Studies

Studies
  • 文章类型: Journal Article
    在过去的五年中,我们的年度报告一直在追踪帕金森病(PD)神经退行性疾病新药的临床开发.这些评论遵循了“对症治疗”(ST-改善/减轻症状)和“疾病改善治疗”(DMT-试图通过解决PD的潜在生物学来延迟/减缓进展)的进展。还努力基于它们的作用机制和药物类别对这些实验治疗进行进一步分类。
    使用从ClinicalTrials.gov在线注册表下载的试验数据,生成了PD药物治疗的临床试验数据集。对截至1月31日所有活跃研究的细分分析,2024年,进行了。该分析涉及根据作用机制(MOA)和药物靶标对试验进行分类。
    在ClinicalTrials.gov上注册了136项积极的1-3期临床试验,评估了PD的药物疗法,截至2024年1月31日。在这些试验中,76例(56%)被分类为ST试验,60例(44%)被指定为DMT。超过一半(58%)的试验处于第二阶段测试阶段,其次是阶段1(30%)和阶段3(12%)。自我们上次报告以来,有35项试验登记,其余101项试验出现在至少一份较早的报告中。
    PD的药物开发管道保持稳健状态,在第1阶段和第2阶段开发和评估了多种方法。再一次,然而,只有有限数量的DMT过渡到阶段3。
    新的医学疗法的发展,特别是对于神经退行性疾病,是一个漫长的过程,涉及多个阶段的测试之前,治疗被批准用于医生的诊所。第一阶段评估药物的短期安全性-通常在健康志愿者中,但有时在受疾病影响的人群中。第二阶段探讨了该药物在受关注疾病影响的人群中的短期安全性和初步疗效,第三阶段调查了受该疾病影响的一大群人的长期安全性和有效性。对于像帕金森病这样的疾病,如果情况的原因没有得到很好的理解,针对不同生物途径的药物需要进行测试,以确定哪些可能对治疗症状有用,并且可以施用以减缓或停止病情的进展。这里,我们提供有关这两项临床试验工作现状的年度报告。总的来说,我们回顾了在名为'ClinicalTrials.gov'的临床试验数据库中注册的136项评估帕金森病治疗方法的积极研究.在这些试验中,大约55%的人正在测试实验性对症治疗,而其余的则专注于减缓疾病进展。超过一半(58%)的研究处于第二阶段的临床试验(短期安全性和初步疗效),但只有三项研究被发现在3期测试中测试阻止帕金森病进展的治疗方法。我们得出的结论是帕金森氏症的药物开发渠道很强大,但更多的进展需要与治疗的后期测试,以减缓疾病。
    UNASSIGNED: For the past five years, our annual reports have been tracking the clinical development of new drug-based therapies for the neurodegenerative condition of Parkinson\'s disease (PD). These reviews have followed the progress both of \"symptomatic treatments\" (ST - improves/reduces symptoms of the condition) and \"disease-modifying treatments\" (DMT - attempts to delay/slow progression by addressing the underlying biology of PD). Efforts have also been made to further categorize these experimental treatments based on their mechanisms of action and class of drug.
    UNASSIGNED: A dataset of clinical trials for drug therapies in PD using trial data downloaded from the ClinicalTrials.gov online registry was generated. A breakdown analysis of all the studies that were active as of January 31st, 2024, was conducted. This analysis involved categorizing the trials based on both the mechanism of action (MOA) and the drug target.
    UNASSIGNED: There were 136 active Phase 1-3 trials evaluating drug therapies for PD registered on ClinicalTrials.gov, as of January 31, 2024. Of these trials, 76 (56%) were classified as ST trials and 60 (44%) were designated DMT. More than half (58%) of the trials were in Phase 2 testing stage, followed by Phase 1 (30%) and Phase 3 (12%). 35 of the trials were registered since our last report, with the remaining 101 trials appearing in at least one earlier report.
    UNASSIGNED: The drug development pipeline for PD remains in a robust state with a wide variety of approaches being developed and evaluated in Phase 1 and 2. Yet again, however, only a limited number of DMTs are transitioning to Phase 3.
