• 제목/요약/키워드: Human trials

검색결과 386건 처리시간 0.036초

백신임상시험에 대한 통계적 고찰 (Statistical Consideration of Vaccine Clinical Trials)

  • 남주선;강승호
    • 응용통계연구
    • /
    • 제24권4호
    • /
    • pp.633-646
    • /
    • 2011
  • 인류의 평균수명 연장과 삶의 질 향상을 위해서 암 예방을 위한 백신 뿐 아니라 치료를 위한 백신 등 백신에 대한 많은 연구가 진행되고 있다. 또한 2009년 전 세계를 공포로 몰았던 신종인플루엔자 등 신종바이러스 유행으로 백신에 대한 임상시험과 연구는 더욱더 활기를 띄게 되었다. 본 논문에서는 백신에 대한 임상시험에서 고려해야할 통계학적인 부분에 대해 기술하고, 현재 우리나라를 포함한 전 세계적인 백신의 개발 현황에 대해서도 언급하겠다.

Role of Probiotics in Human Gut Microbiome-Associated Diseases

  • Kim, Seon-Kyun;Guevarra, Robin B.;Kim, You-Tae;Kwon, Joongi;Kim, Hyeri;Cho, Jae Hyoung;Kim, Hyeun Bum;Lee, Ju-Hoon
    • Journal of Microbiology and Biotechnology
    • /
    • 제29권9호
    • /
    • pp.1335-1340
    • /
    • 2019
  • Probiotics, including bacteria and yeast, are live microorganisms that have demonstrated beneficial effects on human health. Recently, probiotic bacteria are constantly being studied and their applications are also being considered in promising adjuvant treatments for various intestinal diseases. Clinical trials and in vivo experiments have extended our current understanding of the important roles that probiotics play in human gut microbiomeassociated diseases. It has been documented through many clinical trials that probiotics could shape the intestinal microbiota leading to potential control of multiple bowel diseases and promotion of overall wellness. In this review, we focused on the relationship between probiotics and the human gut microbiota and its roles in gut microbiome-associated diseases. Here, we also discuss future directions and research areas that need further elucidation in order to better understand the roles of probiotics in the treatment of intestinal diseases.

김치 및 김치 유래 유산균의 건강 기능성에 대한 연구 동향 조사 (A survey of research papers on the health benefits of kimchi and kimchi lactic acid bacteria)

  • 김보경;문은경;김도연;김영;박용순;이해정;차연수
    • Journal of Nutrition and Health
    • /
    • 제51권1호
    • /
    • pp.1-13
    • /
    • 2018
  • Purpose: This review article provides an overview of the trends of research papers on the health benefits of kimchi and kimchi lactic acid bacteria published from 1995 to 2017. Methods: All publications from 1995 to 2017 regarding kimchi and kimchi lactic acid bacteria were collected, reviewed, and classified. This review article covers the publications of the health benefits of kimchi and kimchi lactic acid bacteria on experimental, clinical trials, and epidemiology studies. Results: The number of publications on kimchi over the period were 590: 385 publications in Korean and 205 publications in English. The number of publications on the health benefits of kimchi and kimchi lactic acid bacteria were 95 in Korean and 54 in English. The number of publications on kimchi and kimchi lactic acid bacteria were 84 and 38, respectively, in the experimental models. Ten research papers on kimchi in clinical trials and 7 publications in epidemiology were found. Kimchi or kimchi lactic acid bacteria had protective effects against oxidative stress, mutagenicity, toxicity, cancer, dyslipidemia, hypertension, immunity, and inflammation in in vitro, cellular, and in vivo animal models. Moreover, kimchi had effects on the serum lipids, intestinal microbiota, iron status, obesity, and metabolic parameters in human clinical trials. In epidemiology, kimchi had effects on hypertension, asthma, atopic dermatitis, rhinitis, cholesterol levels, and free radicals. Conclusion: This review focused on the publications regarding the health benefits of kimchi and kimchi lactic acid bacteria, suggesting the future directions of studies about kimchi and kimchi lactic acid bacteria by producing a database for an evaluation of the health benefits of kimchi.

고려인삼과 당뇨병: 세포와 동물 및 인체실험을 통한 고려인삼의 당뇨병에 대한 효능 (Korean Ginseng and Diabetes: An Insight into Antidiabetic Effects of Korean Ginseng (Panax ginseng C. A. Meyer) in Cultured Cells, Animal Models and Human Studies)

  • 서성호;박건국;박종대
    • 생약학회지
    • /
    • 제51권1호
    • /
    • pp.1-29
    • /
    • 2020
  • Diabetes mellitus, commonly known as diabetes, is a group of metabolic disorders characterized by high blood sugar levels over a prolonged period. Diabetes has been found to show many acute complications such as cardiovascular disease, stroke, chronic kidney disease, foot ulcer and damage to eyes. Korean ginseng (Panax ginseng) has been traditionally known to normalize the functional deficiencies of the lung, spleen and stomach, and thus improve the secretion of body fluids, thereby quenching thirst, suggesting it to be effective in the treatment of diabetes. Experimental studies (in vitro and in vivo) have recently shown that Korean ginseng and its extracts exhibit antidiabetic effects, and also insulin secretion and sensitizing effects related to blood glucose control. Moreover, clinical trials on antidiabetic effects of Korean ginseng have been reported to show blood glucose control, improvement of insulin resistance, reduction of postprandial blood glucose level and improvement of serum lipids (TG, TC, LDL-C). These will be critically examined by means of in vitro studies, cell experiment, animal models and human trials with a focus on understanding of molecular mechanisms.

