• Title/Summary/Keyword: Clinical Trials

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Randomized Controlled Clinical Trials in the Journal of Oriental Rehabilitation Medicine : A Quantitative and Qualitative Analysis(1) (한방재활의학과학회지에 수록된 무작위대조임상연구의 양적, 질적 분석(1))

  • Lee, Hyeon-Yeop;Heo, Kwang-Ho;Cho, Hyun-Woo;Hwang, Eui-Hyoung;Shin, Mi-Suk;Shin, Byung-Cheul
    • Journal of Korean Medicine Rehabilitation
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    • v.23 no.1
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    • pp.87-100
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    • 2013
  • Objectives : The aim of this study is to assess the quantity and quality of randomized controlled clinical trials(RCTs) published in the journal of oriental rehabilitation medicine(JORM). Methods : After searching RCTs from all the articles published in the JORM from the inception(1991) to Oct, 2012, quantity assessment were made on the study design, sample size, main intervention, intervention versus control design and medical condition. Quality assessment were made on the cochrane risk of bias(RoB) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus of all authors. Results : Among the 1013 articles, total 59 RCTs were published. First RCT was published in 1994. 49 RCTs were parallel 2-arm designed. Average sample size was 35.1 per study and 16.3 per arm. The most common medical condition is musculoskeletal disease(30.5%). Quality from cochrane RoB was generally low. Conclusions : Though RCTs published in JORM were increasing, the quality remains low. Researchers should make a effort to follow the RoB checklists and improve the quantity and quality of studies.

Potential Use of a Smartphone to Evaluate Gait during Walking in Stroke Patients (스마트폰 어플리케이션을 이용한 뇌졸중 환자의 보행 평가 가능성)

  • An, Bo-Ra;Ki, Kyong-Il;Woo, Young-Keun
    • PNF and Movement
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    • v.16 no.1
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    • pp.67-73
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    • 2018
  • Purpose: Smartphones, which are widely used worldwide to detect acceleration and position, have been used in the area of rehabilitation medicine in recent clinical research studies and tests. The aim of the present study was to determine the feasibility of using a smartphone application based on center of movement (COM) displacement to measure gait parameters in stroke patients in the clinical field of rehabilitation medicine. Methods: The study consisted of 30 stroke patients. The COM was measured using a smartphone application, Gait Analysis Pro, during a 6-m walk. Each patient performed three 6-m walking trials, and the smartphone application measured gait duration, gait speed, step length, cadence, and vertical and lateral displacement of the COM. The Kolmogorov-Smirnov test was conducted to determine the normality in gait parameters, and a repeated one-way analysis of variance (ANOVA) was performed to determine the consistency among the three trials. A p value of 0.05 was considered statistically significant in all the tests. Results: In all the measured parameters, the smartphone application showed a normal distribution, as shown by the results of the Kolmogorov-Smirnov test. There were no significant differences among the three repetitive walking trials. Conclusion: These results suggest that the smartphone application can be used for evaluating gait in stroke patients, as well as in healthy adults. However, prior to using the smartphone application in the clinical field, further research involving three-dimensional gait analysis is needed to enhance the confidence level of the findings.

Complementary and Alternative Medicine for Oral Health : a Literature Review of Randomized Controlled Clinical Trials (구강건강에 이용되는 보완대체의학 치료: 무작위대조임상연구를 통한 문헌적 고찰)

