Search results for: drug safety

Authors: Yuhua Wang, Mu Li, Jinggen Liu

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Aim: To investigate the different effects of heroin and milk in activating the corticostriatal system that plays a critical role in reward reinforcement learning. Methods: Male SD rats were trained daily for 15 d to self-administer heroin or milk tablets in a classic runway drug self-administration model. Immunohistochemical assay was used to quantify Arc protein expression in the medial prefrontal cortex (mPFC), the nucleus accumbens (NAc), the dorsomedial striatum (DMS) and the ventrolateral striatum (VLS) in response to chronic self-administration of heroin or milk tablets. NMDA receptor antagonist MK801 (0.1 mg/kg) or dopamine D1 receptor antagonist SCH23390 (0.03 mg/kg) were intravenously injected at the same time as heroin was infused intravenously. Results: Runway training with heroin resulted in robust enhancement of Arc expression in the mPFC, the NAc and the DMS on d 1, 7, and 15, and in the VLS on d 1 and d 7. However, runway training with milk led to increased Arc expression in the mPFC, the NAc and the DMS only on d 7 and/or d 15 but not on d 1. Moreover, runway training with milk failed to induce increased Arc protein in the VLS. Both heroin-seeking behavior and Arc protein expression were blocked by MK801 or SCH23390 administration. Conclusion: The VLS is likely to be critically involved in drug-seeking behavior. The NMDA and D1 receptor-dependent Arc expression is important in drug-seeking behavior.

Keywords: arc, mesocorticolimbic system, drug rewarding behavior, NMDA receptor

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Authors: Sudhir Kumar, V. R. Sinha

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Background: The topical and systemic toxicity associated with present nonmelanoma skin cancer (NMSC) treatment therapy using 5-Fluorouracil (5-FU) make it necessary to develop a novel delivery system having lesser toxicity and better control over drug release. Solid lipid nanoparticles offer many advantages like: controlled and localized release of entrapped actives, nontoxicity, and better tolerance. Aim:-To investigate safety and efficacy of 5-FU loaded solid lipid nanoparticles as a topical delivery system for the treatment of nonmelanoma skin cancer. Method: Topical solid lipid nanoparticles of 5-FU were prepared using Compritol 888 ATO (Glyceryl behenate) as lipid component and pluronic F68 (Poloxamer 188), Tween 80 (Polysorbate 80), Tyloxapol (4-(1,1,3,3-Tetramethylbutyl) phenol polymer with formaldehyde and oxirane) as surfactants. The SLNs were prepared with emulsification method. Different formulation parameters viz. type and ratio of surfactant, ratio of lipid and ratio of surfactant:lipid were investigated on particle size and drug entrapment efficiency. Results: Characterization of SLNs like–Transmission Electron Microscopy (TEM), Differential Scannig calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), Particle size determination, Polydispersity index, Entrapment efficiency, Drug loading, ex vivo skin permeation and skin retention studies, skin irritation and histopathology studies were performed. TEM results showed that shape of SLNs was spherical with size range 200-500nm. Higher encapsulation efficiency was obtained for batches having higher concentration of surfactant and lipid. It was found maximum 64.3% for SLN-6 batch with size of 400.1±9.22 nm and PDI 0.221±0.031. Optimized SLN batches and marketed 5-FU cream were compared for flux across rat skin and skin drug retention. The lesser flux and higher skin retention was obtained for SLN formulation in comparison to topical 5-FU cream, which ensures less systemic toxicity and better control of drug release across skin. Chronic skin irritation studies lacks serious erythema or inflammation and histopathology studies showed no significant change in physiology of epidermal layers of rat skin. So, these studies suggest that the optimized SLN formulation is efficient then marketed cream and safer for long term NMSC treatment regimens. Conclusion: Topical and systemic toxicity associated with long-term use of 5-FU, in the treatment of NMSC, can be minimized with its controlled release with significant drug retention with minimal flux across skin. The study may provide a better alternate for effective NMSC treatment.

Keywords: 5-FU, topical formulation, solid lipid nanoparticles, non melanoma skin cancer

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Authors: Debalke Dale, Bezabh Geneta, Yohannes Amene, Yordanos Bergene, Mohammed Yimam

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Background: A drug therapy problem (DTP) is an event or circumstance that involves drug therapies that actually or potentially interfere with the desired outcome and requires professional judgment to resolve. Heart failure is an emerging worldwide threat whose prevalence and health loss burden constantly increase, especially in the young and in low-to-middle-income countries. There is a lack of population-based incidence and prevalence of heart failure (HF) studies in sub-Saharan African countries, including Ethiopia. Objective: The aim of this study was designed to assess drug therapy problems and associated factors among patients with HF in the medical ward of Arba Minch General Hospital(AGH), Ethiopia, from June 5 to August 20, 2022. Methods: A retrospective cross-sectional study was conducted among 180 patients with HF who were admitted to the medical ward of AGH. Data were collected from patients' cards by using questionnaires. The data were categorized and analyzed by using SPSS version 25.0 software, and data were presented in tables and words based on the nature of the data. Result: Out of the total, 85 (57.6%) were females, and 113 (75.3%) patients were aged over fifty years. Of the 150 study participants, 86 (57.3%) patients had at least one DTP identified, and a total of 116 DTPs were identified, which is 0.77 DTPs per patient. The most common types of DTP were unnecessary drug therapy (32%), followed by the need for additional drug therapy (36%), and dose too low (15%). Patients who used polypharmacy were 5.86 (AOR) times more likely to develop DTPs than those who did not (95% CI = 1.625–16.536, P = 0.005), and patients with more co-morbid conditions developed 3.68 (AOR) times more DTPs than those who had fewer co-morbidities (95% CI = 1.28–10.5, P = 0.015). Conclusion: The results of this study indicated that drug therapy problems were common among medical ward patients with heart failure. These problems are adversely affecting the treatment outcomes of patients, so it requires the special attention of healthcare professionals to optimize them.

