• Title/Summary/Keyword: Clinical trial center

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Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol (위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜)

  • Jong-hee Kim;Eunbin Kwag;So-jung Park;Donghyun Kim;Soodam Kim;Jihye Park;Hwa-seung Yoo
    • Herbal Formula Science
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    • v.31 no.4
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.

Biodistribution and Metabolism of I-123 Labelled Fatty Acid(I) : [I-123]15-(p-iodophenyl)pentadecanoic acid(IPPA) (I-123 표지 지방산의 체내 분포 및 대사(I) : [I-123]15-(p-iodophenyl)pentadecanoic acid(IPPA))

  • Chang, Young Soo;Lee, Dong Soo;Jeong, Jae Min;Suh, Yong-Sup;Chung, June-Key;Lee, Myung Chul;Koh, Chang-Soon
    • The Korean Journal of Nuclear Medicine
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    • v.32 no.1
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    • pp.50-60
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    • 1998
  • I-123 labelled fatty acids are suitable for investigation of regional myocardial metabolism, so they are on the clinical trial. However, the precise properties of these materials are not characterized yet. We have synthesized phenylpentadecanoic acid and labeled this compound with I-123. The purpose of this study was to examine the stability, biodistribution, metabolism and SPECT imaging of [I-123]15-(p-iodophenyl)pentadecanoic acid(I-123-IPPA) that we made. The stability test of I-123-IPPA in serum of rat, mouse and human showed no free I-123 after 1 hour. In biodistribution study in mice for various time intervals after injection(5, 10, 15, 30, 60 minutes), uptake in myocardium was 14.5%ID/g(5 min), and 1.9%ID/heart(5 min), while uptake in muscles was 2.6%ID/g(5 min). Myocardium to blood ratio and myocardium to lung ratio increased for 5 min after injection and then decreased rapidly. Chromatographic data of rat blood and urine showed that little PPA was found in blood and urine at 15-20 min after injection. The myocardial I-123-IPPA SPECT images of a dog with myocardial infarction showed defects similar to those of Tc-99m-MIBI and F-18-FDG. These data suggest that I-123-IPPA is quite stable in vitro and shows favorable biodistribution in mice. SPECT imaging with I-123-IPPA demonstrated infarct zone as photon defect in dog model of myocardial infarction. I-123-IPPA may be used for the evaluation of fatty acid metabolism in clinical trials in Korea.

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Study on the Safety of Firefly Luciferase in Human as a Transient Reporter Gene of Oncolytic Virotherapy (항암 바이러스 치료제의 보고유전자로써 반딧불이 루시퍼레이즈의 인체 내 안전성에 대한 연구)

  • Hong, Young Mi;Yoon, Woong Hee;Lee, You Ra;Kim, Soo Ji;Ngabire, Daniel;Narayanasamy, Badrinath;Ornella, Mefotse Saha Cyrelle;Kim, Myunghee;Cho, Euna;Lee, Bora;Hwang, Tae-Ho
    • Journal of Life Science
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    • v.31 no.11
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    • pp.1028-1036
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    • 2021
  • Firefly luciferase (FLuc) can function as an efficient marker in the gene and viral therapies. Nonetheless, its clinical translation has been unaccomplished with the concerns on its exogenous nature and the similarity with human fatty acyl-CoA synthetase. In this study, we aimed to show safety of FLuc by conducting a set of preclinical experiments and a human use. Initially, FLuc permeability across the plasma membrane was investigated by delivering the FLuc-carrying viral vector, OTS-412, or the FLuc recombinant protein. After in vitro infection of OTS-412 into different cancer cell lines, FLuc activity was detected only in the cell lysates, but not in culture media. In addition, recombinant FLuc protein further showed the impermeability against the plasma membrane. Similar result was also observed in the in vivo experiment. After being injected into the VX2 tumor-bearing rabbit, the FLuc exclusively resided within the tumor tissue without being detected in the blood plasma or other organs. Human cancer cell lines originated from various organs were lysed and treated to the FLuc, and none of the human substrates was reactive against the FLuc. As a final step, FLuc recombinant protein was intravenously injected into a human. The luciferase was degraded with the half-life of 20 to 30 minutes in blood, and was untraceable from 1.5 hr after the injection. In addition, the blood plasma was nonresponsive against the fatty acids. Hematological analysis was also comparable between the pre- and post-injection. Altogether, our study collectively demonstrates the safety of the firefly luciferase.

