• 제목/요약/키워드: human clinical trial

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Clinical comparison of resorbable and nonresorbable Barrier in guided tissue regeneration of human intrabony defects (흡수성 차폐막을 이용한 조직유도재생술의 임상적 효과)

  • Hur, Yin-Shik;Kwon, Young-Hyuk;Lee, Man-Sup;Park, Joon-Bong;Herr, Yeek
    • Journal of Periodontal and Implant Science
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    • v.29 no.1
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    • pp.193-207
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    • 1999
  • The purpose of this study was to compare the clinical results of guided tissue regeneration(GTR) using a resorbable barrier manufactured from an copolymer of polylactic acid (PLA) and polylaetic-glycolic acid(PLGA) with those of nonresorbable ePTFE barrier. Thirty two patients(25 to 59 years old) with one radiographically evident intrabony lesion of probing depth ${\geq}$6mm participated in a 6-month controlled clinical trial. The subjects were randomly divided into three independent groups. The first group(n=8) received a ePTFE barrier. The second group (n=12) received a resorbable PLA/PLGA barrier. The third group (n=12) received a resorbable PLA/PLGA barrier combined with an alloplastic bone graft. Plaque index (PI), gingival index(GI), probing depth(PD), gingival recession, clinical attachment level(CAL), and tooth mobility were recorded prior to surgery and at 3, 6 months postsurgery, Statistical tests used to analyze these data included independent t-test, paired t-test, one-way ANOVA. The results were as follows : 1. Probing depth was significantly reduced in all groups at 3, 6 months postsurgery and there were not significant differences between groups. 2. Clinical attachment level was significantly increased in all groups at 3, 6 months postsurgery and there were not significant differences between groups. 3. There were not significant differences in probing depth, clinical attachment level, gingival recession, tooth mobility between second group (PLA/PLGA barrier) and third group (PLA/PLGA barrier combined with alloplastic bone graft) 4. Tooth mobility was not significantly increased in all groups at 3, 6 months postsurgery and there were not significant differences between groups. In conclusion, PLA/PLGA resorbable barrier has similar clinical potential to eP'IFE barrier in GTR procedure of intrabony pockets under the present protocol.

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Clinical trial of leptospires vaccine on it immunogenicity and safety (렙토스피라 백신의 면역성 및 안전성에 관한 임상적 연구)

  • Yoon, Hyeong-Ryeol;Kim, Jeong-Soon;Heo, Yong
    • Journal of Preventive Medicine and Public Health
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    • v.23 no.1 s.29
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    • pp.57-64
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    • 1990
  • Since the reservoir of leptospires organism is consisted of a broad spectrum of animals, the best method of prevention is vaccination. The clinical trial of leptospires vaccine conducted on human volunteer for its immunogenicity and safety. Summarized results are as following : 1. The Oral temperature among vaccinated group ranged from $36.7{\pm}0.46^{\circ}C\;to\;37.0{\pm}0.34^{\circ}C$, while in placebo injected group it ranged from $36.4{\pm}0.46^{\circ}C\;to\;36.7{\pm}0.53^{\circ}C$. There was no association between vaccination and fever (p>0.05) 2. Mild local reactions revealed in vaccinees were swelling (50-75% ), Redness($75{\sim}90%$), and induration ($25{\sim}40%$). Placebo injected group revealed only redness in 12.5% in 1st injection and 37.5% in second injection. The duration local reactions on injection site for th vaccinees and place groups disappeared within 48 hours. 3. Generalized Symptoms complained by the vaccinees were myalgia (25%), back pain(15%), headache (15%), pruritus(15%), and abdominal pain(10%), whereas placebo group complained of headache (25%), myalgia(12.5%), back pain(12.5%), pain in eyes(12.5%), abdominal pain(12.5%) pruritus (12.5%) and nausea(12.5%). 4. The serological test(MAT) of vaccinees showed geometric mean antibody titer as follows : a. L. icterohemorrhagiae lai 1 week after 1st vaccination : 22.45 1 week after 2nd vaccination : 111.23 3 week after 2nd vaccination : 266.64 b. L. canicola canicola 1 week after 1st vaccination : 24.62 1 week after 2nd vaccination : 123.92 3 week after 2nd vaccination : 276.55 c. L. icterohemorrhagiae copenhageni 1 week after 1st vaccination : 28.28 1 week after 2nd vaccination : 128.55 3 week after 2nd vaccination : 247.88 Whereas all of the place injected group showed below 1:20 titers. The sero-conversion rate of vaccinees were 100 percent.

