• 제목/요약/키워드: International registry

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소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 - (The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP-)

  • 정윤경;최서연;방미란;이보람;장규태
    • 대한한방소아과학회지
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    • 제38권1호
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Incidence, mortality, and survival of liver cancer using Korea central cancer registry database: 1999-2019

  • Sung Yeon Hong;Mee Joo Kang;Taegyu Kim;Kyu-Won Jung;Bong-Wan Kim
    • 한국간담췌외과학회지
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    • 제26권3호
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    • pp.211-219
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    • 2022
  • Backgrounds/Aims: Historically, incidence and survival analysis and annual traits for primary liver cancer (LC) has not been investigated in a population-based study in Korea. The purpose of the current study is to determine incidence, survival rate of patients with primary LC in Korea. Methods: We conducted a retrospective cohort study using Korea Central Cancer Registry based on the Korea National Cancer Incidence Database. Statistical analysis including crude rate and age-standadized rate (ASR) of incidence and mortality was performed for LC patients registered with C22 code in International Classification of Diseases, tenth revision from 1999 to 2019. Subgroup analysis was performed for hepatocellular carcinoma (HCC, C22.0) and intrahepatic cholangiocarcinoma (IHCC, C22.1). Results: The crude incidence rate of HCC (21.0 to 22.8 per 100,000) and IHCC (2.3 to 5.6 per 100,000) increased in the observed period from 1999 to 2019. The ASR decreased in HCC (20.7 to 11.9 per 100,000) but remained unchanged in IHCC (2.4 to 2.7 per 100,000). The proportion of HCC patients diagnosed in early stages (localized or regional Surveillance, Epidemiology, and End Results or SEER stage) increased significantly over time. As expected, 5-yeat survival rate of HCC was greatly improved, reaching 42.4% in the period between 2013 and 2019. This trait was more prominent in localized SEER stage. On the other hand, the proportion of IHCC patients diagnosed in localized stage remained unchanged (22.9% between 2013 and 2019), although ASR and 5-year survival rate showed minor improvements. Conclusions: A great improvement in survival rate was observed in patients with newly diagnosed HCCs. It was estimated to be due to an increase in early detection rate. On the contrary, detection rate of an early IHCC was stagnant with a minor improvement in prognosis.

와송 추출물의 면역기능 개선 효과 및 안전성 연구: 단일기관, 무작위배정, 이중눈가림, 위약대조 비교, 임상연구 프로토콜 (Research on Immune Enhancing Effect and Safety of Wasong (Orostachys japonicus) Extract: Study Protocol for a Single Center, Randomized, Double-blind, Placebo-controlled, Clinical Trial)

  • 최진용;최준용;임현우;김정;김소연;한창우
    • 대한한의학방제학회지
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    • 제25권2호
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    • pp.135-143
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    • 2017
  • Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food. Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018. Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.

Rationale, Design, and Interim Observations of the Steady Movement With Innovating Leadership for Heart Failure (SMILE HF) Registry: A Multicenter Prospective Cohort Registry for Patients With Acute Heart Failure

  • Jah Yeon Choi;Mi-Na Kim;Seongwoo Han;Sunki Lee;Myung Soo Park;Min Gyu Kong;Sung-Hea Kim;Yong-Hyun Kim;Sang-Ho Jo;Sungeun Kim;Seonghoon Choi;Jinsung Jeon;Jieun Lee;Byambakhand Battumur;Seong-Mi Park;Eung Ju Kim;SMILE HF Investigators
    • International Journal of Heart Failure
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    • 제6권3호
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    • pp.129-136
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    • 2024
  • Background and Objectives: Heart failure (HF) is a leading cause of hospitalization and death worldwide. The Steady Movement with Innovating Leadership for Heart Failure (SMILE HF) aims to evaluate the clinical characteristics, management, hospital course, and long-term outcomes of patients hospitalized for acute HF in South Korea. Methods: This prospective, observational multicenter cohort study was conducted on consecutive patients hospitalized for acute HF in nine university hospitals since September 2019. Enrolment of 2000 patients should be completed in 2024, and follow-up is planned through 2025. Results: Interim analysis of 1,052 consecutive patients was performed to understand the baseline characteristics. The mean age was 69±15 years; 57.6% were male. The mean left ventricular ejection fraction was 39±15%. The prevalences of HF with reduced ejection fraction, HF with mildly reduced ejection fraction, and HF with preserved ejection fraction were 50.9%, 15.3%, and 29.2%. Ischemic cardiomyopathy (CMP) was the most common etiology (32%), followed by tachycardia-induced CMP (12.8%) and idiopathic dilated CMP (9.5%). The prescription rate of angiotensin-converting enzyme inhibitor/angiotensin receptor blockers/angiotensin receptor/neprilysin inhibitor, beta-blockers, spironolactone, and sodium-glucose cotransporter-2 inhibitors at discharge were 76.8%, 66.5%, 50.0%, and 17.5%, respectively. The post-discharge 90-day mortality and readmission rates due to HF aggravation were 2.0% and 6.4%, respectively. Our analysis reveals the current state of acute HF in South Korea. Conclusions: Our interim analysis provides valuable insights into the clinical characteristics, management, and early outcomes of acute HF patients in South Korea, highlighting the current state and treatment patterns in this population.

