• Title/Summary/Keyword: Healthy volunteers

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Assessment of normal anal sphincter anatomy using transanal ultrasonography in healthy Korean volunteers: a retrospective observational study

  • Shon, Daeho;Kim, Sohyun;Kang, Sung Il
    • Journal of Yeungnam Medical Science
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    • v.39 no.3
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    • pp.230-234
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    • 2022
  • Background: To date, there have been no studies on the normal anatomic values of the anal sphincter in healthy Koreans. Therefore, this study aimed to determine the normal anatomic values of transanal ultrasonography (TAUS). Methods: The thickness of the external anal sphincter (EAS) and internal anal sphincter (IAS) was measured by TAUS from healthy Korean volunteers between September 2019 and August 2021. Results: Thirty-six volunteers with a median age of 37 years (range, 20-77 years) and a median body mass index (BMI) of 23.5 kg/m2 (range, 17.2-31.2 kg/m2) were examined. The median thickness of the EAS at 4 cm and 2 cm from the anal verge was 7.4 mm (range, 5.8-8.8 mm) and 6.5 mm (range, 5.6-8.0 mm), respectively. The median thickness of the IAS at 2 cm from the anal verge was 1.8 mm (range, 0.8-4.3 mm). There were no differences in sphincter muscle thickness between the sexes. However, the EAS tended to thicken as the BMI increased (EAS at 2 cm and 4 cm from the anal verge, Spearman rho=0.433, 0.363; p=0.008 and p=0.029, respectively). Conclusion: In healthy Korean, the median thickness of the IAS at 2 cm from the anal verge was 1.8 mm and the median thickness of the EAS at 2 cm and 4 cm from the anal verge was 6.5 mm and 7.4 mm respectively. There were no differences in anal sphincter thickness between sexes, but BMI was related to EAS thickness.

Safety of Bojungikgi-tang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (보중익기탕연조엑스의 1회 경구투여 후 안전성 평가에 관한 단일기관 연구)

  • An, Sung-Hu;Jeong, Yeong-jin;Kim, Jong-gyu;Shin, Hyeryung;Kwon, Young-Dal
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.157-166
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    • 2021
  • Objectives This study is designed to evaluate the safety of Bojungikgi-tang 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 difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, 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 Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

Pharmacokinetic and Pharmacodynamic Characterization of Gliclazide in Healthy Volunteers

  • Kim, Ho-Soon;Yun, Min-Hyuk;Kwon, Kwang-Il
    • Archives of Pharmacal Research
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    • v.26 no.7
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    • pp.564-568
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    • 2003
  • Pharmacokinetic and pharmacodynamic properties of gliclazide were studied after an oral administration of gliclazide tablets in healthy volunteers. After an overnight fasting, gliclazide tablet was orally administered to 11 volunteers; Additional 10 volunteers were used as a control group (i.e., no gliclazide administration). Blood samples were collected, and the concentration determined for gliclazide and glucose up to 24 after the administration. Standard pharmacokinetic analysis was carried out for gliclazide. Pharmacodynamic activity of the drug was expressed by increase of glucose concentration ($\Delta$PG), by area under the increase of glucose concentration-time curve ($AUC_{$\Delta$PG}$) or by the difference in increase of glucose concentration ($D_{$\Delta$PG}$) at each time between groups with and without gliclazide administration. Pharmacokinetic analysis revealed that $C_{max}, T_{max}$, CL/F (apparent clearance), V/F (apparent volume of distribution) and half-life of gliclazide were $4.69\pm1.38 mg/L, 3.45\pm1.11 h, 1.26\pm0.35 L/h, 17.78\pm5.27 L, and 9.99\pm2.15 h$, respectively. When compared with the no drug administration group, gliclazide decreased significantly the $AUC_{$\Delta$PG}$ s at 1, 1.5, 2, 2.5, 3 and 4 h (p<0.05). The $\Delta$PGs were positively correlated with $AUC_{gliclazide}$ at 1 and 1.5 h (p<0.05), and the correlation coefficient was maximum at 1 h (r = 0.642) and gradually decreased at 4 h after the administration. The $AUC_{$\Delta$PG}$s were positively correlated with $AUC_{gliclazide}$ at 1, 2, 3 and 4 h (p<0.05), and the maximum correlation coefficient was obtained at 2 h (r=0.642) after the administration. The $D_{$\Delta$PG}$ reached the maximum at 1 h, remained constant from 1 h to 3 h, and decreased afterwards. Therefore, these observations indicated that maximum hypoglycemic effect of gliclazide was reached at approximately at 1.5 h after the administration and the effect decreased, probably because of the homeostasis mechanism, in health volunteers.

Effect of Aspartate and Asparagine on Metabolism and Central Nervous System Effect of Alcohol in Healthy Male Volunteers (Aspartate 및 Asparagine 투여가 알코올 대사 및 중추신경계 효과에 미치는 영향)

