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).
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).
A key part of the CP definition is that it's a non-progressive brain injury. However, as people with CP age, their function often deteriorates. This study seeks to determine whether changes in the brain structure may result in function changes, as they do in other types of brain injuries.
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…
The Weinberg Family Cerebral Palsy Center's (WFCPC) research team maintains a cerebral palsy (CP) patient registry of more than 1,000 enrolled patients. This registry contains information collected from children and adults with CP. The goal of the registry is to help us learn more about CP and neuromuscular diseases, to understand the quality of life…
Lymphangioleiomyomatosis (LAM) is a rare lung disease primarily affecting young women. Currently, LAM is often diagnosed in patients with radiology imaging (CTs) and/or lung biopsies; however, these methods can be imprecise, invasive, and/or can carry significant risks. The current study aims to devise a less invasive tool for diagnosis of this rare…
The purpose of this study is to identify genetic causes of lung diseases and to develop a research repository so that we can better understand, prevent and treat these conditions. You should consider joining this study if you have been diagnosed with a lung disease that has a genetic cause or if other family members have been diagnosed with a similar lung…
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…
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…
The purpose of this study is to identify genetic causes of lung diseases and to develop a research repository so that we can better understand, prevent and treat these conditions. You should consider joining this study if you have been diagnosed with a lung disease that has a genetic cause or if other family members have been diagnosed with a similar lung…
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 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…
The use of electronic cigarettes, also known as e-cigs or vaping, has increased among former smokers and young adults who have never smoked. Relatively little is known, however, about their health effects (whether they are adverse, have no effect, or are beneficial). The purpose of this research study is to evaluate (1) the association of e-cig use with…
The purpose of this research study is to help us understand whether blood markers of lung injury are worse in adult patients with interstitial lung disease and obstructive sleep apnea compared with patients with interstitial lung disease who do not have obstructive sleep apnea.
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…
We are asking you to participate in a research study to determine if we can detect minor lung injury that we cannot currently measure with available tests. This injury can occur when somebody is smoking for a long time or when somebody has COPD (chronic obstructive pulmonary disease). We want to compare the results of people who have never smoked, people…
We are asking you to participate in a research study to determine if we can detect changes in enzymes in the blood that may influence lung function decline in COPD (chronic obstructive pulmonary disease), in particular after COPD exacerbations. The procedures of the study include a pulmonary function test (breathing test), a short questionnaire, and blood…
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…
Capnography-Assisted, Learned, Monitored (CALM) Breathing is a mind-body intervention for COPD that uses breathing exercises and biofeedback with the goal of reducing shortness of breath, anxiety symptoms and improving overall quality of life. The intervention is a 4-week (1 hour, twice weekly) program taking place in-person at New York Presbyterian…
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 study the effects of a new study drug known as Riociguat in people diagnosed with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia (IIP). Patients will be in the study for approximately 26 weeks in which they will take the pill Riogciguat three times a day.
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 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…
The Families At-Risk for Interstitial Lung Disease (FAR-ILD) study is designed to detect and study the earliest stages of ILD in adults with a family history of ILD. FAR-ILD is a non-interventional study. This means that FAR-ILD is not involved in testing any new interventions or therapies. The purpose of FAR-ILD is to gather data on family members of…
This study is for patients who have been prescribed tobramycin inhalation powder (TOBI Podhaler) or another inhaled medication used to treat cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. The purpose of this research study is to assess how well TOBI Podhaler works on treating Pseudomonas aeruginosa in the lungs of…
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…
The main purpose of this study is to look at the effectiveness, safety, and tolerability of study drug CTX-4430 when compared to a placebo (sugar pill) taken once-daily for 48 Weeks in adult patients with CysticFibrosis (CF).
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…
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…
This study involves two infusions of either rituximab or placebo, two right heart catheterizations (6 months apart), and a variety of other clinical study procedures and exams.
