This is a randomized, double-blind, multicenter Phase IIIb study comparing remibrutinib tablets with dupilumab injections in adults with chronic spontaneous urticaria (CSU) that is not well controlled by second-generation H1-antihistamines. Participants will receive either remibrutinib or dupilumab for 12 weeks, alongside their usual antihistamine. The goal is to see which treatment works faster and better at reducing symptoms like hives and itching. If remibrutinib is not yet available commercially after the study, participants may continue taking it in an optional extension phase.
The investigational varicella vaccine (hereafter referred to as VNS vaccine) is a new
candidate varicella vaccine derived from the Oka strain. The main rationale for the
development of VNS vaccine is to provide an additional alternative varicella vaccine as an advantage from a public health perspective to prevent varicella disease
This research explores how ultrasound, a common medical imaging tool, can be used to look at the ligaments that support the base of the thumb. These ligaments are important because they help the thumb stay stable during everyday tasks like opening jars, writing, or buttoning clothes. When these ligaments become weak or damaged, it can cause pain and lead to joint problems like arthritis. Right now, it's not easy for doctors to check the condition of these ligaments without advanced scans or surgery. By using ultrasound, which is safe and non-invasive, we hope to find a quicker and easier way to examine ligament health.
Many people with Overactive Bladder (OAB) continue to have symptoms such as urinary urgency, frequency, and leakage even while taking medication. This research study is being done to see whether using the ZIDA sock, an FDA approved wearable device, can help reduce symptoms when added to a person's usual OAB medication. The ZIDA sock provides mild electrical stimulation to a nerve near the ankle and is worn like a regular sock. Participants will use the ZIDA sock at home once a week for 30 minutes over 12 weeks. Participants will be asked to complete bladder diaries to record urinary symptoms and questionnaires about their bladder symptoms, quality of life, and satisfaction with the device. Study staff will also ask about any side effects or discomfort related to device use. The information collected will help determine whether the ZIDA sock is a helpful add-on treatment for people with OAB who still have symptoms despite medication.
This study is for patients who have been diagnosed with bladder cancer and are eligible to receive chemotherapy and radiation therapy while keeping their bladder. The study is testing an investigational radiation schedule called stereotactic body radiation therapy (SBRT), which delivers higher doses of radiation over fewer treatment sessions. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA).
Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive the usual chemotherapy and standard radiation therapy schedule, which involves lower radiation doses given five days a week for 4 to 5 weeks. The other group will receive the usual chemotherapy and the study radiation schedule (SBRT), which delivers higher doses of radiation in fewer treatments over a shorter period of time.
The primary purpose of this study is to find out whether the shorter radiation schedule is as effective as the usual radiation schedule at preventing bladder cancer from getting worse and avoiding bladder removal surgery.
Radiation therapy and chemotherapy will be given while the bladder remains in place. After treatment is complete, participants will be followed by the study doctor for up to 5 years to monitor for side effects and whether the cancer returns or progresses.
All participants can expect to complete questionnaires about symptoms and quality of life at several time points during and after treatment. These questionnaires are part of the research and will not be shared with treating physicians. There will be a total of 16 patients enrolled locally over 48 months.
This study focuses on adolescents who experience both substance use problems and post-traumatic stress disorder (PTSD), which often occur together and can seriously impact mental health, school performance, and relationships if left untreated. The goal is to evaluate a trauma-focused treatment called Concurrent Treatment of PTSD and Substance Use Disorders for Adolescents (COPE-A), which is designed to address both conditions at the same time. Earlier pilot studies showed that COPE-A is safe, feasible, and effective in reducing substance use and PTSD symptoms compared to a supportive counseling approach.
In this larger study, 120 adolescents from across the U.S. will receive treatment through telehealth. Researchers will compare COPE-A to person-centered therapy to see which leads to greater improvements in substance use and PTSD symptoms. The study will also examine effects on depression, HIV risk behaviors, relationships, and overall quality of life, while using brief daily surveys to track changes over time.
The purpose of this study is to better understand how the oral microbiome (bacteria in the mouth) may be associated with different neurologic conditions like Alzheimer's disease and Multiple Sclerosis. This will require one visit, typically less than an hour. We will collect some information about the subject's past medical history including dental history as well as collect saliva and perform a nasal swab. This will also include a measure of genetics. There will be an optional blood collection. Samples will also be stored for future research.
The Car study is being done to collect real-world evidence of how commercially available MicroVention intracranial aneurysm treatment devices function and look at safety outcomes over a year when used per standard of care. The treating physician will use the device they think is most appropriate for each patient. The study will also be used to develop a full database in an effort to inform future studies and further the understanding of the safety and performance of these devices across a wide range of patient populations and disease characteristics.
The purpose of the study is to learn more about an experimental drug called ORC-13661 that may be helpful in treating hearing loss due to antibiotic use. The study is researching whether the drug is safe and tolerable, and trying to find out whether the drug may be able to mitigate or prevent hearing loss in patients being treated with intravenous (IV) amikacin. Participation in the study will consist of up to 10 visits over up to 129 days. The Day 1 visit (following the screening visit) will last up to 8 hours, while other visits will last up to 5 hours Participants will be randomly assigned to receive either ORC-13661at a higher dose or a lower dose or a placebo (a pill that looks the same as the study drug but has no real medicine in it), for up to 90 days to be taken along with IV amikacin. Participants will be asked to have a number of tests and procedures, which include questionnaires about family, medical, and hearing history, physical and hearing examination, and assessments of hearing.
This study will test if bemdaneprocel (the "study drug") is safe and effective in improving symptoms in participants with Parkinson's Disease. The symptoms of PD are due to a loss of cells that make a specific chemical in your brain called dopamine. The study drug is a cell therapy that contains live brain cells that produce dopamine. This study will last 5 to 8 years, and depending on randomization group between 23-32 study visits.