• 제목/요약/키워드: Clinical trial center

검색결과 697건 처리시간 0.029초

국내 동물용의료기기 부작용 관리시스템에 대한 고찰 (Review of Regulatory Management System on Side Effects for Veterinary Medical Devices in Korea)

  • 강경묵;박희명;이창민;강민희;서태영;강환구;문진산
    • 한국임상수의학회지
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    • 제35권1호
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    • pp.1-6
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    • 2018
  • This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.

The immediate effects of patellar taping on balance and gait ability in individuals with chronic stroke

  • Shin, Jin;Mun, Mee-Hyang;Chung, Yijung
    • Physical Therapy Rehabilitation Science
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    • 제3권2호
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    • pp.125-133
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    • 2014
  • Objective: The aim of this study is to investigate the effect of patellar taping on balance and gait abilities in chronic stroke patients. Design: Randomized placebo-controlled trial. Methods: Thirty chronic stroke patients who have been diagnosed at least six months or before were recruited from R hospital. These study subjects were randomized to the experimental group (n=15) or placebo group (n=15). In the experimental group, patellar taping was applied while for the placebo group, placebo taping was applied. The Balance System SD was used for measuring dynamic standing balance in these two groups. In addition, the GAITRite (CIR System Inc.) system was utilized for calculating gait performance in these patients. Results: After application of taping, the patellar taping group showed a significant decrease in dynamic standing balance in their sway area (p<0.05). However, in the placebo group, there was no significant difference in dynamic standing balance ability and gait ability before and after application of taping. Comparison of the patellar taping group and placebo group showed significant differences in dynamic standing balance ability and gait performance (p<0.05). Conclusions: From the results of this study, it appears that application of patellar taping in chronic stroke patients significantly improved dynamic standing balance ability and gait ability in these patients. Based on these results, patellar taping is thought to be useful in real clinical settings where there are many chronic patients who are in need of improvement in their balance and gait ability.

중년여성에게 실행한 한방음악치료 전후(前後) 자아존중감 및 분노와 우울증상 개선에 대한 1례(例) (The Case Study of Oriental Medicine Music Therapy's Effect on Improving Middle Aged Woman's Self-Esteem Inventory & Anger Expression and Depression)

  • 이승현
    • 대한한방부인과학회지
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    • 제27권3호
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    • pp.175-188
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    • 2014
  • Objectives: The study was implemented to observe how Oriental Medicine Music Therapy (Korean Medicine Music Therapy) influences on curing the symptoms of anger and depression. Methods: Study conducted an experiment with an age of 43 female who usually suffers from headache and dizziness, and frequently gets angry at her daughter. The Study was conducted for an hour, 1 times a week. In the present study, the whole program consisted of 7 sessions. Other than the Oriental Medicine Music Therapy, the patient had never been cured by other treatments. Results: 1. According to the result of STAXI analysis, the patient with anger scale of 36 (before treatment) became to have anger scale of 31 after the treatment, indicating that the therapy had positive effect on curing the anger symptom. 2. Moreover, the analysis result of BDI showed that the patient with depression scale of 17 (before treatment) turned out to be non-depression state, which he had the depression scale of 8. Regarding the results above, it was observed that the treatment cured the depression symptom. 3. Based on the result of SEI analysis, the patient with a SEI score of 139 (higher the SEI score, more the self-esteem one has) became to have score of 142 after the treatment. Conclusions: From the research, it was observed that Korean Medicine Music Therapy has positive influence on improving one's anger or depression control and self-esteem. Clinical trial is needed to verify statistical significance.

Comparison of the Suicide Attempt Characteristics Associated with Mixed and Non-Mixed Depression in Koreans

  • Choi, Hyeon-Seok;Kim, Sung-Jin;Nam, Sang-Hun;Jung, Do-Un;Moon, Jung-Joon;Kim, Yeon-Sue;Oh, Min-Kyung;Jeon, Dong-Wook;Ahn, Yong Min
    • 정신신체의학
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    • 제29권2호
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    • pp.199-206
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    • 2021
  • Objectives : This study aimed to compare the characteristics of suicide attempts among Korean patients with mixed and non-mixed depression. Methods : Patients who visited the emergency room due to a suicide attempt and participated in the Korean Cohort for the Model Predicting a Suicide and Suicide-related Behavior study were included. Using the Montgomery-Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS), 111 patients were classified into the mixed depression (n=46) and non-mixed depression groups (n=65). The Koukopoulos Mixed Depression Rating Scale (KMDRS) score was calculated using the MADRS and YMRS scores. Suicide attempt characteristics were evaluated using the Columbia Suicidal Severity Rating Scale (C-SSRS) and Suicide Intent Scale (SIS). Results : In the mixed depression group, the reason item among the ideation intensity score of the C-SSRS was higher, and the deterrent item score was lower. Scores on the timing and suicide note items of the SIS were higher, and scores for overt communication items were lower in the mixed depression group. The KMDRS score was positively correlated with the C-SSRS ideation intensity and total SIS score. After adjusting for additional variables, the KMDRS scores had a significant effect on the C-SSRS ideation intensity and total SIS scores. Conclusions : The mixed depression group showed a difference in the intensity of suicidal ideation and suicidal intention compared to those in the non-mixed depression group. The overall suicidal ideation intensity and suicidal intention increased according to the degree of mixed depression.

