• Title/Summary/Keyword: New Trial

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임상 시험등록정보의 산업적 활용과 시사점: ICTRP에 등록된 COVID-19 사례 중심으로 (A Study of the Implication of Clinical Trial Registration Information and its Application to Industry: Focused on 「COVID-19」 Registered in ICTRP)

  • 이화정;김경미
    • 한국재난정보학회 논문집
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    • 제17권4호
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    • pp.778-785
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    • 2021
  • 연구목적: 본 연구의 목적은 팬데믹 상황에서 의료정보관리방식이 가져다 줄 국가적 통제 가능성과 그 한계를 제시하고자 하는 것으로 의료정보 관리와 정보의 이용허가가 의료산업에 미치는 영향을 분석하고자한다. 연구방법: 연구목적을 위해 본조사는 국가별 대응 움직임의 유일한 표준화 근거인 임상시험등록플랫폼(International Clinical Trial Registry Platform, ICTRP)의 primary registry, 2019년 12월 첫 발생 시점부터 2020년 3월 30일, 해당 기간 기준, 780명의 등록자료를 확보해 임상시험계획 승인을 위한 '임상 시험등록정보'공개 정도를 검토하고 그 영향을 분석하였다. 연구결과: 연구 결과는 임상시험등록의 정보 이용은 COVID-19와 관련된 새 치료제 개발, 백신 개발 등에 효과가 있음을 입증하였다. 결론: 연구의 결론은 각 국가는 이번 COVID-19의 신약 개발을 위해 다양한 임상 시험방법을 시도하고 있는 것으로 나타났으며 제약회사들은 CRIS에 임상시험 결과를 등록하여 많은 나라가 데이터를 공유하도록 하여 치료제나 백신 개발에 전념해야 한다.

A Pilot Study on the Heart Rates of Jeju Horses during Race Trials

  • Seung-Ho Ryu;HeeEun Song;Eliot Forbes;Byung-Sun Kim;Joon-Gyu Kim;Ki-Jeong Na
    • 한국임상수의학회지
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    • 제40권6호
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    • pp.464-467
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    • 2023
  • The autonomic regulation of heart rate (HR) is an indicator of the body's ability to adapt to an exercise stimulus. However, there are no reports on this topic in relation to Jeju horses used for racing. The aim of this study was to analyze the HR responses of Jeju horses during race trials and to investigate the correlation between HR and performance in these horses. HR data were collected from 17 healthy 2- to 7-year-old Jeju horses wearing HR monitors during race trials. Pearson correlation coefficients was used to determine the significance of the association between the race trial time and HR. A significant inverse correlation was observed between the race trial time (performance) and both the maximal HR (HRmax, r = -0.69, p < 0.01) and HR reserve (HRR) (HRmax - average HR during the warm-up period, r = -0.63, p < 0.01) and between the HRR and HRmax (r = 0.73, p < 0.01). Horses with a lower average HR during the warm-up period and higher heart rates during the trial achieved faster race trial times. This study reports the first HR measurements in Jeju horses during race trials, providing new insights into the HR response of this breed to exercise. The use of a noninvasive remote HR monitor system allowed assessment of exercise responses in the field, and the results suggest that both the HRR during warm-up period and HRmax may be useful performance indicators in Jeju horses.

Development of New Radar Beacon

  • Hayashi, Shogo;Sato, Tatsuo;Tanaka, Senji;Suzuki, Tsutomu
    • 한국항해항만학회:학술대회논문집
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    • 한국항해항만학회 2006년도 International Symposium on GPS/GNSS Vol.1
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    • pp.291-296
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    • 2006
  • The restrictions concerning the use of the radio waves have become severe, the marine radar with low spurious is being developed. Therefore, it is necessary to develop aids to navigation as a radar beacon can respond to new type of marine radar. Because the system of radar in the future is an indetermination, new radar beacon should correspond to old and new radar system during a transition period. New radar beacon that is also able to respond to pulse radar, pulse compression radar and FM-CW radar were considered in these years in Japan. The sign of the response of Morse code in a new system is generated by the delay synthesis system. Computer simulation and actual examination using trial circuit were curried out. A big possibility was set up in the development of the new radar beacon that was able to correspond to old and new radar system. These results and the state of new radar beacon is mentioned in this paper.

