The purpose of this research study is to determine whether rosuvastatin is safe and can help people living with cirrhosis lead longer, healthier lives. The study drug, rosuvastatin, is investigational, meaning it has not yet been approved for market use for this disease condition by the United States Food and Drug Administration (FDA). Participants will…
The DROP-AKI Trial is studying whether droxidopa, an FDA-approved medication for low blood pressure, can help patients with liver cirrhosis who develop kidney problems during hospitalization. Although droxidopa is FDA-approved for certain types of low blood pressure, it is not approved to treat patients with cirrhosis of the liver who develop kidney injury…
****The WiseApp in Spanish Study is looking for Spanish-speaking People Living with HIV Residing in the NYC Area**** Are you living with HIV? Are you 18 years or older? Are you a Spanish speaker? Do you own a smartphone? Are you interested in learning more about your health? We are conducting a study at Columbia University School of Nursing to learn more…
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…
Thank you for your interest in our research! We are studying how life experiences impact brain health and memory in people with and without HIV. Your participation can help advance science and improve future care. What's involved? You'll come to the Columbia University Irving Medical Center for a one-time visit, which includes a blood draw, urine…
This study is examining how oral vancomycin, an antibiotic sometimes used to treat Primary Sclerosing Cholangitis (PSC), affects the bacteria living in the gut (the microbiome). The study is observational, meaning it does not alter medical care or prescribe treatment-participants will continue their usual therapy as decided by their doctors. The study will…
The purpose of this study is to learn about the causes of non-alcoholic fatty liver disease (NAFLD). This is the most common type of liver disease, affecting millions of people in the United States alone. The incidence of Nonalcoholic Fatty Liver Disease (NAFLD) is very similar to that of obesity, type-2 diabetes, and the metabolic syndrome, suggesting a…
This study is evaluating how well odevixibat, an approved medication for Alagille Syndrome (ALGS), works in real-world clinical practice and how safe it is for long-term use. Participants with ALGS who are receiving odevixibat as part of their usual medical care will be followed for about five years. During this time, information from routine clinic visits…
The purpose of this study is to evaluate the study drug, pemvidutide, as a possible treatment for alcohol associated liver disease or ALD. ALD is a condition in which excessive alcohol use (commonly defined as more than 2 drinks per day for women and 3 drinks per day for men) leads to liver inflammation and damage. Pemvidutide is investigational, meaning…
The main purpose of this study is to look at whether experimental study drugs are safe, whether your body can handle the effects, and whether these study drugs improve the body's response to human immunodeficiency virus (HIV) in people with HIV (PWH) who started antiretroviral therapy (ART) early after getting HIV-1. The study treatments include: a…
The purpose of this study is to determine if an experimental drug, INT-787, is safe and effective in patients who are hospitalized due to severe alcohol-associated hepatitis. This is a double-blind study, so the study doctors and participants will not know if they are receiving INT-787 or a placebo. Participation will last approximately 3 months. If you…
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three-arm clinical trial of immunosuppressive therapy for children with acute liver failure. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. The study will determine if corticosteroids or equine anti-…
The purpose of this study is to determine whether the investigational drug (maralixibat) is safe and effective in children and participants who have cholestatic liver disease with pruritus (itch) that has been responding to other therapies, and who have no other treatment options.If you have any questions regarding this study, please contact the Transplant…
The purpose of this study is to learn whether wearable technology and the biometric data (e.g. heart rate, activity level, sleep) collected from it can be useful to detect clinical changes in those with liver disease, so that in the future it may help to prevent complications. The wearable technology that will be utilized in this study is the Oura Ring.…
The purpose of this study is to better understand how common and how severe pruritis (itching) is in children and adults under 21 years of age with Primary Sclerosing Cholangitis (PSC). The study involves the completion of two short online surveys. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
TARGET-Liver Disease (TARGET-LD) is an observational research study to learn more about adult patients who have been diagnosed with a chronic liver disease (CLD). This includes collecting information about their health and the medications they take to manage their disease. Participation in this study will be approximately 15 years. If you have any questions…
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).
