• Title/Summary/Keyword: double blind method

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A Prospective, Multi-Center, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used during the TLIF Procedure in Patients with Lumbar Disc Disease

  • Hyun, Seung-Jae;Yoon, Seung Hwan;Kim, Joo Han;Oh, Jae Keun;Lee, Chang-Hyun;Shin, Jun Jae;Kang, Jiin;Ha, Yoon
    • Journal of Korean Neurosurgical Society
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    • v.64 no.4
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    • pp.562-574
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    • 2021
  • Objective : This study is to evaluate the efficacy and safety of demineralized bone matrix (DBM) gel versus DBM gel with recombinant human bone morphogenetic protein-2 (rhBMP-2) used in transforaminal lumbar interbody fusion (TLIF). Methods : This study was designed as a prospective, multi-center, double-blind method, randomized study. All randomized subjects underwent TLIF with DBM gel with rhBMP-2 group (40 patients) as an experimental group or DBM gel group (36 patients) as a control group. Post-operative observations were performed at 12, 24, and 48 weeks. The spinal fusion rate on computed tomography scans and X-rays films, Visual analog scale pain scores, Oswestry disability index and SF-36 quality of life (QOL) scores were used for the efficacy evaluation. The incidence rate of adverse device effects (ADEs) and serious adverse device effects (SADEs) were used for safety evaluation. Results : The spinal fusion rate at 12 weeks for the DBM gel with rhBMP-2 group was higher with 73.68% compared to 58.82% for the DBM gel group. The 24 and 48 weeks were 72.22% and 82.86% for the DBM gel with rhBMP-2 group and 78.79% and 78.13%, respectively, for the DBM gel group. However, there were no significant differences between two groups in the spinal fusion rate at 12, 24, and 48 weeks post-treatment (p=0.1817, p=0.5272, p=0.6247). There was no significant difference between the two groups in the incidence rate of ADEs (p=0.3836). For ADEs in the experimental group, 'Pyrexia' (5.00%) was the most common ADE, followed by 'Hypesthesia', 'Paresthesia', 'Transient peripheral paralysis', 'Spondylitis' and 'Insomnia' (2.50%, respectively). ADEs reported in control group included 'Pyrexia', 'Chest discomfort', 'Pain', 'Osteoarthritis', 'Nephropathy toxic', 'Neurogenic bladder', 'Liver function analyses' and 'Urticaria' (2.86%, respectively). There was no significant difference between the two groups in the incidence rate of SADEs (p=0.6594). For SADE in the experimental group, ''Pyrexia' and 'Spondylitis' were 2.50%. SADE reported in the control group included 'Chest discomfort', 'Osteoarthritis' and 'Neurogenic bladder'. All SADEs described above were resolved after medical treatment. Conclusion : This study demonstrated that the spinal fusion rates of DBM gel group and DBM gel with rhBMP-2 group were not significantly different. But, this study provides knowledge regarding the earlier postoperative effect of rhBMP-2 containing DBM gel and also supports the idea that the longer term follow-up results are essential to confirm the safety and effectiveness.

Sewing Method of Inner Collar of Women's Jeogori in Modern Korea (근대이후 저고리 안감깃 봉제방법 소고)

