• Title/Summary/Keyword: Hospital volunteers

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Safety of Palmultang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (팔물탕연조엑스의 단회 경구 투여 안전성 평가에 관한 연구)

  • Yeong-jin Jeong;Su-Hak Kim;Ji-Sung Lim;Young-Dal Kwon
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.1
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    • pp.77-85
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    • 2023
  • 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.

Effects of Imagery Tennis Training on Cerebral Activity

  • Jung, Seokwon;Choi, Min-sun;Kim, Min-uk;An, Hye-jin;Shin, Min-gyeong;Kwon, Oh-Young
    • Korean Journal of Clinical Laboratory Science
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    • v.47 no.1
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    • pp.46-50
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    • 2015
  • The previous studies showed that the visual imagery activated the occipital and posterior inferior temporal area of the brain, and the damage to the occipital cortex impaired the visual mental imagery. We studied current-source distribution of electroencephalography (EEG) to observe neuronal activity during imagery tennis playing. Eleven healthy volunteers were enrolled. All volunteers were right-handed males and novices for tennis playing. The mean age of them was 24.9 years. The EEGs were recorded on the scalp electrodes located according to the International 10~20 System. The number of electrodes was 25 channels including subtemporal electrodes. The EEG recording session was 13 min including 5 segments: resting-I, scenery-slide show, resting-II, watching tennis-game video, and imagery-tennis playing. The recoding durations were 3, 2, 3, 2, and 3 min respectively. Five 'artifact free 3-sec segments' were selected in each segment of 'imagery-tennis playing' and 'resting-II'. We did the frequency domain analysis with the EEG segments using a distributed model of current-source analysis. The statistical-nonparametric maps (SnPMs) were obtained between the segments of 'imagery-tennis playing' and the segments of 'resting-II' (p<0.01). The significant change of current-source density was observed only in alpha-2 frequency band (10~12 Hz). The current-sourcedensity was increased in the hippocampus, parahippocampus, and occipital fusiform gyrus in the right cerebral hemisphere (p<0.01). Imaginary-tennis playing may activate the hippocampal-occipital alpha networks of nondominant hemisphere.

First Trial of Cervical Cytology in Healthy Women of Urban Laos using by Self-sampling Instrument

  • Nabandith, Viengvansay;Pholsena, Vatsana;Mounthisone, Phouthasone;Shimoe, Kyoko;Kato, Saiko;Aoki, Kunio;Noda, Sadamu;Takamatsu, Reika;Saio, Masanao;Yoshimi, Naoki
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4665-4667
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    • 2012
  • Cervical cancer is the most common cancer in Laos women and a screening programme, even with the PAP smear test (PAP test), has yet to be established for routine use. The Pap test is accepted as the most appropriate for cervical cancer screening in some settings but it is not commonly available in Laos hospitals, because there are few cytopathologists and gynecologists have little experience. As a pilot program, seminars for the PAP test were given in 2007 and 2008, and then PAP tests were carried out using self-sampling instrument (Kato's device) with 200 healthy volunteers in Setthathirath hospital, Laos, in 2008. The actual examination number was 196, divided into class I 104 (53.1%), class II 85 (43.3%), class IIIa 4 (2.0%), class IIIb 1 (0.5%), and class V 1 (0.5%) by modified Papanicolau classification. Four cases had menstruation. There were 6 cases with epithelial cell abnormalities including malignancy. There were 7 cases with fungus and 2 cases with trichomonas in Class II. More than 70% volunteers felt comfortable with the Kato's device and wanted to use it next time, because of the avoidance of the embarrassment and a low cost as compared with pelvic examination by gynecologists. This first trial for PAP test for healthy Laos women related to a hospital found three percent to have abnormal cervical epithelial cells. Therefore, this appraoch using a self-sampling device suggests that it should be planned for cervical cancer prevention in Laos.

Comparative Serum Proteomic Analysis of Serum Diagnosis Proteins of Colorectal Cancer Based on Magnetic Bead Separation and MALDI-TOF Mass Spectrometry

