Search results for: clinical profile

Authors: Mohammed S. Mohammed, Asmaa M. S. Mohammed

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Background: To achieve the quality of cancer care, the oncologic academic programs should be continuously developed with establishing new ones. We highlighted three disciplines, Clinical nutrition, medical biophysics and radiobiology and Psycho-oncology programs; without a doubt, the Egyptian National Cancer Institute, in ‎the accreditation era, will be establishing them ‎ due to their importance in improving the skills of cancer practitioners. Methods: The first suggested program in Clinical Nutrition that is dealing with the assessment of the patient's well-being before, during and after treatment to avoid the defects in the metabolism resulting from the cancer disease and its treatment by giving the supplements in the patient's diet. The second program is Medical Biophysics and Radiobiology, which there's no denying that it ‎is ‎provided ‎in Cairo University as a good program in the faculty of science but lacks the clinical ‎practice. Hence, it is probably better to establish this program in our institute to ‎improve the ‎practitioner skills and introduce a tailored radiation therapy regimen for every patient according to ‎their characteristic profile.‎ While patients are receiving their treatment, the risk of post-traumatic stress disorder arises, so the importance of the third program, Psycho-Oncology, is clearly obtained. This program is concerned with the psychological, social, behavioral, and ethical aspects of cancer. The area of multi-disciplinary interest has boundaries with the major specialties in oncology: the clinical disciplines (surgery, medicine, pediatrics, and radiotherapy), epidemiology, immunology, endocrinology, biology, pathology, bioethics, palliative care, rehabilitation medicine, clinical trials research and decision making, as well as psychiatry and psychology. Results: It is a prospective academic plan which is compatible with the institutional vision and its strategic plan. Conclusion: In this context, evaluating and understanding the suggested academic programs has become a mandatory part of cancer care. And it is essential to be provided by the NCI.

Keywords: clinical nutrition, psycho-oncology, medical biophysics and radiobiology, medical education

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Authors: Atitallah Sofien, Bouyahia Olfa, Hadj Salah Ibrahim, Ben Saleh Foued, Missaoui Nada, Ben Rabeh Rania, Yahyaoui Salem, Mazigh Sonia, Boukthir Samir

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Introduction: Carbon monoxide (CO) poisoning is a common pathology responsible for high morbidity and mortality worldwide. Aim: The purpose of this study was to determine the epidemiological profile of CO poisoning as well as its clinical, paraclinical, therapeutic, and evolutionary aspects. Methods: Our study included observations of CO poisoning in children hospitalized in the pediatric department C of the Children's Hospital in Tunis over a period of 3 years. Results: We have collected 199 cases of CO poisoning in children. The average age was 5.43 years, with a sex ratio of 0.98. The source of CO was inside the home in 73.2% of cases, and it was the gas bath heater in 68.8% of cases. The intoxication was collective in 93.5% of the cases, and it occurred during the month of January in 35.8% of the cases. The clinical manifestations were headaches in 69.5% of cases. The rate of carboxyhemoglobin was pathological in 73.9% of cases. All patients received normobaric oxygen therapy, and only 3.6% of patients had a hyperbaric oxygen therapy session. We did not deplore any case of death in our study. Conclusion: CO poisoning remains a public health problem in Tunisia with high morbidity. The risk of secondary complications, particularly neuropsychiatric, requires clinical and possibly neuroradiological monitoring of these victims.

Keywords: poisoning, carbon monoxide, children, hyperbaric oxygenation

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Authors: Veruska C. Dutra, Mary L. G. S. Senna, Felipe S. Spindler

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The State Park Jalapao - PEJ proved to be one of the protected areas that has attracted tourists from all over the world with its unique scenic landscapes. Although the region already has a considerable tourist flow, to our knowledge there is a lack of continuity of studies in the region capable of drawing a plan of activities, such as the profile of the tourist and analysis of their experiences in the region, carried out from 2006-2007. Therefore, this study was proposed to know the profile and experiences of tourists visiting the park today, making a connection with the earlier study, in order to generate subsidies to trace improvement actions. We conducted interviews with tourists in the main tourism season 2015. The results show that after eight years of carrying out the first study, there were no changes, highlighting the lack of a tourism plan for the park.