  • Kim, Jin-Hong;Cho, Woo-Hyun
    • Journal of the Korea Fashion and Costume Design Association
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    • v.10 no.2
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    • pp.139-147
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    • 2008
  • This study aims to investigate and analyze sewing methods according to the shape of the inner collar among women's jeogories in order to understand such sewing techniques, which has emerged during modern Korea, and has utilized diversly for the shape of the jeogori's inner collar and as part of the inner collar. The study was conducted on relics possessed between 1900 to 1990, or 515 pieces of jeogories. Jeogories were classified into single-layered and double-layered jeogories according to the shape of their composition. Inner collar shapes of jeogories have also been categorized. It was found that single-layered jeogories comprise 49 inner collars with shapes identical to those of the outer collars. Double-layered jeogories comprise of the following three types: 43 pieces of godae close, 18 pieces in which the inner collar of the outer bodice are cut without a connecting line and the inner collar of the godae and inner bodice are suspended, and 405 pieces in which the share of the inner collar is identical to that of the outer collar. From the shapes of inner collars mentioned above, the following sewing methods have been derived: 1. To sew the inner collar of single-layered jeogories, a seaming technique had been used. 2. Among the inner collars of a double-layered jeogori, godae close was sewn with only a short part of the godae by using a lining, and then finished with overage and blind stitches. Godae close was a covenient way to attach inner collars, and also saved much time. 3. Inner collars with shapes identical to the outer collar are divided into two groups: those with outer collars cut out fellowing the cloth without seam and shifted towards the linings and used as an inner collar, and those with outer collars made of outer linings and inner collar of inner linings. To sew the collar, paste and needlework had been employed, where the methods of needlework were divided into blind stitch, overage stitch, and catch stitch. In sewing with paste, only godae was blind stitched or overage stitched, and the remainder had been painted with paste or the collar had been finished with heated soldering iron after the entire inner collar was painted with paste.

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Implementation and evaluation of stereo audio codec using perceptual coding (지각 부호화를 이용한 스테레요 오디오 코덱의 구현 및 음질 평가)

  • 차경환;장대영;홍진우;김천덕
    • Journal of the Korean Institute of Telematics and Electronics B
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    • v.33B no.4
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    • pp.156-163
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    • 1996
  • In this paper, we described the implementation and the sound quality assessment of a real-time stereo audio codec using TMS320C40 DSP (digital signal processing) chip for low bitrte and high quality audio. We implemented hardware and software in order to overcome a real-time processing problem of audio compression algorithm that can be produced by largely recursive computing and complexity of the process. We have studied five types of distortion that can be produced by perceptual coding and the codec was evaluated by eight test musics that are selected in SQAM (sound quality assessment material) 422-2-4-2 produced by EBU (european broadcast union). The subjective listening tests were carried out on the codec quality and preformance by double blind method in a listening room with eleven listeners. As a result, 5 grade-impairment scale was scored under minus one and the codec quality was evaluated to be perceptible, but not annoying.

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Effects of Carbonated Water Intake on Constipation in Elderly Patients Following a Cerebrovascular Accident (노인 뇌졸중환자의 변비완화를 위한 탄산수 음용의 효과)

  • Mun, Jae-Hee;Jun, Seong-Sook
    • Journal of Korean Academy of Nursing
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    • v.41 no.2
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    • pp.269-275
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    • 2011
  • Purpose: This study was done to identify effects of carbonated water intake on constipation in elders who have experienced a cerebrovascular accident (CVA) and are bed-ridden. Methods: Forty elderly patients with CVA were randomly assigned to one of two groups in a double-blind study. Patients in the experimental group drank carbonated water and those in the control group drank tap water for two weeks. Six patients dropped out during the study period. Data were analyzed by repeated measured ANCOVA and the covariance was the dose of laxatives used for the two weeks. Results: Frequency of defecation increased significantly and symptoms of constipation decreased significantly for patients in the experimental group. Conclusion: The study results suggest that the intake of carbonated water is an effective method for the intervention of constipation in elderly patients with CVA.

Caudal Buprenorphine for Postoperative Pain Control after Abdominal Surgery (Buprenorphine 천골강내(薦骨腔內) 주입(注入)에 의(依)한 술후(術後) 제통효과(除痛效果))

  • Yoon, Duck-Mi;Koh, Soon-Young;Oh, Hung-Kun
    • The Korean Journal of Pain
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    • v.1 no.1
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    • pp.80-86
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    • 1988
  • Caudal buprenorphine was investigated as a postoperative analgesic in a randominzed double blind study of 45 patients after abdominal surgery. At the end of surgery, patients were given 0.2 mg of caudal buprenorphine in 20 ml saline(n=30, experimental group) or no injection(n=15, control group). Pain relief was evaluated by the subsequent need for systemic analgesics(pethidine). Arterial blood gas and micturition disturbance were evaluated. In the buprenophine group, use of systemic analgesics was significantly reduced for the first 24 hours postoperatively. Arterial blond gas study values 2 hollers after buprenorphine administration were within normal range. 8 patients of the buprenorphine group developed urinary retention requiring temporary Nelaton catheterization of the bladder. Caudal buprenorphine for postoperative pain control was a good alternate method of postoperative pain management.

