Search results for: clinical indicator (CI)
Commenced in January 2007
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Edition: International
Paper Count: 4278

Search results for: clinical indicator (CI)

4038 Calculation the Left Ventricle Wall Radial Strain and Radial SR Using Tagged Magnetic Resonance Imaging Data (tMRI)

Authors: Mohammed Alenezy

Abstract:

The function of cardiac motion can be used as an indicator of the heart abnormality by evaluating longitudinal, circumferential, and Radial Strain of the left ventricle. In this paper, the Radial Strain and SR is studied using tagged MRI (tMRI) data during the cardiac cycle on the mid-ventricle level of the left ventricle. Materials and methods: The short-axis view of the left ventricle of five healthy human (three males and two females) and four healthy male rats were imaged using tagged magnetic resonance imaging (tMRI) technique covering the whole cardiac cycle on the mid-ventricle level. Images were processed using Image J software to calculate the left ventricle wall Radial Strain and radial SR. The left ventricle Radial Strain and radial SR were calculated at the mid-ventricular level during the cardiac cycle. The peak Radial Strain for the human and rat heart was 40.7±1.44, and 46.8±0.68 respectively, and it occurs at 40% of the cardiac cycle for both human and rat heart. The peak diastolic and systolic radial SR for human heart was -1.78 s-1 ± 0.02 s-1 and 1.10±0.08 s-1 respectively, while for rat heart it was -5.16± 0.23s-1 and 4.25±0.02 s-1 respectively. Conclusion: This results show the ability of the tMRI data to characterize the cardiac motion during the cardiac cycle including diastolic and systolic phases which can be used as an indicator of the cardiac dysfunction by estimating the left ventricle Radial Strain and radial SR at different locations of the cardiac tissue. This study approves the validity of the tagged MRI data to describe accurately the cardiac radial motion.

Keywords: left ventricle, radial strain, tagged MRI, cardiac cycle

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4037 Clinical Efficacy of Nivolumab and Ipilimumab Combination Therapy for the Treatment of Advanced Melanoma: A Systematic Review and Meta-Analysis of Clinical Trials

Authors: Zhipeng Yan, Janice Wing-Tung Kwong, Ching-Lung Lai

Abstract:

Background: Advanced melanoma accounts for the majority of skin cancer death due to its poor prognosis. Nivolumab and ipilimumab are monoclonal antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocytes antigen 4 (CTLA-4). Nivolumab and ipilimumab combination therapy has been proven to be effective for advanced melanoma. This systematic review and meta-analysis are to evaluate its clinical efficacy and adverse events. Method: A systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) on 21 June 2020. Search keywords were nivolumab, ipilimumab, melanoma, and randomised controlled trials. Clinical trials fulfilling the inclusion criteria were selected to evaluate the efficacy of combination therapy in terms of prolongation of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The odd ratios and distributions of grade 3 or above adverse events were documented. Subgroup analysis was performed based on PD-L1 expression-status and BRAF-mutation status. Results: Compared with nivolumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR in combination therapy were 0.64 (95% CI, 0.48-0.85; p=0.002), 0.84 (95% CI, 0.74-0.95; p=0.007) and 1.76 (95% CI, 1.51-2.06; p < 0.001), respectively. Compared with ipilimumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR were 0.46 (95% CI, 0.37-0.57; p < 0.001), 0.54 (95% CI, 0.48-0.61; p < 0.001) and 6.18 (95% CI, 5.19-7.36; p < 0.001), respectively. In combination therapy, the odds ratios of grade 3 or above adverse events were 4.71 (95% CI, 3.57-6.22; p < 0.001) compared with nivolumab monotherapy, and 3.44 (95% CI, 2.49-4.74; p < 0.001) compared with ipilimumab monotherapy, respectively. High PD-L1 expression level and BRAF mutation were associated with better clinical outcomes in patients receiving combination therapy. Conclusion: Combination therapy is effective for the treatment of advanced melanoma. Adverse events were common but manageable. Better clinical outcomes were observed in patients with high PD-L1 expression levels and positive BRAF-mutation.

Keywords: nivolumab, ipilimumab, advanced melanoma, systematic review, meta-analysis

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4036 Distribution and Diversity of Pyrenocarpous Lichens in India with Special Reference to Forest Health

Authors: Gaurav Kumar Mishra, Sanjeeva Nayaka, Dalip Kumar Upreti

Abstract:

Our nature exhibited presence of a number of unique plants which can be used as indicator of environmental condition of particular place. Lichens are unique plant which has an ability to absorb not only organic, inorganic and metaloties but also absorb radioactive nuclide substances present in the environment. In the present study pyrenocarpous lichens will used as indicator of good forest health in a particular place. The Pyrenocarpous lichens are simple crust forming with black dot like perithecia have few characters for their taxonomical segregation as compared to their foliose and fruticose brethrean. The thallus colour and nature, presence and absence of hypothallus are only few characters of thallus are used to segregate the pyrenocarpous taxa. The fruiting bodies of pyrenolichens i.e. ascocarps are perithecia. The perithecia and the contents found within them posses many important criteria for the segregation of pyrenocarpous lichen taxa. The ascocarp morphology, ascocarp arrangement, the perithecial wall, ascocarp shape and colour, ostiole shape and position, ostiole colour, ascocarp anatomy including type of paraphyses, asci shape and size, ascospores septation, ascospores wall and periphyses are the valuable charcters used for segregation of different pyrenocarpous lichen taxa. India is represented by the occurrence of the 350 species of 44 genera and eleven families. Among the different genera Pyrenula is dominant with 82 species followed by the Porina with 70 species. Recently, systematic of the pyrenocarpous lichens have been revised by American and European lichenologists using phylogenetic methods. Still the taxonomy of pyrenocarpous lichens is in flux and information generated after the completion of this study will play vital role in settlement of the taxonomy of this peculiar group of lichens worldwide. The Indian Himalayan region exhibit rich diversity of pyrenocarpous lichens in India. The western Himalayan region has luxuriance of pyrenocarpous lichens due to its unique topography and climate condition. However, the eastern Himalayan region has rich diversity of pyrenocarpous lichens due to its warmer and moist climate condition. The rich moist and warmer climate in eastern Himalayan region supports forest with dominance of evergreen tree vegetation. The pyrenocarpous lichens communities are good indicator of young and regenerated forest type. The rich diversity of lichens clearly indicates that moist of the forest within the eastern Himalayan region has good health of forest. Due to fast pace of urbanization and other developmental activities will defiantly have adverse effects on the diversity and distribution of pyrenocarpous lichens in different forest type and the present distribution pattern will act as baseline data for carried out future biomonitoring studies in the area.

