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Statistical Methods In Medical Research
Abstract
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... The data have been subjected to statistical analysis using ordinary statistical tests. Since some expected frequencies were <5, the data were arranged in four-fold contingency tables and observed frequencies were compared with expected ones using Fisher-lrwing's exact test (Armitage 1983) . In one instance parametrical data were collected (duration of stay in a winter home range). ...
... In one instance parametrical data were collected (duration of stay in a winter home range). The values were not normally distributed and, therefore, analysed using Wilcoxon's rank sum test (Armitage 1983). 1989 -1993 The relative number of sub-adult and adult males (45%) was higher than during previously described invasions in Sweden (11 %; Anonymous 1889, 15%; Roth 1897,5%; Nagell & Fryldund 1965). ...
... Honor 1110bbades oftare vid snoiga forhallanden jiimfort med sl10jria (p<O.05) . Statistisk analys gjordes med hjiilp av Fisher-Irwing test(Armitage 1983). ...
Wintering Snowy Owls Nyctea scandiaca were studied in southern Sweden during four consecutive winters (November—March, 1989—1993). 85% of the known individuals (9–11 males, 11–12 females) in the provinces of Öland and Skåne were considered properly aged and sexed. They were observed for 92 h during daytime roosting and for an additional 29 h during hunting activity. Males were more often mobbed (p<0.001) during snowfree conditions, more often roosted in forests (p<0.01), left fewer pellets (p>0.05), preferred higher perch sites, and stayed shorter periods in the same area (p<0.01), as compared to females. First to second winter females were mobbed more often during snowcover compared to bare ground conditions (p<0.05), and were mainly selecting medium-sized prey (Oryctolagus, Anas, Perdix.) Two older owls (adult female/sub-adult male) were selecting smaller prey (Microtus, Apodermus, Passerinidae) compared to first second winter females (p<0.001). In conclusion, due to their smaller size and contrasting colouration, males were considered less well adapted to the mainly snowfree conditions in the area, because of a less favourable energy budget due to mobbing, presumed lower hunting success and smaller/less abundant prey. Females, due to their larger size and contrast reducing colouration, were considered better adapted to the same area, due to lower mobbing frequency, presumed higher hunting success and selection of larger prey.
... Data are expressed as Mean ±SE. Data were assessed by t-test (Armitage 1974;and Lenter et al., 1982). P-values < 0.05 were considered statistically significant. ...
... Table (6) shows that rats treated with sodium nitrite and/or glutathione revealed insignificant change in total cholesterol in brain, liver, kidney, muscle and heart tissues after three and six months in comparison with the control group while rats treated with sodium nitrite for six months showed a significant decrease (P< 0.01) in total cholesterol in heart tissue. ...
... Data were subjected to statistical analysis including the calculation of mean (M) ± standard error (SE), one-way ANOVA, and two-way ANOVA at a confidence limit of 95% (p<0.05). Statistical analyses were conducted according to the method described in 1971 [17] using the practicing statistical analysis program SPSS for Windows, version 16 (2007) Chicago: SPSS Inc [18]. Duncan's multiple range tests were used for testing pairs of means for comparison at a probability of 5% [19,20]. ...
... [24][25][26] All the results were analyzed by analysis of variance. [29] ...
The antitumour activity of Quercetin-3-O-β-Glucoside (5, 7, 3’, 4’-Tetrahydroxy-3-O-β-D-Glucopyranosyl flavone)
isolated from aerial parts of Cansjera rheedii J.Gmelin (Opiliaceae)
has been evaluated against Dalton’s ascitic lymphoma (DAL) in swiss albino mice. A significant enhancement of
mean survival times of Quercetin-3-O-β-Glucoside treated tumour bearing mice was found with respect to control
group. Quercetin-3-O-β-Glucoside treatment was found to enhance peritoneal cell counts. When these Quercetin-3-
O-β-Glucoside treated animals underwent i.p. inoculation with DAL cells, tumour cell growth was found to be
inhibited. After 14 days of inoculation, Quercetin-3-O-β-Glucoside is able to reverse the changes in the
haematological parameters, protein and PCV consequent to tumour inoculation.
... The statistical analysis of the obtained data was done according to Armitage (18) and Lentner et al. (19) . The analysis was revised by Quattro pro for windows program version 2-Microsoft Windows version 7. ...
... Statistical analysis: Data were computerized and statistically analysis using a Chi square test (SPSS Inc., Chicago, Illinois). P-value <0.05 was considered significant (Armitage, 1983). ...
Campylobacter is common in poultry, including layer and broiler chickens, geese, ducks, and turkeys. This review aimed to emphasize the prevalence of campylobacteriosis, recent poultry diagnoses, and strict prevention measures. Campylobacter species colonize the intestines of poultry and waterfowl but are generally nonpathogenic in poultry. However, they are the most common bacterial cause of sporadic human enteritis in both developed and developing countries. The main species responsible for campylobacteriosis is Campylobacter jejuni, followed by Campylobacter coli. A number of other Campylobacter species, such as Campylobacter lari, fetus, upsaliensis, and hyointestinalis are rarely associated with campylobacteriosis. Campylobacter hepaticus is the species linked to spotty liver disease in layers and breeder chickens, and it may be the etiological agent of the disease previously known as avian vibrionic hepatitis. The most prevalent infection source for Campylobacter is environmental contamination from poultry droppings. However, some Campylobacter species can be transmitted vertically, either on the surface of eggs or via trans-ovarian transmission in addition to consumption of contaminated feed or water. Due to the non-specific clinical signs such as diarrhea and weight loss, diagnosing campylobacteriosis in poultry requires culture or polymerase chain reaction tests. Little is known about the available vaccine or effective antibiotic treatment due to the rapid development of antibiotic resistance. Therefore, strict biosecurity measures play a crucial role in preventing Campylobacter infection in commercial poultry. These measures include decontaminating housing between flocks, preventing the entry of rodents, wild birds, and animals, and eradicating insects. To control campylobacteriosis and reduce infection risks, it is important to implement efficient on-farm biosecurity measures, conduct regular inspections of workers at meat processing plants and poultry farms, and ensure thorough preparation of chicken meat and eggs before consumption. These measures are vital in minimizing the Campylobacter transmission from both broiler and laying chickens, thereby reducing the risk of foodborne diseases caused by contaminated food.
