Ritlecitinib has been approved for treating severe alopecia areata (AA) in adults and adolescents aged 12 and older in the US, EU, and other countries, based on a positive benefit/risk assessment. However, there are no approved treatments for AA in children aged 6 to under 12. Study B7981027 is being conducted to evaluate the efficacy and safety of ritlecitinib in this younger group. This study is part of the EU Pediatric Investigation Plan (PIP) and fulfills a post-marketing requirement in the US.

The purpose of this rollover study is to investigate the long-term safety of etavopivat in participants11 months of age and older with SCD or thalassaemia who have completed a treatment period in previous etavopivat studies (parent studies, see Section 4.1). Long-term clinical efficacy measures of etavopivat treatment will also be assessed. This study will also ensure that participants who are benefiting from etavopivat treatment have prolonged access to the drug in the time before it is commercially available in their country.

The purpose of this research study is to assess if the study drug SION-719 is safe and well-tolerated in people with cystic fibrosis who are already taking Trikafta, understand the effect of SION-719 on the body by measuring chloride levels, and to learn how the body absorbs, distributes, and gets rid of the study drug in people with cystic fibrosis. This study is a placebo controlled cross-over study with two study treatment periods, and participants will take part in both study treatment periods. Participants will be assigned either study drug or placebo. Participants will remain on standard dose of physician-prescribed Trikafta throughout the study. This study will be approximately 16 weeks, or 112 days long.

This study is enrolling two different groups of individuals. The first group are those individuals referred for right heart catheterization (RHC), which is a procedure performed to check heart pressure taken inside the heart. The second group of individuals are those who have tricuspid regurgitation (TR) (blood that leaks due to improper valve closure) and are undergoing tricuspid valve intervention to correct the regurgitation. The RHC group will be referred to as the control group and the tricuspid intervention group will be the treatment group in this study. This study involves collecting existing medical records on both groups, as well as an arterial (from an artery) blood sample and venous (from a vein) blood sample from the vein that carries blood away from the liver. The control group will not involve any additional procedures or follow up. The TR population will perform a 6 minute hall walk test before their tricuspid valve intervention and again during the six month post procedure follow up. The TR group will also have repeat arterial and venous blood collection at the six month follow up. The TR group will have data collected for up to two years post tricuspid valve intervention.

The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.

Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.

You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.

There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.

This study is for adult men with previously untreated prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging treatment techniques (hypofractionated radiotherapy with microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.

This study is testing a new treatment for people with a dangerous heart rhythm problem called ventricular tachycardia (VT). VT can cause the heart to beat too fast, leading to fainting, heart failure, or even sudden death. Some people continue to have VT even after taking medicines and undergoing standard ablation procedures. For these patients, current treatment options are very limited.

The investigational treatment uses the Thermedical Ablation System with the Durablate™ catheter. This device delivers both heat and saline (salt water) deep into the heart muscle to target the areas causing abnormal rhythms. The goal is to safely and effectively reduce or eliminate VT episodes in patients who have not responded to other therapies.

About 130 patients will be enrolled at up to 25 hospitals in the U.S. and Canada. Participants will have the procedure and then be followed for six months with regular checkups to see if the treatment reduces their VT episodes and improves their quality of life. This study will help determine if the new system should be approved for wider clinical use.

This study is recruiting non-metastatic breast cancer survivors who were diagnosed between ages 18 and 51 and are currently 6 months to 5 years post-treatment. Eligible participants must have a score of 5–14 on the PHQ-8 depression screening tool. This study is testing a digital mindfulness meditation-based program. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Participants will be randomly assigned (like drawing one number out of three at random) to one of three groups: (1) live online mindfulness classes over Zoom, (2) a specially designed mindfulness app, or (3) guided audio meditations. The primary purpose of this study is to determine if different ways of delivering digital mindfulness training can improve mental health and well-being in younger breast cancer survivors. The program is delivered either by live online sessions, through a mobile app, or by listening to guided meditation recordings. Participants can expect to be in this study for about 9 months, including a 6-week training program and questionnaires before, during, and after training. Participants will be enrolled for a duration of 9 months, and a total of 15 patients will be recruited locally over the course of 36 months.

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

SV-ONE represents the integration of NPC-QIC within the existing FON framework. As such, SV-ONE will engage in research and improvement efforts through the entire lifespan of patients with SVHD, including but not limited to those with a Fontan circulation. The larger objective of this study is to increase longevity and enhance the QoL by improving physical health and functioning, mental health and resilience, and neurodevelopment for individuals with SVHD and their families. A longer-term goal of SV-ONE will be to serve as a platform for research and improvement that will
accelerate advances, with the potential to nest clinical trials and to link to registries and programs,
nationally and internationally.