Do you identify as a woman or transgender person, or do you have a non-binary gender identity? Has a medical provider ever diagnosed you with a sexually transmitted infection or recommended PrEP/another HIV prevention method? We are conducting a study to understand attitudes and preferences regarding HIV prevention methods among people who do not have HIV.…
We are looking for individuals 18 to 65 years old who are interested in learning more about HIV prevention and biomedical research studies. We will ask you to complete a brief questionnaire to find out if we can schedule you for a one-on-one, 1.5-hour education visit to learn about the research we do. The education visit will help you decide if you want to…
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 study is to understand more about the combination of amivantamab and lazertinib in non-small cell lung cancer (NSCLC) who have a specific mutation in the EGFR (epidermal growth factor receptor) gene and have not had prior treatment for their disease. The Food and Drug Administration (FDA) has not approved the combination of amivantamab…
The purpose of this clinical research study is to learn more about the use of the investigational study drug, volixibat, for the treatment of pruritus (itching) associated with primary sclerosing cholangitis or PSC. Volixibat is a drug that is designed to lower circulating bile acid levels may lead to the itching in patients with PSC. Eligible patients will…
This trial is testing two experimental drugs for HIV called VH3810109 (also called N6LS) and Fostemsavir (FTR). This trial is a Phase 1b study testing whether these drugs are safe to use in people and can be taken comfortably, as well as whether they may be helpful in eliminating HIV from the body. In this study, FTR will be given as a "helper drug…
This trial is testing an experimental treatment for HIV that is called CAB + RPV LA (long-acting cabotegravir and rilpivirine). CAB + RPV LA is a combination of drugs that is used to treat HIV (called antiretroviral therapy ART). It is currently approved in the US for the treatment of people living with HIV who are taking ART and whose viral load is already…
The purpose of this research study is to determine if an investigational drug, VS-01, will help in the treatment of acute-on-chronic liver failure (ACLF) compared to supportive care (standard of therapy). ACLF is a potentially life-threatening condition characterized by a group of signs that occur together (syndrome) in patients with a late stage of…
The purpose of this research study is to determine if an investigational drug, VS-01, will help in the treatment of acute-on-chronic liver failure (ACLF) compared to supportive care (standard of therapy). ACLF is a potentially life-threatening condition characterized by a group of signs that occur together (syndrome) in patients with a late stage of…
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug, BDTX1535, which is not yet approved by the United States Food and Drug Administration (FDA), intreating patients with advanced solid tumors with changes in a protein named epidermal growth factor receptor (EGFR), which may or may not help your condition during…
The purpose this study to learn more about if a medication called durvalumab will work and be safe for the treatment of non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) with certain genetic changes when given in combination with tremelimumab and standard chemotherapy. Additionally, this study is being done to better…
The purpose of this study is to find out if a new laboratory blood test for patients with Wilson's disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Participation will last about 12 months. If you have any questions regarding this study, please contact the Transplant Clinical Research…
The HIV Vaccine Trials Network (HVTN), Division of AIDS (DAIDS), and Columbia University Irving Medical Center (CUIMC) are conducting a trial to learn about the safety and effectiveness of a new experimental HIV vaccine. The goal is to understand if the study products are safe to use in people living with HIV, and whether they can get the study products…
The purpose of this study is to determine if an experimental drug, ALN-HSD, is safe and effective in patients diagnosed with non-alcoholic steatohepatitis (NASH), or metabolic dysfunction associated steatohepatitis (MASH) by improving liver function and lessening liver inflammation. This is a double-blind study, so the study doctors and participants will…
HPTN 102/ PURPOSE 3 is a clinical study being done with cisgender women in the US to see whether an investigational twice-a-year (every 6 months) injection medicine can help reduce the risk of getting HIV from sex. The safety and efficacy of the medicine, which is called lenacapavir (LEN), is being studied for the prevention of HIV as pre-exposure…
LCN Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months for a total of 3 years. Some of the visit…
This study will compare the effectiveness of osimertinib alone to the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene for the epidermal growth factor receptor (EGFR). Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. This…
Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) is a type of kidney failure that progresses very quickly and is due to severe liver disease. Terlipressin is approved in the United States for treatment of HRS-AKI. This study will test the safety and effectiveness of terlipressin alone compared to a combination of an investigational (experimental) drug…
The main purpose of this study is to collect information on patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the long-term outcomes and complications over a 5-year period. Subjects will be asked to complete four…
We are conducting a survey to gather feedback about lung cancer patients experience with treatment and the challenges you faced. Your insights can help shape better care for future patients and explore how technology can be of help! The survey takes 30-40 minutes, and eligible participants who complete it will receive a gift card. Interested in…
