• Title/Summary/Keyword: Human trials

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

  • Nam, Ju-Sun;Kang, Seung-Ho
    • The Korean Journal of Applied Statistics
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    • v.24 no.4
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    • pp.633-646
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    • 2011
  • Clinical vaccines studies (that include cancer prevention vaccines and therapeutic vaccines) are ongoing to improve the quality of life and lengthen the human lifespan. Recently clinical trials and research on vaccines have become more active due to the prevalence of new viruses such as the A(H1N1) virus that freighted the whole word in 2009. In this paper we will describe the statistical aspects of clinical vaccine trials and outline the current situation of domestic and international vaccine development.

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
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    • v.29 no.9
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    • pp.1335-1340
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    • 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.

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

  • Kim, Bohkyung;Mun, Eun-Gyung;Kim, Doyeon;Kim, Young;Park, Yongsoon;Lee, Hae-Jeung;Cha, Youn-Soo
    • Journal of Nutrition and Health
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    • v.51 no.1
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    • pp.1-13
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    • 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.

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 (고려인삼과 당뇨병: 세포와 동물 및 인체실험을 통한 고려인삼의 당뇨병에 대한 효능)

  • Seo, Seong Ho;Park, Gun Kook;Park, Jong Dae
    • Korean Journal of Pharmacognosy
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    • v.51 no.1
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    • pp.1-29
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    • 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
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    • v.16 no.1
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    • pp.10-16
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    • 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.

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

  • Song, Young-Min
    • The Korean Society of Law and Medicine
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    • v.15 no.1
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    • pp.211-237
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    • 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.

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

  • Chung, In-Jae
    • Environmental Analysis Health and Toxicology
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    • v.24 no.1
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    • pp.71-77
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    • 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
    • Proceedings of the IEEK Conference
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    • 2000.07b
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    • pp.681-684
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    • 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.

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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
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    • v.21 no.1
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    • pp.4.1-4.18
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    • 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.

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

  • Park, Han-Seon;Cha, Chong-ju;Jo, Min-chul
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 2019.11a
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    • pp.137-138
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    • 2019
  • The International Maritime Organization (IMO) adopted the Circular 101 (MSC / Circ. 1604) as an interim guidelines for MASS trials at the 101st Maritime Safety Committee. This guideline will be used as a guideline for the sea trials of Maritime Autonomous Surface Ships(MASS) in the future and will be used by government authorities and stake-holders to secure infrastructure for MASS safety, environmental protection and remote operation. The purpose of this study is to analyze the Interim Guidelines for MASS Trials adopted by IMO and to clearly classify the responsibilities and obligations of governments of stake-holders, and to present the main points of risk management necessary for maritime test operation from the perspective of human factors.

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