• Title/Summary/Keyword: Trials

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Gemcitabine Alone or in Combination with Cisplatin for Advanced Biliary Tract Carcinomas: an Overview of Clinical Evidence

  • Sun, Tian-Tian;Wang, Ji-Lin;Fang, Jing-Yuan
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.2
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    • pp.877-883
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    • 2013
  • Background and Objective: There has been no universally agreed standard chemotherapy regimen for patients with advanced biliary tract carcinomas (BTC). We aimed to fully display and evaluate the clinical evidence for gemcitabine or gemcitabine-cisplatin combination for advanced BTC. Methods: Systematic searches were performed to identify relevant randomized controlled trials (RCTs) and uncontrolled trials. Overall survival (OS), progression-free survival (PFS), overall response rates (ORR), tumor control rates (TCR), and toxicity were evaluated. Evidence levels of the results were evaluated with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Results of the eleven gemcitabine-cisplatin trials and ten gemcitabine trials showed both chemotherapy regimens had benefits with reference to mean OS (8.63 vs. 8.79 months), mean PFS (4.86 vs. 4.72 months), pooled ORR (25.3% vs. 19.6%) and TCR (55.2% vs. 53.1%). Two RCTs showed the gemcitabine-cisplatin combination to prolong the mean PFS (mean difference [MD] 2.57, 95%CI 1.69 3.45), substantially increasing the mean OS (MD 3.59, 95% CI 3.48 3.71), and producing a similar effect in ORR (risk ratio [RR] 1.59, 95%CI 1.04 2.43), increasing TCR (RR 1.15, 95%CI 1.02 1.31) compared with gemcitabine alone, with generally manageable grade 3 or 4 adverse events. The evidence level of OS was moderate, and other outcomes (ORR, PFS, TCR, anaemia, neutropenia) were at low evidence levels. Conclusion: Available evidence was limited with low quality, which showed that both gemcitabine-cisplatin and gemcitabine alone had clinical activity with acceptable safety profiles, and gemcitabine-cisplatin appeared to be more useful for advanced BTC patients than gemcitabine alone.

A Study on the Guidelines for IMO Maritime Autonomous Surface Ships(MASS) (IMO 자율운항선박 가이드라인 분석에 관한 연구)

  • Park, Han-Seon;Cha, Chong-ju;Jo, Min-chul
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 2019.11a
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    • pp.137-138
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    • 2019
  • The International Maritime Organization (IMO) adopted the Circular 101 (MSC / Circ. 1604) as an interim guidelines for MASS trials at the 101st Maritime Safety Committee. This guideline will be used as a guideline for the sea trials of Maritime Autonomous Surface Ships(MASS) in the future and will be used by government authorities and stake-holders to secure infrastructure for MASS safety, environmental protection and remote operation. The purpose of this study is to analyze the Interim Guidelines for MASS Trials adopted by IMO and to clearly classify the responsibilities and obligations of governments of stake-holders, and to present the main points of risk management necessary for maritime test operation from the perspective of human factors.

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The Effects of Habituation and Sensitization on Psychophysiological Differentiation of Responses to Auditory Stimulation with Automobile Horns

  • Estate M. Sokhadze;Sohn, Jin-Hun
    • Science of Emotion and Sensibility
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    • v.3 no.2
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    • pp.17-28
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    • 2000
  • Psychoacoustic characteristics of automobile horns play significant role in resulting subjective evaluation and psychphysiological reactions. However, comparison and differentiation of physiological responses to commercially available horns is a complicated task due to the small contrast in technical features of horns and the influence of such processes as habituation on physiological outcome with the increased number of auditory stimulation trials. In a study on 10 college students, there was performed comparative analysis of reactivity of physiological responses mediated by central and autonomic nervous systems in order to identify the role of habituation on decrement of psychophysiological responsivity and assess the ability to differentiate subjectively most and least preferred, as well as most and least appropriate horns according to physiological manifestations. The EEG and autonomic responses to 7 automobile horns were analyzed during 3 blocks of trials, with varying order of stimuli and changed acoustic parameters of horns in each block. Thus, responses were analyzed for totally 21 trials of auditory stimulation. It was shown that electrodermal and cardiovascular responses have different reactivity patterns to repeated stimulation: skin conductance measures habituated, cardiac reactivity showed no signs of habituation, and the vascular response demonstrated sensitization. The temporal EEG exhibited marked habituation of fast beta band power, while alpha-blocking effect did not habituate during the course of experiment. Differentiation of physiological responses of most and least preferred and appropriate horns was possible in our study, however, some cardiovascular reactivity measures differentiated during the entire course of the experiment, while EEG and electrodermal parameters showed significant differences only during first block of trials, and were later affected by the habituation.

