A Multi-Center Phase 2/3 Randomized Double-Blind Placebo-Controlled Parallel- Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare
This is a multi-center Phase 2/3 randomized, double-blind, placebo-controlled,parallel-group safety and efficacy study with a 7-day period of IMP treatment conducted insubjects with an acute gout flare.
A Multi-Center Prospective Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis (ENDEAVOUR-UC)
The purpose of this research study is to observe the effectiveness of Etrasimod (Velsipity®) in adults with moderately to severely active ulcerative colitis (UC). The study consists of 52-weeks of follow-up from etrasimod initiation and an additional 28-day safety follow-up period.
A MULTI-CENTER PROSPECTIVE NON-RANDOMIZED PIVOTAL TRIAL EVALUATING THE SAFETY AND EFFECTIVENESS OF THE POLYMOTION HIP RESURFACING SYSTEM
This research study is being conducted to evaluate the safety and effectiveness of an investigational device, the Polymotion Hip Resurfacing System.
A Multi-Center Prospective Observational Study of Patients with Neuroinflammatory Disease
Patients meeting inclusion criteria for the study will be prospectively enrolled and followed over time to evaluate clinical variables and the natural history of these disorders. Additionally, we will analyze patient electroencephalograms, brain imaging studies, and collect blood, spinal fluid, tissue, and other biospecimens when available, for future biomarker, immunophenotyping, and genetic analyses.
A Multi-Center Prospective Registry to Evaluate the Continued Safety and Effectiveness of Arthrex Products used for Knee Sports Medicine Repair and Reconstruction
The study is being done to evaluate the effectiveness and safety profile of Arthrex knee products when used as standard of care for repair or reconstruction of soft tissues of the knee such as ligaments, tendons, or the meniscus.
A multi-center randomized (1:1) controlled phase 2 trial of STIMULAN VG with debridement and a course of systemic antibiotics vs standard of care (SoC) for the treatment of osteomyelitis associated with stage IV pressure ulcers.
This study is being performed to find out if the use of a new investigational product (meaning not approved by the Food and Drug Administration (FDA)) called STIMULAN-Vancomycin-Gentamicin (known as STIMULAN VG) is better for the treatment of stage IV pr
A multi-center randomized blinded controlled study to evaluate the safety and efficacy of the Urocross Expander System and Retrieval System (EXPANDER-2)
The Urocross Expander System is indicated for the treatment of lowerurinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia(BPH) in men = 45 years old, and while implanted in the prostaticurethra.The Urocross Expander Implant is indicated for an indwell duration of 6months, after which it is retrieved under visualization, using the UrocrossRetrieval Sheath and a commercially available compatible grasper usedduring urological procedures.The Urocross Retrieval Sheath is indicated for use to retrieve theUrocross Expander Implant using a compatible flexible cystoscope andcompatible graspers commonly used during urological procedures.
A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of CK-4021586 in Adults with Symptomatic Heart Failure with Preserved Ejection Fraction
The purpose of this study is to learn about the safety and how well participants tolerate various doses of CK-4021586 when taken orally over time.
A Multi-center Randomized Open-label Parallel-group Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination with Chemoradiotherapy (CRT) in Patients with Head and Neck Cancer
This is a Phase 2 study testing the study medicine VS-101 (an oral radiosensitizer) in combination with Chemoradiotherapy (CRT) in patients with head and neck cancer. Patients will be divided into three groups. Group 1 will receive 2 mg of VS-101 in combination with CRT. Group 2 will receive 5 mg of VS-101 in combination with CRT. Group 3 will receive only CRT. All patients will have their blood samples taken to see how the study medicine is changing their cancer and how their bodies are handling the medicine. The study team will also do genetic testing for all patients in the hope of learning more about the study medicine and helping patients feel better. All patients will be monitored for side effects and safety throughout the study.
A Multi-centered Double-blind Randomized Placebo-controlled Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients with Multiple System Atrophy
The study is evaluating the safety and effectiveness of "TEV-56286" to treat multiple system atrophy (MSA). The total duration of participation is just over one year.