Delray Beach, Florida Clinical Trials

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

This is a randomized, 2-arm, Phase 3, open-label, multicenter study to compare the safety and efficacy of trastuzumab deruxtecan versus the physician's choice (2:1) in HER2-low, unresectable and/or metastatic breast cancer participants. The Sponsor proposes to define a new HER2-low population in this trial including tumors with IHC 1+ and ...

A multi-regional clinical trial with participating sites planned in the following countries pending approval from the applicable oversight authorities: Argentina Brazil Bulgaria Canada Colombia Czech Republic Denmark France Germany Hungary India Israel Japan Mexico Netherlands Poland Romania Russian Federation Slovakia South Africa Spain Ukraine United Kingdom United States

Subjects meeting the inclusion/exclusion criteria will wear Cor for 90 days from the day of fitting. 500 total patients will be enrolled. There will be an interim analysis when the 200th subject has finished the study in the study to assess for distribution of patients with reduced and preserved LVEF. ...

Chronic Lymphocytic Leukemia (CLL) is the most common form of adult leukemia in the U.S. Recent experience with Nipent in conjunction with Rituxan has shown that this combination is well tolerated and is clinically promising. It is expected that the addition of Cytoxan in patients with previously untreated CLL and ...

The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with the surgical procedures and nonoperative treatments.

This study will be divided into 3 timepoints: Epoch 1- Primary- From day 1 to day 301 Epoch 2-Secondary-From day 301 to day 331 Epoch 3-Safety follow up -From day 331 to study end (day 661) In addition to receiving the study vaccines, infants will also receive non-study vaccines such ...

The primary objective of the study is to compare overall survival of patients randomized to receiving custirsen in combination with docetaxel (Arm A) with patients randomized to receive docetaxel alone (Arm B).

The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

This is a multicenter, randomized, parallel-group, placebo-controlled study evaluating the efficacy, safety, and tolerability of double-blind SEP-363856 flexibly dosed at 25, 50, or 75 mg/day for 6 weeks followed by 12 weeks of open-label extension of SEP-363856 flexibly-dosed at 25, 50, or 75 mg/day in male and female subjects 55 ...