Keywords: lichen diversity, indicator species, environmental factors, pyrenocarpous

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4035 Artificial Intelligence in Disease Diagnosis

Authors: Shalini Tripathi, Pardeep Kumar

Abstract:

The method of translating observed symptoms into disease names is known as disease diagnosis. The ability to solve clinical problems in a complex manner is critical to a doctor's effectiveness in providing health care. The accuracy of his or her expertise is crucial to the survival and well-being of his or her patients. Artificial Intelligence (AI) has a huge economic influence depending on how well it is applied. In the medical sector, human brain-simulated intellect can help not only with classification accuracy, but also with reducing diagnostic time, cost and pain associated with pathologies tests. In light of AI's present and prospective applications in the biomedical, we will identify them in the paper based on potential benefits and risks, social and ethical consequences and issues that might be contentious but have not been thoroughly discussed in publications and literature. Current apps, personal tracking tools, genetic tests and editing programmes, customizable models, web environments, virtual reality (VR) technologies and surgical robotics will all be investigated in this study. While AI holds a lot of potential in medical diagnostics, it is still a very new method, and many clinicians are uncertain about its reliability, specificity and how it can be integrated into clinical practice without jeopardising clinical expertise. To validate their effectiveness, more systemic refinement of these implementations, as well as training of physicians and healthcare facilities on how to effectively incorporate these strategies into clinical practice, will be needed.

Keywords: Artificial Intelligence, medical diagnosis, virtual reality, healthcare ethical implications 

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4034 An Algorithm Based on Control Indexes to Increase the Quality of Service on Cellular Networks

Authors: Rahman Mofidi, Sina Rahimi, Farnoosh Darban

Abstract:

Communication plays a key role in today’s world, and to support it, the quality of service has the highest priority. It is very important to differentiate between traffic based on priority level. Some traffic classes should be a higher priority than other classes. It is also necessary to give high priority to customers who have more payment for better service, however, without influence on other customers. So to realize that, we will require effective quality of service methods. To ensure the optimal performance of the network in accordance with the quality of service is an important goal for all operators in the mobile network. In this work, we propose an algorithm based on control parameters which it’s based on user feedback that aims at minimizing the access to system transmit power and thus improving the network key performance indicators and increasing the quality of service. This feedback that is known as channel quality indicator (CQI) indicates the received signal level of the user. We aim at proposing an algorithm in control parameter criterion to study improving the quality of service and throughput in a cellular network at the simulated environment. In this work we tried to parameter values have close to their actual level. Simulation results show that the proposed algorithm improves the system throughput and thus satisfies users' throughput and improves service to set up a successful call.

Keywords: quality of service, key performance indicators, control parameter, channel quality indicator

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4033 Early Detection of Neuropathy in Leprosy-Comparing Clinical Tests with Nerve Conduction Study

Authors: Suchana Marahatta, Sabina Bhattarai, Bishnu Hari Paudel, Dilip Thakur

Abstract:

Background: Every year thousands of patients develop nerve damage and disabilities as a result of leprosy which can be prevented by early detection and treatment. So, early detection and treatment of nerve function impairment is of paramount importance in leprosy. Objectives: To assess the electrophysiological pattern of the peripheral nerves in leprosy patients and to compare it with clinical assessment tools. Materials and Methods: In this comparative cross-sectional study, 74 newly diagnosed leprosy patients without reaction were enrolled. They underwent thorough evaluation for peripheral nerve function impairment using clinical tests [i.e. nerve palpation (NP), monofilament (MF) testing, voluntary muscle testing (VMT)] and nerve conduction study (NCS). Clinical findings were compared with that of NCS using SPSS version 11.5. Results: NCS was impaired in 43.24% of leprosy patient at the baseline. Among them, sensory NCS was impaired in more patients (32.4%) in comparison to motor NCS (20.3%). NP, MF, and VMT were impaired in 58.1%, 25.7%, and 9.4% of the patients, respectively. Maximum concordance of monofilament testing and sensory NCS was found for sural nerve (14.7%). Likewise, the concordance of motor NP and motor NCS was the maximum for ulnar nerve (14.9%). When individual parameters of the NCS were considered, amplitude was found to be the most frequently affected parameter for both sensory and motor NCS. It was impaired in 100% of cases with abnormal NCS findings. Conclusion: Since there was no acceptable concordance between NCS findings and clinical findings, we should consider NCS whenever feasible for early detection of neuropathy in leprosy. The amplitude of both sensory nerve action potential (SNAP) and compound nerve action potential (CAMP) could be important determinants of the abnormal NCS if supported by further studies.

Keywords: leprosy, nerve function impairment, neuropathy, nerve conduction study

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4032 Utilization of Standard Paediatric Observation Chart to Evaluate Infants under Six Months Presenting with Non-Specific Complaints

Authors: Michael Zhang, Nicholas Marriage, Valerie Astle, Marie-Louise Ratican, Jonathan Ash, Haddijatou Hughes

Abstract:

Objective: Young infants are often brought to the Emergency Department (ED) with a variety of complaints, some of them are non-specific and present as a diagnostic challenge to the attending clinician. Whilst invasive investigations such as blood tests and lumbar puncture are necessary in some cases to exclude serious infections, some basic clinical tools in additional to thorough clinical history can be useful to assess the risks of serious conditions in these young infants. This study aimed to examine the utilization of one of clinical tools in this regard. Methods: This retrospective observational study examined the medical records of infants under 6 months presenting to a mixed urban ED between January 2013 and December 2014. The infants deemed to have non-specific complaints or diagnoses by the emergency clinicians were selected for analysis. The ones with clear systemic diagnoses were excluded. Among all relevant clinical information and investigation results, utilization of Standard Paediatric Observation Chart (SPOC) was particularly scrutinized in these medical records. This specific chart was developed by the expert clinicians in local health department. It categorizes important clinical signs into some color-coded zones as a visual cue for serious implication of some abnormalities. An infant is regarded as SPOC positive when fulfills 1 red zone or 2 yellow zones criteria, and the attending clinician would be prompted to investigate and treat for potential serious conditions accordingly. Results: Eight hundred and thirty-five infants met the inclusion criteria for this project. The ones admitted to the hospital for further management were more likely to have SPOC positive criteria than the discharged infants (Odds ratio: 12.26, 95% CI: 8.04 – 18.69). Similarly, Sepsis alert criteria on SPOC were positive in a higher percentage of patients with serious infections (56.52%) in comparison to those with mild conditions (15.89%) (p < 0.001). The SPOC sepsis criteria had a sensitivity of 56.5% (95% CI: 47.0% - 65.7%) and a moderate specificity of 84.1% (95% CI: 80.8% - 87.0%) to identify serious infections. Applying to this infant population, with a 17.4% prevalence of serious infection, the positive predictive value was only 42.8% (95% CI: 36.9% - 49.0%). However, the negative predictive value was high at 90.2% (95% CI: 88.1% - 91.9%). Conclusions: Standard Paediatric Observation Chart has been applied as a useful clinical tool in the clinical practice to help identify and manage young sick infants in ED effectively.

