• 제목/요약/키워드: multi center trial

검색결과 78건 처리시간 0.029초

다기능 보조기구와 체중부하검사 보조기구의 X선 화질 비교 (Comparison of X-ray Image Quality Between Multi-Function Device(MFD) and Weight Bearing Platforms(WBPs))

  • 길종원;이광성
    • 한국방사선학회논문지
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    • 제13권4호
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    • pp.605-611
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    • 2019
  • 본 연구의 목적은 여러 가지 하지입식검사에 적용할 수 있는 Multi-Function Device(MFD)를 제작하여 기존에 사용하던 Weight Bearing Platforms(WBPs)들과 X 선 영상의 비교를 통해 임상 활용을 제안하고자 한다. MFD는 단상(보조기구)를 이용한 Weight Bearing Foot/Ankle, Hindfoot Alignment View 검사시 X선 장치의 X선 관구의 최하 조절 높이를 고려하여 제작하였다. 그리고 Foot/Ankle Phantom으로 MFD와 WBPs에서 Weight Bearing Lateral Foot과 Hindfoot Alignment View를 검사하여 X선 영상의 해상력을 Quick MTF(modulation transfer function)프로그램으로 비교하였다. 연구결과 MFD와 WBPs에서 검사한 두 가지 영상 모두 MTF 50(50% Contrast Spatial Frequency)과 10-90%(10-90% of Maximum Energy Rise Distance) Rise의 C/P(Cycles Per Pixel)평균과 LPH(Lines Per Image Height)평균 모두 유의한 차이는 없었다(p>0.05). 연구에서 제작한 MFD는 환자의 안전과 여러 가지 검사를 복합적으로 수행 할 수 있는 유용한 보조기구로 임상 활용을 제안한다. 또한 정책적으로 보조기구의 활용을 권장한다면 전문 업체의 활성화를 돕는 길이며 의료의 질도 더욱 향상할 수 있을 것이다.

기능성 소화불량증 환자에서 헬리코박터 파일로리 제균 치료 효과 및 관련 요인: 국내 전향적, 다기관 연구 (Female Gender is a Poor Predictive Factor of Functional Dyspepsia Resolution after Helicobacter pylori Eradication: A Prospective, Multi-center Korean Trial)

  • 김성은;김나영;박선미;김원희;백광호;조윤주;박경식;이주엽;심기남;김광하;이봉은;홍수진;박선영;최석채;오정환;김현진
    • 대한소화기학회지
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    • 제72권6호
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    • pp.286-294
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    • 2018
  • Background/Aims: The predictive factors of functional dyspepsia (FD) remain controversial. Therefore, we sought to investigate symptom responses in FD patients after Helicobacter pylori (H. pylori) eradication and used predictive factor analysis to identify significant factors of FD resolution at one-year after commencing eradication therapy. Methods: This prospective, multi-center clinical trial was performed on 65 FD patients that met Rome III criteria and had H. pylori infection. Symptom responses and factors that predicted poor response were determined by analysis one year after commencing H. pylori eradication therapy. Results: A total of 63 patients completed the one-year follow-up. When an eradication success group (n=60) and an eradication failure group (n=3) were compared with respect to FD response rate at one year, results were as follows; complete response 73.3% and 0.0%, satisfactory response 1.7% and 0.0%, partial response 10.0% and 33.3%, and refractory response 15.0% and 66.7%, respectively (p=0.013). Univariate analysis showed persistent H. pylori infection (p=0.021), female gender (p=0.025), and medication for FD during the study period (p=0.013) were associated with poor FD response at one year. However, age, smoking, alcohol consumption, and underlying disease were not found to affect response. Finally, multivariate analysis showed that female gender (OR, 4.70; 95% CI, 1.17-18.88) was the sole independent risk factor of poor FD response at one year after commencing H. pylori eradication therapy. Conclusions: Female gender was found to predict poor response in FD patients despite H. pylori eradication. Furthermore, successful H. pylori eradication appears to be associated with FD improvement, but the number of non-eradicated patients was too small to conclude.

