Search results for: clinical pharmacology
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3679

Search results for: clinical pharmacology

3169 The Study of Periodontal Health Status in Menopausal Women with Osteoporosis Referred to Rheumatology Clinics in Yazd and Healthy People

Authors: Mahboobe Daneshvar

Abstract:

Introduction: Clinical studies on the effect of systemic conditions on periodontal diseases have shown that some systemic deficiencies may provide grounds for the onset of periodontal diseases. One of these systemic problems is osteoporosis, which may be a risk factor for the onset and exacerbation of periodontitis. This study tends to evaluate periodontal indices in osteoporotic menopausal women and compare them with healthy controls. Materials and Methods: In this case-control study, participants included 45-75-year-old menopausal women referred to rheumatology wards of the Khatamolanbia Clinic and Shahid Sadoughi Hospital in Yazd; Their bone density was determined by DEXA-scan and by imaging the femoral-lumbar bone. Thirty patients with osteoporosis and 30 subjects with normal BMD were selected. Then, informed consent was obtained for participation in the study. During the clinical examinations, tooth loss (TL), plaque index (PI), gingival recession, pocket probing depth (PPD), clinical attachment loss (CAL), and tooth mobility (TM) were measured to evaluate the periodontal status. These clinical examinations were performed to determine the periodontal status by catheter, mirror and probe. Results: During the evaluation, there was no significant difference in PPD, PI, TM, gingival recession, and CAL between case and control groups (P-value>0.05); that is, osteoporosis has no effect on the above factors. These periodontal factors are almost the same in both healthy and patient groups. In the case of missing teeth, the following results were obtained: the mean of missing teeth was 22.173% of the total teeth in the case group and 18.583% of the total teeth in the control group. In the study of the missing teeth in the case and control groups, there was a significant relationship between case and control groups (P-value = 0.025). Conclusion: In fact, since periodontal disease is multifactorial and microbial plaque is the main cause, osteoporosis is considered a predisposing factor in exacerbation or persistence of periodontal disease. In patients with osteoporosis, usually pathological fractures, hormonal changes, and aging lead to reduced physical activity and affect oral health, which leads to the manifestation of periodontal disease. But this disease increases tooth loss by changing the shape and structure of bone trabeculae and weakening them. Osteoporosis does not seem to be a deterministic factor in the incidence of periodontal disease, since it affects bone quality rather than bone quantity.

Keywords: plaque index, Osteoporosis, tooth mobility, periodontal packet

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3168 The Effect of Exercise Therapy and Electroacupuncture on Some Clinical Outcomes in People with Post Total Hip Arthroplasty

Authors: Marzieh Yassin, Masoud Rashed, Soheil Mansour Sohani, Reza Salehi

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Background: Hip arthroplasty is one of the surgical methods to improve symptoms in patients with hip osteoarthritis. The use of electroacupuncture and TENS reduces pain, increases range of motion and improves performance. Methods: In this clinical trial study, 30 patients after hip arthroplasty were randomly divided into two groups: electroacupuncture (n=16) with exercise therapy and TENS with exercise therapy (n=14). Severity of pain, quality of life, range of motion, edema and function were evaluated in two groups before and after the interventions. Interventions of 10 sessions (three sessions per week) were conducted for two groups. The significance level in all tests was below 0.05. Results: The results showed that both groups improved all of the symptoms after the intervention (p≤0.05), although there was no statistically significant difference between the two groups in terms of effectiveness (p≥0.05). Conclusion: The results showed that both methods improve symptoms in patients after surgery. According to this study, electroacupuncture is suggested as a new method effective for the treatment of people with post-Total Hip Arthroplasty.

Keywords: electroacupuncture, physical performance, total hip arthroplasty, TENS

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3167 O-(2-18F-Fluoroethyl)-L-Tyrosine Positron Emission Tomography/Computed Tomography in Patients with Suspicious Recurrent Low and High-Grade Glioma

Authors: Mahkameh Asadi, Habibollah Dadgar

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The precise definition margin of high and low-grade glioma is crucial for choosing best treatment approach after surgery and radio-chemotherapy. The aim of the current study was to assess the O-(2-18F-fluoroethyl)-L-tyrosine (18F-FET) positron emission tomography (PET)/computed tomography (CT) in patients with low (LGG) and high grade glioma (HGG). We retrospectively analyzed 18F-FET PET/CT of 10 patients (age: 33 ± 12 years) with suspicious for recurrent LGG and HGG. The final decision of recurrence was made by magnetic resonance imaging (MRI) and registered clinical data. While response to radio-chemotherapy by MRI is often complex and sophisticated due to the edema, necrosis, and inflammation, emerging amino acid PET leading to better interpretations with more specifically differentiate true tumor boundaries from equivocal lesions. Therefore, integrating amino acid PET in the management of glioma to complement MRI will significantly improve early therapy response assessment, treatment planning, and clinical trial design.

Keywords: positron emission tomography, amino acid positron emission tomography, magnetic resonance imaging, low and high grade glioma

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3166 An Alternative to Problem-Based Learning in a Post-Graduate Healthcare Professional Programme

Authors: Brogan Guest, Amy Donaldson-Perrott

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The Master’s of Physician Associate Studies (MPAS) programme at St George’s, University of London (SGUL), is an intensive two-year course that trains students to become physician associates (PAs). PAs are generalized healthcare providers who work in primary and secondary care across the UK. PA programmes face the difficult task of preparing students to become safe medical providers in two short years. Our goal is to teach students to develop clinical reasoning early on in their studies and historically, this has been done predominantly though problem-based learning (PBL). We have had an increase concern about student engagement in PBL and difficulty recruiting facilitators to maintain the low student to facilitator ratio required in PBL. To address this issue, we created ‘Clinical Application of Anatomy and Physiology (CAAP)’. These peer-led, interactive, problem-based, small group sessions were designed to facilitate students’ clinical reasoning skills. The sessions were designed using the concept of Team-Based Learning (TBL). Students were divided into small groups and each completed a pre-session quiz consisting of difficult questions devised to assess students’ application of medical knowledge. The quiz was completed in small groups and they were not permitted access of external resources. After the quiz, students worked through a series of openended, clinical tasks using all available resources. They worked at their own pace and the session was peer-led, rather than facilitator-driven. For a group of 35 students, there were two facilitators who observed the sessions. The sessions utilised an infinite space whiteboard software. Each group member was encouraged to actively participate and work together to complete the 15-20 tasks. The session ran for 2 hours and concluded with a post-session quiz, identical to the pre-session quiz. We obtained subjective feedback from students on their experience with CAAP and evaluated the objective benefit of the sessions through the quiz results. Qualitative feedback from students was generally positive with students feeling the sessions increased engagement, clinical understanding, and confidence. They found the small group aspect beneficial and the technology easy to use and intuitive. They also liked the benefit of building a resource for their future revision, something unique to CAAP compared to PBL, which out students participate in weekly. Preliminary quiz results showed improvement from pre- and post- session; however, further statistical analysis will occur once all sessions are complete (final session to run December 2022) to determine significance. As a post-graduate healthcare professional programme, we have a strong focus on self-directed learning. Whilst PBL has been a mainstay in our curriculum since its inception, there are limitations and concerns about its future in view of student engagement and facilitator availability. Whilst CAAP is not TBL, it draws on the benefits of peer-led, small group work with pre- and post- team-based quizzes. The pilot of these sessions has shown that students are engaged by CAAP, and they can make significant progress in clinical reasoning in a short amount of time. This can be achieved with a high student to facilitator ratio.