Keywords: Jalapao, profile tourist, level, satisfaction

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Authors: Gauri Shankar Shah

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Objectives: The Type I diabetes mellitus in children is frequently a missed diagnosis and children presents in emergency with diabetic ketoacidosis having significant morbidity and mortality. The present study was done to find out the clinical presentation and outcome at a tertiary-care centre. Methods: This was retrospective analysis of data of Type I diabetes mellitus reporting to our centre during last one year (2012-2013). Results: There were 12 patients (8 males) and the age group was 4-14 years (mean ± 3.7). The presenting symptoms were fever, vomiting, altered sensorium and fast breathing in 8 (66.6%), 6 (50%), 4 (33.3%), and 4 (33.3%) cases, respectively. The classical triad of polyuria, polydypsia, and polyphagia were present only in two patients (33.2%). Seizures and epigastric pain were found in two cases each (33.2%). The four cases (33.3%) presented with diabetic ketoacidosis due to discontinuation of insulin doses, while 2 had hyperglycemia alone. The hemogram revealed mean hemoglobin of 12.1± 1.6 g/dL and total leukocyte count was 22,883.3 ± 10,345.9 per mm3, with polymorphs percentage of 73.1 ± 9.0%. The mean blood sugar at presentation was 740 ± 277 mg/ dl (544–1240). HbA1c ranged between 7.1-8.8 with mean of 8.1±0.6 %. The mean sodium, potassium, blood ph, pCO2, pO2 and bicarbonate were 140.8 ± 6.9 mEq/L, 4.4 ± 1.8mEq/L, 7.0 ± 0.2, 20.2 ± 10.8 mmHg, 112.6 ± 46.5 mmHg and 9.2 ± 8.8 mEq/L, respectively. All the patients were managed in pediatric intensive care unit as per our protocol, recovered and discharged on intermediate insulin given twice daily. Conclusions: Thus, it shows that these patients have uncontrolled hyperglycemia and often presents in emergency with ketoacidosis and deranged biochemical profile. The regular administration of insulin, frequent monitoring of blood sugar and health education are required to have better metabolic control and good quality of life.

Keywords: type I diabetes mellitus, hyperglycemia, outcome, glycemic control

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Authors: Golyasamin Khanehzaei, Mohd. Bakri Ishak, Ahmad Makmom Hj Abdullah, Latifah Abd Manaf

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Abstract—Management of clinical waste is a critical problem worldwide. Immediate attention is required to manage the clinical waste in an appropriate way in newly developing economy country such as Malaysia. The increasing amount of clinical waste generated is resulted from rapid urbanization and growing number of private health care facilities in developing countries such as Malaysia. In order to develop a sensible clinical waste management system and improvement of the management, information on factors affecting clinical waste generation has the crucial role. This paper is the study of management characteristics of clinical waste and the level of efficiency of clinical waste management systems operating in private clinics located in Selangor, Malaysia. Are they following the proper international standards? By taking all of this in consideration the aim of this paper is to identify and discuss the current trend, current challenges and also the present opportunities among the challenges of clinical waste management in private clinics of Selangor, Malaysia. The SWOT analysis was characterized for the evaluation of strengths, weaknesses, opportunities and threats. The methodology for this study was constituted of direct observation, Informal interviews, Conducting SWOT analysis, conduction of one sustainability dimensions analysis and application. The results show that clinical waste management in private clinics is far from an ideal model.

Keywords: clinical waste, SWOT analysis, Selangor, Malaysia

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Authors: Hao Wang, Shengchun Wang, Weidong Wang

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On the influence of train vibration and environmental noise on the measurement of track wear, we proposed a method for automatic extraction of circular arc on the inner or outer side of the rail waist and achieved the high-precision registration of rail profile. Firstly, a polynomial fitting method based on truncated residual histogram was proposed to find the optimal fitting curve of the profile and reduce the influence of noise on profile curve fitting. Then, based on the curvature distribution characteristics of the fitting curve, the interval search algorithm based on dynamic window’s maximum curvature entropy was proposed to realize the automatic segmentation of small circular arc. At last, we fit two circle centers as matching reference points based on small circular arcs on both sides and realized the alignment from the measured profile to the standard designed profile. The static experimental results show that the mean and standard deviation of the method are controlled within 0.01mm with small measurement errors and high repeatability. The dynamic test also verified the repeatability of the method in the train-running environment, and the dynamic measurement deviation of rail wear is within 0.2mm with high repeatability.

Keywords: curvature entropy, profile registration, rail wear, structured light, train-running

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Authors: Tambe Daniel Atem

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Background: Clinical Research is an organized research on human beings intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy. The significance of the study is to educate the global health and life science graduates in Clinical Research in depth to perform better as it involves testing drugs on human beings. Objectives: to provide an overall understanding of the scientific approach to the evaluation of new and existing medical interventions and to apply ethical and regulatory principles appropriate to any individual research. Methodology: It is based on – Primary data analysis and Secondary data analysis. Primary data analysis: means the collection of data from journals, the internet, and other online sources. Secondary data analysis: a survey was conducted with a questionnaire to interview the Clinical Research Professionals to understand the need of training to perform clinical trials globally. The questionnaire consisted details of the professionals working with the expertise. It also included the areas of clinical research which needed intense training before entering into hardcore clinical research domain. Results: The Clinical Trials market worldwide worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the U.K, and they form one-third of the total research and development staff. There are more than 2,50,000 vacant positions globally with salary variations in the regions for a Clinical Research Coordinator. R&D cost on new drug development is estimated at US$ 70-85 billion. The cost of doing clinical trials for a new drug is US$ 200-250 million. Due to an increase trained Clinical Research Professionals India has emerged as a global hub for clinical research. The Global Clinical Trial outsourcing opportunity in India in the pharmaceutical industry increased to more than $2 billion in 2014 due to increased outsourcing from U.S and Europe to India. Conclusion: Assessment of training need is recommended for newer Clinical Research Professionals and trial sites, especially prior the conduct of larger confirmatory clinical trials.