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2016년 개정 중재법의 중재판정 집행에 관한 문제점 (Problems on the Arbitral Awards Enforcement in the 2016 Korean Arbitration Act)

  • 윤진기
    • 한국중재학회지:중재연구
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    • 제26권4호
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    • pp.3-41
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    • 2016
  • This paper reviews the problems on the arbitral awards enforcement in the 2016 Korean Arbitration Act. In order to get easy and rapid enforcement of the arbitral awards, the new arbitration act changed the enforcement procedure from an enforcement judgement procedure to an enforcement decision procedure. However, like the old arbitration act, the new act is still not arbitration friendly. First of all, there are various problems in the new act because it does not approve that an arbitral award can be a schuldtitel (title of enforcement) of which the arbitral award can be enforced. In this paper, several problems of the new act are discussed: effect of arbitral award, approval to res judicata of enforcement decision, different trial process and result for same ground, possibility of abuse of litigation for setting aside arbitral awards and delay of enforcement caused by setting aside, infringement of arbitration customer's right to be informed, and non-internationality of enforcement of interim measures of protection, inter alia. The new arbitration act added a proviso on article 35 (Effect of Arbitral Awards). According to article 35 of the old arbitration act, arbitral awards shall have the same effect on the parties as the final and conclusive judgement of the court. The proviso of article 35 in the new act can be interpret two ways: if arbitral awards have any ground of refusal of recognition or enforcement according to article 38, the arbitral awards do not have the same effect on the parties as the final and conclusive judgement of the court; if arbitral awards have not recognised or been enforced according to article 38, the arbitral awards do not have the same effect on the parties as the final and conclusive judgement of the court. In the case of the former, the parties cannot file action for setting aside arbitral awards in article 36 to the court, and this is one of the important problems of the new act. In the new act, same ground of setting aside arbitral awards can be tried in different trial process with or without plead according to article 35 and 37. Therefore, progress of enforcement decision of arbitral awards can be blocked by the action of setting aside arbitral awards. If so, parties have to spend their time and money to go on unexpected litigation. In order to simplify enforcement procedure of arbitral awards, the new act changed enforcement judgement procedure to enforcement decision procedure. However, there is still room for the court to hear a case in the same way of enforcement judgement procedure. Although the new act simplifies enforcement procedure by changing enforcement judgement procedure to enforcement decision procedure, there still remains action of setting aside arbitral awards, so that enforcement of arbitral awards still can be delayed by it. Moreover, another problem exists in that the parties could have to wait until a seventh trial (maximum) for a final decision. This result in not good for the arbitration system itself in the respect of confidence as well as cost. If the arbitration institution promotes to use arbitration by emphasizing single-trial system of arbitration without enough improvement of enforcement procedure in the arbitration system, it would infringe the arbitration customer's right to be informed, and further raise a problem of legal responsibility of arbitration institution. With reference to enforcement procedure of interim measures of protection, the new act did not provide preliminary orders, and moreover limit the court not to recognize interim measures of protection done in a foreign country. These have a bad effect on the internationalization of the Korean arbitration system.

Morphological Change of Crosslinked ${\beta}$-Cyclodextrin after Recycling

  • Han, Eun-Mi;Kim, Song-Hee;Kim, Ki-Woo;Kwak, Hae-Soo
    • Journal of Dairy Science and Biotechnology
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    • 제25권1호
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    • pp.9-13
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    • 2007
  • The present study was carried out to examine the effect of crosslinked ${\beta}$-cyclodextrin(${\beta}$-CD) made by adipic acid on cholesterol removal rate and find the structural change after recycling on SEM observation. The size reduction and morphological changes were found during the recycling process and the profound changes were observed at 8th time reuse. After cholesterol removal in milk, the used crosslinked ${\beta}$-CD was washed for cholesterol dissociation and reused. In recycling study, the cholesterol removal rate at first trial was 92.5% in milk, which was mostly same as that using new crosslinked ${\beta}$-CD(92.4%). With repeated 10th reuse of crosslinked ${\beta}$-CD resulted in 81.4% of cholesterol removal in milk. Similar trend was found in cream and cholesterol removal was 91.5% at 1st trial and 83.4% at 10th trial. In both milk and cream samples, the removal rate at 1st reuse was not significantly different from that at 6th reuse(p>0.05). The present study indicated that crosslinked ${\beta}$-CD made by adipic acid resulted in the effective recycling efficiency, especially up to 6th reuse and morphological modifications were not distinguishable up to 8th reuse.

