Search results for: disease index

Authors: Djamila Benhaddouche, Abdelkader Benyettou

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In this paper, we used data mining to extract biomedical knowledge. In general, complex biomedical data collected in studies of populations are treated by statistical methods, although they are robust, they are not sufficient in themselves to harness the potential wealth of data. For that you used in step two learning algorithms: the Decision Trees and Support Vector Machine (SVM). These supervised classification methods are used to make the diagnosis of thyroid disease. In this context, we propose to promote the study and use of symbolic data mining techniques.

Keywords: biomedical data, learning, classifier, algorithms decision tree, knowledge extraction

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Authors: Ojeka Alexandra

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The study investigated the leadership effectiveness of leaders of tertiary institutions in Nigeria. The study sought to examine the leadership styles adopted, the leadership energy and effectiveness of the leaders of two tertiary institutions. The research was undertaken at two institutions, one Polytechnic and one University. The population of the study was the lecturers and the heads of departments of the two institutions. The leadership matrix and leadership effectiveness index questionnaires were employed to collect quantitative and qualitative data. The preferred and practiced styles were compared and contrasted to determine whether or not they were used to achieve goals and objectives of the lecturers and the organizations. The recommendations contribute towards the academic and professional development of the lecturers and their institutions.

Keywords: leadership, leadership effectiveness, leadership energy, tertiary institutions, and leadership styles

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Authors: Mehves Isiklar Ekici, Ceyda Tuna Kirsaclioglu, Zarife Kuloglu, Aydan Kansu

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Malnutrition is an important cause of morbidity and mortality as it accounts for 45% of child deaths under the age of 5 worldwide. Therefore, early recognition and effective treatment of failure to thrive and malnutrition are important. In this study, it was aimed to retrospectively evaluate the nutritional support treatment approaches (nutrition education and diet enrichment / use of enteral nutrition products) applied in children followed up with growth failure without underlying organic causes, and to compare the efficacy of nutritional support treatments. In this study, children aged 1 month to 18 years diagnosed with growth failure who were followed up for at least 12 months between January 2011 and February 2020, were included. Anthropometric measurements at baseline and during follow-up, type of nutritional support therapy and treatment compliance were evaluated based on the retrospective records. 119 children (median age:3.2, 69 girls) were included in the study. Nutrition education and dietary enrichment were provided to 28% of the patients (Group 1). In addition to dietary education and recommendations, enteral nutrition supplements was given in 78% of them (Group 2). Compliance to the treatment rates of the patients in Group 1 and Group 2 were not significantly different at both 6th and 12th month controls. At the end of the follow up children who comply with the treatment in Group 1 had significant increase in weight for age z scores (-1.74 vs 0.05, respectively, p=0.019) and body mass index z scores (-1.47 vs -0.53, respectively, p=0.034) compared with baseline measurements. Similar to Group 1, in Group 2 children with treatment compliance, had a significant increase in weight for age z scores (-2.24 vs. -0.54, respectively, p=0.00) and body mass index z scores (-2.27 vs. -1.06, respectively, p=0.00) compared with baseline measurements. The rate of patients with severe malnutrition decreased from 15% to 12%, for moderate malnutrition decreased from 54% to 33%. Moreover, it was observed that this decrease in the rate of patients with both severe and moderate malnutrition was more prominent in patients under 3 years of age. Although there was a significant increase in anthropometric measurements with treatment in both groups, there was no significant difference in between two groups terms of change in anthropometric measurements (p>0.05), therefore effectiveness. Failure to thrive and malnutrition in infancy and childhood cause health problems that can affect adult life. To conclude, nutritional education - dietary enrichment. recommendations and use of enteral nutrition supplements were both proven beneficial in this study. Researchers are willing to underline that the most important part of the treatment is to include the family to the process to ensure the treatment compliance.

Keywords: enteral nutrition supplements, failure to thrive, malnutrition, nutritional education

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Authors: Sujata S. Kulkarni

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Effective and efficient texture feature extraction and classification is an important problem in image understanding and recognition. This paper gives a review on effective texture classification method. The objective of the problem of texture representation is to reduce the amount of raw data presented by the image, while preserving the information needed for the task. Texture analysis is important in many applications of computer image analysis for classification include industrial and biomedical surface inspection, for example for defects and disease, ground classification of satellite or aerial imagery and content-based access to image databases.

Keywords: compressed sensing, feature extraction, image classification, texture analysis

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Authors: Ji Jiazheng, Wang Jingrao, Jin Xin, Zhang Hong

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Diabetes mellitus is a metabolic disease characterized by high blood sugar. A long-standing hyperglycemic state can lead to various tissue damage. Diabetic retinopathy is the most common and widely studied ocular complication and has become the leading cause of blindness in my country. At the same time, diabetes has profound clinically relevant effects on the cornea, leading to keratopathy and vision-threatening. The cornea is an avascular tissue and is sensitive to hyperglycemia, Keratopathy caused by diabetes is usually chronic, they are called diabetic keratopathy or diabetic neurotrophic keratopathy, leading to several diabetic corneal complications including delayed epithelial wound healing, recurrent erosions, neuropathy, loss of sensitivity. Corneal stem cell dysfunction in diabetic patients as an important influencing factor of diabetic keratopathy. The consequences of this condition are often underestimated. The limbus is located between the cornea and the sclera tissue. The limbal stroma consists of a series of radial elevations with fibrovascular centers known as palisades of Vogt (POV). Previous studies have shown that palisades of Vogt (POV), as the main site of limbal stem cells, plays an important role in the homeostasis of the corneal epithelium. Therefore, POV plays a vital role in the healing of corneal epithelial surgery and postoperative evaluation. IVCM can observe the condition of the corneal epithelium at the cellular level. It has profound significance and guidance for the evaluation of limbal and limbal stem cells. We have previously observed structural changes in POV in HSK and HZO patients on IVCM. At present, there have been reports involving limbal stem cell dysfunction in diabetic patients, but the specific pathogenesis is still unclear. However, there are no studies on POV morphological changes in patients with DM. Therefore, we performed statistics and compared the correlation between POV morphological changes and corneal epithelial basal cell density, corneal nerves, and length of disease in DM patients and normal humans using IVCM studies. At the same time, fundoscopy was used to observe the correlation between the thickness of RNFL and the thickness of GCC and POV in diabetic patients. And to observe the correlation between SVD, DVD and POV for research.