Keywords: heart failure, drug therapy problems, Arba Minch general hospital, Ethiopia

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Authors: Achim Washington, Reece Clothier, Jose Silva

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System Safety Regulations (SSR) are a central component to the airworthiness certification of Unmanned Aircraft Systems (UAS). There is significant debate on the setting of appropriate SSR for UAS. Putting this debate aside, the challenge lies in how to apply the system safety process to UAS, which lacks the data and operational heritage of conventionally piloted aircraft. The limited knowledge and lack of operational data result in uncertainty in the system safety assessment of UAS. This uncertainty can lead to incorrect compliance findings and the potential certification and operation of UAS that do not meet minimum safety performance requirements. The existing system safety assessment and compliance processes, as used for conventional piloted aviation, do not adequately account for the uncertainty, limiting the suitability of its application to UAS. This paper discusses the challenges of undertaking system safety assessments for UAS and presents current and envisaged research towards addressing these challenges. It aims to highlight the main advantages associated with adopting a risk based framework to the System Safety Performance Requirement (SSPR) compliance process that is capable of taking the uncertainty associated with each of the outputs of the system safety assessment process into consideration. Based on this study, it is made clear that developing a framework tailored to UAS, would allow for a more rational, transparent and systematic approach to decision making. This would reduce the need for conservative assumptions and take the risk posed by each UAS into consideration while determining its state of compliance to the SSR.

Keywords: Part 1309 regulations, risk models, uncertainty, unmanned aircraft systems

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Authors: Pinar Ercan, Bulut Mert

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The baking industry is prone to occupational health challenges like other industries. Workers in bakeries face many hazards in their work environment; hazards have the potential for causing injury, illness or work accidents. Most of these hazards are preventable and arise from the neglect of occupational safety measures. Some bakeries in Izmır Turkey was evaluated according to occupational health and safety. First of all, the production process was evaluated. The survey was administered to a total of 50 employees. The survey consisted of two sections. The first one comprised only demographic questions and items related to job characteristics. The remaining section was assessing the satisfaction and confidence about occupational health and safety in terms of employees consist of a 10-item questionnaire by using HSE (2010) survey with some modifications. Also, hazards, risks and control measures in the bakeries were determined. Risk assessment has been done by the use of '5x5 Risk Assessment Table' for this purpose.

Keywords: bakeries, occupational health and safety, hazards, risks, risk assessment

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Authors: Mia I. Allen, Bernard N. Johnson, Gagan Deep, Yixin Su, Sangeeta Singth, Ashish Kumar, , Michael A. Nader

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With no FDA-approved treatments for cocaine use disorders (CUD), research has focused on the behavioral and neuropharmacological effects of cocaine in animal models, with the goal of identifying novel interventions. While the majority of people with CUD also use tobacco/nicotine, the majority of preclinical cocaine research does not include the co-use of nicotine. The present study examined nicotine and cocaine co-use under several conditions of intravenous drug self-administration in monkeys. In Experiment 1, male rhesus monkeys (N=3) self-administered cocaine (0.001-0.1 mg/kg/injection) alone and cocaine+nicotine (0.01-0.03 mg/kg/injection) under a progressive-ratio schedule of reinforcement. When nicotine was added to cocaine, there was a significant leftward shift and significant increase in peak break point. In Experiment 2, socially housed female and male cynomolgus monkeys (N=14) self-administered cocaine under a concurrent drug-vs-food choice schedule. Combining nicotine significantly decreased cocaine choice ED50 values (i.e., shifted the cocaine dose-response curve to the left) in females but not in males. There was no evidence of social rank differences. In delay discounting studies, the co-use of nicotine and cocaine required significantly larger delays to the preferred drug reinforcer to reallocate choice compared with cocaine alone. Overall, these results suggest drug interactions of nicotine and cocaine co-use is not simply a function of potency but rather a fundamentally distinctive condition that should be utilized to better understand the neuropharmacology of CUD and the evaluation of potential treatments.

Keywords: polydrug use, animal models, nonhuman primates, behavioral pharmacology, drug self-administration

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Authors: Junjira Mahaboon, Anongnard Boonpak, Nattakarn Worrasan, Busma Kama, Mujalin Saikliang, Siripor Dankachatarn

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Rubber wood processing is one of the most important industries in southern Thailand. The process has several safety hazards for example unsafe wood cutting machine guarding, wood dust, noise, and heavy lifting. However, workers’ occupational health and safety measures to promote their behaviors are still limited. This quasi-experimental research was to determine factors affecting workers’ safety behaviors using theory of planned behavior after implementing job safety intervention program. The purposes were to (1) determine factors affecting workers’ behaviors and (2) to evaluate effectiveness of the intervention program. The sample of study was 66 workers from a rubber wood processing factory. Factors in the Theory of Planned Behavior model (TPB) were measured before and after the intervention. The factors of TPB included attitude towards behavior, subjective norm, perceived behavioral control, intention, and behavior. Firstly, Job Safety Analysis (JSA) was conducted and Safety Standard Operation Procedures (SSOP) were established. The questionnaire was also used to collect workers’ characteristics and TPB factors. Then, job safety intervention program to promote workers’ behavior according to SSOP were implemented for a four month period. The program included SSOP training, personal protective equipment use, and safety promotional campaign. After that, the TPB factors were again collected. Paired sample t-test and independent t-test were used to analyze the data. The result revealed that attitude towards behavior and intention increased significantly after the intervention at p<0.05. These factors also significantly determined the workers’ safety behavior according to SSOP at p<0.05. However, subjective norm, and perceived behavioral control were not significantly changed nor related to safety behaviors. In conclusion, attitude towards behavior and workers’ intention should be promoted to encourage workers’ safety behaviors. SSOP intervention program e.g. short meeting, safety training, and promotional campaign should be continuously implemented in a routine basis to improve workers’ behavior.

