the bioformulation containing the three bioagents. The application of the three bioformulation also recorded an enhanced level of caffeine (4.15%) and polyphenols (22.87%). A significant increase in the enzymatic activity of phenylalanine ammonia-lyase, peroxidase and polyphenol oxidase were recorded in the plants treated with the microbial bioformulation of the three bioagents. The present investigation indicates the role of microbial agents in suppressing disease, inducing plant defense response, as well as improving the quality of tea.

Keywords: enzymatic activity, grey blight, microbial bioagents, Pestalotiopsis theae, phytochemicals, plant defense, tea

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Authors: Eashwari Dahoe, Jody Scheuer, Harm-Jan Vink

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Alzheimer's disease is a progressive brain condition and is the most common form of dementia. Dementia is a global concern. It is an increasing crisis due to the worldwide aging population. The disease alters the body in different stages leading to several issues. The most common issues result in memory loss, responsive decline, and social decline. During the various stages, the dementia patient must be supported more in performing daily tasks. Eventually, the patient will have to be cared for entirely. There are many efforts in various domains to support this brain condition. This study focuses on the connection between three generations of solutions in the domain of technology and the struggles they tackle. To gather information regarding the struggles seniors with dementia face data has been acknowledged through reading scientific articles. The struggles are extracted from these articles and classified into various category struggles. To gather information regarding the three generations of technology data has been acknowledged through reading scientific articles regarding the generations. After understanding the difference between the three generations, international technological solutions from the past 20 years are connected to the generation they fit. This info is mainly collected through research on companies that aim to improve the lives of senior citizens with early stages of dementia. Eventually, the technological solutions (divided by generations) are linked to the struggles they tackle. By connecting the struggles and the solutions , it is hoped that this paper contributes to an informative overview of the currently available technological solutions and the struggles they tackle.

Keywords: Alzheimer’s disease, technological solutions to support dementia, struggles of seniors with dementia, struggles of dementia

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Authors: Nebi Gedik

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One of the significant and continual public health problems in the world is breast cancer. Early detection is very important to fight the disease, and mammography has been one of the most common and reliable methods to detect the disease in the early stages. However, it is a difficult task, and computer-aided diagnosis (CAD) systems are needed to assist radiologists in providing both accurate and uniform evaluation for mass in mammograms. In this study, a multiresolution statistical method to classify mammograms as normal and abnormal in digitized mammograms is used to construct a CAD system. The mammogram images are represented by wave atom transform, and this representation is made by certain groups of coefficients, independently. The CAD system is designed by calculating some statistical features using each group of coefficients. The classification is performed by using support vector machine (SVM).

Keywords: wave atom transform, statistical features, multi-resolution representation, mammogram

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Authors: Svetlana V. Topolyanskaya, Tatyana A. Eliseeva, Olga N. Vakulenko, Leonid I. Dvoretski

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Introduction: Limited data are available on osteoporosis in centenarians. Therefore, we evaluated bone mineral density in long-living patients with coronary artery disease (CAD). Methods: 202 patients hospitalized with CAD were enrolled in this cross-sectional study. The patients' age ranged from 90 to 101 years. The majority of study participants (64.4%) were women. The main exclusion criteria were any disease or medication that can lead to secondary osteoporosis. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry. Results: Normal lumbar spine BMD was observed in 40.9%, osteoporosis – in 26.9%, osteopenia – in 32.2% of patients. Normal proximal femur BMD values were observed in 21.3%, osteoporosis – in 39.9%, and osteopenia – in 38.8% of patients. Normal femoral neck BMD was registered only in 10.4% of patients, osteoporosis was observed in 60.4%, osteopenia in 29.2%. Significant positive correlation was found between all BMD values and body mass index of patients (p < 0.001). Positive correlation was registered between BMD values and serum uric acid (p=0.0005). The likelihood of normal BMD values with hyperuricemia increased 3.8 times, compared to patients with normal uric acid, who often have osteoporosis (Odds Ratio=3.84; p = 0.009). Positive correlation was registered between all BMD values and body mass index (p < 0.001). Positive correlation between triglycerides levels and T-score (p=0.02), but negative correlation between BMD and HDL-cholesterol (p=0.02) were revealed. Negative correlation between frailty severity and BMD values (p=0.01) was found. Positive correlation between BMD values and functional abilities of patients assessed using Barthel index (r=0,44; p=0,000002) and IADL scale (r=0,36; p=0,00008) was registered. Fractures in history were observed in 27.6% of patients. Conclusions: The study results indicate some features of BMD in long-livers. In the study group, significant relationships were found between bone mineral density on the one hand, and patients' functional abilities on the other. It is advisable to further study the state of bone tissue in long-livers involving a large sample of patients.

