• Title/Summary/Keyword: Human trials

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Classification of Mental States Based on Spatiospectral Patterns of Brain Electrical Activity

  • Hwang, Han-Jeong;Lim, Jeong-Hwan;Im, Chang-Hwan
    • Journal of Biomedical Engineering Research
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    • v.33 no.1
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    • pp.15-24
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    • 2012
  • Classification of human thought is an emerging research field that may allow us to understand human brain functions and further develop advanced brain-computer interface (BCI) systems. In the present study, we introduce a new approach to classify various mental states from noninvasive electrophysiological recordings of human brain activity. We utilized the full spatial and spectral information contained in the electroencephalography (EEG) signals recorded while a subject is performing a specific mental task. For this, the EEG data were converted into a 2D spatiospectral pattern map, of which each element was filled with 1, 0, and -1 reflecting the degrees of event-related synchronization (ERS) and event-related desynchronization (ERD). We evaluated the similarity between a current (input) 2D pattern map and the template pattern maps (database), by taking the inner-product of pattern matrices. Then, the current 2D pattern map was assigned to a class that demonstrated the highest similarity value. For the verification of our approach, eight participants took part in the present study; their EEG data were recorded while they performed four different cognitive imagery tasks. Consistent ERS/ERD patterns were observed more frequently between trials in the same class than those in different classes, indicating that these spatiospectral pattern maps could be used to classify different mental states. The classification accuracy was evaluated for each participant from both the proposed approach and a conventional mental state classification method based on the inter-hemispheric spectral power asymmetry, using the leave-one-out cross-validation (LOOCV). An average accuracy of 68.13% (${\pm}9.64%$) was attained for the proposed method; whereas an average accuracy of 57% (${\pm}5.68%$) was attained for the conventional method (significance was assessed by the one-tail paired $t$-test, $p$ < 0.01), showing that the proposed simple classification approach might be one of the promising methods in discriminating various mental states.

Robot-Assisted Transoral Odontoidectomy : Experiment in New Minimally Invasive Technology, a Cadaveric Study

  • Yang, Moon-Sul;Yoon, Tae-Ho;Yoon, Do-Heum;Kim, Keung-Nyun;Pennant, William;Ha, Yoon
    • Journal of Korean Neurosurgical Society
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    • v.49 no.4
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    • pp.248-251
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    • 2011
  • Objective : In the field of spinal surgery, a few laboratory results or clinical cases about robotic spinal surgery have been reported. In vivo trials and development of related surgical instruments for spinal surgery are required before its clinical application. We investigated the use of the da $Vinci^{(R)}$ Surgical System in spinal surgery at the craniovertebral junction in a human cadaver to demonstrate the efficacy and pitfalls of robotic surgery. Methods : Dissection of pharyngeal wall to the exposure of C1 and odontoid process was performed with full robotic procedure. Although assistance of another surgeon was necessary for drilling and removal of odontoid process due to the lack of appropriate end-effectors, successful robotic procedures for dural sutures and exposing spinal cord proved its safety and dexterity. Results : Robot-assisted odontoidectomy was successfully performed in a human cadaver using the da $Vinci^{(R)}$ Surgical System with few robotic arm collisions and minimal soft tissue damages. Da $Vinci^{(R)}$ Surgical System manifested more dexterous movement than human hands in the deep and narrow oral cavity. Furthermore, sutures with robotic procedure in the oral cavity demonstrated the advantage over conventional procedure. Conclusion : Presenting cadaveric study proved the probability of robot-assisted transoral approach. However, the development of robotic instruments specific to spinal surgery must first precede its clinical application.

The Wearing Sensation and Physiological Responses in School Wear in the High School Girl's (여고생 통학복의 착용감과 생리반응에 관한 연구)

  • Kweon, Soo-Ae
    • Korean Journal of Human Ecology
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    • v.7 no.2
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    • pp.81-91
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    • 1998
  • The subjects in this research were 368 girls in high school for survey, and wearing sensation and physiological responses were investigated through wearing trials on human body in climatic chamber based on these results from the survey. The results are as follows : 1. They enjoyed wearing t-shirts, jackets, vests, and blouses in order for the upper clothes, and they preferred t-shirts to blouses. For the lower clothes, they enjoyed slacks much more than skirts. The weight of clothes was significantly heavier in the group where they wore the uniforms(U-group) than in the group where they wore the free styles(F-group). When they chose the school wear, activity was the most important of all, and the maintenance was the least. 2. As the classes were a little cool and dry, most of them dissatisfied the environment. The degree of the satisfaction of the class environment and properties to it were higher in the U-group than in F-group. 3. In the textiles, colors, styles, activity, static electricity, seasonal property, and easiness of putting on and taking off the clothes, F-group was more satisfied than U-group. U-group was more satisfied than F-group in the soil of the clothes. 4. The thermal comfort, thickness, and tightness of the clothes were not significantly different between the groups. The clothes of U-group was heavier than those of F-group, and the tactile sensation in U-group was worse than F-group. In U-group the students felt the skirts very inconvenient when they acted. 5. The weight of the clothes influenced the wearing sensation, therefore the heavier the clothes were the less satisfied they felt. 6. The inside temperature of clothes was significantly higher in U-group than in F-group. The skin temperatures of abdomen and arm were significantly higher in U-group than in F-group, while the skin temperatures of thighs and legs were significantly lower in U-group than in F-group. U-group felt heavier than F-group in wearing the clothes. Therefore the improvement of the clothes weight is needed.

