• Title/Summary/Keyword: Clinical Trials

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The utilization of antibiotics and the treatment of bacterial diseases in fish (항생제 사용과 세균성 어류질병의 치료)

  • Jeong, Hyun-Do;Chun, Seh-Kyu
    • Journal of fish pathology
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    • v.5 no.1
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    • pp.37-48
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    • 1992
  • Antibiotics are chemical substances produced by various species of microorganisms that suppress the growth of other microorganisms or may destroy them. Among the more than 4000 antibiotics that has been identified, about 20s are using as the therapy of infectious fish diseases. There are several methods used to classify and group antibiotics, and the most common classification has been based on chemical structure and proposed mechanism of action. The effect of antibiotics may be determined by the kind of fish pathogens and by the external environment surrounded the infected fish. It implies that the kind of antibiotics and its application method should be decided after the determination of the reasons of fish disease. The uncontrolled usages of antibiotics may induce the selection of resistant mutants appeared spontaneously and present in any group of bacteria. The epidemic spread of such antibiotic resistant strains of fish pathogenic bacteria already has been reported in various districts of japan. Importantly, transferable drug resistant(R) plasmids were detected in strains of most of fish pathogens. Based on those reports, the antimicrobial resistance appears to be a rapidly emerging problem in the fish industry on the country. The expanding literatures on the pharmacokinetics, clinical trials, withdrawal periods and efficacy of environmental effect for the commonly using antibiotics have met the needs of data for the practical application of antibiotics. However, the most important thing for the treatment of fish diseases would be the communication and exchanging of information between the site of aquaculture and the diagnostic laboratory.

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Application of Sociodrama for Reducing Burnout of Nurses in General Hospital (종합병원 간호사의 소진개선을 위한 소시오드라마의 활용)

  • Shin, Eun-Hee;Jung, Hyun-Gang;Eun, Hong-Bae;Jung, Kyung-Hee;Lim, Se-Won
    • Korean Journal of Psychosomatic Medicine
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    • v.17 no.2
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    • pp.62-67
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    • 2009
  • Objectives : The aim of this study was to evaluate the effect of sociodrama for reducing burnout among health care workers and to investigate relationship between the job satisfaction, conflict with other professions, and burnout. Methods:15 nurses in general hospital participated in sociodrama directed by psychiatrist. One week after acting sociodrama, they were requested to complete ward organizational feature scale(WOFS) and maslach burnout inventory(MBI). The other twenty nurses in same ward requested to complete questionnaire without participating in sociodrama at the same time. Results : Sociodrama group(N=15) showed significantly lower score in burnout when compared to control group(N=17). Nurse/physician relationship was significantly correlated with job satisfaction and burnout. After controlling for interaction between variables by multivariate regression analysis, only job satisfaction was significant predictive factor to burnout. Conclusion : Our result suggests that the sociodrama can be effective in reducing burnout of health care workers in general hospital. These finding also underline the importance of relationship with physicians in job satisfaction and burnout of healthcare workers in general hospital.

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Effect of Green Coffee Bean Extract Supplementation on Body Fat Reduction in Mildly Obese Women (경도비만 여성에서 생커피두 엑기스의 섭취에 의한 체지방 감소 효과)

  • Kim, Tae-Su;Yang, Woong-Suk;Park, So-I;Lee, Sung-Pyo;Kang, Myung-Hwa;Lee, Jae-Hwan;Park, Il-Bum;Park, Hyun-Jun;Murai, Hiromichi;Okada, Tadashi
    • Journal of the Korean Society of Food Culture
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    • v.27 no.4
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    • pp.407-413
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    • 2012
  • In previous studies, we performed joint animal studies and clinical trials between Yonsei University and Oryza Oil & Fat Chemical Co. Ltd. We have shown that coffee bean extract has potent anti-obesity and hypotriglyceridemic activities as well as beneficial effects on body fat reduction.In this study, the effects of coffee bean extract (100 mg/capsule) on body fat reduction were evaluated in overweight/obese women (body mass index of 25~30 $kg/m^2$ or body fat > 30%) not diagnosed with any type of disease. Subjects were randomly assigned to a coffee bean extract group (n=10) or placebo group (n=10). We measured anthropometric parameters, abdominal fat distribution by computed tomography and blood components before and after the 8week intervention period. After supplementation, the coffee bean extract group showed body weight (p=0.08), body mass index (p=0.06), hip circumference (p<0.05), and upper waist circumference (p< 0.01). In addition, after 8 weeks, the coffee bean extract group showed a significant decrease in abdominal internal fat area compared to 0 weeks (0 weeks : $155.8cm^2$; 8 weeks : $145.9cm^2$, ${\Delta}$ change : $-9.9cm^2$, respectively). However, there were no significant differences in lipid profiles or serological measurements between the coffee bean extract group and placebo group. The results of our human study demonstrated that coffee bean extract supplementation for 8 weeks has beneficial effects on reducing abdominal internal fat area as well as hip and waist circumferences.

