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 research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with HIV compared to donors without HIV. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
We are conducting a study on depression and suicide risk, and participants can earn up to $300 for taking part. Suicide rates in the U.S. are rising, and new treatments are urgently needed. This study focuses on the brain chemical glutamate, which may play an important role in mood and mental health. We will compare glutamate levels at rest and during…
The purpose of this study is to gather data about the safety and effectiveness of a new, investigational device (not FDA approved), the Thor laser atherectomy system (Thor system), for the treatment of peripheral artery disease (PAD). When there is a blockage (a deposit on an artery wall, made of fat or calcium, and/or blood clots) in one or more of your…
The purpose of this study is to understand how liver disease affects thinking and memory, both before and after transplant. Participants will take a cognitive test, which will be a series of tasks and questions similar to a video game, at home on their own computers, tablets, or phones. This will take approximately 45 minutes, and participants will do this…
A complication that can occur after liver transplant (LT) is rejection, in which the patient's immune system damages the transplanted liver. This complication can be prevented with immunosuppressant medications, which are routinely used after LT. The main purpose of this study is to determine if bacteria in the intestine (gut microbiome) may affect the…
The purpose of this observational research study is to identify things that contribute to outcomes in patients with alcohol-associated liver disease who are being considered for liver transplant and who have less than 6 months of sobriety. We will look at many things including images of the liver and heart, blood tests, urine tests, stool tests and liver…
The main purpose of this study is to deeply characterize cognitive function in liver transplant recipients, differentiate among different causes of cognitive impairment, and identify contributors to cognitive impairment. Participants will receive a comprehensive neurological exam, cognitive assessment, neuropsychological testing, MRI of the brain, and blood…
The purpose of this study is to evaluate the safety of siplizumab when used as induction immunosuppression in patients with primary sclerosing cholangitis or autoimmune hepatitis undergoing liver transplantation. Induction immunosuppression drugs are very potent anti-rejection drugs that are given immediately after transplantation to prevent rejection.…
The purpose of this study is to learn more about the effects of functional status (also known as "frailty") using a physical test in patients with liver disease on their health outcomes. We are enrolling patients prior to liver transplantation, and will continue to assess their functional status post transplant. If you have any questions regarding…
The primary objective is to evaluate long-term outcomes in transplant recipients with HIV who receive livers from donors with HIV compared to donors without HIV. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
The primary objective is to determine whether using hearts from HIV+ donors for HIV+ recipients is safe with regard to major transplant-related and HIV-related complications. The primary outcome is patient survival at one year. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
We are recruiting depressed adolescents ages 13-18 years. As a participant in our study, we will: (1) interview your child about current and past thoughts, feelings, and behaviors, (2) teach your child mindfulness strategies, (3) collect brain activity data with MRI (non-invasive) while your child practices mindfulness, and (4) send short surveys to your…
The purpose of this study is to study the safety and feasibility of giving intestinal transplant patients CD34+ stem cells (the cells that make all the types of blood cells) obtained from their organ donor's bone marrow as an IV infusion post-transplant. Researchers will be looking to see whether this CD34+ cell infusion might help control rejection of…
The purpose of this sponsor initiated multi center registry is to collect additional data on the performance of the FDA Approved OCS Liver System and post transplant clinical outcomes for patients who are transplanted with an OCS Liver perfused donor liver in the real world setting. If you have any questions regarding this study, please contact the…
Depression and some antidepressants may be associated with an increased risk of breaking a bone. It is not clear why this could be the case. It is possible that depression and/or certain medications used for the treatment of depression cause bone loss, increase the risk of falls, are associated with lower physical activity, or effects on muscle function.…
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…
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
Are you suffering from chronic depression? We are seeking participants for a depression treatment research study at Columbia University using Transcranial Magnetic Stimulation (TMS). This study develops a more accurate TMS to treat chronic depression. Participation includes clinical assessments and magnetic resonance imaging (MRI). You will receive 27…
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…
In this research study, we want to find out how well patients that receive a kidney from an HIV-positive (HIV+) donor do over 10 years compared to patients who receive a kidney from an HIV-negative (HIV-) donor. This research study is for adults who are HIV+ and are being evaluated for or are waitlisted to receive a kidney transplant. It is also available…
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
