• Title/Summary/Keyword: randomized clinical trial

검색결과 912건 처리시간 0.023초

Safety and Efficacy of Flow Diverter Therapy for Unruptured Intracranial Aneurysm Compared to Traditional Endovascular Strategy : A Multi-Center, Randomized, Open-Label Trial

  • Kim, Junhyung;Hwang, Gyojun;Kim, Bum-Tae;Park, Sukh Que;Oh, Jae Sang;Ban, Seung Pil;Kwon, O-Ki;Chung, Joonho;Committee of Multicenter Research, Korean Neuroendovascular Society,
    • Journal of Korean Neurosurgical Society
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    • 제65권6호
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    • pp.772-778
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    • 2022
  • Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

Clinical and microbiological effects of the supplementary use of an erythritol powder air-polishing device in non-surgical periodontal therapy: a randomized clinical trial

  • Park, Eon-Jeong;Kwon, Eun-Young;Kim, Hyun-Joo;Lee, Ju-Youn;Choi, Jeomil;Joo, Ji-Young
    • Journal of Periodontal and Implant Science
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    • 제48권5호
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    • pp.295-304
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    • 2018
  • Purpose: This study was undertaken to evaluate the clinical and microbiological effects of an erythritol powder air-polishing device (EPAP) as a supplement to scaling and root planing (SRP) therapy in patients with moderate chronic periodontitis. Methods: Clinical and microbiological evaluations were performed at 21 sites treated with SRP (control) and 21 sites treated with SRP+EPAP (test). All examinations were performed before treatment, 1 month after treatment, and 3 months after treatment. Results: There were no significant clinical differences between the test group and the control group. Microbiological analysis revealed that the relative expression level of Porphyromonas gingivalis was significantly lower in the test group than in the control group at 1 month after treatment. Clinical and microbiological results showed improvements at 1 month compared to baseline; in contrast, the results at 3 months after treatment were worse than those at 1 month after treatment. Conclusions: In this study, both SRP and SRP+EPAP were clinically and microbiologically effective as non-surgical periodontal treatments. In particular, the SRP+EPAP group showed an antimicrobial effect on P. gingivalis, a keystone bacterium associated with the onset of chronic periodontitis, in a short-term period. Periodic periodontal therapy, at intervals of at least every 3 months, is important for sustaining the microbiological effects of this treatment.

소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 - (The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP-)

  • 정윤경;최서연;방미란;이보람;장규태
    • 대한한방소아과학회지
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    • 제38권1호
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

소아 야뇨의 한약치료에 대한 임상연구 동향 -중의학 논문을 중심으로- (Review of Clinical Researches for Herbal Medicine Treatment on Nocturnal Enuresis in Children)

  • 신혜진;이보람;이지홍;장규태
    • 대한한방소아과학회지
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    • 제32권2호
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    • pp.43-63
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    • 2018
  • Objectives The purpose of this study is to evaluate the efficacy and safety of herbal medication for the treatment of nocturnal enuresis in children by analyzing randomized controlled trials conducted in China. Methods We searched literatures from China National Knowledge Infrastructure published up to 19 January, 2018. Selected literatures were collected and analyzed in order of publication year, and then demographic information, treatment method, duration of illness, duration of treatment, follow-up period, outcome measurement and adverse events. Results A total of 34 studies were selected for the analysis. In most studies, the total efficacy of the treatment group was reported to be higher than that of the control group, and the recurrence rate and complete cure rate were also found to be more effective in the herbal medicine treatment group. The most frequently used medical herb was Alpiniae Fructus (益智仁), and the use of medical herbs belong to tonifying yang (補陽藥), tonifying qi (補氣藥), and astringing essence strengthening collapse medicine (澁精縮尿止帶藥) were relatively high. The adverse events rate for the herbal medicine treatment group were significantly lower than those in the Western medicine treatment group. Conclusions This study showed that a herbal medicine treatment can be effective and safe option for treating pediatric nocturnal enuresis. However, additional well-designed clinical studies need to be performed to establish a basis.