  • Deng, Bao-Guo;Yao, Jin-Hua;Liu, Qing-Yin;Feng, Xian-Jun;Liu, Dong;Zhao, Li;Tu, Bin;Yang, Fan
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.10
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    • pp.6069-6075
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    • 2013
  • Background: At present, the diagnosis of colorectal cancer (CRC) requires a colorectal biopsy which is an invasive procedure. We undertook this pilot study to develop an alternative method and potential new biomarkers for diagnosis, and validated a set of well-integrated tools called ClinProt to investigate the serum peptidome in CRC patients. Methods: Fasting blood samples from 67 patients diagnosed with CRC by histological diagnosis, 55 patients diagnosed with colorectal adenoma by biopsy, and 65 healthy volunteers were collected. Division was into a model construction group and an external validation group randomly. The present work focused on serum proteomic analysis of model construction group by ClinProt Kit combined with mass spectrometry. This approach allowed construction of a peptide pattern able to differentiate the studied populations. An external validation group was used to verify the diagnostic capability of the peptidome pattern blindly. An immunoassay method was used to determine serum CEA of CRC and controls. Results: The results showed 59 differential peptide peaks in CRC, colorectal adenoma and health volunteers. A genetic algorithm was used to set up the classification models. Four of the identified peaks at m/z 797, 810, 4078 and 5343 were used to construct peptidome patterns, achieving an accuracy of 100% (> CEA, P<0.05). Furthermore, the peptidome patterns could differentiate the validation group with high accuracy close to 100%. Conclusions: Our results showed that proteomic analysis of serum with MALDI-TOF MS is a fast and reproducible approach, which may provide a novel approach to screening for CRC.

Effects of HP228 on Analgesia Alone or in Combination with Morphine (새로운 해열, 진통, 소염제인 HP228의 단독 또는 Morphine과의 병용투여가 제통효과에 미치는 영향)

  • Lee, Seung-Gu;Lee, Seung-Hoon;Kim, Tae-Sung;Kim, Hyun-Soo;Kim, Kwang-Min
    • The Korean Journal of Pain
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    • v.12 no.1
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    • pp.64-69
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    • 1999
  • Background: The new drug HP228 is a cytokine restraining agent with a broad spectrum of anti-inflammatory, analgesic, and antipyretic activity. Six healthy, adult, male volunteers were studied to determine the independent and interactive effects of HP228 and morphine on pain perception. Methods: Two groups of stimuli were applied to each volunteers before drug administration as control, 20 min after morphine and HP228 administration, and 20 min after combined administration of these two drugs. Two adhesive electrically-conducting pads were applied on opposite sides of the arm approximately 8 cm apart. The electrode were connected to an electrical impulse generator and 50 Hz 1 msec pulses of incrementally increasing intensity were delivered at 1 sec intervals. The analgesic endpoints were the current intensity (mA) at which the subject first detected the stimulus (THRESH), the intensity at which the stimulus was first idenfied as being painful (PAIN), and the intensity at which the subject requested that the stimulus be terminated due to discomfort (LIMIT). A second series of stimuli were applied immediately thereafter using 1-sec duration 50 Hz tetanus pulses with increasing intensities at 2~5 sec intervals. Results: There were significant differences between drug treatments (Morphine, HP228, HP228/Morphine) and control (No drugs) in any of the measurements (PAIN, LIMIT) except THRESH with the twitch and tetanus test. Conclusions: The data suggests that HP228 is an analgesic, but it does not appear to interact with morphine in an additive manner.

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FHIT Gene Expression in Acute Lymphoblastic Leukemia and its Clinical Significance

  • Malak, Camelia A Abdel;Elghanam, Doaa M;Elbossaty, Walaa Fikry
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.18
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    • pp.8197-8201
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    • 2016
  • Background: To investigate the expression of the fragile histidine triad (FHIT) gene in acute lymphoblastic leukemia and its clinical significance. Materials and Methods: The level of expressed FHIT mRNA in peripheral blood from 50 patients with acute lymphoblastic leukemia (ALL) and in 50 peripheral blood samples from healthy volunteers was measured via RT-PCR. Correlation analyses between FHIT gene expression and clinical characteristics (gender, age, white blood count, immunophenotype of acute lymphoblastic leukemia and percentage of blast cells) of the patients were performed. Results: The FHIT gene was expressed at $2.49{\pm}7.37$ of ALL patients against $14.4{\pm}17.9$ in the healthy volunteers. The difference in the expression levels between ALL patients and healthy volunteers was statistically significant. The rate of gene expression did not significantly vary with immunophenotype subtypes. Gene expression was also found to be correlated with increase of total leukocyte and decrease in platelets, but not with age, gender, immunophenotyping or percentage of blast cells. Conclusions: FHIT gene expression is low in acute lymphoblastic leukemia and could be a useful marker to monitor minimal residual disease. This gene is also a candidate target for the immunotherapy of acute lymphoblastic leukemia.

