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Displaying 1 - 33 of 33

LT Inflammation and Immunosuppression Biomarkers

Condition: Transplant / Liver Transplant
Investigator: Yael Nobel, MD, MS
Status: Currently Recruiting
A complication that can occur after liver transplant (LT) is rejection, in which the patient's immune system damages the transplanted liver. Tacrolimus is the primary medication used in most patients to suppress the immune system and prevent this complication after LT. The main purpose of this study is to determine if bacteria in the intestine (gut…
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Metabolic Effects of Hypoglossal Nerve Stimulation (Inspire)

Condition: Ear, Nose and Throat
Investigator: Yi Cai, Md
Status: Currently Recruiting
We are currently looking for adult patients who have undergone successful treatment of their obstructive sleep apnea with a hypoglossal nerve stimulator implant (i.e. Inspire therapy). Participants should be willing to participate in at-home sleep studies and come to Columbia University Irving Medical Center for at least 2 study visits. Participants will…
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INTEGRATE Cohort Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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Cognitive Impairment (Problems with Thinking and Memory) in Liver Disease

Condition: Transplant / Liver Transplant
Investigator: Sloane Heller, MD
Status: Currently Recruiting
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…
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Characterizing Alzheimer's Disease & Related Dementias (ADRD) and risk for ADRD among liver transplant recipients with cognitive impairment

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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Does Your Nose Remember? Understanding the Role of Smell in Memory Processes (ENT)

Condition: Ear, Nose and Throat
Investigator: Jonathan Overdevest, MD, PhD
Status: Currently Recruiting
The Columbia Otolaryngology Department is interested in understanding how sense of smell relates to memory and neurocognition. Participation will involve answering a series of questionnaires, completing a formal evaluation of your smell with standardized measurements, and complete short smell and memory games. You can participate in this study if you are…
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SET-SAIL (Siplizumab in patients with AIH undergoing LT)

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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.…
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Functional Assessment in Liver Transplantation (FrAILT) Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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Early Age-Related Hearing Loss Investigation (EARHLI)

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Justin Golub, MD, MS
Status: Currently Recruiting
Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
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Liver Transplant from Donors with HIV for Recipients with HIV: Long Term Follow-up Study (HOPE)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Currently Recruiting
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).
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Live-Viral Vaccination after Pediatric Liver Transplantation

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
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…
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Organ Care System (OCS) Liver Perfusion (OLP-II) Registry

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Currently Recruiting
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…
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Smelling the Juice: Functional Smell and Taste Preferences in Vaping and Cigarette Smoking

Condition: Ear, Nose and Throat
Investigator: Jonathan Overdevest, MD, PhD
Status: Currently Recruiting
The Columbia Otolaryngology Department is interested in understanding the intersection of vaping, smell, and taste and their impact on individuals' preferences for certain flavors. Participation will involve answering a series of questionnaires in addition to completing a formal evaluation of your smell and taste with standardized measurements. You can…
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Smell and Taste Disturbances in COVID-19

Condition: Ear, Nose and Throat / Loss of Smell
Investigator: Jonathan Overdevest, MD, PhD
Status: Currently Recruiting
Our research team at Columbia University is trying to understand the impact of COVID-19 on smell and taste (chemosensory) dysfunction among adult patients from the Greater New York City area. Current areas of study include: 1) Investigation of smell and taste recovery patterns among patients with COVID-19; 2) Studies on how recovery of smell and taste after…
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Speech Perception in Hearing Impaired Listeners

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Nima Mesgarani, PhD
Status: Currently Recruiting
The purpose of this study is to learn more about the mechanisms of hearing loss, specifically to learn how abnormalities in the brain may produce certain experiences that are common in patients with hearing loss. Individuals with hearing loss will be compared to individuals with normal hearing.
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Studies of Pediatric Liver Transplantation (SPLIT)

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Closed
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…
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A Study of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients (Liver Transplant)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Closed
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…
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A study for liver transplant patients with Chronic HCV using study drug Harvoni

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
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/…
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A study of liver transplant recipients to evaluate renal function, effectiveness and safety of a study drug, everolimus

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
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…
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A Study of the Gene Therapy CGF166 in Patients with Severe-to-Profound Hearing Loss

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Lawrence Lustig, MD
Status: Closed
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…
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A study for kidney transplant subjects using study drug eculizumab to prevent delayed graft function

Condition: Transplant / Liver Transplant
Investigator: Lloyd Ratner, MD, MPH, FACS
Status: Closed
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…
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A Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the TULA Iontophoresis and Tube Delivery Systems

Condition: Ear, Nose and Throat
Investigator: Eli Grunstein, MD
Status: Closed
The objective of the study is to evaluate the safety and effectiveness of the TULA System for the placement of tympanostomy tubes (ear tubes) under local anesthesia in an office/clinic setting.
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Study for liver transplant recipients using drug (IgG) to prevent Hepatitis C virus (HCV) recurrence

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
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…
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A Study To Assess The Efficacy And Safety Of 2 Dose Regimens Or Orally Administered SENS-111

Condition: Ear, Nose and Throat
Investigator: Ana Kim, MD
Status: Closed
Acute unilateral vestibulopathy (AUV) (previously called acute vestibular neuritis) is the third most frequent cause of peripheral vestibular vertigo, after benign paroxysmal positional vertigo and Menires disease.The goal of this study is to look at the effects of a new drug (SENS-111) in controlling the acute vertigo and other symptoms related to AUV more…
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Study for adult liver transplant recipients with chronic Hepatitis C infection using study drug (ABT-450/r/ABT-267)

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
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…
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A study to Assess Safety and Effectiveness of Study Drug OTO-104 in Patients at Risk of Hearing Loss From Cisplatin Chemotherapy

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Alice Lee, MD
Status: Closed
Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an…
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Study of Fibrosis in Liver Transplant Recipients with Chronic Hepatitis C

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
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…
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A study on women and fertility using online surveys to determine knowledge and attitude

Condition: Obstetrics & Gynecology / Fertility
Investigator: Nataki Douglas, MD, PhD
Status: Closed
The purpose of this study is to survey study participants to determine their knowledge and attitudes towards fertility, and interest in understanding fertility management options. Recruited participants will be contacted via e-mail and invited to participate in online surveys and have hormone markers measured at the Columbia University Medical Center.
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Study to evaluate the safety and effectiveness of Fibrin sealant during open surgeries

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
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…
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Study to Evaluate Performance of LifePort Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT)

Condition: Transplant / Liver Transplant
Investigator: Adam Griesemer, MD
Status: Closed
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…
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A clinical trial investigating the safety and evaluating how well a study drug works in women having difficulty becoming pregnant

Condition: Obstetrics & Gynecology / Fertility
Investigator: Eric Forman, MD, HCLD
Status: Closed
This clinical research study is for women between the ages of 35 and 42 years who are having difficulty becoming pregnant and who would like to receive treatment within an assisted reproductive technology (ART) program in order to become pregnant. The purpose of this research study is to test the safety and effectiveness of an investigation drug called FE…
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A study for subjects with liver cancer using a drug to prevent recurrence of liver cancer following liver transplantation

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
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…
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A study for Adults with Sudden Sensorineural Hearing Loss Using the drug Am-111 to Evaluate its Effectiveness in Restoring Hearing Loss

Condition: Ear, Nose and Throat / Hearing Loss
Investigator: Anil Lalwani, MD
Status: Closed
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
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