• Title/Summary/Keyword: Single-blind test

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Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test

  • Chang-Hwan Yoon;Jihong Jang;Seung Ho Hur;Jun-Hee Lee;Seung Hwan Han;Soon-Jun Hong;Kiyuk Chang;In-Ho Chae
    • Korean Circulation Journal
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    • v.52 no.5
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    • pp.354-364
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    • 2022
  • Background and objectives: To compare the safety and efficacy of a new everolimus-eluting stent with an abluminal-coated biodegradable polymer (Osstem Cardiotec Centum) with those of the Xience Alpine stent (Xience). Methods: This randomized, prospective, multicenter, parallel-designed, single-blind trial was conducted among patients with myocardial ischemia undergoing percutaneous coronary intervention (PCI) from 21st September 2018 until 3rd July 2020. The primary efficacy endpoint was in-segment late lumen loss (LLL) at 270 days after the procedure and the primary safety endpoints were major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction, and target lesion revascularization. Results: We enrolled 121 patients and analyzed 113 patients who finished 270 days of follow-up for the primary efficacy endpoint. The mean age of the participants was 66.8 years. As for the primary efficacy endpoint, LLL of the Osstem Cardiotec Centum group was 0.09±0.13 mm and that of the Xience group was 0.12±0.14 mm (upper limit of 1-sided 95% confidence interval, 0.02; p for non-inferiority, 0.0084). This result demonstrates the non-inferiority of the Osstem Cardiotec Centum. As for the primary safety endpoint, MACE occurred in one patient (1.59% of the Xience group). Meanwhile, no MACE occurred in the Osstem Cardiotec Centum group. Conclusions: The Osstem Cardiotec Centum is non-inferior to the Xience Alpine® stent and is confirmed to be safe. It could be safely and effectively applied to patients with coronary artery disease undergoing PCI.

SNP Marker Development for Purity Test of Oriental Melon and Melon (멜론 및 참외 순도 검정을 위한 SNP 마커 개발 및 F1 종자 순도 검정)

  • An, Song-Ji;Kwon, Jin-Kyung;Yang, Hee-Bum;Choi, Hye-Jeong;Jeong, Hee-Jin;Kim, Yong-Jae;Choi, Gyung-Ja;Kang, Byoung-Cheorl
    • Korean Journal of Breeding Science
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    • v.42 no.4
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    • pp.397-406
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    • 2010
  • Field screening method has been commonly used for purity test of $F_1$ hybrid seeds in melon and oriental melon. However, as this method takes a lot of time and cost, molecular marker-based purity test is necessary. To develop molecular markers for purity test, thirty pairs of SNP (single nucleotide polymorphism) primers were obtained from melon EST sequences, and 10 polymorphic markers showing HRM (high resolution melting) polymorphisms between parents of two melon cultivars and one oriental melon cultivar were selected. Blind tests were performed to validate usefulness of the selected markers for purity test. Blind test results showed that HRM genotypes were matched with the expected identity of individual sample, $F_1$ hybrid, male or female parents. Three HRM-based SNP markers were converted to CAPS markers for general use which is favor to breeders. We expect that SNP markers developed in this study will be useful for purity test of $F_1$ hybrid seeds in melon and oriental melon.

The Effects of Vibration Exercise after Modified Bröstrom Operation in Soccer Players with Ankle Instability

