clinical research

临床研究
  • 文章类型: Journal Article
    在全球范围内,化脓性汗腺炎(HS)患者中大麻和大麻相关产品的使用正在增加。考虑到潜在的抗炎作用,治疗性的,以及大麻相关产品的疼痛管理益处,我们回顾了主要文献,以评估HS患者使用大麻的患病率和可能目的,并向患者和医师提供建议.使用Embase和OvidMedline数据库对原始研究进行了叙述性审查。该搜索策略得到了图书馆员的确认,并于2023年9月1日进行,使用了针对大麻量身定制的主题标题和关键字的详细列表,大麻相关产品,HS,以及成人和儿科人群。在43项确定的研究中,6符合资格标准,涵盖34,435名患者。患者大多是女性,研究在美国各地进行,加拿大,和法国。研究结果表明,HS患者使用大麻的比例更高,证明疼痛管理的有效性,睡眠,缓解焦虑,瘙痒缓解,提高了生活质量。大麻可能在镇痛中起作用,提高生活质量,疼痛,痒,HS患者的总体心理健康和包括皮肤科医生在内的医疗保健提供者应增加他们对适当使用大麻相关产品的熟悉度。
    The use of cannabis and cannabis-related products among patients with hidradenitis suppurativa (HS) is increasing globally. Given the potential anti-inflammatory, therapeutic, and pain management benefits of cannabis-related products, we reviewed primary literature to evaluate the prevalence and possible purpose for cannabis use among patients with HS and to provide recommendations to patients and physicians. A narrative review of original studies was conducted using Embase and Ovid Medline databases. The search strategy was confirmed by a librarian and conducted on September 1, 2023, using a detailed list of subject headings and keywords tailored to cannabis, cannabis-related products, HS, and both adult and pediatric populations. Among 43 identified studies, 6 met the eligibility criteria and encompassed 34,435 patients. Patients were mostly female, and studies were conducted across the United States, Canada, and France. Findings show higher cannabis use among HS patients, demonstrating efficacy in pain management, sleep, anxiety relief, itch relief, and improved quality of life. Cannabis may play a role in analgesia, improved quality of life, pain, itch, and overall mental health in patients with HS and healthcare providers including dermatologists should increase their familiarity in appropriate use of cannabis-related products.
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  • 文章类型: Journal Article
    2023年9月,美国食品和药物管理局(FDA)发布了指南草案,以就如何获得伴侣动物临床试验的知情客户同意发表评论。本指南有可能大幅改变兽医社区知情同意书的编写和提交给客户的方式。它不仅提供了有关如何获得所有者的知情同意的细节,而且还提供了应获得同意的时间表,同意书中的格式和语言,以及这些同意书中所需要素的详细信息。这些变化将涉及调查人员的额外努力,以确保合规性,但可能导致所有者依从性增加,并增加临床研究的入学率,并为所有人带来后续益处。
    In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.
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  • 双相情感障碍是与患者的显著发病率相关的严重精神障碍之一。尽管我们对这种疾病的理解有了进步,治疗双相情感障碍仍然是一个具有挑战性的命题,主要是因为疾病的预防性治疗需要复杂的临床算法的评估。分类系统的修订也改变了该障碍的概念化。在这样的背景下,我们回顾了印度对双相情感障碍临床方面的研究.
    进行了叙述性审查,重点是印度出版的文献。搜索的数据库包括PubMed,Scopus,和谷歌学者,本综述纳入了印度作者在过去15年中发表的文章。
    在我们的评论中,我们可以从印度获得大量的研究成果。我们可以确定符合大多数双相情感障碍相关主题的研究,包括流行病学,病因学,合并症,污名,残疾,临床课程,认知概况,护理的途径,和恢复。
    研究轨迹与世界其他地方进行的研究一致。然而,在焦点方面也可以观察到某些差异。这种偏差背后的可能原因可能是临床需求的差异以及在印度情况下双相情感障碍患者的管理和康复中面临的独特挑战。
    UNASSIGNED: Bipolar disorder is one of the severe mental disorders that are associated with significant morbidity of the patients. Despite advancements in our understanding about the disorder, it remains a challenging proposition to treat bipolar disorder, largely since the prophylactic treatment of the disorder requires assessment of complex clinical algorithms. The revisions of the classificatory systems have also changed the conceptualization of the disorder. In this background, we conducted a review of the Indian studies conducted on the clinical aspects of bipolar disorder.
