• Title/Summary/Keyword: Clinical Trial

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The Ability of Anti-tumor Necrosis Factor Alpha(TNF-${\alpha}$) Antibodies Produced in Sheep Colostrums

  • Yun, Sung-Seob
    • 한국유가공학회:학술대회논문집
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    • 2007.09a
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    • pp.49-58
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    • 2007
  • Inflammatory process leads to the well-known mucosal damage and therefore a further disturbance of the epithelial barrier function, resulting abnormal intestinal wall function, even further accelerating the inflammatory process[1]. Despite of the records, etiology and pathogenesis of IBD remain rather unclear. There are many studies over the past couple of years have led to great advanced in understanding the inflammatory bowel disease(IBD) and their underlying pathophysiologic mechanisms. From the current understanding, it is likely that chronic inflammation in IBD is due to aggressive cellular immune responses including increased serum concentrations of different cytokines. Therefore, targeted molecules can be specifically eliminated in their expression directly on the transcriptional level. Interesting therapeutic trials are expected against adhesion molecules and pro-inflammatory cytokines such as TNF-${\alpha}$. The future development of immune therapies in IBD therefore holds great promises for better treatment modalities of IBD but will also open important new insights into a further understanding of inflammation pathophysiology. Treatment of cytokine inhibitors such as Immunex(Enbrel) and J&J/Centocor(Remicade) which are mouse-derived monoclonal antibodies have been shown in several studies to modulate the symptoms of patients, however, theses TNF inhibitors also have an adverse effect immune-related problems and also are costly and must be administered by injection. Because of the eventual development of unwanted side effects, these two products are used in only a select patient population. The present study was performed to elucidate the ability of TNF-${\alpha}$ antibodies produced in sheep colostrums to neutralize TNF-${\alpha}$ action in a cell-based bioassay and in a small animal model of intestinal inflammation. In vitro study, inhibitory effect of anti-TNF-${\alpha}$ antibody from the sheep was determined by cell bioassay. The antibody from the sheep at 1 in 10,000 dilution was able to completely inhibit TNF-${\alpha}$ activity in the cell bioassay. The antibodies from the same sheep, but different milkings, exhibited some variability in inhibition of TNF-${\alpha}$ activity, but were all greater than the control sample. In vivo study, the degree of inflammation was severe to experiment, despite of the initial pilot trial, main trial 1 was unable to figure out of any effect of antibody to reduce the impact of PAF and LPS. Main rat trial 2 resulted no significant symptoms like characteristic acute diarrhea and weight loss of colitis. This study suggested that colostrums from sheep immunized against TNF-${\alpha}$ significantly inhibited TNF-${\alpha}$ bioactivity in the cell based assay. And the higher than anticipated variability in the two animal models precluded assessment of the ability of antibody to prevent TNF-${\alpha}$ induced intestinal damage in the intact animal. Further study will require to find out an alternative animal model, which is more acceptable to test anti-TNF-${\alpha}$ IgA therapy for reducing the impact of inflammation on gut dysfunction. And subsequent pre-clinical and clinical testing also need generation of more antibody as current supplies are low.

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Effects of adherence to Korean diets on serum GGT and cardiovascular disease risk factors in patients with hypertension and diabetes (고혈압 및 당뇨병 환자에서 한식 섭취가 혈청 GGT와 심혈관질환 위험인자에 미치는 영향)