Recent Achievements in Stem Cell Therapy for Pediatric Gastrointestinal Tract Disease

  • Bae, Sun Hwan
    • Pediatric Gastroenterology, Hepatology & Nutrition
    • /
    • 제16권1호
    • /
    • pp.10-16
    • /
    • 2013
  • The field of stem cell research has been rapidly expanding. Although the clinical usefulness of research remains to be ascertained through human trials, the use of stem cells as a therapeutic option for currently disabling diseases holds fascinating potential. Many pediatric gastrointestinal tract diseases have defect in enterocytes, enteric nervous system cells, smooth muscles, and interstitial cells of Cajal. Various kinds of therapeutic trials using stem cells could be applied to these diseases. This review article focuses on the recent achievements in stem cell applications for pediatric gastrointestinal tract diseases.

말기 암 환자에 대한 임상시험과 피험자의 자기결정권의 본질 (The Clinical Trial of Terminal Cancer Patients and The Nature of Self-Determination of The Subject)

  • 송영민
    • 의료법학
    • /
    • 제15권1호
    • /
    • pp.211-237
    • /
    • 2014
  • Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

  • PDF

아데노바이러스 유전자치료제의 독성 (Toxicity of the Adenoviral Vector Mediated Gene Therapy)

  • 정인재
    • Environmental Analysis Health and Toxicology
    • /
    • 제24권1호
    • /
    • pp.71-77
    • /
    • 2009
  • Adenoviral vector(AdV) has been the most widely used viral vector for delivering an exogenous therapeutic gene to human. As of this date, more clinical trials utilize recombinant AdV to treat cancer and monogenic inherited disease as well as vaccine applications. However, the number of clinical trials had dropped markedly following the tragic death of a patient ongoing an AdV therapy for the treatment of an ornithine transcarbamylase deficiency(OTCD). This review is an attempt to provide the information on toxicity generated by AdVmediated gene transfer. It would serve as a sobering reality to researchers and clinicians exploring the use of AdV, as to the complications involved in human application.

Performance Analysis of th e Sign Algorithm for an Adaptive IIR Notch Filter with Constrained Poles and Zeros

  • Tani, Naoko;Xiao, Yegui
    • 대한전자공학회:학술대회논문집
    • /
    • 대한전자공학회 2000년도 ITC-CSCC -2
    • /
    • pp.681-684
    • /
    • 2000
  • Gradient-type algorithms for adaptive IIR notch filters are very attractive in terms of both performances and computational requirements. Generally, it is quite difficult to assess their performances analytically. There have been several trials to analyze such adaptive algorithms as the sign and the plain gradient algorithms for some types of adaptive IIR notch filters, but many of them still remain unexplored. Furthermore, analysis techniques used in those trials can not be directly applied to different types of adaptive IIR notch filters. This paper presents a detailed performance analysis of the sign algorithm for a well-known adaptive IIR notch filter with constrained poles and zeros, which can not be done by just applying the related existing analysis techniques, and therefore has not been attempted yet. The steady-state estimation error and mean square error (MSE) of the algorithm are derived in closed forms. Stability bounds of the algorithm are also assessed. extensive simulations are conducted to support the analytical findings.

  • PDF

Current Status of COVID-19 Vaccine Development: Focusing on Antigen Design and Clinical Trials on Later Stages

  • Pureum Lee;Chang-Ung Kim;Sang Hawn Seo ;Doo-Jin Kim
    • IMMUNE NETWORK
    • /
    • 제21권1호
    • /
    • pp.4.1-4.18
    • /
    • 2021
  • The global outbreak of coronavirus disease 2019 (COVID-19) is still threatening human health, economy, and social life worldwide. As a counteraction for this devastating disease, a number of vaccines are being developed with unprecedented speed combined with new technologies. As COVID-19 vaccines are being developed in the absence of a licensed human coronavirus vaccine, there remain further questions regarding the long-term efficacy and safety of the vaccines, as well as immunological mechanisms in depth. This review article discusses the current status of COVID-19 vaccine development, mainly focusing on antigen design, clinical trials in later stages, and immunological considerations for further study.

IMO 자율운항선박 가이드라인 분석에 관한 연구 (A Study on the Guidelines for IMO Maritime Autonomous Surface Ships(MASS))

  • 박한선;채종주;조민철
    • 한국항해항만학회:학술대회논문집
    • /
    • 한국항해항만학회 2019년도 추계학술대회
    • /
    • pp.137-138
    • /
    • 2019
  • 국제해사기구(IMO)가 지난 제101차 해사안전위원회(MSC)에서 자율운항선박에 대한 해상시운전에 관한 임시지침을 회람문서(MSC/Circ.1604)로 채택하였다. 이 지침은 향후 자율운항선박의 해상시운전에 가이드라인으로 사용될 것이며 정부당국과 이해관계자들이 MASS의 안전 확보, 환경보호 및 시스템의 운용을 위한 인프라 구축에 사용될 예정이다. 이에 본 연구에서는 IMO에서 채택한 MASS 임시운항 시운전지침을 분석하고 실제 이해관계자들의 정부책임과 의무를 명확히 구분하여 해상시운전에 필요한 리스크 관리의 주요사항을 인적요소 관점에서 제시하고자 하였다.

  • PDF