• Title/Summary/Keyword: Add-on trials

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The Effect of Thermal Storage/Release and Moisture Transport Properties of Polyethylene Glycol-Treated Acrylic Athletic Socks on the Wear Performance (Polyethylene Glycol 처리한 아크릴 운동용 양말의 축열 . 방열성과 수분전달 특성이 착용 성능에 미치는 영향)

  • 조길수;이은주
    • Journal of the Korean Society of Clothing and Textiles
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    • v.19 no.1
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    • pp.36-50
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    • 1995
  • The purpose of this study was 1) to estimate the improvement of thermal storage/release and moisture transport properties of PEG-treated acrylic athletic socks and suggest the optimum add-on for PEG treatment, 2) to investigate wear performance of untreated cocks and two kinds of socks treated with PEG of minimum and optimum add-on respectively, and 3) to consider the effect of thermal storage/release and moisture transport properties of PEG- treated socks on the wear performance and the subjective comfort zone. Thermal activities of specimens treated by PDC were evaluated on a DSC by measuring the heat of fusion on heating and the heat of crystallization on cooling. Moisture regain, absorption speed, wickability, water retenti on value, and water-vapor permeability were measured. In the wear trials that the subjects performed a subsequent exercise protocol wearing three differently treated socks in a conditioned environment ($14\pm2^{\circ}C$, 65$\pm$2% R.H.), microclimate temperature and humidity, and subjective wear sensations including thermal sensation, wettedness, softness, fit, and overall comfort were obtained. PEC-treated specimens with more than 20% add-on showed thermal storage on heating and thermal release on cooling by a DSC and the heat contents of treated ones were generally proportional to the add-ons. Moisture transport properties were highly improved after PEG treatment and increased rapidly with increasing add-on. The tendencies were, however, relaxed above 50% add-on and the treated knits were much stiffer above that add-on. In the wear trials of untreated, PEG add-on 20%, and 50% acrylic socks, the changes of microclimate temperature of 50% socks were significantly less than that of 20% socks. PEG add-on 50% socks showed significantly less changes of microclimate humidity than other two kinds of socks. Three kinds of socks showed significant differences in overall comfort and add-on 50% socks were accepted more comfortable than other two kinds of socks. Comfort zone of foot was extended after PEG treatment on socks and it implied that the subjects wearing PEG- treated socks felt comfortable in wider ranges of microclimate temperature and humidity.

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Statistical procedures of add-on trials for bioequivalence in 2×k crossover designs (2×k 교차설계법에서 생물학적 동등성 추가시험의 통계적 절차)

  • Woo, Hwahyoung;Park, Sang-Gue
    • Journal of the Korean Data and Information Science Society
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    • v.25 no.6
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    • pp.1181-1193
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    • 2014
  • Currently Ministry of food and drug safety allows add-on trial when the bioequivalence between two drugs fails to show since July 1, 2008. However, bioequivalence of highly variable drugs based on $2{\times}2$ crossover designs would require too many subjects, so the alternative designs like $2{\times}4$ or $2{\times}3$ crossover experiments are preferred. In this paper, we propose and discuss the statistical procedures for add-on trials in $2{\times}4$ and $2{\times}3$ crossover designs.

Some Remarks on Consistency Test of Add-on Test in Bioequivalence Trials (생물학적 동등성 시험에서 추가시험의 일관성 검정에 대한 소고)

  • Ha, Myoung-Ho;Park, Sang-Gue
    • Communications for Statistical Applications and Methods
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    • v.19 no.1
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    • pp.47-55
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    • 2012
  • The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.

Optimal Disposition of Direction Finder using EM Wave Propagation Analysis (전파환경분석을 통한 방향탐지기 최적배치에 관한 연구)

  • Yang, Jong-Won;Choi, Jun-Ho;Kwon, Do-Baeg;Kang, Hee-Seog;Park, Cheol-Sun
    • Journal of the Korea Institute of Military Science and Technology
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    • v.10 no.2
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    • pp.170-179
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    • 2007
  • This paper introduces the optimal disposition of direction finder using EM(Electro-magnetic) wave propagation analysis which is based on LR(Longley-Rice) propagation model and the characteristics of direction finder, emitter and terrain. Initial model is simulated and modified to minimize propagation error as a result of the field trials. Proposed analysis used line-of-sight analysis and mountain-top extraction algorithm to optimize the disposition in the assigned area and the result can be displayed in the 3D map in order of the percentage coverage for direction finding possibility area.

