• Title/Summary/Keyword: randomized clinical trial

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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
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    • v.51 no.4
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    • pp.367-371
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    • 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.

The Effects of Weighted Vest During Task-Oriented Training on Gross Motor Performance and Balance Abilities of Children With Spastic Diplegia : A Randomized Clinical Trial Study (경직형 양마비 아동의 과제지향훈련 시 무게조끼 적용이 대동작 수행력과 균형 능력에 미치는 영향: 무작위배정 위약비교 연구)

  • Kwon, Hae-Yeon
    • The Journal of Korean Academy of Sensory Integration
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    • v.15 no.2
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    • pp.46-65
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    • 2017
  • Objective : The purpose of this research is to find clinical effects of application of weighted vest during task-oriented training focused on gross motor performance and balance abilities of children with spastic diplegia. Methods : 34 subjects were divided by simple random sampling into two groups; experimental group (male : 9, female : 8, average age : 8.12) and placebo group (male : 9, female : 9, average age : 7.53). Both two groups underwent to 40 minute intervention, twice a week for 12 weeks. The intervention was task-oriented training focused on facilitating closed kinematic chain and multi-joint functional movement pattern. During the training, the experimental group received loaded-resistance weighted vest and placebo group also received weighted vest but without loaded-resistance. Participants in both groups underwent 8 to 10 reps of the task-oriented training and there were 3 minutes break time between tasks. There were pre-test of gross motor performance and balance abilities, and two times of post-tests were performed upon 6 weeks and 12 weeks after the intervention completed. And in final, an additional follow-up test was performed 12 weeks after the evaluation was finished in order to find any difference between the two groups over time. Results : There was significant difference in Gross Motor Performance Measure (GMPM) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). There was significant difference in Pediatric Berg's Balance Scale (PBS) between two groups. It is found that average score of the experimental group increased more than the placebo group after 6 weeks and 12 weeks intervention (p<.05). Conclusion : Based on the results in this study, it is proposed that application of weighted vest into task-oriented training to facilitating closed kinematic chain and multi-joint movement can improve gross motor performance and balance abilities of children with cerebral palsy.

Efficacy and Safety of Red Ginseng on Women's Health Related Quality of Life and Sexual Function (여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구)

  • Kim, Dong-II;Choi, Min-Sun;Alm, Hong-Yeop
    • Journal of Ginseng Research
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    • v.33 no.2
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    • pp.115-126
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    • 2009
  • To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

Effect of Magnesium Administration on Preventing Arrhythmias after Coronary Artery Bypass Graft (관상동맥 우회술 후 마그네슘 투여가 심 부정맥을 예방하는 효과)

  • Kim, Jun-Hyun;Song, Hyun;Kim, Yong-Hee;Lee, Eun-Sang;Lee, Jay-Won;Song, Myung-Kun
    • Journal of Chest Surgery
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    • v.31 no.4
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    • pp.339-345
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    • 1998
  • Arrhythmias are common after cardiac surgery and are multifactorial. Intravenous magnesium administration reduces the frequency of ventricular arrhythmias in patient with symptomatic heart failure or acute myocardial infarction. This study was designed to evaluate the role of magnesium in preventing PVCs(premature ventricular contractions) occurred frequently after coronary artery bypass graft(CABG). 50 consecutive patients were prospectively entered into a randomized trial to determine the efficacy of postoperative magnesium therapy on the incidence of cardiac arrhythmias after elective coronary artery bypass graft. The patients underwent coronary angiography, echocardiography, electrocardiography and clinical laboratory study preoperatively. Continuous electrocardiographic monitoring was done and magnesium level was checked 0, 3, 6, 12, 18, 24, 36, 48, 60 and 72 hours postoperatively. Study group of 25 patients were given 4g of magnesium continuously over the first 24 hours and then 2g/24hours from 25 to 72 hours. The clinical characteristics of both groups were similar(p<0.05). The preoperative mean serum magnesium concentration was similar in both study group, 1.59mg/dl and control group, 1.71mg/dl. The mean postoperative serum magnesium concentration in study group elevated significantly over postoperative 12hours through 36hours(p<0.05). The postoperative mean serum magnesium concentration in control group declined and remained significantly depressed over immediate postoperation through 72hours. The mean serum magnesium concentration was significantly greater in the study group compared with the control group over postoperative 3hours through 72hours(p<0.05). There was a significant decrease in the incidence of arrhythmias such as PVCs(p<0.01) which might jeopardize hemodynamics. There were no recognized adverse effects of magnesium Administration. In conclusion, prophylactic magnesium administration seems to lessen the incidence and severity of rrhythmias after coponary artery bypass graft.

