• 제목/요약/키워드: Healthy volunteers

검색결과 860건 처리시간 0.024초

Plasma Lipidomics as a Tool for Diagnosis of Extrahepatic Cholangiocarcinoma in Biliary Strictures: a Pilot Study

  • Prachayakul, Varayu;Thearavathanasingha, Phataraphong;Thuwajit, Chanitra;Roytrakul, Sittiruk;Jaresitthikunchai, Janthima;Thuwajit, Peti
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권8호
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    • pp.4155-4161
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    • 2016
  • Biliary obstruction is a common clinical manifestation of various conditions, including extrahepatic cholangiocarcinoma. However, a screening test for diagnosis of extrahepatic cholangiocarcinoma in patients with biliary obstruction is not yet available. According to the rationale that the biliary system plays a major role in lipid metabolism, biliary obstruction may interfere with lipid profiles in the body. Therefore, plasma lipidomics may help indicate the presence or status of disease in biliary obstruction suspected extrahepatic cholangiocarcinoma. This study aimed to use plasma lipidomics for diagnosis of extrahepatic cholangiocarcinoma in patients with biliary obstruction. Plasma from healthy volunteers, patients with benign biliary obstruction extrahepatic cholangiocarcinoma, and other related cancers were used in this study. Plasma lipids were extracted and lipidomic analysis was performed using matrix-assisted laser desorption ionization time-of-flight mass spectrometry. Lipid profiles from extrahepatic cholangiocarcinoma patients showed significant differences from both normal and benign biliary obstruction conditions, with no distinction between the latter two. Relative intensity of the selected lipid mass was able to successfully differentiate all extrahepatic cholangiocarcinoma samples from patient samples taken from healthy volunteers, patients with benign biliary obstruction, and patients with other related cancers. In conclusion, lipidomics is a non-invasive method with high sensitivity and specificity for identification of extrahepatic cholangiocarcinoma in patients with biliary obstruction.

세파클러 375 mg서방정의 생물학적 동등성 (Bioequivalence of Cefaclor 375 mg SR Tablet)

  • 이신화;윤민혁;최경업;권광일
    • 한국임상약학회지
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    • 제13권1호
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    • pp.13-17
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    • 2003
  • This study was carried out to compare the bioavailability of $Ceclex^{(R)}$ SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor $MR^{(R)}$ SR IAB (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean volunteers. The bioavailability was examined on 24 healthy volunteers who received a single dose (375 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 7 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters $(AUC_{0-7h},\;C_{max},\;T_{max},\;AUC_{inf},\;K_e,\;t_{1/2},\;V_d/F,\;and\;CL/F)$ were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the $T_{max}$, log-transformed $AUC_{0-7h$}$, log-transformed $C_{max},\;t_{1/2},\;V_d/F$, and $CL/F$. The ratios of geometric means of $AUC_{0-7h}\;and\;C_{max}$ between test drug End reference drug were $95.67\%\;(8.55\;vs\;8.18{\mu}g{\cdot}hr/ml)\;and\;103.86\%\;(2.85\;vs\;2.96{\mu}g/ml)$, respectively. The $T_{max}$ of test drug and reference drug was $2.56\pm0.15\;and\;2.23\pm0.13\;hrs,\;respectively.\;The\;90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-7h}\;and\;C_{max}$ were log0.90-log1.04 and log0.91-log1.13, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug.

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Incremental Expression of 14-3-3 Protein Beta/Alpha in Urine Correlates with Advanced Stage and Poor Survival in Patients with Clear Cell Renal Cell Carcinoma

