• 제목/요약/키워드: Electronic Clinical Trial

검색결과 76건 처리시간 0.027초

The Review for Studies of Neurofeedback Training (뇌파를 이용한 생기능자기조절(뉴로피드백) 훈련에 대한 임상연구 동향 - 2000년부터 2013년까지 국내 학술지 논문을 중심으로 -)

  • Lim, Jung Hwa;Seong, Woo-Young
    • Journal of Oriental Neuropsychiatry
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    • 제25권3호
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    • pp.271-286
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    • 2014
  • Objectives: The purpose of this study is to investigate the clinical trial research trends in regards to the neurofeedback training (NFT) in Korean journals. Methods: We researched articles published in Korean journals from 2000 up to 2013 and were related to the NFT. We searched six electronic databases to find relevant articles, using the term 'neurofeedback'. Results: 1) 6 single group comparative studies and 31 randomized controlled trials were found. 2) Healthy volunteers and students were most frequently studied with neurofeedback training. Other studies included attention deficit hyperactivity disorder (ADHD), Poststroke, panic disorder, premenstrual dysphoric disorder (PDD), temporomendibular disorder (TMD), and obesity. NFT interventions were attempted in diverse training protocols and assessed with many different outcome measurements. 3) Most studies showed effective results after NFT. Conclusions: NFT is increasingly studied and used in various clinical fields. Also, there have been efforts to adopt NFT in Korean medical clinics and researches, and more rigorous and innovative studies are needed in the future.

A Study on System for International Standard(IS) based Clinical Information Management (국제표준 기반의 임상정보 관리체계 구축에 관한 연구)

  • Choi, Yongjung
    • Proceedings of the Korean Society of Computer Information Conference
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    • 한국컴퓨터정보학회 2014년도 제49차 동계학술대회논문집 22권1호
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    • pp.429-432
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    • 2014
  • 국내 제약산업의 경쟁력을 제고시키기 위해서는 신약의 심사/허가 기간을 단축시켜 급변하게 변하는 글로벌 제약시장에서 경쟁 우위적 위치를 선점할 수 있도록 기회를 제공할 수 있도록 체계 개선이 시급하다. 신약허가를 위해서는 임상시험 결과에 대한 안전성과 유효성 등에 대한 심사가 수행되게 된다. 하지만 현재 신약허가를 위해서 제약사와 임상시험수탁기관(Contract Research Organization, CRO)에서 데이터 정보체계인 Domain, Variable 및 Parameter 등의 표준을 따르지 않고 다양한 유형의 임상정보데이터를 심사기관에 제출하고 있어 이로 인한 심사기간 증가와 심사업무 비효율성을 야기시키고 있다. 따라서 본 연구에서는 국제민간기구인 CDISC (Clinical Data Interchange Standards Consortium)에서 제정한 글로벌 임상데이터 표준인 CDISC 표준을 준용한 국내 임상시험정보관리 체계 (eCTD 시스템)및 의약품 전주기적 관리체계를 제시하고자 하며, 본 연구를 통한 기대효과로는 국제표준의 임상정보관리 인프라 구축으로 인한 국내 신약개발 및 해외 진출 환경을 마련하여 글로벌 시장선점의 기회를 제공할 수 있고, 규제기관 차원에서는 의약품 허가, 심사업무의 효율성 증가는 물론 전주기적 의약품 안전관리체계를 마련할 수 있을 것으로 사료된다.

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Chuna Manual Therapy for Nocturnal Crying; A Systematic Review (소아 야제에 대한 추나요법 효과; 체계적 문헌고찰)

  • Hwang, Man-Suk;Shin, Byung-Cheul;Heo, Kwang-Ho;Heo, In;Kim, Byung-Jun;Kim, Ki-Bong;Cheon, Jin-Hong;Park, Jae-Hong;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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    • 제25권3호
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    • pp.51-57
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    • 2015
  • Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for nocturnal crying. Methods We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for nocturnal crying. The methodological quality of each RCTs was assessed using the Cochrane Risk of Bias tool and nRCTs was assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study tool. Results Two RCTs and three nRCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with acupoint application therapy to Chuna manual therapy alone, but was not statistically significant. Conclusions Our systematic review found encouraging but limited evidence of Chuna manual therapy for nocturnal crying. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

A Systematic Review of Clinical Researches of Korean Medicine for Alopecia (탈모증의 한약제제 치료효과에 대한 체계적 문헌 고찰)

  • Ryu, Deok-Hyun;Roh, Seok-Sun
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • 제30권2호
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    • pp.1-18
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    • 2017
  • Objectives : This review aims to evaluate a risk of bias by risk of bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.

