Search results for: satisfaction of patients

Authors: Alfrina Marwan, Erna Sulistyawati

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Class III malocclusion shows both skeletal and dentoalveolar component. Sketal Class III malocclusion can have variants in different region, maxilla or mandibular. Skeletal Class III malocclusion during growth period is considered to treat to prevent its severity in adulthood. Orthopedics treatment of skeletal Class III malocclusion in growing patient can be treated by using reverse twin block with expansion screw to modify the growth pattern. The objective of this case report was to describe the functional correction of skeletal Class III maloclussion using reverse twin block with expansion screw in growing patient. A patient with concave profile came with a chief complaint of aesthetic problems. The cephalometric analysis showed that patient had skeletal Class III malocclusion (ANB -5⁰, SNA 75º, Wits appraisal -3 mm) with anterior cross bite and deep bite (overjet -3 mm, overbite 6 mm). In this case report, the patient was treated with reverse twin block appliance with expansion screw. After three months of treatment, the skeletal problems have been corrected (ANB -1°), overjet, overbite and aesthetic were improved. Reverse twin block appliance with expansion screw can be used as orthopedics treatment for skeletal Class III malocclusion in growing patient and can improve the aesthetic with great satisfaction which was the main complaint in this patient.

Keywords: maxilla retrognatism, reverse twin block, skeletal class III malocclusion, growing patient

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Authors: Anisa Suraya Ab Razak, Izza Hayat

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Introduction: The diagnosis and management of severe hyponatremia in neuropsychiatric patients present a significant challenge to physicians. Several factors contribute, including diagnostic shadowing and attributing abnormal behavior to intellectual disability or psychiatric conditions. Hyponatraemia is the commonest electrolyte abnormality in the inpatient population, ranging from mild/asymptomatic, moderate to severe levels with life-threatening symptoms such as seizures, coma and death. There are several documented fatal case reports in the literature of severe hyponatremia secondary to psychogenic polydipsia, often diagnosed only in autopsy. This paper presents a case study of acute severe hyponatremia in a neuropsychiatric patient with early diagnosis and admission to intensive care. Case study: A 21-year old Caucasian male with known epilepsy and learning disability was admitted from residential living with generalized tonic-clonic self-terminating seizures after refusing medications for several weeks. Evidence of superficial head injury was detected on physical examination. His laboratory data demonstrated mild hyponatremia (125 mmol/L). Computed tomography imaging of his brain demonstrated no acute bleed or space-occupying lesion. He exhibited abnormal behavior - restlessness, drinking water from bathroom taps, inability to engage, paranoia, and hypersexuality. No collateral history was available to establish his baseline behavior. He was loaded with intravenous sodium valproate and leveritircaetam. Three hours later, he developed vomiting and a generalized tonic-clonic seizure lasting forty seconds. He remained drowsy for several hours and regained minimal recovery of consciousness. A repeat set of blood tests demonstrated profound hyponatremia (117 mmol/L). Outcomes: He was referred to intensive care for peripheral intravenous infusion of 2.7% sodium chloride solution with two-hourly laboratory monitoring of sodium concentration. Laboratory monitoring identified dangerously rapid correction of serum sodium concentration, and hypertonic saline was switched to a 5% dextrose solution to reduce the risk of acute large-volume fluid shifts from the cerebral intracellular compartment to the extracellular compartment. He underwent urethral catheterization and produced 8 liters of urine over 24 hours. Serum sodium concentration remained stable after 24 hours of correction fluids. His GCS recovered to baseline after 48 hours with improvement in behavior -he engaged with healthcare professionals, understood the importance of taking medications, admitted to illicit drug use and drinking massive amounts of water. He was transferred from high-dependency care to ward level and was initiated on multiple trials of anti-epileptics before achieving seizure-free days two weeks after resolution of acute hyponatremia. Conclusion: Psychogenic polydipsia is often found in young patients with intellectual disability or psychiatric disorders. Patients drink large volumes of water daily ranging from ten to forty liters, resulting in acute severe hyponatremia with mortality rates as high as 20%. Poor outcomes are due to challenges faced by physicians in making an early diagnosis and treating acute hyponatremia safely. A low index of suspicion of water intoxication is required in this population, including patients with known epilepsy. Monitoring urine output proved to be clinically effective in aiding diagnosis. Early referral and admission to intensive care should be considered for safe correction of sodium concentration while minimizing risk of fatal complications e.g. central pontine myelinolysis.

Keywords: epilepsy, psychogenic polydipsia, seizure, severe hyponatremia

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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: Huei Jiun Chen, Hui Mei Huan