A Randomized, Double-Blind, Placebo-Controlled Trial of Early Ursodeoxycholic Acid Administration for Prevention of Total Parenteral Nutrition-Induced Hepatobiliary Complications (총정맥영양법의 간담도 합병증에 대한 Ursodeoxycholic Acid 조기투여의 이중맹검 위약대조군 연구)

  • Choe, Yon-Ho;Beck, Nam-Sun;Kim, Ji-Hee;Lee, Suk-Hyang;Park, Tae-Sung
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.5 no.2
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    • pp.174-180
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    • 2002
  • Purpose: Ursodeoxycholic acid (UDCA) is known to decrease hepatic injury by promoting the biliary secretion of retained toxic endogenous bile acids in hepatobiliary diseases complicated by total parenteral nutrition (TPN). However, most studies have focused on treatment for complications after TPN. We investigated the preventive role of early administration of UDCA in TPN-induced hepatobiliary complications by a randomized, double-blind, placebo-controlled trial. Methods: Between May 2000 and May 2002, thirteen patients, who were given TPN more than 10 days in the hospital, were assigned randomly to two groups. One was the case group (7 patients) who were given UDCA simultaneously with TPN regimen, and the other, the control group (6 patients) who were given placebo. Their age ranged from 1 day to 13 years. They were affected with diseases impossible for enteral nutrition, such as prematurity, cerebral palsy, chronic diarrhea, anorexia nervosa, pancreatitis, and cyclic vomiting. The duration of TPN ranged from 10 to 70 days. Hematologic parameters including liver function test were measured at regular intervals, and the duration, composition, administration rate, total calorie of TPN were recorded. The serum levels of total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase were compared between groups after cessation of the study. Results: The autoregressive coefficient of the control group was 0.4419 (p=0.0651) in bilirubin, -0.0431 (p=0.7923) in AST, 0.2398 (p=0.2416) in ALT, and 0.2459 (p=0.1922) in alkaline phosphatase by mixed procedure model when the parameters were referred to the case group. Conclusion: The serum level of total bilirubin did not increase in comparison with that of the control group, but statistically insignificant, when both TPN and UDCA were administered simultaneously from the beginning.

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Trends in Colorectal Cancer Incidence in Daejeon and Chungcheongnam-do, South Korea (2000-2012) (대전광역시와 충청남도의 13년간(2000-2012) 대장암 발생 추세)

  • Kim, Soon-Young;Kweon, In-Sun;Kim, Jung-A;Lee, Tae-Yong;Nam, Hae-Sung
    • Journal of agricultural medicine and community health
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    • v.40 no.3
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    • pp.115-125
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    • 2015
  • Objectives: Colorectal cancer is one of the major cancers in South Korea. We described the time trends in colorectal cancer incidence in Daejeon, a metropolitan city, and Chungcheongnam-do (Chungnam), a rural province, South Korea. Methods: Using the databases from the Daejeon Cancer Registry (DCR) and the Chungnam Cancer Registry (CCR), age-standardized (to world standard population) rates for incidence (ASRW) were calculated. Average annual percent change (AAPC) was assessed as a trend indicator. The completeness (such as the mortality/incidence ratio) and validity (such as the death certificate only %, microscopic verification %, primary site uncertain %, and age unknown %) were analyzed to examine the data quality of DCR and CCR. Results: Incidence of colorectal cancer showed increasing trend in both sexes. Over the years 2000-2012 in Daejeon, ASRW was increased significantly from 37.2 to 51.7 per 100,000 person-years (AAPC, 3.9%) among men and from 17.1 to 28.4 (AAPC, 3.9%) among women, respectively. In Chungnam, ASRW was also increased from 29.8 to 50.1 per 100,000 person-years (AAPC, 5.1%) among men and from 15.9 to 26.6 (AAPC, 3.2%) among women, respectively. The AAPC for colon cancer was greater than rectal cancer in both Daejeon and Chungnam. The trend of rectal cancer incidence was differ by sex (AAPC in men vs women, 2.7% vs 1.7% in Daejeon; 3.5% vs 0.8% in Chungnam). Indices of completeness and validity showed that the quality control of DCR and CCR was adequate to describe the trends of ASRW. Conclusions: Both Daejeon and Chungnam have had a rapid increase in colorectal cancer incidence. Monitoring and intervention are required on the risk factors which may contribute to this trend.

