• Title/Summary/Keyword: Trial

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A Contractual Study on the Clinical Trial of Medicine (의약품 임상시험의 계약적 일고찰)

  • Song, Young-Min
    • The Korean Society of Law and Medicine
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    • v.12 no.1
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    • pp.257-285
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    • 2011
  • This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

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Development and Demonstration of Trial-run Automation System of Energy Storage System for Frequency Regulation (주파수조정용 에너지저장장치 시운전 자동화 시스템의 개발과 실증)

  • Lim, Geon-Pyo;Choi, Yo-Han;Lee, Seung-Min;Park, Chan-Wook
    • The Transactions of the Korean Institute of Electrical Engineers P
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    • v.66 no.3
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    • pp.110-116
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    • 2017
  • System to automate the trial-run of energy storage system for frequency regulation was developed and demonstrated. Basic strategy was developed on the basis of trial-run procedure and verified in the computer simulation tool. The algorithm was developed and coded for 4MW trial-run automation system. 4MW trial-run automation system was connected to 4MW energy storage system for frequency regulation in Jocheon substation of Jeju city and demonstrated. 24MW trial-run automation system was developed on the basis of 4MW trial-run automation system and verified by operation system for 24MW energy storage system for frequency regulation. The operation system has own simulation model of energy storage system and power system. The verification was performed to improve the system in the view of user. 24MW trial-run automation system was demonstrated in 32MW Ul-san and 36MW Non-gong energy storage system. All tests of trial-run was done by manual and first they ware taken 1 week with no trial-run automation system. The manual trial-run tests were taken by maximum three times. Trial-run test by trial-run automation system was taken 2 days. The system helps reduce the trial-run test period and improve the accuracy of tests.

A Study on Risk Analysis of Marine Accident for Sea Trial Ships (우리나라 시운전 선박의 해양사고 위험성 조사 분석 연구)

  • PARK, Young-Soo;KIM, Jong-Sung;KIM, Jong-Soo;LEE, Yun-Sok;KIM, Se-Won
    • Journal of Fisheries and Marine Sciences Education
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    • v.27 no.3
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    • pp.696-705
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    • 2015
  • Approximately 4,000 vessels including sea trial ships per day are passing, entering or departing from Korea coastal waterway. Sea trial ships have erratic navigating patterns such as quick turning, crash stop and do not communicate with other vessels in appropriate time, so sea trial ships are often to expose dangerous situation such as collision in heavy traffic area. To identify the sea trial vessel's risk factors, this paper surveyed marine traffic volumes for 7 days in Korea harbour & coastal waterway, and it analyzed marine accident rate and intended to identify the risk degree of passing vessels. After that, this researched how many sea trial ship's traffic and what is the sea trial risk among sea trial items. We also conducted survey questionnaire and identified risk factors of sea trial ship. So this paper aimed to enhance the safety of korea coastal waterway to prevent sea trial ship's marine accident.

Kinematical Analysis of Tichonkich Motion in Parallel Bars (평행봉 Tichonkich 동작의 운동학적 분석)