    The development of new medical therapies, particularly for neurodegenerative conditions, is a long process that involves multiple phases of testing before a treatment is approved for use in a doctor’s clinic. The first phase assesses the short-term safety of a drug – most often in healthy volunteers but sometimes in people affected by the disease. The second phase explores the short-term safety and preliminary efficacy of the agent in people affected by the disease of interest, and the third phase investigates long-term safety and efficacy in a large group of people affected by the disease. For a disease like Parkinson’s disease, where the causes of the condition are not well understood, drugs targeting different biological pathways need to be tested to determine which ones may be useful in treating the symptoms, and which could be administered to slow down or stop the progression of the condition. Here, we provide an annual report on the current landscape of both these clinical testing efforts. In total, we reviewed 136 active studies evaluating therapies for Parkinson’s disease registered on a clinical trial database called ‘ClinicalTrials.gov’. Of these trials, approximately 55% were testing experimental symptomatic treatments, while the rest were focused on slowing down disease progression. More than half (58%) of the studies were in the second phase of clinical testing (short-term safety and preliminary efficacy), but only three studies were found to be testing treatments to stop the progression of Parkinson’s in the Phase 3 testing. We concluded that the drug development pipeline for Parkinson’s is robust, but more progress needs to be made with late-stage testing of treatments to slow the disease.
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  • 文章类型: English Abstract
    2011年,加利西亚只有18%的人口知道COPD。从那以后,已经开展了宣传这种疾病的活动。这项研究的目的是评估加利西亚人群中有关COPD知识的现状。
    横断面研究,通过电话调查。问卷中包含的变量,与疾病相关的知识,进行了分析。
    872名受访者,53%的女性,平均年龄54岁。63%有中学/大学学习。40%有COPD知识。相比之下,超过90%的受访者知道其他高频疾病(糖尿病,中风,哮喘)。与COPD知识掌握程度最高的因素为女性,有中学/大学学习,以前做过肺活量测定。
    现在,加利西亚人群对COPD的知晓率为40%,高于2011年,但与其他流行疾病相去甚远。
    UNASSIGNED: In 2011, only 18% of the population in Galician knew the COPD. Since then, activities have been carried out to publicize this disease. The objective of this study was to evaluate the current situation regarding the knowledge of COPD in the Galician population.
    UNASSIGNED: Cross-sectional study, through telephone surveys. Variables included in the questionnaire, related to knowledge of the disease, were analyzed.
    UNASSIGNED: 872 respondents, 53% women, mean age 54 years. 63% with secondary/university studies. 40% has knowledge of COPD. In contrast, more than 90% of respondents know other high-frequency diseases (diabetes, stroke, asthma). The factors most associated with knowledge of COPD were female gender, having secondary/university studies, and having previously performed spirometry.
    UNASSIGNED: The knowledge of COPD in the Galician population is 40% now, higher than in 2011, but it is far from that of other prevalent diseases.
