Search results for: clinical research (CRE)

Authors: Pankaj Prashar, Bimlesh Kumar, Ankita Sood, Anamika Gautam

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Pharmacovigilance (PV) is a rapidly growing discipline in pharmaceutical industries as an integral part of clinical research and drug development over the past few decades. PV carries a breadth of scope from drug manufacturing to its regulation with safer utilization. The fundamental steps of PV not only includes data collection and verification, coding of drugs with adverse drug reactions, causality assessment and timely reporting to the authorities but also monitoring drug manufacturing, safety issues, product quality and conduction of due diligence. Standardization of adverse event information, collaboration of multiple departments in different companies, preparation of documents in accordance to both governmental as well as non-governmental organizations (FDA, EMA, GVP, ICH) are the advancements in discipline of PV. De-harmonization, lack of predictive drug safety models, improper funding by government, non-reporting, and non-acceptability of ADRs by developing countries and reports directly from patients to the monitoring centres respectively are the major road backs of PV. Mandatory pharmacovigilance reporting, frequent inspections, funding by government, educating and training medical students, pharmacists and nurses in this segment can bring about empowerment in PV. This area needs to be addressed with a sense of urgency for the safe utilization of pharmaceuticals.

Keywords: pharmacovigilance, regulatory, adverse event, drug safety

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Authors: Amy Gooden, Meshandren Naidoo

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Genetic research is not confined to a particular jurisdiction. Using direct-to-consumer genetic testing (DTC-GT) as an example, this research assesses the status of data sharing into and out of South Africa (SA). While SA laws cover the sending of genetic data out of SA, prohibiting such transfer unless a legal ground exists, the position where genetic data comes into the country depends on the laws of the country from where it is sent – making the legal position less clear.

Keywords: cross-border, data, genetic testing, law, regulation, research, sharing, South Africa

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Authors: Emad Kouhestani

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Background: Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, as an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. Method: A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane, and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, or cumulative opioid consumption, adverse events) following the administration of pregabalin in patients undergoing ACL reconstruction. Result: Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75 mg and 150 mg of oral pregabalin were used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1 hour before anesthesia induction and 12 hours after. One study used daily pregabalin 7 days before and 7 days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in the pregabalin group compared with the placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. Conclusion: The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample sizes and longer follow-up periods are required.

Keywords: pregabalin, anterior cruciate ligament, postoperative pain, clinical trial

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Authors: Mohammad Hamed Asosheh

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The development of nanobiomaterials has opened new avenues in the field of biomedical engineering, offering unparalleled possibilities for advanced therapeutic applications. This study explores the synthesis and characterization of a distinct class of nanobiomaterials designed to enhance drug delivery systems and support tissue engineering. By integrating biodegradable polymers with bioactive nanoparticles, we have engineered a multifunctional platform that ensures controlled drug release, targeted delivery, and improved biocompatibility. Our findings demonstrate that these nanobiomaterials not only exhibit excellent mechanical properties but also promote cell proliferation and differentiation, making them ideal candidates for regenerative medicine. Furthermore, in vitro and in vivo assessments reveal that the engineered materials significantly reduce cytotoxicity while enhancing the therapeutic efficacy of encapsulated drugs. This research presents a promising approach to addressing current challenges in drug delivery and tissue regeneration, with the potential to revolutionize the treatment of chronic diseases and injury repair. Future work will focus on optimizing the material composition for specific clinical applications and conducting large-scale studies to evaluate long-term safety and effectiveness.

Keywords: nanobiomaterials, drug delivery systems, therapeutic efficacy, bioactive nanoparticles

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Authors: Destha Titi Raharjana

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The finding of this research results from three action researches conducted in three rurals, namely Bokoharjo, Sambirejo, and Tirtomartani. Those rurals are close to Prambanan, a well-known cultural heritage site located in Sleman Regency, Indonesia. This action research is conducted using participative method through observation, interview, and focus group discussion with local residents as the subjects. This research aims to (a) present identifications of potencies, obstacles, and opportunities existed in development process, which is able to give more encouragement, involvement and empowerment for local residents in maintaining the cultural heritage area, (b) present participatory empowerment programs which adjust the needs of local residents and human resources, and (c) identify potential stakeholders that can support empowerment programs. Through action research method, this research is able to present (a) potential mapping; difficulties and opportunities in the development process in each rural, (b) empowerment program planning needed by local residents as a follow-up of this action research. Moreover, this research also presents identifications of potential stakeholders who are able to do an empowerment program follow-up. It is expected that, at the end of the programs, the local residents are able to maintain Prambanan, as one of cultural heritage sites that needs to be protected, in a more sustainable way.

