• 제목/요약/키워드: multi center trial

검색결과 78건 처리시간 0.029초

Home Bioelectrical Impedance Analysis Management System in Patients With Heart Failure: Rationale and Study Design

  • Min Gyu Kong;Inki Moon;Hye-Sun Seo;Jon Suh;Jah Yeon Choi;Jin Oh Na;Eung Ju Kim
    • International Journal of Heart Failure
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    • 제6권1호
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    • pp.22-27
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    • 2024
  • Body fluid monitoring and management are essential to control dyspnea and prevent re-hospitalization in patients with chronic heart failure (HF). There are several methods to estimate and monitor patient's volume status, such as symptoms, signs, body weight, and implantable devices. However, these methods might be difficult to use for reasons that are slow to reflect body water change, inaccurate in specific patients' condition, or invasive. Bioelectrical impedance analysis (BIA) is a novel method for body water monitoring in patients with HF, and the value in prognosis has been proven in previous studies. We aim to determine the efficacy and safety of home BIA body water monitoring-guided HF treatment in patients with chronic HF. This multi-center, open-label, randomized control trial will enroll patients with HF who are taking loop diuretics. The home BIA group patients will be monitored for body water using a home BIA device and receive messages regarding their edema status and direction of additional diuretics usage or behavioral changes through the linked application system once weekly. The control group patients will receive the usual HF management. The primary endpoint is the change in N-terminal prohormone of brain natriuretic peptide levels from baseline after 12 weeks. This trial will provide crucial evidence for patient management with a novel home BIA body water monitoring system in patients with HF.

가동원전에서 공정모델링을 통한 PID 튜닝 시뮬레이션 방법 (A Simulation Method of PID Tuning with Process Modeling in Operating Nuclear Power Plants)

  • 민문기;정창규;이광현;이재기;김희제
    • 전기학회논문지P
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    • 제63권4호
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    • pp.290-294
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    • 2014
  • PID(Proportional, Integral, Derivative) controller is the most popular process controllers in nuclear power plants. The optimized parameter setting of the process controller contributes to the stable operation and the efficiency of the operating nuclear power plants. PID parameter setting is tuned when new process control systems are installed or current process control systems are changed. When the nuclear plant is shut down, a lot of PID tuning methods such as the Trial and Error method, Ultimate Oscillation method operation, Ziegler-Nichols method, frequency method are used to tune the PID values. But inadequate PID parameter setting can be the cause of the unstable process of the operating nuclear power plant. Therefore the results of PID parameter setting should be simulated, optimized and finally verified. This paper introduces the simulation method of PID tuning to optimize the PID parameter setting and confirms them of the actual PID controller in the operating nuclear power plants. The simulation method provides the accurate process modeling and optimized PID parameter setting of the multi-loop control process in particular.

효과적인 대뇌 직접피질자극 검사 및 피질하자극 검사의 술기에 관한 기술적 고찰 (Technical Considerations of Effective Direct Cortical and Subcortical Stimulation)

  • 임성혁;장민환
    • 대한임상검사과학회지
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    • 제54권2호
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    • pp.157-162
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    • 2022
  • 본 술기의 목적은 운동피질 주변에 발생한 뇌종양 환자의 수술에서 TceMEP로 인해 발생하는 위양성을 방지하고 수술 중 운동영역의 정확한 매핑과 피질척수로 보존하기 위함이다. 또한 검사과정에서 발생하는 시행착오를 줄이고 검사시간을 최소화하여 검사결과에 대한 빠른 피드백으로 수술하는 의사에게 정확한 정보를 전달함에 있다. 본 술기의 가장 중요한 요소는 첫번째로 일정 세기의 자극역치로 검사해야 하는 것과 두번째로는 일정 수준의 마취농도를 적정 수준으로 유지하는 것이 수술 중 발생하는 위양성을 막는 기본적이 요소이다. 세번째로는 수술하는 반대쪽 부위에 다중 채널을 이용한 기록전극의 설치로 최대한 많은 근육에서 TceMEP파형과 집접피질자극 및 직접피질하 자극에 대한 반응을 측정하는 것이다. 이런 조건들이 수술이 진행되는 동안 원활하게 유지된다면 검사에서 오는 위양성이 아닌 그 밖의 요인들에서 발생할 수 있는 원인들을 예측할 수 있다.

