• Title/Summary/Keyword: Human trials

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Diagnosis of Collegian's Adaptation Level for Autumn Environment (가을철 온열환경에 대한 대학생의 적응수준 진단)

  • Kim, Yang-Weon
    • Fashion & Textile Research Journal
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    • v.1 no.1
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    • pp.12-17
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    • 1999
  • The actual clothing conditions were surveyed to diagnose clothing condition of collegians in the view point of adaptation to the thermal environment in fall. Then, clothing climate, physiological responses, and subjective sensation were investigated through wearing trials on human subjects in climatic chamber based on the results from the survey. Factors to evaluate validity of clothing condition were clothing weight, clothing climate, physiological responses of human body, and subjective sensation. Adaptability of this research to thermal environment was compared to the results of Toda's and Duno's of Japan, Chung's results of Korea rural area, and Winslow's clo value. The standard values for wearing trials were values at comfortable zone, such as $32{\pm}1^{\circ}C$ of temperature and $50{\pm}10%$ of humidity inside clothing, $36.5{\sim}37.3^{\circ}C$ of ear temperature and $32.2{\sim}34.3^{\circ}C$ of mean skin temperature. Clothing weight per body surface area was 680.9 $g/m^2$ in male and 526.7 $g/m^2$ in women. Cold resistance ability of collegians was superior to Japanese and American, and similar to rural male in Korea. According to the examination of clothing adaptability with clothing weight from the investigation on physiological responses and the actual clothing conditions survey, following were found. Temperature inside clothing ($29.8{\sim}32.3^{\circ}C$) was normal, and humidity inside clothing (32.2~54.8%) was at comfortable zone. Mean skin temperature was at its comfortable zone. Therefore, 615 $g/m^2$ in male and 525 $g/m^2$ in female were a desirable wearing condition.

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A Clinical Study on the Effects of Intravenous Wild ginseng Herbal Acupuncture on the Human Body (정맥 주입용 산삼약침이 인체에 미치는 영향에 관한 임상적 연구)

  • Kwon, Ki-Rok
    • Journal of Pharmacopuncture
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    • v.7 no.1 s.12
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    • pp.15-26
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    • 2004
  • Background : This study was conducted to evaluate the effects of wild ginseng herbal acupuncture developed for the intravenous use. Healthy male and female volunteers(n=57) went through Randomized Control Trials(RCT). Methods : For those who are under a medication due to common cold or other illnesses were excluded in the primary stage and the subjects with possible abnormalities in the pre-screening process were also excluded in the secondary stage. Then the examination groups were determined by random sampling. Experiment groups were divided into Normal saline injection group(control group), cultivated wild ginseng herbal acupuncture group(experiment group 1) and natural wild ginseng herbal acupuncture group(experiment group 2) Blood tension, body temperature, pulse, and other criteria were measured and analyzed. Results : 1. Intravenous injection of cultivated wild ginseng herbal acupuncture and natural wild ginseng herbal acupuncture didn't cause significant changes in the blood tension, pulse, body temperature, and etc. 2. No significant differences were witnessed in CBC, ESR, biochemistry of blood test and UA between the experiment groups. 3. No significant changes were noted in the thermography before and after the test in the experiment groups. 4. Some of the common physical changes occurring during and after the administration were fatigue, chest distension, and headache in all of the experiment groups. 5. Comparing general condition after one week from the termination of administration, the control group showed worst condition while as the natural wild ginseng herbal acupuncture group displayed best condition. Conclusion : From the above results, we can carefully deduce that the intravenous injection of the wild ginseng herbal acupuncture didn't show significant differences compared to injection of the normal saline. We can infer it is safe on the human body and further studies and reports must be followed.

The antioxidant activities of Korean Red Ginseng (Panax ginseng) and ginsenosides: A systemic review through in vivo and clinical trials

  • Park, Soo Kyung;Hyun, Sun Hee;In, Gyo;Park, Chae-Kyu;Kwak, Yi-Seong;Jang, Young-Jin;Kim, Bumseok;Kim, Jong-Hoon;Han, Chang-Kyun
    • Journal of Ginseng Research
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    • v.45 no.1
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    • pp.41-47
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    • 2021
  • A wide range of studies have steadily pointed out the relation of oxidative stress to the primary and secondary causes of human disease and aging. As such, there have been multiple misconceptions about oxidative stress. Most of reactive oxygen species (ROS) generated from chronic diseases cause oxidative damage to cell membrane lipids and proteins. ROS production is increased by abnormal stimulation inside and outside in the body, and even though ROS are generated in cells in response to abnormal metabolic processes such as disease, it does not mean that they directly contribute to the pathogenesis of a disease. Therefore, the focus of treatment should not be on ROS production itself but on the prevention and treatment of diseases linked to ROS production, including types 1 and 2 diabetes, cancer, heart disease, schizophrenia, Parkinson's disease, and Alzheimer's disease. In this regard, Korean Red Ginseng (KRG) has been traditionally utilized to help prevent and treat diseases such as diabetes, cancer, inflammation, nervous system diseases, cardiovascular disease, and hyperlipidemia. Therefore, this review was intended to summarize in vivo animal and human clinical studies on the antioxidant activities of KRG and its components, ginsenosides.