Keywords: action research, local resident, empowerment, cultural heritage area, Prambanan, Sleman, Indonesia

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Authors: Joao Paulo Matheus, Renan Fangel

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Rheumatoid arthritis is a chronic, inflammatory, systemic and progressive disease that affects the synovial joints bilaterally, causing definitive orthopedic damage. It has a higher prevalence in postmenopausal female patients. It is a disabling disease that causes joint deformities that may compromise the functionality of the affected segment. The aim of this study was to evaluate the influence of low-intensity therapeutic laser on the perception of pain and quality of life in patients with rheumatoid arthritis. This is a randomized clinical study involving 6 women with a mean age of 56.8+6.3 years. Exclusion criteria: patients with acute pain, chronic infectious disease, underlying acute or chronic underlying disease. An AsGaAl laser with 808nm wavelength, 100mW power, beam output area of 0.028cm2, power density of 3.57W/cm2 was used. The laser was applied at pre-defined points in the interphalangeal and metacarpophalangeal joints, totaling 24 points, 2 times a week, for 4 weeks, totaling 8 sessions. The Pain Inventory (IBD) and Visual Analogue Scale (VAS) were used for the analysis of pain and for the WHOQOL-bref quality of life assessment. There was no statistical difference between the onset (5.67±2.66) and the final (4.67±3.78) of treatments (p=0.70). There was also no statistical difference between the beginning (5.67±2.66) and the final (4.67±3.78) of the treatments in the VAS analysis (p=0.68). The overall mean quality of life obtained by the questionnaire at the start of treatment was 42.3±7.6, while at the end of treatment it was 58.5±7.6 (p=0.01) and the domains of the questionnaire with significant differences were: psychological domain 42.9±6.8 and 66.7±12.9 (p=0.004), social domain 39.9±5.7 and 68.1±6.3 (p=0,0005) and environmental domain 36.3±7.3 and 56.3±12.5 (p=0.003). It can be concluded that the low-intensity therapeutic laser did not produce significant changes in the painful period of rheumatoid arthritis patients. However, there was an improvement in patients' quality of life in the psychological, social and environmental aspects.

Keywords: laser therapy, pain, quality of life, rheumatoid arthritis

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Authors: Mukta Avachat-Shirke

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The process of manifestation in art has been studied deeply by various Indian and Western philosophers through times. In the art of painting, ‘Practice’ is always considered as techniques or making and ‘Theory’ is related to intelligence or the ‘conceptual.' The question about the significance of ‘Practice’ in artistic research has been a topic of debate. The aim of this qualitative study is to find the relevance of practice and theory while creating artworks. This study analyzes the thoughts and philosophy of Abhinavgupta, Hegel, and Croce to find a new perspective for looking at practice and theory within artistic research. With the method of grounded theory, the study attempts to establish the importance of both in artistic research. It discusses the issues like stages of creating art, role of tacit knowledge and importance of the decision-making the ability of the artist. This comparative analysis of these three philosophers along with the present systems can be used as a point of reference for further developments in the pedagogy of art research and artists, to understand the psychology and to follow the process of creativity effectively.

Keywords: artistic research, Indian philosophy, practice, Western Philosophy

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Authors: Khader A. Almhdawi, Saddam F. Kanaan

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Background: Allied health (AH) students, including rehabilitation sciences students, are subjected to significant levels of physical and mental stressors, which could affect their education. This study aimed to study physical and mental of Health-related Quality of Life (HR-QoL) levels along with their predictors among students of nine AH majors. Methods: Students filled validated anonymous surveys covering demographics and life style, Nordic Musculoskeletal Questionnaire, 12-item Short-Form Health Survey (SF-12), and Depression Anxiety Stress Scale (DASS- 42). SF-12 Mental (MCS) and Physical (PCS) summary scores were compared between academic majors and gender. Multiple linear regression models were conducted to examine potential predictors of PCS and MCS scores. Results: 838 students (77.4% females) participated in this study. Participants’ PCS mean score was 45.64±7.93 and found statistically different between the nine academic majors (P < 0.001). Additionally, participants’’ MCS mean score was 39.45±10.86 and significantly greater in males (P < 0.001). Significant PCS scores predictors included hip and upper back musculoskeletal pain, anxiety score, diet self-evaluation, and GPA. Finally, MCS scores were statistically associated with neck musculoskeletal pain, stress score, depression score, number of weekly clinical training hours, gender, university year, GPA, sleep quality self-evaluation, and diet self-evaluation. Conclusion: Clinical educators of AH need to account for students’ low levels of HR-QoL and their academic-related, health-related, and lifestyle-related associated factors. More studies are recommended to investigate the progression of HR-QoL throughout university years and to create effective interventions to improve HR-QoL among healthcare students.

Keywords: medical education, quality of life, stress, anxiety, depression

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Authors: Angelis P. Barlampas

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Theoretical background Disorders of fixation and rotation of the large intestine, result in the existence of its parts in ectopic anatomical positions. In case of symptomatology, the clinical picture is complicated by the possible symptomatology of the neighboring anatomical structures and a differential diagnostic problem arises. Target The purpose of this work is to demonstrate the difficulty of revealing the real cause of abdominal pain, in cases of anatomical variants and the decisive contribution of imaging and especially that of computed tomography. Methods A patient came to the emergency room, because of acute pain in the right hypochondrium. Clinical examination revealed tenderness in the gallbladder area and a positive Murphy's sign. An ultrasound exam depicted a normal gallbladder and the patient was referred for a CT scan. Results Flexible, unfixed ascending colon and cecum, located in the anatomical region of the right mesentery. Opacities of the surrounding peritoneal fat and a small linear concentration of fluid can be seen. There was an appendix of normal anteroposterior diameter with the presence of air in its lumen and without clear signs of inflammation. There was an impression of possible inflammatory swelling at the base of the appendix, (DD phenomenon of partial volume; e.t.c.). Linear opacities of the peritoneal fat in the region of the second loop of the duodenum. Multiple diverticula throughout the colon. Differential Diagnosis The differential diagnosis includes the following: Inflammation of the base of the appendix, diverticulitis of the cecum-ascending colon, a rare case of second duodenal loop ulcer, tuberculosis, terminal ileitis, pancreatitis, torsion of unfixed cecum-ascending colon, embolism or thrombosis of a vascular intestinal branch. Final Diagnosis There is an unfixed cecum-ascending colon, which is exhibiting diverticulitis.

