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41.
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Introduction/Hypothesis

Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014–2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.

Methods

An online survey which included participants’ prior experience with clinical trials, motivations to participate (including financial incentives), and demographic information was developed to examine the motivations of healthy participants in two phase 1 clinical vaccine trials conducted at the Canadian Center for Vaccinology in Halifax, Nova Scotia. Participants were invited via email to complete the online survey. Readability and clarity were assessed through pilot testing.

Results

A total of 49 (55.7%) of 88 participants of the two studies completed the survey (22 [55%] of 40 participants from the Ebola vaccine study and 27 [56.3%] of 48 from the adjuvanted influenza vaccine study). Motivations that were most frequently ranked among participants' top three in both trials were (1) wanting to contribute to the health of others, (2) wanting to participate in something important, (3) wanting to contribute to the advancement of science, and (4) wanting to receive an incentive such as money or a tablet.

Conclusions/Recommendations

Although media attention and financial compensation were more often cited by Ebola vaccine trial participants as a reason to participate, both altruistic and self-interested factors were important motivations for participants in their decision to participate in a phase 1 vaccine clinical trial.  相似文献   
43.
Deep brain stimulation (DBS) in psychiatric illnesses has been clinically tested over the past 20 years. The clinical application of DBS to the superolateral branch of the medial forebrain bundle in treatment‐resistant depressed patients—one of several targets under investigation—has shown to be promising in a number of uncontrolled open label trials. However, there are remain numerous questions that need to be investigated to understand and optimize the clinical use of DBS in depression, including, for example, the relationship between the symptoms, the biological substrates/projections and the stimulation itself. In the context of precision and customized medicine, the current paper focuses on clinical and experimental research of medial forebrain bundle DBS in depression or in animal models of depression, demonstrating how clinical and scientific progress can work in tandem to test the therapeutic value and investigate the mechanisms of this experimental treatment. As one of the hypotheses is that depression engenders changes in the reward and motivational networks, the review looks at how stimulation of the medial forebrain bundle impacts the dopaminergic system.  相似文献   
44.
Patients with active cancer are at an increased risk of arterial and venous thromboembolism (VTE) and bleeding events. Historically, in patients with cancer, low molecular weight heparins have been preferred for treatment of VTE, whereas warfarin has been the standard anticoagulant for stroke prevention in patients with atrial fibrillation (AF). More recently, direct oral anticoagulants (DOACs) have been demonstrated to reduce the risk of venous and arterial thromboembolism in large randomized clinical trials of patients with VTE and AF, respectively, thus providing an attractive oral dosing option that does not require routine laboratory monitoring. In this review, we summarize available clinical trial data and guideline recommendations, and outline a practical approach to anticoagulation management of VTE and AF in cancer.  相似文献   