Problems and Countermeasures of Control Group Design in Randomized Controlled Trials of Herbal Medicine (한약제제 무작위 대조군 연구에서 대조군 설계의 문제점과 대안)

  • Yun, Young-Hee;Choi, In-Hwa
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.21 no.2
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    • pp.94-101
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    • 2008
  • Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

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Add-on Effect of Herbal Bath Combined with Acitretin Treatment in Patients with Psoriasis : Systemic Review and Meta-analysis (건선 환자에서 아시트레틴 치료에 추가한 한방 약욕 효과 : 체계적 문헌 고찰과 메타 분석)

  • Seoyeon Jun;Soojin Park;Jieun Lee;Kyuseok Kim
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.3
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    • pp.74-98
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    • 2023
  • Objectives : This study aims to evaluate the add-on effect of herbal bath combined with acitretin in patients with psoriasis. Methods : We searched randomized controlled trials(RCTs) reporting the effect of herbal bath and acitretin combined treatment for psoriasis in 10 electronic databases from their inception to January 2023. Study collection, data extraction, and risk of bias assessment were performed by two independent researchers. Data synthesis and risk of bias evaluation was conducted using Revman 5.4. Results : Ten RCTs with 1,008 subjects were included. Herbal bath and acitretin combined treatment group showed higher average total effective rate than acitretin alone group(RR 1.39; 95% CI: 1.15-1.68, P=0.0006, I2 =0%). Herbal bath and additional treatments such as phototherapy(NB-UVB) and oral herbal medicine, combined with acitretin group also showed higher average total effective rate than acitretin alone group(RR 1.81; 95% CI: 1.47-2.22, P<0.00001, I2 =43%). Herbal bath and phototherapy(NB-UVB) combined with acitretin group also showed higher average total effective rate than acitretin alone group(RR 1.51; 95% CI: 1.18-1.93, P=0.0009, I2 =0%). The overall risk of bias of the included studies was unclear or of high risks. Conclusions : This review showed that the add-on of herbal bath combined with acitretin treatment could be more effective than acitretin alone treatment in patients with psoriasis. However, because of few included studies, heterogeneity between studies, and insufficient quality of included studies, further well-designed RCTs are needed to confirm the add-on effect of herbal bath on psoriasis.

Low-Level Laser Therapy including Laser Acupuncture for Non-Specific Chronic Low Back Pain: Systematic Review and Meta-Analysis

  • Yeum, Hyewon;Hong, Yejin;Nam, Dongwoo
    • Journal of Acupuncture Research
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    • v.38 no.1
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    • pp.8-19
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    • 2021
  • Low-level laser therapy including laser acupuncture (LLLT/LA) has been widely used for non-specific chronic low back pain (NCLBP). However, there is no critically appraised evidence of its potential benefits. This study aimed to evaluate the effectiveness of LLLT/LA for NCLBP. There were 12 databases (MEDLINE, CENTRAL, EMBASE, KoreaMed, KMBASE, KISS, NDSL, KISTI, OASIS, CNKI, CiNII, J-stage) searched for randomized controlled trials using LLLT/LA for NCLBP up until June 2019. The primary outcome was pain intensity and functional status/disability due to NCLBP. A random-effects meta-analysis was conducted on 20 studies involving 1,323 participants. LLLT/LA showed a significant positive effect on pain relief scores compared with sham treatments (SMD -0.51, 95% CI: -0.88 to -0.13; χ2 = 31.12, I2 = 74%). Alone, the therapy showed a significant positive effect on function/disability scores (30 participants, MD -11.90, 95% CI: -17.37 to -6.43). As an add-on treatment, it showed a significant positive effect on pain relief (80 participants, MD -5.10, 95% CI: -9.31 to -0.88; χ2 = 28.99, I2 = 97%) and improved function/disability scores (120 participants, MD 5.44, 95% CI: 2.19 to 8.68; χ2 = 4.07, I2 = 75%). Among 20 studies, 9 studies reported no adverse events and 1 study reported mild adverse events. LLLT/LA may be an alternative or add-on treatment for NCLBP.

