Search results for: decreased ciprofloxacin susceptibility

Authors: Vladimíra Kňazovická, Mária Dovičičová, Miroslava Kačániová, Margita Čanigová

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The aim of the study was to test the storage of bee pollen at room temperature and in cold store, and to describe microorganisms originated from it. Fresh bee pollen originating in West Slovakia was collected in May 2010. It was tested for presence of particular microbial groups using dilution plating method, and divided into two parts with different storage (in cold store and at room temperature). Microbial analyses of pollen were repeated after one year of storage. Several bacterial strains were isolated and tested using Gram staining, for catalase and fructose-6-phosphate-phosphoketolase presence, and by rapid ID 32A (BioMérieux, France). Micromycetes were identified at genus level. Fresh pollen contained coliform bacteria, which were not detected after one year of storage in both ways. Total plate count (TPC) of aerobes and anaerobes and of yeasts in fresh bee pollen exceeded 5.00 log CFU/g. TPC of aerobes and anaerobes decreased below 2.00 log CFU/g after one year of storage in both ways. Count of yeasts decreased to 2.32 log CFU/g (at room temperature) and to 3.66 log CFU/g (in cold store). Microscopic filamentous fungi decreased from 3.41 log CFU/g (fresh bee pollen) to 1.13 log CFU/g (at room temperature) and to 1.89 log CFU/g (in cold store). In fresh bee pollen, 12 genera of micromycetes were identified in the following order according to their relative density: Penicillium > Mucor > Absidia > Cladosporium, Fusarium > Alternaria > Eurotium > Aspergillus, Rhizopus > Emericella > Arthrinium and Mycelium sterilium. After one year at room temperature, only three genera were detected in bee pollen (Penicillium > Aspergillus, Mucor) and after one year in cold store, seven genera were detected (Mucor > Penicillium, Emericella > Aspergillus, Absidia > Arthrinium, Eurotium). From the plates designated for anaerobes, eight colonies originating in fresh bee pollen were isolated. Among them, a single yeast isolate occurred. Other isolates were G+ bacteria, with a total of five rod shaped. In three out of these five, catalase was absent and fructose-6-phosphate-phosphoketolase was present. Bacterial isolates originating in fresh pollen belonged probably to genus Bifidobacterium or relative genera, but their identity was not confirmed unequivocally. In general, cold conditions are suitable for maintaining the natural properties of foodstuffs for a longer time. Slight decrease of microscopic fungal number and diversity was recorded in cold temperatures compared with storage at room temperature.

Keywords: bacteria, bee product, microscopic fungi, biosystems engineering

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Authors: A. Masek, M. Zaborski

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Electrochemical oxidation of dodecyl gallate (lauryl gallate), the main monomer flavanol found in green tea, was investigated on platinum electrodes using cyclic voltammetry (CV) and differential pulse (DPV) methods. The rate constant, electron transfer coefficient and diffusion coefficients were determined for dodecyl gallate electrochemical oxidation. The oxidation mechanism proceeds in sequential steps related to the hydroxyl groups in the aromatic ring of dodecyl gallate. Confirmed antioxidant activity of lauryl gallate verified its use in polymers as an environment-friendly stabiliser to improve the resistance to aging of the elastomeric materials. Based on the energy change of the deformation, cross-linking density and time of the oxygen induction with the TG method, we confirmed the high antioxidant activity of lauryl gallate in polymers. Moreover, the research on biodegradation confirmed the environment-friendly influence of the antioxidant by increasing the susceptibility of the elastomeric materials to disintegration by mildew mushrooms.

Keywords: polymers, flavonoids, stabilization, ageing

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Authors: Suat Erel, Gozde Gur

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Background: Recently a supramalleolar type of dynamic ankle foot orthosis (DAFO) has been increasingly used to support all of the dynamic arches of the foot and redistribute the pressure under the plantar surface of the foot to reduce the muscle tone. DAFO helps to maintain balance and postural control by providing stability and proprioceptive feedback in children with disease like Cerebral Palsy, Muscular Dystrophies, Down syndrome, and congenital hypotonia. Aim: The aim of this study was to investigate the role of Dynamic ankle foot orthosis (DAFO) on temporo-spatial parameters of gait and balance in three children with hereditary spastic paraparesis (HSP). Material Method: 13, 14, and 8 years old three children with HSP were included in the study. To provide correction on weight bearing and to improve gait, DAFO was made. Lower extremity spasticity (including gastocnemius, hamstrings and hip adductor muscles) using modified Ashworth Scale (MAS) (0-5), The temporo-spatial gait parameters (walking speed, cadence, base of support, step length) and Timed Up & Go test (TUG) were evaluated. All of the assessments about gait were compared with (with DAFO and shoes) and without DAFO (with shoes only) situations. Also after six months follow up period, assessments were repeated by the same physical therapist. Results: MAS scores for lower extremity were between “2-3” for the first child, “0-2” for the second child and “1-2” for the third child. TUG scores (sec) decreased from 20.2 to 18 for case one, from 9.4 to 9 for case two and from 12,4 to 12 for case three in the condition with shoes only and also from 15,2 to 14 for case one, from 7,2 to 7,1 for case two and from 10 to 7,3 for case three in the condition with DAFO and shoes. Gait speed (m/sec) while wearing shoes only was similar but while wearing DAFO and shoes increased from 0,4 to 0,5 for case one, from 1,5 to 1,6 for case two and from 1,0 to 1,2 for case three. Base of support scores (cm) wearing shoes only decreased from 18,5 to 14 for case one, from 13 to 12 for case three and were similar as 11 for case two. While wearing DAFO and shoes, base of support decreased from 10 to 9 for case one, from 11,5 to 10 for case three and was similar as 8 for case two. Conclusion: The use of a DAFO in a patient with HSP normalized the temporo-spatial gait parameters and improved balance. Walking speed is a gold standard for evaluating gait quality. With the use of DAFO, walking speed increased in this three children with HSP. With DAFO, better TUG scores shows that functional ambulation improved. Reduction in base of support and more symmetrical step lengths with DAFO indicated better balance. These encouraging results warrant further study on wider series.