Keywords: job safety analysis, rubber wood processing workers, safety standard operation procedure, theory of planned behavior

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Authors: Christina Knorr

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Analysis of the evacuation of occupants of a building plays a significant role in Fire Safety Engineering. One of the tools used for the analysis is the concept of the Required Safe Egress Time (RSET). It is generally accepted that RSET is measured from the time the fire ignites until the time that all occupants have evacuated to a safe location. Instructions on how RSET is determined can be found in both the International Fire Engineering Guidelines and, more recently, in the Australian Fire Engineering Guidelines. The guidelines also specify measures that could be applied to reduce the RSET and hence improve the performance of fire-safety measures of a building. Further, it is suggested that the delay period can be reduced through “training programs.” This study examined the overall level of fire-safety awareness among occupants of residential apartment buildings in Australia and investigated the possible effects of fire-safety training on the delay period and, hence, the RSET. A questionnaire, interviews, and an experiment were conducted to collect data about people’s fire-safety knowledge, people’s behaviour and nature, and the duration of activities people are likely to undertake in the event of a fire. The study led to an investigation into the delay and response time approximations and the development of a new equation to incorporate the impact of training into the RSET calculations for the general use of the fire engineering community. Regardless of the RSET, it can be concluded that fire-safety education and training for residents of apartment buildings have a direct impact on improving their behaviour and firefighting equipment usage in a fire incident.

Keywords: fire safety engineering, fire safety training, occupant evacuation behaviour, required safe egress time

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Authors: Chuan Yin

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Cancer stem cells (CSCs) represent a subpopulation of cancer cells that possess the characteristics associated with normal stem cells. CD133 is a phenotype of melanoma CSCs responsible for melanoma metastasis and drug resistance. Although adriamycin (ADR) is commonly used drug in melanoma therapy, but it is ineffective in the treatment of melanoma CSCs. In this study, we constructed CD133 antibody conjugated ADR immunoliposomes (ADR-Lip-CD133) to target CD133+ melanoma CSCs. The results showed that the immunoliposomes possessed a small particle size (~150 nm), high drug encapsulation efficiency (~90%). After 72 hr treatment on the WM266-4 melanoma tumorspheres, the IC50 values of the drug formulated in ADR-Lip-CD133, ADR-Lip (ADR liposomes) and ADR are found to be 24.42, 57.13 and 59.98 ng/ml respectively, suggesting that ADR-Lip-CD133 was more effective than ADR-Lip and ADR. Significantly, ADR-Lip-CD133 could almost completely abolish the tumorigenic ability of WM266-4 tumorspheres in vivo, and showed the best therapeutic effect in WM266-4 melanoma xenograft mice. It is noteworthy that ADR-Lip-CD133 could selectively kill CD133+ melanoma CSCs of WM266-4 cells both in vitro and in vivo. ADR-Lip-CD133 represent a potential approach in targeting and killing CD133+ melanoma CSCs.

Keywords: cancer stem cells, melanoma, immunoliposomes, CD133

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Authors: Anders Thorsén, Behrooz Sangchoolie, Peter Folkesson, Ted Strandberg

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As more parts of the power grid become connected to the internet, the risk of cyberattacks increases. To identify the cybersecurity threats and subsequently reduce vulnerabilities, the common practice is to carry out a cybersecurity risk assessment. For safety classified systems and products, there is also a need for safety risk assessments in addition to the cybersecurity risk assessment in order to identify and reduce safety risks. These two risk assessments are usually done separately, but since cybersecurity and functional safety are often related, a more comprehensive method covering both aspects is needed. Some work addressing this has been done for specific domains like the automotive domain, but more general methods suitable for, e.g., intelligent distributed grids, are still missing. One such method from the automotive domain is the Security-Aware Hazard Analysis and Risk Assessment (SAHARA) method that combines safety and cybersecurity risk assessments. This paper presents an approach where the SAHARA method has been modified in order to be more suitable for larger distributed systems. The adapted SAHARA method has a more general risk assessment approach than the original SAHARA. The proposed method has been successfully applied on two use cases of an intelligent distributed grid.

Keywords: intelligent distribution grids, threat analysis, risk assessment, safety, cybersecurity

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Authors: Raj Kumar, Prem Felix Siril

