Aurora, CO Paid Clinical Trials

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib. Read Less

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults: * At a dose of 120µg. * In adults 60 years of age and older. * The duration of the study for each participant will be up to approximately 24 months. * The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years: * At a dose of 120µg (as studied in the Phase 3 Efficacy Study) * Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study. * Blood samples will be collected for antibody testing. * The duration of the study for each participant will be up to approximately 18 months. * The study will be conducted in the United States and Canada. Read Less

This is a 3 month single arm pilot and feasibility study designed to examine the impact of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical milestones (change in body weight, adherence to the fasting program, and moderate-to vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer after they have completed their cancer treatment. The investigators will also evaluate feasibility of recruitment and retention of study participants, safety of the intervention, and obtain feedback from participants to improve the program. Participants will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent fasting paradigm (3 modified fast days per week) and support to increase physical activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3 month intervention (primary endpoint) and after a 3 month weight maintenance follow up phase. Read Less

Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels. The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery. Read Less

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19. Read Less

Cardiopulmonary bypass during cardiac surgery provides blood flow to the body during surgery but has adverse effects on different organs. Blood flow during cardiopulmonary bypass may be pulsatile or non-pulsatile, which may impact normal organ function after surgery. The study will collect data on the type of cardiopulmonary bypass used during surgery and organ function to determine if there is an association between the type of bypass and organ function. Read Less

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options. Read Less

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD. Read Less

The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes. Read Less

This is a placebo-controlled, double-blind randomized trial of a short course of intravenous corticosteroids for Acute Respiratory Failure Survivors with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) documented laryngeal edema. Study was leveraged using the existing R01 grant infrastructure COMIRB # 21-3873, study design, and research methods. Patients for the study proposed will have already been enrolled in the R01 longitudinal cohort study. The sites to perform this study include Colorado, BU, Yale, and Stanford. Those R01-enrolled patients with laryngeal edema on their initial FEES examination: defined as the revised Patterson edema score greater than zero, will be approached for enrollment. Read Less

This study plans to learn more about what patients think about screening for esophageal cancer (EAC) and Barrett's esophagus (BE); a pre-cancerous condition associated with esophageal cancer. The plan is to use this information to modify screening practices in the United States with the goal to decrease the number of people who die from esophageal cancer. Read Less

Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab. Read Less