• Title/Summary/Keyword: Clinical Trials

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Follow-up of Children with Chronic Hepatitis B Virus Infection (B형 간염 바이러스 만성 감염 소아의 추적 관찰)

  • Hwang, Sung Hyun;Kim, Jong-Hyun;Kang, Jin-Han;Hur, Jae Kyun;Lee, Kyung Il;Oh, Jin Hee;Lee, Seung Hee;Kyun, Dae
    • Pediatric Infection and Vaccine
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    • v.11 no.1
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    • pp.73-80
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    • 2004
  • Purpose : The serial clinical findings, biochemical results, and serological hepatitis B virus(HBV) markers in Korean children with chronic HBV infection were analyzed to determine the relationships among these factors. Methods : Ninety children have been chosen from those who have visited to the Department of Pediatrics at St. Vincent's Hospital in The Catholic University of Korea from July 1st, 1995 to June 30th, 2000. The sample patients were followed up for over six months. HBV markers and liver function tests were all performed. Results : All children were asymptomatic at presentation. Eighty-three percent of the children had a history of chronic HBV infection in their families. Eighty-one percent were HBeAg positive, 16% were anti-HBe positive, while 3% were all HBeAg and anti-HBe negative. The prevalence of HBeAg among three age groups : 0~5; 6~10; and 11~15 year-old was 90%, 96% and 61% respectively. The prevalence of HBeAg in less than 10 year-old group was significantly higher than 11~15 year-old group(P=0.001). Serum ALT levels were within 40 IU/L in 64% children, 41~80 IU/L in 17%, 81~200 IU/L in 10%, and beyond 201 IU/L in 9%. The percentage of abnormality of ALT levels in HBeAg positive patients was significantly higher than that of HBeAg negative(P=0.036). Eleven of the 73 HBeAg positive children lost their HBeAg and seroconverted to anti-HBe. In these cases, all had transient elevations in ALT levels before HBeAg seroconversions. The annual rates of spontaneous seroconversion of HBeAg and HBsAg were 9.7% and 0.6%, respectively. Conclusion : Recognition of the dynamics of these changes in viral markers and biochemical findings is needed in the selection and evaluation of therapeutic regimens, establishment of treatment, and calling for controlled trials with adequate follow-up. The hepatitis B carrier state may be asymptomatic in children however, continued surveillance of carriers is important to determine the individual adverse prognostic factors of chronic HBV infections.

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Development and Evaluation of Consumer Educational Contents on Safety Management of Imported Foods for Female College Students in Seoul (수입식품 안전관리에 관한 소비자 교육 컨텐츠 개발 및 교육효과 조사 - 서울시에 거주하는 여대생 중심으로 -)

  • Jung, Ji-In;Kang, Eun-Jin;Cho, Mi-Young;Choi, Gye-Sun;Hong, Young-Pyo;Seo, Kab-Jong;Kim, Gun-Hee
    • Journal of Food Hygiene and Safety
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    • v.24 no.4
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    • pp.291-298
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    • 2009
  • This study was carried out to evaluate the consumer recognition with regard to the safety management for imported foods. In order to evaluate the effect of the prgram on consumer education, the program was practiced for 89 female college students in Seoul, Korea. The participants were given an instruction with materials on imported food safety, including the safety management of imported foods and their distribution. The results showed that the participants achieved a greater understanding of imported foods. In particular, they had firmly grasped the importance of expiration date in selecting imported foods. Before the instruction, 50.6% of total participants blamed the Korean government for the problems arising from imported foods; only 18.0% placed the blame on individuals or businesses importing from foreign countries. After the instruction, 39.3% had blamed the individuals or businesses importing from foreign countries. Furthermore, 36.0% had disapproved of the foods that are imported from China before the instruction, while 32.6% found objectionable the views on the illegally distributed foods; 29.2% criticized the junk foods that target children (after the instruction). In addition, the level of participant satisfaction via-a-vis imported foods safety supervision had improved from $2.76{\pm}1.59$(before the instruction) to $3.37{\pm}1.58$(after the instruction). The results indicate that consumers are concerned with the imported foods that contain adulterated or forbidden substances and the illegally distributed foods from foreign countries. Thus, consistent and informative educational programs on imported food safety could help consumers in choosing safer products, resulting in an improvement in the consumer confidence with respect to imported foods.

