Noninvasive

非侵入性
  • 文章类型: Journal Article
    背景非侵入性成像模式的主要发展,与传统的计算机断层扫描(CT)和胶囊内窥镜检查相比,计算机断层成像(CTE)具有许多优势.通过利用多探测器计算机断层扫描(MDCT)技术,CTE加快了对小肠疾病的评估,特别是在那些无法通过传统内窥镜检查的部分。本研究的主要目标是全面评估CTE对一系列小肠疾病的诊断准确性。方法论在这次调查中,这是一项前瞻性观察研究,40名患者,25男15女,怀疑小肠疾病和年龄范围从10到70接受CTE。为了评估诊断的准确性,临床症状的组合,成像数据,和组织病理学/超声检查结果进行了评估。在整个研究过程中,纳入了伦理问题和统计分析,以保证有效性和遵守伦理规范。结果CTE最常见的表现是肠管增厚和粘膜过度增强,在25例(62.5%)和20例(50%)患者中观察到,分别。大多数患者(65%)在III级中表现出回肠和空肠环充分扩张。在35%的患者中,观察到回肠和空肠环的II级扩张性。结论在准确检测小肠疾病时,CTE优越。它评估肠外,壁画,和具有疗效的腔内疾病,特别是在难以到达的地方。它对于指导临床决策至关重要,因为它有能力在内窥镜检查之前评估疾病活动并查看后果。
    Background A major development in noninvasive imaging modalities, computed tomographic enterography (CTE) has a number of benefits over conventional computed tomography (CT) and capsule endoscopy. Through the utilization of multidetector computed tomography (MDCT) technology, CTE expedites the assessment of small bowel diseases, especially in those segments that are not accessible through traditional endoscopy. This study\'s main goal is to thoroughly evaluate CTE\'s diagnostic accuracy for a range of small intestinal conditions. Methodology In this investigation, which is a prospective observational study, 40 patients, 25 men and 15 women, with suspected small intestinal disorders and ages ranging from 10 to 70 underwent CTE. To evaluate diagnosis accuracy, a combination of clinical symptoms, imaging data, and histopathological/ultrasonography findings were evaluated. Throughout the research procedure, ethical issues and statistical analysis were incorporated to guarantee validity and adherence to ethical norms. Results The most frequent findings on CTE were bowel thickening and mucosal hyperenhancement, which were seen in 25 (62.5%) and 20 (50%) of the patients, respectively. The majority of patients (65%) exhibited both the ileal and jejunal loops to be adequately distended in grade III. In 35% of the patients, grade II distensibility of the ileal and jejunal loops was seen. Conclusion When it comes to accurately detecting small intestinal disorders, CTE is superior. It evaluates extraintestinal, mural, and intraluminal diseases with efficacy, particularly in places that are difficult to reach. It is essential for directing clinical decisions because of its capacity to assess disease activity prior to endoscopy and see consequences.
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  • 文章类型: Published Erratum
    [这更正了文章DOI:10.3389/fmed.2024.1354363。].
    [This corrects the article DOI: 10.3389/fmed.2024.1354363.].
