• Title/Summary/Keyword: e-clinical data

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Methods for Pharmacodynamic Analysis and Proposed Protocols for Bioequivalence Study of Acarbose (Acarbose 제제의 약력학적 평가 및 생물학적동등성 시험법에 대한 연구)

  • Bae, Jung-Woo;Jang, Choon-Gon;Lee, Seok-Yong
    • YAKHAK HOEJI
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    • v.51 no.6
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    • pp.440-446
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    • 2007
  • Arcabose is a competitive inhibitor of the intestinal ${\alpha}$-glucosidases and reduces the postprandial digestion and absorption of carbohydrate and disaccharides. Due to its negligible oral absorption, measuring drug concentration in the plasma is impractical. Thus, the common pharmacokinetic study is not available to determine the bioequivalence of the generic acarbose preparations. The aim of this study is the establishment of pharmacodynamic assessment method for the bioequivalence test of the generic acarbose preparations. Placebo-controlled cross-over ($3{\times}3$) clinical study was conducted in 23 healthy volunteers. Volunteers received a single oral dose of placebo, reference drug ($Glucoby^{(R)}$ 100 mg, Lot # D043) or test drug ($Glucoby^{(R)}$ 100 mg, Lot # E005) just before breakfast, then blood samples for evaluation of serum glucose and insulin levels were taken during for 4 hours. $C_{max},\;AUC_{0-2},\;AUC_{0-4},\;{\Delta}C_{max},\;{\Delta}AUC_{0-2}\;and\;{\Delta}AUC_{0-4}$ of the postprandial plasma glucose level significantly decreased when a single dose of acarbose 100 mg preparations was administered. However, any significant difference was not detected between the groups taken the reference drug and the test drug. These results proposed that the pharmacodynamic protocols of this study is suitable to use for bioequivalence test of acarbose preparations. On the basis of the results of this study and the data of literature on this subject, the standard protocols of bioequivalence study of acarbose preparation are proposed.

Bio-signal Based Rehabilitation Program and Data Management (국내 연하장애 기능적 전기 자극치료기 사용 현황과 장비관리 실태 분석)

  • Heo, S.Y.;Park, J.H.;Rhee, K.M.
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.8 no.1
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    • pp.57-66
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    • 2014
  • This study has been conducted to identify the current status and practices of electrical stimulation for patients with dysphagia in Korea. Main goal of the study is to find evidences of developing and distributing a quality indicator and organized performance exam. This study analyzed 50 survey questionnaires given to clinical professionals in upper-scale general hospitals, university hospitals, nursing homes and professional rehabilitation hospitals. The survey sent out and collected by E-mails or interviews from August 21, 2013 to November 10, 2013. Most of the hospitals showed lack of using a quality indicator and organized performance exams in device maintenance, pre-operational tests and post-operational tests. It is strongly recommended to develop a standardized guideline of a higher quality indicator and organized performance exam in using neuromuscular electrical stimulator for patients who are suffering from dysphagia.

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A Study on the Relationship among Circadian Types, Sleep Quality and Adaptation to Night Shifts among Nurses Working on Two or Three Day Night Duties (2~3일 밤번근무 간호사의 일주기 수면유형, 수면의 질, 밤번근무 적응도의 관계)

  • Kim, Su Jin;Gu, Mee Ock
    • Journal of Korean Clinical Nursing Research
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    • v.19 no.3
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    • pp.309-320
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    • 2013
  • Purpose: This study was conducted to identify relationships among circadian types, sleep quality, and adaptation to night shifts among nurses working on two or three day night duties. Methods: The participants were 199 ward nurses from two university hospitals in Gyeongnam province. Each nurse worked on two or three day night duties. Data were collected between September 24 and October 14, 2012 and analyzed using t-test, ANOVA, $Scheff{\grave{e}}$ test, Pearson correlation, and multiple regression with SPSS/WIN 14.0 program. Results: Mean scores for sleep quality and adaptation to night shifts was $4.92{\pm}1.46$ on a 10-point scale and $2.66{\pm}0.47$ on a 5-point scale respectively. There were no significant differences in sleep quality and adaptation to night shifts according to circadian types of nurses. There were significant correlation between sleep quality and adaptation to night shifts (r=.25, p<.001). Factors affecting adaptation to night shifts were preference for night shifts, and subjective health status, which together explained about 35% of the total variance. Conclusions: Nurses working on two or three day night duties had low level of sleep quality and adaptation to night shifts. It is necessary to improve preference for night shifts and subjective health status for improving adaptation to night shifts of nurse.