Keywords: confocal microscopy, fundus, limbal stem cells, diabetes

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Authors: Chen Guo, Heng Tang, Ben Niu

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Clustering splits objects into different groups based on similarity, making the objects have higher similarity in the same group and lower similarity in different groups. Thus, clustering can be treated as an optimization problem to maximize the intra-cluster similarity or inter-cluster dissimilarity. In real-world applications, the datasets often have some complex characteristics: sparse, overlap, high dimensionality, etc. When facing these datasets, simultaneously optimizing two or more objectives can obtain better clustering results than optimizing one objective. However, except for the objectives weighting methods, traditional clustering approaches have difficulty in solving multi-objective data clustering problems. Due to this, evolutionary multi-objective optimization algorithms are investigated by researchers to optimize multiple clustering objectives. In this paper, the Data Clustering algorithm based on Multi-objective Periodic Bacterial Foraging Optimization with two Learning Archives (DC-MPBFOLA) is proposed. Specifically, first, to reduce the high computing complexity of the original BFO, periodic BFO is employed as the basic algorithmic framework. Then transfer the periodic BFO into a multi-objective type. Second, two learning strategies are proposed based on the two learning archives to guide the bacterial swarm to move in a better direction. On the one hand, the global best is selected from the global learning archive according to the convergence index and diversity index. On the other hand, the personal best is selected from the personal learning archive according to the sum of weighted objectives. According to the aforementioned learning strategies, a chemotaxis operation is designed. Third, an elite learning strategy is designed to provide fresh power to the objects in two learning archives. When the objects in these two archives do not change for two consecutive times, randomly initializing one dimension of objects can prevent the proposed algorithm from falling into local optima. Fourth, to validate the performance of the proposed algorithm, DC-MPBFOLA is compared with four state-of-art evolutionary multi-objective optimization algorithms and one classical clustering algorithm on evaluation indexes of datasets. To further verify the effectiveness and feasibility of designed strategies in DC-MPBFOLA, variants of DC-MPBFOLA are also proposed. Experimental results demonstrate that DC-MPBFOLA outperforms its competitors regarding all evaluation indexes and clustering partitions. These results also indicate that the designed strategies positively influence the performance improvement of the original BFO.

Keywords: data clustering, multi-objective optimization, bacterial foraging optimization, learning archives

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Authors: Vrushali Guhe, Shailza Singh

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Cutaneous leishmaniasis is neglected tropical disease present worldwide caused by the protozoan parasite Leishmania major, the therapeutic armamentarium for leishmaniasis are showing several limitations as drugs are showing toxic effects with increasing resistance by a parasite. Thus identification of novel therapeutic targets is of paramount importance. Previous studies have shown that autophagy, a cellular process, can either facilitate infection or aid in the elimination of the parasite, depending on the specific parasite species and host background in leishmaniasis. In the present study, our objective was to target the essential autophagy protein ATG8, which plays a crucial role in the survival, infection dynamics, and differentiation of the Leishmania parasite. ATG8 in Leishmania major and its homologue, LC3, in Homo sapiens, act as autophagic markers. Present study manifested the crucial role of ATG8 protein as a potential target for combating Leishmania major infection. Through bioinformatics analysis, we identified non-conserved motifs within the ATG8 protein of Leishmania major, which are not present in LC3 of Homo sapiens. Against these two non-conserved motifs, we generated a peptide library of 60 peptides on the basis of physicochemical properties. These peptides underwent a filtering process based on various parameters, including feasibility of synthesis and purification, compatibility with Selective Reaction Monitoring (SRM)/Multiple reaction monitoring (MRM), hydrophobicity, hydropathy index, average molecular weight (Mw average), monoisotopic molecular weight (Mw monoisotopic), theoretical isoelectric point (pI), and half-life. Further filtering criterion shortlisted three peptides by using molecular docking and molecular dynamics simulations. The direct interaction between ATG8 and the shortlisted peptides was confirmed through Surface Plasmon Resonance (SPR) experiments. Notably, these peptides exhibited the remarkable ability to penetrate the parasite membrane and exert profound effects on Leishmania major. The treatment with these peptides significantly impacted parasite survival, leading to alterations in the cell cycle and morphology. Furthermore, the peptides were found to modulate autophagosome formation, particularly under starved conditions, suggesting their involvement in disrupting the regulation of autophagy within Leishmania major. In vitro, studies demonstrated that the selected peptides effectively reduced the parasite load within infected host cells. Encouragingly, these findings were corroborated by in vivo experiments, which showed a reduction in parasite burden upon peptide administration. Additionally, the peptides were observed to affect the levels of LC3II within host cells. In conclusion, our findings highlight the efficacy of these novel peptides in targeting Leishmania major’s ATG8 and disrupting parasite survival. These results provide valuable insights into the development of innovative therapeutic strategies against leishmaniasis via targeting autophagy protein ATG8 of Leishmania major.

Keywords: ATG8, leishmaniasis, surface plasmon resonance, MD simulation, molecular docking, peptide designing, therapeutics

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Authors: Xiaobo Wang, Zhen-Yu Chen

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Higher plasma total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) are independent risk factors of cardiovascular disease while high-density lipoprotein cholesterol (HDL-C) is protective. Vitamin D is well-known for its regulatory role in calcium homeostasis. Its potential important role in cardiovascular disease has recently attracted much attention. This study was conducted to investigate effects of different dosage of calcitriol on plasma lipoprotein profile and the underlying mechanism. Sixty male Syrian Golden hamsters were randomly divided into 6 groups: no-cholesterol control (NCD), high-cholesterol control (HCD), groups with calcitriol supplementation at 10/20/40/80ng/kg body weight (CA, CB, CC, CD), respectively. Calcitriol in medium-chain triacylglycerol (MCT) oil was delivered to four experimental groups via oral gavage every other day, while NCD and HCD received MCT oil in the equivalent amount. NCD hamsters were fed with non-cholesterol diet while other five groups were maintained on diet containing 0.2% cholesterol to induce a hypercholesterolemic condition. The treatment lasts for 6 weeks followed by sample collection after hamsters sacrificed. Four experimental groups experienced a reduction in average food intake around 11% compared to HCD with slight decrease in body weight (not exceeding 10%). This reduction reflects on the deceased relative weights of testis, epididymal and perirenal adipose tissue in a dose-dependent manner. Plasma calcitriol levels were measured and was corresponding to oral gavage. At the end of week 6, lipoprotein profiles were improved with calcitriol supplementation with TC, non-HDL-C and plasma triglyceride (TG) decreased in a dose-dependent manner (TC: r=0.373, p=0.009, non-HDL-C: r=0.479, p=0.001, TG: r=0.405, p=0.004). Since HDL-C of four experiment groups showed no significant difference compared to HCD, the ratio of nHDL-C to HDL-C and HDL-C to TC had been restored in a dose-dependent manner. For hamsters receiving the highest level of calcitriol (80ng/kg) showed a reduction of TC by 11.5%, nHDL-C by 24.1% and TG by 31.25%. Little difference was found among six groups on the acetylcholine-induced endothelium-dependent relaxation or contraction of thoracic aorta. To summarize, calcitriol supplementation in hamster at maximum 80ng/kg body weight for 6 weeks lead to an overall improvement in plasma lipoprotein profile with decreased TC and TG level. The molecular mechanism of its effects is under investigation.