Keywords: dynamic ankle foot orthosis, gait, hereditary spastic paraparesis, balance in patient

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Authors: Yusuf Jundi Sado

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Changes in land use are mostly credited to human actions that result in negative impacts on biodiversity and ecosystem functions. This study aims to analyze the dynamics of land use and land cover changes for sustainable natural resources planning and management. Chilalo-Galama Mountain Range, Ethiopia. This study used Thematic Mapper 05 (TM) for 1986, 2001 and Landsat 8 (OLI) data 2017. Additionally, data from the Central Statistics Agency on human population growth were analyzed. Semi-Automatic classification plugin (SCP) in QGIS 3.2.3 software was used for image classification. Global positioning system, field observations and focus group discussions were used for ground verification. Land Use Land Cover (LU/LC) change analysis was using maximum likelihood supervised classification and changes were calculated for the 1986–2001 and the 2001–2017 and 1986-2017 periods. The results show that agricultural land increased from 27.85% (1986) to 44.43% and 51.32% in 2001 and 2017, respectively with the overall accuracies of 92% (1986), 90.36% (2001), and 88% (2017). On the other hand, forests decreased from 8.51% (1986) to 7.64 (2001) and 4.46% (2017), and grassland decreased from 37.47% (1986) to 15.22%, and 15.01% in 2001 and 2017, respectively. It indicates for the years 1986–2017 the largest area cover gain of agricultural land was obtained from grassland. The matrix also shows that shrubland gained land from agricultural land, afro-alpine, and forest land. Population dynamics is found to be one of the major driving forces for the LU/LU changes in the study area.

Keywords: Landsat, LU/LC change, Semi-Automatic classification plugin, population dynamics, Ethiopia

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Authors: Ni Luh Putu Harta Wedari

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Background: Clostridium difficile has two main virulence factors, namely TcdA and TcdB. TcdA encoded by the tcdA gene acts as an enterotoxin, pro-inflammatory and fluid accumulation, while TcdB encoded by the tcdB gene is cytotoxic, causes disruption of the actin cytoskeleton, and causes disruption of tight junctions in colon cells. This study aims to explore the relationship between the tcdA and tcdB genes and the duration of diarrhea in elderly patients. Method: This research was an observational analytic with a prospective cross-sectional with samples of elderly diarrhea patients who met the inclusion criteria in Denpasar City health service facilities from 1 December 2022 until 30 June 2023, and then their feces were analyzed using the real-time PCR method. Results: In this study, 40 elderly diarrhea patients met the inclusion criteria and in accordance with the minimum sample size, 28 (70%) men and 12 (30%) women. 5 patients (12.5%) had a history of azithromycin, 4 (10%) levofloxacin, 17 (42.5%) ciprofloxacin, 8 (20%) metronidazole, 1 (2.5%) cefoperazone, 5 (12, 5%) doxycycline. Comorbids, namely 13 (32.5%) type II diabetes mellitus, 4 (10%) chronic kidney disease, 10 (25%) malignancies, 7 (17.5%) urinary tract infections, 3 (7.5%) %) immunocompromised, 2 (5%) cardiac heart failure, and 1 (2.5%) acute on chronic kidney disease. The overall diarrhea duration average was 5 days. 8 samples (20%) were positive for 16s rRNA, and there was no significant difference in diarrhea duration with negative samples (p=0.166). The relationship between the tcdA gene and the duration of diarrhea could not be performed because all samples were negative. Likewise, relationship analysis between the coexistence of tcdA and tcdB could not be performed. There was no significant difference between tcdB positive 3 (7.5%) and negative with diarrhea duration (p=0.739). Conclusion: There is no significant relationship between the presence of the 16s rRNA and tcdB C. difficile genes with the duration of diarrhea in elderly patients.

Keywords: clostridium, difficile, diarrhea, elderly, tcdA, tcdB

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Authors: Iyabode A. Kehinde, Temitope A. Oyedele, Clement G. Afolabi

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One of the limitations of African yam bean (AYB) (Sphenostylis sternocarpa) is poor storage ability due to the adverse effect of seed-borne fungi. This study was conducted to examine the effects of storage methods on the nutritive composition of AYB seeds stored in three types of storage materials viz; Jute bags, Polypropylene bags, and Plastic Bowls. Freshly harvested seeds of AYB seeds were stored in all the storage materials for 6 months using 2 × 3 factorial (2 AYB cultivars and 3 storage methods) in 3 replicates. The proximate analysis of the stored AYB seeds was carried out at 3 and 6 months after storage using standard methods. The temperature and relative humidity of the storeroom was recorded monthly with Kestrel pocket weather tracker 4000. Seeds stored in jute bags gave the best values for crude protein (24.87%), ash (5.69%) and fat content (6.64%) but recorded least values for crude fibre (2.55%), carbohydrate (50.86%) and moisture content (12.68%) at the 6th month of storage. The temperature of the storeroom decreased from 32.9ºC - 28.3ºC, while the relative humidity increased from 78% - 86%. Decreased incidence of field fungi namely: Rhizopus oryzae, Aspergillus flavus, Geotricum candidum, Aspergillus fumigatus and Mucor meihei was accompanied by the increase in storage fungi viz: Apergillus niger, Mucor hiemalis, Penicillium espansum and Penicillium atrovenetum with prolonged storage. The study showed that of the three storage materials jute bag was more effective at preserving AYB seeds.

