• 제목/요약/키워드: Human trials

검색결과 389건 처리시간 0.032초

RCT논문을 중심으로 한 퇴행성 슬관절염 침구 치료 방법에 대한 고찰 (Review of Randomized Controlled Trials on Ideal Acupuncture Treatment for Degenerative Knee Osteoarthtritis)

  • 김은정;이승덕;정찬영;윤은혜;장민기;남동우;김현욱;이은용;김경호;이건목;이재동;김갑성
    • Journal of Acupuncture Research
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    • 제26권2호
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    • pp.125-145
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    • 2009
  • Objectives : To analyze the inclusion criteria of participants, control group interventions, and the results of prior studies of acupuncture for OA. Also to identify aspects of the procedure that are associated with positive outcomes in order to establish ideal acupuncture treatment model. And to assess the methodological quality of the trials with modified Jadad score and FEAS in order to evaluate the quality of prior studies and find out whether or not acupuncture has a positive effect in treating OA. Methods : Articles up to the date of November 2008 were searched via computerized databases of PubMed, Journal of Korean Oriental Medicine, The Journal of Korean Acupuncture & Moxibustion Society and Journal of Oriental Rehabilitation Medicine. Bibliographies of reviewed papers were also searched and reviewed. Only randomized controlled trials (RCTs) and systematic reviews concerning the effects of acupuncture or electroacupuncture (EA) on symptoms of osteoarthritis of the human knee, published in English and Korean were included. The acupuncture treatment methods of the reviewed trials were assessed based on STRICTA. And the methodological quality of the trials was assessed by modified Jadad score and FEAS. Results : Twenty one trials of acupuncture for OA were analyzed. Based on the results of this review the following factors might contribute to optimal results from acupuncture treatment. 1) Usage of $ST_{35}$, $GB_{34$, $EX_{32}$, $ST_{36}$ and $SP_9$ acupuncture points. 2) More than four acupuncture points should be used. 3) More than 15 minutes of needle retention time. 4) Needle length-40mm and diameter-0.30mm 5) Usage of EA 6) more than 10 times treatment 7) Treatment frequency of more than once a week, 8) Treatment duration longer than 6 to 8 weeks. Conclusions : High quality clinical trials of Acupuncture for OA is still in lack. Future investigators must concentrate their attentions on the quality of acupuncture treatment itself used in the trials as well as the methodological quality of trials.

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Effect of sodium bicarbonate supplementation on two different performance indicators in sports: a systematic review with meta-analysis

  • Lino, Ramon Souza;Lagares, Laura Souza;Oliveira, Caio Victor Coutinho;Queiroz, Ciro Oliveira;Pinto, Lelia Lessa Teixeira;Almeida, Luiz Alberto Bastos;Bonfim, Eric Simas;dos Santos, Clarcson Placido Conceicao
    • 운동영양학회지
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    • 제25권1호
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    • pp.7-15
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    • 2021
  • [Purpose] Sodium bicarbonate shows ergogenic potential in physical exercise and sports activities, although there is no strong evidence which performance markers show the greatest benefit from this supplement. This study evaluated the effects of sodium bicarbonate supplementation on time trial performance and time to exhaustion in athletes and sports practitioners. [Methods] A systematic review was conducted using three databases, including 17 clinical trials. Among these clinical trials, 11 were considered eligible for the meta-analysis according to the criteria for the assessment of methodological quality using the PEDro Scale. Time to exhaustion was assessed in six studies, while time trial performance was evaluated in five studies. [Results] A significant beneficial effect of supplementation on time to exhaustion was found in a random effects model (1.48; 95% confidence interval [CI], 0.49 to 2.48). There was no significant effect of supplementation on time trial performance in a fixed effects model (slope = -0.75; 95% CI, -2.04 to 0.55) relative to a placebo group. [Conclusion] Sodium bicarbonate has the potential to improve sports performance in general, especially in terms of time to exhaustion.

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.

