• 제목/요약/키워드: e-Clinical Trials

검색결과 153건 처리시간 0.025초

5-11세 소아에서 코로나19 백신의 효능 및 안전성에 대한 체계적 문헌고찰 (Efficacy and Safety of COVID-19 Vaccines in Children Aged 5 to 11 Years: A Systematic Review)

  • 최미영;유수연;정채림;최영준;최수한
    • Pediatric Infection and Vaccine
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    • 제29권1호
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    • pp.28-36
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    • 2022
  • 목적: 5-11세 소아에서 코로나19 백신의 효능과 안전성을 평가하기 위해서 체계적 문헌고찰을 시행하였다. 방법: 2022년 1월 4일까지 Ovid-MEDLINE 및 medRxiv를 검색하여 문헌을 선정하고 자료를 추출하였다. 근거 수준을 평가하기 위해 GRADE 도구를 사용하였다. 결과: 총 1,675 건의 연구가 일차적으로 검색되었고 최종적으로 5편의 연구가 포함되었다. 서로 다른 4개의 코로나19 백신(BNT162b2, mRNA-1273, CoronaVac, BBIBP-CorV)에 대한 무작위 대조군 연구 결과들은 5-11세 연령에서 각 백신의 양호한 면역원성과 안전성을 보여주었다. 미국에서 5-11세 소아 연령에서 BNT162b2 백신 접종 후 이상사례 모니터링 연구에서는 승인 전 임상시험을 통해 예상되었던 국소반응 및 전신반응이 보고되었으나 중대한 이상사례는 거의 보고되지 않았다. 결론: 5-11세 연령에서 코로나19 백신 접종에 대한 데이터는 제한적이다. 이 연령에서 코로나19 백신의 안전성과 효과에 대한 체계적인 평가를 위해 지속적이고 포괄적인 모니터링이 필요할 것으로 보인다.

Anesthetic efficacy in vital asymptomatic teeth using different local anesthetics: a systematic review with network meta-analysis

  • Amy Kia Cheen Liew;Yi-Chun Yeh ;Dalia Abdullah ;Yu-Kang Tu
    • Restorative Dentistry and Endodontics
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    • 제46권3호
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    • pp.41.1-41.23
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    • 2021
  • Objectives: This study aimed to evaluate the efficacy of various local anesthesia (LA) in vital asymptomatic teeth. Materials and Methods: Randomized controlled trials comparing pulpal anesthesia of various LA on vital asymptomatic teeth were included in this review. Searches were conducted in the Cochrane CENTRAL, MEDLINE (via PubMed), EMBASE, ClinicalTrials.gov, Google Scholar and 3 field-specific journals from inception to May 3, 2019. Study selection, data extraction, and risk of bias assessment using Cochrane Risk of Bias Tool were done by 2 independent reviewers in duplicate. Network meta-analysis (NMA) was performed within the frequentist setting using STATA 15.0. The LA was ranked, and the surface under the cumulative ranking (SUCRA) line was plotted. The confidence of the NMA estimates was assessed using the CINeMA web application. Results: The literature search yielded 1,678 potentially eligible reports, but only 42 were included in this review. For maxillary buccal infiltration, articaine 4% with epinephrine 1:100,000 was more efficacious than lidocaine 2% with epinephrine 1:100,000 (odds ratio, 2.11; 95% confidence interval, 1.14-3.89). For mandibular buccal infiltration, articaine 4% with epinephrine 1:100,000 was more efficacious than various lidocaine solutions. The SUCRA ranking was highest for articaine 4% with epinephrine when used as maxillary and mandibular buccal infiltrations, and lidocaine 2% with epinephrine 1:80,000 when used as inferior alveolar nerve block. Inconsistency and imprecision were detected in some of the NMA estimates. Conclusions: Articaine 4% with epinephrine is superior when maxillary or mandibular infiltration is required in vital asymptomatic teeth.

