Objectives This study is designed to evaluate the safety of Soshihotang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times-screening, pre administration, post administration and follow up-during the whole trial. The incidence of all adverse effects are shown in percentage. The mean and standard deviation were used to to describe and summarize continuous data. To evalate the effectiveness of the intervention, data of blood tests was analyzed by Wilcoxon signed rank test or paired T-test (p<0.05). Results In the case of red blood cell, hemoglobin, hematocrit, neutrophils, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Soshihotang soft extract were considered to be safe for healthy male volunteers.
For electrolysis process using an insoluble electrode, electrochemical performance was greatly affected by the manufacturing method and procedure, such as the firing temperature, pre-treatment, type of precursor solution, coating method, electrode material, etc. Components of the electrode therein is one of the most important factors in electrochemical reaction. To achieve such characteristics, a appropriate ratio of the electrode material should be carefully chosen. The aim of this research was to apply experimental design method in the optimization of electrode component for the maximum generation of oxidants in electrochemical oxidation process. Mixture design, especially expanded simplex lattice design, in DOME (design of mixture experiments) with Design Expert - commercial software - was used to analyze the data. Analysis of variance (ANOVA) showed a high coefficient of determination ($R^2$) value of 0.9470, thus ensuring a satisfactory adjustment of the $3^{rd}$ order special cubic regression model with the experimental data. The application of response surface methodology (RSM) yielded the following regression equation, which is an empirical relationship between the TRO generation concentration and independent variables(mol ratio of 3 electrode components) in a real unit: TRO generation concentration $(mg/L)=TRO\;conc.=98.25{\times}[Ir]+49.71{\times}[Sn]+95.29{\times}[Sb]-16.91{\times}[Ir]{\times}[Sn]-29.47{\times}[Ir]{\times}[Sb]-22.65{\times}[Sn]{\times}[Sb]+703.19{\times}[Ir]{\times}[Sn]{\times}[Sb]$. The optimized formulation of the 3 component electrode for an high TRO (total residual oxidants) generation was acquired at mol ratio of Ir 0.406, Sn 0.210, Sb 0.384 (desirability d value, 1).
Background : This study was conducted to evaluate the effects of wild ginseng herbal acupuncture developed for the intravenous use. Healthy male and female volunteers(n=57) went through Randomized Control Trials(RCT). Methods : For those who are under a medication due to common cold or other illnesses were excluded in the primary stage and the subjects with possible abnormalities in the pre-screening process were also excluded in the secondary stage. Then the examination groups were determined by random sampling. Experiment groups were divided into Normal saline injection group(control group), cultivated wild ginseng herbal acupuncture group(experiment group 1) and natural wild ginseng herbal acupuncture group(experiment group 2) Blood tension, body temperature, pulse, and other criteria were measured and analyzed. Results : 1. Intravenous injection of cultivated wild ginseng herbal acupuncture and natural wild ginseng herbal acupuncture didn't cause significant changes in the blood tension, pulse, body temperature, and etc. 2. No significant differences were witnessed in CBC, ESR, biochemistry of blood test and UA between the experiment groups. 3. No significant changes were noted in the thermography before and after the test in the experiment groups. 4. Some of the common physical changes occurring during and after the administration were fatigue, chest distension, and headache in all of the experiment groups. 5. Comparing general condition after one week from the termination of administration, the control group showed worst condition while as the natural wild ginseng herbal acupuncture group displayed best condition. Conclusion : From the above results, we can carefully deduce that the intravenous injection of the wild ginseng herbal acupuncture didn't show significant differences compared to injection of the normal saline. We can infer it is safe on the human body and further studies and reports must be followed.
Ketelaar, Sarah M.;Nieuwenhuijsen, Karen;Bolier, Linda;Smeets, Odile;Sluiter, Judith K.
Safety and Health at Work
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제5권4호
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pp.216-221
/
2014
Background: Mental health complaints are quite common in health care employees and can have adverse effects on work functioning. The aim of this study was to evaluate an e-mental health (EMH) approach to workers' health surveillance (WHS) for nurses and allied health professionals. Using the waiting-list group of a previous randomized controlled trial with high dropout and low compliance to the intervention, we studied the pre- and posteffects of the EMH approach in a larger group of participants. Methods: We applied a pretest-posttest study design. The WHS consisted of online screening on impaired work functioning and mental health followed by online automatically generated personalized feedback, online tailored advice, and access to self-help EMH interventions. The effects on work functioning, stress, and work-related fatigue after 3 months were analyzed using paired t tests and effect sizes. Results: One hundred and twenty-eight nurses and allied health professionals participated at pretest as well as posttest. Significant improvements were found on work functioning (p = 0.01) and work-related fatigue (p < 0.01). Work functioning had relevantly improved in 30% of participants. A small meaningful effect on stress was found (Cohen d = .23) in the participants who had logged onto an EMH intervention (20%, n = 26). Conclusion: The EMH approach to WHS improves the work functioning and mental health of nurses and allied health professionals. However, because we found small effects and participation in the offered EMH interventions was low, there is ample room for improvement.