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  • 文章类型: Journal Article
    多年来,非侵入性的方法来测量颅内压(ICP)没有成功。然而,这些方法对于评估无意识的非穿透性创伤性脑损伤(TBI)患者至关重要。在这项研究中,我们探索了使用经颅传导超声(TTUS)通过脑搏动来收集实验数据,使用机器学习分析评估其检测高ICP的有效性。我们纳入了重症监护病房中接受侵入性ICP监测的严重TBI患者。在正常和升高的ICP期间,我们同时记录ICP,动脉血压,心率,和TTUS测量。我们的分类模型基于9名患者的数据,包括387例ICP升高(>15mmHg)和345例ICP正常(<10mmHg),并通过留一法验证。这项研究,从2021年10月到2022年10月进行,涉及25名患者,平均年龄为61.6±17.6岁,产生279个数据集,平均ICP为11.3mmHg(第1四分位数6·1mmHg;第3四分位数14·8mmHg)。自动化TTUS分析以100%的灵敏度和47%的特异性有效地识别超过15mmHg的ICP值。它实现了100%的阴性预测值和14%的阳性预测值。这表明TTUS可以准确排除TBI患者高于15mmHg的高ICP,提示可能需要立即成像或干预的患者。这些有希望的结果,如果在更大的研究中得到证实和扩展,可能导致第一个可靠的,用于检测ICP升高的非侵入性筛查工具。
    For many years, noninvasive methods to measure intracranial pressure (ICP) have been unsuccessful. However, such methods are crucial for the assessment of patients with nonpenetrating traumatic brain injuries (TBIs) who are unconscious. In this study, we explored the use of transcranial transmission ultrasound (TTUS) to gather experimental data through brain pulsatility, assessing its effectiveness in detecting high ICP using machine learning analysis. We included patients with severe TBI under invasive ICP monitoring in our intensive care unit. During periods of both normal and elevated ICP, we simultaneously recorded ICP, arterial blood pressure, heart rate, and TTUS measurements. Our classification model was based on data from 9 patients, encompassing 387 instances of elevated ICP (>15 mmHg) and 345 instances of normal ICP (<10 mmHg), and validated through a leave-one-subject-out method. The study, conducted from October 2021 to October 2022, involved 25 patients with an average age of 61.6 ± 17.6 years, producing 279 datasets with an average ICP of 11.3 mmHg (1st quartile 6.1 mmHg; 3rd quartile 14.8 mmHg). The automated TTUS analysis effectively identified ICP values over 15 mmHg with 100% sensitivity and 47% specificity. It achieved a 100% negative predictive value and a 14% positive predictive value. This suggests that TTUS can accurately rule out high ICP above 15 mmHg in TBI patients, indicating patients who may need immediate imaging or intervention. These promising results, if confirmed and expanded in larger studies, could lead to the first reliable, noninvasive screening tool for detecting elevated ICP.
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  • 文章类型: Clinical Trial Protocol
    背景:子痫前期(PE)是最常见的高血压疾病之一,影响所有怀孕的2%-8%。PE的高孕产妇和胎儿死亡率是由于缺乏早期识别受影响的孕妇,这将导致更密切的监测和护理。最近的数据表明,错误折叠的蛋白质可能是PE预测的有希望的生物标志物,根据孕妇的血友病(聚集)特征,可以在孕妇的尿液样本中检测到。
    目的:本试验的主要目的是评估基于尿血友病的错误折叠蛋白检测对疑似PE女性即将发生PE的预测价值。次要目标是证明尿液错误折叠蛋白的存在与PE相关的母体或新生儿不良结局相关。并将错折叠蛋白与多指标相结合,建立准确的PE预测模型。
    方法:这项前瞻性队列研究将招募至少300名临床怀疑PE的孕妇。除怀疑PE外,参与者应符合以下纳入标准:≥18岁,孕周在20+0和33+6之间,单胎妊娠。将连续收集尿液样本,失明,并在入组时和4次随访时检测错误折叠蛋白和其他PE相关生物标志物。所有参与者的PE状态和相关并发症的临床评估将使用严格的诊断标准定期进行。研究人员和参与者将对结果视而不见。随访至产后42天。来自医疗记录的数据,包括母婴结局,将被收集。将对单独的尿液错误折叠蛋白以及与其他生物标志物或临床变量组合用于预测PE的性能进行统计分析。
    结果:报名于2023年7月开始,在提交手稿时仍然开放。截至2024年3月,共有251名符合条件的女性参加了这项研究,预计招生将持续到2024年8月。结果分析计划在所有参与者达到随访终点后开始,并收集完整的临床数据。
    结论:研究完成后,我们希望得到一个准确的PE预测模型,这将允许对临床怀疑PE的孕妇进行积极管理,并可能减少相关的不良妊娠结局。错误折叠蛋白的额外预后价值也有望得到证实。
    背景:中国临床试验注册ChiCTR2300074878;https://www.chictr.org.cn/showproj.html?proj=202096。
    PRR1-10.2196/54026。
    BACKGROUND: Preeclampsia (PE) is one of the most common hypertensive diseases, affecting 2%-8% of all pregnancies. The high maternal and fetal mortality rates of PE are due to a lack of early identification of affected pregnant women that would have led to closer monitoring and care. Recent data suggest that misfolded proteins might be a promising biomarker for PE prediction, which can be detected in urine samples of pregnant women according to their congophilia (aggregated) characteristic.
