Clinical Research

临床研究
  • 文章类型: Case Reports
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    粉刺的清除在痤疮的治疗中具有挑战性,因为它很可能发展成炎性病变。然而,对于密集的粉刺缺乏有效的治疗方法。粉刺提取器已被皮肤科医生广泛采用,但效果是暂时的,可能会引起刺激。CO2激光是一种潜在的致密粉刺方法,但疗效和安全性有待探索。在这个单一中心,随机化,单盲,自我对照研究,将致密粉刺患者的面部随机分配到两侧,分别接受超脉冲动态CO2激光或粉刺摘除术,间隔2周,共4次。经过4次治疗,CO2激光器的平均粉刺减少率为64.49%,高于提取器(46.36%)(P<.001)。79.16%的患者通过CO2激光达到50%以上的减少,而只有37.5%的拔牙器治疗侧达到50%的清除率。纹理指数,卟啉指数,红色区域,红斑指数,两种治疗后,经皮水分流失减少,CO2激光表现出更多的改善。两种处理之间的水合指数和黑色素指数没有差异。在两侧均未观察到永久性或严重的副作用。与粉刺提取器相比,CO2激光显示出更高的粉刺清除率和更低的疼痛评分。
    Clearance of comedone is challenging in the treatment of acne, as it is very likely to develop into inflammatory lesions. However, there is lack of effective treatments for dense comedones. Comedone extractor has been widely employed by dermatologists, but the effect is temporary and may cause irritation. CO2 laser is a potential method for dense comedones, but the efficacy and safety need to be explored. In this single-center, randomized, single-blind, self-controlled study, the faces of patients with dense comedones were randomly assigned into two sides receiving either ultra-pulse dynamic CO2 laser or comedone extraction at an interval of 2 weeks for 4 sessions. After 4 treatments, the average comedone reduction rate of the CO2 laser was 64.49%, which was higher than that by the extractor (46.36%) (P < .001). 79.16% of the patients reached over 50% reduction by CO2 laser, while only 37.5% on extractor treated side reached 50% clearance. Texture index, porphyrin index, red zone, erythema index, and transepidermal water loss decreased after both treatments, and CO2 laser showed more improvement. There was no difference in hydration index and melanin index between the two treatments. No permanent or severe side effects were observed on both sides. The CO2 laser showed higher comedone clearance with lower pain scores than the comedone extractor.
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    文章类型: Journal Article
    PICOT(人口,干预,比较,出来-来吧,时间框架)框架简洁地给出了开发和解决研究或临床问题的结构。它作为一个框架,帮助研究人员或临床医生深入了解他们问题的本质。这指导研究人员或临床医生制定确切的问题,确定相关研究或证据,并调整干预措施,以解决他们希望解决或解决的问题或具有挑战性的情况。本文介绍了PICOT框架,并利用临床案例研究来说明其适用性和实现。
    The PICOT (Population, Intervention, Comparison, Out - come, Timeframe) framework succinctly gives structure to developing and solving a research or clinical question. It acts as a framework to assist a researcher or clinician to drill down to the essence of their question. This guides the researcher or clinician to formulate exact questions, identify relevant research or evidence, and tailor interventions to address the problem or challenging situation they are looking to solve or resolve. This article describes the PICOT framework and utilizes a clinical case study to illustrate its applicability and implementation.
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  • 文章类型: Journal Article
    目的:精神运动行为异常是精神分裂症的核心症状。然而,用专家评定量表评估运动异常是具有挑战性的。阳性和阴性综合征量表(PANSS)包括与运动机能减退行为广泛相关的3个项目。这里,我们测试了PANSS项目的行为和姿态的总和(G5),电机延迟(G7),意志干扰(G13)对应于专家评级,可能有资格作为运动异常的代理标记。
    方法:结合2项临床试验的基线数据集(n=196)(OCoPS-P,BrAGG-SoS),我们将PANSS运动评分(PANSSmot)和5个运动评定量表相关联。此外,我们测试了每个PANSS电机项目的截止值是否设置为≥3,ie,G05,G07和G13的“轻度”(PANSSmot总计≥9)将患者分为运动量表得分高和低的组。我们在一项独立试验中进一步寻求复制(RESIS,n=102),使用OCoPS-P的第3周数据(n=75)测试纵向稳定性,并用体育活动的工具性措施评估了PANSSmot的有效性(n=113)。
    结果:PANSSmot与所有运动量表相关(Spearman-Rho-range0.19-0.52,所有P≤.007)。此外,除了使用异常非自愿运动量表(Mann-Whitney-U-Tests:所有U≥580,P≤.017)外,每个PANSS运动项目的临界值设定≥3能够区分所有运动量表中运动评分高和低的患者.