Keywords: osteoporosis, bone mineral density, centenarians, coronary artery disease

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Authors: Jean-Philippe Amat, Timothée Vergne, Aymeric Hans, Bénédicte Ferry, Pascal Hendrikx, Jackie Tapprest, Barbara Dufour, Agnès Leblond

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The surveillance of infectious diseases is necessary to describe their occurrence and help the planning, implementation and evaluation of risk mitigation activities. However, the exact number of detected cases may remain unknown whether surveillance is based on serological tests because identifying seroconversion may be difficult. Moreover, incomplete detection of cases or outbreaks is a recurrent issue in the field of disease surveillance. This study addresses these two issues. Using a viral animal disease as an example (equine viral arteritis), the goals were to establish suitable rules for identifying seroconversion in order to estimate the number of cases and outbreaks detected by a surveillance system in France between 2006 and 2013, and to assess the sensitivity of this system by estimating the total number of outbreaks that occurred during this period (including unreported outbreaks) using a capture-recapture model. Data from horses which exhibited at least one positive result in serology using viral neutralization test between 2006 and 2013 were used for analysis (n=1,645). Data consisted of the annual antibody titers and the location of the subjects (towns). A consensus among multidisciplinary experts (specialists in the disease and its laboratory diagnosis, epidemiologists) was reached to consider seroconversion as a change in antibody titer from negative to at least 32 or as a three-fold or greater increase. The number of seroconversions was counted for each town and modeled using a unilist zero-truncated binomial (ZTB) capture-recapture model with R software. The binomial denominator was the number of horses tested in each infected town. Using the defined rules, 239 cases located in 177 towns (outbreaks) were identified from 2006 to 2013. Subsequently, the sensitivity of the surveillance system was estimated as the ratio of the number of detected outbreaks to the total number of outbreaks that occurred (including unreported outbreaks) estimated using the ZTB model. The total number of outbreaks was estimated at 215 (95% credible interval CrI95%: 195-249) and the surveillance sensitivity at 82% (CrI95%: 71-91). The rules proposed for identifying seroconversion may serve future research. Such rules, adjusted to the local environment, could conceivably be applied in other countries with surveillance programs dedicated to this disease. More generally, defining ad hoc algorithms for interpreting the antibody titer could be useful regarding other human and animal diseases and zoonosis when there is a lack of accurate information in the literature about the serological response in naturally infected subjects. This study shows how capture-recapture methods may help to estimate the sensitivity of an imperfect surveillance system and to valorize surveillance data. The sensitivity of the surveillance system of equine viral arteritis is relatively high and supports its relevance to prevent the disease spreading.

Keywords: Bayesian inference, capture-recapture, epidemiology, equine viral arteritis, infectious disease, seroconversion, surveillance

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Authors: Kobus-Cisowska Joanna, Flaczyk Ewa, Gramza-Michalowska Anna, Kmiecik Dominik, Przeor Monika, Marcinkowska Agata

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In recent years, proceed to the attractiveness of typical bakery products. Expanding the education and nutrition knowledge society will develop the production of functional foods, which has a positive impact on human health. Therefore, the aim of the present study was to evaluate the effect of the addition of white mulberry fruit on the content of biologically active compounds in the new designed functional bread premixes designed for selected disease: anemia, diabetes, obesity and cardiovascular disease. For flavonols and phenolic acids content UPLC was conducted, using an NovaPack C18 column and a gradient elution system. It was found that all attempts bread characterized by a high content of biologically active compounds: polyphenols, phenolic acids, and flavonoids. The highest total content of polyphenolic compounds found in the samples of bread for anemia, diabetes and cardiovascular disease both before and after storage. The analyzed sample differed in content of phenolic acids. The highest content of these compounds were found in samples of bread for anemia and diabetes. It was found that the analyzed sample contained phenolic acids that are derivatives of hydroxybenzoic and hydroxycinnamic acid. The new designed bread contained significant amounts of flavonols, of which the dominant was routine.