... Statistical analysis: Data were computerized and statistically analysis using a Chi square test (SPSS Inc., Chicago, Illinois). P-value <0.05 was considered significant (Armitage, 1983). ...
... Independent t-test , and one -way analysis of variance (ANOVA) with the least significant differences (LSD) were used. The difference was considered signifycant at p-value < 0.05 levels ( Armitage, 1971) . ...
... It uses the "t" distribution corresponding to the number of degrees of freedom for error mean square.The significance of the measured data was considered as follows : not significant (N.S) when P > 0.05 significant (S) when P < 0.05 highly significant(H.S) when P < 0.01 where P is the probability (reflect of null hypothesis). Details of the formulae used are given by (Armitage, 1971). ...
... in which C ? is the variance and N is the number of replicates for each variable. This formula takes into account the variability in each of the terms (E, C, and M) that are used to calculate R (31). Each panel of target cells included, as a control, NIP-derivatized syngeneic targets. ...
Cytolytic and helper T cells exhibit, in addition to their specificity for foreign antigen, a restriction specificity for self MHC gene products. The present study was designed to assess the degree of diversity within the repertoire of receptors that are involved in T cell recognition of self MHC gene products. For this purpose, we generated a series of murine cytolytic T lymphocyte (CTL) clones specific for a hapten antigen and restricted to the self MHC gene product H-2Kb. An analysis of the hapten fine specificity of these clones by using hapten analogues revealed the presence of substantial diversity within the repertoire of CTL receptors specific for the hapten. The degree of diversity within the repertoire of self H-2 recognition structures on these clones was assessed by testing clones on panels of syngeneic, congenic H-2K disparate, and H-2Kb mutant target cells bearing varying amounts of antigen. A striking degree of heterogeneity in H-2K recognition was found among these H-2Kb restricted CTL. We estimate that there are probably a minimum of 65 different patterns of H-2K recognition among these clones. Our results suggest a high degree of diversity exists within the repertoire of self MHC recognition structures on antigen-specific T cells restricted to a single self MHC gene product.
... Comparison of in vitro induction of turnor immune, oneofetal immune, and "autosensitized" CL. As has been analyzed by the Mann-Whitney-U-test for nonparametric data (30) and the one-tailed probability (p) for group sizes over 20 has been determined. The median of each group is marked on each figure, and the mean and S.E.M. are also recorded. ...
The 51Cr release cytotoxicity assay was used to evaluate whether self-reacting clones of T cells develop in vitro when normal spleen cells are cultured with irradiated syngeneic cells. This phenomenon has previously been described as autosensitization and has been thought to be due to reactivity against self-determinants. It was shown, however, in this present study that the autosensitization phenomenon differs qualitatively and quantitatively from specific immune induction by oncofetal antigens and tumor-associated antigens. A variety of tumor cell lines of different H-2 types are lysed by autosensitized cells, and the lysis appears to be nonspecific and not restricted to identity at the major histocompatibility complex (MHC). Induction of autosensitization follows the same kinetic pattern, and lysis is semilogarithmically related to effector cell to target ratio as in other systems. Analysis of the specificity of the phenomenon by competitive inhibition with tumor cells or congenic derived spleen cells did not, however, indicate any reactivity for self-MHC determinants, but rather showed that a wide range of culture tumor cells were all capable of inhibiting lysis. Since it was further shown that the level of autosensitization was markedly dependent on the batch of fetal calf serum, it is provisionally concluded that this phenomenon does not represent specific T cell activation to self-determinants, but rather reactivity against minor antigens in the system, possibly a cell-bound fetal calf serum component.
... This hypothesis is tested in this case at an alpha level of 0.05 (the significance level related to the probability of having a type I error, that is, rejecting a true hypothesis). The F-value obtained from the ANOVA must exceed an Fcrit value, that is based on this 95% confidence interval, in order to prove that the null hypothesis should be rejected, and therefore that there is a statistically significant difference between replicates [155]. ...
p>Commercial hand prostheses provide the user with insufficient dexterity and functionality due to the highly restricted number of prehensile patterns that may be achieved. Demographic studies show that the potential market for upper limb prostheses is largely stable, and with the identification of the functional differences and inadequacies of existing prostheses, users are increasingly dissatisfied with the status quo.
The six degree of freedom Southampton-Remedi hand has been developed to address this need. The mechanical adaptability of the lightweight prosthesis provides a wide range of grip types with a greater degree of stability than produced by any conventional device. This is due to the ability of each digit to independently contribute to the integrity of the grip.
The command and coordination of more than a single device or function is difficult and frequently increases the cognitive burden on the user. The optimal use of multifunction prostheses lies in the synergistic control of several actuators without increasing the number of inputs that a user must independently initiate. This has been achieved by the development of a hybrid SAMS-UNB controller that enables the user to directly implement prehensile patterns from their myo-signal whilst the process of maintaining a secure grasp remains automated.
The effectiveness of the new prosthesis and controller must be quantified in terms of its functionality. However there is little or no conformity to a standardised and objective procedure for the assessment of either pathological or prosthetic hand function. The Southampton Hand assessment Procedure (SHAP) has been designed to account for these shortcomings and therefore allow the evaluation of hand function in the clinical setting. The outcome measure is a contextual rating of functionality (relative to that of ‘normal’ hand function), which enables the clinician to initially determine the subject’s disability, and subsequently monitor their performance throughout a course of treatment or rehabilitation.</p
... The standardized incidences between subgroups (by sex, by urban-rural area, and by region) were compared using the rate ratio statistics. 28 Individual and population-level risk calculations were restricted to participants without prior CVD (defined as self-reported history of MI or stroke) and with complete data on all risk factors. Associations of modifiable risk factors with outcomes were assessed using Cox frailty models with random intercepts accounting for centre-level clustering effects. ...
Aims:
To examine the incidence of cardiovascular disease (CVD) and mortality in China and in key subpopulations, and to estimate the population-level risks attributable to 12 common modifiable risk factors for each outcome.