  • Kim, Sanghoon;Kim, Yangrae;Kim, Yongyoun
    • Journal of International Academy of Physical Therapy Research
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    • v.10 no.2
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    • pp.1791-1796
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    • 2019
  • Background: Vibration exercise after ankle surgery improves proprioception and ankle muscle strength through vibration stimulation. Objective: To examine the effects of vibration exercise on the ankle stability. Design: Randomized controlled clinical trial (single blind) Methods: Twenty soccer players were randomly divided into experimental group and control group. The Vibration exercise program was conducted 12 weeks and 3 times a week. Ankle joint proprioceptive sensory test and Isokinetic muscle strength test were performed using Biodex system pro III to measure plantar flexion / dorsiflexion and eversion / inversion motion. Results: The result of isokinetic test of ankle joint is showed significant improvement in all measurement items, such as leg flexion, lateral flexion, external and internal muscle forces, compared to previous ones by performing vibration movements for 12 weeks. However, in the comparison group, plantar flexor ($30^{\circ}$), eversion muscle ($120^{\circ}$), inversion ($30^{\circ}$) of limb muscle strength were significantly improved compared with the previous phase; was no significant difference in dorsi-flexion. There was no significant difference between groups in all the items. Conclusions: In this study, we analyzed the effects of rehabilitation exercise on soccer players who had reconstructed with an ankle joint ligament injury through vibration exercise device. As a result, we could propose an effective exercise method to improve the ability, and confirmed the applicability as an appropriate exercise program to prevent ankle injuries and help quick return.

Comparison of the effects of transcutaneous electrical nerve stimulation, low level laser, and placebo treatment on temporomandibular joint disorders: a single-blind randomized controlled trial

  • Kim, Hyunjoong
    • Physical Therapy Rehabilitation Science
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    • v.9 no.4
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    • pp.244-251
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    • 2020
  • Objective: Physical therapy techniques are required for patients with temporomandibular joint disorder (TMD), but the effects of treatment have not been compared. Therefore, effects of transcutaneous electrical nerve stimulation (TENS) and low level laser (LLL), which are most commonly used interventions, were compared. Design: Randomized controlled trial. Methods: Thirty-six participants with pain in the temporomandibular joint were enrolled, and 12 participants were randomly assigned to either the TENS group, LLL group, or placebo group. Each intervention was performed for a total of 6 sessions for 2 weeks. For the evaluation of the participants, the mouth opening (MO), pressure pain threshold (PPT), and stress were measured at three time periods: baseline, post-test, and follow-up at 2 weeks. Results: Significant interaction between groups according to each evaluation point was found only in PPT-masseter (p<0.05). The evaluation time point at which a significant difference appeared was at the post-test and follow-up at 2 weeks time periods. As a result of the post-test, the LLL group showed a significant improvement compared to the TENS group (p<0.05), and at 2 weeks follow-up, the TENS group showed a significant improvement compared to the placebo group (p<0.05). Conclusions: In this study, an experiment was conducted to compare the treatment effects when TENS, LLL, and placebo were given to patients with TMD. In addition, by quantitatively presenting the effect size of each treatment, this study suggests clinical use of TENS and LLL treatment for TMD.

Efficacy of Korean Red Ginseng by Single Nucleotide Polymorphism in Obese Women: Randomized, Double-blind, Placebo-controlled Trial

  • Kwon, Dong-Hyun;Bose, Shambhunath;Song, Mi-Young;Lee, Myeong-Jong;Lim, Chi-Yeon;Kwon, Bum-Sun;Kim, Ho-Jun
    • Journal of Ginseng Research
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    • v.36 no.2
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    • pp.176-189
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    • 2012
  • This study examined the effects of Korean red ginseng (KRG) on obese women and aimed to confirm that the effects of KRG on obesity differ dependently on a gene. Fifty obese women were recruited and randomized to receive KRG (n=24) or placebo (n=26) for 8 wk. Measurements of blood pressure, height, weight, waist circumference, waist-hip ratio (WHR), total fat mass, percentage of body fat, resting metabolic rate, basal body temperature, and daily food intake (FI), blood test (serum lipid, liver and renal function), Korean version of obesity-related quality of life scale (KOQOL), and a gene examination were performed. Comparisons of subjects before and after the administration of KRG revealed significant improvements of obesity in terms of weight, body mass index (BMI), WHR, FI, and KOQOL. However, in the comparison between KRG group and placebo group, only KOQOL was significantly different. KRG displayed significant efficacy on BMI and KOQOL in the CT genotype of the G protein beta 3 gene, but not in the CC genotype, on blood sugar test in the Trp64/Arg genotype of the beta 3 adrenergic receptor gene, but not in Trp64/Trp genotype, on KOQOL in the DD genotype of the angiotensin I converting enzyme gene, but not in the ID and DD genotypes. The effects of KRG on obesity were confirmed to some extent. However, a distinct effect compared to placebo was not confirmed. KRG is more effective for improving the secondary issues of the quality of life derived from obesity rather than having direct effects on the obesity-related anthropometric assessment and blood test indices.