Keywords: problem based learning, team based learning, active learning, peer-to-peer teaching, engagement

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3165 RNA-seq Analysis of Liver from NASH-HCC Model Mouse Treated with Streptozotocin-High Fat Diet

Authors: Bui Phuong Linh, Yuki Sakakibara, Ryuto Tanaka, Elizabeth H. Pigney, Taishi Hashiguchi

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Non-alcoholic steatohepatitis (NASH) is a chronic liver disease, often associated with type II diabetes, which sometimes progresses to more serious conditions such as liver fibrosis and hepatocellular carcinoma (HCC). NASH has become an important health problem worldwide, buttherapeutic agents for NASH have not yet been approved, and animal models with high clinical correlation are required. TheSTAM™ mouse shows the same pathological progression as human NASH patients and has been widely used for both drug efficacy and basic research, such as lipid profiling and gut microbiota research. In this study, we analyzed the RNA-seq data of STAM™mice at each pathological stage (steatosis, steatohepatitis, liver fibrosis, and HCC) and examined the clinical correlation at the genetic level. NASH was induced in male mice by a single subcutaneous injection of 200 µg streptozotocin solution 2 days after birth and feeding with high fat dietafter 4 weeks of age. The mice were sacrificed and livers collected at 6, 8, 10, 12, 16, and 20 weeks of age. For liver samples, the left lateral lobe was snap frozen in liquid nitrogen and stored at -80˚C for RNA-seq analysis. Total RNA of the cells was isolated using RNeasy mini kit. The gene expression of the canonical pathways in NASH progression from steatosis to hepatocellular carcinoma were analyzed, such as immune system process, oxidation-reduction process, lipid metabolic process. Moreover, since it has been reported that genetic traits are involved in the development of NASH-HCC, we next analyzed the genetic mutations in the STAM™mice. The number of individuals showing mutations in Mtorinvolved in Insulin signaling increases as the disease progresses, especially in the liver cancer phase. These results indicated a clinical correlation of gene profiles in the STAM™mouse.

Keywords: steatosis, non-alcoholic steatohepatitis, fibrosis, hepatocellular carcinoma, RNA-seq

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3164 Relationship of Oxidative Stress to Elevated Homocysteine and DNA Damage in Coronary Artery Disease Patients

Authors: Shazia Anwer Bukhari, Madiha Javeed Ghani, Muhammad Ibrahim Rajoka

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Objective: Biochemical, environmental, physical and genetic factors have a strong effect on the development of coronary disease (CAD). Plasma homocysteine (Hcy) level and DNA damage play a pivotal role in its development and progression. The aim of this study was to investigate the predictive strength of an oxidative stress, clinical biomarkers and total antioxidant status (TAS) in CAD patients to find the correlation of homocysteine, TOS and oxidative DNA damage with other clinical parameters. Methods: Sixty confirmed patients with CAD and 60 healthy individuals as control were included in this study. Different clinical and laboratory parameters were studied in blood samples obtained from patients and control subjects using commercially available biochemical kits and statistical software Results: As compared to healthy individuals, CAD patients had significantly higher concentrations of indices of oxidative stress: homocysteine (P=0.0001), total oxidative stress (TOS) (P=0.0001), serum cholesterol (P=0.04), low density lipoprotein cholesterol (LDL) (P=0.01), high density lipoprotein-cholesterol (HDL) (P=0.0001), and malondialdehyde (MDA) (P=0.001) than those of healthy individuals. Plasma homocysteine level and oxidative DNA damage were positively correlated with cholesterol, triglycerides, systolic blood pressure, urea, total protein and albumin (P values= 0.05). Both Hcy and oxidative DNA damage were negatively correlated with TAS and proteins. Conclusion: Coronary artery disease patients had a significant increase in homocysteine level and DNA damage due to increased oxidative stress. In conclusion, our study shows a significantly increase in lipid peroxidation, TOS, homocysteine and DNA damage in the erythrocytes of patients with CAD. A significant decrease level of HDL-C and TAS was observed only in CAD patients. Therefore these biomarkers may be useful diagnosis of patients with CAD and play an important role in the pathogenesis of CAD.

Keywords: antioxidants, coronary artery disease, DNA damage, homocysteine, oxidative stress, malondialdehyde, 8-Hydroxy-2’deoxyguanosine

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3163 Multicenter Evaluation of the ACCESS HBsAg and ACCESS HBsAg Confirmatory Assays on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis B Surface Antigen