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Influence of crown-to-implant ratio of short vs long implants on implant stability and marginal bone loss in the mandibular single molar implant (하악 구치 단일임플란트 수복에서 임플란트 길이에 따른 치관-임플란트 비율이 임플란트안정성 및 변연골소실에 주는 영향)

  • Baek, Yeon-Wha;Kim, Bongju;Kim, Myung-Joo;Kwon, Ho-Beom;Lim, Young-Jun
    • Journal of Dental Rehabilitation and Applied Science
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    • v.34 no.4
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    • pp.280-289
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    • 2018
  • Purpose: The purpose of this randomized clinical trial is to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and peri-implant marginal bone loss (MBL). Materials and Methods: 46 patients with single tooth missing in the posterior molar region of the mandible were included in this study. 19 implants (CMI IS-III $active^{(R)}$ long implant) of 5.0 mm diameter and 10 mm length were installed for the control group, while 27 implants (CMI IS-III $active^{(R)}$ short implant) of 5.5 mm diameter and 6.6, 7.3 or 8.5 mm length were placed for the experimental group. Each implant was inserted and immediately loaded using the digitally pre-fabricated surgical template and provisional restoration. The CAD-CAM monolithic zirconia crown was fabricated at 3 months after the surgery as a definitive restoration. The ISQ value and the MBL was measured at 48 weeks after the surgery. The correlation between the C/I ratio, MBL, and secondary implant stability was analyzed. Results: Successful results in terms of ISQ and MBL were achieved with both groups. There was no significant difference between the groups in terms of ISQ values and MBL at 48 weeks after the surgery (P > 0.05). No significant correlation was found between the C/I ratio and secondary stability as well as the C/I ratio and the MBL (P > 0.05). Conclusion: The influence of C/I ratio in both groups was not shown on the stability nor the marginal bone loss in implants supporting single crown of the mandible. Short implant could be a preferable alternative option in the reduced bone height mandible under the limited condition despite its higher C/I ratio.

Clinical Efficacy of Erdosteine in Patients with Acute or Chronic Bronchitis -A Randomized, Double Blind, Comparative Study vs. Ambroxol- (급.만성 기관지염 환자에서 엘도스$^{(R)}$(Erdosteine)의 임상효과 -염산 암브록솔과의 무작위 이중맹검 비교시험-)

  • Kim, Seok-Chan;Lee, Sang-Hoak;Song, So-Hyang;Kim, Young-Kyoon;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1296-1307
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    • 1997
  • Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

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Nonpharmacologic Pain Relief with Oral 25% Dextrose or/and Pacifier for Newborn Infants (신생아에서 비약물적 통증조절을 위한 25% 경구 포도당과 인공 젖꼭지 사용의 효과)

