Search results for: acute renal failure
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 3431

Search results for: acute renal failure

2921 Antibiotic Susceptibility Pattern of the Pathogens Isolated from Hospital Acquired Acute Bacterial Meningitis in a Tertiary Health Care Centre in North India

Authors: M. S. Raza, A. Kapil, Sonu Tyagi, H. Gautam, S. Mohapatra, R. Chaudhry, S. Sood, V. Goyal, R. Lodha, V. Sreenivas, B. K. Das

Abstract:

Background: Acute bacterial meningitis remains the major cause of mortality and morbidity. More than half of the survivors develop the significant lifelong neurological abnormalities. Diagnosis of the hospital acquired acute bacterial meningitis (HAABM) is challenging as it appears either in the post operative patients or patients acquire the organisms from the hospital environment. In both the situations, pathogens are exposed to high dose of antibiotics. Chances of getting multidrug resistance organism are very high. We have performed this experiment to find out the etiological agents of HAABM and its antibiotics susceptibility pattern. Methodology: A perspective study was conducted at the Department of Microbiology, All India Institute of Medical Sciences, New Delhi. From March 2015 to April 2018 total 400 Cerebro spinal fluid samples were collected aseptically. Samples were processed for cell count, Gram staining, and culture. Culture plates were incubated at 37°C for 18-24 hours. Organism grown on blood and MacConkey agar were identified by MALDI-TOF Vitek MS (BioMerieux, France) and antibiotic susceptibility tests were performed by Kirby Bauer disc diffusion method as per CLSI 2015 guideline. Results: Of the 400 CSF samples processed, 43 (10.75%) were culture positive for different bacteria. Out of 43 isolates, the most prevalent Gram-positive organisms were S. aureus 4 (9.30%) followed by E. faecium 3 (6.97%) & CONS 2 (4.65%). Similarly, E. coli 13 (30.23%) was the commonest Gram-negative isolates followed by A. baumannii 12 (27.90%), K. pneumonia 5 (11.62%) and P. aeruginosa 4(9.30%). Most of the antibiotics tested against the Gram-negative isolates were resistance to them. Colistin was most effective followed by Meropenem and Imepenim for all Gram-negative HAABM isolates. Similarly, most of antibiotics tested were susceptible to S. aureus and CONS. However, E. faecium (100%) were only susceptible to vancomycin and teicoplanin. Conclusion: Hospital acquired acute bacterial meningitis (HAABM) is becoming the emerging challenge as most of isolates are showing resistance to commonly used antibiotics. Gram-negative organisms are emerging as the major player of HAABM. Great care needs to be taken especially in tertiary care hospitals. Similarly, antibiotic stewardship should be followed and antibiotic susceptibility test (AST) should be performed regularly to update the antibiotic patter and to prevent from the emergence of resistance. Updated information of the AST will be helpful for the better management of the meningitis patient.

Keywords: CSF, MALDI-TOF, hospital acquired acute bacterial meningitis, AST

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2920 Contraction and Membrane Potential of C2C12 with GTXs

Authors: Bayan Almofty, Yuto Yamaki, Tadamasa Terai, Sadahito Uto

Abstract:

Culture techniques of skeletal muscle cells are advanced in the field of regenerative medicine and applied research of cultured muscle. As applied research of cultured muscle, myopathy (muscles disease) treatment is expected and development bio of actuator is also expected in biomedical engineering. Grayanotoxins (GTXs) is known as neurotoxins that enhance the permeability of cell membrane for Na ions. Grayanotoxins are extracted from a famous Pieris japonica and Ericaceae as well as a phytotoxin. In this study, we investigated the effect of GTXs on muscle cells (C2C12) contraction and membrane potential. Contraction of myotubes is induced by applied external electrical stimulation. Contraction and membrane potential change of skeletal muscle cells are induced by injection of current. We, therefore, concluded that effect of Grayanotoxins on contraction and membrane potential of C2C12 relate to acute toxicity of GTXs.

Keywords: skeletal muscle cells C2C12, grayanotoxins, contraction, membrane potential, acute toxicity, pytotoxin, motubes

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2919 The Cardiac Diagnostic Prediction Applied to a Designed Holter

Authors: Leonardo Juan Ramírez López, Javier Oswaldo Rodriguez Velasquez

Abstract:

We have designed a Holter that measures the heart´s activity for over 24 hours, implemented a prediction methodology, and generate alarms as well as indicators to patients and treating physicians. Various diagnostic advances have been developed in clinical cardiology thanks to Holter implementation; however, their interpretation has largely been conditioned to clinical analysis and measurements adjusted to diverse population characteristics, thus turning it into a subjective examination. This, however, requires vast population studies to be validated that, in turn, have not achieved the ultimate goal: mortality prediction. Given this context, our Insight Research Group developed a mathematical methodology that assesses cardiac dynamics through entropy and probability, creating a numerical and geometrical attractor which allows quantifying the normalcy of chronic and acute disease as well as the evolution between such states, and our Tigum Research Group developed a holter device with 12 channels and advanced computer software. This has been shown in different contexts with 100% sensitivity and specificity results.

Keywords: attractor , cardiac, entropy, holter, mathematical , prediction

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2918 An Evaluation Method of Accelerated Storage Life Test for Typical Mechanical and Electronic Products

Authors: Jinyong Yao, Hongzhi Li, Chao Du, Jiao Li

Abstract:

Reliability of long-term storage products is related to the availability of the whole system, and the evaluation of storage life is of great necessity. These products are usually highly reliable and little failure information can be collected. In this paper, an analytical method based on data from accelerated storage life test is proposed to evaluate the reliability index of the long-term storage products. Firstly, singularities are eliminated by data normalization and residual analysis. Secondly, with the pre-processed data, the degradation path model is built to obtain the pseudo life values. Then by life distribution hypothesis, we can get the estimator of parameters in high stress levels and verify failure mechanisms consistency. Finally, the life distribution under the normal stress level is extrapolated via the acceleration model and evaluation of the true average life available. An application example with the camera stabilization device is provided to illustrate the methodology we proposed.