Keywords: clinical research, clinical trials, clinical research professionals

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Authors: A. I. O. Zaid

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Deep drawing is considered to be the most widely used sheet metal forming processes among the particularly in automobile and aircraft industries. It is widely used for manufacturing a large number of the body and spare parts. In its simplest form it may be defined as a secondary forming process by which a sheet metal is formed into a cylinder or alike by subjecting the sheet to compressive force through a punch with a flat end of the same geometry as the required shape of the cylinder end while it is held by a blank holder which hinders its movement but does not stop it. The punch and die profile radii play In this paper, the effects of punch and die profile radii on the autographic record, the minimum thickness strain location where the cracks normally start and cause the fracture, the maximum deep drawing force and the total consumed work in the drawing flat ended cylindrical brass cups are investigated. Five punches and five dies each having different profile radii were manufactured for this investigation. Furthermore, their effect on the quality of the drawn cups is also presented and discussed. It was found that the die profile radius has more effect on the maximum drawing force and the total consumed work than the punch profile radius.

Keywords: punch and die profile radii, deep drawing process, maximum drawing force, total consumed work, quality of produced parts, flat ended cylindrical brass cups

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Authors: Bin Liu

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As one of the most important tasks in protein sequence analysis, protein remote homology detection has been studied for decades. Currently, the profile-based methods show state-of-the-art performance. Position-Specific Frequency Matrix (PSFM) is widely used profile. However, there exists noise information in the profiles introduced by the amino acids with low frequencies. In this study, we propose a method to remove the noise information in the PSFM by removing the amino acids with low frequencies called Top frequency profile (TFP). Three new matrix transformation methods, including Autocross covariance (ACC) transformation, Tri-gram, and K-separated bigram (KSB), are performed on these profiles to convert them into fixed length feature vectors. Combined with Support Vector Machines (SVMs), the predictors are constructed. Evaluated on two benchmark datasets, and experimental results show that these proposed methods outperform other state-of-the-art predictors.

Keywords: protein remote homology detection, protein fold recognition, top frequency profile, support vector machines

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Authors: Sedigheh Salemi, Mahnaz Sanjari, Maryam Aalaa, Mohammad Mirzabeigi

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Clinical governance is the framework within which the health service provider is required to ongoing accountability and improvement of the quality of their services. This cross-sectional study was conducted in 661 nurses who work in government hospitals from 35 hospitals of 9 provinces in Iran. The study was approved by the Nursing Council and was carried out with the authorization of the Research Ethics Committee. The questionnaire included 24 questions in which 4 questions focused on clinical governance defining from the nurses' perspective. The reliability was evaluated by Cronbach's alpha (α=0/83). Statistical analyzes were performed, using SPSS version 16. Approximately 40% of nurses correctly answered that clinical governance is not "system of punishment and rewards for the staff". The most nurses believed that "clinical efficacy" is one of the main components of clinical governance. A few of nurses correctly responded that "Evidence Based Practice" and "management" is not part of clinical governance. The small number of nurses correctly answered that the "maintenance of patient records" and "to recognize the adverse effects" is not the role of nurse in clinical governance. Most "do not know" answer was to the "maintenance of patient records". The most nurses unanimously believed that the implementation of clinical governance led to "promoting the quality of care". About a third of nurses correctly stated that the implementation of clinical governance will not lead to "an increase in salaries and benefits of the medical team". As a member of the health team, nurses are responsible in terms of participation in quality improvement and it is necessary to create an environment in which clinical care will flourish and serve to preserve the high standards.

Keywords: clinical governance, nurses, salary, health team

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Authors: Khandoker Akib Mohammad

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While analyzing time-to-event data, it is possible that a certain fraction of subjects will never experience the event of interest, and they are said to be cured. When this feature of survival models is taken into account, the models are commonly referred to as cure models. In the presence of covariates, the conditional survival function of the population can be modelled by using the cure model, which depends on the probability of being uncured (incidence) and the conditional survival function of the uncured subjects (latency), and a combination of logistic regression and Cox proportional hazards (PH) regression is used to model the incidence and latency respectively. In this paper, we have shown the asymptotic normality of the profile likelihood estimator via asymptotic expansion of the profile likelihood and obtain the explicit form of the variance estimator with an implicit function in the profile likelihood. We have also shown the efficient score function based on projection theory and the profile likelihood score function are equal. Our contribution in this paper is that we have expressed the efficient information matrix as the variance of the profile likelihood score function. A simulation study suggests that the estimated standard errors from bootstrap samples (SMCURE package) and the profile likelihood score function (our approach) are providing similar and comparable results. The numerical result of our proposed method is also shown by using the melanoma data from SMCURE R-package, and we compare the results with the output obtained from the SMCURE package.