The Effects of Carthami Semen Pharmacopuncture and Bovis Calculus.Fei Ursi Pharmacopuncture on the Heart Rate Variability(HRV) (홍화자약침과 웅담.우황약침이 심박변이도(HRV)에 미치는 영향)

  • Lee, Jin-Bok;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Acupuncture Research
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    • v.27 no.2
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    • pp.11-21
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    • 2010
  • Objectives : We tried to investigate the effects of Carthami Semen(CF) pharmacopuncture and Bovis Calculus Fei Ursi(BU) pharmacopuncture on the heart rate variability(HRV) in adult men. As well as we tried to observe how CF pharmacopuncture and BU pharmacopuncture effect on the balance of the autonomic nervous system. Methods : We investigated on 40 healthy volunteers consisted of 20 subjects in CF pharmacopuncture group and 20 subjects in BU pharmacopuncture group respectively. We ruled out subjects whose vital sign isn't in normal range, yet they had taken a rest. The study established by a randomized, single-blind clinical trial. CF pharmacopuncture and BU pharmacopuncture was applied on each group. We measured HRV 7 times : baseline measurement and every 5 minutes for 30 minutes after injection. The SPSS 15.0 for Windows was used to analyze the data by the paired t-test(in group) and Independent sample t-test(between the groups). Results 1. After injection of CF pharmacopuncture, SDNN, Ln(TP), Ln(VLF) and Ln(LF) increased significantly, and Complexity, pNN50 decreased significantly. 2. After injection of BU pharmacopuncture, RMSSD, SDSD and HRV-index increased significantly. Conclusions : We suggest that CF pharmacopuncture activate sympathetic nervous system and BU pharmacopuncture tend to activate the autonomic nervous system.

Neuromodulation of the median nerve in carpal tunnel syndrome, a single-blind, randomized controlled study

  • Gevher Rabia Genc Perdecioglu;Mehlika Panpalli Ates;Damla Yuruk;Omer Taylan Akkaya
    • The Korean Journal of Pain
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    • v.37 no.1
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    • pp.34-40
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    • 2024
  • Background: This study aimed to evaluate the efficacy of pulsed radiofrequency applied using transcutaneous electrodes in carpal tunnel syndrome (CTS). Methods: After randomization, the patients received two cycles of noninvasive pulsed radiofrequency (NiPRF), once weekly, or splinting (the control group) for three months. Clinical evaluations were recorded at baseline and weeks 4 and 8. The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) was used to determine the functional status and symptom severity. Results: Sixty-two patients were followed up for three months. There was no difference between the groups in the BCTQ scores before and after treatment. The NiPRF group found a significant difference between the BCTQ measurements at all time intervals (paired sample t-test; P < 0.001). In the splint group, there was a significant difference only between the basal-1st month and basal-3rd month (paired samples t-test; P < 0.001). The main effect of the time variable was statistically significant (ANOVA; P < 0.001), but the group variable was not. There was no correlation between the BCTQ results measured at any time and the electroneuromyelogragphy findings in either group. Conclusions: NiPRF effectively improves symptoms and functionality in patients with CTS for up to 3 months. Thus, NiPRF can be considered an easy, safe, and useful alternative treatment modality for CTS.