Keywords: clinical tool, infants, non-specific complaints, Standard Paediatric Observation Chart

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4031 Investigation of Biofilm Formation in Clinical Strains of Klebsiella pneumoniae and Klebsiella rhinoscleromatis

Authors: Gulcan Sahal, Nermin Hande Avcioglu, Isil Seyis Bilkay

Abstract:

Klebsiella species which are natural colonizers of human upper respiratory and human gastrointestinal tracts are also responsible for every reoccurring nosocomial infections by means of having ability to form slimy layers known as biofilm on many surfaces. Therefore, in this study, investigation of biofilm formation in K. pneumoniae and K. rhinoscleromatis and examination of each Klebsiella strains’ clinical information in the light of their biofilm formation results were aimed. In this respect, biofilm formation of Klebsiella strains was analyzed via crystal violet binding assay. According to our results, biofilm formation levels of K. pneumoniae and K. rhinoscleromatis strains were different from each other. Additionally, in comparison to K. rhinoscleromatis strains, K. pneumoniae was observed to include higher amounts of strong biofilm forming strains. Besides, it was also seen that clinical information of patients from which strong biofilm forming Klebsiella strains were isolated were similar to each other. Our results indicate that there should be more precautions against K. pneumoniae which includes higher amount of strong biofilm forming strains.

Keywords: biofilm formation, Klebsiella pneumoniae, Klebsiella rhinoscleromatis, biosystems engineering

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4030 Establishing Quality Evaluation Indicators of Early Education Center for 0~3 Years Old

Authors: Lina Feng

Abstract:

The study aimed at establishing quality evaluation indicators of an early education center for 0~3 years old, and defining the weight system of it. Expert questionnaire and Fuzzy Delphi method were applied. Firstly, in order to ensure the indicators in accordance with the practice of early education, 16 experts were invited as respondents to a preliminary Expert Questionnaire about Quality Evaluation Indicators of Early Education Center for 0~3 Years Old. The indicators were based on relevant studies on quality evaluation indicators of early education centers in China and abroad. Secondly, 20 scholars, kindergarten principals, and educational administrators were invited to form a fuzzy Delphi expert team. The experts’ opinions on the importance of indicators were calculated through triangle fuzzy numbers in order to select appropriate indicators and calculate indicator weights. This procedure resulted in the final Quality Evaluation Indicators of Early education Center for 0~3 Years Old. The Indicators contained three major levels, including 6 first-level indicators, 30 second-level indicators, and 147 third-level indicators. The 6 first-level indicators were health and safety; educational and cultivating activities; development of babies; conditions of the center; management of the center; and collaboration between family and the community. The indicators established by this study could provide suggestions for the high-quality environment for promoting the development of early year children.

Keywords: early education center for 0~3 years old, educational management, fuzzy delphi method, quality evaluation indicator

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4029 Expression of Metallothionein Gen and Protein on Hepatopancreas, Gill and Muscle of Perna viridis Caused by Biotoxicity Hg, Pb and Cd

Authors: Yulia Irnidayanti , J. J. Josua, A. Sugianto

Abstract:

Jakarta Bay with 13 rivers that flow into, the environment has deteriorated and is the most polluted bays in Asia. The entry of waste into the waters of the Bay of Jakarta has caused pollution. Heavy metal contamination has led to pollution levels and may cause toxicity to organisms that live in the sea, down to the cellular level and may affect the ecological balance. Various ways have been conducted to measure the impact of environmental degradation, such as by measuring the levels of contaminants in the environment, including measuring the accumulation of toxic compounds in the tissues of organisms. Biological responses or biomarkers known as a sensitive indicator but need relevant predictions. In heavy metal pollution monitoring, analysis of aquatic biota is very important from the analysis of the water itself. The content of metals in aquatic biota will usually always be increased from time to time due to the nature of metal bioaccumulation, so the aquatic biota is best used as an indicator of metal pollution in aquatic environments. The results of the content analysis results of sea water in coastal estuaries Angke, Kaliadem and Panimbang detected heavy metals cadmium, mercury, lead, but did not find zinc metal. Based on the results of protein electrophoresis methallotionein found heavy metals in the tissues hepatopancreas, gills and muscles, and also the mRNA expression of has detected.

Keywords: gills, heavy metal, hepatopancreas, metallothionein, muscle

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4028 Analysis of Energy Efficiency Behavior with the Use of Train Dynamics Simulator and Statistical Tools: Case Study of Vitoria Minas Railway, Brazil

Authors: Eric Wilson Santos Cabral, Marta Monteiro Da Costa Cruz, Fabio Luis Maciel Machado, Henrique Andrade, Rodrigo Pirola Pestana, Vivian Andrea Parreira

Abstract:

The large variation in the price of diesel in Brazil directly affects the variable cost of companies operating in the transportation sector. In rail transport, the great challenge is to overcome the annual budget, cargo and ore transported with cost reduction in relation to previous years, becoming more efficient every year. Some effective measures are necessary to achieve the reduction of the liter ratio consumed by KTKB (Gross Ton per Kilometer multiplied by thousand). This acronym represents the indicator of energy efficiency of some railroads in the world. This study is divided into two parts: the first, to identify using statistical tools, part of the controlled variables in the railways, which have a correlation with the energy efficiency indicator, seeking to aid decision-making. The second, with the use of the train dynamics simulator, within scenarios defined in the operational reality of a railroad, seeks to optimize the train formations and the train stop model for the change of train drivers. With the completion of the study, companies in the rail sector are expected to be able to reduce some of their transportation costs.

Keywords: railway transport, railway simulation, energy efficiency, fuel consumption

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4027 Going beyond Stakeholder Participation

Authors: Florian Engel

Abstract:

Only with a radical change to an intrinsically motivated project team, through giving the employees the freedom for autonomy, mastery and purpose, it is then possible to develop excellent products. With these changes, combined with using a rapid application development approach, the group of users serves as an important indicator to test the market needs, rather than only as the stakeholders for requirements.