Increased Catalase Activity by All-trans Retinoic Acid and Its Effect on Radiosensitivity in Rat Glioma Cells (백서 교종 세포에서 레티노인산에 의한 카탈라제의 활성 증가가 방사선감수성에 미치는 효과)

  • Jin, Hua;Jeon, Ha-Yeun;Kim, Won-Dong;Ahn, Hee-Yul;Yu, Jae-Ran;Park, Woo-Yoon
    • Radiation Oncology Journal
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    • v.23 no.4
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    • pp.211-216
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    • 2005
  • Purpose: It has been reported that all-trans retinoic acid (ATRA) can inhibit glioma growing in vitro. However, clinical trials with ATRA alone in gliomas revealed modest results. ATRA has been shown to increase radiosensitivity in other tumor types, so combining radiation and ATRA would be one of alternatives to increase therapeutic efficacy in malignant gliomas. Thus, we intended to know the role of catalase, which is induced by ATRA, for radiosensitivity if radiation-reduced reactive oxygen species (ROS) is removed by catalase, the effect of radiation will be reduced. Materials and Methods: A rat glioma cell line (36B10) was used for this study. The change of catalase activity and radiosensitivity by ATRA, with or without 3-amino-1, 2, 4-triazole (ATZ), a chemical inhibitor of catalase were measured. Catalase activity was measured by the decomposition of $H_2O_2$ spectrophotometrically Radiosensitivity was measured with clonogenic assay. Also ROS was measured using a 2, 7-dichlorofluorescein diacetate spectrophotometrically. Results: When 36B10 cells were exposed to 10, 25 and $50{\mu}M$ of ATRA for 48 h, the expression of catalase activity were increased with increasing concentration and incubation time of ATRA. Catalase activity was decreased with increasing the concentration of AT (1, $10{\mu}M$) dose-dependently. ROS was increased with ATRA and it was augmented with the combination of ATRA and radiation. ATZ decreased ROS production and increased cell survival in combination of ATRA and radiation despite the reduction of catalase. Conclusion: The increase of ROS is one of the reasons for the increased radiosensitivity in combination with ATRA. The catalase that is induced by ATRA doesn't decrease ROS production and radiosensitivity.

The Changes of Physiologic Parameters with Time in Steroid treated-Late Acute Respiratory Distress Syndrome Patients (스테로이드를 투여한 후기 급성호흡곤란증후군 환자에서 시간경과에 따른 생리학적 지표의 변화)

  • Jeon, Ik Soo;Suh, Gee Young;Koh, Won-Jung;Pyun, Yu Jang;Kang, Eun Hae;Ham, Hyoung Suk;Oui, Misook;Chung, Man Pyo;Kim, Hojoong;Kwon, O Jung
    • Tuberculosis and Respiratory Diseases
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    • v.54 no.4
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    • pp.429-438
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    • 2003
  • Background : The mortality from acute respiratory distress syndrome(ARDS) is >40-50%. Although some prospective trials have failed to demonstrate a survival benefit of steroids in the early stages of ARDS, there are some reports showing some success with steroids in the later stages. This study observed the changes in the physiologic parameters with time in late ARDS patients who were treated with steroids. Methods : The medical charts of 28 intensive care unit patients(male:female=24:4; mean age 64 years), who had been diagnosed with refractory late ARDS ($PaO_2/FIO_2$ <200) and were treated with corticosteroids from December 1999 to July 2002, were retrospectively reviewed. The patients were divided into two groups: the weaned group(n=14), which included the patients who had been successfully weaned from a ventilator after corticosteroid therapy, and the failed group(n=14), which included the patients who had failed weaning. The physiologic parameters included the $PaO_2/FIO_2$ ratio, the positive end-expiratory pressure(PEEP) level, the $PaCO_2$, compliance, the sequential organ failure assessment(SOFA) score, the acute physiologic and the chronic health evaluation(APACHE) II score, and the Murray Lung Injury Score(LIS) in the two groups were compared from the day of mechanical ventilation(Dmv) to 7 days after the corticosteroid therapy. Results : There was no significant difference in the clinical characteristics and the physiologic parameters between the two groups prior to the corticosteroid therapy except for the SOFA score at Dmv(weaned group : $6.6{\pm}2.5$ vs failed group : $8.8{\pm}2.9$, p=0.047). However, within 7 days after corticosteroid therapy, there was significant improvement in the $PaO_2/FIO_2$ ratio, the PEEP level, the $PaCO_2$, the SOFA score, the APACHE II score, and the LIS of the weaned group compared to the failed group. Conclusions : During corticosteroid therapy in late ARDS, the continuation of corticosteroid therapy should be determined carefully in patients who do not show improvement in their physiologic parameters by day 7.

