• 제목/요약/키워드: Trial Division

검색결과 619건 처리시간 0.032초

Effects of Acupuncture Stimulation on the Radial artery's Pressure Pulse Wave in Healthy Young Participants: Protocol for a prospective, single-Arm, Exploratory, Clinical Study

  • Shin, Jae-Young;Ku, Boncho;Kim, Tae-Hun;Bae, Jang Han;Jun, Min-Ho;Lee, Jun-Hwan;Kim, Jaeuk U.
    • 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.

여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜 (A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial)

  • 서영경;이은희;김환;이지윤;박채린;최선영;장은수;권오진;김형준;정인철
    • 동의신경정신과학회지
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    • 제29권1호
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

최소압력보조 수준에서 추가적 1시간 T-piece 시도가 이탈에 미치는 영향 (Effect of Additional 1 hour T-piece Trial on Weaning Outcome to the Patients at Minimum Pressure Support)

  • 홍상범;고윤석;임채만;안종준;박완;심태선;이상도;김우성;김동순;김원동
    • Tuberculosis and Respiratory Diseases
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    • 제45권4호
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    • pp.813-822
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    • 1998
  • 연구배경: 압력보조환기로 이탈시 발판 시기는 최소보조압력수준에서 시행하는 것이 추천되고 있다. 그러나 임상에서는 압력보조환기법에 의한 이탈시 기관내 관의 발관을 최소압력보조법에 도달하였다고 판단되는 경우에서도 기관내 관의 재삽관 가능성을 줄이기 위하여 때로는 T-piece 시도를 1 시간 더한 뒤 기관내 관을 제거하는 방법도 시행되고 있다. 이는 환자의 호흡예비력을 좀더 확실하게 검증할 수 있는 장점이 있는 반면, 기관내 관 자체가 높은 기도 저항을 유발하므로 환자의 호흡 일이 증대되어 오히려 이탈이 지연될 가능성도 있다. 본 저자들은 최소압력보조치에서 1 시간 T-piece 추가가 이탈에 어떤 영향을 미치는지 알아보고자하였다. 연구방법: 1997년 5월부터 1998년 3월까지 서울중앙병원 내과계 중환자실에서 이탈을 시도한 44명을 대상으로 무작위 전향적 연구를 시행하였다. 이탈 대상이 되는 환자는 모두 압력보조환기방법으로 이탈을 진행하고 압력보조수준이 최소압력보조치에 이르면 환자를 무작위로 실험군 (1시간 T-piece 시도)과 대조군(즉시 발관)으로 나누었다. 연구결과: 전체 42회 이탈의 최소압력보조치는 7.6 [${\pm}1.9$, (4-13)] cm $H_2O$였다. 1. 환자들의 기저 상태 : 두 군간 환자들의 총 기계환기 시간, APACHE III 접수, 영양지표, 분당 호흡수, 얕은 숨지수, 호흡, 일 등에서 차이가 없었다. 2. 두 군간 성공률 및 호흡역학의 차이 : 실험군이 55%, 대조군이 70%로 즉시 발관한 군이 성공률이 높으나 통계학적 차이는 없었다 (p>0.05). 재삽관률도 실험군이 18%, 대조군이 20%로 두 군간 차이가 없었다. 실험군에서 1시간 T-piece 시도후 일회호흡 용적, 분당 호흡수, 얕은 숨지수, 호흡 일에서 악화된 소견을 보였으며(P<0.05), 특히 실험군내의 실패군에서는 일회호흡용적, 호흡 일, 압력시간곱의 악화가 심하였다 (P<0.05). 3. 성공군과 실패군 분석 : 전체 성공군에서 총 기계환기 시간이 유의있게 낮았고 ($246{\pm}195$ 시간 대 $407{\pm}248$ 시간, P<0.05), 일회호흡용적은 유의하게 높았다 ($0.43{\pm}0.11$ L 대 $0.35{\pm}0.10$ L). 결 론: 이상의 결과로서 최소압력보조치에서 1 시간 T-piece 추가는 환자의 호흡 일을 증가시키며 이탈 성공률에 있어 최소압력보조치에서 즉시 발관하는 방법에 비하여 차이가 없으므로 압력보조환기 양식으로 이탈을 시도할 때는 최소압력보조치에서 즉시 발관하는 것이 나을 것으로 사료된다.

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감기 임상시험 가이드라인 제정을 위한 최신 임상시험 연구 분석 (Analysis of Recent Clinical Studies to Establish Korean Herbal Medicine Clinical Trial Guidelines for the Common Cold)

  • 김관일;이호정;이범준;정희재;정승기;이준희
    • 대한한방내과학회지
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    • 제37권1호
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    • pp.109-134
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    • 2016
  • Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

Non-Randomized Confirmatory Trial of Laparoscopy-Assisted Total Gastrectomy and Proximal Gastrectomy with Nodal Dissection for Clinical Stage I Gastric Cancer: Japan Clinical Oncology Group Study JCOG1401

  • Kataoka, Kozo;Katai, Hitoshi;Mizusawa, Junki;Katayama, Hiroshi;Nakamura, Kenichi;Morita, Shinji;Yoshikawa, Takaki;Ito, Seiji;Kinoshita, Takahiro;Fukagawa, Takeo;Sasako, Mitsuru
    • 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.

