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CT Open to Enrollment

A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination with Ruxolitinib in Participants with Anemia Due to Myeloproliferative Disorders

The purpose of this study is to evaluate the safety of an investigational drug, “INCB000928” alone and in combination with ruxolitinib (Jakafi), and to find out what effects, if any, the drug or investigational combination has on people with anemia due to myeloproliferative disorders.

This is an open-label study, which means that both you and your study doctor will know whether you are receiving study drug alone or the investigational combination.

A Randomized Phase 3 Trial of Nivolumab in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Treatment for Primary Mediastinal (Thymic) Large B-Cell Lymphoma (PMBCL) involves chemotherapy combined with an immunotherapy called rituximab. This combination is also known as the chemo-immunotherapy backbone. There are two types of chemo-immunotherapy backbone treatments for PMBCL: either R-CHOP or DA-EPOCH-R.
   
These drugs effectively treat PMBCL, but are known to cause long-term side effects at high doses. Side effects are unintended and unwanted results of treatment. Study doctors are interested in finding an effective treatment that improves the outcome of PMBCL.
   

A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Treatment for acute myeloid leukemia (AML) involves high doses of a common class of chemotherapy drugs called anthracyclines. One anthracycline drug which is effective in treating AML is daunorubicin, but high doses are known to cause long-term side effects, especially to the heart. (Side effects are unintended and unwanted results of treatment.) Study doctors are interested in finding an effective treatment for AML patients that reduces the potential for long-term side effects.
   

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects with Type 2 Diabetes on Insulin Therapy

This clinical trial is for men or women who have inadequately controlled Type 2 diabetes and are currently on stable doses of basal insulin. The purpose of this study is to learn more about the use of the Fractyl Revita System for the treatment of Type 2 diabetes for individuals who are on insulin therapy.
     
The study device, the Revita System, has not been approved for use by the Food and Drug Administration (FDA) in the United States since the device is experimental. The Revita System is commercially available in the United Kingdom. 

Accelerated TMS for Depression and OCD

Repetitive transcranial magnetic stimulation (rTMS) is an FDA-cleared treatment for depression and obsessive compulsive disorder (OCD) that uses focused magnetic field pulses to stimulate target brain areas. Multiple brain targets in the prefrontal cortex have shown consistent evidence of treatment efficacy in both depression and OCD, but there are currently no established methods for selecting the optimal target site in individual patients.

Transoral Incisionless Fundoplication (TIF) Registry

This study is for men and women over 18 years of age who have suspected or known gastroesophageal reflux disease (GERD) or its associated complications, such as Barrett’s esophagus (a precancerous condition), or trouble swallowing due to esophagitis or scarring (stricture), who are undergoing diagnostic evaluation and treatment with Transoral Incisionless Fundoplication (TIF).  

A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)

This clinical trial is to evaluate the experimental (investigational) study drug Volixibat in men or women who have been diagnosed with Cholestatic Pruritus (itching) with Primary Sclerosing Cholangitis (PSC). PSC is a disease of the bile ducts, which carry the digestive bile acid (used by the body to help with digestion) from your liver to your small intestine. In PSC, inflammation causes scars within the bile ducts. These scars make the ducts hard and narrow and gradually cause serious liver damage.

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr Adults (PREVENTABLE)

The purpose of PREVENTABLE is to learn if taking a statin could help older adults live well for longer by preventing dementia, disability, or heart disease.
   
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. This study seeks to assess the benefit of statins (Atorvastatin) for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.
   

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).

The Effects of Iron on Oxidative Stress and Alzheimer’s Disease Biomarkers in Amyloid-Positive and Negative Elderly Individuals

The purpose of this study is to investigate differences in iron in the brains of subjects with and without beta-amyloid deposition. Iron is an essential mineral in your body, and beta-amyloid is a protein associated with Alzheimer’s disease. Studies suggest that excess iron in the brain may be involved in processes that lead to Alzheimer's disease.