A Molecularly Driven Phase 1b Dose Escalation and Dose Expansion Study of the DNA-PK Inhibitor Peposertib (M3814) in Combination with the ATR Inhibitor M1774
This study tests the effectiveness of two drugs, peposertib (M3814) and M1774, in patients with advanced solid tumors who have certain genetic changes or signs of DNA stress. The study has two parts: first, a phase to find the highest dose with few side effects (maximum tolerated dose, or MTD), and second, to test the most effective dose (recommended Phase 2 dose, or RP2D) in more detail. In the dose escalation phase, groups of patients will receive different doses, and doctors will check for serious side effects over a 28-day period to decide if the dose should go up, stay the same, or go down. The expansion phase will have two groups: one for patients with ATM gene mutations and another for patients with signs of DNA replication stress, to study how the drugs affect these specific markers. The final dose chosen will aim for a side effect rate close to 25%, based on safety data. Rules are in place throughout the study to adjust doses and keep patients safe.
A Multi-Center Observational Study Assessing the Utility of an Immune Cell Function Assay in a Cardiac Sarcoid Population
Sarcoid is an autoimmune disease that can be found in any and every organ system. The greatest degree of morbidity and mortality comes from cardiac involvement where it can lead to sudden cardiac death, heart block, and heart failure. The basics of the treatment for cardiac sarcoid include appropriate preventative treatment for ventricular arrhythmias, guideline directed medical treatment for heart failure, and immunosuppression to decrease active cardiac inflammation. The amount of immunosuppression and with which medication is of expert opinion. Using PET scan, we can help assess for successful suppression of the disease, but often 2nd or 3rd line treatments are required after initial therapy strategy is deemed insufficient. As of now, there are no predictors of who will fail initial treatment. For this study, there are three different hypotheses. First, we suspect the baseline Immuknow tertile (low, medium, high) will correlate with the rate of response to first line immunosuppression with low being more likely than the combined medium/high grouping to be responsive on first clinically indicated PET follow up. Second, that a subsequent decrease in ImmuKnow grade, for those that start in the medium or high range, will be predictive of resolution of inflammation on cardiac PET. Lastly, we would like to assess whether an intermediate ImmuKnow assay, drawn at 1 month, would be predictive of response at 3 month follow up.The study population will include adults with a clinical or histological diagnosis of cardiac sarcoidosis found to have active inflammation on cardiac PET scan who are not currently on immunosuppressive therapy. This should be their first time undergoing treatment for cardiac sarcoid (i.e. not with disease recurrence). This will give us a uniform patient population that will not have effects of prior immunosuppression as to their response to current treatment, and not possibly already have treatment failure. We will also be storing biologic samples for future analysis. We believe that a change in the immunophenotype of an individual in response to treatment will be the hallmark of successful immunosuppression. We will be using these samples to assess this in the future.
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.