• Title/Summary/Keyword: Clinical trial center

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

  • Kim, Juyeon;Kim, Jinsung;Park, Jaewoo;Ryu, Bongha
    • The Journal of Korean Medicine
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    • v.34 no.3
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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.

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

  • Heo, Seo Yoon;Kim, Kyeong-Mi
    • Journal of the Institute of Electronics and Information Engineers
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    • v.53 no.12
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    • pp.180-190
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    • 2016
  • This prospective pilot clinical trial mainly focuses on developing dual chamber-based assistive cups which are suitable for stroke patients who have struggled with using there affected arms. It is unable to provide motor and sensory enhancement during drinking activities and to examine the feasibility of the devices for acute phase, even for chronic stroke survivors. The stroke patients(n=16; male=8, female=8), in this trial, were provided informed consent to the investigation. All the individuals participated in 1 weeks of training for using cups, randomized over dedicated dual chamber based assistive cups(DC) or placebo-cups(PC) training. All the participants were assessed within 1 week before and after the intervention period. 3-dimensional motion analysis, sEMG(surface electromyography) and 3-dimensional trunk movement were assessed. The result presents DC data group compared with PC showed, they needed lesser ROM(range of motion) at the phase of drinking in shoulder movements and lesser muscle activities on upper trapezius, deltoid middle fiber and triceps brachii muscles, lesser tilting movement on front and back side in drinking phase, the differences were statistically significant(p<.05). Dual chamber-based assistive cup could be one of efficient way to complete ADLs(activities of daily living), especially drinking tasks, and these evidence data may contribute to determine certain rehabilitation policies related to assistive devise usage.

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

  • Chung, Soo Im;Nam, Su Jin;Liang, Jie;Ma, Jing Wen;Kang, Mi Young
    • Korean Journal of Food Science and Technology
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    • v.51 no.2
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    • pp.182-187
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    • 2019
  • Women who undergo natural menopause transition have increased numbers of risk factors relating to metabolic syndrome due to estrogen deficiency. This study was conducted to investigate the effect of Superhongmi bran extract on metabolic syndrome improvement in menopausal women. Thirty women, who participated in a randomized, double-blind, placebo-controlled trial, were assigned to placebo-control (n=15) or Superhongmi bran extract (n=15) groups and were asked to consume two tablets (350 mg per extract per tablet) per day. After 12 weeks, weight, body mass index (BMI), plasma triglyceride (TG) levels, and total cholesterol (TC) levels were significantly decreased, whereas HDL-cholesterol (HDL-C), apolipoprotein A1 (ApoA1), adiponectin, superoxide dismutase 1 (SOD1), and GSH (glutathione) concentrations were significantly increased in the Superhongmi bran extract group. Moreover, $17{\beta}-estradiol$, and progesterone levels in the Superhongmi group were significantly higher than those in the placebo-control group. These results suggest that Superhongmi bran extract alleviates metabolic symptom in menopausal women.

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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    • v.22 no.2
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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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    • v.22 no.2
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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.

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

  • Kim, Gi-Young;Park, Gye-Young;Chae, Myoung-Hee
    • Culinary science and hospitality research
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    • v.15 no.4
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    • pp.9-17
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    • 2009
  • The microbiological examinations was conducted for the hygienic evaluation on ten Japanese restaurants during summer season in Gwangju, Korea. Total two hundreds swabbed samples using sponge were collected from the surface of facilities and utensils at restaurants. The number of total microorganism, coliform, E. coli, Staphylococcus, Salmonella, and Listeria were measured. The results demonstrated that most swabbed samples were contaminated with microorganisms and coliforms. The degree of contamination depended on the sample sites. The severely contaminated sites were floor, trench, and working table for the fish and total counts of those samples were over $10^4$ CFU/100 $cm^2$. The coliforms were detected on the floor, trench, and wood cutting board over $10^3$ CFU/100 $cm^2$. Moreover, coliforms was detected on the towel, dish, and working place for fish and vegetables. The E. coli was detected on the floor and trench of several restaurants. The Staphylococcus spp. was detected on the cutting board, towel, floor and trench of several restaurants. The Salmonella spp. and Listeria spp. were not detected all over the samples. From those results showed that sanitation management and disinfection were required on the Japanese restaurants.

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

  • Shin, Hee-Young;Rhee, Jung-Ae;Yoon, Jin-Sang;Kim, Jae-Min;Chung, Eun-Kyung
    • Journal of Preventive Medicine and Public Health
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    • v.38 no.3
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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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    • v.17 no.1
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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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    • v.26 no.6
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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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    • v.63 no.3
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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.