All Clinical Trials

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29. Read Less

Healthcare providers' implicit bias has been identified as a contributor to longstanding health inequities via negative impacts on the patient-clinician relationship and biased delivery of high-quality evidence-based practices (EBP). The implementation of any EBP runs the risk of worsening existing health disparities due to inequitable access, delivery, or benefit of the intervention. Clinician bias can be a critical and unaddressed determinant of implementation for any EBP. Although some implicit bias interventions for healthcare providers are emerging, studies have rarely included mental health professionals. In a previously NIMH funded project, our research team iteratively developed a brief (\~45 minutes), interactive online Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) for school mental health clinicians with promising preliminary findings. The current study will test the effectiveness of VIBRANT-an implementation strategy for promoting equitable adoption, penetration, fidelity, and sustainment of EBPs. One highly learnable, efficient, and scalable EBP that is particularly well-suited for the education sector is Measurement-Base Care (MBC)-the systematic collection of patient-reported progress data to inform clinical decision-making. The proposed study aims to (1) evaluate VIBRANT's feasibility to promote equitable adoption, penetration, fidelity, and sustainment of MBC, with a validated, brief, interactive online training for MBC; (2) examine VIBRANT's impact on proximal mechanisms of change including clinicians' implicit bias as well as distal youth mental health outcomes (i.e., symptoms and functioning) with Black and Latinx youth, and (3) assess feasibility of research procedures for a future large-scale efficacy trial. Read Less

TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202. Read Less

This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia. The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 90 oncologic outpatients will be enrolled and studied with the technology. The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision. For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated Read Less

Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities for early AF detection and subsequent stroke prevention in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long term arrhythmia information via remote monitoring. The ASSERT-AF study seeks to accurately define the burden of AF and other arrhythmias in high-risk HF patients using an ASSERT ICM. Read Less

This study proposes adapting and testing an innovative, behavioral theory-driven deimplementation program called DRAUP in two intensive care units for proof of concept and support that the program can help providers and hospital organizations address context determinants of deimplementation. Study data will be used to optimize the intervention for a subsequent larger trials. Read Less

To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors. Read Less

This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury. Read Less

Pseudohypoparathyroidism is a genetic disorder with limited treatment options. Patients have early-onset obesity, short stature and increased risk of type 2 diabetes. This phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. The investigators hypothesize that theophylline will cause weight loss, improve glucose tolerance and slow growth plate closure in children and young adults. Read Less

The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects with recurrent malignant gliomas (glioblastoma, or GBM). Read Less

The primary goal of this study is to determine the dose of fatty acids that acutely induces mild insulin resistance in healthy volunteers. We hypothesize that a low-dose of fatty acid infusion (Intralipid/heparin) will cause a mild insulin resistance. The dose of fatty acid infusion that reliably causes mild insulin resistance will be selected for use in future studies. Read Less

The main objective of this study is to determine the clinical efficacy of metformin versus placebo and the therapeutic response with regards to functional capacity and hemodynamics in PH-HFpEF. Read Less