Keywords: intrinsic motivation, requirements elicitation, self-directed work, stakeholder participation

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4026 Impact of Serum Estrogen and Progesterone Levels in the Outcome Pregnancy Rate in Frozen Embryo Transfer Cycles. A Prospective Cohort Study

Authors: Sayantika Biswas, Dipanshu Sur, Amitoj Athwal, Ratnabali Chakravorty

Abstract:

Title: Impact of serum estrogen and progesterone levels in the outcome pregnancy rate in frozen embryo transfer cycles. A prospective cohort study Objective: The aim of the current study was to evaluate the effect of serum estradiol (E2) and progesterone (P4) levels at different time points on pregnancy outcomes in frozen embryo transfer (FET) cycles. Materials & Method: A prospective cohort study was performed in patients undergoing frozen embryo transfer. Patients under age 37 years of age with at least one good blastocyst or three good day 3 embryos were included in the study. For endometrial preparation, 14 days of oral estradiol use (2X2 mg for 5 days. 3X2 mg for 4 days, and 4X2 mg for 5 days) was followed by vaginal progesterone twice a day and 50 mg intramuscular progesterone twice a day. Embryo transfer was scheduled 72-76 hrs or 116-120hrs after the initiation of progesterone. Serum E2 and P4 levels were examined at 4 times a) at the start of the menstrual cycle prior to the hormone supplementation. b) on the day of P4 start. c) on the day of ET. d) on the third day after ET. Result: A total 41 women were included in this study (mean age 31.8; SD 2.8). Clinical pregnancy rate was 65.55%. Serum E2 levels on at the start of the menstrual cycle prior to the hormone supplementation and on the day of P4 start were high in patients who achieved pregnancy compared to who did not (P=0.005 and P=0.019 respectively). P4 levels on on the day of ET were also high in patients with clinical pregnancy. On the day of P4 start, a serum E2 threshold of 186.4 pg/ml had a sensitivity of 82%, and P4 had a sensitivity of 71% for the prediction of clinical pregnancy at the threshold value 16.00 ng/ml. Conclusion: In women undergoing FET with hormone replacement, serum E2 level >186.4 pg/ml on the day of the start of progesterone and serum P4 levels >16.00 ng/ml on embryo transfer day are associated with clinical pregnancy.

Keywords: serum estradiol, serum progesterone, clinical pregnancy, frozen embryo transfer

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4025 Antifungal Susceptibility of Yeasts Isolated from Clinical Samples from a Tertiary Hospital from State of Puebla

Authors: Ricardo Munguia-Perez, Nayeli Remigio-Alvarado, M.Miriam Hernandez-Arroyo, Elsa Castañeda-Roldan

Abstract:

Fungi have emerged as important pathogens causing morbidity and mortality mainly in immunosuppressed, malnourished and elderly patients. It has detected an increase in resistance to azoles primarily to fluconazol. The fungal infections have become a problem of public health for the resistance to antifungal agents, they have developed new antifungals with broad-spectrum. The aim of this study was determine the antifungal susceptibility of yeasts isolated from clinical samples (respiratory secretions, exudates, wounds, blood cultures, urine cultures) obtained from inpatients and outpatients of a tertiary hospital from State of Puebla. The antifungal susceptibility of the yeast from several clinical samples were determined by the CLS M44-A disk diffusion methods. 149 samples of yeast were analyzed. All species were 100% susceptible to nystatin and amphotericin B. Candida albicans showed resistance of 95.5 % to fluconazole, 50.7 % to 5-flurocytosine and 55.2 % intermediate susceptibility to ketoconazole. Candida glabrata 81.3 % was susceptibility to ketoconazole and 75 % to fluconazole, for the case of 5-flurocytosine the 56.3 % was susceptible. Candida krusei 100 % was susceptible to ketoconazole, 50 % to fluconazole and 37.5 % to 5-flurocytosine. The internal medicine have greater diversity of yeast, the samples have susceptibility of 64.7% to ketoconazole, 47.1 % to fluconazole and 27.5 % to 5-flurocytosine. Hospitalized patients are more resistant to fluconazole and nystatin, but in the case of outpatients presents resistance to ketoconazole.

Keywords: antifungal, susceptibility, yeast, clinical samples

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4024 Data-Driven Performance Evaluation of Surgical Doctors Based on Fuzzy Analytic Hierarchy Processes

Authors: Yuguang Gao, Qiang Yang, Yanpeng Zhang, Mingtao Deng

Abstract:

To enhance the safety, quality and efficiency of healthcare services provided by surgical doctors, we propose a comprehensive approach to the performance evaluation of individual doctors by incorporating insights from performance data as well as views of different stakeholders in the hospital. Exploratory factor analysis was first performed on collective multidimensional performance data of surgical doctors, where key factors were extracted that encompass assessment of professional experience and service performance. A two-level indicator system was then constructed, for which we developed a weighted interval-valued spherical fuzzy analytic hierarchy process to analyze the relative importance of the indicators while handling subjectivity and disparity in the decision-making of multiple parties involved. Our analytical results reveal that, for the key factors identified as instrumental for evaluating surgical doctors’ performance, the overall importance of clinical workload and complexity of service are valued more than capacity of service and professional experience, while the efficiency of resource consumption ranks comparatively the lowest in importance. We also provide a retrospective case study to illustrate the effectiveness and robustness of our quantitative evaluation model by assigning meaningful performance ratings to individual doctors based on the weights developed through our approach.

Keywords: analytic hierarchy processes, factor analysis, fuzzy logic, performance evaluation

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4023 Application of WHO's Guideline to Evaluating Apps for Smoking Cessation

Authors: Suin Seo, Sung-Il Cho

Abstract:

Background: The use of mobile apps for smoking cessation has grown exponentially in recent years. Yet, there were limited researches which evaluated the quality of smoking cessation apps to our knowledge. In most cases, a clinical practice guideline which is focused on clinical physician was used as an evaluation tool. Objective: The objective of this study was to develop a user-centered measure for quality of mobile smoking cessation apps. Methods: A literature search was conducted to identify articles containing explicit smoking cessation guideline for smoker published until January 2018. WHO’s guide for tobacco users to quit was adopted for evaluation tool which assesses smoker-oriented contents of smoking cessation apps. Compared to the clinical practice guideline, WHO guideline was designed for smokers (non-specialist). On the basis of existing criteria which was developed based on 2008 clinical practice guideline for Treating Tobacco Use and Dependence, evaluation tool was modified and developed by an expert panel. Results: There were five broad categories of criteria that were identified including five objective quality scales: enhancing motivation, assistance with a planning and making quit attempts, preparation for relapse, self-efficacy, connection to smoking. Enhancing motivation and assistance with planning and making quit attempts were similar to contents of clinical practice guideline, but preparation for relapse, self-efficacy and connection to smoking (environment or habit which reminds of smoking) only existed on WHO guideline. WHO guideline had more user-centered elements than clinical guideline. Especially, self-efficacy is the most important determinant of behavior change in accordance with many health behavior change models. With the WHO guideline, it is now possible to analyze the content of the app in the light of a health participant, not a provider. Conclusion: The WHO guideline evaluation tool is a simple, reliable and smoker-centered tool for assessing the quality of mobile smoking cessation apps. It can also be used to provide a checklist for the development of new high-quality smoking cessation apps.