Antioxidant Activity of Rhododendron brachycarpum D. Don Extracts and Its Skin Hydration Effect Measure (만병초 추출물의 항산화활성과 보습효과 측정)

  • Park, Jung-Ok;Lim, Gyu-Nam;Park, Su-Nam
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.36 no.2
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    • pp.157-165
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    • 2010
  • In this study, the antioxidative effects, inhibitory effects on tyrosinase and elastase of Rhododendron brachycarpum D. Don extracts were investigated. And the moisturizing effect of cream containing R. brachycarpum D. Don extract were investigated by clinical trial. The ethyl acetate fraction of R. brachycarpum D. Don extract (1.83 ${\mu}g/mL$) showed the most prominent the free radical (1,1-diphenyl-2-picrylhydrazyl, DPPH) scavenging activity ($FSC_{50}$). Reactive oxygen species (ROS) scavenging activities ($OSC_{50}$) of R. brachycarpum D. Don extracts on ROS generated in $Fe^{3+}$-EDTA/$H_2O_2$ system were investigated using the luminol-dependent chemiluminescence assay. The 50 % extract fraction (0.064 ${\mu}g/mL$) showed the most prominent ROS scavenging activity. The protective effects of extract/fractions of R. brachycarpum D. Don on the rose-bengal sensitized photohemolysis of human erythrocytes were investigated. The R. brachycarpum D. Don extracts suppressed photohemolysis in a concentration dependent manner (1 ~ 10 ${\mu}g/mL$). The inhibitory effects ($IC_{50}$) of R. brachycarpum D. Don extracts on tyrosinase were determined with ethyl acetate fraction of R. brachycarpum D. Don extract (70.5 ${\mu}g/mL$) and aglycone fraction of extract (122.40 ${\mu}g/mL$). The inhibitory effects ($IC_{50}$) on elastase were determined with ethyl acetate of R. brachycarpum D. Don extract (43.50 ${\mu}g/mL$) and aglycone fraction of extract (20.73 ${\mu}g/mL$). The cream containing the ethyl acetate fraction of R. brachycarpum D. Don extracts was formulated for skin hydration effect and transepidermal water loss (TEWL). The cream containing R. brachycarpum D. Don extract was applied to the right lower arm. After 180 min, the water contents in skin were increased by 1 ~ 4 % than the placebo cream. And TEWL of parts was decreased as 7.7 $g/m^2h$ (experimental cream) and 8.9 $g/m^2h$ (placebo cream) respectively. These results indicate that extract/fractions of R. brachycarpum D. Don can function as antioxidants in biological systems, particularly skin exposed to UV radiation by scavenging $^1O_2$ and other ROS, and protect cellular membranes against ROS. And inhibitory activity on tyrosinase of the aglycone fraction could be applicable to new functional cosmetics for whitening and anti-wrinkle products. Also the increase of skin hydration of the cream containing extract could be applicable to new functional cosmetics for antiaging.