Keywords: accelerated storage life test, failure mechanisms consistency, life distribution, reliability

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2917 A High Content Screening Platform for the Accurate Prediction of Nephrotoxicity

Authors: Sijing Xiong, Ran Su, Lit-Hsin Loo, Daniele Zink

Abstract:

The kidney is a major target for toxic effects of drugs, industrial and environmental chemicals and other compounds. Typically, nephrotoxicity is detected late during drug development, and regulatory animal models could not solve this problem. Validated or accepted in silico or in vitro methods for the prediction of nephrotoxicity are not available. We have established the first and currently only pre-validated in vitro models for the accurate prediction of nephrotoxicity in humans and the first predictive platforms based on renal cells derived from human pluripotent stem cells. In order to further improve the efficiency of our predictive models, we recently developed a high content screening (HCS) platform. This platform employed automated imaging in combination with automated quantitative phenotypic profiling and machine learning methods. 129 image-based phenotypic features were analyzed with respect to their predictive performance in combination with 44 compounds with different chemical structures that included drugs, environmental and industrial chemicals and herbal and fungal compounds. The nephrotoxicity of these compounds in humans is well characterized. A combination of chromatin and cytoskeletal features resulted in high predictivity with respect to nephrotoxicity in humans. Test balanced accuracies of 82% or 89% were obtained with human primary or immortalized renal proximal tubular cells, respectively. Furthermore, our results revealed that a DNA damage response is commonly induced by different PTC-toxicants with diverse chemical structures and injury mechanisms. Together, the results show that the automated HCS platform allows efficient and accurate nephrotoxicity prediction for compounds with diverse chemical structures.

Keywords: high content screening, in vitro models, nephrotoxicity, toxicity prediction

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2916 Tobephobia: Fear of Failure in Education Caused by School Violence and Drug Abuse

Authors: Prakash Singh

Abstract:

Schools throughout the world are facing increasing challenges in dealing with school violence and drug abuse by pupils. Therefore, the question of the fear of failure to meet the aims and objectives of education inevitably surfaces as it places increasing and challenging demands on educators and all other stakeholders to address this malaise. Multiple studies on the construct tobephobia (TBP) simply define TBP as the fear of failure in education. This study is a continuation of the exploratory studies on the manifestation of fear in education. The primary purpose of this study was to establish how TBP, caused by school violence and drug abuse affects teaching and learning in our schools. The qualitative research method was used for this study. Teachers admitted that they fear for their safety at school. Working in a fearful situation places a high rate of stress and anxiety on them. Tobephobic educators spend most of their time worrying about their fear of violence and drug abuse by pupils and are too frightened to carry out their normal duties. They prefer to stay in familiar surroundings for fear of being attacked by inebriated learners. This study, therefore, contributes to our understanding of the effects of TBP in our schools caused by school violence and drug abuse. Also, this study supplements the evidence accumulated over the past fifteen years that TBP is not a figment of someone’s imagination; it is a gruesome reality affecting the very foundation of our educational system globally to provide quality and equal education to all our learners in a harmonious, collegial school environment.

Keywords: tobephobia, tobephobic educators, fear of failure in education, school violence, drug abuse

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2915 The Effects of Androgen Receptor Mutation on Cryptorchid Testes in 46, XY Female

Authors: Ihtisham Bukhari

Abstract:

In the current study, we enrolled a 46, XY phenotypically female patient bearing testes in her inguinal canal. DNA sequencing of the AR gene detected a missense mutation C.1715A > G (p. Y572C) in exon 2 which is already known to cause Complete androgen insensitivity syndrome (CAIS). We further studied the effects of this mutation on the testicular histopathology of the patient. No spermatocytes were seen in the surface spreading of testicular tissues while H&E staining showed that seminiferous tubules predominantly have only Sertoli cells. To confirm this meiotic failure is likely due to the current AR mutation we performed mRNA expression of genes associated with AR pathway, expression and location of the associated proteins in testicular tissues. Western blot and real-time PCR data showed that the patient had high levels of expression of AMH, SOX9, and INNB in testis. Tubules were stained with SOX9 and AMH which revealed Sertoli cell maturation arrest. Therefore, we suggest that AR mutation enhances AMH expression which ultimately leads to failure in the maturation of Sertoli cells and failure in spermatogenesis.

Keywords: androgen receptor, spermatogenesis, infertility, Sertoli cell only syndrome

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2914 Angiotensin Converting Enzyme (ACE) and Angiotensinogen (AGT) Gene Variants in Pakistani Patients of Diabetes Mellitus and Diabetic Nephropathy

Authors: Rozeena Shaikh, Syed M Shahid, Jamil Ahmad, Qaisar Mansoor, Muhammad Ismail, Abid Azhar

Abstract:

Introduction: Diabetes mellitus (DM) is a prevalent non-communicable disease worldwide. In most high-income countries as well as middle-income and low- income countries. DM is among the top causes of deaths. DM may lead to many vascular complications like hypertension, nephropathy, retinopathy, neuropathy, and foot. Diabetic nephropathy (DN) characterized by persistent albuminuria is a leading cause of end stage renal failure (ESRF). Pathogenesis of diabetic nephropathy is implicated by the polymorphisms in genes encoding the components of reninangiotensin- aldosteron system (RAAS) which include angiotensinogen (AGT), angiotensin-II receptor and particularly angiotensin converting enzyme (ACE) gene. Method: Study subjects include 110 control, 110 patients with DM without hypertension, 110 patients with DM with hypertension and 110 patients with DN. Blood samples were collected for Biochemical analysis and PCR and sequencing for the specific region of both genes. Results: The frequency of DD genotype and D allele of ACE (I/D) was significantly (p<0.05) high in DM normotensive, DM hypertensive and DN patients when compared to control. The ACE G2350A genotypes and allele frequencies were significantly different (p<0.05) in DM hypertensive patients as compared to control and DN, while no difference was observed between DM normotensive and DN when compared to control. The genotypes and alleles of AGT (M268T) polymorphism were significantly different (p<0.05) in DM normotensive, DM hypertensive and DN when compared to control. Conclusion: The DD genotype and D allele of ACE (I/D), GG genotype and G allele of ACE (G2350A) and the TT genotype and T allele of AGT (M268T) polymorphism have shown a significant difference in genotype and allele frequencies between controls and patients.