Interleukin-18 Binding Protein (IL-18BP): A Long Journey From Discovery to Clinical Application

  • Soohyun Kim;Hyeon Yu;Tania Azam;Charles A. Dinarello
    • IMMUNE NETWORK
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    • v.24 no.1
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    • pp.1.1-1.6
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    • 2024
  • IL-18 binding protein (IL-18BP) was originally discovered in 1999 while attempting to identify an IL-18 receptor ligand binding chain (also known as IL-18Rα) by subjecting concentrated human urine to an IL-18 ligand affinity column. The IL-18 ligand chromatography purified molecule was analyzed by protein microsequencing. The result revealed a novel 40 amino acid polypeptide. To isolate the complete open reading frame (ORF), various human and mouse cDNA libraries were screened using cDNA probe derived from the novel IL-18 affinity column bound molecule. The identified entire ORF gene was thought to be an IL-18Rα gene. However, IL-18BP has been proven to be a unique soluble antagonist that shares homology with a variety of viral proteins that are distinct from the IL-18Rα and IL-18Rβ chains. The IL-18BP cDNA was used to generate recombinant IL-18BP (rIL-18BP), which was indispensable for characterizing the role of IL-18BP in vitro and in vivo. Mammalian cell lines were used to produce rIL-18BP due to its glycosylation-dependent activity of IL-18BP (approximately 20 kDa). Various forms of rIL-18BP, intact, C-terminal his-tag, and Fc fusion proteins were produced for in vitro and in vivo experiments. Data showed potent neutralization of IL-18 activity, which seems promising for clinical application in immune diseases involving IL-18. However, it was a long journey from discovery to clinical use although there have been various clinical trials since IL-18BP was discovered in 1999. This review primarily covers the discovery of IL-18BP along with how basic research influences the clinical development of IL-18BP.

Research Trends in Evidence Based Medicine on Acupuncture -Randomized Controlled Trial- (침 관련 근거중심의학의 연구 동향 - Randomized Controlled Trial을 중심으로 -)

  • Lee, Ro-Min;Nam, Sang-Su;Lee, Sang-Hoon;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.26 no.2
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    • pp.147-158
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    • 2009
  • Objectives : The purpose of this study is to review the recent research trends of evidence based medicine, especially human randomized controlled trials on acupuncture. Methods : The articles were collected by retrieving the database of Pubmed and Journal of Korean Acupuncture & Moxibustion Society. The retrieving period was from October 2003 to September 2008, and the search term was 'acupuncture'. The articles were classified according to their publication journals, countries, publication years, targeted diseases, types of acupuncture and types of control. Results : In total, 558 articles in Pubmed and 35 articles in Journal of Korean Acupuncture & Moxibustion Society were searched. The number of articles on acupuncture research has increased with higher rate since 2000, but the Qualitative development has not achieved the same amplitude. Studies in Korea were insufficient both in Qualitative and Quantitative aspects. In countries, China had the most papers, and in targeted diseases, pain diseases were most dominant. In the types of acupuncture, classical acupuncture, and in the types of control, conventional western treatment showed the highest frequency. Conclusions: We need to do many-sided and more high Quality researches on acupuncture. For that, well-designed randornized trials are absolutely necessary.

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Job Stress and Turnover of Fashion Designers and Fashion Merchandisers (어패럴업계 전문직 종사자의 직무스트레스와 이직에 관한 연구)