Methods and results:
In this prospective cohort of 47 262 middle-aged participants from 115 urban and rural communities in 12 provinces of China, it was examined how CVD incidence and mortality rates varied by sex, by urban-rural area, and by region. In participants without prior CVD, population-attributable fractions (PAFs) for CVD and for death related to 12 common modifiable risk factors were assessed: four metabolic risk factors (hypertension, diabetes, abdominal obesity, and lipids), four behavioural risk factors (tobacco, alcohol, diet quality, and physical activity), education, depression, grip strength, and household air pollution. The mean age of the cohort was 51.1 years. 58.2% were female, 49.2% were from urban areas, and 59.6% were from the eastern region of China. The median follow-up duration was 11.9 years. The CVD was the leading cause of death in China (36%). The rates of CVD and death were 8.35 and 5.33 per 1000 person-years, respectively, with higher rates in men compared with women and in rural compared with urban areas. Death rates were higher in the central and western regions of China compared with the eastern region. The modifiable risk factors studied collectively contributed to 59% of the PAF for CVD and 56% of the PAF for death in China. Metabolic risk factors accounted for the largest proportion of CVD (PAF of 41.7%), and hypertension was the most important risk factor (25.0%), followed by low education (10.2%), high non-high-density lipoprotein cholesterol (7.8%), and abdominal obesity (6.9%). The largest risk factors for death were hypertension (10.8%), low education (10.5%), poor diet (8.3%), tobacco use (7.5%), and household air pollution (6.1%).
Conclusion:
Both CVD and mortality are higher in men compared with women, and in rural compared with urban areas. Large reductions in CVD could potentially be achieved by controlling metabolic risk factors and improving education. Lowering mortality rates will require strategies addressing a broader range of risk factors.
... This rule yielded the highest value among any of the rules tested in the Youden index, a statistic combining sensitivity and specificity for selection of an optimal rule, assuming equal importance of sensitivity and specificity. 27 When the first rule was modified to use only three most predictive features ('confusion' replacing 'urea>7mmol/L), immediate application was possible with this second rule referred to as BTS2 rule. This modified rule had the highest overall accuracy (93%) and the highest specificity (94%) of any rule tested, but correctly identified only 39% of the patients who died; a positive rule was associated with a relative risk of death of 10.2. ...
... Data were analysed using unpaired ttest . The results were expressed as mean ± standard deviation ( SD), P < 0.05 was considered as statistically significant (15) . ...
... Data were analyzed using unpaired ttest. The results were expressed as mean ± standard deviation (SD) & P <0.001 was considered as statistically significant (14) . ...
Cigarette smoking cause many effects in human body. These effects can be studied by measurement of various biochemical parameters in the blood. In the present study (3) biochemical parameters (aspartate aminotransferase AST , alanine aminotransferase ALT ,and alkaline phosphatase ALP) had been measured in blood of 139 apparently healthy volunteers ,including 88 smokers (55 males and 33 females) and 51 nonsmokers as a control group ,in order to investigate the effect of cigarette smoking on these liver enzymes , and comparison the mean enzymes activities between male and female smokers .It is found a significant increase of serum AST, ALT and ALP activity noticed in smokers compared with nonsmokers ,and no significant changes was found in mean activity of serum AST , ALT and ALP between male and female smokers.
... Statistical software (version 11.0 SPSS inc., Chicago, USA), the results were expressed as mean. Data were subjected to analysis of variance (ANOVA) according to Armitage and Berry (1987). ...
... For the 3-month study in mice, Fisher's exact test, 123 a procedure that uses the overall proportion of affected animals, was used to identify statistically significant differences between animals administered RES and vehicle control animals, and the Cochran-Armitage trend test was used to test for significant trends. 124 Because up to two pups/sex/litter were present in the perinatal and 3-month study in rats, the Cochran-Armitage test was modified to accommodate litter effects using the Rao-Scott approach. 125 The Rao-Scott approach accounts for litter effects by estimating the ratio of the variance in the presence of litter effects to the variance in the absence of litter effects. ...
Trans-resveratrol (RES) is a polyphenol found in various fruits and plants. Numerous in vitro studies have shown its clear antioxidant and anti-inflammatory effects, which has led to additional in vivo and clinical studies evaluating the use of RES to treat diseases such as cancer, cardiometabolic disease, and neurodegenerative disease. Despite growing interest in and use of RES, limited studies have assessed the safety of RES exposure, especially perinatally. The National Toxicology Program conducted toxicity studies to provide these data.
... The probability distributions define the dispersion of random variable values. Consequently, the type of variable determines the type of distribution of the likelihood [8]. For a single random variable, the statisticians split the distributions into the following two types: ...
Probability and sampling in dentistry are two fundamentals which have great importance in clinical research. Many research works in dentistry shows lack of proper understanding and use of these two factors. The definition of probability is incredibly significant in daily life. Statistical analysis is based on this particularly useful definition. In fact, the function of probability in modern science is that of substituting for certainty. Probabilities are numbers that represent the probability that a specific occurrence will occur. We learn about the odds of many daily cases, ranging from weather predictions (probability of rain or snow) to lotteries (probability of winning a major jackpot). In biostatistical applications, probability theory underlies the statistical inference. Statistical inference means drawing generalizations or inferences on unknown population parameters. After selecting a sample from the population of interest, we calculate the characteristics under analysis, summarize the characteristics in our sample, and then draw inferences about the population based on what we find in the sample. Population and sampling are two critical aspects of study design. The population is a group of individuals who share common relations. A sample is a population subset. The size of the sample is the number of individuals in the sample. The more representative the sample of the population, the surer the researcher can be about the validity of the data. In this module, we will explore sampling methods, basic principles of probability, and applications of probability theory. The definition of probability is introduced, and the function of probability distributions is discussed in the statistical theory, with reference to the normal distribution and its characteristics. Sampling and sampling variations are defined, along with the sampling error, the standard error of the mean and the confidence intervals for determining the likely magnitude of the population mean. Medical study typically includes patients with an illness or disorder. The generalization of clinical research results is focused on several factors linked to the internal and external validity of the research methods. The sampling process is the key methodological problem that affects the generalizability of clinical research results. In this educational article, we also clarify the various methods of sampling in clinical research.
... Statistical analyses were performed using SPSS statistics program version 19, Chi-squared (x2) test was used to find the statistical associationP-value < 0.05 used as a significant statistical association. (19) ...
Background: Breast cancer is the most common cancer in women, a second leading cause of cancer death;
... [17] To achieve a maximum error of 2%, it was calculated that 3012 individuals would need to be screened in the new survey. [19] We choose to recruit 3400 individuals (1088 males, 2312 females). The east of Guilan is constituted by the urban and rural regions of the cities Rasht, Lahijan, Bandar Anzali, and Astaneh Ashrafieh. ...