    UNASSIGNED: A narrative review was conducted with focus on the literature published from India. The databases searched included PubMed, Scopus, and Google Scholar, and articles published over the last 15 years by Indian authors were included for this review.
    UNASSIGNED: In our review, we could access a substantial volume of research published from India. We could identify studies that catered to most of the relevant themes in bipolar disorder including epidemiology, etiology, comorbidities, stigma, disability, clinical course, cognitive profile, pathways to care, and recovery.
    UNASSIGNED: The research trajectory was in line with the research conducted elsewhere in the world. However, certain dissimilarities in terms of focus could also be observed. The possible reason behind this deviation could be the difference in clinical need and unique challenges faced in the management and rehabilitation of patients in bipolar disorder in Indian scenario.
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  • 文章类型: Journal Article
    Clerodendranthusspicatus(Thunb.)C.Y.Wu(CS)是一种被广泛研究的植物,显示出治疗泌尿系疾病的潜力。以前的研究集中在它的化学成分上,药理作用,和临床应用。这篇综述旨在对现有的CS文献进行全面的总结和评价。它还提出了未来的研究方向,以增加我们对其药用价值的理解。从几个数据库中选择了129篇文献,包括PubMed,WebofScience,中国国家知识基础设施(CNKI),万方数据库,和谷歌学者,并进行了分析。CS的45种活性化合物具有降低尿酸等药理作用,抗炎,抗氧化,和肾脏保护。这些作用的潜在机制可能与抑制转化生长因子β1(TGF-β1)的激活有关。减少炎症因子,如IL-8,IL-1β,TNF-α,PGE2,IFN-γ,和IL-6水平,抑制NF-κB的激活,JAK/STAT通路,增强ROS的清除,MDADPPH·,和O2--,调节凋亡相关通路和蛋白的表达。本文还讨论了CS的质量控制及其治疗泌尿系疾病的有效性和安全性。该研究得出结论,CS具有很高的治疗泌尿系疾病的潜力。未来的研究应集中在观察CS活性化合物在体内的代谢变化以及研究CS对关键信号通路的影响。此外,应进行更加规范合理的临床研究和安全性评价实验,以获得更多的临床数据。
    Clerodendranthus spicatus (Thunb.) C.Y.Wu (CS) is a widely studied plant that shows potential in treating urinary diseases. Previous studies have focused on its chemical composition, pharmacological effects, and clinical applications. This review aims to provide a comprehensive summary and evaluation of the existing literature on CS. It also suggests future research directions to increase our understanding of its medicinal value. 129 pieces of literature were selected from several databases, including PubMed, Web of Science, China National Knowledge Infrastructure (CNKI), Wan-fang Database, and Google Scholar, and were analyzed. Forty-five active compounds of CS have pharmacological effects such as lowering uric acid, anti-inflammation, anti-oxidation, and kidney protection. The potential mechanisms of these effects may be related to inhibiting transforming growth factor β1 (TGF-β1) activation, reducing inflammatory factors such as IL-8, IL-1β, TNF-α, PGE2, IFN-γ, and IL-6 levels, suppressing the activation of NF-κB, JAK/STAT pathway, enhancing the clearance of ROS, MDA DPPH·, and O2 ̇ -, and regulating the expression of apoptosis-related pathways and proteins. This paper also discusses the quality control of CS and its efficacy and safety in treating urinary diseases. The study concludes that CS has a high potential for treating urinary diseases. Future studies should focus on observing the metabolic changes of CS active compounds in vivo and investigating the effects of CS on key signaling pathways. Additionally, more standardized and reasonable clinical studies and safety evaluation experiments should be conducted to obtain more clinical data.