  • Jung, Su-Jin;Chae, Soo-Wan
    • Journal of Nutrition and Health
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    • v.51 no.5
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    • pp.386-399
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    • 2018
  • Purpose: This study examined whether the supply of healthy Korean diets for 12 weeks is effective in improving the risk factors related to serum GGT and cardiovascular diseases in patients with hypertension and diabetes. Methods: This study selected 41 patients, who were treated with hypertension and diabetes. The Korean diet was composed of cooked-rice, soup, kimchi, and various banchan with one serving called bapsang, which emphasize proportionally high consumption of vegetables and fermented foods, moderate to high consumption of legumes and fish, and low consumption of animal foods. The control group was instead instructed to "eat and exercise as usual" while following the Korean Diabetes Association's dietary guidelines with an intake that can assist in glycemic control, maintain adequate weight, and meet the nutritional requirements. The Korean diet group (21 patients) were served three healthy Korean meals a day for 12 weeks, and the control group (20 patients, who trained in the diet guideline of diabetes) maintained their usual diabetic diet. The serum GGT, blood pressure, heart rate, glycemic control data, cardiovascular risk indicators, and changes in diet measured at the four visits (week 0, 4, 8, and 12) during the course of 12 weeks were compared and evaluated. Results: The serum GGT (p < 0.001), HbA1c (p = 0.004), heart rate (p = 0.007), weight (p = 0.002), Body Mass Index (p = 0.002), body fat mass (p < 0.001), body fat (%) (p < 0.001), and free fatty acid (p = 0.007) in the Korean diet group decreased significantly after the dietary intervention compared to the control group. The amount of intake of rice, whole grains, green vegetables, Kimchi, and soybean fermented food were increased significantly compared to the control group (p < 0.001). The Korean diet group showed significant decreases (p < 0.001) in the intake of animal protein, lipid, and cholesterol derived from animal foods compared to the control group but significant increases (p < 0.001) in the intake of total calories, folic acid, dietary fiber, sodium, potassium, and vitamins A, E, and C. Conclusion: In patients with hypertension and diabetes, it was confirmed that regular eating of a healthy Korean diet helps improve the risk factors for GGT and cardiovascular diseases.

Nicardipine Hydrochloride Injectable Phase IV Clinical Trial-Study on the antihypertensive effect and safely of nicardipine for acute aortic dissection (급성대동맥해리에 대한 혈압강하요법으로서의 Nicardipine.HCI 주사액(Perdipine$^{circledR}$)의 유효성 및 안전성을 검토하기 위한 다기관 공동, 공개 제4상 임상시험)

  • Kim, Kyung-Hwan;Moon, In-Sung;Park, Jang-Sang;Koh, Yong-Bok;Ahn, Hyuk
    • Journal of Chest Surgery
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    • v.35 no.4
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    • pp.267-273
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    • 2002
  • Background: We performed a phase IV clinical trial to examine the usefulness of a continuous infusion of nicardipine hydrochloride to control hypertension in patients with acute aortic dissection. material and Method: Systolic/diastolic blood pressure, and heart rate were monitored before and after the intravenous administration of nicardipine in 31 patients with aortic diseases. The period of nicardipine administration in each patient was from 3 to 14 days. Efficacy was evaluated by determining the average amount of blood pressure reduction on the 3rd day of drug administration. The dosage of another antihypertensive agent was slowly tapered down, and ultimately replaced by the test drug. Result: 28 patients were diagnosed as acute aortic dissection, 2 patients as rupture of the aortic arch aneurysm, and 1 patient as traumatic aortic rupture. Mean age was 53.9 $\pm$ 14.9(29~89) years, and 21 patients(67.7%) were male. 14 patients(32.3%) had complications associated with underlying aortic disease: aortic insufficiency in 7, hemopericardium in 6, acute renal failure in 1, paraplegia in 1, lower extremity ischemia in 1, and hemothorax in 1. The time needed to reach the target blood pressure was within 15 minutes in 16, from 15 to 30 minutes in 10, from 30 to 45 minutes in 3 and from 45 to 60 minutes in 2, and their baseline average systolic, diastolic, and mean arterial blood pressures(mmHg) were 147$\pm$23, 82.3$\pm$ 18.6, and 104 $\pm$ 18, respectively. Average systolic, diastolic, and mean arterial blood pressures(mmHg) on the third day of nicardipine infusion were 119$\pm$ 12, 69$\pm$9, and 86$\pm$8, and they all showed statistically significant decrease(p<0.05). The average systolic, diastolic, and mean arterial blood pressure(mmHg) after the discontinuation of the nicardipine infusion were 119 $\pm$ 15, 71 $\pm$ 14, and 86$\pm$ 13, respectively. No significant difference was observed between the average pressures measured on the third day and those measured after the discontinuation of the nicardipine infusion, and no definite side effects were observed during the study period. Conclusion: Nicardipine hydrochloride was both effective and safe at controlling blood pressure in patients with acute aortic dissection.

