• 제목/요약/키워드: Healthy volunteers

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Constant score in asymptomatic shoulders varies with different demographic populations: derivation of adjusted score equation

  • Nitesh Gahlot;Ankit Rai;Jeshwanth Netaji
    • Clinics in Shoulder and Elbow
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    • v.25 no.4
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    • pp.274-281
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    • 2022
  • Background: In the present study, the age- and sex-adjusted Constant score (CS) in a normal Indian population was calculated and any differences with other population cohorts assessed. Methods: The study participants were patients who visited the outpatient department for problems other than shoulder and healthy volunteers from the local population. Patients without shoulder pain/discomfort during activity were included in the study. Subjects with any problem that might affect shoulder function (e.g., cervical, thoracic spine, rib cage deformity, inflammatory arthritis) were excluded. Constant scoring of all participants was performed by trained senior residents under the supervision of the senior faculty. Shoulder range of movement and strength were measured following recommendations given by the research and Development Committee of the European Society for Shoulder and Elbow Surgery (2008). A fixed spring balance was used for strength measurement; one end was fixed on the floor and the other end tied with a strap to the wrist of the participant, arm in 90° abduction in scapular plane with palm facing down. Results: Among the 248 subjects (496 shoulders), the average age was 37 years (range, 18-78 years), 65.7% were males (326 shoulders) and 34.3% females (170 shoulders). The mean CS was 84.6±2.9 (males, 86.1±3.0; females, 81.8±2.9). CS decreased significantly after 50 years of age in males and 40 years of age in females (p<0.05). The mean CS was lower than in previous studies for both males and females. Heavy occupation workers had higher mean CS (p<0.05). A linear standardized equation was estimated for calculating the adjusted CS for any age. Conclusions: Mean CS and its change with age differed from previous studies among various population cohorts.

Effect of propofol on salivary secretion from the submandibular, sublingual, and labial glands during intravenous sedation

  • Keisuke Masuda;Akira Furuyama;Kenji Ohsuga;Shota Abe;Hiroyoshi Kawaai
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.23 no.3
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    • pp.153-162
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    • 2023
  • Background: Recent animal studies have suggested the role of GABA type A (GABA-A) receptors in salivation, showing that GABA-A receptor agonists inhibit salivary secretion. This study aimed to evaluate the effects of propofol (a GABA-A agonist) on salivary secretions from the submandibular, sublingual, and labial glands during intravenous sedation in healthy volunteers. Methods: Twenty healthy male volunteers participated in the study. They received a loading dose of propofol 6 mg/kg/h for 10 min, followed by 3 mg/kg/h for 15 min. Salivary flow rates in the submandibular, sublingual, and labial glands were measured before, during, and after propofol infusion, and amylase activity was measured in the saliva from the submandibular and sublingual glands. Results: We found that the salivary flow rates in the submandibular, sublingual, and labial glands significantly decreased during intravenous sedation with propofol (P < 0.01). Similarly, amylase activity in the saliva from the submandibular and sublingual glands was significantly decreased (P < 0.01). Conclusion: It can be concluded that intravenous sedation with propofol decreases salivary secretion in the submandibular, sublingual, and labial glands via the GABA-A receptor. These results may be useful for dental treatment when desalivation is necessary.

The effect of Oligonol intake on cortisol and related cytokines in healthy young men