Keywords: Cox PH model, cure model, efficient score function, EM algorithm, implicit function, profile likelihood

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Authors: Hye-Kyung Kang

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Social justice is a central principle of the social work profession and education. However, scholars have long questioned the profession’s commitment to putting social justice values into practice. Clinical social work has been particularly criticized for its lack of attention to social justice and for failing to address the concerns of the oppressed. One prominent criticism of clinical social work is that it often relies on individual intervention and fails to take on system-level changes or advocacy. This concern evokes the historical macro-micro tension of the social work profession where micro (e.g., mental health counseling) and macro (e.g., policy advocacy) practices are conceptualized as separate domains, creating a false binary for social workers. One contributor to this false binary seems to be that most clinical practice models do not prepare social work students and practitioners to make a clear link between clinical practice and social justice. This paper presents a model of clinical social work practice that clearly recognizes the essential and necessary connection between social justice, advocacy, and clinical practice throughout the clinical process: engagement, assessment, intervention, and evaluation. Contemporary relational theories, critical social work frameworks, and anti-oppressive practice approaches are integrated to build a clinical social work practice model that addresses the urgent need for mental health practice that not only helps and heals the person but also challenges societal oppressions and aims to change them. The application of the model is presented through case vignettes.

Keywords: social justice, clinical social work, clinical social work model, integrative model

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Authors: Jacqueline M. Dias, Amina A Khowaja

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Clinical education is one of the most important components of a nursing curriculum as it develops the students’ cognitive, psychomotor and affective skills. Clinical teaching ensures the integration of knowledge into practice. As the numbers of students increase in the field of nursing coupled with the faculty shortage, clinical preceptors are the best choice to ensure student learning in the clinical settings. The clinical preceptor role has been introduced in the undergraduate nursing programme. In Pakistan, this role emerged due to a faculty shortage. Initially, two clinical preceptors were hired. This study will explore clinical preceptors views and experiences of precepting Bachelor of Science in Nursing (BScN) students in an undergraduate program. A case study design was used. As case studies explore a single unit of study such as a person or very small number of subjects; the two clinical preceptors were fundamental to the study and served as a single case. Qualitative data were obtained through an iterative process using in depth interviews and written accounts from reflective journals that were kept by the clinical preceptors. The findings revealed that the clinical preceptors were dedicated to their roles and responsibilities. Another, key finding was that clinical preceptors’ prior knowledge and clinical experience were valuable assets to perform their role effectively. The clinical preceptors found their new role innovative and challenging; it was stressful at the same time. Findings also revealed that in the clinical agencies there were unclear expectations and role ambiguity. Furthermore, clinical preceptors had difficulty integrating theory into practice in the clinical area and they had difficulty in giving feedback to the students. Although this study is localized to one university, generalizations can be drawn from the results. The key findings indicate that the role of a clinical preceptor is demanding and stressful. Clinical preceptors need preparation prior to precepting students on clinicals. Also, institutional support is fundamental for their acceptance. This paper focuses on the views and experiences of clinical preceptors undertaking a newly established role and resonates with the literature. The following recommendations are drawn to strengthen the role of the clinical preceptors: A structured program for clinical preceptors is needed along with mentorship. Clinical preceptors should be provided with formal training in teaching and learning with emphasis on clinical teaching and giving feedback to students. Additionally, for improving integration of theory into practice, clinical modules should be provided ahead of the clinical. In spite of all the challenges, ten more clinical preceptors have been hired as the faculty shortage continues to persist.

Keywords: baccalaureate nursing education, clinical education, clinical preceptors, nursing curriculum

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Authors: Maha Salah, Hanaa Hashem, Mahmoud M. Alsagheir, Mohammed Salah

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Acute respiratory distress syndrome (ARDS) represents a complex clinical syndrome and carries a high risk for mortality. The severity of the clinical course, the uncertainty of the outcome, and the reliance on the full spectrum of critical care resources for treatment mean that the entire health care team is challenged. Researchers and clinicians have investigated the nature of the pathological process and explored treatment options with the goal of improving outcome. Through this application of research to practice, we know that some previous strategies have been ineffective, and innovations in mechanical ventilation, sedation, nutrition, and pharmacological intervention remain important research initiatives. Developed Clinical pathway is multidisciplinary plans of best clinical practice for this specified groups of patients that aid in the coordination and delivery of high quality care. They are a documented sequence of clinical interventions that help a patient to move, progressively through a clinical experience to a desired outcome. Although there is a lot of heterogeneity in patients with ARDS, this suggested developed clinical pathway with alternatives was built depended on a lot of researches and evidence based medicine and nursing practices which may be helping these patients to improve outcomes, quality of life and decrease mortality.

Keywords: acute respiratory distress syndrome (ARDS), clinical pathway, clinical syndrome

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Authors: S. M. Dash, K. B. Lua, T. T. Lim

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This paper presents results of numerical and experimental studies on a two-dimensional (2D) flapping elliptic airfoil in a forward flight condition at Reynolds number of 5000. The study is motivated from an earlier investigation which shows that the deterioration in thrust performance of a sinusoidal heaving and pitching 2D (NACA0012) airfoil at high flapping frequency can be recovered by changing the effective angle of attack profile to square wave, sawtooth, or cosine wave shape. To better understand why such modifications lead to superior thrust performance, we take a closer look at the transient aerodynamic force behavior of an airfoil when the effective angle of attack profile changes gradually from a generic smooth trapezoidal profile to a sinusoid shape by modifying the base length of the trapezoid. The choice of using a smooth trapezoidal profile is to avoid the infinite acceleration condition encountered in the square wave profile. Our results show that the enhancement in the time-averaged thrust performance at high flapping frequency can be attributed to the delay and reduction in the drag producing valley region in the transient thrust force coefficient when the effective angle of attack profile changes from sinusoidal to trapezoidal.

