• 제목/요약/키워드: Human trials

검색결과 389건 처리시간 0.024초

국내 임상시험 및 대상자 보호프로그램 도입 현황과 안전관 리체계에 대한 설문조사 연구 (A Survey on the Current Status of Human Research Protection Program Settlement and Subject Protection Activities in Korea)

  • 박신영;조수진;서경정;김진석
    • 대한기관윤리심의기구협의회지
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    • 제3권2호
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    • pp.28-36
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    • 2021
  • Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

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Differential Behaviour of Selenium Analogs against Anticancer Drug Induced Apoptosis of Lymphocytes in Human Peripheral Blood

  • Elango, Sonaa;Subbiah, Usha;Jain, Jeong
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권5호
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    • pp.2527-2533
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    • 2016
  • Sensitising cancer cells and at the same time desensitizing normal cells is a double task in cancer management. Agents which can combat the debilitating side effects of cancer therapeutics and simultaneously synergize with anticancer agents in specifically targeting cancer cells are needed. Selenium, a proven anticarcinogen, gains due importance in terms of its efficacy to combat the side effects of cancer therapy. This study is a comparative analysis of the chemoprotective effects of selenium compounds, methyl selenol (generated from organic selenomethionine (5mmol/L ; METase 40U/L)) and sodium selenite (inorganic form)($30{\mu}M$) in peripheral blood human lymphocytes exposed to cisplatin and mitomycin. Biochemical alterations occurring in many cells during apoptosis include loss of plasma membrane phospholipid asymmetry, DNA fragmentation, and activation of caspase-3. The present study demonstrated that the selenium metabolite and selenite are efficient in protecting lymphocytes undergoing DNA damage and exerted their activity by reducing caspase 3 expression. Interestingly organic methylselenol (MeSe) was found to offer more protective effects compared to inorganic selenite (SeL), by reducing the induction of apoptosis by the cytotoxic agents. This suggests that MeSe and to a lesser extent selenite might have potential for assessment in clinical trials and could be considered as strong candidates in pharmacogenomics or in the nutriprotective arena.

인간 지방조직에서 분리된 줄기세포의 표면항원 및 다분화능 확인 (Isolation and Characterization of Cells from Human Adipose Tissue Developing into Osteoblast and Adipocyte)

  • 조혜경
    • 대한임상검사과학회지
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    • 제40권2호
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    • pp.106-112
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    • 2008
  • Bone marrow derived mesenchymal stem cells (BMSCs) are largely studied for their potential clinical use. But it is hard to get enough number of those cells for clinical trials and give serious pain to the patients. Adipose tissue is derived from the embryonic mesenchyme and contains a stroma that is easily isolated with large amount. This cell population (adipose derived stem cells: ADSCs) can be isolated from human lipoaspirates and like MSCs, differentiate toward the osteogenic, adipogenic, myogenic and chondrogenic lineages. To confirm whether adipose tissue contains stem cells, the ADSCs extracted from omental or subcutaneous fat tissue were expanded during third to fifth passages. The phenotype of the ADSCs was identified by the conventional cell surface markers using flow cytometry: positive for CD29 and CD44, but negative for CD34, CD45, CD117 and HLA-DR that similar to those observed on BMSCs. The ADSCs were able to differentiate into the osteoblast or adipocytes with induction media. Finally, ADACs expressed multiple CD marker antigens similar to those observed on BMSCs and differentiated into osteoblast, adipocyte. With this, human adipotissue contains multipotent cells and may represent an alternative stem cell source to bone marrow-derived MSCs.

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Exploring the Potential of Modifying Visual Stimuli in Virtual Reality to Reduce Hand Tremor in Micromanipulation Tasks

  • Prada, John;Park, Taiwoo;Jang, Sunjin;Im, Jintaek;Song, Cheol
    • Current Optics and Photonics
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    • 제1권6호
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    • pp.642-648
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    • 2017
  • Involuntary hand tremor has been a serious challenge in micromanipulation tasks and thus draws a significant amount of attention from related fields. To minimize the effect of the hand tremor, a variety of mechanically assistive solutions have been proposed. However, approaches increasing human awareness of their own hand tremor have not been extensively studied. In this paper, a head mount display based virtual reality (VR) system to increase human self-awareness of hand tremor is proposed. It shows a user a virtual image of a handheld device with emphasized hand tremor information. Provided with this emphasized tremor information, we hypothesize that subjects will control their hand tremor more effectively. Two methods of emphasizing hand tremor information are demonstrated: (1) direct amplification of tremor and (2) magnification of virtual object, in comparison to the controlled condition without emphasized tremor information. A human-subject study with twelve trials was conducted, with four healthy participants who performed a task of holding a handheld gripper device in a specific direction. The results showed that the proposed methods achieved a reduced level of hand tremor compared with the control condition.