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Study on an Image Reconstruction Algorithm for 3D Cartilage OCT Images (A Preliminary Study) (3차원 연골 광간섭 단층촬영 이미지들에 대한 영상 재구성 알고리듬 연구)

  • Ho, Dong-Su;Kim, Ee-Hwa;Kim, Yong-Min;Kim, Beop-Min
    • Progress in Medical Physics
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    • v.20 no.2
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    • pp.62-71
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    • 2009
  • Recently, optical coherence tomography (OCT) has demonstrated considerable promise for the noninvasive assessment of biological tissues. However, OCT images difficult to analyze due to speckle noise. In this paper, we tested various image processing techniques for speckle removal of human and rabbit cartilage OCT images. Also, we distinguished the images which get with methods of image segmentation for OCT images, and found the most suitable method for segmenting an image. And, we selected image segmentation suitable for OCT before image reconstruction. OCT was a weak point to system design and image processing. It was a limit owing to measure small a distance and depth size. So, good edge matching algorithms are important for image reconstruction. This paper presents such an algorithm, the chamfer matching algorithm. It is made of background for 3D image reconstruction. The purpose of this paper is to describe good image processing techniques for speckle removal, image segmentation, and the 3D reconstruction of cartilage OCT images.

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Bioequivalence of Procare Tablet to Proscar® Tablet (Finasteride 5 mg) (프로스카 정(피나스테리드 5 mg)에 대한 푸로케어 정의 생물학적동등성)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.2
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    • pp.143-148
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    • 2006
  • Finasteride $[N-(1, 1-dimethylethyl)-3-oxo-4-aza-5{\alpha}-androst-1-ene-17{\beta}-carboxamide]$ is a 4-aza-3-oxosteroidal inhibitor of human $5{\alpha}-reductase$. The purpose of the present study was to evaluate the bioequivalence of two finasteride tablets, $Proscar^{\circledR}$ (MSD Korea Ltd.) and Procare (Hana Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of finasteride from the two finasteride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.7\;{\pm}\;2.24$ years in age and $67.2\;{\pm}\;8.55\;kg$ in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After two tablets containing 5 mg as finasteride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of finasteride in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Proscar^{\circledR}$, were 6.39, 4.65 and -13.9% for $AUC_t,\;C_{max},\;and\;T_{max},$ respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.800 to log 1.25 $(e.g.,\;log\;0.990{\sim}log\;1.14\;and\;log\;0.977{\sim}log\;1.13 for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procare tablet was bioequivalent to $Proscar^{\circledR}$ tablet.

A 4 week Randomized, Double-blind Human Trial to Compare the Efficacy and Safety of Aureobasidium pullulans Cultured Solution and Placebo on Improvement of Immune in Subjects (흑효모배양액 분말의 면역관련 사이토카인에 미치는 영향에 대한 무작위 배정 임상연구)

  • Choi, Hae-Yun;Kim, Jong-Dae;Park, Mee-Yeon
    • Korean Journal of Oriental Medicine
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    • v.15 no.3
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    • pp.83-91
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    • 2009
  • $\beta$-glucan is a fiber-type complex sugar (polysaccharide) derived from the cell wall of baker's yeast, oat and barley fiber, and many medicinal mushrooms, such as maitake. The primary uses of $\beta$-glucan are to enhance the immune system, to lower blood cholesterol levels and to treat tumor. $\beta$-glucan has no systemic toxicity in mice, therefore it needed clinical trail to prove efficacy and safety for human. The subjects total 56 healty volunteers were divided into two groups including taken $\beta$-glucan tablet group and placebo group. Subjects were taken two tablets per oral for 4 weeks. They had agreed to take part in this experiment, and didn't take any other clinical trail products. After 4 weeks blood of subjects were checked. The check list are TNF-$\alpha$, INF-$\gamma$, IL-2, IL-4, total WBC, differential WBC, RBC, hemoglobin, platelet, MCV, MCH, MCHC, HCT, Na, K, Ca, Cl, AST, ALT, ALP, $\gamma$-GTP, total protein, triglyceride, total cholesterol, total bilirubin, albumin, uric acid, creatinine, BUN, pH, protein, glucose, ketone body, blood, bilirubin. We evaluated efficacy by cytokines that compare before and after taking. Collected data were analyzed as two sample t-test, chi-square test and ANOVA using SAS V.9.1.This study results are that in TNF-$\alpha$ of $1^{st}$ efficacy measurement item, all of two groups figure were increased significantly compare to before figure. In IL4 of $2^{nd}$ efficacy measurement item, experimental group figure were decreased significantly but placebo group figure were increased. The conclusions show that based on the above results, $\beta$-glucan has favorable effect to enhance immune system, especially IL4 results showed that it has effect to improve the allergic immune system.