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  • 文章类型: Journal Article
    背景:自2020年以来,关于帕金森病(PD)神经退行性疾病的新药临床开发的年度报告已经产生。这些评论遵循了“对症治疗”(ST-改善/减轻症状)和“疾病修饰治疗”(DMT-试图通过解决PD的潜在生物学来延迟/减缓进展)的进展。已经做出了额外的努力来基于它们的作用机制和药物类别对这些实验治疗进行进一步分类。
    方法:使用从ClinicalTrials.gov在线注册表下载的试验数据,获得了PD药物治疗临床试验的数据集。对截至1月31日所有活跃研究的细分分析,2023年,进行。
    结果:在ClinicalTrials.gov网站上注册的临床试验共有139项(自上次报告以来新注册的试验有35项)。在这些试验中,76(55%)被认为是ST,63(45%)被称为DMT。与往年相似,大约三分之一的研究处于第一阶段(n=47;34%),一半(n=72,52%)在第二阶段,有20(14%)在第三阶段。在今年的报告中,新疗法再次代表了最主要的实验性治疗方法,其中58项(42%)试验测试了新药。在三分之一(n=49,35%)的试验中,重新制定和新索赔占研究的19%和4%,分别。
    结论:我们对评估ST和DMT治疗PD的积极临床试验的第四次年度回顾表明,药物开发管道是动态的和不断发展的。从第二阶段过渡到第三阶段的进展缓慢和缺乏药物令人担忧,但是各种利益相关者正在集体努力加快临床试验过程,目的是更快为PD社区带来新疗法。
    Since 2020, annual reports on the clinical development of new drug-based therapies for the neurodegenerative condition of Parkinson\'s disease (PD) have been generated. These reviews have followed the progress of both \"symptomatic treatments\" (ST - improves/reduces symptoms of the condition) and \"disease modifying treatments\" (DMT - attempts to delay/slow progression by addressing the underlying biology of PD). Additional efforts have been made to further categorize these experimental treatments based on their mechanisms of action and class of drug.
    A dataset of clinical trials for drug therapies in PD was obtained using trial data downloaded from the ClinicalTrials.gov online registry. A breakdown analysis of all the studies that were active as of January 31st, 2023, was conducted.
    There was a total of 139 clinical trials registered on the ClinicalTrials.gov website as active (with 35 trials newly registered since our last report). Of these trials, 76 (55%) were considered ST and 63 (45%) were designated DMT. Similar to previous years, approximately a third of the studies were in Phase 1 (n = 47; 34%), half (n = 72, 52%) were in Phase 2 and there were 20 (14%) studies in Phase 3. Novel therapies again represented the most dominant group of experimental treatments in this year\'s report with 58 (42%) trials testing new agents. Repurposed drugs are present in a third (n = 49, 35%) of trials, with reformulations and new claims representing 19% and 4% of studies, respectively.
    Our fourth annual review of active clinical trials evaluating ST and DMT therapeutics for PD demonstrates that the drug development pipeline is dynamic and evolving. The slow progress and lack of agents transitioning from Phase 2 to Phase 3 is concerning, but collective efforts by various stakeholders are being made to accelerate the clinical trial process, with the aim of bringing new therapies to the PD community sooner.
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  • 文章类型: Journal Article
    睾丸癌(TC)是年轻男性中最常见的癌症之一,由于有效的治疗,存活率超过97%。治疗后的后续护理对于长期生存和监测心理社会症状非常重要,然而,TC幸存者(TCS)对治疗后护理的依从性较差.基于移动健康的干预措施在男性癌症患者中显示出较高的可接受性。这项研究将研究使用Zamplo健康应用程序来提高对治疗后护理的依从性并支持TCS的心理社会结果的可行性。
    这种混合方法,纵向,单臂试点研究将招募N=30例诊断为TC的患者,这些患者在≤6个月内完成治疗,目前年龄≥18岁.遵守后续任命(例如血液工作,扫描)将被评估(主要结果),和疲劳的措施,抑郁症,焦虑,性满意度和功能,社会角色满意度,一般的身心健康和身体形象(次要结果)将在四个时间点完成:基线,3、6和12个月。干预后将进行一对一的半结构化访谈(第12个月)。
    治疗后随访预约依从性和心理社会结果的改善将使用描述性统计进行分析,配对样本t检验确定时间点1至4的变化,并进行相关分析。定性数据将使用主题分析进行分析。
    研究结果将通知未来,纳入可持续性和经济影响评估的大型试验,以提高对TC随访指南的依从性。调查结果将通过信息图表传播,社交媒体,与技术合作支持组织合作并在会议上进行的出版物和介绍。
    UNASSIGNED: Testicular cancer (TC) is one of the most common cancers among young men, with survival rates exceeding 97% due to effective treatments. Post-treatment follow-up care is important for long-term survival and monitoring psychosocial symptoms, yet TC survivors (TCS) show poor adherence to post-treatment care. Mobile-health-based interventions show high acceptability in men with cancer. This study will examine the feasibility of using the Zamplo health app to improve adherence to post-treatment care and support psychosocial outcomes in TCS.
