• Title/Summary/Keyword: trial registration

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A Study on the Issues for Developing e-Trade Service Provider (e-무역상사의 발전과제에 관한 연구)

  • Lee, Bong-Soo
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.20
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    • pp.423-440
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    • 2003
  • The trial business of e-trade service providers for supporting small enterprises to find their markets abroad is about to begin from the end of March, 2003. The department of Industrial Resources held the "Committee of e-trade service provider selection" with professors of e-trade field, and selected three companies: ECplaza, EC21 and Tpage Global. The e-trade service providers combine the various technologies of on-line trades and off-line trades to support small enterprises with lack of marketing skills by intermediation of overseas buyers and production, registration of e-catalogs and offers, administration of inquiries, trade negotiations, and contract settlement. Prospective small enterprises with exports under US$ 5 million will be selected by 2005. The selected companies will be supported fully by the government, and will be provided with the services by the e-trade service providers. e-Trade service will be the most potential and successful ones in the future, which helps traders and organizations preparing for globalization.

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Effect of Salvia plebeia Extract on Patients with Solid Cancer: A Preliminary Clinical Trial Protocol (배암차즈기의 투여가 고형암환자에 미치는 영향을 평가하기 위한 선행적 인체적용시험)

  • Boram, Lee;Sookjin, Pyo;Ae-Ran, Kim;Eunbin, Kwag;Jang-Gi, Choi;Hwaseung, Yoo;Hwan-Suck, Chung;Jongkwan, Jo
    • Herbal Formula Science
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    • v.30 no.4
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    • pp.241-248
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    • 2022
  • Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

A Study on the Indemnity System of Fishery Damage by Natural Disasters (자연재해로 인한 어업피해 전보방안에 관한 연구)

  • Kim, In-Yu
    • Journal of Fisheries and Marine Sciences Education
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    • v.26 no.5
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    • pp.1044-1057
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    • 2014
  • This study has seen about a indemnity system of fishery damage by natural disasters such as a problem and improvement methods of government aid system and system on accident insurance for cultured fishery products. Recently, in the situation that the demage of aquaculture industry caused by frequent typhoon resulted from global warming and abnormal changed of weather is nasty, the accident insurance for cultured fishery products is necessary to show its true quality and to protect fishers against natural disasters owing to the limitation of government's aid for them. However, The objects of accident insurance for cultured fishery products which is progress on, is too short to apply, so that it is absolutely insufficient to fulfill the demands of culturing fishermen. Therefore, It could be a certain preparation to magnify the range of object items of it and to convert the trial industry being adjusted to limited area into full scale industry to adjust over all nationally. Furthermore, This insurance is complicated and strict to join rather than other insurances. As it can be seen by examples that got in trouble, despite culturing fishermen applied to join the insurance, they took all demage because the insurance was not realized. So, It is hard to say that causes impute the responsibility of it to the authority of insurance, not culturing fishery. They should simplify the registration process, limit the period each registration process and consider a countermeasure to complete it. Concerning compensation for the loss, agriculture part is easier to investigate the loss due to remained dead crop damaged by natural disaster, meanwhile, in fishing part, especially in case of cultivation of fish, it is difficult to investigate the loss and demage because crops are blown all together with typhoon when it comes plus the facilities of them are also very old. Consequently to solve the problem needs more positive attitude as it is policy insurance.

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.
    • Journal of Pharmacopuncture
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    • v.19 no.3
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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.

Effective Recruitment Strategies in Clinical Trials : An analysis of methods used in functional dyspepsia clinical trial (임상연구의 효과적인 대상자 모집 전략 - 기능성 소화불량증 임상시험 자료에 대한 분석 -)

  • Jerng, Ui-Min;Ko, Seok-Jae;Han, Ga-Jin;Oh, Seung-Hwan;Kim, Jin-Sung;Ryu, Bong-Ha;Park, Jae-Woo
    • The Journal of Internal Korean Medicine
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    • v.31 no.4
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    • pp.722-730
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    • 2010
  • Objectives : While the proportion of clinical trials is increasing in oriental medical research, no studies in recruitment strategies exist. This study was conducted to investigate which recruitment strategy was efficient to increase the number of potential subject and to reduce cost. Methods : Data from 179 callers in a single-center between June 22 and August 12, 2010 were analyzed. Results : We found that daily newspaper and free newspaper advertisement collected maximal participants. Advertisements in the hospital and on the Internet were considered as the most cost-effective methods. Conclusions : Intensive multiple overlapping recruitment strategies might be effective in success of participant registration in a clinical trial.