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 objective of this study is to learn more about how safe and effective the Bare Temporary Spur Stent System is when used in patients who have blocked arteries in their lower limbs. The selection of subjects will be those with Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in the lower leg (…
The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications. This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related…
Are you undergoing a stem cell transplant? You may be at high risk for infections after the transplant. This study is looking at the safety and effectiveness of an investigational medication for those who have undergone a stem cell transplant. Recovery after a stem cell transplant can already be challenging without the added worry of life-threatening viral…
This study is testing a drug called GDC-8264, which is being developed to treat acute graft-versus-host-disease (acute GVHD). GDC-8264 is an experimental drug, which means health authorities have not approved GDC-8264 in combination with standard medications for the treatment of acute GVHD. The purpose of this study is to evaluate the effects, good or bad,…
The purpose of this research is to study the effects of liver transplantation and standard immunosuppression on body composition in patients with compensated cirrhosis and hepatocellular carcinoma (HCC). Patients with a diagnosis of HCC and cirrhosis who are listed for a liver transplant will be enrolled in this study. If you agree to participate, you will…
This study uses smartphone technology to better understand changes in adolescent moods over time. As a participant in our study, we would: (a) interview your child about current and past thoughts, feelings, and behaviors and (b) collect data from your child's smartphone for 6 months through an app called the Effortless Assessment of Risk States (EARS;…
We are conducting research to explore self-stigma around depression, racial/ethnic and cultural experiences, and barriers to care (e.g., embarrassment, limited access, low expectations/motivation). Self-stigma refers to negative beliefs a person has about themself due to their mental illness. We are looking for Latinx or Black young adults ages 18-25 who…
We are conducting research to explore the level of self-stigma around depression, racial/ethnic and cultural experiences, and barriers to care (e.g., embarrassment, limited access, low expectations/motivation). Self-stigma refers to negative beliefs a person has about themself due to their mental illness. We are looking for Latinx or Black young adults ages…
We are conducting a research study to explore discrimination around depression and barriers to care in youth ages 14-18. We will use what we learn to create videos to reduce such discrimination. Parental permission is required for this study. Adolescents (ages 14-18) will participate in an individual interview that will be approximately 45 minutes long. We…
The objective of the LIFE-BTK RCT is to evaluate the safety and efficacy of the ESPRIT BTK device (which is a bioresorbable polymeric scaffold with the everolimus drug and a bioresorbable polymeric coating mounted on a balloon dilatation catheter) compared to Percutaneous Transluminal Angioplasty (PTA), which is is a procedure that can open up a blocked…
This research study uses non-invasive brain imaging called functional near-infrared spectroscopy (fNIRS). For fNIRS, a small infrared bulb shines light through the skull, and a special light detector is able to measure oxygen use in the brain. Our goal is to understand oxygen use by brain mitochondria cells in major depression and how this is affected by…
The goal of this study is to examine how effective and well-tolerated a possible new treatment for individuals who injure themselves frequently will be. All research procedures can be done from home no in-person visits are required. We are studying a minimal-risk form of electrical brain stimulation called transcranial direct current stimulation, or tDCS.…
We are currently enrolling individuals with Major Depressive Disorder (MDD) to participate in this research study. This is a one-year open-label study to evaluate the long-term safety and tolerability of an investigational drug called REL-1017 (esmethadone) when taken alone (monotherapy) or when taken with other antidepressants (adjunctive therapy). Study…
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…
Do you suffer from depression? Have standard treatments not been helpful? Researchers at Columbia University Irving Medical Center are conducting a study of an experimental antidepressant called ketamine, which can provide rapid relief of depressive symptoms in some patients. The study involves an inpatient stay, during which participants undergo brain…
A research team at Columbia University Irving Medical Center is collecting information for a registry studying how safely and effectively the ClotTriever device works in treating patients at least 18 years old with Deep Vein Thrombosis (DVT), or blood clots in the vessels of the leg. The sponsor of this study, Inari Medical, Inc., is paying the research…
Has your doctor determined that you have Type B Aortic Dissection and you would like to learn more about an alternative to open surgery? Type B Aortic Dissection patients are being invited to take part in a research study of an investigational device. Bolton Medical, Inc., the company sponsoring this clinical trial, is studying an investigational device…
The purpose of this study is to see if study drugs ABT-450/r/ABT-267, and ABT-333 taken with RBV are safe and able to reduce the amount of Hepatitis C Virus (HCV) in subjects' blood over a 24-week treatment period. These drugs are intended to prevent the HCV from multiplying in the human body. Subjects who participate in this study will be expected to…
The purpose of this study is to see which study drug is the better treatment for CMV infection. The study also wants to see how safe the study drugs are. The study drugs are Maribavir and Valganciclovir. Those who participate in the study will not know which drug they are taking. The study team will not know either.