This is a research study evaluating a new investigational drug, called CLN-081. CLN-081 is a type of drug called a tyrosine kinase inhibitor. It targets a mutation in the tumor cell called EGFR exon 20 insertion with the goal to slow down or stop cancer cell growth. It is taken orally (by mouth). There are several different parts to this study, each with…
The purpose of this study to learn more about whether the study drug osimertinib (TAGRISSOTM) is more effective than placebo in participants with epidermal growth factor receptor (EGFR) mutated stage IA2 or IA3 Non-Small Cell Lung Cancer (NSCLC) after complete surgical removal of the tumor. Stages IA2 and IA3 refer to tumor size. A placebo is an inactive…
Scientists are looking for ways to effectively clear HIV that rests in areas of the body where standard antiretroviral treatment (ART) is unable to reach. IL-15 superagonist (N-803) appears to reactivate HIV that is asleep and is also thought to increase the body's natural immune response to HIV. Broadly neutralizing antibodies (bNAbs), such as 10-1074…
The purpose of this study is to assess the benefits and risks of the study drug, adagrasib, when given either by itself or with another drug, nivolumab, to participants with non-small cell lung cancer and a specific cancer mutation, called KRAS G12C, and whether the study drug or the combination may treat or shrink tumors when given before cancer surgery.…
The purpose of this study is to compare the drugs ramucirumab and pembrolizumab to standard-of-care treatment in patients whose lung cancer has progressed on immunotherapy. The study doctors hope to learn if the drug combination will help patients with stage IV or recurrent non-small cell lung cancer (NSCLC) live longer. The study is set up to find out if…
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of…
This research study is being conducted to see if HIV antiretroviral medicines that you are taking continue to work well in transgender women and other individuals identifying as female or transfeminine, but with male sex assigned at birth (referred to as transgender) when taken with feminizing hormone therapy (FHT), also known in this study as estradiol.…
We are doing this study because we want to find out if MRI brain scans alone is better or worse than MRI brain scans plus preventative brain radiation for patients with small lung cancer. The usual approach for patients with small cell lung cancer is prophylactic cranial irradiation. If you decide to take part in this study, you will either receive PCI for…
This study evaluates whether odevixibat is safe and effective compared to placebo in children with biliary atresia who have recently undergone a Kasai procedure. This is a double-blind study, so the study doctors and the child/parent will not know whether the child is receiving odevixibat or placebo. Participation will involve several research visits over…
We are doing this research study to learn more about the lived experiences of discrimination and oppression based on race, sexual orientation, and HIV-status among Black men who have sex with men and live with HIV. We are interested in understanding how these experiences influence antiretroviral therapy use. Black men who have sex with men are heavily…
The main purpose of this study is to determine how safe and effective fazirsiran is in patients with alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD) compared to placebo. Eligible participants will receive either fazirsiran or placebo for about 4 years. This is a double-blind study, so the study doctors and participants will not know…
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 are doing a research study to find out if Long-Acting Injectable anti-HIV medications will be more successful than standard pills for people who have a hard time taking their HIV pills. If you are over the age of 18 years old, have been prescribed HIV medications but have had difficulty getting undetectable viral load (when the levels of virus in the…
This is a 20-year study of adult patients with Primary Sclerosing Cholangitis (PSC). The purpose of this research study is to evaluate PSC throughout North America, as PSC is a rare disease, and not enough information is available for patients, clinicians, and researchers to help guide medical decisions and to help find new treatment options. Participants…
The purpose of this study is to see whether the medication osimertinib (TAGRISSOTM) alone or when used in combination with chemotherapy is more effective than chemotherapy alone for the treatment of early stage Non-Small Cell Lung Cancer prior to surgery. Osimertinib is an EGFR TKI therapy that targets EGFR mutations. When a tumor is found to have this type…
Pre-exposure prophylaxis, or PrEP, is the term used for medications that reduce the risk of getting HIV. There are approved medications that can be taken daily to prevent HIV infection. We are studying a PrEP medication that is a pill that can be taken once a month. It is being compared to an approved PrEP pill that is taken once daily. All women who take…
Are you living with HIV? Are you 18 years or older? Do you own a smartphone? Are you interested in learning more about your health? We are conducting a study at Columbia University to learn more about how a phone app and sessions with a community health worker can help people living with HIV improve their health. You may receive up to $90 for your…
The purpose of this study is to compare the usual treatment for Non-Small Cell Lung Cancer (osimertinib) to a combination therapy (osimertinib plus ramucirumab). The combination therapy arm is testing if ramucirumab can help osimertinib control the abnormal EGRG protein for a longer time and keep the disease inactive longer. EGRF protein typically helps the…
Weight gain after starting antiretroviral therapy (ART) is common, but recent studies have found that some people living with HIV (PLWH) who are taking an integrase strand transfer inhibitor (INSTI) combined with tenofovir alafenamide/emtricitabine (TAF/FTC) or tenofovir alafenamide/lamivudine (TAF/3TC) may gain more weight than people taking other drug…
