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Discover 16,968 clinical trials near Atlanta, Georgia. Find research studies in your area.
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NCT06824987
The purpose of this study is to assess the efficacy and safety of AZD2373 in participants diagnosed with APOL1-Mediated Kidney Disease (AMKD) who are homozygotes or compound heterozygotes for APOL1 high-risk genotypes (G1 and G2). The primary hypothesis to be evaluated is that AZD2373, compared with placebo, will result in a greater reduction in UACR as assessed by the relative change from Baseline in UACR at Week 30.
NCT05438407
This is a 2-part, prospective, open-label, single arm, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of leniolisib in at least 15 pediatric patients (aged 4 to 11 years) with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).
NCT05972889
This is a prospective, sham-controlled, randomized, single-blinded, multi-center study comparing two different modes of the NexWave device, transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC), with an identical non-functioning NexWave sham device or self-defined standard of care for improvement of pain intensity of non-specific CLBP.
NCT01586910
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
NCT05456685
IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.
NCT05377996
A Study of XMT-1660 in Solid Tumors
NCT06203054
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
NCT04394351
The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: * To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) * To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE * To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation * To study the effects of dupilumab on the type 2 inflammation gene expression signature * To evaluate the concentration-time profile of functional dupilumab in serum in this population * To assess efficacy of long-term (up to 160 weeks) dupilumab treatment * To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study * To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment * To evaluate the impact of dupilumab treatment on EoE signs and symptoms
NCT03911505
This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric subjects with Pompe disease, aged 0 to \< 18 years
NCT05809934
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele
NCT05081388
Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7 Phase 1/2/3 (Clinical Efficacy) • Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs) Phase 2 and Phase 3 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity) * Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy * Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy * Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy
NCT05590884
This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach. Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).
NCT06377488
This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.
NCT02756962
The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.
NCT05478499
The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.
NCT06496217
Evaluate the Safety and Pharmacokinetics of MBX 2109 in Adult Subjects with Normal and Impaired Renal Function
NCT04501536
The purpose of this study is to determine the amount of speech-language intervention children with language impairment need to make vocabulary gains. The investigators hope to identify the optimal amount of intervention needed as well as the point at which adding more intervention is no longer beneficial. Participants will be randomly assigned (like a flip of a coin) to attend therapy either one time a week for 10 weeks (2 hours a session) or 4 times a week for 10 weeks (30 min per session). Each therapy session will follow a word learning intervention that is designed to increase children's word learning abilities using rich, robust word learning strategies within story book readings. The optimal amount of intervention relates to duration, dose, and frequency. Duration refers to how long the child is seen for (e.g., 10 weeks, 1 year). Dose represents the number of exposures to each new vocabulary word within a therapy session. Frequency represents the number of therapy sessions per week. The investigators will test the hypothesis that distributed learning leads to higher gains. The investigators propose that the greatest gains will be observed for children who receive high-frequency/low-dose or low-frequency/high-dose treatments as compared to children who receive high-frequency/high-dose or low-frequency/low-dose treatments. The investigators will test the hypothesis that for both low-frequency and high-frequency treatments, there is a point at which increases in treatment dose do not correspond to any additional gains in children's vocabulary skills during treatment. At the close of this four-year study, evidence concerning optimal treatment intensity of a word learning intervention will be instrumental for immediately informing speech-language pathologists in how much vocabulary treatment to prescribe as well as for designing additional clinical trials by our and other research teams.
NCT05929807
TransCon CNP administered once-weekly in children and adolescents with achondroplasia who have completed a prior TransCon CNP clinical trial. Participants who complete a prior TransCon CNP trial and meet all eligibility criteria will be invited to continue into the long-term open label extension trial to receive 100 µg CNP/kg/week of TransCon CNP. Trial treatment will be completed when the participant reaches 16 years of age for females and 18 years of age for males and have femur and tibial epiphyseal closure. TransCon CNP treatment will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years for females, and 18 years for males. Treatment with TransCon CNP will be completed once femur and tibial epiphyseal closure is confirmed by radiographic imaging. The trial duration is individual for each trial participant. Visits will occur every 12-14 weeks throughout the trial.
NCT05654103
Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein. Until recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF. This study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.
NCT04665206
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered, alone or in combination, once daily in patients with mesothelioma and/or metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.