Carotid Intima-Media Thickness Measurement in Obese Children (비만 소아들에서의 경동맥 내막중막 두께 측정)

  • Park, Kyung Ok;Choi, Suk Ju;Yeom, Hee Hyun;Chung, Sochung;Yu, Jeong Jin;Park, Youngshin;Lee, Dong Hwan
    • Clinical and Experimental Pediatrics
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    • v.48 no.9
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    • pp.935-938
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    • 2005
  • Purpose : The aim of the present study was to ascertain whether the increase of carotid intima-media thickeness(cIMT) as one of premature pathologic changes of atherosclerosis, was present in obese children compared to normal weight children. Methods : The obese group consisted of 21 obese/overweight(body mass index(BMI) above 85 percentile of age, sex standards) children and the control group of 11 normal weight children. None of the children had any chronic illnesses or previous medication history. We investigated the age, sex, height, weight, and systolic/diastolic blood pressure. We measured cIMT by ultrasonogram. In 19 of the obese group, we tested the serum glucose level, liver transaminase level, and cholesterol level etc. Results : The increase of cIMT in obese group did not achieved statistical significance(obese group vs. control group; 0.42 vs. 0.40 mm, P=0.0592). In addition, cIMT showed no significant correlation with any physical/laboratory variables including BMI(P=0.0585). Conclusion : To our knowledge, this is the first study to measure the cIMT in Korean children. Though the results approached statistical significance, we could not prove an increase of cIMT in obese children or an association between cIMT and BMI, due to the study's small sample size. In the future, larger and more extensive trials are needed.

Radiation Therapy of Nasopharyngeal Cancers (비인강암의 방사선치료성적)

  • Shin, Sei-One;Kim, Sung-Kyu;Kim, Myung-Se
    • Journal of Yeungnam Medical Science
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    • v.9 no.2
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    • pp.312-320
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    • 1992
  • Radiotherapeutically, nasopharyngeal cancer is an important disease in korea. Because of its blind anatomic location, early detection is relatively uncommon. Clinically, most of cases are locally advanced and nodal involvement are common. Recently better understanding of nature of the disease and improvement of radio-therapy technique permit better treatment results, including locoregional control and survival rate, and minimal normal tissue damages comparing with previously published data. We analyzed 31 patients of pathologically proven and previously untreated naso-pharyngeal carcinoma with different treatment techniques, retrospectively. Minimal and maximal follow up period of the survuor is 6 months and 68 months, respectively. Thirteen patients with squamous cell carcinoma are included in this analysis. The median age is 49 years(range from 20 to 64 years). Twenty two patients are stage III. Eleven patients are treated with radiotherapy alone and 20 are treated with comblined modalities treatment. The degree of responses after radiotherapy are categorized by 3-classes, i.e. complete response, partial response. In spite of simioarities of complete response rate and 1-year survival rate between two different treatment techniques, those patients with undifferentiated carcinoma appear to benefit from the adjuvant chemotherapy. In addition, systemic failure is more prominant in radiotherapy alone group than in combined modalities treatment group. These results suggest that adjuvant therapy in the radiotherapeutic management of nasopharyngeal cancers needs additional research according to histologic types and future extensive clinical trials.