    OBJECTIVE: The main purpose of this trial is to evaluate the value of the urine congophilia-based detection of misfolded proteins for the imminent prediction of PE in women presenting with suspected PE. The secondary objectives are to demonstrate that the presence of urine misfolded proteins correlates with PE-related maternal or neonatal adverse outcomes, and to establish an accurate PE prediction model by combining misfolded proteins with multiple indicators.
    METHODS: At least 300 pregnant women with clinical suspicion of PE will be enrolled in this prospective cohort study. Participants should meet the following inclusion criteria in addition to a suspicion of PE: ≥18 years old, gestational week between 20+0 and 33+6, and single pregnancy. Consecutive urine samples will be collected, blinded, and tested for misfolded proteins and other PE-related biomarkers at enrollment and at 4 follow-up visits. Clinical assessments of PE status and related complications for all participants will be performed at regular intervals using strict diagnostic criteria. Investigators and participants will remain blinded to the results. Follow-up will be performed until 42 days postpartum. Data from medical records, including maternal and fetal outcomes, will be collected. The performance of urine misfolded proteins alone and combined with other biomarkers or clinical variables for the prediction of PE will be statistically analyzed.
    RESULTS: Enrollment started in July 2023 and was still open upon manuscript submission. As of March 2024, a total of 251 eligible women have been enrolled in the study and enrollment is expected to continue until August 2024. Results analysis is scheduled to start after all participants reach the follow-up endpoint and complete clinical data are collected.
    CONCLUSIONS: Upon completion of the study, we expect to derive an accurate PE prediction model, which will allow for proactive management of pregnant women with clinical suspicion of PE and possibly reduce the associated adverse pregnancy outcomes. The additional prognostic value of misfolded proteins is also expected to be confirmed.
    BACKGROUND: Chinese Clinical Trials Registry ChiCTR2300074878; https://www.chictr.org.cn/showproj.html?proj=202096.
    UNASSIGNED: PRR1-10.2196/54026.
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  • 文章类型: Journal Article
    背景:呼吸系统疾病,包括活动性结核病(TB),哮喘,和慢性阻塞性肺疾病(COPD),构成重大的全球卫生挑战,需要及时准确的诊断以进行有效的治疗和管理。
    目的:本研究旨在开发和评估一种无创的用户友好型人工智能(AI)驱动的咳嗽音频分类器,以检测坦桑尼亚农村的这些呼吸状况。
    方法:这是一项非实验性的横断面研究,主要目的是收集和分析活动性结核病患者的咳嗽声音,哮喘,和COPD在门诊诊所生成和评估非侵入性咳嗽音频分类器。专门的咳嗽录音设备,设计为非侵入性和用户友好,将有助于收集来自Shinyanga地区20个医疗机构门诊的患者的各种咳嗽声音样本。收集的咳嗽声音数据将经过严格的分析,使用先进的AI信号处理和机器学习技术。通过比较与TB相关的声学特征和模式,哮喘,COPD,将生成能够自动辨别疾病的稳健算法,从而促进基于智能手机的咳嗽声音分类器的开发.分类器将根据计算的参考标准进行评估,包括临床评估,痰涂片,GeneXpert,胸部X光,文化和敏感性,肺活量测定和峰值呼气流量,以及灵敏度和预测值。
    结果:这项研究代表了提高门诊诊所诊断能力的重要一步。有可能彻底改变呼吸疾病诊断领域。研究四个阶段的结果将作为相关图像支持的描述呈现,tables,和数字。这项研究的预期结果是创建一个可靠的,非侵入性诊断咳嗽分类器,使医疗保健专业人员和患者自己能够根据咳嗽声音模式识别和区分这些呼吸道疾病。
    结论:咳嗽声音分类器使用先进的技术来早期检测和管理呼吸系统疾病,为传统诊断提供一种侵入性更低、更有效的替代方案。这项技术有望减轻公共卫生负担,改善患者预后,加强资源不足地区的医疗保健服务,可能改变全球呼吸道疾病管理。
    PRR1-10.2196/54388。
    BACKGROUND: Respiratory diseases, including active tuberculosis (TB), asthma, and chronic obstructive pulmonary disease (COPD), constitute substantial global health challenges, necessitating timely and accurate diagnosis for effective treatment and management.