    UNASSIGNED: This mixed-methods, longitudinal, single-arm pilot study will recruit N = 30 patients with a diagnosis of TC who finished treatment within ≤ 6 months and are currently aged ≥18 years old. Adherence to follow-up appointments (e.g. blood work, scans) will be assessed (primary outcome), and measures for fatigue, depression, anxiety, sexual satisfaction and function, social roles satisfaction, general mental and physical health and body image (secondary outcomes) will be completed at four-time points: baseline, 3, 6 and 12 months. One-on-one semi-structured interviews will be conducted post-intervention (month 12).
    UNASSIGNED: Improvements in post-treatment follow-up appointment adherence and psychosocial outcomes will be analyzed using descriptive statistics, paired samples t-tests to determine changes across time points 1 through 4, and correlation analysis. Qualitative data will be analyzed using thematic analysis.
    UNASSIGNED: Findings will inform future, larger trials that incorporate evaluation of sustainability and economic implications to improve adherence to TC follow-up guidelines. Findings will be disseminated via infographics, social media, publications and presentations conducted in partnership with TC support organizations and at conferences.
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  • 文章类型: Journal Article
    背景和目的:心脏大手术后,一些患者报告视觉幻觉不能归因于精神病或谵妄。这项研究旨在调查(在泵上)和没有(在泵下)体外循环的冠状动脉旁路移植术后患者的幻觉发生率。材料和方法:前瞻性地纳入了184名连续的择期体外循环或非体外循环冠状动脉旁路移植术患者。术前基线调查24-48小时(t0)和术后随访24-48小时(t1)和术后5-6天(t2)包括认知测试和临床视力测试(Landolt环)。报告视觉幻觉的患者使用结构化调查进行访谈以记录类型,定时,持续时间,和他们幻觉的频率。如果需要,所有患者均接受了神经系统检查和颅磁共振成像。结果:在样本中的患者中,155名患者接受了泵上旁路手术,29例患者接受非体外循环手术。其中,停泵组25名患者,但是在非抽水组中没有,报告短暂性幻觉(p=0.020),这不能归因于中风,谵妄,精神病,偏头痛,或者视力严重受损.观察到视觉幻觉的发生以及尼古丁消耗量和主动脉钳/体外循环时间的显着相关性。结论:在体外循环心脏手术后,有明显比例的患者会出现短暂的视觉幻觉。了解这种现象的良性对于患者预防焦虑和不确定感以及治疗医生避免不必要的药物治疗和药物引起的谵妄非常重要。
    Background and Objectives: After major heart surgery, some patients report visual hallucinations that cannot be attributed to psychosis or delirium. This study aimed to investigate the hallucination incidence in patients after coronary artery bypass grafting with (on-pump) and without (off-pump) extracorporeal circulation. Materials and Methods: A total of 184 consecutive patients listed for elective on- or off-pump coronary artery bypass grafting were prospectively enrolled into the study. Preoperative baseline investigations 24-48 h before surgery (t0) and postoperative follow-up 24-48 h (t1) and 5-6 days (t2) after surgery included cognitive testing and a clinical visual acuity test (Landolt rings). Patients reporting visual hallucinations were interviewed using a structured survey to record the type, timing, duration, and frequency of their hallucinations. All the patients received a neurological examination and cranial magnetic resonance imaging if indicated. Results: Of the patients in the sample, 155 patients underwent on-pump bypass surgery, and 29 patients received off-pump surgery. Of these, 25 patients in the on-pump group, but none in the off-pump group, reported transient visual hallucinations (p = 0.020), which could not be attributed to stroke, delirium, psychosis, migraine, or severely impaired vision. Significant correlations were observed for the occurrence of visual hallucinations and the amount of nicotine consumption and aortic clamp/extracorporeal circulation time. Conclusions: Transient visual hallucinations occur in a noticeable proportion of patients after on-pump heart surgery. Knowledge of the phenomenon\'s benignity is important for patients to prevent anxiety and uncertainty and for treating physicians to avoid unnecessary medication and drug-induced delirium.
