• Title/Summary/Keyword: Clinical Trial

Search Result 2,060, Processing Time 0.038 seconds

Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험)

  • Lee, Sang-Do;Seo, Kwang Won;Lee, Jung Yeon;Huh, Jin Won;Choi, Ik Su;Park, Jae Sun;Shim, Tae Sun;Oh, Yeon-Mok;Park, In Won;Ryu, Wang-Seong;Choi, Byoung Whui
    • Tuberculosis and Respiratory Diseases
    • /
    • v.57 no.4
    • /
    • pp.320-328
    • /
    • 2004
  • Background : Pulmonary vascular changes which occur early in the course of chronic obstructive pulmonary disease (COPD) are prevalent manifestation and later cause pulmonary hypertension, which is a bad prognostic factor in COPD. Beraprost sodium (BPS), an orally active prostacyclin analogue, has been shown to improve survival in patients with primary pulmonary hypertension. This study investigated the effect of BPS in the patients with COPD. Methods : This is a double-blind randomized placebo-controlled, two center clinical trial. Twenty one consecutive patients with COPD were enrolled from June 2003 to June 2004 (patients treated with BPS for 3 months, BPS group, n=11; those with placebo, placebo group, n=10). The baseline demographic, pulmonary function and hemodynamic data were not significantly different between two groups. Results : On echocardiographic examination, trans tricuspid valve pressure gradient has decreased significantly after 3 months with beraprost in the BPS group [17.7(${\pm}11.4$) to 8.2(${\pm}8.9$) mm Hg, p-value<0.05], while there was no significant change in the control group. Six-minute walking distance has decreased in the control group and increased in the BPS group, but there was no statistical significance. Conclusion : In patients with COPD oral administration of BPS reduced the pulmonary arterial pressure. The clinical significance of this finding, that is improving symptoms and natural course of the disease, needs further study.

THE PREVALENCE OF WHITE SPOT LESIONS ON THE MESIAL SURFACES OF THE 1ST MOLARS IN CHILDREN AND MINIMAL INVASIVE APPROACH - A PILOT STUDY (어린이 제1대구치 근심면 초기 우식의 유병률과 최소 침습적 접근)

  • Ahn, Myung-Ki;Lee, Geum-Lang;Jeong, Tae-Sung;Kim, Shin
    • Journal of the korean academy of Pediatric Dentistry
    • /
    • v.36 no.1
    • /
    • pp.102-107
    • /
    • 2009
  • In clinical pediatric dentistry, we have many chances to encounter the white spot like incipient enamel lesions on the mesial surfaces of the 1st molars with direct vision, especially just after the 2nd primary molars were exfoliated. But it was thought highly desirable to assess if these lesions are properly and effectively managed yet. This study aims at surveying the prevalence of incipient lesions on the mesial surfaces of the 1st molars in children through direct observation and examining the suitability of adhesive sealing on them as a pilot trial in searching for their proper management. 1. Among the 124 mesial surfaces of the 1st molars examined, 34% were sound, 53% had incipient carious lesions and 13% had cavitated lesions. 2. In the sectional views of the specimens, 20% showed microleakage after thermo-cycling and it was thought not recommendable as a permanent method. Therefore in order to effectively fight against the incipient caries lesions in children‘s permanent teeth, it was thought proper not to rely on any one method, but to perform reinforcing oral hygiene and promotion of remineralization in combination with therapeutic sealing which is stronger in short-term sealing effect. Although therapeutic sealing has been considered as the core in minimally invasive concept to treat the white spot lesions, its long-term clinical trials have not been suggested. Continuous research is strongly required for making this approach to acquire permanent nature, especially in regards of proper pretreatment and high molecular materials deeply penetrable into enamel.

