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…
Bariatric surgery and a once-weekly glucagon-like peptide-1 medicine both cause major weight loss in teens, but their effects on mouth and gut bacteria and on damaged blood fats tied to metabolism are still unknown. This study will collect saliva, stool, and routine blood samples from adolescents before treatment and six months later to see how these…
We are conducting a research study on the effect of high insulin levels on the buildup of excessive liver fat ("fatty liver disease") in people at risk for type 2 diabetes. We are seeking adult volunteers, ages 18-65, who have obesity with a body mass index of 30-45, and have been diagnosed with, or are at risk for, prediabetes and metabolic…
We are researchers at Columbia studying the learning and decision making. We are looking for participants over the age of 18, who have been prescribed Trizepatide for weight loss. Participants will be asked to complete an MRI scan and play computer games. Participants earn $25 per hour. Help us understand how the GLP-1 agonists affect brain and cognition!
The Physiology of the Weight Reduced State (POWERS) is a national research study designed to discover and learn what happens to the human body after weight loss and to learn why some people regain their lost weight. Understanding why this happens could help health professionals improve strategies for successful weight loss maintenance after weight loss.…
The purpose of this study is to evaluate if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The participation lasts ten months and includes six in-person visits at CUIMC with blood sampling and questionnaires, virtual nutritional counseling, and taking an oral weight…
We are conducting a research study on how insulin controls blood sugar in both healthy people and those at risk of type 2 diabetes. We are seeking adult volunteers, aged 18-65, who have body mass indices either in the lean range (18-25 kg/m2) or in the obesity range (30-45 kg/m2) but who do not have prediabetes or diabetes. Participants will undergo a…
We are recruiting volunteers, aged 18-70, for a research study on the buildup of excessive liver fat ("fatty liver disease") in people with or at risk for type 2 diabetes because their bodies are resistant to the actions of the blood sugar-lowering hormone, insulin. To do this, we seek to temporarily induce or accentuate insulin resistance in 14…
We are seeking adult volunteers with body mass index in the obesity range (30-45 kg/m2) to come in for a single study visit where they answer some health questions and have a small volume of blood drawn (25 cc/1.7 tbsp). We will measure levels of the blood sugar-lowering hormone insulin as well as glucose (sugar), certain fats, and other molecules related…
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…
The purpose of this study is to compare V940 plus pembro given after surgery to a placebo plus pembro given after surgery and to study how effective the study drug is. A placebo looks like a study drug, but it has no active ingredients. V940 has not yet been approved by the Food and Drug Administration (FDA). Pembrolizumab is FDA approved but it has not…
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…
We're conducting a research study on how much insulin is needed to control blood sugar in people who are made temporarily resistant to insulin's effects. Insulin is the main hormone (chemical signal) that the body uses to lower the levels of sugar in the blood. We are interested in looking at insulin levels because we think that lowering insulin…
The purpose of this study is to determine the safety and efficacy of CMP-001 when given in combination with nivolumab for patients with unresectable (not capable of being surgically removed) or metastatic (cancer spreads to a different body part from where it started) melanoma. CMP-001 will be given as an injection into the tumor and nivolumab will be given…
The purpose of this research study is to test the safety and efficacy of AU-011 at different doses and different number of doses of study drug when it is injected into the suprachoroidal space of the eye with one or two laser light applications and to find out what effects, if any, it has on research participants with a choroidal melanoma tumor or…
This study consists of two treatment groups, Part 1 and Part 2. The purpose of this study is to: Part 1 - Test the safety and tolerability of the study drug IN10018, see how well the drug works on your metastatic uveal melanoma, and see how your body handles the drug. Part 2 - Test the safety and tolerability of the study drug IN10018 with cobimetinib, see…
The purpose of the study is to evaluate the effectiveness (how well the drug works) of the investigational drug called bempegaldesleukin when combined with drug nivolumab in comparison with nivolumab alone after complete resection (removal of all sites of known disease) of melanoma in participants at high risk of cancer returning after surgery (recurrence).
This research study is a phase II clinical trial that will study the combination of adjuvant nivolumab and ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma. This study is being done to see if the combination of the study drugs is safe and effective in preventing the return of their cancer. If you are eligible…
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…
The purpose of this study is to gather information on the safety of TH-302 and its effect on your cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about your specific cancer such as the level of oxygen that is present. This may help us understand…
The purpose of this study is to compare the efficacy and safety of cobimetinib plus atezolizumab with the efficacy and safety of pembrolizumab in patients with a type of skin cancer called melanoma that has spread to other parts of the body (metastatic), cannot be removed by surgery (unresectable), and have not received any prior treatment.
The purpose of this research study is to determine if high-dose versus standard-dose regimens of encorafenib and binimetinib are safe and have positive effects in people who have melanoma brain metastasis and also have been found by their doctor to have a mutated gene called BRAFV600. The time frame for the study is approximately 2 years.
The purpose of this study is to find out if the drugs LEE011 and MEK162, administered in combination, are safe and effective in treating people who have melanoma. Specifically, this study will evaluate the effects of the combination of the two drugs, LEE011 and MEK162, in melanoma, carrying specific mutation in a gene called NRAS. The changes in the NRAS…
The purpose of the first part (Phase I) of the study is to test the safety of navitoclax in combination with dabrafenib and trametinibat different doses to find out what effects, if any, it has on people. There will be about 18 people treated in this part of the study. The purpose of the second part of this study (Phase II) is to compare the good and bad…
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 determine how effective and safe the immune drug Nivolumab is for patients who have newly diagnosed cutaneous melanoma. Nivolumab is an anti-body, a type of human protein, that is being tested to see if it will allow the body's immune system to work against tumor cells. If you are eligible for the study, you will…
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 study is to find out more about the Amgen agent called talimogene laherparepvec in people with advanced melanoma when given in combination with another drug developed by Merck called pembrolizumab. Melanoma is a type of skin cancer. Advanced melanoma means the tumor is not removable by surgery or has spread to other parts of the body.
The purpose of this study is to find out which participants with melanoma respond best to nivolumab and ipilimumab treatment and to identify tumor and blood based markers that may predict response to the combination. This study is asking that participants submit tumor tissue samples from their initial tumor specimen and blood samples before they receive…
This is a phase II research study for individuals with resectable, stage IIIB to IVM1a Melanoma. The research drug being studied is talimogene laherparepvec. Talimogene laherparepvec is still experimental and has not been approved by the Food and Drug Administration (FDA) for use in people with melanoma. The purpose of this study is to find out more about…
The purpose of this research study is to test the safety of Light-activated AU-011 at three different doses of the study drug and repeat dose regimens (two or three doses of highest safe dose) to find out what effects, if any, it has on research participants with a choroidal melanoma tumor. This study will have a high dose, a medium dose, and a low dose of…