Aurora, Colorado Clinical Trials

V Victoria Shay, MS

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

I Isabella Henderson

Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human …

K Kathleen Dorris, MD

ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

ACTEMRA (tocilizumab) is an IL-6 receptor antagonist used for the treatment of adult Rheumatoid Arthritis as well as Polyarticular (PJIA) and Systemic (SJIA) Juvenile Idiopathic Arthritis. In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery …

J Julia Kim

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

A Alyssa Avilez

Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod

This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive …

J Jamie Walters

Gene Therapy for HER-Positive Cancer (SENTRY-HER2)

This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.

I Ibraheem Al-Aref

Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS). The study …

K Kilinsky

BeSMART Secure Storage Counseling in the Inpatient Setting

Firearm injuries are the leading cause of death for American youth. While most of these deaths are homicides, approximately one third are suicides and 5% are unintentional shootings where a child gains access to an unsecured firearm and unintentionally pulls the trigger injuring or killing themselves or someone else. Secure …

C Christine Hovater, BS

Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations

The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring (CGM) obtained during pulmonary exacerbations, both outpatient and inpatient, in youth with cystic fibrosis (CF).

D Dezhi Clinical Operation derictor

A Clinical Study of YL205 in Patients With Advanced Solid Tumors

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.