A Design of the Cloud Aggregator on the MapReduce in the Multi Cloud

  • Hwang, Chigon;Shin, Hyoyoung;Lee, Jong-Yong;Jung, Kye-Dong
    • International Journal of Internet, Broadcasting and Communication
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    • 제8권1호
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    • pp.83-90
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    • 2016
  • The emergence of cloud has been able to provide a variety of IT service to the user. As organizations and companies are increased that provide these cloud service, many problems arises on integration. However, with the advent of latest technologies such as big data, document-oriented database, and MapReduce, this problem can be easily solved. This paper is intended to design the Cloud Aggregator to provide them as a service to collect information of the cloud system providing each service. To do this, we use the DBaaS(DataBase as a Service) and MapReduce techniques. This makes it possible to maintain the functionality of existing system and correct the problem that may occur depending on the combination.

e-Learning 콘텐츠의 남북한 표준언어 지원시스템 연구 (A study on Support System for Standard Korean Language of e-Learning Contents)

  • 최성;정지문;유갑상
    • 디지털융복합연구
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    • 제5권2호
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    • pp.25-36
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    • 2007
  • In this paper, we studied on the effective structure of an e-Learning Korean Support System for foreigner based on computer systems which is to obey the rules of IMS/AICC International Standard regulations based on LCMS and SCORM. The most important task on this study is to support the function of self-study module through the review of the analysis and results of Korean learning and learning customs. We studied the effective PMS detail modules as well as the Standard Competency Module Management System, which related to LMS/LCMS, Learning an Individual Competency Management System, Competency Registry/Repository System, Knowledge Management System based on Community Competency Module, Education e-survey System and Module learning Support Service System. We suggested one of standard Effective Model of learning Korean Support System which is adopted in a various techniques for foreigner.

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Distributed Data Platform Collaboration Agent Design Using EMRA

  • Park, Ho-Kyun;Moon, Seok-Jae
    • International Journal of Internet, Broadcasting and Communication
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    • 제14권2호
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    • pp.40-46
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    • 2022
  • Recently, as the need for data access by integrating information in a distributed cloud environment increases in enterprise-wide enterprises, interoperability for collaboration between existing legacy systems is emphasized. In order to interconnect independent legacy systems, it is necessary to overcome platform heterogeneity and semantic heterogeneity. To solve this problem, middleware was built using EMRA (Extended MetaData Registry Access) based on ISO/IEC 11179. However, the designed middleware cannot guarantee the efficiency of information utilization because it does not have an adjustment function for each node's resource status and work status. Therefore, it is necessary to manage and adjust the legacy system. In this paper, we coordinate the correct data access between the information requesting agent and the information providing agent, and integrate it by designing a cooperative agent responsible for information monitoring and task distribution of each legacy system and resource management of local nodes. to make efficient use of the available information.

Fabricator based on B+Tree for Metadata Management in Distributed Environment

  • Chae-Yeon Yun;Seok-Jae Moon
    • International journal of advanced smart convergence
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    • 제13권3호
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    • pp.125-134
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    • 2024
  • In a distributed environment, data fabric refers to the technology and architecture that provides data management, integration, and access in a consistent and unified manner. To build a data fabric, it is necessary to maintain data consistency, establish a data governance system, reduce structural differences between data sources, and provide a unified view. In this paper, we propose the Fabricator system, a technology that provides data management and access in a consistent and unified manner by building a metadata registry. Fabricator manages the addition and modification of metadata schemas and matching processes by designing a matching tool called MetaSB Manager that applies B+Tree. This allows real-time integration of various data sources in a distributed environment, maximizing the flexibility and usability of data.