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  • 文章类型: Journal Article
    当COVID-19大流行于2020年初开始时,全球的临床试验被中断。由于对亲自研究活动的限制,大多数干预试验转向某种形式的远程实施。虽然远程试验的比例越来越大,他们仍然是绝大多数的研究,部分原因是很少有成功的例子。我们的团队过渡了实现最佳健康的目标(GROWell),NIH资助的(R01NR017659)随机对照试验(RCT;ClinicalTrials.gov标识符NCT04449432)最初设计为混合干预,完全远程临床试验。GROWell是针对超重或肥胖怀孕的人的数字饮食干预。主要结果包括妊娠体重增加和产后六个月体重保留。我们测试过的策略,精致,和部署包括:(A)使用符合HIPAA的,基于网络的参与者招募和参与平台;(b)使用符合HIPAA标准的数字健康平台传播GROWell并进行研究访问;(c)这两个平台的互联互通,实现无缝招募,同意,招生,干预交付,后续行动,和研究小组致盲;(d)详细的SMS消息,以解决遵守协议的初始挑战;(e)电子邮件通知,提醒研究小组错过的参与者调查,以便他们可以跟进;(f)使用电子邮件礼品卡和收件人选择供应商的报酬;(g)地理定位社交媒体活动,以提高黑人土著和有色人种社区的参与度。这些策略使屏幕故障率提高了7%,研究任务的依从性在整个研究访问中平均提高了20-30%,研究完成率为82%。研究人员可能会在未来的远程mHealth试验中考虑部分或全部这些方法。
    Clinical trials worldwide were disrupted when the COVID-19 pandemic began in early 2020. Most intervention trials moved to some form of remote implementation due to restrictions on in-person research activities. Although the proportion of remote trials is growing, they remain the vast minority of studies in part due to few successful examples. Our team transitioned Goals for Reaching Optimal Wellness (GROWell), an NIH-funded (R01NR017659) randomized control trial (RCT; ClinicalTrials.gov identifier NCT04449432) originally designed as a hybrid intervention, into a fully remote clinical trial. GROWell is a digital dietary intervention for people who enter pregnancy with overweight or obesity. Primary outcomes include gestational weight gain and six-month postpartum weight retention. Strategies that we have tested, refined, and deployed include: (a) use of a HIPAA-compliant, web-based participant recruitment and engagement platform; (b) use of a HIPAA-compliant digital health platform to disseminate GROWell and conduct study visits (c) interconnectivity of these two platforms for seamless recruitment, consent, enrollment, intervention delivery, follow-up, and study team blinding; (d) detailed SMS messages to address initial challenges with protocol adherence; (e) email notifications alerting the study team about missed participant surveys so they can follow-up; (f) remuneration using email gift cards with recipient choice of vendor; and (g) geotargeting social media campaigns to improve participation of Black Indigenous and People of Color Communities. These strategies have resulted in screen failure rates improving by 7%, study task adherence improving by an average of 20-30% across study visits, and study completion rates of 82%. Researchers may consider some or all of these approaches in future remote mHealth trials.
