• Title/Summary/Keyword: Clinical trial center

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The Ability of Anti-tumor Necrosis Factor Alpha(TNF-${\alpha}$) Antibodies Produced in Sheep Colostrums

  • Yun, Sung-Seob
    • 한국유가공학회:학술대회논문집
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    • 2007.09a
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    • pp.49-58
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    • 2007
  • Inflammatory process leads to the well-known mucosal damage and therefore a further disturbance of the epithelial barrier function, resulting abnormal intestinal wall function, even further accelerating the inflammatory process[1]. Despite of the records, etiology and pathogenesis of IBD remain rather unclear. There are many studies over the past couple of years have led to great advanced in understanding the inflammatory bowel disease(IBD) and their underlying pathophysiologic mechanisms. From the current understanding, it is likely that chronic inflammation in IBD is due to aggressive cellular immune responses including increased serum concentrations of different cytokines. Therefore, targeted molecules can be specifically eliminated in their expression directly on the transcriptional level. Interesting therapeutic trials are expected against adhesion molecules and pro-inflammatory cytokines such as TNF-${\alpha}$. The future development of immune therapies in IBD therefore holds great promises for better treatment modalities of IBD but will also open important new insights into a further understanding of inflammation pathophysiology. Treatment of cytokine inhibitors such as Immunex(Enbrel) and J&J/Centocor(Remicade) which are mouse-derived monoclonal antibodies have been shown in several studies to modulate the symptoms of patients, however, theses TNF inhibitors also have an adverse effect immune-related problems and also are costly and must be administered by injection. Because of the eventual development of unwanted side effects, these two products are used in only a select patient population. The present study was performed to elucidate the ability of TNF-${\alpha}$ antibodies produced in sheep colostrums to neutralize TNF-${\alpha}$ action in a cell-based bioassay and in a small animal model of intestinal inflammation. In vitro study, inhibitory effect of anti-TNF-${\alpha}$ antibody from the sheep was determined by cell bioassay. The antibody from the sheep at 1 in 10,000 dilution was able to completely inhibit TNF-${\alpha}$ activity in the cell bioassay. The antibodies from the same sheep, but different milkings, exhibited some variability in inhibition of TNF-${\alpha}$ activity, but were all greater than the control sample. In vivo study, the degree of inflammation was severe to experiment, despite of the initial pilot trial, main trial 1 was unable to figure out of any effect of antibody to reduce the impact of PAF and LPS. Main rat trial 2 resulted no significant symptoms like characteristic acute diarrhea and weight loss of colitis. This study suggested that colostrums from sheep immunized against TNF-${\alpha}$ significantly inhibited TNF-${\alpha}$ bioactivity in the cell based assay. And the higher than anticipated variability in the two animal models precluded assessment of the ability of antibody to prevent TNF-${\alpha}$ induced intestinal damage in the intact animal. Further study will require to find out an alternative animal model, which is more acceptable to test anti-TNF-${\alpha}$ IgA therapy for reducing the impact of inflammation on gut dysfunction. And subsequent pre-clinical and clinical testing also need generation of more antibody as current supplies are low.

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Depression and Coronary Artery Disease(I) : Pathophysiologic Mechanisms (우울증과 관상동맥 질환(I) : 병태생리적 기전)

  • Bae, Kyung-Yeol;Kim, Jae-Min;Yoon, Jin-Sang
    • Korean Journal of Biological Psychiatry
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    • v.15 no.4
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    • pp.275-287
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    • 2008
  • Depression and coronary artery disease are both highly prevalent diseases. Many previous studies suggest that depression is a common comorbid condition in patients with coronary artery disease and has a significant negative impact on the onset, course, and prognosis of coronary artery disease. However, the exact mechanisms that underlie the association between these two diseases remain unclear. Pathophysiologic mechanisms that may explain the effect of depression on coronary artery disease include hypercoagulability, hypothalamus-pituitary-adrenal axis and autonomic nervous system dysregulation, altered inflammatory response. On the contrary, pathophysiologic mechanisms in coronary artery disease that affect depression are less well known. It is also suggested that both diseases may share a common genetic vulnerability. The authors reviewed the literature on the pathophysiologic relationships of depression and coronary heart disease.