  • Park, Jong-Hoon;Back, Jin-Ho
    • Korean Journal of Applied Biomechanics
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    • v.15 no.3
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    • pp.21-30
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    • 2005
  • The purpose of this study is helps to make full use for perfect performance by grasping the defects of Tichonkich motion performed by athlete CSM For this, the study analyzed kinematical variables through Tichonkich motions performed at the first selection competition(1st trial) and final selection competition(2nd trial) for the dispatch to the 28th Athens Olympic Games using the three-dimensional cinematographical method with a high-speed video camera, and obtained the following results. 1. During Tichonkich motion, the execution time of up swing and the right hand moving to the left bar was shorter in the 2nd trial than the 1st one, while the execution time of down swing, the support of the left bar and the right hand moving to the right bar was longer in the 2nd trial than the 1st trial. 2. The horizontal position of COG in the 2nd trial was -35cm in the 1st stage, 42cm in the 3rd stage and 29cm in the 4th stage, that is, it showed a great swing focused on the circular movement compared to the 1st trial, while the vertical position of COG was -59cm in the 2nd stage, that is, it showed a small swing focused on a up and down movement. Also the 5th stage vertical position was 98cm, and the 6th stage vertical position was 95cm in the 2nd trial which were higher than those of the 1st trial, so it has provided magnificence required in the modern gymnastics. 3. And it was indicated that the horizontal velocity at the down swing phase proceeded forward more rapidly in the 2nd trial than that in the 1st trial, and the reverse ascent made a rapid vertical rise lessening left and right velocity change. And in the 5th stage, the 2nd trial was kept very slower in horizontal, vertical and left and right velocity that in the 1st trial, so it reached a handstand with leisurely movement. 4. In the 2nd trial, shoulder joint of the 1st, 2nd, 3rd stages kept a larger angle than that in the 1st trial, that is, it made a great swing while in the 1st trial, it showed a swing movement dependent on kick movement by the flexion and extension of hip joint. Also in the 2nd trial, the body formed a vertical posture with both hands supporting the left bar and hip joint was kept larger as $198^{\circ}$ and $190^{\circ}$ in the 5th and 6th stage than that in the 1st trial, so it made a handstand with the body uprightly stretched out, and magnificent and stable movement.

Estrus Induction and Embryo Transfer in Post-Weaning Sows (이유후 모돈에서 발정유기 및 수정란이식)

  • 이종수
    • Journal of Embryo Transfer
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    • v.6 no.2
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    • pp.37-46
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    • 1991
  • A field trial was performed to evaluate the effects of hormone treatment on estrus induction, ovulation, embryo transfer and reproductive performance in post-weaning sows. This trial involved 61 mixed breed sows of varying parity on a commercial pig farm. Sows were allocated to one of five trials: control group involved 25 sows that were treated with a single intramuscular injection of 5 ml physiological saline, 6 sows received 1,500 IU PMSG on the day of weanning and 500 IU HCG at the onset of estrus in trial I, 7 sows received 750 IU PMSG on the day of weanning and 500 IU HCG at the onset of estrus in trial II, 5 sows were treated with the same as trial II on day 28 after weanning in trial III. and 18 sows were treated with 10 mg PGF$_2$$\alpha$ plus 2 mg estradiol benzoate on day 31 after weanning in trial IV. Ovarian responses were checked by laparotomy and ova were recovered by oviducal flushing between 40 and l00hrs after mating. Fertilized ova were transferred into the oviduts of recipient sows synchroni- zed. The results obtained were summarized as follows: 1. Percentages of sows detected in standing estrus following treatment were 86~100% among trial groups. The interval from treatment to standing estrus(6l.7$\pm$0.5lhrs) in lOmg PGF$_2$$\alpha$ and 2mg estradial henzoate treated group was significantly earlier than in other trial groups(P<0.05). 2. Average number of ovulations was 11.5~37.8 among trial groups. The ovulation rate in 1,500 IU PMSG and 500 IU RCG treated group (37.8$\pm$ 19.87) was significantly different from other trial groups(P<0.05). 3. Ova were recovered by oviducal flushing between 40~ l00hrs after mating and recovery rates of ova wore 91.4% between 40~59hrs. 4. Fertilized ova were transferred into the oviducts of 8 recipient sows synchronized with 7 to 17 ova per animal. Three of the recipients were pregnant and delivered 25 piglets. 5. Four of the donor sows in those embryo collection was not successful were pregnant following oviducal flushing and delivered 23 piglets. 6. Recurrence of estrus and farrowing performance of experimental sows were observed following the experiment was no difference among trial groups, respectively.