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Effects of Posttraumatic MgSO4 Injection and Hypothermia an Animal Model of Traumatic Brain Injury(TBI) (실험적 외상성 뇌손상모델에서 외상 후 저체온과 MgSO4의 효과)

  • Han, Seong Rok;Hyun, Dong Keun;Park, Chong Oon;Ha, Young Soo;Kim, Joon Mee
    • Journal of Korean Neurosurgical Society
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    • v.29 no.10
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    • pp.1296-1302
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    • 2000
  • Objective : Traumatic brain injury including diffuse axonal injury has been shown to result in a decrease in brainfree magnesium concentration, an endogenous inhibitor of calcium entry into neuron, that is associated with the development of neurological motor deficits. The goal of this study is to establish the therapeutic window during which the therapy with $MgSO_4$ and/or hypothermia improve damaged neurons by TUNEL stain. Method : Moderate brain injury was induced in 64 adult Sprague-Dawley rats, weighing 350 to 450gm each, by using a simple weight-drop device(Marmarou model). The animals were randomly assigned to four groups(sixteen rats each, a control group, a group treated with $MgSO_4$, a group treated with hypothermia, and a group treated with $MgSO_4$ and hypothermia) and the rats in each group were sacrificed and studied after 12 hrs, 24 hrs, 1 wk, and 2 wks after insult. In hypothermic group, these rats were subjected to hypothermia after injury, with their rectal temperatures maintained at $32^{\circ}C$ for 1 hour. After 1-hour period of hypothermia, rewarming to normothermic level was accomplished over 30-minute period. In the groups treated $MgSO_4$, hypothermia and $MgSO_4$ were subsequently treated with $MgSO_4$($750{\mu}moles/kg$) infused intra-muscularly at 30 minutes after trauma. Result : In all treated groups, a significant reduction in TUNEL positive cells was found in comparison with the control group each time(p<0.001). Between treatment groups, No differnce was seen 12hrs, 24hrs, and 1wk. However, hypothermic group treated with or without $MgSO_4$ showed more significant reduction in apoptotic cells than group treated with $MgSO_4$ 2 weeks after trauma(p<0.05). However, hypothermic group treated with $MgSO_4$ showed no significant reduction in apoptotic cells compared with hypothermic group(p>0.05). Conclusion : These findings suggest that both hypothermia and $MgSO_4$ significantly improve pathological changes. Otherwise simultaneously $MgSO_4$ and hypothermia treatment groups is failed to provide additional neuroprotection. These results may be relevant to the design of future clinical trials of therapeutic hypothermia and $MgSO_4$ for traumatic brain injury.

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The relationship between the patient's health beliefs and the implementation of functional movement rehabilitation and ability to perform ADL in stroke patients (뇌졸중 환자의 건강신념과 운동기능 재활 이행 및 일상생활동작 행능력과의 상관성)

  • Mun, Byeong-Mu;Lee, Yeon-Seop;Lee, Byung-Hoon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.13 no.7
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    • pp.3057-3064
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    • 2012
  • In this study, we have tried to identify the relationship between the patient's health belief and the implementation of functional movement rehabilitation and ability to perform ADL in stroke patient, and have done this study to use this as evidence in treating stroke patients in clinical trials by providing a basis data of stroke patients' successful rehabilitation program. We targeted stroke patients who were diagnosed with stroke and are hospitalized in D hospital in J City, Jeollabuk-do, South Korea. More over, we distributed a total of 150 questionnaires to patients who understand the purpose of the research and agreed to participate. We were able to collect 132questionnaires at the end. However, 11 had insufficient data so we only analyzed and evaluated 121 of the said questionnaires. We did frequency analysis to understand the general characteristics by using SPSS for Windows(ver.12.0) program and we used Pearson's Correlation Coefficient and regression analysis to know the relationship between the patient's health beliefs and the implementation of rehabilitation and ability to perform ADL in stroke patients. The results of this study shows that patients with higher perceived sensitivity, perceived benefit and perceived severity equates to an implementation of the rehabilitation better, however patients with a lower perceived disability equates an implementation of functional movement rehabilitation better than those with a higher perceived disability.