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Skin Improvement Effects and Development of Liposome Capsule Technology Using Centella Asiatica Extract Powder (센텔라아시아티카정량추출물의 리포좀 캡슐기술 개발과 피부개선효과)

  • Kim, Seong Jang;Ju, Yeon Jeong;Kim, In-Young
    • Journal of the Korean Applied Science and Technology
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    • v.37 no.5
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    • pp.1285-1297
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    • 2020
  • In this study, we report the results of a study on the clinical evaluation of wrinkle improvement by developing a method for liposome of high-purity Centella asiatica extract used in pharmaceuticals and cosmetics, and a cream using the same. In order to make Centellasome-10EX stabilizing centella asiatica extract in liposome lamella vesicle, it could be completed using 5% hydrogenated lecithin and 2% sucrose distearate. The appearance of Centellasome-10EX was a creamy form of low viscosity, the color was pale yellow, and the odor had the inherent odor of the raw material. The pH was about 6.12, the specific gravity was 1.09, and the acid value was about 0.35. The content of the main constituents of centella asiatica extract contained in the liposome vesicle contains 10,800 ppm of asiatic acid, 10,900 ppm of asiaticoside, 6,000 ppm of madecasic acid, and 1,600 ppm of madecassoside, and long-term storage. There was no discoloration even at the time, and it was found that the main component remained stable thermodynamically. To mechanistically analyze the structure of the liposome vesicle of Centellasome-10EX, as a result of observation with a transmission electron microscope (Cryo-TEM), the multilayer vesicles are formed and filled with moisture, and there are 10 to 60 multilayers around it. It was confirmed that the liposome lamella vesicle was formed. As a clinical trial (in-vivo) test, the moisturizing effect of centellasome cream after application for 5 weeks was 28.3%, which was significantly increased compared to placebo. The skin elasticity effect was 13.6%, which significantly increased the moisturizing power than the placebo. The effect of improving fine wrinkles around the eyes was improved by 23.52% compared to placebo cream. Through the results of this study, it was possible to study the formulation and manufacturing method for encapsulation and stabilization of the developed Centellasome-10EX in the liposome vesicle. It is expected that the results obtained through clinical research on the wrinkle improvement effect of the cream using this can be widely used to study skin science in the cosmetic industry and to develop high-quality cosmetics with high efficacy.

Comparison of Different Methods of Aortic Valve Conduit Xenograft Preservation in an Animal Experiment Model; Fresh Cryopreservation versus Acellularized Cryopreservation (동물 실험 모델에서 적용한 이종대동맥판막도관의 조직보존방법 비교; 신선 냉동보존과 무세포화 냉동보존)

  • Kim, Chang Young;Kim, Kyung-Hwan;Moon, Kyung Chul;Kim, Woong-Han;Sung, Si-Chan;Kim, Yong-Jin
    • Journal of Chest Surgery
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    • v.43 no.1
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    • pp.11-19
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    • 2010
  • Background: The commercially used vascular xenografts have some problems such as calcification, fibrosis and tissue degeneration that are associated with inflammatory and immunologic reactions. We compared two methods of xenograft preservation (fresh cryopreservation versus acellularized cryopreservation) of goat aorta. Material and Method: Aortic valved xenografts were harvested from adult pigs, and these were preserved using fresh cryopreservation (FC group, n=4) or acellularized crypreservation (AC group, n=4). These xenografts were implanted into adult goats. There were 2 short-term survivors (less than 100 days) and 2 long-term survivors in each group. These xenografts were explanted and they underwent microscopic examination. Result: The goats survived 31, 40, 107 and 411 days in the FC group and the other goats survived 5, 40, 363 and 636 days in the AC group. All the short-term survivors in each group expired because of rupture at the proximal anastomosis site. Marked neutrophil infiltration was observed in the FC group FC and lymphocytes were observed in the AC group. There were no differences in the occurrence of calcification, fibrosis and thrombosis among the groups. Conclusion: Some goats survived more than 100 days after the xenograft implantation irrespective of the methods of preservation. Because severe tissue degeneration developed in both groups, we think these methods are not appropriate for xenograft preservation of aorta. It was worth a preliminary trial for improving the preservation method or to modify the processing of xenografts.