Keywords: unfixed cecum-ascending colon, abdominal pain, malrotation, abdominal CT, congenital anomalies

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Authors: Kerem Rızvanoğlu, Serhat Güney, Emre Kızılkaya, Betül Aydoğan, Ayşegül Boyalı, Onurcan Güden

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This study addresses the re-construction and implementation process of the methodological framework developed to evaluate how locative media applications accompany the urban experiences of international students coming to Istanbul with exchange programs in 2022. The research design was built on a three-stage model. The research team conducted a qualitative questionnaire in the first stage to gain exploratory data. These data were then used to form three persona groups representing the sample by applying cluster analysis. In the second phase, a semi-structured digital diary study was carried out on a gamified task list with a sample selected from the persona groups. This stage proved to be the most difficult to obtaining valid data from the participant group. The research team re-evaluated the design of this second phase to reach the participants who will perform the tasks given by the research team while sharing their momentary city experiences, to ensure the daily data flow for two weeks, and to increase the quality of the obtained data. The final stage, which follows to elaborate on the findings, is the “Walk & Talk,” which is completed with face-to-face and in-depth interviews. It has been seen that the multiple methods used in the research process contribute to the depth and data diversity of the research conducted in the context of urban experience and locative technologies. In addition, by adapting the research design to the experiences of the users included in the sample, the differences and similarities between the initial research design and the research applied are shown.

Keywords: digital diary study, gamification, multi-model research, persona analysis, research design for urban experience, user-centered research, “Walk & Talk”

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Authors: Xiao-Yin Liu, Liang-Xue Zhou

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Traumatic brain injury (TBI), as a kind of nerve trauma caused by an external force, affects people all over the world and is a global public health problem. Although there are various clinical treatments for brain injury, including surgery, drug therapy, and rehabilitation therapy, the therapeutic effect is very limited. To improve the therapeutic effect of TBI, scaffolds combined with exosomes are a promising but challenging method for TBI repair. In this study, we examined whether a novel 3D-printed collagen/chitosan scaffold/exosomes derived from neural stem cells (NSCs) pretreated with insulin growth factor-1 (IGF-I) scaffolds (3D-CC-INExos) could be used to improve TBI repair and functional recovery after TBI. Our results showed that composite scaffolds of collagen-, chitosan- and exosomes derived from NSCs pretreated with IGF-I (INExos) could continuously release the exosomes for two weeks. In the rat TBI model, 3D-CC-INExos scaffold transplantation significantly improved motor and cognitive function after TBI, as assessed by the Morris water maze test and modified neurological severity scores. In addition, immunofluorescence staining and transmission electron microscopy showed that the recovery of damaged nerve tissue in the injured area was significantly improved by 3D-CC-INExos implantation. In conclusion, our data suggest that 3D-CC-INExos might provide a potential strategy for the treatment of TBI and lay a solid foundation for clinical translation.

Keywords: traumatic brain injury, exosomes, insulin growth factor-1, neural stem cells, collagen, chitosan, 3D printing, neural regeneration, angiogenesis, functional recovery

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Authors: Sundaresan Soundararajan, George Ezekiel Silvananthan, Chor Ngee Tan

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Introduction: Transforaminal Interbody Fusion (TLIF) has been adopted for many decades now, however, XLIF, still in relative infancy, has grown to be accepted as a new Minimally Invasive Surgery (MIS) option. There is a paucity of reports directly comparing lateral approach surgery to other MIS options such as TLIF in the treatment of lumbar degenerative disc diseases. Aims/Objectives: The objective of this study was to compare the efficacy and clinical outcomes between Minimally Invasive Transforaminal Interbody Fusion (TLIF) and Minimally Invasive Lateral Interbody Fusion (XLIF) in the treatment of patients with degenerative disc disease of the lumbar spine. Methods: A single center, retrospective cohort study involving a total of 38 patients undergoing surgical intervention between 2010 and 2013 for degenerative disc disease of lumbar spine at single L4/L5 level. 18 patients were treated with MIS TLIF, and 20 patients were treated with XLIF. Results: The XLIF group showed shorter duration of surgery compared to the TLIF group (176 mins vs. 208.3 mins, P = 0.03). Length of hospital stay was also significantly shorter in XLIF group (5.9 days vs. 9 days, p = 0.03). Intraoperative blood loss was favouring XLIF as 85% patients had blood loss less than 100cc compared to 58% in the TLIF group (P = 0.03). Radiologically, disc height was significantly improved post operatively in the XLIF group compared to the TLIF group (0.56mm vs. 0.39mm, P = 0.01). Foraminal height increment was also higher in the XLIF group (0.58mm vs. 0.45mm , P = 0.06). Clinically, back pain and leg pain improved in 85% of patients in the XLIF group and 78% in the TLIF group. Post op hip flexion weakness was more common in the XLIF group (40%) than in the TLIF group (0%). However, this weakness resolved within 6 months post operatively. There was one case of dural tear and surgical site infection in the TLIF group respectively and none in the XLIF group. Visual Analog Scale (VAS) score 6 months post operatively showed comparable reduction in both groups. TLIF group had Owsterty Disability Index (ODI) improvement on 67% while XLIF group showed improvement of 70% of its patients. Conclusions: Lateral approach surgery shows comparable clinical outcomes in resolution of back pain and radiculopathy to conventional MIS techniques such as TLIF. With significantly shorter duration of surgical time, minimal blood loss and shorter hospital stay, XLIF seems to be a reasonable MIS option compared to other MIS techniques in treating degenerative lumbar disc diseases.

