Search results for: cirrhotic patients

Authors: Alison Ryan, Himani Chhabra, Mohammed Dungarwalla, Judith Jones

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Background: Impacted and ectopic teeth present in 1-2% of orthodontic patients and often require joint surgical and orthodontic management. The authors present two patients undergoing orthodontic treatment, where the impacted teeth, in a hopeless position, spontaneously erupted during the period of cessation of general anaesthetic lists during the COVID-19 pandemic. Patient information: A healthy 11-year-old boy was referred to the Department of Oral and Maxillofacial Surgery for the management of a mesioangular impacted LR7. The patient was seen by the joint oral surgery/orthodontic team, who planned for the removal of the LR7 under general anaesthetic. A healthy 13-year-old boy was referred to the same Department and team for surgical extraction of unerupted and buccally impacted UL3 and UR3 under general anaesthetic. Management and outcome: The majority of elective dental-alveolar work ceased as a result of the global pandemic. On resumption of activity, the first patient was reviewed in July 2021. The LR7 had spontaneously erupted in a favourable position, and following MDT review, a decision was made to forgo any further surgical intervention. The second patient was reviewed in July 2021. The UL3 had clinically erupted, and there was radiographic evidence of favourable movement of UR3. Due to the nature of the patient’s malocclusion, the decision was made to proceed with the extractions as previously planned. Key Learning Points: Severely impacted teeth do have a prospect of spontaneous eruption or alignment without clinical intervention, and current literature states the initial location, axial inclination, degree of root formation, and relation of the impacted tooth to adjacent teeth roots may influence spontaneous eruption. There is potential to introduce a period of observation to account for this possibility in the developing dentition, with the aim of reducing the unnecessary need for surgical intervention. This could help prevent episodes of general anaesthetic and allocate theatre space more appropriately.

Keywords: spontaneous eruption, impaction, observation, hopeless position, surgical, orthodontic, change in treatment plan

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Authors: Leszek Szpakowski, Daniel Celiński, Sławomir Pilip, Grzegorz Michalak

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The aim of the study was to analyse the usefulness of the 'E-rescuer' pilot project planned to be implemented in a chosen area of Eastern Poland in the cases of suspected sudden cardiac arrests in the extra-urban areas. Inventing an application allowing to dispatch simultaneously both Medical Emergency Teams and the E-rescuer to the place of the accident is the crucial assumption of the mentioned pilot project. The E-rescuer is defined to be the trained person able to take effective basic life support and to use automated external defibrillator. Having logged in using a smartphone, the E-rescuer's readiness is reported online to provide cardiopulmonary resuscitation exactly at the given location. Due to the accurately defined location of the E-rescuer, his arrival time is possible to be precisely fixed, and the substantive support through the displayed algorithms is capable of being provided as well. Having analysed the medical records in the years 2015-2016, cardiopulmonary resuscitation was considered to be effective when an early indication of circulation was provided, and the patient was taken to hospital. In the mentioned term, there were 2.291 cases of a sudden cardiac arrest. Cardiopulmonary resuscitation was taken in 621 patients in total including 205 people in the urban area and 416 in the extra-urban areas. The effectiveness of cardiopulmonary resuscitation in the extra-urban areas was much lower (33,8%) than in the urban (50,7%). The average ambulance arrival time was respectively longer in the extra-urban areas, and it was 12,3 minutes while in the urban area 3,3 minutes. There was no significant difference in the average age of studied patients - 62,5 and 64,8 years old. However, the average ambulance arrival time was 7,6 minutes for effective resuscitations and 10,5 minutes for ineffective ones. Hence, the ambulance arrival time is a crucial factor influencing on the effectiveness of cardiopulmonary resuscitation, especially in the extra-urban areas where it is much longer than in the urban. The key role of trained E-rescuers being nearby taking basic life support before the ambulance arrival can effectively support Emergency Medical Services System in Poland.

Keywords: basic life support, bystander, effectiveness, resuscitation

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Authors: Irfan Abdulrahman Sheth, Sohil Pothiawala

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Dermatomyositis is an idiopathic inflammatory myopathy, traditionally characterized by a progressive, symmetrical proximal muscle weakness and pathognomonic or characteristic cutaneous manifestations. We report a case of a 60-year old Chinese female who was referred from polyclinic for allergic rash over the body after applying hair dye 3 weeks ago. It was associated with puffiness of face, shortness of breath and hoarse voice since last 2 weeks with decrease effort tolerance. She also complained of dysphagia/ myalgia with progressive weakness of proximal muscles and palpitations. She denied chest pain, loss of appetite, weight loss, orthopnea or fever. She had stable vital signs and appeared cushingoid. She was noted to have rash over the scalp/ face and ecchymosis over the right arm with puffiness of face and periorbital oedema. There was symmetrical muscle weakness and other neurological examination was normal. Initial impression was of allergic reaction and underlying nephrotic syndrome and Cushing’s syndrome from TCM use. Diagnostic tests showed high Creatinine kinase (CK) of 1463 u/l, CK–MB of 18.7 ug/l and Troponin –T of 0.09 ug/l. The Full blood count and renal panel was normal. EMG showed inflammatory myositis. Patient was managed by rheumatologist and discharged on oral prednisolone with methotrexate/ ergocalciferol capsule and calcium carb, vitamin D tablets and outpatient follow up. In some patients, cutaneous disease exists in the absence of objective evidence of muscle inflammation. Management of dermatomyositis begins with careful investigation for the presence of muscle disease or of additional systemic involvement, particularly of the pulmonary, cardiac or gastrointestinal systems, and for the possibility of an accompanying malignancy. Muscle disease and systemic involvement can be refractory and may require multiple sequential therapeutic interventions or, at times, combinations of therapies. Thus, we want to highlight to the physicians that the cutaneous disease of dermatomyositis should not be confused with allergic reaction. It can be particularly challenging to diagnose. Early recognition aids appropriate management of this group of patients.

Keywords: dermatomyositis, myopathy, allergy, cutaneous disease

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Authors: Benhamouda Amira Chaimae

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Osteonecrosis of the jaw (ONJ) is a rare but serious complication associated with the use of bone-modifying agents, such as Denosumab, commonly prescribed to treat osteoporosis and other bone-related conditions. This case report presents a detailed account of a patient who developed ONJ following treatment with Denosumab. The patient’s clinical presentation, diagnostic process, and management are discussed, highlighting the challenges of diagnosing and treating ONJ in individuals undergoing Denosumab therapy. The report examines the potential pathophysiological mechanisms linking Denosumab treatment to ONJ, including its effects on bone remodeling and the immune response.