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Introduction: Pain is an unpleasant experience for hospitalized patients that impacts both their physical and mental well-being. It is important to select appropriate pain assessment tools to ensure effective pain management. Therefore, it is suggested to use Verbal Rating Scale (VRS) instead for better assessment. The Wong-Baker FACES Pain Rating Scale(WBS) is a widely used pain assessment tool in Taiwan to help individuals communicate the intensity of their pain. However, in clinical practice, even when using various assessment tools to evaluate pain, Numeric Rating Scale-11 (NRS-11) is still commonly utilized to quantify the intensity of pain. The correlation between NRS and other pain assessment tools has not been extensively explored in Taiwan. Additionally, the influence of gender and education level on pain assessment among elderly individuals has not been extensively studied in Taiwan. The aim of this study is to investigate the correlation between pain assessment scales (NRS-11, VRS, WBS) in assessing pain intensity among elderly inpatients. The secondary objective of this study is to examine how gender and education level influence pain assessment among individuals, as well as to explore their preferences regarding pain assessment tools. Method: In this study, a questionnaire survey and purposive sampling were employed to recruit participants from a medical center located in central Taiwan. Participants were requested to assess their pain intensity in the past 24 hours using NRS-11, VRS, and WBS. Additionally, the study investigated their preferences for pain assessment tools. Result: A total of 252 participants were included in this study, with a mean age of 71.1 years (SD=6.2). Of these participants, 135 were male (53.6%), and 44.4% had a primary level or below education. Participants were asked to use NRS-11, VRS, and WBS to assess their current, maximum, and minimum pain intensity experienced in the past 24 hours. The findings indicated a significant correlation (p< .01) among all three pain assessment tools. No significant differences were observed in gender across the three pain assessment scales. For severe pain, there were significant differences in self-rated pain scales among the elderly participants with different education levels (F=3.08, p< .01; X²=17.25, X²=17.21, p< .01), but there were no significant differences observed for mild pain. Regarding preferences for pain assessment tools, 158 participants (62.7%) favored VRS, followed by WBS; gender and education level had no influence on their preferences. Conclusion: Most elderly participants prefer using VRS (Verbal Rating Scale) to self-reported their pain. The reason for this preference may be attributed to the verbal nature of VRS, as it is simple and easy to understand. Furthermore, it could be associated with the level of education among the elderly participants. The pain assessment using VRS demonstrated a significant correlation with NRS-11 and WBS, and gender was not found to have any influence on these assessment. Further research is needed to explore the effect of different education levels on self-reported pain intensity among elderly people in Taiwan.

Keywords: pain assessment, elderly, gender, education

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Authors: Deepa Vasudevan, Thomas Northrup, Angela Stotts, Michelle Klawans

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To date, we have conducted three studies on this subject. The research done to date is through three studies. The initial study was to document that modified criteria independently identified higher numbers of overweight/obese South Asian Indians. The second study was to document physician knowledge of appropriate diagnosis of obesity among South Asian Indians. The final study was an intervention to evaluate the efficacy of a training module on improving physician diagnosis and counseling of overweight/obese Asian patients.

Keywords: South Asian Indians, obesity, physicians, BMI and waist circumference

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Authors: Svetlana Ignatjeva, Jelena Slesareva

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The aim of the study is development and adaptation of the method to analyze and quantify the indicators characterizing the relationship between a company and its employees. Diagnostics of such indicators is one of the most complex and actual issues in psychology of labour. The offered method is based on the questionnaire; its indicators reflect cognitive, affective and connotative components of socio-psychological attitude of employees to be as efficient as possible in their professional activities. This approach allows measure not only the selected factors but also such parameters as cognitive and behavioural dissonances. Adaptation of the questionnaire includes factor structure analysis and suitability analysis of phenomena indicators measured in terms of internal consistency of individual factors. Structural validity of the questionnaire was tested by exploratory factor analysis. Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Factor analysis allows reduce dimension of the phenomena moving from the indicators to aggregative indexes and latent variables. Aggregative indexes are obtained as the sum of relevant indicators followed by standardization. The coefficient Cronbach's Alpha was used to assess the reliability-consistency of the questionnaire items. The two-step cluster analysis in the space of allocated factors allows classify employees according to their attitude to work in the company. The results of psychometric testing indicate possibility of using the developed technique for the analysis of employees’ attitude towards their work in companies and development of recommendations on their optimization.

Keywords: involved in the organization, loyalty, organizations, method

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Authors: Elham Zabetian Targhi, Niusha Fardnava, Saba Saghafi

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Urban resilience to Corona Virus has become a major concern for cities these days. Our country also has not been safe from the destructive effects of this virus in social, economic, physical, governance, and management dimensions; and according to official statistics, hundreds of thousands of people in Iran have been infected with this virus and tens of thousands have died so far. Therefore, to measure urban resilience to this pandemic, some criteria and sub-criteria were developed based on the authors’ documentary and field studies, and their significance or weights were determined using analytical-comparative research method using a questionnaire of paired or L-Saati comparisons from the viewpoint of experts in urban sciences and urban development using AHP hierarchical analysis in EXPERT CHOICE software. Then, designing a questionnaire with a five-point Likert scale, the satisfaction of Tehran residents with the extracted criteria and sub-criteria was measured and the correlation between the important criteria in each dimension was assessed using correlation tests in SPSS16 software. According to the obtained results of AHP analysis and the scores of each sub-criterion, the weight of all criteria was normal. In the next stage, according to the pairwise correlation tests between the important criteria in each dimension from the viewpoint of urban science experts and Tehran residents, it was concluded that the reliability of the correlation between the criteria is 99%. In all the cases, the P-value or the same significance level was less than 0.05, which indicated the significance of the pairwise relations between the variables.

Keywords: Urban Resilience, Pandemics, Corona Virus (Covid-19), Criteria.

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Authors: Ila Gupta

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The government hospitals in India by and large lack the necessary aesthetic therapeutic components, both in their interior and exterior space designs. These components especially in terms of color application are important to the emotional as well as physical well being of the patients and other participants of the space. The preliminary survey of few government hospitals in Uttarakhand, India, reveals that the government health care industry provides a wide scope for intervention. All most all of the spaces do not adhere to a proper therapeutic color scheme which directly helps the well-being of their patients and workers. The paper aims to conduct a survey and come up with recommendations in this regard. The government hospitals also lack a proper signage system which allows the space to be more user-friendly. The hospital spaces in totality also have scope for improvement in terms of space/landscape design which enhances the work environment in an efficient and positive way. This study will thus enable to come up with feasible recommendations for healthcare and built environment as well as retrofitting the existing spaces. The objective of the paper is mainly on few case studies. The present ambience in many government hospitals generally lacks a welcoming ambience. It is proposed to select one or two government hospitals and demonstrate application of appropriate and self-sustainable color schemes, placement of artifacts, changes in outdoor and indoor space design to bring about a change that is conducive for cognitive healing. Exterior changes to existing and old hospital buildings in depressed historic areas signify financial investment and change, and have the potential to play a significant role in both urban preservation and revitalization. Changes to exterior architectural colors are perhaps the most visible signifier of such revitalization, as the use of color changes as a tool in façade and interior improvement programs. The present project will provide its recommendations on the basis of case studies done in the Indian Public Health Care system. Furthermore, the recommendations will be in accordance with the extended study conducted in Indian Ayurvedic, Yogic texts as well as Vastu texts, which provides knowledge about built environments and healing properties of color.