The purpose of this study is to assess the effects, good or bad, of atezolizumab and tiragolumab given with or without chemotherapy (in this study, chemotherapy will be a combination of either paclitaxel with carboplatin, pemetrexed with carboplatin or cisplatin, or gemcitabine with carboplatin or cisplatin) on patients who are able to have surgery to…
The purpose of the study is to see whether tomivosertib in combination with pembrolizumab treatment slows down the growth of cancers. The study drug, tomivosertib, works by inhibiting the activity of proteins in a pathway that allows tumor cells to grow and go unnoticed by your immune system. This study will evaluate the safety and antitumor activity of…
Interested in quitting smoking? Help researchers at Columbia University School of Nursing test an intervention to help people living with HIV quit smoking cigarettes! To be eligible you must be 18 years or older, be a person living with HIV, be a current smoker, be interested in quitting smoking within the next 30 days, and owns a smartphone (Android). You…
The purpose of this study is to gain a better understanding of why some patients with non-small cell lung cancer and an epidermal growth factor receptor (EGFR-sensitizing mutation, fail first-line treatment with the drug osermitinib. Additionally, the purpose is to explore different drug therapies for patients whose cancer has progressed (gotten worse)…
The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self-testing and PrEP adherence among cisgender and transgender women over a twelve-month period. We will help you to download the app on your phone and provide you with HIV self-test kits and PrEP (if not already taking PrEP) in order to understand if the…
The purpose of this study is to see if amivantamab in combination with administration of standard of care chemotherapy (carboplatin and pemetrexed) is safe and useful for treating patients with Non-Small Cell Lung Cancer (NSCLC), specifically in patients with a gene abnormality called EGFR Exon 20 insertions. There are two study arms for this trial.…
The purpose of this study is to see if the study drug, JNJ-61186372, is safe and useful for treating patients with advanced, metastatic, non-small cell lung cancer (NSCLC). There are 2 parts of this study. The first part is to determine the dose of JNJ-61186372 that is safe to give to patients with non-small cell lung cancer. The second part of the study is…
****CHAMPS Study for People Living with HIV Residing in NYC Area**** Are you living with HIV? Are you 18 years or older? Do you own a smartphone? Are you interested in learning more about your health? We are conducting a study at Columbia University to learn more about how a phone app and sessions with a community health worker can help people living with…
This study is aimed at finding patients who have small amounts of cancer DNA in their blood (called circulating tumor DNA or ctDNA) after surgery. This may indicate that you have minimal residual disease (MRD), meaning that even after surgery, there are still some remaining cancer cells releasing cancer DNA into your bloodstream. MRD after surgery may mean…
The purpose of this research study is to find out if a drug called capmatinib is safe and effective (can help people) in people who have non-small cell lung cancer (NSCLC) who are also eligible for surgery. Capmatinib is an oral drug that targets particular processes, which may not be working properly in the cancer cells (dysregulation) in the body. Prior…
The purpose of this study is to see if lazertinib and JNJ-61186372 are safe and useful for treating patients with a type of lung cancer called advanced non-small cell lung cancer (NSCLC) as well as looking at the effects that lazertinib and JNJ-61186372 have when taken together. Lazertinib is taken orally and JNJ-61186372 is an intravenous drug. Lazertinib…
This study is looking at hepatitis B virus (HBV) vaccination in adults 18 to 70 years of age living with HIV around the world. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. A vaccine (a shot of medicine given through a needle) can prevent HBV, but there is no cure. A new vaccine approved by…
We are conducting a study to see if offering pre-exposure prophylaxis (PrEP) together with another health service that many transgender women use or would like to use, gender-affirming hormone therapy (GAHT), improves HIV-related outcomes, as compared to offering PrEP and referring study participants to get GAHT at area health providers. This study is for…
The mLab study at Columbia University is looking for cisgender men or trans women who are 18-29 years old and have sex with guys. Eligible individuals can earn up to $170 by participating in the online study and completing 3 surveys over the course of 1 year. Contact us if you are interested! Text/Call: 347-743-0104
The Red-C 3131 Study is a phase 3 study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE in adults who have been diagnosed with advanced liver cirrhosis. Adults who have been diagnosed with advanced liver cirrhosis, but who don't yet have HE may be eligible to join. About 466 patients will be enrolled across 200 sites.…
The purpose of this research study is to see how effective durvalumab andtremelimumab is in patients with early stage non-small cell lung cancer (NSCLC). A a special blood test will be done to see if subjects have circulating tumor DNA (ctDNA) in their blood. ctDNA are pieces of genetic material shed from the tumor cells that can be detected in the blood,…
The purpose of this study screening step is to perform genetic tests on your tumor sample for certain features that investigational targeted agents used in this study are specifically designed to work against. Then the purpose is to assign you to a treatment sub-study that is chosen based on the results (genes and proteins called biomarkers) of this genetic…