Keywords: genetic variations, ACE, AGT, diabetes mellitus, diabetic nephropathy, Pakistan

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2913 Moderating Effect of Owner's Influence on the Relationship between the Probability of Client Failure and Going Concern Opinion Issuance

Authors: Mohammad Noor Hisham Osman, Ahmed Razman Abdul Latiff, Zaidi Mat Daud, Zulkarnain Muhamad Sori

Abstract:

The problem that Malaysian auditors do not issue going concern opinion (GC opinion) to seriously financially distressed companies is still a pressing issue. Policy makers, particularly the Financial Statement Review Committee (FSRC) of Malaysian Institute of Accountant, have raised this issue as early as in 2009. Similar problem happened in the US, UK, and many developing countries. It is important for auditors to issue GC opinion properly because such opinion is one signal about the viability of a company much needed by stakeholders. There are at least two unanswered questions or research gaps in the literature on determinants of GC opinion. Firstly, is client’s probability of failure associated with GC opinion issuance? Secondly, to what extent influential owners (management, family, and institution) moderate the association between client probability of failure and GC opinion issuance. The objective of this study is, therefore, twofold; (1) To examine the extent of the relationship between the probability of client failure and the issuance of GC opinion and (2) To examine the level of management, family, and institutional ownerships moderate the association between client probability of failure and the issuance of GC opinion. This study is quantitative in nature, and the sources of data are secondary (mainly company’s annual reports). A total of four hypotheses have been developed and tested on data accumulated from annual reports of seriously financially distressed Malaysian public listed companies. Data from 2006 to 2012 on a sample of 644 observations have been analyzed using panel logistic regression. It is found that certainty (rather than probability) of client failure affects the issuance of GC opinion. In addition, it is found that only the level of family ownership does positively moderate the relationship between client probability of failure and GC opinion issuance. This study is a contribution to auditing literature as its findings can enhance our understanding about audit quality; particularly on the variables that are associated with the issuance of GC opinion. The findings of this study shed light on the roles family owners in GC opinion issuance process, and this would open ways for the researcher to suggest measures that can be used to tackle the problem of auditors do not want to issue GC opinion to financially distressed clients. The measures to be suggested can be useful to policy makers in formulating future promulgations.

Keywords: audit quality, auditing, auditor characteristics, going concern opinion, Malaysia

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2912 The Capacity of Bolted and Screw Connections in Cold-Formed Steel Truss Structure through Analytical and Experimental Method

Authors: Slamet Setioboro, Rahutami Kusumaningsih, Prabowo Setiyawan, Danna Darmayadi

Abstract:

Designing of cold-formed steel capacity connections often based on the formula used for hot rolled steel. It makes the result of the actual capacity connection doesn’t accurate anymore. When the hot rolled steel receives the axial load pull, it will have different characteristics. As the result, there will be failure result when designing Truss structure made of hot rolled steel. This research aims to determine the capacity of actual cold-formed steel connections section which is loaded by the axial tensile force. It will test the appeal of the connection using bolt grafting tool and screw grafting tool. The variations of the test will be on the type of connection (single and double slap), the number of the connection tools and connection configuration. Bold and screw connections failure mode observed in this research are different each other. Failure mode of bolted connections includes sliding pivot plate, tearing at the plate and cutting of the bolt head. While the failure mode of screw connections includes tilting, hole-bearing, pull over and cutting the screw body out. This research was conducted using a laboratory test of HW2-600S Universal Testing Machine model with ASTM E8. It has done in the materials testing laboratory of Mechanical Engineering Department, Faculty of Engineering UNNES. The results obtained through the laboratory diversification towards theoretical calculations using the standards specified in ISO 7971-2013 Cold-Rolled Steel Structures. Based on the research, it can be concluded that the effective connection in receiving force strength is bolted connections neither single nor double plate. The method used is by applying 4 bolts through 2 parallel lines configuration. Furthermore, this connection deals with the consequences of holding the highest Pmaks, lowest failure risk and getting a little kind of mode of failure.

Keywords: axial load, cold-formed steel, capacity connections, bolted connections, screw connections

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2911 An Attempt of Cost Analysis of Heart Failure Patients at Cardiology Department at Kasr Al Aini Hospitals: A Micro-Costing Study from Social Perspective

Authors: Eman Elsebaie, A. Sedrak, R. Ziada

Abstract:

Introduction: In the recent decades, heart failure (HF) has become one of the most prevalent cardio-vascular disease (CVDs), especially in the elderly and the main cause of hospitalization in Egypt cardiology departments. By 2030, the prevalence of HF is expected to increase by 25%. Total direct costs will increase to $818 billion, and the total indirect cost in terms of lost productivity is close to $275 billion. The current study was conducted to estimate the economic costs of services delivered for heart failure patients at the cardiology department in Cairo University Hospitals (CUHs). Aim: To gain an understanding of the cost of heart failure disease and its main drivers aiming to minimize associated health care costs. Subjects and Methods: Economic cost analysis study was conducted for a prospective group of all cases of HF admitted to the cardiology department in CUHs from end of March till end of April 2016 and another retrospective randomized sample from patients with HF, during the first 3 months of 2016 to measure estimated average cost per patient per day. Results: The mean age of the prospective group was 48.6 ± 17.16 years versus 52.3 ± 11.5 years for the retrospective group. The median (IQR) of Length of stay was 15 (15) days in the prospective group versus 9 (16) days in the retrospective group. The average HF inpatient cost/day in the cardiology department during April 2016 was 362.32 (255.5) L.E. versus 391.2(255.9) L.E. during January and February 2016. Conclusion: Up to 70% of expenditure in the management of HF is related to hospital admission. The average cost of such an admission was 5540.03 (IQR=7507.8) L.E. and 4687.4 (IQR=7818.8) L.E. with the average cost per day estimated at 362.32 (IQR=255.5) L.E. and 386.2(IQR=255.9) L.E. in prospective and retrospective groups respectively.