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Antioxidant and Protective Effects of Leonurus sibiricus L. Extract on Ultraviolet B (UVB)-induced Damage in Human Keratinocytes (익모초 추출물의 항산화 효과와 자외선으로 유도된 각질형성세포 손상에 대한 보호효과)

  • Kim, Tae Yeon;Jang, Seon A;Chae, Yong Byung;Bak, Jong Phil
    • Korean Journal of Plant Resources
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    • v.29 no.1
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    • pp.11-19
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    • 2016
  • In this study, we investigated the anti oxidative potential and protective effects of water extract of Leonurus sibiricus L. leaf (LSLW) against ultraviolet B (UVB)-induced oxidative damage in human keratinocytes (HaCaT cells). To evaluate the anti oxidative activity of LSLW, we measured DPPH radical, hydroxyl radical, hydrogen peroxide, superoxide anion scavenging activities, lipid peroxidation inhibition, and reducing power of LSLW. For induction of oxidative stress in HaCaT cells, the cells were irradiated with UVB at 40 mJ/㎠. To investigate the protective effects of LSLW against UVB, we measured cell viability and apoptotic bodies using annexin V staining. LSLW showed anti oxidative activities by scavenging DPPH radical, hydroxyl radical, hydrogen peroxide, superoxide anion and by reducing lipid peroxidation. In addition, LSLW showed high reducing values. The UVB-induced oxidative conditions led to cell apoptosis. However, treatment with LSLW ameliorated oxidative stress conditions, including inhibition of cell death, apoptotic body. Taken together, LSLW exhibited anti oxidative and protective effects against UVB-induced damage in HaCaT cells. Thus, LSLW could be useful for the development of cosmetics for UVB-induced skin aging.

A 8-Week, Randomized, Double-Blind, Placebo-Controlled Human Trial to Evaluate the Efficacy and Safety of Punica granatum L.·Actinidia chinensis Planch. Mixed Extract on Body Fat (석류·참다래 혼합추출물의 체지방 감소에 대한 유효성 및 안전성을 평가하기 위한 8주, 무작위 배정, 이중눈가림, 위약-대조 인체적용시험)

  • Choi, Jin-Bong;Lee, Ji-Eun;Do, Yun-Kyoung
    • Journal of Korean Medicine for Obesity Research
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    • v.17 no.2
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    • pp.87-95
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    • 2017
  • Objectives: This study was conducted to evaluate efficacy and safety of Punica granatum L. Actinidia chinensis Planch. mixed extract on body fat. Methods: Thirty women were recruited ($25kg/m^2{\leq}body$ mass index [BMI]${\leq}29.9kg/m^2$) ($19yr{\leq}age{\leq}38yr$) and randomized to receive Punica granatum L. Actinidia chinensis Planch. mixed extract or placebo for 8 weeks. During the test, they visited four times including screening. Body fat mass, body fat rate, anthropometric dimensions at waist and hip, waist-hip ratio, total cholesterol, triglyceride, low density lipoprotein-cholesterol (LDL-C), and high density lipoprotein-cholesterol (HDL-C) were measured at screening and 8 weeks after screening. Adverse reaction were also checked each visit. Results: There were no significant differences in all index. But when divide experimental group by BMI index, age, and compliance, less than BMI $27kg/m^2$ group decreased body weight, body fat mass and more than BMI $27kg/m^2$ group also decreased body weight, body fat mass and waist circumference. Less than age 30 years group showed decline of waist circumference, fat free rate and T-cholesterol and more than age 30 years group showed decline of fat free mass. Group with compliance more than 95% was decreased BMI, fat free mass, and hip circumference. Conclusions: There was no significant efficacy as compared with placebo group, but as divide experimental group according to BMI index, age, compliance, mixed extract might be effective to reduce obesity index.

