This study is for patients who have been diagnosed with relapsed or refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL). The overall goal of this study is to find out what effect, good and/or bad, the drug inotuzumab ozogamicin has on children and young adults with relapsed or refractory B-ALL. Participants can expect to be on this study for up 2 months and followed for up to 5 years.
This study is enrolling participants with severe aortic stenosis, which is narrowing of one of the heart valves. This condition reduces the amount of blood that can get to the body. This study is collecting data on the safety and effectiveness of an investigational (not yet approved for commercial use by the US FDA (Food and Drug Administration)) device called the ACURATE Aortic Valve System. The procedure to place the device, referred to as TAVR - transcatheter replacement of aortic valve is done in place of open heart surgery. In this study the ACURATE Aortic Valve System will be compared to two commercially available Aortic Valve Systems (valve replacement systems). Participants will be randomized (assigned by choice, like a flip of a coin, in a 1:1 fashion so 50% chance of being assigned to either group like the flip of a coin) to one of two groups. One group will receive the ACURATE Aortic Valve System while the other group will receive one of the commercially available systems. This study will last up to 10 years. Pre-procedure testing is done and reviewed by an eligibility committee to confirm you qualify. Study visits will occur prior to your procedure, during the procedure and throughout your hospital stay, and prior to discharge. Additional visits will occur 1 month and 6 months after your discharge, and then you will either seen or telephoned once per year for the next ten years. Study related testing includes CT scans, physical exams, echocardiograms (ultrasound test of the heart), blood work, and questionnaires.
This study is for patients with advanced kidney cancer and the purpose is to see if by adding a drug called cabozantinib to another treatment after receiving the standard treatment can prolong their life.
A main focus of the study is to identify characteristics that can be changed such as smoking, vaping and diet, environmental exposures (e.g. pollution such as car exhaust, allergies such as pet dander) that affect lung function and risk of future lung disease. We also are looking for biomarkers (e.g. measurements of specific substances in nose, blood, and urine samples) and genetic markers that can provide us with information about lung health. The findings in this study are considered research and are not the same as "genetic testing."
This study is for participants that have been diagnosed with previously untreated CD30 Negative Peripheral T-cell Lymphomas. The purpose of this study is to determine if the effects (good or bad) of adding a study drug (duvelisib or CC-486 (azacitidine)) to the usual combination of drugs. Participants can expect to be on treatment for 18 months and followed by the study team for up to 5 years after study completion.
This study is designed to evaluate a new therapy formulation for Alpha-1 Antitrypsin Deficiency (AATD). AATD is an inherited condition in which a person has low blood levels of a protein known as alpha-1 protease inhibitor (called Alpha1-PI). AATD causes an increased risk of chronic obstructive pulmonary disease (COPD) in the form of emphysema (long term lung disease) and, less frequently, other diseases.
This study is being conducted to evaluate the safety and tolerability of 2 different doses of Alpha-1 drugs (Alpha-1 15% and Liquid Alpha1-PI) in participants with AATD. Participants will be placed into one of two groups. Each group will receive both drugs at different points in the treatment period and because this is an "open label", study participants and the study staff know which dose of study drug participants receive. The study will last up to 486 days (16 months). Many visits are able to be conducted through home health care, lessening the need to come into the clinic.
Alpha-1 15% is an investigational product, meaning it is not approved by the U.S. Food and Drug Administration (FDA). The other drug in this study is Liquid Alpha1-PI (licensed as Prolastin®-C Liquid) and is an FDA approved treatment for adults with emphysema due to AATD. However, it is only approved for the recommended dose of 60 mg/kg. This study includes both the FDA approved 60mg/kg of Liquid Alpha1-PI and an experimental dose of 120 mg/kg that is not FDA approved. Alpha-1 15% is given as an injection under the skin and Liquid Alpha1-PI is given as an infusion into the veins.
You may or may not directly benefit from participation. However, you may help advance scientific knowledge in the treatment of AATD. Currently, the only FDA approved treatment for AATD is IV infusions of Liquid Alpha1-PI. Since the drug being studied, Alpha-1 15%, is injected with a small needle under your skin, there may be a benefit to future patients by providing flexibility of treatment route options as well as stability in serum alpha1-antitrypsin levels.
The goal of this study is to determine the differences in severity and disparities of lupus in Black lupus patients, focusing on the highest risk group, Black females. We are interested in enrolling Black females with lupus as well as smaller numbers of White females with lupus, White females as Healthy Controls and Black males with lupus.
Study participation involves the collection of 4 tablespoons of blood. Patients with lupus will have their study participation during a standard of care (SOC) visit with their rheumatologist as part having routine blood drawn for their lupus care. After the initial study visit, patients with lupus may have an additional 2-3 visits. Controls will have a single study visit at the MUSC Nexus clinical research center.
This is not a clinical trial and does not involve study medications. Compensation is available for participation.
This study is to find the causes of treatment failure in some HIV patients. Thus, HIV-infected patients under antiretroviral treatment and uninfected healthy controls will be recruited in this study to donate blood, urine, saliva, and nasal swab. Compensation will be paid for you to participate in this study.
This study is for patients with newly diagnosed diffuse Large B Cell Lymphoma.
This study will help the study doctors find out if taking R-mini-CHOP plus the study drug CC-486 (oral azacitidine) is better, the same, or worse than taking the R-mini-CHOP drug combination alone. To decide if it is better, the study doctors will be comparing the drug combinations to see which drug combination allows more patients to have no disease symptoms at 1 year or more after the start of the study treatment and which drug combination extends the overall survival (how long people live) of patients at 5 years after the start of the study treatment.
The purpose of this research is to evaluate whether the Relivion®DP device is safe and helpful in alleviating Major Depressive Disorder (MDD) symptoms. The research study includes up to 6 visits, each visit could be performed either at the clinic or remotely using digital means such as a video call or the use of another dedicated platform.In this research study the participant will randomly receive either an active device or a non-active (sham) device and the participant will be asked to preform daily treatments with the device for 8 weeks after which the participant will have the option to continue to an additional 8 week open-label extension with the active device.
We expect that the time commitment for taking part in this research will last up to 20 weeks (including the screening period).