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  • 文章类型: Journal Article
    随着国际社会应对持续的COVID-19大流行,2021年,帕金森病(PD)神经退行性疾病新药的开发继续取得重要进展。这一进展包括“对症治疗”(ST-改善/减轻症状)和“疾病改善治疗”(DMT-试图通过解决PD的潜在生物学来延迟/减缓进展),可以根据它们的作用机制和药物类别进一步分类。
    本报告继续之前的努力,在2021年至2022年期间的PD临床试验中提供了药物疗法-ST和DMT-的概述,目的是提高对临床试验过程的认识和参与。我们还希望促进所有利益相关者之间的合作,包括工业,学术界,倡导组织,最重要的是耐心社区。
    我们使用从ClinicalTrials.gov和世界卫生组织(WHO)注册局获得的试验数据,对PD药物治疗的临床试验进行了审查。并对截至2022年1月31日活跃的研究进行了细分分析。我们还评估了已经完成一个临床阶段但尚未开始下一个阶段的活性药物开发项目。
    在分析期间,共有147项临床试验在ClinicalTrials.gov网站上注册为活跃。在这些试验中,91人(62%)正在调查STs,而56(38%)专注于DMT。大约1/3的研究(34.7%;51项试验)处于第一阶段,而超过一半的试验处于第二阶段(50.3%;74项试验)。只有15%(22项试验)的研究处于3期,其中只有3项试验正在评估DMT。新型疗法(42%)是所有测试阶段中最常见的药物类型,其次是再利用药物(34%)和再制剂(20%)。
    尽管全球面临严重的健康限制,2021年继续开发新的PD药物疗法。希望随着向大流行后世界的转变,在这个世界中,COVID-19得到了更好的管理,我们将看到专注于PD药物开发的临床试验数量有所增加。对DMT进行更多的3期研究的需求仍然非常迫切。
    As the international community dealt with the ongoing COVID-19 pandemic, important progress continued to be made in the development of new drug-based therapies for the neurodegenerative condition of Parkinson\'s disease (PD) in 2021. This progress included both \"symptomatic treatments\" (ST - improves/reduces symptoms of the condition) and \"disease modifying treatments\" (DMT - attempts to delay/slow progression by addressing the underlying biology of PD), which can be categorised further based on their mechanisms of action and class of drug.
    This report continues previous efforts to provide an overview of the pharmacological therapies - both ST and DMT - in clinical trials for PD during 2021- 2022, with the aim of creating greater awareness and involvement in the clinical trial process. We also hope to stimulate collaboration amongst all stakeholders, including industry, academia, advocacy organizations, and most importantly patient community.
    We conducted a review of clinical trials of drug therapies for PD using trial data obtained from the ClinicalTrials.gov and World Health Organisation (WHO) registries, and performed a breakdown analysis of studies that were active as of January 31st 2022. We also assessed active drug development projects that had completed one clinical phase but were yet to start the next.
    There was a total of 147 clinical trials registered on the ClinicalTrials.gov website as active during the period of analysis. Of these trials, 91 (62%)were investigating STs, while 56 (38%)focused on DMTs. Approximately 1/3 of the studies (34.7%; 51 trials) were in Phase 1, while over half of the trials were in Phase 2 (50.3%; 74 trials). Only 15% (22 trials) of the studies were in Phase 3, of which only 3 trials were evaluating DMTs. Novel therapeutics (42%)were the most common type of agents being tested across all phases of testing, followed by repurposed agents (34%)and reformulations (20%).
    Despite significant global health constraints, the development of new drug-based therapies for PD continued in 2021. Hopefully with a shift towards a post-pandemic world in which COVID-19 is better managed, we will see an increase in the number of clinical trials focused on drug development for PD. The need for more Phase 3 studies for DMTs remains acute.
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  • 文章类型: Journal Article
    UNASSIGNED:诸如社会警报系统之类的技术包含了对如何将其集成并在实践中使用的期望。这些期望,也称为技术脚本,通常不考虑护理实践中的所有复杂性。将重点从技术脚本转移到护理实践,本文探讨了如何在养老院的助理护士护理实践中使用社会报警系统。
    UNASSIGNED:本文借鉴了两个瑞典养老院中助理护士的日常任务(32小时)和对助理护士(n=12)的半结构化访谈。观察数据用于了解护理环境和助理护士技术介导的护理实践,虽然访谈被用来深入了解助理护士对系统的看法,他们的护理实践,以及他们在提供护理期间考虑了哪些方面。
    UNASSIGNED:我们展示了基于助理护士对技术脚本和护理质量的情境和个人解释,将社会报警系统集成到护理实践中所涉及的复杂性。以技术为媒介的护理实践包括接收居民的警报,通过报警电话检查报警,通过报警电话响应报警,亲自检查特定居民的情况,记录所有已完成的警报,并记录一些已完成的警报。在这些实践中,助理护士根据他们的预期要求和结果定义技术脚本,同时通过评估实际的优先级来考虑护理质量,在手头的情况下的道德或关系关怀。通过与定义的脚本和所考虑的护理质量的进一步谈判,助理护士决定了在实践中遵循(或不遵循)特定脚本的最终方式。
    UNASSIGNED:我们研究的结果描绘了护理实践中技术的复杂性。这些发现有助于增加对养老院中技术介导的护理实践的理解,以及机构环境中技术脚本的研究。
    UNASSIGNED: Technologies such as social alarm systems contain expectations about how they should be integrated and used in practice. These expectations, also called technology scripts, usually fail to consider all the complexity in care practice. Shifting the focus from technology scripts to care practice, this paper examines how a social alarm system is used in assistant nurses\' care practices in nursing homes.