새로운 당뇨병 치료제 Pramlintide의 Systematic Review (Systemic Review of Pramlintide, a New Drug for the Treatment of Diabetes Mellitus)

  • 스리니바산 샨무감;정희용;용철순;최한곤;김정애;유봉규
    • 약학회지
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    • 제50권6호
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    • pp.386-392
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    • 2006
  • Pramlintide, a synthetic analogue of human hormone amylin, is the first of a new class of amylinomimetic compounds. Present study was undertaken to compile and analyze the clinical trials of pramlintide, and thereby to facilitate the design of the bridging study for the earlier introduction of the drug, which might be needed by diabetes patients in Korea. Sixty-two articles from Pubmed and MEDLINE search were used to analyze the trials of pramlintide along with prescribing information and New Drug Application packet obtained form the manufacturer. The efficacy of the new drug was attributed to three mechanisms: delay of gastric emptying time, inhibition of post-prandial glucagon secretion, and reduction of food intake by enhanced satiety. Clinical trials consistently identified the effectiveness of the drug for the treatment of type 1and type 2 diabetes who have failed to achieve glycemic control despite optimal therapy with insulin. However, the six pivotal Phase III clinical trials were peformed with mostly caucasian and some black and hispanic people. None of the trials documented the proportion of either Asian or Korean participants. Since Korean diabetes patients show different epidemiology and characteristics in their disease state, it appears that the bridging study of pramlintide should be designed in the level of full scale Phase III clinical trial along with pharmacokinetic and pbarmacodynamic studies.

Chicken Egg Yolk Antibodies (IgY) for Prophylaxis and Treatment of Rotavirus Diarrhea in Human and Animal Neonates: A Concise Review

  • Thu, Hlaing Myat;Myat, Theingi Win;Win, Mo Mo;Thant, Kyaw Zin;Rahman, Shofiqur;Umeda, Kouji;Nguyen, Sa Van;Icatlo, Faustino C. Jr.;Higo-Moriguchi, Kyoko;Taniguchi, Koki;Tsuji, Takao;Oguma, Keiji;Kim, Sang Jong;Bae, Hyun Suk;Choi, Hyuk Joon
    • 한국축산식품학회지
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    • 제37권1호
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    • pp.1-9
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    • 2017
  • The rotavirus-induced diarrhea of human and animal neonates is a major public health concern worldwide. Until recently, no effective therapy is available to specifically inactivate the rotavirion particles within the gut. Passive immunotherapy by oral administration of chicken egg yolk antibody (IgY) has emerged of late as a fresh alternative strategy to control infectious diseases of the alimentary tract and has been applied in the treatment of diarrhea due to rotavirus infection. The purpose of this concise review is to evaluate evidence on the properties and performance of anti-rotavirus immunoglobulin Y (IgY) for prevention and treatment of rotavirus diarrhea in human and animal neonates. A survey of relevant anti-rotavirus IgY basic studies and clinical trials among neonatal animals (since 1994-2015) and humans (since 1982-2015) have been reviewed and briefly summarized. Our analysis of a number of rotavirus investigations involving animal and human clinical trials revealed that anti-rotavirus IgY significantly reduced the severity of clinical manifestation of diarrhea among IgY-treated subjects relative to a corresponding control or placebo group. The accumulated information as a whole depicts oral IgY to be a safe and efficacious option for treatment of rotavirus diarrhea in neonates. There is however a clear need for more randomized, placebo controlled and double-blind trials with bigger sample size to further solidify and confirm claims of efficacy and safety in controlling diarrhea caused by rotavirus infection especially among human infants with health issues such as low birth weights or compromised immunity in whom it is most needed.

10℃ 환경에서 기류가 겨울철 패딩 의류의 한 벌 보온력에 미치는 영향 -인체 착용 및 서멀마네킹 측정 비교- (Effects of Air Velocity on the Thermal Insulation of Winter-padded Clothing Ensembles at 10℃ Air Temperature -Comparison of Human Wear Trials with a Thermal Manikin-)