Keywords: denosumab, bone loss, osteonecrosis, rankl

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Authors: Maria Vargas Hernandez, Jose Rojas Suarez, Carmelo Dueñas Castell, Sandra Contreras, Camilo Bello, Diana Borre, Walter Anichiarico, Harold Vasquez, Eduard Perez, Jose Santacruz

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In the last two decades, there have been outbreaks of emerging infectious diseases, with an impact on both the general population and the obstetric population. These infections, which affect the general population, pose a high risk for adverse maternal and perinatal outcomes, taking into account that physiological and immunological changes that occur during pregnancy can increase their risk or severity. Among these, the pandemics of viral infections, Influenza A/H1N1 and SARS-CoV-2/COVID-19, stand out. In 2009, Influenza A/H1N1 infection (H1N1 2009pdm) affected approximately 3,110 obstetric patients, with data reported from 29 countries, including 1,625 (52.3%) cases that were hospitalized, 378 (23.3%) admissions to ICU and 130 (8%) deaths; and since the end of 2019, the Severe Acute Respiratory Syndrome - 2 (SARS-CoV-2) has been identified, causing the COVID-19 pandemic, with global mortality that is around 2-4% for the general population, and higher mortality in patients requiring admission to the intensive care unit. Its impact on the obstetric population is still unknown. Objectives: To evaluate the impact on maternal and perinatal outcomes of COVID-19 infection in reference to influenza A/H1N1 infection in the obstetric population. Methodology: Systematic review of the literature and meta-analysis. Results: Mortality from maternal infection with influenza A/H1N1 appears to be higher (8%) than mortality due to maternal infection with COVID-19 (3%). The rates of ICU admission, hospitalization, the requirement for invasive mechanical ventilation, and fetal death also appear to be higher in the maternal population with A/H1N1 infection, in reference to the maternal population with COVID-19 infection. Within perinatal outcomes, the admission to the neonatal ICU appears to be higher in the infants born to mothers with COVID-19 infection (28% vs. 15% for COVID-19 and A/H1N1, respectively). Conclusion: A/H1N1 infection in the obstetric population seems to be associated with a higher proportion of adverse outcomes in relation to COVID-19 infection. The actual impact of maternal influenza A/H1N1 infection on perinatal outcomes is unknown. More COVID-19 studies are needed to understand the impact of maternal infection on perinatal outcomes in this population.

Keywords: A/H1N1, COVID-19, maternal outcomes, perinatal outcomes

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Authors: Benjamin Osei-Tutu, Henrietta Awewole Kolson

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Background: Acute gastroenteritis is one of the frequently reported Out-Patient Department (OPD) cases. However, the causative pathogens of these cases are rarely identified at the OPD due to delay in laboratory results or failure to obtain specimens before antibiotics is administered. Method: A retrospective review of surveillance data from the Adentan Municipality, Accra, Ghana that were recorded in the National foodborne disease surveillance system of Ghana, was conducted with the main aim of describing the epidemiology and food practice of cases reported from the Adentan Municipality. The study involved a retrospective review of surveillance data kept on patients who visited health facilities that are involved in foodborne disease surveillance in Ghana, from January 2015 to December 2016. Results: A total of 375 cases were reviewed and these were classified as viral hepatitis (hepatitis A and E), cholera (Vibrio cholerae), dysentery (Shigella sp.), typhoid fever (Salmonella sp.) or gastroenteritis. Cases recorded were all suspected case and the average cases recorded per week was 3. Typhoid fever and dysentery were the two main clinically diagnosed foodborne illnesses. The highest number of cases were observed during the late dry season (Feb to April), which marks the end of the dry season and the beginning of the rainy season. Relatively high number of cases was also observed during the late wet seasons (Jul to Oct) when the rainfall is the heaviest. Home-made food and street vended food were the major sources of suspected etiological food, recording 49.01% and 34.87% of the cases respectively. Conclusion: Majority of cases recorded were classified as gastroenteritis due to the absence of laboratory confirmation. Few cases were classified as typhoid fever and dysentery based on clinical symptoms presented. Patients reporting with foodborne diseases were found to consume home meal and street vended foods as their predominant source of food.

Keywords: accra, etiologic food, food poisoning, gastroenteritis, illness, surveillance

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Authors: Rachel Talbot, Nasuh Malas

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Stigma in child and adolescent psychiatry continues to be a significant barrier for youth to receive much needed psychiatric care. Parents misperceptions regarding mental health may interfere with their child’s care and negatively influence their child’s view of mental health. For some children, their first experience with psychiatry may occur during medical hospitalization when they are seen by the Psychiatry Consultation-Liaison (C/L) Service. Despite this unique role, there is limited data on how to address mental health stigma with patients and families within the context of Child and Adolescent C/L Psychiatry. This study explores the use of a brief introductory video with messages from the psychiatry C/L team, families who have accessed mental health consultation in the hospital, as well as clips of family and C/L team interactions to address parental stigma of psychiatry. Common stigmatized concerns shared by parents include concerns about confidentiality, later ramifications of mental healthcare, outsider status, and parental self-blame. There are also stigmatized concerns about psychiatric medication use including overmedication, sedation, long-term effects, medicating ‘real problems’ and personality blunting. Each of these are addressed during the video parents will see with the intent of reducing negative parental perceptions relating to mental healthcare. For this study, families are given a survey highlighting these concerns, prior to and after watching the video. Pre-and post-video responses are compared with the hypothesis that watching the video will effectively reduce parental stigma about psychiatric care. Data collection is currently underway and will be completed by the end of November 2017 with data analysis completed by January 2018. This study will also give vital information about the demographic differences in perceptions of stigma so future interventions can be targeted towards those with higher perceived stigma. This study posits that use of an introductory video is an effective strategy to combat stigma and help educate and empower families. In this way, we will be reducing further barriers for patients and families to seek out mental health resources and supports that are often desperately needed for these youths.

Keywords: child and adolescent psychiatry, consult-liaison psychiatry, media, stigma

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Authors: Mohamed Khalifa Zayet, Salma Belal Eiid, Mushira Mohamed Dahaba

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Introduction: Malignant tumors may not be easily detected by traditional radiographic techniques especially in an anatomically complex area like maxillofacial region. At the same time, the advent of biological functional MRI was a significant footstep in the diagnostic imaging field. Objective: The purpose of this study was to define the malignant metabolic profile of maxillofacial lesions using diffusion MRI and magnetic resonance spectroscopy, as adjunctive aids for diagnosing of such lesions. Subjects and Methods: Twenty-one patients with twenty-two lesions were enrolled in this study. Both morphological and functional MRI scans were performed, where T1, T2 weighted images, diffusion-weighted MRI with four apparent diffusion coefficient (ADC) maps were constructed for analysis, and magnetic resonance spectroscopy with qualitative and semi-quantitative analyses of choline and lactate peaks were applied. Then, all patients underwent incisional or excisional biopsies within two weeks from MR scans. Results: Statistical analysis revealed that not all the parameters had the same diagnostic performance, where lactate had the highest areas under the curve (AUC) of 0.9 and choline was the lowest with insignificant diagnostic value. The best cut-off value suggested for lactate was 0.125, where any lesion above this value is supposed to be malignant with 90 % sensitivity and 83.3 % specificity. Despite that ADC maps had comparable AUCs still, the statistical measure that had the final say was the interpretation of likelihood ratio. As expected, lactate again showed the best combination of positive and negative likelihood ratios, whereas for the maps, ADC map with 500 and 1000 b-values showed the best realistic combination of likelihood ratios, however, with lower sensitivity and specificity than lactate. Conclusion: Diffusion weighted imaging and magnetic resonance spectroscopy are state-of-art in the diagnostic arena and they manifested themselves as key players in the differentiation process of orofacial tumors. The complete biological profile of malignancy can be decoded as low ADC values, high choline and/or high lactate, whereas that of benign entities can be translated as high ADC values, low choline and no lactate.