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The poor aqueous solubility of many pharmaceutical drugs and potential drug candidates is a big challenge in drug development. Nanoformulation of such candidates is one of the major solutions for the delivery of such drugs. We initially developed the evaporation assisted solvent-antisolvent interaction (EASAI) method. EASAI method is use full to prepared nanoparticles of poor water soluble drugs with spherical morphology and particles size below 100 nm. However, to further improve the effect formulation to reduce number of dose and side effect it is important to control the delivery of drugs. However, many drug delivery systems are available. Among the many nano-drug carrier systems, solid lipid nanoparticles (SLNs) have many advantages over the others such as high biocompatibility, stability, non-toxicity and ability to achieve controlled release of drugs and drug targeting. SLNs can be administered through all existing routes due to high biocompatibility of lipids. SLNs are usually composed of lipid, surfactant and drug were encapsulated in lipid matrix. A number of non-steroidal anti-inflammatory drugs (NSAIDs) have poor bioavailability resulting from their poor aqueous solubility. In the present work, SLNs loaded with NSAIDs such as Nabumetone (NBT), Ketoprofen (KP) and Ibuprofen (IBP) were successfully prepared using different lipids and surfactants. We studied and optimized experimental parameters using a number of lipids, surfactants and NSAIDs. The effect of different experimental parameters such as lipid to surfactant ratio, volume of water, temperature, drug concentration and sonication time on the particles size of SLNs during the preparation using hot-melt sonication was studied. It was found that particles size was directly proportional to drug concentration and inversely proportional to surfactant concentration, volume of water added and temperature of water. SLNs prepared at optimized condition were characterized thoroughly by using different techniques such as dynamic light scattering (DLS), field emission scanning electron microscopy (FESEM), transmission electron microscopy (TEM), atomic force microscopy (AFM), X-ray diffraction (XRD) and differential scanning calorimetry and Fourier transform infrared spectroscopy (FTIR). We successfully prepared the SLN of below 220 nm using different lipids and surfactants combination. The drugs KP, NBT and IBP showed 74%, 69% and 53% percentage of entrapment efficiency with drug loading of 2%, 7% and 6% respectively in SLNs of Campul GMS 50K and Gelucire 50/13. In-vitro drug release profile of drug loaded SLNs is shown that nearly 100% of drug was release in 6 h.

Keywords: nanoparticles, delivery, solid lipid nanoparticles, hot-melt sonication, poor water soluble drugs, solubility, bioavailability

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Authors: Hugo d’Albert, Udo Lindemann

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The number of automotive electronic systems that allow realizing new functions, like driver assistance systems, has been increasing extremely in the last decade. Although they bring several benefits, their malfunctions can lead to severe consequences, such as personal injury of road users. Functional safety is an approach to identify these critical malfunctions and arrange technical systems that include only tolerable risk. This approach is– in comparison with other technical areas– relatively new in the automotive sector. For a long time, the automotive systems have based on mechanical components and approved principles, like robust design. With a growing number of electric and electronic components in the modern cars and realizing by software of the system functions, the need for new standards and methods to assure the functional safety has arisen. This paper described the current state of engineering for safety in automotive sector and discusses new directions to meet the challenges of the future.

Keywords: automotive systems, functional safety, quality engineering, quality management

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Authors: Seyed Abolhassan Naeini, Azam Kouhpeyma

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Reduction of water level at which a slope is submerged with it is called drawdown. Draw down can took place rapidly or slowly and in both situations, it can affect slope stability. Using coupled analysis (seepage and stability analysis) causes more accurate results. In this study, the stability of homogeneous embankment is investigated numerically. Slope safety factor changes due to changes in three factors of height, slope and drawdown rate have been investigated and compared. It was found that with increasing height and slope, the safety factor decreases, and with increasing the discharge rate, the safety factor increases.

Keywords: drawdown, slope stability, coupled seepage and stability analysis

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Authors: Kyung-Jung Lee, Hyun-Sik Ahn

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This paper suggests a design methodology for the hardware and software of the Electronic Control Unit (ECU) of safety-critical vehicle applications such as braking and steering. The architecture of the hardware is a high integrity system such that it incorporates a high performance 32-bit CPU and a separate Peripheral Control-Processor (PCP) together with an external watchdog CPU. Communication between the main CPU and the PCP is executed via a common area of RAM and events on either processor which are invoked by interrupts. Safety-related software is also implemented to provide a reliable, self-testing computing environment for safety critical and high integrity applications. The validity of the design approach is shown by using the Hardware-in-the-Loop Simulation (HILS) for Electric Power Steering (EPS) systems which consists of the EPS mechanism, the designed ECU, and monitoring tools.

Keywords: electronic control unit, electric power steering, functional safety, hardware-in-the-loop simulation

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Authors: Camilla Trevor, Matthew K. Higgins, Andrea Gonzalez-Munoz, Mark Carrington

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Trypanosomiasis is a devastating disease affecting both humans and livestock in sub-Saharan Africa. The diseases are caused by infection with African trypanosomes, protozoa transmitted by tsetse flies. Treatment currently relies on the use of chemotherapeutics with ghastly side effects. Here, we describe the development of effective antibody-drug conjugates that target the T. brucei transferrin receptor. The receptor is essential for trypanosome growth in a mammalian host but there are approximately 12 variants of the transferrin receptor in the genome. Two of the most divergent variants were used to generate recombinant monoclonal immunoglobulin G using phage display and we identified cross-reactive antibodies that bind both variants using phage ELISA, fluorescence resonance energy transfer assays and surface plasmon resonance. Fluorescent antibodies were used to demonstrate uptake into trypanosomes in culture. Toxin-conjugated antibodies were effective at killing trypanosomes at sub-nanomolar concentrations. The approach of using antibody-drug conjugates has proven highly effective.

