• Title/Summary/Keyword: Multi-center Trial

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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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    • v.13 no.12
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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
    • Proceedings of the Korean Society of Crop Science Conference
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    • 2017.06a
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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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The Effects of Taeeumjowi-tang Extract Granule on Metabolic Syndrome Risk Factors with Obesity: A Single Group, Prospective, Multi-Center Trial (태음조위탕 엑스과립이 비만을 포함한 대사증후군 위험인자에 미치는 영향에 대한 연구: 단일군, 전향적, 다기관 임상연구)

  • Kwak, Jin-Young;Ahn, Taek-Won
    • Journal of Sasang Constitutional Medicine
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    • v.32 no.2
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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
    • Journal of the Korean Applied Science and Technology
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    • v.36 no.2
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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 Classifier for the Detection of Ventricular Fibrillation (SVM 분류기를 통한 심실세동 검출)

  • Song, Mi-Hye;Lee, Jeon;Cho, Sung-Pil;Lee, Kyoung-Joung
    • Journal of the Institute of Electronics Engineers of Korea SC
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    • v.42 no.5 s.305
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    • pp.27-34
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    • 2005
  • Ventricular fibrillation(VF) is generally caused by chaotic behavior of electrical propagation in heart and may result in sudden cardiac death. In this study, we proposed a ventricular fibrillation detection algorithm based on support vector machine classifier, which could offer benefits to reduce the teaming costs as well as good classification performance. Before the extraction of input features, raw ECG signal was applied to preprocessing procedures, as like wavelet transform based bandpass filtering, R peak detection and segment assignment for feature extraction. We selected input features which of some are related to the rhythm information and of others are related to wavelet coefficients that could describe the morphology of ventricular fibrillation well. Parameters for SVM classifier, C and ${\alpha}$, were chosen as 10 and 1 respectively by trial and error experiments. Each average performance for normal sinus rhythm ventricular tachycardia and VF, was 98.39%, 96.92% and 99.88%. And, when the VF detection performance of SVM classifier was compared to that of multi-layer perceptron and fuzzy inference methods, it showed similar or higher values. Consequently, we could find that the proposed input features and SVM classifier would one of the most useful algorithm for VF detection.

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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    • v.23 no.6
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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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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 (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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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.

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

  • Shin, Seong-Soo;Choi, Eun-Kyung;Kim, Jong-Hoon;Ahn, Seung-Do;Lee, Sang-Wook;Kim, Yeun-Sil;Lee, Kyu-Chan;Lee, Chang-Geol;Loh, John-JK;Chun, Mi-Son;Oh, Young-Teak;Kim, Ok-Bae;Huh, Seung-Jae
    • Radiation Oncology Journal
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    • v.24 no.4
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    • pp.263-271
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    • 2006
  • $\underline{Purpose}$: To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. $\underline{Materials\;and\;Methods}$: Our study was open labelled prospective phase IV multi-center study. the study population included patients with more 4 numeric rating scale(NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups; patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief; second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. $\underline{Results}$: Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, p=0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. $\underline{Conclusion}$: Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There was no major side effect.

Prospective Multi-Center Korean Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolics for Nodular Hepatocellular Carcinoma: A Two-Year Outcome Analysis

