The main goal of this clinical trial is to determine if an investigational medication called VEL101 is safe, well tolerated, and effective in people receiving a new kidney transplant. Participants will be randomly assigned to 2 different doses of VEL-101 or to tacrolimus, which is standardly used post-transplant to prevent rejection. Participants will be…
This purpose of this study is to understand the interaction between two different medications, tacrolimus and Paxlovid (nirmatrelvir/ritonavir), in patients who have had a kidney transplant and are being treated by their doctor for COVID-19 infection. Tacrolimus is an oral medication that is used standardly in kidney transplant recipients to prevent…
This is a 60-month adaptive to evaluate three siplizumab-based treatment regimens in kidney transplant recipients. The purpose of this research study is to see if the anti-rejection medications that patients normally take after transplant can be reduced or stopped completely by using several medications including the investigational drug siplizumab in the…
Kidney transplant extends life, improves quality of life, and reduces healthcare costs. Unfortunately, there are not enough donated kidneys, so many people who need a transplant spend years on the waiting list. Kidneys from organ donors who have hepatitis C virus (HCV) are often thrown away, but these kidneys work well, and hepatitis C can be cured. The…
The purpose of this study is to determine if an investigational drug called tegoprubart (also known as AT1501) is safe and effective in preventing rejection in patients who are undergoing a kidney transplant for the first time. Participants will be randomly assigned to tegoprubart or standard treatment with tacrolimusat the time of transplant. If you have…
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of…
This is a prospective, single arm, three stage, multi-site, clinical investigation evaluating the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant hole in the atrial septal defect compared to other commercially approved devices. The study is being done to determine the safety and efficacy of…
Kidney transplant patients are at a higher risk for bone fractures compared to the general population. We are doing a clinical trial to examine the effects of 12-months of treatment with denosumab, a monoclonal antibody against RANKL, on bone density and strength as determined by bone imaging and by non-invasive measures of bone activity from blood and…
This prospective, multicenter, open-label, single arm, first-in human study will enroll up to 75 subjects aimed at examining the performance of the LAAC device for LAA closure.
The purpose of this study is to survey patients who have undergone a percutaneous coronary intervention (PCI) at Columbia University Medical Center in which the physician used a stent called the Promus Premier stent. Patients will be asked to do a brief 15-30 minute survey regarding their health since the PCI and stent implantation.
This study will compare the effectiveness of three different FDA approved medicines for Hepatitis C Genotype 1 patients: HARVONI , Viekira Pak and Zepatier and will observe subject experiences before, during, and after HCV treatment. Subjects will be asked to respond to several survey questionnaires and if they would allow their leftover blood collected for…
The purpose of this study is to evaluate the efficacy, safety, and tolerability of SOF/VEL/GS- 9857 FDC in patients infected with Hepatitis C (HCV), and previously treated unsuccessfully. Information about any side effects that may occur will also be collected.
Subjects who undergo a kidney transplant require long term use of anti-rejection (immunosuppressive)drugs to prevent their body's immune system from attacking and damaging the newly transplanted kidney (rejection).The purpose of this study is to evaluate benefits and risks of two combinations(regimens) of immunosuppressive therapies: Thymoglobulin…
The purpose of this study is to evaluate the Biosensors BioFreedom Biolimus A9 Drug Coated Coronary Stent on people with coronary artery disease (blockages in the heart arteries) to determine if it is safe and effective.
This research trial is being conducted to determine the safety and efficacy of HARVONI (an FDA-approved Hepatitis C Virus medication) in HCV (genotype 1, 4, 5, an 6) infected patients who also have advanced heart failure or chronic lung disease. HARVONI has not been tested in patients with HCV and heart failure or chronic lunch disease. Subjects will take…
The purpose of this study is to learn more about the effects of the combination of telaprevir peginterferon alfa2b (Peg-IFN) and ribavirin (RBV) in children with chronic hepatitis C. Investigators will look at how these study drugs may affect childrens bodies and how children break down and eliminate telaprevir. Participants of this study will receive Peg-…
The purpose of this research study is to see if an investigational drug, BB3, is safe and effective forincreasing the amount of urine that a transplanted kidney will produce. An investigational drugis one that is not approved by the United States Food and Drug Administration (FDA). BB3 is agrowth factor-like drug, which means that it can affect cell…
The purpose of this research is to find out whether it is safe to shorten the length of time that people at high risk for bleeding take blood thinners after being treated with a coronary stent.
The purpose of this study is to determine how safe and effective using three medications (pegylated-interferon, ribavirin and boceprevir) are in curing HCV in patients with end stage kidney disease on hemodialysis. Participants will be prescribed these three medications and will be followed closely through treatment, then for 6 months afterwards. During…
This study is for patients with Coronary Artery Disease (CAD) and require a stent placement. The purpose of this clinical research study is to assess the safety and effectiveness of the Orsiro stent or a non-investigational Xience stent. The Orsiro stent is investigational, which means it is not yet approved by the FDA and can only be used in research…
The purpose of this study is to see if study drug Sofosbuvir/Ledipasvir fixed-dose combination + Ribavirin (SOF/LDV FDC + RBV) are effective in treating people infected with the hepatitis C virus with genotypes 1 and 4, who have advanced liver disease with permanent liver damage (cirrhosis) and may be showing signs of liver failure or who have undergone…
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL FDC) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) infection in subjects who have previously been unsuccessfully treated for chronic HCV.. An experimental drug is one that…
The purpose of this research study, is to learn whether an experimental device (called Evolut R) can help clear hardened blockage in coronary arteries (blood vessels that feed the heart muscle) in patients with a disease is called aortic stenosis.Subjects that choose to participate and are eligible will have their interventional cardiologist use this device…
NOTE: YOU MUST HAVE HIV AND HAVE EVER HAD HEPATITIS C TO BE ELIGIBLE FOR THIS STUDY!! ............... For individuals who have both HIV and Hepatitis C virus (HCV), heavy drinking poses serious risks to their health. We do not yet know which interventions are effective at helping individuals with HIV and HCV drink less. The goal of the study is to compare…
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL) FDC for the treatment ofchronic genotype 3 hepatitis C virus (HCV) infection in patients who have cirrhosis, or scarring of the liver. The purpose of this study is to determine the efficacy,…
The purpose of this study is to see if a new medication called ticagrelor given twice daily ismore effective than aspirin alone in preventing the occurrence of heart attack, stroke and/ordeath due to cardiovascular events in patients who have type 2 diabetes. Ticagrelor is anantiplatelet therapy (stop platelets from clumping together) and is approved for…
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of study drugs Sofosbuvir, Velpatasvir and GS-9857 in comparison to Sofosbuvir and Velpatasvir in patients infected with HCV. Information about any side effects that may occur will also be collected.