Search results for: drug safety

Authors: Tania Viju, Bimal P., Naseer M. A.

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This study aims to develop a conceptual framework for the decision support system (DSS), that helps the decision-makers to dynamically choose appropriate safety measures for each identified accident blackspot. An accident blackspot is a segment of road where the frequency of accident occurrence is disproportionately greater than other sections on roadways. According to a report by the World Bank, India accounts for the highest, that is, eleven percent of the global death in road accidents with just one percent of the world’s vehicles. Hence in 2015, the Ministry of Road Transport and Highways of India gave prime importance to the rectification of accident blackspots. To enhance road traffic safety and reduce the traffic accident rate, effectively identifying and rectifying accident blackspots is of great importance. This study helps to understand and evaluate the existing methods in accident blackspot identification and prediction that are used around the world and their application in Indian roadways. The decision support system, with the help of IoT, ICT and smart systems, acts as a management and planning tool for the government for employing efficient and cost-effective rectification strategies. In order to develop a decision criterion, several factors in terms of quantitative as well as qualitative data that influence the safety conditions of the road are analyzed. Factors include past accident severity data, occurrence time, light, weather and road conditions, visibility, driver conditions, junction type, land use, road markings and signs, road geometry, etc. The framework conceptualizes decision-making by classifying blackspot stretches based on factors like accident occurrence time, different climatic and road conditions and suggesting mitigation measures based on these identified factors. The decision support system will help the public administration dynamically manage and plan the necessary safety interventions required to enhance the safety of the road network.

Keywords: decision support system, dynamic management, road accident blackspots, road safety

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Authors: Pallavi Roe

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Violent crime is a significant public safety concern in urban areas across the United States, and Washington, DC, is no exception. This research discusses the prevalence and types of crime, particularly violent crime, in Washington, DC, along with the factors contributing to the high rate of violent crime in the city, including poverty, inequality, access to guns, and racial disparities. The organizations working towards ensuring safety in neighborhoods are also listed. The proposal to perform spatial and temporal analysis on violent crime and the use of guns in crime analysis is presented to identify patterns and trends to inform evidence-based interventions to reduce violent crime and improve public safety in Washington, DC. The stakeholders for crime analysis are also discussed, including law enforcement agencies, prosecutors, judges, policymakers, and the public. The anticipated result of the spatial and temporal analysis is to provide stakeholders with valuable information to make informed decisions about preventing and responding to violent crimes.

Keywords: crime analysis, spatial analysis, temporal analysis, violent crime

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Authors: C. Bay, A. Mahr, H. Groneberg, F. Döpper

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Additive Manufacturing processes are becoming increasingly established in the industry for the economic production of complex prototypes and functional components. Laser beam melting (LBM), the most frequently used Additive Manufacturing technology for metal parts, has been gaining in industrial importance for several years. The LBM process chain – from material storage to machine set-up and component post-processing – requires many manual operations. These steps often depend on the manufactured component and are therefore not standardized. These operations are often not performed in a standardized manner, but depend on the experience of the machine operator, e.g., levelling of the build plate and adjusting the first powder layer in the LBM machine. This lack of standardization limits the reproducibility of the component quality. When processing metal powders with inhalable and alveolar particle fractions, the machine operator is at high risk due to the high reactivity and the toxic (e.g., carcinogenic) effect of the various metal powders. Faulty execution of the operation or unintentional omission of safety-relevant steps can impair the health of the machine operator. In this paper, all the steps of the LBM process chain are first analysed in terms of their influence on the two aforementioned challenges: reproducibility and work safety. Standardization to avoid errors increases the reproducibility of component quality as well as the adherence to and correct execution of safety-relevant operations. The corresponding lean method 5S will therefore be applied, in order to develop approaches in the form of recommended actions that standardize the work processes. These approaches will then be evaluated in terms of ease of implementation and their potential for improving reproducibility and work safety. The analysis and evaluation showed that sorting tools and spare parts as well as standardizing the workflow are likely to increase reproducibility. Organizing the operational steps and production environment decreases the hazards of material handling and consequently improves work safety.

Keywords: additive manufacturing, lean production, reproducibility, work safety

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Authors: Ipek Goktepe, Israa Elnemr, Hammad Asim, Hao Feng, Mosbah Kushad, Hee Park, Sheikha Alzeyara, Mohammad Alhajri

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Food safety management in Qatar is under the shared oversight of multiple agencies in two government ministries (Ministry of Public Health and Ministry of Municipality and Environment). Despite the increasing number and diversity of the food service establishments, no systematic food surveillance system is in place in the country, which creates a gap in terms of determining the food safety attitudes and practices applied in the food service operations. Therefore, this study seeks to partially address this gap through determination of food safety knowledge among food handlers, specifically with respect to food preparation and handling practices, and sanitation methods applied in food service providers (FSPs) and a major market in Doha, Qatar. The study covered a sample of 53 FSPs randomly selected out of 200 FSPs. Face-to-face interviews with managers at participating FSPs were conducted using a 40-questions survey. Additionally, 120 produce handlers who are in direct contact with fresh produce at the major produce market in Doha were surveyed using a questionnaire containing 21 questions. A written informed consent was obtained from each survey participant. The survey data were analyzed using the chi-square test and correlation test. The significance was evaluated at p ˂ 0.05. The results from the FSPs surveys indicated that the average age of FSPs was 11 years, with the oldest and newest being established in 1982 and 2015, respectively. Most managers (66%) had college degree and 68% of them were trained on the food safety management system known as HACCP. These surveys revealed that FSP managers’ training and education level were highly correlated with the probability of their employees receiving food safety training while managers with lower education level had no formal training on food safety for themselves nor for their employees. Casual sit-in and fine dine-in restaurants consistently kept records (100%), followed by fast food (36%), and catering establishments (14%). The produce handlers’ survey results showed that none of the workers had any training on safe produce handling practices. The majority of the workers were in the age range of 31-40 years (37%) and only 38% of them had high-school degree. Over 64% of produce handlers claimed to wash their hands 4-5 times per day but field observations pointed limited handwashing as there was soap in the settings. This observation suggests potential food safety risks since a significant correlation (p ˂ 0.01) between the educational level and the hand-washing practices was determined. This assessment on food safety culture through determination of food and produce handlers' level of knowledge and practices, the first of its kind in Qatar, demonstrated that training and education are important factors which directly impact the food safety culture in FSPs and produce markets. These findings should help in identifying the need for on-site training of food handlers for effective food safety practices in food establishments in Qatar.