A Review of Statistical Methods in the Korean Journal of Orthodontics and the American Journal of Orthodontics and Dentofacial Orthopedics (대한치과교정학회지(KJO)와 미국교정학회지(AJODO)에서 사용된 통계기법의 비교분석 및 고찰(1999-2003))

  • Lim, Hoi-Jeong
    • The korean journal of orthodontics
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    • v.34 no.5 s.106
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    • pp.371-379
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    • 2004
  • The purpose of this study was to investigate the changes and types of statistical methods used in the Korean Journal of Orthodontics (KJO) and the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) from )999 to 2003. The frequency of use, transitions, assumption check of statistical methods and types of advanced statistical methods were examined from each journal. The study consisted of 247 articles published in the KJO and randomly chosen 50 articles per year which were original articles and used statistical methods T-test, analysis of variance(ANOVA), correlation analysis, nonparametric analysis. regression analysis chi-square test. factor analysis, were the order of statistical methods most frequently used in the KJO, while t-test. ANOVA, nonparametric analysis, correlation analysis, regression analysis, chi-square test. factor analysis. were the order of statistical methods used in the AJODO The changes of statistical methods observed in the KJO were not significant $(X^2=17.4\;p=0.5881)$ but the changes observed in the AJODO was seen to be significant $(x^2=42.4,\;p=0.0397)$ Some of the studies examined had overlooked the assumptions of the statistical methods employed. Data investigation such as outlier should be performed before analysis and alternative statistical approaches are applied for a small sample size. Types of advanced statistical methods were factor analysis and discriminant analysis in the KJO and Intention-To-Treat (ITT) analysis in clinical trials through multi-center, survival analysis and Generalized Estimating Equations (GEE) in the AJODO. Appropriate analysis approaches and interpretations should be applied for the correlated and repeated measurements of the orthodontic data set.

Investigation of aerodynamic evaluation in female patients undergoing thyroidectomy (갑상선절제술을 받은 여성 환자의 공기역학 검사변수 조사)

  • Kang, Young Ae;Kwon, In Sun;Won, Ho-Ryun;Chang, Jae Won;Koo, Bon Seok
    • Phonetics and Speech Sciences
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    • v.12 no.2
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    • pp.73-80
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    • 2020
  • Breathing is the voice's driving force and also acts as a regulator of larynx function and efficiency. Respiratory distress is a side effect of general anesthesia in thyroid surgery. Therefore, this study's objective was to provide practical and complementary information for voice recovery after thyroid surgery, based on aerodynamic evaluation pre- and post-thyroidectomy. From May 2014 to July 2015, aerodynamic evaluations were performed on 34 female patients diagnosed with thyroid papillary cancer one week before surgery (PRE), one month after surgery (P1), and three months after surgery (P3). The Phonatory Aerodynamic System (model 6600, KayPENTAX, USA) was employed for this purpose, and a total of 29 analysis parameters were selected. The results showed statistically significant differences in peak expiratory airflow (p=0.004), mean pitch (p<0.01), expiration airflow duration (p=0.001), and expiratory volume (p=0.018), based on time factors. In the comparison of time factors, peak expiratory airflow and mean pitch parameters were different in PRE-P1 and PRE-P3. Expiration airflow duration and expiratory volume parameters were different in PRE-P3 and P1-P3. The interaction effect of time and surgical range was significant only for expiratory volume (p=0.024). Female patients who undergo thyroidectomy require post-operative breathing training, and exhalation improvement is considered to reflect a positive lifestyle after surgery.