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  • 文章类型: Journal Article
    脑机接口(BCI)技术在医学研究和应用中迅速发展。作为一种新兴的生物医学工程技术,它在脑疾病诊断和治疗的临床研究中引起了极大的关注,神经康复,和心理健康。然而,BCI在临床研究中也提出了一些挑战和伦理问题。在这篇文章中,作者调查和讨论了BCI在医药保健中的三个方面:伦理治理状况,临床研究中与BCI相关的多维伦理挑战,以及对伦理审查的暗示关注。尽管BCI在医疗保健领域的前沿研究和发展潜力巨大,自身引发的伦理挑战,临床研究和脑功能的复杂性为BCI的伦理学提出了新的特殊领域。确保BCI在医疗保健和医学领域的“负责任的创新”研究,建立道德全球治理框架和体系,以及医学前沿BCI研究的特殊指南。
    Brain-computer interface (BCI) technology is rapidly advancing in medical research and application. As an emerging biomedical engineering technology, it has garnered significant attention in the clinical research of brain disease diagnosis and treatment, neurological rehabilitation, and mental health. However, BCI also raises several challenges and ethical concerns in clinical research. In this article, the authors investigate and discuss three aspects of BCI in medicine and healthcare: the state of international ethical governance, multidimensional ethical challenges pertaining to BCI in clinical research, and suggestive concerns for ethical review. Despite the great potential of frontier BCI research and development in the field of medical care, the ethical challenges induced by itself and the complexities of clinical research and brain function have put forward new special fields for ethics in BCI. To ensure \"responsible innovation\" in BCI research in healthcare and medicine, the creation of an ethical global governance framework and system, along with special guidelines for cutting-edge BCI research in medicine, is suggested.
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  • 文章类型: Journal Article
    神经科学界基本上接受了这样的观点,即成人大脑中的神经干细胞可以产生功能性神经元,尤其是在两个大脑区域:侧脑室的脑室下区和海马齿状回的颗粒下区。然而,在一些神经退行性疾病中观察到受损的神经发生,特别是在阿尔茨海默氏症中,帕金森,和亨廷顿病,还有路易体痴呆症。因此,神经退行性疾病中神经源性功能的恢复是一种潜在的治疗策略,或者至少是延迟,疾病进展。考虑到这一点,本研究总结了不同的神经元生态位,在临床前和临床研究中提供了不同的前神经源策略的治疗潜力的集合,提供他们可能的行动方式的细节,指导未来的研究和临床实践。
    The neuroscience community has largely accepted the notion that functional neurons can be generated from neural stem cells in the adult brain, especially in two brain regions: the subventricular zone of the lateral ventricles and the subgranular zone in the dentate gyrus of the hippocampus. However, impaired neurogenesis has been observed in some neurodegenerative diseases, particularly in Alzheimer\'s, Parkinson\'s, and Huntington\'s diseases, and also in Lewy Body dementia. Therefore, restoration of neurogenic function in neurodegenerative diseases emerges as a potential therapeutic strategy to counteract, or at least delay, disease progression. Considering this, the present study summarizes the different neuronal niches, provides a collection of the therapeutic potential of different pro-neurogenic strategies in pre-clinical and clinical research, providing details about their possible modes of action, to guide future research and clinical practice.