The effects of different types of media on in vitro maturation outcomes of human germinal vesicle oocytes retrieved in intracytoplasmic sperm injection cycles

  • Fesahat, Farzaneh;Firouzabadi, Razieh Dehghani;Faramarzi, Azita;Khalili, Mohammad Ali
    • Clinical and Experimental Reproductive Medicine
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    • v.44 no.2
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    • pp.79-84
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    • 2017
  • Objective: Optimizing in vitro maturation (IVM) media to achieve better outcomes has been a matter of interest in recent years. The aim of this prospective clinical trial was to investigate the effects of different media on the IVM outcomes of immature oocytes at the germinal vesicle (GV) stage. Methods: A total of 400 immature oocytes at the GV stage with normal morphology were retrieved from 320 infertile women aged $31{\pm}4.63years$ during stimulated intracytoplasmic sperm injection (ICSI) cycles. They were divided into groups of homemade IVM medium (I, n = 100), cleavage medium (II, n = 100), blastocyst medium (III, n = 100), and Sage IVM medium (IV, n = 100) and cultured for 24 to 48 hours at $37^{\circ}C$. ICSI was performed, and the rates of fertilization and embryo formation were compared across the four groups. Results: In the 400 retrieved GV oocytes, the total maturation rates showed significant differences in groups I to IV (55%, 53%, 78%, and 68%, respectively, p<0.001). However, there were no significant differences in the fertilization, embryo formation, or arrest rates of metaphase II oocytes across these groups. In all groups, GV maturation was mostly completed after 24 hours, with fewer oocytes requiring 48 hours to mature (p<0.01). Moreover, the rate of high-quality embryos was higher in group IV than in the other groups (p=0.01). Conclusion: The quality of the IVM medium was found to affect clinical IVM outcomes. Additionally, blastocyst medium may be a good choice in IVM/ICSI cycles as an alternative IVM medium.

The Safety and Pharmacokinetics of Cyanidin-3-Glucoside after 2-Week Administration of Black Bean Seed Coat Extract in Healthy Subjects

  • Jeon, Sang-Il;Han, Seung-Hoon;Lee, Jong-Tae;Hong, Tae-Gon;Yim, Dong-Seok
    • The Korean Journal of Physiology and Pharmacology
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    • v.16 no.4
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    • pp.249-253
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    • 2012
  • We analyzed the pharmacokinetics of C3G on data from twelve subjects, after 2-week multiple dosing of black bean (Phaseolus vulgaris, Cheongjakong-3-ho) seed coat extract, using the mixed effect analysis method (NONMEM, Ver. 6.2), as well as the conventional non-compartmental method. We also examined the safety and tolerability. The PK analysis used plasma concentrations of the C3G on day 1 and 14. There was no observed accumulation of C3G after 2-week multiple dosing of black bean seed coat extract. The typical point estimates of PK were CL (clearance)=3,420 l/h, V (volume)=7,280 L, Ka (absorption constant)=9.94 $h^{-1}$, ALAG (lag time)=0.217 h. The black bean seed coat extract was well tolerated and there were no serious adverse events. In this study, we confirmed that a significant amount of C3G was absorbed in human after given the black bean seed coat extract.

Profiling of endogenous metabolites and changes in intestinal microbiota distribution after GEN-001 (Lactococcus lactis) administration

  • Min-Gul Kim;Suin Kim;Ji-Young Jeon;Seol Ju Moon;Yong-Geun Kwak;Joo Young Na;SeungHwan Lee;Kyung-Mi Park;Hyo-Jin Kim;Sang-Min Lee;Seo-Yeon Choi;Kwang-Hee Shin
    • The Korean Journal of Physiology and Pharmacology
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    • v.28 no.2
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    • pp.153-164
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    • 2024
  • This study aimed to identify metabolic biomarkers and investigate changes in intestinal microbiota in the feces of healthy participants following administration of Lactococcus lactis GEN-001. GEN-001 is a single-strain L. lactis strain isolated from the gut of a healthy human volunteer. The study was conducted as a parallel, randomized, phase 1, open design trial. Twenty healthy Korean males were divided into five groups according to the GEN-001 dosage and dietary control. Groups A, B, C, and D1 received 1, 3, 6, and 9 GEN-001 capsules (1 × 1011 colony forming units), respectively, without dietary adjustment, whereas group D2 received 9 GEN-001 capsules with dietary adjustment. All groups received a single dose. Fecal samples were collected 2 days before GEN-001 administration to 7 days after for untargeted metabolomics and gut microbial metagenomic analyses; blood samples were collected simultaneously for immunogenicity analysis. Levels of phenylalanine, tyrosine, cholic acid, deoxycholic acid, and tryptophan were significantly increased at 5-6 days after GEN-001 administration when compared with predose levels. Compared with predose, the relative abundance (%) of Parabacteroides and Alistipes significantly decreased, whereas that of Lactobacillus and Lactococcus increased; Lactobacillus and tryptophan levels were negatively correlated. A single administration of GEN-001 shifted the gut microbiota in healthy volunteers to a more balanced state as evidenced by an increased abundance of beneficial bacteria, including Lactobacillus, and higher levels of the metabolites that have immunogenic properties.