San Ramone, California
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Phase
N/ASpan
3027 weeksSponsor
MedtronicEast Palo Alto, California
Recruiting
Large Language Models To Improve the Quality of Care of Cardiology Patients
Large language models have been shown to improve physician performance in simulated settings. Large language models have demonstrated promise in various healthcare contexts, including medical note-writing, addressing patient inquiries, and facilitating medical consultation. However, it remains uncertain whether large language models improve clinical reasoning of clinicians using real world cases. Clinicians dedicate years of training to develop expertise, with clinical knowledge a key component. Clinicians have different areas of expertise, from generalists spanning diseases of all organ systems and patients of all ages, to subspecialists dedicated to often a handful of diseases effecting a specific organ. Both skill sets are vital to a well-functioning medical system, as generalists generally care for patients and refer to specialists when dedicated, specialty knowledge is required. There is a paucity of specialists, and thus the quality of triaging and referral to specialists is of upmost importance. We hypothesis that large language models may be able help generalists management complex patients, and improve their triage to specialists and subspecialists. The scarcity of subspecialist medical expertise, particularly in rare, complex and life-threatening diseases, poses a significant challenge for healthcare delivery. This issue is particularly acute in cardiology where timely, accurate management determines outcomes. In this study, we will recruit General Cardiologists as participants who will be randomized to answer clinical management cases with or without access to a large language model. Each case is a real patient case of a patient referred to a subspeciality cardiovascular genetic cardiomyopathy clinic. Each case will be performed by two general cardiologists (one with access to a large language model and one without access). Each case has multiple components, and the participants will be asked to answer questions related to the management. Answers will be graded by independent, blinded subspeciality Cardiologists with expertise and training in genetic cardiomyopathies. An evaluation rubric was developed by 10 expert discussants.
Phase
N/ASpan
51 weeksSponsor
Stanford UniversityPalo Alto, California
Recruiting
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled, parallel group study to evaluate the efficacy of oral doses of VX-01 in subjects with moderate to severe NPDR, without CI-DME. Approximately 100 male and female subjects aged ≥ 18 years with a documented diagnosis of Type 1 Diabetic Mellitus or Type 2 Diabetic Mellitus with moderate to severe NPDR (without CI-DME) will be enrolled, if they meet all the eligibility criteria for the study. Subjects will be randomized 1:1 to 1 of 2 study cohorts: - Cohort 1 (n = 50): VX-01 (film-coated tablets, 150 mg administered BID) - Cohort 2 (n = 50): Placebo (film-coated tablets, administered BID) Subjects will be stratified by the presence or absence of proliferative diabetic retinopathy (PDR) and by glycated hemoglobin (HbA1c) of ≥ 8.5% or < 8.5% at Screening. All subjects will take 1 tablet of VX-01 or placebo BID for 52 consecutive weeks. All subjects will be followed for 12 weeks after completion of treatment at Week 52. The Sponsor, study site staff, monitors, personnel, and subjects will be masked to treatment assignment during the entirety of the study.
Phase
2Span
112 weeksSponsor
Vantage Biosciences LtdPalo Alto, California
Recruiting
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED)
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with active TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/SC injections given every 4 weeks or every 8 weeks compared to placebo in participants with active TED. Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.
Phase
3Span
116 weeksSponsor
Viridian Therapeutics, Inc.Palo Alto, California
Recruiting
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED)
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as subcutaneous/SC injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic TED. Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.
Phase
3Span
120 weeksSponsor
Viridian Therapeutics, Inc.Palo Alto, California
Recruiting
Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
Participants who fulfill the study eligibility criteria and who are planned to undergo a pars plana vitrectomy will be enrolled in the study. Eligible participants scheduled for a diagnostic vitrectomy may also be enrolled. The study will consist of two stages: Stage One - Open label dose escalation: Up to three subsequent dose-escalation groups will receive Laquinimod eye drops for 2 weeks and samples will be assayed for Laquinimod concentration in aqueous humor, vitreous and plasma. Stage Two- Randomized, Controlled Comparison of 2 Laquinimod doses: After the dose escalation cohorts are analysed, 2 Laquinimod doses will be selected for a randomized comparison. The doses in stage 2 will not exceed those studied in stage 1.
Phase
1Span
65 weeksSponsor
Quan Dong NguyenPalo Alto, California
Recruiting
Immersive Mixed Reality Simulation to Evoke Empathy
Phase
N/ASpan
51 weeksSponsor
Stanford UniversityPalo Alto, California
Recruiting
Healthy Volunteers
Pivotal Study of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (DIAMOND-2)
A Phase 3 Pivotal Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema
Phase
3Span
120 weeksSponsor
OculisPalo Alto, California
Recruiting
Hyperbaric Oxygen Therapy for Optic Neuropathies
Phase
N/ASpan
166 weeksSponsor
Stanford UniversityPalo Alto, California
Recruiting
Prospective Study of oncRNA Stratification of Cancer by Size and Stage
Phase
N/ASpan
366 weeksSponsor
Exai Bio Inc.Palo Alto, California
Recruiting
Healthy Volunteers