  • Kim, Min-Kyung;Kim, In-Ah;Jung, Min-Hee;Han, Myung-Ki;Park, Kie-Young;Kim, Bong-Seong;Jin, Hyun-Seong
    • Neonatal Medicine
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    • v.18 no.2
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    • pp.353-358
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    • 2011
  • Purpose: The goal of this study was to compare the efficacy of oral 25% dextrose treatment or/and pacifier for analgesia in healthy newborns during intramuscular injection of a hepatitis B vaccine. Methods: A prospective, randomized, partially blinded, clinical trial was performed in 132 healthy newborns. They were assigned randomly to 4 treatment groups: control group (2 mL distilled water), dextrose group (2 mL 25% dextrose), pacifier group, dextrose+pacifier group (pacifier coating with 25% dextrose) during intramuscular injection of hepatitis B vaccine. For all groups, Neonatal Infant Pain Scale (NIPS), Neonatal Facial Coding System (NFCS), Premature Infant Pain Profile (PIPP) scores were evaluated before the injection, during the injection, and at 2 minutes after the injection. Pain scores were compared among the 4 groups. Results: Maternal and neonatal characteristics were similar among the 4 groups. 25% dextrose treatment led to lower NIPS pain scores during injection (6.4${\pm}$0.9 vs. 5.5${\pm}$1.7, P=0.01) and after injection (1.6${\pm}$2.0 vs. 0.6${\pm}$0.9, P=0.01) and NFCS pain scores after injection (1.5${\pm}$2.3 vs. 0.7${\pm}$0.8, P=0.04) than control group. The number of neonates who feel the pain (indication of scores: NIPS${\geq}$4, NFCS${\geq}$3) decreased (9 (23.1%) vs. 0 (0%), P=0.04 via NIPS, 7 (17.9%) vs. 0 (0%), P=0.02 via NFCS). However, all treatment groups did not decreased PIPP scores, compared with the control group. Conclusion: Oral 25% dextrose is effective than distilled water or using pacifier with or without 25% dextrose in reducing pain during intramuscular injection of hepatitis B vaccinations. Further study based on this preliminary study need about nonpharmacologic management of pain in newborns.

Risk Factors Related to Uterine Leiomyoma in Korean Women - A Retrospective Study - (한국인 여성에서 자궁근종 발생에 관여하는 인자들에 대한 연구 - 후향적 연구 -)

  • Hong, D.G.;Chung, M.J.;Kim, B.S.;Lee, J.M.;Cho, Y.L.;Lee, T.H.;Chun, S.S.
    • Clinical and Experimental Reproductive Medicine
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    • v.33 no.3
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    • pp.159-170
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    • 2006
  • Objective: The purpose of this study is to find out risk factors related to uterine leiomyoma in Korean women and to compare with the results of previous western studies. Methods: A retrospective analysis was carried out. All the cases of uterine leiomyoma (n=244) were diagnosed surgically or sonographically between Jannuary 1998 and December 2004. Total of 269 controls not having uterine leiomyoma were collected from patients who visited Kyungpook national university hospital for routine gynecologic check-up or treatment of their gynecologic or obstetric diseases other than uterine leiomyoma. Data were collected through review of medical records and interviews and analyzed with $x^2$ and logistic regression model. Results: In multivariate analysis, patient's age (OR 1.070; 95% CI 1.041~1.099), number of artificial abortion (OR 1.182; 95% CI 1.018~1.374) and alcohol drinking (OR 1.865; 95% CI 1.231~2.824) had significantly positive correlation with uterine leiomyoma. The duration of lactation was the only factor which had negative correlation (OR 0.985; 95% CI 0.972~0.998). BMI, parity, age at menarche, the duration and interval of menstruation, caffeine consumption and marital status did not show any correlations. Conclusion: In this study, patient's age, number of artificial abortion, and alcohol drinking were the risk factors of uterine leiomyoma in Korean women and the result was similar to that of western studies. Though we couldn't find out the specific risk factors related to the development of uterine leiomyoma in this study, but it has a great meaning to be the first trial in Korean women. The role of information bias should be carefully evaluated and further multicentered, randomized, controlled prospective studies will be needed to know the possible risk factors among Korean women.

