clinical research

临床研究
  • 文章类型: Journal Article
    与其他精神疾病的精神药理学干预不同,很少有药物有助于改善饮食失调的认知和循证心理治疗使许多患者失败。迫切需要新的治疗方法来解决神经性厌食症(AN),越来越普遍和难以治疗。本文概述了大麻二酚的初步研究,psilocybin治疗,氯胺酮和生酮饮食,经颅磁刺激,和迷走神经刺激患有AN的个体。这些试点研究强调了需要更大的临床试验,包括更多参与者的多样性,以便将研究结果快速转化为现实世界的临床实践。
    Unlike psychopharmacologic interventions for other psychiatric conditions, few medications have emerged as helpful in improving eating disorder cognitions and evidence-based psychotherapies fail many patients. Novel treatments are urgently needed to address anorexia nervosa (AN), which is increasingly prevalent and difficult to treat. This article provides an overview of preliminary investigations into cannabidiol, psilocybin therapy, ketamine and the ketogenic diet, transcranial magnetic stimulation, and vagus nerve stimulation in individuals with AN. These pilot studies underscore the need for larger clinical trials that include more participant diversity in order to rapidly translate findings to real-world clinical practice.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    胶质瘤是中枢神经系统最常见的恶性肿瘤,给患者带来巨大的健康负担。由于神经胶质瘤的内在特征和治疗方式缺乏突破,大多数患者的预后仍然较差。这导致全球范围内沉重的心理和财务负担。近年来,大麻二酚(CBD)由于其抗肿瘤作用而引起了广泛的关注和研究,抗炎,和神经保护特性。本文综述了CBD在脑胶质瘤治疗中的临床前和临床研究。以及CBD纳米药物配方的现状,并讨论了CBD在未来胶质瘤治疗中的潜力和挑战。
    Glioma is the most common malignant tumor in central nervous system, with significant health burdens to patients. Due to the intrinsic characteristics of glioma and the lack of breakthroughs in treatment modalities, the prognosis for most patients remains poor. This results in a heavy psychological and financial load worldwide. In recent years, cannabidiol (CBD) has garnered widespread attention and research due to its anti-tumoral, anti-inflammatory, and neuroprotective properties. This review comprehensively summarizes the preclinical and clinical research on the use of CBD in glioma therapy, as well as the current status of nanomedicine formulations of CBD, and discusses the potential and challenges of CBD in glioma therapy in the future.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 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    In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained.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.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Editorial
    传统的牙科或牙周研究通常忽略人体成分,而有利于临床结果和生物学原因。临床研究是由结果参数的统计意义而不是患者的满意度驱动的。在这种情况下,以患者为中心的牙周研究(PCCPR)是一种考虑患者对其功能状态的反馈的方法,经验,临床结果,以及他们治疗的可及性。有人认为,由于患者个人信念的混淆作用,患者自我报告的数据可能具有较低的可靠性,文化背景,以及社会和经济因素。然而,文献表明,"以患者为中心的结局"成分的加入大大提高了研究结果的有效性和适用性.不同研究结果的差异可能是由于使用了不同的和非标准化的评估工具。为了克服这个问题,这篇社论列举了文献中可用的各种可靠工具。总之,我们主张研究者的研究重点应该从单纯的牙周研究转移到PCPR,这样研究结果可以有效地应用于临床,治疗策略也可以从单纯的牙周治疗转变为以患者为中心的牙周治疗.