Keywords: storage methods, proximate composition, African Yam Bean, fungi

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Authors: E. A. Krasikov

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As the service life of an operating nuclear power plant (NPP) increases, the potential misunderstanding of the degradation of aging components must receive more attention. Integrity assurance analysis contributes to the effective maintenance of adequate plant safety margins. In essence, the reactor pressure vessel (RPV) is the key structural component determining the NPP lifetime. Environmentally induced cracking in the stainless steel corrosion-preventing cladding of RPV’s has been recognized to be one of the technical problems in the maintenance and development of light-water reactors. Extensive cracking leading to failure of the cladding was found after 13000 net hours of operation in JPDR (Japan Power Demonstration Reactor). Some of the cracks have reached the base metal and further penetrated into the RPV in the form of localized corrosion. Failures of reactor internal components in both boiling water reactors and pressurized water reactors have increased after the accumulation of relatively high neutron fluences (5´1020 cm–2, E>0,5MeV). Therefore, in the case of cladding failure, the problem arises of hydrogen (as a corrosion product) embrittlement of irradiated RPV steel because of exposure to the coolant. At present when notable progress in plasma physics has been obtained practical energy utilization from fusion reactors (FR) is determined by the state of material science problems. The last includes not only the routine problems of nuclear engineering but also a number of entirely new problems connected with extreme conditions of materials operation – irradiation environment, hydrogenation, thermocycling, etc. Limiting data suggest that the combined effect of these factors is more severe than any one of them alone. To clarify the possible influence of the in-service synergistic phenomena on the FR structural materials properties we have studied hydrogen-irradiated steel interaction including alternating hydrogenation and heat treatment (annealing). Available information indicates that the life of the first wall could be expanded by means of periodic in-place annealing. The effects of neutron fluence and irradiation temperature on steel/hydrogen interactions (adsorption, desorption, diffusion, mechanical properties at different loading velocities, post-irradiation annealing) were studied. Experiments clearly reveal that the higher the neutron fluence and the lower the irradiation temperature, the more hydrogen-radiation defects occur, with corresponding effects on the steel mechanical properties. Hydrogen accumulation analyses and thermal desorption investigations were performed to prove the evidence of hydrogen trapping at irradiation defects. Extremely high susceptibility to hydrogen embrittlement was observed with specimens which had been irradiated at relatively low temperature. However, the susceptibility decreases with increasing irradiation temperature. To evaluate methods for the RPV’s residual lifetime evaluation and prediction, more work should be done on the irradiated metal–hydrogen interaction in order to monitor more reliably the status of irradiated materials.

Keywords: hydrogen, radiation, stability, structural steel

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Authors: Sajjad Rezaei, Mahdieh Molanouri Shamsi, Azadeh Jamali

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Background and purpose: Surfactant protein D (SP-D) is a lung-specific protein that is detectable in human plasma. Effect of exercise training on SP-D levels as well as its relation to metabolic indices is not known. The present study then aimed to investigate the effects of 10 weeks of aerobic training on serum levels of SP-D and insulin resistance in women with type 2 diabetes. Materials and methods: Twenty-two overweight women with type 2 diabetes mellitus were recruited through deliberate sampling and randomly assigned to intervention and control groups (11 in each group). The intervention group underwent a progressive aerobic training program for 10 weeks, 3 days per week, 30-55 min/day at 50-75% heart rate reserve (HRR). Control group continued with its everyday routine. Blood samples were obtained before and after training for biochemical analysis. Within-group and between-group differences were analyzed with paired and independent t-tests in spss software, respectively, and the relation between variables was analyzed with Pearson’s correlation coefficient (all at P = 0.05). Results: Significant differences were observed between groups in leptin, glucose, waist circumference and VO2 max after training. SP-D was decreased and VO2 max was increased significantly in intervention group. However, no significant correlation was observed between SP-D and other variables. Conclusion: Since there was no corresponding decrease in insulin resistance with decreased levels of SP-D, it seems unlikely for SP-D to mediate the association between obesity and insulin resistance in type 2 diabetics.

Keywords: exercise training, SP-D, insulin resistance, type 2 diabetes

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Authors: Abdullah Almusharraf, Andrew Whyte

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The sub-task pattern in terms of the deviations and defects should be identified and understand in order to improve the quality practices in construction projects. Therefore, the sub-task susceptibility to exposure to deviations and defects have been evaluated and classified via six classifications that have proposed in this study. 34 case studies on specific sub-task (from compression member in construction concrete structure) have been collected from seven construction projects in order to examined study’s classifications. The study revealed that the sub-task has high sensitive to deviation where (91%) of the cases recorded as deviations, however, only (19%) of cases recorded as defects. Another findings were that the actual work during the execution process has high source of deviation for this sub-task (74%) while only (26%) of the deviation source was due to both design documentations with the actual work. These findings significantly imply that it could be used the study’s classifications to determine the pattern of each sub-task and develop the proactive actions to overcome issues of the sub-task deviations and defects.

Keywords: sub-tasks, deviations, defects, quality, construction projects

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Authors: S. Benchelha, H. Chennaoui, M. Hakdaoui, L. Baidder, H. Mansouri, H. Ejjaaouani, T. Benchelha

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Northern Morocco is characterized by relatively young mountains experiencing a very important dynamic compared to other areas of Morocco. The dynamics associated with the formation of the Rif chain (Alpine tectonics), is accompanied by instabilities essentially related to tectonic movements. The realization of important infrastructures (Roads, Highways,...) represents a triggering factor and favoring landslides. This paper is part of the establishment of landslides susceptibility map and concerns the mapping of unstable areas in the province of Taounate. The landslide was identified using the components of the false color (FCC) of images Landsat OLI: i) the first independent component (IC1), ii) The main component (PC), iii) Normalized difference index (NDI). This mapping for landslides class is validated by in-situ surveys.

Keywords: landslides, False Color Composite (FCC), Independent Component Analysis (ICA), Principal Component Analysis (PCA), Normalized Difference Index (NDI), Normalized Difference Mid Red Index (NDMIDR)

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Authors: Phillip Minnaar, Neil Jolly, Louisa Beukes, Santiago Benito-Saez

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Dovyalis caffra is a tree found on the African continent. Limited information exists on the effect of acetous fermentation on the phytochemicals of Kei-apple fruit. The phytochemical content of vinegars is derived from compounds present in the fruit the vinegar is made of. Kei-apple fruit juice was co-inoculated with Schizosaccharomyces pombe and Saccharomyces cerevisiae to induce alcoholic fermentation (AF). Acetous fermentation followed AF, using an acetic acid bacteria consortium as an inoculant. Juice had the lowest pH and highest total acidity (TA). The wine had the highest pH and vinegars lowest TA. Total soluble solids and L-malic acid decreased during AF and acetous fermentation. Volatile acidity concentration was not different among vinegars. Gallic, syringic, caffeic, p-coumaric, and chlorogenic acids increased during acetous fermentation, whereas ferulic, sinapic, and protocatechuic acids decreased. Chlorogenic acid was the most abundant phenolic acid in both wines and vinegars. It is evident from this investigation that Kei-apple vinegar is a source of plant-derived phenolics, which evolved through fermentation. However, the AAB selection showed minimal performance with respect to VA production. Acetic acid bacteria selection for acetous fermentation should be reconsidered, and the reasons for the decrease of certain phenolic acids during acetous fermentation needs to be investigated.