Keywords: two-dimensional flapping airfoil, thrust performance, effective angle of attack, CFD, experiments

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Authors: Mohsen Salesi, Seyyed Zoheir Rabei

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Exercise has been considered a cornerstone of diabetes prevention and treatment for decades, but the benefits of resistance training are less clear. The purpose of this study was to determine the impact of resistance training on blood profile and inflammatory marker (CRP) of type 2 diabetes mellitus people. Thirty diabetic male were recruited (age: 50.34±10.28 years) and randomly assigned to 8 weeks resistance exercise training (n=15) and control groups (n=15). Before and after training blood pressure, weight, lipid profile (TC, TG, LDL-c, and HDL-c) and hs-CRP were measured. The resistance exercise training group took part in supervised 50–80 minutes resistance training sessions, three days a week on non-consecutive days for 8 weeks. Each exercise session included approximately 10 min of warm-up and cool-down periods. Results showed that TG significantly decreased (pre 210.19±9.31 vs. 101.12±7.25, p=0.03) and HDL-c significantly increased (pre 42.37±3.15 vs. 47.50±2.19, p=0.01) after exercise training. However, there was no difference between groups in TC, LDL-c, BMI and weight. In addition, a decrease in fasting blood glucose levels showed significant difference between groups (pre 144.65±5.73 vs. 124.21±6.48 p=0.04). Regular resistance exercise training can improve the lipid profile and reducing the cardiovascular risk factors in T2DM patients.

Keywords: lipid profile, resistance exercise, type 2 diabetes mellitus, men

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Authors: Nanyombi Lubimbi, Josette Niyokindi

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Background: As in many other developing countries in Africa, Rwanda suffers from a chronic shortage of skilled Health Care professionals including Clinical Instructors. This shortage negatively affects the clinical instruction quality therefore impacting student-learning outcomes. Due to poor clinical supervision, it is often noted that students have no structure or consistent guidance in their learning process. The Clinical Educators and the Rwandan counterparts identified the need to create a favorable environment for learning. Description: During orientation the expectations of the student learning process, collaboration of the clinical instructors with the nurses and Clinical Educators is outlined. The ward managers facilitate structured learning by helping the students identify a maximum of two patients using the school’s objectives to guide the appropriate selection of patients. Throughout the day, Clinical Educators with collaboration of Clinical Instructors when present conduct an ongoing assessment of learning and provide feedback to the students. Post-conference is provided once or twice a week to practice critical thinking skills of patient cases that they have been taking care of during the day. Lessons Learned: The students are found to be more confident with knowledge and skills gained during rotations. Clinical facility evaluations completed by students at the end of their rotations highlight the student’s satisfaction and recommendation for continuation of structured learning. Conclusion: Based on the satisfaction of both students and Clinical Instructors, we have identified need for structured learning during clinical rotations. We acknowledge that more evidence-based practice is necessary to effectively address the needs of nursing and midwifery students throughout the country.

Keywords: Rwanda, clinical rotation, structured learning, critical thinking skills, post-conference

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Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

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Authors: Yaxian Chen, Yeonhee Park

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Driven by evolving FDA recommendations, modern clinical trials demand innovative designs that strike a balance between statistical rigor and ethical considerations. Covariate-adjusted response-adaptive (CARA) designs bridge this gap by utilizing patient attributes and responses to skew treatment allocation in favor of the treatment that is best for an individual patient’s profile. However, existing CARA designs for survival outcomes often hinge on specific parametric models, constraining their applicability in clinical practice. In this article, we address this limitation by introducing a CARA design for survival outcomes (CARAS) based on the Cox model and a variance estimator. This method addresses issues of model misspecification and enhances the flexibility of the design. We also propose a group sequential overlapweighted log-rank test to preserve type I error rate in the context of group sequential trials using extensive simulation studies to demonstrate the clinical benefit, statistical efficiency, and robustness to model misspecification of the proposed method compared to traditional randomized controlled trial designs and response-adaptive randomization designs.

Keywords: cox model, log-rank test, optimal allocation ratio, overlap weight, survival outcome

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Authors: Ragy Raafat Gaber Attaalla

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Despite having the greatest rates of mortality and morbidity in the world, low- and middle-income (LMIC) nations trail high-income nations in terms of the number of clinical trials, the number of qualified researchers, and the amount of research information specific to their people. Health inequities and the use of precision medicine may be hampered by a lack of local genomic data, clinical pharmacology and pharmacometrics competence, and training opportunities. These issues can be solved by carrying out health care infrastructure development, which includes data gathering and well-designed clinical pharmacology training in LMICs. It will be advantageous if there is international cooperation focused at enhancing education and infrastructure and promoting locally motivated clinical trials and research. This paper outlines various instances where clinical pharmacology knowledge could be put to use, including pharmacogenomic opportunities that could lead to better clinical guideline recommendations. Examples of how clinical pharmacology training can be successfully implemented in LMICs are also provided, including clinical pharmacology and pharmacometrics training programmes in Africa and a Tanzanian researcher's personal experience while on a training sabbatical in the United States. These training initiatives will profit from advocacy for clinical pharmacologists' employment prospects and career development pathways, which are gradually becoming acknowledged and established in LMICs. The advancement of training and research infrastructure to increase clinical pharmacologists' knowledge in LMICs would be extremely beneficial because they have a significant role to play in global health.