Keywords: color, environment, facade, architectural color history, interior improvement programs, community development, district/government hospitals

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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: Amirreza Razzaghipour Sorkhab

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One of the most common disorders among humans is hearing impairment. This paper provides an evidence base that recovers understanding of Meniere’s disease and highlights the physical and mental health correlates of the disorder. Meniere's disease is more common in the elderly. The term idiopathic endolymphatic hydrops has been attributed to this disease by some in the previous. Meniere’s disease demonstrations a genetic tendency, and a family history is found in 10% of cases, with an autosomal dominant inheritance pattern. The COCH gene may be one of the hereditary factors contributing to Meniere’s disease, and the possibility of a COCH mutation should be considered in patients with Meniere’s disease symptoms. Should be considered Missense mutations in the COCH gene cause the autosomal dominant sensorineural hearing loss and vestibular disorder. Meniere’s disease is a complex, heterogeneous disorder of the inner ear and that is characterized by episodes of vertigo lasting from minutes to hours, fluctuating sensorineural hearing loss, tinnitus, and aural fullness. The existing evidence supports the suggestion that age and sleep disorder are risk factors for Meniere's disease. Many factors have been reported to precipitate the progress of Menier, including endolymphatic hydrops, immunology, viral infection, inheritance, vestibular migraine, and altered intra-labyrinthine fluid dynamics. Although there is currently no treatment that has a proven helpful effect on hearing levels or on the long-term evolution of the disease, however, in the primary stages, the hearing may improve among attacks, but a permanent hearing loss occurs in the majority of cases. Current publications have proposed a role for the intratympanic use of medicine, mostly aminoglycosides, for the control of vertigo. more than 85% of patients with Meniere's disease are helped by either changes in lifestyle and medical treatment or minimally aggressive surgical procedures such as intratympanic steroid therapy, intratympanic gentamicin therapy, and endolymphatic sac surgery. However, unilateral vestibular extirpation methods (intratympanic gentamicin, vestibular nerve section, or labyrinthectomy) are more predictable but invasive approaches to control the vertigo attacks. Medical therapy aimed at reducing endolymph volume, such as low-sodium diet, diuretic use, is the typical initial treatment.

Keywords: meniere's disease, endolymphatic hydrops, hearing loss, vertigo, tinnitus, COCH gene

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Authors: Chengcao Sun, Shujun Li, Dejia Li

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Sulforaphane (SFN) possesses powerful chemo-preventive effects and plays a crucial role on oxidative stress and inflammatory. In our recent study, SFN treatment could relieve muscular dystrophy in mdx mice by activating Nrf2 (NF-E2 related factor 2). Moreover, our findings indicated that SFN-activated Nrf2 alleviated muscle inflammation in dystrophin-deficient mdx mice through suppressing NF-κB signaling pathway. Collectively, SFN-induced Nrf2 molecular pathway might be a promising approach for treatment of the patients with Duchenne muscular dystrophy.

Keywords: sulforaphane, Duchenne muscular dystrophy, Nrf2, inflammation, fibrosis, oxidative stress

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Authors: Y. T. Gee, I. N. Umar

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Students’ achievement and motivation in learning English in Malaysia is a worrying trend as it is lagging behind several other countries in Asia. Thus, necessary actions have to be taken by the parties concerned to overcome this problem. The purpose of this research was to study the effects of drill and practice courseware on students’ achievement and motivation in learning English language. A multimedia courseware was developed for this purpose. The independent variable was the drill and practice courseware while the dependent variables were the students’ achievement and motivation. Their achievement was measured using pre-test and post-test scores, while motivation was measured using a questionnaire adapted from Keller’s (1979) Instructional Materials Motivation Scale. A total of 60 students from three vernacular primary schools in a northern state in Malaysia were randomly selected in this study. The findings indicate: (1) a significant difference between the students’ pre-test and post-test scores after using the courseware, (2) no significant difference in the achievement score between male and female students after using the courseware, (3) a significant difference in motivation score between the female and the male students, and (4) while the female students scored significantly higher than the male students in the aspects of relevance, confidence and satisfaction, no significant difference in terms of attention was observed between them. Overall, the findings clearly indicate that although the female students are significantly more motivated than their male students, they are equally good in terms of achievement after learning from the courseware. Through this study, the drill and practice courseware is proven to influence the students’ learning and motivation.

Keywords: courseware, drill and practice, English learning, motivation

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Authors: Edo Shonin, William Van Gordon, Mark D. Griffiths

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Due to its potential to concurrently improve Work-Related Wellbeing (WRW) and job performance; occupational stakeholders are becoming increasingly interested in meditation. Despite this, there is a scarcity of methodologically robust research examining the utility of meditation within occupational contexts. This study conducted the first randomized controlled trial to assess the effects of meditation on outcomes relating to both WRW and job performance. Office-based middle-hierarchy managers (n=152) were allocated to either an eight-week meditation intervention (Meditation Awareness Training: MAT) or an active control intervention. MAT participants demonstrated significant improvements (with strong effect-sizes) over control-group participants in levels of work-related stress, job satisfaction, psychological distress, and employer-rated job performance. It is concluded that MAT appears to be effective for improving both WRW and job performance in middle-hierarchy managers. There are a number of novel implications: (i) meditation can effectuate a perceptual shift in how employees experience their work and psychological environment and may thus constitute a cost-effective WRW intervention, (ii) meditation-based (i.e., present-moment-focused) working styles may be more effective than goal-based (i.e., future-orientated) working styles, and (iii) meditation may reduce the separation made by employees between their own interests and those of the organizations they work for.