Keywords: health care cost, heart failure, hospitalization, inpatient

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2910 Landfill Failure Mobility Analysis: A Probabilistic Approach

Authors: Ali Jahanfar, Brajesh Dubey, Bahram Gharabaghi, Saber Bayat Movahed

Abstract:

Ever increasing population growth of major urban centers and environmental challenges in siting new landfills have resulted in a growing trend in design of mega-landfills some with extraordinary heights and dangerously steep slopes. Landfill failure mobility risk analysis is one of the most uncertain types of dynamic rheology models due to very large inherent variabilities in the heterogeneous solid waste material shear strength properties. The waste flow of three historic dumpsite and two landfill failures were back-analyzed using run-out modeling with DAN-W model. The travel distances of the waste flow during landfill failures were calculated approach by taking into account variability in material shear strength properties. The probability distribution function for shear strength properties of the waste material were grouped into four major classed based on waste material compaction (landfills versus dumpsites) and composition (high versus low quantity) of high shear strength waste materials such as wood, metal, plastic, paper and cardboard in the waste. This paper presents a probabilistic method for estimation of the spatial extent of waste avalanches, after a potential landfill failure, to create maps of vulnerability scores to inform property owners and residents of the level of the risk.

Keywords: landfill failure, waste flow, Voellmy rheology, friction coefficient, waste compaction and type

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2909 Self-reported Acute Pesticide Intoxication in Ethiopia

Authors: Amare Nigatu, Mågne Bratveit, Bente E. Moen

Abstract:

Background: Pesticide exposure is an important public health concern in Ethiopia, but there is limited information on pesticide intoxications. Residents may have an increased risk of pesticide exposure through proximity of their homes to farms using pesticides. Also the pesticide exposure might be related to employment at these farms. This study investigated the prevalence of acute pesticide intoxications (API) by residence proximity to a nearby flower farm and assessed if intoxications are related to working there or not. Methods: A cross-sectional survey involving 516 persons was conducted. Participants were grouped according to their residence proximity from a large flower farm; living within 5 kilometers and 5-12 kilometers away, respectively. In a structured interview, participants were asked if they had health symptoms within 48 hours of pesticide exposure in the past year. Those, who had experienced this and reported two or more typical pesticide intoxication symptoms, were considered as having had API. Chi-square and independent t-tests were used to compare categorical and continuous variables, respectively. Confounding variables were adjusted by using binomial regression model. Results: The prevalence of API in the past year among the residents in the study area was 26%, and it was higher in the population living close to the flower farm (42%) compared to those living far away (11%), prevalence ratio (PR) = 3.2, 95% CI: 2.2-4.8, adjusted for age, gender & education. A subgroup living close to the farm & working there had significantly more API (56%) than those living close & did not work there (16%), adjusted PR = 3.0, 95% CI: 1.8-4.9. Flower farm workers reported more API (56%) than those not working there (13%,), adjusted PR = 4.0, 95% CI: 2.9-5.6. Conclusion: The residents living closer than 5 kilometers to the flower farm reported significantly higher prevalence of API than those living 5-12 kilometers away. This increased risk of API was associated with work at the flower farm.

Keywords: acute pesticide intoxications, self-reported symptoms, flower farm workers, living proximity

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2908 Reliability-Simulation of Composite Tubular Structure under Pressure by Finite Elements Methods

Authors: Abdelkader Hocine, Abdelhakim Maizia

Abstract:

The exponential growth of reinforced fibers composite materials use has prompted researchers to step up their work on the prediction of their reliability. Owing to differences between the properties of the materials used for the composite, the manufacturing processes, the load combinations and types of environment, the prediction of the reliability of composite materials has become a primary task. Through failure criteria, TSAI-WU and the maximum stress, the reliability of multilayer tubular structures under pressure is the subject of this paper, where the failure probability of is estimated by the method of Monte Carlo.

Keywords: composite, design, monte carlo, tubular structure, reliability

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2907 Emblica officinalis Fruit Extract Ameliorates Cisplatin-Induced Nephrotoxicity in Experimental Rats

Authors: Prerna Kalra, Surender Singh

Abstract:

Cisplatin is the most common chemotherapeutic agent used in different solid tumors, but its main limiting factor is dose-dependent nephrotoxicity by generating reactive oxygen species, by stimulating inflammatory and apoptotic pathways. Additional adjuvant therapies to decrease the toxicity of this chemotherapeutic drug are essential. This study was designed to evaluate the protective role of Emblica officinalis Geartn (Indian gooseberry) against cisplatin induced nephrotoxicity. Emblica officinalis was orally administered to Wistar rats (n=6) for 10 days in 50, 100 and 200mg/kg body weight. On day 7, 8mg/kg of cisplatin was administered intra-peritoneally to rats in all groups. Serum creatinine, blood urea nitrogen and antioxidant levels were measured on day10. The renal damage was evaluated by histopathological and transmission electron microscopy. We found that 200mg/kg dose of Emblica officinalis significantly inhibited the elevation of biochemical parameters i.e. serum creatinine, blood urea nitrogen, oxidant stress marker (malondialdehyde) and increased the reduced levels of antioxidant marker (endogenous glutathione and superoxide dismutase). Cisplatin treated rats have shown acute tubular necrosis and infiltration of inflammatory cells in rat kidney which was reversed after treating the animals with Emblica officinalis in the treatment group. In ultrastructural changes cisplatin treated group showed the damaged mitochondria (M) with dissolved cristae and large number of lysosomes (L) and vacuole (V) formation in tubular epithelial cells. EOE administered group showed visible cristae formation and sign of autophagy vacuoles at a dose of 200mg/kg. Further in-silico studies revealed that ellagic acid is responsible for its nephroprotective effect. The above findings conclude that the Emblica officinalis may be used as an adjuvant therapy in cisplatin induced nephrotoxicity.

Keywords: antioxidant, cisplatin, Emblica officinalis, in silico, nephrotoxicity

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2906 Overtopping Protection Systems for Overflow Earth Dams

Authors: Omid Pourabdollah, Mohsen Misaghian

Abstract:

Overtopping is known as one the most important reasons for the failure of earth dams. In some cases, it has resulted in heavy damages and losses. Therefore, enhancing the safety of earth dams against overtopping has received much attention in the past four decades. In this paper, at first, the overtopping phenomena and its destructive consequences will be introduced. Then, overtopping failure mechanism of embankments will be described. Finally, different types of protection systems for stabilization of earth dams against overtopping will be presented. These include timber cribs, riprap and gabions, reinforced earth, roller compacted concrete, and the precast concrete blocks.

