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).
During pregnancy, a baby's heart rate can tell us a lot about how their brain and body develop. Our team is testing a new, easy-to-use device that you can wear at home to track the baby's heartbeat for up to 24 hours. By using the monitor in your everyday environment, we can learn more about your baby's development in a natural setting,…
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study to better understand experiences related to extreme heat during pregnancy and to inform the development of heat preparedness resources for perinatal care. We are recruiting English-speaking participants who are 18 years of age or older and reside in New York State and…
We are conducting a research trial to determine if low dose Aspirin either 81 or 162 mg will prevent preterm birth in patients who have had a previous preterm birth, still birth, or complications of pregnancy including preeclampsia, small for gestational age baby, fetal growth restriction, or placental abruption. You will be randomized to 81 or 162 mg and…
You are invited to participate in a research study to understand how environmental exposures during pregnancy influence the health and development of children. This study will begin at pregnancy and follow your child through age 11. A trained research worker will work with you and your child, administering questionnaires to you and developmental evaluations…
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…
The Lugo Lab at Columbia University's Department of Psychiatry is conducting a study of stress and sleep in childhood and pregnancy, which will take place over the next year. We are recruiting pregnant people who identify as Latinx/Hispanic. You will be compensated for your time! We are flexible in scheduling convenient times for you to come in. The…
Our team is looking at the relationship between a mother and her baby to see how different prenatal and infant experiences affect a baby's brain development. Specifically, we are looking at maternal immune activation (MIA) and how prenatal exposure to MIA can affect a baby's development. For our study, we ask participants to come in for up to 3…
The Center for Intergenerational Psychiatry at Columbia University is recruiting pregnant individuals. We want to learn how feeling worried or anxious (or not having these feelings) may impact pregnant individuals and their babies. We would like to invite people from a wide-range backgrounds who are in between 12 to 34 weeks of their pregnancy to…
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 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…
We are doing this study to test the use of a drug called bromocriptine for women with a condition called Peripartum cardiomyopathy (PPCM). The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.
This research study is being done to understand how CPAP for sleep apnea may affect hypertensive disorders of pregnancy and other complications of pregnancy such as gestational diabetes. The purpose of the home sleep test is to find women with sleep apnea. Sleep apnea is when you have one or more pauses in breathing or shallow breaths while you sleep.…
This study will enroll participants who did or did not receive a SARS-CoV-2 vaccine during their pregnancy and have a child who is now 18-30 months of age. In order to assess the long-term outcomes of the offspring of those who received SARS-CoV-2 vaccine in pregnancy, a cohort study examining child developmental outcomes is needed. There are a number of…
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…
Women will be enrolled at or prior to prenatal visit at 34-40 weeks gestation with follow-up visits within 48 hours of delivery, and 6 and 12 months postpartum among the mother and infant. Maternal and infant measurements will be conducted at each visit. The purpose of the study is to estimate cardiovascular disease risk in healthy and medically complicated…
Researchers at Columbia are looking at the changes that happen in the placenta when people become pregnant. Participation in this study involves a blood draw at three time points. Participants will be paid $50 at each time point. Participants who complete all three time points will receive bonus compensation.
Researchers at Columbia are looking into possible viral causes of stillbirth or late-term miscarriages in patients. We are looking for people who have recently had a late-term pregnancy loss (within the past week). Participation in this research involves a one-time blood draw. Participants will receive $50.
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…
Are you currently pregnant or were you pregnant in the last 2 years? We want to hear from you! We are conducting interviews to understand how we can support physical and mental health during pregnancy and postpartum. Interviews will take place virtually over Zoom or via telephone and last about 60 minutes. There are also options to participate in person (…
GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements and/or early pregnancy oral glucose tolerance testing (OGTT) at 10w0d-14w0d gestation that are predictive, along with clinical factors, of adverse pregnancy…
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 purpose of the study is to test the following: 1) The safety and tolerability (how you feel when you take the drug) of the study drug, 2) The pharmacokinetics (PK) (how the study drug is absorbed within your body, spread throughout your body, and eliminated from your body) of the study drug, 3) The pharmacodynamics (PD) (how the study drug affects…
The primary purposes of this research study are to learn the safety and tolerability of the investigational drug, XmAb23104, for up to eight dose levels; to see if XmAb23104 works in treating tumors like the one that you have, and to see if side effects from XmAb23104 occur in order to find the maximum tolerated dose or recommended dose for treating your…
The purpose of the study is to test the safety of an investigational study drug called BMS-986218 (also known as Anti-CTLA4-NF monoclonal antibody) administered alone and in combination with nivolumab, and in comparison to Ipilimumab. This study will investigate how research subjects with advanced solid tumors tolerate these drugs and identify the highest…
The purpose of this study is to test what dose of BPX-601 can be given safely with rimiducid to patients with certain types of cancer. The study will look for side effects (good and bad) and how your body responds to the treatment. The study will also see if the treatment helps to stop your cancer from growing or spreading. BPX-601 is a treatment made from…
The purpose of this study is to determine the highest dose of the study drug that can be given safely to people with certain cancers. The study will also look at how effective the study drug is in treating certain cancers. The study drug is PLX2853. The participants in this study will be the first people to receive PLX2853.