Keywords: acetic acid bacteria, acetous fermentation, liquid chromatography, phenolic acids

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Authors: Ben Abderrahmane Ayoub El Fateh, Bnina Rachid

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A comprehensive comparison of antioxidant defenses in the dermis and epidermis and their response to exposure to ultraviolet (UV) irradiation has not previously been attempted. In this study, enzymic and non-enzymic antioxidants in epidermis and dermis of hairless mice were compared. Enzyme activities are presented both as units/gram of skin and units/milligram of protein; arguments are presented for the superiority of skin wet weight as a reference base. Catalase, glutathione peroxidase, and glutathione reductase (units/gram of skin) were higher in the epidermis than dermis by 49%, 86%, and 74%, respectively. Superoxide dismutase did not follow this pattern. Lipophilic antioxidants ( -tocopherol, ubiquinol 9, and ubiquinone 9) and hydrophilic antioxidants (ascorbic acid, dehydroascorbic acid, and glutathione) were 24–95% higher in the epidermis than in dermis. In contrast, oxidized glutathione was 60% lower in the epidermis than in dermis. Mice were irradiated with solar light to examine the response of these cutaneous layers to UV irradiation. After irradiation with 25 J/cm2 (UVA + UVB, from a solar simulator), 10 times the minimum erythemal dose, epidermal and dermal catalase and superoxide dismutase activities were greatly decreased. Tocopherol, ubiquinol 9, ubiquinone 9, ascorbic acid, dehydroascorbic acid, and reduced glutathione decreased in both epidermis and dermis by 26-93%. Oxidizedgiutathione showed a slight, non-significant increase. Because the reduction in total ascorbate and catalase was much more severe in the epidermis than dermis, it can be concluded that UV light is more damaging to the antioxidant defenses in the epidermis than in the dermis.

Keywords: antioxidant defenses, enzymic, epidermis, oxidizedgiutathione

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Authors: Hao-Hsi Tseng, Hsin-Yun Lee

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The Most Advantageous Tender (MAT) has been criticized for its susceptibility to dictatorial situations and for its processing of same score, same rank issues. This study applies the four criteria from Arrow's Impossibility Theorem to construct a mechanism for revealing illegitimate scores in scoring methods. While commonly be used to improve on problems resulting from extreme scores, ranking methods hide significant defects, adversely affecting selection fairness. To address these shortcomings, this study relies mainly on the overall evaluated score method, using standardized scores plus normal cumulative distribution function conversion to calculate the evaluation of vender preference. This allows for free score evaluations, which reduces the influence of dictatorial behavior and avoiding same score, same rank issues. Large-scale simulations confirm that this method outperforms currently used methods using the Impossibility Theorem.

Keywords: Arrow’s impossibility theorem, cumulative normal distribution function, most advantageous tender, scoring method

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Authors: Nilofar Mohammadi Ahvazi, Somayeh Ansari, Mohammad Hossein Haghighizadeh, Zahra Abbaspoor

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Introduction: Dysmenorrhea is one of the common causes of decreased efficiency at work, education and decreased quality of life of women. The aim of this study was to compare virtual and face-to-face training programs in reducing pain and improving the quality of life of female students with primary dysmenorrhea in Ahvaz. Methods: In this quasi-experimental study, 112 female students living in the dormitories of Ahvaz University of Medical Sciences with moderate to severe primary dysmenorrhea were divided into two face-to-face and virtual groups using blocks of size 4. The educational intervention was carried out in two groups at a specific hour before the start of the first menstrual cycle. Data were collected with the help of a quality-of-life questionnaire (Sf-36), visual analog scale (VAS), and McGill questionnaire and were analyzed using descriptive and analytical tests with the help of SPSS version 25 software. Findings: The average age of the research subjects was 25.93±2.00, and the average duration of dysmenorrhea in each period was 2.49 days. There was no statistically significant difference in the quality of life of the students before the intervention, but after the educational intervention, a statistically significant difference was found between the two groups in terms of the quality of life and its dimensions (p<0.001). They were the same before the intervention, But after the intervention, the difference became significant (p<0.001). Conclusion: The virtual training method, like face-to-face training, can improve the quality of life and reduce the severity of primary dysmenorrhea pain in students. Therefore, depending on the conditions, both educational methods can be used.

Keywords: primary dysmenorrhea, face-to-face training, virtual, training

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Authors: Amidu Owolabi Ayeni

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Studies have shown that spatio-temporal distribution and variability of climatic variables, urban land use, and population have had substantial impact on water supply. It is based on these facts that the impacts of climate, urbanization, and population on water supply in Lagos State Nigeria remain the focus of this study. Population and water production data on Lagos State between 1963 and 2006 were collected, and used for time series and projection analyses. Multi-temporal land-sat images of 1975, 1995 and NigeriaSat-1 imagery of 2007 were used for land use change analysis. The population of Lagos State increased by about 557.1% between 1963 and 2006, correspondingly, safe water supply increased by 554%. Currently, 60% of domestic water use in urban areas of Lagos State is from groundwater while 75% of rural water is from unsafe surface water. Between 1975 and 2007, urban land use increased by about 235.9%. The 46years climatic records revealed that temperature and evaporation decreased slightly while rainfall and Relatively Humidity (RH) decreased consistently. Based on these trends, the Lagos State population and required water are expected to increase to about 19.8millions and 2418.9ML/D respectively by the year 2026. Rainfall is likely to decrease by -6.68mm while temperature will increase by 0.950C by 2026. Urban land use is expected to increase by 20% with expectation of serious congestion in the suburb areas. With these results, over 50% of the urban inhabitants will be highly water poor in future if the trends continue unabated.