Keywords: embankment dam, overtopping, roller compacted concrete, wedge concrete block

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2905 Physical and Mechanical Phenomena Associated with Rock Failure in Brazilian Disc Specimens

Authors: Hamid Reza Nejati, Amin Nazerigivi, Ahmad Reza Sayadi

Abstract:

Failure mechanism of rocks is one of the fundamental aspects to study rock engineering stability. Rock is a material that contains flaws, initial damage, micro-cracks, etc. Failure of rock structure is largely due to tensile stress and was influenced by various parameters. In the present study, the effect of brittleness and loading rate on the physical and mechanical phenomena produced in rock during loading sequences is considered. For this purpose, Acoustic Emission (AE) technique is used to monitor fracturing process of three rock types (onyx marble, sandstone and soft limestone) with different brittleness and sandstone samples under different loading rate. The results of experimental tests revealed that brittleness and loading rate have a significant effect on the mode and number of induced fracture in rocks. An increase in rock brittleness increases the frequency of induced cracks, and the number of tensile fracture decreases when loading rate increases.

Keywords: brittleness, loading rate, acoustic emission, tensile fracture, shear fracture

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2904 The Acute Effects of Higher Versus Lower Load Duration and Intensity on Morphological and Mechanical Properties of the Healthy Achilles Tendon: A Randomized Crossover Trial

Authors: Eman Merza, Stephen Pearson, Glen Lichtwark, Peter Malliaras

Abstract:

The Achilles tendon (AT) exhibits volume changes related to fluid flow under acute load which may be linked to changes in stiffness. Fluid flow provides a mechanical signal for cellular activity and may be one mechanism that facilitates tendon adaptation. This study aimed to investigate whether isometric intervention involving a high level of load duration and intensity could maximize the immediate reduction in AT volume and stiffness compared to interventions involving a lower level of load duration and intensity. Sixteen healthy participants (12 males, 4 females; age= 24.4 ± 9.4 years; body mass= 70.9 ± 16.1 kg; height= 1.7 ± 0.1 m) performed three isometric interventions of varying levels of load duration (2 s and 8 s) and intensity (35% and 75% maximal voluntary isometric contraction) over a 3 week period. Freehand 3D ultrasound was used to measure free AT volume (at rest) and length (at 35%, 55%, and 75% of maximum plantarflexion force) pre- and post-interventions. The slope of the force-elongation curve over these force levels represented individual stiffness (N/mm). Large reductions in free AT volume and stiffness resulted in response to long-duration high-intensity loading whilst less reduction was produced with a lower load intensity. In contrast, no change in free AT volume and a small increase in AT stiffness occurred with lower load duration. These findings suggest that the applied load on the AT must be heavy and sustained for a long duration to maximize immediate volume reduction, which might be an acute response that enables optimal long-term tendon adaptation via mechanotransduction pathways.

Keywords: Achilles tendon, volume, stiffness, free tendon, 3d ultrasound

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2903 Numerical Investigation for External Strengthening of Dapped-End Beams

Authors: A. Abdel-Moniem, H. Madkour, K. Farah, A. Abdullah

Abstract:

The reduction in dapped end beams depth nearby the supports tends to produce stress concentration and hence results in shear cracks, if it does not have an adequate reinforcement detailing. This study investigates numerically the efficiency of applying different external strengthening techniques to the dapped end of such beams. A two-dimensional finite element model was built to predict the structural behavior of dapped ends strengthened with different techniques. The techniques included external bonding of the steel angle at the re-entrant corner, un-bounded bolt anchoring, external steel plate jacketing, exterior carbon fiber wrapping and/or stripping and external inclined steel plates. The FE analysis results are then presented in terms of the ultimate load capacities, load-deflection and crack pattern at failure. The results showed that the FE model, at various stages, was found to be comparable to the available test data. Moreover, it enabled the capture of the failure progress, with acceptable accuracy, which is very difficult in a laboratory test.

Keywords: dapped-end beams, finite element, shear failure, strengthening techniques, reinforced concrete, numerical investigation

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2902 A Failure Criterion for Unsupported Boreholes in Poorly Cemented Granular Formations

Authors: Sam S. Hashemi

Abstract:

The breakage of bonding between sand particles and their dislodgment from the borehole wall are among the main factors resulting in a borehole failure in poorly cemented granular formations. The grain debonding usually precedes the borehole failure and it can be considered as a sign that the onset of the borehole collapse is imminent. Detecting the bonding breakage point and introducing an appropriate failure criterion will play an important role in borehole stability analysis. To study the influence of different factors on the initiation of sand bonding breakage at the borehole wall, a series of laboratory tests was designed and conducted on poorly cemented sand samples. The total absorbed strain energy per volume of material up to the point of the observed particle debonding was computed. The results indicated that the particle bonding breakage point at the borehole wall was reached both before and after the peak strength of the thick-walled hollow cylinder specimens depending on the stress path and cement content. Three different cement contents and two borehole sizes were investigated to study the influence of the bonding strength and scale on the particle dislodgment. Test results showed that the stress path has a significant influence on the onset of the sand bonding breakage. It was shown that for various stress paths, there is a near linear relationship between the absorbed energy and the normal effective mean stress.

Keywords: borehole stability, experimental studies, poorly cemented sands, total absorbed strain energy

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2901 Shear Strengthening of Reinforced Concrete Flat Slabs Using Prestressing Bars

Authors: Haifa Saleh, Kamiran Abduka, Robin Kalfat, Riadh Al-Mahaidi

Abstract:

The effectiveness of using pre-stressing steel bars for shear strengthening of high strength reinforced concrete (RC) slabs was assessed. Two large-scale RC slabs were tested, one without shear reinforcement and the second strengthened against punching shear failure using pre-stressing steel bars. The two slabs had the same dimensions, flexural reinforcement ratio, loading and support arrangements. The experimental program including the method of strengthening, set up and instrumentation are described in this paper. The experimental results are analyzed and discussed in terms of the structural behavior of the RC slabs, the performance of pre-stressing steel bolts and failure modes. The results confirmed that the shear strengthening technique increased the shear capacity, ductility and yield capacity of the slab by up to 15%, 44%, and 22%, respectively compared to the unstrengthened slab. The strengthening technique also successfully contributed to changing the failure mode from a brittle punching shear mode to ductile flexural failure mode. Vic3D digital image correlation system (photogrammetry) was also used in this research. This technique holds several advantages over traditional contact instrumentations including that it is inexpensive, it produces results that are simple to analyze and it is remote visualization technique. The displacement profile along the span of the slab and rotation has been found and compared with the results obtained from traditional sensors. The performance of the photogrammetry technique was very good and the results of both measurements were in very close agreement.