Keywords: antibody-drug conjugates, phage display, transferrin receptor, trypanosomes

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Authors: Yeo Ryeong Jeon, Pyong Kon Cho, Eun Ok Han, Hyon Chul Jang, Yong Min Kim

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This study surveyed on recognition related to radiation safety for radiation safety managers and workers those who have been worked in Republic of Korea education and research institution. At present, South Korea has no guideline and manual of radiation safety for education and research institution. Therefore, we tried to find an educational basis for development of radiation safety guideline and manual. To check the level of knowledge, attitude, and behavior about radiation safety, we used the questionnaire that consisted of 29 questions against knowledge, attitude and behavior, 4 questions against self-efficacy and expectation based on four factors (radiation source, human, organizational and physical environment) of the Haddon's matrix. Responses were collected between May 4 and June 30, 2015. We analyzed questionnaire by means of IBM SPSS/WIN 15 which well known as statistical package for social science. The data were compared with mean, standard deviation, Pearson's correlation, ANOVA (analysis of variance) and regression analysis. 180 copies of the questionnaire were returned from 60 workplaces. The overall mean results for behavior level was relatively lower than knowledge and attitude level. In particular, organizational environment factor on the radiation safety management indicated the lowest behavior level. Most of the factors were correlated in Pearson’s correlation analysis, especially between knowledge of human factors and behavior of human factors (Pearson’s correlation coefficient 0.809, P<.01). When analysis performed in line with the main radiation source type, institutions where have been used only opened RI (radioisotope) behavior level was the lowest among all subjects. Finally, knowledge of radiation source factor (β=0.556, P<.001) and human factor(β=0.376, P<.001) had the greatest impact in terms of behavior practice. Radiation safety managers and workers think positively about radiation safety management, but are poorly informed organizational environment of their institution. Thus, each institution need to efforts to settlement of radiation safety culture. Also, pedagogical interventions for improving knowledge on radiation safety needs in terms of safety accident prevention.

Keywords: radiation safety management, factor analysis, SPSS, republic of Korea

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Authors: Aliasghar Arab

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Autonomous robots interacting with humans, as safety-critical nonlinear control systems, are complex closed-loop cyber-physical dynamical machines. Keeping these intelligent yet complicated systems safe and smooth during their operations is challenging. The aim of the safe predictive output feedback linearization control synthesis is to design a novel controller for smooth trajectory following while unsafe situations must be avoided. The controller design should obtain a linearized output for smoothness and invariance to a safety subset. Inspired by finite-horizon nonlinear model predictive control, the problem is formulated as constrained nonlinear dynamic programming. The safety constraints can be defined as control barrier functions. Avoiding unsafe maneuvers and performing smooth motions increases the predictability of the robot’s movement for humans when robots and people are working together. Our results demonstrate the proposed output linearization method obeys the safety constraints and, compared to existing safety-guaranteed methods, is smoother and performs better.

Keywords: robotics, collaborative robots, safety, autonomous robots

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Authors: S. S. Patil, B. U. Janugade, S. V. Patil

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Pulsatile systems are gaining a lot of interest as they deliver the drug at the right site of action at the right time and in the right amount, thus providing spatial and temporal delivery thus increasing patient compliance. These systems are designed according to the circadian rhythm of the body. Chronotherapeutics is the discipline concerned with the delivery of drugs according to inherent activities of a disease over a certain period of time. It is becoming increasingly more evident that the specific time that patients take their medication may be even more significant than was recognized in the past. The tradition of prescribing medication at evenly spaced time intervals throughout the day, in an attempt to maintain constant drug levels throughout a 24-hour period, may be changing as researcher’s report that some medications may work better if their administration is coordinated with day-night patterns and biological rhythms. The potential benefits of chronotherapeutics have been demonstrated in the management of a number of diseases. In particular, there is a great deal of interest in how chronotherapy can particularly benefit patients suffering from allergic rhinitis, rheumatoid arthritis and related disorders, asthma, cancer, cardiovascular diseases, and peptic ulcer disease.

Keywords: pulsatile drug delivery, chronotherapeutics, circadian rhythm, asthma, chronobiology

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Authors: Khawaja A. Wahaj Wani, Aykut Erkal

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Pakistan's construction industry, a key player in economic development, has experienced remarkable growth. However, the surge in activities has been accompanied by dangerous working conditions, attributed to legislative gaps and flaws. Unhealthy construction practices, uncertain site conditions, and hazardous environments contribute to a concerning rate of injuries and fatalities. The principal aim of this research study is to undertake a thorough evaluation based on the assessment of the current situation of Health & Safety policies and the surveys performed by stakeholders of Pakistan with the aim of providing solution-centric methodologies for the enforcement of health and safety regulations within construction companies operating on project sites. Recognizing the pivotal role that the construction industry plays in bolstering a nation's economy, it is imperative to address the pressing need for heightened awareness among site engineers and laborers. The study adopts a robust approach, utilizing questionnaire surveys and interviews. As an exclusive investigative study, it encompasses all stakeholders: clients, consultants, contractors, and subcontractors. Targeting PEC-registered companies. Safety performance was assessed through the examination of sixty safety procedures using SPSS-18. A high Cronbach's alpha value of 0.958 ensures data reliability, and non-parametric tests were employed due to the non-normal distribution of data. The safety performance evaluation revealed significant insights. "Using Hoists and Cranes" and "Precautionary Measures (Shoring and Excavation)" exhibited commendable safety levels. Conversely, "Trainings on Safety" displayed a lower safety performance, alongside areas such as "Safety in Contract Documentation," "Meetings for Safety," and "Worker Participation," indicating room for improvement. These findings provide stakeholders with a detailed understanding of current safety measures within Pakistan's construction industry.