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  • 文章类型: Journal Article
    皮肤癌与大量遗传性皮肤病有关。关于这些遗传性皮肤病表现的现有知识和指南不成比例地集中在白人患者身上。我们的目标是确定位置的显着特征,频率,和皮肤发现的严重程度以及皮肤癌相关遗传性皮肤病的皮肤(SOC)患者的皮肤癌中位年龄,以提高诊断率。我们在六个数据库中搜索了遗传性皮肤病。审查了每个病例报告或病例系列,包括报告,以英文出版,包含成人患者描述。使用EndNote删除了重复的手稿。从手稿中收集了以下病例级别的数据:年龄,性别,患者所在国家或地区,作者国家/居住大陆,皮肤癌相关,和其他关键的皮肤病学特征。发表了381篇文章,共有578名SOC患者,符合纳入标准。SOC患者可以呈现较少的经典发现,如SOCGorlin综合征患者基底细胞癌(44%)的发生率低于掌窝(66%)和下颌囊肿(66%)。还注意到SOC人群之间的差异,例如,与非洲先天性角化障碍患者(44%)相比,亚洲先天性角化障碍患者(80%)更常见白斑。SOC患者也有不同的皮肤癌发作取决于遗传性皮肤病,从Rothmund-Thomson综合征的中位年龄25岁到Muir-Torre综合征的中位年龄53岁。在这次审查中,患有遗传性皮肤病的SOC患者可以有不同的表现。认识到这些特征可能导致早期诊断和干预以减轻SOC患者中皮肤癌相关的发病率。
    Skin cancers are associated with a large number of genodermatoses. Existing knowledge and guidelines on the presentations of these genodermatoses focus disproportionately on White patients. Our goal is to identify notable characteristics in location, frequency, and severity of cutaneous findings along with the median age of skin cancers in skin-of-color (SOC) patients with skin-cancer-associated genodermatoses to improve diagnosis rates. We searched for genodermatoses on six databases. Each case report or case series was reviewed, including reports, published in English, containing adult patient descriptions. Duplicate manuscripts were removed using EndNote. The following case-level data were collected from the manuscripts: age, gender, patient country or region of origin, author country/continent of residence, skin cancer-related, and other key dermatologic features. 381 published articles, with a total of 578 SOC patients, met criteria for inclusion. SOC patients can present with fewer classic findings, such as a lower incidence of basal cell carcinomas (44%) in SOC Gorlin syndrome patients than palmar pits (66%) and mandibular cysts (66%). Differences between SOC populations were also noted, such as leukoplakia being more common in Asian dyskeratosis congenita patients (80%) in comparison to African dyskeratosis congenita patients (44%). SOC patients also have varying onset of skin cancer depending on the genodermatosis, from a median of 25 years of age in Rothmund-Thomson syndrome to 53 in Muir-Torre syndrome. In this review, SOC patients with genodermatoses can have varying presentations. Being cognizant of these characteristics may lead to earlier diagnosis and interventions to mitigate skin-cancer-related morbidity in SOC patients.
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  • 文章类型: Systematic Review
    目的:作为开发坐骨神经病变核心结果集(COS)的第一步,本研究的目的是对文献进行系统回顾,以确定先前在坐骨神经病变研究中报道的结局指标.
    方法:使用PubMed和医学主题词(MeSH)对2000-2024年的文献进行了系统综述。根据研究纳入/排除标准筛选鉴定的文章。记录每个纳入研究中报告的结果指标,并将其分类为运动,感官,疼痛,患者报告的结果,电诊断结果,成像结果,和综合结果。进行描述性统计。
    结果:初步确定共1586篇文章,31篇文章符合纳入标准并接受分析.最常见的结果领域是疼痛。在17项(63%)研究中报告了疼痛结果。10项(37%)研究报告了运动结果;6项(22%)报告了感觉结果;1项(4%)报告了复合结果;4项(15%)报告了电诊断结果;5项(19%)报告了患者报告的结果;3项(11%)报告了影像学结果。在纳入的研究中,报告了21个独特的结果。
    结论:我们已经确定了先前在坐骨神经病变研究中使用的结局指标。以前使用的结果测量分为七个领域:运动结果,感官结果,疼痛结果,患者报告的结果,电诊断结果,成像结果,和综合结果。在纳入的研究中,疼痛结果是最常用的。
    OBJECTIVE: As a first step towards developing a core outcome set (COS) for sciatic neuropathy, the goal of the current study was to perform a systematic review of the literature to identify outcome measures that have been previously reported in studies on sciatic neuropathy.