자하거 약침의 신경정신과 임상 응용에 관한 체계적 문헌 고찰 (A Systematic Review of Placenta Pharmacopuncture for Neuropsychiatric Diseases in Practice)

  • 신혜규;이재혁;강형원
    • 동의신경정신과학회지
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    • 제33권2호
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    • pp.157-180
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    • 2022
  • Objectives: To perform a systematic review of placenta pharmacopuncture for treating neuropsychiatric diseases, focusing on its efficacy and the safety so that evidence on its clinical use could be obtained, thus contributing to further studies. Methods: Through Korean, English, and Chinese databases (OASIS, Korean TK, KISS, RISS, ScienceON, Pubmed, Cochrane, EMBASE, CINAHL, AMED, CNKI, and Wanfang), combinations of keywords (placenta, pharmacopuncture, etc.) were used to select clinical studies published until January 2021 about placenta pharmacopuncture for neuropsychiatric diseases. Interventions included combined treatments. Study design included cases studies, series, and clinical trials. Cohort studies, literature reviews, in vitro and animal experiments were excluded. The primary outcomes involved measurements of symptoms, Visual Analogue Scale, or questionnaires. Data extracted from databases were imported to Endnote X7 to remove duplicates. The quality of the literature was assessed based on CAse REports Guidelines and Cochrane's Risk of Bias (ROB). Results: Twenty-one studies were selected, including ten case reports, three case series, two one-armed clinical trials, one non-randomized clinical trial, and five randomized clinical trials. There were six studies on sleep disorders, five studies on stroke sequela, two on mood disorders, two on enuresis, two on Guillain-Barré syndrome, two on multiple sclerosis, one on neurocognitive disorder, and one on vertigo. The most frequent combined treatment was acupuncture in both the experimental group (n=10) and the control group (n=3). Acupoints were ST36, SP6, BL23, CV4, GB20, GV20, N-HN54, and so on. All studies reported improvement of symptoms. The quality of case studies was relatively high. Assessment of ROBs resulted in low risks. Conclusions: Placenta pharmacopuncture is effective for neuropsychiatric diseases such as sleep disorders, mood disorders, enuresis, and neurocognitive disorders. Regarding insomnia, several studies have reported significant improvements with placenta pharmacopuncture. There was no adverse event associated with placenta pharmacopuncture.

기능성 자궁출혈에 대한 한약치료 : 체계적 문헌 고찰 (Traditional Herbal Medicine for Dysfunctional Uterine Bleeding versus Western Medicine: A Systematic Review of Randomized Controlled Trials)

  • 박어진;조희근;최지현
    • 대한한방부인과학회지
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    • 제31권4호
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    • pp.110-127
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    • 2018
  • Objectives: To evaluate the effectiveness and safety of traditional herbal medicine (THM) in the treatment of dysfunctional uterine bleeding (DUB) versus conventional western medicine. Methods: Randomized Controlled Trials (RCTs) comparing THM vs. conventional western medicine for DUB, were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, KISS and OASIS. The risk of bias was assessed by using Cochrane's risk of bias tool. Results: 16 RCTs with 1,659 patients were identified and reviewed. 10 RCTs reported THM was statistically effective than control group in effective rate. Also recurrent rate was estimated in 6 RCTs and was lower than control group. 7 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: Despite several limitations, this review suggested that THM was safe and effective in the treatment of DUB. THM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more sternly designed trials are warranted.

Systematic Review of Fire Needling or Warm Needling Treatment for Ankle Sprain

  • Ko, Hong Je;Yoo, Jae Hee;Kim, Min Wook;Shin, Jeong Cheol
    • Journal of Acupuncture Research
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    • 제37권1호
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    • pp.19-27
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    • 2020
  • The effectiveness of fire needling or warm needling treatment in clinical studies for the treatment of ankle sprains was reviewed using 4 international (PubMed, Cochrane library, EMBASE, CNKI) and 5 Korean databases (NDSL, RISS, KISS, OASIS, KTKP). Randomized controlled trials, that performed fire needling or warm needling treatment for ankle sprains until October, 2018 were retrieved (n = 8). All studies were performed in China, and 7 out of 8 studies were published within the last 5 years. There were 4 studies that used fire needling treatment, 3 studies used warm needling treatment, and 1 study used fire and warm needling treatment. The ashi-points and gallbladder meridian were the most frequently selected acupoint and meridian each. All intervention groups in the 8 studies showed statistically significant beneficial effects compared with control groups. The results of this study could provide preliminary data as the basis for well-designed randomized controlled trials on fire needling or warm needling treatment for ankle sprains.