Authors: Vanessa Roulet, Marc Turini, Juliane Hey, Stéphanie Bord-Romeu, Emilie Bonzom, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Vanessa Viotti, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. has recently developed fully automated assays for the detection of HBsAg on a new immunoassay platform. The objective of this European multicenter study was to evaluate the performance of the ACCESS HBsAg and ACCESS HBsAg Confirmatory assays† on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer. Methods: The clinical specificity of the ACCESS HBsAg and HBsAg Confirmatory assays was determined using HBsAg-negative samples from blood donors and hospitalized patients. The clinical sensitivity was determined using presumed HBsAg-positive samples. Sample HBsAg status was determined using a CE-marked HBsAg assay (Abbott ARCHITECT HBsAg Qualitative II, Roche Elecsys HBsAg II, or Abbott PRISM HBsAg assay) and a CE-marked HBsAg confirmatory assay (Abbott ARCHITECT HBsAg Qualitative II Confirmatory or Abbott PRISM HBsAg Confirmatory assay) according to manufacturer package inserts and pre-determined testing algorithms. False initial reactive rate was determined on fresh hospitalized patient samples. The sensitivity for the early detection of HBV infection was assessed internally on thirty (30) seroconversion panels. Results: Clinical specificity was 99.95% (95% CI, 99.86 – 99.99%) on 6047 blood donors and 99.71% (95%CI, 99.15 – 99.94%) on 1023 hospitalized patient samples. A total of six (6) samples were found false positive with the ACCESS HBsAg assay. None were confirmed for the presence of HBsAg with the ACCESS HBsAg Confirmatory assay. Clinical sensitivity on 455 HBsAg-positive samples was 100.00% (95% CI, 99.19 – 100.00%) for the ACCESS HBsAg assay alone and for the ACCESS HBsAg Confirmatory assay. The false initial reactive rate on 821 fresh hospitalized patient samples was 0.24% (95% CI, 0.03 – 0.87%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS HBsAg assay had equivalent sensitivity performances compared to the Abbott ARCHITECT HBsAg Qualitative II assay with an average bleed difference since first reactive bleed of 0.13. All bleeds found reactive in ACCESS HBsAg assay were confirmed in ACCESS HBsAg Confirmatory assay. Conclusion: The newly developed ACCESS HBsAg and ACCESS HBsAg Confirmatory assays from Beckman Coulter have demonstrated high clinical sensitivity and specificity, equivalent to currently marketed HBsAg assays, as well as a low false initial reactive rate. †Pending achievement of CE compliance; not yet available for in vitro diagnostic use. 2023-11317 Beckman Coulter and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

Keywords: dxi 9000 access immunoassay analyzer, hbsag, hbv, hepatitis b surface antigen, hepatitis b virus, immunoassay

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3162 Perception and Attitudes of Medical Students towards Dermatology as a Future Specialty.

Authors: Rakan Alajmi, Rahaf Alnazzawi, Yara Aljefri, Abdullah Alafif, Ali Alraddadi, Awadh Alamri

Abstract:

Background: The distribution of physicians in different specialties across Saudi Arabia is determined by the career choices of medical students. Dermatology residency program is one of the highly competitive programs here in Saudi Arabia. Assessing and understanding the factors perceived to be attractive in choosing dermatology will aid the directors of the specialty programs to plan for a more balanced workforce distribution to better suit the needs of the specialties. Aim: The aim of our study is to determine and assess the factors perceived to be significantly attractive when choosing dermatology as a future specialty. Methods: The study is a cross-sectional study conducted in King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. A validated questionnaire was sent electronically to clinical year medical students. In addition to the questionnaire, gender, grade point average, preferred specialty, and other socio-demographic data were assessed. Results: A total of 121 clinical years medical students completed the questionnaire, 8 (6.6%) preferred dermatology as a specialty. 76 (62.8%) of the participants score a grade point average of more than 4.5 and 83 students (68.6%) chose their specialty during clinical years. The appeal of being a dermatologist (P= 0.047), the portrayal of different specialities in the media (P= 0.005), and the likelihood that dermatologists can influence patients’ lives (P=0.010) were shown to be significantly attractive factors. Conclusion: There are many factors that are affecting students’ choices when choosing a medical specialty. The appeal of being a dermatologist, the portrayal of different specialities in the media, and the likelihood that dermatologists can influence patients’ lives were shown to be significantly attractive factors when choosing dermatology as a future specialty. Recognizing medical students’ specialty perception will lead them to a proper specialty tailored to their needs.

Keywords: dermatology, career choice, medical specialties, student's perception

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3161 Correlation of Clinical and Sonographic Findings with Cytohistology for Diagnosis of Ovarian Tumours

Authors: Meenakshi Barsaul Chauhan, Aastha Chauhan, Shilpa Hurmade, Rajeev Sen, Jyotsna Sen, Monika Dalal

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Introduction: Ovarian masses are common forms of neoplasm in women and represent 2/3rd of gynaecological malignancies. A pre-operative suggestion of malignancy can guide the gynecologist to refer women with suspected pelvic mass to a gynecological oncologist for appropriate therapy and optimized treatment, which can improve survival. In the younger age group preoperative differentiation into benign or malignant pathology can decide for conservative or radical surgery. Imaging modalities have a definite role in establishing the diagnosis. By using International Ovarian Tumor Analysis (IOTA) classification with sonography, costly radiological methods like Magnetic Resonance Imaging (MRI) / computed tomography (CT) scan can be reduced, especially in developing countries like India. Thus, this study is being undertaken to evaluate the role of clinical methods and sonography for diagnosis of the nature of the ovarian tumor. Material And Methods: This prospective observational study was conducted on 40 patients presenting with ovarian masses, in the Department of Obstetrics and Gynaecology, at a tertiary care center in northern India. Functional cysts were excluded. Ultrasonography and color Doppler were performed on all the cases.IOTA rules were applied, which take into account locularity, size, presence of solid components, acoustic shadow, dopper flow etc . Magnetic Resonance Imaging (MRI) / computed tomography (CT) scans abdomen and pelvis were done in cases where sonography was inconclusive. In inoperable cases, Fine needle aspiration cytology (FNAC) was done. The histopathology report after surgery and cytology report after FNAC was correlated statistically with the pre-operative diagnosis made clinically and sonographically using IOTA rules. Statistical Analysis: Descriptive measures were analyzed by using mean and standard deviation and the Student t-test was applied and the proportion was analyzed by applying the chi-square test. Inferential measures were analyzed by sensitivity, specificity, negative predictive value, and positive predictive value. Results: Provisional diagnosis of the benign tumor was made in 16(42.5%) and of the malignant tumor was made in 24(57.5%) patients on the basis of clinical findings. With IOTA simple rules on sonography, 15(37.5%) were found to be benign, while 23 (57.5%) were found to be malignant and findings were inconclusive in 2 patients (5%). FNAC/Histopathology reported that benign ovarian tumors were 14 (35%) and 26(65%) were malignant, which was taken as the gold standard. The clinical finding alone was found to have a sensitivity of 66.6% and a specificity of 90.9%. USG alone had a sensitivity of 86% and a specificity of 80%. When clinical findings and IOTA simple rules of sonography were combined (excluding inconclusive masses), the sensitivity and specificity were 83.3% and 92.3%, respectively. While including inconclusive masses, sensitivity came out to be 91.6% and specificity was 89.2. Conclusion: IOTA's simple sonography rules are highly sensitive and specific in the prediction of ovarian malignancy and also easy to use and easily reproducible. Thus, combining clinical examination with USG will help in the better management of patients in terms of time, cost and better prognosis. This will also avoid the need for costlier modalities like CT, and MRI.