Patients who have been diagnosed with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis may be eligible to participate in this clinical trial. NASH is liver inflammation and damage caused by a buildup of fat in the liver. The main purpose of the study is to test the safety and efficacy of a drug called Emricasan (IDN-6556) in reducing the risk…
HVTN 108 is an HIV vaccine study for 18-50 year old and HIV-negative people. We would like the test vaccine to teach your immune system to defend against HIV in a manner that is safe and well-tolerated. We will ask that all participants prevent HIV as best as possible and reduce risk of getting HIV. We will ask you to come to the clinic 12 times over 12…
This study is for patients with non-alcoholic steatohepatitis (NASH) fibrosis in which there is too much fat in the liver causing inflammation and fibrosis. This condition is similar to the type of liver damage that occurs from too much alcohol use, but is not primarily caused by alcohol use. The main purpose of the study is to test whether a drug called…
The purpose of this study is to look at the effects of treating Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer with the standard treatment or standard treatment in addition to Erlotinib. Subjects will be randomized to one of the two study groups. Subjects will be on the study for up to two years.
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab on patients with advanced or metastatic non-small cell lung cancer . Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the bodys immune system to work against…
The Sponsor is conducting this study to find out how safe and effective the investigational drug (alsocalled a study drug) obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH. Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several…
The purpose of this study is to evaluate the efficacy of the drug OCR-002 for the treatment of an acute hepatic encephalopathy episode in cirrhotic patients requiring hospitalization. Subjects who have been recently hospitalized will potentially receive OCR-002 via infusion on top of their standard care for 5 days. Patients will be assessed 24-hours after…
This study is being done to test the safety and efficacy of immunotherapy based treatment combinations in patients with metastatic non-small cell lung cancer. Participants will be assigned to one of two groups, Cohort 1 or Cohort 2. Each cohort will be split into Stage 1 and Stage 2 phases.
Antibodies are one of the natural ways that our bodies fight or prevent infection. Were testing an antibody to find out if its safe, if it doesn't make people feel uncomfortable and to find out what may be the best dose if its given by IV infusion or sub-cutaneous injection. You cannot get HIV from the Bispecific Antibody. We'll ask you to…
The purpose of this study is to determine the doses of RO7121661 that can be administered safely to patients and what the side effects of RO7121661 are. In addition, how RO7121661 affects your body and, in particular, your tumor will be measured. The study also aims to investigate if RO7121661 can slow down or stop the growth of tumors in patients with…
The purpose of this master study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) alone or in combination with standard of care therapies.
The main purpose of this research study is to investigate the effectiveness of avatrombopag (the study drug under investigation) in increasing the amount of platelets (a type of cell found in the blood) in patients with chronic liver disease who need to have an elective procedure but have thrombocytopenia (low platelet counts) related to the chronic liver…
The purpose of this study is to test the safety of the study drugs and how well your body tolerates it. The study will also test how well the study drugs work to slow down the growth of you tumor or stop your cancer. The study drugs are Cergutuzumab Amunaleukin and Atezolizumab. Atezolizumab is FDA approved for the treatment of patients with metastatic non-…
This research trial is being conducted to determine the safety and efficacy of HARVONI (an FDA-approved Hepatitis C Virus medication) in HCV (genotype 1, 4, 5, an 6) infected patients who also have advanced heart failure or chronic lung disease. HARVONI has not been tested in patients with HCV and heart failure or chronic lunch disease. Subjects will take…
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL FDC) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) infection in subjects who have previously been unsuccessfully treated for chronic HCV.. An experimental drug is one that…
The purpose of this study is to compare the effects of using crizotinib (also known as Xalkori) after completion of surgery, and in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer patients versus placebo. Participants will be randomized to crizotinib or placebo. Participants will take crizotinib/placebo…
The purpose of this study is to see if study drug AZD9291 is effective in treating non-small cell lung cancer (NSCLC) and if so, how it compares with chemotherapy. Only patients with NSCLC that has been confirmed as having the EGFR mutation are eligible to participate. Before patients can participate in the main study a tumor sample will be taken to check…
This study is a multicenter study to assess the efficacy, safety, and tolerability of vk2809 administered for12 weeks followed by a 4-week off-drug Phase in subjects with primary hypercholesterolemia and nonalcoholic Fatty liver disease. This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in…
The purpose of this study is to see if study drug Sofosbuvir/Ledipasvir fixed-dose combination + Ribavirin (SOF/LDV FDC + RBV) are effective in treating people infected with the hepatitis C virus with genotypes 1 and 4, who have advanced liver disease with permanent liver damage (cirrhosis) and may be showing signs of liver failure or who have undergone…
The purpose of this study is to look at whether the combination of MEDI9447 and osimertinib or MEDI9447 and AZD4635 will improve the outcome in subjects with advanced epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC).