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目的 探讨电针复合靶控输注(Target Controlled Infusion, TCI)在单肺通气食管癌开胸手术麻醉中的应用价值。方法 选取于我院拟行单肺通气食管癌开胸切除手术患者60例作为研究对象。随机将其分为试验组与对照组,对照组30例采取气管插管全麻及TCI靶控输注维持麻醉深度,试验组30例则在对照组方案基础上辅助电针麻醉,记录两组患者手术麻醉时间、药物用量、苏醒时间、并发症;以及术前(T)、插管前即刻(T)、插管后1 min(T)、切皮即刻(T)、去骨时(T)、拔管即刻(T)时平均动脉压(MAP)、平均心率(HR)、BIS值;术前、术后1天、术后3天简易智能精神状态检查量表(MMSE);并于麻醉诱导前(T0)、手术开始2 h(T1)、术后1天(T2)、术后3天(T3)时抽取患者外周静脉血检测IL-1β、IL-6、IL-10、TNF-α浓度。结果 试验组手术用时、麻醉时间略低于对照组,但差异无统计学意义(P>0.05),试验组异丙酚、舒芬太尼用量以及苏醒时间均明显低于对照组(P<0.05);T时两组平均动脉压(Mean Arterial Pressure, MAP)、心率(Heartrate, HR)较术前明显降低,且试验组MAP明显低于对照组(P<0.05),但两组T时HR比较无显著差异(P>0.05);T、T时对照组MAP、HR明显高于T时,而试验组MAP、HR与T比较无显著差异(P>0.05)。术后1天、3天试验组简易智能精神状态检查量表(Mini-Mental State Examination, MMSE)评分低于对照组,有显著性差异(P<0.05)。T1、T2、T3时试验组白介素-1β(IL-1β)、白介素-6(IL-6)、肿瘤坏死因子(Tumor Necrosis Factor-α, TNF-α)水平明显低于对照组(P<0.05),白介素-10(IL-10)水平明显高于对照组(P<0.05)。结论 采用电针复合TCI靶控输注麻醉方案可有效提升单肺通气食管癌开胸手术麻醉效果,能够降低患者术后认知功能障碍发生风险。  相似文献   
48.
目的:探讨中西医结合护理干预妊娠晚期合并急性单纯性阑尾炎的临床疗效。方法:将2017 年9 月—2018 年12月于我院接受中西医结合保守治疗的31 例妊娠晚期合并急性单纯性阑尾炎患者作为研究对象,按随机数表法随机分为中西医结合护理组(观察组16 例)与常规护理组(对照组15 例),对照组采取常规护理措施,观察组在对照组的基础上增加中西医结合护理措施,对比两组患者的临床疗效。结果:观察组患者的心理状态变化、新生儿体质状况以及临床疗效等指标等情况均明显优于对照组,且组间对比差异显著有统计学意义(P < 0.05)。结论:中西医结合护理对妊娠晚期合并急性单纯性阑尾炎有较好的临床效果,可减少、甚至避免孕妇因合并急性阑尾炎而造成的打击和创伤。  相似文献   
49.
随着我国医疗机构临床药师队伍的不断壮大,其在医疗服务中发挥着越来越重要的作用,对其工作进行绩效考核也是当今医疗领域的重要内容。以现有文献为基础,对国内外临床药师绩效考核体系进行分析,发现现有体系可分为为基于临床药师职责、基于临床药师业务流程、国外临床药师绩效考核体系三个方面;通过结合医疗机构的实际情况对现有绩效考核体系进行分析,发现存在考核指标和标准确定困难、考核难以做到实时性和延续性等问题,并针对这些问题提出清晰职责定位、重视临床药师价值体现等修改说明。  相似文献   
50.
Treatment of posterior eye diseases is more challenging than the anterior segment ailments due to a series of anatomical barriers and physiological constraints confronted by drug delivery to the back of the eye. In recent years, concerted efforts in drug delivery have been made to prolong the residence time of drugs injected in the vitreous humor of the eye. Our previous studies demonstrated that poly(ortho ester) (POE) nanoparticles were biodegradable/biocompatible and were capable of long-term sustained release. The objective of the present study was to investigate the safety and localization of POE nanoparticles in New Zealand white rabbits and C57BL/6 mice after intravitreal administration for the treatment of chronic posterior ocular diseases. Two concentration levels of POE nanoparticles solution were chosen for intravitreal injection: 1.5?mg/ml and 10?mg/ml. Our results demonstrate that POE nanoparticles were distributed throughout the vitreous cavity by optical coherence tomography (OCT) examination 14 days post-intravitreal injection. Intraocular pressure was not changed from baseline. Inflammatory or adverse effects were undetectable by slit lamp biomicroscopy. Furthermore, we demonstrate that POE nanoparticles have negligible toxicity assessed at the cellular level evidenced by a lack of glia activation or apoptosis estimation after intravitreal injection. Collectively, POE nanoparticles are a novel and nontoxic as an ocular drug delivery system for the treatment of posterior ocular diseases.  相似文献   
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