Keywords: challenges, climate change, urbanization, water supply

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Authors: Kaavya Rathnakumar

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Minimally processed fruits have the attributes of convenience and fresh like quality. In minimally processed products, the cells of the tissue are alive, and the essential nutrients and flavours are retained. Some of the procedures include washing, trimming, sorting, cutting, slicing and shredding. Fruits such as pineapple and guava were taken for the study of textural properties for a period of five days. After the performance of various unit operations 50g cubes of pineapple and guava has been weighed. For determining the textural properties, samples were taken in which set of 12 samples were treated by using 1% citric acid solution and dried for 5 minutes the remaining set of 12 samples were untreated. In set of treated samples 6 were vacuum packed and stored in the refrigerator, and the other sample was normally stored. For untreated samples was done in a similar way. In texture profile analysis the force required for 1cm penetration of 2mm cylindrical needle inside the fruits were recorded for all packages. It was observed that guava the fresh sample had a force of penetration of 3250mm and as the days increased the force decreased to 357.4 mm for vacuum packed refrigerated storage. In the case of pineapple, the force of penetration of the fresh sample was 2325mm which was decreased to 26.3mm on the fourth day and very low at the fifth day for vacuum packed refrigerated storage. But in case of untreated samples, the fruits were spoiled may be because of no pre-treatment and packaging. Comparatively, it was found that vacuum packed refrigerated samples had higher shelf life than normal packed samples in ambient conditions.

Keywords: 1% citric acid solution, normal packed, refrigerated storage, vacuum packed

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Authors: Anguo Chen, Huajie Chen, Caimei Yang, Qihua Hong, Jun Feng

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The experiment was conducted with 360 one-day-old Avian commercial broilers to study the effects of dietary cinnamon extract (CE), garlic extract (GE) and yucca extract (YE) on growth performance and serum biochemical parameters in broilers. The chickens were randomly divided equally into 4 treatment groups, each group with 3 replications, and received the same basal corn-bean diets included a starter from 1 d to 21 d and then a grower until 42 d, added with recommended dose 250 mg/kg CE, 25 mg/kg GE and 10 mg/kg YE to relevant group, respectively. The birds were kept in a stainless steel net coop each replication with 24 h light and were fed and drunk ad libitum. At 21 d and 42 d of age, 6 chicks were respectively picked out from every group and were bled to collect serum samples and intestinal samples for laboratory analysis. The results showed that the average daily gain (ADG) of CE, GE and YE group were increased by 7.20% (P<0.05), 3.43% (P>0.05) and 4.89% (P>0.05), feed gain ratio (F/G) was improved by 9.71% (P<0.05), 3.40% (P>0.05) and 3.40% (P>0.05) compared with the control, respectively. At 21 d of age, the content of serum urea nitrogen (SUN) and serum uric acid (SUA) and the activity of serum xanthine oxidase (SXO) in CE group were reduced by 35.17% (P<0.01), 13.73% (P<0.01) and 16.33% (P<0.05) compared with the control, respectively. At 42 d of age, SUN and SUA level and SXO activity were lowered by 24.35% (P<0.01), 15.49% (P<0.05) and 23.09% (P<0.01), respectively. The SXO activity in CE group was decreased by 14.86% (P<0.01) and 15.34%(P<0.01) compare with GE and YE group, respectively. Also, adding CE, GE and YE into broiler diets resulted in lower UN and UA level of intestinal contents. It is clear that CE was more significantly decreased the SXO activity and SUA levels than GE and YE, especially at the latter period, thereby it may play a more important role in improving the growth performance of broilers.

Keywords: cinnamon extract, broiler, growth performance, serum uric acid, serum xanthine oxidase

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Authors: Amina M. Ibrahim, Ahmed A. Abdel-Haleem, Rania G. Taha

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Metal pollution results in many dangerous consequences to the environment and human health due to the bioaccumulation in their tissues. The present study aims to measure the bioaccumulation factor of the Manganese (Mn) heavy metal in Biomphlaria alexandrina snails' tissues and water samples. The present results showed the concentration of Mn heavy metal in water (87.5 mg/l) and its bioaccumulation factor in Helisoma duryi tissue was higher than that in tissues of Physa acuta and B. alexandrina snails. Results showed that 87.5 mg/l Mn concentration had miracidial and cercaricidal activities. Also, this concentration decreased the mean total number of the hemocytes after exposure for 24h or 48h, while increased both the mean mortality and phagocytic indices of the hemocytes of exposed snails. It caused alterations in the cytomorphology of the hemocytes of exposed snails after 24 or 48h, where, the granulocytes had irregular cell membrane, and forming pseudopodia. Besides, both levels of Testosterone (T) and Estradiol (E) were increased after exposure to 87.5mg/l Mn metal compared to the control group. Also, it increased MDA (Malonaldehyde) and TAC (Total antioxidant capacity) contents, while, decreased SOD (superoxide dismutase). Besides, it caused great histopathological damages in both hermaphrodite and digestive glands, represented in the degeneration of the gonadal, digestive, secretory cells and the connective tissues. Therefore, B. alexandrina might be used as sensitive bio-indicator of pollution with Mn heavy metal to avoid ethics rules; beside they are easily available and large in number.

Keywords: manganese metal, B. alexandrina, hormonal alterations, histopathology

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Authors: Riddhi Shukla, Rajeshri Patel, Prakruti Buch, Tejas Sharma, Mihir Raval, Navin Sheth

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Many classical drugs are claimed to have blood sugar lowering properties that make them valuable for people with or at high risk of type 2 diabetes. Vijaysar (Pterocarpus marsupium) and Gaumutra (Indian cow urine) both have been shown antidiabetic property since primordial time and both shows synergistic effect in combination for hypoglycaemic activity. The study was undertaken to investigate the hypoglycaemic and anti-diabetic effects of the combination of Vijaysar and Gaumutra which is a classical preparation mentioned in Ayurveda named as Pramehari ark. Rats with Type 2 diabetes which is induced by streptozotocin (STZ, 35mg/kg) given a high-fat diet for one month and compared with normal rats. Diabetic rats showed raised level of body weight, triglyceride (TG), total cholesterol, HDL, LDL, and D-glucose concentration and other serum, cardiac and hypertrophic parameters in comparison of normal rats. After treatment of different doses of drug the level of parameters like TG, total cholesterol, HDL, LDL, and D-glucose concentration found to be decreased in standard as well as in treatment groups. In addition treatment groups also found to be decreased in the level of serum markers, cardiac markers, and hypertrophic parameters. The findings demonstrated that Pramehari ark prevented the pathological progression of type 2 diabetes in rats.