Keywords: mulberry, antioxidant, polyphenols, phenolic acids, flavonols

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Authors: Sutapa Som Chaudhury, Chitrangada Das Mukhopadhyay

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Alzheimer’s disease is a well-known form of dementia since its discovery in 1906. Current Food and Drug Administration approved medications e.g. cholinesterase inhibitors, memantine offer modest symptomatic relief but do not play any role in disease modification or recovery. In last three decades many small molecules, chaperons, synthetic peptides, partial β-secretase enzyme blocker have been tested for the development of a drug against Alzheimer though did not pass the 3rd clinical phase trials. Here in this study, we designed a PEGylated, aminogenic, tripeptidic polymer with two different molecular weights based on the aggregation prone amino acid sequence 17-20 in amyloid beta (Aβ) 1-42. Being conjugated with poly-ethylene glycol (PEG) which self-assembles into hydrophilic nanoparticles, these PEGylated tripeptides constitute a very good drug delivery system crossing the blood brain barrier while the peptide remains protected from proteolytic degradation and non-specific protein interactions. Moreover, being completely aminogenic they would not raise any side effects. These peptide inhibitors were evaluated for their effectiveness against Aβ42 fibrillation at an early stage of oligomer to fibril formation as well as preformed fibril clearance via Thioflavin T (ThT) assay, dynamic light scattering analyses, atomic force microscopy and scanning electron microscopy. The inhibitors were proved to be safe at a higher concentration of 20µM by the reduction assay of 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) dye. Moreover, SHSY5Y neuroblastoma cells have shown a greater survivability when treated with the inhibitors following Aβ42 fibril and oligomer treatment as compared with the control Aβ42 fibril and/or oligomer treated neuroblastoma cells. These make the peptidic inhibitors a promising compound in the aspect of the discovery of alternative medication for Alzheimer’s disease.

Keywords: Alzheimer’s disease, alternative medication, amyloid beta, PEGylated peptide

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Authors: Rhodine Hickman, Craig Wylie, Michael G. McCaul

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Introduction: The World Health Organisation has called on governments around the world to recognise emergency conditions as a global public health problem and respond with appropriate steps for effective preventative strategies. However, to understand the magnitude of the problem, good quality epidemiological data is required. This is especially challenging in low and middle-income countries, where routine data is scarce, specifically within the prehospital setting. Methods: We conducted a retrospective cross-sectional study of a national prehospital private sector EMS database. The database being the property of ER24 (private Emergency Medical Services (EMS) company in South Africa) contains claims submitted by the majority of ambulance services in South Africa during the period between 1 January 2008 to 28 March 2017. We used descriptive statistics and control charts to describe the data using STATA 14. Results: 299,257 calls were included in the analysis. The top clinical conditions requiring ambulance transport were transport accidents (10% of total call volume) and ischaemic heart disease (4.4%). The number of transport accidents consistently increased between 2009 and 2014 and reached beyond the limit for normal variation in 2015. Victims of transport accidents required basic life support services 60% of the time with 80% of injuries being minor to moderate. The frequency of ischaemic heart disease had a steady incline from 2011 to 2016. Advanced life support services were required about 50% of the time, with 60% of patients needing urgent care. Conclusion: Transport accidents, followed by ischaemic heart disease, are the most prevalent conditions in South African private EMS. There is a potential to address these conditions by developing the capacity of low and mid-level providers in trauma and advanced EMS providers in ischaemic heart disease.