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Acupuncture Treatment of Plantar Fasciitis: A Literature Review (족저근막염의 침치료에 대한 국내외 연구동향 분석)

  • Koh, Nak-Yong;Kim, Chang-Gon;Ko, Youn-Suk;Lee, Jung-Han
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.2
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    • pp.97-110
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    • 2015
  • Objectives Plantar fasciitis is one of the most common causes of heel pain. Plantar fasciitis can be managed with acupuncture, but the evidence for its effectiveness is uncertain. The aim of this review was to assess the effectiveness of acupuncture for plantar fasciitis. Methods I searched specific Korean and foreign electronic databases (KCI, RISS, NDSL, OASIS, KTKP, National Assembly Library, KMbase, PubMed, The Cochrane Library and China National Knowledge Infrastructure). The key search terms were 'heel pain', 'plantar fasciitis' and 'acupuncture'. Twenty-seven trials were included; eleven case reports, fourteen randomized controlled trials (RCTs) and two non-randomized controlled trials (NRCTs). Results Twenty-seven studies reported that acupuncture treatment reduced plantar fasciitis pain. However, the evidence provided by the case reports was regarded as weak because the methodological quality was poor, and the placebo effect of acupuncture was not accounted for in the RCTs and NRCTs. Overall, the methodological quality of the RCTs and NRCTs was weak. Conclusions There is some evidence for the effectiveness of acupuncture for plantar fasciitis. However, in order to reinforce the evidence for acupuncture's effectiveness, additional placebo-controlled trials with well-designed methodologies are required.

Clinical Research of the Effect of Traditional Herbal Medicine with In Vitro Fertilization and Embryo Transfer in Pubmed (체외 수정과 한약 치료 중재에 대한 임상연구 동향 - Pubmed를 중심으로 -)

  • Lee, Mi-Joo;Son, Sung-Se;Park, Seung-Hyeok;Park, Kyoung-Sun;Hwang, Deok-Sang;Lee, Jin-Moo;Jang, Jun-Bock;Lee, Chang-Hoon
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.4
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    • pp.89-109
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    • 2018
  • Objectives: The purpose of this systematic review is to assess the effects of herbal medicine with in vitro fertilization-embryo transfer (IVF-ET) based on the current evidence. Methods: Eligible randomized controlled trials (RCT) searched from Pubmed which compared a combination of herbal medicine and IVF with IVF alone were included. Results: Sixteen trials, in which 2025 women involved, were included in this review. The review results showed that the effect of traditional herbal medicine can improve the clinical pregnancy rate (herbal medicine intervention: 30.36~63.64%, Control: 9.38~47.5%) and rate of high quality oocytes and embryos. The mechanism may be through regulating follicular fluid to improve microenvironment for oocytes which would lead to a successful embryo implantation. Conclusions: This analysis showed that combination of IVF and traditional herbal medicine used in the included trials improve clinical pregnancy rate and IVF success. During in vitro fertilization, TCM can regulate the microenvironment in the follicular fluid to mature the oocyte, improve the quality of the embryo, and help the development and implantation of the embryo. Further large randomized placebo controlled trials are needed to confirm the effectiveness of traditional herbal medicine with concurrent IVF.

Is Gwibitang and its modification beneficial for alleviating symptoms in chronic fatigue syndrome: A systematic review and meta-analysis (귀비탕과 그 변방의 만성피로증후군 증상완화에 대한 효용성: 체계적인 문헌고찰)

  • Nam, Donghyun
    • Herbal Formula Science
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    • v.28 no.2
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    • pp.199-209
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    • 2020
  • Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I2=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

Systematic Review of Bee Venom Therapy for Traumatic Injury (임상에서 흔히 접하는 외상성 손상에 대한 봉독약침요법의 체계적 문헌고찰)

  • Lee, Jae-Eun;Lee, Chi-Ho;Lee, Eun-Jung;Lee, Jung-Min;Oh, Min-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.26 no.3
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    • pp.67-77
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    • 2016
  • Objectives To evaluate the evidence supporting the effectiveness of Bee Venom therapy for traumatic injury. Methods We conducted search across 3 electronic databases (Pubmed, CAJ and Oasis) to find clinical trials that used Bee Venom therapy as treatment for traumatic injury. The methodological quality of RCTs (Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 87 articles that were searched, 10 RCTs and 19 NRCTs were finally selected. Among 19 selected studies, all studies showed that Bee Venom therapy has significant effect on traumatic injury. Conclusions Our systematic review found encouraging but limited evidence of Bee Venom therapy for traumatic injury. We recommend clinical trials which compare the effectiveness of Bee Venom therapy with other pharmacopuncture therapies to clarify the effectiveness of Bee Venom therapy from other pharmacopuncture therapies.