척추전방전위증의 추나 치료에 대한 체계적 문헌 고찰 및 메타 분석 (Chuna Manual Therapy for Spondylolisthesis: A Systematic Review and Meta-analysis)

  • 홍수민;하현주;윤광식
    • 한방재활의학과학회지
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    • 제30권4호
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    • pp.65-77
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    • 2020
  • Objectives This study is aimed to evaluate the effectiveness of Chuna therapy for spondylolisthesis. Methods We searched th following 10 online databases without a language restriction (National Digital Science Library [NDSL], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS], KMBASE, MEDLINE/PubMed, Cochrane library, Ebscohost, EMBASE, Ovid, China National Knowledge Infrastru [CNKI]) to find randomized controlled trials that used Chuna therapy for spondylolisthesis. The methodological quality of each randomized controlled clinical trial was assessed using the Cochrane risk of bias tool and meta-analyses were perfomed. Results Eleven randomized controlled trials were included. Chuna therapy showed statistically significant reduction of symptoms. Meta-analysis showed positive results for Chuna therapy for spondylolisthesis in terms of therapeutic effects to traction, chinese medicine, therapeutic exercise. Conclusion In this study, we reviewed studies about Chuna therapy used for spondylolisthesis. The studies showed that Chuna therapy can significantly effective on spondylolisthesis. But according to Cochrane risk of bias evaluation method, most of the studies's risk of bias were unclear. Therefore, more high-quality studies will be needed.

위축성 질염에 대한 한약 투약의 효과 : 체계적 문헌 고찰 (Application of Traditional East Asian Herbal Medicine for Atrophic Vaginitis: A Systematic Review of Randomized Controlled Trials)

  • 박어진;조희근
    • 대한한방부인과학회지
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    • 제32권3호
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    • pp.227-244
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    • 2019
  • Objectives: To evaluate the effectiveness and safety of application of Traditional East Asian Herbal Medicine (TEAM) in the treatment of Atrophic Vaginitis (AV). Methods: Randomized Controlled Trials (RCTs) were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, and KISS. The risk of bias was assessed by using Cochrane's risk of bias tool, and RevMan 5.3 software was used. Results: 26 RCTs with 3,162 patients were identified and reviewed. Among them, 21 RCTs observe the effect of integrated traditional Chinese and Western medicine. 23 RCTs reported treatment groups was statistically effective than control groups in the study. Also, the recurrence rate was estimated in 10 RCTs and was lower than control groups. 12 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: This review suggested that TEAM was safe and effective in the treatment of AV. TEAM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, well-designed trials with larger sample sizes are needed.

항문생식기 헤르페스에 대한 한의학적 치료의 국내외 연구동향 분석 (A Review of the Effect of Korean Medicine on Genital Herpes)

  • 박연경;박치영
    • 대한한방부인과학회지
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    • 제31권1호
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    • pp.99-121
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    • 2018
  • Objectives: Genital herpes is common disease in gynecological field. Although various treatment options such as herbal medicine, acupuncture, moxibustion are used in genital herpes, there is not enough evidence about the treatment options. This study is to prove the efficacy of oriental medicine on genital herpes by investigating papers and suggest direction of future research. Method: We searched for papers which had both genital herpes and oriental medicine from Cochrane, Pubmed, Scopus, CNKI, Oasis, Korean traditional knowledge portal, Journal of Korean Obstetrics & Gynecology up to November 2017. After searching papers, we classified according to the study design and analyzed selected studies. Results: Sixteen papers were finally selected. Four papers are laboratory studies with Hartley guinea pig with recurrent genital herpes. Twelve papers are clinical trials which includes one single group trial, one controlled trial, ten randomized controlled trials. All of the studies have shown that herbal medicine is effective in improving the symptom of genital herpes and decreasing the recurrent rate of genital herpes and also has immunoregulatory effect. Conclusions: This study shows that herbal medicine could be a good treatment option for genital herpes. However, more well-designed clinical studies and laboratory studies will be needed.