Keywords: smoking cessation, evaluation, mobile application, WHO, guideline

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4022 Understanding the Prevalence and Expression of Virulence Factors Harbored by Enterotoxigenic Escherichia Coli

Authors: Debjyoti Bhakat, Indranil Mondal, Asish K. Mukhopadayay, Nabendu S. Chatterjee

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Enterotoxigenic Escherichia coli is one of the leading causes of diarrhea in infants and travelers in developing countries. Colonization factors play an important role in pathogenesis and are one of the main targets for Enterotoxigenic Escherichia coli (ETEC) vaccine development. However, ETEC vaccines had poorly performed in the past, as the prevalence of colonization factors is region-dependent. There are more than 25 classical colonization factors presently known to be expressed by ETEC, although all are not expressed together. Further, there are other multiple non-classical virulence factors that are also identified. Here the presence and expression of common classical and non-classical virulence factors were studied. Further studies were done on the expression of prevalent colonization factors in different strains. For the prevalence determination, multiplex polymerase chain reaction (PCR) was employed, which was confirmed by simplex PCR. Quantitative RT-PCR was done to study the RNA expression of these virulence factors. Strains negative for colonization factors expression were confirmed by SDS-PAGE. Among the clinical isolates, the most prevalent toxin was est+elt, followed by est and elt, while the pattern was reversed in the control strains. There were 29% and 40% strains negative for any classical colonization factors (CF) or non-classical virulence factors (NCVF) among the clinical and control strains, respectively. Among CF positive ETEC strains, CS6 and CS21 were the prevalent ones in the clinical strains, whereas in control strains, CS6 was the predominant one. For NCVF genes, eatA was the most prevalent among the clinical isolates and etpA for control. CS6 was the most expressed CF, and eatA was the predominantly expressed NCVF for both clinical and controlled ETEC isolates. CS6 expression was more in strains having CS6 alone. Different strains express CS6 at different levels. Not all strains expressed their respective virulence factors. Understanding the prevalent colonization factor, CS6, and its nature of expression will contribute to designing an effective vaccine against ETEC in this region of the globe. The expression pattern of CS6 also will help in examining the relatedness between the ETEC subtypes.

Keywords: classical virulence factors, CS6, diarrhea, enterotoxigenic escherichia coli, expression, non-classical virulence factors

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4021 Coffee Consumption and Glucose Metabolism: a Systematic Review of Clinical Trials

Authors: Caio E. G. Reis, Jose G. Dórea, Teresa H. M. da Costa

Abstract:

Objective: Epidemiological data shows an inverse association of coffee consumption with risk of type 2 diabetes mellitus. However, the clinical effects of coffee consumption on the glucose metabolism biomarkers remain controversial. Thus, this paper reviews clinical trials that evaluated the effects of coffee consumption on glucose metabolism. Research Design and Methods: We identified studies published until December 2014 by searching electronic databases and reference lists. We included randomized clinical trials which the intervention group received caffeinated and/or decaffeinated coffee and the control group received water or placebo treatments and measured biomarkers of glucose metabolism. The Jadad Score was applied to evaluate the quality of the studies whereas studies that scored ≥ 3 points were considered for the analyses. Results: Seven clinical trials (total of 237 subjects) were analyzed involving adult healthy, overweight and diabetic subjects. The studies were divided in short-term (1 to 3h) and long-term (2 to 16 weeks) duration. The results for short-term studies showed that caffeinated coffee consumption may increase the area under the curve for glucose response, while for long-term studies caffeinated coffee may improve the glycemic metabolism by reducing the glucose curve and increasing insulin response. These results seem to show that the benefits of coffee consumption occur in the long-term as has been shown in the reduction of type 2 diabetes mellitus risk in epidemiological studies. Nevertheless, until the relationship between long-term coffee consumption and type 2 diabetes mellitus is better understood and any mechanism involved identified, it is premature to make claims about coffee preventing type 2 diabetes mellitus. Conclusion: The findings suggest that caffeinated coffee may impairs glucose metabolism in short-term but in the long-term the studies indicate reduction of type 2 diabetes mellitus risk. More clinical trials with comparable methodology are needed to unravel this paradox.

Keywords: coffee, diabetes mellitus type 2, glucose, insulin

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4020 Patients' Quality of Life and Caregivers' Burden of Parkinson's Disease

Authors: Kingston Rajiah, Mari Kannan Maharajan, Si Jen Yeen, Sara Lew

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Parkinson’s disease (PD) is a progressive neurodegenerative disorder with evolving layers of complexity. Both motor and non-motor symptoms of PD may affect patients’ quality of life (QoL). Life expectancy for an individual with Parkinson’s disease depends on the level of care the individual has access to, can have a direct impact on length of life. Therefore, improvement of the QoL is a significant part of therapeutic plans. Patients with PD, especially those who are in advanced stages, are in great need of assistance, mostly from their family members or caregivers in terms of medical, emotional, and social support. The role of a caregiver becomes increasingly important with the progression of PD, the severity of motor impairment and increasing age of the patient. The nature and symptoms associated with PD can place significant stresses on the caregivers’ burden. As the prevalence of PD is estimated to more than double by 2030, it is important to recognize and alleviate the burden experienced by caregivers. This study focused on the impact of the clinical features on the QoL of PD patients, and of their caregivers. This study included PD patients along with their caregivers and was undertaken at the Malaysian Parkinson's Disease Association from June 2016 to November 2016. Clinical features of PD patients were assessed using the Movement Disorder Society revised Unified Parkinson Disease Rating Scale (MDS-UPDRS); the Hoehn and Yahr Staging of Parkinson's Disease were used to assess the severity and Parkinson's disease activities of daily living scale were used to assess the disability of Parkinson’s disease patients. QoL of PD patients was measured using the Parkinson's Disease Questionnaire-39 (PDQ-39). The revised version of the Zarit Burden Interview assessed caregiver burden. At least one of the clinical features affected PD patients’ QoL, and at least one of the QoL domains affected the caregivers’ burden. Clinical features ‘Saliva and Drooling’, and ‘Dyskinesia’ explained 29% of variance in QoL of PD patients. The QoL domains ‘stigma’, along with ‘emotional wellbeing’ explained 48.6% of variance in caregivers’ burden. Clinical features such as saliva, drooling and dyskinesia affected the QoL of PD patients. The PD patients’ QoL domains such as ‘stigma’ and ‘emotional well-being’ influenced their caregivers’ burden.