심적환$^{(R)}$이 흉통 흉민에 대하여 미치는 영향에 대한 다기관 무작위배정 이중맹검 임상연구 (Effect of Cardiotonic Pills$^{(R)}$ on Chest Pain and Discomfort: A Multi-center Double-blind Randomized Controlled Trial.)

  • 장인수;고창남;이인;박정미;김세현;김상우
    • 대한한의학회지
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    • 제26권2호
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    • pp.95-104
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    • 2005
  • Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

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Jonckheere-Terpstra 추세 검정통계량에 근거한 비모수적 층화분석법 (A Nonparametric Stratified Test Based on the Jonckheere-Terpstra Trend Statistic)

  • 조도연;양수;송혜향
    • 응용통계연구
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    • 제23권6호
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    • pp.1081-1091
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    • 2010
  • 각 의료기관에서 수집될 수 있는 환자수가 한정되어 있는 질병의 경우에는 주로 다기관연구로써 임상연구가 진행된다. Jonckheere (1954)와 Terpstra (1952)의 추세 검정법으로 분석해야 하는 독립된 여러 군의 자료를 다기관에서 수집한 경우에 이질성을 고려하여 각 연구기관을 하나의 층으로 보아 층화분석법으로 분석하지 않으면 옳지 않은 결론에 도달할 수가 있다. 본 논문에서는 van Elteren (1960)이 제시한 Wilcoxon (1945) 검정통계량의 층화분석법을 이용하여 Jonckheere (1954)와 Terpstra (1952)의 추세 검정통계량에 근거한 층화분석법을 제시한다. 예제 자료에 이 층화분석법을 적용하며 효율성을 모의실험으로 알아본다.

혼합물 실험계획법을 이용한 OH라디칼 최적 생성을 위한 삼성분 전극의 비율 선정 (Using Design of Mixture Experiments to Select the Ratio of a Three-Component Electrode for Optimal Generation of Hydroxyl Radicals)

  • 박영식
    • 한국환경과학회지
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    • 제29권8호
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    • pp.793-800
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    • 2020
  • The conventional development of multi-component electrodes is based on the researcher's experience and is based on trial and error. Therefore, there is a need for a scientific method to reduce the time and economic losses thereof and systematize the mixing of electrode components. In this study, we use design of mixture experiments (DOME)- in particular a simplex lattice design with Design Expert program- to attempt to find an optimum mixing ratio for a three-component electrode for the high RNO degradation; RNO is an indictor of OH radical formation. The experiment included 12 experimental points with 2 center replicates for 3 different independent variables (with the molar ratio of Ru, Ti, Ir). As the Prob > F value of the 'Quadratic' model is 0.0026, the secondary model was found to be suitable. Applying the molar ratio of the electrode components to the corrected response model results is an RNO removal efficiency (%) = 59.89 × [Ru] + 9.78 × [Ti] + 67.03 × [Ir] + 66.38 × [Ru] × [Ir] + 132.86 × [Ti] × [Ir]. The R2 value of the equation is 0.9374 after the error term is excluded. The optimized formulation of the ternary electrode for an high RNO degradation was acquired when the molar ratio of Ru 0.100, Ti 0.200, Ir 0.700 (desirability d value, 1).

GIS와 RS를 이용한 도시확산 포텐셜 평가기법의 개발 (Development of a potential evaluation method for urban expansion using GIS and RS technologies)

  • 김대식;정하우
    • 농촌계획
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    • 제10권3호
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    • pp.41-51
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    • 2004
  • This study aims to develop a potential evaluation method for urban spatial expansion using remote sensing (RS) and geographic information system (GIS). A multi-criteria evaluation method with several criteria and their weighting values was introduced to evaluate the score and quantification of the potential surface around the existing cities. The six criteria with one geographic factor, slope, and five accessibility factors, time distance from center of the city, national road, interchange of expressway, a big city, and station, were defined for the potential. RS techniques were applied for classification of the actual urban expansion maps between two periods, and GIS functions were used for score of accessibility criteria with a distance decay function from geographic, road and several point maps, which was developed in this study. The new methodology was applied to a test area, Suwon, between 1986 and 1996. In order to optimize the six weighting values, this study made new findings to search the optimal combination of the weighting values from new methodology, weighted scenario method for intensity order (WSM), combined with intensity order and AHP method, including a trial and error method for sensitivity analysis to make the intensity order. The optimal combination of the weighting values by the new method generated the optimal potential surface, considering spatial trend of urban expansion in the test area.