Keywords: work-related stress, workplace wellbeing, occupational stress, job performance, meditation awareness training, mindfulness

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Authors: Bharat Rawat, Shekhar Rajbhandari, Yadav Bhatta, Jay Prakash Jaiswal, Shivaji Bikram Silwal, Rajiv Shrestha, Shova Sunuwar

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Introduction: The honey produced by the bees fed on Rhobdodendron species containing grayanotoxin is known as mad honey. Grayanotoxin is found in honey obtained from the nectar of Rhododendron species growing on the mountains of the Black Sea region of Turkey and also in Japan, Nepal, Brazil, parts of North America, and Europe. Although the incidence of grayanotoxin poisoning is rare, there is concern that the number of cases per year will rise with the increasing demand for organic products. Mad honey intoxication might present with mild symptoms of cardiovascular, gastrointestinal and neurological systems or might also present with a life-threatening form with AV block and cardiovascular collapse. In this article, we describe the summary of five cases, which came to our hospital with mad honey related cardiac complications. Findings: In last one year, five cases presented in the emergency department with sudden onset of Loss of consciousness, dizziness, shortness of breath. They felt difficulty after the consumption of 1-3 teaspoonful of wild honey. The honey was brought from most of the rural parts of Nepal like khotang. Some of them also came with vomiting, dizziness, and loose stool. On examination, most of them had severe bradycardia and low blood pressure. No abnormalities were detected on systemic examinations. In one patient, ECG and cardiac enzymes showed features of the acute coronary syndrome, but his treadmill test done few days later was normal. All patients were managed with inj. Atropine, I/V normal saline, and other supportive measures and discharged in a stable condition within one or two days. Conclusions: Rhododendrons is the national flower of Nepal. The specific species of rhododendron found in Nepal which contains the toxin is not known. Bees feeding on these rhododendrons are known to transfer the grayanotoxin to the honey they produce. Most symptoms are mild and resolve themselves without medical intervention. Signs and symptoms of grayanotoxin poisoning rarely last more than 24 hours and are usually not fatal. Some signs of mad honey poisoning include Bradycardia, Cardiac arrhythmia, Hypotension, Nausea and Vomiting. They respond to close monitoring and appropriate supportive treatment. Normally, patients recover completely with no residual damage to the heart or its conduction system.

Keywords: rhobdodendron, honey, grayanotoxin, bradycardia

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Authors: Marjan Kamyabi

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Attending tourism in the current century is one of the key factors in the success of the tourism industry and, consequently, the prosperity of the economies of the countries. In this regard, accessible tourism can play a major role in the development of tourism, taking into account the attractions, facilities and capabilities of the development of tourism in Northern Cyprus, and given that the satisfaction of tourists from the product and destination of tourism has an undeniable role in attracting tourists. The purpose of this study is to investigate the environmental barriers and accessibility of the tourism industry in Northern Cyprus. Another goal of this study is to introduce this consumer group to the tourism community. In order to achieve the objectives of this paper, a questionnaire was designed and provided to three tourism professionals to assess the reliability, and then, among the 200 people with physical and mental disabilities who travelled to Cyprus, The data analysis was used as a confirmatory factor analysis method. The environmental barrier for tourists with disabilities is classified in three sections of transport, attractions and accommodation, each section being separately identified separately. In general, observance of the principles and standards of proper fitting in the main sectors of the tourism industry of Northern Cyprus in the situation The facilities and transportation were identified as the first problem and obstacle for the development of tourism for people with physical and mental disabilities and, finally, suggestions and solutions for the development of tourism for people with physical and physical disabilities were presented.

Keywords: accessible tourism, environmental barriers, tourism, people with disability, accessibility

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Authors: C. Lalitha, R. Sayee, D. Apoorva

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Reproductive failure or infertility may be due to several factors that are not limited to one sex. It remains a common problem causing significant psychological distress to those affected individuals and who are increasingly seeking medical advice. Male infertility means inability to induce conception in normal woman within a year. The etiological factors associated with male infertility are anatomical, developmental, seminal, hormonal, immunological and environmental factors. The paper was aimed to highlight the environmental factors and its association to male infertility and seasonality of birth and its influence. The data was collected from the 75 male patients referred with infertility for karyotyping and counseling. Their age ranged from 21 to 45 years. It is opined that certain occupations are preferentially associated with male infertility.

Keywords: environmental, occupational, seasonal, male infertility

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Authors: Abdulaziz Alakeel, Abdulrahman Alomair, Mohammed Fouda