    Conventional dentistry or periodontal research often ignores the human component in favor of clinical outcomes and biological causes. Clinical research is driven by the statistical significance of outcome parameters rather than the satisfaction level of the patient. In this context, patient-centric periodontal research (PCPR) is an approach that considers the patient´s feedback concerning their functional status, experience, clinical outcomes, and accessibility to their treatments. It is argued that data self-reported by the patient might have low reliability owing to the confounding effect of their personal belief, cultural background, and social and economic factors. However, literature has shown that the incorporation of \"patient-centric outcome\" components considerably enhances the validity and applicability of research findings. Variations in the results of different studies might be due to the use of different and non-standardized assessment tools. To overcome this problem, this editorial enlists various reliable tools available in the literature. In conclusion, we advocate that the focus of researchers should shift from mere periodontal research to PCPR so that the results can be effectively applied in clinical settings and the therapeutic strategy can also change from mere periodontal therapy to patient-centric periodontal therapy.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:从历史上看,钙中毒患者经历过诊断挑战和高发病率,然而,随着时间的推移,有限的数据可用于检查这些特征。
    目的:主要目标是a)调查与钙化延迟诊断相关的因素和b)评估发病率结果。次要目标是提供最新的死亡率。
    方法:对2006年1月1日至2022年12月31日诊断为钙化的302例成年患者进行回顾性分析。进行单变量和多变量统计分析。
    结果:非肾源性钙化(p=0.0004)和手指受累(p=0.0001)与诊断延迟增加显著相关,而手臂(p=0.01)和生殖器(p=0.022)的受累导致诊断天数减少。几乎所有生殖器患者,手指,或脚趾受累有肾源性疾病。每位患者的并发症数量随着时间的推移而减少,尤其是伤口感染(p=0.028),病变数量增加(p=0.012),和反复住院(p=0.020)。更新后的1年死亡率分别为36.70%和30.77%的肾性和非肾性钙化,分别。
    结论:限制包括回顾性性质和来自单一机构的数据。
    结论:诊断延迟,特别是在非肾源性钙化中,每位患者的并发症随着时间的推移而减少,强调持续意识对加快诊断的重要性。近年来死亡率持续改善。
    BACKGROUND: Calciphylaxis patients historically have experienced diagnostic challenges and high morbidity, however limited data is available examining these characteristics over time.
    OBJECTIVE: The primary goals were to a) investigate factors associated with diagnostic delay of calciphylaxis and b) assess morbidity outcomes. The secondary goal was to provide updated mortality rates.
    METHODS: A retrospective review of 302 adult patients diagnosed with calciphylaxis between January 1, 2006 and December 31, 2022 was conducted. Univariate and multivariate statistical analyses were performed.
    RESULTS: Non-nephrogenic calciphylaxis (p=0.0004) and involvement of the fingers (p=0.0001) were significantly associated with an increased diagnostic delay, whereas involvement of the arms (p=0.01) and genitalia (p=0.022) resulted in fewer days to diagnosis. Almost all patients with genitalia, finger, or toe involvement had nephrogenic disease. The number of complications per patient decreased with time, especially for wound infections (p=0.028), increase in lesion number (p=0.012), and recurrent hospitalizations (p=0.020). Updated 1-year mortality rates were 36.70% and 30.77% for nephrogenic and non-nephrogenic calciphylaxis, respectively.
    CONCLUSIONS: Limitations include the retrospective nature and data from a single institution.
    CONCLUSIONS: Diagnostic delay, particularly in non-nephrogenic calciphylaxis, and complications per patient decreased with time, highlighting the importance of continued awareness to expedite diagnosis. Mortality rates have continued to improve in recent years.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:参与临床研究包括面临关于结果的不确定性和结果在实践中可能产生的后果的挑战。这与骨病有关,对临床试验中涉及的骨病的经验知之甚少。这项研究的目的是探索参与小儿绞痛随机对照试验的骨科医生的生活经历。该研究基于基于原则的临床伦理学方法及其在实践中的应用。
    方法:使用半结构化访谈和反身主题分析的定性研究。
    方法:一项国际双臂实用随机对照试验(CUTIES试验),旨在评估骨科治疗婴儿绞痛的有效性。
    方法:采用了基于原则的临床伦理学方法,并将其应用于被要求做出参与临床试验决定的骨科医生的实践。来自英国和澳大利亚的完成了CUTIES试验培训的骨科医生被邀请接受关于他们的经历的采访。无论他们是否继续在试验中招募婴儿。受访者被问及他们想要参加CUTIES审判的原因,为什么他们决定继续或不继续审判,对于那些完成审判的人来说,他们作为试验参与者的个人经历。使用反身性主题分析对数据进行了分析。
    结果:对9名骨科医生进行了访谈。从数据中确定了三个主题:范式困境-观察到的临床结果与影响机制的科学证据;与试验相关的伦理困境;和试验结果困境。
    结论:参与CUTIES试验需要骨科医生克服临床伦理困境,以造福患者,研究,和职业。
    BACKGROUND: Engaging in clinical research includes confronting challenges about the uncertainty around outcomes and ramifications the results may have on practice. This is pertinent for osteopathy where little is known about the experiences of osteopaths involved in clinical trials. The aim of this study was to explore the lived experience of osteopaths who participated in a randomised controlled trial for infantile colic. The study was informed by a principles-based approach to clinical ethics and their application to practice.