Association of Human Epidermal Growth Factor Receptor-2 Expression and Clinicopathological Findings in Patients with Colorectal Cancer

  • Karaca, Halit;Deniz, Kemal;Berk, Veli;Inanc, Mevlude;Ozkan, Metin
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권12호
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    • pp.6221-6225
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    • 2012
  • Background: To determine the frequency of HER-2 overexpression in colorectal cancer (CRC) patients, and to explore the relationship between clinicopathological prognostic factors and their effects on survival, based on immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) analysis. Materials and Methods: The study included 80 patients with a histologically proven diagnosis of CRC that received adjuvant FOLFOX-4 chemotherapy at our department between March 2006 and September 2010. Patient data were analyzed retrospectively. Results: The median follow-up period and age of the patients were 24 months and 59 years, respectively. In immunohistochemical staining, 3+ staining was found in 2 patients (2.5%) while 2+ was in 13 (16%). FISH for HER-2 was performed for all of these 15 patients; samples which were 3+ showed positivity but the ones with 2+ were negative. There was no significant correlation between HER-2 expression and age, gender, tumor localization, histological subtype, grade, lymphovascular and perineural invasion, or pTN stage (P>0.05), even when the patients with HER-2 overexpression were analyzed separately. There was also no significant relationship between progression-free survival (PFS) and overall survival (OS), and HER-2 expression, gender, tumor localization, obstruction-perforation, bleeding, histological type, grade, lymphovascular and perineural invasion, or pT staging (P>0.05); however, there was a significant relationship between lymph node involvement, and PFS and OS (P<0.05). Conclusions: Evaluation of HER-2 overexpression in a more comprehensive, multi-center, prospective trial with standardized methods will be an appropriate approach.

Genetic improvement of potato plants

  • Suharsono, Sony
    • 한국작물학회:학술대회논문집
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    • 한국작물학회 2017년도 9th Asian Crop Science Association conference
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    • pp.12-12
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    • 2017
  • Genetic improvement in potato can be carried out through several approaches, as sexual crosses, somatic hybridization, mutation and genetic engineering. Although the approach is different, but the goal is the same, to get a superior cultivar. Mutation and genetic engineering are very interesting methods for genetic improvement of potato plants. Mutation by gamma-ray irradiation have been performed to get some new potato cultivars which are more resistant to disease and have higher productivity. We have carried out a mutation of some potato cultivars and obtained some excellent clones to be potentially released as new superior cultivars. By the mutation method, we have released one potato cultivar for the French fries industry, and we registered one cultivar of potato for chips, and two cultivar for vegetable potatoes. Actually we are doing multi-location trial for three clones to be released as new cultivars. Through genetic engineering, several genes have been introduced into the potato plant, and we obtained several clones of transgenic potato plants. Transgenic potato plants containing FBPase gene encoding for fructose bisphosphatase, have a higher rate of photosynthesis and higher tuber productivity than non-transgenic plants. This result suggests that FBPase plays an important role in increasing the rate of photosynthesis and potato tuber productivity. Some transgenic potatoes containing the Hd3a gene are currently being evaluated for their productivity. Over expression of the Hd3a gene is expected to increase tuber productivity and induce flowering in potatoes. Transgenic potato plants containing MmPMA gene encoding for plasma membrane ATPse are more tolerant to low pH than non-transgenic plants, indicating that plasma membrane ATPase plays an important role in the potato plant tolerance to low pH stress. Transgenic potato plants containing c-lysozyme genes, are highly tolerant of bacterial wilt diseases caused by Ralstonia solanacearum and bacterial soft rot disease caused by Pectobacterium carotovorum. Expression of c-lyzozyme gene plays an important role in increasing the resistance of potato plants to bacterial diseases.

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태음조위탕 엑스과립이 비만을 포함한 대사증후군 위험인자에 미치는 영향에 대한 연구: 단일군, 전향적, 다기관 임상연구 (The Effects of Taeeumjowi-tang Extract Granule on Metabolic Syndrome Risk Factors with Obesity: A Single Group, Prospective, Multi-Center Trial)