The purpose of this study is see if an experimental gene product, the Hepatocyte Growth Factor (HGF) Plasmid (AMG0001) which will be injected into the affected leg's muscles is effective in treating the blockages in your leg without causing adverse effects. Affected leg means the leg that has the severest disease relating to the blockage or narrowing…
The purpose of this study is to see if the study drug Harvoni given for 4 weeks immediately after liver transplantation is safe and able to clear the Hepatitis C virus (HCV) from the body. This study will test a drug named Harvoni for the treatment of chronic genotype 1 or 4 Hepatitis C Virus (HCV) in peri-operative liver transplant patients. Harvoni (LDV/…
We are performing functional MRI (fMRI) scans before starting and after completing an acute course of electroconvulsive therapy (ECT) treatment. These scans are being performed to identify brain changes that occur after an acute course of ECT for participants with treatment-resistant depression. We also intend to perform two follow-up fMRI scans at two-…
We are studying the relationship between mitochondrial function and the experience of fatigue. Mitochondria are the powerhouses of the cell. Cells within different organs contain hundreds to thousands of mitochondria, which sustain life and fuel energy-dependent processes that we do every day including muscle contraction and cognitive activity. They act…
Has your doctor determined that you have Peripheral Arterial Disease (PAD), and that an artery in your upper leg is blocked as a result? Is blood flow to your upper leg(s) blocked?This study will test the safety and effectiveness of the PQ Bypass System (two catheters called the DETOUR Crossing Device and the DETOUR Snare) in improving blood flow to your…
We are seeking adolescents ages 13-17 to participate in a study on anhedonia. Anhedonia is the reduced ability to feel pleasure or enjoy things, and is a key feature of depression and other mental illnesses. If you believe your child is experiencing anhedonia, they may be eligible to participate in this study. If your child participates in this study, we…
The purpose of this study is to determine if the administration of non-absorbable antibiotics (rifaximin) for the first three months after liver transplant period will reduce the amount of fibrosis (scarring of the liver) in liver transplant patients with hepatitis C virus (HCV) by lowering serum LPS (a protein in the blood that comes from the bacteria in…
In this trial, we will evaluate whether partially-HLA matched allogeneic multivirus-specific VSTs, will be safe and produce anti-viral effects in immunodeficient recipients infected with one of more of the targeted viruses that are persistent despite conventional anti-viral therapy. This will be in patients who have received a hematopoietic stem cell…
The purpose of this research study is to determine if PerClot is safe and effective to stop bleeding during surgery. PerClot is a medical device in granule form made from the starch of a potato. The starch has been engineered in a way that the powder absorbs water and helps to form a clot. This kind of device is intended for use in surgical procedures when…
Patients who are either interested in discontinuing their current antidepressant or have discontinued an antidepressant in the past 6 weeks will be provided with an FDA approved medicine, Vortioxetine (brand name Trintellix). Treatment with Vortioxetine will start after the past antidepressant is discontinued. Vortioxetine dosage is adjustable throughout…
The goal of this open-administration treatment study of escitalopram (or duloxetine) is to evaluate the effect of antidepressant medication on treating the syndrome of frailty in older adults with depressive symptoms. Patients with significant depressive symptoms and 1 or more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss,…
All vascular repair and reconstruction surgery requires patching material. PhotoFix, made of cow heart membrane, is one of the FDA-approved patches on the market for use in vascular repair and reconstruction surgery. Other vascular patches on the market are also available and used by other surgeons for procedures like the one you need. This trial will study…
Approximately half of the individuals with Post-traumatic Stress Disorder (PTSD) present with major depressive disorder (MDD). Compared to PTSD alone, patients with comorbid PTSD-MDD demonstrate greater distress and poorer treatment outcome. The goal of this pilot study is to collect preliminary data on the feasibility, safety, and initial efficacy of an…
The purpose of this study is to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during parenchyomous tissue open surgical procedures. Baseline assessments will be performed within 24 hours prior to the scheduled surgery. There will be a physical assessment and a blood draw at the first study visit. Subjects will be randomly…
The primary objectives of this study are to measure the safety and effectiveness of bone marrow transplant (BMT) using specific chemotherapy in children with less severe SCD and to understand the long term effects of bone marrow transplant in children with SCD, by evaluating ovarian reserve, sickle cell related brain problems, sickle cell related kidney…
This study is for patients who have had a lung transplant and whose doctors believe that their body is rejecting the new lung, resulting in damage to the transplanted lung or lungs. This condition is called Bronchiolitis Obliterans Syndrome (BOS). In some patients, BOS progressively worsens, causing more breathing difficulty, worse quality of life. We are…
This study will allow cancer survivors an opportunity to learn whether light therapy is helpful to them in addressing common concerns of cancer survivors such as fatigue, feeling low, and/or trouble sleeping by engaging in an N-of-1 or individualized trial.