Keywords: benign, international ovarian tumor analysis classification, malignant, ovarian tumours, sonography

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3160 Nurses' and Patients’ Perception about Care: A Comparative Study

Authors: Evangelia Kotrotsiou, Mairy Gouva, Theodosios Paralikas, Maria Fiaka, Styliani Kotrotsiou, Maria Malliarou

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The purpose of this research is to investigate the way nurses perceive the care provided in comparison to the way patients perceive it, taking into account existing literature. As far as the sample of research is concerned, it has come from the population of nurses working in the General Hospital of Thessaloniki, St. Paul and the patients of its surgical clinic. In the present study, the sample consists of 100 nurses and 88 patients. The questionnaire used was the Caring Nurse-Patient Interactions Scale: 23-Item Version, created by Cossette et al. (2006). In the case of both patients and nurses, a high score was observed in relational care in the case of the frequency of nursing care in daily practice, as well as the satisfaction of providing nursing care. Overall, patients rated higher clinical care in the case of the frequency of nursing care in daily practice, as well as the satisfaction of the clinical care they were given. On the other hand, nurses rated higher comfort care in the case of the frequency of nursing care in everyday practice, as well as relational care in the area of the importance of nursing care in everyday practice.

Keywords: nursing care, patient needs, patient satisfaction, care giving

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3159 Congenital Heart Defect(CHD) “The Silent Crises”; The Need for New Innovative Ways to Save the Ghanaian Child - A Retrospective Study

Authors: Priscilla Akua Agyapong

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Background: In a country of nearly 34 million people, Ghana suffers from rapidly growing pediatric CHD cases and not enough pediatric specialists to attend to the burgeoning needs of these children. Most of the cases are either missed or diagnosed late, resulting in increased mortality. According to the National Cardiothoracic Centre, 1 in every 100,000 births in Ghana has CHD; however, there is limited data on the clinical presentation and its management, one of the many reasons I decided to do this case study coupled with the loss my 2 month old niece to multiple Ventricular Septal Defect 3 years ago due late diagnoses. Method: A retrospective cohort study was performed at the child health clinic of one of Ghana’s public tertiary Institutions using data from their electronic health record (EHR) from February 2021 to April 2022. All suspected or provisionally diagnosed cases were included in the analysis. Results: Records of over 3000 children were reviewed with an approximate male to female ratio of 1:1.53 cases diagnosed during the period of study, most of whom were less than 5 years of age. 25 cases had complete clinical records, with acyanotic septal defects being the most diagnosed. 62.5% of the cases were ventricular septal defects, followed by Patent Ductus Arteriosus (23%) and Atrial Septal Defects (4.5%). Tetralogy of Fallot was the most predominant and complex cyanotic CHD with 10%. Conclusion: The indeterminate coronary anatomy of infants makes it difficult to use only echocardiography and other conventional clinical methods in screening for CHDs. There are rising modernizations and new innovative ways that can be employed in Ghana for early detection, hence preventing the delay of a potential surgical repair. It is, therefore, imperative to create the needed awareness about these “SILENT CRISES” and help save the Ghanaian child’s life.

Keywords: congenital heart defect(CHD), ventricular septal defect(VSD), atrial septal defect(ASD), patent ductus arteriosus(PDA)

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3158 Grape Seed Extract and Zinc Containing Multivitamin-Mineral Nutritional Food Supplement Protects Heart against Myocardial Ischemic-Reperfusion Injury in Wistar Rats

Authors: S. M. Satyam, K. L. Bairy, R. Pirasanthan, R. L. Vaishnav

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Zincovit tablets have been used as nutritional food supplement over a prolonged period of time. The aim of the present study was to investigate the cardio-protective effect of combined formulation of grape seed extract and Zincovit tablets (40, 80 and 160 mg/kg) using a Langendorff model of ischemia-reperfusion in Wistar rats. Following 21 days of pre-treatment, combined formulation of grape seed extract and Zincovit tablets significantly attenuated ischemia-reperfusion induced cardiac injury in terms of increased coronary flow rate (p < 0.01), decreased creatine kinase activity in coronary effluent (p < 0.05), decreased MDA (p < 0.001), 4-HNE (p < 0.001) and increased protein thiol content (p < 0.01) in comparison with the untreated (control) group. This study opens an avenue to clinical studies to demonstrate the validity of this paradigm as a nutritional food supplement, which could improve the clinical outcome of patients subjected to percutaneous angioplasty.

Keywords: grape seed extract, myocardial ischemia-reperfusion injury, oxidative stress, Zincovit tablets

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3157 A Quantitative Model for Replacement of Medical Equipment Based on Technical and Environmental Factors

Authors: Ghadeer Mohammad Said El-Sheikh, Samer Mohamad Shalhoob

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Medical equipment operation state is a valid reflection of health care organizations' performance, where such equipment highly contributes to the quality of healthcare services on several levels in which quality improvement has become an intrinsic part of the discourse and activities of health care services. In healthcare organizations, clinical and biomedical engineering departments play an essential role in maintaining the safety and efficiency of such equipment. One of the most challenging topics when it comes to such sophisticated equipment is the lifespan of medical equipment, where many factors will impact such characteristics of medical equipment through its life cycle. So far, many attempts have been made in order to address this issue where most of the approaches are kind of arbitrary approaches and one of the criticisms of existing approaches trying to estimate and understand the lifetime of a medical equipment lies under the inquiry of what are the environmental factors that can play into such a critical characteristic of a medical equipment. In an attempt to address this shortcoming, the purpose of our study rises where in addition to the standard technical factors taken into consideration through the decision-making process by a clinical engineer in case of medical equipment failure, the dimension of environmental factors shall be added. The investigations, researches and studies applied for the purpose of supporting the decision making process by a clinical engineers and assessing the lifespan of healthcare equipment’s in the Lebanese society was highly dependent on the identification of technical criteria’s that impacts the lifespan of a medical equipment where the affecting environmental factors didn’t receive the proper attention. The objective of our study is based on the need for introducing a new well-designed plan for evaluating medical equipment depending on two dimensions. According to this approach, the equipment that should be replaced or repaired will be classified based on a systematic method taking into account two essential criteria; the standard identified technical criteria and the added environmental criteria.