Thermoradiotherapy in the Treatment of Advanced Stomach Cancer - To compare the difference between the results of Pre- and post-radiotherapy hyperthermia - (진행성 위암 환자에서 방사선 치료 전후에 실시한 국소온열치료)

  • Kay Chul Seung;Choi Ihl Bohng;Jang Ji Young;Kim In Ah
    • Radiation Oncology Journal
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    • v.16 no.1
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    • pp.27-33
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    • 1998
  • Purpose : To improve the therapeutic results of postoperative recurrent disease and inoperable disease of stomach cancer, we used the thermoradiotherapy. We conducted a retrospective analysis of the results and compared the results of hyperthermia before radiotherapy and those of hyperthermia after radiotherapy Materials and Methods : From July 1994 to November 1996, we treated twenty patients with locally advanced stomach cancer and recurrent stomach cancer with thermoradiotherapy. We divided those patients into two groups : hyperthermia before radiotherapy group (PreRT group : 13 Patients) and hyperthermia after radiotherapy group (PostRT group : 7 patients). We performed radiation therapy with the total tumor dose of 3000-5040cGy in a traction of 180-300cGy and 5 fractions per week. Hyperthermia was performed with 8 MHz radiofrequency apparatus. PreRT group patients were treated daily for 30 minutes before the radiation therapy within the interval of ten minutes. And PostRT group patients were treated with 1-2 sessions Per week for 40-60 minutes after the radiation therapy within the interval of 10 minutes. Results : Overall response rate was $33.3\%$. This response rate appeared the same in both groups. Mean survival and 1 rear survival rate were 10.3 months and $16.5\%$. In PreRT group, mean survival and 1 year survival rate were 6.8 months and $9.0\%$, and in PostRT group, mean survival and 1 year survival rate were 7.7 months and $34\%$. There were no statistically significant difference between the prognostic factors and therapeutic results. Conclusion : The thermoradiotherapy was a safe treatment method in advanced and recurrent gastric cancer when compared with other treatment. Because the number of patients we treated was small and the follow up period was short. we were not able to draw any conclusions about the therapeutic efficacy of the sequence of radiation therapy and hyperthermia. Therefore, further clinical trials of thermoradiotherauy for stomach cancer appear to be warranted.

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The Immunogenicity and Safety Study of 47 Passaged Oka Strain Live Attenuated Varicella Vaccine in Healthy Children (건강한 소아에서의 47계대 Oka주 수두약독화 생백신의 면역원성 및 안전성에 관한 연구)

  • Kang, Jin Han;Kim, Jong Hyun;Suh, Byung Kyu
    • Pediatric Infection and Vaccine
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    • v.4 no.2
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    • pp.257-264
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    • 1997
  • Purpose: We performed this study to find out short period humoral immunogenicity and safety of 47 passaged Oka strain live attenuated varicella vaccine(1,400PFU) in 12 months to 15 years aged healthy children. Methods: Ninety nine healthy chidren, who have no histories of varicella vaccination, recent chicken pox illness and contact, allergy to other vaccines and underlying severe diseases, were involved in this study from April 1997 to August 1997. 5ml blood were collected before vaccination and after vaccination from all vaccinees to measure varicella membrane antibody by FAMA, and varicella IgG antibody by EIA. And immediate reactions within 30 minutes after vaccination, local and systemic reactions within 3 days after vaccination and vaccine induced systemic illness during 6 weeks postvaccination period were observed in all vaccinees to identify side effects of study vaccine. Results: 1) 49 seronegative and 50 seropositive vaccinees were identified in both prevaccination serologic tests. 2) Serologic responses after vaccination measured by the FAMA in seronegative group showed that the mean GMT level revealed 64.0, and seroconversion rate was 97.9%. And serologic responses after vaccination measured by the FAMA in seropositive group showed that the mean GMT level(242.2) was markedly elevated comparing with the mean GMT level(9.2) of pre vaccination. 3) The results of EIA in seronegative group revealed that postvaccination mean GMT was 435.2(prevaccination GMT; 78.7), and 100% seroconversion rate. Also, the results of EIA in seropositve group showed that the mean GMT level(769.9) of postvaccination was almostly two fold hihger than the mean GMT level(419.7) of prevaccination. 4) Observed local reactions like injection sites redness, pain, hardness and itching sense were mild and disappeared within 3 days, also shorterm systemic reactions like irritability, lethargy, poor appetites and rash were not remarkable. And there were no remarkable side effects due to vaccine during study period in all vaccinees. Conclusion: We confirmed that 47 paasaged Oka strain live attenuated varicella vaccine has high shorterm humoral immunogenicity and safety. However, we need more detail and longterm humoral and cell mediated immunogenicity studies of this vaccine including clinical field trials.