The purpose of the study is to test the safety of an investigational study drug called BMS-986249. BMS-986249 will be given alone and in combination with nivolumab. This study will investigate how patients with advanced solid tumors tolerate these drugs. The study will identify the highest dose or most suitable dose of BMS-986249 alone and in combination…
The primary purpose of this research study is to learn the safety and tolerability of the investigational drug, XmAb 22841 when given alone or in combination with another drug called pembrolizumab. You will be assigned to either receive XmAb22841 alone or in combination with pembrolizumab and you will know what treatment you are receiving. This study will…
The experimental drug being investigated in this study is called rucaparib. Rucaparib is being developed by Clovis Oncology, Inc. (the Sponsor), a biopharmaceutical company with headquarters in the United States (US). Rucaparib (trade name: Rubraca) is a medicine that is approved in the European Union (EU) and the US for use in certain types of ovarian…
The main purpose of the study is to determine at what dose the study drug (ASP1951) is safe and tolerated and how it is processed in the blood of subjects with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study drug treatment…
BioAtla (the sponsor of the clinical trial) is studying BA3021 as a potential treatment for varieties of cancers including but not limited to lung, triple negative breast cancer and soft tissue sarcoma. The purpose of this research study is to test the safety of different doses of BA3021 and to find out what effects, good and/or bad, it has on the body and…
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…
The purpose of this study is to see if IMC-CS4 (LY3022855) is safe to give to patients. We want to see how you feel when you are receiving treatment, what effects, good and/or bad, the study drug has on you and your tumor and which may be the best dose.
The main purpose of this study is to learn more about the study drug called LY3321367. The study wants to know more about the following: The safety of LY3321367 alone and in combination with another drug called LY3300054 and any side effects you might have Whether LY3321367 is tolerable when taken alone and in combination with LY3300054. How much…
The purpose of this study is to test the effect of a drug called retosiban on stopping preterm labor and delaying the birth of her baby. We will also study the safety of the drug to find out what effects; good or bad, retosiban has on women in preterm labor and their fetuses. A previous small study, involving 93 women with preterm labor, found that…
The purpose of this study is to learn whether IDH305 is safe and can have possible benefits for people diagnosed with glioma, cholangiocarcinoma, acute myeloid leukemia (AML), chondrosarcoma or other types of solid tumors and have IDH1R132-mutant tumors cancers that have the IDH1R132 mutation and are not getting better after treatment with currently…
The purpose of this study is to test the safety, tolerability, and effectiveness (how well these drugs work together) of NKTR-214 given in combination with KEYTRUDA or TECENTRIQ. We want to find out what effects, good or bad, the study drug has on the body and cancer when combined with KEYTRUDA or TECENTRIQ. The study will recruit participants at least 18…
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…
This is a Phase 2-3 study evaluating the effects of selinexor in patients with advanced unresectable dedifferentiated liposarcoma (DDLS). This study drug selinexor works by trapping tumor suppressing proteins within the nucleus of the cells and thus causing the cancer cells to die or stop growing. Selinexor has previously been tested in humans to define a…
The purpose of this study is to find a safe dose of JNJ-63898081 that can be used for further studies in subjects with advanced cancers such as metastatic castration resistant prostate cancer (mCRPC) or metastatic kidney cancer, also referred to as renal cell carcinoma. This is a Phase 1 study and the first time JNJ-63898081 is being given to humans.