Keywords: technical, environmental, healthcare, characteristic of medical equipment

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3156 Effects of Ubiquitous 360° Learning Environment on Clinical Histotechnology Competence

Authors: Mari A. Virtanen, Elina Haavisto, Eeva Liikanen, Maria Kääriäinen

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Rapid technological development and digitalization has affected also on higher education. During last twenty years multiple of electronic and mobile learning (e-learning, m-learning) platforms have been developed and have become prevalent in many universities and in the all fields of education. Ubiquitous learning (u-learning) is not that widely known or used. Ubiquitous learning environments (ULE) are the new era of computer-assisted learning. They are based on ubiquitous technology and computing that fuses the learner seamlessly into learning process by using sensing technology as tags, badges or barcodes and smart devices like smartphones and tablets. ULE combines real-life learning situations into virtual aspects and can be flexible used in anytime and anyplace. The aim of this study was to assess the effects of ubiquitous 360 o learning environment on higher education students’ clinical histotechnology competence. A quasi-experimental study design was used. 57 students in biomedical laboratory science degree program was assigned voluntarily to experiment (n=29) and to control group (n=28). Experimental group studied via ubiquitous 360o learning environment and control group via traditional web-based learning environment (WLE) in a 8-week educational intervention. Ubiquitous 360o learning environment (ULE) combined authentic learning environment (histotechnology laboratory), digital environment (virtual laboratory), virtual microscope, multimedia learning content, interactive communication tools, electronic library and quick response barcodes placed into authentic laboratory. Web-based learning environment contained equal content and components with the exception of the use of mobile device, interactive communication tools and quick response barcodes. Competence of clinical histotechnology was assessed by using knowledge test and self-report developed for this study. Data was collected electronically before and after clinical histotechnology course and analysed by using descriptive statistics. Differences among groups were identified by using Wilcoxon test and differences between groups by using Mann-Whitney U-test. Statistically significant differences among groups were identified in both groups (p<0.001). Competence scores in post-test were higher in both groups, than in pre-test. Differences between groups were very small and not statistically significant. In this study the learning environment have developed based on 360o technology and successfully implemented into higher education context. And students’ competence increases when ubiquitous learning environment were used. In the future, ULE can be used as a learning management system for any learning situation in health sciences. More studies are needed to show differences between ULE and WLE.

Keywords: competence, higher education, histotechnology, ubiquitous learning, u-learning, 360o

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3155 Integrating AI into Breast Cancer Diagnosis: Aligning Perspectives for Effective Clinical Practice

Authors: Mehrnaz Mostafavi, Mahtab Shabani, Alireza Azani, Fatemeh Ghafari

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Artificial intelligence (AI) can transform breast cancer diagnosis and therapy by providing sophisticated solutions for screening, imaging interpretation, histopathological analysis, and treatment planning. This literature review digs into the many uses of AI in breast cancer treatment, highlighting the need for collaboration between AI scientists and healthcare practitioners. It emphasizes advances in AI-driven breast imaging interpretation, such as computer-aided detection and diagnosis (CADe/CADx) systems and deep learning algorithms. These have shown significant potential for improving diagnostic accuracy and lowering radiologists' workloads. Furthermore, AI approaches such as deep learning have been used in histopathological research to accurately predict hormone receptor status and categorize tumor-associated stroma from regular H&E stains. These AI-powered approaches simplify diagnostic procedures while providing insights into tumor biology and prognosis. As AI becomes more embedded in breast cancer care, it is crucial to ensure its ethical, efficient, and patient-focused implementation to improve outcomes for breast cancer patients ultimately.

Keywords: breast cancer, artificial intelligence, cancer diagnosis, clinical practice

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3154 Pulmonary Complications of Dengue Infection

Authors: Shilpa Avarebeel

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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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3153 Delivering Safer Clinical Trials; Using Electronic Healthcare Records (EHR) to Monitor, Detect and Report Adverse Events in Clinical Trials

Authors: Claire Williams

Abstract:

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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3152 Study of Non-hodgkin’s Lymphoma

Authors: Zidani Abla

Abstract:

Lymphoma is a common type of cancer that affects the lymphatic system, including the lymph nodes, spleen and other associated organs. There are two main types of lymphoma: Hodgkin's lymphoma and non-Hodgkin's lymphoma. The epidemiological, clinical and biological features of lymphoma are poorly studied in Algeria. The main objective of our study is to investigate the epidemiological, clinical, paraclinical, etiological, evolutionary and biological characteristics of non-Hodgkin's lymphoma (NHL) in the hematology department of the University Hospital Center (HUC) of Batna. This is a study of 10 patients diagnosed at Batna University Hospital. 70% were male and 30% female (sex ratio M/F= 2.33). Median age was 51.7 years. Pain, especially abdominal pain, was the main reason for consultation. Stage IV predominated (40%), followed by stage III (20%). Abdominal adenopathies (34%) were the most abundant. Secondary hepatic localization was predominant. Large B-cell NHL predominated, accounting for 60% of cases, followed by small B-cell NHL (30%). Serology for hepatitis B and C, and human immunodeficiency virus (HIV) was negative. Biologically, a predominance of hyperleukocytosis, polynuclear neutrophilic leukocytosis, lymphopenia and hypoalbuminemia were present in the majority of cases. In summary, our results remain to be compared with other works for other periods and other regions in order to generalize lymphoma percentages for the entire Algerian population.

Keywords: non Hodgkin's lymphoma, epidemiology, clinic, biology

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3151 Target and Biomarker Identification Platform to Design New Drugs against Aging and Age-Related Diseases

Authors: Peter Fedichev

Abstract:

We studied fundamental aspects of aging to develop a mathematical model of gene regulatory network. We show that aging manifests itself as an inherent instability of gene network leading to exponential accumulation of regulatory errors with age. To validate our approach we studied age-dependent omic data such as transcriptomes, metabolomes etc. of different model organisms and humans. We build a computational platform based on our model to identify the targets and biomarkers of aging to design new drugs against aging and age-related diseases. As biomarkers of aging, we choose the rate of aging and the biological age since they completely determine the state of the organism. Since rate of aging rapidly changes in response to an external stress, this kind of biomarker can be useful as a tool for quantitative efficacy assessment of drugs, their combinations, dose optimization, chronic toxicity estimate, personalized therapies selection, clinical endpoints achievement (within clinical research), and death risk assessments. According to our model, we propose a method for targets identification for further interventions against aging and age-related diseases. Being a biotech company, we offer a complete pipeline to develop an anti-aging drug-candidate.