Keywords: food safety, food safety culture, food service providers, food handlers

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Authors: Sherine Farrag

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Magnetic resonance imaging (MRI) presents safety hazards, with the general physical environment. The principal hazard of the MRI is the presence of static magnetic fields. Proper architectural design of MRI’s room ensure environment and health care staff safety. This research paper presents an easy approach for numerical computation of fringe static magnetic fields. Iso-gauss line of different MR intensities (0.3, 0.5, 1, 1.5 Tesla) was mapped and a polynomial function of the 7th degree was generated and tested. Matlab script was successfully applied for MRI SMF mapping. This method can be valid for any kind of commercial scanner because it requires only the knowledge of the MR scanner room map with iso-gauss lines. Results help to develop guidelines to guide healthcare architects to design of a safer Magnetic resonance imaging suite.

Keywords: designing MRI suite, MRI safety, radiology occupational exposure, static magnetic fields

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Authors: Lito M. Amit, Venecio U. Ultra, Young Woong Song

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The purpose of this study was to document the prevalence and types of work-related health and safety problems among Filipino migrant workers and the link between their migration status and occupational health and safety (OHS) problems. We conducted a survey among 116 Filipino migrant workers who were both legal and undocumented. To assess the various forms of occupational health problems, we utilized the Korean occupational stress scale (KOSS), Nordic musculoskeletal questionnaire (NMQ) and a validated health and safety questionnaire. A focus group discussion (FGD) was also conducted to record relevant information that was limited by the questionnaires. Descriptive data were presented in frequency with percentages, mean, and standard deviation. Chi-square tests and logistic regression analyses were performed to estimate the degree of association between variables (p < 0.05). Among the eight subscales of KOSS, inadequate social support (2.48), organizational injustice (2.57), and lack of reward (2.52) were experienced by workers. There was a 44.83% prevalence of musculoskeletal disorders with arm/elbow having the highest rate, followed by shoulder and low back regions. Inadequate social support and discomfort in organizational climate and overall MSDs prevalence showed significant relationships with migration status (p < 0.05). There was a positive association between migration status and seven items under language and communication. A positive association was seen between migration status and some of the OHS problems of Filipino migrant workers in Korea. Undocumented workers in this study were seen to be more vulnerable to those stressors compared to those employed legally.

Keywords: Filipino workers, migration status, occupational health and safety, undocumented workers

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Authors: Abhay Asthana, Shally Toshkhani, Gyati Shilakari

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The objective of the present research work is to develop a topical biodegradable dermal patch based formulation to aid accelerated wound healing. It is always better for patient compliance to be able to reduce the frequency of dressings with improved drug delivery and overall therapeutic efficacy. In present study optimized formulation using biodegradable components was obtained evaluating polymers and excipients (HPMC K4M, Ethylcellulose, Povidone, Polyethylene glycol and Gelatin) to impart significant folding endurance, elasticity, and strength. Molten gelatin was used to get a mixture using ethylene glycol. Chitosan dissolved in acidic medium was mixed with stirring to Gelatin mixture. With continued stirring to the mixture Curcumin was added with the aid of DCM and Methanol in an optimized ratio of 60:40 to get homogenous dispersion. Polymers were dispersed with stirring in the final formulation. The mixture was sonicated casted to get the film form. All steps were carried out under strict aseptic conditions. The final formulation was a thin uniformly smooth textured film with dark brown-yellow color. The film was found to have folding endurance was around 20 to 21 times without a crack in an optimized formulation at RT (23°C). The drug content was in range 96 to 102% and it passed the content uniform test. The final moisture content of the optimized formulation film was NMT 9.0%. The films passed stability study conducted at refrigerated conditions (4±0.2°C) and at room temperature (23 ± 2°C) for 30 days. Further, the drug content and texture remained undisturbed with stability study conducted at RT 23±2°C for 45 and 90 days. Percentage cumulative drug release was found to be 80% in 12h and matched the biodegradation rate as tested in vivo with correlation factor R2>0.9. In in vivo study administration of one dose in equivalent quantity per 2 days was applied topically. The data demonstrated a significant improvement with percentage wound contraction in contrast to control and plain drug respectively in given period. The film based formulation developed shows promising results in terms of stability and in vivo performance.

Keywords: wound healing, biodegradable, polymers, patch

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Authors: Huseyin Duran, Yesim Benal Oztekin, Kazim Kubilay Vursavus, Ilker Huseyin Celen

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There are two main approaches to manufacturing, market and usage of plant protection machinery in Turkey. The first approach is called as ‘Product Safety Approach’ and could be summarized as minimum health and safety requirements of consumer needs on plant protection equipment and machinery products. The second approach is the practices related to the Plant Protection Equipment and Machinery Directive. Product safety approach covers the plant protection machinery product groups within the framework of a new approach directive, Machinery Safety Directive (2006/42 / AT). The new directive is in practice in our country by 03.03.2009, parallel to the revision of the EU Regulation on the Directive (03.03.2009 dated and numbered 27158 published in the Official Gazette). ‘Pesticide Application for Machines’ paragraph is added to the 2006/42 / EC Machinery Safety Directive, which is, in particular, reveals the importance of primary health care and product safety issue, explaining the safety requirements for machines used in the application of plant protection products. The Ministry of Science, Industry and Technology is the authorized organizations in our country for the publication and implementation of this regulation. There is a special regulation, carried out by Ministry of Food, Agriculture and Livestock General Directorate of Food and Control, on the manufacture and sale of plant protection machinery. This regulation, prepared based on 5996 Veterinary Services, Plant Health, Food and Feed Law, is ‘Regulation on Plant Protection Equipment and Machinery’ (published on 02.04.2011 whit number 27893 in the Official Gazette). The purposes of this regulation are practicing healthy and reliable crop production, the preparation, implementation and dissemination of the integrated pest management programs and projects for the development of human health and environmentally friendly pest control methods. This second regulation covers: approval, manufacturing, licensing of Plant Protection Equipment and Machinery; duties and responsibilities of the dealers; principles and procedures related to supply and control of the market. There are no inspection procedures for the application of currently used plant protection machinery in Turkey. In this study, content and application principles of all regulation approaches currently used in Turkey are summarized.

