The purpose of this registry is to keep track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having molecular testing known as DCISionRT. A Registry is a databank of people who have something in common. Molecular testing looks at how certain genes are used by your tumor cells. The goal of this Registry is to help…
Seeking participants for a study about how individuals prefer to receive nutrition recommendations to support health management and preferences for visualizing health data. Participants may be invited to complete a 60-minute session to answer questionnaires and evaluate different styles of nutritional recommendations. In addition, they may be invited to…
A future without Type 1 Diabetes (T1D) starts with you. Get screened! Thanks in large part to T1D family members, we understand T1D as a disease that progresses in three distinct stages. This new definition in conjunction with TrialNet's Pathway to Prevention screening, allows for earlier detection and intervention.
The overall goal of this project is to determine whether the timing of your meals and sleep influences health. We are looking for adults aged 30 and older with type 2 diabetes to participate in a sleep study. Participants must be willing to keep a written food and sleep record for 7 consecutive days. Participants who complete this study will receive a total…
The Department of Occupational Therapy at Columbia University will be conducting research to understand the impact of aromatase inhibitors (AIs) on performing everyday activities, like bathing and making meals, for women diagnosed with breast cancer. The purpose of this study is to understand how functional performance is impacted by the use of AIs, and its…
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 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…
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…
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…
In PRECIDENTD, we hope to learn which diabetes medications work best to reduce the risk of heart and kidney disease in people with type 2 diabetes. People with type 2 diabetes are twice as likely to have heart disease or a stroke compared to someone who does not have diabetes, and they are likely to have heart disease or stroke at a younger age. People with…
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…
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 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).
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…
The purpose of this study is testing two different Janus kinase (JAK) inhibitors, Abrocitinib and Ritlecitinib, to see if either or both can preserve insulin production in people recently diagnosed with type 1 diabetes (T1D). Researchers believe JAK inhibitors may be able to calm the immune system's attack on insulin producing beta cells in the…
We are looking for children between the ages of 8-14 with Type 1 diabetes and without Type 1 diabetes who are interested to participate on a research study to find out how bones are affected in children and adolescents with Type 1 diabetes as compared to people without Type 1 diabetes.
The purpose of this study is to learn if the use of two drugs, Rituximab and Abatacept, one after the other, will help to extend insulin production in people newly diagnosed with type 1 diabetes (T1D). These two medications may potentially help each other with altering the immune response that causes the attack on insulin-secreting cells in the pancreas.…
This study is being done to answer the following question: Is treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients with HER2-positive breast cancer who have had surgery, chemotherapy, and HER2-targeted therapy? This study is being done to find out if this approach is…
The purpose of this study is to Assess Treatments for Painful Diabetic Peripheral Neuropathy (PDPN). To be in this study you must have type II Diabetes Mellitus, PDPN, must be 18 years of age or older, and be able to stop taking some of your current pain medications including pills, creams, patches, marijuana, cannabidiol (CBD) oil, etc. Acetaminophen (…
We are conducting a series of focus group sessions to investigate the attitudes and opinions of young Black women regarding breast cancer, breast cancer risk, and biomarker-based screening to inform current breast cancer screening guidelines.
This is a randomized trial that will examine the effect of self-monitoring food intake via a smartphone application, and of a novel lifestyle intervention called time-restricted eating, on improvement of metabolic health in persons with overweight or obesity. The intervention lasts 12 months and will be administered via a smartphone app. Participants will…
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…
To be in this study you must have Diabetic Peripheral Neuropathic (DPN) and be 18 years of age, inclusive, with the presence of bilateral pain in lower extremities due to DPN for at least 6 months prior to Screening and be in a stable regimen for the treatment of T1DM or T2DM for 3 months prior to Screening.
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is…
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…
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…
We are conducting an academic study to understand how people solve problems related to health. In the study, participants will be presented with a hypothetical problem related to diabetes self-management and asked to use an online health application to explore information and propose a solution. We invite all participants between 18 and 65 years old, who…
We are currently looking for men and non-pregnant women aged 40 years and above to participate in an at-home study on sleep and activity patterns in relation to blood pressure and blood glucose. Participants should not have critical/severe illness and should not be on dialysis or have a pacemaker or other implanted medical device. You must be willing to…
We are recruiting healthy volunteers, aged 18-65, 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 induce temporary insulin resistance in 10-12…
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of VX-548 in participants with pain due to Diabetic Peripheral Neuropathy (DPN). To be in this study you must have DPN and be 18 through 80 years of age, inclusive, with presence of bilateral pain in lower extremities due to DPN for at least 1 year.
The purpose of the study is to determine whether ablation, which is the removal or destruction of a tumor (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients improves progression-free survival (PFS) and overall survival (OS).
The purpose of this registry study is to assess information obtained from the Agendia Breast Cancer Suite of diagnostic tests and other clinical information to study ways to assist in breast cancer diagnosis and treatment decisions in Chinese patients. The Agendia Breast Cancer Suite includes MammaPrint, TargetPrint, BluePrint, and TheraPrint which are…
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 assess the performance and ease of use of the AeroDorm Tissue Expander System in women who are undergoing breast reconstruction surgery. This device is for use in women who are having or have had a mastectomy procedure to remove their breast(s) because of breast cancer (or to decrease their risk of breast cancer). The study…
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 find out how Black and Latina women with type 2 diabetes prefer to learn about getting healthy before pregnancy. Participation will involve a conversation for 1-2 hours. We will ask questions and get your thoughts on your health, your diabetes, pregnancy, and birth control. We have prepared some questions, but will be…
This study is for women who have been diagnosed with stage 2 or stage 3 breast cancer whose doctor has recommended that you receive radiation therapy after your mastectomy to prevent your breast cancer from coming back. Radiation uses particles of energy to kill any remaining cancer cells where your breast was removed or in the lymph nodes. Radiation after…
The purpose of this study is to capture and evaluate clinical data about the long-term safety and effectiveness of Novilasee - a FDA-cleared minimally invasive treatment for benign breast tumors in hopes that tracking and analyzing the safety and effectiveness of Novilase in a real world application will benefit future patients and the breast cancer…
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 study is to determine if a specific form of Vitamin B known as pyridoxamine helps improve bone strength over one year in women (65 yrs old) with Type 2 Diabetes. We know that people with type 2 diabetes have the lower bone material strength and we suspect this is due to high levels of circulating sugars that build up over time (known as…
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 purpose of this research study is to learn more about bone strength in women with type 2 diabetes, and to find out whether an experimental drug called Denosumab may help preserve bone strength. Type 2 Diabetes Mellitus (T2DM) has become one of the most important diseases of our time. Recent research shows that diabetes has negative effects on bones and…
The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only…
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 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…
Some people who are treated for breast cancer develop swelling in their arms as a result of their treatment. This swelling is called lymphedema and it can be chronic. The purpose of this study is to see if early detection of arm swelling using a small painless device (called bioelectrical impedance), immediately followed by compression treatment, prevents…
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/…
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 main purpose of this study is to determine the safety and tolerability of Faslodex given directly into thebreast ducts of women with invasive breast cancer or Ductal Carcinoma In Situ (DCIS). This study is for women who have been diagnosed with invasive breast cancer or DCIS. DCIS is the presence of abnormal cells inside a milk duct in the breast, 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…