Development of a Washout Algorithm for a Vehicle Driving Simulator Using New Tilt Coordination and Return Mode

  • You Ki Sung;Lee Min Cheol;Kang Eugene;Yoo Wan Suk
    • Journal of Mechanical Science and Technology
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    • 제19권spc1호
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    • pp.272-282
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    • 2005
  • A vehicle driving simulator is a virtual reality device which makes a man feel as if he drove an actual vehicle. Unlike actual vehicles, the simulator has limited kinematical workspace and bounded dynamic characteristics. So it is difficult to simulate dynamic motions of a multi-body vehicle model. In order to overcome these problems, a washout algorithm which controls the workspace of the simulator within the kinematical limitation is needed. However, a classical washout algorithm contains several problems such as generation of wrong sensation of motions by filters in tilt coordination, requirement of trial and error method in selecting the proper cut-off frequencies and difficulty in returning the simulator to its origin using only high pass filters. This paper proposes a washout algorithm with new tilt coordination method which gives more accurate sensations to drivers. To reduce the time in returning the simulator to its origin, an algorithm that applies selectively onset mode from high pass filters and return mode from error functions is proposed. As a result of this study, the results of the proposed algorithm are compared with the results of classical washout algorithm through the human perception models. Also, the performance of the suggested algorithm is evaluated by using human perception and sensibility of some drivers through experiments.

60세 이상 뇌경색환자에서 황태는 심혈관질환의 유용한 지표가 될 수 있는가? - 다기관임상연구 (Can Yellow Fur on the Tongue be Useful as an Index of Cardiovascular Disease in Stroke Patients over 60 Years Old? - Multi Center Trial)

  • 임정태;박수경;우수경;곽승혁;정우상;문상관;조기호;박성욱;고창남
    • 대한한방내과학회지
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    • 제31권3호
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    • pp.569-577
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    • 2010
  • Background & Objectives : Yellow fur on the tongue is known to be associated with prognosis of disease in oriental medicine. Higher ratios of low-density lipoprotein cholesterol(LDL) to high-density lipoprotein cholesterol(HDL) & total cholesterol (TC) to high-density lipoprotein cholesterol(HDL) are associated with a greater risk of cardiovascular disease. The aim of this study was to assess the relationship between cardiovascular disease index and yellow fur - oriental medical index - in stroke patients over 60 years old. Methods & Subjects : Among 802 of the recruited patients(434 male, 368 female), 340 were yellow fur group(209 male, 131 female). We assessed their general characteristics and risk factors. We compared the cardiovascular disease index between yellow fur and non-yellow fur groups by sex. Results : On the General Characteristics males have yellow fur more often than females. In cardiovascular disease index, the male yellow fur group showed higher ratios of TC/HDL(atherogenic index), (TC-HDL)/HDL, LDL/HDL and higher LDL and showed lower HDL than the non-yellow fur group. In female patients, there were no differences between the two groups about cardiovascular disease index. There were more patients diagnosed with Fire & Heat in the male yellow fur group, and Dampness & Phlegm in the male non-yellow fur group. The male yellow fur group eat fast food more than the non-yellow fur group. Conclusions : The results indicated that yellow fur may be associated with a high risk of cardiovascular disease. We can thus use yellow fur on the tongue as a cardiovascular disease index in male stroke patients over 60 years old.

Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna;Eom, Yoon Ji;Kwon, Dohyung;Lee, Jae Hyok;Jung, In Chul;Cho, Eun;Lee, Ji Eun;Cho, Seung-Hun
    • 동의신경정신과학회지
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    • 제32권2호
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    • pp.81-93
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    • 2021
  • Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.