• 제목/요약/키워드: Double Blind

검색결과 545건 처리시간 0.025초

이중 스텝 크기를 가지는 MSAG-SCS-MMA-I 적응 블라인드 등화 알고리즘의 성능 평가 (Performance Evaluation of MSAG-SCS-MMA-I Adaptive Blind Equalization Algorithm with dual step-size)

  • 정영화
    • 한국인터넷방송통신학회논문지
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    • 제19권5호
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    • pp.115-121
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    • 2019
  • 본 논문은 256-QAM 시스템에서 기존 SCS-MMA-I 알고리즘의 수렴 속도를 현저히 개선하면서도 정상상태에서 매우 작은 잔류 ISI 및 MSE를 가지는 이중 스텝 크기를 가지는 MSAG-SCS-MMA-I 적응 블라인드 등화 알고리즘을 제안하고, 이 알고리즘에 대한 등화 성능을 평가한다. SCS-MMA-I 와 결정지향 알고리즘으로 부터 얻어지는 '1' 또는 '0'의 이진 Flag에 의해 제어되는 MSAG-SCS-MMA-I의 탭 갱신 식에 고정된 스텝 크기 대신에 결정지향 오차의 크기에 따라 서로 다른 스텝 크기를 적용함으로써 우수한 등화 성능을 가지도록 하였다. 컴퓨터 모의실험 수행 결과 잔류 ISI과 MSE, 그리고 MD등의 성능 지표면에서 제안한 알고리즘이 MMA나 SCS-MMA-I, 그리고 MSAG-SCS-MMA-I 알고리즘보다 훨씬 뛰어난 성능을 가짐을 확인하였다.

만성치주염 환자에 대한 저용량 독시싸이클린의 임상적 효과 (Clinical Effect of the Subantimicrobial Dose of Doxycycline ( SDD ) on the Chronic Periodontitis)

  • 김윤식;백정원;김창성;최성호;김종관
    • Journal of Periodontal and Implant Science
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    • 제32권2호
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    • pp.415-428
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    • 2002
  • Periodontal disease is a complex infectious disease caused by bacteria in the oral mucosa, which results in gingival inflammation, breakdown of periodontal tissues, bone resorption, and finally tooth loss. Mechanical plaque control methods-scaling and root planing are effective methods to stop the progression of such periodontal disease. It was reported that subantimicrobial dose of doxycycline(SDD) regimen could improve clinical conditions of periodontal tissues without causing the overgrowth of opportunistic organisms that was a typical antibiotic side effect. Therefore pharmacological therapy, used in conjunction with mechanical therapy could be considered a useful treatment modality in the treatment of chronic periodontal disease. In this study, 30 patients diagnosed as moderate to advanced chronic periodontitis were divided into 2 groups. In this double-blind, placebo-controlled study, the patients were administered 20mg doxycycline capsule or placebo capsule b.i.d. for 4months, after scaling and root planing. Clinical parameters-bleeding on probing, pocket depth and clinical attachment level were compared and evaluated between these groups at periods of first visit, 1 month, 2 months, 3 months, 4 months. The results were as follows ; 1. In case of moderate periodontitis, pocket depth showed significant reduction after treatment in both the control & experiment groups, when compared with the baseline values(p<0.01), but in case of advanced periodontitis, only the experiment group showed significant reduction after treatment when compared with the baseline values(p<0.05). Statistically significant reduction in pocket depth was observed in the experiment group compared to the control group(p<0.05). 2. In case of moderate periodontitis, clinical attachment level showed significant reduction after treatment in both the control & experiment groups, when compared with the baseline values(p<0.01), but in case of advanced periodontitis, only the experiment group showed significant reduction after treatment when compared with the baseline values(p<0.05). Statistically significant reduction in clinical attachment level was observed in the experiment group compared to the control group(p<0.05). 3. Bleeding on probing improved after treatment in both the groups. In case of moderate periodontitis, the experiment group showed statistically significant reduction of bleeding on probing when compared with the control group at 1 and 4 months after treatment(p<0.05). In case of advanced periodontitis, treatment resulted in statistically significant reduction of bleeding on probing in both the groups(p<0.05). These results indicate that the use of subantimicrobial dose of doxycycline is a useful supplement to mechanical treatment for periodontal patients in ameliorating the clinical parameters such as periodontal pocket, attachment level, and bleeding on probing.