Keywords: low- and middle-income, clinical pharmacology, pharmacometrics, career development pathways

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Authors: Claire Williams

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Randomised controlled Trials (RCTs) of efficacy are still perceived as the gold standard for the generation of evidence, and whilst advances in data collection methods are well developed, this progress has not been matched for the reporting of adverse events (AEs). Assessment and reporting of AEs in clinical trials are fraught with human error and inefficiency and are extremely time and resource intensive. Recent research conducted into the quality of reporting of AEs during clinical trials concluded it is substandard and reporting is inconsistent. Investigators commonly send reports to sponsors who are incorrectly categorised and lacking in critical information, which can complicate the detection of valid safety signals. In our presentation, we will describe an electronic data capture system, which has been designed to support clinical trial processes by reducing the resource burden on investigators, improving overall trial efficiencies, and making trials safer for patients. This proprietary technology was developed using expertise proven in the delivery of the world’s first prospective, phase 3b real-world trial, ‘The Salford Lung Study, ’ which enabled robust safety monitoring and reporting processes to be accomplished by the remote monitoring of patients’ EHRs. This technology enables safety alerts that are pre-defined by the protocol to be detected from the data extracted directly from the patients EHR. Based on study-specific criteria, which are created from the standard definition of a serious adverse event (SAE) and the safety profile of the medicinal product, the system alerts the investigator or study team to the safety alert. Each safety alert will require a clinical review by the investigator or delegate; examples of the types of alerts include hospital admission, death, hepatotoxicity, neutropenia, and acute renal failure. This is achieved in near real-time; safety alerts can be reviewed along with any additional information available to determine whether they meet the protocol-defined criteria for reporting or withdrawal. This active surveillance technology helps reduce the resource burden of the more traditional methods of AE detection for the investigators and study teams and can help eliminate reporting bias. Integration of multiple healthcare data sources enables much more complete and accurate safety data to be collected as part of a trial and can also provide an opportunity to evaluate a drug’s safety profile long-term, in post-trial follow-up. By utilising this robust and proven method for safety monitoring and reporting, a much higher risk of patient cohorts can be enrolled into trials, thus promoting inclusivity and diversity. Broadening eligibility criteria and adopting more inclusive recruitment practices in the later stages of drug development will increase the ability to understand the medicinal products risk-benefit profile across the patient population that is likely to use the product in clinical practice. Furthermore, this ground-breaking approach to AE detection not only provides sponsors with better-quality safety data for their products, but it reduces the resource burden on the investigator and study teams. With the data taken directly from the source, trial costs are reduced, with minimal data validation required and near real-time reporting enables safety concerns and signals to be detected more quickly than in a traditional RCT.

Keywords: more comprehensive and accurate safety data, near real-time safety alerts, reduced resource burden, safer trials

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Authors: Camilo Andrés Agudelo Vélez, Lina María Martínez Sánchez, Isabel Cristina Ortiz Trujillo, Evert Armando Jiménez Cotes, Natalia Perilla Hernández, María de los Ángeles Rodríguez Gázquez, Daniel Duque Restrepo, Felipe Hernández Restrepo, Dayana Andrea Quintero Moreno, Juan José Builes Gómez, Camilo Ruiz Mejía, Ana Lucia Arango Gómez

Abstract:

Preeclampsia is a clinical complication during pregnancy with high incidence in Colombia; therefore, it is important to evaluate the influence of external conditions and medical interventions, in order to promote measures that encourage improvements in the quality of life. Objective: Determine clinical and sociodemographic variables in women with preeclampsia. Methods: This cross-sectional study enrolled 50 patients with the diagnosis of preeclampsia, from a private institution in Medellin, during 2015. We used the software SPSS ver.20 for statistical analysis. For the qualitative variables, we calculated the mean and standard deviation, while, for ordinal and nominal levels of quantitative variables, ratios were estimated. Results: The average age was 26.8±5.9 years. The predominant characteristics were socioeconomic stratum 2 (48%), students (55%), mixed race (46%) and middle school as level of education (38%). As for clinical features, 72% of the cases were mild preeclampsia, and 22% were severe forms. The most common clinical manifestations were edema (46%), headache (62%), and proteinuria (55%). As for the Gyneco-obstetric history, 8% reported previous episodes of this disease and it was the first pregnancy for 60% of the patients. Conclusions: Preeclampsia is a frequent condition in young women; on the other hand, headache and edema were the most common reasons for consultation, therefore, doctors need to be aware of these symptoms in pregnant women.