Disinfectant effectiveness of chlorhexidine gel compared to sodium hypochlorite: a systematic review with meta-analysis

  • Theodoro Weissheimer;Karem Paula Pinto;Emmanuel Joao Nogueira Leal da Silva;Lina Naomi Hashizume;Ricardo Abreu da Rosa;Marcus Vinicius Reis So
    • Restorative Dentistry and Endodontics
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    • 제48권4호
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    • pp.37.1-37.17
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    • 2023
  • This study aimed to compare the disinfectant ability of chlorhexidine (CHX) gel and sodium hypochlorite (NaOCl). Systematic searches were conducted from inception until December 8th, 2022 (MEDLINE/PubMed, Cochrane Library, Web of Science, Scopus, Embase, and Grey Literature databases). Only randomized clinical trials were included. The revised Cochrane risk of bias tools for randomized trials were used to assess the quality of studies. Meta-analyses were performed. The overall quality of evidence was assessed through the Grading of Recommendations Assessment, Development, and Evaluation tool. Six studies were included. Five had a low risk of bias and 1 had some concerns. Three studies assessed bacterial reduction. Two were included in the meta-analysis for bacterial reduction (mean difference, 75.03 [confidence interval, CI, -271.15, 421.22], p = 0.67; I2 = 74%); and 3 in the meta-analysis for cultivable bacteria after chemomechanical preparation (odds ratio, 1.03 [CI, 0.20, 5.31], P = 0.98; I2 = 49%). Five studies assessed endotoxin reduction. Three were included in a meta-analysis (mean difference, 20.59 [CI, -36.41, 77.59], p = 0.48; I2 = 74%). There seems to be no difference in the disinfectant ability of CHX gel and NaOCl, but further research is necessary.

Calcium hydroxide intracanal medication effects on pain and flare-up: a systematic review and meta-analysis

  • Ibrahim, Ahmed Mohamed;Zakhary, Siza Yacoub;Amin, Suzan Abdul Wanees
    • Restorative Dentistry and Endodontics
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    • 제45권3호
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    • pp.26.1-26.18
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    • 2020
  • Objectives: This study aimed to systematically review the pain and flare-up effects of calcium hydroxide (CH) as intracanal medication (ICM) in non-vital mature teeth. Materials and Methods: Electronic-databases searching for published and grey literature and manual searching were conducted. Only randomized clinical trials (RCTs) were included comparing CH to other ICMs in non-vital mature teeth. The risk of bias was assessed using the RoB 2.0 Cochrane tool. The main outcomes were pain and flare-up. Qualitative and quantitative analysis, wherever applicable, was performed. The certainty of evidence (CoE) was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: Sixteen articles were included in 6 comparisons at different time points for different outcomes. CH reduced pain risk than no ICM within the 1-14-days interval (p < 0.05) and than triple-antibiotic paste within the first day (p < 0.05) and was similar to corticosteroid/antibiotics combination (p > 0.05). Chlorhexidine (CHX) or CH/CHX, however, reduced pain levels than CH alone (p < 0.05). CH showed higher flare-up risk than CHX (p < 0.05). CoE, however, ranged from very low to moderate. Conclusion: Most comparisons for different outcomes are based on very few studies, mostly low-powered, with an overall low CoE. Thus, the available evidence is considered insufficient to either support or refute CH effectiveness or to recommend one ICM over another. Therefore, further well-designed, larger RCTs are required.

산소중독에 대한 Vitamin E의 보호효과에 관한 실험적 연구 (An Experimental Study on the Efficacy of Vitamin E aganinst Oxygen Toxicity)

  • 이승규;이상일;조수헌;윤덕로
    • Journal of Preventive Medicine and Public Health
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    • 제19권2호
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    • pp.184-192
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    • 1986
  • Since the wide spread application of hyperbaric oxygenation in clinical setting, the problems of oxygen toxicity have been attracting a deep interest from the researchers on hyperbaric medicine as a practical issue. Among extensive research trials, the study on the protective agents against oxygen toxicity occupied one of the most challenging field. As the mechanisms of oxygen toxicity, the role of the oxygen free radicals produced by peroxidation process are strongly accepted by the leading researchers on oxygen toxicity, the probable protective effects of antioxidant against oxygen toxicity are sustaining a sufficient rationale. In this study, the author attempted to evaluate the effect of vitamin E as a protective agent against oxygen toxicity through the observation of death rate, convulsion rate, time to convulsion, and macroscopic and microscopic pathological changes of experimental rats exposed to 100% oxygen at 5 ATA for 120 minutes. The findings observed are as follows: 1) The death rate, convulsion rate, time to convulsion, organ/body weight ratio and microscopic pathological findings were identified as reliable objective and quantitative indices for oxygen toxicity. 2) Vitamin E showed excellent protective effects against CNS and pulmonary oxygen toxicity as a strong antioxidant. The most effective dose seemed to be around 400 mg/kg 3) The results of this study are supporting the oxygen free radical hypothesis on oxygen toxicity.