  • 하유선;정성지
    • Journal of the Korean Society of Clothing and Textiles
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    • v.24 no.8
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    • pp.1103-1114
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    • 2000
  • The purpose of the study was to investigate the level and the major causes of job stress, and the causes of the high level of job turnover rate of fashion merchandisers and fashion designers. The study also examined the correlations among the major causes of job stress, job results and job turnover rate. A part of the questionnaire consisted of questions on major causes of job stress, job result, and intention and trial to leave a job. The subjects were to rate on 5 point Likert-type scales. The other part included the questions on demographic and individual characteristics of the subjects and their company characteristics. For the survey, the subjects were 99 fashion merchandisers and 128 fashion designers who are employed by mens or womens wear manufacturers. The SAS PC+ package was used to calculate frequency, Cronbach $\alpha$, multiple regressions. The results of the study were as follows: 1. The high degree of the job results were resulted from the high degree of specialties in their job characteristics, high contentment in human relations, career development and income, and low role conflict. 2. Stronger intentions and more trials to leave their job were correlated to better task performance in the workplace, lower commitment to their job, and lower job satisfaction. 3. Higher level of job stress caused by interpersonal relationship in the organization and contentment in career development and income affected stronger intentions and more trials to leave their job.

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Applications of Genetically Modified Tools to Safety Assessment in Drug Development

  • Kay, Hee-Yeon;Wu, Hong-Min;Lee, Seo-In;Kim, Sang-Geon
    • Toxicological Research
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    • v.26 no.1
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    • pp.1-8
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    • 2010
  • The process of new drug development consists of several stages; after identifying potential candidate compounds, preclinical studies using animal models link the laboratory and human clinical trials. Among many steps in preclinical studies, toxicology and safety assessments contribute to identify potential adverse events and provide rationale for setting the initial doses in clinical trials. Gene modulation is one of the important tools of modern biology, and is commonly employed to examine the function of genes of interest. Advances in new drug development have been achieved by exploding information on target selection and validation using genetically modified animal models as well as those of cells. In this review, a recent trend of genetically modified methods is discussed with reference to safety assessments, and the exemplary applications of gene-modulating tools to the tests in new drug development were summarized.

Intracoronary Radiation Therapy Using Re-188 after percutaneous Coronary Angioplasty (경피적 관동맥혈관성형술 후 Re-188을 이용한 혈관 내 방사선조사요법)

  • Chae, In-Ho;Lee, Myoung-Mook;Lee, Dong-Soo
    • 대한핵의학회:학술대회논문집
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    • 1999.05a
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    • pp.228-241
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    • 1999
  • Percutaneous coronary angioplasty is well established therapeutic modality in the management of coronary artery disease. However, the high restenosis rate of 30 to 50% limits its usefulness. The principal mechanism of restenosis, intimal hyperplasia, is the proliferative response of vessel wall to injury, which consists largely of smooth muscle cells. A large body of animal investigations and a limited number of clinical studies have established the ability of ionizing radiation to reduce neointimal proliferation and restenosis rate significantly. Human studies have been reported that intravascular radiation after first restenosis inhibits a second restenosis. Encouraged by these reports, we are also conducting a double blind, placebo-controlled, randomized trial to evaluate this new therapeutic modality in patients with coronary artery stenosis. The objective of our trial is to determine the safety and efficacy of catheter-based solutional beta emitting radioisotope system in preventing restenosis after angioplasty. This review describes the vascular brachytherapy systems and isotopes that have been utilized in the initial clinical trials performed in this area of post PTCA coronary restenosis. The results of many worldwide ongoing clinical trials will determine whether this new technology will change the future practice of vascular intervention.

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Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients (한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰)

  • Park, Bong-Ky;Wang, Jing-Hua;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.5
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

Enteral Feeding for Preterm Infants-Benefits and Risks (미숙아의 장관영양)

  • Sin, Jong-Beom
    • Neonatal Medicine
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    • v.16 no.2
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    • pp.121-130
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    • 2009
  • Over the past 20 years, neonatal mortality rates for preterm infants, particularly those born extremely preterm and with a very low birth weight, have decreased steadily. As more very immature preterm infants survive, provision of enteral feeding has become a major focus of concern. According to many experts on neonatal nutrition, the goal for the nutrition of preterm infants should be to achieve a postnatal growth rate approximating that of a normal fetus of the same gestational age. Total parenteral nutrition for maintaining nutritional integrity is mandatory before successful transition to enteral feeding. Early initiation of trophic enteral feeding is vital for postnatal adaptation. Recently published randomized controlled trials provide no evidence to support the practice of postponing enteral feeding to reduce the incidence of necrotizing enterocolitis. Early trophic feeding yields demonstrable benefits and there is currently no evidence of any adverse effects following early feeding. Preterm milk from the infant's own mother is the milk of choice, which can always be supplemented with a human milk fortifier. Here we review over 50 randomized controlled trials and over seven systematic reviews published on neonatal parenteral and enteral feeding of preterm infants. Neonatologists must make use of the evidence from these studies as a reference for feeding protocols for preterm infants in their NICUs are to be based.