Purpose:
To estimate carrier frequencies of CYP1B1 mutations p.Gly61Glu and p.Arg368His, respectively, in Talesh and the east of Guilan province in Iran with a maximum error of 2%. Previously, it was shown that these CYP1B1 mutations may be relatively prevalent in these regions.
Methods:
Population-based screenings were performed. DNA was extracted from saliva samples of 1036 individuals from Talesh and 3029 individuals from the east of Guilan. P.Gly61Glu and p.Arg368His screenings were performed, respectively, by RFLP and ARMS-based PCR protocols. For confirmation, the DNA of individuals with mutations was sequenced using the Sanger protocol.
Results:
Nine individuals from Talesh (0.86%; 95%CI: 0.45-1.64%) carried the p.Gly61Glu mutation, and 73 from the east of Guilan (2.41%; 95%CI: 1.91-3.04%) carried p.Arg368His. There was no significant difference in frequencies between urban and rural regions of the various cities, nor among four cities within the east of Guilan.
Conclusion:
The frequencies of p.Gly61Glu carriers in Talesh and of p.Arg368His carriers in the east of Guilan were within the 95% confidence interval of a previous study based on screenings of fewer individuals. The reliability of the recent estimates is higher, as the confidence interval for p.Gly61Glu decreased from 6.5% to 1.19% and the interval for p.Arg368His decreased from 4% to 1.13%. Based on the new findings, the maximum expected frequency of p.Gly61Glu carriers in Talesh is 1.64%, and of p.Arg368His carriers in the east of Guilan is 3%. The need for performing premarital screenings in the respective cities can be evaluated.
SARS-CoV-2 virus triggered a worldwide crisis, with world nations putting up massive efforts to halt its spread. Molnupiravir (MLN) was the first oral, direct-acting antiviral drug approved for nasopharyngeal SARS-CoV-2 infection with favorable safety and tolerability profile. This study aims at determination of MLN and N4-hydroxycytidine (NHC), its main degradation product and its main metabolite, using sensitive, simple, and green HPLC–DAD method. Moreover, under different stress conditions using NaOH, HCl, neutral, H2O2, dry heat and sun light, the method was applied for MLN assay along with kinetics degradation investigation. The linearity range for MLN and NHC were both 0.1–100 µg/mL with LOD and LOQ of 0.013 & 0.043 and 0.003 & 0.011 µg/mL, for MLN and NHC, respectively. MLN was found to be extremely vulnerable to alkali hydrolysis compared with acid and dry heat degradation. In contrast, MLN was stable under conditions of oxidative, neutral, and sunlight-induced deterioration. Acid and alkali-induced degradation followed pseudo first-order kinetics model. In addition, LC–MS-UV was used to suggest the mechanism of the stress-induced degradation route and to characterize the eluted degradation products. Toxicities of both MLN and its degradation products were evaluated using ProTox-II and they were found to be negligibly harmful. The proposed HPLC–DAD was effectively used for the analysis of MLN in commercial pharmaceutical formulations. The proposed method for MLN determination after greenness and whiteness appraisal was found to be superior compared to the reported methods for MLN analysis.
The work introduces green and white sustainable micellar electrokinetic chromatography (MEKC) procedure that could analyze therapeutically related drugs, empagliflozin (EMP), linagliptin (LIN) and metformin (MET) which are antidiabetic drugs with different mechanism of action, in their different pharmaceutical combinations. The method not only comply with the green analytical concepts, but also it is in line with sustainable analytical concepts as it is economic by applying the same operating conditions to analyze different pharmaceuticals in quality control (QC) labs which is a crucial step in QC labs and research centers to save time, effort, and money. Moreover, the method functionality regarding its scope with its achieved levels of accuracy, precision, low detection, and quantitation limits is tested using white assessment tool and compared with reported methods. The proposed MEKC coupled with a diode array detector (DAD) has been developed and validated for micro estimation of EMP and LIN in their low critical concentrations with MET in a ratio of (EMP: MET, 1:40) and (LIN: MET, 1:200). Separation was achieved within 6 min using fused silica capillary (40 cm × 50 µm id) using 20 mM Tris buffer (pH 10) in presence of 50 mM sodium dodecyl sulphate and 10% v/v methanol. The concentration ranges of the studied anti-diabetic drugs were 10–500, 10–100 and 2.5–100 µg. mL⁻¹ for MET, EMP and LIN, respectively. The developed method is the first MEKC for concurrent determination of EMP, LIN and MET with high separation efficiency, low solvent consumption and regard as an easy green and white analytical tool. Moreover, Greenness and whiteness assessment were done via the most widely used Analytical Eco-Scale, the innovative AGREE tool and the RGB 12 algorithm.
An increase in cases of chikungunya fever is reported in the Caribbean, Central and South America, and Southeast Asia. As there is no specific treatment for this disease and the only available treatment is symptomatic, it is very relevant to develop vaccines against chikungunya fever. To develop an inactivated whole-virion vaccine against the disease, it is important to choose a susceptible cell culture that both provides high virus yields and is used for vaccine production.
The aim of the study was to evaluate the susceptibility of multiple cell lines to Chikungunya virus infection and to select the monolayer culture method with the highest virus accumulation and yield.
Materials and methods. The study used the CHIKV_Nic strain of the Chikungunya virus and cell lines C6/36 (for virus titration), CEF, MRC-5, Vero, and 4647. While choosing the culture method, the authors used culture flasks, a cell factory, and roller bottles. The authors determined the susceptibility of the cell lines to viral infection by the degree of accumulation of the infectious agent in the culture fluid. The results of virus titration were calculated on day 5 on the basis of a pronounced viral cytopathic effect.
Results. The Vero and 4647 cell lines demonstrated the highest susceptibility to infection and virus concentrations in the culture fluid. The СEF and MRC-5 cell lines accumulated the virus at lower concentrations. The maximum virus titres (7.10–7.75 log 10 TCID 50 /mL) were observed in the culture fluid 48 h after infection. The optimal multiplicity of infection (MOI) ranged between 0.001 and 0.0001 MOI/cell. At 0.0001 MOI/cell, the virus accumulated in the Vero cells cultured in roller bottles on day 2, with the maximum virus titre being 8.6±0.2 log 10 TCID 50 /mL.
Conclusions. Vero cells meet the safety and stability requirements set for the production of chikungunya vaccines. The study determined the minimum MOI of the Chikungunya virus for cell culture. The roller bottle culture method provides the highest cell culture yield and the highest titre of the virus in the culture fluid.