    METHODS: A systematic review of the literature from 2000-2024 was performed utilizing PubMed and Medical Subject Headings (MeSH). Identified articles were screened according to study inclusion/exclusion criteria. Outcome measures reported in each included study were recorded and categorized into motor, sensory, pain, patient-reported outcomes, electrodiagnostic outcomes, imaging outcomes, and composite outcomes. Descriptive statistics were performed.
    RESULTS: A total of 1586 articles were initially identified, and 31 articles met criteria for inclusion and underwent analysis. The most common outcome domain was pain. A pain outcome was reported in 17 (63%) studies. A motor outcome was reported in 10 (37%) studies; 6 (22%) reported a sensory outcome; 1 (4%) reported a composite outcome; 4 (15%) reported an electrodiagnostic outcome; 5 (19%) reported a patient-reported outcome; 3 (11%) reported an imaging outcome. Across the included studies, 21 unique outcomes were reported.
    CONCLUSIONS: We have identified the outcome measures that have previously been utilized in studies on sciatic neuropathy. Previously used outcome measures fell into seven domains: motor outcomes, sensory outcomes, pain outcomes, patient-reported outcomes, electrodiagnostic outcomes, imaging outcomes, and composite outcomes. Pain outcomes were most commonly used across the included studies.
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  • 文章类型: Journal Article
    临床研究有利于医学的持续发展和更广泛的科学知识。临床研究可以纳入一系列环境,从大型学习机构到小型私人实践。由于需要继续推进药物干预措施的发展以及其他形式的临床理解,创造一个更小的环境是有利的,私人实践在建立临床研究方面感到舒适和指导。很难找到最好的方法来纳入内部临床研究。这篇综述旨在解决文献中的这一差距,建立临床试验,特别是临床药物试验,更容易在皮肤科私人诊所。
    Clinical research is beneficial for the continued progression of medicine and the larger body of scientific knowledge. Clinical research can be incorporated into a range of settings, ranging from larger learning institutions to small private practices. With the need for continued advancement of the development of pharmaceutical interventions as well as other forms of clinical understanding, it is advantageous to create an environment where smaller, private practices feel comfortable and guided in establishing clinical research. It can be difficult to find the best methods to incorporate in-house clinical research. This review aims to address this gap in the literature, making the establishment of clinical trials, specifically clinical drug trials, more accessible in dermatology for private practices.
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  • 文章类型: Systematic Review
    目的:本研究是一项开创性的系统评价和荟萃分析,探讨五湖汤联合阿奇霉素治疗小儿肺炎支原体肺炎的临床疗效和安全性。方法:本研究进行了全面的计算机搜索,涵盖6个中文数据库和6个英文数据库,收集五湖汤联合阿奇霉素治疗小儿肺炎支原体肺炎的随机对照试验。搜索时间延长至2023年8月。两名独立研究人员参与文献筛选,数据提取,和偏差风险评估。采用Stata14.0和RevMan5.4软件进行Meta分析。此外,对主要结局进行荟萃回归分析和亚组分析,以确定异质性和混杂因素的潜在来源.结果:共纳入22项随机对照试验,涉及2,026例患者。五湖汤联合阿奇霉素治疗效果优于单用阿奇霉素(RR=1.17,95%CI[1.13,1.21],p<0.00001;证据的确定性低)。此外,接受联合治疗的患者发热消失时间显著缩短(MD=-1.42,95%CI[-1.84,-1.00],p<0.00001;证据的确定性非常低),咳嗽消失时间(MD=-2.08,95%CI[-2.44,-1.71],p<0.00001;证据的确定性非常低),肺部啰音消失(MD=-1.97,95%CI[-2.31,-1.63],p<0.00001;证据的确定性非常低),和喘息消失时间(MD=-1.47,95%CI[-1.72,-1.22],p<0.00001;证据的确定性非常低)。Meta回归分析表明,病程,样本量,年龄可能是异质性的来源。亚组和敏感性分析重申了这些结果的稳定性。此外,分析次要结果,如T淋巴细胞,血清炎症因子,与单用阿奇霉素相比,WHD和阿奇霉素联合治疗的不良反应发生率始终较高,具有统计学上的显著差异。结论:根据我们的荟萃分析结果,五湖汤联合阿奇霉素治疗小儿肺炎支原体肺炎的总体疗效优于阿奇霉素单药治疗。然而,在纳入的22项研究中,大多数被评估的因素显示出不清楚的偏见风险,并且在一个类别中始终存在持续的偏倚风险。此外,由于证据质量低,解释这些结果应谨慎。因此,我们强调未来高质量的必要性,多中心,和大样本临床随机对照试验。这些试验对于为循证研究提供更可靠的数据和建立更高质量的证据支持至关重要。系统审查注册:https://www。crd.约克。AC.英国/普华永道/,标识符CRD42023465606。