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제 1상 임상시험에서 멈춤 규칙을 이용한 수정된 최대허용용량 추정법 (Adjusted maximum tolerated dose estimation by stopping rule in phaseⅠclinical trial)

  • 박주희;김동재
    • Journal of the Korean Data and Information Science Society
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    • 제23권6호
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    • pp.1085-1091
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    • 2012
  • 제 1상 임상시험의 주목적은 신약 후보 물질의 독성을 평가하여 부작용 및 안전하게 투여할 수 있는 약물의 적정한 용량인 최대허용용량의 추정이다. 기존에 최대허용용량을 추정하는 방법에는 표준방법 (Storer, 1989; Korn 등, 1994) 그리고 NM방법 (Lee와 Kim, 2012) 등이 있다. 본 연구에서는 많은 피험자들이 낮은 용량에 많이 할당되는 점을 보완하고 기존의 최대허용용량 추정법보다 적은 수의 피험자로 실험하기 위해서 기존 최대허용용량 추정법을 수정한 멈춤 규칙을 적용시킨 추정법을 제안하였다. 기존의 방법들과 새롭게 제시한 방법을 모의실험을 통하여 비교하였다.

활성대조군을 이용한 두 군 설계와 위약군을 포함한 세 군 설계의 비열등성 시험 (Non-Inferiority Test in a Two-Arm Trial and a Three-Arm Trial Including a Placebo)

  • 이지선;김동재
    • 응용통계연구
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    • 제21권6호
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    • pp.947-957
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    • 2008
  • 비열등성 시험시에 치료군(treatment group)과 활성대조군(active control group)을 이용한 모형으로 Hauschke 등 (1999)이 제안한 모수적 검정법이 있다. 이 방법은 위약군(placebo group)과 직접적인 비교가 불가능하므로 Pigeot 등 (2003)이 세 군으로 확장한 검정법을 제안하였다. 그러나 이와 같은 두 검정법은 구체적인 분포가정이 필요하다. 이런 단점을 보완하기 위하여 본 논문에서는 비모수적 방법으로서 두 군 설계에 Wilcoxon 순위합 검정(Wilcoxon, 1945)을 이용한 방법을, 세 군 설계에 Scheirer 등 (1976)이 제안한 선형대비검정을 확장한 새로운 방법을 제안한다. 또한 모의실험을 통하여 모수적 방법과 비모수적 방법간의 검정력을 비교하였다.

성인 호흡곤란 증후군에 있어 체외막 산소화 장치를 이용한 치료 (The Treatment of Adult Respiratory Distress Syndrome (ARDS) Using Extracorporeal Membrane Oxygenation (ECMO))

  • 김고운;최은영;홍상범
    • Tuberculosis and Respiratory Diseases
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    • 제72권1호
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    • pp.1-7
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    • 2012
  • Extracorporeal Membrane Oxygenation (ECMO) support to tissue oxygenation has been shown to improve survival in patients with life threatening respiratory distress syndrome or cardiac failure. Extracorporeal life support such as ECMO, including extracorporeal $CO_2$ removal ($ECCO_2R$), is used as temporary support until successful recovery of organs. A recently published multicentre randomized controlled trial, known as the CESAR (conventional ventilation or extracorporeal membrane oxygenation for severe adult respiratory failure) trial, was the first trial to demonstrate the utility of ECMO in acute respiratory distress syndrome (ARDS). During the 2009 influenza A (H1N1) pandemic, there were many reports of patients with severe ARDS related to H1N1 infection treated with ECMO. These reports revealed a high survival rate and effectiveness of ECMO. In this review, we explain the indication of ECMO clinical application, the practical types of ECMO, and complications associated with ECMO. In addition, we explain recent new ECMO technology and management of patients during ECMO support.

파킨슨병 변증 유형 및 지표 분포에 대한 전향적 다기관 관찰연구 프로토콜 (An Observational Multi-Center Study Protocol for Distribution of Pattern Identification and Clinical Index in Parkinson's Disease)

  • 조혜연;권오진;서복남;박성욱;유호룡;장정희
    • 대한한방내과학회지
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    • 제45권1호
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    • pp.1-10
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    • 2024
  • Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

I. 새로운 직교 변환군 : 매개변수형 삼각함수 행렬에 의한 유도 (I.A New Family of Orthogonl Transforms: Derivation based on the Parametric Sinusoidal Matrix)

  • Park, Tae-Young
    • 대한전자공학회논문지
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    • 제24권1호
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    • pp.159-166
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    • 1987
  • A new family of sinusoidal orthogoal trnasform is introduced. For a derivation, a parametric sinusoidal matrix whose transform might be implemented by a suitable FFT algorithm is modeled basically on the analogy of well-known sinusoidal transform such as DCT,SCT, etc., and its orthogonality condition is calculated. The parameters satisfying orthogonality condition are determined, in a sense, by particular solution after trial and error. However more than then transform matrices not yet known are obtained. It is also shown that these transforms can be computed by a DFT. of an image.

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