A study of prosodic features of patients with idiopathic Parkinson's disease (파킨슨병 환자와 정상노인 간의 문장 읽기에 나타난 운율 특성 비교)

  • Kang, Young-Ae;Seong, Cheol-Jae;Yoon, Kyu-Chul
    • Phonetics and Speech Sciences
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    • v.3 no.1
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    • pp.145-151
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    • 2011
  • In view of the hypothesis that the effects of Parkinson's disease on voice production can be detected before pharmacological intervention, the prosodic features of patients with idiopathic Parkinson's disease (IPD) and a healthy aging group were diagnostically analyzed with the long term object of establishing, for clinical purposes, early disease-progression biomarkers. Twenty patients (male 8; female 12) with IPD (prior to pharmacological intervention) and a healthy control group of 22 (male 10; female 12) were selected. Ten sentences were recorded with a head-worn microphone. One sentence was chosen for the analysis of this paper. Relevant parameters, i.e. 3-dimensional model (F0, intensity, duration) and pitch and intensity related slopes (maxEnergy, maxF0, meanAbS, semiT, meanEnergy, meanF0), were analyzed by two-group discriminant analysis. The stepwise estimation method of discriminant analysis was performed by gender. The discriminant functions predicted 83.9% of the male test data correctly while the prediction rate was 93.1% for the female group. The results showed that meanF0_slope and semiT_slope were more important parameters than the others for the male group. For the female group, the meanEnergy_slope and maxEnergy_slope were the important ones. These findings indicate that significant parameters are different for the male and female group. Gender lifestyle may be responsible for this difference. Dysprosodic features of IPD show not simultaneously but progressively in terms of F0, intensity and duration.

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CLINICAL AND STATISTICAL STUDIES ON FIXED BRIDGE (가공의치의 임상 통계적 연구)

  • Kim, Seung-Jae
    • The Journal of Korean Academy of Prosthodontics
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    • v.18 no.1
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    • pp.99-109
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    • 1980
  • An investigation was made Into 1,357 fixed bridges which had been performed at the Department of Prosthetic Dentistry, Seoul National University Hospital from 1973 to 1979. The purpose of this investigation was to establish a basic reference of the treatment with fixed bridges by obtaining statistical conclusions from the data concerning the patients who had been treated with fixed bridges. The following conclusions were obtained; 1. The ratio of the fixed bridges made on the maxillae to those made on the mandible was 1:1. 2. The cases of fixed bridges with one pontic were the most frequent, i.e., 946 cases out of total 1,357 cases, which were 69.7% of the total. 3. As the number of missing teeth increased, the number of the relevant cases of fixed bridges decreased. 4. The most frequent age group of the patients who had been treated with fixed bridges was the twenties, which was 40.8% of the total. As the age of the patients increased, the number of corresponding cases of fixed bridges decreased. 5. Most of the fixed bridges with more than three pontics were made at the anterior portion samely on the maxilla and on the mandible. 6. As for the retainers, the porcelain fused to metal crown and the partial veneer crown were frequently used at the anterior portion, while the full veneer crown was frequently used and the inlay and the attachment were used in some cases at the posterior portion. The locations of fixed bridges in the order of their frequency were: canine, lateral incisor, second bicuspid, central incisor, second molar, first bicuspid, first molar, and third molar on the maxilla; second bicuspid, second molar, first bicuspid, first molar, canine, third molar, lateral incisor, and central incisor on the mandible.