Keywords: cholesterol, vitamin D, calcitriol, hamster

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Authors: Ann Enright

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More than ever, animal shelters need to identify ways to reduce the number of animals entering shelter facilities and the incidence of euthanasia. Managing animal overpopulation using euthanasia can have detrimental health and emotional consequences for the shelter staff involved. There are also community expectations with moral and financial implications to consider. To achieve the goals of reducing animal intake and the incidence of euthanasia, shelter best practice involves combining programs, procedures and partnerships to increase live release rates (LRR), reduce the incidence of disease, length of stay (LOS) and shelter intake whilst overall remaining financially viable. Analysing daily processes, tracking outcomes and implementing simple strategies enabled shelter staff to more effectively focus their efforts and achieve amazing results. The objective of this retrospective study was to assess the effect of implementing the capacity for care (C4C) management model. Data focusing on the average daily number of animals on site for a two year period (2016 – 2017) was exported from a shelter management system, Customer Logic (CL) Vet to Excel for manipulation and comparison. Following the implementation of C4C practices the average daily number of animals on site was reduced by >50%, (2016 average 103 compared to 2017 average 49), average LOS reduced by 50% from 8 weeks to 4 weeks and incidence of disease reduced from ≥ 70% to less than 2% of the cats on site at the completion of the study. The total number of stray cats entering the shelter due to council contracts reduced by 50% (486 to 248). Improved cat outcomes were attributed to strategies that increased adoptions and reduced euthanasia of poorly socialized cats, including foster programs. To continue to achieve improvements in LRR and LOS, strategies to decrease intake further would be beneficial, for example, targeted sterilisation programs. In conclusion, the study highlighted the benefits of using C4C as a management tool, delivering a significant reduction in animal intake and euthanasia with positive emotional, financial and community outcomes.

Keywords: animal welfare, capacity for care, cat, euthanasia, length of stay, managed intake, shelter

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Authors: Mihaela Munteanu (Pila), Silvius Stanciu

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This paper presents the aspects of the official control of fishery in the Republic of Moldova. Currently, the regulations and the activity of national institutions with responsibilities in the field of food quality are in a process of harmonization with the European rules, aiming at European integration, quality improvement and providing a higher level of food safety. The National Agency for Food Safety is the main national body with responsibilities in the field of food safety. In the field of fishery products, the Agency carries out an intensive activity of informing the citizen and controlling the products marketed. The paper presents the dangers related to the consumption of fish and fishery products traded on the national market, the sanitary-veterinary inspections conducted by the profile institution and the improper situations identified. The national market of fishery products depends largely on imports, mainly focused on ocean fish. The research carried out has shown that during the period 2011-2018, following the inspections carried out on fishery products traded on the national market, a number of inconsistencies have been identified. Thus, indigenous products were frequently detected with sensory characteristics unfit for consumption, and being commercialized in inappropriate locations or contaminated with chemical pollutants. On import products controlled, the most frequent inconsistent situations have been represented by inconsistent sensory aspects and by parasite contamination. Taking into account the specific aspects of aquatic products, including the high level of alterability, special conditions of growth, marketing, culinary preparation and consumption are necessary in order to decrease the risk of disease over the population. Certificates, attestations and other documents certifying the quality of batches, completed by additional laboratory examinations, are necessary in order to increase the level of confidence on the quality of products marketed in the Republic. The implementation of various control procedures and mechanisms at national level, correlated with the focused activity of the specialized institutions, can decrease the risk of contamination and avoid cases of disease on the population due to the consumption of fishery products.

Keywords: fishery products, food safety, quality control, Republic of Moldova

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Authors: Agnieszka Rolinska, Marta Makara-Studzinska

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Introduction: In recent years, there has been an intensive development of research into the physiological relationships between the experienced stress and obesity. Moreover, strong chronic stress leads to the disorganization of a person’s activeness on various levels of functioning, including the behavioral and cognitive sphere (also in one’s diet). Aim: The present work addresses the following research questions: Is there a relationship between an increase in stress related to the disease and the need for the cyclicality of diabetologic education in gestational diabetes? Are there any differences in terms of the experienced stress during the last three months of pregnancy in women with gestational diabetes and in normal pregnancy between the patients with normal weight gains and those with abnormal weight gains? Are there any differences in terms of stress coping styles in women with gestational diabetes and in normal pregnancy between the patients with normal weight gains and those with abnormal weight gains? Method: The study involved pregnant women with gestational diabetes (treated with diet, without insulin therapy) and in normal pregnancy – 206 women in total. The following psychometric tools were employed: Perceived Stress Scale (PSS; Cohen, Kamarck, Mermelstein), Coping Inventory for Stressful Situations (CISS; Endler, Parker) and authors’ own questionnaire. Gestational diabetes mellitus was diagnosed on the basis of the results of fasting oral glucose tolerance test (75 g OGTT). Body weight measurements were confirmed in a diagnostic interview, taking into account medical data. Regularities in weight gains in pregnancy were determined according to the recommendations of the Polish Gynecological Society and American norms determined by the Institute of Medicine (IOM). Conclusions: An increase in stress related to the disease varies in patients with differing requirements for the cyclical nature of diabetologic education (i.e. education which is systematically repeated). There are no differences in terms of recently experienced stress and stress coping styles between women with gestational diabetes and those in normal pregnancy. There is a relationship between weight gains in pregnancy and the stress experienced in life as well as stress coping styles – both in pregnancy complicated by diabetes and in physiological pregnancy. In the discussion of the obtained results, the authors refer to scientific reports from English-language magazines of international range.

