• Title/Summary/Keyword: Clinical trial,

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Recent Studies on the Edible Plant Vaccine for Prophylactic Medicine against Microorganism-Mediated Diseases (세균성 질병 예방을 위한 식물 경구 백신 연구 동향)

  • Hahn Bum-Soo;Jeong Young-Jae;Roh Kyung-Hee;Park Jong-Sug;Cho Kang-Jin;Kim Yong-Hwan;Kim Jong-Bum
    • Journal of Plant Biotechnology
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    • v.32 no.4
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    • pp.233-241
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    • 2005
  • Plants have considerable advantages for the production of antigenic proteins because they provide an inexpensive source of protein and an easy administration of vaccine. Since a publication describing edible plant vaccine of HBsAg in 1992, a number of laboratories around the world have studied the use of plants as the bioreactor to produce antigenic proteins of human or animal pathogens. Over the last ten years, these works have been mainly focused on three major strategies for the production of antigenic proteins in plants: stable genetic transformation of either the nuclear or plastid genome, or transient expression in plants using viral vectors. As many antigenic proteins have been expressed in tobacco, also several laboratories have succeeded to express genes encoding antigenic proteins in other crop plants: potato, tomato, maize, carrot, soybean and spinach. At present many works for the production of edible plant vaccine against bacteria-mediated diseases have mostly performed the studies of enterotoxins and adhesion proteins. Also the development of new-type antigens (pili, flagella, surface protein, other enterotoxin and exotoxin etc.) is required for various targets and more efficacy to immunize against microorganism pathogens. Many works mostly studied in experimental animals had good results, and phase I clinical trial of LTB clearly indicated its immunogenic ability. On the other hand, edible plant vaccines have still problems remained to be solved. In addition to the accumulation of sufficient antigen in plants, human health, environment and agriculture regulation should be proven. Also oral tolerance, the physiological response to food antigens and commensal flora is the induction of a state of specific immunological unresponsiveness, needs to be addressed before plant-derived vaccine becomes a therapeutic option.

The Comparison of Trunk Repositioning Errors in Individuals with and without Low Back Pain at Different Postures (요통 환자와 정상인의 자세에 따른 체간 위치 오류 비교)

  • Yuk, Goon-Chang;Han, Jin-Tae;Shin, Hyun-Suk;Lee, Ho-Geon;Park, Rea-Joon
    • Journal of the Korean Society of Physical Medicine
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    • v.3 no.2
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    • pp.63-74
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    • 2008
  • Purpose : The purpose of this study was to compare trunk repositioning errors between subjects with and without low back pain in sitting and standing. Methods : Total 81 participants were recruited who consisted of 41 subjects with low back pain and 40 normal subjects. The subjects were instructed to replicate the predetermined target positions of the trunk toward upright and $30^{\circ}$ flexion in sitting and standing. During each of movement, digital inclinometer was used to measure the angular movement of $T_{12}$ spinal process. Repositioning error was calculated as the absolute difference between the predetermined target positions and replicated target positions. Results : In subjects with low back pain, upright repositioning error was $1.26^{\circ}{\pm}0.14^{\circ}$ in sitting and $1.55^{\circ}{\pm}0.24^{\circ}$ in standing, and $30^{\circ}$ flexion repositioning error was $3.23^{\circ}{\pm}0.33^{\circ}$ in sitting and $5.50^{\circ}{\pm}0.50^{\circ}$ in standing. In subjects without low back pain, upright repositioning error was $1.38^{\circ}{\pm}0.15^{\circ}$ in sitting and $1.67^{\circ}{\pm}0.18^{\circ}$ in standing, and flexion repositioning error was $2.61^{\circ}{\pm}0.28^{\circ}$ in sitting and $3.70^{\circ}{\pm}0.52^{\circ}$ in standing. It was demonstrated that flexion repositioning error increased significantly in standing position. In subjects with low back pain, $30^{\circ}$ flexion repositioning error was significantly higher in standing than in sitting. Conclusion : The repositioning error of subjects with low back pain increased during flexion and it implies that some aspects of proprioception are decreased in subjects with low back pain. Therefore, it will be emphasis that a clinical trial to increase the trunk flexion stability of subjects with low back pain in standing.