    结论:我们的研究结果表明,PANSSmot可能是运动减退运动异常的替代测量。这可能有助于结合临床试验中的大型数据集,以探索某些干预措施是否有望缓解精神病中的运动障碍。
    OBJECTIVE: Abnormal psychomotor behavior is a core schizophrenia symptom. However, assessment of motor abnormalities with expert rating scales is challenging. The Positive and Negative Syndrome Scale (PANSS) includes 3 items broadly related to hypokinetic motor behavior. Here, we tested whether a sum score of the PANSS items mannerisms and posturing (G5), motor retardation (G7), and disturbance of volition (G13) corresponds to expert ratings, potentially qualifying as a proxy-marker of motor abnormalities.
    METHODS: Combining baseline datasets (n = 196) of 2 clinical trials (OCoPS-P, BrAGG-SoS), we correlated PANSS motor score (PANSSmot) and 5 motor rating scales. In addition, we tested whether the cutoff set at ≥3 on each PANSS motor item, ie, \"mild\" on G05, G07, and G13 (in total ≥9 on PANSSmot) would differentiate the patients into groups with high vs low scores in motor scales. We further sought for replication in an independent trial (RESIS, n = 102), tested the longitudinal stability using week 3 data of OCoPS-P (n = 75), and evaluated the validity of PANSSmot with instrumental measures of physical activity (n = 113).
    RESULTS: PANSSmot correlated with all motor scales (Spearman-Rho-range 0.19-0.52, all P ≤ .007). Furthermore, the cutoff set at ≥3 on each PANSS motor item was able to distinguish patients with high vs low motor scores in all motor scales except using Abnormal Involuntary Movement Scale (Mann-Whitney-U-Tests: all U ≥ 580, P ≤ .017).
    CONCLUSIONS: Our findings suggest that PANSSmot could be a proxy measure for hypokinetic motor abnormalities. This might help to combine large datasets from clinical trials to explore whether some interventions may hold promise to alleviate hypokinetic motor abnormalities in psychosis.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:高流量鼻插管(HFNC)装置通常用于治疗小儿重症急性哮喘。然而,几乎没有证据表明它在现实世界中的有效性。
    目的:我们试图比较HFNC治疗重度急性哮喘患儿与对照组患儿的生理效应和临床结局。
    方法:这是一项在一家四级保健儿童医院进行的单中心回顾性配对队列研究。包括2015年至2022年因严重急性哮喘住院的2-18岁儿童。病例包括在住院的前24小时内接受HFNC治疗的患者。对照主要用氧气面罩处理。使用人口统计进行Logistic回归1:1倾向评分匹配,初始生命体征,和药物。主要结果是在住院的最初24小时内临床哮喘症状的改善,以相对于最初的百分比变化来衡量。
    结果:在693个符合条件的案例中,443与合格的对照匹配。倾向得分在队列之间紧密对齐,临床特征的唯一显着差异是对照组中黑人种族患者的百分比更高(54.3%vs.46.6%;p=0.02)。与匹配的对照相比,HFNC队列的心率改善较小(-11.5%[-20.9;-0.9]vs.-14.7%[-22.6;-5.7];p<0.01),呼吸频率(-14.3%[-27.9;5.4]vs.-16.7%[-31.5;0.0];p=0.03),和小儿哮喘严重程度评分(-14.3%[-28.6;0.0]vs.住院24小时后-20.0%[-33.3;0.0];p<0.01)。HFNC队列也有更长的儿科重症监护病房(PICU)住院时间(LOS)(1.5天[1.1;2.1]vs.1.2天[0.9;1.8];p<0.01)和医院LOS(2.8天[2.1;3.8]vs.2.5天[1.9;3.4];p<0.01)。当分组到年轻患者(2-3岁)时,或严重程度得分最高的人(通过>9),接受HFNC治疗的患者在临床症状改善方面无差异,但维持了较长的PICULOS.
    结论:与对照组相比,使用HFNC治疗严重急性小儿哮喘的患者在住院24小时内的临床改善程度降低,LOS增加。年轻患者和严重程度评分最高的患者的特定亚组在临床症状改善方面没有差异,表明在特定患者人群中存在差异。
    BACKGROUND: The high-flow nasal cannula (HFNC) device is commonly used to treat pediatric severe acute asthma. However, there is little evidence regarding its effectiveness in real-world practice.