스마트디바이스를 활용한 인지 능력 훈련 기능성 게임 개발 (The Development of Serious Game for the Cognitive Ability Training using Smart Device)

  • 양영욱;임희석
    • 한국게임학회 논문지
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    • 제11권6호
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    • pp.23-31
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    • 2011
  • 인지능력은 뇌가 담당하고 있는 기능을 의미하며, 실생활과 밀접하게 연관되어 있다. 인간이 노화하면 뇌의 기능이 저하되며, 그것은 인지능력의 상실을 의미한다. 하지만 뇌의 가소성이라는 특성으로 훈련을 통해 뇌 기능의 회복과 저하를 도모할 수 있다. 이러한 훈련 작업을 두뇌 훈련 또는 인지능력 훈련이라고 한다. 인지능력 훈련은 주기적으로 해주어야 한다. 하지만 인지 능력 훈련은 반복적인 수행을 요구하기 때문에 사용자는 일반적으로 따분함을 느끼기 쉽다. 본 논문은 스마트디바이스 기반의 기능성 게임을 제안한다. 제안하는 기능성 게임은 인지능력 훈련을 반복적으로 수행할 수 있도록 게임적인 요소를 활용하여 사용자의 참여와 집중을 유도하였다. 수집된 데이터의 분석을 통하여 주의력과 인지적 유연성의 효과성을 확인할 수 있었다.

Ginseng and Diabetes: The Evidences from In Vitro, Animal and Human Studies

  • Yuan, Hai-Dan;Kim, Jung-Tae;Kim, Sung-Hoon;Chung, Sung-Hyun
    • Journal of Ginseng Research
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    • 제36권1호
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    • pp.27-39
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    • 2012
  • Panax ginseng exhibits pleiotropic beneficial effects on cardiovascular system, central nervous system, and immune system. In the last decade, numerous preclinical findings suggest ginseng as a promising therapeutic agent for diabetes prevention and treatment. The mechanism of ginseng and its active components is complex and is demonstrated to either modulate insulin production/secretion, glucose metabolism and uptake, or inflammatory pathway in both insulin-dependent and insulin-independent manners. However, human studies are remained obscure because of contradictory results. While more studies are warranted to further understand these contradictions, ginseng holds promise as a therapeutic agent for diabetes prevention and treatment. This review summarizes the evidences for the therapeutic potential of ginseng and ginsenosides from in vitro studies, animal studies and human clinical trials with a focus on diverse molecular targets including an AMP-activated protein kinase signaling pathway.

Effects of Adenoviral Gene Transduction on the Stemness of Human Bone Marrow Mesenchymal Stem Cells

  • Marasini, Subash;Chang, Da-Young;Jung, Jin-Hwa;Lee, Su-Jung;Cha, Hye Lim;Suh-Kim, Haeyoung;Kim, Sung-Soo
    • Molecules and Cells
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    • 제40권8호
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    • pp.598-605
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    • 2017
  • Human mesenchymal stem cells (MSCs) are currently being evaluated as a cell-based therapy for tissue injury and degenerative diseases. Recently, several methods have been suggested to further enhance the therapeutic functions of MSCs, including genetic modifications with tissue- and/or diseasespecific genes. The objective of this study was to examine the efficiency and stability of transduction using an adenoviral vector in human MSCs. Additionally, we aimed to assess the effects of transduction on the proliferation and multipotency of MSCs. The results indicate that MSCs can be transduced by adenoviruses in vitro, but high viral titers are necessary to achieve high efficiency. In addition, transduction at a higher multiplicity of infection (MOI) was associated with attenuated proliferation and senescence-like morphology. Furthermore, transduced MSCs showed a diminished capacity for adipogenic differentiation while retaining their potential to differentiate into osteocytes and chondrocytes. This work could contribute significantly to clinical trials of MSCs modified with therapeutic genes.

치약에 대한 YD-38 세포주를 활용한 새로운 구강 점막 자극 시험방법 (The New in vitro Oral Irritation Test Method for Toothpaste using YD-38 Oral Mucosal Cell Line)