Did you know that people living with HIV are 50-100% more likely to develop heart disease (including heart attack and stroke) than people without HIV? And did you know that women with HIV are 3 times more likely to have a heart attack than women without HIV? Heart disease in HIV-infected people is a big deal. We are doing a study to test if a daily dose of…
The purpose of this study is to assess the overall safety and efficacy (how well the drug works) of study drug M7824 in the treatment of unresectable, non-small cell lung cancer. Another purpose is to determine whether use of the study drug in combination with chemoradiation (chemotherapy plus radiation therapy) followed by the study drug will result in…
This study is for patients who are being considered for surgical removal of a specific kind of lung cancer called "non-small lung cancer" (NSCLC), which is a description of the way it looks under a microscope. The purpose of this study is to determine whether adding an investigational treatment called atezolizumab (also called MPDL3280A) to…
NOTE: YOU MUST HAVE HIV AND HAVE EVER HAD HEPATITIS C TO BE ELIGIBLE FOR THIS STUDY!! ............... For individuals who have both HIV and Hepatitis C virus (HCV), heavy drinking poses serious risks to their health. We do not yet know which interventions are effective at helping individuals with HIV and HCV drink less. The goal of the study is to compare…
The purpose of this study is to learn more about the effects of the combination of telaprevir peginterferon alfa2b (Peg-IFN) and ribavirin (RBV) in children with chronic hepatitis C. Investigators will look at how these study drugs may affect childrens bodies and how children break down and eliminate telaprevir. Participants of this study will receive Peg-…
This is an open-label, Phase II study in patients with metastatic non-small cell lung cancer (NSCLC) whose cancer has gotten worse on an anti-programmed cell death-1/anti-programmed cell death ligand 1 (anti-PD-1/PD-L1) containing therapy. This study consists of a number of treatment cohorts to test the efficacy, safety, and tolerability of multiple…
This study is for patients with Nonalcoholic Steatohepatitis (NASH) and also suffer from obesity and Type 2 diabetes Mellitus type II or prediabetes. The purpose of this study is to determine the effect of Aramchol on liver inflammation, in addition to fat reduction in the liver. NASH (Nonalcoholic Steatohepatitis) is a common, often silent liver disease.…
The purpose of this study is to compare the effects, good or bad, of drugs alectinib and crizotnib on patients with lung disease to find out which is better for patients with a special type of non-small cell lung cancer (NSCLC) that is called anaplastic lymphoma kinase (ALK)-positive NSCLC. In this study, participants will receive either alectinib or…
This study will compare the effectiveness of three different FDA approved medicines for Hepatitis C Genotype 1 patients: HARVONI , Viekira Pak and Zepatier and will observe subject experiences before, during, and after HCV treatment. Subjects will be asked to respond to several survey questionnaires and if they would allow their leftover blood collected for…
The purpose of this study is to determine the safety and effects of a drug, sorafenib in adults diagnosed with hepatopulmonary syndrome (HPS). The study will evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood and the function of the lung vessels. Participants will be randomly assigned to receive either sorafenib or a…
This purpose of this study is to determine whether the tumor cells of lung cancer patients contain changes to the DNA sequence of two proteins found on the cells surface- ALK and EGFR. If the tumor contains changes to the DNA of one of these proteins, the patient may be invited to participate on a trial that will look at drugs which may target tumors that…
We are testing two antibodies directed against HIV virus. The human body uses antibodies as one way to help fight infection.The antibodies are called VRC01LS and VRC07-523LS and they are given by IV infusion. Each participant will receive one dose by infusion. The main purpose of this study is to see if these two antibodies are safe and how a participants…
This research study is testing two potential new drugs called AB928 and AB122. AB928 is an investigational drug that has been shown in animal studies to improve the functioning of the immune system, without causing any immune effects on its own. This research study will help us understand whether AB928, the study drug, can be safely given in combination…
This is a research study to test the effectiveness of pembrolizumab on cancer types having a known relationship to smoking carcinogen exposure. The study will enroll 120 subjects age 18 and above with advanced solid tumor related to smoking exposure. All patients will receive the treatment of pembrolizumab. The study aims to determine if tumor genetics can…
The purpose of this study is to evaluate whether cirrhosis occurs as a result of NASH. NASH is a disease that results when fat accumulates in the liver. GS-6624 is an experimental medication designed to help reverse the scarring process, and the purpose of this study is to see if GS-6624 can reverse the scarring in the liver and heal cirrhosis.