Keywords: aging, longevity, biomarkers, senescence

Procedia PDF Downloads 274
3150 Role of P53, KI67 and Cyclin a Immunohistochemical Assay in Predicting Wilms’ Tumor Mortality

Authors: Ahmed Atwa, Ashraf Hafez, Mohamed Abdelhameed, Adel Nabeeh, Mohamed Dawaba, Tamer Helmy

Abstract:

Introduction and Objective: Tumour staging and grading do not usually reflect the future behavior of Wilms' tumor (WT) regarding mortality. Therefore, in this study, P53, Ki67 and cyclin A immunohistochemistry were used in a trial to predict WT cancer-specific survival (CSS). Methods: In this nonconcurrent cohort study, patients' archived data, including age at presentation, gender, history, clinical examination and radiological investigations, were retrieved then the patients were reviewed at the outpatient clinic of a tertiary care center by history-taking, clinical examination and radiological investigations to detect the oncological outcome. Cases that received preoperative chemotherapy or died due to causes other than WT were excluded. Formalin-fixed, paraffin-embedded specimens obtained from the previously preserved blocks at the pathology laboratory were taken on positively charged slides for IHC with p53, Ki67 and cyclin A. All specimens were examined by an experienced histopathologist devoted to the urological practice and blinded to the patient's clinical findings. P53 and cyclin A staining were scored as 0 (no nuclear staining),1 (<10% nuclear staining), 2 (10-50% nuclear staining) and 3 (>50% nuclear staining). Ki67 proliferation index (PI) was graded as low, borderline and high. Results: Of the 75 cases, 40 (53.3%) were males and 35 (46.7%) were females, and the median age was 36 months (2-216). With a mean follow-up of 78.6±31 months, cancer-specific mortality (CSM) occurred in 15 (20%) and 11 (14.7%) patients, respectively. Kaplan-Meier curve was used for survival analysis, and groups were compared using the Log-rank test. Multivariate logistic regression and Cox regression were not used because only one variable (cyclin A) had shown statistical significance (P=.02), whereas the other significant factor (residual tumor) had few cases. Conclusions: Cyclin A IHC should be considered as a marker for the prediction of WT CSS. Prospective studies with a larger sample size are needed.

Keywords: wilms’ tumour, nephroblastoma, urology, survival

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3149 Neuromyelitis Optica area Postrema Syndrome(NMOSD-APS) in a Fifteen-year-old Girl: A Case Report

Authors: Merilin Ivanova Ivanova, Kalin Dimitrov Atanasov, Stefan Petrov Enchev

Abstract:

Backgroud: Neuromyelitis optica spectrum disorder, also known as Devic’s disease, is a relapsing demyelinating autoimmune inflammatory disorder of the central nervous system associated with anti-aquaporin 4 (AQP4) antibodies that can manifest with devastating secondary neurological deficits. Most commonly affected are the optic nerves and the spinal cord-clinically this is often presented with optic neuritis (loss of vision), transverse myelitis(weakness or paralysis of extremities),lack of bladder and bowel control, numbness. APS is a core clinical entity of NMOSD and adds to the clinical representation the following symptoms: intractable nausea, vomiting and hiccup, it usually occurs isolated at onset, and can lead to a significant delay in the diagnosis. The condition may have features similar to multiple sclerosis (MS) but the episodes are worse in NMO and it is treated differently. It could be relapsing or monophasic. Possible complications are visual field defects and motor impairment, with potential blindness and irreversible motor deficits. In severe cases, myogenic respiratory failure ensues. The incidence of reported cases is approximately 0.3–4.4 per 100,000. Paediatric cases of NMOSD are rare but have been reported occasionally, comprising less than 5% of the reported cases. Objective: The case serves to show the difficulty when it comes to the diagnostic processes regarding a rare autoimmune disease with non- specific symptoms, taking large interval of rimes to reveal as complete clinical manifestation of the aforementioned syndrome, as well as the necessity of multidisciplinary approach in the setting of а general paediatric department in аn emergency hospital. Methods: itpatient's history, clinical presentation, and information from the used diagnostic tools(MRI with contrast of the central nervous system) lead us to the conclusion .This was later on confirmed by the positive results from the anti-aquaporin 4 (AQP4) antibody serology test. Conclusion: APS is a common symptom of NMOSD and is considered a challenge in a differential-diagnostic plan. Gaining an increased awareness of this disease/syndrome, obtaining a detailed patient history, and performing thorough physical examinations are essential if we are to reduce and avoid misdiagnosis.

Keywords: neuromyelitis, devic's disease, hiccup, autoimmune, MRI

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3148 Abdominal Pregnancy with a Live Newborn in a Low Resource Setting: A Case Report

Authors: Olivier Mulisya, Guelord Barasima, Henry Mark Lugobe, Philémon Matumo, Bienfait Mumbere Vahwere, Hilaire Mutuka, Zawadi Léocadie, Wesley Lumika

Abstract:

Abdominal pregnancy is defined as pregnancy anywhere within the peritoneal cavity, exclusive of tubal, ovarian, or broad ligament locations. It is a rare form of ectopic pregnancy with high morbidity and mortality for both the mother and the fetus. Diagnosis can be frequently missed in most poor-resource settings because of poor antenatal coverage, low socioeconomic status in most of the patients as well as lack of adequate medical resources. Clinical diagnosis can be very difficult and an ultrasound scan is very helpful during the early stages of gestation but can also be disappointing in the later stages. We report a case of a 25-year-old woman with severe abdominal pain not amended with any medication. A clinical picture of shock lead to an emergency laparotomy which confirmed the diagnosis of abdominal pregnancy. The ministry of health in developing countries should make an effort to make routine early ultrasounds accessible to pregnant women, and obstetricians should keep in mind the possibility of ectopic pregnancy, irrespective of the gestational age.