Keywords: diffusion magnetic resonance imaging, magnetic resonance spectroscopy, malignant tumors, maxillofacial

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Authors: Eda Ozkara San

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Nurse educators have been charged by several nursing organizations and accrediting bodies to provide innovative and evidence-based educational experiences, both didactic and clinical, to help students to develop the knowledge, skills, and attitudes needed to provide culturally competent nursing care to patients. Clinical simulation, which offers the opportunity for students to practice nursing skills in a risk-free, controlled environment and helps develop self-efficacy (confidence) within the nursing role. As one simulation method, the standardized patients (SPs) simulation helps educators to teach nursing students variety of skills in nursing, medicine, and other health professions. It can be a helpful tool for nurse educators to enhance cultural competence of nursing students. An alarming gap exists within the literature concerning the effectiveness of SP strategy to enhance cultural competence development of diverse student groups, who must work with patients from various backgrounds. This grant-supported, longitudinal, one-group, pretest and post-test educational intervention study aimed to examine the effect of the Diverse Standardized Patient Simulation (DSPS) cultural competence education strategy on students’ (n = 53) transcultural self-efficacy (TSE). The researcher-developed multidimensional DSPS strategy involved careful integration of transcultural nursing skills guided by the Cultural Competence and Confidence (CCC) model. As a carefully orchestrated teaching and learning strategy by specifically utilizing the SP pedagogy, the DSPS also followed international guidelines and standards for the design, implementation, evaluation, and SP training; and had content validity review. The DSPS strategy involved two simulation scenarios targeting underrepresented patient populations (Muslim immigrant woman with limited English proficiency and Irish-Italian American gay man with his partner (Puerto Rican) to be utilized in a second-semester, nine-credit, 15-week medical-surgical nursing course at an urban public US university. Five doctorally prepared content experts reviewed the DSPS strategy for content validity. The item-level content validity index (I-CVI) score was calculated between .80-1.0 on the evaluation forms. Jeffreys’ Transcultural Self-Efficacy Tool (TSET) was administered as a pretest and post-test to assess students’ changes in cognitive, practical, and affective dimensions of TSE. Results gained from this study support that the DSPS cultural competence education strategy assisted students to develop cultural competence and caused statistically significant changes (increase) in students’ TSE perceptions. Results also supported that all students, regardless of their background, benefit (and require) well designed cultural competence education strategies. The multidimensional DSPS strategy is found to be an effective way to foster nursing students’ cultural competence development. Step-by-step description of the DSPS provides an easy adaptation of this strategy with different student populations and settings.

Keywords: cultural competence development, the cultural competence and confidence model, CCC model, educational intervention, transcultural self-efficacy, TSE, transcultural self-efficacy tool, TSET

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Authors: Achitphol Chookaew, Paramee Thongsukhsai, Patamarerk Engsontia, Narongwit Nakwan, Pritsana Raugrut

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Lung cancer is one of the most common malignancies and primary cause of death due to cancer worldwide. Non-small cell lung cancer (NSCLC) is the main subtype in which majority of patients present with advanced-stage disease. Herein, we analyzed differentially expressed genes to find potential biomarkers for lung cancer diagnosis as well as prognostic markers. We used transcriptome data from our 2 NSCLC patients and public data (GSE81089) composing of 8 NSCLC and 10 normal lung tissues. Differentially expressed genes (DEGs) between NSCLC and normal tissue and between early-stage and late-stage NSCLC were analyzed by the DESeq2. Pairwise correlation was used to find the DEGs with false discovery rate (FDR) adjusted p-value £ 0.05 and |log2 fold change| ³ 4 for NSCLC versus normal and FDR adjusted p-value £ 0.05 with |log2 fold change| ³ 2 for early versus late-stage NSCLC. Bioinformatic tools were used for functional and pathway analysis. Moreover, the top ten genes in each comparison group were verified the expression and survival analysis via GEPIA. We found 150 up-regulated and 45 down-regulated genes in NSCLC compared to normal tissues. Many immnunoglobulin-related genes e.g., IGHV4-4, IGHV5-10-1, IGHV4-31, IGHV4-61, and IGHV1-69D were significantly up-regulated. 22 genes were up-regulated, and five genes were down-regulated in late-stage compared to early-stage NSCLC. The top five DEGs genes were KRT6B, SPRR1A, KRT13, KRT6A and KRT5. Keratin 6B (KRT6B) was the most significantly increased gene in the late-stage NSCLC. From GEPIA analysis, we concluded that IGHV4-31 and IGKV1-9 might be used as diagnostic biomarkers, while KRT6B and KRT6A might be used as prognostic biomarkers. However, further clinical validation is needed.

Keywords: differentially expressed genes, early and late-stages, gene ontology, non-small cell lung cancer transcriptomics

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Authors: Panas Gerasimos, Kotidou Varvara, Halkiopoulos Constantinos, Gkintoni Evgenia

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As a result of growing technology and briefing by the internet, users resort to the internet and subsequently to the opinion of an expert. In many cases, they take control of their health in their hand and make a decision without the contribution of a doctor. According to that, this essay intends to analyze the confidence of searching health issues on the internet. For the fulfillment of this study, there has been a survey among doctors in order to find out the reasons a patient uses the internet about their health problems and the consequences that health information could lead by searching on the internet, as well. Specifically, the results regarding the research of the users demonstrate: a) the majority of users make use of the internet about health issues once or twice a month, b) individuals that possess chronic disease make health search on the internet more frequently, c) the most important topics that the majority of users usually search are pathological, dietary issues and the search of issues that are associated with doctors and hospitals. However, it observed that topic search varies depending on the users’ age, d) the most common sources of information concern the direct contact with doctors, as there is a huge preference from the majority of users over the use of the electronic form for their briefing and e) it has been observed that there is large lack of knowledge about e-health services. From the doctor's point of view, the following conclusions occur: a) almost all doctors use the internet as their main source of information, b) the internet has great influence over doctors’ relationship with the patients, c) in many cases a patient first makes a visit to the internet and then to the doctor, d) the internet significantly has a psychological impact on patients in order to for them to reach a decision, e) the most important reason users choose the internet instead of the health professional is economic, f) the negative consequence that emerges is inaccurate information, g) and the positive consequences are about the possibility of online contact with the doctor and contributes to the easy comprehension of the doctor, as well. Generally, it’s observed from both sides that the use of the internet in health issues is intense, which declares that the new means the doctors have at their disposal, produce the conditions for radical changes in the way of providing services and in the doctor-patient relationship.

Keywords: cognitive models, health marketing, e-health, psychological factors, digital marketing, e-health services

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Authors: G. Cunningham, E. Cantor, X. Wu, F. Shen, G. Jiang, S. Philips, C. Bales, Y. Xiao, T. R. Cummins, J. C. Fehrenbacher, B. P. Schneider

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Background: Taxane-induced peripheral neuropathy (TIPN) is the most devastating survivorship issue for patients receiving therapy. Dose reductions due to TIPN in the curative setting lead to inferior outcomes for African American patients, as prior research has shown that this group is more susceptible to developing severe neuropathy. The mechanistic underpinnings of TIPN, however, have not been entirely elucidated. While it would be appealing to use primary tissue to study the development of TIPN, procuring nerves from patients is not realistically feasible, as nerve biopsies are painful and may result in permanent damage. Therefore, our laboratory has investigated paclitaxel-induced neuronal morphological and molecular changes using an ex vivo model of human-induced pluripotent stem cell (iPSC)-derived neurons. Methods: iPSCs are undifferentiated and endlessly dividing cells that can be generated from a patient’s somatic cells, such as peripheral blood mononuclear cells (PBMCs). We successfully reprogrammed PBMCs into iPSCs using the Erythroid Progenitor Reprograming Kit (STEMCell Technologiesᵀᴹ); pluripotency was verified by flow cytometry analysis. iPSCs were then induced into neurons using a differentiation protocol that bypasses the neural progenitor stage and uses selected small-molecule modulators of key signaling pathways (SMAD, Notch, FGFR1 inhibition, and Wnt activation). Results: Flow cytometry analysis revealed expression of core pluripotency transcription factors Nanog, Oct3/4 and Sox2 in iPSCs overlaps with commercially purchased pluripotent cell line UCSD064i-20-2. Trilineage differentiation of iPSCs was confirmed with immunofluorescent imaging with germ-layer-specific markers; Sox17 and ExoA2 for ectoderm, Nestin, and Pax6 for mesoderm, and Ncam and Brachyury for endoderm. Sensory neuron markers, β-III tubulin, and Peripherin were applied to stain the cells for the maturity of iPSC-derived neurons. Patch-clamp electrophysiology and calcitonin gene-related peptide (CGRP) release data supported the functionality of the induced neurons and provided insight into the timing for which downstream assays could be performed (week 4 post-induction). We have also performed a cell viability assay and fluorescence-activated cell sorting (FACS) using four cell-surface markers (CD184, CD44, CD15, and CD24) to select a neuronal population. At least 70% of the cells were viable in the isolated neuron population. Conclusion: We have found that these iPSC-derived neurons recapitulate mature neuronal phenotypes and demonstrate functionality. Thus, this represents a patient-derived ex vivo neuronal model to investigate the molecular mechanisms of clinical TIPN.