Keywords: extreme lateral interbody fusion, lateral approach, minimally invasive, XLIF

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Authors: Jay L. Fu

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Patients with Alzheimer's disease progressively lose their memory and thinking skills and, eventually, the ability to carry out simple daily tasks. The disease is irreversible, but early detection and treatment can slow down the disease progression. In this research, publicly available MRI data and demographic data from 373 MRI imaging sessions were utilized to build models to predict dementia. Various machine learning models, including logistic regression, k-nearest neighbor, support vector machine, random forest, and neural network, were developed. Data were divided into training and testing sets, where training sets were used to build the predictive model, and testing sets were used to assess the accuracy of prediction. Key risk factors were identified, and various models were compared to come forward with the best prediction model. Among these models, the random forest model appeared to be the best model with an accuracy of 90.34%. MMSE, nWBV, and gender were the three most important contributing factors to the detection of Alzheimer’s. Among all the models used, the percent in which at least 4 of the 5 models shared the same diagnosis for a testing input was 90.42%. These machine learning models allow early detection of Alzheimer’s with good accuracy, which ultimately leads to early treatment of these patients.

Keywords: Alzheimer's disease, clinical diagnosis, magnetic resonance imaging, machine learning prediction

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Authors: Bitewulign Mekonnen

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Context: This scientific paper focuses on the use of near-infrared (NIR) spectroscopy to determine glucose concentration in aqueous solutions accurately and rapidly. The study compares six different machine learning methods for predicting glucose concentration and also explores the development of a deep learning model for classifying NIR spectra. The objective is to optimize the detection model and improve the accuracy of glucose prediction. This research is important because it provides a comprehensive analysis of various machine-learning techniques for estimating aqueous glucose concentrations. Research Aim: The aim of this study is to compare and evaluate different machine-learning methods for predicting glucose concentration from NIR spectra. Additionally, the study aims to develop and assess a deep-learning model for classifying NIR spectra. Methodology: The research methodology involves the use of machine learning and deep learning techniques. Six machine learning regression models, including support vector machine regression, partial least squares regression, extra tree regression, random forest regression, extreme gradient boosting, and principal component analysis-neural network, are employed to predict glucose concentration. The NIR spectra data is randomly divided into train and test sets, and the process is repeated ten times to increase generalization ability. In addition, a convolutional neural network is developed for classifying NIR spectra. Findings: The study reveals that the SVMR, ETR, and PCA-NN models exhibit excellent performance in predicting glucose concentration, with correlation coefficients (R) > 0.99 and determination coefficients (R²)> 0.985. The deep learning model achieves high macro-averaging scores for precision, recall, and F1-measure. These findings demonstrate the effectiveness of machine learning and deep learning methods in optimizing the detection model and improving glucose prediction accuracy. Theoretical Importance: This research contributes to the field by providing a comprehensive analysis of various machine-learning techniques for estimating glucose concentrations from NIR spectra. It also explores the use of deep learning for the classification of indistinguishable NIR spectra. The findings highlight the potential of machine learning and deep learning in enhancing the prediction accuracy of glucose-relevant features. Data Collection and Analysis Procedures: The NIR spectra and corresponding references for glucose concentration are measured in increments of 20 mg/dl. The data is randomly divided into train and test sets, and the models are evaluated using regression analysis and classification metrics. The performance of each model is assessed based on correlation coefficients, determination coefficients, precision, recall, and F1-measure. Question Addressed: The study addresses the question of whether machine learning and deep learning methods can optimize the detection model and improve the accuracy of glucose prediction from NIR spectra. Conclusion: The research demonstrates that machine learning and deep learning methods can effectively predict glucose concentration from NIR spectra. The SVMR, ETR, and PCA-NN models exhibit superior performance, while the deep learning model achieves high classification scores. These findings suggest that machine learning and deep learning techniques can be used to improve the prediction accuracy of glucose-relevant features. Further research is needed to explore their clinical utility in analyzing complex matrices, such as blood glucose levels.

Keywords: machine learning, signal processing, near-infrared spectroscopy, support vector machine, neural network

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Authors: Yasuyuki Takahashi, Hayato Ishimura, Masao Miyagawa, Teruhito Mochizuki