  • 남기백;조선아;조준철;김찬호;김유진;이존환;신계호
    • 대한화장품학회지
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    • 제38권4호
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    • pp.305-310
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    • 2012
  • 우리는 평생 동안 하루도 빠짐없이 치약과 같은 구강관리 제품들을 사용한다. 이와 같이 매일 입에 사용되는 제품의 안전성이 담보되어야 함은 매우 중요한 일이다. 이전까지 이루어진 동물시험이나 임상시험에서 치약 내 계면활성제 등에 의한 구강 자극이 유발될 수 있음이 알려져 있다. 하지만, 동물복지를 위하여 유럽 화장품 법안은 화장품과 그에 사용하는 원료에 대한 동물 시험을 금지했다. 그로 인해 여러 분야에서 동물을 대체하거나 동물의 사용을 줄일 수 있는 동물대체 시험법의 개발이 활발하게 이루어지고 있다. 하지만, 현재까지 구강 점막 독성을 측정할 수 있는 방법으로 임상시험과 동물시험이 있었으며, 최근에는 구강 점막 조직 모델이나 구강 세포들을 활용한 방법들이 연구되고 있다. 이번 연구의 목적은 구강관리 제품의 안전성을 확보할 수 있는 동물대체 시험법을 개발하는 것이다. 구강 세포주(YD-38 cell)를 활용해 불용성 물질을 포함한 치약에 대한 시험이 가능하도록 구강 점막 자극 시험법을 개발하였고, 이 시험법으로 이전에 이루어진 동물시험에서 자극유발원으로 알려진 물질에 의한 자극을 구별해낼 수 있었다. 또한, 유아와 어린이 치약의 자극 수준이 일반 성인 치약에 비해 낮음을 증명하였다. 이 결과를 바탕으로 동물을 사용하지 않고 인체에 대한 위해성을 줄일 수 있도록, 구강관리 제품의 구강 점막 자극 수준을 평가할 수 있는 이 시험법이 하나의 새로운 구강 자극 시험 방법으로 사용될 수 있으리라 사료된다.

Mid-infrared (MIR) spectroscopy for the detection of cow's milk in buffalo milk

  • Anna Antonella, Spina;Carlotta, Ceniti;Cristian, Piras;Bruno, Tilocca;Domenico, Britti;Valeria Maria, Morittu
    • Journal of Animal Science and Technology
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    • 제64권3호
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    • pp.531-538
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    • 2022
  • In Italy, buffalo mozzarella is a largely sold and consumed dairy product. The fraudulent adulteration of buffalo milk with cheaper and more available milk of other species is very frequent. In the present study, Fourier transform infrared spectroscopy (FTIR), in combination with multivariate analysis by partial least square (PLS) regression, was applied to quantitatively detect the adulteration of buffalo milk with cow milk by using a fully automatic equipment dedicated to the routine analysis of the milk composition. To enhance the heterogeneity, cow and buffalo bulk milk was collected for a period of over three years from different dairy farms. A total of 119 samples were used for the analysis to generate 17 different concentrations of buffalo-cow milk mixtures. This procedure was used to enhance variability and to properly randomize the trials. The obtained calibration model showed an R2 ≥ 0.99 (R2 cal. = 0.99861; root mean square error of cross-validation [RMSEC] = 2.04; R2 val. = 0.99803; root mean square error of prediction [RMSEP] = 2.84; root mean square error of cross-validation [RMSECV] = 2.44) suggesting that this method could be successfully applied in the routine analysis of buffalo milk composition, providing rapid screening for possible adulteration with cow's milk at no additional cost.

면역보조제의 작용 및 개발 (A Current Research Insight into Function and Development of Adjuvants)

  • 손은수;손은화;표석능
    • IMMUNE NETWORK
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    • 제4권3호
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    • pp.131-142
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    • 2004
  • In recent years, adjuvants have received much attention because of the development of purified subunit and synthetic vaccines which are poor immunogens and require adjuvants to evoke the immune response. Therefore, immunologic adjuvants have been developed and testing for most of this century. During the last years much progress has been made on development, isolation and chemical synthesis of alternative adjuvants such as derivatives of muramyl dipeptide, monophosphoryl lipid A, liposomes, QS-21, MF-59 and immunostimulating complexes (ISCOMS). Biodegradable polymer microspheres are being evaluated for targeting antigens on mucosal surfaces and for controlled release of vaccines with an aim to reduce the number of doses required for primary immunization. The most common adjuvants for human use today are aluminum hydroxide and aluminum phosphate. Calcium phosphate and oil emulsions have been also used in human vaccination. The biggest issue with the use of adjuvants for human vaccines is the toxicity and adverse side effects of most of the adjuvant formulations. Other problems with the development of adjuvants include restricted adjuvanticity of certain formulations to a few antigens, use of aluminum adjuvants as reference adjuvant preparations under suboptimal conditions, non-availability of reliable animal models, use of non-standard assays and biological differences between animal models and humans leading to the failure of promising formulations to show adjuvanticity in clinical trials. The availability of hundreds of different adjuvants has prompted a need for identifying rational standards for selection of adjuvant formulations based on safety and sound immunological principles for human vaccines. The aim of the present review is to put the recent findings into a broader perspective to facilitate the application of these adjuvants in general and experimental vaccinology.