Keywords: chemotherapy, iPSC-derived neurons, peripheral neuropathy, taxane, paclitaxel

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Authors: Duncan Wallace, M-Tahar Kechadi

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In recent years, Machine Learning (ML) approaches have been successfully applied to an analysis of patient symptom data in the context of disease diagnosis, at least where such data is well codified. However, much of the data present in Electronic Health Records (EHR) are unlikely to prove suitable for classic ML approaches. Furthermore, as scores of data are widely spread across both hospitals and individuals, a decentralized, computationally scalable methodology is a priority. The focus of this paper is to develop a method to predict outliers in an out-of-hours healthcare provision center (OOHC). In particular, our research is based upon the early identification of patients who have underlying conditions which will cause them to repeatedly require medical attention. OOHC act as an ad-hoc delivery of triage and treatment, where interactions occur without recourse to a full medical history of the patient in question. Medical histories, relating to patients contacting an OOHC, may reside in several distinct EHR systems in multiple hospitals or surgeries, which are unavailable to the OOHC in question. As such, although a local solution is optimal for this problem, it follows that the data under investigation is incomplete, heterogeneous, and comprised mostly of noisy textual notes compiled during routine OOHC activities. Through the use of Deep Learning methodologies, the aim of this paper is to provide the means to identify patient cases, upon initial contact, which are likely to relate to such outliers. To this end, we compare the performance of Long Short-Term Memory, Gated Recurrent Units, and combinations of both with Convolutional Neural Networks. A further aim of this paper is to elucidate the discovery of such outliers by examining the exact terms which provide a strong indication of positive and negative case entries. While free-text is the principal data extracted from EHRs for classification, EHRs also contain normalized features. Although the specific demographical features treated within our corpus are relatively limited in scope, we examine whether it is beneficial to include such features among the inputs to our neural network, or whether these features are more successfully exploited in conjunction with a different form of a classifier. In this section, we compare the performance of randomly generated regression trees and support vector machines and determine the extent to which our classification program can be improved upon by using either of these machine learning approaches in conjunction with the output of our Recurrent Neural Network application. The output of our neural network is also used to help determine the most significant lexemes present within the corpus for determining high-risk patients. By combining the confidence of our classification program in relation to lexemes within true positive and true negative cases, with an inverse document frequency of the lexemes related to these cases, we can determine what features act as the primary indicators of frequent-attender and non-frequent-attender cases, providing a human interpretable appreciation of how our program classifies cases.

Keywords: artificial neural networks, data-mining, machine learning, medical informatics

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Authors: Asif Khaliq, Sayeeda A. Sayed

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The drug information centers provide drug related information to the requesters that include physicians, pharmacist, nurses and other allied health care professionals. The International Pharmacist Federation (FIP) describes basic functions of a drug and poison information centers as drug evaluation, therapeutic counseling, pharmaceutical advice, research, pharmaco-vigilence and toxicology. Continuous advancement in the field of medicine has expanded the medical literature, which has increased demand of a drug and poison information center for the guidance, support and facilitation of physicians. The objective of the study is to determine the need of drug and poison information centers in public and private hospitals of Karachi, Pakistan. A cross sectional study was conducted during July 2013 to April 2014 using a self-administered, multi-itemed questionnaire. Non Probability Convenient sampling was used to select the study participants. A total of 307 physicians from public and private hospitals of Karachi participated in the study. The need for 24/7 Drug and poison information center was highlighted by 92 % of physicians and 67% physicians suggested opening a drug information center at the hospital. It was reported that 70% physicians take at least 15 minutes for searching the information about the drug while managing a case. Regarding the poisoning case management, 52% physicians complaint about the unavailability of medicines in hospitals; and mentioned the importance of medicines for safe and timely management of patients. Although 73% physicians attended continued medical education (CME) sessions, 92 % physicians insisted on the need of 24/7 Drug and poison information center. The scarcity of organized channel for obtaining the information about drug and poisons is one of the most crucial problems for healthcare workers in Pakistan. The drug and poison information center is an advisory body that assists health care professional and patients in provision of appropriate drug and hazardous substance information. Drug and poison information center is one of the integral needs for running an effective health care system. Provision of a 24 /7 drug information centers with specialized staff offer multiple benefits to the hospitals while reducing treatment delays, addressing awareness gaps of all stakeholders and ensuring provision of quality health care.

Keywords: drug and poison information centers, Pakistan, physicians, public and private hospitals

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Authors: Joshua W. Edefo, Shafiul Azam, Murray D. Smith

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Introduction: In April 2022, the Welsh Government introduced the six goals for urgent and emergency care programs. One of these goals was to provide access to clinically safe alternatives, leading to the establishment of the Same Day Emergency Care (SDEC) program. The SDEC initiative aims to offer viable options that maintain patient safety while avoiding unnecessary hospital stays. The aim of the study is to determine the duration of patient stay in SDEC and compare it with that of Emergency department (ED) stay to ascertain if one of the objectives of SDEC is achieved. Methods: Patient stays and attendance datasets were constructed from Withybush SDEC and ED patient records. These records were provided by Hywel Dda University Health Board Informatics. Some hypothetical pathways were identified, notably SDEC visits involving a single attendance and ED visits then immediately transferred to SDEC. Descriptive statistics were used to summarise the data, and hypothesis tests for mean differences used the student t-test. Propensity scoring was employed to match a set of ED patient stays to SDEC patient stays which were then used to determine the average treatment effect (ATE) to compare durations of stay in SDEC with ED. Regression methods were used to model the natural logarithm of the duration of SDEC attendance, and the level of statistical significance was set to 0.05. Results: SDEC visits involving a single attendance (170 of 384; 44.3%) is the most frequently observed pathway with patient length of stay at 256 minutes (95%CI 237.4 - 275.1). The next most frequently observed pathway of patient stay was SDEC attendance after presenting to ED (80 of 384; 20.8%) and gave the length of stay of 440 minutes (95%CI 351.6 - 529.2). Time spent in this pathway significantly increased by 184 minutes (95%CI 118.0 - 250.2, support for no difference p<0.001) compared to the most seen pathway. When SDEC data were compared with ED, the estimate for the ATE from SDEC single attendance was -272 minutes (95%CI -334.1 - -210.5; p<0.001), while that of ED then SDEC pathway was -50.6 min (95%CI -182.7-81.5; p=0.453). Conclusion: When patients are admitted to SDEC and successfully discharged, their stays are significantly shorter, approximately 4.5 hours, compared to patients who spend their entire stay in the Emergency Department. That difference vanishes when the patient stay includes a period spent previously in ED before transfer to SDEC.