  • 백윤정;조가영;홍유진;이주영
    • 한국의류학회지
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    • 제45권4호
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    • pp.703-713
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    • 2021
  • This study was to investigate the thermal insulation of clothing ensembles, including padded jackets with two different filling types. Thermal insulation of the ensemble was measured using a thermal manikin in four conditions (10℃, 30% RH and 20℃, 50% RH with an air velocity of less than 0.15 m·s-1 and 1.5 m·s-1). Ten males participated at 10℃ and 30% RH with an air velocity of less than 0.15 m·s-1 and 1.5 m·s-1. The results showed that the polyester ensemble was warmer than a goose down ensemble in 0.15 m·s-1 conditions and the goose down ensemble had greater thermal insulation than the polyester ensemble at an air velocity of 1.5 m·s-1. Thermal insulation was reduced 5-7% when temperature decreased 10℃ and reduced 40-50% when air velocity reached 1.5 m·s-1 for both ensembles. Thermal insulation of the ensemble in human trials decreased more than a thermal manikin at 10℃, 30% RH with an air velocity of 1.5 m·s-1. Lower temperatures and human trials were effective in identifying the properties of the thermal insulation by filling types even though there were restrictions on the general application because of two types of a clothing ensemble.

초대받은 임상시험: 한국 임상시험 산업화 과정에서 생명자본(biocapital)과 윤리 가변성(ethical variability) (Invited Clinical Trials: Biocapital, Ethical Variability, and the Industrialization of Clinical Trial in Korea)

  • 송화선;박범순
    • 과학기술학연구
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    • 제18권3호
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    • pp.1-45
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    • 2018
  • 한국은 최근 세계 임상시험 중심지의 하나로 떠올랐다. 임상시험을 가장 많이 한 국가 순위에서 미국과 독일 등 전통적 제약 강국에 이어 6위를 차지했고, 도시별 순위에선 서울이 1위 자리에 올랐다. 이 논문은 한국에서 임상시험이 급격하게 증가한 배경으로 수요공급의 시장 메카니즘 외에 다른 요인, 즉 정부의 임상시험 산업화 정책이 중요했음을 보일 것이다. 1990년대 말 금융위기 이후 정부는 바이오테크놀로지(BT)를 차세대 국가 성장 동력으로 정하고 이를 위한 정책개발에 심혈을 기울였다. 바로 이러한 맥락에서 다국적 제약사의 임상시험을 국내에 유치하고 이 분야를 키울 계획을 세우게 된 것이다. 정부가 제도정비, 인프라 구축, 관련 인력 양성 및 국민의식 개선 등의 작업을 수행하는 가운데, 해외 CRO(Contract Research Organization: 임상시험수탁기관)가 들어와 사업을 시작했고, 국내 업체들도 생겨났다. 한국에서 임상시험은 정부에 의해 '초대?된 것이다. 이 논문은 한국의 임상시험 산업화 과정 속에 묻혀있는 생명윤리의 문제를 끄집어내 다루고자 한다. 이를 위해 최근 인류학과 과학기술학에서 논의되고 있는 ??생명자본?? (biocapital)과 ??윤리 가변성??(ethical variability)의 개념을 활용하여, 임상시험을 둘러싼 주요 행위자인 정부 담당자, CRO 직원, 병원 의료진, 환자 등이 실제로 어떤 동기와 목적을 가지고 여기에 참여했는지를 사회 구조적 관점에서 분석할 것이다. 임상시험 참여자의 동의서를 받고, IRB의 심의를 통과하고, 국제기준을 충분히 만족시킨다고 해도, 실제 상황에선 생명윤리의 원칙이 무시될 여지는 충분히 있고, 국가의 산업육성 프레임 안에서 생명윤리는 관련 서류를 갖추면 되는 절차상의 문제로 환원될 수 있음을 보일 것이다.

대한민국 동하절기 해군 함상복의 착용쾌적성 평가를 통한 디자인 요소 요구성능 분석 (Design Requirements by Evaluating Comfort while Wearing Korean Naval Duty Uniforms for Summer and Winter)

