Round Rock, TX Paid Clinical Trials

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1. Read Less

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD. Read Less

This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy. Read Less

The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region. Read Less

The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%. Read Less

Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant solid tumors. Read Less

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1) Read Less

EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201. All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4 weeks apart. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE201 will be assessed at increasing doses in branch retinal vein occlusion (BRVO) participants. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part, 2 doses of EYE201 will be selected and their effectiveness will be compared. This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD). Approximately 80 participants will be entered in this part of the study. Read Less

This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease. The study includes a screening period, a 28-day double-blind treatment period, and a 7-day follow-up period after last dose. Approximately 30 patients will be randomized into 1 of the 2 treatment arms. Read Less

Given the increasing prevalence of autism spectrum disorder (ASD), estimated to be 1 in 68 in the United States alone, ASD has become one of the fastest-growing pediatric concerns. The deficits of children with ASD range across social communication and academic skills. One of the effective interventions that have been used commonly for ASD is the model-lead-test, which includes modeling, prompting children to practice target skills together, and providing children with affirmative feedback or error correction. Previous research has demonstrated that the model-lead-test is successful in teaching different skills for individuals with ASD, including functional, social, and academic skills. The vast majority of the studies had researchers, therapists, or teachers implement the intervention. However, there is clear empirical support and implications for interventions mediated by more familiar persons, such as parents and siblings, which may lead to better effects, maintenance, and generalization due to more practice opportunities in the natural environments. Research has supported the effectiveness of using parents or peers as agents to deliver interventions for individuals with ASD, whereas fewer studies explored the use of siblings to deliver or mediate intervention. As typically developing siblings are an essential part of the daily life of children with ASD, it makes logical extensions to have siblings as mediators to deliver interventions. In the initial findings, the investigators found the typically developing siblings can accurately implement the model-lead-test procedure that improved various skills of their siblings with ASD. This project will extend these findings by examining the efficacy of the sibling-implemented intervention on early literacy (reading) and social reciprocity (conversation and play) of children with ASD as well as the sibling relationship before, during, and after the intervention. Read Less

This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access. Read Less

An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures Read Less