  • 곽진영;안택원
    • 사상체질의학회지
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    • 제32권2호
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    • pp.48-60
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    • 2020
  • Objective The purpose of this study is to study the effects of Taeeumjowi-tang extract granule on metabolic syndrome with obesity in Taeeumin. Methods We studied 206 subjects who diagnosed metabolic syndrome with obesity and classified Taeeumin by a Sasang constitution analysis tool. The subjects were administered by Taeeumjowi-tang for 12 weeks. We investigated the changes of body mass index, abdominal circumference, the number of risk factors for metabolic syndrome, lipid, fasting blood sugar, Hemoglobin A1c, free fatty acid, insulin, and blood pressure. Results Body mass index and abdominal circumference, systolic and diastolic blood pressure were significantly reduced after 4 weeks, 8 weeks, and 12 weeks of administration compared to before administration. Triglyceride significantly decreased after 8 weeks and 12 weeks of dosing compared to before taking. Low density lipoprotein cholesterol, fasting blood sugar were significantly increased after 8 weeks of administration compared to before administration. High density lipoprotein cholessterol was decreased significantly after 4 weeks of administration compared to before administration. The number of risk factors for metabolic syndrome, Hemoglobin A1c increased significantly after 12 weeks of administration compared to screening. Conclusions In this study we knew that Taeeumjowi-tang extract granule is very efficient in metabolic syndrome, especially in obesity and hypertension, triglyceride, insulin resistance.

Study on Application of Skin Care Cosmetic and Stabilization of Idebenone by Forming Niosome Vesicle Technology

  • Kim, In-Young
    • 한국응용과학기술학회지
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    • 제36권2호
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    • pp.592-599
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    • 2019
  • This study is to stabilize insoluble and unstable active ingredient which is Idebenone (INCI name: hydroxydecyl ubiquinone) in a multi-lamellar vesicle (MLV) and to stabilize it in the skin care cosmetics. Idebenone is good effective raw material in the treatment of Alzheimer's disease in the medical field and a powerful antioxidant in dermatology. It is well known as a substance that inhibits the formation of melanin and cleans the skin pigment. However, it did not dissolve in any solvent and it was difficult to apply in cosmetic applications. Niosome vesicle was able to develop a nano-particle by making a multi-layer of idebenone encapsulated with a nonionic surfactant, hydrogenated lecithin and glycine soja (soybean) sterols and passing it through a high pressure microfluidizer. Idebenone niosome vesicle (INV) has been developed to have the ability to dissolve transparently in water and to promote transdermal penetration. The appearance of the INV was a yellowish liquid having specific odor, and the particle size distribution of INV was about 10~80 nm. The pH was 5~8 (mean=6.8). This capsulation with idebenone was stored in a $45^{\circ}C$ incubator for 3 months and its stability was observed and quantitatively measured by HPLC. As a result, the stability of the sample encapsulated in the niosome vesicle (97.5%) was about 66.3% higher than that of the non-capsule sample of 32.5%. Idebenone 1% INV was used for the efficacy test and clinical trial evaluation as follows. The anti-oxidative activity of INV was 38.2%, which was superior to that of 12.8% tocopherol (control). The melanin-reducing effect of B16 melanoma cells was better than INV (17.4%) and Albutin (control) (9.6%). Pro-collagen synthesis rate was 128.2% for INV and 89.3% for tocopherol (control). The skin moisturizing effect was 15.5% better than the placebo sample. The elasticity effect was 9.7% better than the placebo sample. As an application field, INV containing 1% of idebenone is expected to be able to develop various functional cosmetic formulations such as skin toner, ampoule essence, cream, eye cream and sunblock cream. In addition, it is expected that this encapsulated material will be widely applicable to emulsifying agents for skin use in the pharmaceutical industry as well as the cosmetics industry.

SVM 분류기를 통한 심실세동 검출 (SVM Classifier for the Detection of Ventricular Fibrillation)