The Effect of Virtual Reality Based Rehabilitation Program on Balance of Patient with Stroke: A Meta-analysis of Studies in Korea (가상현실기반 재활프로그램이 뇌졸중환자의 균형에 미치는 영향 : 국내연구에 대한 메타분석)

  • Roh, Jung-suk
    • Journal of Korean Physical Therapy Science
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    • 제24권1호
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    • pp.59-68
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    • 2017
  • Purpose : The aims of this study was to conduct a systematic literature review with meta-analysis to investigate the effect of virtual reality based rehabilitation program on balance of patient with stroke in Korean studies. Method : The studies for analysis were searched in electronic databases(Research Information Sharing Service; RISS, Korean Studies Information Service; KISS, DBpia, e-articles, National Assembly Library). The key words for search were 'virtual reality', 'stroke', and 'balance' and only randomized controlled trials and clinical controlled trials were included. Of 40 studies identified in the search, 20 studies met the criteria of this study and included in this meta-analysis. Result : The results were as follows: 1) The overall effect size of virtual reality based rehabilitation program was 0.557(95% critical interval; 0.340~0.774). 2) In the analysis of sub-categorical variables, effect size was as follows; the commercial game type(0.621) > virtual environment type(0.335); the dynamic balance measurement(0.750) > static balance measurement(0.226); randomized controlled trial(0.653) > clinical controlled trial(0.275); and thesis type(0.706) > article of journal type(0.339). 3) In the analysis of sub-continuous variables, as time of program(per session) increased, the balance increased(p<0.05). Conclusion : The results of this study showed that virtual reality based rehabilitation program moderately improves the balance of stroke patient. Further studies are recommended to investigate the effect of sub-variables related to virtual reality programs on motor functions of patient with stroke.

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The Present Clinical Studies of Oriental Medicine and CAM Therapies in Chemotherapy-induced Peripheral Neurotoxicity (항암제 유발 신경독성을 관리하는 한의학 및 보완대체요법들과 임상시험 현황)

  • Park, Sun-Ju;Go, Ho-Yeon;Han, Yoo-Jin;Ko, Seong-Gyu;Kim, Sung-Hoon
    • The Korea Journal of Herbology
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    • 제24권4호
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    • pp.205-213
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    • 2009
  • Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

Acupuncture for Upper Extremity Peripheral Nerve Injury: A Systematic Review (상지말초신경손상에 대한 침술치료의 효과: 체계적 문헌고찰)

  • Kim, Young-Jun;Kim, Tae-Ryeong;Woo, Chang-Hoon;Shin, Byung-Cheul
    • Journal of Korean Medicine Rehabilitation
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    • 제28권2호
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    • pp.73-82
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    • 2018
  • Objectives The purpose of this study is to systematically explore the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury and to review the methodology of clinical trials. Methods We searched 9 electronic databases(3 international, 1 Chinese, 5 Korean) including English, Korean and Chinese, up to December 2017 for randomized controlled trials which evaluated the effects of the acupuncture in patients with upper extremity peripheral nerve injury. We abstracted the designs of the randomized clinical trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). Results A total of 8 papers were reviewed. All randomized clinical trials were conducted in China. Of them, five studies(62.5%) were electro-acupuncture as intervention. All randomized clinical trials reported favorable effects of acupuncture treatments compared to baseline or control group with outcomes of efficacy rate. However risk of bias seemed high. LI4, LI11, SI3, PC3, PC6 were most frequently used for acupoints to treat upper extremity peripheral nerve injury. Conclusions These results suggest that it is recommended to develop more detailed reporting standards for acupuncture treatment method. In the future, well designed randomized clinical trials which evaluate the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury is highly needed.