New Whitening Agent : Selina-4(14), 7(11)-dien-8-one (신규 미백제 : Selina-4(14), 7(11)-dien-8-one)

  • Kim, Cheong-Taek;Chang, Yun-Hee;Lee, Sang-Hwa;Kang, Sang-Jin;Cho, Wan-Goo
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.31 no.1 s.49
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    • pp.17-23
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    • 2005
  • We had previously reported that Selina (selina-4(14), 7(11)-dien-8-one) was isolated from methanol extract of Afractylodes rhizome and has strong whitening activity in B16 melanoma cells. In this report, we demonstrated its action mechanism in melan-a cells, non-tumorigenic melanocytes. We also investigated the clinical efficacy of cosmetic preparation containing Selina. Selina reduced the melanin synthesis of Melan-a cells by $50\%$ at a concentration of $10 {\mu}g/mL$ without any apparent cytotoxicity. We also found that the treatment of cells with Selina decreased tyrosinase activity by $60\%$ at a concentration of $10 {\mu}g/mL$ but Selina was not a direct inhibitor of tyrosinase activities. To elucidate the action mechanism of Selina, we investigated the changes in mRNA and protein level of tyrosinase, TRP-1 and TRP-2 using RT-PCR and western blotting, respectively. As a result, the mRNA and protein level of tyrosinase were markedly reduced at $10 {\mu}g/mL$ of Selina without any effect on TRP-1 and TRP-2. These results suggest that Selina exerts its whitening effect mainly through regulating expression of tyrosinase. A 7 week-clinical trial using formulation containing $0.2\%$ selina-4(14), 7(11)-dien-8-one with 20 volunteers resulted in statistically significant whitening effect (p < 0.05), without any adverse effect. Based on these results, Selina (selina-4(14), 7(11)-dien-8-one) can be s useful and safe ingredient for the cleanness and brightness of skin.

A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration (Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험)

  • Oh, Dal-Seok;Jung, So-Young;Kim, Ae-Ran;Kang, Wee-Chang;Park, Ji-Eun;Koo, Chang-Mo;Choi, Jun-Yong;Jung, Hee-Jung;Choi, Sun-Mi;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.29 no.1
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    • pp.1-6
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    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

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Advances in Radiation Oncology in New Millennium in Korea (21세기 방사선종양학의 전망:최근의 진보와 한국에서의 발전)

  • Huh, Seung-Jae;Park, Chan-Il
    • Radiation Oncology Journal
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    • v.18 no.3
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    • pp.167-176
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    • 2000
  • The objective of recent radiation therapy is to improve the quality of treatment and the after treatment quality of life. In Korea, sharing the same objective, significant advancement was made due to the gradual increase of patient number and rapid increase of treatment facilities. The advancement includes generalization of three-dimensional conformal radiotherapy (3D-CRT), application of linac-based stereotactic radiosurgery (SRS), and furthermore, the introduction of intensity modulated radiation therapy (IMRT). Authors in this paper prospectively review the followings: the advancement of radiation oncology in Korea, the recent status of four-dimensional radiation therapy, IMRT, the concept of the treatment with biological conformity, the trend of combined chemoradiotherapy, the importance of internet and radiation oncology information management system as influenced by the revolution of information technology, and finally the global trend of telemedicine in radiation oncology. Additionally, we suggest the methods to improve radiotherapy treatment, which include improvement of quality assurance (QA) measures by developing Koreanized QA protocol and system, regional study about clinical protocol development for phase three clinical trial, suggestion of unified treatment protocol and guideline by academic or research societies, domestic generation of treatment equipment's or system, establishment of nationwide data base of radiation-oncology-related information, and finally patterns-of-care study about major cancers.