<참여정부>의 가족정책 성격: 3개 법을 중심으로 (Some Characteristics of Family Policy in Korea During Roh, Moo Hyun Government, 2003-2008)

  • 김미숙
    • 한국인구학
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    • 제31권3호
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    • pp.27-55
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    • 2008
  • 이 글은 노무현 정부 5년(2003.3-2008.2)(이하 <참여정부>)동안 이루어졌던 가족정책의 내용을 해당 가족관련법을 중심으로 살펴보고 그 성격을 진단해 보는데 목적이 있다. '여성이 행복한 나라'를 만들기위하여 <참여정부>는 과거 어느 정권보다 가족정책에 적극적인 관심을 보였고 급변하는 가족현실에 대한 대응책을 강구한 정권이기도 하였다. 논의의 편의상, <참여정부> 때에 입안.제정되었던 3개 가족정책법 -"호주제" 폐지 및 "가족관계등록부" 도입(2008.1), "건강가정기본법" 실시(2005.1), 그리고 "다문화가족지원법" 실시 (2008.9)- 을 중심으로 이들 법의 내용 소개 및 평가를 가하였다. 이러한 작업에 기반하여 <참여정부> 기의 가족정책의 가능성과 한계를 지적하였다. 나름대로의 시행착오나 보완사항이 지적되고는 있으나, 우리사회에 양성평등적 개인주의 삶의 양식이 제도적으로 보장되는데 기여한 "가족관계등록부"의 도입이 이루어졌다. 또한, 저출산 고령화 추세 및 가족불안정성에의 대응책으로서 최초의 가족단위 기본법인 "건강가정기본법"의 설정이 있었다. 그리고 다문화 다중정체성이 필요하게 된 시대적 분위기의 반영책으로서 결혼이민자의 법적 지위를 인정한 "다문화가족지원법"의 실시가 그것이다. 이렇듯 과거 어느 정권 보다 전향적이고 적극적인 양성평등지향의, 최초의 가족단위 기본법 제정, 그리고 미래 다문화사회를 위한 가족법의 입안과 집행을 시도했다고 평가할 수 있을 것이다.

Black Hispanic and Black Non-Hispanic Breast Cancer Survival Data Analysis with Half-normal Model Application

  • Khan, Hafiz Mohammad Rafiqullah;Saxena, Anshul;Vera, Veronica;Abdool-Ghany, Faheema;Gabbidon, Kemesha;Perea, Nancy;Stewart, Tiffanie Shauna-Jeanne;Ramamoorthy, Venkataraghavan
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권21호
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    • pp.9453-9458
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    • 2014
  • Background: Breast cancer is the second leading cause of cancer death for women in the United States. Differences in survival of breast cancer have been noted among racial and ethnic groups, but the reasons for these disparities remain unclear. This study presents the characteristics and the survival curve of two racial and ethnic groups and evaluates the effects of race on survival times by measuring the lifetime data-based half-normal model. Materials and Methods: The distributions among racial and ethnic groups are compared using female breast cancer patients from nine states in the country all taken from the National Cancer Institute's Surveillance, Epidemiology, and End Results cancer registry. The main end points observed are: age at diagnosis, survival time in months, and marital status. The right skewed half-normal statistical probability model is used to show the differences in the survival times between black Hispanic (BH) and black non-Hispanic (BNH) female breast cancer patients. The Kaplan-Meier and Cox proportional hazard ratio are used to estimate and compare the relative risk of death in two minority groups, BH and BNH. Results: A probability random sample method was used to select representative samples from BNH and BH female breast cancer patients, who were diagnosed during the years of 1973-2009 in the United States. The sample contained 1,000 BNH and 298 BH female breast cancer patients. The median age at diagnosis was 57.75 years among BNH and 54.11 years among BH. The results of the half-normal model showed that the survival times formed positive skewed models with higher variability in BNH compared with BH. The Kaplan-Meir estimate was used to plot the survival curves for cancer patients; this test was positively skewed. The Kaplan-Meier and Cox proportional hazard ratio for survival analysis showed that BNH had a significantly longer survival time as compared to BH which is consistent with the results of the half-normal model. Conclusions: The findings with the proposed model strategy will assist in the healthcare field to measure future outcomes for BH and BNH, given their past history and conditions. These findings may provide an enhanced and improved outlook for the diagnosis and treatment of breast cancer patients in the United States.