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Quantitative measurement of myocardium perfusion is possible with single photon emission computed tomography (SPECT) using a semiconductor detector. However, accumulation of ^99mTc-tetrofosmin in the liver may make it difficult to assess that accurately in the inferior myocardium. Our idea is to reduce the high accumulation in the liver by using dynamic SPECT imaging and a technique called time subtraction. We evaluated the performance of a new SPECT system with a cadmium-zinc-telluride solid-state semi- conductor detector (Discovery NM 530c; GE Healthcare). Our system acquired list-mode raw data over 10 minutes for a typical patient. From the data, ten SPECT images were reconstructed, one for every minute of acquired data. Reconstruction with the semiconductor detector was based on an implementation of a 3-D iterative Bayesian reconstruction algorithm. We studied 20 patients with coronary artery disease (mean age 75.4 ± 12.1 years; range 42-86; 16 males and 4 females). In each subject, 259 MBq of ^99mTc-tetrofosmin was injected intravenously. We performed both a phantom and a clinical study using dynamic SPECT. An approximation to a liver-only image is obtained by reconstructing an image from the early projections during which time the liver accumulation dominates (0.5~2.5 minutes SPECT image-5~10 minutes SPECT image). The extracted liver-only image is then subtracted from a later SPECT image that shows both the liver and the myocardial uptake (5~10 minutes SPECT image-liver-only image). The time subtraction of liver was possible in both a phantom and the clinical study. The visualization of the inferior myocardium was improved. In past reports, higher accumulation in the myocardium due to the overlap of the liver is un-diagnosable. Using our time subtraction method, the image quality of the ^99mTc-tetorofosmin myocardial SPECT image is considerably improved.

Keywords: 99mTc-tetrofosmin, dynamic SPECT, time subtraction, semiconductor detector

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Authors: Boon Lee

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Research publication is an essential output of universities because it not only promotes university recognition, it also receives government funding. The history of university research culture has been one of ‘publish or perish’ and universities have consistently encouraged their academics and researchers to produce research articles in reputable journals in order to maintain a level of competitiveness. In turn, the United Kingdom (UK) government funding is determined by the number and quality of research publications. This paper aims to investigate on whether more government funding leads to more quality papers. To that end, the paper employs a Network DEA model to evaluate the UK higher education performance over a period. Sources of efficiency are also determined via second stage regression analysis.

Keywords: efficiency, higher education, network data envelopment analysis, universities

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Authors: V. N. Chebotkevich, E. E. Schetinkina, V. V. Burylev, E. I. Kaytandzhan, N. P. Stizhak

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Objective: Blood stream infections (BSI) are severe, life-threatening illness for immuno compromised patients with hematological malignancies. We report the trend in blood-stream infections in this group of patients in the period 1991-2013. Methods: A total of 4742 blood samples investigated. All blood cultures were incubated in a continuous monitoring system for 7 days before discarding negative. On signaled positive, organism was identified by conventional methods. The Real-time polymerase chain reaction (PCR) was used for the indication of human herpes virus 6 (HHV-6), Cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Results: Between 1991 and 2001 the incidence of Gram-positive bacteria (Staphylococcus epidermidis, Staphylococcus aureus) being the most common germs isolated (70,9%) were as Gram-negative rods (Escherichia coli, Klebsiella spp., Pseudomonas spp.) – 29,1%. In next decade 2002-2012 the number of Gram-negative bacteria was increased up to 40.2%. It is shown that the incidence of bacteremia was significantly more frequent at the background of detectable Cytomegalovirus and Epstein-Barr virus-specific DNA in blood. Over recent years, an increased frequency of micro mycetes was registered in blood of the patients with hematological malignancies (Candida spp. was predominant). Conclusion: Accurate and timely detection of BSI is important in determining appropriate treatment of infectious complications in patients with hematological malignancies. The isolation of Staphylococcus epidermidis from blood cultures remains a clinical dilemma for physicians and microbiologists. But in many cases this agent is of the clinical significance in immunocompromised patients with hematological malignancies. The role of CMV and EBV in development of bacteremia was demonstrated.

Keywords: infectious complications, blood stream infections, bacteremia, hemoblastosis

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Authors: Asma Khalid

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Children’s drawings are unique as children are. Children manifest their happiness, sadness, future dreams, likes, dislikes through drawings. Research with children aged 8-12 was conducted in 2017 in which it was asked to them ‘what they think about child-friendly cities?’ The focus was to get ideas from children about the cities in which they live and what they want in their cities. The research was conducted in different private schools. Children were accessed through teachers and principals of the schools (the gatekeepers). Consent forms were developed for children which contained information about the research project and their consent was taken on paper. It was ensured that children are not forced to take part in the research and they can leave the research whenever they want, without informing anyone. The qualitative participatory approach was taken where children were given papers and colors to draw their ideas. During the research, it was found that children are interested in showing their emotions and liking through drawing as this medium seems easy and comfortable to them as compared to have the individual face to face interviews or participate in surveys. However, the clarity of the ideas presented in the drawings was discussed at length with children in their school’s premises. Results of the research show that children like to live in clean, green places which are also safe for them. Furthermore, they want to live with their families and want to have recreational activities including parks in their nearby vicinity.

Keywords: qualitative participative research clean, children, drawing, clean, green and protected place, family

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Authors: Bassma A. Abdelhaleem, Mamdouh A. Abdulrhman, Nagwa I. Mohamed