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Effects of endurance exercise under hypoxia on acid-base and ion balance in healthy males

  • Nam, Sang-Seok;Park, Hun-Young
    • Korean Journal of Exercise Nutrition
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    • v.24 no.3
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    • pp.7-12
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    • 2020
  • [Purpose] This study was performed to investigate the acid-base and ion balance at rest and after exercise in healthy males under normoxia, moderate hypoxia, and severe hypoxia. [Methods] Ten healthy Korean males completed three different trials on different days, comprising exercise under normoxia (FiO2 = 20.9%, N trial), moderate hypoxia (FiO2 = 16.5%, MH trial), and severe hypoxia (FiO2 = 12.8%, SH trial). They undertook endurance exercise for 30 min on a cycle ergometer at the same relative exercise intensity equivalent to 80% maximal heart rate under all conditions. Capillary blood samples were obtained to determine acid-base and ion balance at rest and after exercise. [Results] Exercise-induced blood lactate elevations were significantly increased as hypoxic conditions became more severe; SH > MH > N trials (P = 0.003). After exercise, blood glucose levels were significantly higher in the SH trial than in the N and MH trials (P = 0.001). Capillary oxygen saturation (SCO2) levels were significantly lowered as hypoxic conditions became more severe; SH > MH > N trials (P < 0.001). The pH levels were significantly lower in the MH trial than that in the N trial (P = 0.010). Moreover, HCO3- levels were significantly lower in the SH trial than in the N trial, with significant interaction (P = 0.003). There were no significant differences in blood Na+, K+, and Ca2+ levels between the trials. [Conclusion] MH and SH trials induced greater differences in glucose, lactate, SCO2, pH, and HCO3- levels in capillary blood compared to the N trial. Additionally, lactate, SCO2, and HCO3- levels showed greater changes in the SH trial than in the MH trial. However, there were no significant differences in Na+, K+, and Ca2+ levels in MH and SH trials compared to the N trial.

An Analysis of Clinical Trials for Understanding and Application of Pragmatic Clinical Trial (실용적 임상연구에 대한 이해와 적용을 위한 연구 사례 분석)

  • Yun, Young-Ju;Kang, Kyung-Won;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.26 no.5
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    • pp.105-116
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    • 2009
  • The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

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Pk/PD Study Using PET Biomarker

  • Yu, Kyung-Sang;Jang, In-Jin;Lim, Kyoung-Soo;Kwon, Jun-Soo;Jeong, Jae-Min;Lee, Jae-Sung;Kim, Jung-Ryul;Cho, Joo-Youn;Shin, Sang-Goo
    • 대한임상약리학회:학술대회논문집
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    • 2006.11a
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    • pp.141-142
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    • 2006
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A Study on a Sea Trial and repaired test ship (시운전과 수리시험선박에 관한 고찰)

  • Jung-Hoon Park;Jung-Hyun An
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 2023.05a
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    • pp.7-9
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    • 2023
  • The domestic law establishes a sea trial prohibited area and stipulates that a sea trial is prohibited in this area. However, depending on the user, the term is used interchangeably with on-board test after repaired, In particular, ships undergoing test called a sea trial after remodeling and repairing ships at repair shipyards do not comply with these regulations. By this study, we would like to look at the relevant laws and regulations to see if these ships can be interpreted as sea trial, and suggest the necessity of managing repaired test ships with risks comparable to those of sea trial ships.

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A Study on the deployment of IPv6 based VoIP trial service provided by LG Dacom (LG 데이콤의 차세대인터넷(IPv6) 기반 VoIP 시범서비스에 대한 연구)

  • Lee, Dong-Yeal;Kim, Hee-Dong
    • 한국정보통신설비학회:학술대회논문집
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    • 2007.08a
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    • pp.163-166
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    • 2007
  • This paper describes a IPv6 trial service provided by LG DACOM and discusses about the output of trial service. MIC has urged public organizations to introduce IPv6 technology into their network. As one of propelling policies, MIC and NIA launched some IPv6 trial project. LG DACOM, MIC's agent in doing IPv6 trial project, has selected three public organizations in order to deploy IPv6 based VoIP trial service. KMA, KISITI and MND gave out their different service requirements. In achieve this project we developed IPv6 supported voice IP phone, video IP phone, media gateway and IP-PBX. Furthermore, two KMA provincial offices adopted trial IP phone as working phone and replaced legacy PBX with IP-PBX. At the same time, public organizations introduced IPv6 technology into their local networks.

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