Keywords: diabetologic education, gestational diabetes, stress, weight gain in pregnancy

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Authors: Moustafa Osman Mohammed

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The modeling of a spatial-economic database is crucial in recitation economic network structure to social development. Sustainability within the spatial-economic model gives attention to green businesses to comply with Earth’s Systems. The natural exchange patterns of ecosystems have consistent and periodic cycles to preserve energy and materials flow in systems ecology. When network topology influences formal and informal communication to function in systems ecology, ecosystems are postulated to valence the basic level of spatial sustainable outcome (i.e., project compatibility success). These referred instrumentalities impact various aspects of the second level of spatial sustainable outcomes (i.e., participant social security satisfaction). The sustainability outcomes are modeling composite structure based on a network analysis model to calculate the prosperity of panel databases for efficiency value, from 2005 to 2025. The database is modeling spatial structure to represent state-of-the-art value-orientation impact and corresponding complexity of sustainability issues (e.g., build a consistent database necessary to approach spatial structure; construct the spatial-economic-ecological model; develop a set of sustainability indicators associated with the model; allow quantification of social, economic and environmental impact; use the value-orientation as a set of important sustainability policy measures), and demonstrate spatial structure reliability. The structure of spatial-ecological model is established for management schemes from the perspective pollutants of multiple sources through the input–output criteria. These criteria evaluate the spillover effect to conduct Monte Carlo simulations and sensitivity analysis in a unique spatial structure. The balance within “equilibrium patterns,” such as collective biosphere features, has a composite index of many distributed feedback flows. The following have a dynamic structure related to physical and chemical properties for gradual prolong to incremental patterns. While these spatial structures argue from ecological modeling of resource savings, static loads are not decisive from an artistic/architectural perspective. The model attempts to unify analytic and analogical spatial structure for the development of urban environments in a relational database setting, using optimization software to integrate spatial structure where the process is based on the engineering topology of systems ecology.

Keywords: ecological modeling, spatial structure, orientation impact, composite index, industrial ecology

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Authors: Ying Wang, Haiyan Xie, Aoming Zhang

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The degree distance of a graph is a graph invariant that is more sensitive than the Wiener index. In this paper, we calculate the vertex degree distances of one vertex union of the cycle and the star, and the degree distance of one vertex union of the cycle and the star. These results lay a foundation for further study on the extreme value of the vertex degree distances, and the distribution of the vertices with the extreme value in one vertex union of the cycle and the star.

Keywords: degree distance, vertex-degree-distance, one vertex union of a cycle and a star, graph

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Authors: Artem Kim, Clara Savary, Christele Dubourg, Wilfrid Carre, Houda Hamdi-Roze, Valerie Dupé, Sylvie Odent, Marie De Tayrac, Veronique David

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Holoprosencephaly (HPE) is a rare congenital brain malformation resulting from the incomplete separation of the two cerebral hemispheres. It is characterized by a wide phenotypic spectrum and a high degree of locus heterogeneity. Genetic defects in 16 genes have already been implicated in HPE, but account for only 30% of cases, suggesting that a large part of genetic factors remains to be discovered. HPE has been recently redefined as a complex multigenic disorder, requiring the joint effect of multiple mutational events in genes belonging to one or several developmental pathways. The onset of HPE may result from accumulation of the effects of multiple rare variants in functionally-related genes, each conferring a moderate increase in the risk of HPE onset. In order to decipher the genetic basis of HPE, unconventional patterns of inheritance involving multiple genetic factors need to be considered. The primary objective of this study was to uncover possible disease causing combinations of multiple rare variants underlying HPE by performing trio-based Whole Exome Sequencing (WES) of familial cases where no molecular diagnosis could be established. 39 families were selected with no fully-penetrant causal mutation in known HPE gene, no chromosomic aberrations/copy number variants and without any implication of environmental factors. As the main challenge was to identify disease-related variants among a large number of nonpathogenic polymorphisms detected by WES classical scheme, a novel variant prioritization approach was established. It combined WES filtering with complementary gene-level approaches: transcriptome-driven (RNA-Seq data) and clinically-driven (public clinical data) strategies. Briefly, a filtering approach was performed to select variants compatible with disease segregation, population frequency and pathogenicity prediction to identify an exhaustive list of rare deleterious variants. The exome search space was then reduced by restricting the analysis to candidate genes identified by either transcriptome-driven strategy (genes sharing highly similar expression patterns with known HPE genes during cerebral development) or clinically-driven strategy (genes associated to phenotypes of interest overlapping with HPE). Deeper analyses of candidate variants were then performed on a family-by-family basis. These included the exploration of clinical information, expression studies, variant characteristics, recurrence of mutated genes and available biological knowledge. A novel bioinformatics pipeline was designed. Applied to the 39 families, this final integrated workflow identified an average of 11 candidate variants per family. Most of candidate variants were inherited from asymptomatic parents suggesting a multigenic inheritance pattern requiring the association of multiple mutational events. The manual analysis highlighted 5 new strong HPE candidate genes showing recurrences in distinct families. Functional validations of these genes are foreseen.

Keywords: complex genetic disorder, holoprosencephaly, multiple rare variants, whole exome sequencing

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Authors: Marielle Leijten, Catherine Meulemans, Sven De Maeyer, Luuk Van Waes

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For the diagnosis of Alzheimer's disease (AD), a large variety of neuropsychological tests are available. In some of these tests, linguistic processing - both oral and written - is an important factor. Language disturbances might serve as a strong indicator for an underlying neurodegenerative disorder like AD. However, the current diagnostic instruments for language assessment mainly focus on product measures, such as text length or number of errors, ignoring the importance of the process that leads to written or spoken language production. In this study, it is our aim to describe and test differences between cognitive and impaired elderly on the basis of a selection of writing process variables (inter- and intrapersonal characteristics). These process variables are mainly related to pause times, because the number, length, and location of pauses have proven to be an important indicator of the cognitive complexity of a process. Method: Participants that were enrolled in our research were chosen on the basis of a number of basic criteria necessary to collect reliable writing process data. Furthermore, we opted to match the thirteen cognitively impaired patients (8 MCI and 5 AD) with thirteen cognitively healthy elderly. At the start of the experiment, participants were each given a number of tests, such as the Mini-Mental State Examination test (MMSE), the Geriatric Depression Scale (GDS), the forward and backward digit span and the Edinburgh Handedness Inventory (EHI). Also, a questionnaire was used to collect socio-demographic information (age, gender, eduction) of the subjects as well as more details on their level of computer literacy. The tests and questionnaire were followed by two typing tasks and two picture description tasks. For the typing tasks participants had to copy (type) characters, words and sentences from a screen, whereas the picture description tasks each consisted of an image they had to describe in a few sentences. Both the typing and the picture description tasks were logged with Inputlog, a keystroke logging tool that allows us to log and time stamp keystroke activity to reconstruct and describe text production processes. The main rationale behind keystroke logging is that writing fluency and flow reveal traces of the underlying cognitive processes. This explains the analytical focus on pause (length, number, distribution, location, etc.) and revision (number, type, operation, embeddedness, location, etc.) characteristics. As in speech, pause times are seen as indexical of cognitive effort. Results. Preliminary analysis already showed some promising results concerning pause times before, within and after words. For all variables, mixed effects models were used that included participants as a random effect and MMSE scores, GDS scores and word categories (such as determiners and nouns) as a fixed effect. For pause times before and after words cognitively impaired patients paused longer than healthy elderly. These variables did not show an interaction effect between the group participants (cognitively impaired or healthy elderly) belonged to and word categories. However, pause times within words did show an interaction effect, which indicates pause times within certain word categories differ significantly between patients and healthy elderly.

