• 동의신경정신과학회지
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• 제21권4호
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• pp.151-161
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• 2010

Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

• The Journal of Advanced Prosthodontics
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• 제5권2호
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• pp.204-208
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• 2013

PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.

• Journal of Gastric Cancer
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• 제16권2호
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• pp.93-97
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• 2016

Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.

• 대한치과교정학회지
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• 제35권5호
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• pp.381-387
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• 2005

본 연구의 목적은 교정치료 초기에 사용되는 스테인레스스틸, 다가닥철선. 초탄성 NiTi, 열활동성 NiTi재료로 이루어진 총 4가지 호선의 초기 치료효과를 비교하기 위하여 시행되었으며, 실험의 설계는 전향적 임상 실험(prospective randomized clinical trial)으로서 브라질 리오데자네이로 주립 치과대대학에 내원한 45명의 고정식 교정장치 환자를 대상으로 시행되었다. 각 호선의 재료는 환자의 치열에 무작위로 배당되었는데 스테인레스스틸은 20명, 다가닥철선은 22명, 초탄성 NiTi는 22명, 열활동성 NiTi는 20명에게 할당되었고. 8주 후에 모형을 다시 제작한 후 3차원 디지털영상 장비를 이용하여 모형의 치관에 설정된 해부학적 지표의 변화를 측정하였는데 치료전 및 치료후 치열불규칙지수(Dental Irregularity Index)의 차이로 초기 교정치료 효과를 비교하였다. 분산분석을 시행하여 불규칙지수의 변화를 살펴본 결과 호선의 재료에 따른 초기 치료 효과는 유의한 차이가 나타나지 않았다

• Radiation Oncology Journal
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• 제35권4호
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• pp.325-331
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• 2017

Purpose: There is controversy regarding the cosmetic outcome after accelerated partial breast radiation (APBR). We report the cosmetic outcome from a single-arm prospective clinical trial of APBR delivered using intensity-modulated radiation therapy (IMRT) in elderly patients with stage I breast cancer (BC), using a novel fractionation schedule. Materials and Methods: Forty-two patients aged ${\geq}65$, with Stage I BC who underwent breast-conserving surgery were enrolled in a phase I/II study evaluating a 2-week course of APBR. Thirty eligible patients received 40 Gy in 4 Gy daily fractions. Cosmetic outcome was assessed subjectively by physician/patient and objectively by using a computer program (BCCT.core) before APBR, during, and after completion of the treatment. Results: The median age was 72 years, the median tumor size was 0.8 cm, and the median follow-up was 50.5 months. The 5-year locoregional control in this cohort was 97% and overall survival 87%. At the last follow-up, patients and physicians rated cosmesis as 'excellent' or 'good' in 100% and 91 %, respectively. The BCCT.core program scored the cosmesis as 'excellent' or 'good' in 87% of the patients at baseline and 81% at the last follow-up. The median $V_{50}$ (20 Gy) of the whole breast volume (WBV) was 37.2%, with the median WBV $V_{100}$ (40 Gy) of 10.9%. Conclusion: An excellent rate of tumor control was observed in this prospective trial. By using multiple assessment techniques, we are showing acceptable cosmesis, supporting the use of IMRT planned APBR with daily schedule in elderly patients with early stage BC.

• Journal of Gastric Cancer
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• 제12권1호
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• pp.7-12
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• 2012

More than ten years have passed since the sentinel node (SN) concept for gastric cancer surgery was first discussed. Less invasive modified surgical approaches based on the SN concept have already been put into practice for malignant melanoma and breast cancer, however the SN concept is not yet placed in a standard position in gastric cancer surgery even after two multi-institutional prospective clinical trials, the Japan Clinical Oncology Group trial (JCOG0302) and the Japanese Society for Sentinel Node Navigation Surgery (SNNS) trial. What is the problem in the clinical application of the SN concept to gastric cancer surgery? There is no doubt that we need reliable indicator(s) to determine with certainty the absence of metastasis in the lymph nodes in order to avoid unnecessary lymphadenectomy. There are several matters of debate in performing the actual procedure, such as the type of tracer, the site of injection, how to detect and harvest, how to detect metastases of SNs, and learning period. These issues have to be addressed further to establish the most suitable procedure. Novel technologies such as indocyanine green (ICG) fluorescence imaging and one-step nucleic acid amplification (OSNA) may overcome the current difficulties. Once we know what the problems are and how to tackle them, we can pursue the goal.