Keywords: emergency care, emergency medicine, prehospital providers, South Africa

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Authors: Turki J. Alharbi, Jencia Wong, Dennis Yue, Tania P. Markovic, Julie Hetherington, Ted Wu, Belinda Brooks, Radhika Seimon, Alice Gibson, Stephanie L. Silviera, Amanda Sainsbury, Tanya J. Little

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Fasting has been practiced for centuries and is incorporated into the practices of different religions including Islam, whose followers intermittently fast throughout the month of Ramadan. Thus, Ramadan presents a unique model of prolonged intermittent fasting (IF). Despite a growing body of evidence for a cardio-metabolic and endocrine benefit of IF, detailed studies of the effects of IF on these indices in type 2 diabetes are scarce. We studied 5 subjects with type 2 diabetes (T2DM) and 7 healthy controls (C) at baseline (pre), and in the last week of Ramadan (post). Fasting circulating levels of glucose, HbA1c and lipids, as well as body composition (with DXA) and resting energy expenditure (REE) were measured. Plasma gut hormone levels and appetite responses to a mixed meal were also studied. Data are means±SEM. Ramadan decreased total fat mass (-907±92 g, p=0.001) and trunk fat (-778±190 g, p=0.014) in T2DM but not in controls, without any reductions in lean mass or REE. There was a trend towards a decline in plasma FFA in both groups. Ramadan had no effect on body weight, glycemia, blood pressure, or plasma lipids in either group. In T2DM only, the area under the curve for post-meal plasma ghrelin concentrations increased after Ramadan (pre:6632±1737 vs. post:9025±2518 pg/ml.min-1, p=0.045). Despite this increase in orexigenic ghrelin, subjective appetite scores were not altered by Ramadan. Meal-induced plasma concentrations of the satiety hormone pancreatic polypeptide did not change during Ramadan, but were higher in T2DM compared to controls (post: C: 23486±6677 vs. T2DM: 62193±6880 pg/ml.min-1, p=0.003. In conclusion, Ramadan, as a model for IF appears to have more favourable effects on body composition in T2DM, without adverse effects on metabolic control or subjective appetite. These data suggest that IF may be particularly beneficial in T2DM as a nutritional intervention. Larger studies are warranted.

Keywords: type 2 diabetes, obesity, intermittent fasting, appetite regulating hormones

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Authors: Amna Abdalla Mohammed Khalid, Pietro Parisse, Silvia Onesti, Loredana Casalis

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Basic cellular processes as DNA replication are crucial to cell life. Understanding at the molecular level the mechanisms that govern DNA replication in proliferating cells is fundamental to understand disease connected to genomic instabilities, as a genetic disease and cancer. A key step for DNA replication to take place, is unwinding the DNA double helix and this carried out by proteins called helicases. The archaeal MCM (minichromosome maintenance) complex from Methanothermobacter thermautotrophicus have being studied using Atomic Force Microscopy (AFM), imaging in air and liquid (Physiological environment). The accurate analysis of AFM topographic images allowed to understand the static conformations as well the interaction dynamic of MCM and DNA double helix in the present of ATP.

Keywords: DNA, protein-DNA interaction, MCM (mini chromosome manteinance) complex, atomic force microscopy (AFM)

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Authors: Priyanka Jain, Sushila Pareek

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Skin disease is often considered to be ‘only cosmetic’ by many medical professionals and lay-people alike but unlike most internal illnesses, skin disease is often immediately visible to others and therefore people suffering from dermatological conditions may suffer serious social and emotional consequences. The purpose of this research was to compare patients suffering from acne, alopecia areata (AA) and melanosis on perceived stress, social appearance anxiety and coping. The study included 120 patients (acne = 40 AA = 40 melanosis = 40) ages ranged from 15 to 25 years. Perceived Stress Scale (PSS), Social Appearance Anxiety Scale (SAAS), and The Brief COPE were administered to the patients. Analytical evaluation was done by Kruskal Wallis and ANOVA-tests. The results of the present study clearly revealed that perceived stress and social appearance anxiety were highest in patients with AA followed by acne patients and found least in patients with melanosis. With regard to coping, self-distraction as a coping technique was found highest in patients suffering from AA followed by acne and then melanosis. Denial was highest in acne patients followed by AA and experienced least by patients with melanosis. Behavioural disengagement was almost equal in patients with melanosis and acne and a little less in patients suffering from AA Acceptance was highest in patients with melanosis, followed by AA and least in acne patients. Self-blame was found highest in patients with acne, followed by AA patients further followed by patients suffering from melanosis. This study is an attempt to stimulate professionals working in the field of dermatology and mental health to explore their supportive communication and increase awareness regarding the difficulties that patients with skin disease can face.