Etiology and Analysis of Severity in Childhood Pancreatitis (소아 췌장염의 원인과 중증도 분석)

  • Park, Jun-Eun;Kim, Kyong-Mo
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.2 no.2
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    • pp.194-203
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    • 1999
  • Purpose: Childhood pancreatitis has more various and somewhat different etiology than adult. Until now the analysis of severity in childhood pancreatitis were not well-known, although several studies have been made. Therefore, we studied the etiology and complications in childhood pancreatitis and analyzed whether Ranson and CT criteria could be applicated to evaluate the severity of childhood pancreatitis patients. Methods: The records of 30 patients with pancreatitis under 15 years of ages who were diagnosed in Asan medical center were reviewed. Age, sex, history, etiology, clinical features and treatment was reviewed in all patients but complications, Ranson and CT criteria were available in only 12 patients. Correlation between the number of complications and both Ranson and CT criteria were calculated with Spearman correlation coefficient. Results: 1. Median age at diagnosis was 7.3 years of age. 28 cases were acute pancreatitis and 2 cases were chronic pancreatitis. 2. Etiology: choledochal cyst(8 cases), drug (7 cases), trauma (4 cases), infection (3 cases), biliary stone or bile sludge (3 cases), idiopathic (2 cases) Hemolytic uremic syndrome, pancreatic duct obstruction, iatrogenic (1 case). 3. Local complications were ascites (5 cases), pseudocyts (4 cases) and systemic complications were hyperglycemia (4 cases), hypocalcemia (3 cases), pleural effusion (3 cases), etc. 4. Positive correlation was found between the number of complication and Ranson creteria (r=0.78, P=0.0016) and between the number of complication and CT criteria (r=0.65, P=0.015) in 13 cases. Conclusion: A trial to search the biliary duct anomaly may help to find the causes of childhood idiopathic pancreatitis, and both Ranson and CT criteria can be applicated to pediatric patients to evaluate the severity of childhood pancreatitis.

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Cytotoxicity test on human contact area with L-929 cells using extracorporeal shock wave therapy cartridge (체외충격파치료기 카트리지의 L-929 세포를 통한 인체접촉부의 세포독성시험)

  • Jun-tae Kim;Se-jin Yoon;So-hyun Park;Kyung-ah Kim;Jae-hyun Jo;Jin-hyoung Jeong
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.17 no.5
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    • pp.389-395
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    • 2024
  • This study was conducted to determine the cytotoxicity of the extracts from the human body contact area of the test substance during a test on the Good Laboratory Practice (GLP), which is the medical device safety evaluation standard, using the extracorporeal shock wave therapy (ESWT) cartridge as a sample, using L-929 cells. The test and control substances were extracted with 1xMEM culture medium containing 10% FBS at 37±1℃ for 24±2 hours. The test substance extract (test group), negative control substance extract (negative control group), positive control substance extract (positive control group), and blank test solution extract (solvent control group) were applied to L929 cells and cultured for 48±2 hours in a 37±1℃, 5±1% CO2 incubator. As a result of observing cell reactions under a microscope, the cells to which the blank test solution extract and negative control substance extract were applied were grade 0, the cells to which the positive control substance extract was applied were grade 4, and the cells to which the test substance extract was applied were grade 0. As a result of quantitative evaluation through cell counting, the cell viability rate of the cells to which the negative control substance extract was applied was 106.28% compared to the blank test solution extract, the cells to which the positive control substance extract was applied were 0.00%, and the cells to which the test substance extract was applied were 99.58%. Therefore, when the results of the negative and positive control groups were confirmed, the test process was appropriate, and it was determined that it did not cause cytotoxicity because the qualitative evaluation method was less than grade 2 and the quantitative evaluation method showed a cell viability rate of more than 70%.