This trial will look at how the study drug will work in combination with traditional chemotherapy at treating extensive-stage small cell lung cancer in the first-line setting. The study will also determine if these drugs cause any side effects compared to traditional chemotherapy alone. The study drug is Durvalumab by itself or with Tremelimumab. Both…
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL) FDC for the treatment ofchronic genotype 3 hepatitis C virus (HCV) infection in patients who have cirrhosis, or scarring of the liver. The purpose of this study is to determine the efficacy,…
This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence…
The purpose of this study is to find out whether the drug, ruxolitinib, is effective, tolerable and safe in combination with two chemotherapy medicines called pemetrexed and cisplatin. The study will test if this combination has beneficial effects in people diagnosed with certain types of non-small cell lung cancer. Only participants with Stage IIIB,…
This is a 5-year, longitudinal, observational study of patients with NAFL or NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. The main purpose of this research study is to collect and study information on patients with NAFLD/NASH.The goal of this study is to observe any treatment…
The purpose of this study is to obtain information on the safety and effectiveness of NovoTTF-100M (study device) in subjects with brain metastases (tumors) as a result of non-small cell lung cancer (NSCLC).
The purpose of this study is to test whether local radiotherapy combined with Ipilimumab is safe. The study will try to find out if it can help patients with metastatic non-small cell lung cancer better than treatment with Ipilimumab and Nivolumab alone.
The purpose of this study is to evaluate the combination of MEDI4736 and tremelimumab in treating non-small cell lung cancer. This study will look to see whether MEDI4736 combined with tremelimumab or MEDI4736 alone are more effective than standard of care chemotherapy in treating lung cancer and to collect information on the safety of these drugs. Both…
If you have primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, you may qualify for a clinical research study. In this study, doctors are trying to learn more about the effectiveness and safety of an investigational drug called seladelpar for patients with PBC. The ENHANCE clinical research study is enrolling patients who…
The purpose of this study is to determine how safe and effective using three medications (pegylated-interferon, ribavirin and boceprevir) are in curing HCV in patients with end stage kidney disease on hemodialysis. Participants will be prescribed these three medications and will be followed closely through treatment, then for 6 months afterwards. During…
The purpose of this study is to find if adding the study drug, nivolumab (also known as OPVIDO), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Nivolumab is a drug that may turn on the body's immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help…
The purpose of this study is to determine the amount (dose) of telaglenastat that is safe and tolerable when given together with the recommended treatment regimen of pembrolizumab, carboplatin, and pemetrexed and to determine if the combination of standard drugs with telaglenastat is more active against non-small cell lung cancer (NSCLC) than the standard…
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of study drugs Sofosbuvir, Velpatasvir and GS-9857 in comparison to Sofosbuvir and Velpatasvir in patients infected with HCV. Information about any side effects that may occur will also be collected.
Research has shown that early involvement of a team of clinicians that specialize in lessening (or palliating) many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients and their loved ones experience with their cancer. This team is called palliative care, and consists of…
This is a randomized, double-blinded, placebo-controlled phase 2 study. The purpose of this study is to evaluate the safety and efficacy of Saroglitazar magnesium 2 mg and 4mg versus placebo in the treatment of subjects with Primary Biliary Cholangitis. The research study consists of a Screening Phase (Visits 1 and 2) that lasts up to 42 days, a Treatment…
This study is for adults who have non-small cell lung cancer and have had surgery to remove their lung tumor. People who have lung cancer and undergo surgery still have a significant risk of their cancer returning outside of the lung. The purpose of this study is to determine if a new type of immune-based therapy can increase your chance of being cured.…
The Wellness Study is a 6-month study looking at how a phone app, a fitness tracker, and a pill dispenser can help people living with HIV monitor and improve their health by tracking their fitness and helping them remember to take their medication. You may receive up to $200.00 for your participation.