Keywords: coping, dermatology, perceived stress, psychosocial impact, social appearance anxiety

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Authors: Ofosuhene O. Apenteng, Noor Azina Ismail

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The human immunodeficiency virus (HIV) that causes acquired immune deficiency syndrome (AIDS) remains a global cause of morbidity and mortality. It has caused panic since its emergence. Relationships between migration and HIV/AIDS have become complex. In the absence of prospectively designed studies, dynamic mathematical models that take into account the migration movement which will give very useful information. We have explored the utility of mathematical models in understanding transmission dynamics of HIV and AIDS and in assessing the magnitude of how migration has impact on the disease. The model was calibrated to HIV and AIDS incidence data from Malaysia Ministry of Health from the period of 1986 to 2011 using Bayesian analysis with combination of Markov chain Monte Carlo method (MCMC) approach to estimate the model parameters. From the estimated parameters, the estimated basic reproduction number was 22.5812. The rate at which the susceptible individual moved to HIV compartment has the highest sensitivity value which is more significant as compared to the remaining parameters. Thus, the disease becomes unstable. This is a big concern and not good indicator from the public health point of view since the aim is to stabilize the epidemic at the disease-free equilibrium. However, these results suggest that the government as a policy maker should make further efforts to curb illegal activities performed by migrants. It is shown that our models reflect considerably the dynamic behavior of the HIV/AIDS epidemic in Malaysia and eventually could be used strategically for other countries.

Keywords: epidemic model, reproduction number, HIV, MCMC, parameter estimation

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Authors: Aliyu Maje Bello, Yaowaluck Maprang Roshorm

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Hand, foot, and mouth disease (HFMD) is a highly contagious viral infection affecting mostly infants and children. Although the Enterovirus A71 (EV71) is usually the major causative agent of HFMD, other enteroviruses such as coxsackievirus A16, A10, and A6 are also found in some of the recent outbreaks. The commercially available vaccines have demonstrated their effectiveness against only EV71 infection but no protection against other enteroviruses. To address the limitation of the monovalent EV71 vaccine, the present study thus designed a tetravalent vaccine against the four major enteroviruses causing HFMD and primarily evaluated the designed vaccine using an immunoinformatics approach. The immunogen was designed to contain the EV71 VP1 protein and multiple reported epitopes from all four distinct enteroviruses and thus designated a tetravalent vaccine. The 3D structure of the designed tetravalent vaccine was modeled, refined, and validated. Epitope screening showed the presence of B-cell, CTL, CD4 T cell, and IFN epitopes with vast application among the Asian population. Docking analysis confirmed the stable and strong binding interactions between the immunogen and immune receptor B-cell receptor (BCR). In silico cloning and immune simulation analyses guaranteed high efficiency and sufficient expression of the vaccine candidate in humans. Overall, the promising results obtained from the in-silico studies of the proposed tetravalent vaccine make it a potential candidate worth further experimental validation.

Keywords: enteroviruses, coxsackieviruses, hand foot and mouth disease, immunoinformatics, tetravalent vaccine

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Authors: Maria Cristina B. Cabanag, Elijinese Marie S. Culangen

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Pregnancy is a period in a woman's life wherein the body may undergo different physiological changes. These changes can be attributed to the interplay of hormones in the body but can mask a more sinister type of disease such as malignancy on rare occasions. Colorectal cancer (CRC) in pregnancy is an epidemiologically rare disease worldwide. To our knowledge, no available studies were reported in the Philippines at the time of this writing, posing a dilemma for its appropriate diagnosis and management. Signs and symptoms of colorectal malignancy may camouflage a normal pregnancy and, when overlooked, impedes an appropriate approach. This case of a 38-year-old elderly primigravid who presented with hematochezia on her 25th week of gestation. She was diagnosed with rectal adenocarcinoma later in pregnancy which warranted a predicament regarding her appropriate care and management. This paper explores the repertoire of the different diagnostic and treatment approaches to colorectal cancer in the second trimester of pregnancy, with the least possible maternal and fetal hazards.