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Introduction: Methotrexate (MTX) is an antimetabolite used to treat multiple conditions, including neoplastic diseases, severe psoriasis, and rheumatoid arthritis. Skin cancer is the out-of-control growth of abnormal cells in the epidermis, the outermost skin layer, caused by unrepaired DNA damage that triggers mutations. These mutations lead the skin cells to multiply rapidly and form malignant tumors. The aim of this review is to evaluate the risk of skin cancer associated with the use of methotrexate and to suggest regulatory recommendations if required. Methodology: Signal Detection team at Saudi Food and Drug Authority (SFDA) performed a safety review using National Pharmacovigilance Center (NPC) database as well as the World Health Organization (WHO) VigiBase, alongside with literature screening to retrieve related information for assessing the causality between skin cancer and methotrexate. The search conducted in July 2020. Results: Four published articles support the association seen while searching in literature, a recent randomized control trial published in 2020 revealed a statistically significant increase in skin cancer among MTX users. Another study mentioned methotrexate increases the risk of non-melanoma skin cancer when used in combination with immunosuppressant and biologic agents. In addition, the incidence of melanoma for methotrexate users was 3-fold more than the general population in a cohort study of rheumatoid arthritis patients. The last article estimated the risk of cutaneous malignant melanoma (CMM) in a cohort study shows a statistically significant risk increase for CMM was observed in MTX exposed patients. The WHO database (VigiBase) searched for individual case safety reports (ICSRs) reported for “Skin Cancer” and 'Methotrexate' use, which yielded 121 ICSRs. The initial review revealed that 106 cases are insufficiently documented for proper medical assessment. However, the remaining fifteen cases have extensively evaluated by applying the WHO criteria of causality assessment. As a result, 30 percent of the cases showed that MTX could possibly cause skin cancer; five cases provide unlikely association and five un-assessable cases due to lack of information. The Saudi NPC database searched to retrieve any reported cases for the combined terms methotrexate/skin cancer; however, no local cases reported up to date. The data mining of the observed and the expected reporting rate for drug/adverse drug reaction pair is estimated using information component (IC), a tool developed by the WHO Uppsala Monitoring Centre to measure the reporting ratio. Positive IC reflects higher statistical association, while negative values translated as a less statistical association, considering the null value equal to zero. Results showed that a combination of 'Methotrexate' and 'Skin cancer' observed more than expected when compared to other medications in the WHO database (IC value is 1.2). Conclusion: The weighted cumulative pieces of evidence identified from global cases, data mining, and published literature are sufficient to support a causal association between the risk of skin cancer and methotrexate. Therefore, health care professionals should be aware of this possible risk and may consider monitoring any signs or symptoms of skin cancer in patients treated with methotrexate.

Keywords: methotrexate, skin cancer, signal detection, pharmacovigilance

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Authors: Firdaous Zair, Zoubir Elfelsoufi, Mohammed Fourka

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The allocation of resources is an issue that is needed on the tactical and operational strategic plan. This work considers the allocation of resources in the case of pure players, manufacturers and Click & Mortars that have launched online sales. The aim is to improve the level of customer satisfaction and maintaining the benefits of e-retailer and of its cooperators and reducing costs and risks. Our contribution is a decision support system and tool for improving the allocation of resources in logistics chains e-commerce B2C context. We first modeled the B2C chain with all operations that integrates and possible scenarios since online retailers offer a wide selection of personalized service. The personalized services that online shopping companies offer to the clients can be embodied in many aspects, such as the customizations of payment, the distribution methods, and after-sales service choices. In addition, every aspect of customized service has several modes. At that time, we analyzed the optimization problems of supply chain resource allocation in customized online shopping service mode, which is different from the supply chain resource allocation under traditional manufacturing or service circumstances. Then we realized an optimization model and algorithm for the development based on the analysis of the allocation of the B2C supply chain resources. It is a multi-objective optimization that considers the collaboration of resources in operations, time and costs but also the risks and the quality of services as well as dynamic and uncertain characters related to the request.

Keywords: e-commerce, supply chain, B2C, optimisation, resource allocation

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Authors: Johnson C. Y. Pang, Bo Peng, Kara K. L. Reeves, Allan C. L. Fud

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Objective: Dry needling (DN) has long been used as a treatment method for various musculoskeletal pain conditions. However, the evidence level of the studies was low due to the limitations of the methodology. Lack of randomization and inappropriate blinding is potentially the main sources of bias. A method that can differentiate clinical results due to the targeted experimental procedure from its placebo effect is needed to enhance the validity of the trial. Therefore, this study aimed to validate the method as a placebo ultrasound(US)-guided DN for patients with knee osteoarthritis (KOA). Design: This is a randomized controlled trial (RCT). Ninety subjects (25 males and 65 females) aged between 51 and 80 (61.26 ± 5.57) with radiological KOA were recruited and randomly assigned into three groups with a computer program. Group 1 (G1) received real US-guided DN, Group 2 (G2) received placebo US-guided DN, and Group 3 (G3) was the control group. Both G1 and G2 subjects received the same procedure of US-guided DN, except the US monitor was turned off in G2, blinding the G2 subjects to the incorporation of faux US guidance. This arrangement created the placebo effect intended to permit comparison of their results to those who received actual US-guided DN. Outcome measures, including the visual analog scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) subscales of pain, symptoms, and quality of life (QOL), were analyzed by repeated measures analysis of covariance (ANCOVA) for time effects and group effects. The data regarding the perception of receiving real US-guided DN or placebo US-guided DN were analyzed by the chi-squared test. The missing data were analyzed with the intention-to-treat (ITT) approach if more than 5% of the data were missing. Results: The placebo US-guided DN (G2) subjects had the same perceptions as the use of real US guidance in the advancement of DN (p<0.128). G1 had significantly higher pain reduction (VAS and KOOS-pain) than G2 and G3 at 8 weeks (both p<0.05) only. There was no significant difference between G2 and G3 at 8 weeks (both p>0.05). Conclusion: The method with the US monitor turned off during the application of DN is credible for blinding the participants and allowing researchers to incorporate faux US guidance. The validated placebo US-guided DN technique can aid in investigations of the effects of US-guided DN with short-term effects of pain reduction for patients with KOA. Acknowledgment: This work was supported by the Caritas Institute of Higher Education [grant number IDG200101].