Keywords: attendance, emergency-department, patient-stay, same-day-emergency-care

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Authors: Zohreh Bayat, Dariush Minai-Tehrani

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Pseudomonas aeruginosa is a Gram-negative, rode shape and aerobic bacterium that has shown to be resistance to many antibiotics. This resistance makes the bacterium very harmful in some diseases. It can also generate diseases in any part of the gastrointestinal tract from oropharynx to rectum. P. aeruginosa has become an important cause of infection, especially in patients with compromised host defense mechanisms. One of the most important reasons that make P. aeruginosa an emerging opportunistic pathogen in patients is its ability to use various compounds as carbon sources. Lipase is an enzyme that catalyzes the hydrolysis of lipids. Most lipases act at a specific position on the glycerol backbone of lipid substrate. Some lipases are expressed and secreted by pathogenic organisms during the infection. Muscarinic antagonist used as an antispasmodic and in urinary incontinence. The drug has little effect on glandular secretion or the cardiovascular system. It does have some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms. Aim: In this study the inhibitory effect of a muscarinic antagonist on lipase of P. aeruginosa was investigated. Methods: P. aeruginosa was cultured in minimal salt medium with 1% olive oil as carbon source. The cells were harvested and the supernatant, which contained lipase, was used for enzyme assay. Results: Our results showed that the drug can inhibit P. aeruginosa lipase by competitive manner. In the presence of different concentrations of the drug, the Vmax (2 mmol/min/mg protein) of enzyme did not change, while the Km raised by increasing the drug concentration. The Ki (inhibition constant) and IC50 (the half maximal inhibitory concentration) value of drug was estimated to be about 30 uM and 60 uM which determined that the drug binds to enzyme with high affinity. Maximum activity of the enzyme was observed at pH 8 in the absence and presence of muscarinic antagonist, respectively. The maximum activity of lipase was observed at 600C and the enzyme became inactive at 900C. Conclusion: The muscarinic antagonist drug could inhibit lipase of P. aeruginosa and changed the kinetic parameters of the enzyme. The drug binded to enzyme with high affinity and did not chang the optimum pH of the enzyme. Temperature did not affect the binding of drug to musmuscarinic antagonist.

Keywords: Pseudomonas aeruginosa, drug, enzyme, inhibition

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Authors: Rachel Fanelwa Ajayi, Anovuyo Jonnas, Emmanuel I. Iwuoha

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Tuberculosis (TB) is an infectious disease caused by the bacterium (Mycobacterium tuberculosis) which has a predilection for lung tissue due to its rich oxygen supply. The mycobacterial cell has a unique innate characteristic which allows it to resist human immune systems and drug treatments; hence, it is one of the most difficult of all bacterial infections to treat, let alone to cure. At the same time, multi-drug resistance TB (MDR-TB) caused by poorly managed TB treatment, is a growing problem and requires the administration of expensive and less effective second line drugs which take much longer treatment duration than fist line drugs. Therefore, to acknowledge the issues of patients falling ill as a result of inappropriate dosing of treatment and inadequate treatment administration, a device with a fast response time coupled with enhanced performance and increased sensitivity is essential. This study involved the synthesis of electroactive platforms for application in the development of nano-biosensors suitable for the appropriate dosing of clinically diagnosed patients by promptly quantifying the levels of the TB drug; Isonaizid. These nano-biosensors systems were developed on gold surfaces using the enzyme N-acetyletransferase 2 coupled to the cysteamine modified poly(8-anilino-1-napthalene sulphonic acid)/zinc oxide nanocomposites. The morphology of ZnO nanoparticles, PANSA/ZnO nano-composite and nano-biosensors platforms were characterized using High-Resolution Transmission Electron Microscopy (HRTEM) and High-Resolution Scanning Electron Microscopy (HRSEM). On the other hand, the elemental composition of the developed nanocomposites and nano-biosensors were studied using Fourier Transform Infra-Red Spectroscopy (FTIR) and Energy Dispersive X-Ray (EDX). The electrochemical studies showed an increase in electron conductivity for the PANSA/ZnO nanocomposite which was an indication that it was suitable as a platform towards biosensor development.

Keywords: N-acetyletransferase 2, isonaizid, tuberculosis, zinc oxide

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Authors: I. N. Nwafia, U. C. Ozumba, M. E. Ohanu, S. O. Ebede

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Antibiotic resistance is increasing globally and has become a major health challenge. Extended-spectrum beta-lactamase is clinically important because the ESBL gene are mostly plasmid encoded and these plasmids frequently carry genes encoding resistance to other classes of antimicrobials thereby limiting antibiotic options in the treatment of infections caused by these organisms. The specific objectives of this study were to determine the prevalence of ESBLs production in Escherichia coli, to determine the antibiotic susceptibility pattern of ESBLs producing Escherichia coli, to detect TEM, SHV and CTX-M genes and the risk factors to acquisition of ESBL producing Escherichia coli. The protocol of the study was approved by Health Research and Ethics committee of the University of Nigeria Teaching Hospital (UNTH), Enugu. It was a descriptive cross-sectional study that involved all hospitalized patients in UNTH from whose specimens Escherichia coli was isolated during the period of the study. The samples analysed were urine, wound swabs, blood and cerebrospinal fluid. These samples were cultured in 5% sheep Blood agar and MacConkey agar (Oxoid Laboratories, Cambridge UK) and incubated at 35-370C for 24 hours. Escherichia coli was identified with standard biochemical tests and confirmed using API 20E auxanogram (bioMerieux, Marcy 1'Etoile, France). The antibiotic susceptibility testing was done by disc diffusion method and interpreted according to the Clinical and Laboratory Standard Institute guideline. ESBL production was confirmed using ESBL Epsilometer test strips (Liofilchem srl, Italy). The ESBL bla genes were detected with polymerase chain reaction, after extraction of DNA with plasmid mini-prep kit (Jena Bioscience, Jena, Germany). Data analysis was with appropriate descriptive and inferential statistics. One hundred and six isolates (53.00%) out of the 200 were from urine, followed by isolates from different swabs specimens 53(26.50%) and the least number of the isolates 4(2.00) were from blood (P value = 0.096). Seventy (35.00%) out of the 200 isolates, were confirmed positive for ESBL production. Forty-two (60.00%) of the isolates were from female patients while 28(40.00%) were from male patients (P value = 0.13). Sixty-eight (97.14%) of the isolates were susceptible to imipenem while all of the isolates were resistant to ampicillin, chloramphenicol and tetracycline. From the 70 positive isolates the ESBL genes detected with polymerase chain reaction were blaCTX-M (n=26; 37.14%), blaTEM (n=7; 10.00%), blaSHV (n=2; 2.86%), blaCTX-M/TEM (n=7; 10.0%), blaCTX-M/SHV (n=14; 20.0%) and blaCTX-M/TEM/SHV (n=10; 14.29%). There was no gene detected in 4(5.71%) of the isolates. The most associated risk factors to infections caused by ESBL producing Escherichia coli was previous antibiotics use for the past 3 months followed by admission in the intensive care unit, recent surgery, and urinary catheterization. In conclusion, ESBLs was detected in 4 of every 10 Escherichia coli with the predominant gene detected being CTX-M. This knowledge will enable appropriate measures towards improvement of patient health care, antibiotic stewardship, research and infection control in the hospital.