Keywords: cancer in pregnancy, chemotherapy in pregnancy, colorectal cancer, hematochezia in pregnancy

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Authors: R. Bužgová, R. Kozáková, M. Škutová, M. Bar, P. Ressner, P. Bártová

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Introduction: Currently, there has been an increasing concern about the provision of palliative care in non-oncological patients in both professional literature and clinical practice. However, there is not much scientific information on how to provide neurological and palliative care together. The main objective of the project is to create and to verify a concept of neuro-palliative and rehabilitative care for patients with selected neurological diseases in an advanced stage of the disease and also to evaluate bio-psychosocial and spiritual needs of these patients and their caregivers related to the quality of life using created standardized tools. Methodology: Triangulation of research methods (qualitative and quantitative) will be used. A concept of care and assessment tools will be developed by analyzing interviews and focus groups. Qualitative data will be analyzed using grounded theory. The concept of care will be tested in the context of the intervention study. Using quantitative analysis, we will assess the effect of an intervention provided on the saturation of needs, quality of life, and quality of care. A research sample will be made up of the patients with selected neurological diseases (Parkinson´s syndrome, motor neuron disease, multiple sclerosis, Huntington’s disease), together with patients´ family members. Based on the results, educational materials and a certified course for health care professionals will be created. Findings: Based on qualitative data analysis, we will propose the concept of integrated care model combining neurological, rehabilitative and specialist palliative care for patients with selected neurological diseases in different settings of care and services. Patients´ needs related to quality of life will be described by newly created and validated measuring tools before the start of intervention (application of neuro-palliative and palliative approach) and then in the time interval. Conclusion: Based on the results, educational materials and a certified course for doctors and health care professionals will be created.

Keywords: multidisciplinary approach, neuropalliative care, research, quality of life

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Authors: Dimakatso B. Gumede, Nicolette N. Houreld

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Diabetic foot ulcers (DFUs) are a complication of diabetes mellitus (DM), a metabolic disease caused by insulin resistance or insufficiency, resulting in hyperglycaemia and low-grade chronic inflammation. Current therapies for treating DFUs include wound debridement, glycaemic control, and wound dressing. However, these therapies are moderately effective as there is a recurrence of these ulcers and an increased risk of lower limb amputations. Photobiomodulation (PBM), which is the application of non-invasive low-level light for wound healing at the spectrum of 660-1000 nm, has shown great promise in accelerating the healing of chronic wounds. However, its underlying mechanisms are not clearly defined. Studies have indicated that PBM induces wound healing via the activation of signaling pathways that are involved in tissue repair, such as the transforming growth factor-β (TGF-β). However, other signaling pathways, such as the WNT/β-catenin pathway, which is also critical for wound repair, have not been investigated. This study aimed to elucidate if PBM at 660 nm and a fluence of 5 J/cm² activates the WNT/β-catenin signaling pathway for wound healing in a diabetic cellular model. Human dermal fibroblasts (WS1) were continuously cultured high-glucose (26.5 mM D-glucose) environment to create a diabetic cellular model. A central scratch was created in the diabetic model to ‘wound’ the cells. The diabetic wounded (DW) cells were thereafter irradiated at 660 nm and a fluence of 5 J/cm². Cell migration, gene expression and protein assays were conducted at 24- and 48-h post-PBM. The results showed that PBM at 660 nm and a fluence of 5 J/cm² significantly increased cell migration in diabetic wounded cells at 24-h post-PBM. The expression of CTNNB1, ACTA2, COL1A1 and COL3A1 genes was also increased in DW cells post-PBM. Furthermore, there was increased cytoplasmic accumulation and nuclear localization of β-catenin at 24 h post-PBM. The findings in this study demonstrate that PBM activates the WNT/β-catenin signaling pathway by inducing the accumulation of β-catenin in diabetic wounded cells, leading to increased cell migration and expression of wound repair markers. These results thus indicate that PBM has the potential to improve wound healing in diabetic ulcers via activation of the WNT/β-catenin signaling pathway.