Keywords: flat slab, photogrammetry, punching shear, strengthening

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2900 A Multidisciplinary Team Approach for Limb Salvage in a Rare Case of Pyoderma Gangrenosum in a Significant Circumferential Lower Extremity Wound Complicated by Diabetes and End-stage Renal Disease

Authors: Jenee Gooden, Kevin Vasquez-monterroso, Lady Paula Dejesus, Sandra Wainwright, Daniel Kim, Mackenzie Walker

Abstract:

Introduction: Pyoderma gangrenosum (PG) is a rare, rapidly progressive, neutrophilic ulcerative colitis condition with an incidence of 3 to 10 cases per year ¹ ². Due to the similar appearance, PG is often misdiagnosed as a diabetic ulcer in diabetic patients. Though they may clinically appear similar in appearance, the treatment protocol and diagnostic criteria differ. Also, end-stage renal disease (ESRD) is often a condition seen in diabetic patients, which can have a significant impact on wound healing due to the wide range of uremic toxins³. This case study demonstrates a multidisciplinary team and multimodal treatment approach by podiatric surgery, general surgery, rheumatology, infectious disease, interventional cardiology, wound care and hyperbaric medicine for an uncontrolled diabetic with pyoderma gangrenosum of a significant circumferential wound, covering almost the entire right lower extremity. Methods:56 y.o male presents with multiple PG ulcerations, including the chest, right posterior lower extremity and sacrum. All ulcerations were previously managed by the same wound care specialist. His chief complaint was worsening PG ulcerations accompanied by a fever of 103 °F . This case study focuses on the wound to his RLE. Past medical history significant for diabetes mellitus type 2 with hemoglobin A1c of 10% and end stage renal disease (ESRD) on hemodialysis. A multidisciplinary team approach by podiatric surgery, general surgery, rheumatology, infectious disease, interventional cardiology, wound care and hyperbaric medicine was successfully used to perform right lower extremity limb salvage. The patient was managed by rheumatology for the continuation of prior medication, as well as the mutual agreement with wound care for the addition of dapsone. A coronary CT angiogram was performed by interventional cardiology, but no significant disease was noted, and no further vascular workup was necessary. Multiple surgical sharp wide excisional debridements with application of allografts and split thickness skin grafts for the circumferential ulceration that encompassed almost the entire right lower extremity were performed by both podiatric surgery and general surgery. Wound cultures and soft tissue biopsies were performed, and infectious disease managed antibiotic therapy. Hyperbaric oxygen therapy and wound vac therapy by wound care were also completed as adjunct management. Results: Prevention of leg amputation by limb salvage of the RLE was accomplished by a multidisciplinary team approach, with the wound size decreasing over a total of 29 weeks from 600 cm² to 12.0 x 3.5 x 0.2 cm. Our multidisciplinary team included podiatric surgery, general surgery, rheumatology, infectious disease, interventional cardiology, wound care and hyperbaric medicine. Discussion: Wound healing, in general, can have its challenges, and those challenges are only magnified when accompanied by multiple systemic illnesses. Though the negative impact of diabetes on wound healing is well known, the compound impact of being a diabetic with ESRD and having pyoderma gangrenosum is not. This case demonstrates the necessity for a multidisciplinary team approach with a wide array of treatment modalities to optimize wound healing and perform limb salvage with prevention of lower extremity amputation.

Keywords: diabetes, podiatry, pyoderma gangrenosum, end stage renal disease

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2899 Outcome of Naive SGLT2 Inhibitors Among ICU Admitted Acute Stroke with T2DM Patients a Prospective Cohort Study in NCMultispecialty Hospital, Biratnagar, Nepal

Authors: Birendra Kumar Bista, Rhitik Bista, Prafulla Koirala, Lokendra Mandal, Nikrsh Raj Shrestha, Vivek Kattel

Abstract:

Introduction: Poorly controlled diabetes is associated with cause and poor outcome of stroke. High blood sugar reduces cerebral blood flow, increases intracranial pressure, cerebral edema and neuronal death, especially among patients with poorly controlled diabetes.1 SGLT2 inhibitors are associated with 50% reduction in hemorrhagic stroke compared with placebo. SGLT2 inhibitors decrease cardiovascular events via reducing glucose, blood pressure, weight, arteriosclerosis, albuminuria and reduction of atrial fibrillation.2,3 No study has been documented in low income countries to see the role of post stroke SGLT2 inhibitors on diabetic patients at and after ICU admission. Aims: The aim of the study was to measure the 12 months outcome of diabetic patients with acute stroke admitted in ICU set up with naïve SGLT2 inhibitors add on therapy. Method: It was prospective cohort study carried out in a 250 bedded tertiary neurology care hospital at the province capital Biratnagar Nepal. Diabetic patient with acute stroke admitted in ICU from 1st January 2022 to 31st December 2022 who were not under SGLT2 inhibitors were included in the study. These patients were managed as per hospital protocol. Empagliflozin was added to the alternate enrolled patients. Empagliflozin was continued at the time of discharged and during follow up unless contraindicated. These patients were followed up for 12 months. Outcome measured were mortality, morbidity requiring readmission or hospital visit other than regular follow up, SGLT2 inhibitors related adverse events, neuropsychiatry comorbidity, functional status and biochemical parameters. Ethical permission was taken from hospital administration and ethical board. Results: Among 147 diabetic cases 68 were not treated with empagliflozin whereas 67 cases were started the SGLT2 inhibitors. HbA1c level and one year mortality was significantly low among patients on empaglifozin arm. Over a period of 12 months 427 acute stroke patients were admitted in the ICU. Out of them 44% were female, 61% hypertensive, 34% diabetic, 57% dyslipidemia, 26% smoker and with median age of 45 years. Among 427 cases 4% required neurosurgical interventions and 76% had hemorrhagic CVA. The most common reason for ICU admission was GCS<8 (51%). The median ICU stay was 5 days. ICU mortality was 21% whereas 1 year mortality was 41% with most common reason being pneumonia. Empaglifozin related adverse effect was seen in 11% most commonly lower urinary tract infection in 6%. Conclusion: Empagliflozin can safely be started among acute stroke with better Hba1C control and low mortality outcome compared to treatment without SGLT2 inhibitor.