Keywords: plant protection equipment and machinery, product safety, market surveillance, inspection procedures

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Authors: Zahid Iqbal, Ijaz Javed, Riaz Hussain, Ibadullah Jan, Amir Ali Khan

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This study was conducted to investigate the disposition kinetics of ciprofloxacin and calculate its optimal dosage in Pakistani sheep of Lohi breed. Injectable preparation of ciprofloxacin was given intramuscularly to eight sheep at a dose of 5 mg/Kg. Before administration of drug blood sample was drawn from each animal. Post drug administration, blood samples were also drawn at various predetermined time periods. Drug concentration in the blood samples was assessed through high performance liquid chromatograph (HPLC). Data were best described by two compartment open model and different pharmacokinetic (PK) parameters were calculated. Cmax of 1.97 ± 0.15 µg/ml was reached at Tmax of 0.88 ± 0.09 hours. Half life of absorption (t1/2 abs) was observed to be 0.63 ± 0.16 hours while t1/2 α (distribution half life) and t1/2 ß (elimination half life) were found to be 0.46 ± 0.05 and 2.93 ± 0.45 hours, respectively. Vd (apparent volume of distribution) was calculated as 2.89 ± 0.30 L/kg while AUC (area under the curve) was 7.19 ± 0.38 µg.hr/mL and CL (total body clearance) was 0.75 ± 0.04 L/hr/kg. Using these parameters, an optimal intramuscular dosage of ciprofloxacin in adult Lohi sheep was calculated as 21.43 mg/kg, advised to be repeated after 24 hours. From this, we came to the conclusion that calculated dose was much higher than the dose advised by the foreign manufacturer and to avoid antimicrobial resistance, it is advised that this locally investigated dosage regimen should be strictly followed in local sheep.

Keywords: pharmacokinetics, dosage regimen, ciprofloxacin, HPLC, sheep

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Authors: G. Wagner, R. Herrmann

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Cytotoxic platinum compounds play a major role in the chemotherapy of a large number of human cancers. However, due to the severe side effects for the patient and other problems associated with their use, there is a need for the development of more efficient drugs and new methods for their selective delivery to the tumours. One way to achieve the latter could be in the use of nanoparticular substrates that can adsorb or chemically bind the drug. In the cell, the drug is supposed to be slowly released, either by physical desorption or by dissolution of the particle framework. Ideally, the cytotoxic properties of the platinum drug unfold only then, in the cancer cell and over a longer period of time due to the gradual release. In this paper, we report on our first steps in this direction. The binding properties of a series of cytotoxic Pt(II) oxadiazoline compounds to mesoporous silica particles has been studied by NMR and UV/vis spectroscopy. High loadings were achieved when the Pt(II) compound was relatively polar, and has been dissolved in a relatively nonpolar solvent before the silica was added. Typically, 6-10 hours were required for complete equilibration, suggesting the adsorption did not only occur to the outer surface but also to the interior of the pores. The untreated and Pt(II) loaded particles were characterised by C, H, N combustion analysis, BET/BJH nitrogen sorption, electron microscopy (REM and TEM) and EDX. With the latter methods we were able to demonstrate the homogenous distribution of the Pt(II) compound on and in the silica particles, and no Pt(II) bulk precipitate had formed. The in vitro cytotoxicity in a human cancer cell line (HeLa) has been determined for one of the new platinum compounds adsorbed to mesoporous silica particles of different size, and compared with the corresponding compound in solution. The IC50 data are similar in all cases, suggesting that the release of the Pt(II) compound was relatively fast and possibly occurred before the particles reached the cells. Overall, the platinum drug is chemically stable on silica and retained its activity upon prolonged storage.

Keywords: cytotoxicity, mesoporous silica, nanoparticles, platinum compounds

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Authors: Sertac Arslan, Guven Guney, Ayse Ipek Akyuz Unsal, Emre Demir, Buket Demirci

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Purpose: There is little histologic data concerning effects of nasal decongestants on the respiratory tract. We aimed to put forth the effects of nasal decongestants on the trachea and lower airways of rats. Materials and Methods: Four to six months old 60 male rats were randomly categorized into 6 groups. Experimental drugs were applied to the same nostril of rats twice daily for 8 weeks (Xylometazolin, Benzalkolyum, EDTA, Sorbitol and combined drug solutions). We applied normal saline solution (NaCl %0.9) for the control group. In the end, trachea and both lungs were dissected and kept in formaldehyde for histopathologic evaluation. Results: Inflammation and bronchial edema were most common findings. While all rats in sorbitol group had increased numbers of type 2 pneumocytes; 80% of BAC group had increased numbers of type 2 pneumocytes. Spillover of tracheal epithelium was seen mostly in sorbitol, EDTA and combined drug groups (60%, 87.5%, 50% respectively). Bronchial smooth muscle hypertrophy was seen mostly in BAC and EDTA group (70%, 62.5% respectively). The number of goblet cells showed the significant difference between control-combined drug (p=0.025) and control-BAC (p=0.001) groups. Conclusions: Nasal decongestants can cause permanent changes at lower respiratory tract in addition to changes in upper respiratory tract.

Keywords: decongestive agents, xylometazoline, lung, trachea

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Authors: Danish Farooq, Janos Juhasz

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Car-motorcycle accidents have been observed higher in recent years, which caused mainly riders’ fatalities and serious injuries. In-depth crash investigation methods aim to investigate the main factors which are likely involved in fatal road accidents and injury outcomes. The main objective of this study is to investigate the involved factors in car-motorcycle accidents in Budapest city. The procedure included statistical analysis and data sampling to identify car-motorcycle accidents by dominant accident types based on collision configurations. The police report was used as a data source for specified accidents, and simulation models were plotted according to scale (M 1:200). Car-motorcycle accidents were simulated in Virtual Crash software for 5 seconds before the collision. The simulation results showed that the main involved factors to car-motorcycle accidents were human behavior and view obstructions. The comprehensive, in-depth analysis also found that most of the car drivers and riders were unable to perform collision avoidance manoeuvres before the collision. This study can help the traffic safety authorities to focus on simulated involved factors to solve road safety issues in car-motorcycle accidents. The study also proposes safety measures to improve safe movements among road users.