Keywords: carers, quality of life, clinical features, Malaysia

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4019 Comparison of the Results of a Parkinson’s Holter Monitor with Patient Diaries, in Real Conditions of Use: A Sub-Analysis of the MoMoPa-EC Clinical Trial

Authors: Alejandro Rodríguez-Molinero, Carlos Pérez-López, Jorge Hernández-Vara, Àngels Bayes-Rusiñol, Juan Carlos Martínez-Castrillo, David A. Pérez-Martínez

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Background: Monitoring motor symptoms in Parkinson's patients is often a complex and time-consuming task for clinicians, as Hauser's diaries are often poorly completed by patients. Recently, new automatic devices (Parkinson's holter: STAT-ON®) have been developed capable of monitoring patients' motor fluctuations. The MoMoPa-EC clinical trial (NCT04176302) investigates which of the two methods produces better clinical results. In this sub-analysis, the concordance between both methods is analyzed. Methods: In the MoMoPa-EC clinical trial, 164 patients with moderate-severe Parkinson's disease and at least two hours a day of Off will be included. At the time of patient recruitment, all of them completed a seven-day motor fluctuation diary at home (Hauser’s diary) while wearing the Parkinson's holter. In this sub-analysis, 71 patients with complete data for the purpose of this comparison were included. The intraclass correlation coefficient was calculated between the patient diary entries and the Parkinson's holter data in terms of time On, Off, and time with dyskinesias. Results: The intra-class correlation coefficient of both methods was 0.57 (95% CI: 0.3-0.74) for daily time in Off (%), 0.48 (95% CI: 0.14-0.68) for daily time in On (%), and 0.37 (95% CI %: -0.04-0.62) for daily time with dyskinesias (%). Conclusions: Both methods have a moderate agreement with each other. We will have to wait for the results of the MoMoPa-EC project to estimate which of them has the greatest clinical benefits. Acknowledgment: This work is supported by AbbVie S.L.U, the Instituto de Salud Carlos III [DTS17/00195], and the European Fund for Regional Development, 'A way to make Europe'.

Keywords: Parkinson, sensor, motor fluctuations, dyskinesia

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4018 Intelligent Drug Delivery Systems

Authors: Shideh Mohseni Movahed, Mansoureh Safari

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Intelligent drug delivery systems (IDDS) are innovative technological innovations and clinical way to advance current treatments. These systems differ in technique of therapeutic administration, intricacy, materials and patient compliance to address numerous clinical conditions that require different pharmacological therapies. IDDS capable of releasing an active molecule at the proper site and at a amount that adjusts in response to the progression of the disease or to certain functions/biorhythms of the organism is particularly appealing. In this paper, we describe the most recent advances in the development of intelligent drug delivery systems.

Keywords: drug delivery systems, IDDS, medicine, health

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4017 Factors Associated with Commencement of Non-Invasive Ventilation

Authors: Manoj Kumar Reddy Pulim, Lakshmi Muthukrishnan, Geetha Jayapathy, Radhika Raman

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Introduction: In the past two decades, noninvasive positive pressure ventilation (NIPPV) emerged as one of the most important advances in the management of both acute and chronic respiratory failure in children. In the acute setting, it is an alternative to intubation with a goal to preserve normal physiologic functions, decrease airway injury, and prevent respiratory tract infections. There is a need to determine the clinical profile and parameters which point towards the need for NIV in the pediatric emergency setting. Objectives: i) To study the clinical profile of children who required non invasive ventilation and invasive ventilation, ii) To study the clinical parameters common to children who required non invasive ventilation. Methods: All children between one month to 18 years, who were intubated in the pediatric emergency department and those for whom decision to commence Non Invasive Ventilation was made in Emergency Room were included in the study. Children were transferred to the Paediatric Intensive Care Unit and started on Non Invasive Ventilation as per our hospital policy and followed up in the Paediatric Intensive Care Unit. Clinical profile of all children which included age, gender, diagnosis and indication for intubation were documented. Clinical parameters such as respiratory rate, heart rate, saturation, grunting were documented. Parameters obtained were subject to statistical analysis. Observations: Airway disease (Bronchiolitis 25%, Viral induced wheeze 22%) was a common diagnosis in 32 children who required Non Invasive Ventilation. Neuromuscular disorder was the common diagnosis in 27 children (78%) who were Intubated. 17 children commenced on Non Invasive Ventilation who later needed invasive ventilation had Neuromuscular disease. High frequency nasal cannula was used in 32, and mask ventilation in 17 children. Clinical parameters common to the Non Invasive Ventilation group were age < 1 year (17), tachycardia n = 7 (22%), tachypnea n = 23 (72%) and severe respiratory distress n = 9 (28%), grunt n = 7 (22%), SPO2 (80% to 90%) n = 16. Children in the Non Invasive Ventilation + INTUBATION group were > 3 years (9), had tachycardia 7 (41%), tachypnea 9(53%) with a male predominance n = 9. In statistical comparison among 3 groups,'p' value was significant for pH, saturation, and use of Ionotrope. Conclusion: Invasive ventilation can be avoided in the paediatric Emergency Department in children with airway disease, by commencing Non Invasive Ventilation early. Intubation in the pediatric emergency department has a higher association with neuromuscular disorders.

Keywords: clinical parameters, indications, non invasive ventilation, paediatric emergency room

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4016 Diagnostic Clinical Skills in Cardiology: Improving Learning and Performance with Hybrid Simulation, Scripted Histories, Wearable Technology, and Quantitative Grading – The Assimilate Excellence Study

Authors: Daly M. J, Condron C, Mulhall C, Eppich W, O'Neill J.

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Introduction: In contemporary clinical cardiology, comprehensive and holistic bedside evaluation including accurate cardiac auscultation is in decline despite having positive effects on patients and their outcomes. Methods: Scripted histories and scoring checklists for three clinical scenarios in cardiology were co-created and refined through iterative consensus by a panel of clinical experts; these were then paired with recordings of auscultatory findings from three actual patients with known valvular heart disease. A wearable vest with embedded pressure-sensitive panel speakers was developed to transmit these recordings when examined at the standard auscultation points. RCSI medical students volunteered for a series of three formative long case examinations in cardiology (LC1 – LC3) using this hybrid simulation. Participants were randomised into two groups: Group 1 received individual teaching from an expert trainer between LC1 and LC2; Group 2 received the same intervention between LC2 and LC3. Each participant’s long case examination performance was recorded and blindly scored by two peer participants and two RCSI examiners. Results: Sixty-eight participants were included in the study (age 27.6 ± 0.1 years; 74% female) and randomised into two groups; there were no significant differences in baseline characteristics between groups. Overall, the median total faculty examiner score was 39.8% (35.8 – 44.6%) in LC1 and increased to 63.3% (56.9 – 66.4%) in LC3, with those in Group 1 showing a greater improvement in LC2 total score than that observed in Group 2 (p < .001). Using the novel checklist, intraclass correlation coefficients (ICC) were excellent between examiners in all cases: ICC .994 – .997 (p < .001); correlation between peers and examiners improved in LC2 following peer grading of LC1 performances: ICC .857 – .867 (p < .001). Conclusion: Hybrid simulation and quantitative grading improve learning, standardisation of assessment, and direct comparisons of both performance and acumen in clinical cardiology.