This study is being done to learn more about the safety and effectiveness of study drug VX-661 in combination with ivacaftor in patients aged 12 years and older with Cystic Fibrosis (CF). In this Study there are two treatment groups. If the patient meets all the rules for being in the Study, they willbe in one of the two treatment groups. The patient will…
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…
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 is for subjects with Idiopathic Pulmonary Fibrosis (IPF). IPF is an uncommon long-term disease that causes scar tissue to build up in the lungs, damaging the lung tissue. Idiopathic means that there is no known cause. Subjects with IPF have symptoms such as cough, shortness of breath, and reduced ability to exercise. The purpose of this study is…
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…
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 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…
The purpose of this study is to find out if you can take the prescribed dose of VX-371 without problems, and whether VX-371 is safe and helps subjects with PCD. VX-371 is called an investigational or experimental drug because it has not been approved for use in people by the Food and Drug Administration (FDA), the branch of U.S. government which approves…
This study is for patients who have been diagnosed Idiopathic Pulmonary Fibrosis (IPF). The purpose of the IPF-PRO registry is to collect data and biological samples that will support future research studies. The IPF-PRO Registry is actively enrolling patients to collect information regarding the natural history of IPF and healthcare interactions. The…
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-…
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 clinical research study is to evaluate the safety and effectiveness of INS1007 as a treatment for non-CF bronchiectasis and to measure the concentration of INS1007 in the blood after treatment. INS1007 is taken as tablets and has been studied in animals and humans. Patients like you, with non CF bronchiectasis, may have problems with…
Our clinic is seeking patients with nontuberculous mycobacterial, or NTM, lung disease caused by Mycobacterium avium Complex (MAC), ages 18 years and older, for possible participation in a clinical trial. The CONVERT Study is evaluating the safety and effectiveness of an inhaled investigational drug called Liposomal Amikacin for Inhalation, or LAI
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 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 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…
The purpose of the ELEVATE CF study is to evaluate an oral investigational medication called VX-440 tosee if it is safe, effective, and well-tolerated when taken alone or with two other oral medications(VX-661 tezacaftor and ivacaftor) in people with cystic fibrosis (CF). This triple combination(TC) is being tested to see if it improves chloride transport (…
The purpose of this research study is to gather information about how respiratory syncytial virus (RSV) disease affects babies who were born earlier than their full-term due date, and how the hospitalization for RSV disease affects the parents/guardians daily routine activities. Information about the cost of healthcare and other costs related to the RSV…
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 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 clinical research study designed to determine the safety and effectiveness of the TIVUS system, an investigational device used in the treatment of PAH. The TIVUS System is intended to treat patients with pulmonary artery hypertension by injuring the sympathetic nerves surrounding the pulmonary vasculature (denervation) using ultrasonic energy. The…
The purpose of this study is to find out if subjects can take the prescribed dose of GBT440 without problems, and whether GBT440 is safe and helps subjects with IPF. GBT440 is called an investigational or experimental drug because it has not been approved for use in people by the Food and Drug Administration (FDA), the branch of U.S. government which…
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,…
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…
The purpose of this study is to assess how effective the study drug Pulmaquin is in the management of chronic lung infections with Pseudomonas aeruginosa in subjects with non cystic fibrosis (nonCF) bronchiectasis by evaluating the time to first pulmonary exacerbation. A pulmonary exacerbation is defined as the new appearance or worsening in 4 or more of…
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 investigate the safety of adding nentedanib to treatment with pifenidone in patients with Idiopathic Pulmonary Fibrosis (IPF). Eligible patients must be receiving consistent treatment with pifenidone for at least 16 weeks on a stable dose. Nintedanib will be added as an additional treatment for IPF (combination treatment) for…
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…
This study is being done to learn more about the safety and effectiveness of VX-440 used in combination with tezacaftor and ivacaftor in patients with cystic fibrosis. VX-440 given in combination with tezacaftor and ivacaftor is an investigational drug; investigational means the drug is not approved by the Food and Drug Administration (FDA), and is still…
The purpose of this study is to find out whether the study drug altaluren can help lung function and can reduce the symptoms associated with cystic fibrosis (CF), and decrease the number of hospitalizations and the use of antibiotics for CF-related lung infections. The study will also investigate whether the drug can help improve overall patient quality of…
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 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 objective of the Block-COPD Study is to determine if beta-blockers are safe and effective at reducing the number of exacerbations or flare-ups that people living with Chronic Obstructive Pulmonary Disease (COPD) experience. A beta-blockers is a drug that is taken by mouth and is currently used to treat a wide range of diseases including high blood…
This study is for patients with systemic sclerosis (SSc) and associated Interstitial Lung Disease. Systemic sclerosis or systemic scleroderma is a disease that causes thickening of the skin and the internal organs which often includes the kidneys, heart, lungs and gastrointestinal tract. Your disease affects the skin but also it affects the lungs. As the…
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/…
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema, a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few…