한의의료 이용자의 통증 평가와 한의의료 이용 영향요인 분석 - 고령화 패널을 이용하여 - (Analysis of Choice factors of Korean Medicine and Pain Assessment - Using a Korean Longitudinal Study of Ageing(KLoSA) -)

  • 장혜경;정인철;박양춘;박소정
    • 동의생리병리학회지
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    • 제32권6호
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    • pp.411-417
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    • 2018
  • Last year, the elderly population aged 65 years and over exceeded 14.2 percent of the total population, and Korea has entered the ageing society. At the same time, social interest in improving the health level and quality of life in the elderly has also increased. In particular, pain is one of the most common diseases experienced by middle-aged and elderly people and is one of the factors that closely affect the quality of life. The purpose of this study was to analyze the factors affecting the pain level and pain region of Korean medicine users and the use of Korean medicine in the Korean middle aged and elderly using the 6th Korean Longitudinal Study of Ageing (KLoSA) panel. As a result, the main influencing factors of Korean medical care were subjective factors such as gender, subjective health status, and education level. In particular, half of the middle-aged and elderly who used Korean medicine experienced back and knee pain, and generally complained of low level of pain. This study suggests the need for research and development of Korean medicine that can control and relieve the pain of the middle-aged and elderly.

Epidemiological Survey on Schistosomiasis and Intestinal Helminthiasis among Village Residents of the Rural River Basin Area in White Nile State, Sudan

  • Lee, Young-Ha;Lee, Jin-Su;Jeoung, Hoo-Gn;Kwon, In-Sun;Mohamed, Abd Al Wahab Saed;Hong, Sung-Tae
    • Parasites, Hosts and Diseases
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    • 제57권2호
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    • pp.135-144
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    • 2019
  • There have been some reports on schistosomiasis of school children in Sudan's Nile River basin area; however, information about the infection status of Schistosoma species and intestinal helminths among village residents of this area is very limited. Urine and stool samples were collected from the 1,138 residents of the Al Hidaib and Khour Ajwal villages of White Nile State, Sudan in 2014. The prevalence of overall schistosomiasis and intestinal helminthiasis was 36.3% and 7.7%, respectively. Egg positive rates were 35.6% for Schistosoma haematobium, 2.6% for S. mansoni, and 1.4% were mixed. The prevalence of schistosomiasis was significantly higher in men (45.6%) than in women (32.0%), in Khou Ajwal villagers (39.4%) than in Al Hidaib villagers (19.2%), and for age groups ${\leq}15$ years old (51.5%) than for age groups >15 years old (13.2%). The average number of eggs per 10 ml urine (EP10) of S. haematobium infections was 18.9, with 22.2 eggs in men vs 17.0 in women and 20.4 in Khou Ajwal villagers vs 8.1 in Al Hidaib villagers. In addition to S. mansoni eggs, 4 different species of intestinal helminths were found in the stool, including Hymenolepis nana (6.6%) and H. diminuta (1.0%). Collectively, urinary schistosomiasis is still prevalent among village residents in Sudan's White Nile River basin and was especially high in men, children ${\leq}15$ years, and in the village without a clean water system. H. nana was the most frequently detected intestinal helminths in the 2 villages.

Endoscopic Ultrasonography in Pediatric Patients with Pancreatobiliary Disease: Single-Center Trial

  • Demirbas, Fatma;Kaymazli, Mustafa;Caltepe, Gonul;Abbasguliyev, Hasan;Kalayci, Ayhan Gazi;Bektas, Ahmet
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제24권2호
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    • pp.164-172
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    • 2021
  • Purpose: The use of Endoscopic ultrasonography (EUS) in pediatric patients is not as common as in adults. The aim of this study is to evaluate the role of EUS in the diagnosis of pancreatobiliary disease in childhood. Methods: Between December 2016 and January 2018, the findings of patients who underwent EUS were evaluated retrospectively. Results: Of the 41 patients included in the study 25 were girls (61.0%), mean age was 12.2±4.2 years. EUS was performed for biliary colic in 21 (51.2%), for recurrent pancreatitis in 12 (29.2%), for cholecystitis/cholangitis in 5 (12.2%), and for acute pancreatitis in 3 (7.4%) patients. EUS had a significant clinical effect in the decision of treatment and follow-up of 6/21 biliary colic cases, in diagnosis and follow-up of 6/12 recurrent pancreatitis cases, in decision-making and monitoring of invasive procedures (ERCP/surgery) of 3/5 acute cholecystitis/cholangitis and 2/3 of acute pancreatitis cases as well as in follow-up of the other cases. The effectiveness of EUS in determining direct treatment and invasive intervention was 43.9%. None of the patients had complications related to the EUS procedure. Conclusion: Although current guidelines show that EUS can be used in pediatric patients, this is limited to a few published studies. In this study, it is shown that EUS is a safe method for the diagnosis, follow-up and treatment of common pancreatobiliary pathologies in childhood.