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Malnutrition in children is an increasing problem worldwide which may result in both short and long-term irreversible negative health outcomes. Severe Acute Malnutrition (SAM) affects more than 18 million children each year, mostly living in low-income settings. SAM contributes to 45% of all deaths in children less than five years of age. Honey is a natural sweetener, containing mainly monosaccharides (up to 80%), disaccharides (3–5%), water (17–20%), and a wide range of minor constituents such as vitamins, minerals, proteins, amino acids, enzymes, and phytochemicals, mainly phenolic acids, and flavonoids. Honey has been used in many cultures around the world due to its known nutritional and medicinal benefits including the treatment of hypercholesterolemia. Despite its use since ancient times yet little is known about its potential benefits for malnourished children. Honey has the potential to be an affordable solution for malnourished low-income children as it is nutrient-dense and calorie dense food, easily absorbed, highly palatable, enhances appetite, and boosts immunity. This study assessed the effect of clover honey supplementation on the anthropometric measurements and lipid profile of malnourished infants and children. A prospective interventional clinical trial was conducted between November 2019 to November 2020, on 40 malnourished infants and children divided into two groups: Group A (20 children; 11 males and 9 females) received honey in a dose of 1.75ml/kg/dose, twice weekly for 12 weeks and Group B (20 children; 6 males and 14 females) received placebo. Written informed consent was obtained for parents/guardians. Patients were recruited from the Pediatric Nutrition Clinic at Ain Shams University. Anthropometric measurements (weight, height, body mass index, head circumference, and mid-arm circumference) and fasting serum cholesterol levels were measured at baseline and after 3 months. The 3-month honey consumption had a statistically highly significant effect on increasing weight, height, and body mass index and lowering fasting serum cholesterol levels in primary malnourished infants and children. Weight, height, body mass index, and fasting serum cholesterol level before honey consumption were (9.49 ± 2.03, 81.45 ± 8.31, 14.24 ± 2.15, 178.00 ± 20.91) and after 3 months of honey consumption were (10.91 ± 2.11, 84.80 ± 8.23, 15.07 ± 2.05, 162.45 ± 19.73) respectively with P-value < 0.01. Our results showed a significant desirable effect of honey consumption on changes in nutritional status based on weight, height, and body mass index, and has a favourable effect on lowering fasting serum cholesterol levels. These results propose the use of honey as an affordable solution to improve malnutrition, particularly in low-income countries. However, further research needs to weigh benefits against potential harms including the risk of botulinum toxin that is historically associated with honey consumption in early childhood.

Keywords: clinical trial, dyslipidemia, honey, malnutrition

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Authors: Ashit Syngle, Inderjit Verma, Pawan Krishan

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Therapeutic approaches used previously relied on disease-modifying antirheumatic drugs (DMARDs) that had only partial clinical benefit and were associated with significant toxicity. Spironolactone, an oral aldosterone antagonist, suppresses inflammatory mediators. Clinical efficacy of spironolactone compared with placebo in patients with active psoriatic arthritis despite treatment with prior traditional DMARDs. In the 24-week, placebo-controlled study patients (n=31) were randomized to placebo and spironolactone (2 m/kg/day). Patients on background concurrent DMARDs continued stable doses (methotrexate, leflunomide, and/or sulfasalazine). Primary outcome measures were the assessment of disease activity measures i.e. 28-joint disease activity score (DAS28) and diseases activity in psoriatic arthritis (DAPSA) at week 24. The key secondary endpoint was change from baseline in Health Assessment Questionnaire–Disability Index (HAQ-DI) at week 24. Additional efficacy outcome measures at week 24 included improvements in the markers of inflammation (ESR and CRP) and pro-inflammatory cytokines TNF-α, IL-6 and IL-1. At week 24, spironolactone significantly reduced disease activity measure DAS-28 (p<0.001) and DAPSA (p=0.001) compared with placebo. Significant improvements in key secondary measures HAQ-DI (disability index) were evident with spironolactone (p=0.02) versus placebo. After week 24, there was significant reduction in pro-inflammatory cytokines level TNF-α, IL-6 (p<0.01) as compared with placebo group. However, there was no significant improvement in IL-1 in both treatment and placebo groups. There were minor side effects which did not mandate stopping of spironolactone. No change in any biochemical profile was noted after spironolactone treatment. Spironolactone was effective in the treatment of PsA, improving disease activity, physical function and suppressing the level of pro-inflammatory cytokines. Spironolactone demonstrated an acceptable safety profile and was well tolerated.

Keywords: spironolactone, inflammation, inflammatory cytokine, psoriatic arthritis

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Authors: Adegoke Yinka Adebayo

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An understanding of the critical product attributes that impact on in vivo performance is key to the production of safe and effective medicines. Thus, a key driver for our research is the development of new basic science and technology underpinning the development of new pharmaceutical products. Research includes the structure and properties of drugs and excipients, biopharmaceutical characterisation, pharmaceutical processing and technology and formulation and analysis.

Keywords: drug discovery, drug development, drug delivery

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Authors: Athena Johnson

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Veganism has seen a rapid increase in members over recent years. Understanding the mechanisms of social change associated with these dietary practices in relation to gender is significant as these groups may seem small, but they have a large impact as they influence many and change the food market. This research article's basic methodology is primarily a deep article research literature review with empirical research. The research findings show that the popularity of veganism is growing, in large part due to the extensive use of social media, which dispels longstanding gendered connotations with food, such as the correlations between meat and masculinity.

Keywords: diversity, gender roles, social media, veganism

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Authors: Krisada Sungkhamanee

Abstract:

The objectives of this research are to know the management form of Samut Songkram lodging entrepreneurs with sufficient economy framework, to know the threat that affect this business and drawing the fit model for this province in order to sustain their business with Samut Songkram style. What will happen if they do not use this philosophy? Will they have a cash short fall? The data and information are collected by informal discussion with 8 managers and 400 questionnaires. We will use a mix of methods both qualitative research and quantitative research for our study. Bent Flyvbjerg’s phronesis is utilized for this analysis. Our research will prove that sufficient economy can help small and medium business firms solve their problems. We think that the results of our research will be a financial model to solve many problems of the entrepreneurs and this way will use to practice in other areas of our country.