The SARS-CoV-2 virus sets up a global catastrophe, and countries all around the world made significant efforts to halt the spread. Nirmatrelvir (NMV) was lately approved by the FDA as a safe and well-tolerated oral direct-acting antiviral medication for SARS-CoV-2 virus infection. Therefore, a fast completely validated stability indicating method was established-for the first time- for NMV determination. The study used NaOH, HCl, neutral, H2O2, and sunlight to test NMV stability under various stress conditions followed by kinetics degradation investigation and derivation of Arrhenius plot. The analysis was performed using Agilent Zorbax Eclipse-C18 column (5 µm, 4.6 × 250 mm) with a mobile phase consisting of acetonitrile: 50 mM ammonium acetate, pH = 5 (50:50, v/v, respectively) at a flow rate of 1.0 mL/min with 5 min run time. Diode array detector (DAD) was set at 225 nm to quantify NMV at the concentration range of 5–500 µg/mL with LOD and LOQ of 0.6 and 2 µg/mL, respectively. Method’s greenness was assessed using different metrics including Analytical Eco-Scale, Greenness Assessment Procedure Index, GAPI, and Analytical Greenness, AGREE. A thorough study of stress stability revealed that NMV was more susceptible to alkaline hydrolysis compared with acid hydrolysis. In contrast, it was found that NMV remained stable when subjected to oxidative, neutral, and sun-induced degradation conditions. Moreover, acid and alkali-induced hydrolysis were found to follow pseudo first order kinetics. Consequently, the half lifetime of the studied degradation conditions at room temperature were calculated using the Arrhenius plot. The mechanism of the degradation pathways under stress circumstances was proposed using LC–MS-UV. Toxicities of the proposed degradation products were assessed using ProTox-II, along with the parent medication NMV, and were shown to be hardly hazardous.
Oral human exposure to vanadium may occur due to its presence in food and drinking water and its use in dietary supplements. The most prevalent oxidation states of vanadium in food and drinking water have been characterized as tetravalent and pentavalent. Vanadyl sulfate and sodium metavanadate were selected as representative tetravalent (V4+) and pentavalent (V5+) test articles for these studies, respectively. To assess the potential for oral toxicity of vanadium compounds with differing oxidation states under similar test conditions, the 3-month National Toxicology Program (NTP) toxicity studies of sodium metavanadate and vanadyl sulfate in male and female Sprague Dawley (Hsd:Sprague Dawley SD) rats (including perinatal exposure) and in B6C3F1/N mice. Drinking water concentrations for sodium metavanadate (0, 31.3, 62.5, 125, 250, and 500 mg/L) and vanadyl sulfate (0, 21.0, 41.9, 83.8, 168, and 335 mg/L) were selected on the basis of previously published 14-day drinking water studies conducted as part of the NTP vanadium research program.
In order to check hypoglycemic property of Momordica charantia, experiments were conducted in streptozotocin induced diabetic albino mice. The LD50 of STZ was seen to be 650 mg/kg bw. Significant reduction in blood glucose level was seen within 24 hours after administration of ethanolic extract of MC. On administration of subsequent doses of ethanolic extract, significant decrease has also been seen in serum glucose level, creatinine, ALT, AST, AP of STZ induced albino mice. Thus one or other part of MC can be used in lowering down blood glucose level.
Acute spontaneous intracerebral hemorrhage (ICH) is the most severe stroke subtype, with a high risk of death, dependence, and dementia. Knowledge about the clinical profile and early outcomes of ICH patients with lobar versus deep subcortical brain topography remains limited. In this study, we investigated the effects of ICH topography on demographics, cerebrovascular risk factors, clinical characteristics, and early outcomes in a sample of 298 consecutive acute ICH patients (165 with lobar and 133 with subcortical hemorrhagic stroke) available in a single-center-based stroke registry over 24 years. The multiple logistic regression analysis shows that variables independently associated with lobar ICH were early seizures (OR 6.81, CI 95% 1.27–5.15), chronic liver disease (OR 4.55, 95% CI 1.03–20.15), hemianopia (OR 2.55, 95% CI 1.26–5.15), headaches (OR 1.90, 95% CI 1.90, 95% IC 1.06–3.41), alcohol abuse (>80 gr/day) (OR 0–10, 95% CI 0.02–0,53), hypertension (OR 0,41, 95% CI 0.23–0–70), sensory deficit (OR 0.43, 95% CI 0.25–0.75), and limb weakness (OR: 0.47, 95% CI 0.24–0.93). The in-hospital mortality was 26.7% for lobar and 16.5% for subcortical ICH. The study confirmed that the clinical spectrum, prognosis, and early mortality of patients with ICH depend on the site of bleeding, with a more severe early prognosis in lobar intracerebral hemorrhage.
Relevance. An increase in the incidence of whooping cough, a high proportion of severe forms of the disease, and a decrease in the sensitivity of circulating strains of B. pertussis to antibiotics require the development of more effective etiotropic therapies, including those capable of influencing biofilm forms of the whooping cough pathogen, which differ from planktonic cells by increased resistance to the host immune system and antibacterial drugs.
А im of the work is to study the effect of trypsin and lidase in combination with gentamycin on the growth of biofilms of Bordetella pertussis strains on an abiotic substrate.
Materials and methods . In the experiments B. pertussis strains isolated in the Russian Federation from whooping cough patients in 2001‒2010 were used: No. 178 (serotype 1.2.0), No. 287 (serotype 1.0.3) and No. 317 (serotype 1.2.3), grown on a dense nutrient medium. The intensity of biofilm formation in a liquid nutrient medium in the presence of trypsin (10 mcg/ml), lidase (20 IU/ml), gentamycin (2.0 mg/ml, 0.4 mg/ml and 0.08 mg/ml) and their combinations in roundbottomed polystyrene 96well plates was evaluated by staining with 0.1% gentianviolet solution.