  • 송미혜;이전;조성필;이경중
    • 전자공학회논문지SC
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    • 제42권5호
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    • pp.27-34
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    • 2005
  • 심실세동은 심장의 무질서한 전기적 활동으로 인해 심근 수축이 동시에 이뤄지지 않게 되어 급성심장사에 이르게 하는 부정맥이다. 본 연구에서는 이러한 심실세동 검출을 위해 적은 양의 학습 데이터만으로 좋은 분류 성능을 보이는 SVM(Support Vector Machine) 분류기 기반의 심실세동 검출 알고리즘을 제안하였다. 심전도 신호로부터 SVM 분류기에 입력할 입력 특징을 추출하기 위하여 웨이브렛 변환기반의 대역통과 필터링, R점 검출, 입력 특징 추출구간 설정의 전처리 과정을 수행하였으며 입력 특징으로는 리듬 기반의 정보 및 웨이브렛 변환 계수를 선택하였다. SVM 다원분류기는 정상리듬(NSR) 분류기, 심실 세동과 유사한 심실빈맥(VT) 분류기, 심실세동(VF) 분류기 그리고 그 외 부정맥 분류기로 구성하였다. SVM 분류기의 파라미터 C값과 ${\alpha}$값은 실험을 통하여 최고 성능을 나타내는 C=10, ${\alpha}=1$을 선택하였다. SVM 다원 분류기를 통한 정상리듬, 심실빈맥 심실세동의 검출 평균값은 98.39%, 96.92%, 99.88%의 우수한 검출 성능을 나타냈다. 본 연구에서 제안된 동일 입력특징을 사용하여 SVM 분류기의 심실세동 검출 결과와 다층퍼셉트론 신경망 및 퍼지추론 방법에 의한 결과를 비교하였으며 SVM 분류기가 비슷하거나 우수한 결과를 보였다. 또한 기존 다른 알고리즘에 비하여도 우수한 결과를 보임으로써 제안된 입력 특징을 통한 SVM 분류기 기반의 심실세동 검출이 유용함을 확인할 수 있었다.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • 제23권6호
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜 (Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial)

  • 이보람;조민진;최영은;권오진;임미영;고석재;김소연;김용주;남동현;최동준;이준환;박재우;김호준
    • 대한한방내과학회지
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    • 제43권6호
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

방사선치료로 인한 통증 및 암성통증에 대한 듀로제식의 효과: 다기관연구 (Effectiveness of Fentanyl Transdermal Patch (Fentanyl-TTS, $Durogegic^{(R)}$) for Radiotherapy Induced Pain and Cancer Pain: Multi-center Trial)

  • 신성수;최은경;김종훈;안승도;이상욱;김연실;이규찬;이창걸;노준규;전미선;오영택;김옥배;허승재
    • Radiation Oncology Journal
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    • 제24권4호
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    • pp.263-271
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    • 2006
  • 목 적: 방사선치료로 인해 발생하는 점막염, 식도염 등의 통증과 암성 통증을 가진 환자에 대한 듀로제식의 통증 완화 및 일상생활 개선 효과를 알아보고자 하였다. 대상 및 방법: 다기관 전향적 4상 임상시험으로 방사선치료로 인한 통증을 호소하거나(A군) 암성통증으로 방사선치료를 시행 받고 있는 환자(B군) 중에 진통제를 복용 중임에도 숫자등급평가(Numeric rating scale, NRS)가 4 이상 이거나 진통제 복용 없이 NRS가 6 이상인 환자를 대상으로 듀로제식 25 ug/hr을 처방한 후에 1주일과 2주일 후에 통증횟수와 강도변화, 통증이 일상생활에 미치는 영향평가, 피험자와 임상의 만족도 평가, 그리고 이상반응 평가를 시행하였다. 결 과: 2005년 3월 28일부터 6월 15일까지 26개 기관에서 총 312명의 피험자를 등록하였고 그 중 249명이 임상시험을 완료하였는데 A군은 185명, B군은 64명이였다. 평균 연령은 60세였고, 남자가 189명, 여자가 60명이였다. 2주 후 가장 심한 통증의 강도 변화를 보면 A군에서 6.9에서 3.9로 B군에서는 7.1에서 3.9로 통계적으로 유의하게(p=0.003) 감소하였고 일상생활의 미치는 영향을 보기 위한 수면방해 정도와 일상적인 일의 저하 그리고 삶의 질의 저하는 투여 2주 후에 모두 호전되었다. 연하통증의 변화는 A군에서만 유의하게 투여 후 호전되었으며 피험자의 만족도는 매우 만족이 A에서 47%, B군에서 41%로 좋았고 만족 이유는 진통효과 우수, 전반적 만족, 편리성 순이었다. 임상의 만족도는 매우만족이 50% 정도로 좋았다. 이상반응은 A군에서 40% B군에서 34%로 총 38%에서 나타났고 오심이 30%로 가장 많았고 소양증 16%, 어지러움 14%, 변비 10% 순이었다. 중대한 이상반응은 없었다. 결 론: 듀로제식의 통증완화 효과 일상생활 개선효과는 우수하였고 피험자와 임상의의 만족도도 좋았고 중대한 이상반응도 없었다.