일치성규칙과 목표값이 없는 데이터 증대를 이용하는 학습의 성능 향상 방법에 관한 연구 (A study on the performance improvement of learning based on consistency regularization and unlabeled data augmentation)

  • 김현웅;석경하
    • 응용통계연구
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    • 제34권2호
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    • pp.167-175
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    • 2021
  • 준지도학습(semi-supervised learning)은 목표값이 있는 데이터와 없는 데이터를 모두 이용하는 학습방법이다. 준지도학습에서 최근에 많은 관심을 받는 일치성규칙(consistency regularization)과 데이터 증대를 이용한 준지도학습(unsupervised data augmentation; UDA)은 목표값이 없는 데이터를 증대하여 학습에 이용한다. 그리고 성능 향상을 위해 훈련신호강화(training signal annealing; TSA)와 신뢰기반 마스킹(confidence based masking)을 이용한다. 본 연구에서는 UDA에서 사용하는 KL-정보량(Kullback-Leibler divergence)과 TSA 대신 JS-정보량(Jensen-Shanon divergene)과 역-TSA를 사용하고 신뢰기반 마스킹을 제거하는 방법을 제안한다. 실험을 통해 제안된 방법의 성능이 더 우수함을 보였다.

염증성 근육뼈대계 질환에 대한 미세전류의 효과: 메타분석 (Effects of Microcurrent on Inflammatory Musculoskeletal Diseases: A Meta-Analysis)

  • 이정우;고운;두영택
    • 대한통합의학회지
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    • 제8권4호
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    • pp.1-11
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    • 2020
  • Purpose : The purpose of this meta-analysis was to examine the effects of microcurrent on inflammatory musculoskeletal diseases. Methods : Domestic databases (RISS, NDSL, KISS, DBpia, and Kmbase) were searched for studies that conducted clinical trials associated with microcurrent and its impact on inflammatory musculoskeletal diseases. A total of 606 studies published between 2002 and 2019 were identified, with 8 studies satisfying the inclusion data. The studies were classified according to patient, intervention, comparison, and outcome (PICO). The search outcomes were items associated with blood component, pain, and function. The 8 studies that were included in the study were evaluated using R meta-analysis (version 4.0). The quality of 7 randomized control trials was evaluated using Cochrane risk of bias (ROB). The quality of 1 non-randomized control trial was evaluated using risk of bias assessment tool for non-randomized studies (RoBANS). Effect sizes were computed as the corrected standard mean difference (SMD). A random-effect model was used to analyze the effect size because of the high heterogeneity among the studies. Egger's regression test was carried out to analyze the publishing bias. Results : The following factors had a large effect size involving microcurrent on inflammatory musculoskeletal diseases: blood component (Hedges's g=-2.46, 95 % CI=-4.20~-0.73), pain (Hedges's g=3.51, 95 % CI=2.44~4.77), and function (Hedges's g=3.06, 95 % CI: 1.53~4.58). Except for function (t=1.572, p=.191), Egger's regression test showed that the publishing bias had statistically significant differences. Conclusion : This study provides evidence for the effectiveness of microcurrent on inflammatory musculoskeletal diseases in terms of blood component, pain, and function. However, due to the small sample sizes used in the included studies, the results of our study should be interpreted cautiously, especially considering the publishing bias.

Adjustment for Multimorbidity in Estimations of the Burden of Diseases Using Korean NHIS Data

  • Shin, Yoonhee;Choi, Eun Jeong;Park, Bomi;Lee, Hye Ah;Lee, Eun-Kyung;Park, Hyesook
    • Journal of Preventive Medicine and Public Health
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    • 제55권1호
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    • pp.28-36
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    • 2022
  • The current multimorbidity correction method in the Global Burden of Disease studies assumes the independent occurrence of diseases. Those studies use Monte-Carlo simulations to adjust for the presence of multiple disease conditions for all diseases. The present study investigated whether the above-mentioned assumption is reasonable based on the prevalence confirmed from actual data. This study compared multimorbidity-adjusted years of lived with disability (YLD) obtained by Monte-Carlo simulations and multimorbidity-adjusted YLD using multimorbidity prevalence derived from National Health Insurance Service data. The 5 most common diseases by sex and age groups were selected as diseases of interest. No significant differences were found between YLD estimations made using actual data and Monte-Carlo simulations, even though assumptions about the independent occurrence of diseases should be carefully applied. The prevalence was not well reflected according to disease characteristics in those under the age of 30, among whom there was a difference in YLD between the 2 methods. Therefore, when calculating the burden of diseases for Koreans over the age of 30, it is possible to calculate the YLD with correction for multimorbidity through Monte-Carlo simulation, but care should be taken with under-30s. It is useful to apply the efficiency and suitability of calibration for multiplicative methods using Monte-Carlo simulations in research on the domestic disease burden, especially in adults in their 30s and older. Further research should be carried out on multimorbidity correction methodology according to the characteristics of multiple diseases by sex and age.