• 제목/요약/키워드: Clinical trial center

검색결과 697건 처리시간 0.028초

노인 구강건조증에 대한 음허 진단의 유용성 및 주관적 구강건조감의 영향요인 : 전향적 단면 조사 연구 (Availability of Diagnosis of Yin-deficiency in Elderly People with Xerostomia and Factors Influencing Subjective Oral Dryness: A Prospective Cross-sectional Study)

  • 김주연;김진성;박재우;류봉하
    • 대한한의학회지
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    • 제34권3호
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    • pp.13-24
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    • 2013
  • Objectives: The aims of this study were to investigate the availability of diagnosis of Yin-deficiency in the elderly with xerostomia and factors influencing subjective oral dryness. Methods: We surveyed 50 patients recruited by the clinical trial, 'Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized, Double-blind, Placebo-controlled, Two-center Trial'. The subjects were assessed on their subjective oral dryness using the Dry Mouth Symptom Questionnaire (DMSQ). Their salivary functions were measured by Unstimulated Salivary Flow Rate (USFR) measurements. In addition, the subjects were evaluated on their Qi-stagnation and Yin-deficiency conditions using the Qi-stagnation questionnaire and Yin-deficiency questionnaire. Results: There were statistically significant correlations between three variables (USFR, DMSQ score and Qi-stagnation score) and Yin-deficiency score. In the multiple regression analysis, the regression model was statistically significant (F = 10.273, p < .001). The factor most strongly influencing the subjective oral dryness was USFR (${\beta}$ = -0.386). Yin-deficiency had the next strongest impact on the subjective oral dryness (${\beta}$ = 0.371). Qi-stagnation affected the subjective oral dryness weakly (${\beta}$ = 0.075). In the simple regression analysis, Yin-deficiency had a statistically significant effect on each of six subscales of DMSQ (p < .01). Among the six subscales, DMSQ-1 ('Oral dryness at night or on awakening') was the most strongly influenced by Yin-deficiency. Conclusions: The results of this study show that the diagnosis of Yin-deficiency in the elderly with xerostomia was available and Yin-deficiency was an important factor influencing the subjective oral dryness. Therefore, the consideration of Yin-deficiency is significant for diagnosis and treatment in the elderly with xerostomia.

이중 체임버 구조가 내장된 뇌졸중 환자용 컵의 개발과 3차원 동작분석을 통한 운동 형상학적 유용성 검증: 전향적 예비연구 (Development and Tree-Dimensional Kinematic Analysis of the Dual Chamber-based Drinking Aid for Stroke Patients: A Prospective Pilot Study)

  • 허서윤;김경미
    • 전자공학회논문지
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    • 제53권12호
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    • pp.180-190
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    • 2016
  • 본 전향적 예비 임상연구를 통하여 이중 체임버 구조를 기반으로 하는 뇌졸중 환자용 컵을 개발하고 임상적으로 유용한지 검증하고자 했다. 체계적 과정을 거쳐 컵을 개발하고, 남녀 동수의 뇌졸중 환자 16명을 대상으로 개발된 컵을 사용하여 이들의 제한된 운동기능을 보완 할 수 있는지 3차원 동작 분석(3-dimensional motion analysis), 표면 근전도 검사(surface electromyography; sEMG), 3차원 체간 움직임 분석(3-dimensional trunk movement analysis)의 운동 형상학적 방법을 통하여 검증하고자 했다. 실험 결과, 이중 체임버 컵(dual chamber based assistive cups; DC) 데이터 그룹에서 플라시보 컵(placebo-cups; PC)의 경우 보다 어깨부위의 ROM(range of motion)이 더 적게 사용되었고, sEMG에서는 상부 승모근, 삼각근, 삼두근에서 근 활성도가 낮게 나타났다. 체간 분석에서 전방, 후방의 방향에서 체간의 개입이 더 적게 관찰되었다.

