The purpose of this study is to explore whether stimulating different outer parts of the ear using a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) will create different brain activation images. We will recruit 24 healthy participants. The ear stimulation will be delivered while taking brain images using a magnetic resonance imaging (MRI) machine.
This phase II/III study purpose is to see if neck and shoulder function and pain are better after sentinel lymph node (SLN) biopsy surgery compared to the usual approach and to see if SLN biopsy surgery is as good as the usual approach in extending your time without cancer. If decided to participate in this study participants will go through a pre-treatment period to determine if they are eligible for the study including a PET/CT scan to determine if their cancer has spread. They will also receive a quality of life questionnaire to determine their physical well-being. Participants will complete these questionnaires 5 times: before surgery; at 3 weeks after surgery; and at 3, 6 and 12 months after surgery. If their cancer has not spread participants will be randomized to receive SLN or the SOC Elective Neck Dissection (END) to remove their cancer/lymph nodes during the treatment period. Following treatment, participants will enter the follow-up period and the study doctor will continue to follow participates condition and watch for side effects of the surgery. Participants will visit in the clinic at 3 weeks after surgery, then every 3 months for the first year, then every 4 months for the second year, then every 6 months for the third year, then yearly for their lifetime. The study duration for the phase II portion is about 37 months (~3.1 years) and around 132 months (11 years) for the phase III portion. The main risk associated with this study are leakage of lymph fluid called "chyle" into the neck, nerve injury and shoulder movement problems, swallowing difficulty, lung infection, and bleeding. There is evidence that the SLN biopsy technique causes less shoulder and neck movement problems and pain, and is effective in removing your cancer. It is not possible to know now if the SLN biopsy approach will be as good at extending your time without disease compared to the usual END approach. This study will help the study doctors learn things that will help people in the future.
This study is intended to determine the efficacy and safety of the study drug AMX0035 in people living with Progressive Supranuclear Palsy (PSP). Participants will between the ages of 40 and 80 and will be randomized to receive AMX0035 or placebo. Study participation will last 52 weeks with 7 visits to the clinic. After study participation ends, there is the option for the participant to continue into the open-label extension period where they would receive AMX0035 for another 56 weeks.
Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared to active control (ustekinumab) in children and adolescents (from 6 to <18 years of age) with moderate to severe plaque PSO. This study will consist of the following periods:
• Screening Period: up to 5 weeks
• Initial Treatment Period: 16 weeks
• Maintenance Period: 32 weeks
• OLE Period: 104 weeks
• SFU Period: 20 weeks after final dose of IMP
After the Screening Period of up to 5 weeks, eligible study participants will be randomized in a 2:1 ratio of bimekizumab to ustekinumab. Study participants will participate in a 16-week double-blinded Initial Treatment Period and continue into a 32-week double-blinded Maintenance Period. After completion of the Maintenance Period, study participants will be offered the opportunity to continue in a 104-week open label extension period and receive bimekizumab.
The purpose of this study is to evaluate the effect of pegozafermin compared to placebo to see how well pegozafermin might improve liver fibrosis after 52 weeks.
The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Nonadvanced Systemic Mastocytosis. The investigational drug is known as bezuclastinib and will be taken daily orally. Participation in the study is expected to be approximately 3 years.
This study is for subjects that have been diagnosed with lung cancer and the disease has progressed on prior therapy. The purpose of the study is to determine the safety and efficacy of Fingolimod and whether it can aid in treatment against lung cancer tumors. Fingolimod is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 8 months, with routine visits occurring at MUSC.
To undertake the first prospective randomized controlled trial that compares early aortic surgery to aneurysm surveillance.
The purpose of the study is to compare different treatment plans for patients with abnormal aortas. Patients who have an abnormal aorta measuring at least 5.5cm will have surgery to replace the aorta. We do not know, however, whether patients with abnormal aortas that are not quite 5.5cm should have surgery or should be monitored to see if their aorta continues to grow. Therefore, through this registry and interventional study, the hope is to collect more data on which treatment is better for the patient. The interventional group will undergo surgery to repair their abnormal aorta, and the surveillance group will be closely monitored and medically managed per standard of care. Both groups will have data collected from their care and at the end of the study this data will be analyzed. The goal of this study is to determine if performing surgery earlier helps to prevent abnormal aortas below 5.5cm from tearing or bursting.
This phase III study is for participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is negative for a type of virus called human papilloma virus (HPV). If decided to participate in this study, participants will be receive either ficlatuzumab in combination with cetuximab, or placebo in combination with cetuximab. There are 3 Arms participants will be randomly assigned to: Arm 1 will receive ficlatuzumab (10mg/kg by intravenous (IV) infusion) and cetuximab (by IV infusion), Arm 2 will be given ficlatuzumab (20mg/kg by IV infusion) and cetuximab, and Arm 3 will receive placebo and cetuximab. The effectiveness of the 2 different ficlatuzumab groups (Arm 1 and Arm 2) will be compared at the first on-study scan, and the more successful Arm will began enroll more participants. This study is estimated to last approximately 5 years. Study drugs will be administered until disease progression or unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). The main risk associate with the trial are swelling of your lower legs or arms, fatigue, shortness of breath, vomiting, diarrhea or constipation, bone pain, decreased appetite, anemia, high level of liver enzymes in your blood, dizziness, infusion reactions, cardiopulmonary arrest, pulmonary (lung) toxicity, skin reactions, inflammation of the mouth, low blood counts, liver problems, infection, headache, allergic reactions, and there may be unknown risks. This treatment can not guarantee the cancer will get better, since it may stay the same or get worse. What is discovered from this study may help other people in the future. The alternative to this study is not participating in this study and receiving HNSCC in patients who have previously received immunotherapy including chemotherapy with other treatment drugs or another clinical trial.