  • Kim, Da-Hee;Choi, Gwang-Ho;Hwang, Eui-Hyoung;Heo, Kwang-Ho;Kim, Yong-Deok;Shin, Byung-Cheul
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.3
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    • pp.23-39
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    • 2014
  • Objective : This review aims at analyzing Complementary and Alternative Medicine (CAM) therapies, using for oral health to know current use of CAM in dental area by analyzing randomized controlled clinical trials (RCTs). Method : We searched the following 6 electronic databases until 1 July 2014. : Pubmed, Medline, Embase, Allied and Complementary Medicine Database(AMED), Cumulative Index to Nursing and Allied Health Literature(CINAHL), the Cochrane Library. We included parallel RCTs and cross-over RCTs that assessed the efficacy of CAM regardless of blinding and language. Results : A total of 154 RCT articles were included. There were 2-arm parallel study design(69.5%), 3-arm parallel study design(20.8%), 4-arm parallel study design(4.5%) and Cross-over design(5.2%). Complementary and alternative medicine RCTs in oral health tend to increase in the early-2000s and in the mid-2010s. In addition, 154 citations were classified according to diseases and interventions that categorized Natural Products studies(68.2%), Mind and Body Practices studies(31.8%). We classified in detail that vitamin and mineral therapies(29.9%), dietary supplements(24.7%), acupuncture(23.3%), Herbal medicine(13.6%), homeopathy (2.6%), energy therapies(2.6%), Massage(1.9%), biofeedback(0.6%), traditional medicine(0.6%). Conclusion : Increasing publications and diverse interventions regarding CAM for oral health is observed by analyzing RCTs from the literature review. Further studies are needed to be performed as systematic reviews to verify their effectiveness and the research to inquire into side effect.

A survey of research papers on the health benefits of kimchi and kimchi lactic acid bacteria (김치 및 김치 유래 유산균의 건강 기능성에 대한 연구 동향 조사)

  • Kim, Bohkyung;Mun, Eun-Gyung;Kim, Doyeon;Kim, Young;Park, Yongsoon;Lee, Hae-Jeung;Cha, Youn-Soo
    • Journal of Nutrition and Health
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    • v.51 no.1
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    • pp.1-13
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    • 2018
  • Purpose: This review article provides an overview of the trends of research papers on the health benefits of kimchi and kimchi lactic acid bacteria published from 1995 to 2017. Methods: All publications from 1995 to 2017 regarding kimchi and kimchi lactic acid bacteria were collected, reviewed, and classified. This review article covers the publications of the health benefits of kimchi and kimchi lactic acid bacteria on experimental, clinical trials, and epidemiology studies. Results: The number of publications on kimchi over the period were 590: 385 publications in Korean and 205 publications in English. The number of publications on the health benefits of kimchi and kimchi lactic acid bacteria were 95 in Korean and 54 in English. The number of publications on kimchi and kimchi lactic acid bacteria were 84 and 38, respectively, in the experimental models. Ten research papers on kimchi in clinical trials and 7 publications in epidemiology were found. Kimchi or kimchi lactic acid bacteria had protective effects against oxidative stress, mutagenicity, toxicity, cancer, dyslipidemia, hypertension, immunity, and inflammation in in vitro, cellular, and in vivo animal models. Moreover, kimchi had effects on the serum lipids, intestinal microbiota, iron status, obesity, and metabolic parameters in human clinical trials. In epidemiology, kimchi had effects on hypertension, asthma, atopic dermatitis, rhinitis, cholesterol levels, and free radicals. Conclusion: This review focused on the publications regarding the health benefits of kimchi and kimchi lactic acid bacteria, suggesting the future directions of studies about kimchi and kimchi lactic acid bacteria by producing a database for an evaluation of the health benefits of kimchi.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on Acupuncture for Improving Post-Operative Cognitive Dysfunction (POCD) and Chemotherapy-Related Cognitive Impairment (CRCI)