지역적응 시험 자료를 활용한 옥수수 작물모형 CERES-MAIZE의 품종모수 추정시의 문제점 (Calibration of crop growth model CERES-MAIZE with yield trial data)

  • 김준환;상완규;신평;조현숙;서명철
    • 한국농림기상학회지
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    • 제20권4호
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    • pp.277-283
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    • 2018
  • 기후변화 영향평가를 위해 작물생육모형을 폭넓게 사용하고 있지만 모형을 구동하기 위해서는 품종모수를 결정하는 것이 필수적이다. 그러나 품종모수 결정을 위한 실험은 장시간의 노력이 필요하여 대부분 작황자료 또는 지역적응 시험 자료를 많이 사용하고 있다. 그러나 밭작물의 경우 작황자료 또는 지역적응 시험을 사용하는 경우에는 포장의 관개량과 시기에 대한 자료가 없고 또한 별도의 기상관측 없이 최인접지역의 기상자료를 사용하기 때문에 문제가 발생할 수 있다. CERES-MAIZE를 이용하여 밭작물인 옥수수에 대해서 이 문제점들을 검토하였다. 출사기와 관련된 품종모수는 최대 27km 내에 기상관측 지점이 있는 경우에도 신뢰성있는 품종모수가 얻어졌다. 온도의 경우에는 지형에 따라 유효한 거리가 달라질 수 있지만 본 연구의 대상 지역에서는 품종 모수 추정에 문제가 크지는 않을 것으로 보인다. 또한 온도 이외의 요소인 강수 또는 관개량은 생물계절관련 품종모수와는 큰 영향이 없기 때문에 비교적 정확도가 높은 결과가 나온 것으로 보인다. 그러나 수량과 관련된 품종 모수 요소에서는 그렇지 못하였다. 이는 밭작물의 경우 강수량에 따라 스트레스 정도가 결정되기 때문에 관개 및 강수량 정보가 중요한데, 관개량에 대한 정보를 작황 또는 지적시험 보고서에서는 얻을 수 없기 때문이다. 더구나 강수량의 경우에 온도보다 더 가까운 위치에 기상관측소가 존재해야만 유의미한 정보를 제공할 수 있다. 그러나 시험포장에 따라 기상관측소와의 거리가 충분히 가깝지 않은 경우가 대부분이었다. 따라서, 작황 또는 지역적응 시험자료를 이용하여 옥수수의 품종모수를 결정할 때는 기상관측 지점이 최소한 20km 이내의 인접지역에서 생물계절과 관련된 모수에 대해서만 결정하는 것이 타당할 것으로 생각된다. 그 반면에 수량과 관련된 요소의 결정은 적절하지 않을 것으로 생각된다. 수량과 관련된 요소를 결정하기 위해서는 가급적 직접 기상관측망을 설치하여 해당 포장에서 관개시기와 관개량을 모두 확보한 실험한 결과를 바탕으로 얻는 것이 적절할 것으로 생각된다.

방풍통성산 및 대시호탕의 항비만효과 분석: 단일기관 무작위배정 이중맹검 임상시험 프로토콜 (The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial)

  • 오지홍;심혜윤;차지윤;김호석;김민지;안은경;이명종;이준환;김호준
    • 한방비만학회지
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    • 제20권2호
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    • pp.138-148
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    • 2020
  • Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

The Influence of Metastatic Lymph Node Ratio on the Treatment Outcomes in the Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) Trial: A Phase III Trial

  • Kim, Youjin;Park, Se Hoon;Kim, Kyoung-Mee;Choi, Min Gew;Lee, Jun Ho;Sohn, Tae Sung;Bae, Jae Moon;Kim, Sung;Lee, Su Jin;Kim, Seung Tae;Lee, Jeeyun;Park, Joon Oh;Park, Young Suk;Lim, Ho Yeong;Kang, Won Ki
    • Journal of Gastric Cancer
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    • 제16권2호
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    • pp.105-110
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    • 2016
  • Purpose: In the Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) trial, we investigated whether chemoradiotherapy after D2 gastrectomy reduces the rate of recurrence. Recently, the ratio of metastatic lymph nodes to examined lymph nodes (N ratio) has been proposed as an independent prognostic factor in gastric cancer (GC). The aim of this study was to investigate the relationship between the metastatic N ratio and prognosis of GC after curative D2 surgery. Materials and Methods: We retrospectively reviewed the data of 458 ARTIST patients who underwent D2 gastrectomy followed by adjuvant chemotherapy (XP, n=228) or chemoradiotherapy (XPRT, n=230). The disease-free survival (DFS) rates of patients were used to evaluate the influence of N ratio on the treatment outcome. To achieve this, 4 different N ratio categories (0%, 1%~9%, 10%~25%, and >25%) were compared on the basis of their influence on the treatment outcome. Results: On multivariate analysis, the N ratio remained an independent prognostic factor for DFS. The hazard ratios (HRs) for the N ratio categories of 0%, 1%~9%, 10%~25%, and >25% were 1, 1.061, 1.202, and 3.571, respectively. In patients having N ratio >25%, the 5-year DFS rates were 55% and 28% for the XPRT and XP arms, respectively (HR, 0.527; 95% confidence interval, 0.307~0.904; P=0.020). Conclusions: In patients with curatively resected GC, the N ratio was independently associated with DFS. Although this finding warrants further investigation in future prospective studies, the benefit of chemoradiotherapy for D2 resected GC appears to be more beneficial in cancers having N ratios >25%.