• 제목/요약/키워드: Clinical Trials

검색결과 2,331건 처리시간 0.027초

Neuroimaging in Randomized, Multi-Center Clinical Trials of Endovascular Treatment for Acute Ischemic Stroke: A Systematic Review

  • Chong Hyun Suh;Seung Chai Jung;Byungjun Kim;Se Jin Cho;Dong-Cheol Woo;Woo Yong Oh;Jong Gu Lee;Kyung Won Kim
    • Korean Journal of Radiology
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    • 제21권1호
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    • pp.42-57
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    • 2020
  • Appropriate use and analysis of neuroimaging techniques is an inevitable aspect of clinical trials for patients with acute ischemic stroke. Neuroimaging examinations were recently used to define the core eligibility criteria and outcomes in acute ischemic stroke research. Recent clinical trials for endovascular treatment in acute ischemic stroke have also demonstrated the efficacy or safety of endovascular treatment using various imaging modalities as well as clinical indices. Furthermore, independent imaging reviews and imaging core laboratory assessments are essential to manage and analyze imaging data in order to enhance the reliability of the outcomes. Therefore, we systematically reviewed the use of neuroimaging in recent randomized clinical trials for endovascular treatment of acute ischemic stroke in order to provide a thorough summary, which would serve as a resource guiding the use of appropriate imaging protocols and analyses in future clinical trials for acute ischemic stroke. This review will help researchers select appropriate imaging biomarkers among the various imaging protocols available and apply the selected type of imaging examination for each study in accordance with the academic purpose.

백신임상시험에 대한 통계적 고찰 (Statistical Consideration of Vaccine Clinical Trials)

  • 남주선;강승호
    • 응용통계연구
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    • 제24권4호
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    • pp.633-646
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    • 2011
  • 인류의 평균수명 연장과 삶의 질 향상을 위해서 암 예방을 위한 백신 뿐 아니라 치료를 위한 백신 등 백신에 대한 많은 연구가 진행되고 있다. 또한 2009년 전 세계를 공포로 몰았던 신종인플루엔자 등 신종바이러스 유행으로 백신에 대한 임상시험과 연구는 더욱더 활기를 띄게 되었다. 본 논문에서는 백신에 대한 임상시험에서 고려해야할 통계학적인 부분에 대해 기술하고, 현재 우리나라를 포함한 전 세계적인 백신의 개발 현황에 대해서도 언급하겠다.

음부-골반통/삽입질환에 대한 중의학 임상연구 동향 (Review of Clinical Studies of Traditional Chinese Medicine on Genito-Pelvic Pain/Penetration Disorder in Women)

  • 남은영
    • 대한한방부인과학회지
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    • 제32권3호
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    • pp.214-226
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    • 2019
  • Objectives: The purpose of this study is to review clinical studies of Traditional Chinese medicine (TCM) on Genito-Pelvic Pain/Penetration Disorder (GPPPD) in women. Methods: Key words "Dyspareunia", "Vaginismus" were searched on Chinese National Knowledge Infrastructure Database (CNKI) on April 21th 2019. Results: 2 case reports and 7 clinical trials were collected in accordance with the selection and exclusion criteria. Among the 7 trials, 4 were controlled trials, and 3 were single-arm trials. The types of intervention were herb medication in 8 studies, and compound TCM treatment including acupuncture, moxibustion, and cupping therapy in 1 study. All 4 controlled trials were about dyspareunia and conducted by herbal medicine of TCM. The study results and methods of intervention were analyzed. Conclusions: 2 case reports described the effectiveness of compound TCM treatments (acupuncture, moxibustion, cupping therapy) and herb medicine in dyspareunia. In 4 controlled trials, 2 trials described the effectiveness of herb medicine (oral or vaginal agent) compared to western treatment in dyspareunia, and other 2 trials described no effectiveness of herbal enema compared to danazol. In 3 single-arm trials, 1 trial of dyspareunia and 2 trials of vaginismus described the effectiveness of herb medicine. All the 9 selected studies reported improved or disappeared symptoms of GPPPD, or high effective rate after TCM treatment. There was limitation that the selected studies were retrieved from only one site of CNKI, and generalized results could not be derived, further studies should be carried out. Additional well-designed clinical studies on GPPPD in women are needed in Korea.

