Köthen-anhalt, Germany
TTVR STRONG Under Coverage With Evidence Development (CED) Study
This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world. This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data. This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records. We will evaluate the primary outcome measure in various subgroups. There will be continued access enrollment after the primary completion date.
Phase
N/ASpan
407 weeksSponsor
Edwards LifesciencesIrvine, California
Recruiting
GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder
This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed dose clinical trial designed to evaluate the safety and efficacy of GATE-251 versus placebo in subjects with symptoms of major depressive disorder. Each subject will participate in this study up to 98 days: up to 28 days for screening, 42 days for double-blind treatment, and a 4-week follow-up period. Subjects will return to the clinic one time each week to have the severity of their depression assessed using the Hamilton depression rating scale-17. Adverse events that occurred since the last study visit will be recorded.
Phase
2Span
100 weeksSponsor
Gate Neurosciences, IncIrvine, California
Recruiting
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma
This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy. The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.
Phase
2Span
262 weeksSponsor
Hoag Memorial Hospital PresbyterianIrvine, California
Recruiting
PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)
This study is a Phase 1b, randomized, double-blind, placebo controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (350 mg, 700 mg, and 1400 mg are planned). Patients will be randomly assigned 3:1, PMN310: placebo. Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.
Phase
1Span
107 weeksSponsor
ProMis Neurosciences, IncIrvine, California
Recruiting
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
Phase
2Span
520 weeksSponsor
Janssen Pharmaceutica N.V., BelgiumIrvine, California
Recruiting
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.
Phase
2Span
379 weeksSponsor
Eli Lilly and CompanyIrvine, California
Recruiting
A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)
Phase
3Span
327 weeksSponsor
Eli Lilly and CompanyIrvine, California
Recruiting
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Phase
3Span
253 weeksSponsor
Eli Lilly and CompanyIrvine, California
Recruiting
Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder
Phase
3Span
119 weeksSponsor
Neumora Therapeutics, Inc.Irvine, California
Recruiting
Study to Assess the Safety and Effectiveness of NMRA-335140-501
Phase
3Span
190 weeksSponsor
Neumora Therapeutics, Inc.Irvine, California
Recruiting