Effects for kangaroo care: systematic review & meta analysis (캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석)

  • Lim, Junghee;Kim, Gaeun;Shin, Yeonghee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.599-610
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    • 2016
  • This paper reports the results of a systematic review (SR) and meta-analysis research to compare the effect of Kangaroo care, targeting mothers and premature infants. A randomized clinical trial study was performed until February 2015. The domestic literature contained the non-randomized clinical trial research without restriction according to the level of the study design. A search of the Ovid-Medline, CINAHL, PubMed and KoreaMed, the National Library of KOREA, the National Assembly Library, NDSL, KISS and RISS. Through the KMbase we searched and combined the main term ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((kangaroo OR kangaroo OR kangaroo) AND (care OR nursing care OR management OR skin contact)) was made; these were all combined with a keywords search through the selection process. They were excluded in the final 25 studies (n=3051). A methodology checklist for randomized controlled trials (RCTs) designed by SIGN (Scottish Intercollegiate Guidelines Network) was utilized to assess the risk of bias. The overall risk of bias was regarded as low. In 16 studies that were evaluated as a grade of "++", 9 studies were evaluated as a grade of "+". As a result of meta-analysis, kangaroo care regarding the effects of premature mortality, severe infection/sepsis had an insignificant effect. Hyperthermia incidence, growth and development (height and weight), mother-infant attachment, hypothermia incidence, length of hospital days, breast feeding rate, sleeping, anxiety, confidence, and gratification of mothering role were considered significant. In satisfaction of the role performance, depression and stress presented contradictory research results for individual studies showing overall significant difference. This study has some limitations due to the few RCTs comparing kangaroo care in the country. Therefore, further RCTs comparing kangaroo care should be conducted.

Clinical Trial of Nasal Flumazenil Administration (플루마제닐의 경비 투여)

  • Hong, Soo-Jin;Kim, Hyun-Jung;Yum, Kwang-Won
    • Journal of the korean academy of Pediatric Dentistry
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    • v.28 no.3
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    • pp.441-446
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    • 2001
  • Flumazenil is a competitive antagonist of benzodiazepines. It is usually administered intravenously. However, if the intravenous route is not available then other routes of drug administration should be considered. This study was designed to evaluate the reversal effects of flumazenil after nasal administration. Twenty-five young, healthy adult volunteers participated in this clinical trial. The dosage of 0.08mg/kg midazolam was administered intravenously to induce deep sedation. Ten minutes after midazolam administration, 0.5mg of flumazenil was dropped nasally, over a period of one minute. Blood samples were taken to measure the concentration of midazolam and flumazenil at 0, 5, 10, and 20min after nasal administration of flumazenil, using High Performance Liquid Chromatography. The degree of sedation was evaluated with sedation score and bispectral index (BIS), Statistical analysis was performed by multivariate ANOVA and correlation analysis (P<0.05). Peak serum flumazenil concentration was reached in 10min. Sedation score decreased after midazolam administration and showed a significant increase after flumazenil administration. However, BIS decreased during the first 10min after midazolam administration and then no significant changes after flumazenil administration. There were two instances representing rapid and complete reversal of midazolam after intranasal administration of flumazenil. In conclusion, intranasal flumazenil administration may be effective in some patients when intravenous route is not available in condition of benzodiazepine overdose.

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Effects of Germanium-fortified Yeast on the Serum Lipids and Immune Cell Subset (게르마늄강화효모가 혈청지질 및 면역세포변화에 미치는 영향)

  • Lee, Sung-Hee;Oh, Sun-Woo;Rho, Sook-Nyung;Lee, Bog-Hieu;Lee, Hyun-Joo;Jin, Dong-Kyu
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.35 no.6
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    • pp.683-689
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    • 2006
  • This study was established to investigate the effect of germanium-fortified yeasts on the serum lipid composition and immune system of human body. All 50 subjects with the age range of $50{\sim}75$ were entered in this clinical trial for 6 months. The effects were determined by the proliferative responses of immune-mediated cells, T-cell, B-cell and NK-cell during daily supplementation with/without germanium-fortified yeast. The results of hematology and blood chemistry didn't show any significant differences during administration periods. Serum lipid compositions also didn't show any significant differences during administration periods except triglyceride (TG) and VLDL-cholesterol. TG and VLDL-cholesterol levels were increased significantly by the consumption of germanium-fortified yeast (p<0.05). Immune mediated T-celt and NK-cell didn't increased in both control and test group supplemented with germanium fortified yeast, while B-cell increased in the germanium fortified yeast group after 8 week (p<0.05). Also $TNF-{\alpha}$ increased in the group of germanium fortified yeast after 8 week (p<0.05) but not in the control group. From the above results, germanium fortified yeast is expected to be useful on the improvement of the cellular immune response and protection of organs from various chronic diseases.