한방 임상시험에 참여한 노인 대상자들의 사전 동의에 대한 인식도 조사 (Study on the Perception of Informed Consent for Elderly Subjects Participated in Oriental Medicine Clinical Trials)

  • 김윤영;권지혜;이시우;김호석;유종향
    • 동의생리병리학회지
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    • 제26권2호
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    • pp.248-252
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    • 2012
  • This study aimed to evaluate the perception of informed consent for subjects who are participated in oriental medicine clinical trials and over 60 years old. In this research, 215 subjects who were participated in clinical trials were surveyed between Apr. 13, 2011 and Jul. 20, 2011. And the collected data was analyzed with computer software of SPSS 17.0. In the case of objective perception, almost all of subjects answered that they have ever heard of the consent form. However, 50.7 points were collected for the question of "As I already signed the consent form, I have to participate in the clinical trials", which showed the subjects had misperception about quitting the clinical trials. In the case of subjective perception, subjects well knew that the purpose of clinical trial is research, not medical treatment. However, the perception about the purpose of clinical trials that they are participated in was low. In the both cases of objective and subjective perception with general characteristics, they showed differences (p<0.045) with the marital status of subjects, however other categories did not show any difference. In conclusion, researchers should provide sufficient explanation as well as adequate Information in order to protect the personality of subjects, so that the subjects can make a right decision.

약침을 활용한 비만연구의 실험실적 및 임상적 연구동향 고찰 (Study of Experimentations and Clinical Trials' Trends for Obesity Treatment using Pharmacupuncture)

  • 김민우;송윤경;임형호
    • 한방비만학회지
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    • 제11권1호
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    • pp.47-60
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    • 2011
  • Objectives The objective of this study was to contribute to the development of pharmacupuncture for obesity treatment by reviewing the studies of pharmacupuncture experimentations and clinical trials. Methods We searched the papers with keywords of 'obesity' and 'pharmacupuncture' in the search site, RISS, Oriental medicine advanced searching integrated system(OASIS), Korean traditional knowledge portal, the society of Korean medicine for obesity research, Korean pharmacupuncture institute, the Korean academy of oriental rehabitation medicine and Korean acupuncture & moxibustion society. Results 1. We reviewed 37 articles searched. 27 articles(73.0%) were animal experimentations, 5 articles(13.5%) were cell experimentations, 4 articles(10.8%) were clinical trials and 1 article(2.7%) was study analysis. 2. The herbs, using for animal experimentations, were atratylodes japonica, coix lachrymajobi, ephedra sinica, crataegus pinnatifida, wild ginseng and etc. Acupucture points were joksamni(ST36), zhongwan(CV12), gansoo(BL18), pungnyung(ST40), umnungchon(SP9), bisu(BL20), gokji (LI11), cheun-chu(ST25) and etc. 3. For cell experimentations, preadipocytes and adipocytes performed on cell cultures with using rats, 3T3-L1 preadipocytes and porcine skin including fat tissue were treated with fel ursi, bovis calculus, ephedrae herba, spirodelae herba, wild ginseng. 4. For clinical trials, Sangsik no.1, Bigiheo, ephedra, green tea and sweet bee venom were injected at the region where a lot of fat like zhongwan(CV12), xiawan(CV10), kwanwon(CV4), cheun-chu(ST25) and thigh. Conclusion Through animal and cell experimentations and clinical trials, the treatment of obesity using local acupuncture therapy was effective. For clinical use, however, it is considered that animal and cell experimentation and clinical trial's connection using one kind of herb and studies about more clinical trials and associated side effects are needed.

Review of Pragmatic Clinical Trials on Acupuncture

  • Lee, Sang-Hoon;Seo, Byung-Kwan;Seo, Jung-Chul;Lee, Seung-Deok;Choi, Sun-Mi;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • 제22권2호
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    • pp.163-170
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    • 2005
  • Background : Over the last thirty years, majority of researches on clinical effectiveness of acupuncture have been explanatory (or experimental) randomized controlled trial. The benefits of acupuncture in clinical trials are still controversial and most studies concluded that further control studies were required. Standardized combinations of acupuncture points for all the experimental subjects in various past studies have been criticized because such treatments do not reflect current routine clinical treatment. Objective : This paper aims to review pragmatic clinical trials on the effect of acupuncture treatment and to develop the ideal clinical research methodology of acupuncture study. Method : Clinical studies of acupuncture relevant with pragmatic or individualized trials were searched mainly in Pubmed and Science direct databases. All articles were fully reviewed by researchers, and data were evaluated by usage of a standardized form. Results & Suggestion : Pragmatic acupuncture researches were tried for various symptoms (eg. low back pain, hypertension, depression during pregnancy, sleep quality in HIV disease, chronic poststroke leg spasticity, headache, etc). Individualized acupuncture treatments based on oriental disease pattern diagnosis reflexes practical treatments which is more effective than unified and fixed acupuncture treatments without any theoretical basis of oriental medical philosophy. Conclusion : To overcome the controversies and limitations of past explanatory acupuncture trials, more individualized and tailored acupuncture trials with the theoretical basis of oriental medical diagnosis is highly recommended. Also clear definition and categorization of pattern identification should be established for further active clinical researches and applications of acupuncture.

