Baltimore, MD Paid Clinical Trials

ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives. The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care. Read Less

Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Inspire™ is an FDA-approved hypoglossal nerve stimulation device (HGNS) used in select patients with OSA who are intolerant of CPAP. The device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. Despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to HGNS and remain at risk for complications from untreated OSA. The current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to HGNS therapy. Drug induced sleep endoscopy (DISE) is a prerequisite for HGNS treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. The amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of OSA with HGNS. As a result, CPAP titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of DISE to select parties for HGNS at multiple institutions. Nevertheless, changes in upper airway collapsibility in response HGNS may differ significantly between patients. This stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of DISE predicts successful treatment with HGNS as defined by a 50% reduction on apnea-hypopnea index (AHI) and an on-treatment AHI \<20. Read Less

Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and/or other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD. Read Less

Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Studies have shown that women with Afib are more likely to be symptomatic, have increased mortality from stroke resulting from Afib, and are less likely to receive treatment for Afib. University of Maryland Department of Neurology and Vascular Neurology are recruiting women older than 70 years of age to participate in the study. Read Less

This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset. Read Less

The Sickle Cell Children's Exercise Study (SuCCESs) will explore the feasibility and effects of a moderate intensity strengthening, balance, speed, and agility intervention program in children with sickle cell disease. Read Less

Purpose of this study is to test the preliminary efficacy, acceptability, accessibility, cost, and sustainability of an innovative mental health treatment model for young children from low-income, under-resourced communities through a partnership with Head Start programs in urban and rural communities in Maryland. Read Less

Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Reduction of cerebral blood flow has been suggested as the pathophysiological pathway linking HF and structural brain changes. Indeed, lower cardiac index levels were related to lower cerebral blood flow in older adults without stroke, dementia, or heart failure. A few prior studies have examined the subcortical structural differences in patients with HF compared to controls. Brain volume loss (including putamen and hippocampal volumes) have been reported in patients with low ejection fraction. Significant gray matter loss was found in specific brain regions of HF patients and included structures that serve demonstrated roles in cognitive functions. In the investigator's previous study (Comprehensive Imaging Exam of Convalesced COVID-19 Patients - COVID-19 RELATED SUBMISSION-IRB00252436), involving 100 participants (volunteers with normal heart function (ejection fraction; 50%)), the investigators observed significant correlations between thalamic volumes and ventricular stroke volumes in volunteers. Building on these findings, the investigators intend to expand the research to include individuals with heart failure (HF), employing the same MRI protocol. The study will involve obtaining a set of T1-weighted brain images to measure the volumes of seven subcortical structures. The investigators goal is to explore the relationship between subcortical volumes and cardiac parameters. Additionally, the investigators will examine whether patients with HF experience a more rapid reduction in subcortical volumes compared to those with normal cardiac function (EF;50%). Read Less

Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes. Read Less

This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). Read Less

This study sets out to register imaging of small biopsy specimens obtained during bronchoscopy using full-field optical coherence tomography against standard histologic evaluation. Read Less

The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times. The availability of technology to reconstruct conventional resolution (CR) simulation images from the raw CT acquisition data acquired on the UHR-CT scanner offers a unique platform to study this question without subjecting individuals to two different scans. The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is superior to conventional resolution CT for identifying patients with obstructive CHD. Read Less