Keywords: construction industry, health and safety regulations, Pakistan, risk management

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Authors: Ria Ghosh, Soumendra Singh, Dipanjan Mukherjee, Susmita Mondal, Monojit Das, Uttam Pal, Aniruddha Adhikari, Aman Bhushan, Surajit Bose, Siddharth Sankar Bhattacharyya, Debasish Pal, Tanusri Saha-Dasgupta, Maitree Bhattacharyya, Debasis Bhattacharyya, Asim Kumar Mallick, Ranjan Das, Samir Kumar Pal

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Drug delivery to a target without adverse effects is one of the major criteria for clinical use. Herein, we have made an attempt to explore the delivery efficacy of SDS surfactant in a monomer and micellar stage during the delivery of the model drug, Toluidine Blue (TB) from the micellar cavity to DNA. Molecular recognition of pre-micellar SDS encapsulated TB with DNA occurs at a rate constant of k1 ~652 s 1. However, no significant release of encapsulated TB at micellar concentration was observed within the experimental time frame. This originated from the higher binding affinity of TB towards the nano-cavity of SDS at micellar concentration which does not allow the delivery of TB from the nano-cavity of SDS micelles to DNA. Thus, molecular recognition controls the extent of DNA recognition by TB which in turn modulates the rate of delivery of TB from SDS in a concentration-dependent manner.

Keywords: DNA, drug delivery, micelle, pre-micelle, SDS, toluidine blue

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Authors: Peaceman Sopazi, Mabila Mathebula, John Smallwood

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Recent health and safety (H&S) concerns and their resultant impact on railway operations, namely, the severe acute respiratory syndrome (SARS) or collectively known as SARS-CoV-2 (Covid-19) pandemic and the Fourth Industrial Revolution (4IR), which have dominated public discourse, brought into question as to whether, or not, some aspects of how we have so far managed safety oversight as railway regulatory bodies and operators will remain relevant in a changing railway environment. Railway practitioners have generally found themselves between a proverbial rock and a hard place by being confronted by emerging challenges which have brought along great opportunities for sustainability. As witnesses and participants to the progressively introduced railway safety management, and transformation regimes, this paper attempts to share gathered field experience on adaptable regulatory oversight and safety awareness. The discourse is approached from a South African context but also with an informed perspective of what seems to work and what usually does not. The authors share their own multi and transdisciplinary experience coupled with insights they have gained as researchers of global trends in general safety management and specific aspects of railway safety management, for sustainability. In addition to sharing a largely experience-based methodology for survival, suggestions are offered for consideration as a way of keeping the railway safety management discourse alive as practitioners navigate a new path which is shrouded in a cloud of untold uncertainty. The authors further believe that the right timing for the implementation of the proposed suggestions in this paper will produce beneficial outcomes. Finally, the paper will identify areas that are still open for further investigation for and by researchers and practitioners alike.

Keywords: health & safety management, safety awareness, railway safety management, railway systems sustainability

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Authors: Sharmin Akhter, M. Salahuddin, Sukalyan Kumar Kundu, Mohammad Fahim Kadir

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Relatively insoluble candidate drug like carbamazepine (CBZ) often exhibit incomplete or erratic absorption; and hence wide consideration is given to improve aqueous solubility of such compound. Solid dispersions were formulated with an aim of improving aqueous solubility, oral bioavailability and the rate of dissolution of Carbamazepine using different hydrophyllic polymer like Polyethylene Glycol (PEG) 6000, Polyethylene Glycol (PEG) 4000, kollidon 30, HPMC 6 cps, poloxamer 407 and povidone k 30. Solid dispersions were prepared with different drug to polymer weight ratio by the solvent evaporation method where methanol was used as solvent. Drug-polymer physical mixtures were also prepared to compare the rate of dissolution. Effects of different polymer were studied for solid dispersion formulation as well as physical mixtures. These formulations were characterized in the solid state by Fourier Transform Infrared (FTIR) spectroscopy and Scanning Electron Microscopy (SEM). Solid state characterization indicated CBZ was present as fine particles and entrapped in carrier matrix of PEG 6000 and PVP K30 solid dispersions. Fourier Transform Infrared (FTIR) spectroscopic studies showed the stability of CBZ and absence of well-defined drug-polymer interactions. In contrast to the very slow dissolution rate of pure CBZ, dispersions of drug in polymers considerably improved the dissolution rate. This can be attributed to increased wettability and dispersibility, as well as decreased crystallinity and increase in amorphous fraction of drug. Solid dispersion formulations containing PEG 6000 and Povidone K 30 showed maximum drug release within one hour at the ratio of 1:1:1. Even physical mixtures of CBZ prepared with both carriers also showed better dissolution profiles than those of pure CBZ. In conclusions, solid dispersions could be a promising delivery of CBZ with improved oral bioavailability and immediate release profiles.

Keywords: carbamazepine, FTIR, kollidon 30, HPMC 6 CPS, PEG 6000, PEG 4000, poloxamer 407, water solubility, povidone k 30, SEM, solid dispersion

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Authors: Surya R. Niraula, Devendra B Chhetry, Girish K. Singh, S. Nagesh, Frederick A. Connell

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Background: Although random sampling is generally considered to be the gold standard for population-based research, the majority of drug abuse research is based on non-random sampling despite the well-known limitations of this kind of sampling. Method: We compared the statistical properties of two surveys of drug abuse in the same community: one using snowball sampling of drug users who then identified “friend controls” and the other using a random sample of non-drug users (controls) who then identified “friend cases.” Models to predict drug abuse based on risk factors were developed for each data set using conditional logistic regression. We compared the precision of each model using bootstrapping method and the predictive properties of each model using receiver operating characteristics (ROC) curves. Results: Analysis of 100 random bootstrap samples drawn from the snowball-sample data set showed a wide variation in the standard errors of the beta coefficients of the predictive model, none of which achieved statistical significance. One the other hand, bootstrap analysis of the random-sample data set showed less variation, and did not change the significance of the predictors at the 5% level when compared to the non-bootstrap analysis. Comparison of the area under the ROC curves using the model derived from the random-sample data set was similar when fitted to either data set (0.93, for random-sample data vs. 0.91 for snowball-sample data, p=0.35); however, when the model derived from the snowball-sample data set was fitted to each of the data sets, the areas under the curve were significantly different (0.98 vs. 0.83, p < .001). Conclusion: The proposed method of random sampling of controls appears to be superior from a statistical perspective to snowball sampling and may represent a viable alternative to snowball sampling.