    UNASSIGNED: The paper draws on observations of assistant nurses\' daily tasks (32 h) and semi-structured interviews with assistant nurses (n = 12) in two Swedish nursing homes. The observation data were used to understand the care contexts and assistant nurses\' technology-mediated care practices, while interviews were used to deeply understand assistant nurses\' perceptions of the system, their care practices, and which aspects they considered during the provision of care.
    UNASSIGNED: We show the complexities involved in integrating a social alarm system into care practices based on assistant nurses\' situational and personal interpretations of both technology scripts and quality of care. The technology-mediated care practices consist of receiving alarms from residents, checking alarms via alarm phones, responding to alarms via alarm phones, checking specific residents\' situations in person, documenting all finished alarms, and documenting some finished alarms. In these practices, the assistant nurses defined technology scripts according to their expected requirements and outcomes, and meanwhile considered the quality of care by evaluating the priority of practical, moral or relational care in the situations at hand. Through further negotiations with the defined scripts and the considered quality of care, the assistant nurses decided on the final way of following (or not following) specific scripts in practice.
    UNASSIGNED: Results from our study portray the complexity of technology in care practices. The findings contribute to increased understanding of technology-mediated care practices in nursing homes, and research on technology scripts in institutional settings.
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  • 文章类型: Journal Article
    尽管COVID-19大流行,在2020年期间,针对帕金森病(PD)的神经退行性疾病的新型和改进的基于药物的疗法的临床开发中已经有相当多的活动。所研究的药物可以分为“症状”(缓解病情的特征)和“疾病修饰”(试图解决PD的潜在生物学)治疗,分别为ST和DMT,根据作用机制和治疗类别进行进一步分类。
    我们在本报告中的目标是提供2020-2021年PD临床试验中的药物疗法-ST和DMT的概述,目的是提高对临床试验过程的认识和参与。我们还希望促进商业和学术研究人员之间以及研究和患者社区之间的合作。
    我们使用从ClinicalTrials.gov和世界卫生组织(WHO)注册局获得的试验数据,对PD药物治疗的临床试验进行了审查。并对截至2021年2月18日活跃的研究进行了细分分析。我们还评估了已经完成一个临床阶段但尚未开始下一个阶段的活性药物开发项目。
    我们在ClinicalTrials.gov上确定了142项试验,在WHO注册中心确定了14项符合我们分析标准的研究。在这156项试验中,91例为ST,65例为DMT,在我们2020年的分析中,在ClinicalTrials.gov上注册的145项试验中,45个从列表中删除,而42个被添加。尽管有这种变化,ST与DMT的平衡;各阶段的分布;治疗类别的概况;以及再用途治疗的比例(33.5%);所有这些都非常相似.第三阶段只有两个DMT,我们确定了33个中间阶段项目。
    尽管冠状病毒大流行的影响,PD临床试验的投资和努力似乎仍然强劲。临床试验的概况几乎没有变化,尽管,在过去的一年里,清单的内容有了相当大的变化。
    Despite the COVID-19 pandemic, there has been considerable activity in the clinical development of novel and improved drug-based therapies for the neurodegenerative condition of Parkinson\'s disease (PD) during 2020. The agents that were investigated can be divided into \"symptomatic\" (alleviating the features of the condition) and \"disease modifying\" (attempting to address the underlying biology of PD) treatments, ST and DMT respectively, with further categorisation possible based on mechanism of action and class of therapy.