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Efficacy of intralipid administration to improve in vitro fertilization outcomes: A systematic review and meta-analysis

  • Han, E Jung;Lee, Hye Nam;Kim, Min Kyoung;Lyu, Sang Woo;Lee, Woo Sik
    • Clinical and Experimental Reproductive Medicine
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    • 제48권3호
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    • pp.203-210
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    • 2021
  • We performed a systematic review and meta-analysis to evaluate whether intralipid administration improved the outcomes of in vitro fertilization. Online databases (PubMed, Cochrane Library, Medline, and Embase) were searched until March 2020. Only randomized controlled trials (RCTs) that assessed the role of intralipid administration during in vitro fertilization were considered. We analyzed the rates of clinical pregnancy and live birth as primary outcomes. Secondary outcomes included the rates of chemical pregnancy, ongoing pregnancy, and missed abortion. We reviewed and assessed the eligibility of 180 studies. Five RCTs including 840 patients (3 RCTs: women with repeated implantation failure, 1 RCT: women with recurrent spontaneous abortion, 1 RCT: women who had experienced implantation failure more than once) met the selection criteria. When compared with the control group, intralipid administration significantly improved the clinical pregnancy rate (risk ratio [RR], 1.48; 95% confidence interval [CI], 1.23-1.79), ongoing pregnancy rate (RR, 1.82; 95% CI, 1.31-2.53), and live birth rate (RR, 1.85; 95% CI, 1.44-2.38). However, intralipid administration had no beneficial effect on the miscarriage rate (RR, 0.75; 95% CI, 0.48-1.17). A funnel plot analysis revealed no publication bias. Our findings suggest that intralipid administration may benefit women undergoing in vitro fertilization, especially those who have experienced repeated implantation failure or recurrent spontaneous abortion. However, larger, well-designed studies are needed to confirm these findings.

WHO 침구임상 지침서 개정을 위한 국제회의 보고 (Reports on 'Meeting on the Revision of Guidelines for Clinical Research on Acupuncture')

  • 박히준;서정철;김세현;김상우;안경애;임사비나;김용석;최도영;강성길
    • Journal of Acupuncture Research
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    • 제22권5호
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    • pp.195-199
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    • 2005
  • The Working Group on the revision of Clinical Research Methodology for Acupuncture met in Seoul, Republic of Korea from 24 to 26 August 2005. The main objectives of the meeting were to review the regional publication guidelines for Clinical Research on Acupuncture, to make necessary revisions in the guidelines, to make recommendations on further collaboration and activities in the field of research on acupuncture, and to discuss scientific evidence-based approaches in the clinical research on acupuncture. Fourteen members from the eight Member States, one secretariat staff from the WHO Regional Office for the Western Pacific and ten observers from the Republic of Korea attended the meeting. The members presented their papers to review the current status of clinical research on acupuncture. The drafts of proposed revision to the previous guidelines for clinical research methodology on acupuncture were discussed extensively. The issues covered during the discussion included: the definition of the new terms; reorganization of clinical research design; revision and update of contents (e.g., control group); introduction of Institutional Review Board (IRB) on the section of ethical approval; additional outcomes including health-related quality of life (HRQOL), qualitative measures, etc. In the course of these discussions, the working group developed the revised guidelines for clinical research on acupuncture and made recommendations for promoting the dissemination of the revised guidelines.