Keywords: Samut Songkram, hospitality business, sufficient economy philosophy, style

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Authors: Iris Xiaohong Quan

Abstract:

The global digital health market reached 175 billion U.S. dollars in 2019, and is expected to grow at about 25% CAGR to over 650 billion USD by 2025. Different terms such as digital health, e-health, mHealth, telehealth have been used in the field, which can sometimes cause confusion. The term digital health was originally introduced to refer specifically to the use of interactive media, tools, platforms, applications, and solutions that are connected to the Internet to address health concerns of providers as well as consumers. While mHealth emphasizes the use of mobile phones in healthcare, telehealth means using technology to remotely deliver clinical health services to patients. According to FDA, “the broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.” Some researchers believe that digital health is nothing else but the cultural transformation healthcare has been going through in the 21st century because of digital health technologies that provide data to both patients and medical professionals. As digital health is burgeoning, but research in the area is still inadequate, our paper aims to clear the definition confusion and provide an overall picture of digital health companies. We further investigate how business models are designed and differentiated in the emerging digital health sector. Both quantitative and qualitative methods are adopted in the research. For the quantitative analysis, our research data came from two databases Crunchbase and CBInsights, which are well-recognized information sources for researchers, entrepreneurs, managers, and investors. We searched a few keywords in the Crunchbase database based on companies’ self-description: digital health, e-health, and telehealth. A search of “digital health” returned 941 unique results, “e-health” returned 167 companies, while “telehealth” 427. We also searched the CBInsights database for similar information. After merging and removing duplicate ones and cleaning up the database, we came up with a list of 1464 companies as digital health companies. A qualitative method will be used to complement the quantitative analysis. We will do an in-depth case analysis of three successful unicorn digital health companies to understand how business models evolve and discuss the challenges faced in this sector. Our research returned some interesting findings. For instance, we found that 86% of the digital health startups were founded in the recent decade since 2010. 75% of the digital health companies have less than 50 employees, and almost 50% with less than 10 employees. This shows that digital health companies are relatively young and small in scale. On the business model analysis, while traditional healthcare businesses emphasize the so-called “3P”—patient, physicians, and payer, digital health companies extend to “5p” by adding patents, which is the result of technology requirements (such as the development of artificial intelligence models), and platform, which is an effective value creation approach to bring the stakeholders together. Our case analysis will detail the 5p framework and contribute to the extant knowledge on business models in the healthcare industry.

Keywords: digital health, business models, entrepreneurship opportunities, healthcare

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Authors: Yong Hwang, Kang Yeol Suh, Yundeok Jang, Tae Hoon Kim

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Introduction: Rhabdomyolysis is a syndrome characterized by muscle necrosis and the release of intracellular muscle constituents into the circulation. Acute kidney injury is a potential complication of severe rhabdomyolysis and the prognosis is substantially worse if renal failure develops. We try to identify the factors that were predictive of AKI in severe trauma patients with rhabdomyolysis. Methods: This retrospective study was conducted at the emergency department of a level Ⅰ trauma center. Patients enrolled that initial creatine phosphokinase (CPK) levels were higher than 1000 IU with acute multiple trauma, and more than 18 years older from Oct. 2012 to June 2016. We collected demographic data (age, gender, length of hospital day, and patients’ outcome), laboratory data (ABGA, lactate, hemoglobin. hematocrit, platelet, LDH, myoglobin, liver enzyme, and BUN/Cr), and clinical data (Injury Mechanism, RTS, ISS, AIS, and TRISS). The data were compared and analyzed between AKI and Non-AKI group. Statistical analyses were performed using IMB SPSS 20.0 statistics for Window. Results: Three hundred sixty-four patients were enrolled that AKI group were ninety-six and non-AKI group were two hundred sixty-eight. The base excess (HCO3), AST/ALT, LDH, and myoglobin in AKI group were significantly higher than non-AKI group from laboratory data (p ≤ 0.05). The injury severity score (ISS), revised Trauma Score (RTS), Abbreviated Injury Scale 3 and 4 (AIS 3 and 4) were showed significant results in clinical data. The patterns of CPK level were increased from first and second day, but slightly decreased from third day in both group. Seven patients had received hemodialysis treatment despite the bleeding risk and were survived in AKI group. Conclusion: We recommend that HCO3, CPK, LDH, and myoglobin should be checked and be concerned about ISS, RTS, AIS with injury mechanism at the early stage of treatment in the emergency department.

Keywords: acute kidney injury, emergencies, multiple trauma, rhabdomyolysis

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Authors: Merav Ben Natan, May Revach, Or Sade, Yaniv Yonay, Yaron Berkovich