Keywords: car motorcycle accidents, in-depth analysis, microscopic simulation, safety measures

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Authors: Muhammad Mustaqeem, Musa Kaleem Baloch, Irfan Ullah, Ammarah Luqman, Afshan Ahmad

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Flurbiprofen is one of the most potent nonsteroidal anti-inflammatory drugs. It is widely used for relief of pain in patients suffering from rheumatic diseases, migraine, sore throat and primary dysmenorrhea. However, its aqueous solubility is very low and hinders the skin permeation. Thus, it is imperative to develop such a drug delivery systems which can improve its aqueous solubility and hence improve the skin permeation and therapeutic compliance. Microemulsions have been also proven to increase the cutaneous absorption of lipophilic drugs as compared to conventional vehicles. Micro-emulsion is thermodynamically stable emulsion that has the capacity to ‘hide/solubilize’ water-insoluble molecules within a continuous oil phase. Therefore, flurbiprofen was converted to Easters through chemical reactions with alcohols such as methanol, ethanol, propanol and butanol. The product was further treated with hydrazine to get hydrazide. The solubility of the parent drug Flurbiprofen and the products were solubilized in microemulsions formed using various surfactants like ionic, non-ionic and zwitterions. It has been concluded that the product was more soluble than the parent compound. The biological activities of these were also investigated. The outcome was very promising and the product was more active than the parent compound. It, therefore, concluded that in this way, we can not only enhance the solubility of the drug and increase its bioactivity, but also reduce the risk of stomach cancer.

Keywords: Flurbiprofen, microemulsion, surfactants, hyrazides

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Authors: Abdul Musaweer Habib, Habibul Hasan Mazumder, Saiful Islam, Sohel Sikder, Omar Faruk Sikder

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The plethora of genome sequence information of bacteria in recent times has ushered in many novel strategies for antibacterial drug discovery and facilitated medical science to take up the challenge of the increasing resistance of pathogenic bacteria to current antibiotics. In this study, we adopted subtractive genomics approach to analyze the whole genome sequence of the Fusobacterium nucleatum, a human oral pathogen having association with colorectal cancer. Our study divulged 1499 proteins of Fusobacterium nucleatum, which has no homolog in human genome. These proteins were subjected to screening further by using the Database of Essential Genes (DEG) that resulted in the identification of 32 vitally important proteins for the bacterium. Subsequent analysis of the identified pivotal proteins, using the KEGG Automated Annotation Server (KAAS) resulted in sorting 3 key enzymes of F. nucleatum that may be good candidates as potential drug targets, since they are unique for the bacterium and absent in humans. In addition, we have demonstrated the 3-D structure of these three proteins. Finally, determination of ligand binding sites of the key proteins as well as screening for functional inhibitors that best fitted with the ligands sites were conducted to discover effective novel therapeutic compounds against Fusobacterium nucleatum.

Keywords: colorectal cancer, drug target, Fusobacterium nucleatum, homology modeling, ligands

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Authors: M. Doudi, M. H. Pazandeh, L. Rahimzadeh Torabi

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Bedsores are pressure ulcers that occur on the skin or tissue due to being immobile and lying in bed for extended periods. Bedsores have the potential to progress into open ulcers, increasing the possibility of a variety of bacterial infections. Acinetobacter baumannii, a pathogen of considerable clinical importance, exhibited a significant correlation with Bedsores (pressure ulcers) infections, thereby manifesting a wide spectrum of antibiotic resistance. The emergence of drug resistance has led researchers to focus on alternative methods, particularly phage therapy, for tackling bacterial infections. Phage therapy has emerged as a novel therapeutic approach to regulate the activity of these agents. The management of bacterial infections greatly benefits from the clinical utilization of bacteriophages as a valuable antimicrobial intervention. The primary objective of this investigation consisted of isolating and discerning potent bacteriophage capable of targeting multi-drug-resistant (MDR) and extensively drug-resistant (XDR) bacteria obtained from pressure ulcers. The present study analyzed and isolated A. baumannii strains obtained from a cohort of patients suffering from pressure ulcers at Taleghani Hospital in Ahvaz, Iran. An approach that included biochemical and molecular identification techniques was used to determine the taxonomic classification of bacterial isolates at the genus and species levels. The molecular identification process was facilitated by using the 16S rRNA gene in combination with universal primers 27 F and 1492 R. Bacteriophage was obtained through the isolation process conducted on treatment plant sewage located in Isfahan, Iran. The main goal of this study was to evaluate different characteristics of phage, such as their appearance, the range of hosts they can infect, how quickly they can enter a host, their stability at varying temperatures and pH levels, their effectiveness in killing bacteria, the growth pattern of a single phage stage, mapping of enzymatic digestion, and identification of proteomics patterns. The findings demonstrated that an examination was conducted on a sample of 50 specimens, wherein 15 instances of A. baumannii were identified. These microorganisms are the predominant Gram-negative agents known to cause wound infections in individuals suffering from bedsores. The study's findings indicated a high prevalence of antibiotic resistance in the strains isolated from pressure ulcers, excluding the clinical strains that exhibited responsiveness to colistin. According to the findings obtained from assessments of host range and morphological characteristics of bacteriophage VbɸAB-1, it can be concluded that this phage possesses specificity towards A. Baumannii BAH_Glau1001 was classified as a member of the Podoviridae family. The bacteriophage mentioned earlier showed the strongest antibacterial effect at a temperature of 18 °C and a pH of 6.5. Through the utilization of sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) analysis on protein fragments, it was established that the bacteriophage VbɸAB-1 exhibited a size range between 50 and 75 kilodaltons (KDa). The numerous research findings on the effectiveness of phages and the safety studies conducted suggest that the phages studied in this research can be considered as a practical solution and recommended approach for controlling and treating stubborn pathogens in burn wounds among hospitalized patients. The findings of our research indicated that isolated phages could be an effective antimicrobial and an appreciate candidate for prophylaxis against pressure ulcers.