Keywords: ultrasound-guided dry needling, dry needling, knee osteoarthritis, physiotheraphy

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Authors: Tiago Sigal Linhares, Ana Amélia Nascimento da Silva Bones, Juliana Miola, McArthur Alexander Barrow, Airton Tetelbom Stein

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Introduction: As a result of increased globalization and changing migration trends, it is expected that a significant portion of People Living with HIV/AIDS (PLWHA) will change their place of residence over time. In order to provide better health care, monitor the HIV epidemic and plan urban public health care and policies, there is a growing need to formulate a strategy for monitoring PLWHA care, location and migration patterns. The Porto Alegre District is characterized by a high prevalence of PLWHA and is considered one of the epicenters of HIV epidemic in Latin America. Objectives: The aim of this study is to create a digital and easily editable map in order to create a visual representation of the location of PLWHA and to monitor their migration within the city and the country in an effort to promote longitudinal care. Methods: This Experience Report used Google Maps Map Creator to generate an active digital map showing the location and changes in residence of 165 PLWHA who received care at two Primary Health Care (PHC) clinics, which attended an estimated population of five thousand patients, in downtown Porto Alegre over the last four years. Their current addresses were discovered in the unified Brazilian health care system digital records (e-SUS) and updated on the map. Results: A digital map with PLWHA current residence location was created. It was possible to demonstrate visually areas with a large concentration of PLWHA and the migration of the population within the city as wells as other cities, regions and states. Conclusions: An easily reproducible and free map could aid in PLWHA monitoring, urban public health planning, target interventions and situational diagnosis. Moreover, a visual representation of PLWHA location and migration could help bring more attention and investments to areas with geographic inequities or higher prevalence of PLWHA. It also enables notification of local PHC units of monitored patients inside their area, which are in clinical risk or with treatment abandonment through active case findings, improving the care of PLWHA.

Keywords: health care, medical public health, theoretical and conceptual innovations, urban public health

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Authors: Ramanjaneyulu Mogili, G.V.R.K. Acharyulu

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Indian organized retail sector is growing at a faster pace and gaining popularity. Indian Brand Equity Foundation (IBEF) reveals that the current market size of Indian retail industry is about US$ 520 billion with for growth rate 14 to 15 percent annually by 2018 the Indian retail sector is likely to grow at a CAGR of 13% to reach a size of US$ 950 billion. Developments in Information Technology have enabled online Retail sector that empowers customers to order products, conduct transactions without the need to interact physically with the retailers. In recent years, the online shopping industry has gained popularity to the point where certain categories of customers would consider buying electronic products online rather than visiting the stores. Conventionally the physical location of a store is seen as a source of competitive advantage. Online Retailing service sites provide virtual shopping space to the customers. Online Retail services are gaining momentum in India, with internet penetration improving in the country and smartphones becoming affordable along with changing lifestyles and preferences of customers. Although online shoppers prefer the convenience and choice available in online shopping, certain issues raised due to the occurrence of service failure. The proposed study attempts to measure the service recovery and failure process of electronic goods in Indian retail channels.

Keywords: service recovery, customer satisfaction, e-shopping, service failure

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Authors: Mamidi Ramakrishna Rao, Jagdish Mamidi

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With advancing technology, the market environment for wind power generation systems has become highly competitive. The industry has been moving towards higher wind generator power ratings, in particular, off-shore generator ratings. Current off-shore wind turbine generators are in the power range of 10 to 12 MW. Unlike traditional induction motors, slow-speed permanent magnet surface mounted (PMSM) high-power generators are relatively challenging and designed differently. In this paper, PMSM generator design features have been discussed and analysed. The focus attention is on armature windings, harmonics, and permanent magnet. For the power ratings under consideration, the generator air-gap diameters are in the range of 8 to 10 meters, and active material weigh ~60 tons and above. Therefore, material weight becomes one of the critical parameters. Particle Swarm Optimization (PSO) technique is used for weight reduction and performance improvement. Four independent variables have been considered, which are air gap diameter, stack length, magnet thickness, and winding current density. To account for core and teeth saturation, preventing demagnetization effects due to short circuit armature currents, and maintaining minimum efficiency, suitable penalty functions have been applied. To check for performance satisfaction, a detailed analysis and 2D flux plotting are done for the optimized design.

Keywords: offshore wind generator, PMSM, PSO optimization, design optimization

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Authors: Supriadi Hardianto, Aditya Daniswara

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Today's workplace, flooded by millennial Generation or known also as Generation Y. A common problem that faced by the company towards Gen Y is a high turnover rate, attitudes problem, communication style, and different work style than the older generation. This is common in private sector. The objective of this study is to get a better understanding of the Gen Y Career Attitude at the workplace. The subject of this study is focusing on 430 respondent of Gen Y which age between 20 – 35 years old who works for a private company. The Questionnaire as primary data source captured 9 aspects of career attitude based on Career Attitudes Strategy Inventory (CASI). This Survey distributes randomly among Gen Y in the IT Industry (125 Respondent) and Manufacture Company (305 Respondent). A Random deep interview was conducted to get the better understanding of the etiology of their primary obstacles. The study showed that most of Indonesia Gen Y have a moderate score on Job satisfaction but in the other aspects, Gen Y has the lowest score on Skill Development, Career Worries, Risk-Taking Style, Dominant Style, Work Involvement, Geographical Barrier, Interpersonal Abuse, and Family Commitment. The top 5 obstacles outside that 9 aspects that faced by Gen Y are 1. Lower communication & networking support; 2. Self-confidence issues; 3. Financial Problem; 4. Emotional issues; 5. Age. We also found that parent perspective toward the way they are nurturing their child are not aligned with their child’s real life. This research fundamentally helps the organization and other Gen Y’s Stakeholders to have a better understanding of Gen Y Career Attitude at the workplace.