  • Lee, Jeong-Beom;Shin, Young-Oh;Min, Young-Ki;Yang, Hun-Mo
    • Nutrition Research and Practice
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    • v.4 no.3
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    • pp.203-207
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    • 2010
  • This study investigated the effects of Oligonol intake on cortisol, interleukin (IL)-$1{\beta}$, and IL-6 concentrations in the serum at rest and after physical exercise loading. Nineteen healthy sedentary male volunteers participated in this study. The physical characteristics of the subjects were: a mean height of $174.2{\pm}2.7$ cm, a mean weight of $74.8{\pm}3.6$ kg and a mean age of $22.8{\pm}1.3$ years. Each subject received 0.5 L water with Oligonol (100 mg/day) (n = 10) or a placebo (n = 9) daily for four weeks. The body composition, the white blood cell (WBC) and differential counts as well as the serum cortisol, IL-$1{\beta}$, and IL-6 concentrations were measured before and after Oligonol intake. The cortisol concentration and serum levels of IL-$1{\beta}$ and IL-6 after Oligonol intake were significantly decreased compared to before treatment (P < 0.01, respectively). In addition, the rate of increase of these factors after exercise was decreased compared to the placebo group. There was no change in the WBC and differential cell counts. These results suggest that oral Oligonol intake for four weeks had a significant effect on inhibition of inflammatory markers in healthy young men.

Effects of Interferential Current Stimulation on the Peripheral Blood Velocity in Healthy Subjects (간섭전류자극이 말초 혈류속도에 미치는 영향)

  • Park Jang-Sung;Lee Jae-Hyoung
    • The Journal of Korean Physical Therapy
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    • v.11 no.2
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    • pp.37-42
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    • 1999
  • The purpose of this study was to determine whether percutaneous interferential current stimulation on thoracic sympathetic ganglia with amplitude modulated frequency (AMF) $90\~100$ bps and subthreshold of muscle contraction for 10 minutes on peripheral blood flow velocity in healthy subjects. Thirty-seven healthy volunteers were assigned randomly into an experimental group (n=25) and a control group (n=12). the experimental group received interferential current stimulation with subthreshold of the muscle contraction of current at AMF $90\~100$ bps on $1st\~5th$ thoracic sympathetic ganglial region for 10 minutes. The control group received same handling and electode placement, but no current was applied. Using a Doppler blood flow meter, the radial arterial blood flow velocities and the pulse raters were determined for two-way analysis of variance for repeated measures on time and group. There were no significant difference between the two groups with respect to the changes in arterial blood flow velocity and pulse rate over the four measurement times. Interferential current stimulation did not change in mean blood flow velocity and pulse rate. We conclude that interferential current stimulation on the thoracic sympathetic ganglia, as used in this study, did not dilate peripheral artery. This results suggests that interferential current stimulation dose not alter the activtiy of sympathetic nerve.

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Effects of Oral Taurine Supplementation on Plasma Concentration and Urinary Excretion of Free Amino Acids in Healthy Female Adults (타우린복용이 정상 성인여성의 혈장 유리아미노산 농도 및 소변내 배설에 미치는 영향)

  • 차희숙
    • Journal of Nutrition and Health
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    • v.32 no.2
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    • pp.158-165
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    • 1999
  • Effects of oral taurine supplementation (6g/day) on plasma concentration and urinary of free amino acids were evaluated in healthy female adults. Among twenty five female volunteers(23.6$\pm$0.3 years old) participated in the taurine supplementation program, twenty four subjects successfully completed the two supplementation program. Plasma and urinary levels of free amino acids were determined by using an automated amino acid analyzer based on ion-exchange chromatography. Two weeks of taurine supplementation resulted in a 65% increase in plasma taurine concentration (p<0.001), Changes in fasting plasma amino acid concentrations followed by taurine supplementation were not spectacular, and were all within the normal range for human aldults. Taurine supplementation significantly elevated urinary methionine, asparagine, hydorxyproline and phosphoserine excretions(31~280%), and significantly decreased the urinary excretions of isoleucine, glutamate and serine compared to the values prior to taurine supplementation. For almost every individual amino acids, 24 hr urinary excretion level was significantly correlated to the urinary excretion value expressed as nmol/mg creatinine(p<0.001). A significant negative correlation found between plasma glutamine concentration and urinary glutamine excretion level suggests that the decrease in plasma glutamine concentration might be associated with the enhanced glutamine excretion in urine followed by taurine supplementation.