Keywords: Alzheimer's disease, keystroke logging, matching, writing process

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Authors: Georges F. Hatoum, Thomas H. Temple, Silvio Garcia, Xiaodong Wu

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Soft Tissue Sarcomas (STS) represent a diverse group of malignancies with heterogeneous clinical and pathological features. The treatment of extremity STS aims to achieve optimal local tumor control, improved survival, and preservation of limb function. The National Comprehensive Cancer Network guidelines, based on the cumulated clinical data, recommend radiation therapy (RT) in conjunction with limb-sparing surgery for large, high-grade STS measuring greater than 5 cm in size. Such treatment strategy can offer a cure for patients. However, when recurrence occurs (in nearly half of patients), the prognosis is poor, with a median survival of 12 to 15 months and with only palliative treatment options available. The spatially-fractionated-radiotherapy (SFRT), with a long history of treating bulky tumors as a non-mainstream technique, has gained new attention in recent years due to its unconventional therapeutic effects, such as bystander/abscopal effects. Combining single fraction of GRID, the original form of SFRT, with conventional RT was shown to have marginally increased the rate of pathological necrosis, which has been recognized to have a positive correlation to overall survival. In an effort to consistently increase the pathological necrosis rate over 90%, multiple fractions of Lattice RT (LRT), a newer form of 3D SFRT, interdigitated with the standard RT as neoadjuvant therapy was conducted in a preliminary clinical setting. With favorable results of over 95% of necrosis rate in a small cohort of patients, a Phase I/II clinical study was proposed to exam the safety and feasibility of this new strategy. Herein the design of the clinical study is presented. In this single-arm, two-stage phase I/II clinical trial, the primary objectives are >80% of the patients achieving >90% tumor necrosis and to evaluation the toxicity; the secondary objectives are to evaluate the local control, disease free survival and overall survival (OS), as well as the correlation between clinical response and the relevant biomarkers. The study plans to accrue patients over a span of two years. All patient will be treated with the new neoadjuvant RT regimen, in which one of every five fractions of conventional RT is replaced by a LRT fraction with vertices receiving dose ≥10Gy while keeping the tumor periphery at or close to 2 Gy per fraction. Surgical removal of the tumor is planned to occur 6 to 8 weeks following the completion of radiation therapy. The study will employ a Pocock-style early stopping boundary to ensure patient safety. The patients will be followed and monitored for a period of five years. Despite much effort, the rarity of the disease has resulted in limited novel therapeutic breakthroughs. Although a higher rate of treatment-induced tumor necrosis has been associated with improved OS, with the current techniques, only 20% of patients with large, high-grade tumors achieve a tumor necrosis rate exceeding 50%. If this new neoadjuvant strategy is proven effective, an appreciable improvement in clinical outcome without added toxicity can be anticipated. Due to the rarity of the disease, it is hoped that such study could be orchestrated in a multi-institutional setting.

Keywords: lattice RT, necrosis, SFRT, soft tissue sarcoma

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Authors: Mariola Głowacka

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Aim: The aim of this study was to present the assessment of dyspnea and anxiety in seniors staying in the hospice in the context of the nurse's tasks. Materials and methods: The presented research was carried out at the "Hospicjum Płockie" Association of St. Urszula Ledóchowska in Płock, in a stationary ward, for adults. The research group consisted of 100 people, women, and men. In the study described in this paper, the method of diagnostic survey, the method of estimation and analysis of patient records were used, and the research tools were the numerical scale of the NRS assessment, the modified Borg scale to assess dyspnea, the Trait Anxiety scale to test the intensity of anxiety and the sociodemographic assessment of the respondent. Results: Among the patients, the greatest number were people without dyspnoea (38 people) and with average levels of dyspnoea (26 people). People with lung cancer had a higher level of breathlessness than people with other cancers. Half of the patients included in the study felt anxiety at a low level. On average, men had a higher level of anxiety than women. Conclusion: 1) Patients staying in the hospice require comprehensive nursing care due to the underlying disease, comorbidities, and a wide range of medications taken, which aggravate the feeling of dyspnea and anxiety. 2) The study showed that in patients staying in the hospice, the level of dyspnea was of varying severity. The greatest number of people were without dyspnea (38) and patients with a low level of dyspnea (34). There were 12 people experiencing an average level of dyspnea and a high level of dyspnea 15. 3) The main factor influencing the severity of dyspnea in patients was the location of cancer. There was no significant relationship between the intensity of dyspnea and the age, gender of the patient, and time from diagnosis. 4) The study showed that in patients staying in the hospice, the level of anxiety was of varying severity. Most people experience a low level of anxiety (51). There were 16 people with a high level of anxiety, while there were 33 people experiencing anxiety at an average level. 5) The patient's gender was the main factor influencing the increase in anxiety intensity. Men had higher levels of anxiety than women. There was no significant correlation between the intensity of anxiety and the age of the respondents, as well as the type of cancer and time since diagnosis. 6) The intensity of dyspnea depended on the type of cancer the subjects had. People with lung cancer had a higher level of breathlessness than those with breast cancer and bowel cancer. It was not found that the anxiety increased depending on the type of cancer and comorbidities of the examined person.

Keywords: cancer, shortness of breath, anxiety, senior, hospice

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Authors: Vito Telesca, Giuseppina A. Giorgio, M. Ragosta

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The effects of extreme heat events are increasing in recent years. Humans are forced to adjust themselves to adverse climatic conditions. The impact of weather on human health has become public health significance, especially in light of climate change and rising frequency of devasting weather events (e.g., heat waves and floods). The interest of scientific community is widely known. In particular, the associations between temperature and mortality are well studied. Weather conditions are natural factors that affect the human organism. Recent works show that the temperature threshold at which an impact is seen varies by geographic area and season. These results suggest heat warning criteria should consider local thresholds to account for acclimation to local climatology as well as the seasonal timing of a forecasted heat wave. Therefore, it is very important the problem called ‘local warming’. This is preventable with adequate warning tools and effective emergency planning. Since climate change has the potential to increase the frequency of these types of events, improved heat warning systems are urgently needed. This would require a better knowledge of the full impact of extreme heat on morbidity and mortality. The majority of researchers who analyze the associations between human health and weather variables, investigate the effect of air temperature and bioclimatic indices. These indices combine air temperature, relative humidity, and wind speed and are very important to determine the human thermal comfort. Health impact studies of weather events showed that the prevention is an essential element to dramatically reduce the impact of heat waves. The summer Italian of 2012 was characterized with high average temperatures (con un +2.3°C in reference to the period 1971-2000), enough to be considered as the second hottest summer since 1800. Italy was the first among countries in Europe which adopted tools for to predict these phenomena with 72 hours in advance (Heat Health Watch Warning System - HHWWS). Furthermore, in Italy heat alert criteria relies on the different Indexes, for example Apparent temperature, Scharlau index, Thermohygrometric Index, etc. This study examines the importance of developing public health policies that protect the most vulnerable people (such as the elderly) to extreme temperatures, highlighting the factors that confer susceptibility.