Results. Gentamycin partially suppressed the formation of biofilms and caused partial destruction of the formed biofilms in the absence of growth of microbial colonies when sowing supernatants from biofilm cultures on a dense nutrient medium. The minimum suppressive concentration of gentamycin (MSC) was 2 mg/ml. Trypsin completely suppressed the growth of biofilms and caused the complete destruction of the formed biofilms. Lidase also suppressed the growth of biofilms, but less effectively affected the formed biofilms. The growth of colonies typical of B. pertussis was noted when sowing supernatants from biofilm cultures in the presence of trypsin and lidasе on a dense nutrient medium. Trypsin in combination with all the studied concentrations of gentamycin completely suppressed the growth of biofilms (MSC 0.08 mg/ml), and in combination with gentamycin at a concentration of 2.0 mg/ml caused complete destruction of biofilms in the absence of microbial growth on a dense nutrient medium. Lidase in combination with all the studied concentrations of gentamycin also suppressed the formation of biofilms (MSC 0.08 mg/ml), and in combination with gentamycin at a concentration of 2.0 mg/ml caused partial destruction of the formed biofilms in the absence of microbial growth on a dense nutrient medium.
Conclusion. The synergistic effect of the combination of trypsin and lidase with gentamycin on growing and formed biofilms of B. pertussis strains was revealed. The combined use of trypsin or lidase with gentamicin reduced its MSC for growing biofilms by 25 times. The most pronounced effect on the formed biofilms was the combination of trypsin with gentamycin at a concentration of 2 mg/ml, which caused their complete destruction and death of planktonic cells. The effect of the combination of lidase with gentamycin on the formed biofilms was less pronounced.
Genotoxicity encompasses all the potential means by which the genetic material of higher organisms may be damaged, with resulting serious consequences to both the organism they occur in and potentially their offspring. The International Conference on Harmonization recommends a rather different profile of genotoxicity tests for drugs than is used for environmental chemicals. With the exception of certain viruses, the blueprint for all organisms is contained in a code saved in the form of deoxyribonucleic acid (DNA), a giant macromolecule whose structure allows a vast amount of information to be stored accurately. DNA can exist in a single‐stranded or double‐stranded form. There are various types of cytogenetic changes which can be detected in chromosomes. These are structural chromosomal aberrations, numerical changes which could result in aneuploidy, and sister chromatid exchanges. The in vitro cytogenetic assay is a short‐term mutagenicity test for detecting chromosomal damage in cultured mammalian cells.
Background
The development of chromatographic method and the validation of a sensitive, simple, efficient, and reversed-phase high-performance liquid chromatography (RP-HPLC) approach were adopted for the drug flurbiprofen (FBP) in nanoparticles formulation by using a design of experiment (DoE). The critical method variables (CMVs) were screened using a statistical two-level fractional factorial design (FFD) followed by optimization of the selected CMVs that influence the analytical responses (ARs) of the RP-HPLC process by using two-level full factorial design.
Results
Statistical models are used to investigate the effects of system factors including column temperature, flow rate, and methanol in orthophosphoric acid (OPA) on the dependent responses, retention time, peak area, tailing factor, and theoretical plates in HPLC. The ideal column temperature (25 °C), flow rate (1 ml/min), and mobile phase (methanol 85 percent v/v in 0.05 percent OPA in water) were selected independently from the response surface at three levels (1, + 1, and 0) for further validation at constant solvent p H 2.75. Optimized method in the RP-HPLC resulted a retention time of 4.75 min, a peak area of 3975.12, a tailing factor of 0.73, and a total of 9697.7 theoretical plates followed by validation in accordance with the current ICH recommendations Q2 (R1). Linearity, precision, accuracy, assay, limit of detection (LOD), limit of quantification (LOQ), and robustness were all included in validation. The calibration curve was linear ( r ² = 0.9997, slope = 70.72) for the concentration of 10 to 50 µg/ml, with a limit of detection of 0.14 µg/ml. Furthermore, stability-indicating methods demonstrate that drug degradation is highest in the presence of basic circumstances (about 96.49%), followed by oxidation (about 76.41%), and acidic conditions (about 48.12%), whereas drug is stable in some extent under neutral, photo (sunlight), and dry heat conditions.
Conclusions
Effect of independent variables on dependent responses was screened and optimized by using statistical software design. A method for drug development could be successfully implemented for the estimation of drug in nanoparticles formulation as well as for the routine analysis in bulk and pharmaceutical formulations. The high recovery and low relative standard deviation support the suitability of proposed method that could be employed.
Graphical Abstract
Background
The 2009 H1N1 influenza pandemic (influenza A(H1N1)pdm09) disproportionately impacted Indigenous peoples. Indigenous Australians are also affected by a health gap in chronic disease prevalence. We hypothesised that the disparity in influenza incidence and severity was accounted for by higher chronic disease prevalence.
Methods
We analysed influenza data from Western Australia, South Australia, the Northern Territory, and Queensland. We calculated population prevalence of chronic diseases in Indigenous and non-Indigenous Australian populations using nationally-collected health survey data. We compared influenza case notifications, hospitalisations, intensive care admissions, and deaths reported amongst the total population of Indigenous and non-Indigenous Australians ≥ 15 years. We accessed age-specific influenza data reported to the Australian Department of Health during the 2009 ‘swine flu’ pandemic, stratified by Indigenous status and the presence of one of five chronic conditions: chronic lower respiratory conditions, diabetes mellitus, obesity, renal disease, and cardiac disease. We calculated age-standardised Indigenous: non-Indigenous rate ratios and confidence intervals.
Findings
Chronic diseases were more prevalent in Indigenous Australians. Rates of influenza diagnoses were higher in Indigenous Australians and more frequent across all indices of severity. In those with chronic conditions, Indigenous: non-Indigenous influenza notification rate ratios were no lower than in the total population; in many instances they were higher. Rate ratios remained above 1·0 at all levels of severity. However, once infected (reflected in notifications), there was no evidence of a further increase in risk of severe outcomes (hospitalisations, ICU admissions, deaths) amongst Indigenous Australians compared to non-Indigenous Australians with a chronic disease.
Interpretation
Higher rates of influenza infection was observed amongst those Indigenous compared to non-Indigenous Australians, and this difference was preserved amongst those with a chronic condition. However, there was no further increase in prevalence of more severe influenza outcomes amongst Indigenous Australians with a chronic condition. This suggests that the prevalence of chronic disease, rather than Indigenous status, affected influenza severity. Other factors may be important, including presence of multiple morbidities, as well as social and cultural determinants of health.