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Comparison of the Effects of Virtual Reality and Task-Oriented Programs of Balance for the Elderly (가상현실 프로그램과 현실화된 과제 지향 프로그램이 노인의 균형에 미치는 효과 비교)

  • Kim, Jin-Joo;Shin, Sun-Jung;An, Seul-Gi;Lee, Eun-Byeol;Jo, Han-Ul;Paik, Young-Rim;Cha, Jung-Jin;Lee, Hyang-Sook;Noh, Jong-Su
    • The Journal of Korean society of community based occupational therapy
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    • v.3 no.2
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    • pp.33-46
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    • 2013
  • Objective : The purpose of this research is to discuss on comparative assessments between virtual reality and task-oriented programs of balance for elderly. Method : 12 healthy elderly for each program are received twice a week for 6 week period. Changes in balance ability were assessed using Berg Balance Scale (BBS), Timed Up and Go(TUG), One-Legged Stance Test(OLST) and 5 - Repetition Sit-To-Stand test(5R-STS test). Result : All groups were not statistically meaningful differences between pre- and post-program. However, comparative outcomes among three groups were statistically significant in opening the eyes of One-Legged Stance Test(OLST) from the left and right side, and Berg Balance Scale(BBS). In post hoc, shows a statistically significant in both programs with opening the eyes of One-Legged Stance Test(OLST) from left side. Conclusion : Task-oriented programs is more useful and effective clinical methodology for balance excise programs for elderly. In addition, this clinical trial may be easily implemented by elder care facilities.

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The Study on the Effectiveness of Acupuncture in Stroke Rehabilitation (중풍(中風) 재활(再活)의 침치료(鍼治療) 효과(效果)에 대한 고찰(考察) -최근 RCT(Randomized controlled trial) 논문을 중심으로-)

  • Kim, Eun-jung;Lee, Jae-dong;Kang, Sung-keel
    • Journal of Acupuncture Research
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    • v.22 no.1
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    • pp.211-221
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    • 2005
  • Objective : The aim of this study is to review clinical trials on the effectiveness of acupuncture in stroke rehabilitation. Methods : Computerized literature searches was carried out on three electronic databases, and hand-searching on some chinese medical journals in library of Kyung Hee Medical Center. Results : 1) Sixteen articles of clinical trials were collected and reviewed. Among these articles, randomized controlled trials were achieved in nine articles. 2) In three articles, statically significant results in improvement of mobile abilities, activities of daily life and Quality of life were reported after acupuncture treatment applied as a part of stroke rehabilitation. In three articles no statically significant changes were reported. 3) Among two articles about spasticity, One about the upper limbs and the results showed statically significant improvement of the spasticity after acupuncture treatment as stroke rehabilitation, and the other was about the lower limbs and the results showed no statically significant changes. 4) One article about acupuncture and postural control showed statically significant results suggesting that acupuncture promotes normalization of postural control after stroke.

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Assessment of the Therapeutic Potential of Persimmon Leaf Extract on Prediabetic Subjects

  • Khan, Mohd M.;Tran, Bao Quoc;Jang, Yoon-Jin;Park, Soo-Hyun;Fondrie, William E.;Chowdhury, Khadiza;Yoon, Sung Hwan;Goodlett, David R.;Chae, Soo-Wan;Chae, Han-Jung;Seo, Seung-Young;Goo, Young Ah
    • Molecules and Cells
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    • v.40 no.7
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    • pp.466-475
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    • 2017
  • Dietary supplements have exhibited myriads of positive health effects on human health conditions and with the advent of new technological advances, including in the fields of proteomics, genomics, and metabolomics, biological and pharmacological activities of dietary supplements are being evaluated for their ameliorative effects in human ailments. Recent interests in understanding and discovering the molecular targets of phytochemical-gene-protein-metabolite dynamics resulted in discovery of a few protein signature candidates that could potentially be used to assess the effects of dietary supplements on human health. Persimmon (Diospyros kaki) is a folk medicine, commonly used as dietary supplement in China, Japan, and South Korea, owing to its different beneficial health effects including anti-diabetic implications. However, neither mechanism of action nor molecular biomarkers have been discovered that could either validate or be used to evaluate effects of persimmon on human health. In present study, Mass Spectrometry (MS)-based proteomic studies were accomplished to discover proteomic molecular signatures that could be used to understand therapeutic potentials of persimmon leaf extract (PLE) in diabetes amelioration. Saliva, serum, and urine samples were analyzed and we propose that salivary proteins can be used for evaluating treatment effectiveness and in improving patient compliance. The present discovery proteomics study demonstrates that salivary proteomic profile changes were found as a result of PLE treatment in prediabetic subjects that could specifically be used as potential protein signature candidates.