Effects of Age and Sex on the Pharmacokinetics of Tacrolimus during Pediatric Kidney Transplantation: A Single Center Study (소아 신장이식 환자에서 연령 및 성별에 따른 타크롤리 무스의 약동학적 차이에 관한 단일기관 연구)

  • Choe, Jae Young;Jang, Kyung Mi;Hwang, Young Ju;Choi, Bong Seok;Park, Jong Kwang;Yoon, Young Ran;Kim, Chan Duck;Cho, Min Hyun
    • Childhood Kidney Diseases
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    • v.18 no.1
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    • pp.18-23
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    • 2014
  • Purpose: The pharmacokinetics of tacrolimus, one of the most widely used immunosuppressive drugs, are known to vary by sex, age, and ethnicity during pediatric transplantation. This study assessed the pharmacokinetic characteristics and associated factors of tacrolimus in Korean children receiving a kidney transplant. Methods: We retrospectively reviewed the pharmacokinetic data (therapeutic dose, trough level, clearance, and half-life) of 9 children who were given tacrolimus as one of their initial immunosuppressive drugs after kidney transplantation. In addition, we compared the findings to data from 10 adult kidney transplant recipients. Results: The mean age of our pediatric patients was 13.9 years, and the maleto- female ratio was 4:5. The mean dose of tacrolimus was $0.19{\pm}0.14$ mg/kg/day. The mean dose of tacrolimus for males was $0.23{\pm}0.12$ mg/kg/day, which was significantly higher than the dose for females ($0.16{\pm}0.14$ mg/kg/day). The trough level was not significantly different between both groups. The clearance rate of tacrolimus for males was also significantly higher than females. Although the dosage of tacrolimus for patients over the age of 12 years was lower ($0.18{\pm}0.13$ vs. $0.21{\pm}0.16$ mg/kg/day) and the trough level was higher ($8.2{\pm}4.5$ vs. $7.2{\pm}4.2$ mg/mL) than that for patients under the age of 12 years, there was no significant difference between them. However, there were significant differences between children and adults in dose, clearance, and half-life of tacrolimus. Conclusion: Out study suggests that the pharmacokinetics of tacrolimus tends to vary with sex and age. Therefore, large-scale prospective studies are required to verify the proper therapeutic dosage of tacrolimus in Korean children.

Effects of Korean diet control nutrition education on cardiovascular disease risk factors in patients who underwent cardiovascular disease surgery (심혈관질환 수술을 받은 환자에서 한식식이조절 영양교육이 심혈관질환 위험요인에 미치는 영향)

  • Jung, Su-Jin;Chae, Soo-Wan
    • Journal of Nutrition and Health
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    • v.51 no.3
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    • pp.215-227
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    • 2018
  • Purpose: This study was conducted to verify the effects of increases in consuming Korean food in patients who underwent cardiovascular disease (CVD) surgery based on a Korean diet control education program and to investigate the effects of Korean diet control nutrition education on risk factors of CVD, changes in amounts of medication, and nutritional intakes. Methods: The subjects consisted of 15 patients who have undergone CVD surgery within three years and continuously taken cardiovascular drugs. The Korean traditional diet (KTD) emphasizes intake of vegetables and fermented foods to lower saturated fat and cholesterol intake. We applied a KTD education program that included a modified DASH (The dietary approaches to stop hypertension) diet for cardiovascular disease patients. Korean diet control education was then applied to the patients for 12 weeks to evaluate the risk factors of CVD and the state of nutritional intakes. Results: The Korean diet control compliance score increased significantly (p < 0.001) as Korean diet control education was implemented. Additionally, the obesity indexes, waist circumference (WC) (p = 0.002) and waist-to-hip ratio (WHR) decreased significantly (p < 0.001) after subjects received the education. Moreover, the glycemic control index, HbA1c, was significantly decreased (p < 0.05) from $7.3{\pm}1.0%$ before the education to $7.0{\pm}1.1%$ after the education. Changes in the amounts of Korean diet intake consisted of significant increases in cooked rice with whole grains, narmuls (vegetables either raw or cooked), kimchi, and traditional fermented foods following the education. Moreover, the nutritional intake after the education showed significant decreases (p < 0.05) in animal protein, animal lipids, and cholesterol. However, the intakes of Na, K, dietary fiber, vitamin A, vitamin $B_6$, vitamin C, and folic acid were significantly increased. Conclusion: The active encouragement of consuming Korean food and the intervention of implementing diet control education positively affected nutritional intake, the obesity index and glycemic control of patients who have undergone CVD surgery.

