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644 recruiting in CA
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Diagnostic Innovations in Glaucoma Study

Primary Open Angle Glaucoma · Myopia

The overarching goal of our research study is to evaluate changes in visual function and optic nerve topography (the structure of the back of the eye) in patients with glaucoma (increased susceptibility to pressure inside the eye that can cause loss of vision) or those with an increased risk of developing the disease. The purpose of this study is to determine the best methods for detecting the presence or progression (worsening over time) of glaucoma in patients with and without myopia and its effects on daily and visual function and quality of life. With several sources of NIH and foundation funding over the last twenty years we have designed a robust research protocol to address the most challenging aspects of glaucoma management. The most recent focus of this research is 1) to improve our ability to detect open angle glaucoma in individuals with myopia and in individuals of European and African descent, 2) to determine whether monitoring of the retinal vasculature with new optical imaging instruments can improve glaucoma management and elucidate the pathophysiology of the disease, and 3) to differentiate between age-related changes and glaucomatous progression. The grants supporting this project include 3 NIH funded studies, 1) the University of California, San Diego UCSD -based "Diagnostic Innovations in Glaucoma Study" (DIGS funded since 1995): 2) the "African Descent and Glaucoma Evaluation Study" (ADAGES funded since 2002), 3) the Brightfocus Foundation National Glaucoma Research Program and 4) the UCSD-based "Diagnosis and Monitoring of Glaucoma with Optical Coherence Tomography Angiography" (funded since 2018). The ADAGES is a multi-center study with data collection also conducted at 2 other academic sites, the University of Alabama at Birmingham, and Columbia University. Enrolled healthy participants, glaucoma suspects and glaucoma patients are generally asked to return for two or more visits a year for several years. We then analyze whether the glaucoma patients are progressing and what factors influence their glaucoma status compared to healthy subjects and individuals suspected of having glaucoma.

La Jolla, CA18+ yrsAll genders
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A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Duarte, Irvine, CA18+ yrsAll genders
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A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)

Diabetic Retinopathy · Macular Edema

Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME. An available standard (usual) treatment for DME is aflibercept. However, standard treatments such as aflibercept may not work for every person. The main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME.

Glendale, Sacramento, CA18+ yrsAll genders
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Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

Aortic Stenosis · Coronary Artery Disease · Coronary Stenosis

Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.

Palo Alto, Redlands +more, CAAll agesAll genders
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Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Pulmonary Embolism

This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.

Irvine, Long Beach +more, CA18–85 yrsAll genders
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Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)

Heart Failure · Heart Failure - NYHA II - IV

This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.

Los Angeles, CA18+ yrsAll genders
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Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)

Tachycardia, Ventricular

RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after CA and are candidates for additional CA.

Los Angeles, CA18+ yrsAll genders
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Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

Vascular Disease · Dissection · Dissection Aortic Aneurysm

An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.

Los Angeles, Stanford +more, CA18+ yrsAll genders
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A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments

Multiple Myeloma

The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Clovis, Fresno +more, CA18+ yrsAll genders
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Global Paradise System US Post Approval Study

Hypertension · Cardiovascular Diseases · Vascular Diseases

The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.

Long Beach, Los Angeles +more, CA18+ yrsAll genders
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