  • Kaneko, Shiho;Matsumoto, Kazumasa;Minamida, Satoru;Hirayama, Takahiro;Fujita, Tetsuo;Kodera, Yoshio;Iwamura, Masatsugu
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권3호
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    • pp.1399-1404
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    • 2016
  • We investigated the urinary levels of 14-3-3 protein beta/alpha to evaluate their diagnostic significance with regard to clear cell renal cell carcinoma (ccRCC) and angiomyolipoma (AML). Urine samples from 91 patients with ccRCC, 16 patients with AML and 24 healthy volunteers were assessed. We used an enzyme-linked immunosorbent assay (ELISA) to quantify 14-3-3 protein beta/alpha levels in urine. Values were higher in patients with ccRCC than in those with AML and in healthy volunteers. High levels were associated with pathologic stage, lymph node status, distant metastasis and poor survival. Urinary levels of 14-3-3 protein beta/alpha were significantly increased in patients with small-sized carcinoma, irrespective of being less than 4.0 cm and 2.0 cm, compared with levels in patients with AML. This study is the first to report that increased expression of 14-3-3 protein beta/alpha in urine is associated with advanced stage and poor survival in patients with ccRCC. In addition, urinary 14-3-3 protein beta/alpha may differentiate AML from RCC, even when small sized. These results suggest that examination of urinary 14-3-3 protein beta/alpha could serve as a diagnostic and prognostic marker in patients with ccRCC.

Radial displacement of clinical target volume in node negative head and neck cancer

  • Jeon, Wan;Wu, Hong-Gyun;Song, Sang-Hyuk;Kim, Jung-In
    • Radiation Oncology Journal
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    • 제30권1호
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    • pp.36-42
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    • 2012
  • Purpose: To evaluate the radial displacement of clinical target volume in the patients with node negative head and neck (H&N) cancer and to quantify the relative positional changes compared to that of normal healthy volunteers. Materials and Methods: Three node-negative H&N cancer patients and five healthy volunteers were enrolled in this study. For setup accuracy, neck thermoplastic masks and laser alignment were used in each of the acquired computed tomography (CT) images. Both groups had total three sequential CT images in every two weeks. The lymph node (LN) level of the neck was delineated based on the Radiation Therapy Oncology Group (RTOG) consensus guideline by one physician. We use the second cervical vertebra body as a reference point to match each CT image set. Each of the sequential CT images and delineated neck LN levels were fused with the primary image, then maximal radial displacement was measured at 1.5 cm intervals from skull base (SB) to caudal margin of LN level V, and the volume differences at each node level were quantified. Results: The mean radial displacements were 2.26 (${\pm}1.03$) mm in the control group and 3.05 (${\pm}1.97$) in the H&N cancer patients. There was a statistically significant difference between the groups in terms of the mean radial displacement (p = 0.03). In addition, the mean radial displacement increased with the distance from SB. As for the mean volume differences, there was no statistical significance between the two groups. Conclusion: This study suggests that a more generous radial margin should be applied to the lower part of the neck LN for better clinical target coverage and dose delivery.

한방(韓方) 훈법(熏法)을 이용한 '청운(淸雲)'의 집중력 효과에 관한 연구 (A Study on Effects of incense smokes of 'Cheung-Woon' on Concentration)

  • 엄지태;김병수;김경신
    • 동의신경정신과학회지
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    • 제23권2호
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    • pp.33-48
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    • 2012
  • Objectives : This study aimed to assess the effects of incense smokes of 'Cheung-Woon' on the concentration and EEG in healthy individuals. Methods : A total of 48 healthy volunteers participated in this study. The volunteers were examined with K-MAS, CBT(Corsi block tapping task), and EEG before and after smelling the incense smokes of 'Cheung-Woon'. K-MAS measured the recalled words, and CBT measured the recalled positions and orders of the color boxes. EEG measured the relative power of ${\theta}$ wave, ${\alpha}$ wave, SMR wave, mid-${\beta}$ wave, high-${\beta}$ wave, ${\gamma}$ wave and T(concentraion index T = (SMR wave + mid-${\beta}$ wave) / ${\theta}$ wave). 'Cheung-Woon' consists of 7 herbal powder, known as a useful effect on the concentration and memory. Results : After smelling 'Cheung-Woon', K-MAS were increased significantly(p<0.05). In relative power of ${\theta}$ wave, F4, T3, and P4 were decreased significantly(p<0.05) and P3 was also decreased significantly(p<0.01). In the relative power of ${\alpha}$ wave, SMR wave, and mid-${\beta}$ wave, the values were not significant. In the relative power of high-${\beta}$ wave, Fp1, and P4 were increased significantly(p<0.05). In relative power of ${\gamma}$ wave, T3 were increased significantly (p<0.05). In T value, F4, T3, T4, and P4 were increased significantly(p<0.05) and P3 were also increased significantly(p<0.01). Conclusions : This results show that smelling incense smokes of 'Cheung-Woon' is an effective way of increasing concentration and memory.

Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers

  • Kwon Oh-Seung;Kim Hye-Jung;Pyo Hee-Soo;Chung Youn-Bok
    • Biomolecules & Therapeutics
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    • 제14권1호
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    • pp.50-55
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    • 2006
  • The objective of the study was to evaluate the bioequivalency between the $Rozid^{TM}$ Tablet (Ilhwa Pharm. Co., Ltd.) as a test formulation and the $Rulid^{TM}$ Tablet (Handok Pharm. Co., Ltd) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with fluorescence detector. $AUC_t,\;C_{max}\;and\;T_{max}$ were obtained from the time-plasma concentration curves, and log-transformed $AUC_t\;and\;C_{max}$ and log-untransformed $T_{max}$ values for two formulations were compared by statistical tests and analysis of variation. $AUC_t$ was determined to be $63.30{\pm}25.57{\mu}g.hr/ml$ for the test formulation and $64.02{\pm}29.27mg.hr/ml$ for the reference formulation. The mean values of $C_{max}$ for the test and reference formulations were $5.07{\pm}2.14\;and\;5.53{\pm}2.60{\mu}g/ml$, respectively. The $AUC_t,\;and\;C_{max}$ ratios of the test $Rozid^{TM}$ Tablet to the reference $Rulid^{TM}$ Tablet were -1.12% and -8.32%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for log-transformed $AUC_t,\;and\;C_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for $AUC_t,\;and\;C_{max}$ were located in ranges from log 0.80 and log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The RozidTM Tablet as the test formulation was considered to be bioequivalent to the RulidTM Tablet used as its reference formulation, based on $AUC_t,\;and\;C_{max}$ values.

Changes in Sensory Function After Transcranial Direct Current Stimulation on Primary Motor Cortex Area

  • Min, Dong-Ki
    • 한국전문물리치료학회지
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    • 제21권4호
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    • pp.1-8
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    • 2014
  • Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity direct current to cortical areas, thereby facilitating or inhibiting spontaneous neuronal activity. This study was designed to investigate changes in various sensory functions after tDCS. We conducted a single-center, single-blinded, randomized trial to determine the effect of a single session of tDCS with the current perception threshold (CPT) in 50 healthy volunteers. Nerve conduction studies were performed in relation to the median sensory and motor nerves on the dominant hand to discriminate peripheral nerve lesions. The subjects received anodal tDCS with 1 mA for 15 minutes under two different conditions, with 25 subjects in each groups: the conditions were as follows tDCS on the primary motor cortex (M1) and sham tDCS on M1. We recorded the parameters of the CPT a with Neurometer$^{(R)}$ at frequencies of 2000, 250, and 5 Hz in the dominant index finger to assess the tactile sense, fast pain and slow pain, respectively. In the test to measure CPT values of the M1 in the tDCS group, the values of the distal part of the distal interphalangeal joint of the second finger statistically increased in all of 2000 Hz (p=.000), 250 Hz (p=.002), and 5 Hz (p=.008). However, the values of the sham tDCS group decreased in all of 2000 Hz (p=.285), 250 Hz (p=.552), and 5 Hz (p=.062), and were not statistically significant. These results show that M1 anodal tDCS can modulate sensory perception and pain thresholds in healthy adult volunteers. The study suggests that tDCS may be a useful strategy for treating central neurogenic pain in rehabilitation medicine.

건강한 지원자에 있어서 리세드로네이트 35 mg 함유 악토넬정과 리세넬정의 약물 동력학적 비교 (Pharmacokinetic Comparison of Actonel and Risenel Tablet Containing Risedronate sodium in Healthy Volunteers)