  • PDF

Growth and clinical efficacy of fortified human milk and premature formula on very low birth weight infants (극소 저체중출생아에서 강화된 모유와 미숙아 전용분유가 성장 및 임상에 미치는 효과)

  • Chueh, Heewon;Kim, Myo Jing;Lee, Young-A;Jung, Jin-A
    • Clinical and Experimental Pediatrics
    • /
    • v.51 no.7
    • /
    • pp.704-712
    • /
    • 2008
  • Purpose : A prospective, controlled trial was conducted to evaluate growth, efficacy, safety and nutritional status for very low birth weight infants fed with human milk fortified with Maeil human milk fortifier (Maeil $HMF^{(R)}$; Maeil Dairies Co., Ltd.). Methods : We enrolled 45 premature infants with a birth weight <1,500 g and gestational age <33 weeks, who were born at Dong-A University Hospital from October, 2006 through December, 2007. They were divided into 2 groups: infants in one group were fed with human milk fortified with $HMF^{(R)}$, and the second were fed with preterm formula. Growth, biochemical indices, feeding tolerance, and other adverse events in each group were assessed serially and compared relatively. Follow-up data were also collected after discharge at 1, 3, and 6 months corrected age. Results : Characteristics of the 2 groups including average gestational age, birth weight, sex, respiratory distress syndrome, patent ductus arteriosus, and other adverse events (sepsis, retinopathy of prematurity, and intraventricular hemorrhage) showed no significant difference. Average feeding start day ($8.00{\pm}3.27d$ vs. $8.86{\pm}5.37d$) (P=0.99) and the number of days required to reach full feeding after start feeding ($41.78{\pm}20.47d$ vs $36.86{\pm}20.63d$) (P=0.55) were not significantly different in the group fed human milk fortified with $HMF^{(R)}$ when compared with the group that was fed preterm formula. The duration of total parenteral nutrition and the incidence of feeding intolerance also showed no differences between the 2 groups. Although infants fed with human milk fortified with $HMF^{(R)}$ showed faster weight gain than those fed with preterm formula at the end stage of the admission period, other growth indices of the two groups showed no significant difference. No significant correlations were found between the 2 groups with regard to weight gain velocity, height gain velocity, head circumference velocity, and post-discharge follow up growth indices. Conclusion : Premature infants fed human milk fortified with $HMF^{(R)}$ showed no significant difference compared with those fed preterm formula in growth, biochemical indices, and adverse events. Using human milk fortifier can be an alternative choice for very low birth weight infants, who need high levels nutritional support even after discharge from NICU.

Effect of surfactant lavage in severe meconium aspiration syndrome (중증 태변 흡인 증후군에서 인공 폐표면활성제 세정요법의 효과에 관한 비교 연구)

  • Lee, Soon Min;Kim, He Min;Jeon, Ji Hyun;Park, Min Soo;Park, Kook In;Namgung, Ran;Lee, Chul
    • Clinical and Experimental Pediatrics
    • /
    • v.51 no.4
    • /
    • pp.367-371
    • /
    • 2008
  • Purpose : The surfactant dysfunction may play an important role in meconium aspiration syndrome (MAS). We aim to evaluate the effect of surfactant lavage in the treatment of term infants with MAS. Methods : The medical records of 15 neonates with severe MAS admitted at Yongdong Severance Hospital from 2005 to 2007 were reviewed and analyzed. Seven infants with severe MAS necessitating mechanical ventilation underwent tracheobronchial lavage with 20 mL/kg of diluted (5.3 mg phospholipid/mL) surfactant saline suspension ($Newfactan^{(R)}$). Data regarding clinical outcomes was assessed by comparison with 8 control infants with equally severe MAS retrospectively. Results : In the lavage group, radiological improvement was evident after 6 hours of treatment. The duration of artificial ventilation and duration of hospital day were also significantly shorten in the lavage group compared with the control group. The mean oxygen index, mean ventilation index improved significantly within the first 6 hours after treatment. No differences were found in the incidence of major complications and mortality between the two groups. Conclusion : The surfactant lavage seems to be an effective and safe method for treatment of severe MAS. A multicenter, large scaled randomized controlled trial is needed for further study.

A Study on the Necessary Number of Bolus Treatments in Radiotherapy after Modified Radical Mastectomy (변형 근치적 유방절제술 후 방사선치료에서 볼루스 적용횟수에 대한 고찰)