Keywords: heat waves, Italy, local warming, temperature

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Authors: Aktar-Uz-Zaman, M. Tuhina-Khatun, Mohamed Hanafi Musa

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Three rust diseases: leaf (brown) rust caused by Puccinia triticina Eriks, stripe (yellow) rust caused by Puccinia striiformis West, and stem (black) rust caused by Puccinia graminis f. sp. tritici are economically important diseases of wheat in world wide. Yield loss due to leaf rust is 40% in susceptible cultivars. Yield losses caused by the stem rust pathogens in the mid of 20 century reached 20-30% in Eastern and Central Europe and the most virulent stem rust race Ug99 emerged first in Uganda and after that in Kenya, Ethiopia, Yemen, in the Middle East and South Asia. Yield losses were estimated up to 100%, whereas, up to 80% have been reported in Kenya during 1999. In case of stripe rust, severity level has been recorded 60% - 70% as compared to 100% severity of susceptible check in disease screening nurseries in Kenya. Improvement of resistant varieties or cultivars is the sustainable, economical and environmentally friendly approaches for increasing the global wheat production to suppress the rust diseases. More than 68 leaf rust, 49 stripe rust and 53 stem rust resistance genes have been identified in the global wheat cultivars or varieties using different molecular breeding approaches. Among these, Lr1, Lr9, Lr10, Lr19, Lr21, Lr24, Lr25, Lr28, Lr29, Lr34, Lr35, Lr37, Lr39, Lr47, Lr51, Lr3bg, Lr18, Lr40, Lr46, and Lr50 leaf rust resistance genes have been identified by using molecular, enzymatic and microsatellite markers from African, Asian, European cultivars of hexaploid wheat (Triticum aestivum), durum wheat and diploid wheat species. These genes are located on 20, of the 21 chromosomes of hexaploid wheat. Similarly, Sr1, Sr2, Sr24, and Sr3, Sr31 stem rust resistance genes have been recognized from wheat cultivars of Pakistan, India, Kenya, and Uganda etc. A race of P. striiformis (stripe rust) Yr9, Yr18, and Yr29 was first observed in East Africa, Italy, Pakistan and India wheat cultivars. These stripe rust resistance genes are located on chromosomes 1BL, 4BL, 6AL, 3BS and 6BL in bread wheat cultivars. All these identified resistant genes could be used for notable improvement of susceptible wheat cultivars in the future.

Keywords: hexaploid wheat, resistance genes, rust disease, triticum aestivum

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Authors: Dipanshu Sur, Ratnabali Chakravorty, Rimi Pal, Siddhartha Chatterjee, Joyshree Chaterjee, Amal Mallik

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Background: Polycystic ovary syndrome (PCOS) is a common endocrine disease in reproductive women with a complex hormonal disturbance that affects the menstrual cycle and leads to metabolic consequences in later life. Hyperandrogenaemia is noticeable features of PCOS and influence the process of folliculogenesis in women. The levels of Antimüllerian Hormone (AMH) reflect the number of pre-antral follicles and thus are a marker of oocyte pool – germinal reserve of the ovary for reproduction. Besides its utilization in IVF (In-vitro fertilization), determination of AMH may serve as an additional marker in the diagnostics of PCOS, where increased AMH levels reflect the severity of the disease. The positive correlation of serum AMH with the number of antral follicles was found also in patients with PCOS. Objective: The objective of this study was to investigate the relationship between AMH androgens and whether AMH contributes to altered folliculogenesis in non-obese women with PCOS. Methods: We designed a prospective study which included a total of 65 IVF individuals. It enrolled 26 cases of PCOS based on 2003 Rotterdam criteria and 39 ovulatory normal- non PCOS, healthy, age-matched controls. AMH levels and ovarian morphology were assessed. The relationships between AMH and androgenaemia in patients with and without PCOS were studied. Results: Mean age of PCOS patients were slightly higher than controls (32±4 and 28±3 years, respectively). AMH generally increased with antral follicle count (AFC) [P=0.001], testosterone, and luteinising hormone, and decreased with age, and serum sex hormone binding globulin (SHBG). No significant relationships were found between circulating AMH levels and BMI between PCOS and non-PCOS patients. The calculation of AMH production per antral follicle (AMH/AF) showed that there was a significant difference in median AMH/AF between PCOS and non-PCOS (P =0.001). Both PCOS and non-PCOS groups showed a very similar increase in AMH with increases in AFC, but the PCOS patients had consistently higher AMH across all AFC levels. Conclusions: These observations indicate that there is a connection between AMH and androgens levels between PCOS and non-PCOS East Indian women. Excessive granulosa cell activity may be implicated in the abnormal follicular dynamic of the syndrome. They are higher in women with PCOS and, on the other hand, very low in women with an ovarian failure.

Keywords: anti-Mullerian hormone, polycystic ovary syndrome, antral follicle count, androgens

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Authors: Autcha Araveeporn

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This paper presents a study about a nonparametric regression model consisting of a smoothing spline method and a penalized spline regression method. We also compare the techniques used for estimation and prediction of nonparametric regression model. We tried both methods with crude oil prices in dollars per barrel and the Stock Exchange of Thailand (SET) index. According to the results, it is concluded that smoothing spline method performs better than that of penalized spline regression method.