    OBJECTIVE: This research seeks to develop and evaluate a noninvasive user-friendly artificial intelligence (AI)-powered cough audio classifier for detecting these respiratory conditions in rural Tanzania.
    METHODS: This is a nonexperimental cross-sectional research with the primary objective of collection and analysis of cough sounds from patients with active TB, asthma, and COPD in outpatient clinics to generate and evaluate a noninvasive cough audio classifier. Specialized cough sound recording devices, designed to be nonintrusive and user-friendly, will facilitate the collection of diverse cough sound samples from patients attending outpatient clinics in 20 health care facilities in the Shinyanga region. The collected cough sound data will undergo rigorous analysis, using advanced AI signal processing and machine learning techniques. By comparing acoustic features and patterns associated with TB, asthma, and COPD, a robust algorithm capable of automated disease discrimination will be generated facilitating the development of a smartphone-based cough sound classifier. The classifier will be evaluated against the calculated reference standards including clinical assessments, sputum smear, GeneXpert, chest x-ray, culture and sensitivity, spirometry and peak expiratory flow, and sensitivity and predictive values.
    RESULTS: This research represents a vital step toward enhancing the diagnostic capabilities available in outpatient clinics, with the potential to revolutionize the field of respiratory disease diagnosis. Findings from the 4 phases of the study will be presented as descriptions supported by relevant images, tables, and figures. The anticipated outcome of this research is the creation of a reliable, noninvasive diagnostic cough classifier that empowers health care professionals and patients themselves to identify and differentiate these respiratory diseases based on cough sound patterns.
    CONCLUSIONS: Cough sound classifiers use advanced technology for early detection and management of respiratory conditions, offering a less invasive and more efficient alternative to traditional diagnostics. This technology promises to ease public health burdens, improve patient outcomes, and enhance health care access in under-resourced areas, potentially transforming respiratory disease management globally.
    UNASSIGNED: PRR1-10.2196/54388.
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  • 文章类型: Journal Article
    超声已成为评估子宫内膜容受性(ER)的常规方法。然而,各种超声指标的独立评估值存在争议。一些研究人员设计了多指标预测系统,但是它们的预测值是不均匀的。为了进一步了解ER,我们进行了这项前瞻性队列研究,目的是无创且有效地估计ER.
    从2019年4月至2021年7月接受第一个冻融胚胎移植(FET)周期的女性被纳入研究。转移当天,经阴道三维超声检查评价ER,包括子宫内膜厚度,形态学,volume,运动,血流和血流指数。临床妊娠率是主要结局。根据是否达到临床妊娠,纳入的患者分为妊娠组和非妊娠组.
    这项研究分析了197例FET患者(总共139例怀孕,70.5%)。临床妊娠的保护因素包括原发性不孕症[调整比值比(aOR),1.98;95%置信区间(CI),1.01-3.882;p=0.047]和更频繁的子宫内膜蠕动(aOR,1.33;95%CI,1.028-1.722;p=0.03)。根据不同超声指标与临床妊娠率(CPR)的关系,分为1~2分。患者的ER评分为6项评分的总和。妊娠组的ER评分明显高于非妊娠组(7.40±1.73vs.6.33±1.99,p=0.001)。CPR随着ER评分的增加而增加。ER<6组的CPR明显低于ER>6组(45.5%vs.75.6%,p=0.001)。
    提出了一种用于ER的无创超声评分系统。该系统可以提供非侵入性的引导视角,结合目前在临床实践中使用的侵入性评估,实现更有效的胚胎移植。
    Ultrasound has become a routine method for endometrial receptivity (ER) evaluation. However, there is controversy over the independent evaluation values of various ultrasound indicators. Some researchers have designed multi-indicator prediction systems, but their prediction values are uneven. To further our understanding of ER, we conducted this prospective cohort study to estimate ER noninvasively and effectively.