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The Effect of InGaAlP Laser Transcutaneous Blood Irradiation on Heart Rate Variability in Healthy Adults (InGaAlP 레이저 경피혈액조사가 정상성인의 심박변이도에 미치는 영향)

  • Lee, Tae-Ho;Yeo, Jin-Ju;Seol, Hyun;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.25 no.4
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    • pp.25-33
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    • 2004
  • Objective : The effects of Indium-Gallium-Aluminium-Phosphide(InGaAlP) laser transcutaneous irradiation on heart rate variability(HRV) in healthy adults are investigated with power spectrum analysis(PSA) of HRV. Methods : The control group consisted of 20 healthy volunteers (10 men, 10 women). The experiment was divided into 5 different periods, the pre-1st laser period(10 minutes), the 1st laser period(30 minutes), the post-1st laser period(5 minutes), the 2nd laser period( 30 minutes) and the post-2nd laser period(30 minutes). HRV was measured for 5 minutes at the pre-1 st laser period, the post-l st laser period and the post-2nd laser period. The laser period is the period in which InGaAlP laser transcutaneous Irradiation treatment occurs. Results : 1. SDNN of volunteers at post-1st laser period and post-2nd laser period significantly increased compared with that of the pre- 1 st laser period. 2, Ln(VLF) at post-I st laser period significantly increased compared with that of pre-1st laser period, while Ln(HF) at post-2nd laser period significantly decreased compared with those of pre- I st laser period and post-1st laser period, 3. Ln(TP) at post-1st laser period and post-2nd laser period significantly increased compared with that of pre-1st laser period, 4, LF/HF Ratio at post-2nd laser period significantly increased compared with those of pre-1st laser period and post-1st laser period. But the other variables did not significantly change. Conclusions : The results suggest that InGaAlp laser transcutaneous Irradiation in healthy adults is associated with the autonomic nervous systems. Further study is needed for investigating the effects of laser irradiation on autonomic nervous systems.

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The Effect of Oak Wood Vinegar Extract on Blood Alcohol Concentration and Hangover Syndrome

  • Choi, Young-In;Kwon, Jin-Soo;Song, Yoon-Seok;Wang, Sung-Ho
    • Biomolecules & Therapeutics
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    • v.13 no.1
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    • pp.41-47
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    • 2005
  • The study was conducted to determine whether oak wood vinegar extract influences blood alcohol concentration and hangover syndrome in healthy volunteers. 2% wood vinegar extract was effective to inhibit increase of blood alcohol concentration after alcohol intake and showed significantly different (P<0.1) compared to placebo. By result of questionnaire of volunteers, wood vinegar extract showed effects improving hangover syndrome. In comparative study about blood alcohol concentration and hangover syndrome of wood vinegar extract and other extract that hangover improvement effect was reported, average maximum blood alcohol concentration was lowered in those taking wood vinegar extract than those taking other extract. At drinking completion 210minutes (T210), blood alcohol concentration of those taking wood vinegar extract was the lowest by 0.063% compared with other extract but was not significantly different between in those taking wood vinegar extract and in those taking other extract. However, wood vinegar extract's experimental group was the highest by 0.462 in decrement rate of blood alcohol concentration and, when did P<0.1 by significance level, indicated difference that mean statistically compared to placebo group uniquely. At those taking wood vinegar extract, the improvement rate and the aggravation rate of hangover syndrome was each 87%, 2%. Thus it was concluded that wood vinegar extract showed excellent alcohol oxidation and was effective in hangover improvement.