  • Kim, Ju-Young;Cho, Han-Byul;Kim, Man-Gi;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.1
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    • pp.49-78
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    • 2022
  • Objectives: This study was conducted to evaluate the efficacy of Korean Medicine Therapy (KMT) for the treatment of Chemotherapy-induced Cognitive Impairment (CICI) through systematic review and meta-analysis of randomized controlled trials (RCTs) as proceeding research to further research the efficacy of KMT for CICI patients. Methods: We conducted a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines (PRISMA). The RCTs on the efficacy of KMT for treatment of CICI were searched by structured search strategies in MEDLINE, EMBASE, Cochrane library, CAJD, KISS, NDSL, KoreaMed, and OASIS. The searched RCTs were screened by inclusion and exclusion criteria. We evaluated the quality of the method in the included studies using the Jadad score and Cochran ROB tool. The efficacy outcomes were the Visual Analogue Scale (VAS) and the Clinical total Effective Rate (CER) of CICI. They were analyzed using mean difference for continuous variable or Relative Risk (RR) for Dichotomous variable in the random-effect model. The RevMan 5.3 program was used for meta-analysis. Results: We included 19 RCTs, including 653 participants, in the systematic review and meta-analysis. There were favorable results for the KMT group after the intervention compared with the pharmacotherapy group, physiotherapy group, and combined treatment group. KMT group showed improvement using CER and VAS compared with exercises, but their heterogeneities were slightly significant. KMT was more effective compared to the Rehabilitation program in CER and the subgroup analysis results showed that KMT had a significant difference compared to other therapies in VAS, to Medication therapy in CER. Conclusions: KMT presented reasonable evidence on improving the Clinical total Effective Rate and Visual Analogue Scale in CICI patients. However, further evaluation in future research is required.

The Effect of Boyanghwano-tang for Diabetic Retinopathy: A Systematic Review and Meta-Analysis (당뇨병성 망막병증에 대한 보양환오탕(補陽還五湯)의 효과: 체계적 문헌 고찰 및 메타분석)

  • Jeong-Hwa Oh;Hae-Na Kim;Hwa-Jung Yoon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.4
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    • pp.51-69
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    • 2023
  • Objectives : The purpose of this study is to assess the effect of using Boyanghwano-tang(BYHWT) for diabetic retinopathy. Methods : We searched randomized controlled trials(RCTs) that used BYHWT for diabetic retinopathy in 10 databases(RISS, KISS, ScienceON, KCI, OASIS, DBpia, CNKI, Wanfang Database, PubMed, Cochrane Library) on August 12, 2023. Outcome measurements included total effective rate(TER) and visual acuity as the primary outcome measurements, and the secondary outcome measurements included fasting blood glucose(FBG), 2hPG, HbA1c, ET-1, NO, etc. The indicator of stability included adverse reactions. A meta-analysis was conducted according to TER, visual acuity, FBG. Results : A total of 8 randomized control trials were selected. The treatment group which used BYHWT showed significant improvement effects in TER and visual acuity compared to the control group which used western medicine or chinese patent medicine alone. TER: (RR: 1.22, CI 1.14 to 1.31, P=<0.00001), visual acuity: (RR: 2.06, CI 1.40 to 3.03, P=0.0002). Secondary outcome measurements including FBG also showed improvement in the treatment group compared to the control group. FBG: (MD: -0.15, CI -0.43 to 0.31, P=0.28). Adverse reactions were only mentioned in one study, which showed that no adverse reactions occurred in both the treatment and control groups. Conclusions : This study suggests that BYHWT is effective for diabetic retinopathy. However these findings should be interpreted cautiously due to the insufficient number of studies and unknown or high risk of bias in the included trials.

Manual Therapy for Plantar Fasciitis: A Review of Clinical Study (족저근막염의 수기요법에 대한 문헌 연구 보고)

  • In-hwa Park;Yun-Yeop Cha;Min-Jeong Kim;In Heo;Byung-Jun Kim
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.3
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    • pp.53-63
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    • 2024
  • Objectives This study aims to analyze the effectiveness of manual therapy for the treatment of plantar fasciitis by reviewing existing randomized controlled trials. Specifically, it seeks to identify various manual therapy techniques and evaluate their applicability in clinical settings. Methods The study reviewed literature from six databases (PubMed, the Cochrane Library, China National Knowledge Infrastructure, ScienceON, Research Information Sharing Service, Korean studies Information Service System) up to April 2024. Studies were selected based on criteria including randomized controlled trials involving manual therapy for plantar fasciitis. Results An analysis of ten studies involving 714 patients revealed the use of techniques such as joint mobilization, muscle relaxation, and pressure point techniques. Manual therapy was found to be more effective in reducing pain than both extracorporeal shock wave therapy and routine physical therapy alone. However, caution is needed in generalizing these results due to the limited number of studies analyzed. No significant adverse effects were reported. Conclusions Manual therapy demonstrates potential as an effective treatment for plantar fasciitis, offering benefits in pain management and functional recovery. However, further high-quality randomized controlled trials are necessary to strengthen the clinical evidence and establish standardized treatment protocols.