Keywords: nonparametric regression model, penalized spline regression method, smoothing spline method, Stock Exchange of Thailand (SET)

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Authors: Joana Beyer

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Background: Alzheimer’s disease (AD) is the predominant cause of dementia, characterized by progressive cognitive decline. Posterior cortical atrophy (PCA) is a less common variant of AD, primarily affecting younger individuals and presenting with visual, visuospatial, and visuoperceptual deficits, often leading to delayed diagnosis due to its atypical presentation. Case Presentation: We report the case of a 58-year-old woman referred to psychiatric services with a two-year history of progressive visuospatial decline, mild memory difficulties, and language impairments, notably anomia. Despite undergoing cataract and squint surgeries, her visual symptoms persisted, impacting her professional life as a music educator. The neuropsychological evaluation revealed profound visuoperceptual and visuospatial disturbances, with neuroimaging supporting a diagnosis of PCA. Treatment with Donepezil showed symptom improvement, highlighting the challenges and importance of early intervention and managing this atypical form of AD. Methods: The diagnostic process involved comprehensive physical, neuropsychological assessments, and neuroimaging, including MRI and F18 FDG PET CT, which demonstrated severe bilateral posterior cortical involvement. The case underscores the utility of these modalities in diagnosing PCA. Results: The initiation of Donepezil, an acetylcholinesterase inhibitor, resulted in symptom improvement, emphasizing the potential for AD treatments to benefit PCA patients. However, challenges in management, including treatment side effects and the necessity of multidisciplinary care, are discussed. Conclusion: This case highlights PCA's diagnostic challenges due to its atypical presentation and the broader implications for managing younger patients with early-onset dementia. It underscores the necessity for early recognition, comprehensive assessment, and tailored management strategies, including both pharmacological and non-pharmacological interventions, to improve patients' quality of life. Additionally, the case illustrates the need for expanding community memory services to accommodate younger patients with atypical forms of dementia, advocating for a more inclusive approach to dementia care.

Keywords: Alzheimer’s disease, posterior cortical atrophy, dementia, diagnosis, management, donepezil, early-onset dementia

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Authors: Ying Shi, June Zhang, Lu Shao, Xiyan Xie, Aidi Lao, Zhangan Wang

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Background: Low levels of physical activity are associated with poorer health outcomes, and this situation is more critical in older adults living in long‐term care facilities. Objectives: To systematically identify, appraise, and synthesize current qualitative research evidence regarding the barriers and facilitators to physical activity as reported by older adults and care staff in long‐term care facilities. Design: This is a systematic review with qualitative evidence synthesis adhering to PRISMA guidelines. Methods: We conducted a systematic search on PubMed, Science Citation Index Expanded, Social Sciences Citation Index, EMBASE, CINAHL, and PsychInfo databases from inception until 30 June 2023. Thematic synthesis was undertaken to identify the barriers and facilitators relating to physical activity. Then, we mapped them onto the Capability, Opportunity, Motivation, and Behavior model and Theoretical Domains Framework. Methodological quality was assessed using the CASP Qualitative Studies Checklist, and confidence in review findings was assessed using the GRADE-CERQual approach. Results: We included 32 studies after screening 10496 citations and 177 full texts. Seven themes and 17 subthemes were identified relating to barriers and facilitators influencing physical activity in elderly residents. The main themes were mapped onto COM-B) model-Capability (physical activity knowledge gaps and individual health issues), Opportunity (social support and macro-level resources) and Motivation (health beliefs, fear of falling or injury, and personal and social incentives to physical activity). Most subthemes were graded as high (n = 9) or moderate (n = 3) confidence. Conclusions and Implications: Our comprehensive synthesis of 32 studies provides a wealth of knowledge of barriers and facilitators to physical activity from both residents and care staff’s perspectives. Intervention components were also suggested within the context of long‐term care facilities. End users such as older residents, care staff, and researchers can have confidence in our findings when formulating policies and guidance on promoting physical activity among elderly residents in long‐term care facilities.

Keywords: long‐term care, older adults, physical activity, qualitative, systematic review

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Authors: Murat Yildiz, Burcu Yildiz

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Price Cap Regulation is a form of economic regulation designed in the 1980s in the United Kingdom. Price cap regulation sets a cap on the price that the utility provider can charge. The cap is set according to several economic factors, such as the price cap index, expected efficiency savings and inflation. It has been used by several countries as a regulatory regime in several sectors. Container port privatization is still in early stages in some countries. Lack of a general framework can be an impediment to privatization. This paper aims a general framework to comprising decisions to be made for variables which are able to accommodate the variety of container terminals. Several approaches that may be needed as well as a passage between approaches.

Keywords: Price Cap Regulation, ports privatization, container terminal price regime, earning sharing

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Authors: Hancy Issac, Gerben Keijzers, Ian Yang, Clint Moloney, Jackie Lea, Melissa Taylor

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Introduction: Chronic obstructive pulmonary disease guideline non-adherence is associated with a reduction in health-related quality of life in patients (HRQoL). Improving guideline adherence has the potential to mitigate fragmented care thereby sustaining pulmonary function, preventing acute exacerbations, reducing economic health burdens, and enhancing HRQoL. The development of an electronic proforma stemming from expert consensus, including digital guideline resources and direct interdisciplinary referrals is hypothesised to improve guideline adherence and patient outcomes for emergency department (ED) patients with COPD. Aim: The aim of this study was to develop consensus among ED and respiratory staff for the correct composition of a COPD electronic proforma that aids in guideline adherence and management in the ED. Methods: This study adopted a mixed-method design to develop the most important indicators of care in the ED. The study involved three phases: (1) a systematic literature review and qualitative interdisciplinary staff interviews to assess barriers and solutions for guideline adherence and qualitative interdisciplinary staff interviews, (2) a modified Delphi panel to select interventions for the proforma, and (3) a consensus process through three rounds of scoring through a quantitative survey (ED and Respiratory consensus) and qualitative thematic analysis on each indicator. Results: The electronic proforma achieved acceptable and good internal consistency through all iterations from national emergency department and respiratory department interdisciplinary experts. Cronbach’s alpha score for internal consistency (α) in iteration 1 emergency department cohort (EDC) (α = 0.80 [CI = 0.89%]), respiratory department cohort (RDC) (α = 0.95 [CI = 0.98%]). Iteration 2 reported EDC (α = 0.85 [CI = 0.97%]) and RDC (α = 0.86 [CI = 0.97%]). Iteration 3 revealed EDC (α = 0.73 [CI = 0.91%]) and RDC (α = 0.86 [CI = 0.95%]), respectively. Conclusion: Electronic proformas have the potential to facilitate direct referrals from the ED leading to reduced hospital admissions, reduced length of hospital stays, holistic care, improved health care and quality of life and improved interdisciplinary guideline adherence.