The Hippo pathway was originally discovered in Drosophila by genetic screening and it has been shown to be conserved in various organisms including human. Until now, the essential roles of Hippo pathway in regulating cell proliferation, apoptosis, tumorigenesis, and organ size control is extensively studied. Currently, Mats1/2 (Mob1a/1b), one of the important components in Hippo pathway, mutant mice were generated which has abnormal phenotype such as resistance to apoptosis and spontaneous tumorigenesis. Of note, Mats1/2 mutant mice also showed dental malocclusion. Therefore, in this study, we have evaluated the bone phenotype of Mats1/2 mutant mice. Although the mRNA expressions of Mats1 or Mats2 were observed in both osteoclastogenesis and osteoblastogenesis, the increase of Mats1 level was most prominent during osteoblastogenesis. The RANKL-induced osteoclast differentiation from bone marrow-derived macrophages (BMMs) was unaltered upon Mats1/2 mutation; however, the osteoblast differentiation using calvarial pre-osteoblasts was significantly reduced in Mats1/2 mutant mice compare to that of wild type mice. In accordance with in vitro results, Mats1/2 mutant mice showed decreased bone volume as well as increased trabecular separation in ${\mu}CT$ analyses. These results may provide novel prospect of the probable linkage between Hippo pathway and bone homeostasis.
Seo, Hyewon;Yoo, Hye Hyun;Kim, Young-Hoon;Hong, Jin;Sheen, Yhun Yhong
Mass Spectrometry Letters
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제10권1호
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pp.18-26
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2019
We developed a bioanalytical method for simultaneous determination of nine NBOMe derivatives (25H-NBOMe, 25B-NBOMe, 25E-NBOMe, 25N-NBOMe, 25C-NBOH, 25I-NBOH, 25B-NBF, 25C-NBF, and 25I-NBF) in human plasma using liquid chromatography tandem mass spectrometry (LC-MS/MS). Human plasma samples were pre-treated using solid-phase extraction. Separation was achieved on a C18 column under gradient elution using a mobile phase containing 0.1% formic acid in acetonitrile and 0.1% formic acid in water at a flow rate of 0.3 mL/min. Mass detection was performed in the positive ion mode using multiple reaction monitoring. The calibration range was 1-100 ng/mL for all quantitative analytes, with a correlation coefficient greater than 0.99. The intra- and inter-day precision and accuracy varied from 0.85 to 6.92% and from 90.19 to 108.69%, respectively. The recovery ranged from 86.36 to 118.52%, and the matrix effects ranged from 27.09 to 99.72%. The stability was acceptable in various conditions. The LC-MS/MS method was validated for linearity, accuracy, precision, matrix effects, recovery and stability in accordance with the FDA guidance. The proposed method is suitable for reliable and robust routine screening and analysis of nine NBOMe derivatives in forensic field.
Background and Objectives: The Gaps-In-Noise (GIN) test is a clinically effective measure of the integrity of the central auditory nervous system. The GIN procedure can be applied to a pediatric population above 7 years of age. The present study conducted the GIN test to compare the abilities of auditory temporal resolution among typically developing children, children with speech sound disorder (SSD), and children with cognitive difficulty (CD). Subjects and Methods: Children aged 8 to 11 years-(total n=30) participated in this study. There were 10 children in each of the following three groups: typically developing children, children with SSD, and children with CD. The Urimal Test of Articulation and Phonology was conducted as a clinical assessment of the children's articulation and phonology. The Korean version of the Wechsler Intelligence Scale for Children-III (K-WISC-III) was administered as a screening test for general cognitive function. According to the procedure of Musiek, the pre-recorded stimuli of the GIN test were presented at 50 dB SL. The results were scored by the approximated threshold and the overall percent correct score (%). Results: All the typically developing children had normal auditory temporal resolution based on the clinical cutoff criteria of the GIN test. The children with SSD or CD had significantly reduced gap detection performance compared to age-matched typically developing children. The children's intelligence score measured by the K-WISC-III test explained 37% of the variance in the percent-correct score. Conclusions: Children with SSD or CD exhibited poorer ability to resolve rapid temporal acoustic cues over time compared to the age-matched typically developing children. The ability to detect a brief temporal gap embedded in a stimulus may be related to the general cognitive ability or phonological processing.