    OBJECTIVE: We sought to compare the physiologic effects and clinical outcomes for children treated for severe acute asthma with HFNC versus matched controls.
    METHODS: This was a single-center retrospective matched cohort study at a quaternary care children\'s hospital. Children ages 2-18 hospitalized for severe acute asthma from 2015 to 2022 were included. Encounters receiving treatment with HFNC within the first 24 h of hospitalization were included as cases. Controls were primarily treated with oxygen facemask. Logistic regression 1:1 propensity score matching was done using demographics, initial vital signs, and medications. The primary outcome was an improvement in clinical asthma symptoms in the first 24 h of hospitalization measured as percent change from initial.
    RESULTS: Of 693 eligible cases, 443 were matched to eligible controls. Propensity scores were closely aligned between the cohorts, with the only significant difference in clinical characteristics being a higher percentage of patients of Black race in the control group (54.3% vs. 46.6%; p = 0.02). Compared to the matched controls, the HFNC cohort had smaller improvements in heart rate (-11.5% [-20.9; -0.9] vs. -14.7% [-22.6;-5.7]; p < 0.01), respiratory rate (-14.3% [-27.9;5.4] vs. -16.7% [-31.5;0.0]; p = 0.03), and pediatric asthma severity score (-14.3% [-28.6;0.0] vs. -20.0% [-33.3;0.0]; p < 0.01) after 24 h of hospitalization. The HFNC cohort also had longer pediatric intensive care unit (PICU) length of stay (LOS) (1.5 days [1.1;2.1] vs. 1.2 days [0.9;1.8]; p < 0.01) and hospital LOS (2.8 days [2.1;3.8] vs. 2.5 days [1.9;3.4]; p < 0.01). When subgrouping to younger patients (2-3 years old), or those with the highest severity scores (PASS > 9), those treated with HFNC had no difference in clinical symptom improvements but maintained a longer PICU LOS.
    CONCLUSIONS: Encounters using HFNC for severe acute pediatric asthma had decreased clinical improvement in 24 h of hospitalization compared to matched controls and increased LOS. Specific subgroups of younger patients and those with the highest severity scores showed no differences in clinical symptom improvement suggesting differential effects in specific patient populations.
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  • 文章类型: Journal Article
    临床研究能力和服务提供的全球不平等可以简单地通过一个国家或地区在临床试验注册数据库中注册的临床试验的比例来表示。在非洲注册的临床试验比例很低,只有0.02%,尽管该地区约占世界人口的15%。尽管大多数非洲国家面临经济挑战,近年来,它们显示出增长和变化的潜力。
    我们对在肯尼亚进行的介入临床试验进行了案头审查,埃塞俄比亚,和尼日利亚在2015年至2023年5月之间。搜索是在临床试验存储库中进行的,和日记存储库。搜索的重点是干预临床试验。通过出版物和临床试验平台筛选提取数据。从出版物中提取的数据包括临床试验的类型,临床试验阶段,疾病,等。从报告中提取的数据包括:进行临床试验的挑战,能力建设努力,以及临床试验的影响。
    在肯尼亚确定的临床试验研究数量为113(28个为婴儿临床试验)。该研究确定了尼日利亚的97项临床试验,其中11项研究是关于婴儿临床试验的。在埃塞俄比亚,有28项临床试验,只有5项是婴儿临床试验。景观审查还扩大了这三个国家临床试验的能力和差距。在肯尼亚进行的临床试验中,最大的比例是伤害,职业病,中毒,30.5%(n=18),最小的比例是肾病,新生儿疾病,产科,和妇科。大多数婴儿临床试验是在感染和感染领域进行的,占33.3%(n=7)。这三个国家的临床试验所面临的挑战大多包括缺乏基础设施,缺乏人力资源,缺乏财政资源。
    有必要绘制非洲研究人员在非洲进行的临床试验,以排除非洲非非洲研究人员进行的试验。应支持临床试验的机会并应对挑战。
    UNASSIGNED: Global inequality in clinical research capacity and service delivery can be indicated simply by the proportion of clinical trials that a country or region has registered in clinical trial registry databases. The proportion of clinical trials registered in Africa is very low at 0.02%, even though the region accounts for approximately 15% of the world\'s population. Despite the economic challenges in most African countries, they have shown potential for growth and change in recent years.