Erector spinae plane block for spinal surgery: a systematic review and meta-analysis

  • Liang, Xiao;Zhou, Weilong;Fan, Yuchao
    • The Korean Journal of Pain
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    • 제34권4호
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    • pp.487-500
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    • 2021
  • Background: Although the erector spinae plane block has been used in various truncal surgical procedures, its clinical benefits in patients undergoing spinal surgery remain controversial. The aim of this meta-analysis was to evaluate the clinical benefits of erector spinae plane block in patients undergoing spinal surgery. Methods: We searched the Cochrane Library, PubMed, EMBASE, and China National Knowledge Infrastructure for randomized controlled trials comparing the erector spinae plane block with a nonblocked control for spinal surgery. Results: Twelve studies encompassing 696 subjects were included in our systematic review and meta-analysis. We found that the erector spinae plane block decreased postoperative pain scores and opioid consumption in the postoperative and intraoperative periods. Moreover, it prolonged the time to the first rescue analgesic, reduced the number of patients who required rescue analgesia, and lowered the incidence of postoperative nausea and vomiting. However, it did not exhibit efficacy in decreasing the incidence of urinary retention and itching or shortening the length of hospital stays, or the time to first ambulation. Conclusions: Erector spinae plane block improves analgesic efficacy among patients undergoing spinal surgery compared with nonblocked controls; however, there is insufficient evidence regarding the benefits of erector spinae plane block for rapid recovery.

A Systematic Review of Herbal Medicine in the Treatment of Cirrhotic Ascites

  • Kim, Seungmo;Lee, Yuri;Cho, Nakyung;Choi, Hongsik;Kim, Kyungsoon
    • The Journal of Korean Medicine
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    • 제42권4호
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    • pp.222-237
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    • 2021
  • Objectives: The purpose of this study was to investigate the trend in the research on cirrhotic ascites using t herbal medicine. Methods: This review was conducted using six electronic databases(NDSL, KMBASE, Koreantk, KISS, KISTI, KoreaMed) with no restriction in year. The search term was 'liver cirrhosis', 'ascites', or 'cirrhotic ascites', 'herbal medicine', 'traditional Chinese medicine', and 'randomized clinical trial', and there was no restriction in year. The searched studies were analyzed according to the type of research. Results: After scanning the titles and abstracts, 13 articles were ultimately included. Of the outcome measures of 13 studies, effective rate, liver function test, and ascites regression time were included in the meta-analysis, which showed that the effective rate of herbal medicine-supportive treatment combination therapy was 1.27 times higher than that of supportive treatment alone, and the difference was statistically significant. Conclusions: We analyzed the trends of cirrhotic ascites treatment in herbal medicine through this review. It is necessary to conduct further studies, such as well-designed clinical trials based on the results from experimental research.

Systematic Review of Soyeom Pharmacopuncture Therapy for Pain (임상에서 흔히 접하는 통증에 대한 소염약침요법의 체계적 문헌고찰)

  • Kim, Myeong-Kyu;Seo, Ha-Ra;Ha, Hyun-Ju;O, Tae-Yeong;Jeon, Dong-Hwi;Li, Yu-Chen;Lee, Jae-eun;Lee, Eun-Jung;Oh, Min-Seok
    • Journal of Korean Medicine Rehabilitation
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    • 제27권3호
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    • pp.95-105
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    • 2017
  • Objectives To evaluate the evidence supporting the effectiveness of Soyeom pharmacopuncture therapy for Pain. Methods We conducted search across 6 electronic databases (Pubmed, CAJ, Oasis, RISS, DBPIA and KoreanTK) and 2 journals to find clinical trials that used Soyeom pharmacopuncture therapy as treatment for pain. The methodological quality of Randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 75 articles that were searched, 5 RCTs and 2 NRCTs were finally selected. Among 7 selected studies, all studies showed that Soyeom pharmacopuncture therapy has significant effect on Pain. Conclusions Our systematic review found encouraging but limited evidence of Soyeom pharmacopuncture therapy for Pain. We recommend clinical trials which compare the effectiveness of Soyeom pharmacopuncture therapy with other pharmacopuncture therapies to clarify the effectiveness of Soyeom pharmacopuncture therapy from other pharmacopuncture therapies.