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Background: The inclusion of nurse practitioners (NPs) specializing in orthopedics holds promise for enhancing the quality of care for orthopedic patients. Understanding patients’ perspectives on this role is crucial for evaluating the feasibility and acceptance of integrating NPs into orthopedic settings. This study aims to explore the receptiveness of orthopedic patients to treatment by orthopedic NPs and examines potential associations between patients’ willingness to engage with NPs, their familiarity with the NP role, perceptions of nursing, and satisfaction with orthopedic nursing care. Methods: This cross-sectional study involved patients admitted to an orthopedic department at a central Israeli hospital between January and February 2023. Data was collected using a validated questionnaire consisting of five sections, reviewed by content experts. Statistical analyses were conducted using SPSS and included descriptive statistics, independent samples t-tests, Pearson correlations, and linear regression. Results: Participants in the study showed a moderate willingness to receive treatment from orthopedic NPs, with more than two-thirds expressing strong openness. Patients were generally receptive to NPs performing various clinical tasks, though there was less enthusiasm for NPs’ involvement in medication management and preoperative evaluations. Positive attitudes towards nurses and familiarity with the NP role were significant predictors of patient receptiveness to NP treatment. Conclusion: Patient acceptance of orthopedic NPs varies across different aspects of care. While there is a general willingness to receive care from NPs, these nuanced preferences must be considered when implementing NPs in orthopedic settings. Awareness and positive perceptions of the NP role play crucial roles in shaping patients’ willingness to engage with NPs.

Keywords: orthopedic nurse practitioners, patient receptiveness, perceptions of nursing, clinical tasks

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Authors: Farhood Rismanchian, Seong Hyeon Park, Young Hoon Lee

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This paper proposes a method to optimize the layout of an emergency department (ED) based on real executions of care processes by considering several planning objectives simultaneously. Recently, demand for healthcare services has been dramatically increased. As the demand for healthcare services increases, so do the need for new healthcare buildings as well as the need for redesign and renovating existing ones. The importance of implementation of a standard set of engineering facilities planning and design techniques has been already proved in both manufacturing and service industry with many significant functional efficiencies. However, high complexity of care processes remains a major challenge to apply these methods in healthcare environments. Process mining techniques applied in this study to tackle the problem of complexity and to enhance care process analysis. Process related information such as clinical pathways extracted from the information system of an ED. A 0-1 goal programming approach is then proposed to find a single layout that simultaneously satisfies several goals. The proposed model solved by optimization software CPLEX 12. The solution reached using the proposed method has 42.2% improvement in terms of walking distance of normal patients and 47.6% improvement in walking distance of critical patients at minimum cost of relocation. It has been observed that lots of patients must unnecessarily walk long distances during their visit to the emergency department because of an inefficient design. A carefully designed layout can significantly decrease patient walking distance and related complications.

Keywords: healthcare operation management, goal programming, facility layout problem, process mining, clinical processes

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Authors: Ms. Patamasuda Intuprapa , Professor Dr. Nancy Longnecker

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This research examines the impact of biodiversity and wildlife conservation messages on school children. It was designed to document science communication activities that relate to biodiversity and wildlife conservation in a residential camp held at Research Station X in Thailand. This research is one of the case studies in a PhD research project. The objectives of this research are to examine environmental program and ultimately develop a model of communicating biodiversity and wildlife conservation issues to Thai children. Observations and report of the surveys were used to examine the residential camp at Research Station X. There were 49 children and five camp leaders agreed to participate in this study. The results of the study show that the children enjoyed their stay at the camp and have positive attitudes toward wildlife and environment but not actually related them with their own well-being. The camp leaders were well prepared and enthusiastic on leading the camp but fail in related contents with the activities.

Keywords: informal education, environmental education, wildlife conservation, residential camp, excursion, Thailand

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Authors: Ramuel Spirituel Mattathiah A. San Juan, Neil Ambasing

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Background: Reversal of vision metamorphopsia is a transient form of metamorphopsia described as an upside-down alteration of the visual field in the coronal plane. Patients would describe objects, such as cups, upside down, but the tea would not spill, and people would walk on their heads. It is extremely rare as a stable finding, lasting days or weeks. We report a case wherein this type of metamorphopsia occurred only in written words and lasted for six months. Objective: To the best of our knowledge, we report the first rare occurrence of reversal of vision metamorphopsia described as inverted words as the sole initial presentation of an underlying stroke. Case Presentation: We report a 59-year-old male with poorly controlled hypertension and diabetes mellitus who presented with a 3-day history of difficulty reading, described as the words were turned upside down as if the words were inverted horizontally then with the progression of deficits such as right homonymous hemianopia and achromatopsia, prosopagnosia. Cranial magnetic resonance imaging (MRI) revealed an acute infarct on the left posterior cerebral artery territory. Follow-up after six months revealed improvement of the visual field cut but with the persistence of the higher cortical function deficits. Conclusion: We report the first rare occurrence of metamorphopsia described as purely inverted words as the sole initial presentation of an underlying stroke. The differential diagnoses of a patient presenting with text reversal metamorphopsia should include stroke in the occipitotemporal areas. It further expands the landscape of metamorphopsias due to its exclusivity to written words and prolonged duration. Knowing these clinical features will help identify the lesion locus and improve subsequent stroke care, especially in time-bound management like intravenous thrombolysis.

Keywords: rare presentation, text reversal metamorphopsia, ischemic stroke, stroke

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Authors: Hadj Abd El Kader Benghenia, Fethi Bereksi Reguig

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In clinical medicine, blood pressure, raised blood hemodynamic monitoring is rich pathophysiological information of cardiovascular system, of course described through factors such as: blood volume, arterial compliance and peripheral resistance. In this work, we are interested in analyzing these signals to propose a detection algorithm to delineate the different sequences and especially systolic blood pressure (SBP), diastolic blood pressure (DBP), and the wave and dicrotic to do their analysis in order to extract the cardiovascular parameters.

Keywords: blood pressure, SBP, DBP, detection algorithm

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