Keywords: acinetobacter baumannii, extremely drug-resistant, phage therapy, surgery wound

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Authors: Suliman Al-Fayoumi, Sherri Amberg, Huafeng Zhou, Jack W. Singer, James P. Dean

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Pacritinib is an oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1, and CSF1R. In clinical studies, pacritinib was well tolerated with clinical activity in patients with myelofibrosis. The most frequent adverse events (AEs) observed with pacritinib are gastrointestinal (diarrhea, nausea, and vomiting; mostly grade 1-2 in severity) and typically resolve within 2 weeks. A human ADME mass balance study demonstrated that pacritinib is predominantly cleared via hepatic metabolism and biliary excretion (>85% of administered dose). The major hepatic metabolite identified, M1, is not thought to materially contribute to the pharmacological activity of pacritinib. Hepatic diseases are known to impair hepatic blood flow, drug-metabolizing enzymes, and biliary transport systems and may affect drug absorption, disposition, efficacy, and toxicity. This phase 1 study evaluated the pharmacokinetics (PK) and safety of pacritinib and the M1 metabolite in study subjects with mild, moderate, or severe hepatic impairment (HI) and matched healthy subjects with normal liver function to determine if pacritinib dosage adjustments are necessary for patients with varying degrees of hepatic insufficiency. Study participants (aged 18-85 y) were enrolled into 4 groups based on their degree of HI as defined by Child-Pugh Clinical Assessment Score: mild (n=8), moderate (n=8), severe (n=4), and healthy volunteers (n=8) matched for age, BMI, and sex. Individuals with concomitant renal dysfunction or progressive liver disease were excluded. A single 400 mg dose of pacritinib was administered to all participants. Blood samples were obtained for PK evaluation predose and at multiple time points postdose through 168 h. Key PK parameters evaluated included maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration time curve (AUC) from hour zero to last measurable concentration (AUC0-t), AUC extrapolated to infinity (AUC0-∞), and apparent terminal elimination half-life (t1/2). Following treatment, pacritinib was quantifiable for all study participants at 1 h through 168 h postdose. Systemic pacritinib exposure was similar between healthy volunteers and individuals with mild HI. However, there was a significant difference between those with moderate and severe HI and healthy volunteers with respect to peak concentration (Cmax) and plasma exposure (AUC0-t, AUC0-∞). Mean Cmax decreased by 47% and 57% respectively in participants with moderate and severe HI vs matched healthy volunteers. Similarly, mean AUC0-t decreased by 36% and 45% and mean AUC0-∞ decreased by 46% and 48%, respectively in individuals with moderate and severe HI vs healthy volunteers. Mean t1/2 ranged from 51.5 to 74.9 h across all groups. The variability on exposure ranged from 17.8% to 51.8% across all groups. Systemic exposure of M1 was also significantly decreased in study participants with moderate or severe HI vs. healthy participants and individuals with mild HI. These changes were not significantly dissimilar from the inter-patient variability in these parameters observed in healthy volunteers. All AEs were grade 1-2 in severity. Diarrhea and headache were the only AEs reported in >1 participant (n=4 each). Based on these observations, it is unlikely that dosage adjustments would be warranted in patients with mild, moderate, or severe HI treated with pacritinib.

Keywords: pacritinib, myelofibrosis, hepatic impairment, pharmacokinetics

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Authors: Atheer Al-Nuaimi, Harry Evdorides

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Every day many people die or get disabled or injured on roads around the world, which necessitates more specific treatments for transportation safety issues. International road assessment program (iRAP) model is one of the comprehensive road safety models which accounting for many factors that affect road safety in a cost-effective way in low and middle income countries. In iRAP model road safety has been divided into five star ratings from 1 star (the lowest level) to 5 star (the highest level). These star ratings are based on star rating score which is calculated by iRAP methodology depending on road attributes, traffic volumes and operating speeds. The outcome of iRAP methodology are the treatments that can be used to improve road safety and reduce fatalities and serious injuries (FSI) numbers. These countermeasures can be used separately as a single countermeasure or mix as multiple countermeasures for a location. There is general agreement that the adequacy of a countermeasure is liable to consistent losses when it is utilized as a part of mix with different countermeasures. That is, accident diminishment appraisals of individual countermeasures cannot be easily added together. The iRAP model philosophy makes utilization of a multiple countermeasure adjustment factors to predict diminishments in the effectiveness of road safety countermeasures when more than one countermeasure is chosen. A multiple countermeasure correction factors are figured for every 100-meter segment and for every accident type. However, restrictions of this methodology incorporate a presumable over-estimation in the predicted crash reduction. This study aims to adjust this correction factor by developing new models to calculate the effect of using multiple countermeasures on the number of fatalities for a location or an entire road. Regression models have been used to establish relationships between crash frequencies and the factors that affect their rates. Multiple linear regression, negative binomial regression, and Poisson regression techniques were used to develop models that can address the effectiveness of using multiple countermeasures. Analyses are conducted using The R Project for Statistical Computing showed that a model developed by negative binomial regression technique could give more reliable results of the predicted number of fatalities after the implementation of road safety multiple countermeasures than the results from iRAP model. The results also showed that the negative binomial regression approach gives more precise results in comparison with multiple linear and Poisson regression techniques because of the overdispersion and standard error issues.

Keywords: international road assessment program, negative binomial, road multiple countermeasures, road safety

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Authors: Ritu Shitak

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Humans are social mammals, of the primate order. Our biology, behaviour, and pathologies are unique to us. In our desire to understand, reduce solitary confinement one source of information is the many reports of social isolation of other social mammals, especially primates. A behavioural study was conducted in the department of pharmacology at Indira Gandhi Medical College, Shimla in Himachal Pradesh province in India using white albino mice. Different behavioural parameters were observed by using open field, tail suspension, tests for aggressive behaviour and social interactions and the effect of isolation was studied. The results were evaluated and the standard statistics were applied. The said study was done to establish facts that isolation itself impairs social behaviour and can lead to alcohol dependence as well as related drug dependence.

Keywords: social isolation, albino mice, drug dependence, isolation on social behaviour

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Authors: Olusola Omolola Olafuyi, Michael Coleman, Raj Kumar Singh Badhan