    Objective: This study constitutes a pioneering systematic review and meta analysis delving into the clinical efficacy and safety of the combined therapy involving Wuhu Decoction and azithromycin for treating Mycoplasma pneumoniae pneumonia in pediatric patients. Methods: This study conducted a comprehensive computerized search, covering 6 Chinese databases and 6 English databases, to collect randomized controlled trials related to the combined use of Wuhu Decoction and azithromycin for treating Mycoplasma pneumoniae pneumonia in pediatric patients. The search was extended until August 2023. Two independent researchers were involved in literature screening, data extraction, and bias risk assessment. Meta-analysis was performed using Stata 14.0 and RevMan 5.4 software. Additionally, meta-regression analysis and subgroup analysis were carried out on primary outcomes to identify potential sources of heterogeneity and confounding factors. Results: A total of 22 randomized controlled trials involving 2,026 patients were included in this study. The combined therapy of Wuhu Decoction and azithromycin demonstrated superior efficacy compared to azithromycin alone (RR = 1.17, 95% CI [1.13, 1.21], p < 0.00001; low certainty of evidence). Additionally, patients receiving the combination therapy experienced significantly reduced the disappearance time of fever (MD = -1.42, 95% CI [-1.84, -1.00], p < 0.00001; very low certainty of evidence), disappearance time of cough (MD = -2.08, 95% CI [-2.44, -1.71], p < 0.00001; very low certainty of evidence), disappearance of pulmonary rales (MD = -1.97, 95% CI [-2.31, -1.63], p < 0.00001; very low certainty of evidence), and disappearance time of wheezing (MD = -1.47, 95% CI [-1.72, -1.22], p < 0.00001; very low certainty of evidence). Meta-regression analysis suggested that course of disease, sample size, and age might be sources of heterogeneity. Subgroup and sensitivity analyses reaffirmed the stability of these results. Furthermore, analyses of secondary outcomes such as T lymphocytes, serum inflammatory factors, and the incidence rate of adverse reactions consistently favored the combination therapy of WHD and azithromycin over azithromycin alone, with statistically significant differences. Conclusion: Based on our meta-analysis findings, the combined therapy of Wuhu Decoction and azithromycin for treating pediatric Mycoplasma pneumoniae pneumonia exhibited superior overall efficacy in comparison to azithromycin monotherapy. However, in the included 22 studies, the majority of evaluated factors showed unclear bias risks, and a persistent bias risk was consistently present within one category. Moreover, due to the low quality of evidence, interpreting these results should be approached with caution. Hence, we emphasize the necessity for future high-quality, multicenter, and large-sample clinical randomized controlled trials. These trials are essential to provide more robust data for evidence-based research and to establish higher-quality evidence support. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42023465606.
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