마황용량에 따른 이상반응에 관한 예비연구: 무작위배정이중맹검시험 (Adverse Effects of Ma-huang according to Dose : A Randomized Double-Blind Placebo-Controlled Pilot Study)

  • 형례창;이태호;손동혁;여진주;양창섭;서의석;장인수
    • 대한한방내과학회지
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    • 제27권1호
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    • pp.188-196
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    • 2006
  • Background: Ma-huang (Ephedra sinica) has been widely used to treat respiratory disease in oriental medicine for over a hundred years. Ma-huang preparations contain approximately 1.25% ephedrine alkaloids. Recently, the ephedra alkaloids have received much press lately due to adverse effects in those using whole extracts as 'dietary supplements' for weight loss or athletic performance enhancement, and these reports are troubling given the increasing use of Ma-huang by the general public. The purpose of this report is to determine the proper dosage to minimize adverse effects and maximize the potential curative value. Objectives : The object of this study was to find an effective yet low risk dosage of Ma-huang. Methods : The study was designed as a double-blind randomized placebo-controlled trial. The subjects of this study were 26 adults between 20 to 40 of age who agreed to participate in this study. They were allocated through randomization into three groups. Each group took three opaque capsules three times a day. A group (N=9) took one Ma-huang capsule and two placebo capsules, B group (N=8) took two Ma-huang capsules and one placebo capsule, C group (N=9) took three Ma-huang capsules. The total trial periods was two days. To compare the adverse effects of Ma-huang according to dosage, blood pressure and pulse were checked, and other adverse effects were assessed using a morning questionnaire, patient's global assessment scale and Wong-Baker faces pain rating. Results : The following result were obtained: 1. After taking 18 g of Ma-huang per day, pulse rate had a significant increase. 2. After taking more than 6 g of Ma-huang per day, palpitation would be increased significantly. 3. After taking more than 18 g of Ma-huang per day, tiredness would be increased significantly. Conclusion: According to the results, 12 g of Ma-huang per day will minimize adverse effects and maximize the potential curative value.

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자일로올리고당을 함유한 설탕이 20대 여성의 변비 개선에 미치는 효과: 이중맹검 연구 (Effect of xylooligosaccharide-sugar mixture on defecation frequency and symptoms in young women with constipation: a randomized, double-blind, placebo-controlled trial)

  • 전진호;경명옥;정상원;조성은;장문정
    • Journal of Nutrition and Health
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    • 제48권1호
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    • pp.19-29
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    • 2015
  • 본 연구는 자일로올리고당을 설탕에 혼합하여 변비를 앓고 있는 젊은 여성을 대상으로 변비개선효과를 확인하였다. 평균연령 22.1세인 젊은 여성 56명을 대상으로 실험 1에서는 설탕을 플라시보로 하는 이중맹검 임상연구를 통해 자일로올리고당 0.7 g이 함유된 설탕 10 g (n = 19명) 또는 설탕 10 g (n = 19명)을 블랙커피와 함께 복용하도록 하였고, 실험 2에서는 자일로올리고당 0.4 g 함유한 설탕 5.6 g과 1.6 g의 커피, 4.8 g의 식물성 크림이 함유된 커피믹스를 1일 2회씩 6주간 섭취하도록 하였다 (n = 18명). 섭취결과 XOS군과 XOSmix군의 경우 섭취전 주간 배변횟수가 2.47회에서 섭취 1주째부터 증가하여 섭취 6주째에는 주간 배변횟수가 4.11회와 5.67회로 각각 증가하였다. XOS와 XOS 함유 커피믹스는 통계적으로 유의하게 복부 불쾌감과 잔변감을 개선하였으며, 배변횟수의 증가는 섭취초반 부터 효과가 있는 것으로 나타났다. 따라서 XOS는 0.7 g의 적은양으로도 변비를 개선하는 효과가 있는 것으로 나타나 음료에 기능성을 갖춘 감미료로서의 활용이 기대된다.