Keywords: pre-eclampsia, hypertension, pregnancy complications, pregnancy, abdominal, edema

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Authors: Shilpa Avarebeel

Abstract:

Background: India is one of the seven identified countries in South-East Asia region, regularly reporting dengue infection and may soon transform into a major niche for dengue epidemics. Objective: To study the clinical profile of dengue in our setting with special reference to respiratory complication. Study design: Descriptive and exploratory study, for one year in 2014. All patients confirmed as dengue infection were followed and their clinical profile, along with outcome was determined. Study proforma was designed based on the objective of the study and it was pretested and used after modification. Data was analyzed using statistical software SPSS-Version 16. Data were expressed as mean ±S .D for parametric variables and actual frequencies or percentage for non-parametric data. Comparison between groups was done using students’ t-test for independent groups, Chie square test, one-way ANOVA test, Karl Pearson’s correlation test. Statistical significance is taken at P < 0.05. Results: Study included 134 dengue positive cases. 81% had dengue fever, 18% had dengue hemorrhagic fever, and one had dengue shock syndrome. Most of the cases reported were during the month of June. Maximum number of cases was in the age group of 26-35 years. Average duration of hospital stay was less than seven days. Fever and myalgia was present in all the 134 patients, 16 had bleeding manifestation. 38 had respiratory symptoms, 24 had breathlessness, and 14 had breathlessness and dry cough. On clinical examination of patients with respiratory symptoms, all twenty-eight had hypoxia features, twenty-four had signs of pleural effusion, and four had ARDS features. Chest x-ray confirmed the same. Among the patients with respiratory symptoms, the mean platelet count was 26,537 c/cmm. There was no statistical significant difference in the platelet count in those with ARDS and other dengue complications. Average four units of platelets were transfused to all those who had ARDS in view of bleeding tendency. Mechanical ventilator support was provided for ARDS patients. Those with pleural effusion and pulmonary oedema were given NIV (non-invasive ventilation) support along with supportive care. However, steroids were given to patients with ARDS and 10 patients with signs of respiratory distress. 100%. Mortality was seen in patients with ARDS. Conclusion: Dengue has to be checked for those presenting with fever and breathlessness. Supportive treatments remain the cornerstone of treatment. Platelet transfusion has to be given only by clinical judgment. Steroids have no role except in early ARDS, which is controversial. Early NIV support helps in speedy recovery of dengue patients with respiratory distress.

Keywords: adult respiratory distress syndrome, dengue fever, non-invasive ventilation, pulmonary complication

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Authors: Matza Gusto Andika, Malinda Sabrina, Syarie Fatunnisa

Abstract:

Aerodynamic and aeroelastics studies on the hanger bridge profile are important to analyze the aerodynamic phenomenon and Aeroelastics stability of hanger. Wind tunnel tests were conducted on a model of H-beam profile from hanger bridge. The purpose of this study is to investigate steady aerodynamic characteristics such as lift coefficient (Cl), drag coefficient (Cd), and moment coefficient (Cm) under the different angle of attack for preliminary prediction of aeroelastics stability problems. After investigation the steady aerodynamics characteristics from the model, dynamic testing is also conducted in wind tunnel to know the aeroelastics phenomenon which occurs at the H-beam hanger bridge profile. The studies show that the torsional vortex induced vibration occur when the wind speed is 7.32 m/s until 9.19 m/s with maximum amplitude occur when the wind speed is 8.41 m/s. The result of wind tunnel testing is matching to hanger vibration where occur in the field, so wind tunnel studies has successful to model the problem. In order that the H-beam profile is not good enough for the hanger bridge and need to be modified to minimize the Aeroelastics problem. The modification can be done with structure dynamics modification or aerodynamics modification.

Keywords: aerodynamics, aeroelastic, hanger bridge, h-beam profile, vortex induced vibration, wind tunnel

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Authors: Joanna Dzieńdziora

Abstract:

Lobbying is an instrument of influence in various decision-making processes. It is also the underestimated issue as a research problem. The lack of research on the modern lobbyist competencies is the most crucial element. The paper presents attempts of finding answers to the following questions: Who should run the lobbying activity? What competencies should a lobbyist possess in order to implement lobbying activities effectively? Searching for answers for the mentioned above questions requires positioning the opportunity to change the image of lobbying in the area of competencies of entities that provide lobbying activities. The aim of the paper is presenting the lobbyist competencies profile in the framework of his professional role. The essence of lobbying activity and its significance in the modern economy as well as areas, the scope of lobbying activities, diagnosis of a modern lobbyist’s competences, lobbyist’s competencies profile that is focused on the professionalization of the lobbying activity, will have been presented in this paper. Indicated research tasks let emerge lobbyist’s competencies in the way that allows identifying and elaborating the lobbyist competencies profile. The profile lets improve lobbying activities. Its elaboration is based on the author’s research results analysis. Taking into consideration the shortages within the theory and research on the lobbying activity, the implementation of this research enables to fill the cognitive gap existing in the theory of management sciences.