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Development and Evaluation of Silicon Passive Layer Dosimeter Based Lead-Monoxide for Measuring Skin Dose (피부선량 측정을 위한 Lead-Monoxide 기반의 Silicon Passive layer PbO 선량계 개발 및 평가)

  • Yang, Seung-Woo;Han, Moo-Jae;Jung, Jae-Hoon;Bae, Sang-Il;Moon, Young-Min;Park, Sung-Kwang;Kim, Jin-Young
    • Journal of the Korean Society of Radiology
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    • v.15 no.6
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    • pp.781-788
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    • 2021
  • Due to the high sensitivity to radiation, excessive exposure needs to be prevented by accurately measuring the dose irradiated to the skin during radiation therapy. Although clinical trials use dosimeters such as film, OSLD, TLD, glass dosimeter, etc. to measure skin dose, these dosimeters have difficulty in accurate dosimetry on skin curves. In this study, to solve these problems, we developed a skin dosimeter that can be attached according to human flexion and evaluated its response characteristics. For the manufacture of the dosimeter, lead oxide (PbO) with high atomic number (ZPb: 82, ZO: 8) and density (9.53 g/cm3) and silicon binders that can bend according to human flexion were used. In the case of a dosimeter made of PbO material, the performance degradation has been prevented by using parylene and others due to the presence of degradation due to oxidation, but the previously used parylene is affected by bending, so a new form of passive layer was produced and applied to the skin dosimeter. The characteristic evaluation of the skin dosimeter was evaluated by analyzing SEM, reproducibility, and linearity. Through SEM analysis, bending was evaluated, reproducibility and linearity at 6 MeV energy were evaluated, and applicability was assessed with a skin dosimeter. As a result of observing the dosimeter surface through SEM analysis, the parylene passive layer PbO dosimeter with the positive layer raised to the parylene produced cracks on the surface when bent. On the other hand, no crack was observed in the silicon passive layer PbO dosimeter, which was raised to silicon passive layer. In the reproducibility measurement results, the RSD of the silicon passive layer PbO dosimeter was 1.47% which satisfied the evaluation criteria RSD 1.5% and the linearity evaluation results showed the R2 value of 0.9990, which satisfied the evaluation criteria R2 9990. The silicon passive layer PbO dosimeter was evaluated to be applicable to skin dosimeters by demonstrating high signal stability, precision, and accuracy in reproducibility and linearity, without cracking due to bending.

A Study on the General Characteristics, Correlation of COVID-19 and Prevention Behavior of Radiologists at K University Hospital (K 대학병원 방사선사의 COVID-19(코로나19)에 대한 일반적 특성, 지식 및 행위와 상관성, 감염 예방 행위에 관한 연구)

  • Choi, Hyeun-Woo;Park, Sung-Hwa;Cho, Eun-Kyung;Ryeom, Hunkyu;Lee, Jong-Min
    • Journal of the Korean Society of Radiology
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    • v.15 no.2
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    • pp.211-217
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    • 2021
  • The purpose of this study is based on the convergence establishment of a coronavirus infection management system that can occur during clinical trials by grasping the knowledge of corona, infection possibility, infection prevention possibility, and implementation level of infection prevention behavior of radiologists working at K University Hospital. It is in providing data. This study was a descriptive research study, and data were collected from 50 radiologists working at K University Hospital from March 25 to June 30, 2020. The characteristics of the subjects and their knowledge of the COVID-19, the possibility of infection, the possibility of infection prevention, and the level of implementation of infection prevention actions were surveyed, and the collected data were analyzed with SPSS 25.0. The frequency and percentage were calculated for the general characteristics and infection-related characteristics of the subjects. The correlation between variables was analyzed by Pearson's correlation coefficient, and the factors influencing the progression of infection prevention behavior were analyzed by multiple regression analysis. Factors influencing COVID-19 infection prevention behavior shown in this study were 1.7 points for infection prevention behavior when corona knowledge increased by 1 point, and infection prevention activity increased by 11.3 points when the level of transmission pathway recognition rose 1 point. When the figure rose by 1 point, the infection prevention behavior increased by 4.2 points. When looking at the standard regression coefficient, preventive behavior is performed. Among knowledge, transmission path perception, and anxiety, the factor that has the greatest influence was the perception of the transmission path of COVID-19. As factors influencing the implementation of infection prevention actions, knowledge of COVID-19, awareness of transmission paths, and anxiety appear to be the potential of infection prevention, so in the event of a corona outbreak, information on infectious diseases and education on the possibility of infection prevention should be provided to promote the implementation of preventive action.