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Pre-clinical Screening Methods for Evaluating Anti-wrinkle Effect

  • Cho Moon Kyun
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.29 no.2 s.43
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    • pp.37-65
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    • 2003
  • Nowadays, we find out new anti-wrinkle-care-ingredients by in vitro searching methods using many kind of cell-culture-models for investigation of the effective anti-wrinkle-care-ingredients. But, theses new ingredients don't have effect on the human-model for anti-wrinkle, not likely on in vitro. In other words, there are so many differences between the effects on in vitro models and the clinical human models, practically. But, we actually have difficulty in putting all of the new anti-wrinkle-care-ingredients to the test on human models directly. To solve this problem, we have investigated that by using the artificial skin-culture-model or the animal model, In this lecture I will review the detail of assessment method far evaluation of anti-wrinkle agents in vitro and animal model and discuss the pros and cons of each method. Then I will present the results of Preclinical Screening trials, And especially animal model may be a good candidate for evaluation of anti-wrinkle agents.

Trials of Novel $^{13}C-Urea-Containing$ Capsule for More Economic and Sensitive Diagnosis of Helicobacter pylori Infection in Human Subjects

  • Yong, Chul-Soon;Kim, Yong-Il;Park, San-Man;Kwon, Rham;Han, Hong-Hee;Park, Jung-Gil;Yang, Chan-Yoo;Kim, Jung-Ae;Yoo, Bong-Kyu;Rhee, Jong-Dal;Choi, Han-Gon
    • Archives of Pharmacal Research
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    • v.29 no.10
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    • pp.879-883
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    • 2006
  • To develop a $^{13}C-urea-containing$ capsule for more economic and sensitive diagnosis of Helicobacter pylori infection, the $^{13}C-urea-containing$ capsules were prepared with various additives such as polyethylene glycol, microcrystalline cellulose, sodium lauryl sulfate and citric acid. Their dissolution test and $^{13}C-urea$ Breath Test in human volunteers were then performed. Polyethylene glycol increased the initial dissolution rates of urea and difference ${\sigma}$ $^{13}C$ values from $^{13}C-urea$, while microcrystalline cellulose and sodium lauryl sulfate decreased them. Irrespective of addition of citric acid, the compositions with polyethylene glycol showed higher values from $^{13}C-urea$ compared to a commercial 76 mg $^{13}C-urea-containing$ capsule due to higher initial dissolution rate. The capsules with 38 mg $^{13}C-urea$ and 1.9 mg polyethylene glycol, which showed higher Helicobacter pylori-positive value of about $8{\textperthousand}$ at 10 min, improved the sensitivity of $^{13}C-urea$ in human volunteers. Thus, the $^{13}C-urea-containing$ capsule with polyethylene glycol would be a more economical and sensitive preparation for diagnosis of Helicobacter pylori infection.

John Ruskin's Study of Nature (존 러스킨의 자연 연구)

  • Lim, Shan
    • The Journal of the Convergence on Culture Technology
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    • v.6 no.2
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    • pp.299-304
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    • 2020
  • This paper considers the research content and its historical significance of the Study of Nature conducted by John Ruskin(1819-1900) who had a profound influence on art, architecture, social reformation, and preservation of natural environment in Great Britain. Because Ruskin's Study of Nature would be the key to understand totally the implicative meaning of his various academic trials for integrating a wider contexts among human, culture, and society, without being bound by the rules of conventional disciplines. For Ruskin, 'Nature' is defined as 'a system' governing every aspects of human and non-human beings, formulating certain laws of composition. This system has an ecological quality to form a state of harmony by internal interaction and process. Such organic quality of nature worked as 'a metaphor' in Ruskin's research practices. Therefore, Ruskin's Study of Nature would be the conceptual basis for organizing and connecting its various elements of Ruskin's spiritual world.