Multicenter, Open-Labeled, Observational Clinical Trial to Investigate the Efficacy and Safety of Oral Administration of Megace Suspension in Patients with Head and Neck Cancer During Radiotherapy (방사선 치료 중인 두경부 종양 환자를 대상으로 메게이스 내복 현탁액 경구투여 후 유효성 및 안전성에 관한 다기관, 공개, 관측연구)

  • Kim, Se-Heon;Kim, Min-Sik;Kim, Young-Mo;Kim, Hyun-Su;Nam, Soon-Yuhl;Rho, Young-Soo;Park, Young-Hak;Baek, Chung-Hwan;Bong, Jung-Pyo;Lee, Kang-Dae;Lee, Yong-Seop;Jung, Kwang-Yoon;Chung, Sung-Min;Chung, Pil-Sang;Joo, Young-Hoon;Chu, Hyung-Ro;Choi, Eun-Chang;Tae, Kyung;Hong, Ki-Hwan
    • Korean Journal of Head & Neck Oncology
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    • v.24 no.1
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    • pp.57-63
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    • 2008
  • Background and Purpose:Nausea, vomiting and weight loss are common problems that are encountered in the course of cancer patient treatment who are receiving radiotherapy. In this study, we are aiming to analyze the effect of megestrol acetate on quality of life of head and neck cancer patients receiving radiotherapy, resulting from improvement of weight loss, appetite and nutritional status via multicenter, open-labeled, observational clinical trial. Material and Methods:A total of 270 patients from 10 medical institutes who are receiving radiotherapy or who have completed radiotherapy within 3 months, between February 2007 and February 2008, were selected as candidates for the study. Megestrol acetate suspension(megace) was given to the subjectives once a week for 4 weeks with the amount of 20ml(megestrol 800mg). Measurement of weight and questionnaire surveys were carried out three times: at the start of the study, 4 weeks after the start of the medication, and 4 weeks after the end of the medication, respectively. Results:The group who has received megace had a total number of 199, and control group was 70. The group who have received megace showed mean weight loss of 1kg in 8 weeks, compared with the weight loss of 5.5kg in control group, which showed that the medication was effective in reducing the amount of weight loss(P=0.027). The group who received megace had a tendency to report a reduced rate of decrease in the score of appetite, nausea and vomiting, and QOL score, but it did not have statistical significance(P>0.05). Conclusion:Megestrol acetate have reduced the degree of weight loss significantly, and it has a tendency to reduce the rate of decrease in appetite, aggravation of nausea and vomiting, and quality of life.

Success and failure of endodontic microsurgery (미세 치근단 수술의 성공과 실패)

  • Song, Min-Ju;Kim, Eui-Seong
    • Restorative Dentistry and Endodontics
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    • v.36 no.6
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    • pp.465-476
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    • 2011
  • In current endodontic practice, introduction of operating microscope, ultrasonic instruments, and microinstruments has induced a big change in the field of surgical retreatment. In this study, we aimed to offer key steps of endodontic microsurgery procedure compared with traditional root-end surgery, and to evaluate factors influencing success and failure based on published articles. Endodontic microsurgery is a surgical procedure performed with the aid of a microscope, ultrasonic instruments and modern microsurgical instruments. The microscope provides magnification and illumination - essential for identifying minute details of the apical anatomy. Ultrasonic instruments facilitate the precise root-end preparation that is within the anatomical space of the canal. Modern endodontics can therefore be performed with precision and predictability, thus eliminating the disadvantages inherent in traditional periapical surgery such as large osteotomy, beveled apicoectomy, inaccurate root-end preparation and the inability to observe isthmus. Factors influencing the outcomes of endodontic microsurgery may be diverse, but standardization of procedures can minimize its range. Among patient and tooth-related factors, periodontal status and tooth position are known to be prognostic, but there are only few articles concerning this matter. High-evidence randomized clinical trials or prospective cohort studies are needed to confirm these findings.