    Women who underwent the first frozen-thawed embryo transfer (FET) cycle from April 2019 to July 2021 were included in the study. On the day of transfer, transvaginal three-dimensional ultrasound examination was performed to evaluate ER, including endometrial thickness, morphology, volume, movement, blood flow and flow index. The clinical pregnancy rate was the primary outcome. Based on whether clinical pregnancy was achieved, enrolled patients were divided into pregnant and nonpregnant groups.
    This study analyzed 197 FET patients (139 pregnancies in total, 70.5%). The protective factors for clinical pregnancy included primary infertility [adjusted odds ratio (aOR), 1.98; 95% confidence interval (CI), 1.01-3.882; p = 0.047] and more frequent endometrial peristalsis (aOR, 1.33; 95% CI, 1.028-1.722; p = 0.03). Scores of 1-2 were assigned according to the relationship between different ultrasound indicators and the clinical pregnancy rate (CPR). The ER score of the patient was the sum of the scores of the 6 items. The ER score of the pregnant group was significantly higher than that of the nonpregnant group (7.40 ± 1.73 vs. 6.33 ± 1.99, p = 0.001). The CPR increased with an increasing ER score. The CPR in the ER < 6 group was significantly lower than that in the ER >6 group (45.5% vs. 75.6%, p = 0.001).
    A noninvasive ultrasound scoring system for ER was proposed. This system may provide a non-invasive guidance perspective, in conjunction with invasive assessments currently used in clinical practice, to achieve more effective embryo transfer.
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  • 文章类型: Journal Article
    背景:在过去的几十年里,糖尿病已成为全球严重的公共卫生问题,特别是在孟加拉国。人工智能的进步可以在血糖水平的预测中收获,以更好地进行健康管理。然而,使用来自低收入和中等收入国家的数据预测健康参数的机器学习(ML)技术的实际有效性,比如孟加拉国,非常低。具体来说,孟加拉国缺乏使用ML技术根据基本的非侵入性临床测量以及饮食和社会人口统计学信息来预测血糖水平的研究。
    目的:制定公共卫生规划和糖尿病控制的策略,这项研究旨在开发一种个性化的ML模型,该模型可预测孟加拉国城市企业员工的血糖水平。
    方法:基于基本的无创健康检查测试结果,饮食信息,以及孟加拉国格莱en银行综合体271名员工的社会人口统计学特征,5个著名的ML模型,即,线性回归,增强决策树回归,神经网络,决策森林回归,和贝叶斯线性回归,用于预测血糖水平。在这项研究中使用连续的血糖数据来训练模型,然后使用训练的数据来预测新的血糖值。
    结果:在所有评估模型中,Boosted决策树回归显示出最大的预测性能(均方根误差=2.30)。这意味着,平均而言,我们模型的预测血糖水平偏离实际血糖水平约2.30mg/dL。研究人群的平均血糖值为128.02mg/dL(SD56.92),指示大多数样品的边界结果(正常值:140mg/dL)。这表明个体应该定期监测他们的血糖水平。
    结论:这个支持ML的血糖预测网络应用程序有助于个人自我监测自己的健康状况。该应用程序是在低收入和中等收入国家偏远地区的社区开发的,比如孟加拉国,在心里。这些地区通常缺乏卫生设施,合格的医生和护士数量不足。基于Web的应用程序是一个简单的,实用,以及社区可以采用的有效解决方案。使用Web应用程序可以节省医疗费用,时间,和健康管理费用。创建的系统还有助于实现可持续发展目标,特别是确保社区中的每个人都享有良好的健康和福祉,并降低总发病率和死亡率。
    BACKGROUND: Over the past few decades, diabetes has become a serious public health concern worldwide, particularly in Bangladesh. The advancement of artificial intelligence can be reaped in the prediction of blood glucose levels for better health management. However, the practical validity of machine learning (ML) techniques for predicting health parameters using data from low- and middle-income countries, such as Bangladesh, is very low. Specifically, Bangladesh lacks research using ML techniques to predict blood glucose levels based on basic noninvasive clinical measurements and dietary and sociodemographic information.