• Journal of Gastric Cancer
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• 제5권2호
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• pp.79-88
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• 2005

질 관리란 진료 행위의 표준화 작업과 행위의 다양한 평가를 통해서 더 나은 치료 결과를 얻고자 이루어지는 체계적이고 종합적인 작업이다. 일반적으로 외과 영역의 질 관리는 항암화학치료나 방사선치료에 비해 적용이 어려운 것으로 알려져 있다. 하지만 최근 다기관 전향적 임상시험이 활발히 진행되면서, 두 가지의 수술법을 비교하거나 수술 전후 보조요법의 유용성을 확인하는 임상 연구에서 있어서 수술의 질 관리의 중요성이 점점 더 강조되고 있다. 위암의 경우 몇몇 대규모 전향적 임상시험이 시행되었으나 수술의 질 관리가 만족할 만한 수준으로 유지된 경우는 많지 않다. 유럽에서 시행되었던 D1-D2 림프절 절제술 비교 임상시험은 수술의 질 관리에 많은 노력을 기울인 연구였으나 우리나라의 실정과는 차이가 있는 반면, 현재 일본에서 시행 중인 D2와 D2 및 대동맥 주위림프절 절제술을 비교하는 임상시험에서는 우리에게도 적용 가능한 질 관리 프로그램이 다수 포함되어 있다. 향후 위암 수술에서의 다기관 무작위 전향적 임상시험을 성공적으로 수행하기 위해서는 learning curve 와 연간 증례 수를 고려한 치료자의 선택, 다양한 교육 및 의견 교류를 통한 수술 방법의 표준화, 체계적이고 통일된 전향적 데이터베이스 프로그램의 개발, 표준화된 수술 후 환자 관리 프로그램의 개발, 표준화된 수술 후 환자 관리 프로그램의 개발, 병리 검사 및 병리 기록의 표준화 등이 요구된다. 하지만 지나치게 세세한 표준화 작업 및 너무 많은 감시 프로그램은 환자 및 치료자 대상군 확보를 어렵게 만들고 프로토콜 위반율을 높일 수 있다는 점을 염두에 두어야 할 것이다.

• 대한약침학회지
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• 제19권3호
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• pp.197-206
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• 2016

Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz ($SE_{10-30Hz}$) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.

• 한국의료질향상학회지
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• 제7권2호
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• pp.168-179
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• 2000

Background : Economic evaluation of clinical pharmacokinetic consultation services for theophylline, which is being widely used recently, is considered in patients for both proper care and cost efficiency. Mathods : This is a cost-benefit analysis of clinical pharmacokinetic consultation service for theophylline. Trial groups were chosen from 2 general hospitals which was performing clinical pharmacokinetic consultation- services in 1998. Control group was chosen from another one general hospital. The analysis includes 25 patients (sample patients) for trial group and 17 patients for control group. Results : On the basis of incremental analysis, it is estimated that the total (direct and indirect) annual costs of the clinical, pharmacokinetic services of theophylline for the patients in the trial group was about \65 million, whereas total annual benefits from those services was estimated to be about \551 million. The net benefits incurred to the sample patients, thus calculated, was about \485 million per year. In the analysis, we assumed that indirect benefits accruing to those services were non-existent. If that amount was included, the estimated net benefits would be much greater than the calculated one. Conclusion : We found that clinical pharmacokinetic consultation services for theophylline could produce more marginal benefits than marginal costs by those services from the social point of view. More controlled prospective trial in the future would be helpful for affirmation of the results of this study.

• Journal of Gastric Cancer
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• 제19권2호
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• pp.157-164
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• 2019

Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.