슈퍼홍미 미강 추출물의 폐경 후 여성의 혈중 지질 농도 및 대사성 질환 개선 효과 (Superhongmi bran extract improves lipid profile and menopause symptoms: a randomized, placebo-controlled clinical trial)

  • 정수임;남수진;;;강미영
    • 한국식품과학회지
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    • 제51권2호
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    • pp.182-187
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    • 2019
  • 본 연구는 슈퍼홍미 미강 추출물이 폐경 후 갱년기 증상에 및 대사 개선 효과를 확인하고자 수행되었다. 무월경이 지속된 지 5년 미만의 여성을 대상으로 12주동안 진행되었으며 위약대조군 15명, 실험군 15명으로 배정하였고, 1일 2개의 캡슐을 섭취하도록 하였다(슈퍼홍미 미강추출물 700 mg/day). 시험 종료 후 슈퍼홍미 미강 추출물 섭취군의 체중과 BMI 그리고 중성지질과 및 총콜레스테롤은 수준이 유의하게 감소하였다. 혈중 HDL 콜레스테롤과 ApoA1 농도는 약 10% 증가하여 지질대사 개선에 효과를 기대할 수 있었다. 항당뇨과 관련된 지표 중 혈중 glucose와 인슐린이 유의하게 감소하여 인슐린 저항성 지표인 HOMA-IR이 감소한 것을 확인할 수 있었고, 아디포넥틴 수준이 유의하게 증가하였으며, $TNF-{\alpha}$는 슈퍼홍미 미강 추출물 섭취군에서 투여 전보다 유의하게 감소하여 폐경 이후 당질대사 개선에 도움을 줄 수 있을 것으로 보인다. 항산화활성 분석 결과 SOD1, GSH 그리고 TBARS 수준이 실험군에서 감소하였으며, AOPP 는 유의적인 차이를 보이지 않았다. 여성호르몬 중 $17{\beta}-estradiol$과 progesterone 농도는 위약대조군에서 유의하게 감소하였으나 실험군은 섭취기간동안 호로몬 농도를 유지한 것으로 나타나 대조군에 비해 높은 수준을 나타났다. 폐경을 겪은 여성들은 여성호르몬 저하로 인해 갱년기 증상 및 대사증후군 발병 가능성이 증가하는데 슈퍼홍미 미강과 같은 기능성 식품 섭취로 대사증후군 위험인자들에 대한 호전이 높을 것이라 보고 이러한 연구 결과는 갱년기 여성 건강에 시사하는 바가 크다고 생각된다.

Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial

  • Hwang, Sun-Hwi;Park, Do Joong;Kim, Hyung-Ho;Hyung, Woo Jin;Hur, Hoon;Yang, Han-Kwang;Lee, Hyuk-Joon;Kim, Hyoung-Il;Kong, Seong-Ho;Kim, Young Woo;Lee, Han Hong;Kim, Beom Su;Park, Young-Kyu;Lee, Young-Joon;Ahn, Sang-Hoon;Lee, In-Seob;Suh, Yun-Suhk;Park, Ji-Ho;Ahn, Soyeon;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • 제22권2호
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    • pp.94-106
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    • 2022
  • Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. Materials and Methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

  • Jae Won Choi;Jeong Min Lee;Dong Ho Lee;Jung-Hwan Yoon;Yoon Jun Kim;Jeong-Hoon Lee;Su Jong Yu;Eun Ju Cho
    • Korean Journal of Radiology
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    • 제22권2호
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    • pp.179-188
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    • 2021
  • Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC). Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes. Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265). Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

일식 레스토랑 설비와 조리기구의 미생물 오염 실태 분석 (An Analysis Microbiological Contamination on the Facilities and Utilities of Japanese Restaurants)