This is a Phase 1 multiple dose, dose escalation trial in patients with advanced solid tumors who have failed or cannot tolerate standard therapies. Your study doctor has determined that you have an advanced cancer (solid tumor). You are invited to take part in this research study. This study has two parts. In Part 1, the dose escalation portion, the…
The primary purpose of this study is to determine a safe dose for the combinations of LY3022855 with durvalumab or LY3022855 with tremelimumab. This study will help answer the following research questions- What side effects may be experienced when taking LY3022885 with durvalumab ortremelimumab and how much LY302255, in combination with durvalumab or…
The purpose of this research study is to test the effectiveness (how well the drug works), safety, and tolerability varlilumab and nivolumab (investigational drugs) together in patients with advanced solid tumors. Varlilumab and nivolumab are antibodies (types of human protein) that are manufactured in a laboratory and are being tested to see if they will…
This is a Phase 1/2 multicenter study of VX15/2503 in pediatric patients and young adults with solid tumors which have come back or have not responded to standard therapy. The study treatment is considered experimental because VX15/2503 is not approved by the United States (US) Food and drug Administration (FDA) for treating pediatric patients and young…
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 main purpose of this study is to determine the best dose of MEDI0562 that is safe and tolerable in subjects with advanced solid tumors. This study will also evaluate hows much MEDI0562 is in your blood at various times (which is called pharmacokinetics), whether your immune system becomes activated following administration of MEDI0562, whether your body…
The purpose of the study is to test the safety, anti-tumor activity, and the ability of a new investigational drug called BMS-986179 (also known as anti-CD73) plus nivolumab (also known as BMS-936558) to block the protein CD73 from producing high amounts of a product known as adenosine which blocks your immune system from killing your cancer cells.…
This study is for patients with the following types of cancer: Triple negative breast cancer, non-small cell lung cancer, mesothelioma, renal cell carcinoma, melanoma, head and and neck squamous cell carcinoma, colorectal cancer, sarcoma and pancreatic cancer. The purpose of this study is to evaluate the effectiveness of the study drug CB-839 in helping…
The study drug (TSR-042) in this study is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. The Study Drug is designed to help your immune system by attaching to a protein called PD-1 and stopping one of the signals that keeps your immune system from recognizing the cancer. This may help your immune system…
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 purpose of this research study is to confirm the safety of ASP5878. It is also intended to assess how the body reacts to ASP5878 after administration, how ASP5878 functions in the body, and the antitumor effect of the ASP5878. Participants in this study will have been diagnosed with urothelial carcinoma, hepatocellular carcinoma, or squamous cell lung…
Four different treatment regimens will be evaluated simultaneously in groups of patients who have advanced solid tumors that has progressed following administration of standard of care treatment, or for whom no standard therapy exists, or for whom therapies that will convey clinical benefit are not available, and in whom a trial of targeted therapy is…
The purpose of this study is to test the efficacy and safety of an experimental drug, demcizumab, when given in combination with pembrolizumab (Arm A of the study). Demcizumab is a humanized monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the growth of cancer stem cells, in addition to the remaining cancer cells, and…
GSK3359609 is a drug that is a type of antibody. It is a kind of immunotherapy that targets the ICOS (anti-Inducible T cell Co-Stimulator) protein present on specific immune cells. ICOS is a cell receptor that enhances the immune response to foreign bodies, and which is expected to help your immune system find and fight cancer cells. It will also be called…
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 is an open-label, multicenter phase 1/2 study. The study is designed in two parts, the first is designed to evaluate the safety of the study drug ulocuplumab in combination with nivolumab in subjects with small cell lung cancer (SCLC) and pancreatic adenocarcinoma (PAC). Subjects will receive a low dose of ulocuplumab in combination with…
The purpose of this study is to find the highest dose and the best schedule of the study drug, DS-3032b, that can be given safely in subjects with advanced solid tumors and for subjects that did not respond or no longer respond to standard therapy. DS-3032b works against cancer by blocking the activity of a protein called MDM2. DS-3032b works against…
The main purpose of this study is to determine the best dose of MEDI0562 in combination with durvalumab, and MEDI0562 in combination with tremelimumab, that is safe and tolerable in subjects with advanced solid tumors.
This is a study of patients delivering at Columbia University Medical Center-Allen Hospital. The investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also try to find out if there is a correlation between estimated blood loss and measured blood loss.
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 primary purpose of this research study is to evaluate the safety, tolerability and maximum tolerated dose of BAY 1143572. Moreover, concentrations of BAY 1143572 as well as of biomarker proteins may provide information about the effects of BAY 1143572, will be determined in blood and tumor tissue.
SY-1365 is an investigational drug that stops the function of a protein known as CDK7. Previous workhas shown that CDK7 is necessary for some cancers to grow. Therefore, SY-1365 could be used to slow down the growth of cancer. This research study is being done to understand the highest tolerated dose of SY-1365, and to assess the safety of SY-1365 in…
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 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 study is for subjects with either cancer of the head and neck, lung cancer or colorectal cancer. The aim of this research study is to identify the best dose of an experimental drug called MEDI1873 and to see if it is safe and tolerable in subjects with advanced solid tumor types. The study will occur in two parts: Part 1 (dose escalation) and Part 2 (…
The goal of the study is to determine whether coming to the hospital and having the labor started with medicine (i.e., labor induction) at 39 weeks of pregnancy can improve the baby's health at birth when compared with waiting for labor to start on its own.
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 this research study is to learn about the safety and effectiveness of the study drug, PF-06650808, when given as a single agent and to find the best dose for treating cancer. Prior to this study, PF-06650808 has never been given to people. PF-06650808 is known as an antibody drug conjugate. A toxic agent is chemically linked to an antibody.…
The purpose of this study is to find out what effects nivolumab or nivolumab given in combination with ipilimumab have on you and your cancer given the presence of genetic biomarkers (POLE and POLD1). This study will also look at the side effects of these two new immunotherapy drugs.