Keywords: wound healing, diabetic ulcers, photobiomodulation, WNT/β-catenin, signalling pathway

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Authors: Eva Kirzner

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Based on outcome studies published over the past two decades, in 2018, the ACC/AHA published new guidelines for the management of hypercholesterolemia that incorporate the use of coronary artery calcium (CAC) scanning as a decision tool for ascertaining which patients may benefit from statin therapy. This use is based on the recognition that the absence of calcium on CAC scanning (i.e., a CAC score of zero) usually signifies the absence of significant atherosclerotic deposits in the coronary arteries. Specifically, in patients with a high risk for atherosclerotic cardiovascular disease (ASCVD), initiation of statin therapy is generally recommended to decrease ASCVD risk. However, among patients with intermediate ASCVD risk, the need for statin therapy is less certain. However, there is a need for new outcome studies that provide evidence that the management of hypercholesterolemia based on these new ACC/AHA recommendations is safe for patients. Based on a Pub-Med and Google Scholar literature search, four relevant population-based or patient-based cohort studies that studied the relationship between CAC scanning, risk assessment or mortality, and statin therapy that were published between 2017 and 2021 were identified (see references). In each of these studies, patients were assessed for their baseline risk for atherosclerotic cardiovascular disease (ASCVD) using the Pooled Cohorts Equation (PCE), an ACC/AHA calculator for determining patient risk based on assessment of patient age, gender, ethnicity, and coronary artery disease risk factors. The combined findings of these four studies provided concordant evidence that a zero CAC score defines patients who remain at low clinical risk despite the non-use of statin therapy. Thus, these new studies confirm the use of CAC scanning as a safe tool for reducing the potential overuse of statin therapy among patients with zero CAC scores. Incorporating these new data suggest the following best practice: (1) ascertain ASCVD risk according to the PCE in all patients; (2) following an initial attempt trial to lower ASCVD risk with optimal diet among patients with elevated ASCVD risk, initiate statin therapy for patients who have a high ASCVD risk score; (3) if the ASCVD score is intermediate, refer patients for CAC scanning; and (4) and if the CAC score is zero among the intermediate risk ASCVD patients, statin therapy can be safely withheld despite the presence of an elevated serum cholesterol level.

Keywords: cholesterol, cardiovascular disease, statin therapy, coronary calcium

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Authors: Fanniyah Anis, Bram Kilapong

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Myocardial reperfusion injury is defined as the cellular damage that results from a period of ischemia, followed by the reestablishment of the blood supply to the infarcted tissue. Ventricular tachycardia is one of the most commonly encountered reperfusion arrhythmia as one of the types of myocardial perfusion injury. Prompt and early treatment can reduce mortality, despite limited resources of the hospital in high risk patients with history of triple vessel disease. Case report, Male 53 years old has been diagnosed with NSTEMI with 3VD and comorbid disease of Hypertension and has undergone revascularization management with Percutaneous coronary intervention. Ventricular tachycardia leading to cardiac arrest occurred right after the stent was inserted. Resuscitation was performed for almost 2 hours until spontaneous circulation returned. Patient admitted in ICU with refractory cardiac shock despite using combination of ionotropic and vasopressor agents under standard non-invasive monitoring due to the limitation of the hospital. Angiography was performed again 5 hours later to exclude other possibilities of blockage of coronary arteries and conclude diagnosis of myocardial reperfusion injury. Patient continually managed with combination of antiplatelet agents and maintenance dose of anti-arrhythmia agents. The handling of the patient was to focus more on supportive and preventive from further deteriorating of the condition. Patient showed clinically improvement and regained consciousness within 24 hours. Patient was successfully discharged from ICU within 3 days without any neurological sequela and was discharge from hospital after 3 days observation in general ward. Limited Resource of hospital did not refrain the physician from attaining a good outcome for this myocardial reperfusion injury case and angiography alone can be used to confirm the diagnosis of myocardial reperfusion injury.