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한방임상시험센터의 수요 예측에 대한 조사연구 (Survey on the Demand for Clinical Trial Centers for Oriental Medicine)

  • 서정철;김승호;라중덕;정승기;권영규
    • 대한한의학회지
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    • 제26권2호
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    • pp.85-94
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    • 2005
  • Objectives: This study was carried out to estimate the demand for clinical trials and contribute to the consolidation of function and role in the clinical trial centers of oriental medicine. Methods: A survey of the demand was made of 379 faculties of oriental medicine in 11 oriental medical colleges throughout the country using two?part investigations by e-mail questionnaire over 1 month. The final data from 56 faculties were analyzed. Results: Clinical trials of oriental medicine have been continuously increasing. Furthermore, the demand and necessity for clinical trials of oriental medicine have also been continuously enhanced. Although there were arguments for and against the establishment of a clinical trial center for oriental medicine, the demand and necessity for the establishment was the overall consensus. Concerning objections, a high intention of use was observed. Conclusions: These results imply that the demand for clinical trials will increase remarkably through the establishment of a clinical trial center for oriental medicine. Further study is needed about the demand for such a center.

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급성기관지염의 약물중재 임상시험에 대한 체계적 문헌 고찰: 임상시험 가이드라인 개발을 위한 예비연구 (A Systemic Review of Clinical Trials Using Medication for Acute Bronchitis: A Pre-study on the Development of Traditional Korean Medicine Clinical Practice Guideline)

  • 유이란;박소정;이은정;전주현;정인철;박양춘
    • 대한한의학회지
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    • 제38권1호
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    • pp.93-111
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    • 2017
  • Objectives: The aim of this study is to make evidence-based data for developing a traditional Korean medicine clinical practice guideline for acute bronchitis. Methods: We searched 3 international databases(PubMed, EMBASE, CENTRAL) and 7 domestic databases (KoreaMed, Kmbase, NDSL, KISS, KISTI, OASIS, KoreaTK) to identify randomized controlled trials (RCTs) of acute bronchitis using medicine in recent 10 years. The chosen trials were analyzed by their study design, age range, intervention group, control group, primary and second outcome measure, inclusion and exclusion of participants and adverse events. Results: 15 RCTs are finally included in this study and most of their medications are herbal medicine. For diagnosis and outcome measure of acute bronchitis, Bronchitis Severity Score(BSS) was mostly used. Other measurements eligible are coughing fits, quality of life scale, sputum viscosity, change of individual symptoms and patient's satisfaction. Test duration was for average 7days and safety assessment was held by recording adverse events. Except for anti-inflammatory and antibiotic trials, all medications are found to be effective and well-tolerated. General risk of bias of chosen trials is evaluated low. Conclusions: A well designed clinical trials for traditional Korean medicine of acute bronchitis is needed and this study is expected to make it available.

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

  • 김영준;김태령;우창훈;신병철
    • 한방재활의학과학회지
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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.

치과위생사의 임상시험에 대한 인식도 (The perception in regard to the clinical trial of dental hygienists)

  • 장나희;정의정;장계원
    • 한국치위생학회지
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    • 제14권6호
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    • pp.839-847
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    • 2014
  • Objectives: The purpose of the study was to investigate the perception of clinical trials of dental hygienist. Methods: A self-reported questionnaire was filled out by 126 dental hygienists in Seoul, Kyonggi and other area from October 1 to November 15, 2012. The instrument of the study was adapted from Jung and reconstructed. The questionnaire consisted of general characteristics of the subjects(9 questions) and recognition for clinical trials(10 questions). Recognition for clinical trials instrument included recognition for clinical trial conception(2 questions), objective recognition(5 questions), and subjective recognition for clinical trial(3 questions). The instrument was score by Likert 5 scale and Cronbach alpha was 0.936 in the study. Data were analyzed by SPSS 20.0 program and set at p<0.05. Independent t-test, chi-square test, one way ANOVA, and post-hoc Duncan test were done. Results: Those who had higher ages and higher education tended to have longer clinical careers(p<0.05). There was a significant difference in clinical trials between the level of education, clinical dental hygienists and professors. The differences in problem perception for activation of clinical trial according to workplace appeared to lack of publicity and inadequacy of facilities(p<0.05). Conclusions: To improve the perception of the clinical trials in dental hygienists, it is necessary to prepare the human resources programs, the additional curricula, continuing education courses and active publicity.