  • Hong, Chae-Seon;Kim, Jong-Sik;Kim, Young-Kon;Park, Young-Hwan
    • The Journal of Korean Society for Radiation Therapy
    • /
    • v.18 no.2
    • /
    • pp.113-117
    • /
    • 2006
  • Purpose: Post-mastectomy radiotherapy (PMR) is known to decrease loco-regional recurrence. Adequate skin and dermal dose are achieved by adding bolus. The more difficult clinical issue is determining the necessary number of bolus treatment, given the limits of normal skin tolerance. The aim of this study is to evaluate the necessary number of bolus treatment after PMR in patients with breast cancer. Materials and Methods: Four female breast cancer patients were included in the study. The median age was 53 years(range, $38{\sim}74$), tumor were left sided in 2 patients and right sided in 2patients. All patients were treated with postoperative radiotherapy after MRM. Radiotherapy was delivered to the chest wall (C.W) and supraclavicular lymph nodes (SCL) using 4 MV X-ray. The total dose was 50 Gy, in 2 Gy fractions (with 5 times a week). CT was peformed for treatment planning, treatment planning was peformed using $ADAC-Pinnacles^3$ (Phillips, USA) for all patients without and with bolus. Bolus treatment plans were generated using image tool (0.5 cm of thickness and 6 cm of width). Dose distribution was analyzed and the increased skin dose rate in the build-up region was computed and the skin dose using TLD-100 chips (Harshaw, USA) was measured. Results: No significant difference was found in dose distribution without and with bolus; C.W coverage was $95{\sim}100%$ of the prescribed dose in both. But, there was remarkable difference in the skin dose to the scar. The skin dose to the scar without and with bolus were $100{\sim}105%\;and\;50{\sim}75%$. The increased skin dose rates in the build-up region for Pt. 1, Pt. 2. Pt. 3 and Pt. 4 were 23.3%, 35.6%, 34.9%, and 41.7%. The results of measured skin dose using TLD-100 chips in the cases without and with bolus were 209.3 cGy and 161.1 cGy, 200 cGy and 150.2 cGy, 211.4 cGy and 160.5 cGy, 198.6 cGy and 155.5 cGy for Pt. 1, Pt. 2, Pt. 3, and Pt. 4. Conclusion: It was concludes through this analysis that the adequate number of bolus treatments is 50-60% of the treatment program. Further, clinical trial is needed to evaluate the benefit and toxicity associated with the use of bolus in PMR.

  • PDF

Analysis of temperature changes and sterilization effect of diode laser for the treatment of peri-implantitis by wavelength and irradiation time (임플란트 주위염 치료용 diode laser의 파장 및 조사시간에 따른 온도 변화와 살균효과 분석)

  • Seol, Jeong-Hwan;Lee, Jun Jae;Kum, Kee-Yeon;Lee, Jong-Ho;Lim, Young-Joon
    • Journal of Dental Rehabilitation and Applied Science
    • /
    • v.33 no.3
    • /
    • pp.178-188
    • /
    • 2017
  • Purpose: We compared the effects of newly developed diode laser (Bison 808 nm Diode laser) on the treatment of peri-implantitis with conventional products (Picasso 810 nm Diode laser) by comparing the surface temperature of titanium disc and bacterial sterilization according to laser power. Materials and Methods: The titanium disc was irradiated for 60 seconds and 1 - 2.5 W using diode laser 808 nm and 810 nm. The surface temperature of the titanium disc was measured using a temperature measurement module and a temperature measurement program. In addition, in order to investigate the sterilizing effect according to the laser power, 808 nm laser was irradiated after application of bacteria to sandblasted large-grit acid-etched (SLA) and resorbable blast media (RBM) coated titanium discs. The irradiated disks were examined with scanning electron microscopy. Results: Both 808 nm and 810 nm lasers increased disk surface temperature as the power increased. When the 810 nm was irradiated under all conditions, the initial temperature rise rate, the descending rate, and the temperature change before and after was higher than that of 808 nm. Disk surface changes were not observed on both lasers at all conditions. Bacteria were irradiated with 808 nm, and the bactericidal effect was increased as the power increased. Conclusion: When applying these diode lasers to the treatment of peri-implantitis, 808 nm which have a bactericidal effect with less temperature fluctuation in the same power conditions would be considered safer. However, in order to apply a laser treatment in the dental clinical field, various safety and reliability should be secured.