    OBJECTIVE: To formulate strategies for public health planning and the control of diabetes, this study aimed to develop a personalized ML model that predicts the blood glucose level of urban corporate workers in Bangladesh.
    METHODS: Based on the basic noninvasive health checkup test results, dietary information, and sociodemographic characteristics of 271 employees of the Bangladeshi Grameen Bank complex, 5 well-known ML models, namely, linear regression, boosted decision tree regression, neural network, decision forest regression, and Bayesian linear regression, were used to predict blood glucose levels. Continuous blood glucose data were used in this study to train the model, which then used the trained data to predict new blood glucose values.
    RESULTS: Boosted decision tree regression demonstrated the greatest predictive performance of all evaluated models (root mean squared error=2.30). This means that, on average, our model\'s predicted blood glucose level deviated from the actual blood glucose level by around 2.30 mg/dL. The mean blood glucose value of the population studied was 128.02 mg/dL (SD 56.92), indicating a borderline result for the majority of the samples (normal value: 140 mg/dL). This suggests that the individuals should be monitoring their blood glucose levels regularly.
    CONCLUSIONS: This ML-enabled web application for blood glucose prediction helps individuals to self-monitor their health condition. The application was developed with communities in remote areas of low- and middle-income countries, such as Bangladesh, in mind. These areas typically lack health facilities and have an insufficient number of qualified doctors and nurses. The web-based application is a simple, practical, and effective solution that can be adopted by the community. Use of the web application can save money on medical expenses, time, and health management expenses. The created system also aids in achieving the Sustainable Development Goals, particularly in ensuring that everyone in the community enjoys good health and well-being and lowering total morbidity and mortality.
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  • 文章类型: Journal Article
    背景:系统性红斑狼疮是一种慢性,多系统,自身免疫性病因的炎症性疾病主要发生在女性。诊断的主要障碍,治疗,这种疾病的治疗进展是其异质性,表现为广泛的症状,如疲劳,发烧,肌肉骨骼受累,神经精神疾病,和不同严重程度的心血管受累。目前对这种疾病的治疗方法包括施用可能产生不利的副作用的免疫调节药物。
    目的:本研究探讨了自主神经系统与炎症通路之间的已知关系,通过无创迷走神经刺激治疗患者的自主神经系统失调来改善患者的预后。在这项研究中,数据包括生物标志物,生理信号,患者结果,和患者的生活质量正在被收集和分析。临床试验完成后,将开发一个计算机模型来识别与狼疮活动相关的生物标志物和生理信号,以了解它们如何随着不同的非侵入性迷走神经刺激频率参数而变化。最后,我们建议建立一个决策支持系统,集成非侵入式可穿戴技术,用于连续的心血管和外周生理传感,实时优化非侵入性迷走神经刺激频率参数。
    方法:该方案旨在评估经耳廓迷走神经刺激对系统性红斑狼疮患者的疗效和安全性。这个多中心,国家,随机化,双盲,平行组,安慰剂对照研究将招募至少18名被诊断患有这种疾病的患者。患者的评估和治疗将在门诊进行,包括12次就诊。访问1包括筛选会议。随后的访问直到访问6包括混合治疗和评估会议。最后,其余访视与治疗后的早期和晚期随访相对应.