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The Pyramid of Injury: Estimation of the Scale of Adolescent Injuries According to Severity

  • Han, Hyejin;Park, Bomi;Park, Bohyun;Park, Namsoo;Park, Ju Ok;Ahn, Ki Ok;Tak, Yang Ju;Lee, Hye Ah;Park, Hyesook
    • Journal of Preventive Medicine and Public Health
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    • v.51 no.3
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    • pp.163-168
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    • 2018
  • Objectives: Due to their developmental characteristics, adolescents have a higher probability than other age groups of experiencing injuries caused by accidents, violence, and intentional self-harm. The severity and characteristics of injuries vary by the intentionality and mechanism of injury; therefore, there is a need for a national-level estimate of the scale and the severity of injuries in adolescents that takes these factors into account. Methods: By using data from the Emergency Department-based Injury In-depth Surveillance Data, National Emergency Department Information System, the Korean National Hospital Discharge In-depth Injury Survey, and cause of death statistics, we calculated the emergency department (ED) visit rate, hospitalization rate, and death rate of injuries per 100 000 adolescents for each injury mechanism. The calculated rates were used to generate the injury pyramid ratio (ratio of death rate to hospitalization rate to ED visit rate) to visualize the scale and the severity of the injury. Results: The mortality rate in adolescents due to injury was 10/100 000; the corresponding rates for hospitalization and ED visits were 1623 and 4923, respectively, resulting in an injury pyramid ratio with the general pyramid form, with a 1:162:492 ratio of deaths to hospitalizations to ED visits. The mortality rate due to suicide/intentional self-harm was 5/100 000, while 35 were hospitalized for this reason and 74 made ED visits. The pyramid ratio of 1:7:15 for intentional self-harm/suicide showed a steep pyramidal form, indicating considerable lethality. The mortality rate due to motor vehicle collisions (MVCs) was 3/100 000; 586 were hospitalized for this reason, while 1023 made ED visits. The pyramid ratio of 1:195:341 for MVCs showed a gradual pyramid form, indicating that the lethality was low and the scale of injury was high. Conclusions: The main categories of injuries in adolescents were visualized in pyramid form, contributing to an understanding of the scale of each injury by mechanism in terms of levels of death, hospitalization, and ED visits. These findings will be helpful for understanding how to prioritize injuries in adolescents.

Efficacy of 23-valent Pneumococcal Polysaccharide Vaccine in Steroid Responsive Nephrotic Syndrome (스테로이드 반응성 신증후군 환아에서 23-valent pneumococcal polysaccharide vaccine의 예방효과)

  • Hahn, Hye-Won;Ha, Il-Soo;Cheong, Hae-Il;Lee, Hoan-Jong;Choi, Yong
    • Childhood Kidney Diseases
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    • v.6 no.1
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    • pp.56-60
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    • 2002
  • Purpose Streptococcus pneumoniae is a major pathogen in both adults and children, causing significant morbidity and mortality In patients with nephrotic syndrome, Streptococcus pneumoniae is a major cause of spontaneous peritonitis, and the increasing incidence of penicillin-resistance strain facilitates the development of effective vaccine. The limitation of current pneumococcal polysaccharide vaccine prompted development of polysaccharide- protein conjugate vaccine. Methods: We reviewed the medical record of total 225 steroid responsive nephrotic patients to ascertain the effectiveness of 23- valent pneumococcal polysaccharide vaccine. Results. Twenty- eight patients have developed peritonitis during the courses, and 7 of those have recurrent peritonitis. Fifty- five patients were vaccinated and followed- up for 1- 108 months (mean 38.5 months), and during the follow- up period, pneumococcus related peritonitis was not detected. Vaccine- related relapse of nephrotic syndrome w as absent. Conclusion: In spite of the non- consensus about the efficacy of PPV23, clinically it benefits, and until the clinical trial of PCV7 is completed, PPV23 will be recommended. (J Korean Soc Pediatr Nephrol 2002;6: 56-60)

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Usefulness Evaluation of Application of Metallic Algorithm Reducing for Beam Hardening Artifact Occur in Typical Brain CT Image (머리 CT영상에서 흔히 발생하는 선속경화인공물 감소를 위한 금속인공물감소 알고리즘 적용의 유용성 평가)

  • Kim, Hyeon ju
    • Journal of the Korean Society of Radiology
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    • v.12 no.3
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    • pp.389-395
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    • 2018
  • The study attempted to use computed tomography images to determine the usefulness of the reduction in the axial reduction algorithm in the event of a metallic artifacts reduction in the image of the beam-hardening effect, which is known as the most effective method of reducing metallic artifact reduction in the image and the reduction of the metal produced in this study. As a result, the result is increased to 140 kVp to reduce the value of the CT value by 0.02 to 0.05 %, resulting in decreased axial effect (P > 0.05). The CT value decreased from 12.4 to 26.9 % when applied to the reduction of the metallic. 12.4 to 26.9 % (p<0.05). In addition, in the qualitative assessment by the clinical trial evaluation, it was assessed as 1.8 points after applying the MAR algorithm, In the resolution of resolution and contrast evaluations, the estimation of the decrease in metallic artifact effects was assessed as the metal was assessed to be scored 7.2 points after the MAR algorithm was evaluated. Therefore, in case of artifacts due to irreversible beam hardening effect, it is useful to reduce artifacts caused by beam hardening effect by using various methods derived from existing researches and scanning by applying the metal artifact reduction algorithm proposed in this experiment.