Keywords: cow urine, hypoglycemic effect, synergic effect, type 2 diabetes, vijaysar

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Authors: K. Rasool

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Sulfate-reducing bacteria (SRBs) induced biofilm formation is a global industrial concern due to its role in the development of microbial-induced corrosion (MIC). Herein, we have developed a biodegradable chitosan/lignosulfonate nanocomposite (CS@LS) as an efficient green biocide for the inhibition of SRBs biofilms. We investigated in detail the inhibition mechanism of SRBs by CS@LS in seawater media. Stable CS@LS-1:1 with 150–200 nm average size and zeta potential of + 34.25 mV was synthesized. The biocidal performance of CS@LS was evaluated by sulfate reduction profiles coupled with analysis of extracted extracellular polymeric substances (EPS) and lactate dehydrogenase (LDH) release assays. As the nanocomposite concentration was increased from 50 to 500 µg/mL, the specific sulfate reduction rate (SSRR) decreased from 0.278 to 0.036 g-sulfate/g-VSS*day showing a relative sulfate reduction inhibition of 86.64% as compared to that of control. Similarly, the specific organic uptake rate (SOUR) decreased from 0.082 to 0.039 0.036 g-TOC/g-VSS*day giving a relative co-substrate oxidation inhibition of 52.19% as compared to that of control. The SRBs spiked with 500 µg/mL CS@LS showed a reduction in cell viability to 1.5 × 106 MPN/mL. To assess the biosafety of the nanocomposite on the marine biota, the 72-hours acute toxicity assays using the zebrafish embryo model revealed that the LC50 for the CS@LS was 103.3 µg/mL. Thus, CS@LS can be classified as environmentally friendly. The nanocomposite showed long-term stability and excellent antibacterial properties against SRBs growth and is thus potentially useful for combating the problems of biofilm growth in harsh marine and aquatic environments.

Keywords: green biocides, chitosan/lignosulfonate nanocomposite, SRBs, toxicity

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Authors: Mohand Yaghi, O. Kehinde

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Background: For the diagnosis of prostate cancer Trans-rectal prostate biopsy (TRPB) is used commonly, the procedure is associated with infective complications. There is evidence that antibiotics (ABx) decrease infective events after TRPB, but different regimens are used. Aim: To systematically review different regimens of prophylactic oral antibiotics in TRPB. Design: Medline, Embase, Clinical trials site, and Cochrane library were searched, experts were consulted about relevant studies. Randomized clinical trials (RCT) conducted in the last twenty years, which investigated different oral antibiotic regimens in TRPB, and compared their efficacy to reduce infectious complications were analyzed. Measurements: Primary outcomes were bacteriuria, urinary tract infection (UTI), fever, bacteremia, sepsis. Secondary outcomes were hospitalization rate, and the prevalence of ABx-resistant bacteria. Results: Nine trials were eligible with 3012 patients. Antibiotics prevented bacteriuria (3.5% vs. 9.88%), UTI (4.46% vs. 9.75%), and hospitalization (0.21% vs. 2.13%) significantly in comparison with placebo or no treatment. No significant difference was found in all outcomes of the review between the single dose regimen and the 3 days. The single dose regimen was as effective as the multiple dose except in Bacteriuria (6.75% vs. 3.25%), and the prevalence of ABx-resistant bacteria (1.57% vs. 0.27%). Quinolones reduced only UTI significantly in comparison with other antibiotics. Lastly, Ciprofloxacin is the best Quinolone to prevent UTI, and hospitalization. Conclusion: it is essential to prescribe prophylactic Antibiotics in TRPB. No conclusive evidence could be claimed about the superiority of the multiple or the 3 days regimens to the single dose regimen. Unexpectedly, ABx-resistant bacteria was identified more often in the single dose cohorts.

Keywords: infection, prostate cancer, sepsis, TRPB

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Authors: S. J. Shahidzadeh Tabatabaei, A. M. Fattahi

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Modal analysis of an FGM plate composed of Al2O3 ceramic phase and 304 stainless steel metal phases was performed in this paper by ABAQUS software with the assumption that the behavior of material is elastic and mechanical properties (Young's modulus and density) are variable in the thickness direction of the plate. Therefore, a sub-program was written in FORTRAN programming language and was linked with ABAQUS software. For modal analysis, a finite element analysis was carried out similar to the model of other researchers and the accuracy of results was evaluated after comparing the results. Comparison of natural frequencies and mode shapes reflected the compatibility of results and optimal performance of the program written in FORTRAN as well as high accuracy of finite element model used in this research. After validation of the results, it was evaluated the effect of material (n parameter) on the natural frequency. In this regard, finite element analysis was carried out for different values of n and in simply supported mode. About the effect of n parameter that indicates the effect of material on the natural frequency, it was observed that the natural frequency decreased as n increased; because by increasing n, the share of ceramic phase on FGM plate has decreased and the share of steel phase has increased and this led to reducing stiffness of FGM plate and thereby reduce in the natural frequency. That is because the Young's modulus of Al2O3 ceramic is equal to 380 GPa and Young's modulus of SUS304 steel is 207 GPa.

Keywords: FGM plates, modal analysis, natural frequency, finite element method

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Authors: Muhammad Karim Ahmadzai

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Floods are natural phenomena and are an integral part of the water cycle. The majority of them are the result of climatic conditions, but are also affected by the geology and geomorphology of the area, topography and hydrology, the water permeability of the soil and the vegetation cover, as well as by all kinds of human activities and structures. However, from the moment that human lives are at risk and significant economic impact is recorded, this natural phenomenon becomes a natural disaster. Flood management is now a key issue at regional and local levels around the world, affecting human lives and activities. The majority of floods are unlikely to be fully predicted, but it is feasible to reduce their risks through appropriate management plans and constructions. The aim of this Case Study is to identify, and map areas of flood risk in the Khinch District of Panjshir Province, Afghanistan specifically in the area of Peshghore, causing numerous damages. The main purpose of this study is to evaluate the contribution of remote sensing technology and Geographic Information Systems (GIS) in assessing the susceptibility of this region to flood events. Panjsher is facing Seasonal floods and human interventions on streams caused floods. The beds of which have been trampled to build houses and hotels or have been converted into roads, are causing flooding after every heavy rainfall. The streams crossing settlements and areas with high touristic development have been intensively modified by humans, as the pressure for real estate development land is growing. In particular, several areas in Khinch are facing a high risk of extensive flood occurrence. This study concentrates on the construction of a flood susceptibility map, of the study area, by combining vulnerability elements, using the Analytical Hierarchy Process/ AHP. The Analytic Hierarchy Process, normally called AHP, is a powerful yet simple method for making decisions. It is commonly used for project prioritization and selection. AHP lets you capture your strategic goals as a set of weighted criteria that you then use to score projects. This method is used to provide weights for each criterion which Contributes to the Flood Event. After processing of a digital elevation model (DEM), important secondary data were extracted, such as the slope map, the flow direction and the flow accumulation. Together with additional thematic information (Landuse and Landcover, topographic wetness index, precipitation, Normalized Difference Vegetation Index, Elevation, River Density, Distance from River, Distance to Road, Slope), these led to the final Flood Risk Map. Finally, according to this map, the Priority Protection Areas and Villages and the structural and nonstructural measures were demonstrated to Minimize the Impacts of Floods on residential and Agricultural areas.