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The use of gonadotropin-releasing hormone antagonist post-ovulation trigger in ovarian hyperstimulation syndrome

  • Chappell, Neil;Gibbons, William E.
    • Clinical and Experimental Reproductive Medicine
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    • 제44권2호
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    • pp.57-62
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    • 2017
  • The purpose of this paper is to assimilate all data pertaining to the use of gonadotropin-releasing hormone (GnRH) antagonists in in vitro fertilization cycles after ovulation trigger to reduce the symptoms of ovarian hyperstimulation syndrome (OHSS). A systematic review of the literature was performed to identify all studies performed on the use of a GnRH antagonist in IVF cycle post-ovulation trigger with patients at high risk for OHSS. Ten studies were identified and reviewed. Descriptions of the studies and their individual results are presented in the following manuscript. Due to significant heterogeneity among the studies, it was not possible to perform a group analysis. The use of GnRH antagonists post-ovulation trigger for treatment of OHSS has been considered for almost 20 years, though research into its use is sparse. Definitive conclusions and recommendations cannot be made at this time, though preliminary data from these trials demonstrate the potential for GnRH antagonists to play a role in the treatment of OHSS in certain patient populations.

Flavonols, Flavones, Flavanoues and Human Health: Epidemiological Evidence

  • Graf Brigitte A.;Milbury Paul E.;Blumberg Jeffrey B.
    • 한국식품영양과학회:학술대회논문집
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    • 한국식품영양과학회 2004년도 Annual Meeting and International Symposium
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    • pp.24-36
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    • 2004
  • Polyphenolic flavonoids are among a wide variety of phytochemicals present in the human diet. Basic research, animal model, and human studies suggest flavonoid intake may reduce the risk of several age-related chronic diseases. The vast number of flavonoids and mixtures of their subclasses, including flavonols, flavones and flavanones, and the variety of agricultural practices that affect their concentration in foods have presented a challenge to the development of adequate food composition databases for these com-pounds. Nonetheless, dietary assessments have been applied to cohort and case-control epidemiological studies and several reveal an inverse association with risk of some forms of cancer, cardiovascular disease, and other chronic conditions. Those observational studies that have examined these relationships with regard to flavonols, flavones, and flavanones are reviewed. The requirement for caution in interpreting these studies is discussed with regard to the limited information available on the bioavailability and biotransformation of these flavonoids. As the totality of the available evidence on these flavonoids suggests a role in the prevention of cancer and cardiovascular disease, further research is warranted, particularly in controlled clinical trials.

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렙틴 저항성의 개선 (Improvement of Leptin Resistance)

  • 김용운
    • Journal of Yeungnam Medical Science
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    • 제30권1호
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    • pp.4-9
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    • 2013
  • Leptin, a 16-kDa cytokine, is secreted by adipose tissue in response to the surplus of fat store. Thereby, the brain is informed about the body's energy status. In the hypothalamus, leptin triggers specific neuronal subpopulations (e.g., POMC and NPY neurons) and activates several intracellular signaling events, including the JAK/STAT, MAPK, PI3K, and mTOR pathway, which eventually translates into decreased food intake and increased energy expenditure. Leptin signal is inhibited by a feedback inhibitory pathway mediated by SOCS3. PTP1B involves another inhibitory pathway of leptin. Leptin potently promotes fat mass loss and body weight reduction in lean subjects. However, it is not widely used in the clinical field because of leptin resistance, which is a common feature of obesity characterized by hyperleptinemia and the failure of exogenous leptin administration to provide therapeutic benefit in rodents and humans. The potential mechanisms of leptin resistance include the following: 1) increases in circulating leptin-binding proteins, 2) reduced transport of leptin across the blood-brain barrier, 3) decreased leptin receptor-B (LRB), and/or 4) the provocation of processes that diminish cellular leptin signaling (inflammation, endoplasmic reticulum stress, feedback inhibition, etc.). Thus, interference of the cellular mechanisms that attenuate leptin signaling improves leptin action in cells and animal models, suggesting the potential utility of these processes as points of therapeutic intervention. Various experimental trials and compounds that improve leptin resistance are introduced in this paper.