Keywords: limited resources hospital, myocardial reperfusion injury, prolonged resuscitation, refractory cardiogenic shock, reperfusion arrhythmia, revascularization, triple-vessel disease

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Authors: Yaiprae Chatree, Tawan Chaiwon, Rodjana Chunhabundit, Kritsana Piriyawatcharakon, Waralai Ratwiset, Sasiwimol Chaiya

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The world is facing a serious situation of aging society. Elderly may have many physical health problems due to degenerative diseases including Alzheimer’s disease. Riceberry rice relatively contain high levels of carbohydrate, vitamin E, -oryzanol, and also abundant of bioactive compound of anthocyanin. This study aimed to determine the inhibitory effect of Riceberry rice crude extract on acetylcholinesterase activity. The active compound was extracted by using 70% ethanol (v/v). The inhibitory effect of Riceberry rice on acetylcholinesterase was evaluated by using slightly modified method of Ellman’s method. The 120 seconds time interval of kinetics measurement showed that Riceberry rice extract at concentrations of 2.5-12.5 mg/ml presented the acetylcholinesterase inhibitory activity at the statistically significant difference at p  0.05 compared to control group over 60 -120 seconds. At the concentrations of 10 and 12.5 mg/ml of Riceberry rice extract expressed the high percentage of inhibitory activity of 50.86 and 71.22%, respectively. The half maximal inhibitory concentration (IC50) of acetylcholinesterase inhibitory activity of Riceberry rice extract; considered to the end point, was found at concentration of 9.34 mg/ml. The physostigmine (positive control); however, showed a higher inhibitory capacity than that of Riceberry rice extract. The inhibitory activity of the positive control group was around at 80.40 – 90.41%. In conclusion, the results of this study indicated that Riceberry rice extract possessed the inhibitory capacity of acetylcholinesterase activity. Moreover, at the concentrations of 12.5 mg/ml it showed the identical inhibitory effect with physostigmine group. The Riceberry rice extract might be able to alleviate the clinical manifestations of Alzheimer’s disease.

Keywords: acetylcholine, acetylcholinesterase, Alzheimer's disease, riceberry rice

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Authors: Marziye Hadian, Alireza Jabbari

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Background: The World Health Organization has identified COVID-19 as a public health emergency and is urging governments to stop the virus transmission by adopting appropriate policies. In this regard, authorities have taken different approaches to cut the chain or controlling the spread of the disease. Now, the questions we are facing include what these approaches are? What tools should be used to implement each preventive protocol? In addition, what is the impact of each approach? Objective: The aim of this study was to determine the approaches to biological epidemics and related prevention tools with an emphasis on COVID-19 disease. Data sources: Databases including ISI web of science, PubMed, Scopus, Science Direct, Ovid, and ProQuest were employed for data extraction. Furthermore, authentic sources such as the WHO website, the published reports of relevant countries, as well as the Worldometer website were evaluated for gray studies. The time-frame of the study was from 1 December 2019 to 30 May 2020. Methods: The present study was a systematic study of publications related to the prevention strategies for the COVID-19 disease. The study was carried out based on the PRISMA guidelines and CASP for articles and AACODS for grey literature. Results: The study findings showed that in order to confront the COVID-19 epidemic, in general, there are three approaches of "mitigation", "active control" and "suppression" and four strategies of "quarantine", "isolation", "social distance" and "lockdown" in both individual and social dimensions to deal with epidemics. Selection and implementation of each approach requires specific strategies and has different effects when it comes to controlling and inhibiting the disease. Key finding: One possible approach to control the disease is to change individual behavior and lifestyle. In addition to prevention strategies, use of masks, observance of personal hygiene principles such as regular hand washing and non-contact of contaminated hands with the face, as well as an observance of public health principles such as sneezing and coughing etiquettes, safe extermination of personal protective equipment, must be strictly observed. Have not been included in the category of prevention tools. However, it has a great impact on controlling the epidemic, especially the new coronavirus epidemic. Conclusion: Although the use of different approaches to control and inhibit biological epidemics depends on numerous variables, however, despite these requirements, global experience suggests that some of these approaches are ineffective. The use of previous experiences in the world, along with the current experiences of countries, can be very helpful in choosing the accurate approach for each country in accordance with the characteristics of that country and lead to the reduction of possible costs at the national and international levels.

Keywords: novel corona virus, COVID-19, approaches, prevention tools, prevention strategies

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Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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