Analysis of temperature changes and sterilization effect of diode laser for the treatment of peri-implantitis by wavelength and irradiation time (임플란트 주위염 치료용 diode laser의 파장 및 조사시간에 따른 온도 변화와 살균효과 분석)

  • Seol, Jeong-Hwan;Lee, Jun Jae;Kum, Kee-Yeon;Lee, Jong-Ho;Lim, Young-Joon
    • Journal of Dental Rehabilitation and Applied Science
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    • v.33 no.3
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    • pp.178-188
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    • 2017
  • Purpose: We compared the effects of newly developed diode laser (Bison 808 nm Diode laser) on the treatment of peri-implantitis with conventional products (Picasso 810 nm Diode laser) by comparing the surface temperature of titanium disc and bacterial sterilization according to laser power. Materials and Methods: The titanium disc was irradiated for 60 seconds and 1 - 2.5 W using diode laser 808 nm and 810 nm. The surface temperature of the titanium disc was measured using a temperature measurement module and a temperature measurement program. In addition, in order to investigate the sterilizing effect according to the laser power, 808 nm laser was irradiated after application of bacteria to sandblasted large-grit acid-etched (SLA) and resorbable blast media (RBM) coated titanium discs. The irradiated disks were examined with scanning electron microscopy. Results: Both 808 nm and 810 nm lasers increased disk surface temperature as the power increased. When the 810 nm was irradiated under all conditions, the initial temperature rise rate, the descending rate, and the temperature change before and after was higher than that of 808 nm. Disk surface changes were not observed on both lasers at all conditions. Bacteria were irradiated with 808 nm, and the bactericidal effect was increased as the power increased. Conclusion: When applying these diode lasers to the treatment of peri-implantitis, 808 nm which have a bactericidal effect with less temperature fluctuation in the same power conditions would be considered safer. However, in order to apply a laser treatment in the dental clinical field, various safety and reliability should be secured.

A Study on the Moisturizing Effect and Preparation of Liquid Crystal Structures Using Sucrose Distearate Emulsifier (슈크로오스디스테아레이트를 사용한 액정구조의 생성과 보습효과에 관한 연구)

  • Kwak, Myeong-Heon;Kim, In-Young;Lee, Hwan-Myung;Park, Joo-Hoon
    • Journal of the Korean Applied Science and Technology
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    • v.33 no.1
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    • pp.1-12
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    • 2016
  • This study is to make the liquid crystalline structure using sucrose distearate (Sucro-DS) emulsifier to create the hydrophilic type oil-in-water (O/W) emulsion, the droplets of the emulsion having a structure of a multi-lamellar structure. We have studied the physicochemical properties of Sucro-DS using those techniques. And it has been studied in the emulsion performance. In order to form the liquid crystalline structure applying 3 wt% of Sucro-DS, 5 wt% of glycerin, 5 wt% of squalane, 5 wt% of capric/caprylic triglyceride, 3wt% of cetostearyl alcohol, 1wt% of glyceryl mono-stearate, 78 wt% of pure water in mixture having the lamellar structure of stable multi-layer system was found to formed. By applying them, they were described how to create an unstable active material encapsulated cream. Further, the moisturizing cream was studied using this technique. It reported the results to the skin improvement effect by the human clinical trials. The pH range to produce a stable liquid crystal phase using a Sucro-DS was maintained in 5.2~7.5. In order to increase the stability of the liquid crystal, it was when behenyl alcohol containing 3 wt%, the hardness at this time was 13 kg/mm,min. Viscosity of the same amount was 25,000mPas/min. After a test for the effects of the emulsions, the concentration of 6 wt% Sucro-DS is that was appropriate, the particle size of the liquid crystal was 4~6mm. It was observed through a microscope analysis, reliability of the liquid crystal changes for 3 months was found to get stable at each $4^{\circ}C$, $25^{\circ}C$ and $45^{\circ}C$. In clinical trial test, before applying a moisturizing effect it was $13.4{\pm}7%$. Moisturizing cream liquid crystal was not formed in $14.5{\pm}5%$. Therefore, applying than ever before could see the moisture about 8.2% was improved. On the other hand, it was the moisturizing effect of the liquid cream is $19.2{\pm}7%$. The results showed that 43.3% improvement than that previously used. Applications fields, Sucro-DS emulsifier used liquid cream, lotion, eye cream and a variety of formulations can be developed, as well as the cosmetics industry is expected to be wide fields in the application of the external preparation for skin emulsion technology in the pharmaceutical industry and pharmaceutical industry.