Background and Objectives: The Gaps-In-Noise (GIN) test is a clinically effective measure of the integrity of the central auditory nervous system. The GIN procedure can be applied to a pediatric population above 7 years of age. The present study conducted the GIN test to compare the abilities of auditory temporal resolution among typically developing children, children with speech sound disorder (SSD), and children with cognitive difficulty (CD). Subjects and Methods: Children aged 8 to 11 years-(total n=30) participated in this study. There were 10 children in each of the following three groups: typically developing children, children with SSD, and children with CD. The Urimal Test of Articulation and Phonology was conducted as a clinical assessment of the children's articulation and phonology. The Korean version of the Wechsler Intelligence Scale for Children-III (K-WISC-III) was administered as a screening test for general cognitive function. According to the procedure of Musiek, the pre-recorded stimuli of the GIN test were presented at 50 dB SL. The results were scored by the approximated threshold and the overall percent correct score (%). Results: All the typically developing children had normal auditory temporal resolution based on the clinical cutoff criteria of the GIN test. The children with SSD or CD had significantly reduced gap detection performance compared to age-matched typically developing children. The children's intelligence score measured by the K-WISC-III test explained 37% of the variance in the percent-correct score. Conclusions: Children with SSD or CD exhibited poorer ability to resolve rapid temporal acoustic cues over time compared to the age-matched typically developing children. The ability to detect a brief temporal gap embedded in a stimulus may be related to the general cognitive ability or phonological processing.
Chandrika J Piyathilake;Suguna Badiga;Nongnut Thao;Pauline E Jolly
대한지역사회영양학회지
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제28권1호
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pp.61-73
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2023
Objectives: Prophylactic vaccines against high-risk human papillomaviruses (HR-HPVs) hold promise to prevent the development of higher grade cervical intraepithelial neoplasia (CIN 2+) and cervical cancer (CC) that develop due to HR-HPV genotypes that are included in HPV vaccines, but women will continue to develop CIN 2+ and CC due to HR-HPV genotypes that are not included in the quadrivalent HPV vaccine (qHPV) and 9-valent HPV vaccine (9VHPV). Thus, the current vaccines are likely to decrease but not entirely prevent the development of CIN 2+ or CC. The purpose of the study was to determine the prevalence and determinants of CIN 2+ that develop due to HR-HPVs not included in vaccines. Methods: Study population consisted of 1476 women tested for 37 HPVs and known to be negative for qHPVs (6/11/16/18, group A, n = 811) or 9VHPVs (6/11/16/18/31/33/45/52/58, group B, n = 331), but positive for other HR-HPVs. Regression models were used to determine the association between plasma concentrations of micronutrients, socio-demographic, lifestyle factors and risk of CIN 2+ due to HR-HPVs that are not included in vaccines. Results: The prevalence of infections with HPV 31, 33, 35 and 58 that contributed to CIN 2+ differed by race. In group A, African American (AA) women and current smokers were more likely to have CIN 2 (OR = 1.76, P = 0.032 and 1.79, P = 0.016, respectively) while in both groups of A and B, those with higher vitamin B12 were less likely to have similar lesions (OR = 0.62, P = 0.036 and 0.45, P = 0.035, respectively). Conclusions: We identified vitamin B12 status and smoking as independent modifiable factors and ethnicity as a factor that needs attention to reduce the risk of developing CIN 2+ in the post vaccination era. Continuation of tailored screening programs combined with non-vaccine-based approaches are needed to manage the residual risk of developing HPV-related CIN 2+ and CC in vaccinated women.
Objectives This study is designed to evaluate the safety of palmul-tang soft extract in healthy male volunteers. Methods Twelve healthy male volunteers were recruited. And this study was conducted in a single center. As a result of the laboratory test, the safety was evaluated by collecting vital signs of volunteers. Twelve subjects were assigned by serial number according to the registration order. For safety evaluation, blood samples were collected and vital signs were checked four times throughout the test period, including screening, pre-administration, post-administration (after 48 hours) and post-administration (after 7 days). The difference in variables was summarized as the mean±standard deviation. The normality was performed using Kolmogorov-Smirnov and Shapiro-Wilk test. If normality is satisfied, a paired t-test is applied. Otherwise, the Wilcoxon sign rank test, which is a nonparametric method, is applied. The significance was p<0.05. The incidence of all side effects is expressed as a percentage. Results In the case of red blood cell, hemoglobin, and hematocrit values, the result of normality test of variables for the difference value before and after administration is significant level p<0.05. However, all laboratory test values before and after administration did not deviate from the normal range. Also the deviations in the normal range could not be seen as significance related to this clinical trial. And no side effects related to clinical trial drugs were observed. Conclusions The soft extract of palmul-tang was considered safe for healthy male volunteers.
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