Design of Optimized Ultrasound Clinical Work-Flow; Usability Perspective

  • Bag, ByungEun;Yoo, SunKook;Jang, WonSeuk
    • Journal of International Society for Simulation Surgery
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    • v.2 no.1
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    • pp.40-42
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    • 2015
  • Purpose Usability is an important factor in our life. This paper presents an approach to design the clinical work-flow for ultrasound system. And, we tried to apply this work-flow in diagnosis ultrasound system. Materials and Methods For user learnability, we follow international standard IEC 60601-1-1 and IEC 62366 which describes usability of medical instrument. User requirement are applied by 10 clinicians who are well aware of usability. We considered user environment and designed clinical work-flow into two types: general use and emergency use. The designed clinical work-flow was evaluated by 10 clinicians and results derived from the evaluation were analyzed. Results We could successfully design optimized clinical workflow of ultrasound system. Conclusion This paper suggests usability testing for optimized ultrasound clinical workflow. Using this clinical work flow, users can enhance their clinical performance and reduce operation time.

Clinical Judgment Force and Nursing Performance Satisfaction by Application of Simulation-based Myocardial Infarction Education (시뮬레이션 기반한 심근경색증 상황 교육 적용에 따른 임상판단력과 간호수행자신감)

  • Shin, Seung-Ok
    • Journal of the Korean Society of Industry Convergence
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    • v.22 no.6
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    • pp.721-727
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    • 2019
  • The purpose of this study is to investigate the relationship between clinical judgment and nursing performance based on myocardial infarction simulation applied to nursing students. Method: 39 fourth grade nursing students participated in this explanatory study with sampling of accommodations. The Lasater Clinical Judgment Rubric has been used in self-reported clinical trials and satisfaction with judging practices. Data were analyzed by descriptive statistics, t-test and Pearson's correlation coefficient using SPSS WIN 19. Results: Scenarios with myocardial infarction were scored by self-reported clinical judgment. Total mean score of clinical judgment and total mean value of clinical judgment is 4.17 ± 0.80. Correlation Between Variables After Simulation Practice is highly significant for providing positive clinical judgment and satisfaction with nursing performance. Conclusion: The simulation-based practice associated with adult nursing in myocardial infarction was useful for clinical judgment and nursing performance satisfaction, which improved the core basic skills of nursing students.

Aplastic anemia (재생불량빈혈(Aplastic anemia))

  • Kim, Hack Ki
    • Clinical and Experimental Pediatrics
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    • v.50 no.6
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    • pp.519-523
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    • 2007
  • Aplastic anemia is a rare disease, which is characterized by pancytopenia and hypocellular bone marrow without infiltration of abnormal cells or fibrosis. The incidence in Asia is higher than in the West and new cases are diagnosed at a rate of 5.1 per million pediatric populations per year in Korea. The pathophysiology is understood roughly by defective hematopoiesis, impaired bone marrow micro-environment and immune mechanism. Treatments are performed on basis of pathogenesis and selected depending on the severity. Immunosuppressive therapy with antilymphocyte or antithymocyte globulin and cyclosporine is effective in the majority of patients but has some problems including relapse or clonal evolution. Recently, there have been clinical trials of immunosuppression with hematopoietic growth factors or other drugs. Allogeneic hematopoietic stem cell transplantation (HSCT) is curative in children with severe aplastic anemia. The overall survival in HSCT from HLA-identical sibling is higher than alternative donor, including HLA matched unrelated donor or cord blood. We have to consider quality of life after HSCT because of high survival rate. However, chronic graft versus host disease and graft failure are important factors that affect the quality of life and overall survival. We need further investigation to make new regimens aimed at overcoming these risk factors and perform clinical trials.