Occurrence of infections in schoolchildren subsequent to supplementation with vitamin D-calcium or zinc: a randomized, double-blind, placebo-controlled trial

  • Mandlik, Rubina;Mughal, Zulf;Khadilkar, Anuradha;Chiplonkar, Shashi;Ekbote, Veena;Kajale, Neha;Patwardhan, Vivek;Padidela, Raja;Khadilkar, Vaman
    • Nutrition Research and Practice
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    • 제14권2호
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    • pp.117-126
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    • 2020
  • BACKGROUND/OBJECTIVES: Vitamin D and zinc are recognized for their roles in immune-modulation, and their deficiencies are suggested to be important risk factors for childhood infections. This study, therefore, undertook to assess the occurrence of infections in rural Indian schoolchildren, subsequent to daily supplementation with vitamin D-calcium or zinc for 6 months. SUBJECTS/METHODS: This was a randomized, double-blind, placebo-controlled trial in apparently healthy 6-12 year-old rural Indian children, recruited to 3 study arms: vitamin D arm (1,000 IU D3 - 500 mg calcium, n = 135), zinc arm (10 mg, n = 150) and placebo arm (n = 150). The infection status was assessed using a validated questionnaire, and the biochemical parameters of serum 25(OH)D and serum zinc were measured by ELISA and colorimetry, respectively. The primary outcome variable was occurrence of infections (upper respiratory and total infections). RESULTS: Serum 25(OH)D concentration in the vitamin D arm improved significantly by 34%, from 59.7 ± 10.9 nmol/L to 80 ± 23.3 nmol/L (P < 0.0001), but no improvement was observed for serum zinc concentration. While there was significant increase in the percentage of children reporting no or mild upper respiratory tract infections (URTI) and total infections (TI) in all three groups, improvements in the supplemented groups were similar to the placebo group. However, the vitamin D arm reported lower URTI and TI status in the vitamin D sufficient versus insufficient children. Also, URTI and TI status were found to be significantly (P < 0.0001) lower in children with improved 25(OH)D versus unchanged 25(OH)D. CONCLUSIONS: Vitamin D-calcium supplementation helped to improve the vitamin D status but exerts no effect on the occurrence of infections when compared to the placebo group. Improvement in the serum 25(OH)D concentrations and attainment of vitamin D sufficiency may exert a beneficial effect on the infection status and needs to be investigated further. To evaluate the efficacy of zinc supplementation, higher dosages need to be administered in future studies.

Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6-10 weeks: a randomized double-blind active-controlled trial

  • Shin, Jonghoon;Teeratakulpisarn, Jamaree;Puthanakit, Thanyawee;Theerawit, Tuangtip;Ryu, Ji Hwa;Shin, Jinhwan;Lee, Seulgi;Lee, Hayoung;An, Kyungjun;Kim, Hun
    • Clinical and Experimental Pediatrics
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    • 제63권7호
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    • pp.265-271
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    • 2020
  • Background: Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates. Purpose: This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants. Methods: This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6-10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group. Results: After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 ㎍/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 ㎍/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003). Conclusion: The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.

Randomized, Double-blind, Placebo-controlled Trial of the Effects of Polycan, β-glucan Originating from Aureobasidium Pullulans, on Bone Biomarkers in Healthy Women

