Baltimore, MD Paid Clinical Trials

The Problem: Adolescent Idiopathic Scoliosis (AIS), the pre-eminent spinal pathology affecting over 5% of children and adolescents, presents a pronounced spinal curvature exceeding 10 degrees, with prevalence amongst female adolescents at a ratio of 3:1 compared to males. A significant portion of these patients are not immediate candidates for surgical intervention. The acute shortage of viable non-operative management strategies, which is becoming increasingly imperative given the current barriers to physical therapy access and the growing opioid crisis. The investigator's research intends to explore the addition of a structured yoga protocol to standard of care. This research will thus explore the potential for improved relief and quality-of-life improvements for AIS patients not ready for surgery. Significance: AIS is a pervasive condition which correlates with chronic and episodic lower back pain, diminished sleep quality, and depressive symptoms. This extensive comorbid association coupled with the financial pressure to patients and the healthcare system cannot be understated. Needs Statement: There is a lack of sufficient non-operative management options for AIS. Many patients face limited access and require supplementary management strategies to address the patient's conditions effectively, creating a significant unmet need for non-pharmacological pain management interventions. This need is further highlighted in the context of the escalating opioid crisis, a leading cause of death among adolescents and young adults. Hypothesis: The introduction of a structured yoga protocol can serve as a non-inferior or even superior alternative to traditional standard of care i management of AIS, addressing both the physical and psychosocial aspects intertwined with the condition. IMPACT: Change in Problem Significance: This research trial aims to enhance current standard of care for patients grappling with AIS. If the trial demonstrates superiority of yoga, it will delineate a paradigm shift in the current care standards for AIS patients, fostering a move towards a more cost-effective and holistic approach. Yoga could help alleviate the burdens on the healthcare system by reducing costs and enhancing accessibility for patients. Improvement in Pediatric Orthopedics Practice: By paving the way for non-pharmacological interventions, the trial aspires to mitigate the reliance on opioids for pain management in the pediatric demographic, therefore promoting overall well-being. This project not only seeks to develop alternative pain management strategies amidst a growing opioid epidemic but also champions the cause of improving the quality of life for the pediatric population battling chronic conditions like AIS. It echoes the urgent call to innovate and expand upon the current strategies in place, steering the medical community towards a future where integrative approaches are not the exception but the norm. Ultimately, this research aspires to guide the trajectory of pediatric orthopedics towards a healthcare system that is more inclusive, accessible, and holistically oriented, thereby enhancing the quality of life for pediatric patients grappling with conditions like AIS. 2. Objectives (include all primary and secondary objectives) Goals/Objectives: To create a randomized clinical trial aimed to evaluate the efficacy of yoga in conjunction with standard of care treatments for AIS patients. SPECIFIC AIMS Aim 1: Evaluate the feasibility and challenges of implementing a yoga protocol for AIS patients. Methodology: Online class attendance, survey completions, and follow-up appointments. Anticipated Results: Adequate participant adherence and data reliability. Aim 2: Compare clinical outcomes between patients who receive traditional care modalities versus those who added yoga to treatment plan. Methodology: Utilize validated tools such as the SRS-22 questionnaire and monitor outcomes including depression scale, sleep quality, analgesic usage, activity levels, and Cobb angle. Anticipated Results: Significant physical and psychological improvements in the yoga group. Read Less

The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy. Read Less

The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS). Read Less

The Registry for Systemic Eczema Therapies (RESET) registry is a database and biospecimen repository for patients with pediatric-onset atopic dermatitis (AD) who have used or will initiate any systemic treatment(s) for AD. The goal of the registry is to enable more efficient research recruitment and data collection as well as timely notification to enrollees about newly FDA-approved treatments for AD. Read Less

Rates of suicide have increased significantly over the past two decades, particularly among youth. Compared to the general population, autistic people are significantly more likely to think about suicide, attempt suicide, and die by suicide. Autistic individuals have identified suicide prevention as a top research priority; however, little is known about how to best help autistic youth at risk for suicide. The purpose of this study is to compare the effectiveness, feasibility, and acceptability of two suicide prevention strategies tailored for autistic individuals: the Safety Planning Intervention tailored for Autistic individuals (SPI-A) and SPI-A plus structured follow-up contacts (SPI-A+). Read Less

Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma. Read Less

This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy. Read Less

Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (\<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification. This project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD. Read Less

More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of hospitalized Veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System (GTS), with which glucose values can be wirelessly transmitted from the patient's bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes. Read Less

The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to : 1. to gain a better understanding of the biological mechanisms that predispose to SCD 2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly Read Less

The Principal Investigator's (PI) working hypothesis is that the PI can utilize the high predictive value of 18F-DCFPyl PSMA to identify clinically significant tumors in patients who will undergo brachytherapy, as well as areas which are uninvolved or contain only clinically insignificant disease. In the PI's clinical trial, the uninvolved regions (as defined by combined PET-MR-biopsy data) will not be targeted and receive only fall-off dose, which we have shown to be associated with reductions in toxicity. Read Less

Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB. Read Less