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Effect of QMix irrigant in removal of smear layer in root canal system: a systematic review of in vitro studies

  • Chia, Margaret Soo Yee;Parolia, Abhishek;Lim, Benjamin Syek Hur;Jayaraman, Jayakumar;de Moraes Porto, Isabel Cristina Celerino
    • Restorative Dentistry and Endodontics
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    • v.45 no.3
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    • pp.28.1-28.13
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    • 2020
  • Objectives: To evaluate the outcome of in vitro studies comparing the effectiveness of QMix irrigant in removing the smear layer in the root canal system compared with other irrigants. Materials and Methods: The research question was developed by using Population, Intervention, Comparison, Outcome and Study design framework. Literature search was performed using 3 electronic databases PubMed, Scopus, and EBSCOhost until October 2019. Two reviewers were independently involved in the selection of the articles and data extraction process. Risk of bias of the studies was independently appraised using revised Cochrane Risk of Bias tool (RoB 2.0) based on 5 domains. Results: Thirteen studies fulfilled the selection criteria. The overall risk of bias was moderate. QMix was found to have better smear layer removal ability than mixture of tetracycline isonomer, an acid and a detergent (MTAD), sodium hypochlorite (NaOCl), and phytic acid. The efficacy was less effective than 7% maleic acid and 10% citric acid. No conclusive results could be drawn between QMix and 17% ethylenediaminetetraacetic acid due to conflicting results. QMix was more effective when used for 3 minutes than 1 minute. Conclusions: QMix has better smear layer removal ability compared to MTAD, NaOCl, Tubulicid Plus, and Phytic acid. In order to remove the smear layer more effectively with QMix, it is recommended to use it for a longer duration.

Micro-computed tomographic evaluation of a new system for root canal filling using calcium silicate-based root canal sealers

  • Tanomaru-Filho, Mario;Torres, Fernanda Ferrari Esteves;Pinto, Jader Camilo;Santos-Junior, Airton Oliveira;Tavares, Karina Ines Medina Carita;Guerreiro-Tanomaru, Juliane Maria
    • Restorative Dentistry and Endodontics
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    • v.45 no.3
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    • pp.34.1-34.7
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    • 2020
  • Objectives: This study evaluated by using micro-computed tomography (micro-CT) the filling ability and sealer apical extrusion promoted by a new Sealer Injection System (SIS; Angelus) with side openings needle, in comparison with the conventional injection system, associated with a new ready-to-use calcium silicate-based sealer (Bio-C Sealer). Materials and Methods: Acrylic resin models containing a main curved artificial canal and 3 simulated lateral canals in apical, middle and cervical thirds were used. The main root canals were prepared using a rotary system up to size 35.05. The canals were filled with Bio-C sealer by using a single cone technique and the conventional delivery system or SIS. Samples were scanned in micro-CT. The percentage of voids throughout the entire extension of the main root canal and in each third of the lateral canals, besides the apical extrusion of the sealer was calculated. Data were submitted to t-test (p < 0.05). Results: There was no difference between both systems in the main root canals filling. Although the volume percentage of voids was similar in the apical and middle thirds of lateral canals, SIS had the greatest filling ability of the cervical third lateral canal. Moreover, the conventional system showed the highest apical extrusion of the sealer. Conclusions: The conventional and SIS obturation systems had an appropriate filling ability of the main root canal. SIS had the best filling of the cervical third of the lateral canals, besides lower sealer apical extrusion, suggesting its clinical indication.

Biomechanical Evaluation of Cement type hip Implants as Conditions of bone Cement and Variations of Stem Design (골시멘트 특성 및 스템 형상에 따른 시멘트 타입 인공관절의 생체역학적 평가)