  • Kim, Jong Dae;Park, Mi Yeon;Kim, Joo Wan;Kim, Ki Young;Cho, Hyung Rae;Choi, In Soon;Choi, Jae Suk;Ku, Sae Kwang;Park, Soo-Jin
    • 동의생리병리학회지
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    • 제29권4호
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    • pp.330-336
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    • 2015
  • Polycan originating from Aureobasidium pullulans is mostly composed of β-1, 3/1, 6 glucans and possesses an anti-osteoporotic effect. We conducted a randomized, double-blind, placebo-controlled trial to examine the efficacy and safety of the polycan on bone biochemical markers in healthy perimenopausal women. Sixty subjects were randomly allocated to 2 groups-group 1 received 400 mg of polycan and group 2 received placebo-these were administered once daily for 28 days. Fasting blood and urine samples were collected at baseline and 4 weeks after treatment. The primary outcome was change in osteocalcin (OSC) and bone-specific alkaline phosphatase (BALP). Changes in calcium (Ca), phosphorus (P), C-telopeptide of collagen cross-links (CTx), N-telopeptide of collagen cross-links (NTx), and deoxypyridinoline (DPYR) were the secondary outcomes. A safety assessment was performed using adverse event (AE) and laboratory data. After 4 weeks of polycan treatment, OSC, DPYR, and BALP levels changed (P < 0.05) significantly from baseline in both groups. However, no significant differences were observed in any markers between the 2 groups, except for P (P < 0.05). Interestingly, group 2 showed a significant increase in CTx (65.2%, P < 0.05), while CTx in group 1 slightly increased (17.2%). Both groups showed no significant differences in AE. Although 4 weeks of polycan treatment did not have a statistically significant effect on bone metabolism biomarkers, increases in CTx were modestly inhibited by polycan. Further studies in a large population and longer treatment periods are needed to confirm the effect of polycan on bone turnover.

와송 추출물의 면역기능 개선 효과 및 안전성 연구: 단일기관, 무작위배정, 이중눈가림, 위약대조 비교, 임상연구 프로토콜 (Research on Immune Enhancing Effect and Safety of Wasong (Orostachys japonicus) Extract: Study Protocol for a Single Center, Randomized, Double-blind, Placebo-controlled, Clinical Trial)

  • 최진용;최준용;임현우;김정;김소연;한창우
    • 대한한의학방제학회지
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    • 제25권2호
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    • pp.135-143
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    • 2017
  • Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food. Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018. Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.

Agrobacterium sp.-derived β-1,3-glucan enhances natural killer cell activity in healthy adults: a randomized, double-blind, placebo-controlled, parallel-group study

  • Lee, Yeon Joo;Paik, Doo-Jin;Kwon, Dae Young;Yang, Hye Jeong;Park, Yongsoon
    • Nutrition Research and Practice
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    • 제11권1호
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    • pp.43-50
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    • 2017
  • BACKGROUND/OBJECTIVES: The present study investigated the hypothesis that a highly pure linear ${\beta}$-1,3-glucan produced by Agrobacterium sp. R259 enhances human natural killer (NK) cell activity and suppresses pro-inflammatory cytokines. SUBJECTS/METHODS: In an eight-week, double-blind, randomized, placebo-controlled clinical trial, 83 healthy adults with white blood cell counts of $4,000-8,000cells/{\mu}L$ were participated and randomly assigned to take two capsules per day containing either 350 mg ${\beta}$-1,3-glucan or placebo. Six participants withdrew their study consent or were excluded due to NK cell activity levels outside the normal range. NK cell activity and serum levels of immunoglobulin G (IgG) and cytokines, such as interferon (IFN)-${\gamma}$, interleukin (IL)-2, IL-4, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-${\alpha}$ were measured. RESULTS: NK cell activity and the serum levels of IL-10 were significantly higher from baseline to week 8 in the ${\beta}$-glucan group compared with the placebo group (P = 0.048, P = 0.029). Consumption of ${\beta}$-1,3-glucan also significantly increased NK cell activity compared with placebo after adjusting for smoking and stress status (P = 0.009). In particular, the effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants with severe stress than in those experiencing mild stress. However, the administration ${\beta}$-1,3-glucan did not significantly modulate the levels of IFN-${\gamma}$, IL-2, IL-4, IL-6, IL-12, TNF-${\alpha}$ and IgG compared with the placebo. CONCLUSION: The results showed that supplementation with bacterial ${\beta}$-1,3-glucan significantly increased NK cell activity without causing any adverse effects. Additionally, the beneficial effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants experiencing severe stress.