Keywords: antimicrobial, Escherichia coli, extended spectrum beta lactamase, resistance

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Authors: Mariia Karizhenskaia, Tanvi Nandani, Ali Tafazoli Moghadam

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Hospice palliative care (HPC) is one of the most complicated philosophies of care in which physical, social/cultural, and spiritual aspects of human life are intermingled with an undeniably significant role in every aspect. Among these dimensions of care, culture possesses an outstanding position in the process and goal determination of HPC. This study shows the importance of cultural elements in the establishment of effective and optimized structures of HPC in the Canadian healthcare environment. Our systematic search included Medline, Google Scholar, and St. Lawrence College Library, considering original, peer-reviewed research papers published from 1998 to 2023 to identify recent national literature connecting culture and palliative care delivery. The most frequently presented feature among the articles is the role of culture in the efficiency of the HPC. It has been shown frequently that including the culturespecific parameters of each nation in this system of care is vital for its success. On the other hand, ignorance about the exclusive cultural trends in a specific location has been accompanied by significant failure rates. Accordingly, implementing a culture-wise adaptable approach is mandatory for multicultural societies. The following outcome of research studies in this field underscores the importance of culture-oriented education for healthcare staff. Thus, all the practitioners involved in HPC will recognize the importance of traditions, religions, and social habits for processing the care requirements. Cultural competency training is a telling sample of the establishment of this strategy in health care that has come to the aid of HPC in recent years. Another complexity of the culturized HPC nowadays is the long-standing issue of racialization. Systematic and subconscious deprivation of minorities has always been an adversity of advanced levels of care. The last part of the constellation of our research outcomes is comprised of the ethical considerations of culturally driven HPC. This part is the most sophisticated aspect of our topic because almost all the analyses, arguments, and justifications are subjective. While there was no standard measure for ethical elements in clinical studies with palliative interventions, many research teams endorsed applying ethical principles for all the involved patients. Notably, interpretations and projections of ethics differ in varying cultural backgrounds. Therefore, healthcare providers should always be aware of the most respectable methodologies of HPC on a case-by-case basis. Cultural training programs have been utilized as one of the main tactics to improve the ability of healthcare providers to address the cultural needs and preferences of diverse patients and families. In this way, most of the involved health care practitioners will be equipped with cultural competence. Considerations for ethical and racial specifications of the clients of this service will boost the effectiveness and fruitfulness of the HPC. Canadian society is a colorful compilation of multiple nationalities; accordingly, healthcare clients are diverse, and this divergence is also translated into HPC patients. This fact justifies the importance of studying all the cultural aspects of HPC to provide optimal care on this enormous land.

Keywords: cultural competence, end-of-life care, hospice, palliative care

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Authors: Yijun Shao, Yan Cheng, Rashmee U. Shah, Charlene R. Weir, Bruce E. Bray, Qing Zeng-Treitler

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Deep neural network (DNN) models are being explored in the clinical domain, following the recent success in other domains such as image recognition. For clinical adoption, outcome prediction models require explanation, but due to the multiple non-linear inner transformations, DNN models are viewed by many as a black box. In this study, we developed a deep neural network model for predicting 1-year mortality of patients who underwent major cardio vascular procedures (MCVPs), using temporal image representation of past medical history as input. The dataset was obtained from the electronic medical data warehouse administered by Veteran Affairs Information and Computing Infrastructure (VINCI). We identified 21,355 veterans who had their first MCVP in 2014. Features for prediction included demographics, diagnoses, procedures, medication orders, hospitalizations, and frailty measures extracted from clinical notes. Temporal variables were created based on the patient history data in the 2-year window prior to the index MCVP. A temporal image was created based on these variables for each individual patient. To generate the explanation for the DNN model, we defined a new concept called impact score, based on the presence/value of clinical conditions’ impact on the predicted outcome. Like (log) odds ratio reported by the logistic regression (LR) model, impact scores are continuous variables intended to shed light on the black box model. For comparison, a logistic regression model was fitted on the same dataset. In our cohort, about 6.8% of patients died within one year. The prediction of the DNN model achieved an area under the curve (AUC) of 78.5% while the LR model achieved an AUC of 74.6%. A strong but not perfect correlation was found between the aggregated impact scores and the log odds ratios (Spearman’s rho = 0.74), which helped validate our explanation.

Keywords: deep neural network, temporal data, prediction, frailty, logistic regression model

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Authors: Tian Yi Du, Guan Rong Fan, Dong Dong Zou, Di Xue

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Background: The patient satisfaction survey is becoming of increasing importance for hospitals or other providers to get more reimbursement and/or more governmental subsidies. However, when the results of patient satisfaction survey are compared among medical institutions, there are some concerns. The primary objectives of this study were to evaluate patient satisfaction in tertiary hospitals of Shanghai and to compare the satisfaction rating on physician services between patients and observers. Methods: Two hundred outpatients were randomly selected for patient satisfaction survey in each of 28 public tertiary hospitals of Shanghai. Four or five volunteers were selected to observe 5 physicians’ practice in each of above hospitals and rated observed physicians’ practice. The outpatients that the volunteers observed their physician practice also filled in the satisfaction questionnaires. The rating scale for outpatient survey and volunteers’ observation was: 1 (very dissatisfied) to 6 (very satisfied). If the rating was equal to or greater than 5, we considered the outpatients and volunteers were satisfied with the services. The validity and reliability of the measure were assessed. Multivariate regressions for each of the 4 dimensions and overall of patient satisfaction were used in analyses. Paired t tests were applied to analyze the rating agreement on physician services between outpatients and volunteers. Results: Overall, 90% of surveyed outpatients were satisfied with outpatient care in the tertiary public hospitals of Shanghai. The lowest three satisfaction rates were seen in the items of ‘Restrooms were sanitary and not crowded’ (81%), ‘It was convenient for the patient to pay medical bills’ (82%), and ‘Medical cost in the hospital was reasonable’ (84%). After adjusting the characteristics of patients, the patient satisfaction in general hospitals was higher than that in specialty hospitals. In addition, after controlling the patient characteristics and number of hospital visits, the hospitals with higher outpatient cost per visit had lower patient satisfaction. Paired t tests showed that the rating on 6 items in the dimension of physician services (total 14 items) was significantly different between outpatients and observers, in which 5 were rated lower by the observers than by the outpatients. Conclusions: The hospital managers and physicians should use patient satisfaction and observers’ evaluation to detect the room for improvement in areas such as social skills cost control, and medical ethics.

Keywords: patient satisfaction, observation, quality, hospital

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Authors: Ilana Margalith, Adaya Meirowitz, Sigalit Cohavi

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Violence against health professionals by patients and their families have recently become a disturbing phenomenon worldwide, exacting psychological as well as economic tolls. Health workplaces in Israel (e.g. hospitals and H.M.O clinics) provide workshops for their employees, supplying them with coping strategies. However, these workshops do not focus on nursing students, who are also subjected to this violence. Their learning environment is no longer as protective as it used to be. Furthermore, coping with violence was not part of the curriculum for Israeli nursing students. Thus, based on human aggression theories which depict the pivotal role of the professional's correct response in preventing the onset of an aggressive response or the escalation of violence, a workshop was developed for undergraduate nursing students at the Clalit Nursing Academy, Rabin Campus (Dina), Israel. The workshop aimed at reducing students' anxiety vis a vis the aggressive patient or family in addition to strengthening their ability to cope with such situations. The students practiced interpersonal skills, especially relevant to early detection of potential violence, as well as ‘a correct response’ reaction to the violence, thus developing the necessary steps to be implemented when encountering violence in the workplace. In order to assess the efficiency of the workshop, the participants filled out a questionnaire comprising knowledge and self-efficacy scales. Moreover, the replies of the 23 participants in this workshop were compared with those of 24 students who attended a standard course on interpersonal communication. Students' self-efficacy and knowledge were measured in both groups before and after the course. A statistically significant interaction was found between group (workshop/standard course) and time (before/after) as to the influence on students' self-efficacy (p=0.004) and knowledge (p=0.007). Nursing students, who participated in this ‘coping with workplace violence’ workshop, gained knowledge, confidence and a sense of self-efficacy with regard to workplace violence. Early detection of signs of imminent violence amongst patients or families and the prevention of its escalation, as well as the ability to manage the threatening situation when occurring, are acquired skills. Encouraging nursing students to learn and practice these skills may enhance their ability to cope with these unfortunate occurrences.