Keywords: flood hazard, flood risk map, flood mitigation measures, AHP analysis

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Authors: Raja Arunprasath, P. Gajalakshmi

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Antimycobacterial activity of C. roseus rosea and piperine was evaluated against ofloxacin resistant M. tuberculosis. Among the 68 suspected sputum samples, 32 were AFB positive belongs to age group of 40-50years. Susceptibility of M. tuberculosis was evaluated against ofloxacin and streptomycin by colorimetric assay. Of these 32 positive samples, 20 isolates were resistant to ofloxacin, 12 were resistant to Streptomycin and none of them were found to be multidrug resistant. The sensitivity pattern of ofloxacin resistant M. tuberculosis against two tested plant extracts showed potent tubercular activity. Antimycobacterial activity of C. roseus was 22 + 2.21mm and piperine was found to be 20 + 1.08 mm. The percentage of relative inhibitory zone of C. roseus was 133 % and piperine was found to be 111 %. The MIC of C. roseus and piperine was found at 50 µg/ml. Based on the FICI value 0.37 confirms that both the tested phytochemicals were synergistically active against M. tuberculosis. The MIC of ofloxacin was reduced from 8 mg to 2 mg/l in the presence of piperine but not by C. roseus. This is the first report on Synergistic bioactivity of C. roseus rosea and piperine fractionation leads development of novel antimycobacterial prophylaxis in future.

Keywords: C. roseus, ofloxacin, piperine, synergistic

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Authors: F. Arslan, S.D. Guven, A. Özcan, H. Vatansev, Ö. Taşgin

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Weight, hypertension and dyslipidemia control and increased physical activity are required for the treatment of metabolic syndrome (METS). The purpose of this study was to investigate the effect of core exercise, reflexology and intake chrome picolinate on METS. This study comprised a twelve-week randomized controlled trial. A total of 25 university workers with metabolic risk factors participated in this study voluntarily. They were randomly divided into three groups: Those undertaking a core exercise program (n=7), reflexology intervention group (n=8) and intake chrome group (n=10). The subjects took part in a core exercise program for one hour per day, three days a week and a reflexology interfered for thirty minutes per day, one days a week and chrome group took chrome picolinate every day in week for twelve weeks. The components of metabolic syndrome were analyzed before and after the completion of all the intervention. There were significant differences at pre-prandial blood glucose in the core exercise group and at systolic blood pressure in chrome group after the twelve week interventions (p < 0.005). While High Density Lipoprotein (HDL) excluding the components of METS decreased after the interventions on the all groups; levels of HDL and the other components of METS decreased in reflexology group. There was a clear response to the twelve-week interventions in terms of METS control. Besides, the reflexology intervention should not be applied to individuals with low HDL levels and core exercise and intake chrome picolinate suggested to improve the components of METS.

Keywords: blood pressure, body mass index, exercise, METS, pre-prandial blood glucose

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Authors: Konstantinos Sotiriadis, Michael Tupý, Nikol Žižková, Vít Petránek

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The acid attack on cement mortars modified with rubber aggregates and EVA polymer binder was studied. Mortar specimens were prepared using a type CEM I 42.5 Portland cement and siliceous sand, as well as by substituting 25% of sand with shredded used automobile tires, and by adding EVA polymer in two percentages (5% and 10% of cement mass). Some specimens were only air cured, at laboratory conditions, and their compressive strength and water absorption were determined. The rest specimens were stored in acid solutions (HCl, H2SO4, HNO3) after 28 days of initial curing, and stored at laboratory temperature. Compressive strength tests, mass measurements and visual inspection took place for 28 days. Compressive strength and water absorption of the air-cured specimens were significantly decreased when rubber aggregates are used. The addition of EVA polymer further reduced water absorption, while had no important impact on strength. Compressive strength values were affected in a greater extent by hydrochloric acid solution, followed by sulfate and nitric acid solutions. The addition of EVA polymer decreased compressive strength loss for the specimens with rubber aggregates stored in hydrochloric and nitric acid solutions. The specimens without polymer binder showed similar mass loss, which was higher in sulfate acid solution followed by hydrochloric and nitric acid solutions. The use of EVA polymer delayed mass loss, while its content did not affect it significantly.

Keywords: acid attack, mortar, EVA polymer, rubber aggregates

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Authors: Lakmali Anthony, Madeline Gillies

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Purpose: Long-term survivorship in colorectal cancer (CRC) is increasing as mortality decreases, leading to increased focus on patient-reported outcomes such as quality of life (QoL). CRC patients often have decreased QoL even after treatment is complete. This systematic review of the literature aims to identify psychosocial factors associated with decreased QoL in post-treatment CRC patients. Methodology: This systematic review was performed in accordance with the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations. The search was conducted in MEDLINE, EMBASE, and PsychINFO using MeSH headings. The two authors screened studies for relevance and extracted data. Results: Seventeen studies were identified, including 6,272 total participants (mean = 392, 58% male) with a mean age of 60.6 years. The European Organisation for Research and Treatment of Cancer QLQ-C30 was the most common measure of QoL (n=14, 82.3%). Most studies (n=15, 88.2%) found that emotional distress correlated with poor global QoL. This was most commonly measured with the Hospital Anxiety & Depression Scale (n=11, 64.7%). Other psychosocial factors associated with QoL were lack of social support, body image, and financial difficulties. Clinicopathologic determinants included presence of stoma and metastasis. Conclusion: This systematic review provides a summary of the psychosocial determinants of poor QoL in post-treatment CRC patients, as well as the most commonly reported measures of these. An understanding of these potentially modifiable determinants of poor outcome is pivotal to the provision of quality, patient-centred care in surgical oncology.