  • 김기영;박계영;채명희
    • 한국조리학회지
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    • 제15권4호
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    • pp.9-17
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    • 2009
  • 광주 지역 하절기 동안 일식 레스토랑 10곳의 위생 평가를 위해 미생물 검사를 실시하였다. 일식 레스토랑의 설비 및 조리기구 표면에서 swab sampling 방법으로 스폰지로 200개의 도말 표본을 채취하였다. 총 균수, 대장균군, 대장균, 포도상구균, 살모네라균, 리스테리아균을 측정하였다. 그 결과, 대부분의 도말 표본이 미생물과 대장균군으로 오염된 것으로 입증되었다. 오염 정도는 샘플 채취 장소에 따라 달랐다. 심하게 오염된 곳은 바닥, 트렌치, 생선 취급 코너였고, 이러한 표본의 총 균수는 $10^4$ CFU/100 $cm^2$이 넘었다. 바닥, 트렌치, 나무 도마의 대장균군은 $10^3$ CFU/100 $cm^2$이 넘었다. 게다가 대장균군은 행주, 식기, 그리고 생선 및 채소 코너에서도 검출되었다. 대장균은 몇몇 식당의 바닥과 트렌치에서 검출되었다. 포도상구균은 몇몇 식당의 도마, 행주, 바닥, 트렌치에서 발견되었다. 살모넬라균과 리스테리아균은 모든 표본에서 검출되지 않았다. 이러한 결과는 일식 레스토랑에서 위생관리와 소독이 필요함을 보여준다.

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새로운 치매 선별검사를 이용한 도시지역 노인의 치매 유병률과 관련요인 (Prevalence and Related Factors of Dementia in an Urban Elderly Population Using a New Screening Method)

  • 신희영;이정애;윤진상;김재민;정은경
    • Journal of Preventive Medicine and Public Health
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    • 제38권3호
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    • pp.351-358
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    • 2005
  • Objectives : Dementia has rapidly increased with the prolongation of life expectancy and aging in Korea. This study was conducted to estimate the prevalence of, and find related factors for, dementia in an urban elderly population, using a newly developed screening method. Methods : Seven hundred and six people, aged over 65 years-old, in Dong district of Gwangju, Korea, were recruited using stratified cluster sampling, and completed Korean version of Geriatric Mental State Schedule B3 (GMS B3-K), the Korean version of the Community Screening Interview for Dementia (CSID-K) and modified 10 word list-learning from the Consortium to Establish a Registry of Alzheimer's Disease (CERAD). Dementia was diagnosed by an algorithm derived from all three of these measures. Results : The crude and age adjusted prevalence rates of dementia were 13.0 and 11.5%, respectively. Age, education, marital status and a history of cerebrovascular disease were identified as factors related with dementia. Conclusions : The new instrument, using the GMS B3-K, CSID-K and modified 10 word list-learning from the CERAD, was considered effective as a community screening and diagnostic tool for dementia. The results of this study can also be used to develop a community-based prevention and management system for dementia in the future.

Perioperative Epirubicin, Oxaliplatin, and Capecitabine Chemotherapy in Locally Advanced Gastric Cancer: Safety and Feasibility in an Interim Survival Analysis

  • Ostwal, Vikas;Sahu, Arvind;Ramaswamy, Anant;Sirohi, Bhawna;Bose, Subhadeep;Talreja, Vikas;Goel, Mahesh;Patkar, Shraddha;Desouza, Ashwin;Shrikhande, Shailesh V.
    • Journal of Gastric Cancer
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    • 제17권1호
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    • pp.21-32
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    • 2017
  • Purpose: Perioperative chemotherapy improves survival outcomes in locally advanced (LA) gastric cancer. Materials and Methods: We retrospectively analyzed patients with LA gastric cancer who were offered perioperative chemotherapy consisting of epirubicin, oxaliplatin, and capecitabine (EOX) from May 2013 to December 2015 at Tata Memorial Hospital in Mumbai. Results: Among the 268 consecutive patients in our study, 260 patients (97.0%) completed neoadjuvant chemotherapy, 200 patients (74.6%) underwent D2 lymphadenectomy, and 178 patients (66.4%) completed adjuvant chemotherapy. The median follow-up period was 17 months. For the entire cohort, the median overall survival (OS), 3-year OS rate, median progression-free survival (PFS), and 3-year PFS rate were 37 months, 64.4%, 31 months, and 40%, respectively. PFS and OS were significantly inferior in patients who presented with features of obstruction than in those who did not (P=0.0001). There was no difference in survival with respect to tumor histology (well to moderately differentiated vs. poorly differentiated, signet ring vs. non-signet ring histology) or location (proximal vs. distal). Survival was prolonged in patients with an early pathological T stage and a pathological node-negative status. In a multivariate analysis, postoperative pathological nodal status and gastric outlet obstruction on presentation significantly correlated with survival. Conclusions: EOX chemotherapy with curative resection and D2 lymphadenectomy is a suggested alternative to the existing perioperative regimens. The acceptable postoperative complication rate and relatively high resections, chemotherapy completion, and survival rates obtained in this study require further evaluation and validation in a clinical trial.

