Search Results

The purpose of RESTORATiVE303 is to see if the study drug, which is called VE303, is safe and effective in preventing another episode of Clostridioides Difficile Infection (CDI). VE303 is an investigational drug that has 8 strains of live bacteria, called “commensals.” Commensals are the type of bacteria that live in harmony with the body, without harming health. These specific bacteria are often found in the intestines of normal, healthy people. They were selected for inclusion in VE303 because they rarely infect humans (mostly in very weakened patients), they do not carry any toxins that can make one sick, and they are not known to carry any risk of creating or spreading resistance to antibiotics.

The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.

The BEET PAD Trial is a multi-centered double-blind randomized clinical trial of beetroot juice vs. placebo in 210 people with PAD. We hypothesize that by simultaneously increasing lower extremity perfusion, gastrocnemius muscle mitochondrial activity, and myofiber health and regeneration, beetroot juice will significantly improve walking performance in people with PAD. Our primary aim is to determine whether beetroot juice significantly improves six-minute walk distance at 4-month follow-up in people with PAD, compared to placebo. Preliminary evidence suggests that beetroot juice has both acute and chronic effects on walking performance in PAD. Our primary outcome will measure the combined acute and chronic effect of beetroot juice (i.e. the maximal effect) on change in 6-minute walk at 4-month follow-up. In secondary aims, we will distinguish between acute and chronic effects of beetroot juice on six-minute walk and delineate biologic pathways by which beetroot juice improves walking performance in PAD, by measuring change in gastrocnemius muscle perfusion (MRI arterial spin labeling), and gastrocnemius muscle health. We will assess the durability of beetroot juice effects on six-minute walk. Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5 hours after ingestion (1). Inter-individual variability exists in the extent of metabolic conversion of nitrate to nitrite (1,2). Therefore, we will determine whether a higher peak or a greater increase in plasma nitrite at 2.5 hours after beetroot juice consumption at baseline has a greater effect on six-minute walk at 4-month follow-up, compared to a lower peak or a smaller increase, respectively. To achieve our specific aims, we will randomize 210 participants age 50 and older with PAD to one of two groups: beetroot juice vs placebo. Participants will be followed for 4.5 months.

Hidradenitis Suppurativa (HS) is a chronic condition that causes bumps or boils, often in the folds of armpits, chest, breasts, groin, stomach, back or sides, or buttocks. This Study is being done to compare the safety and effectiveness of a Study Drug called ruxolitinib cream with a vehicle cream for people with hidradenitis suppurative. A vehicle cream looks like the Study Cream but does not have active drug in it. Participants will be in the Study for approximately 60 weeks. This includes a 28-day screening period, 16 weeks of receiving either the Study Cream or vehicle cream, 36 weeks of receiving the Study Cream, and a 30-day follow-up.

Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.

The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).

This study aims to quantify the rates of cervical cancer screening and endometrial sampling prior to gender-affirming hysterectomy, assess the need for these tests in TGD individuals, and explore patient-centered options for these tests.

This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).

To assess and characterize the risk of malignancies, and long-term safety following treatment with atidarsagene autotemcel (Lenmeldy).

To evaluate the long-term safety of BEAM-101 up to 15 years after treatment.

This clinical study is for adults whose cancer has spread to the bones of the middle or lower back (spine). Doctors are comparing two common treatments: (1) a needle procedure to treat the tumor and strengthen the bone, followed by radiation, and (2) radiation therapy alone. The goal is to see which option better relieves pain, protects the spine, and improves quality of life. The treatment you receive will be chosen at random (by chance), meaning you will be placed into a study group by chance.

We are studying the safety and feasibility of microbiota transplant therapy (MTT) for patients with Primary Sclerosing Cholangitis (PSC). The purpose of this study is to evaluate whether MTT from a healthy donor is safe and can be used to restore the healthy composition of microbiota to help decrease disease severity and improve symptoms. All patients in this study will receive capsules of the drug, MTT.

This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.

The purpose of this study is to find out if a study drug called BI 765423 can improve lung function in people with idiopathic pulmonary fibrosis (IPF). This study compares BI 765423 with a placebo to see if there is a difference in lung function or blood test results related to lung health after 3 month. The placebo looks like BI 765423 but does not contain any active drug.

The purpose of this study is to learn the effects, good or bad, of the study drug, vosoritide, for treating children who have hypochondroplasia. This condition affects the growth of bone and cartilage and in which kids who have it are shorter than other kids of the same age. In this study, your child will get either the study drug or placebo, which is an inactive medicine.

This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory).

This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.

This study is being done to test if GSK5733584, the study drug, can improve cancer, is safe, well-tolerated, works and helps to treat cancer, how the body reacts to and how the body uses the study drug at different doses.

This study aims to find out whether MyoPAXon, a genetically modified cellular therapy treatment, is safe to give to patients with Duchenne Muscular Dystrophy (DMD), and whether it has any positive effect on their disease. It will also determine how much MyoPAXon is safe to give to a person at one time.

This study is for people who feel very hungry all the time, have trouble controlling eating (hyperphagia) and have Prader-Willi Syndrome (PWS). ARD-101 is being studied to see if it can help the body release certain gut hormones that may help reduce excessive hunger and food-seeking behaviors in people with PWS. The investigational treatment is a tablet taken by mouth and swallowed whole. The study will continue for up to 20 weeks (about 5 months).

This study is about quality of life and physical sensation in the nipple-areola area of people who have undergone deep inferior epigastric perforator (DIEP) flap breast reconstruction with or without nerve grafting. At the post-operative clinic visits at 3, 6, 12, and 18-months post-op, participants will have sensory assessments and be asked to complete a series of questionnaires.

The purpose of this research is to determine the impact of providing personalized legal and financial services on the financial and emotional health of people with advanced stage colorectal cancer and their caregiver. We have partnered with a local nonprofit company called Cancer Legal Care (CLC) to provide the legal and financial services as part of this research. Participation in this study lasts for up to 3 months.

We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.

The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices. We are looking at cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

This study is for people who have been diagnosed with advanced cancer that has not has not responded to standard treatment. FT836 is a type of cell product made up of “T cells” which are part of the immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells. We want to test the safety of FT836 at different doses, to understand how the body processes and responds to FT836, and to find out what effects FT836 may have on participants and the cancer. The study will also find out what effects FT836, when given alone and with or without chemotherapy treatment (paclitaxel) and/or a monoclonal antibody (cetuximab or trastuzumab.

This research study is being done so that we can better understand why women with post-traumatic stress disorder (PTSD) may have higher risk of cardiovascular disease as they get older. This study looks at how trauma and PTSD affect blood vessels in young women. The study is also testing whether a dietary supplement called beetroot juice might help improve the function of blood vessels in women suffering from PTSD. Study participation involves coming to the University of Minnesota campus in Minneapolis for two visits. Each of the visits with take about 3 and a half hours.

This study will help to identify challenges and barriers to self-performing anal cancer screening tests, and may identify unique ways to make this form of screening easier, more cost-effective, and more frequently performed. We believe that it has the potential to minimize the frequency of both disease and death from anal cancer among high-risk patient groups.