Keywords: abdominal pregnancy, live new bron, ultrasound imaging, abdominal pain

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3147 A Case of Apocrine Sweat Gland Adenocarcinoma in a Tabby Cat

Authors: Funda Terzi, Elif Dogan, Ayse B. Kapcak

Abstract:

In this report, clinical, radiological, macroscopic, and histopathological findings of apocrine sweat gland adenocarcinoma are presented in a 13-year-old male tabby cat. In clinical examination, soft tissue masses were detected in the caudal abdomen and left tuber coxae. On radiological examination, subcutaneous masses with soft tissue contrast appearance were detected, and the masses were surgically removed under general anesthesia. The sizes of the masses were approximately 2x2x3 cm in the caudal abdomen and approximately 1x1x2 cm in the tuber coxae region. The cross-section of the mass was whitish-yellow in color. After the masses were fixed in 10% formaldehyde solution, a routine histopathology procedure was applied. In histopathological examination, apocrine sweat glands in a cystic structure and extensions from the center of the cyst to the lumen were determined, and anisonucleosis, anisocytosis, and anaplastic cells with giant nuclei were observed in the epithelial cells of the gland facing the lumen. A diagnosis of papillary-cystic type apocrine sweat gland adenocarcinoma was made with these findings.

Keywords: apocrine sweat gland, carcinoma, cat, histopathology

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3146 Opportunities and Challenges in Midwifery Education: A Literature Review

Authors: Abeer M. Orabi

Abstract:

Midwives are being seen as a key factor in returning birth care to a normal physiologic process that is woman-centered. On the other hand, more needs to be done to increase access for every woman to professional midwifery care. Because of the nature of the midwifery specialty, the magnitude of the effect that can result from a lack of knowledge if midwives make a mistake in their care has the potential to affect a large number of the birthing population. So, the development, running, and management of midwifery educational programs should follow international standards and come after a thorough community needs assessment. At the same time, the number of accredited midwifery educational programs needs to be increased so that larger numbers of midwives will be educated and qualified, as well as access to skilled midwifery care will be increased. Indeed, the selection of promising midwives is important for the successful completion of an educational program, achievement of the program goals, and retention of graduates in the field. Further, the number of schooled midwives in midwifery education programs, their background, and their experience constitute some concerns in the higher education industry. Basically, preceptors and clinical sites are major contributors to the midwifery education process, as educational programs rely on them to provide clinical practice opportunities. In this regard, the selection of clinical training sites should be based on certain criteria to ensure their readiness for the intended training experiences. After that, communication, collaboration, and liaison between teaching faculty and field staff should be maintained. However, the shortage of clinical preceptors and the massive reduction in the number of practicing midwives, in addition to unmanageable workloads, act as significant barriers to midwifery education. Moreover, the medicalized approach inherent in the hospital setting makes it difficult to practice the midwifery model of care, such as watchful waiting, non-interference in normal processes, and judicious use of interventions. Furthermore, creating a motivating study environment is crucial for avoiding unnecessary withdrawal and retention in any educational program. It is well understood that research is an essential component of any profession for achieving its optimal goal and providing a foundation and evidence for its practices, and midwifery is no exception. Midwives have been playing an important role in generating their own research. However, the selection of novel, researchable, and sustainable topics considering community health needs is also a challenge. In conclusion, ongoing education and research are the lifeblood of the midwifery profession to offer a highly competent and qualified workforce. However, many challenges are being faced, and barriers are hindering their improvement.

Keywords: barriers, challenges, midwifery education, educational programs

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3145 Bioproduction of Indirubin from Fermentation and Renewable Sugars Through Genomic and Metabolomic Engineering of a Bacterial Strain

Authors: Vijay H. Ingole, Efthimia Lioliou

Abstract:

Indirubin, a key bioactive component of traditional Chinese medicine, has gained increasing recognition for its potential in modern biomedical applications, particularly in pharmacology and therapeutics. The present work aimed to harness the potential by engineering an Escherichia coli strain capable of high-yield indirubin production. Through meticulous genetic engineering, we optimized the metabolic pathways in E. coli to enhance indirubin synthesis. Further, to explored the optimization of culture media and indirubin yield via batch and fed-batch fermentation techniques. By fine-tuning upstream process (USP) parameters, including nutrient composition, pH, temperature, and aeration, we established conditions that maximized both cell growth and indirubin production. Additionally, significant efforts were dedicated to refining downstream process (DSP) conditions for the extraction, purification, and quantification of indirubin. Utilizing advanced biochemical methods and analytical techniques such as UHPLC, we ensured the production of high purity indirubin. This approach not only improved the economic viability of indirubin bioproduction but also aligned with the principles of green production and sustainability.

Keywords: indirubin, bacterial strain, fermentation, HPLC

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3144 Characterization and Predictors of Paranoid Ideation in Youths

Authors: Marina Sousa, Célia Barreto Carvalho, Carolina da Motta, Joana Cabral, Vera Pereira, Suzana Nunes Caldeira, Ermelindo Peixoto

Abstract:

Paranoid ideation is a common thought process that constitutes a defense against perceived social threats. The current study aimed at the characterization of paranoid ideation in youths and to explore the possible predictors involved in the development of paranoid ideations. Paranoid ideation, shame, submission, early childhood memories and current depressive, anxious and stress symptomatology was assessed in a sample of 1516 Portuguese youths. Higher frequencies of paranoid ideation were observed, particularly in females and youths from lower socio-economic status. The main predictors identified relates to submissive behaviors and adverse childhood experiences, and especially to shame feelings. The current study emphasizes that the these predictors are similar to findings in adults and clinical populations, and future implications to research and clinical practice aiming at paranoid ideations are discussed, as well as the pertinence of the study of mediating factors that allow a wider understanding of this thought process in younger populations and the prevention of psychopathology in adulthood.

Keywords: adolescence, early memories, paranoid ideation, parenting styles, shame, submissiveness

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3143 Antimicrobial Activity of Different Essential Oils in Synergy with Amoxicillin against Clinical Isolates of Methicillin-Resistant Staphylococcus aureus

Authors: Naheed Niaz, Nimra Naeem, Bushra Uzair, Riffat Tahira

Abstract:

Antibacterial activity of different traditional plants essential oils against clinical isolates of Methicillin-resistant Staphylococcus aureus (MRSA) through disk diffusion method was evaluated. All the tested essential oils, in different concentrations, inhibited growth of S. aureus to varying degrees. Cinnamon and Thyme essential oils were observed to be the “best” against test pathogen. Even at lowest concentration of these essential oils i.e. 25 µl/ml, clear zone of inhibition was recorded 9+0.085mm and 8+0.051mm respectively, and at higher concentrations there was a total reduction in growth of MRSA. The study also focused on analyzing the synergistic effects of essential oils in combination with amoxicillin. Results showed that oregano and pennyroyal mint essential oils which were not very effective alone turned out to be strong synergistic enhancers. The activity increased with increase in concentration of the essential oils. It may be concluded from present results that cinnamon and thyme essential oils could be used as potential antimicrobial source for the treatment of infections caused by Methicillin-resistant Staphylococcus aureus (MRSA).