  • Yim, Dong-Seok;Lee, Kyung-Hun;Jang, In-Jin;Shin, Sang-Goo;Lee, Yoon-Sung;Park, Sang-Chul
    • The Korean Journal of Pharmacology
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    • v.31 no.2
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    • pp.261-269
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    • 1995
  • Background; To explore the efficacy of aspartate as NAD regenerating agent for ethanol and acetaldehyde oxidation, we performed crossover challenge in two groups of volunteers by coadministration of various doses of aspartate, asparagine and ethanol. Methods; 18 healthy male volunteers were randomly divided into two groups. 6 volunteers of the first group were administered 5 gm monosodium aspartate(MSA), 5 gm asparagine or placebo with 100 ml of $40^{\circ}$ whiskey by the 3 way-crossover design, while 12 volunteers of the other group were administered placebo, 1, 2 or 5 bottles of $Aspar^(circledR)$ containing 1 gm of MSA per bottle with 100 ml of $40^{\circ}$ whiskey by the 4 way-crossover design. Ethanol(and acetaldehyde) concentrations in venous blood drawn at 0, 0.25, 0.5, 1, 2, 4, 8th hour after ethanol ingestion were analysed by gas chromatogaphy. Subjective symptoms, liver function tests and psychomotor function tests were also performed during the study periods. Result; Plasma concentration and AUC of acetaldehyde in asparagine and MSA trials on ethanol ingestion were significantly lower than those of placebo trial in the 1st group. Plasma ethanol concentration of 5 bottle $Aspar^(circledR)$ trial was significantly lower than that of placebo trial in the 2nd group. Improvement of subjective symptoms or psychomotor performance by the treatment was not statistically significant. Conclusion; Aspartate and asparagine may be prospective candidates for acceleration of ethanol metabolism and prevention of ethanol toxicity.

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Background Breast Parenchymal Signal During Menstrual Cycle on Diffusion-Weighted MRI: A Prospective Study in Healthy Premenopausal Women

  • Yeon Soo Kim;Bo La Yun;A Jung Chu;Su Hyun Lee;Hee Jung Shin;Sun Mi Kim;Mijung Jang;Sung Ui Shin;Woo Kyung Moon
    • Korean Journal of Radiology
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    • v.25 no.6
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    • pp.511-517
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    • 2024
  • Objective: To prospectively investigate the influence of the menstrual cycle on the background parenchymal signal (BPS) and apparent diffusion coefficient (ADC) of the breast on diffusion-weighted MRI (DW-MRI) in healthy premenopausal women. Materials and Methods: Seven healthy premenopausal women (median age, 37 years; range, 33-49 years) with regular menstrual cycles participated in this study. DW-MRI was performed during each of the four phases of the menstrual cycle (four examinations in total). Three radiologists independently assessed the BPS visual grade on images with b-values of 800 sec/mm2 (b800), 1200 sec/mm2 (b1200), and a synthetic 1500 sec/mm2 (sb1500). Additionally, one radiologist conducted a quantitative analysis to measure the BPS volume (%) and ADC values of the BPS (ADCBPS) and fibroglandular tissue (ADCFGT). Changes in the visual grade, BPS volume (%), ADCBPS, and ADCFGT during the menstrual cycle were descriptively analyzed. Results: The visual grade of BPS in seven women varied from mild to marked on b800 and from minimal to moderate on b1200 and sb1500. As the b-value increased, the visual grade of BPS decreased. On b800 and sb1500, two of the seven volunteers showed the highest visual grade in the early follicular phase (EFP). On b1200, three of the seven volunteers showed the highest visual grades in EFP. The BPS volume (%) on b800 and b1200 showed the highest value in three of the six volunteers with dense breasts in EFP. Three of the seven volunteers showed the lowest ADCBPS in the EFP. Four of the seven volunteers showed the highest ADCBPS in the early luteal phase (ELP) and the lowest ADCFGT in the late follicular phase (LFP). Conclusion: Most volunteers did not exhibit specific BPS patterns during their menstrual cycles. However, the highest BPS and lowest ADCBPS were more frequently observed in EFP than in the other menstrual cycle phases, whereas the highest ADCBPS was more common in ELP. The lowest ADCFGT was more frequent in LFP.

Significance test for electric potential of meridian system(2) -Among circadian rhythms and classification of Sasang constitution- (정상인의 12경맥 측정전위에 대한 유의성 분석(2) -서카디안 리듬, 사상체질분류를 중심으로-)

  • Nam, Bong-Hyun;Choi, Hwan-Soo
    • Korean Journal of Oriental Medicine
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    • v.7 no.1
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    • pp.85-103
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    • 2001
  • Objectives : Assuming that the characteristic of meridian system has been similar to this of electric potentials in human body and that measurements of electric potential at well(井穴) and sea(合穴) points in branches of the twelves meridians will be representative of measurements of the twelve meridians, to measure the electric potentials in twenty aged(TAG) and fifty aged(FAG) healthy volunteers groups when they were sleeping or awakening respectively, to do significance test for electric potential of meridian system among circadian rhythms(CR) and Sasang constitutions(SC). Methods : We selected who thirty healthy volunteers were diagnosed by a blood test, urine examination and differentiation of syndromes by five viscera among volunteers. When they were sleeping, their electric potentials of well and sea points in branches of the twelve meridians were simultaneously measured by physiograph. After a minute we measured them again, totally 5 times. And then when they were awakening, their electric potentials were measured 5 times by the above method. Results : Measurements were analyzed by statistical ANOVA test, we obtained that some of the electric potentials of TAG at sleeping significantly varied with CR, SC, and at awakening some of the electric potentials of FAG also significantly did with CR, SC.

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The Effects of Oral Administrations of Panax ginseng and P. quinquefolium on Hemodynamics and Body Temperature in Healthy Young Men: Results of Single Blind Test

  • Han, Yong-Nam;Lee, Jee-Hwan
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.428.2-428.2
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    • 2002
  • The present study was performed to examine the effects of oral administrations of Panax ginseng(PG) and P. quinquefolium(PQ) roots on hemodynamics and body temperature in healthy young men, since it was claimed that PG raises heat whereas PQ lowers heat by some ethnopharmacologists. The 42 healthy young male volunteers were divided into live groups. which were treated with mineral water(control), each high (9.0 g) and low (4.5 g) dose of PG and PQ. (omitted)

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