    UNASSIGNED: We conducted desk reviews on the interventional clinical trials done in Kenya, Ethiopia, and Nigeria between 2015 to May 2023. The search was done in clinical trials repositories, and journal repositories. The search focused on intervention clinical trials. Data was extracted by screening through the publications and clinical trial platforms. The data extracted from the publications included the type of clinical trial, clinical trial phase, diseases, etc. The data extracted from the reports included: challenges in conducting clinical trials, capacity-building efforts, and the impact of the clinical trial.
    UNASSIGNED: The number of clinical trial studies identified in Kenya was 113 (28 were on infant clinical trials). The study identified 97 clinical trials in Nigeria, of which 11 studies were on infant clinical trials. In Ethiopia, there were 28 clinical trials and only five were on infant clinical trials. The landscape review also expanded to capacity and gaps in clinical trials in the three countries. The largest proportion of clinical trials carried out in Kenya was on injury, occupational disease, and poisoning, 30.5% (n = 18) and the smallest proportion was on kidney disease, neonatal disease, obstetrics, and gynecology. Most Infant clinical trials were carried out in the area of infections and infestations 33.3% (n = 7). Most of the challenges faced by clinical trials in the three countries include a lack of infrastructure, a lack of human resources, and a lack of financial resources.
    UNASSIGNED: There is a need to map clinical trials done by African researchers based in Africa to exclude the trials done by non-African researchers based in Africa. Opportunities for clinical trials should be supported and challenges addressed.
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  • 文章类型: Journal Article
    在任何假设驱动的临床研究项目中,假设的产生都是早期和关键的步骤。因为它还不是一个很好理解的认知过程,改进这一过程的必要性没有得到认可。没有有效的假设,任何研究项目的意义都值得怀疑,无论在研究的其他步骤中应用的严格或勤奋,例如,研究设计,数据收集,和结果分析。在这篇透视文章中,作者首先对以下主题进行了文献综述:科学思维,推理,医学推理,基于文献的发现,以及探索科学思维和发现的实地研究。多年来,科学思维在认知科学及其应用领域:教育,医学,和生物医学研究。然而,对文献的回顾表明,缺乏关于临床研究中假设生成的原始研究。然后,作者总结了他们的第一个人类参与者研究,探索了临床研究人员在模拟环境中产生的数据驱动的假设。结果表明,二级数据分析工具,VIADS-用于过滤的可视化交互式分析工具,总结,并可视化使用分层术语编码的大型健康数据集,可以缩短参与者需要的时间,平均而言,生成一个假设,并且还需要更少的认知事件来生成每个假设。作为对立面,这一探索还表明,在应用VIADS时,由此产生的假设的质量评级对可行性的评级明显较低.尽管规模小,这项研究证实了在临床研究中直接进行人类参与者研究以探索假设产生过程的可行性。这项研究提供了支持证据,可以使用专门设计的工具进行更大规模的研究,以促进经验不足的临床研究人员的假设生成过程。一项更大的研究可以提供可推广的证据,这反过来又有可能提高临床研究生产率和整体临床研究企业。
    Hypothesis generation is an early and critical step in any hypothesis-driven clinical research project. Because it is not yet a well-understood cognitive process, the need to improve the process goes unrecognized. Without an impactful hypothesis, the significance of any research project can be questionable, regardless of the rigor or diligence applied in other steps of the study, e.g., study design, data collection, and result analysis. In this perspective article, the authors provide a literature review on the following topics first: scientific thinking, reasoning, medical reasoning, literature-based discovery, and a field study to explore scientific thinking and discovery. Over the years, scientific thinking has shown excellent progress in cognitive science and its applied areas: education, medicine, and biomedical research. However, a review of the literature reveals the lack of original studies on hypothesis generation in clinical research. The authors then summarize their first human participant study exploring data-driven hypothesis generation by clinical researchers in a simulated setting. The results indicate that a secondary data analytical tool, VIADS-a visual interactive analytic tool for filtering, summarizing, and visualizing large health data sets coded with hierarchical terminologies, can shorten the time participants need, on average, to generate a hypothesis and also requires fewer cognitive events to generate each hypothesis. As a counterpoint, this exploration also indicates that the quality ratings of the hypotheses thus generated carry significantly lower ratings for feasibility when applying VIADS. Despite its small scale, the study confirmed the feasibility of conducting a human participant study directly to explore the hypothesis generation process in clinical research. This study provides supporting evidence to conduct a larger-scale study with a specifically designed tool to facilitate the hypothesis-generation process among inexperienced clinical researchers. A larger study could provide generalizable evidence, which in turn can potentially improve clinical research productivity and overall clinical research enterprise.
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