Keywords: cardiology, clinical skills, long case examination, hybrid simulation, checklist

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4015 An Electrocardiography Deep Learning Model to Detect Atrial Fibrillation on Clinical Application

Authors: Jui-Chien Hsieh

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Background:12-lead electrocardiography(ECG) is one of frequently-used tools to detect atrial fibrillation (AF), which might degenerate into life-threaten stroke, in clinical Practice. Based on this study, the AF detection by the clinically-used 12-lead ECG device has only 0.73~0.77 positive predictive value (ppv). Objective: It is on great demand to develop a new algorithm to improve the precision of AF detection using 12-lead ECG. Due to the progress on artificial intelligence (AI), we develop an ECG deep model that has the ability to recognize AF patterns and reduce false-positive errors. Methods: In this study, (1) 570-sample 12-lead ECG reports whose computer interpretation by the ECG device was AF were collected as the training dataset. The ECG reports were interpreted by 2 senior cardiologists, and confirmed that the precision of AF detection by the ECG device is 0.73.; (2) 88 12-lead ECG reports whose computer interpretation generated by the ECG device was AF were used as test dataset. Cardiologist confirmed that 68 cases of 88 reports were AF, and others were not AF. The precision of AF detection by ECG device is about 0.77; (3) A parallel 4-layer 1 dimensional convolutional neural network (CNN) was developed to identify AF based on limb-lead ECGs and chest-lead ECGs. Results: The results indicated that this model has better performance on AF detection than traditional computer interpretation of the ECG device in 88 test samples with 0.94 ppv, 0.98 sensitivity, 0.80 specificity. Conclusions: As compared to the clinical ECG device, this AI ECG model promotes the precision of AF detection from 0.77 to 0.94, and can generate impacts on clinical applications.

Keywords: 12-lead ECG, atrial fibrillation, deep learning, convolutional neural network

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4014 Neutrophil-to-Lymphocyte Ratio: A Predictor of Cardiometabolic Complications in Morbid Obese Girls

Authors: Mustafa M. Donma, Orkide Donma

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Obesity is a low-grade inflammatory state. Childhood obesity is a multisystem disease, which is associated with a number of complications as well as potentially negative consequences. Gender is an important universal risk factor for many diseases. Hematological indices differ significantly by gender. This should be considered during the evaluation of obese children. The aim of this study is to detect hematologic indices that differ by gender in morbid obese (MO) children. A total of 134 MO children took part in this study. The parents filled an informed consent form and the approval from the Ethics Committee of Namik Kemal University was obtained. Subjects were divided into two groups based on their genders (64 females aged 10.2±3.1 years and 70 males aged 9.8±2.2 years; p ≥ 0.05). Waist-to-hip as well as head-to-neck ratios and body mass index (BMI) values were calculated. The children, whose WHO BMI-for age and sex percentile values were > 99 percentile, were defined as MO. Hematological parameters [haemoglobin, hematocrit, erythrocyte count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, red blood cell distribution width, leukocyte count, neutrophil %, lymphocyte %, monocyte %, eosinophil %, basophil %, platelet count, platelet distribution width, mean platelet volume] were determined by the automatic hematology analyzer. SPSS was used for statistical analyses. P ≤ 0.05 was the degree for statistical significance. The groups included children having mean±SD value of BMI as 26.9±3.4 kg/m2 for males and 27.7±4.4 kg/m2 for females (p ≥ 0.05). There was no significant difference between ages of females and males (p ≥ 0.05). Males had significantly increased waist-to-hip ratios (0.95±0.08 vs 0.91±0.08; p=0.005) and mean corpuscular hemoglobin concentration values (33.6±0.92 vs 33.1±0.83; p=0.001) compared to those of females. Significantly elevated neutrophil (4.69±1.59 vs 4.02±1.42; p=0.011) and neutrophil-to-lymphocyte ratios (1.70±0.71 vs 1.39±0.48; p=0.004) were detected in females. There was no statistically significant difference between groups in terms of C-reactive protein values (p ≥ 0.05). Adipose tissue plays important roles during the development of obesity and associated diseases such as metabolic syndrom and cardiovascular diseases (CVDs). These diseases may cause changes in complete blood cell count parameters. These alterations are even more important during childhood. Significant gender effects on the changes of neutrophils, one of the white blood cell subsets, were observed. The findings of the study demonstrate the importance of considering gender in clinical studies. The males and females may have distinct leukocyte-trafficking profiles in inflammation. Female children had more circulating neutrophils, which may be the indicator of an increased risk of CVDs, than male children within this age range during the late stage of obesity. In recent years, females represent about half of deaths from CVDs; therefore, our findings may be the indicator of the increasing tendency of this risk in females starting from childhood.

Keywords: children, gender, morbid obesity, neutrophil-to-lymphocyte ratio

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4013 Vegetation Assessment Under the Influence of Environmental Variables; A Case Study from the Yakhtangay Hill of Himalayan Range, Pakistan

Authors: Hameed Ullah, Shujaul Mulk Khan, Zahid Ullah, Zeeshan Ahmad Sadia Jahangir, Abdullah, Amin Ur Rahman, Muhammad Suliman, Dost Muhammad

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The interrelationship between vegetation and abiotic variables inside an ecosystem is one of the main jobs of plant scientists. This study was designed to investigate the vegetation structure and species diversity along with the environmental variables in the Yakhtangay hill district Shangla of the Himalayan Mountain series Pakistan by using multivariate statistical analysis. Quadrat’s method was used and a total of 171 Quadrats were laid down 57 for Tree, Shrubs and Herbs, respectively, to analyze the phytosociological attributes of the vegetation. The vegetation of the selected area was classified into different Life and leaf-forms according to Raunkiaer classification, while PCORD software version 5 was used to classify the vegetation into different plants communities by Two-way indicator species Analysis (TWINSPAN). The CANOCCO version 4.5 was used for DCA and CCA analysis to find out variation directories of vegetation with different environmental variables. A total of 114 plants species belonging to 45 different families was investigated inside the area. The Rosaceae (12 species) was the dominant family followed by Poaceae (10 species) and then Asteraceae (7 species). Monocots were more dominant than Dicots and Angiosperms were more dominant than Gymnosperms. Among the life forms the Hemicryptophytes and Nanophanerophytes were dominant, followed by Therophytes, while among the leaf forms Microphylls were dominant, followed by Leptophylls. It is concluded that among the edaphic factors such as soil pH, the concentration of soil organic matter, Calcium Carbonates concentration in soil, soil EC, soil TDS, and physiographic factors such as Altitude and slope are affecting the structure of vegetation, species composition and species diversity at the significant level with p-value ≤0.05. The Vegetation of the selected area was classified into four major plants communities and the indicator species for each community was recorded. Classification of plants into 4 different communities based upon edaphic gradients favors the individualistic hypothesis. Indicator Species Analysis (ISA) shows the indicators of the study area are mostly indicators to the Himalayan or moist temperate ecosystem, furthermore, these indicators could be considered for micro-habitat conservation and respective ecosystem management plans.