Keywords: diabetes, ICU, mortality, SGLT2 inhibitors, stroke

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2898 Blood Pressure Level, Targeted Blood Pressure Control Rate, and Factors Related to Blood Pressure Control in Post-Acute Ischemic Stroke Patients

Authors: Nannapus Saramad, Rewwadee Petsirasan, Jom Suwanno

Abstract:

Background: This retrospective study design was to describe average blood pressure, blood pressure level, target blood pressure control rate post-stroke BP control in the year following discharge from Sichon hospital, Sichon District, Nakhon Si Thammarat province. The secondary data analysis was employed from the patient’s health records with patient or caregiver interview. A total of 232 eligible post-acute ischemic strokes in the year following discharge (2017-2018) were recruited. Methods: Data analyses were applied to identify the relationship values of single variables were determined through univariate analyses: The Chi-square test, Fisher exact test, the variables found to have a p-value < 0.2 were analyzed by the binary logistic regression Results: Most of the patients in this study were men 61.6%, an average age of 65.4 ± 14.8 years. Systolic blood pressure levels were in the grade 1-2 hypertension and diastolic pressure at optimal and normal at all times during the initial treatment through the present. The results revealed 25% among the groups under the age of 60 achieved BP control; 36.3% for older than 60 years group; and 27.9% for diabetic group. The multivariate analysis revealed the final relationship of four significant variables: 1) receiving calcium-channel blocker (p =.027); 2) medication adherence of antihypertensive (p = .024) 3) medication adherence of antiplatelet ( p = .020); and 4) medication behavior ( p = . 010) . Conclusion: The medical nurse and health care provider should promote their adherence to behavior to improve their blood pressure control.

Keywords: acute ischemic stroke, target blood pressure control, medication adherence, recurrence stroke

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2897 Role of Human Wharton’s Jelly Mesenchymal Stem Cells Conditioned Media in Alleviating Kidney Injury via Inhibition of Renin-Angiotensin System in Diabetic Nephropathy

Authors: Pardis Abolghasemi, Benyamin Hatamsaz

Abstract:

Background: Diabetic nephropathy is a serious health problem described by specific kidney structure and functional disturbance. Renoprotective effects of the stem cells secretase have been shown in many kidney diseases. The aim is to evaluate the capability of human Wharton’s jelly mesenchymal stem cells conditioned media (hWJMSCs-CM) to alleviate DN in streptozotocin (STZ)-induced diabetes. Methods: Diabetic nephropathy was induced by injection of STZ (60 mg/kg, IP) in twenty rats. Conditioned media was extracted from hWJMSCs at third passages. At week 8, diabetic rats were divided into two groups: treated (hWJMSCs-CM, 500 μl/rat for three weeks, IP) and not treated (DN). In the 11th week, three groups (control, DN and DN+hWJMSCs-CM) were kept in metabolic cages and urine was collected for 24h. Blood pressure (BP) and heart rate (HR) were continuously recorded. The serum samples were maintained for measuring BUN, Cr and angiotensin-converting enzyme (ACE) activity. The left kidney was kept at -80°C for ACE activity assessment. The right kidney and pancreas were used for histopathologic evaluation. Result: Diabetic nephropathy was detected by microalbuminuria and increased albumin/creatinine ratio, as well as the pancreas and renal structural disturbance. Glomerular filtration rate, BP and HR increased in the DN group. The ACE activity was elevated in the serum and kidneys of the DN group. Administration of hWJMSCs-CM modulated the renal functional and structural disturbance and decreased the ACE activity. Conclusion: Conditioned media was extracted from hWJMSCs may have a Renoprotective effect in diabetic nephropathy. This may happen through regulation of ACE activity and renin-angiotensin system inhibition.

Keywords: diabetic nephropathy, mesenchymal stem cells, immunomodulation, anti-inflammation

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2896 Prayer Therapy in a Case of Acute Myeloid Leukemia: The Good, the Bad and the Ugly

Authors: Rubai M. Ochieng

Abstract:

Cancer, which accounts for 7 percent of deaths per year in Kenya, is the third highest cause of death after infectious and cardiovascular diseases. Awareness Campaigns have tended to focus on leading cancers including breast and cervical for women as well as prostrate and Esophageal for men. Consequently, less common cancers such as Acute Myeloid Leukemia (AML) are rarely properly understood by the general population and a section of the medical fraternity. Diagnoses of AML in patients who may not have heard about it sometimes results in shock, denial and confusion not just to the diagnosed, but also to their family and friends. The diagnosed and caregivers are bound to receive a lot of contradicting information about prognosis, care and treatment of AML. This information, which often comes from diverse sources including doctors, friends, internet and social media platforms, causes further confusion and panic. The situation is handled differently by different people. Religious people sometimes resort to prayer. This paper, written from the perspective of a care giver, is based on data collected from a case of Acute Myeloid Leukemia diagnosed in a 32 year old male who lost his life within six weeks of diagnosis. The sample constitutes of 16 people who participated in prayers. Out of this total, 5 were males including the diagnosed and 11 were females. All the 16 were Christians of protestant orientation including Anglicans, Quakers and Church of God members. Data was collected by the researcher herself through participant of observation. Findings discuss how the 16 participants prayed individually at different times, together in an overnight prayer meeting and every morning through a group social media platform. They shared songs and words of encouragement from the bible. The group prayed for healing, peace and strength to the diagnosed and family, financial breakthrough and doctors’ work and decisions, among other challenges that came with the situation. The paper reveals the immense benefits of prayer to the diagnosed and his close relatives and friends. They include acceptance of the condition and a positive attitude in handling the challenges that arose from the disease and treatment processes. The challenges arising from the prayer approach of handling the situation are also discussed. The paper concludes that prayer as therapy goes a long way in cancer management.