  • 이효현;신소라;이주영
    • 한국지역사회생활과학회지
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    • 제27권3호
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    • pp.419-435
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    • 2016
  • The purpose of the present study was to suggest the design requirements for Korean naval duty uniforms by evaluating the physiological and psychological comfort while wearing the uniforms. Two sets of wear trials were conducted with summer uniforms(eight young males) and winter uniforms(seven other young males). The summer wear trial consisted of 10-min rest, 60-min exercise, and 10-min recovery at an air temperature($T_{air} $) of $33^{\circ}C$ and 62%RH, followed by 10-min recovery at a $T_{air} $ of $23^{\circ}C$ and 64%RH(total 90 min). The winter wear trial consisted of 20-min rest at $T_{air} $ $20^{\circ}C$ and 55%RH, 25-min rest, 30-min exercise, and 35-min recovery at a $T_{air} $ of 0oC and 43%RH(total 110 min). Rectal and seven skin temperatures, clothing microclimate, heart rate, oxygen consumption, total sweat rate, and subjective perceptions were measured during the wear trials. By evaluating the experimental results from the wear trials, we extracted the following psycho-physiological design requirements to improve the current Korean naval uniforms: (1) It is important to maintain the skin temperatures within their comfort range, which depends on the body region (higher than $30^{\circ}C$ in winter, but less than $35^{\circ}C$ in summer). (2) In summer, the feet should be protected from the high heat of the ship floor surface. (3) In summer, sweat from the back should be sufficiently absorbed and allowed to dry quickly.

고혈압 침치료에 관한 최근 연구 동향 고찰 - Pubmed와 국내 논문 중심으로 - (A Review of Recent Acupuncture Treatment for Hypertension - PubMed and Domestic Studies)

  • 김승연;원재호;이인
    • 대한한방내과학회지
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    • 제41권1호
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    • pp.29-43
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    • 2020
  • Objectives: The purpose of this study was to summarize current research trends and results regarding acupuncture treatment for hypertension. Methods: Articles published from 2009 to 2019 were searched on domestic databases (OASIS, NDSL, RISS) and PubMed using the keywords 'Hypertension', 'Hypertensive', 'Acupuncture', 'EA' (electroacupuncture), 'Autonomic nervous system', 'ANS', 'CVD' (cardiovascular disease), '고혈압', '침', '전침', and '자율신경계'. The studies were analyzed according to the year, type of study (domestic or foreign articles, nationality of the first author), acupuncture type for human and animal studies, BP (blood pressure) measurement, and acupuncture intervention. Results: In total, 21 articles were selected. There were 8 randomized controlled trials (RCTs), 3 non-randomized controlled trials (nRCTs), 2 before-after studies, 1 case series, and 7 animal studies. Manual acupuncture (11 articles) was most frequently used, and ST36 (足三里) was most frequently used in human studies. In 18 of 21 articles, acupuncture was reported as effective in lowering systolic blood pressure (SBP) or diastolic blood pressure (DBP) in hypertensive patients. Conclusions: Acupuncture treatment for hypertension is deemed useful. Further studies are necessary for application of acupuncture therapy in clinical practice.

Nanotechnology in reproductive medicine: Opportunities for clinical translation

  • Shandilya, Ruchita;Pathak, Neelam;Lohiya, Nirmal Kumar;Sharma, Radhey Shyam;Mishra, Pradyumna Kumar
    • Clinical and Experimental Reproductive Medicine
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    • 제47권4호
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    • pp.245-262
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    • 2020
  • In recent years, nanotechnology has revolutionized global healthcare and has been predicted to exert a remarkable effect on clinical medicine. In this context, the clinical use of nanomaterials for cancer diagnosis, fertility preservation, and the management of infertility and other pathologies linked to pubertal development, menopause, sexually transmitted infections, and HIV (human immunodeficiency virus) has substantial promise to fill the existing lacunae in reproductive healthcare. Of late, a number of clinical trials involving the use of nanoparticles for the early detection of reproductive tract infections and cancers, targeted drug delivery, and cellular therapeutics have been conducted. However, most of these trials of nanoengineering are still at a nascent stage, and better synergy between pharmaceutics, chemistry, and cutting-edge molecular sciences is needed for effective translation of these interventions from bench to bedside. To bridge the gap between translational outcome and product development, strategic partnerships with the insight and ability to anticipate challenges, as well as an indepth understanding of the molecular pathways involved, are highly essential. Such amalgamations would overcome the regulatory gauntlet and technical hurdles, thereby facilitating the effective clinical translation of these nano-based tools and technologies. The present review comprehensively focuses on emerging applications of nanotechnology, which holds enormous promise for improved therapeutics and early diagnosis of various human reproductive tract diseases and conditions.