1.1 O RISCO DE MÃES DE 15 A 29 ANOS DE PERDEREM PELO MENOS UM FILHO
2 POBREZA E SOBREVIVÊNCIA NA INFÂNCIA
1.3 DIFERENÇAS ESPACIAIS E SOCIOECONÔMICAS DO RISCO DE MORTALIDADE DE JOVENS UTILIZANDO INFORMAÇÕES DA AMOSTRA DOS CENSOS DEMOGRÁFICOS NO MUNICÍPIO DO RIO DE JANEIRO.
1.4 MEDIDAS INDIRETAS DA MORTALIDADE POR CAUSAS EXTERNAS
1.5 - ESTIMATIVAS DE DIFERENCIAIS SÓCIO-ECONÔMICOS DE MORTALIDADE INFANTIL UTILIZANDO A TÉCNICA DE ESTUDO DE CASO-CONTROLE
2 ARTIGOS INTERNACIONAIS APRESENTADOS NO BRASIL OU NO EXTERIOR
2.1 -THE RISK OF CHILD AND ADOLESCENT MORTALITY AMONG VULNERABLE POPULATIONS IN RIO DE JANEIRO, BRAZIL
2.2 - Regional and socioeconomic differentials of mortality risk at young ages in Brazil.
2.3 - Determinants of Mortality at Young Ages
2.4 - The association of ethnicity and maternal education with mortality risk at young ages using indirect estimates. Brazil, 2000 and 2010
The association of ethnicity and maternal education with mortality risk at young ages using indirect estimates. Brazil, 2000 and 2010
1.1 O RISCO DE MÃES DE 15 A 29 ANOS DE PERDEREM PELO MENOS UM FILHO
2 POBREZA E SOBREVIVÊNCIA NA INFÂNCIA
1.3 DIFERENÇAS ESPACIAIS E SOCIOECONÔMICAS DO RISCO DE MORTALIDADE DE JOVENS UTILIZANDO INFORMAÇÕES DA AMOSTRA DOS CENSOS DEMOGRÁFICOS NO MUNICÍPIO DO RIO DE JANEIRO.
1.4 MEDIDAS INDIRETAS DA MORTALIDADE POR CAUSAS EXTERNAS
1.5 - ESTIMATIVAS DE DIFERENCIAIS SÓCIO-ECONÔMICOS DE MORTALIDADE INFANTIL UTILIZANDO A TÉCNICA DE ESTUDO DE CASO-CONTROLE
2 ARTIGOS INTERNACIONAIS APRESENTADOS NO BRASIL OU NO EXTERIOR
2.1 -THE RISK OF CHILD AND ADOLESCENT MORTALITY AMONG VULNERABLE POPULATIONS IN RIO DE JANEIRO, BRAZIL
2.2 - Regional and socioeconomic differentials of mortality risk at young ages in Brazil.
2.3 - Determinants of Mortality at Young Ages
2.4 - The association of ethnicity and maternal education with mortality risk at young ages using indirect estimates. Brazil, 2000 and 2010
Ionic liquids (ILs) are synthetic solvents with applications in a variety of industrial and chemical industries. Human exposure to this diverse chemical class is primarily through dermal or oral routes. Research suggests toxicity may be associated with IL structural characteristics, including the type of cation base or alkyl chain substitutions associated with the cation. To further investigate this hypothesis, the National Toxicology Program (NTP) conducted 3-month toxicity studies in male and female Sprague Dawley (Hsd:Sprague Dawley SD) rats and B6C3F1/N mice (n = 10/sex/exposure group; 3 exposure concentrations per IL) to compare the relative toxicities of four ILs administered via drinking water-1-ethyl-3-methylimidazolium chloride (Emim-Cl), 1-butyl-3-methylimidazolium chloride (Bmim-Cl), 1-butyl-1-methylpyrrolidinium chloride (Bmpy-Cl), and n-butylpyridinium chloride (NBuPy-Cl).
Cancer cells do not always follow the same pattern of attack. They often display a very heterogeneous nature of growths and movements confusing the body and confusing even expert doctors. Uncertainty is the very nature of certainty of cancer. So, principles of statistics are often applied to study their behavior. We have discussed here some statistical principles to analyze and understand treatments of cancer. Before and after solving mathematical models computationally, medical professionals often apply statistical principles to analyze data and estimate their validity and applicability.
While previous research has shown that language use in the home is an important factor in bilingual language development, little research has focused on how specific language strategies used by parents relate to bilingual children's language exposure and vocabulary development. Yet, for parents, this information has the potential to inform their day-to-day decisions about language use in their home. The present study aims to contribute to this understanding by applying a Bioecological Systems Model to understand how language use within the community and within the family influenced young children’s amount of language exposure and vocabulary abilities. A total of 51 French-English bilingual four-year-old Canadian children participated in the present study. Children’s exposure to each language was measured through parent reports, and their vocabulary was assessed in each language. Differences in community context were not a significant predictor of the amount of exposure or vocabulary abilities. Family language strategies predicted vocabulary scores in English but not French, whereas the amount of exposure predicted vocabulary scores in French but not English. These findings suggest that, in the preschool years, family language use strategies and amount of exposure impact vocabulary development and that their role differs based on context.
Environment is polluted by vehicular exhaust due to increased number of automobiles working on petrol and diesel fuels. Air quality crisis in cities, is mainly due to vehicular emissions. This study was carried out to assess the effects of vehicular exhaust in lung functions of traffic policemen working at Batticaloa town. The study settings of this investigation were Chest clinic, Teaching Hospital, Batticaloa and Police station, Batticaloa. Data were collected by the investigators through the Pre Designed Structured Self-Administered Questionnaire and the measurements of Spirometer which is testing pulmonary function. Statistical analysis was performed by statistical software (SPSS 16.0) and the p-value < 0.05 was considered significant for all analyses. The occurrence of shortness of breath was high among traffic policemen and occurrence of cough had higher value among controls. The values of Odds ratio for shortness of breath and frequent coughing were 1.80 & 0.64 respectively, however occurrence of shortness of breath was high and significantly differ from control group. Parameters of lung functions declined in the group of traffic policemen compared to the control; however FEV1 of the traffic policemen significantly (p=0.038) reduced compared to the control group. All parameters were declined in the group of traffic policemen who had exposure more than 5 years compared to the police men with less than 5 years exposure, however FEV1 significantly (0.041) reduced in the policemen had the more than 5 years exposure. Respiratory illness of traffic police men has been become considerable problem in Batticaloa town and initial state of impairment of lung's functions of traffic policemen has been observed. It is recommended to seek the necessary solutions for the arising problems in traffic policemen in Batticaloa.