A Study on the Development of Baby Powder Using Silk gland Powder of Silkworm (누에생실샘 미세분말을 이용한 베이비파우더 소재 개발에 대한 연구)

  • Chon, Jeong-Woo;Kweon, Haeyong;Jo, You-Young;Ryu, Kang-Sun;Lee, Kwang-Gill;Yeo, Joo-Hong;Kang, Pil-Don;Nam, Sung-Hee;Park, Kwang-Young;Kim, Mi-Ja;Park, Myung-Ki;Son, Yong-Ho;Kim, Sung-Hyun;Kim, Sang-Gyu;Im, Sung-Bin;Choi, Byung-Hoon;Ha, Soo-Yeon;Lee, Heui-Sam
    • Journal of Sericultural and Entomological Science
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    • v.50 no.1
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    • pp.20-26
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    • 2012
  • In this study, silk gland powder of silkworm were investigated to see the possibility for baby powder cosmetics materials. To test possibility as a baby powder cosmetics, total content rate of amino acids, DPPH free radical scavenging assay, MTT assay, and clinical trial were done. According to the result of the analysis of the amino acids of silk gland powder, serin (26.77%) content was the highest and asparatic acid (15.47%), and glycine (9.62%) were followed. DPPH free radical scavenging activity of silk gland powder was lower than vitamin C by 82.3% and 97%, respectively, which is relatively good. Moisture effect were increased in silk gland powder compared to control cosmetics by 50%. Also, silk gland powder was classified as a practically non-irritating material based on the score 0.05 of primary irritation index. Thus, these results suggest that silk gland powder of silkworm may have beneficial properties as a material for baby powder cosmetics.

Evaluation of Antioxidant Activity of Sugar Alcohols Using TOSC (Total Oxy-radical Scavenging Capacity) Assay (TOSC 법을 이용한 당알코올의 항산화 활성 평가)

  • Kang, Keon-Wook;Kwak, Sang-Hoon;Yun, Sei-Young;Kim, Sang-Kyum
    • Toxicological Research
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    • v.23 no.2
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    • pp.143-150
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    • 2007
  • Although animal and epidemiological studies have suggested oxidative stress as an etiological factor in pathogenesis including cancer, inflammation, sepsis, fibrosis, cardiovascularlneurodegenerative diseases and aging-related disorders, conflicting results have been obtained in clinical trial with antioxidants. The reason for this discrepancy remains unknown but may be due, in part, to the lack of a validated assay system for evaluating antioxidant capacity. The antioxidant activity of a series of sugar alcohols against peroxyl radicals, hydroxyl radicals and peroxynitrites was determined by the total oxy-radical scavenging capacity (TOSC) assay and cell-based assay using H4IIE cells. Specific TOSC values calculated from the slope of the linear regression for erythritol, xylitol, sorbitol or mannitol against peroxyl radicals was $2.1{\pm}0.2,\;3.7{\pm}0.3,\;9.1{\pm}0.3$ or $8.7{\pm}1.1$ TOSC/mM, respectively. Specific TOSC values for erythritol, xylitol, sorbitol or mannitol against peroxynitrite was $1.9{\pm}0.3,\;3.9{\pm}0.4,\;7.8{\pm}0.7$ or $7.7{\pm}0.5$ TOSC/mM, respectively. These results suggest that oxy-radical scavenging capacity is dependent on the number of aliphatic hydroxyl group in sugar alcohols of monosaccharide. Tert-butylhydroperoxide (t-BHP)-induced cell toxicity determined by MTT assay was marginally attenuated by 10 mM erythritol, but completely inhibited by 10 mM xylitol, 2 mM sorbitol or 0.75 mM maltitol, a disaccharide alcohol. Oxidative stress markers, such as glutathione (GSH) and malondial-dehyde (MDA) levels, were measured in t-BHP-treated cells using HPLC equipped with a fluorescence detector and a reverse phase column. Erythritol did not change the levels of GSH and MDA in H411E cells treated with t-BHP. The t-BHP-induced changes in cellular GSH and MDA levels were ameliorated by 10 mM xylitol and completely blocked by 10 mM sorbitol and maltitol. These results indicate that sugar alcohols protect cells against oxidative stress via scavenging oxy-radical and suggest that TOSC assay in conjunction with cell-based assay is a valid method for evaluating antioxidant capacity of natural and synthetic chemicals.