A Systematic Review of the Effectiveness of Eastern-Western Integrative Medicine for Musculoskeletal Disorders (근골격계 질환의 한·양방협진치료 효과 연구에 대한 체계적 문헌 고찰)

  • Lee, Seung-Jin;Shin, Byung-Cheul;Song, Geun-Sung;Hwang, Eui-Hyoung;Yun, Young-Ju;Cho, Hyun-Woo
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.4
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    • pp.87-96
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    • 2011
  • Objectives: This study aims to systematically evaluate the effectiveness of Eastern-Western integrative medicine for musculoskeletal disorders compared with Eastern or Western Medicine. Methods: Systematic sea-mes of 9 major Korean databases were conducted for articles published up to July 2011. Searching keyword was "Integrative Medicine". Prospective studies dealt with musculoskeletal disorders by Eastern-Western integrative medicine were included. Quality assessment of included studies was evaluated by Cochrane risk of bias tool. Results: 470 studies in total were seamed, Amalg them 7 studies met our inclusion criteria(3 randomized controlled clinical trials, 2 non-randomized controlled trials and 2 uncontrolled clinical trials). Included studies dealt with lumbar pan(3), shoulder pain(2), pain after traffic injury(1), spinal compression fracture(1). Eastern-Western integrative medicine showed better or equal effect for the treatment of various muscloskeletal disorders compared with Eastern or Western medicine alone. Conclusions: There is very weak evidence for the effectiveness of Eastern-Western integrative medicine for musculoskeletal disorders compared with Eastern or Western medicine alone. Well designed randomized controlled trials with rigorous methodology are needed to evaluate the effectiveness of Eastern-Western integrative medicine objectively in the future.

The State of Clinical Trials on Acupotomy for Lumbar Disc Herniation in China (요추 추간판 탈출증에 대한 중국 내 도침 임상 연구의 현황 분석)

  • Jun, Purumea;Liu, Yan;Park, Ji-Eun;Jung, So-Young;Han, Chang-Hyun
    • Journal of Korean Medicine Rehabilitation
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    • v.27 no.2
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    • pp.39-54
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    • 2017
  • Objectives This study aimed to search the Chinese literature on acupotomy for lumbar disc herniation and to analyze their methodologies. Methods Using 4 Chinese databases (CBM [www.sinomed.ac.cn], CNKI [www.cnki.net], WANFANG [www.wanfangdata.com], and WEIPU [www.cqvip.com]), we searched for clinical trials conducted in China over the past 10 years on acupotomy for lumbar disc herniation. The search terms used were "(腰椎椎間板脫出症 or 椎間板脫出症 or 椎間板脫出) and (针刀or 针刀松解术)" and we selected only meta-analyses that were published before December 2016. From among these meta-analyses, we excluded duplicates and selected the remaining 36 randomized controlled trials (RCTs) for our final analysis. Results The largest numbers of acupotomy papers were published in 2008 and 2013 (8 papers each). The average number of subjects was 120; the most common treatment method used for the control group was standard acupuncture (in 11 papers), and the most common concurrent treatment in the treatment group was massage (in 10 papers). The most common site of needle insertion was between the spinous processes, or at less than 0.5 cm on either side of the spinous processes (in 24 papers). The most common site of adhesion lysis was at the transverse process (in 24 papers). Two studies were blinded, and the mean Jadad score was 1.17. Conclusions A large number of RCTs on the use of acupotomy for lumbar disc herniation are conducted every year in China, and the procedure has been shown to be very effective, with few adverse effects. However, the average quality of the studies was not very high. Based on our study, we expect several high-quality clinical trials on acupotomy to be conducted in Korea in the future.

Analysis of the statistical validity of clinical effectiveness data of a systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent (Insadol) (경구용 옥수수불검화정량추출물 치료제(인사돌)의 임상적 유효성 데이터의 통계적 타당성에 대한 연구)

  • Choi, Yong-Geun;Eckert, Steven E;Lee, Jeong-Yol;Shin, Sang-Wan
    • The Journal of the Korean dental association
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    • v.53 no.7
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    • pp.476-484
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    • 2015
  • Purpose: This study intended to analyze the validity of clinical effectiveness data of clinical trials testing systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent. Material and Methods: Among 5 clinical trials claimed as proof of clinical effectiveness on the Web site of the manufacturer of this chemotherapeutic agent, a review of 4 clinical trials, written in either Korean or English, was conducted. Data were extracted from studies for the following variables: year of publication, age, sample size, follow-up period, combination with contemporary periodontal treatments, randomization, randomization check, blinded measurement, and statistical test type. Results: The study subjects' age intervals were too diverse to decide a common target population to generalize the findings. No study stated clearly the rationale for the sample size determination. Follow-up period to observe the start of clinical effectiveness was inconsistent and decided without any rationale of pathophysiological latent period. Randomization to make the comparisons on the same start line was performed but failed in a study. Randomization effect was not checked in 4 studies. Performance of blinded measurement of clinical outcomes to prevent bias was unclear in 2 studies. Type of statistical test was inappropriate in 3 studies. Conclusions: Based on the analysis of the validity of data on clinical and demographic variables, the four available clinical trials have not demonstrated compelling evidence of therapeutic effectiveness of systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent to improve prognosis of periodontal disease either with the contemporary periodontal treatment or without it.