Background . The live-attenuated vaccine based on the Yersinia pestis strain EV line NIIEG is still used in Russia, providing protective efficacy against plague. Nevertheless, there is an urgent need for developing new ways to increase the immunogenicity of the Y. pestis EV NIIEG vaccine strain. In this study, the ability of direct action of immunoadjuvant azoximer bromide (polyoxidonium, PO) on the immunobiological properties of vaccine strain Y. pestis EV NIIEG during cultivation on a dense nutrient medium was evaluated. Materials & Methods . Y.pestis EV NIIEG, cultivated at 28 °С for 48 h on LB agar, Miller pH 7.2 ± 0.1 (Sigma-Aldrich, USA) with the addition of PO and without. MALDI-TOF mass-spectrometry was deployed for the obtainment of mass-spectra of ribosomal proteins from Y. pestis EV NIIEG cells on the MicroflexTM LT mass spectrometer (Bruker Daltonics, Germany). Protective efficacy was evaluated under subcutaneously challenge guinea pigs and mice BALB's with 400 LD50 doses of the Y. pestis 231, Y. pestis P-13268 Vietnam (MLD=5 CFU). Antibody titers to F1 in serum were determined using an ELISA. Results . The addition of the therapeutic concentration of PO in the cultivation medium induced a significant increase in the immunogenicity of Y. pestis EV NIIEG that resulted in enhancement of serum antibody levels against Y. pestis F1 antigen and several times the growth of protective efficacy in the bubonic plague model on two types of experimental animals. ImD50 of the vaccine strain Y. pestis EV NIIEG, cultivated with PO, was significantly (p < 0,05) lower in comparison to ImD50 for Y. pestis EV NIIEG in standard cultivation conditions. One year of storage at a temperature of 4 °С did not alter the protective properties of the vaccine strain Y. pestis EV NIIEG, cultivated with PO. Conclusions . Morphological studies confirmed the absence of influence PO introduction into the cultivation environment on the safety of the vaccine strain. MALDI-TOF MS profile of the Y. pestis EV NIIEG, cultivated with PO, had peaks characteristic features. The mass peak at m/z 3,061 was significantly down-regulated and new mass peaks at m/z 2,759, m/z 3,533 were determined. These changes are accompanied by the increase of Y. pestis EV NIIEG immunogenicity.
This chapter, “Post-COVID Statehood,” is the concluding part of the first volume. A study offers the dedicatedly changing role of the state and the very phenomenon of statehood during periods of a pandemic in the history of mankind. The author examines the problem of state participation in the fight against pandemics in historical terms. The conclusion is that a strong state and its active role during periods of a pandemic allows quickly cope with the virus and save lives, while liberal states with minimal state participation experience more negative consequences of the pandemic. Quarantine measures are most effective in saving lives of citizens, even when their rights to movement, free assembly, freedom of speech, etc. are violated. The inherently dire conclusion is faced with an even more dire consequences of the pandemic in the form of more deaths.
Exposure to unpleasant tastes leads to disturbances of interdigestive gastric myoelectrical activity (GMA) and may affect sympathetic/parasympathetic balance (SPB). We made a careful study to determine whether taste stimulation modulates the postprandial GMA, SPB, and gastric emptying (GE) of a solid meal. Eighteen healthy volunteers (9F/9M) entered the study. On six separate days, we recorded a four-channel electrogastrogram from each volunteer during a 35-min fasting period, then for 90 min after ingestion of a solid test meal of 300 kcal. GE was measured using a ¹³C-octanoic acid breath test. Heart rate variability (HRV) analysis was simultaneously performed. At the start of the 21st min after the test meal, subjects received an agar cube delivering either a sweet, salty, sour, or bitter taste, which they kept in the mouth for 35 min. Control procedures involved sessions performed with a tasteless agar cube, and without any stimulation. There was no effect of the experimental intervention upon the relative power share of particular GMA rhythms. Stimulation with the salty and the bitter taste evoked a statistically significant increase in the dominant frequency, whereas the sweet and sour taste did not affect it. Taste stimulation did not interfere with the meal-induced rise in the dominant power, nor affect slow wave coupling. The kinetics of the solid GE remained unchanged by the intervention. None of the taste stimulations affected the postprandial SPB. Taste stimulation elicited after ingestion of a meal, in contrast to that during a fast, did not adversely modify the postprandial pattern of either the GMA or SPB, nor affect the GE of solids.
BACKGROUND: Diagnostics and treatment of acute poisoning, as well as the rehabilitation measures carried out in relation to them, including the stationary stage, are aimed at the most complete restoration of the lost capabilities of the body. AIMS: Increasing the efficiency of medical rehabilitation of acute poisoning (AP) in a toxicological hospital through a combination of drug therapy and non-drug treatment with preformed physical factors. MATERIAL AND METHODS: Of 1,207 patients with AP psychopharmacological agents (pPFA), neurotoxicants (pNT), cauterizing agents (pCA) and snake bites (SB), who were in the toxicology department of the N.V. Sklifosovsky, 421 patients with an unfavorable course of AP were subjected to an in-depth examination. Intravenous laser hemotherapy (LGT), hyperbaric oxygenation (HBO), mesodiencephalic modulation (MDM), wave biomechanotherapy (WBMT) and ethylmethylhydroxypyridine succinate (EP) were used in cases of 291 patients of the main groups. RESULTS: The unfavorable course of AP was accompanied by an increase in the duration of treatment by 2.26.8 times due to the addition of pneumonia (pPFA), toxicohypoxic encephalopathy (pNT), severe burns of the gastrointestinal tract (pCA) and local edematous-inflammatory changes (SB). There was a syndrome of high blood viscosity and moderate endotoxicosis. The best clinical and laboratory results were obtained with a combination of LHT (90 minutes) with EP (pPFA), HBO and EP (pCA), HBO, MDM, EP (heavy pNT), HBO, EP (moderate pNT) and WBMT (SB). The adaptive capabilities of the organism, the state of the autonomic nervous system (pNT), neuropsychological indicators and electrical activity of the brain (pNT) improved. CONCLUSION: Programmed rehabilitation made it possible to achieve a noticeable reduction in the incidence of symptoms of the studied poisoning (by 54.693.4%), the time to resolve their manifestations (by 9.175%), as well as inpatient treatment (by 16.159.3%), improving functional performance.
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