Keywords: species richness, edaphic gradients, canonical correspondence analysis (CCA), TWCA

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4012 Machine Learning for Feature Selection and Classification of Systemic Lupus Erythematosus

Authors: H. Zidoum, A. AlShareedah, S. Al Sawafi, A. Al-Ansari, B. Al Lawati

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Systemic lupus erythematosus (SLE) is an autoimmune disease with genetic and environmental components. SLE is characterized by a wide variability of clinical manifestations and a course frequently subject to unpredictable flares. Despite recent progress in classification tools, the early diagnosis of SLE is still an unmet need for many patients. This study proposes an interpretable disease classification model that combines the high and efficient predictive performance of CatBoost and the model-agnostic interpretation tools of Shapley Additive exPlanations (SHAP). The CatBoost model was trained on a local cohort of 219 Omani patients with SLE as well as other control diseases. Furthermore, the SHAP library was used to generate individual explanations of the model's decisions as well as rank clinical features by contribution. Overall, we achieved an AUC score of 0.945, F1-score of 0.92 and identified four clinical features (alopecia, renal disorders, cutaneous lupus, and hemolytic anemia) along with the patient's age that was shown to have the greatest contribution on the prediction.

Keywords: feature selection, classification, systemic lupus erythematosus, model interpretation, SHAP, Catboost

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4011 Effect of Non-Surgical Periodontal Therapy According to Periodontal Severity

Authors: Jungbin Lim, Bohee Kang, Heelim Lee, Sunjin Kim, GeumHee Choi, Jae-Suk Jung, Suk Ji

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Nonsurgical periodontal therapies have, for several decades, been the basis of periodontal treatment concepts. The aim of this paper is to investigate the effectiveness of non-surgical periodontal therapy according to the severity of periodontitis disease. Methods: Retrospective data of patients who visited Department of periodontics in Ajou University Medical Center from 2016 to 2022 were collected. Among the patients, those who took full mouth examination of clinical parameters and non-surgical periodontal therapy were chosen for this study. Selected patients were divided into initial, moderate, and severe periodontitis based on severity and complexity of management (2018 World Workshop EFP/AAP consensus). Recall visits with clinical periodontal examination were scheduled for 1,2,3 months or 1,3,6 months after the treatment. The results were evaluated by recordings of mean probing pocket depth (mean PD), mean clinical attachment levels (mean CAL), bleeding on probing (BOP%), mean gingival index (mean GI), mean regression, mean sulcus bleeding index (mean SBI), mean plaque scores (mean PI). All statistical analyses were performed with R software, version 4.3.0. A level of significance, P<0.05, was considered to be statistically significant. Results: A total of 92 patients were included in this study. 15 patients were diagnosed as initial periodontitis, 14 moderate periodontitis, and 63 severe periodontitis. The all parameters except for mean recession decreased over time in all groups. The amount of mean PD decreased were the greatest in severe periodontitis group followed by moderate and initial, which was found to be statistically significant. The changes of mean PD were 0.15±0.05 mm, 0.37±0.06 mm, and 1.01±0.07 mm (initial, moderate, and severe, respectively, P<0.001). When comparing before and after treatment, the reductions in BOP(%), mean GI, mean SBI, and mean PI were statistically significant. Conclusion: All patients who received non-surgical periodontal therapy showed periodontal healing in terms of improvements in clinical parameters, and it was greater in the severe group.

Keywords: periodontology, clinical periodontology, oral treatment, comprehensive preventive dentistry, non-surgical periodontal therapy

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4010 The Use of Respiratory Index of Severity in Children (RISC) for Predicting Clinical Outcomes for 3 Months-59 Months Old Patients Hospitalized with Community-Acquired Pneumonia in Visayas Community Medical Center, Cebu City from January 2013 - June 2

Authors: Karl Owen L. Suan, Juliet Marie S. Lambayan, Floramay P. Salo-Curato

Abstract:

Objective: To predict the outcome among patients admitted with community-acquired pneumonia (ages 3 months to 59 months old) admitted in Visayas Community Medical Center using the Respiratory Index of Severity in Children (RISC). Design: A cross-sectional study design was used. Setting: The study was done in Visayas Community Medical Center, which is a private tertiary level in Cebu City from January-June 2013. Patients/Participants: A total of 72 patients were initially enrolled in the study. However, 1 patient transferred to another institution, thus 71 patients were included in this study. Within 24 hours from admission, patients were assigned a RISC score. Statistical Analysis: Cohen’s kappa coefficient was used for inter-rater agreement for categorical data. This study used frequency and percentage distribution for qualitative data. Mean, standard deviation and range were used for quantitative data. To determine the relationship of each RISC score parameter and the total RISC score with the outcome, a Mann Whitney U Test and 2x2 Fischer Exact test for testing associations were used. A p value less of than 0.05 alpha was considered significant. Results: There was a statistical significance between RISC score and clinical outcome. RISC score of greater than 4 was correlated with intubation and/or mortality. Conclusion: The RISC scoring system is a simple combination of clinical parameters and a reliable tool that will help stratify patients aged 3 months to 59 months in predicting clinical outcome.

Keywords: RISC, clinical outcome, community-acquired pneumonia, patients

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4009 The Ecosystem of Food Allergy Clinical Trials: A Systematic Review

Authors: Eimar Yadir Quintero Tapias

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Background: Science is not generally self-correcting; many clinical studies end with the same conclusion "more research is needed." This study hypothesizes that first, we need a better appraisal of the available (and unavailable) evidence instead of creating more of the same false inquiries. Methods: Systematic review of ClinicalTrials.gov study records using the following Boolean operators: (food OR nut OR milk OR egg OR shellfish OR wheat OR peanuts) AND (allergy OR allergies OR hypersensitivity OR hypersensitivities). Variables included the status of the study (e g., active and completed), availability of results, sponsor type, sample size, among others. To determine the rates of non-publication in journals indexed by PubMed, an advanced search query using the specific Number of Clinical Trials (e.g., NCT000001 OR NCT000002 OR...) was performed. As a prophylactic measure to prevent P-hacking, data analyses only included descriptive statistics and not inferential approaches. Results: A total of 2092 study records matched the search query described above (date: September 13, 2019). Most studies were interventional (n = 1770; 84.6%) and the remainder observational (n = 322; 15.4%). Universities, hospitals, and research centers sponsored over half of these investigations (n = 1208; 57.7%), 308 studies (14.7%) were industry-funded, and 147 received NIH grants; the remaining studies got mixed sponsorship. Regarding completed studies (n = 1156; 55.2%), 248 (21.5%) have results available at the registry site, and 417 (36.1%) matched NCT numbers of journal papers indexed by PubMed. Conclusions: The internal and external validity of human research is critical for the appraisal of medical evidence. It is imperative to analyze the entire dataset of clinical studies, preferably at a patient-level anonymized raw data, before rushing to conclusions with insufficient and inadequate information. Publication bias and non-registration of clinical trials limit the evaluation of the evidence concerning therapeutic interventions for food allergy, such as oral and sublingual immunotherapy, as well as any other medical condition. Over half of the food allergy human research remains unpublished.

Keywords: allergy, clinical trials, immunology, systematic reviews

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