A Prospective and Open-Label Trial of Quetiapine and Haloperidol in the Treatment of Delirium (섬망의 치료에 대한 Quetiapine과 Haloperidol의 전향적 개방형 연구)

  • Choi, Hag-Gyu;Park, Byoung-Sun;Lee, Hyun-Jung;Choi, Jin-Sook;Jho, Kyeong-Hyeong;Shin, Young-Min
    • Korean Journal of Psychosomatic Medicine
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    • v.13 no.2
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    • pp.85-94
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    • 2005
  • Objectives: This prospective and open-label study was conducted to evaluate the efficacy and safety of quetiapine and haloperidol in patients with delirium. Methods : Fourty patients(19 patients in a quetiapine group : 21 patients in a haloperidol group) with delirium by DSM-IV were treated with flexible doses of open-label qvetiapine and haloperidol. To evaluate the primary efficacy of the medication, scores from the Korean version of Delirium Rating Scale(K-DRS) were assessed every seven days and to evaluate the secondary efficacy and safety, scores from the Clinical Global Impression-Severity, Korean Version of Mini-Mental State Examination, and the Drug-Induced Extrapyramidal Symptoms Scale were assessed at the baseline and the seventh day. Data were gathered from November 2004 to June 2005. Results : K-DRS scores for each group decreased significantly over the study period; however, no significant differences between groups were found. The group-by-time effect was not significant. In addition, there was no significant difference in the frequency of response to drugs between the two groups. No patients reported clinically significant side effects. Conclusion : These data show no significant difference in the efficacy and safety between quetiapine and haloperidol in the treatment of delirium. Since haloperidol has a great possibility of causing a extrapyramidal side effect resulted by previous studies, it is expected that quetiapine, a renowned medication with low side effects, may be a useful alternative agent to haloperidol, the classical antipsy-chotics, in the treatment of delirium.

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Effects of Healing Beats program on patients' anxiety, stress, systolic blood pressure, heart rate and Bis Index after epidural blocking : A randomized controlled trial (Healing Beats 프로그램이 경막외강차단 시술 후 환자의 불안, 스트레스, 수축기 혈압, 심박동수 및 Bis Index에 미치는 효과 : 무작위대조군)

  • Bae, Ik Lyul;Song, Ji Ah
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.7
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    • pp.54-65
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    • 2020
  • This randomized pre-post-controlled experimental study determined the effect on patients' anxiety, stress, systolic blood pressure, heart rate and Bis index when the Healing Beats program is applied after epidural blockage. The subjects were selected from the patients who visited the Department of Anesthesiology and Pain for the treatment of epidural blockage and volunteered through the recruitment announcement. A total of 74 sets of data were collected and analyzed with 25 subjects in the experimental group, 24 in the placebo group, and 25 in the control group. The data was analyzed using descriptive statistics, x2-tests, F-tests and repeated measures of ANOVA. As a result of the study, the general characteristics and variables of the experimental group, placebo group, and control group were all the same, and anxiety was measured twice before and after the study. There were significant differences between groups (F=27.175, p<.001), and stress (F=4.78, p<.001), heart rate (F=4.22, p<.001) and the Bis index (F=7.96, p<.001) were analyzed by variance according to population and time. There was a significant difference. However, there was no significant difference in systolic blood pressure (F=1.23, p=.298). In conclusion, the Healing Beats program can be used as an effective and effective intervention for sedation in clinical situations or stressful situations.

The adsorption pattern of protein to the soft contact lens and its effect on the visible light transmission and the contact angle (소프트콘택트렌즈의 단백질 부착 양상 및 가시광선투과도와 접촉각에 미치는 영향)

  • Park, Mijung;Kwon, Mi Jeong;Lee, Sun Hee;Kim, Daesoo
    • Journal of Korean Ophthalmic Optics Society
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    • v.9 no.1
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    • pp.53-68
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    • 2004
  • Protein deposit buildup on soft contact lenses(SCLs) is responsible for discomfort, optical defects and is even damaging to the eye. To better understand protein deposit formation on SCL, we investigated the pattern of protein attachment on patient-worn SCLs and the effect of the protein on the contact angle of SCLs and the transmission of visible light. This study used data from a clinical trial where subjects wore either daily-wear SCL(etafilcon A, N=40) for various period up to 14 days, or extended-wear SCL(balafilcon A, N=40) for 8 h day or night. The adsorption of protein in daily-wear SCLs was significantly increased in patient-worn time-dependent manner although the lenses were cleaned everyday by using the multi-purpose SCL solution. After 2 weeks wearing, the protein on the SCL influenced the contact angle of the lenses. Furthermore, the transmission of visible light of the lenses decreased up to almost 7%. Extended-wear SCLs worn during the closed eye condition were found to deposit significantly more protein than SCLs worn during the open eye condition. The amounts of protein adsorbed both after daily SCL wear and after overnight SCL wear were not affected the contact angle and the transmission of visible light of the lenses. The protein deposit buildup on SCL related to the corneal temperature and pH of tear fluid.

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