    Our goal in this report was to provide an overview of the pharmacological therapies -both ST and DMT - in clinical trials for PD during 2020-2021, with the aim of creating greater awareness and involvement in the clinical trial process. We also hope to stimulate collaboration amongst commercial and academic researchers as well as between the research and patient communities.
    We conducted a review of clinical trials of drug therapies for PD using trial data obtained from the ClinicalTrials.gov and World Health Organisation (WHO) registries, and performed a breakdown analysis of studies that were active as of February 18th 2021. We also assessed active drug development projects that had completed one clinical phase but were yet to start the next.
    We identified 142 trials on ClinicalTrials.gov and 14 studies on the WHO registries that met our analysis criteria. Of these 156 trials, 91 were ST and 65 were DMT, Of the 145 trials registered on ClinicalTrials.gov in our 2020 analysis, 45 fell off the list and 42 were added. Despite this change, the balance of ST to DMT; the distribution across phases; the profile of therapeutic categories; and the proportion of repurposed therapies (33.5%); all remained very similar. There are only two DMTs in phase 3, and we identified 33 in-between-phase projects.
    Despite the effects of the coronavirus pandemic, investment and effort in clinical trials for PD appears to remain strong. There has been little change in the profile of the clinical trial landscape even though, over the past year, there has been considerable change to the content of the list.
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  • 文章类型: Journal Article
    目前大多数帕金森病(PD)的药物治疗在上个世纪下半叶被批准用于临床,它们仅提供症状缓解。这些疗法的衍生物继续在临床试验中探索,连同潜在的疾病改善疗法,停止或反转条件。
    为了提供目前正在临床评估的PD的药物治疗-症状和疾病改变的概述,目的是为商业和学术研究人员以及研究和患者社区之间的合作创造更大的意识和机会。
    我们使用从ClinicalTrials.gov数据库获得的试验数据对PD药物治疗的临床试验进行了审查,并对截至2020年1月21日活跃的研究进行了细分分析。
    我们确定了145个注册和正在进行的针对PD治疗的临床试验,其中51个是第一阶段(占试验总数的35%),66人是第二阶段(46%),28人是第三阶段(19%)。有57项试验(39%)专注于长期疾病改善疗法,其余88项试验(61%)侧重于缓解症状的治疗.共有50项(34%)试验正在测试再利用的疗法。
    目前在PD的临床试验中,有广泛的症状和疾病改善疗法正在测试。
    The majority of current pharmacological treatments for Parkinson\'s disease (PD) were approved for clinical use in the second half of the last century and they only provide symptomatic relief. Derivatives of these therapies continue to be explored in clinical trials, together with potentially disease modifying therapies that can slow, stop or reverse the condition.
    To provide an overview of the pharmacological therapies- both symptomatic and disease modifying- currently being clinically evaluated for PD, with the goal of creating greater awareness and opportunities for collaboration amongst commercial and academic researchers as well as between the research and patient communities.
    We conducted a review of clinical trials of drug therapies for PD using trial data obtained from the ClinicalTrials.gov database and performed a breakdown analysis of studies that were active as of January 21, 2020.
    We identified 145 registered and ongoing clinical trials for therapeutics targeting PD, of which 51 were Phase 1 (35% of the total number of trials), 66 were Phase 2 (46% ), and 28 were Phase 3 (19% ). There were 57 trials (39% ) focused on long-term disease modifying therapies, with the remaining 88 trials (61% ) focused on therapies for symptomatic relief. A total of 50 (34% ) trials were testing repurposed therapies.
    There is a broad pipeline of both symptomatic and disease modifying therapies currently being tested in clinical trials for PD.
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