Keywords: career attitudes, CASI, Gen Y, career attitude at workplace

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Authors: S. El-Azzeh, A. Al-Aqqad, M. Salem, H. Al-Khaldi, S. Thaher

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Thermal comfort studies are very important during the early stages of the building’s design. If this study was ignored, problems will start to occur for the occupants in the future. In hot climates, where solar radiations are entering buildings all year long, occupant’s thermal comfort in office buildings needs to be examined. This study aims to investigate the thermal comfort at an existing office building at the Australian College of Kuwait and test its validity and improve occupant’s thermal satisfaction by covering windows with a heat rejection tint material that enables sunlight to pass through the office while reflecting solar heat outside. Environmental variables were measured using thermal comfort data logger INNOVA 1221 to find the predicted mean vote (PMV) in the selected location. Also, subjective variables were measured to find the actual mean vote (AMV) through surveys distributed among occupants in the selected case study office. All the variables collected were analyzed and classified according to international standards ISO 7730 and ASHRAE55. The results of this study showed improvement in both PMV and AMV. The mean value of PMV based on the original design was 0.691 which dropped to 0.32 after installation and it still at comfort zone. Also, the mean value of the AMV has improved for the first occupant, where before it was -0.46 and it became -1 which is cooler. For the other occupant, it was slightly warm with a mean value of 0.9 and it was improved and became cooler with a -0.25 mean value based on American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) seven-point scale.

Keywords: thermal comfort, office buildings, indoor environments, predicted mean vote

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Authors: Zbigniew Izdebski, Alicja Kozakiewicz, Maciej Białorudzki, Joanna Mazur

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Work is an extremely important part of everyone's life and affects functioning in daily life. Healthcare workers (HCW) are suffering from negative actions in and out of the workplace, such as harassment, abuse, long working hours, mental suffering, exhaustion, and professional burnout. Staff burnout is detrimental not only in terms of individual employees but also to working with patients and to the healthcare institution as a whole. The purpose of this study was to explore the level of professional burnout among HCW working in medical institutions during the COVID-19 pandemic in Poland. The extent to which selected sociodemographic factors and perceived stress increase the risk of professional burnout was assessed. In addition, the frequency of use of professional psychological help and less formal support groups by HCW in relation to the level of professional burnout was presented. The survey was conducted as part of a larger project on the humanization of medicine and clinical communication from February-April 2022. This study used a self-administered online survey (CAWI) technique and PAPI (pen and paper interview) technique. The BAT-12 scale was used to measure burnout, the PSS-4 scale was used to measure stress, and questions formulated by the research team were also used. For the purpose of analysis, the sample was limited to 2196 HCWs who worked on a daily basis with patients during the COVID-19 pandemic. Frequency distributions were analyzed, and multivariate logistic regression was performed. The mean scores (scores) of job burnout as measured by the BAT-12 scale ranged among the professional groups from 2.15(0.69) to 2.30 (0.69) and remained highest for the nurses' group. The groups differed significantly in levels of burnout (chi-sq=17.719; d.f.=8; p<0.023). In the final model, raised stress most likely increased the risk of burnout (OR=3.88; 95%CI <3.13-3.81>; p<0,001). Other significant predictors of burnout included: traumatic work-related experience (OR=1.91, p<0.001), mobbing (OR=1.83, p<0.001), and a higher workload than before the pandemic (OR=1.41, p=0.002). Only 7% of respondents decided to use various forms of psychological support during the pandemic. HCW experiences challenges in dealing with an unpredictable pandemic. Limited preparedness can lead to physical and psychological problems such as high-stress levels, anxiety, fear, helplessness, hopelessness, anger and stigma. The workload can lead to professional burnout, as well as threaten patient safety.

Keywords: burnout, work, healthcare, healthcare worker, stress

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Authors: Varsha Salian, Shama Rao, N. Narendra, B. Mohana Kumar

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Evolving evidence proposes the existence of a highly tumorigenic subpopulation of undifferentiated, self-renewing cancer stem cells, responsible for exhibiting resistance to conventional anti-cancer therapy, recurrence, metastasis and heterogeneous tumor formation. Importantly, the mechanisms exploited by cancer stem cells to resist chemotherapy are very less understood. Oral squamous cell carcinoma (OSCC) is one of the most regularly diagnosed cancer types in India and is associated commonly with alcohol and tobacco use. Therefore, the isolation and in vitro characterization of cancer stem-like cells from patients with OSCC is a critical step to advance the understanding of the chemoresistance processes and for designing therapeutic strategies. With this, the present study aimed to establish and characterize cancer stem-like cells in vitro from OSCC. The primary cultures of cancer stem-like cell lines were established from the tissue biopsies of patients with clinical evidence of an ulceroproliferative lesion and histopathological confirmation of OSCC. The viability of cells assessed by trypan blue exclusion assay showed more than 95% at passage 1 (P1), P2 and P3. Replication rate was performed by plating cells in 12-well plate and counting them at various time points of culture. Cells had a more marked proliferative activity and the average doubling time was less than 20 hrs. After being cultured for 10 to 14 days, cancer stem-like cells gradually aggregated and formed sphere-like bodies. More spheroid bodies were observed when cultured in DMEM/F-12 under low serum conditions. Interestingly, cells with higher proliferative activity had a tendency to form more sphere-like bodies. Expression of specific markers, including membrane proteins or cell enzymes, such as CD24, CD29, CD44, CD133, and aldehyde dehydrogenase 1 (ALDH1) is being explored for further characterization of cancer stem-like cells. To summarize the findings, the establishment of OSCC derived cancer stem-like cells may provide scope for better understanding the cause for recurrence and metastasis in oral epithelial malignancies. Particularly, identification and characterization studies on cancer stem-like cells in Indian population seem to be lacking thus provoking the need for such studies in a population where alcohol consumption and tobacco chewing are major risk habits.