Detection of Multidrug Resistance Using Molecular Nuclear Technique (분자핵의학 기법을 이용한 다약제내성 진단)

  • Lee, Jae-Tae;Ahn, Byeong-Cheol
    • The Korean Journal of Nuclear Medicine
    • /
    • v.38 no.2
    • /
    • pp.180-189
    • /
    • 2004
  • Although the outcome of cancer patients after cytotoxic chemotherapy is related diverse mechanisms, multidrug resistance (MDR) for chemotherapeutic drugs due to cellular P-glycoprotein (Pgp) or multidrug-resistance associated protein (MRP) is most important factor in the chemotherapy failure to cancer. A large number of pharmacologic compounds, including verapamil, quinidine, tamoxifen, cyclosporin A and quinolone derivatives have been reported to overcome MDR. Single photon emission computed tomography (SPECT) and positron emission tomography (PET) are available for the detection of Pgp and MRP-mediated transporter. $^{99m}Tc$-MIBI and other $^{99m}Tc$-radiopharmaceuticals are substrates for Pgp and MRP, and have been used in clinical studies for tumor imaging, and to visualize blockade of PgP-mediated transport after modulation of Pgp pump. Colchicine, verapamil and daunorubicin labeled with $^{11}C$ have been evaluated for the quantification of Pgp-mediated transport with PET in vivo and reported to be feasible substrates with which to image Pgp function in tumors. Leukotrienes are specific substrates for MRP and $N-[^{11}C]acetyl-leukotriene$ E4 provides an opportunity to study MRP function non-invasively in vivo. SPECT and PET pharmaceuticals have successfully used to evaluate pharmacologic effects of MDR modulators. Imaging of MDR and reversal of MDR with bioluminescence in a living animal is also evaluated for future clinical trial. We have described recent advances in molecular imaging of MDR and reviewed recent publications regarding feasibility of SPECT and PET imaging to study the functionality of MDR transporters in vivo.

Biodistribution and Metabolism of I-123 Labelled Fatty Acid(I) : [I-123]15-(p-iodophenyl)pentadecanoic acid(IPPA) (I-123 표지 지방산의 체내 분포 및 대사(I) : [I-123]15-(p-iodophenyl)pentadecanoic acid(IPPA))

  • Chang, Young Soo;Lee, Dong Soo;Jeong, Jae Min;Suh, Yong-Sup;Chung, June-Key;Lee, Myung Chul;Koh, Chang-Soon
    • The Korean Journal of Nuclear Medicine
    • /
    • v.32 no.1
    • /
    • pp.50-60
    • /
    • 1998
  • I-123 labelled fatty acids are suitable for investigation of regional myocardial metabolism, so they are on the clinical trial. However, the precise properties of these materials are not characterized yet. We have synthesized phenylpentadecanoic acid and labeled this compound with I-123. The purpose of this study was to examine the stability, biodistribution, metabolism and SPECT imaging of [I-123]15-(p-iodophenyl)pentadecanoic acid(I-123-IPPA) that we made. The stability test of I-123-IPPA in serum of rat, mouse and human showed no free I-123 after 1 hour. In biodistribution study in mice for various time intervals after injection(5, 10, 15, 30, 60 minutes), uptake in myocardium was 14.5%ID/g(5 min), and 1.9%ID/heart(5 min), while uptake in muscles was 2.6%ID/g(5 min). Myocardium to blood ratio and myocardium to lung ratio increased for 5 min after injection and then decreased rapidly. Chromatographic data of rat blood and urine showed that little PPA was found in blood and urine at 15-20 min after injection. The myocardial I-123-IPPA SPECT images of a dog with myocardial infarction showed defects similar to those of Tc-99m-MIBI and F-18-FDG. These data suggest that I-123-IPPA is quite stable in vitro and shows favorable biodistribution in mice. SPECT imaging with I-123-IPPA demonstrated infarct zone as photon defect in dog model of myocardial infarction. I-123-IPPA may be used for the evaluation of fatty acid metabolism in clinical trials in Korea.