Sperm-Associated Antigen 9 is a Promising marker for Early Diagnosis of Endometrial Cancer

  • Baser, Eralp;Togrul, Cihan;Ozgu, Emre;Ayhan, Sevgi;Caglar, Mete;Erkaya, Salim;Gungor, Tayfun
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7635-7638
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    • 2013
  • Background: Sperm-associated antigen 9 (SPAG9) has been recently proposed as a novel biomarker for early diagnosis of several human tumors, including ovarian, cervical and breast cancers. Its clinical value remains to be clarified for endometrial cancer (EC). In this study, we investigated the utility of serum SPAG9 levels in diagnosis of EC and its association with important clinicopathological parameters. Materials and Methods: This cross-sectional study was performed at a tertiary women's referral center in Ankara, Turkey. Preoperative serum samples were collected from patients surgically treated for endometrial cancer between June 2012-April 2013. Similar aged women with a biopsy proven benign endometrium were used as controls. Serum SPAG9 levels were measured with an enzyme-linked immunosorbent assay (ELISA) method and assessed for links with clinicopathological factors. Receiver operating characteristic (ROC) curve analysis was performed to assess power of SPAG9 levels for EC prediction. P values less than 0.05 were considered statistically significant. Results: A total of 63 women with EC and 27 with benign endometrium were included in the study. Mean age in the EC group was $58.7{\pm}1.1$. Median SPAG9 levels in the EC and control groups were 18.3 (range, 12.7-53.8) and 14.1 (range, 4.3-65.3), respectively (p<0.001). A cut-off value of 17 ng/ml for SPAG9 predicted presence of malignant endometrium with 74% sensitivity and 83% specificity [Area under curve (AUC)=0.82, p<0.001]. SPAG9 levels did not demonstrate any significant association with histological type, FIGO stage, tumor grade, size, myometrial invasion, lymphovascular space invasion, cervical involvement, adnexal involvement, peritoneal cytology or lymph node status (all p>0.05). Conclusions: Testing for SPAG9 may be useful for early detection of EC in asymptomatic high-risk women. Its role in post-treatment follow-up and early detection of recurrence should be assessed in future trials.

Preliminary Results of a Phase I/II Study of Simultaneous Boost Irradiation Radiotherapy for Locally Advanced Nasopharyngeal Carcinoma

  • Xiang, Li;Wang, Yan;Xu, Bing-Qing;Wu, Jing-Bo;Xia, Yun-Fei
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7569-7576
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    • 2013
  • Background: The purpose of this article is to present preliminary results of simultaneous boost irradiation radiotherapy for locally advanced nasopharyngeal carcinoma (NPC). Methods: Fifty-eight patients who underwent simultaneous boost irradiation radiotherapy for NPC in Cancer Center of Sun Yat-sen University between September 2004 and December 2009 were eligible. Acute and late toxicities were scored weekly according to the Radiation Therapy Oncology Group (RTOG) acute and late radiation morbidity scoring schemes. An especial focus was on evidence of post-radiation brain injury. Also quality of life was analysed according to the EORTC (European Organisation for Research and Treatment of Cancer) recommendations. Discrete variables were compared by ${\chi}^2$ test. The Kaplan-Meier method was used to calculate the survival rates and generate survival curves. Results: A total of 58 patients with a mean follow-up time of 36 months completed clinical trials.Fifty-seven patients (98.3) achieved complete remission in the primary sites and cervical lymph nodes, with only one patient (1.7%) showing partial remission.The most frequently observed acute toxicities during the concurrent chemoradiotherapy were mucositis and leucopenia. Four patients (6.9%) had RTOG grade 3 mucositis, whereas four patients (6.9%) had grade 3 leucopenia. No patient had grade 4 acute toxicity. Three (5.17%) of the patients exhibited injury to the brain on routine MRI examination, with a median observation of 32 months (range, 25-42months). All of them were RTOG grade 0. The 3-year overall, regional-free and distant metastasis-free survival rates were 85%, 94% and 91%, respectively. Conclusion: Simultaneous boost irradiation radiotherapy is feasible in patients with locally advanced nasopharyngeal carcinoma. The results showed excellent local control and overall survival, with no significant increase the incidence of radiation brain injury or the extent of damage. A larger population of patients and a longer follow-up period are needed to evaluate ultimate tumor control and late toxicity.

Bioequivalence of Traline Tablet to Zoloft® Tablet (Sertraline HCI 50 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.41 no.5
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    • pp.317-322
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    • 2011
  • Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.