Keywords: colorectal cancer, cancer surgery, quality of life, oncology, social determinants

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Authors: Orsolya Horvath, Laszlo Deres, Krisztian Eros, Katalin Ordog, Tamas Habon, Balazs Sumegi, Kalman Toth, Robert Halmosi

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Introduction: Oxidative stress induces an imbalance in mitochondrial fusion and fission processes, finally leading to cell death. The two antioxidant molecules, BGP-15 and L2286 have beneficial effects on mitochondrial functions and on cellular oxidative stress response. In this work, we studied the effects of these compounds on the processes of mitochondrial quality control. Methods: We used H9c2 cardiomyoblast and isolated neonatal rat cardiomyocytes (NRCM) for the experiments. The concentration of stressors and antioxidants was beforehand determined with MTT test. We applied 1-Methyl-3-nitro-1-nitrosoguanidine (MNNG) in 125 µM, 400 µM and 800 µM concentrations for 4 and 8 hours on H9c2 cells. H₂O₂ was applied in 150 µM and 300 µM concentration for 0.5 and 4 hours on both models. L2286 was administered in 10 µM, while BGP-15 in 50 µM doses. Cellular levels of the key proteins playing role in mitochondrial dynamics were measured in Western blot samples. For the analysis of mitochondrial network dynamics, we applied electron microscopy and immunocytochemistry. Results: Due to MNNG treatment the level of fusion proteins (OPA1, MFN2) decreased, while the level of fission protein DRP1 elevated markedly. The levels of fusion proteins OPA1 and MNF2 increased in the L2286 and BGP-15 treated groups. During the 8 hour treatment period, the level of DRP1 also increased in the treated cells (p < 0.05). In the H₂O₂ stressed cells, administration of L2286 increased the level of OPA1 in both H9c2 and NRCM models. MFN2 levels in isolated neonatal rat cardiomyocytes raised considerably due to BGP-15 treatment (p < 0.05). L2286 administration decreased the DRP1 level in H9c2 cells (p < 0.05). We observed that the H₂O₂-induced mitochondrial fragmentation could be decreased by L2286 treatment. Conclusion: Our results indicated that the PARP-inhibitor L2286 has beneficial effect on mitochondrial dynamics during oxidative stress scenario, and also in the case of directly induced DNA damage. We could make the similar conclusions in case of BGP-15 administration, which, via reducing ROS accumulation, propagates fusion processes, this way aids preserving cellular viability. Funding: GINOP-2.3.2-15-2016-00049; GINOP-2.3.2-15-2016-00048; GINOP-2.3.3-15-2016-00025; EFOP-3.6.1-16-2016-00004; ÚNKP-17-4-I-PTE-209

Keywords: H9c2, mitochondrial dynamics, neonatal rat cardiomyocytes, oxidative stress

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Authors: Sandy Elsayed, Aya Mohamed, Noha Nassar

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Introduction: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by social deficits and repetitive behavior. Multiple studies suggest that oxidative stress and neuroinflammation are key factors in the etiology of ASD and often associated with worsening of ASD-related behaviors. Nuclear factor erythroid 2-related factor 2 (NRF-2) is a transcription factor that promotes expression of antioxidant response element genes in oxidative stress. In ASD subjects, decreased expression of NRF-2 in frontal cortex shifted the redox homeostasis towards oxidative stress, and resulted in inflammation evidenced by elevation of nuclear factor kappa B (NF-κB) transcriptional activity. Dimethyl fumarate (DMF) is a NRF-2 activator that is used in the treatment of psoriasis and multiple sclerosis. It participates in the transcriptional control of inflammatory factors via inhibition of NF-κB and its downstream targets. This study aimed to investigate the role of DMF in alleviating the cognitive impairments and behavior deficits associated with ASD through mitigation of oxidative stress and inflammation in prenatal valproic acid (VPA) rat model of autism. Methods: Pregnant female Wistar rats received a single intraperitoneal injection of VPA (600 mg/kg) to induce autistic-like-behavioral and neurobiological alterations in their offspring. Chronic oral gavage of DMF (150mg/kg/day) started from postnatal day (PND) 24 till PND62 (39 days). Prenatal VPA exposure elicited autistic behaviors including decreased social interaction and stereotyped behavior. Social interaction was evaluated using three-chamber sociability test and calculation of sociability index (SI), while stereotyped repetitive behavior and anxiety associated with ASD were assessed using marble burying test (MBT). Biochemical analyses were done on prefrontal cortex homogenates including NRF-2, and NF-κB expression. Moreover, inducible nitric oxide synthase (iNOS) gene expression and tumor necrosis factor (TNF-) protein expression were evaluated as markers of inflammation. Results: Prenatal VPA elicited decreased social interaction shown by decreased SI compared to control group (p < 0.001) and DMF enhanced SI (p < 0.05). In MBT, prenatal injection of VPA manifested stereotyped behavior and enhanced number of buried marbles compared to control (p < 0.05) and DMF reduced the anxiety-related behavior in rats exhibiting ASD-like behaviors (p < 0.05). In prefrontal cortex, NRF-2 expression was downregulated in prenatal VPA model (p < 0.0001) and DMF reversed this effect (p < 0.0001). The inflammatory transcription factor NF-κB was elevated in prenatal VPA model (p < 0.0001) and reduced (p < 0.0001) upon NRF-2 activation by DMF. Prenatal VPA expressed higher levels of proinflammatory cytokine TNF- compared to control group (p < 0.0001) and DMF reduced it (p < 0.0001). Finally, the gene expression of iNOS was downregulated upon NRF-2 activation by DMF (p < 0.01). Conclusion: This study proposes that DMF is a potential agent that can be used to ameliorate autistic-like-changes through NRF-2 activation along with NF-κB downregulation and therefore, it is a promising novel therapy for ASD.

Keywords: autism spectrum disorders, dimethyl fumarate, neuroinflammation, NRF-2

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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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