  • Park, H.S.;Chun, H.J.;Youn, I.C.;Lee, M.K.;Choi, K.W.
    • Journal of Biomedical Engineering Research
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    • v.29 no.3
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    • pp.212-221
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    • 2008
  • The total hip replacement (THR) has been used as the most effective way to restore the function of damaged hip joint. However, various factors have caused some side effects after the THR. Unfortunately, the success of the THR have been decided only by the proficiency of surgeons so far. Hence, It is necessary to find the way to minimize the side effect caused by those factors. The purpose of this study was to suggest the definite data, which can be used to design and choose the optimal hip implant. Using finite element analysis (FEA), the biomechanical condition of bone cement was evaluated. Stress patterns were analyzed in three conditions: cement mantle, procimal femur and stem-cement contact surface. Additionally, micro-motion was analyzed in the stem-cement contact surface. The 3-D femur model was reconstructed from 2-D computerized tomography (CT) images. Raw CT images were preprocessed by image processing technique (i.e. edge detection). In this study, automated edge detection system was created by MATLAB coding for effective and rapid image processing. The 3-D femur model was reconstructed based on anatomical parameters. The stem shape was designed using that parameters. The analysis of the finite element models was performed with the variation of parameters. The biomechanical influence of each parameter was analyzed and derived optimal parameters. Moreover, the results of FE A using commercial stem model (Zimmer's V erSys) were similar to the results of stem model that was used in this study. Through the study, the improved designs and optimal factors for clinical application were suggested. We expect that the results can suggest solutions to minimize various side effects.

The Natural History and Growth Rate of Meningiomas

  • Han, Jung-Ho;Seol, Ho-Jun;Kim, Dong-Gyu;Jung, Hee-Won
    • Journal of Korean Neurosurgical Society
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    • v.39 no.3
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    • pp.198-203
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    • 2006
  • Objective : To evaluate the natural histories and growth rates of meningiomas, the authors perform this retrospective observational study and attempt to identify those factors predicting tumor growth. Methods : Between 1993 and 2004, a total of 83 patients were diagnosed by computed tomography[CT] scans or magnetic resonance[MR] imaging as having an intracranial meningioma, and were treated by observation only using regular clinical and radiological examinations. Twenty-six of these 83 patients, with available data were included in this study. Follow up periods ranged from 9 to 137 months [mean, 55.6 mo.; median, 60 mo.]. The tumor volumes, absolute growth rates, and tumor doubling times were calculated. Results : Patient age and sex distributions were comparable to those of other studies, but exceptionally 16 meningiomas [62%] were located at the skull base in the present study. During follow-up monitoring, the majority of meningiomas grew, though 77% showed low absolute annual growth rates [$<1cm^3/yr$]. The tumor doubling times ranged from 2.87 to 201.72 years [mean, 42.91 yr]. Based on Imaging analysis, peritumoral edema and the absence of calcification were probable factors predicting tumor growth. Tumor-related symptoms seemed to be slightly related to tumor growth. Other factors, e.g., gender, age, tumor location, and T2-weighted signal Intensities on MR imaging, were not significantly related to tumor growth. Conclusion : This study shows that the majority of meningiomas are slow growing. However, variations in tumor growth are unexplained, thus individualized optimal treatment strategies should be provided in each meningioma.

Factors related to the Performance of Mammography Screening among Women with a Family History of Breast Cancer in Korea

  • Oh, Jin-A;Kim, Tae-Hyun;Park, Young-Ok
    • Women's Health Nursing
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    • v.17 no.5
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    • pp.439-446
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    • 2011
  • Purpose: Early diagnosis is the primary method aimed at controlling breast cancer. The purpose of this study was to analyze some factors affecting the performance of mammography screening among women with a family history of breast cancer in Korea. Methods: This study applied a descriptive design method through structured self-report questionnaires. The Care Seeking Behavior Theory provided a theoretical framework for the study. Factors measured in this study represent demographic, clinical, and psychosocial variables including anxiety, barriers, utility, habits, perception, and facilitators. A total of 212 participants, of at least 20 years old, were sampled from April 8, 2010 to March 31, 2011. The data was analyzed by logistic regression method using the Statistical Package for the Social Science 18.0 software. Results: Of the 212 participants, 122 women (57.5%) went through mammography screening. The results of the analysis showed that (a) age (Odds Ratio [OR] =1.10, p<.001), (b) facilitating influences (OR=1.83, p=.008), (c) perception of mammography importance (OR=1.92, p=.011), (d) barriers to mammography (OR=0.60, p=.031), and (e) utility of mammography (OR=2.01, p=.050) significantly affect mammography screening. Conclusion: The results underscore the impact that psychosocial variables in obtaining mammography have on adherence to screening. Women with a family history of breast cancer should be given accurate information and recommendation about mammography by healthcare provider and a regular source of healthcare.