The Processed Radish Extract Melanogenesis in Humans and Induces Anti-Photoaging Effects in Ultraviolet B-Induced Hairless Mouse Model

  • Kim, Hyun-Kyoung
    • International Journal of Advanced Culture Technology
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    • v.7 no.4
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    • pp.125-136
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    • 2019
  • The radish skin and radish greens are an edible part of the radish. But they are removed before eating the radish and used as a byproduct or an animal feed material because of their tough and rough texture. Melanin is a pigment that gives colour to our skin. But increased production of melanin can turn into benign or malignant tumours. These days due to global warming, the amount of Ultra violet (UVB) rays has been extensively increased with sunlight. Due to this, a phenomenon called exogenous photo aging is widely observed for all skin colour and types. As a result of this phenomenon, a set of enzymes called matrix metalloproteinases (MMP's) that serves as degradation enzymes for extracellular matrix proteins mainly collagen is increased, causing depletion in collagen and resulting in early wrinkles formation. Therefore in our study we used the murine melanoma cell line B16/F10 to study the melanogenesis inhibition by Heated radish extract (HRE) in vitro and we used HRM-2 hair less mice exposed to artificial UVB for checking the efficacy of Heated radish extract in vivo. Furthermore, we prepared a 3% Heated radish extract (HRE) cream and checked its effects on human skin. Our results have clearly demonstrated that Heated radish extract (HRE) have potently suppressed the tyrosinase activity and melanin production in B16/F10 cells. It had also reduced the expression of components involved in melanin production pathway both transcriptionally and transitionally. In in vivo studies, HRE had potently suppressed the expression of MMP's and reduced the wrinkle formation and inhibited collagen degradation. Moreover, on human skin, ginseng cream increased the resilience, skin moisture and enhanced the skin tone. Therefore in light of these findings, we conclude that HRE is an excellent skin whitening and antiaging product.

Split genome-based retroviral replicating vectors achieve efficient gene delivery and therapeutic effect in a human glioblastoma xenograft model

  • Moonkyung, Kang;Ayoung, Song;Jiyoung, Kim;Se Hun, Kang;Sang-Jin, Lee;Yeon-Soo, Kim
    • BMB Reports
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    • v.55 no.12
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    • pp.615-620
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    • 2022
  • The murine leukemia virus-based semi-retroviral replicating vectors (MuLV-based sRRV) had been developed to improve safety and transgene capacity for cancer gene therapy. However, despite the apparent advantages of the sRRV, improvements in the in vivo transduction efficiency are still required to deliver therapeutic genes efficiently for clinical use. In this study, we established a gibbon ape leukemia virus (GaLV) envelope-pseudotyped semi-replication-competent retrovirus vector system (spRRV) which is composed of two transcomplementing replication-defective retroviral vectors termed MuLV-Gag-Pol and GaLV-Env. We found that the spRRV shows considerable improvement in efficiencies of gene transfer and spreading in both human glioblastoma cells and pre-established human glioblastoma mouse model compared with an sRRV system. When treated with ganciclovir after intratumoral injection of each vector system into pre-established U-87 MG glioblastomas, the group of mice injected with spRRV expressing the herpes simplex virus type 1-thymidine kinase (HSV1-tk) gene showed a survival rate of 100% for more than 150 days, but all control groups of mice (HSV1-tk/PBS-treated and GFP/GCV-treated groups) died within 45 days after tumor injection. In conclusion, these findings sug-gest that intratumoral delivery of the HSV1-tk gene by the spRRV system is worthy of development in clinical trials for the treatment of malignant solid tumors.

An Ethical Consideration on the Standard Operating Procedure Operation Status and the Ethical Review of the Vulnerable Research Subjects of Institutional Review Board, a Medical Institution in Korea (우리나라 의료기관 Institutional Review Board의 취약한 연구 대상자 관련 표준운영지침서 운영 현황과 윤리적 고찰)

  • Eun Hwa Byun;Byung In Choe
    • The Journal of KAIRB
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    • v.5 no.1
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    • pp.21-32
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    • 2023
  • Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

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A Qualitative Case Study on Rights-Based Social Work Practice in a Residential Facility for People with Intellectual Disabilities (인권관점에 기초한 사회복지실천 경험에 관한 질적 사례연구 - 장애인거주시설의 종사자 경험을 중심으로 -)

  • Kim, Mi-Ok;Kim, Kyung-Hee
    • Korean Journal of Social Welfare
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    • v.63 no.1
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    • pp.29-55
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    • 2011
  • This study aims to understand the experiences of rights-based social work practice in a residential facility for people with intellectual disabilities. A representative residential facility practicing a human rights perspective was selected by recommendation of professional groups. Using a qualitative case study method, data was collected and analysed. In detail, it explores the experiences of rights-based social work practice at both organizational and individual levels respectively, and then discusses ethical dilemmas that arise from workers in the process of rights-based social work practice. According to results at the organizational level, rights-based social work practice of the residential facility began from workers' interests in needs of users with intellectual disabilities. Some trials to apply human rights in social work practice resulted in regulations for people with intellectual disabilities and stepped up organizational culture on human rights perspectives. And, at the individual level, self determination and choice of users with intellectual disabilities were stressed among various forms of human rights. As the results of rights-based social work practice, it appeared to be improved for the participation of the users, workers' human rights sensitivity, and qualities of rights-based activities. However, ethical dilemmas still existed. Hence, rights-based social work practice should understand a process of dynamic interaction between users and workers, which require workers to endeavor continuously. This study is significant in that it explored rights-based social work practice, focusing on field experiences for the first time in Korea, and suggested practical tasks to settle it down in the future.

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