    METHODS: Qualitative study using semi-structured interviews and reflexive thematic analysis.
    METHODS: An international two-arm pragmatic randomised controlled trial (the CUTIES trial) to evaluate the effectiveness of osteopathic care for infantile colic.
    METHODS: A principles-based approach to clinical ethics and their application to practice for osteopaths asked to make decisions about participating in a clinical trial was used. Osteopaths from the UK and Australia who completed the CUTIES trial training were invited to be interviewed about their experiences, regardless of whether they went on to recruit infants in the trial. Interviewees were asked about their reasons for wanting to participate in the CUTIES trial, why they decided to continue or not to continue in the trial and, for those who completed the trial, their personal experiences as participants in the trial. Data were analysed using reflexive thematic analysis.
    RESULTS: Nine osteopaths were interviewed. Three themes were identified from the data: Paradigm dilemma - observed clinical outcomes vs scientific evidence for mechanism of effects; trial-related ethical dilemmas; and trial outcome dilemmas.
    CONCLUSIONS: Participating in the CUTIES trial required osteopaths to overcome clinical ethical dilemmas for the benefit of patients, the research, and the profession.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    背景:随着早期阿尔茨海默病(AD)的疾病修饰治疗(DMT)的批准,对脑淀粉样β(Aβ)病理的有效和非侵入性检测方法的需求增加。目前的方法,包括正电子发射断层扫描(PET)和脑脊液(CSF)分析,是昂贵且侵入性的方法,可能会限制获得新的治疗方法。在苏氨酸-217(P-tau217)磷酸化的血浆tau提出了一个有希望的替代方案,然而,使用aducanumab等DMT的最佳治疗资格还需要进一步研究.这项研究评估了在巴特勒医院记忆与衰老计划(MAP)中确定DMT资格的一截止和两截止策略的有效性。
    方法:在本回顾性研究中,横断面诊断队列研究,我们首先使用特定站点和BioFINDER-2训练数据开发了P-tau217截止值,然后在来自ButlerMAP的潜在DMT候选物中进行测试(总n=150)。ROC分析用于计算曲线下面积(AUC)和P-tau217解释策略的准确性,使用Aβ-PET/CSF测试作为真理的标准。
    结果:巴特勒MAP的潜在DMT候选者(n=50),主要诊断为轻度认知障碍(n=29[58%])或轻度痴呆(21[42%]),主要为Aβ阳性(38[76%]),一半(25[50%])随后接受了阿杜卡单抗治疗。P-tau217在潜在的DMT候选物中预测脑Aβ阳性(AUC=0.97[0.92-1]),诊断准确性范围从0.88(0.76-0.95,p=0.028)到0.96(0.86-1,p<.001)。使用特定于站点的截止值时,一部分DMT候选物(10%)显示P-tau217临界线(0.273~0.399pg/mL),可能需要进行验证性测试.