The effect of different micro-osteoperforation depths on the rate of orthodontic tooth movement: A single-center, single-blind, randomized clinical trial

  • Ozkan, Tugba Haliloglu;Arici, Selim
    • The korean journal of orthodontics
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    • v.51 no.3
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    • pp.157-165
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    • 2021
  • Objective: This study aimed to identify the clinical effectiveness of two different penetration depths of micro-osteoperforations (MOPs) on the rate of orthodontic tooth movement. Methods: Twenty-four patients requiring the removal of the upper first premolar teeth were selected and randomly divided into two groups. The control group participants did not undergo MOPs. Participants in the experimental group underwent three MOPs each at 4-mm (MOP-4) and 7-mm (MOP-7) depths, which were randomly and equally performed to either the left or right side distal to the canine. The retraction amount was measured on three-dimensional digital models on the 28th day of retraction. MOP-related pain was measured using a visual analog scale (VAS). Between-group statistical differences in the VAS scores were determined using an independent t-test and those in canine retraction were determined using analysis of variance and post-hoc Tukey test. Results: No significant difference was found between the MOP-4 (1.22 ± 0.29 mm/month) and MOP-7 (1.29 ± 0.31 mm/month) groups in terms of the canine retraction rate. Moreover, both the groups demonstrated a significantly higher canine movement than the control group (0.88 ± 0.19 mm/month). MOPs did not significantly affect the mesialization of the posterior teeth (p > 0.05). Moreover, the pain scores in the MOP-4 and MOP-7 groups were similar and showed no statistically significant difference. Conclusions: Three MOPs with a depth of 4 mm can be performed as an effective method to increase the rate of tooth movement. However, three MOPs with depths of 4-7 mm does not additionally enhance tooth movement.

A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial (여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜)

  • Seo, Young Kyung;Lee, Eun Hee;Kim, Hwan;Lee, Ji-yoon;Park, Chae Rin;Choi, Sunyoung;Jang, Eunsu;Kwon, Ojin;Kim, Hyungjun;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.1
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

Effects of Electroacupuncture on Parameters Related to Obesity in Adults with Abdominal Obesity:Three arm Randomized Single Blind Pilot Study (전침이 복부비만 성인의 비만관련 지표에 미치는 영향-무작위배정 단일 맹검 예비연구-)

  • Chung, Jie-Youn;Kim, Jong-In;Lee, Sang-Hoon;Kang, Sung-Keel
    • Journal of Acupuncture Research
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    • v.27 no.6
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    • pp.43-57
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    • 2010
  • Objectives : To investigate the effects of electroacupuncture on parameters related to obesity in adults with abdominal obesity. Methods : A three arm randomized single blind pilot study was conducted from Jan 4 to March 25, 2010 in Kyung Hee Oriental Medical Hospital. The subjects were 39 adults with abdominal obesity and were randomly divided by computer generated random table into 3 groups; EA(electroacupuncture), sham EA(sham electroacupuncture) and waitlist groups. Acupuncture points located at abdomen($CV_{12}$, $CV_6$, $ST_{25}$, $SP_{15}$, $SP_{14}$) and extremities($LI_4$, $LI_{11}$, $ST_{36}$, $ST_{44}$) were inserted by disposable stainless steel needles and were stimulated 30 minutes with 24Hz, 0.27~1.3mA(tolerable strength), asymmetric biphasic continuous pulse wave form by STN-111 Stratek device in EA group. Two treatment sessions per week for 5 weeks(10 sessions in total) were done in EA and sham EA groups. The primary outcome measurement was WC(waist circumference), and the secondary outcome measurements included WHR(waist hip ratio), ASF(thickness of abdominal subcutaneous fat), and inbody measurements of BW(body weight), BMI(body mass index), BFR(body fat ratio) and VFA(visceral fat area), and also scores of BULIT-R(bulimia test revised), KoQoL(Korean obesity of QoL) and BSQ(body shape questionnaire). Results : All of 39 subjects were included in ITT(intention-to-treat) analysis. There were significant reductions in WC, WHR and ASF after 5-week electroacupuncture treatments and the percentage reductions were significantly greater than sham EA or waitlist group. There were no significant differences between groups in percentage reductions of other parameters(BW, BMI, BFR, VFA, BULIT-R, KoQoL and BSQ). But, there were continuous reductions in BW, BMI, BFR and VFA at 3 weeks after the end of treatment and there was significant reduction in BW compared with the baseline value in EA group. No seriously adverse effects were reported during the period. Conclusions : Electroacupuncture was more effective than sham electroacupuncture or no intervention on the reduction of WC, WHR and ASF in adults with abdominal obesity.