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Effects of Antioxidant Supplementation on the Lipid Peroxidation and Antioxidative Enzyme Activities in Patients with Coronary Heart Disease - Randomized Controlled Clinical Trial with Double Blind Method - (항산화영양제의 보충이 관상동맥질환 환자의 지질산화정도와 항산화계 효소의 활성도에 미치는 영양 - 무작위할당 이중맹검 임상시험 -)

  • Jun Jae-Eun;Joung Hyo-Jee;Chun Byung-Yeol;Choi Young-Sun;Park Wee-Hyun;Chae Shung-Chull;Song Kyung-Eun;Cho Sung-Hee;Oh Hee-Sook
    • 대한예방의학회:학술대회논문집
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    • 2000.10a
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    • pp.126-127
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    • 2000
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Tooth whitening effect of toothpaste containing hydrogen peroxide (과산화수소가 배합된 제제의 치아미백효과에 관한 연구)

  • Ahn, Jae-Hyun;Kim, Ji-Hye;Kim, Jong-Hoon;Jang, Jong-Hwa;Oh, Yoon-Jong;Park, Yong-Duk
    • Journal of Korean society of Dental Hygiene
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    • v.14 no.1
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    • pp.101-108
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    • 2014
  • Objectives : The purpose of this study was to evaluate the tooth whitening effect of 0.74% and 2.80% hydrogen peroxide toothpastes and safety on tooth and gingival tissue. Methods : Toothpastes containing 0.74% and 2.80% hydrogen peroxide were evaluated. In in-vitro test, some additives (sodium metaphosphate, sodium pyrophosphate and titanium dioxide) were added to the toothpastes. Hydroxyapatite specimens (HAPs) were made and stained using modified Stookey's methods. HAPs were treated for 1 hour at shaking incubator and brushed for 1,000 times as 250 gF with each diluted toothpaste. Before and after color was measured by colorimeter. Using double blind method, 99 Korean with natural maxillary anterior teeth were selected and the initial brightness (baseline) was measured by SHADEEYE-EX. Based on this measurement they were crossly distributed into control group (0% hydrogen peroxide), test 1 (0.74% hydrogen peroxide) and test 2 (2.80% hydrogen peroxide). After 2 weeks, people of each group were provided toothpaste and told to use 3 times a day right after every meal for 3 minutes. The brightness of teeth was measured 3 times for every one month. Results : ${\Delta}L$ was statistically significant among three groups in shaking test. ${\Delta}L$ of two test groups was statistically significant compared with control group but not between each test group in brushing test. After using toothpaste for 3 months, test 1 group and test 2 group were 15.89% and 31.23% more whitened compared with control group respectively (p<0.05). Rate of more whitened person of each test group was 24.2% and 40.5% more than control group respectively (p<0.05). There was no difference in the hypersensitivity during 3 months using toothpastes and no side effect on teeth or gums. Conclusions : Toothpastes containing 0.74% and 2.80% hydrogen peroxide showed tooth whitening effect and both were safe enough to use for tooth whitening.