    结论:这项研究,其中包括接受aducanumab治疗的参与者,确认了一截止和两截止策略在评估DMT合格性时解释血浆P-tau217的实用性。使用P-tau217可能会取代更具侵入性的诊断方法,根据P-tau217,所有接受aducanumab治疗的参与者均被视为符合条件.然而,假阳性仍然是一个令人担忧的问题,特别是当应用外部来源的显示较低特异性的截止值时,这可能导致对Aβ阴性参与者的不适当治疗。未来的研究应该集中在P-tau217截止值的前瞻性验证上,以增强其普遍性,并为不同人群的标准化治疗决策提供信息。
    With the approval of disease-modifying treatments (DMTs) for early Alzheimer\'s disease (AD), there is an increased need for efficient and non-invasive detection methods for cerebral amyloid-β (Aβ) pathology. Current methods, including positron emission tomography (PET) and cerebrospinal fluid (CSF) analysis, are costly and invasive methods that may limit access to new treatments. Plasma tau phosphorylated at threonine-217 (P-tau217) presents a promising alternative, yet optimal cutoffs for treatment eligibility with DMTs like aducanumab require further investigation. This study evaluates the efficacy of one- and two-cutoff strategies for determining DMT eligibility at the Butler Hospital Memory & Aging Program (MAP).
    In this retrospective, cross-sectional diagnostic cohort study, we first developed P-tau217 cutoffs using site-specific and BioFINDER-2 training data, which were then tested in potential DMT candidates from Butler MAP (total n = 150). ROC analysis was used to calculate the area under the curve (AUC) and accuracy of P-tau217 interpretation strategies, using Aβ-PET/CSF testing as the standard of truth.
    Potential DMT candidates at Butler MAP (n = 50), primarily diagnosed with mild cognitive impairment (n = 29 [58%]) or mild dementia (21 [42%]), were predominantly Aβ-positive (38 [76%]), and half (25 [50%]) were subsequently treated with aducanumab. Elevated P-tau217 predicted cerebral Aβ positivity in potential DMT candidates (AUC = 0.97 [0.92-1]), with diagnostic accuracy ranging from 0.88 (0.76-0.95, p = 0.028) to 0.96 (0.86-1, p < .001). When using site-specific cutoffs, a subset of DMT candidates (10%) exhibited borderline P-tau217 (between 0.273 and 0.399 pg/mL) that would have potentially required confirmatory testing.
    This study, which included participants treated with aducanumab, confirms the utility of one- and two-cutoff strategies for interpreting plasma P-tau217 in assessing DMT eligibility. Using P-tau217 could potentially replace more invasive diagnostic methods, and all aducanumab-treated participants would have been deemed eligible based on P-tau217. However, false positives remain a concern, particularly when applying externally derived cutoffs that exhibited lower specificity which could have led to inappropriate treatment of Aβ-negative participants. Future research should focus on prospective validation of P-tau217 cutoffs to enhance their generalizability and inform standardized treatment decision-making across diverse populations.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Letter
    暂无摘要。
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Case Reports
    暂无摘要。
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    胆囊癌(GBC)是印度最常见的胆道恶性肿瘤之一,阿根廷,和日本。该疾病具有令人沮丧的结果,因为由于非特异性症状和体征而发现得很晚。早期发现是改善结果的唯一途径。在西方和其他发达国家,肝胆和胰腺疾病的基础和临床研究取得了一些进展,但在GBC方面做得还不够。因此,重要的是,GBC负担很高的国家有责任找到许多未解决的问题的解决方案,例如病因,早期诊断,治疗,和预测。印度是全球最大的GBC中心之一,重要的是要了解该国在GBC上的进展。在这次审查中,我们将讨论来自印度的出版物的结果,强调过去几十年在基础和临床研究方面的工作和发展。
    Gallbladder cancer (GBC) is one of the commonest biliary malignancies seen in India, Argentina, and Japan. The disease has dismal outcome as it is detected quite late due to nonspecific symptoms and signs. Early detection is the only way to improve the outcome. There have been several advances in basic as well as clinical research in the hepatobiliary and pancreatic diseases in the West and other developed countries but not enough has been done in GBC. Therefore, it is important and the responsibility of the countries with high burden of GBC to find solutions to the many unanswered questions like etiopathogenesis, early diagnosis, treatment, and prognostication. As India being one of the largest hubs for GBC in the world, it is important to know how the country has progressed on GBC. In this review, we will discuss the outcome of the publications from India highlighting the work and the developments taken place in past several decades both in basic and clinical research.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

公众号