Combinatorial Antitumor Activity of Oxaliplatin with Epigenetic Modifying Agents, 5-Aza-CdR and FK228, in Human Gastric Cancer Cells

  • Park, Jong Kook;Seo, Jung Seon;Lee, Suk Kyeong;Chan, Kenneth K;Kuh, Hyo-Jeong
    • Biomolecules & Therapeutics
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    • 제26권6호
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    • pp.591-598
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    • 2018
  • Epigenetic silencing is considered to be a major mechanism for loss of activity in tumor suppressors. Reversal of epigenetic silencing by using inhibitors of DNA methyltransferase (DNMT) or histone deacetylases (HDACs) such as 5-Aza-CdR and FK228 has shown to enhance cytotoxic activities of several anticancer agents. This study aims to assess the combinatorial effects of genesilencing reversal agents (5-Aza-CdR and FK228) and oxaliplatin in gastric cancer cells, i.e., Epstein-Barr virus (EBV)-negative SNU-638 and EBV-positive SNU-719 cells. The doublet combinatorial treatment of 5-Aza-CdR and FK228 exhibited synergistic effects in both cell lines, and this was further corroborated by Zta expression induction in SNU-719 cells. Three drug combinations as 5-Aza-CdR/FK228 followed by oxaliplatin, however, resulted in antagonistic effects in both cell lines. Simultaneous treatment with FK228 and oxaliplatin induced synergistic and additive effects in SNU-638 and SNU-719 cells, respectively. Three drug combinations as 5-Aza-CdR prior to FK228/oxaliplatin, however, again resulted in antagonistic effects in both cell lines. This work demonstrated that efficacy of doublet synergistic combination using DNMT or HDACs inhibitors can be compromised by adding the third drug in pre- or post-treatment approach in gastric cancer cells. This implies that the development of clinical trial protocols for triplet combinations using gene-silencing reversal agents should be carefully evaluated in light of their potential antagonistic effects.

In-Vitro Study of Urokinase Thrombolysis Following Stereotactic Aspiration of Intracerebral Hematoma

  • Son, Wonsoo;Park, Jaechan;Kang, Dong-Hun;Han, Young-Min;Choi, Yeon-Ju;Ohk, Boram
    • Journal of Korean Neurosurgical Society
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    • 제63권3호
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    • pp.380-385
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    • 2020
  • Objective : A consensus regarding the ideal regimen for urokinase (UK) thrombolysis subsequent to stereotactic spontaneous intracerebral hemorrhage aspiration has yet to be established. The purpose of this study is to evaluate the efficacy of UK thrombolysis relative to when the regimen is changed. Methods : Venous blood from 30 heathy volunteers was obtained for this in-vitro study. Various concentrations of UK solution were added to microcentrifuge tubes containing the clotted blood. The efficacy of UK thrombolysis was identified by checking the weight of lysed hematoma following various time intervals with different concentrations of UK solution. Group one, the "3×4" group involved four administrations every 3 hours over 12 hours, and group two, the "6×2" group involved two administrations every 6 hours over 12 hours. Results : More hematoma was lysed in the 3×4 group than the 6×2 group across all concentration levels (however, the differences were only significant between groups at the 500 and 1000 IU concentration levels, p<0.05). There were no significant differences of lysed hematoma among the various UK solution concentrations within groups. Conclusion : This study suggests that frequent administrations of UK thrombolysis may result in a greater degree of lysed hematoma in comparison to a higher concentration of UK.