  • PDF

Sequential Chemotherapy and Radiation Therapy for Advanced Nasopharyngeal Carcinoma (진행된 비인강암의 화학요법 및 방사선 치료)

  • Park, In-Kyu;Kim, Song-Bo;Yun, Sang-Mo;Kim, Jae-Cheol;Park, Jun-Sik
    • Radiation Oncology Journal
    • /
    • v.11 no.2
    • /
    • pp.259-265
    • /
    • 1993
  • Between January 1985 and July 1992, 52 patients with locally advanced nasopharyngeal carcinoma were studied retrospectively for the effectiveness of sequential chemotherapy and radiation therapy. The male to female ratio was 3.3:1 with a median age of 41 years. Forty patients had squamous cell carcinoma and the remaining 12 had undifferentiated carcinoma. Seven patients had stage III disease and the remainder had stage IV disease at time of presentation. All patients were treated two courses of chemotherapy followed by radiation therapy. Chemotherapy consisted of either CVB (cisplatin, vincristine and bleomycin) or CF (cisplatin and 5-FU). Total radiation dose to the primary site ranged from 6000 cGy to 7500 cGy. Neck nodes were given booster treatment to maximum of 7000 cGy, depending on the extent of disease. Local control, overall survival and disease-free survival rates were analyzed. The complete response (CR) rate to chemotherapy was $15\%$ and the partial response (PR) rate was $46\%,$ for overall major response rate of $61\%.$ The CR rate was $87\%$ after radiation therapy. Median follow-up time was 51 months. The overall survival and disease-free survival rates at 36 months were $54\%\;and\;49\%,$ respectively. Median time to relapse was 15 months. The patterns of initial relapse in CR patients was as follows: locoregional failure only, 12 patients; distant metastasis only,11: both,2. Cox's multivariate regression model revealed that nodal status was the single most important independant prognostic factor influencing disease-free survival (p=0.001). Comparision of these results with other published reports with radiation therapy alone showed that a high rate of initial response to chemotherapy did not translate into local control or survival. At present time radiation therapy alone remains the standard treatment for locoregional cancer of the nasopharyngeal cancer. More controlled clinical trials must be completed before acceptance of chemotherapy as a part of treatment of advanced nasopharyngeal carcinoma.

  • PDF

A Study on the Moisturizing Effect and Preparation of Liquid Crystal Structures Using Sucrose Distearate Emulsifier (슈크로오스디스테아레이트를 사용한 액정구조의 생성과 보습효과에 관한 연구)

  • Kwak, Myeong-Heon;Kim, In-Young;Lee, Hwan-Myung;Park, Joo-Hoon
    • Journal of the Korean Applied Science and Technology
    • /
    • v.33 no.1
    • /
    • pp.1-12
    • /
    • 2016
  • This study is to make the liquid crystalline structure using sucrose distearate (Sucro-DS) emulsifier to create the hydrophilic type oil-in-water (O/W) emulsion, the droplets of the emulsion having a structure of a multi-lamellar structure. We have studied the physicochemical properties of Sucro-DS using those techniques. And it has been studied in the emulsion performance. In order to form the liquid crystalline structure applying 3 wt% of Sucro-DS, 5 wt% of glycerin, 5 wt% of squalane, 5 wt% of capric/caprylic triglyceride, 3wt% of cetostearyl alcohol, 1wt% of glyceryl mono-stearate, 78 wt% of pure water in mixture having the lamellar structure of stable multi-layer system was found to formed. By applying them, they were described how to create an unstable active material encapsulated cream. Further, the moisturizing cream was studied using this technique. It reported the results to the skin improvement effect by the human clinical trials. The pH range to produce a stable liquid crystal phase using a Sucro-DS was maintained in 5.2~7.5. In order to increase the stability of the liquid crystal, it was when behenyl alcohol containing 3 wt%, the hardness at this time was 13 kg/mm,min. Viscosity of the same amount was 25,000mPas/min. After a test for the effects of the emulsions, the concentration of 6 wt% Sucro-DS is that was appropriate, the particle size of the liquid crystal was 4~6mm. It was observed through a microscope analysis, reliability of the liquid crystal changes for 3 months was found to get stable at each $4^{\circ}C$, $25^{\circ}C$ and $45^{\circ}C$. In clinical trial test, before applying a moisturizing effect it was $13.4{\pm}7%$. Moisturizing cream liquid crystal was not formed in $14.5{\pm}5%$. Therefore, applying than ever before could see the moisture about 8.2% was improved. On the other hand, it was the moisturizing effect of the liquid cream is $19.2{\pm}7%$. The results showed that 43.3% improvement than that previously used. Applications fields, Sucro-DS emulsifier used liquid cream, lotion, eye cream and a variety of formulations can be developed, as well as the cosmetics industry is expected to be wide fields in the application of the external preparation for skin emulsion technology in the pharmaceutical industry and pharmaceutical industry.