This study is testing whether an investigational compound called oleoylethanolamide (OEA) may help reduce alcohol use in young adults with alcohol use disorder. Young adults ages 18-25 will be randomly assigned to receive either OEA (250mg per day) or a placebo for six weeks. Researchers will measure alcohol use, immune function, oral bacteria, and thinking and decision-making. Compensation is available for those who qualify.
The purpose of this study is to measure the efficacy and safety of KP-001 compared to placebo in patients with common venous malformations (VM), common lymphatic malformations (LM), or KTS/CLOVES syndrome. This phase 3, double-blind, randomized, placebo-controlled, parallel-group study will take place at multiple sites across North America. Vascular malformations like VM, LM, and KTS/CLOVES syndrome are serious, rare diseases with significant unmet medical needs. The study includes a 24-week double-blind treatment period with either KP-001 or placebo, followed by an open-label phase where all patients receive KP-001 up to Week 52. Patients weighing 40 kg or more will receive 100 mg of KP-001 once daily after breakfast, while those weighing less than 40 kg will receive a reduced dose based on their body weight.
This study will enroll patients that were either diagnosed with hepatocellular cancer (HCC) in the past 6 weeks or have been diagnosed with cirrhosis but do not have HCC. Patients will have a blood sample collected to test if a new blood-based biomarker is accurate in the early detectection of HCC.
This research study is being conducted at the Medical University of South Carolina (MUSC). The purpose of this study is to better understand injury to the small nerves that run between the ribs following rib fractures, and to learn what normal sensation and muscle appearance of the abdominal wall (muscles of the stomach area) look like in healthy adults. This information will help doctors better recognize and diagnose nerve injuries in patients who have had trauma, surgery, or other conditions affecting the abdominal wall.
Researchers will use simple sensory testing of the skin of the abdomen and ultrasound imaging to measure abdominal muscle structure. The sensory testing, called two-point discrimination, measures how well participants can tell the difference between two nearby points touching the skin using a small measuring tool that lightly touches the skin of the abdomen. Ultrasound imaging uses sound waves to create images of the inside of the body and will be used to measure the thickness and appearance of the abdominal muscles. This study includes two groups of participants: healthy volunteers and individuals with rib fractures.
Healthy volunteers will complete a single study visit lasting about 45 minutes, during which participants will undergo sensory testing, ultrasound imaging, and a short questionnaire. Participants with rib fractures will complete research procedures during their scheduled clinical follow-up visits, which include a baseline visit and three follow-up visits over approximately 12 weeks; research activities, including ultrasound imaging, will add about 30 minutes to each visit.
To investigate the safety, tolerability, PD, and PK of BI 3802876
when administered intravenously in single rising doses following
MABEL dose administration in adult patients with compensated
cirrhosis due to MASH.
This will be a retrospective chart and imaging review of the patients who have undergone this procedure since its inception. From the patient charts, we will collect demographic and surgical information. From their imaging, we will collect pre- and postoperative radiographic measures to assess whether adequate distalization has been achieved. Patients that have received this surgery and are willing to provide patient reported outcomes will be contacted and asked about post-operative pain, functionality, and satisfaction.
This is a post approval study for those being implanted with the WiSE System. Data will be collected from your medical records including medical history, medications, the implant procedure, and device check as well as routine follow up visits, and you will be asked to complete a questionnaire at 3 visits. Participation in this post approval registry will last about 5 years. There is a risk of loss of confidentiality.
This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active CD. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active CD due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 1092 participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).
This Phase III trial aims to investigate the efficacy and safety of survodutide (BI 456906) once weekly versus placebo on defined as resolution of steatohepatitis, reduction of liver fibrosis in liver biopsy and long-term improvement in clinical liver outcomes observed in trial participants with MASH and fibrosis stage F2-F3.
This study is for patients who have been diagnosed with low grade, intermediate risk non-muscle invasive bladder cancer. It is testing an investigational drug called TYRA-300. "Investigational" means that the drug has not been approved by the United States Food and Drug Administration (FDA).
The purpose of the study is to see whether TYRA-300 can shrink or eliminate bladder tumors without surgery. Normally, standard care involves a surgery called transurethral resection of bladder tumor (TURBT), but in this study at least one tumor will remain in place to see if the study drug works. The study will also evaluate the genetics of the cancer to see if certain mutations or changes in proteins affect how the drug works.
TYRA-300 is taken by mouth once daily. The dose level will be assigned by the study doctor. Participants may be in the study for about 36 months, which includes a screening period (up to 28 days), a study treatment phase (with visits every 4 weeks and more frequent visits during the first 8 weeks), an end-of-treatment visit, a safety follow-up about 28 days later, and long-term follow-up every 12 weeks. There will be a total of 3 patients enrolled locally over the course of 12 months.