Enantioselective Pharmacokinetics of Carvedilol in Human Volunteers

  • Phuong, Nuyen-Thi;Lee, Beam-Jin;Choi, Jung-Kap;Kang, Jong-Seong;Kwon, Kwang-il
    • Archives of Pharmacal Research
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    • v.27 no.9
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    • pp.973-977
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    • 2004
  • Carvedilol is administered as a racemic mixture of the R(+)- and S(-)-enantiomers, although they exhibit different pharmacological effects. To investigate the stereoselective pharmacoki-netics, the enantiomeric separation of carvedilol in human plasma was undertaken using capil-lary electrophoresis (CE). Resolution of the enantiomers was achieved using 2-hydoxypropyl-$\beta$-cyclodextrin as the chiral selector. Phosphate buffer (50 mM, pH 4.0) containing 10 mM of 2-hydoxypropropyl-$\beta$-cyclodextrin was used as electrolytic buffer. Achiral separation was carried out with the same electrolytic buffer without chiral selector. Following a single oral administra-tion of 25-mg carvedilol to 11 healthy, male volunteers, stereoselective pharmacokinetic analy-sis was undertaken. The maximum plasma concentrations ( $C_{max}$) were 48.9 and 21.6 ng/mL for (R)-carvedilol and (S)-carvedilol, respectively, determined by the chiral method. The profiles of the plasma concentration of (RS)-carvedilol showed $C_{max}$ of 71.5, 72.2, and 73.5 ng/mL, as determined by the CE, HPLC/FD methods and calculations from the data of the chiral method, respectively.y.y.

The Effect of Mental Stress Stimulation and Acupuncture at Shinmun(HT7) on Heart Rate Variability (정신적 스트레스와 신문(神門)(HT7) 자침(刺鍼)이 정상성인의 심박변이도(HRV)에 미치는 영향)

  • Kang, Mun-Su;Kim, Lak-Hyung
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.1
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    • pp.165-176
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    • 2009
  • Objectives : The purpose of this study was to assess the effects of mental stress stimulation and acupucnture applied at HT7 point on heart rate variability (HRV) in normal subjects. Methods : Thirty seven healthy volunteers participated in this study. The volunteers were randomly allocated into two groups. Both groups performed a mental arithmetic stress test and stroop color-word test for 10 minute. Then, acupuncture needles were inserted on HT7 for the study group and on non-acupucnture point for the control group. HRV was recorded three times at test time and before and after acupuncture stimulation. Results : After giving mental stress stimulation to both groups, LF and LF!HF ratio were increased and HF was decreased significantly. After giving acupuncture to study group, LF and LF/HF ratio were decreased and HF was increased, but it was not significant. After giving acupuncture to control group, LF and LF/HF ratio were increased and HF was decreased, but it was not significant. Conclusions : This results show that mental arithmetic stress test and stroop color-word test contribute to activation of the sympathetic nervous system Acupuncture at HT7 could be relatively useful to decrease sympathetic activity and balance autonomic nervous system for those who are under stress.

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GLP Perspectives of Bioequivalence Studies

  • Jeong, Eun-Ju
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2006.11a
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    • pp.80-86
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    • 2006
  • Bioequivalence is a term in pharmacokinetics used to access the expected in vivo biological equivalence of two proprietary preparations of a drug. Bioequivalence studies are usually performed for generic drugs. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilioes after administration in the same molar dose are similar. Bioequivalence is usually accessed by single dose in vivo studies in healthy volunteers and the reference product is usually the innovator product that is marketed. Regulatory definition of bioequivalence is based on the statistical analysis of thebioavailability of the reference and test product. In general, two products are evaluated as bioequivalent if the 90% confidence interval of the relative mean Cmaxand AUC of the test to reference product are within 80.00% to 125.00% in the fasting state. Key process in bioequivalence study is development and validation of bioanalytical method, determination of the drug concentration in the biosamples (usually plasma or serum) obtained from volunteers, calculation of the pharmacokinetic parameters and statistical analysis of the pharmacokinetic parameters. Although current guidelines and regulations do not require the bioequivalence studies to be done under good laboratory practice (CLP), the issues to perform the bioequivalence studies under GLP environment is emerged both from the regulatory and industry side. GLP perspectives of bioequivalence studiesare needed to be discussed in respect to achieve quality assurance in bioequivalence studies.

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