Keywords: cancer stem-like cells, characterization, in vitro, oral squamous cell carcinoma

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Authors: Gia Sirbiladze

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Route planning problems are among the activities that have the highest impact on logistical planning, transportation, and distribution because of their effects on efficiency in resource management, service levels, and client satisfaction. In extreme conditions, the difficulty of vehicle movement between different customers causes the imprecision of time of movement and the uncertainty of the feasibility of movement. A feasibility level of vehicle movement on the closed route of the disaster-streaking zone is defined for the construction of an objective function. Experts’ evaluations of the uncertain parameters in q-rung ortho-pair fuzzy numbers (q-ROFNs) are presented. A fuzzy bi-objective combinatorial optimization problem of fuzzy vehicle routine problem (FVRP) is constructed based on the technique of possibility theory. The FVRP is reduced to the bi-criteria partitioning problem for the so-called “promising” routes which were selected from the all-admissible closed routes. The convenient selection of the “promising” routes allows us to solve the reduced problem in real-time computing. For the numerical solution of the bi-criteria partitioning problem, the -constraint approach is used. The main results' support software is designed. The constructed model is illustrated with a numerical example.

Keywords: q-rung ortho-pair fuzzy sets, facility location selection problem, multi-objective combinatorial optimization problem, partitioning problem

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Authors: Nattapong Techarattanased

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The purposes of this research are to make comparisons in respect of the behaviors on the use of the services of metered taxi classified by the demographic factor and to study the influence of the recognition on service quality having the effect on usage behaviors of metered taxi services of consumers in Bangkok Metropolitan Areas. The samples used in this research are 400 metered taxi service users in Bangkok Metropolitan Areas and use a questionnaire as the tool for collecting the data. Analysis statistics is mean and multiple regression analysis. Results of the research revealed that the consumers recognize the overall quality of services in each aspect include tangible aspects of the service, responses to customers, assurance on the confidence, understanding and knowing of customers which is rated at the moderate level except the aspect of the assurance on the confidence and trustworthiness which are rated at a high level. For the result of a hypothetical test, it is found that the quality in providing the services on the aspect of the assurance given to the customers has the effect on the usage behaviors of metered taxi services and the aspect of the frequency on the use of the services per month which in this connection. Such variable can forecast at one point nine percent (1.9%). In addition, quality in providing the services and the aspect of the responses to customers have the effect on the behaviors on the use of metered taxi services on the aspect of the expenses on the use of services per month which in this connection, such variable can forecast at two point one percent (2.1%).

Keywords: consumer behavior, metered taxi service, satisfaction, service quality

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Authors: Sakshi Chopra, Ashima Nehra, Sumit Sinha, Harsimarpreet Kaur, Ravindra Mohan Pandey

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Background: Cognitive rehabilitation aims to retrain brain injured individuals with cognitive deficits to restore or compensate lost functions. As illiterates or people with low literacy levels represent a significant proportion of the world, specific rehabilitation modules for such populations are indispensable. Literacy is significantly associated with all neuropsychological measures and retraining programs widely use written or spoken techniques which essentially require the patient to read or write. So, the aim of the study was to develop and standardize a literacy free neuropsychological rehabilitation program for improving cognitive functioning in patients with mild and moderate Traumatic Brain Injury (TBI). Several studies have pointed out to the impairments seen in memory, executive functioning, and attention and concentration post-TBI, so the rehabilitation program focussed on these domains. Visual item memorization, stick constructions, symbol cancellations, and colouring techniques were used to construct the retraining program. Methodology: The development of the program consisted of planning, preparing, analyzing, and revising the different modules. The construction focussed on areas of retraining immediate and delayed visual memory, planning ability, focused and divided attention, concentration, and response inhibition (to control irritability and aggression). A total of 98 home based retraining modules were prepared in the 4 domains (42 for memory, 42 for executive functioning, 7 for attention and concentration, and 7 for response inhibition). The standardization was done on 20 healthy controls to review, select and edit items. For each module, the time, errors made and errors per second were noted down, to establish the difficulty level of each module and were arranged in increasing level of difficulty over a period of 6 weeks. The retraining tasks were then administered on 11 brain injured individuals (5 after Mild TBI and 6 after Moderate TBI). These patients were referred from the Trauma Centre to Clinical Neuropsychology OPD, All India Institute of Medical Sciences, New Delhi, India. Results: The time was taken, errors made and errors per second were analysed for all domains. Education levels were divided into illiterates, up to 10 years, 10 years to graduation and graduation and above. Mean and standard deviations were calculated. Between group and within group analysis was done using the t-test. The performance of 20 healthy controls was analyzed and only a significant difference was observed on the time taken for the attention tasks and all other domains had non-significant differences in performance between different education levels. Comparing the errors, time taken between patient and control group, there was a significant difference in all the domains at the 0.01 level except the errors made on executive functioning, indicating that the tool can successfully differentiate between healthy controls and patient groups. Conclusions: Apart from the time taken for symbol cancellations, the entire cognitive rehabilitation program is literacy free. As it taps the major areas of impairment post-TBI, it could be a useful tool to rehabilitate the patient population with low literacy levels across the world. The next step is already underway to test its efficacy in improving cognitive functioning in a randomized clinical controlled trial.

Keywords: cognitive rehabilitation, illiterates, India, traumatic brain injury

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Authors: Umamaheswari Shanmugam, Silvia Ronchi, Radu Vornicu

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that are able to use the large amount and variety of data generated during healthcare services every day. As we read the news, over 500 machine learning or other artificial intelligence medical devices have now received FDA clearance or approval, the first ones even preceding the year 2000. One of the big advantages of these new technologies is the ability to get experience and knowledge from real-world use and to continuously improve their performance. Healthcare systems and institutions can have a great benefit because the use of advanced technologies improves the same time 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 also to protect patients’ safety. The evolution and the continuous improvement of software used in healthcare must take into consideration 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 approval, but they are necessary to ensure performance, quality, and safety, and at the same time, they can be a business opportunity if the manufacturer is able to define in advance the appropriate regulatory strategy. 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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