Keywords: early detection of violence, nursing students, patient aggression, self-efficacy, workplace violence

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Authors: Boris Bajer, Andrea Havranova, Miroslav Vlcek, Richard Imrich, Adela Penesova

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Lifestyle interventions can prevent the deterioration of impaired glucose tolerance to manifest type 2 diabetes, and also prevent cardiovascular diseases, as it showed many studies (the Finnish Diabetes Prevention Study, Diabetes Prevention Program (DPP), . the China Da Qing Diabetes Prevention Study, etc.) Therefore the aim of our study was to compare the effect of intensified lifestyle intervention on cardiometabolic parameters. Methods: It is an ongoing randomized interventional clinical study (NCT02325804) focused on the reduction of body weight/fat. Intervention: hypocaloric diet (30% restriction of calories) and physical activity 150 minutes/week. Before and after 8 weeks of intervention all patients underwent complete medical examination (measurement of physical fitness, resting metabolic rate (RMR), body composition analysis, oral glucose tolerance test, parameters of lipid metabolism, and other cardiometabolic risk factors. Results: So far 39 patients finished the intervention. The average reduction of body weight was 6,8 + 4,9 kg (0-15 kg; p=0,0006), accompanied with significant reduction of body fat percentage (p ≤ 0,0001), amount of fat mass (p=0,03), waist circumference (p=0.02). Amount of lean mass and RMR remained unchanged. Heart rate (p=0,02), systolic and diastolic blood pressure was reduced (p=0,01 p=0,02 resp.) as well as insulin sensitivity was improved. Lipid parameters also changed - cholesterol, LDL decreased (p=0,05, p=0,04 resp.), while triglycerides showed tendency to decrease (p=0,055). Liver function improved, alanine aminotrasnferase (ALT) were reduced (p=0,01). Physical fitness significantly improved (as measure VO2 max (p=0,02). Conclusion: Results of our study are in line with previous results about the beneficial effect of intensive lifestyle changes on the reduction of cardiometabolic risk factors and improvement of liver function. Supported by grants APVV 15-0228; VEGA 2/0161/16

Keywords: obesity, weight loss, diet lipids, blood pressure, liver enzymes

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Authors: Ramzi Shawahna

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Background: Neonatal intensive care units are high-risk settings where medication errors can occur and cause harm to this fragile segment of patients. This multicenter qualitative study was conducted to describe medication errors that occurred in neonatal intensive care units in Palestine from the perspectives of healthcare providers. Methods: This exploratory multicenter qualitative study was conducted and reported in adherence to the consolidated criteria for reporting qualitative research checklist. Semi-structured in-depth interviews were conducted with healthcare professionals (4 pediatricians/neonatologists and 11 intensive care unit nurses) who provided care services for patients admitted to neonatal intensive care units in Palestine. An interview schedule guided the semi-structured in-depth interviews. The qualitative interpretive description approach was used to thematically analyze the data. Results: The total duration of the interviews was 282 min. The healthcare providers described their experiences with 41 different medication errors. These medication errors were categorized under 3 categories and 10 subcategories. Errors that occurred while preparing/diluting/storing medications were related to calculations, using a wrong solvent/diluent, dilution errors, failure to adhere to guidelines while preparing the medication, failure to adhere to storage/packaging guidelines, and failure to adhere to labeling guidelines. Errors that occurred while prescribing/administering medications were related to inappropriate medication for the neonate, using a different administration technique from the one that was intended and administering a different dose from the one that was intended. Errors that occurred after administering the medications were related to failure to adhere to monitoring guidelines. Conclusion: In this multicenter study, pediatricians/neonatologists and neonatal intensive care unit nurses described medication errors occurring in intensive care units in Palestine. Medication errors occur in different stages of the medication process: preparation/dilution/storage, prescription/administration, and monitoring. Further studies are still needed to quantify medication errors occurring in neonatal intensive care units and investigate if the designed strategies could be effective in minimizing medication errors.

Keywords: medication errors, pharmacist, pharmacology, neonates

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Authors: Umamaheswari Shanmugam, Silvia Ronchi

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

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

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Authors: Ayman K. El Essawy, Amal M. Hosny, Hala M. Abu Shady

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The rapid detection of TB and drug resistance, both optimizes treatment and improves outcomes. In the current study, respiratory specimens were collected from 155 patients. Conventional susceptibility testing and MIC determination were performed for rifampicin (RIF) and isoniazid (INH). Genotype MTBDRplus assay, which is a molecular genetic assay based on the DNA-STRIP technology and specific gene sequencing with primers for rpoB, KatG, and mab-inhA genes were used to detect mutations associated with resistance to rifampicin and isoniazid. In comparison to other categories, most of rifampicin resistant (61.5%) and isoniazid resistant isolates (47.1%) were from patients relapsed in treatment. The genotypic profile (using Genotype MTBDRplus assay) of multi-drug resistant (MDR) isolates showed missing of katG wild type 1 (WT1) band and appearance of mutation band katG MUT2. For isoniazid mono-resistant isolates, 80% showed katG MUT1, 20% showed katG MUT1, and inhA MUT1, 20% showed only inhA MUT1. Accordingly, 100% of isoniazid resistant strains were detected by this assay. Out of 17 resistant strains, 16 had mutation bands for katG distinguished high resistance to isoniazid. The assay could clearly detect rifampicin resistance among 66.7% of MDR isolates that showed mutation band rpoB MUT3 while 33.3% of them were considered as unknown. One mono-resistant rifampicin isolate did not show rifampicin mutation bands by Genotype MTBDRplus assay, but it showed an unexpected mutation in Codon 531 of rpoB by DNA sequence analysis. Rifampicin resistance in this strain could be associated with a mutation in codon 531 of rpoB (based on molecular sequencing), and Genotype MTBDRplus assay could not detect the associated mutation. If the results of Genotype MTBDRplus assay and sequencing were combined, this strain shows hetero-resistance pattern. Gene sequencing of eight selected isolates, previously tested by Genotype MTBDRplus assay, could detect resistance mutations mainly in codon 315 (katG gene), position -15 in inhA promotes gene for isoniazid resistance and codon 531 (rpoB gene) for rifampicin resistance. Genotyping techniques allow distinguishing between recurrent cases of reinfection or reactivation and supports epidemiological studies.

Keywords: M. tuberculosis, rpoB, KatG, inhA, genotype MTBDRplus

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Authors: Sandeep Kumar Agrawal, Aditi Bhattacharya, Janvie Manhas, Krushna Bhatt, Yatin Kholakiya, Nupur Khera, Ajoy Roychoudhury, Sudip Sen

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Autologous cultured explants of human oral mucosal epithelial cells (OMEC) are a potential therapeutic modality for limbal stem cell deficiency (LSCD). Injury or inflammation of the ocular surface in the form of burns, chemicals, Stevens Johnson syndrome, ocular cicatricial pemphigoid etc. can lead to destruction and deficiency of limbal stem cells. LSCD manifests in the form of severe ocular surface diseases (OSD) characterized by persistent and recurrent epithelial defects, conjuntivalisation and neovascularisation of the corneal surface, scarring and ultimately opacity and blindness. Most of the cases of OSD are associated with severe dry eye pertaining to diminished mucin and aqueous secretion. Mycophenolate mofetil (MMF) has been shown to upregulate the mucin expression in conjunctival goblet cells in vitro. The aim of this study was to evaluate the effects of MMF on mucin expression in primary cultures of oral mucosal epithelial cells. With institutional ethics committee approval and written informed consent, thirty oral mucosal epithelial tissue samples were obtained from patients undergoing oral surgery for non-malignant conditions. OMEC were grown on human amniotic membrane (HAM, obtained from expecting mothers undergoing elective caesarean section) scaffold for 2 weeks in growth media containing DMEM & Ham’s F12 (1:1) with 10% FBS and growth factors. In vitro dosage of MMF was standardised by MTT assay. Analysis of stem cell markers was done using RT-PCR while mucin mRNA expression was quantified using RT-PCR and q-PCR before and after treating cultured OMEC with graded concentrations of MMF for 24 hours. Protein expression was validated using immunocytochemistry. Morphological studies revealed a confluent sheet of proliferating, stratified oral mucosal epithelial cells growing over the surface of HAM scaffold. The presence of progenitor stem cell markers (p63, p75, β1-Integrin and ABCG2) and cell surface associated mucins (MUC1, MUC15 and MUC16) were elucidated by RT-PCR. The mucin mRNA expression was found to be upregulated in MMF treated primary cultures of OMEC, compared to untreated controls as quantified by q-PCR with β-actin as internal reference gene. Increased MUC1 protein expression was validated by immunocytochemistry on representative samples. Our findings conclude that OMEC have the ability to form a multi-layered confluent sheet on the surface of HAM similar to a cornea, which is important for the reconstruction of the damaged ocular surface. Cultured OMEC has stem cell properties as demonstrated by stem cell markers. MMF can be a novel enhancer of mucin production in OMEC. It has the potential to improve dry eye in patients undergoing OMEC transplantation for bilateral OSD. Further clinical trials are required to establish the role of MMF in patients undergoing OMEC transplantation.