Clinical Efficacy of Belotecan (CKD-602), Newly Developed Camptothecin Analog, in the 2nd Line Treatment of Relapsed Small Cell Lung Cancer (재발된 소세포폐암환자에서 이차 약제로 사용되는 Belotecan (CKD-602)의 임상적 효용성)

  • Ban, Hee-Jung;Oh, In-Jae;Kim, Kyu-Sik;Ju, Jin-Yung;Kwon, Yong-Soo;Kim, Yu-Il;Lim, Sung-Chul;Kim, Young-Chul
    • Tuberculosis and Respiratory Diseases
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    • v.66 no.2
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    • pp.93-97
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    • 2009
  • Background: Belotecan (Camtobell, CKD-602, Chongkundang Pharm., Korea), a camptothecin derivative, has anticancer effects by inhibiting topoisomerase I such as topotecan. This study observed the response, survival and toxicity of belotecan monotherapy after the failure of etoposide and platinum (EP). Methods: Forty nine small cell lung cancer (SCLC) patients (M/F=41/8; age, 64.5${\pm}$7.6 (mean${\pm}$SD) years), who failed in their first line chemotherapy were enrolled in this study. Twenty one SCLC patients showed relapsed lung cancer more than 90 days after their priorEP chemotherapy (sensitive relapse group, SR) and 28 patients relapsed within 90 days (refractory relapse group, RR). Results: The response rate was 25%. Eleven patients showed partial responses and 5 patients could not be checked. The response rate of the SR and RR patients was similar. The relative dose intensity was lower in the responders (78${\pm}$15%) than non-responders (83${\pm}$13%, p=0.03). The median survival time (MST) was 10.3 months (290 days). The MST of the non-responders and responders was 186 days (95% CI; 67-305) and 401 days (95% CI; 234-568, p=0.07), respectively. The median progression free survival (MPFS) was similar in the SR (79 days) and RR (67 days) patients. Grade 3-4 neutropenia, anemia, and thrombocytopenia were observed in 59.6%, 12.8% and 23.4% of patients, respectively. Conclusion: The efficacy and survival were demonstrated in the second-line setting. However, a randomized comparative trial with topotecan will be needed.

The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention

  • Pil Sang Song;Seok-Woo Seong;Ji-Yeon Kim;Soo Yeon An;Mi Joo Kim;Kye Taek Ahn;Seon-Ah Jin;Jin-Ok Jeong;Jeong Hoon Yang;Joo-Yong Hahn;Hyeon-Cheol Gwon;Woo Jin Jang;Hyuck Jun Yoon;Jang-Whan Bae;Woong Gil Choi;Young Bin Song
    • Korean Circulation Journal
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    • v.54 no.4
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    • pp.189-200
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    • 2024
  • Background and Objectives: Concerns remain that early aspirin cessation may be associated with potential harm in subsets at high risk of ischemic events. This study aimed to assess the effects of P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) vs. prolonged DAPT (12-month or longer) based on the ischemic risk stratification, the CHADS-P2A2RC, after percutaneous coronary intervention (PCI). Methods: This was a sub-study of the SMART-CHOICE trial. The effect of the randomized antiplatelet strategies was assessed across 3 CHADS-P2A2RC risk score categories. The primary outcome was a major adverse cardiac and cerebral event (MACCE), a composite of all-cause death, myocardial infarction, or stroke. Results: Up to 3 years, the high CHADS-P2A2RC risk score group had the highest incidence of MACCE (105 [12.1%], adjusted hazard ratio [HR], 2.927; 95% confidence interval [CI], 1.358-6.309; p=0.006) followed by moderate-risk (40 [1.4%], adjusted HR, 1.786; 95% CI, 0.868-3.674; p=0.115) and low-risk (9 [0.5%], reference). In secondary analyses, P2Y12 inhibitor monotherapy reduced the Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding without increasing the risk of MACCE as compared with prolonged DAPT across the 3 CHADS-P2A2RC risk strata without significant interaction term (interaction p for MACCE=0.705 and interaction p for BARC types 2, 3, or 5 bleeding=0.055). Conclusions: The CHADS-P2A2RC risk score is valuable in discriminating high-ischemic-risk patients. Even in such patients with a high risk of ischemic events, P2Y12 inhibitor monotherapy was associated with a lower incidence of bleeding without increased risk of ischemic events compared with prolonged DAPT.