Survey of Sonoanatomic Distances For Lumbar Medial Branch Nerve Blocks in Healthy Volunteers

  • Gharaei, Helen;Imani, Farnad;Solaymani-Dodaran, Masoud
    • The Korean Journal of Pain
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    • v.27 no.2
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    • pp.133-138
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    • 2014
  • Background: The precise knowledge of anatomy and the region of transverse process (TP) and superior articular processes (AP) and their distance from the skin are important in blocking and treating lumbar facet syndrome. Evaluation of these anatomic distances from 3rd and 5th lumbar vertebrae in both sides and in different body mass index (BMI) in healthy volunteers might improve knowledge of ultrasound (US) lumbar medial branch nerve blocks (LMBB). Methods: Bilateral US in the 3rd and 5th lumbar vertebrae of 64 volunteers carried out and the distance between skin to TP and skin to AP was measured. These distances were compared on both sides and in different BMI groups. The analysis was done using SPSS 11. Analysis of variance was used to compare the means at three vertebral levels (L3-L5) and different BMI groups. P values less than 0.05 were considered statistically significant. The paired t-test was used to compare the mean distance between skin to TP and skin to AP on both sides. Results: The distance between skin to TP and skin to AP of 3rd vertebrae to 5th vertebrae was increased in both right and left sides (P < 0.001) from up to down. The mean distance from skin to TP were greater on the left side compared to the right in all three vertebral levels from L3 to L5 (P values 0.014, 0.024, and 0.006 respectively). The mean distance from skin to TP and the skin to AP was statistically significant in different BMI groups (P < 0.001). Conclusions: We found many anatomic distances which may increase awareness of US guided LMBB.

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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Clinical Pharmacokinetics of Gentamicin in Gastrointestinal Surgical Patients (위장관 수술환자에서 겐타마이신의 임상약물동태)

  • Choi, Jun-Shik;Moon, Hong-Seog;Choi, In;Burm, Jin-Pil
    • YAKHAK HOEJI
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    • v.40 no.1
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    • pp.1-9
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    • 1996
  • The purpose of this investigation was to determine pharmacokinetic parameters of gentamicin using nonlinear least square regression(NLSR) and Bayesian analysis in Korean normal volunteers and gastrointestinal surgical patients. Nonparametric expected maximum(NPEM) method for population pharmacokinetic parameters was used. Gentamicin was administered every 8 hours for 3 days by infusion over 30 minutes. The volume of distribution(V) and elimination rate constant(K) of gentamicin were $0.226{\pm}0.032,\;0.231{\pm}0.063L/Kg\;and\;0.357{\pm}0.024,\;0.337{\pm}0.041hr^{-1}$ for normal volunteers and gastrointestinal surgical patients using NLSR analysis. Population pharmacokinetic parameters, KS and VS were $0.00344{\pm}0.00049(hr{\cdot}ml/min/1.73m^2)^{-1}\;and\;0.214{\pm}0.0502L/Kg$ for gastrointestinal surgical patients using NPEM method. The V and K were $0.216{\pm}0.048L/Kg\;and\;0.336{\pm}0.043hr^{-1}$ for gastrointestinal surgical patients using Bayesian analysis. There were no differences in gentamicin pharmacokinetics between NLSR and Bayesian analysis in gastrointestinal surgical patient.

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Bioavailability of Digoxin Tablets in Healthy Volunteers

  • Lee, Chi-Ho;Park, Yun-Ju;Charies-D. Sands;Daniel-W. Jones;John-M. Trang
    • Archives of Pharmacal Research
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    • v.17 no.2
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    • pp.80-86
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    • 1994
  • The bioavailability of digoxin generic tablets manufactures in Korea (formulations A & B) wwere compared to a standard (formulation C; Lanoxin brand digoxin, Burroughs Wellcome, USA) in 12 healthy Korean male volunteers (mean age 31.4 years) in a single dose, randomized, complete block crossover study. Using a latin square design, each of the subjects was randomized to the order number and allocated to each of the three treatments of 0.5mg oral digoxin. Digoxin conc4ntrations in serum and urine samples collected for 48 hours after dosing were measured by fluoprescence polarization immunoassy and radioimmunoassy, respectively. Treatments were compared by using nonlinear least squares regession analysis to evaluate the following pharmacokinetic parameters : maximum serum concentation $(C_{max})$; time of maximum serum concentation $(T_{max})$; area under the serum concentration-time curve $AUC_{0-12}$, $C_{max}$\;and\;(AUC_{0-12})$; and cummulative urinary excretion for 0-48 hours $(CLE_{0-48}.\;Mean\;AUC_{0-12},\;C_{max},\;and\;CUE_{0-48}$ values for formulations B and C were significantly different from formulation A (P<0.001), but not significantly diffeerent form each other. Basede on $AUL_{0-12}\;and\;CUE_{0-48}$ respectively, the relative availability of formulation B was 87.5% and 89.6% and the relative availability of formultation A was 43% and 35% when compared to formulation C(the standard).

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