Effects of San-Yin-Jiao (SP6) Acupressure on Anxiety, Pulse and Neonatal Status in Women during Labor (삼음교(SP6) 지압이 산부의 불안, 맥박 및 신생아 상태에 미치는 효과)

  • Lee, Mi-Kyeong
    • Women's Health Nursing
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    • v.9 no.2
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    • pp.138-151
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    • 2003
  • Purpose: In the study effects of San-Yin-Jiao (SP6) acupressure on anxiety and pulse during labor, and on neonatal status were examined. Method: The design was a randomized controlled clinical trial with a double-blind method. Data were collected before (pre) and after (post) treatment using structured questionnaire, anxiety scale, pulse rate, umbilical vein pH and Apgar scores. The experimental group received SP6 acupressure for the duration of each uterine contraction over a period of 30 minutes, but the control group received SP6 touch. Results: The anxiety scores between the two groups increased, but the increase was less in the SP6 acupressure group and the difference was statistically significant (p=0.019). Maternal pulse rate was not significantly different immediately after treatment (p=0.711), at 30 and at 60 minutes (p=0.140 ; p=0.108), but while the SP6 acupressure group had a stable pulse, the SP6 touch group showed an increased rate. There was no significant difference between the two groups for umbilical vein pH (p=0.124), and neonatal Apgar score at one and five minutes (p=0.387 ; p=0.979). Conclusion: These findings strengthen the belief that SP-6 acupressure can be used to relieve anxiety during labor with no side effects to either mother or baby.

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Lateral Osteotomy with Sawing Technique in Open Rhinoplasty (개방 코성형술에서 톱을 이용한 외절골술)

  • Kim, Youn-Hwan;Lee, Hak-Sung;Naidu, Shenthilkumar;Kim, Jeong-Tae
    • Archives of Plastic Surgery
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    • v.37 no.4
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    • pp.499-530
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    • 2010
  • Purpose: Lateral osteotomy is an essential step in the correction of nasal bony asymmetry. Direct visualization allows accurate repositioning of the nasal bones compared to blind techniques, which require precision and manual dexterity. We propose direct visualization procedures in open corrective rhinoplasty. Methods: The technique was used on 16 patients. All patients underwent open rhinoplasty with a columellar incision. The marginal incisions were extended on either side to allow access to the piriform aperture. A double hook was used to caudally retract the lower lateral cartilages and the fibrous connections between the upper and lower lateral cartilages were released until the piriform aperture was visualized. Through the incision, lateral osteotomy was performed using a reciprocating saw at that time with direct visualization. Additional procedures including augmentation rhinoplasty, hump resection, septoplasty and tip plasty were performed simultaneously. Results: This method provided excellent exposure to the lateral nasal bones and allowed the lateral osteotomy to be carried out precisely using the reciprocating saw. Conclusion: This extended open rhinoplasty method is suitable for most individuals, allowing a wide surgical field.

An Architectural Study on the Improvement of Energy Efficiency of Public Institution - Focused on Public Office Buildings Remodeling of Passive Design Elements - (공공기관 에너지 효율등급 향상을 위한 적용 설계요소에 관한 연구 - 공공청사 리모델링시 패시브 디자인요소를 중심으로 -)

  • Cho, Jung-Chul;Park, Jae-Seung
    • Korean Institute of Interior Design Journal
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    • v.21 no.4
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    • pp.114-120
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    • 2012
  • There are lots of buildings which were built before the Legislation on building energy rating system. Remodeling of the buildings would be required for an improvement of the building energy rating system was enforced by the government. In the Passive Building Design, Elements which will be used for the remodeling are Insulation, Window, External venetian blind, Heat exchanger. The Purpose of this study is to indicate a Method for the improvement of Energy saving by an analysis of Construction Cost, Cost Evaluation, Energy performance Efficiency in applied design elements. In this study, the remodeling of existing public buildings to improve energy efficiency rating was applied to extract the elements of design-specific energy performance, efficiency, and the application of the designs that has been analyzed. The results were as follows: applying the design-specific cost-effective investment that represents the economy (investment efficiency/%) surveyed the average insulation(7.0%), triple glazed windows(10.1%), double glazed windows(12.1%), external shading(24.5%), and Heat(77.2%) were analyzed in order to be more efficient. Analysis of the basis of information on the existing public buildings to improve energy efficiency rating for the remodeling depending on driving conditions at a degree of individual difference. The main effect, however, depending on economic investment, design elements, heat exchangers, external awning, double glazed windows, triple glazed windows, insulation, is recommended as review of the order shall be determined.

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