Search Results

We want to find out whether lifileucel is safe and works in treating untreated, unresectable or metastatic melanoma. Lifileucel is a type of medicine, known as immunotherapy, that uses your body’s immune system to fight cancer. Lifileucel is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells known as lymphocytes or “T cells” obtained from a piece of your tumor. T cells are a part of your immune system that help your body fight against infections and diseases including fight cancer.

This research study is testing a potential new treatment for pulmonary hypertension (high lung blood pressure due to heart failure) called TX000045 (study drug). Participants will be assigned to a study group and receive active study drug or a placebo (drug with no active ingredients). The study will last approximately 9 months

The Cordella™ Pulmonary Artery Sensor System is a possible treatment for New York Heart Association (NYHA) Class II and III heart failure. The main purpose of this study is to investigate the safety and effectiveness of the study device in helping to reduce Heart Failure hospitalizations.

The purpose of this study is to learn if removing the donor T cells from the donor product using this new method will be a better way to reduce the risk of GVHD. The benefit of removing these cells with this new method is that they will prevent GVHD without requiring drugs to suppress the immune system. Potentially, the immune system will recover from the transplant faster, which in turn will also lessen the risk of severe infections. As well, the patient will not have the other common undesired side effects of these immunosuppressive drugs.

This research study is about early development in children diagnosed with congenital cytomegalovirus infection (cCMV), identified by newborn screening that has been confirmed with a follow-up test. Study visits, when the child is 12, 24 and 36 months of age, will include questionnaires, direct assessment of child and interviews with parent(s). A brain MRI will also be completed at about 12 months. Parents will receive a report summarizing a child’s developmental, language, and behavioral assessments, reported as within normal ranges or if clinical follow-up is recommended.

The purpose of this research is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression. Participants will have a 50% chance of being assigned to either the ivonescimab treatment group or the pembrolizumab treatment group.

We are doing this study because we want to find out if observation is as good as the usual care for breast cancer. The usual approach for patients with early-stage triple-negative breast cancer (TNBC) who receive preoperative chemotherapy plus pembrolizumab is to continue to receive FDA-approved pembrolizumab for up to 27 weeks after surgery. Participants will either get pembrolizumab for up to 27 weeks, or will not receive any treatment and will be observed for up to 27 weeks. We will continue to follow participants every 6 months for 5 years and watch for side effects or cancer coming back. After that, participants will be checked every year for a total of 10 years after the study.

A clinical research study for primary focal segmental glomerulosclerosis (FSGS), or genetic focal segmental glomerulosclerosis (FSGS), or focal segmental glomerulosclerosis (FSGS) of undetermined cause in pediatric (12-17 years) and adult patients. Eligible participants will be assigned to receive either DMX-200 (repagermanium) or placebo (50/50 chance) over a treatment period, with total participation up to 28 month, with potential for participation in an Open Label Extension study period. The main purpose of this study is to see if DMX-200 reduces proteinuria and slows the loss of kidney function in those with FSGS.

The rate of lung cancer screening is not optimal among Chinese American high-risk smokers, although there is a high lung cancer rate among this population. We want to validate the adapted Chinese Lung Cancer Screening Health Belief Scale, enable its usage in Chinese Americans, and further explore the relationship between lung cancer screening health beliefs and health behavior among Chinese Americans. We will also aim to identify the differences in health beliefs regarding lung cancer screening between high-risk populations in China and Chinese Americans, and to examine factors influencing these differences.

We are doing this study to compare the effectiveness of Single Fraction Stereotactic Radiosurgery (SRS) to radiation treatment called fractionated SRS (or FSRS). SRS delivers a high dose of radiation in a single treatment to the small areas of cancer in the brain. FSRS that delivers a high dose of radiation given over 3 treatments. Both SRS and FSRS only deliver radiation to the small areas of cancer in the brain and minimizes dose to the surrounding normal brain tissue.

Ritlecitinib (LITFULO™, PF-06651600) 50 mg daily is currently approved for people 12 years of age and older to treat severe alopecia areata (hair loss). Ritlecitinib 100 mg will be compared to Ritlecitinib 50 mg to find out if a larger daily dose is safe and can improve regrowth of hair. The study will last about 57 weeks and will have up to 9 visits. Everyone will get one of the two doses of the study drug.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various organs of the body, especially the skin, joints, blood, kidneys and central nervous system. "Chronic" means that it can last for a long time. "Autoimmune" means that there is a disorder of the immune system, which, instead of protecting the body from bacteria and viruses, attacks the one’s own tissues. We are doing this study to see if the investigational medication called anifrolumab may have an effect in treating pediatric SLE, to see how well it is tolerated or how safe it is, to measure levels of anifrolumab in the blood and learn more about the disease and associated health problems.