In this study, patients who are listed for a kidney or a liver transplant may be eligible for enrollment, asdetermined by their transplant doctors. The study is looking at patients who do not have hepatitis C virus (HCV) and provide their informed consent to receive a liver or kidney from a HCV positive donor. FDA approved medications that are used to…
If you are depressed and have not received course of medication treatment for depression in the past, you may be eligible for a study involving brain imaging and research treatment at no cost to you. The research treatment is with a medication that is not FDA-approved for depression. The study uses two types of brain imaging, position emission tomography (…
The purpose of this study is to see whether or not the medicine, Abatacept, when given after hematopoietic stem cell transplantation (HSCT) is effective in treating GVHD in children and adolescents with sickle cell disease (SCD). We are also planning to gather additional information about the safety of treating sickle cell disease with a hematopoietic stem…
The purpose of this study is to determine if Nexavar (sorafenib), the study medication, is effective in preventing cancer recurrence in high risk patients following liver transplantation. The purpose of this study is to determine if sorafenib is a safe and effective treatment option for preventing the recurrence of liver cancer in high risk subjects…
This is a research study of a new drug for the treatment of new onset chronic graft versus host disease (cGVHD). Chronic GVHD is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted donor cells attack the transplant recipient's body. The current way to treat cGVHD is to use prednisone (a type of…
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…
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learn more about which anti-rejection (or immunosuppressive) medications best protect infants, children, adolescents, and young adults after they have had a heart transplant. Two different drug regimens will be will be compared. All of these drugs are FDA-…
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…
This is a pre-marketing (Phase 2A) multi-site study of an investigational drug, ganaxolone, as a potential treatment for non-psychotic post-partum depression. Eligible subjects who agree by signing informed consent will spend four days on the 5-South Research Unit (5-S) of the New York State Psychiatric Institute. For 6 hours they will have an tube in a…
The purpose of this study is to investigate a new therapeutic regimen with or without steroids in the pediatric population. The aim is to find out whether everolimus is safe and has beneficial effects in children who receive a liver transplant. All children will receive a study drug called everolimus twice a day plus a reduced dose of cyclosporine or…
This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft…
The purpose of this study is to determine if eculizumab is safe and could be used to prevent Delayed Graft Function (DGF) following kidney transplantation. DGF is an early complication of kidney transplantation. This condition occurs when the transplanted kidney does not recover instantly after transplantation and can take days to weeks before recovering…
This is a prospective, randomized, multi-center, controlled study for subjects with end stage liver disease who require a liver transplant, comparing whole liver preservation via hypothermic machine perfusion (HMP) using the LLT System with Vasosol with livers preserved via static cold storage (which is standard of care). During Hypothermic Machine…
The main purpose of the study is to find out about whether the study drug is safe in humans and aneffective treatment in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD mayoccur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue orcells from a donor (called an allogeneic transplant). The new,…
We are conducting research to compare different ways of improving sleep and mood in teens. Treatment involves Behavioral Sleep Therapy and Interpersonal Psychotherapy for Adolescents targeting: depression trouble falling and staying asleep not feeling rested on waking feeling sleepy during the day. Study Procedures: ~ A free, thorough diagnostic evaluation…
The purpose of this study is to test a new medicine to prevent liver venoocclusive disease (VOD) in patients undergoing hematopoietic stem cell transplant (HSCT) who are at high risk or very high risk for liver VOD following HSCT. Liver VOD can be a complication of bone marrow and/or stem cell transplant,which may be life threatening. The condition is a…
Are you scheduled for an interventional vascular procedure, such as a Trans-catheter Aortic Valve Replacement (TAVR), Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair (TEVAR), or Balloon Aortic Valvuloplasty (BAV)? If yes, you may be eligible for this trial. This research trial studies the safety and efficacy of an Investigational…
The purpose of this study is to test the safety of different doses of HCIG when given to patients with HCV who receive a liver transplant. It will also provide information about whether HCIG can prevent HCV infection. Participation in the study is expected to last about 10 months. Participants will be randomly assigned to either receive HCIG or not. Your…
The purpose of this study is to evaluate the safety and tolerability of study drug CCX168 when it is given to patients who are receiving the standard therapy for a certain type of vasculitis called ANCA-associated vasculitis (AAV). The study will also assess the effectiveness of the study drug, CCX168, in combination with the standard treatment of AAV. This…
The purpose of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) at an early stage. Bronchiolitis Obliterans (BOS) is a form of chronic lung transplant dysfunction that affects many lung transplant recipients and can limit long-term survival. This study aims to increase the success rate of lung transplants by using advanced imaging tools to…
If you're experiencing an acute psychiatric emergency, please stop negotiating this website and call 911 or go to the nearest emergency room. This website is not designed to address an acute psychiatric emergency. Purpose: To find out whether intranasal ketamine, when added to standard antidepressant treatment, improves the outcome of treatment for…