The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole brain radiation to the usual whole-brain radiation. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It also is…
The FLAURA Study is a new clinical research study underway in NSCLC and we are looking for people who would like to join. This study will examine an investigational drug, called AZD9291, and compare it tostandard, approved drugs that are already used to treat lung cancer. These drugs are called gefitinib and erlotinib. When we talk about investigational, it…
The primary objective of the study is to evaluate safety and effectiveness of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (ALID). Subjects will be randomly assigned to receive either standard of care treatment for ALID plus treatment with the ELAD system or standard of care treatment…
The purpose of this study is to compare the effects of atezolizumab, an immunotherapy drug, with chemotherapy or placebo with chemotherapy in patients with resectable NSCLC to find out which is better. In this study, you will receive treatment before undergoing surgery to remove the tumor.
The purpose is to study the safety and the effect of AB122, AB154, and AB928 in participants with stage IV non-small cell lung cancer. Researchers will study the treatment response of AB122 alone as well as in combination with AB154 and AB928. There are three possible groups a participant can be randomly assigned to. Group 1 will include AB122 alone, Group…
The purpose of this study is to evaluate the efficacy, safety, and tolerability of SOF/VEL/GS- 9857 FDC in patients infected with Hepatitis C (HCV), and previously treated unsuccessfully. Information about any side effects that may occur will also be collected.
This study is being done to determine if REGN2810 (anti-PD-1) in combination with ipilimumab (anti-CTLA-4) plus initial platinum-based doublet chemotherapy, or REGN2810 in combination with ipilimumab will prolong how long you live without your disease progressing compared to the standard of care pembrolizumab (anti-PD-1) monotherapy treatment. Neither…
The purpose of this study is to test a drug called GSK2330672 that is not yet approved for doctors to prescribe for patients who have a condition called primary biliary cholangitis (PBC) which has caused moderate to severe pruritus, or itching, in parts or all of the body. The objective is to find out if the drug can help to decrease the itchiness that…
This study will investigate the safety and effectiveness of the study drug SGI-110 in combination with two immunotherapy drugs named durvalumab and tremelimumab in patients with small cell lung cancer who have progressed on other treatments. SGI-110 is a form of chemotherapy known as a "hypomethylating agent" and may help the immunotherapy work…
For People Living With HIV (PLWH) with HIV-Associated Non-AIDS (HANA) conditions such as cardiovascular disease or diabetes, the situation is complex given the added burden of coping with a secondary chronic illness and potential effects on treatment. How sex/gender differences in HIV symptom interpretation and management influence treatment success has not…
This research study is being done to test the combination of two new drugs, GSK3359609 and Tremelimumab, in certain cancers. These two drugs are experimental which means they have not been fully tested yet and are not yet approved to treat any disease. There are two parts to this study. Part 1 determines the best dose for the study drugs and part 2 compares…
The purpose of this study is to evaluate the combination of study drug MEDI4736 and tremelimumab in treating advanced non-small cell lung cancer that is resistant to or returned after receiving standard therapies, for which there is no available standard therapies, or for individuals who have declined standard therapies. MEDI4736 and tremelimumab are fully…
NASH is a liver disease associated with inflammation and liver cell injury visible under a microscope with a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Once cirrhosis has developed, the serious complications of liver disease may occur, including liver failure. NASH might also lead to…
The purpose of this study is to compare the time to onset of an episode of overt HE, in subjects with previously demonstrated overt HE after treatment with rifaximin 550 mg BID and lactulose, or rifaximin 550 mg BID. Subjects will be screened to confirm eligibility into the study. Once confirmed, subjects will begin the treatment phase and will be randomly…
The purpose of this study is to determine if the study drug is safe and evaluate whether adjuvant therapy with the study drug will improve overall survival. The study drug is crizotinib (also known as XALKORI). The study will also collect tumor tissue and blood samples for future research.
NOTE: YOU MUST HAVE HIV AND HAVE EVER HAD HEPATITIS C TO BE ELIGIBLE FOR THIS STUDY!! ............... For individuals who have both HIV and Hepatitis C virus (HCV), heavy drinking poses serious risks to their health. We do not yet know which interventions are effective at helping individuals with HIV and HCV drink less. The goal of the study is to compare…
The purpose of this study is to find out how doctors describe hepatic encephalopathy episodes in patients medical records in the course of their regular practice. The aim of the study is simply to collect information from their medical records about how their episodes of overt hepatic encephalopathy are described. There is nothing that will be required of…