    结果:2022年11月,开始数据收集。在预定初次任命的10名参与者中,8符合纳入标准,和6成功完成了整个协议。目前正在进行患者登记和数据收集,预计将于2023年12月完成。
    结论:这项研究的结果将促进患者定制的迷走神经刺激疗法,为系统性红斑狼疮提供辅助治疗解决方案,这将促进技术的采用,因此,扩大可以从改善自主神经失调中受益的系统性红斑狼疮的人群,转化为降低成本和更好的生活质量。
    背景:ClinicalTrials.govNCT05704153;https://clinicaltrials.gov/study/NCT05704153。
    DERR1-10.2196/48387。
    BACKGROUND: Systemic lupus erythematosus is a chronic, multisystem, inflammatory disease of autoimmune etiology occurring predominantly in women. A major hurdle to the diagnosis, treatment, and therapeutic advancement of this disease is its heterogeneous nature, which presents as a wide range of symptoms such as fatigue, fever, musculoskeletal involvement, neuropsychiatric disorders, and cardiovascular involvement with varying severity. The current therapeutic approach to this disease includes the administration of immunomodulatory drugs that may produce unfavorable secondary effects.
    OBJECTIVE: This study explores the known relationship between the autonomic nervous system and inflammatory pathways to improve patient outcomes by treating autonomic nervous system dysregulation in patients via noninvasive vagus nerve stimulation. In this study, data including biomarkers, physiological signals, patient outcomes, and patient quality of life are being collected and analyzed. After completion of the clinical trial, a computer model will be developed to identify the biomarkers and physiological signals related to lupus activity in order to understand how they change with different noninvasive vagus nerve stimulation frequency parameters. Finally, we propose building a decision support system with integrated noninvasive wearable technologies for continuous cardiovascular and peripheral physiological sensing for adaptive, patient-specific optimization of the noninvasive vagus nerve stimulation frequency parameters in real time.
    METHODS: The protocol was designed to evaluate the efficacy and safety of transauricular vagus nerve stimulation in patients with systemic lupus erythematosus. This multicenter, national, randomized, double-blind, parallel-group, placebo-controlled study will recruit a minimum of 18 patients diagnosed with this disease. Evaluation and treatment of patients will be conducted in an outpatient clinic and will include 12 visits. Visit 1 consists of a screening session. Subsequent visits up to visit 6 involve mixing treatment and evaluation sessions. Finally, the remaining visits correspond with early and late posttreatment follow-ups.
    RESULTS: On November 2022, data collection was initiated. Of the 10 participants scheduled for their initial appointment, 8 met the inclusion criteria, and 6 successfully completed the entire protocol. Patient enrollment and data collection are currently underway and are expected to be completed in December 2023.
    CONCLUSIONS: The results of this study will advance patient-tailored vagus nerve stimulation therapies, providing an adjunctive treatment solution for systemic lupus erythematosus that will foster adoption of technology and, thus, expand the population with systemic lupus erythematosus who can benefit from improved autonomic dysregulation, translating into reduced costs and better quality of life.
    BACKGROUND: ClinicalTrials.gov NCT05704153; https://clinicaltrials.gov/study/NCT05704153.
    UNASSIGNED: DERR1-10.2196/48387.