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Introduction: Malaria in pregnancy has morbidity and mortality implication on both mother and unborn child. Piperaquine (PQ) based antimalarial treatment is emerging as a choice antimalarial for pregnant women in the face of resistance to current antimalarial treatment recommendation in pregnancy. Physiological and biochemical changes in pregnant women may affect the pharmacokinetics of the antimalarial drug in these. In malaria endemic regions other infectious diseases like HIV/AIDs are prevalent. Pregnant women who are co-infected with malaria and HIV/AID are at even more greater risk of death not only due to complications of the diseases but also due to drug-drug interactions (DDIs) between antimalarials (AMT) and antiretroviral (ARVs). In this study, physiologically based pharmacokinetic (PBPK) modelling was used to investigate the effect of physiological and biochemical changes on the impact of ARV mediated DDIs in pregnant women in three countries. Method: A PBPK model for PQ was developed on SimCYP® using published physicochemical and pharmacokinetic data of PQ from literature, this was validated in three customized population groups from Thailand, Sudan and Papua New Guinea with clinical data. Validation of PQ model was also done in presence of interaction with efavirenz (pre-validated on SimCYP®). Different albumin levels and pregnancy stages was simulated in the presence of interaction with standard doses of efavirenz and ritonavir. PQ day 7 concentration of 30ng/ml was used as the efficacy endpoint for PQ treatment.. Results: The median day 7 concentration of PQ remained virtually consistent throughout pregnancy and were satisfactory across the three population groups ranging from 26-34.1ng/ml; this implied the efficacy of PQ throughout pregnancy. DDI interaction with ritonavir and efavirenz resulted in modest effect on the day 7 concentrations of PQ with AUCratio ranging from 0.56-0.8 and 1.64-1.79 for efavirenz and ritonavir respectively over 10-40 gestational weeks, however, a reduction in human serum albumin level reflective of severe malaria resulted in significantly reduced the number of subjects attaining the PQ day 7 concentration in the presence of both DDIs. The model demonstrated that the DDI between PQ and ARV in pregnant women with different malaria severities can alter the pharmacokinetic of PQ.

Keywords: antiretroviral, malaria, piperaquine, pregnancy, physiologically-based pharmacokinetics

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Authors: B. Sathyanarayana

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As per the report of World Health Organization, more than 80% of world population uses medicines made from herbal and natural materials. They have stood the test of time for their safety, efficacy, cultural acceptability and lesser side effects. Quality assurance and control measures, such as national quality specification and standards for herbal materials, good manufacturing practices (GMP) for herbal medicines, labelling, and licensing schemes for manufacturing, imports and marketing, should be in place in every country where herbal medicines are regulated. These measures are vital for ensuring the safety and efficacy of herbal medicines. In the case of herbal products challenge begins at the stage of designing itself except the classical products. Selection of herbal ingredients, officinal parts to be used, proportions are vital. Once the formulation is designed one should take utmost care to produce the standardized product of assured quality and safety. Quality control measures should cover the validation of quality and identity of raw materials, in process control (as per SOP and GMP norms) and at the level of final product. Quality testing, safety and efficacy studies of the final product are required to ensure the safe and effective use of the herbal products in human beings. Medicinal plants being the materials of natural resource are subjected to great variation making it really difficult to fix quality standards especially in the case of polyherbal preparations. Manufacturing also needs modification according to the type of ingredients present. Hence, it becomes essential to develop Standard operative Procedure for a specific herbal product. Present paper throws a light on the challenges that are encountered during the design and development of herbal products.

Keywords: herbal product, challenges, quality, safety, efficacy

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Authors: Mattia Testuzza

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Public health is a social endeavour, which involves many different actors: from extremely stratified, structured health systems to unofficial networks of people and knowledge. Health and diseases are an intertwined individual and social experiences. Both patients and health workers navigate this public space through relations of trust. Trust in healthcare goes from the personal trust between a patient and her/his doctor to the trust of both the patient and the health worker in the medical knowledge and the healthcare system. Trust it is not a given, but it is continuously negotiated, given and gained. The key to understand these essential relations of trust in health is to recognise them as a social practice, which therefore implies agency and power. In these terms, health is constantly public and made public, as trust emerges as a meaningfully political phenomenon. Trust as a power relation can be observed at play in the implementation of public health policies such as the WHO’s Directly-Observed Theraphy Short-course (DOTS), and with the increasing concern for drug-resistance that tuberculosis pose, looking at the role of trust in the healthcare delivery system and implementation of public health policies becomes significantly relevant. The ethnographic fieldwork was carried out in four months through observation of the daily practices at the National Tuberculosis Center of Nepal, and semi-structured interviews with MultiDrug-Resistant Tuberculosis (MDR-TB) patients at different stages of the treatment, their relatives, MDR-TB specialised nurses, and doctors. Throughout the research, the role which trust plays in tuberculosis treatment emerged as one fundamental ax that cuts through all the different factors intertwined with drug-resistance development, unfolding a tension between the DOTS policy, which undermines trust, and the day-to-day healthcare relations and practices which cannot function without trust. Trust also stands out as a key component of the solutions to unforeseen issues which develop from the overall uncertainty of the context - for example, political instability and extreme poverty - in which tuberculosis treatment is carried out in Nepal.

Keywords: trust, tuberculosis, drug-resistance, politics of health

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Authors: Salwa Mohamed Salah Eldin, Howida Kamal Ibrahim

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Introduction: Major depressive disorder affects high proportion of the world’s population presenting cost load in health care. Extended release venlafaxine is more convenient and could reduce discontinuation syndrome. The once daily dosing also reduces the potential for adverse events such as nausea due to reduced Cmax. Venlafaxine is an effective first-line agent in the treatment of depression. A once daily formulation was designed to enhance patient compliance. Complexing with a resin was suggested to improve loading of the water soluble drug. The formulated systems were thoroughly evaluated in vitro to prove superiority to previous trials and were compared to the commercial extended release product in experimental animals. Materials and Methods: Venlafaxine-resinates were prepared using Dowex®50WX4-400 and Dowex®50WX8-100 at drug to resin weight ratio of 1: 1. The prepared resinates were evaluated for their drug content, particle shape and surface properties and in vitro release profile in gradient pH. The release kinetics and mechanism were evaluated. Venlafaxine-Dowex® resinates were encapsulated using O/W solvent evaporation technique. Poly-ε-caprolactone, Poly(D, L-lactide-co-glycolide) ester, Poly(D, L-lactide) ester and Eudragit®RS100 were used as coating polymers alone and in combination. Drug-resinate microcapsules were evaluated for morphology, entrapment efficiency and in-vitro release profile. The selected formula was tested in rabbits using a randomized, single-dose, 2-way crossover study against Effexor-XR tablets under fasting condition. Results and Discussion: The equilibrium time was 30 min for Dowex®50WX4-400 and 90 min for Dowex®50WX8-100. The percentage drug loaded was 93.96 and 83.56% for both resins, respectively. Both drug-Dowex® resintes were efficient in sustaining venlafaxine release in comparison to the free drug (up to 8h.). Dowex®50WX4-400 based venlafaxine-resinate was selected for further encapsulation to optimize the release profile for once daily dosing and to lower the burst effect. The selected formula (coated with a mixture of Eudragit RS and PLGA in a ratio of 50/50) was chosen by applying a group of mathematical equations according to targeted values. It recorded the minimum burst effect, the maximum MDT (Mean dissolution time) and a Q24h (percentage drug released after 24 hours) between 95 and 100%. The 90% confidence intervals for the test/reference mean ratio of the log-transformed data of AUC0–24 and AUC0−∞ are within (0.8–1.25), which satisfies the bioequivalence criteria. Conclusion: The optimized formula could be a promising extended release form of the water soluble, short half lived venlafaxine. Being a multiple unit formulation, it lowers the probability of dose dumping and reduces the inter-subject variability in absorption.