Keywords: competencies, competencies profile, lobbying, lobbyist

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Authors: Praveen Kumar, Satish Kumar, Jashanpreet Singh

Abstract:

Transportation of unrefined crude oil from the production unit to a refinery or large storage area by a pipeline is difficult due to the different properties of crude in various areas. Thus, the design of a crude oil pipeline is a very complex and time consuming process, when considering all the various parameters. There were three very important parameters that play a significant role in the transportation and processing pipeline design; these are: viscosity profile, temperature profile and the velocity profile of waxy crude oil through the crude oil pipeline. Knowledge of the Rheological computational technique is required for better understanding the flow behavior and predicting the flow profile in a crude oil pipeline. From these profile parameters, the material and the emulsion that is best suited for crude oil transportation can be predicted. Rheological computational fluid dynamic technique is a fast method used for designing flow profile in a crude oil pipeline with the help of computational fluid dynamics and rheological modeling. With this technique, the effect of fluid properties including shear rate range with temperature variation, degree of viscosity, elastic modulus and viscous modulus was evaluated under different conditions in a transport pipeline. In this paper, two crude oil samples was used, as well as a prepared emulsion with natural and synthetic additives, at different concentrations ranging from 1,000 ppm to 3,000 ppm. The rheological properties was then evaluated at a temperature range of 25 to 60 °C and which additive was best suited for transportation of crude oil is determined. Commercial computational fluid dynamics (CFD) has been used to generate the flow, velocity and viscosity profile of the emulsions for flow behavior analysis in crude oil transportation pipeline. This rheological CFD design can be further applied in developing designs of pipeline in the future.

Keywords: surfactant, natural, crude oil, rheology, CFD, viscosity

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Authors: Shahad Nagoor, Lucy Hederman, Kevin Koidl, Annalina Caputo

Abstract:

Doctors’ notes reflect their impressions, attitudes, clinical sense, and opinions about patients’ conditions and progress, and other information that is essential for doctors’ daily clinical decisions. Despite their value, clinical notes are insufficiently researched within the language processing community. Automatically extracting information from unstructured text data is known to be a difficult task as opposed to dealing with structured information such as vital physiological signs, images, and laboratory results. The aim of this research is to investigate how Natural Language Processing (NLP) techniques and machine learning techniques applied to clinician notes can assist in doctors’ decision-making in Intensive Care Unit (ICU) for coronavirus disease 2019 (COVID-19) patients. The hypothesis is that clinical outcomes like survival or mortality can be useful in influencing the judgement of clinical sentiment in ICU clinical notes. This paper introduces two contributions: first, we introduce COVID_ICU_BERT, a fine-tuned version of clinical transformer models that can reliably predict clinical sentiment for notes of COVID patients in the ICU. We train the model on clinical notes for COVID-19 patients, a type of notes that were not previously seen by clinicalBERT, and Bio_Discharge_Summary_BERT. The model, which was based on clinicalBERT achieves higher predictive accuracy (Acc 93.33%, AUC 0.98, and precision 0.96 ). Second, we perform data augmentation using clinical contextual word embedding that is based on a pre-trained clinical model to balance the samples in each class in the data (survived vs. deceased patients). Data augmentation improves the accuracy of prediction slightly (Acc 96.67%, AUC 0.98, and precision 0.92 ).

Keywords: BERT fine-tuning, clinical sentiment, COVID-19, data augmentation

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Authors: Ashit Syngle, Inderjit Verma, Pawan Krishan

Abstract:

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: Jonah Kenei, Elisha Opiyo

Abstract:

Electronic health records, as a repository of patient information, is nowadays the most commonly used technology to record, store and review patient clinical records and perform other clinical tasks. However, the accurate identification and retrieval of relevant information from clinical records is a difficult task due to the unstructured nature of clinical documents, characterized in particular by a lack of clear structure. Therefore, medical practice is facing a challenge thanks to the rapid growth of health information in electronic health records (EHRs), mostly in narrative text form. As a result, it's becoming important to effectively manage the growing amount of data for a single patient. As a result, there is currently a requirement to visualize electronic health records (EHRs) in a way that aids physicians in clinical tasks and medical decision-making. Leveraging text visualization techniques to unstructured clinical narrative texts is a new area of research that aims to provide better information extraction and retrieval to support clinical decision support in scenarios where data generated continues to grow. Clinical datasets in electronic health records (EHR) offer a lot of potential for training accurate statistical models to classify facets of information which can then be used to improve patient care and outcomes. However, in many clinical note datasets, the unstructured nature of clinical texts is a common problem. This paper examines the very issue of getting raw clinical texts and mapping them into meaningful structures that can support healthcare professionals utilizing narrative texts. Our work is the result of a collaborative design process that was aided by empirical data collected through formal usability testing.

Keywords: classification, electronic health records, narrative texts, visualization

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Authors: Ali Raad Hassan

Abstract:

In this paper, an (irregular) case relating to base circle, root circle, and pressure angle has been discussed and a computer programme has been developed to simulate and plot spur gear tooth profile, including involute and trochoid curves based on the formulation of rack cutter using different values of pressure angle and profile shift factor and it gave the values of all important geometric parameters. The results showed the flexibility of this approach and versatility of the programme to draw many different cases of spur gear teeth of any module, pressure angle, profile shift factor, number of teeth and rack cutter tip radius. The procedure developed can be extended to produce finite element models of heretofore intractable geometrical forms, to exploring fabrication of nonstandard tooth forms also. Finite elements model of these irregular cases have been built using above programme, and modal analysis has been done using ANSYS software, and natural frequencies of these selected cases have been obtained and discussed.

Keywords: involute, trochoid, pressure angle, profile shift factor, natural frequency

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