Keywords: drug abuse, matched case-control study, non-probability sampling, probability sampling

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Authors: S. Bouameur, S. Chirani

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The aim of this study was to evaluate the potential use of EthylCellulose in the preparation of microspheres as a Drug Delivery System for sustained release of phenobarbital. The microspheres were prepared by solvent evaporation technique using ethylcellulose as polymer matrix with a ratio 1:2, dichloromethane as solvent and Polyvinyl alcohol 1% as processing medium to solidify the microspheres. Size, shape, drug loading capacity and entrapement efficiency were studied.

Keywords: phenobarbital, microspheres, ethylcellulose, polyvinylacohol

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Authors: André Furtado, Rafael Mineiro, Isabel Gonçalves, Cecília Santos, Telma Quintela

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The development of therapies for central nervous system (CNS) disorders is one of the biggest challenges of current pharmacology, given the unique features of brain barriers, which limit drug delivery. Efflux transporters (ABC transporters) expressed at the blood-cerebrospinal fluid barrier (BCSFB), are the main obstacles for the delivery of therapeutic compounds into the CNS, compromising the effective treatment of brain cancer, brain metastasis from peripheral cancers, or even neurodegenerative disorders. It is thus extremely important to understand the regulation of these transporters for reducing their expression while treating a brain disorder or choosing the most appropriate conditions for drug administration. Based on the fact that the BCSFB have fine-tuned biological rhythms, studying the circadian variation of drug transport processes is critical for choosing the most appropriate time of the day for drug administration. In our study, using an in vitro model of the BCSFB, we characterized the circadian transport profile of methotrexate (MTX) and donepezil (DNPZ), two drugs involved in the treatment of cancer and Alzheimer’s Disease symptoms, respectively. We found that MTX is transported across the basal and apical membranes of the BCSFB in a circadian way. The circadian pattern of an ABC transporter, Abcc4, might be partially responsible for MTX circadian transport. Furthermore, regarding the DNPZ transport study, we observed that the regulation of Abcg2 expression by the circadian rhythm will impact the circadian-dependent transport of DNPZ across the BCSFB. Overall, our results will contribute to the current knowledge on brain pharmacoresistance at the BCSFB by disclosing how circadian rhythms control drug delivery to the brain, setting the grounds for a potential application of chronotherapy to brain diseases to enhance the efficacy of medications and minimize their side effects.

Keywords: blood-cerebrospinal fluid barrier, ABC transporters, drug transport, chronotherapy

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Authors: Fatma M. Benrabha

Abstract:

The aim of the study was to determine the type and pattern of antibiotic susceptibility of the pathogenic microorganisms causing chronic suppurative otitis media (CSOM), which could lead to better therapeutic decisions and consequently avoidance of appearance of resistance to specific antibiotics. Most frequently isolated agents were Pseudomonas aeruginosa 28.5%; followed by Staphylococcus aureus 18.2%; proteus mirabilis 13.9%; Providencia stuartti 6.7%; Bacteroides melaninogenicus, Aspergillus sp., candida sp., 4.2% each; and other microorganisms were represented in 3-0.2%. Drug sensitivities pattern of Pseudomonas aeruginosa showed that ciprofloxacin was active against the majority of isolates (93.9%) followed by ceftazidime 86.2%, amikacin 76.2% and gentamicin 40.8%. However, Staphylococcus aureus isolates were resistant to penicillin 72.7%, erythromycin 28.6%, cephalothin 18.2%, cloxacillin 8.3% and ciprofloxacin was active against 96.2% of isolates. The resistance pattern of proteus mirabilis were 55.6% to ampicillin, 47.1% to carbencillin, 29.4% to cephalothin, 14.3% to gentamicin and 4.8% to amikacin while 100% were sensitive to ciprofloxacin. We conclude that ciprofloxacin is the best drug of choice in treatment of CSOM caused by the common microorganisms.

Keywords: otitis media, chronic suppurative otitis media (CSOM), microorganism, drug sensitivity

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Authors: Reena K., Mamatha H. G., Somshekarayya, P. Kumar

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Objectives: The annual proficiency testing of intermediate reference laboratories is conducted by the National Reference Laboratory (NRL) to assess the efficiency of the laboratories to correctly identify Mycobacterium tuberculosis and to determine its drug susceptibility pattern. The proficiency testing results from 2013 to 2017 were analyzed to determine laboratories that were consistent in reporting quality results and those that had difficulty in doing so. Methods: A panel of twenty cultures were sent out to each of these laboratories. The laboratories were expected to grow the cultures in their own laboratories, set up drug susceptibly testing by all the methods they were certified for and report the results within the stipulated time period. The turnaround time for reporting results, specificity, sensitivity positive and negative predictive values and efficiency of the laboratory in identifying the cultures were analyzed. Results: Most of the laboratories had reported their results within the stipulated time period. However, there was enormous delay in reporting results from few of the laboratories. This was mainly due to improper functioning of the biosafety level III laboratory. Only 40% of the laboratories had 100% efficiency in solid culture using Lowenstein Jensen medium. This was expected as a solid culture, and drug susceptibility testing is not used for diagnosing drug resistance. Rapid molecular methods such as Line probe assay and Genexpert are used to determine drug resistance. Automated liquid culture system such as the Mycobacterial growth indicator tube is used to determine prognosis of the patient while on treatment. It was observed that 90% of the laboratories had achieved 100% in the liquid culture method. Almost all laboratories had achieved 100% efficiency in the line probe assay method which is the method of choice for determining drug-resistant tuberculosis. Conclusion: Since the liquid culture and line probe assay technologies are routinely used for the detection of drug-resistant tuberculosis the laboratories exhibited higher level of efficiency as compared to solid culture and drug susceptibility testing which are rarely used. The infrastructure of the laboratory should be maintained properly so that samples can be processed safely and results could be declared on time.