Keywords: COPD, electronic proforma, modified delphi study, interdisciplinary, guideline adherence, COPD-X plan

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Authors: Jeroen S. de Bruin, Karin Schindler, Christian Schuh

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With increasingly more mobile health applications appearing due to the popularity of smartphones, the possibility arises that these data can be used to improve the medical diagnostic process, as well as the overall quality of healthcare, while at the same time lowering costs. However, as of yet there have been no reports of a successful combination of patient-generated data from smartphones with data from clinical routine. In this paper, we describe how these two types of data can be combined in a secure way without modification to hospital information systems, and how they can together be used in a medical expert system for automatic nutritional classification and triage.

Keywords: mobile health, data integration, expert systems, disease-related malnutrition

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Authors: Sandhya Devi A

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The protein content of the cranberry squash (protein: 0g) may be increased by extracting protein from the lentils (9 g), which is particularly linked to a lower risk of developing heart disease. Using the technique of alkaline extraction from the lentils flour, protein may be extracted. Alkaline extraction of protein from lentil flour was optimized utilizing response surface approach in order to maximize both protein content and yield. Cranberry squash may be taken if a protein fortification syrup is prepared and processed into the squash.

Keywords: alkaline extraction, cranberry squash, protein fortification, response surface methodology

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Authors: Kasun U. G. Palihakkara

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Although vaccine coverage in Sri Lanka is close to 100%, with the widely spreading vaccine rejection trend reaching South Asian regions, it is essential to catch on whether Sri Lankans are being misinformed from the common misconceptions regarding vaccines. As the rates of target diseases decrease, parents become less accepting of even minor common adverse events. It is essential to preserve the integrity of immunization programs and protect public health by finding out the prevalence of anti-immunization trends. The primary objective of this study was to assess the immunization practices and prevalence of trends related to anti-immunization among urban community in Sri Lanka. A descriptive cross-sectional quantitative study on 323 participants using convenient sampling with 213 self-administered questionnaires. Additionally, 110 online questionnaires were distributed. 31% of the study population does not maintain immunization records for their children. While majority seek information regarding immunization from reliable sources such as the family physician or specialist pediatricians, 30% also refer to unreliable sources such as online communities for their opinion. 31% of study population had not vaccinated for Japanese encephalitis. 73% of the study population had encountered with side effects of vaccination such as fever & 47% believed that such side effects are rare. 52% of the population had hostile attitude regarding the administration of several doses multiple vaccines within a child’s first year. Diseases like polio had been successfully eradicated from Sri Lanka with the help of vigorous vaccination programs. However, majority of the study population believe that there’s no need to keep vaccinating the children for those eradicated diseases and exposing the child for adverse effects of such vaccines. Majority of the population were aware of the existing misconceptions regarding immunization. The most popular misconceptions about vaccines popular among the study population were the MMR (Measles, Mumps, and Rubella) vaccine being a possible cause leading to autism and bowel disease and children getting infected with the disease even after they get vaccinated, may be due to the inactivated vaccine. Disturbingly 22% of the study population believed that vaccines are useless in preventing diseases nowadays. These data obtained from the urban study population reveals that even though statistically Sri Lankan immunization coverage is 100%, there is a possibility of anti-vaccination trend arising in Sri Lanka due to the prevalence of various misconceptions and rumors related to it. Therefore these data recommend the need for thorough awareness among the mothers.

Keywords: anti-vaccination, immunization, infectious diseases, pediatric health

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Authors: Manjit Singh

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Multiscale entropy (MSE) is an extensively used index to provide a general understanding of multiple complexity of physiologic mechanism of heart rate variability (HRV) that operates on a wide range of time scales. Accurate selection of electrocardiogram (ECG) sampling frequency is an essential concern for clinically significant HRV quantification; high ECG sampling rate increase memory requirements and processing time, whereas low sampling rate degrade signal quality and results in clinically misinterpreted HRV. In this work, the impact of ECG sampling frequency on MSE based HRV have been quantified. MSE measures are found to be sensitive to ECG sampling frequency and effect of sampling frequency will be a function of time scale.

Keywords: ECG (electrocardiogram), heart rate variability (HRV), multiscale entropy, sampling frequency

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Authors: Jee-Young Lee, Joaquim J. Ferreira, Hyeo-il Ma, José-Francisco Rocha, Beomseok Jeon

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The effective management of wearing-off is a key driver of medication changes for patients with Parkinson’s disease (PD) treated with levodopa (L-DOPA). While L-DOPA is well tolerated and efficacious, its clinical utility over time is often limited by the development of complications such as dyskinesia. Still, common first-line option includes adjusting the daily L-DOPA dose followed by adjunctive therapies usually counting for the L-DOPA equivalent daily dose (LEDD). The LEDD conversion formulae are a tool used to compare the equivalence of anti-PD medications. The aim of this work is to compare the effects of opicapone (OPC) 50 mg, a catechol-O-methyltransferase (COMT) inhibitor, and an additional 100 mg dose of L-DOPA in reducing the off time in PD patients with early motor fluctuations receiving different daily L-DOPA doses. OPC was found to be well tolerated and efficacious in advanced PD population. This work utilized patients' home diary data from a 4-week Phase 2 pharmacokinetics clinical study. The Korean ADOPTION study randomized (1:1) patients with PD and early motor fluctuations treated with up to 600 mg of L-DOPA given 3–4 times daily. The main endpoint was change from baseline in off time in the subgroup of patients receiving 300–400 mg/day L-DOPA at baseline plus OPC 50 mg and in the subgroup receiving >300 mg/day L-DOPA at baseline plus an additional dose of L-DOPA 100 mg. Of the 86 patients included in this subgroup analysis, 39 received OPC 50 mg and 47 L-DOPA 100 mg. At baseline, both L-DOPA total daily dose and LEDD were lower in the L-DOPA 300–400 mg/day plus OPC 50 mg group than in the L-DOPA >300 mg/day plus L-DOPA 100 mg. However, at Week 4, LEDD was similar between the two groups. The mean (±standard error) reduction in off time was approximately three-fold greater for the OPC 50 mg than for the L-DOPA 100 mg group, being -63.0 (14.6) minutes for patients treated with L-DOPA 300–400 mg/day plus OPC 50 mg, and -22.1 (9.3) minutes for those receiving L-DOPA >300 mg/day plus L-DOPA 100 mg. In conclusion, despite similar LEDD, OPC demonstrated a significantly greater reduction in off time when compared to an additional 100 mg L-DOPA dose. The effect of OPC appears to be LEDD independent, suggesting that caution should be exercised when employing LEDD to guide treatment decisions as this does not take into account the timing of each dose, onset, duration of therapeutic effect and individual responsiveness. Additionally, OPC could be used for keeping the L-DOPA dose as low as possible for as long as possible to avoid the development of motor complications which are a significant source of disability.

Keywords: opicapone, levodopa, pharmacokinetics, off-time

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