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  • 文章类型: Journal Article
    动脉灌注减少是外周动脉疾病(PAD)患者的典型病症,微血管图片尤其存在于女性中。这项观察性研究旨在通过红外热像仪(IRT)检测两性家庭锻炼计划后的足部灌注变化。共有76例PADlau行患者(72±4岁;52例男性)参加了结构化的家庭锻炼计划,该计划由两次每天8分钟的间隔步行(步行:休息比1:1)组成,速度逐渐增加。在基线(T0)和5周后每次医院就诊时收集的结果测量值,12周和20周包括通过IRT测量的足部温度(胫骨前,胫骨后端,足背和弓形动脉区域),踝臂指数和6分钟步行试验。20周后,双肢足温呈明显上升趋势,受损肢体的平均变异为1.3°C,对侧肢体的平均变异为0.9°C(t=8.88,p<0.001和t=5.36;p<0.001),训练5周后发生显著变化。性别导向分析没有突出任何显著差异,女性平均足温改善为1.5±0.6°C,男性为1.2±0.5°C(p=0.42)。踝臂指数和表现也随着时间的推移而显著改善(p<0.001),没有性别差异。在PAD患者中,结构化的低强度运动计划显着改善了足部温度和运动能力,而没有任何与性别相关的差异。
    Decreased arterial perfusion is a typical condition of patients with peripheral artery disease (PAD), with the microvascular picture particularly present among women. This observational study aimed to detect foot perfusion changes by infrared thermography (IRT) after a home-based exercise program in both sexes. A total of 76 PAD patients with claudication (72 ± 4 years; 52 males) were enrolled in a structured in-home exercise program composed of two daily 8 min interval walking sessions (1:1 walk:rest ratio) with progressively increasing speed. Outcome measures collected at baseline (T0) and at each hospital visit after 5 weeks, 12 weeks and 20 weeks included foot temperature measured by IRT (anterior tibial, posterior tibial, dorsalis pedis and arcuate artery regions), ankle brachial index and the 6 min walking test. After 20 weeks, foot temperature in both limbs showed a significant increasing trend, with a mean variation of 1.3 °C for the more impaired limb and 0.9 °C for the contralateral limb (t = 8.88, p < 0.001 and t = 5.36; p < 0.001, respectively), with significant changes occurring after 5 weeks of training. The sex-oriented analysis did not highlight any significant difference, with an improvement of mean foot temperature of 1.5 ± 0.6 °C in females versus 1.2 ± 0.5 °C in males (p = 0.42). Ankle brachial index and performance also significantly improved over time (p < 0.001) without gender differences. In patients with PAD, a structured low-intensity exercise program significantly improved foot temperature and exercise capacity without any sex-related difference.
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  • 文章类型: Journal Article
    背景:低温脂肪分解是一种局部脂肪减少的非侵入性技术,使用受控暴露于强烈的寒冷诱导脂肪细胞的选择性凋亡。在过去的10年里,该技术已被证明是安全有效的,其应用已大大增加。在这种情况下,Cooltech®设备已在世界各地广泛使用。
    目的:这项回顾性研究的目的是评估使用新型Cooltech®Define受控冷却系统去除不同身体区域局部脂肪组织的有效性和安全性。
    方法:这项单中心研究对287名患者进行,女性和男性,用Cooltech®治疗在不同的身体区域定义总共1118个程序。进行后续评估以评估疗效和安全性。通过倍率测量和照片评价功效。还报道了副作用。
    结果:冷冻溶脂处理后,折叠厚度显着减少(-69.91±12.55%)(折叠前厚度:35.33±8.41mm;折叠后厚度:10.69±5.27mm)。几乎没有副作用的报道,其中包括治疗后疼痛(1.70%)和1例矛盾的脂肪增生(0.09%)。
    结论:Cooltech®Define冷冻分解装置是一种安全的,有效,和耐受性良好的非手术治疗减少局部脂肪。
    BACKGROUND: Cryolipolysis is a noninvasive technique for localized fat reduction, which induces selective apoptosis of the adipocytes using controlled exposure to intense cold. During the past 10 years, this technique has been shown to be safe and effective and its application has significantly increased. In this context, Cooltech® devices have been widely used around the world.
    OBJECTIVE: The purpose of this retrospective study was to evaluate the efficacy and safety of the removal of localized fatty tissue in different body areas using the new Cooltech® Define controlled cooling system.
    METHODS: This single-center study was carried out on 287 patients, both female and male, treated with Cooltech® Define on different body areas for a total of 1118 procedures. Follow-up evaluations were conducted to estimate efficacy and safety. Efficacy was evaluated through plicometry and photographs. Side effects were also reported.
    RESULTS: Fold thickness showed a significant reduction (-69.91 ± 12.55%) after cryolipolysis treatment (fold thickness before: 35.33 ± 8.41 mm; fold thickness after: 10.69 ± 5.27 mm). Few side effects were reported, they included posttreatment pain (1.70%) and one case of paradoxical adipose hyperplasia (0.09%).
    CONCLUSIONS: The Cooltech® Define cryolipolysis device is a safe, effective, and well-tolerated nonsurgical procedure for reducing localized fat.
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