Keywords: acute myeloid leukemia, Kenya, participant observation, prayer

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2895 Business Continuity Risk Review for a Large Petrochemical Complex

Authors: Michel A. Thomet

Abstract:

A discrete-event simulation model was used to perform a Reliability-Availability-Maintainability (RAM) study of a large petrochemical complex which included sixteen process units, and seven feeds and intermediate streams. All the feeds and intermediate streams have associated storage tanks, so that if a processing unit fails and shuts down, the downstream units can keep producing their outputs. This also helps the upstream units which do not have to reduce their outputs, but can store their excess production until the failed unit restart. Each process unit and each pipe section carrying the feeds and intermediate streams has a probability of failure with an associated distribution and a Mean Time Between Failure (MTBF), as well as a distribution of the time to restore and a Mean Time To Restore (MTTR). The utilities supporting the process units can also fail and have their own distributions with specific MTBF and MTTR. The model runs are for ten years or more and the runs are repeated several times to obtain statistically relevant results. One of the main results is the On-Stream factor (OSF) of each process unit (percent of hours in a year when the unit is running in nominal conditions). One of the objectives of the study was to investigate if the storage capacity of each of the feeds and the intermediate stream was adequate. This was done by increasing the storage capacities in several steps and through running the simulation to see if the OSF were improved and by how much. Other objectives were to see if the failure of the utilities were an important factor in the overall OSF, and what could be done to reduce their failure rates through redundant equipment.

Keywords: business continuity, on-stream factor, petrochemical, RAM study, simulation, MTBF

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2894 A Case Study on Re-Assessment Study of an Earthfill Dam at Latamber, Pakistan

Authors: Afnan Ahmad, Shahid Ali, Mujahid Khan

Abstract:

This research presents the parametric study of an existing earth fill dam located at Latamber, Karak city, Pakistan. The study consists of carrying out seepage analysis, slope stability analysis, and Earthquake analysis of the dam for the existing dam geometry and do the same for modified geometry. Dams are massive as well as expensive hydraulic structure, therefore it needs proper attention. Additionally, this dam falls under zone 2B region of Pakistan, which is an earthquake-prone area and where ground accelerations range from 0.16g to 0.24g peak. So it should be deal with great care, as the failure of any dam can cause irreparable losses. Similarly, seepage as well as slope failure can also cause damages which can lead to failure of the dam. Therefore, keeping in view of the importance of dam construction and associated costs, our main focus is to carry out parametric study of newly constructed dam. GeoStudio software is used for this analysis in the study in which Seep/W is used for seepage analysis, Slope/w is used for Slope stability analysis and Quake/w is used for earthquake analysis. Based on the geometrical, hydrological and geotechnical data, Seepage and slope stability analysis of different proposed geometries of the dam are carried out along with the Seismic analysis. A rigorous analysis was carried out in 2-D limit equilibrium using finite element analysis. The seismic study began with the static analysis, continuing by the dynamic response analysis. The seismic analyses permitted evaluation of the overall patterns of the Latamber dam behavior in terms of displacements, stress, strain, and acceleration fields. Similarly, the seepage analysis allows evaluation of seepage through the foundation and embankment of the dam, while slope stability analysis estimates the factor of safety of the upstream and downstream of the dam. The results of the analysis demonstrate that among multiple geometries, Latamber dam is secure against seepage piping failure and slope stability (upstream and downstream) failure. Moreover, the dam is safe against any dynamic loading and no liquefaction has been observed while changing its geometry in permissible limits.

Keywords: earth-fill dam, finite element, liquefaction, seepage analysis

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2893 The Risk of Post-stroke Pneumonia and Its One-Year Disability in Taiwan

Authors: Hui-Chi Huang, Su-Ju Yang, Ching-Wei Lin, Jui-Yao Tsai, Liang-Yiang

Abstract:

Background: Evidence exists that pneumonia is a frequently encountered complication after stroke which is associated with a higher rate of mortality and increased long-term disability Purpose: To determine the predictors associated with the risk of one-year disability in acute stroke. Methods: Data for this longitudinal follow-up study were extracted from a tertiary referral medical center’s stroke registry database in Northern Taipei. Eligible patients with acute stroke admitted to the hospital and completed a one-year follow up were recruited for analysis. Favorable outcome was defined as a modified Rankin Scale score ≤ 2. SAS version 9.2 was used for the multivariable regression analyses to examine the factors correlated with the one-year disability in stroke patients. Results: From January 2012 to December 2013, a total of 1373 (mean age: 70.49±15.4 years, 913(66.5%) males) consecutively administered acute stroke patients were recruited. Overall, the rate of one-year disability was 37.20%(404/1086) in those without post-stroke pneumonia. It increased to 82.93 %(238/287) in patients developed post-stroke pneumonia. Factors associated with increased risk of disability were age ≧ 75(OR= 4.845, p<.0001), female /gender (OR=1.568, p =.0062), previous stroke (OR= 1.868, p = <. 0001) ,dementia (OR= 2.872, p =.0047), ventilator use (OR= 4.653, p <. 0001),age ≧ 75 /pneumonia (OR=1.236, p <. 0001) , ICU admission (OR=3.314, p <.0001) , nasogastric tube insertion (OR= 4.28, p <.0001), speech therapy (OR= 1.79, p =.0142), urinary tract infection (OR= 1.865, p =.0018), estimated glomerular filtration rate (eGFR > 60 )(OR= 0.525, p= .0029), Admission NIHSS >11 (OR= 2.101, p = .0099), Length of hospitalization > 30(d) (OR= 5.182, p <.0001). Conclusion: Older age, severe neurological deficit, complications, rehabilitation intervention, length of hospitalization >30(d), and cognitive impairment were significantly associated with Post-stroke functional impairment, especially those with post-stroke pneumonia. These findings could open new avenues in the management of stroke patients.

Keywords: stroke, risk, pneumonia, disability

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2892 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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