Keywords: annual proficiency testing, drug susceptibility testing, intermediate reference laboratory, national reference laboratory

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Authors: Özden Kuşcu, Yağmur Kuşcu, Zeynep Çetintaş, S. Sunay Yildirim Doğru

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The purpose of this work is to evaluate the effect of the subjects “personal safety” and “protection from dangers” included in primary school curriculum on the students’ levels of knowledge about safety and protection from social dangers. The study group included 469 students between 5–11 years old with 231 preschoolers and 238 primary school students and their parents and teachers. Instruments used to collect data were “Personal Safety Interview Form” for children, “Parent Interview Form” and “Teacher Interview Form”. Forms included 15 open-ended questions about personal safety. The researchers collected the research data through one-on-one interviews with children. Results of the study revealed that preschoolers and 1st, 2nd, and 3rd graders did not know their home addresses and telephone numbers and their families were not aware of that. The study also showed that those who had this information were unsure as to who to share this information with. Accordingly, more should be done to increase the levels of knowledge of preschoolers and 1st, 2nd, and 3rd graders about personal safety and protection from dangers.

Keywords: security, social danger, elementary school, preschool

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Authors: Carmen Silvia Gabriel, Dsniele Bernardi da Costa, Andrea Bernardes, Sabrina Elias Mikael, Daniele da Silva Ramos

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The goal of this quantitative study is to investigate patient safety culture from the perspective of professional from the hospital nursing team.It was conducted in two Brazilian hospitals,.The sample included 282 nurses Data collection occurred in 2013, through the questionnaire Hospital Survey on Patient Safety Culture.Based on the assessment of the dimensions is stressed that, in the dimension teamwork across hospital units, 69.4% of professionals agree that when a lot of work needs to be done quickly, they work together as a team; about the dimension supervisor/ manager expectations and actions promoting safety, 70.2% agree that their supervisor overlooks patient safety problems.Related to organizational learning and continuous improvement, 56.5% agree that there is evaluation of the effectiveness of the changes after its implementation.On hospital management support for patient safety, 52.8% refer that the actions of hospital management show that patient safety is a top priority.On the overall perception of patient safety, 57.2% disagree that patient safety is never compromised due to higher amount of work to be completed.In what refers to feedback and communication about error, 57.7% refer that always and usually receive such information. Relative to communication openness, 42.9% said they never or rarely feel free to question the decisions / actions of their superiors.On frequency of event reporting, 64.7% said often and always notify events with no damages to patients..About teamwork across hospital units is noted similarity between the percentages of agreement and disagreement, as on the item there is a good cooperation among hospital units that need to work together, that indicates 41.4% and 40.5% respectively.Related to adequacy of professionals, 77.8 % disagree on the existence of sufficient amount of employees to do the job, 52.4% agree that shift changes are problematic for patients. On nonpunitive response to errors, 71.7% indicate that when an event is reported it seems that the focus is on the person.On the patient safety grade of the institution, 41.6 % classified it as very good. it is concluded that there are positive points in the safety culture, and some weaknesses as a punitive culture and impaired patient safety due to work overload .

Keywords: quality of health care, health services evaluation, safety culture, patient safety, nursing team

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Authors: Alaa Hamed Salama, Rehab Nabil Shamma

Abstract:

Introduction: Polymeric micelles that can deliver drug to intended sites of the eye have attracted much scientific attention recently. The aim of this study was to review the aqueous-based formulation of drug-loaded polymeric micelles that hold significant promise for ophthalmic drug delivery. This study investigated the synergistic performance of mixed polymeric micelles made of linear and branched poly (ethylene oxide)-poly (propylene oxide) for the more effective encapsulation of Lornoxicam (LX) as a hydrophobic model drug. Methods: The co-micellization process of 10% binary systems combining different weight ratios of the highly hydrophilic poloxamers; Synperonic® PE/P84, and Synperonic® PE/F127 and the hydrophobic poloxamine counterpart (Tetronic® T701) was investigated by means of photon correlation spectroscopy and cloud point. The drug-loaded micelles were tested for their solubilizing capacity towards LX. Results: Results showed a sharp solubility increase from 0.46 mg/ml up to more than 4.34 mg/ml, representing about 136-fold increase. Optimized formulation was selected to achieve maximum drug solubilizing power and clarity with lowest possible particle size. The optimized formulation was characterized by 1HNMR analysis which revealed complete encapsulation of the drug within the micelles. Further investigations by histopathological and confocal laser studies revealed the non-irritant nature and good corneal penetrating power of the proposed nano-formulation. Conclusion: LX-loaded polymeric nanomicellar formulation was fabricated allowing easy application of the drug in the form of clear eye drops that do not cause blurred vision or discomfort, thus achieving high patient compliance.

Keywords: confocal laser scanning microscopy, Histopathological studies, Lornoxicam, micellar solubilization

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