Keywords: biodegradable polymers, cation-exchange resin, microencapsulation, venlafaxine hcl

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Authors: Ana Claudia de Souza Costa, Beatriz de Cássia Pinheiro Goulart, Karine de Cássia Cavalari, Henrique Ceretta Oliveira, Edineis de Brito Guirardello

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Background: During the COVID-19 pandemic, nursing represents the largest category of health professionals who were on the front line. Thus, investigating the practice environment and the job satisfaction of nursing professionals during the pandemic becomes fundamental since it reflects on the quality of care and the safety climate. The aim of this study was to evaluate and compare the nursing professionals' perception of the work environment, job satisfaction, and safety climate of the different hospitals and work shifts during the COVID-19 pandemic. Method: This is a cross-sectional survey with 130 nursing professionals from public, private and mixed hospitals in Brazil. For data collection, was used an electronic form containing the personal and occupational variables, work environment, job satisfaction, and safety climate. The data were analyzed using descriptive statistics and ANOVA or Kruskal-Wallis tests according to the data distribution. The distribution was evaluated by means of the Shapiro-Wilk test. The analysis was done in the SPSS 23 software, and it was considered a significance level of 5%. Results: The mean age of the participants was 35 years (±9.8), with a mean time of 6.4 years (±6.7) of working experience in the institution. Overall, the nursing professionals evaluated the work environment as favorable; they were dissatisfied with their job in terms of pay, promotion, benefits, contingent rewards, operating procedures and satisfied with coworkers, nature of work, supervision, and communication, and had a negative perception of the safety climate. When comparing the hospitals, it was found that they did not differ in their perception of the work environment and safety climate. However, they differed with regard to job satisfaction, demonstrating that nursing professionals from public hospitals were more dissatisfied with their work with regard to promotion when compared to professionals from private (p=0.02) and mixed hospitals (p< 0.01) and nursing professionals from mixed hospitals were more satisfied than those from private hospitals (p= 0.04) with regard to supervision. Participants working in night shifts had the worst perception of the work environment related to nurse participation in hospital affairs (p= 0.02), nursing foundations for quality care (p= 0.01), nurse manager ability, leadership and support (p= 0.02), safety climate (p< 0.01), job satisfaction related to contingent rewards (p= 0.04), nature of work (p= 0.03) and supervision (p< 0.01). Conclusion: The nursing professionals had a favorable perception of the environment and safety climate but differed among hospitals regarding job satisfaction for the promotion and supervision domains. There was also a difference between the participants regarding the work shifts, being the night shifts, those with the lowest scores, except for satisfaction with operational conditions.

Keywords: health facility environment, job satisfaction, patient safety, nursing

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Authors: Emy Nayana Pinto, Denise Bomtempo Birche De Carvalho

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In the present study, the harmful use of illicit drugs is seen as a public health problem and as one of the expressions of the social question, since its consequences fall mainly on the poorer classes of the population. This perspective is a counterpoint to the dominant paradigm on illicit drug policy at the global level, whose centrality lies within the criminal justice arena. The 'drug problem' is internationally combated through fragmented approaches that focus its actions on banning and criminalizing users. In this sense, the research seeks to answer the following key questions: What are the influences of the prohibitionism in the recommendations of the United Nations (UN), the World Health Organization (WHO), and the formulation of drug policies in member countries? What are the actors that have been provoking the prospect of breaking with the prohibitionist paradigm? What is the WHO contribution to the rupture with the prohibitionist paradigm and the displacement of the drug problem in the field of public health? The general objective of this work is to seek evidence from the perspective of rupture with the prohibitionist paradigm in the field of drugs policies at the global and regional level, through analysis of documents of the World Health Organization (WHO), between the years of 2001 to 2016. The research was carried out in bibliographical and documentary sources. The bibliographic sources contributed to the approach with the object and the theoretical basis of the research. The documentary sources served to answer the research questions and evidence the existence of the perspective of change in drug policy. Twenty-two documents of the UN system were consulted, of which fifteen had the contribution of the World Health Organization (WHO). In addition to the documents that directly relate to the subject of the research, documents from various agencies, programs, and offices, such as the Joint United Nations Program on HIV/AIDS (UNAIDS) and the United Nations Office on Drugs and Crime (UNODC), which also has drugs as the central or transversal theme of its performance. The results showed that from the 2000s it was possible to find in the literature review and in the documentary analysis evidence of the critique of the prohibitionist paradigm parallel to the construction of a new perspective for drug policy at the global level and the displacement of criminal justice approaches for the scope of public health, with the adoption of alternative and pragmatic interventions based on human rights, scientific evidence and the reduction of social damages and health by the misuse of illicit drugs.

Keywords: illicit drugs, international organizations, prohibitionism, public health, World Health Organization

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Authors: H. Tayefih, F. farajzade ahari, F. Zarghami, V. Zeighamian, N. Zarghami, Y. Pilehvar-soltanahmadi

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Breast cancer is the most frequently occurring cancer among women throughout the world. Natural compounds such as curcumin hold promise to treat a variety of cancers including breast cancer. However, curcumin's therapeutic application is limited, due to its rapid degradation and poor aqueous solubility. On the other hand, previous studies have stated that drug delivery using nanoparticles might improve the therapeutic response to anticancer drugs. Poly (N-isopropylacrylamide-co-methacrylic acid) (PNIPAAm–MAA) is one of the hydrogel copolymers utilized in the drug delivery system for cancer therapy. The aim of this study was to examine the cytotoxic potential of curcumin encapsulated within the NIPAAm-MAA nanoparticle, on the MCF-7 breast cancer cell line. In this work, polymeric nanoparticles were synthesized through the free radical mechanism, and curcumin was encapsulated into NIPAAm-MAA nanoparticles. Then, the cytotoxic effect of curcumin-loaded NIPAAm-MAA on the MCF-7 breast cancer cell line was measured by MTT assays. The evaluation of the results showed that curcumin-loaded NIPAAm-MAA has more cytotoxic effect on the MCF-7 cell line and efficiently inhibited the growth of the breast cancer cell population, compared with free curcumin. In conclusion, this study indicates that curcumin-loaded NIPAAm-MAA suppresses the growth of the MCF-7 cell line. Overall, it is concluded that encapsulating curcumin into the NIPAAm-MAA copolymer could open up new avenues for breast cancer treatment.