Effects of Aromatherapy on Sleep Quality: A Systematic Review and Meta-Analysis (아로마테라피가 수면에 미치는 효과: 체계적 문헌고찰 및 메타분석)

  • Kim, Mi-Eun;Jun, Ji Hee;Hur, Muyng-Haeng
    • Journal of Korean Academy of Nursing
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    • v.49 no.6
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    • pp.655-676
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    • 2019
  • Purpose: The purpose of this study was to investigate the effects of aromatherapy on sleep quality. Methods: This is a systematic review of randomized controlled trial studies (PROSPERO registration number CRD42017064519). In this study, the PICO were adults and the elderly, aromatherapy intervention, a comparative intervention with the control and placebo oil groups, and sleep. The selected articles were in English, Korean, and Chinese. Results: The results of the meta-analysis showed that the effect sizes of the experimental group were 1.03 (n=763, SMD=1.03, 95% CI 0.66 to 1.39) (Z=5.47, p<.001). In the aromatherapy intervention group, the effect size of sleep was statistically significant (QB=9.39, df=2, p=.009), with a difference of 0.77 for inhalation, 1.12 for oral intake and 2.05 for massage. A post-analysis showed that the effect of massage on sleep was significantly greater than the inhalation method. The regression coefficient of the intervention period, B=0.01 (Z=1.43, p=.154), also showed that the longer the intervention period, the larger the effect size; however, it was not statistically significant. Conclusion: A total of 23 literature analyses showed that aromatherapy is effective in improving quality of sleep, and the massage method is more effective in improving quality of sleep than the inhalation method. A meta-ANOVA showed that the aromatherapy intervention affected the high heterogeneity of the effect size. Thus, future research with stricter control in methods and experimental procedures is necessary.

Safety of Palmultang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study (팔물탕연조엑스의 단회 경구 투여 안전성 평가에 관한 연구)

  • Yeong-jin Jeong;Su-Hak Kim;Ji-Sung Lim;Young-Dal Kwon
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.1
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    • pp.77-85
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    • 2023
  • Objectives This study is designed to evaluate the safety of palmul-tang soft extract in healthy male volunteers. Methods Twelve healthy male volunteers were recruited. And this study was conducted in a single center. As a result of the laboratory test, the safety was evaluated by collecting vital signs of volunteers. Twelve subjects were assigned by serial number according to the registration order. For safety evaluation, blood samples were collected and vital signs were checked four times throughout the test period, including screening, pre-administration, post-administration (after 48 hours) and post-administration (after 7 days). The difference in variables was summarized as the mean±standard deviation. The normality was performed using Kolmogorov-Smirnov and Shapiro-Wilk test. If normality is satisfied, a paired t-test is applied. Otherwise, the Wilcoxon sign rank test, which is a nonparametric method, is applied. The significance was p<0.05. The incidence of all side effects is expressed as a percentage. Results In the case of red blood cell, hemoglobin, and hematocrit values, the result of normality test of variables for the difference value before and after administration is significant level p<0.05. However, all laboratory test values before and after administration did not deviate from the normal range. Also the deviations in the normal range could not be seen as significance related to this clinical trial. And no side effects related to clinical trial drugs were observed. Conclusions The soft extract of palmul-tang was considered safe for healthy male volunteers.

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

  • HuiYan Zhao;Ojin Kwon;Bok-Nam Seo;Seong-Uk Park;Horyong Yoo;Jung-Hee Jang
    • The Journal of Internal Korean Medicine
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    • v.45 no.1
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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)

The Volume Editor for the Virtual Surgery of Artificial Heart (인공심장 가상수술을 위한 체적 편집기)

  • Lee, D.H.;Kim, D.W.;Ahn, J.Y.;Kim, J.H.;Kim, N.K.;Min, B.G.
    • Proceedings of the KOSOMBE Conference
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    • v.1998 no.11
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    • pp.287-288
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    • 1998
  • The virtual surgery of Artificial Heart has focused on the simple fitting trial. But, as the processes of heart surgery being complex and detail, the requests of virtual surgery become more complex. One of the complex requests is volume editing. It may contain various editing functions: 3-dimensional cutting, registration, merging, splitting, inserting, deleting, translation and deformation. We have designed and implemented 3-dimensional volume editor that can be operated in Windows NT platform. With the results of this research, we can get convenient tools for the total virtual surgery system.

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Manual Therapy in the Treatment of Temporomandibular Disorders: A Protocol for a Systematic Review (측두하악 장애 치료를 위한 수기치료에 대한 체계적 고찰의 프로토콜)

  • Kim, Hyungsuk;Jung, Jae-Young;Chung, Seok-Hee
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.4
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    • pp.41-46
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    • 2015
  • Objectives This systematic review will analyse randomised controlled trials (RCTs) of manual therapy in patients with temporomandibular disorders (TMDs) to evaluate the efficacy of this approach. Methods RCTs will be identified in the following ten databases based on searches starting with their inception: MEDLINE, EMBASE, CENTRAL, four Korean databases as KoreaMed, DBPIA, NDSL, and RISS and three Chinese databases as CNKI, VIP and Wanfang. The quality of these studies will be analysed using the Cochrane risk of bias. A meta-analysis will be conducted, and subgroup analysis will be considered if comparatively large heterogeneity is detected. Conclusions We plan to publish this systematic review in a peer-reviewed journal. Findings from this review may contribute to the treatment process in clinical situations. Trial registration number: PROSPERO 2015: CRD42015024090