Keywords: Staphylococcus aureus, essential oils, antibiotics, combination therapy, minimum inhibitory concentration

Procedia PDF Downloads 447
3142 Multi Data Management Systems in a Cluster Randomized Trial in Poor Resource Setting: The Pneumococcal Vaccine Schedules Trial

Authors: Abdoullah Nyassi, Golam Sarwar, Sarra Baldeh, Mamadou S. K. Jallow, Bai Lamin Dondeh, Isaac Osei, Grant A. Mackenzie

Abstract:

A randomized controlled trial is the "gold standard" for evaluating the efficacy of an intervention. Large-scale, cluster-randomized trials are expensive and difficult to conduct, though. To guarantee the validity and generalizability of findings, high-quality, dependable, and accurate data management systems are necessary. Robust data management systems are crucial for optimizing and validating the quality, accuracy, and dependability of trial data. Regarding the difficulties of data gathering in clinical trials in low-resource areas, there is a scarcity of literature on this subject, which may raise concerns. Effective data management systems and implementation goals should be part of trial procedures. Publicizing the creative clinical data management techniques used in clinical trials should boost public confidence in the study's conclusions and encourage further replication. In the ongoing pneumococcal vaccine schedule study in rural Gambia, this report details the development and deployment of multi-data management systems and methodologies. We implemented six different data management, synchronization, and reporting systems using Microsoft Access, RedCap, SQL, Visual Basic, Ruby, and ASP.NET. Additionally, data synchronization tools were developed to integrate data from these systems into the central server for reporting systems. Clinician, lab, and field data validation systems and methodologies are the main topics of this report. Our process development efforts across all domains were driven by the complexity of research project data collected in real-time data, online reporting, data synchronization, and ways for cleaning and verifying data. Consequently, we effectively used multi-data management systems, demonstrating the value of creative approaches in enhancing the consistency, accuracy, and reporting of trial data in a poor resource setting.

Keywords: data management, data collection, data cleaning, cluster-randomized trial

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3141 Revalidation and Hormonization of Existing IFCC Standardized Hepatic, Cardiac, and Thyroid Function Tests by Precison Optimization and External Quality Assurance Programs

Authors: Junaid Mahmood Alam

Abstract:

Revalidating and harmonizing clinical chemistry analytical principles and optimizing methods through quality control programs and assessments is the preeminent means to attain optimal outcome within the clinical laboratory services. Present study reports revalidation of our existing IFCC regularized analytical methods, particularly hepatic and thyroid function tests, by optimization of precision analyses and processing through external and internal quality assessments and regression determination. Parametric components of hepatic (Bilirubin ALT, γGT, ALP), cardiac (LDH, AST, Trop I) and thyroid/pituitary (T3, T4, TSH, FT3, FT4) function tests were used to validate analytical techniques on automated chemistry and immunological analyzers namely Hitachi 912, Cobas 6000 e601, Cobas c501, Cobas e411 with UV kinetic, colorimetric dry chemistry principles and Electro-Chemiluminescence immunoassay (ECLi) techniques. Process of validation and revalidation was completed with evaluating and assessing the precision analyzed Preci-control data of various instruments plotting against each other with regression analyses R2. Results showed that: Revalidation and optimization of respective parameters that were accredited through CAP, CLSI and NEQAPP assessments depicted 99.0% to 99.8% optimization, in addition to the methodology and instruments used for analyses. Regression R2 analysis of BilT was 0.996, whereas that of ALT, ALP, γGT, LDH, AST, Trop I, T3, T4, TSH, FT3, and FT4 exhibited R2 0.998, 0.997, 0.993, 0.967, 0.970, 0.980, 0.976, 0.996, 0.997, 0.997, and R2 0.990, respectively. This confirmed marked harmonization of analytical methods and instrumentations thus revalidating optimized precision standardization as per IFCC recommended guidelines. It is concluded that practices of revalidating and harmonizing the existing or any new services should be followed by all clinical laboratories, especially those associated with tertiary care hospital. This is will ensure deliverance of standardized, proficiency tested, optimized services for prompt and better patient care that will guarantee maximum patients’ confidence.

Keywords: revalidation, standardized, IFCC, CAP, harmonized

Procedia PDF Downloads 269
3140 Inelastic and Elastic Taping in Plantar Pressure of Runners Pronators: Clinical Trial

Authors: Liana Gomide, Juliana Rodrigues

Abstract:

The morphology of the foot defines its mode of operation and a biomechanical reform indispensable for a symmetrical distribution of plantar pressures in order not to overload some of its components in isolation. High plantar pressures at specific points in the foot may be a causal factor in several orthopedic disorders that affect the feet such as pain and stress fracture. With digital baro-podometry equipment one can observe an intensity of pressures along the entire foot and quantify some of the movements, such as a subtalar pronation present in the midfoot region. Although, they are involved in microtraumas. In clinical practice, excessive movement has been limited with the use of different taping techniques applied on the plantar arch. Thus, the objective of the present study was to analyze and compare the influence of the inelastic and elastic taping on the distribution of plantar pressure of runners pronators. This is a randomized clinical trial and blind-crossover. Twenty (20) male subjects, mean age 33 ± 7 years old, mean body mass of 71 ± 7 kg, mean height of 174 ± 6 cm, were included in the study. A data collection was carried out by a single research through barop-odometry equipment - Tekscan, model F-scan mobile. The tests were performed at three different times. In the first, an initial barop-odometric evaluation was performed, without a bandage application, with edges at a speed of 9.0 km/h. In the second and third moments, the inelastic or elastic taping was applied consecutively, according to the definition defined in the randomization. As results, it was observed that both as inelastic and elastic taping, provided significant reductions in contact pressure and peak pressure values when compared to the moment without a taping. However, an elastic taping was more effective in decreasing contact pressure (no bandage = 714 ± 201, elastic taping = 690 ± 210 and inelastic taping = 716 ± 180) and no peak pressure in the midfoot region (no bandage = 1490 ± 42, elastic taping = 1273 ± 323 and inelastic taping = 1487 ± 437). It is possible to conclude that it is an elastic taping provided by pressure in the middle region, thereby reducing the subtalar pronunciation event during the run.

Keywords: elastic taping, inelastic taping, running, subtalar pronation

Procedia PDF Downloads 156