Keywords: PNIPAAm-MAA, breast cancer, curcumin, drug delivery

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Authors: Chi-Rung Jiang, Chun-Chung Chen, Sheng-Yuan Shiao, Fang-Yao Yeh

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Transmission lines are essential for power systems which play a significant role in a city for the development of infrastructures. Once a tower on the transmission line is damaged or becomes unstable, small-scale transmission tower damage might cause a large-scale electric power failure, and consequently, the enormous economic losses will occur. This paper assesses the structural safety and considers the impact of earthquakes and winds, presents a preliminary study of transmission tower with high-low legs by building structural analysis models of towers. The result shows that the high-low legs towers do have some structural characteristics need to be considered, such as the length of the difference of high legs and low legs should be restricted and the deployment direction of legs must be carefully planned during the design of transmission towers. The outcome of this study is beneficial to power systems authorities.

Keywords: power transition tower, structural analysis, high-low legs, safety assessment

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Authors: Amos Sunday Onikanni, Bashir Lawal, Babatunji Emmanuel Oyinloye, Gomaa Mostafa-Hedeab, Mohammed Alorabi, Simona Cavalu, Augustine O. Olusola, Chih-Hao Wang, Gaber El-Saber Batiha

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The increasing global burden of diabetes mellitus has called for the search for a therapeutic alternative that offers better activities and safety than conventional chemotherapy. Herein, we evaluated the neuroprotective and antioxidant properties of different fractions (ethyl acetate, N-butanol and residual aqueous) of Clompanus pubescens leaves in streptozotocin (STZ)-induced diabetic rats. Our results revealed a significant elevation in the levels of blood glucose, pro-inflammatory cytokines, lipid peroxidation, neuronal activities of acetylcholinesterase, butyrylcholinesterase, nitric oxide, epinephrine, norepinephrine, and Na+/K+-ATPase in diabetic non treated rats. In addition, decreased levels of enzymatic and non-enzymatic antioxidants were observed. Treatment with different fractions of C. pubescens leaves resulted in a significant reversal of the biochemical alteration and improved the neurocognitive deficit in STZ-induced diabetic rats. However, the ethyl-acetate fraction demonstrated higher activities than the other fractions and was characterized for its phytoconstituents, revealing the presence of Gallic acid (713.00 ppm), catechin (0.91 ppm), ferulic acid (0.98 ppm), rutin (59.82 ppm), quercetin (3.22 ppm) and kaempferol (4.07 ppm). Our molecular docking analysis revealed that these compounds exhibited different binding affinities and potentials for targeting BChE/AChE/ IL-1 β/Na+-K+-ATPase. However, only Kampferol and ferulic exhibited good drug-like, ADMET, and permeability properties suitable for use as a neuronal drug target agent. Hence, the ethyl-acetate fraction of C. pubescent leaves could be considered a source of promising bioactive metabolite for the treatment and management of cognitive impairments related to type II diabetes mellitus.

Keywords: diabetes mellitus, neuroprotective, antioxidant, pro-inflammatory cytokines

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Authors: Brandtner-Hafner Martin

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Adhesives have established themselves as an innovative joining technology in the industry. Their strengths lie in joining different materials, avoiding structural weakening as in welding or screwing, and enabling lightweight construction methods. Now there are a variety of ways to improve the efficiency and effectiveness of bonded joints. One way is to add fiber fillers. This leads to an improvement in adhesion and cohesion (structural integrity). In this study, the effectiveness of fiber-modified adhesives for bonding different construction materials is reviewed. A series of experimental tests were performed using the fracture analytical GF principle to study the adhesive bonding safety and performance of the joint. Three different structural adhesive systems based on epoxy, CA/A hybrid, and PUR were modified with different fiber materials on different substrates. The results show that significant performance improvements can be achieved and that bonding reliability can be sustainably increased.

Keywords: fiber-modified adhesives, bonding safety, GF-principle, fracture analysis

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Authors: Zeeshan Hamid, Asher Ramish

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The purpose of this paper is to focus on security and safety issues facing by pharmaceutical industry globally when counterfeit drugs are in question. Hence, there is an intense need to secure and authenticate pharmaceutical products in the emerging counterfeit product market. This paper will elaborate the application of radio frequency identification (RFID) in pharmaceutical industry and to identify its key benefits for patient’s care. The benefits are: help to co-ordinate the stream of supplies, accuracy in chains of supplies, maintaining trustworthy information, to manage the operations in appropriate and timely manners and finally deliver the genuine drug to patient. It is discussed that how RFID supported supply chain information sharing (SCIS) helps to combat against counterfeit drugs. And a solution how to tag pharmaceutical products; since, some products prevent RFID implementation in this industry. In this paper, a proposed model for pharma industry distribution suggested to combat against the counterfeit drugs when they are in supply chain.

Keywords: supply chain, RFID, pharmaceutical industry, counterfeit drugs, patients care

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Authors: Sergio Saponara, Luca Fanucci, Riccardo Cassettari, Ruggero Piernicola, Marco Righetto

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The paper presents an innovative networked radar system for detection of obstacles in a railway level crossing scenario. This Monitoring System (MS) is able to detect moving or still obstacles within the railway level crossing area automatically, avoiding the need of human presence for surveillance. The MS is also connected to the National Railway Information and Signaling System to communicate in real-time the level crossing status. The architecture is compliant with the highest Safety Integrity Level (SIL4) of the CENELEC standard. The number of radar sensors used is configurable at set-up time and depends on how large the level crossing area can be. At least two sensors are expected and up four can be used for larger areas. The whole processing chain that elaborates the output sensor signals, as well as the communication interface, is fully-digital, was designed in VHDL code and implemented onto a Xilinx Virtex 6.

Keywords: radar for safe mobility, railroad crossing, railway, transport safety

Procedia PDF Downloads 483