  • Myungsu Lee;Jin Wook Chung;Kwang-Hun Lee;Jong Yun Won;Ho Jong Chun;Han Chu Lee;Jin Hyoung Kim;In Joon Lee;Saebeom Hur;Hyo-Cheol Kim;Yoon Jun Kim;Gyoung Min Kim;Seung-Moon Joo;Jung Suk Oh
    • Korean Journal of Radiology
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    • v.22 no.10
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    • pp.1658-1670
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    • 2021
  • Objective: To assess the two-year treatment outcomes of chemoembolization with drug-eluting embolics (DEE) for nodular hepatocellular carcinoma (HCC). Materials and Methods: This study was a prospective, multicenter, registry-based, single-arm trial conducted at five university hospitals in Korea. Patients were recruited between May 2011 and April 2013, with a target population of 200. A DC Bead loaded with doxorubicin was used as the DEE agent. Patients were followed up for two years. Per-patient and per-lesion tumor response analysis, per-patient overall survival (OS) and progression-free survival (PFS) analysis, and per-lesion tumor control analysis were performed. Results: The final study population included 152 patients, with 207 target lesions for the per-lesion analysis. At one-month, six-month, one-year, and two-year per-patient assessments, complete response (CR) rates were 40.1%, 43.0%, 33.3%, and 19.6%, respectively. The objective response (OR) rates were 91.4%, 55.4%, 35.1%, and 19.6%, respectively. The cumulative two-year OS rate was 79.7%. The cumulative two-year PFS rate was 22.4% and the median survival was 9.3 months. In multivariable analysis, the Child-Pugh score (p = 0.019) was an independent predictor of OS, and tumor multiplicity (p < 0.001), tumor size (p = 0.020), and Child-Pugh score (p = 0.006) were independent predictors of PFS. In per-lesion analysis, one-month, six-month, one-year and two-year CR rates were 57.5%, 58.5%, 45.2%, and 33.3%, respectively, and the OR rates were 84.1%, 65.2%, 46.6%, and 33.3%, respectively. The cumulative two-year per-lesion tumor control rate was 36.2%, and the median time was 14.1 months. The Child-Pugh score (p < 0.001) was the only independent predictor of tumor control. Serious adverse events were reported in 11 patients (7.2%). Conclusion: DEE chemoembolization for nodular HCCs in the Korean population showed acceptable survival, tumor response, and safety profiles after a two-year follow-up. Good liver function (Child-Pugh score A5) was a key predictor of per-patient OS, PFS, and per-lesion tumor control.

Temozolomide Salvage Chemotherapy for Recurrent Anaplastic Oligodendroglioma and Oligo-Astrocytoma

  • Gwak, Ho-Shin;Yee, Gi Taek;Park, Chul-Kee;Kim, Jin Wook;Hong, Yong-Kil;Kang, Seok-Gu;Kim, Jeong Hoon;Seol, Ho Jun;Jung, Tae-Young;Chang, Jong Hee;Yoo, Heon;Hwang, Jeong-Hyun;Kim, Se-Hyuk;Park, Bong Jin;Hwang, Sun-Chul;Kim, Min Su;Kim, Seon-Hwan;Kim, Eun-Young;Kim, Ealmaan;Kim, Hae Yu;Ko, Young-Cho;Yun, Hwan Jung;Youn, Ji Hye;Kim, Juyoung;Lee, Byeongil;Lee, Seung Hoon
    • Journal of Korean Neurosurgical Society
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    • v.54 no.6
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    • pp.489-495
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    • 2013
  • Objective : To evaluate the efficacy of temozolomide (TMZ) chemotherapy for recurrent anaplastic oligodendroglioma (AO) and anaplastic oligoastrocytoma (AOA). Methods : A multi-center retrospective trial enrolled seventy-two patients with histologically proven AO/AOA who underwent TMZ chemotherapy for their recurrent tumors from 2006 to 2010. TMZ was administered orally (150 to 200 $mg/m^2/day$) for 5 days per 28 days until unacceptable toxicity occurred or tumor progression was observed. Results : TMZ chemotherapy cycles administered was median 5.3 (range, 1-41). The objective response rate was 24% including 8 cases (11%) of complete response and another 23 patients (32%) were remained as stable disease. Severe side effects (${\geq}$grade 3) occurred only in 9 patients (13%). Progression-free survival (PFS) of all patients was a median 8.0 months (95% confidence interval, 6.0-10.0). The time to recurrence of a year or after was a favorable prognostic factor for PFS (p<0.05). Overall survival (OS) was apparently differed by the patient's histology, as AOA patients survived a median OS of 18.0 months while AO patients did not reach median OS at median follow-up of 11.5 months (range 2.7-65 months). Good performance status of Eastern Cooperative Oncology Group 0 and 1 showed prolonged OS (p<0.01). Conclusion : For recurrent AO/AOA after surgery followed by radiation therapy, TMZ could be recommended as a salvage therapy at the estimated efficacy equal to procarbazine, lomustine, and vincristine (PCV) chemotherapy at first relapse. For patients previously treated with PCV, TMZ is a favorable therapeutic option as 2nd line salvage chemotherapy with an acceptable toxicity rate.