Comparison of Clinical Development and Evaluation of Triple Antihypertensive Therapy in Advanced Foreign Countries (항고혈압 약물 3종 복합제에 대한 선진 외국의 임상자료 심사사례 비교)

  • Wang, So Young;Shon, Soo Jung;Um, Jung Yoon;Lim, Hwa Kyung;Lim, Sook;Kang, Seung Ho;Lee, Sun Hee
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.239-247
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    • 2013
  • Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

Effectiveness of Acupuncture and Acupotomy for Trigger Finger: A Systematic Review and Meta-Analysis

  • Hae-Won Hong;Myung-In Jeong;Hyun-Il Jo;Sun-Ho Lee;Ka-Hyun Kim;Sung-Won Choi;Jae-Won Park;Ji-Su Ha
    • Journal of Acupuncture Research
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    • v.40 no.2
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    • pp.111-128
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    • 2023
  • Trigger finger is a common cause of hand disability that results in finger catching, clicking, or locking. Conventional treatment options such as medication, injection, and surgery have limitations. Studies have indicated that acupuncture and acupotomy can be effective in treating trigger finger. However, no review regarding these treatment modalities has been published yet. This review included randomized controlled trials published until January 2023, investigating acupuncture-related interventions. The primary outcomes of interest included the effectiveness rate (ER) and pain intensity, measured using a visual analog scale (VAS) and Numerical Rating Scale (NRS), and secondary outcomes were the Quinnell grade (QG) and recurrence rate (RR). Adverse events (AEs) have also been reported wherever available. Overall, 19 studies were included, and results demonstrated that arcedge acupuncture improved the ER and QG and reduced NRS, and acupuncture was effective in reducing VAS. Compared with conventional surgery, acupotomy alone improved the ER and QG and lowered VAS and RR, with relatively fewer AEs. Acupotomy add-on treatment was more effective than conventional treatment; however, careful interpretation is needed for VAS. Acupotomy add-on treatment was more effective than acupotomy alone. However, the overall results must be interpreted with caution because of study quality, small sample size, and heterogeneity of the results.

Corticosteroids Add-on Therapy in the Acute Phase of Kawasaki Disease (고위험군 가와사끼병에서 스테로이드 추가 요법의 효과)

  • Kang, Seon-Mi;Moon, Eun-Kyung;In, Su-Mi;Kil, Hong-Ryang
    • Clinical and Experimental Pediatrics
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    • v.45 no.12
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    • pp.1571-1576
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    • 2002
  • Purpose : Recently, clinical trials of steroid add-on therapy were reported with variable results in Kawasaki disease. We analyzed the clinical outcomes of patients at high risk of with Kawasaki disease(${\geq}4$ points of Harada score) treated by three commonly used different treatment regimens, with or without corticosteroids. Methods : Medical records of 96 children with Kawasaki disease treated with one of the threee regimens were reviewed retrospectively. Regimen 1 was aspirin(100 mg/kg/day) plus intravenous gamma globulin 2 g/kg single dose; regimen 2, aspirin(100 mg/kg/day) plus intravenous gamma globulin 1 g/kg single dose; regimen 3, regimen 2 plus prednisolone(2 mg/kg/day), followed by tapering two weeks and pulse therapy of methyl prednisolone performed in cases of retreatment. Also low dose aspirin was given in all three regimens for eight weeks after the acute phase. The cardiovascular and laboratory evaluations were performed on acute phase, immediate after acute phase, and subacute phase, eight weeks after treatment. Results : The frequency of coronary artery lesions and laboratory findings in the three different regimens were similar. The more rapid control of fever after treatment was noted in regimen 3. Furthermore the frequency of retreatment was decreased in regimen 3 compared to the other two regimens. Conclusion : Steroid add-on therapy showed some beneficial outcome compared to conventional treatment regimens. The role of steroid in the treatment of Kawasaki disease should be reassessed in systemic manner.