  • 최성업;김영일;박영준;이종오;송진호;조성완
    • 한국임상약학회지
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    • 제19권1호
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    • pp.23-31
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    • 2009
  • The aim of this study was to evaluate the pharmacokinetic parameters of two risedronate preparations. The clinical assessment was conducted on 46 healthy volunteers who received one tablet (Risedronate sodium 35 mg/tablet) in the fasting state, in a randomized balanced $2{\times}2$ cross-over study design. After dosing of one tablet containing 35 mg risedronate sodium, blood samples were collected serially for a period of 48 hours. Plasma was analyzed for risedronate by using LC/MS/MS assay method. The analysis system was validated in specificity, accuracy, precision, and linearity. $AUC_t$, (the area under the plasma concentration-time curve from the zero-time to 48 hr) was calculated through the trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) were compiled from the plasma risedronate concentration-time data of each volunteer. No significant sequence effect was found for the pharmacokinetic parameters indicating that the cross-over design was properly performed. The 90 % - Confidence intervals of the $AUC_t$ ratio and the $C_{max}$ were from log 0.8752 to log 1.1888 and log 0.8457 to log 1.1478, respectively. These values were within the acceptable intervals between 0.80 and 1.25. Therefore, this study demonstrated that no statistically significant difference was identified with respect to the rate and extent of absorption.

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Improving High-resolution Impedance Manometry Using Novel Viscous and Super-viscous Substrates in the Supine and Upright Positions: A Pilot Study

  • Wong, Uni;Person, Erik B;Castell, Donald O;von Rosenvinge, Erik;Raufman, Jean-Pierre;Xie, Guofeng
    • Journal of Neurogastroenterology and Motility
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    • 제24권4호
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    • pp.570-576
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    • 2018
  • Background/Aims Swallows with viscous or solid boluses in different body positions alter esophageal manometry patterns. Limitations of previous studies include lack of standardized viscous substrates and the need for chewing prior to swallowing solid boluses. We hypothesize that high-resolution impedance manometry (HRiM) using standardized viscous and super-viscous swallows in supine and upright positions improves sensitivity for detecting esophageal motility abnormalities when compared with traditional saline swallows. To establish normative values for these novel substrates, we recruited healthy volunteers and performed HRiM. Methods Standardized viscous and super-viscous substrates were prepared using "Thick-It" food thickener and a rotational viscometer. All swallows were administered in 5-mL increments in both supine and upright positions. HRiM metrics and impedance (bolus transit) were calculated. We used a paired two-tailed t test to compare all metrics by position and substrate. Results The 5-g, 7-g, and 10-g substrates measured 5000, 36 200, and 64 $700mPa{\cdot}sec$, respectively. In 18 volunteers, we observed that the integrated relaxation pressure was lower when upright than when supine for all substrates (P < 0.01). The 10-g substrate significantly increased integrated relaxation pressure when compared to saline in the supine position (P < 0.01). Substrates and positions also affected distal contractile integral, distal latency, and impedance values. Conclusions We examined HRiM values using novel standardized viscous and super-viscous substrates in healthy subjects for both supine and upright positions. We found that viscosity and position affected HRiM Chicago metrics and have potential to increase the sensitivity of esophageal manometry.

Effect of 8% lidocaine spray on the sensory and pain thresholds of the skin of the face and hands evaluated by quantitative sensory testing

  • Okayasu, Ichiro;Komiyama, Osamu;Ayuse, Takao;De Laat, Antoon
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제18권6호
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    • pp.361-365
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    • 2018
  • Background: Recently, we examined the effects of 2% lidocaine gel on the tactile sensory and pain thresholds of the face, tongue and hands of symptom-free individuals using quantitative sensory testing (QST); its effect was less on the skin of the face and hands than on the tongue. Consequently, instead of 2% lidocaine gel, we examined the effect of 8% lidocaine spray on the tactile sensory and pain thresholds of the skin of the face and hands of healthy volunteers. Methods: Using Semmes-Weinstein monofilaments, QST of the skin of the cheek and palm (thenar skin) was performed in 20 healthy volunteers. In each participant, two topical sprays were applied. On one side, 0.2 mL of 8% lidocaine pump spray was applied, and on the other side, 0.2 mL of saline pump spray was applied as control. In each participant, QST was performed before and 15 min after each application. Pain intensity was measured using a numeric rating scale (NRS). Results: Both the tactile detection threshold and filament-prick pain detection threshold of the cheek and thenar skin increased significantly after lidocaine application. A significant difference between the effect of lidocaine and saline applications was found on the filament-prick pain detection threshold only. NRS of the cheek skin and thenar skin decreased after application of lidocaine, and not after application of saline. Conclusion: The significant effect of applying an 8% lidocaine spray on the sensory and pain thresholds of the skin of the face and hands can be objectively scored using QST.