The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.

This study will assess how effective and safe the use of the medication named Upadacitinib is for the treatment of signs and symptoms of severe hair loss in adults.

The study is to evaluate the safety and effectiveness of the investigational BrioVAD® System compared to the commercially available HeartMate 3™ LVAS. Both the BrioVAD System and the HeartMate 3 LVAS are left ventricular assist devices (LVAD) that help pump blood from the lower left chamber of the heart to the rest of the body. An LVAD is used to treat weakened hearts or heart failure and may be a temporary measure while waiting for a heart transplant or a permanent solution.

To evaluate the addition of two cycles of blinatumomab for all infants with newly diagnosed ALL and will evaluate in a randomized manner the safety, tolerability, and early activity of venetoclax in infants with KMT2A-R ALL.

This study aims to learn more about how continuous glucose monitor (CGM) data can be used to personalize lifestyle interventions for type 2 diabetes. Participation in the study would require 4-5 clinic visits over a period of 14 weeks. Participants will also be asked to: meet with study staff every 2 weeks (virtually), keep food logs, periodically wear an activity monitor and/or a CGM, answer survey questions, and provide blood samples to measure markers of diabetes control (like hemoglobin A1c).

The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what are the best methods for diagnosing lung problems and follow-up care. The lung problems that may develop after transplant varies from patient to patient, and we don’t exactly know what risk factors influence who develops them or how patients respond to pulmonary (breathing system) therapies. Also, we wish to improve how we monitor lung function and quality of life after transplant, especially in children and young adults.

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers, such as Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill specific cancer cells commonly present in Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia.

This study is being conducted to compare the efficacy of subcutaneous amivantamab plus lazertinib in previously untreated EGFR mutated non-small cell lung cancer OR subcutaneous amivantamab plus chemotherapy after having received prior therapy for EGFR mutated non-small cell lung cancer.

Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.

The research objective is to evaluate performance of ultrasound stimulation of the spleen for the treatment of rheumatoid arthritis (RA). In particular, a new wearable ultrasound device has been developed for anti-inflammatory treatment by a company called SecondWave Systems. We will measure RA disease activity, biomarkers and clinical metrics for up to 24 weeks of investigational ultrasound treatment.

The purpose of this study is to help investigators learn more about what are the best methods for diagnosing and monitoring lung problems.

This study will enroll people who receive TRX103 as part of a separate research study, in order to monitor these patients for long-term safety, and discover more about the long-term effects of TRX103.

In this study, participants will complete two to three appointments within two weeks. During these appointments, they will complete interviews and questionnaires about their life experiences and mental health. An EEG test will also be conducted while they complete computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis spectrum disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.

The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.

This study is about assessing compliance, satisfaction, and usability of a take-home device for tinnitus management, specifically a bimodal neuromodulation device using customized acoustic stimulation paired with electrical ear stimulation. This study also examines whether integrative health (IH) practices – such as deep breathing – paired with bimodal neuromodulation can enhance long-term plasticity of the brain and reduce stress.

Blood vessel inflammation can damage parts of the body. The medicines we use to treat AAV try to turn off the blood vessel inflammation to prevent damage to the body. The purpose of this study is to see how safe and how well a medicine called avacopan works when combined with a child’s regular medicine used to treat their AAV. This medicine is not approved in children, so will be called a “study drug.”

Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.

This study is testing an “investigational” drug referred to as peptide alarm therapy (PAT) that was specially made for this study. PAT is using the peptide to stimulate the immune system for people who have failed prior treatment with a PD-1/PD-L1 inhibitor. Examples of PD-1/PD-L1 inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), cemiplimab (Libtayo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi). The goal of the 1st part of the study is to identify an acceptable, safe dose of PAT and up to 3 dose levels of PAT will be tested. If dose level 3 is reached without toxicity, it becomes the dose used for the next part of the study. In the 2nd part of the study, additional patients are treated at the PAT dose identified as safe in the 1st part to gain additional safety information and provide an initial estimate of anti-cancer effect.