Keywords: limbal stem cell deficiency, mycophenolate mofetil, mucin, ocular surface disease

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Authors: Masoud Swalehe, Semra Günay

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Developed countries are losing many lives to non-communicable diseases as compared to their developing counterparts. The effects of these diseases are mostly sudden and manifest at a very short time prior to death or a dangerous attack and this has consolidated the significance of emergency medical system (EMS) as one of the vital areas of healthcare service delivery. The primary objective of this research is to reduce ambulance response times (RT) of Eskişehir province EMS since a number of studies have established a relationship between ambulance response times and survival chances of patients especially out of hospital cardiac arrest (OHCA) victims. It has been found out that patients who receive out of hospital medical attention in few (4) minutes after cardiac arrest because of low ambulance response times stand higher chances of survival than their counterparts who take longer times (more than 12 minutes) to receive out of hospital medical care because of higher ambulance response times. The study will make use of geographic information systems (GIS) technology to dynamically reallocate ambulance resources according to demand and time so as to reduce ambulance response times. Geospatial-time distribution of ambulance calls (demand) will be used as a basis for optimal ambulance deployment using system status management (SSM) strategy to achieve much demand coverage with the same number of ambulance resources to cause response time reduction. Drive-time polygons will be used to come up with time specific facility coverage areas and suggesting additional facility candidate sites where ambulance resources can be moved to serve higher demands making use of network analysis techniques. Emergency Ambulance calls’ data from 1st January 2014 to 31st December 2014 obtained from Eskişehir province health directorate will be used in this study. This study will focus on the reduction of ambulance response times which is a key Emergency Medical Services performance indicator.

Keywords: emergency medical services, system status management, ambulance response times, geographic information system, geospatial-time distribution, out of hospital cardiac arrest

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Authors: Demet Devrimsel Dogan, Ecem Deniz Kirkpantur, Muharrem Dogan, Ahmet Aykut, Ebru Unal Akoglu, Ozge Ecmel Onur

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Introduction: Median Arcuate Ligament Syndrome (MALS) is a rare cause of chronic abdominal pain due to external compression of the celiac trunk by a fibrous arch that unites diaphragmatic crura on each side of the aortic hiatus. While 10-24% of the population may suffer from compression of celiac trunk, it rarely causes patients to develop symptoms. The typical clinical triad of symptoms includes postprandial epigastric pain, weight loss and vomiting. The diagnosis can be made using thin section multi-detector computed tomography (CT) scans which delineate the ligament and the compressed vessel. The treatment of MALS is aimed at relieving the compression of the celiac artery to restore adequate blood flow through the vessel and neurolysis to address chronic pain. Case: A 68-year-old male presented to our clinic with acute postprandial epigastric pain. This was patients’ first attack, and the pain was the worst pain of his life. The patient did not have any other symptoms like nausea, vomiting, chest pain or dyspnea. In his medical history, the patient has had an ischemic cerebrovascular stroke 5 years ago which he recovered with no sequel, and he was using 75 mg clopidogrel and 100 mg acetylsalicylic acid. He was not using any other medication and did not have a story of cardiovascular disease. His vital signs were stable (BP:113/72 mmHg, Spo2:97, temperature:36.3°C, HR:90/bpm). In his electrocardiogram, there was ST depression in leads II, III and AVF. In his physical examination, there was only epigastric tenderness, other system examinations were normal. Physical examination through his upper gastrointestinal system showed no bleeding. His laboratory results were as follows: creatinine:1.26 mg/dL, AST:42 U/L, ALT:17 U/L, amylase:78 U/L, lipase:26 U/L, troponin:10.3 pg/ml, WBC:28.9 K/uL, Hgb:12.7 gr/dL, Plt:335 K/uL. His serial high-sensitive troponin levels were also within normal limits, his echocardiography showed no segmental wall motion abnormalities, an acute myocardial infarction was excluded. In his abdominal ultrasound, no pathology was founded. Contrast-enhanced abdominal CT and CT angiography reported ‘thickened diaphragmatic cruras are compressing and stenosing truncus celiacus superior, this is likely compatible with MALS’. The patient was consulted to general surgery, and they admitted the patient for laparoscopic ligament release. Results: MALS is a syndrome that causes postprandial pain, nausea and vomiting as its most common symptoms. Affected patients are normally young, slim women between the ages of 30 and 50 who have undergone extensive examinations to find the source of their symptoms. To diagnose MALS, other underlying pathologies should initially be excluded. The gold standard is aortic angiography. Although diagnosis and treatment of MALS are unclear, symptom resolution has been achieved with multiple surgical modalities, including open, laparoscopic or robotic ligament release as well as celiac ganglionectomy, which often requires celiac artery revascularisation.

Keywords: differential diagnosis, epigastric pain, median arcuate ligament syndrome, celiac trunk

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Authors: Isomar Lima da Silva, Alcilene Batalha Pontes, Aristeu Jonatas Leite de Oliveira, Roberto Maia Augusto

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Context: Mechanical ventilators are medical devices that help provide oxygen and ventilation to patients with respiratory difficulties. This equipment consists of a manual breathing unit that can be operated by a doctor or nurse and a mechanical ventilator that controls the airflow and pressure in the patient's respiratory system. This type of ventilator is commonly used in emergencies and intensive care units where it is necessary to provide breathing support to critically ill or injured patients. Objective: In this context, this work aims to develop a reliable and low-cost mechanical ventilator to meet the demand of hospitals in treating people affected by Covid-19 and other severe respiratory diseases, offering a chance of treatment as an alternative to mechanical ventilators currently available in the market. Method: The project presents the development of a low-cost auxiliary ventilator with a controlled ventilatory system assisted by integrated hardware and firmware for respiratory cycle control in non-invasive mechanical ventilation treatments using a manual artificial respiration unit. The hardware includes pressure sensors capable of identifying positive expiratory pressure, peak inspiratory flow, and injected air volume. The embedded system controls the data sent by the sensors. It ensures efficient patient breathing through the operation of the sensors, microcontroller, and actuator, providing patient data information to the healthcare professional (system operator) through the graphical interface and enabling clinical parameter adjustments as needed. Results: The test data of the developed mechanical ventilator presented satisfactory results in terms of performance and reliability, showing that the equipment developed can be a viable alternative to commercial mechanical ventilators currently available, offering a low-cost solution to meet the increasing demand for respiratory support equipment.

Keywords: mechanical fans, breathing, medical equipment, COVID-19, intensive care units

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