This is a study to test the safety of ALN-6400 which is considered to be "an investigational drug", meaning it is not currently approved by regulatory authorities, including the United States Food and Drug Administration (FDA), for the treatment of any disease and find out what effects, if any, it has on people with Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB). ALN-6400 works by lowering protein in the blood breakdown blood clots and reduce bleeding in women ages 16-45. This study is a 24 week study with an optional extension period of 84 weeks.
This study is being offered for patients with metastatic pancreatic adenocarcinoma who have tried available approved treatments and do not have satisfactory treatment options or are unable to participate in a clinical trial. The purpose of this Expanded Access Program (EAP) is to provide access to daraxonrasib, an investigational drug that has not yet been approved by the FDA.
Daraxonrasib is an oral tablet. Clinic visit are every 28 days to receive a new supply of daraxonrasib. Participation is expected to last until whichever of the following occurs first - 1: you are no longer benefiting from daraxonrasib; 2: daraxonrasib becomes commercially available (FDA approved); 3: Revolution Medicines, the Sponsor of the EAP, the IRB, or the FDA decides to stop the EAP.
Risks include skin rash, diarrhea, nausea and vomiting, mouth sores, and swelling. This EAP is not a research study. Its main goal is to provide access to daraxonrasib to patients who may benefit based on what information is known about the drug so far. There is no guarantee that your cancer will get better as a result of receiving daraxonrasib. It is possible that you will show no improvement or that your cancer could get worse.
This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called At0365-P1-01. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate how safe the drug is, how well participants can handle the drug, how it moves through the body, how it affects the body, and if the drug helps treat the cancer of AT03-65. AT03-65 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. The estimated study duration is approximately 30-35 months for subjects screening, treatment and follow-up.
This study is recruiting patients receiving cancer treatment that includes a type of drug called an "alkylating agent", which may cause side effects such as damage to the ovaries (female reproductive organs). The goal of the study is to determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age <40 years (exclusive of breast cancer). The triptorelin used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. Participants will receive the medications through an intramuscular (IM) injection in their arm. Study participation is expected to last up to three years.
This study is trying to find out whether early repair of small Abdominal Aortic Aneurysms (AAAs) in women improves health outcomes compared to routine monitoring. An AAA occurs when a section of the aorta in the abdomen weakens and bulges outward, resembling a balloon. This condition is serious because if the aneurysm ruptures, it can cause severe internal bleeding and can be fatal. This question is important because women with small AAAs may have a higher risk of rupture than men, and doctors are not yet sure whether early repair is better than standard monitoring. Surgical repair is the elective standard of care for aneurysms above 5.5cm in size. In our study we are evaluating if earlier repair (between 4.0- 5.4 cm) might be beneficial to women with abdominal aneurysms, but it is important to note that surgical repair involves risks and could lead to other complications, including death. These risks are discussed later in this form. There is also the possibility that you may need additional procedures, including open surgery.
The 16-week main phase of the study is designed to assess the efficacy and safety of the once daily pitolisant, administered orally upon wakening, in comparison to a placebo. The effects of HBS-301 on excessive daytime sleepiness, sleep inertia (slow to wake up/groggy), and fatigue will be examined.
After the main phase period, there is an option to be in the second part of the study, which will span 1 year. During this period, subjects will receive open label of the active drug, HBS-301.
This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active UC. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active UC 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 822 adult and 60 adolescent participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).
The purpose of this study is to better understand how ear stimulation techniques may impact how people think about themselves in social situations. The goal is to identify how the addition of ear stimulation can impact cognitive processes, including the ways that people think about themselves in social situations and attend to or process social information, that underly an activity known as "self-imagery rescripting." Eligible individuals who are between the ages of 18 and 65 years will complete a variety of activities after providing consent to study participation. These include: (1) completing questionnaires on the computer, (2) completing tasks similar to a video game on the computer, (3) having an electrode attached to their ear that will stimulate nerve activity, (4) completing an interview about how they feel in social situations, and (5) engaging in an activity during which they will be prompted about how they see themselves in social situations. Throughout these activities, participants also will be asked to wear a variety of sensors, bundled together in a cap for their head and individually on other parts of their body, that will collect information about brain activity, heart rate, and eye blinking. Participation in this research study is entirely voluntary and will last approximately 3 hours during a single session at the Medical University of South Carolina in Charleston. Participants will be compensated for their time.
There are some risks associated with this study. Some survey questions ask about personal thoughts and feelings. Ear stimulation may cause tingling sensations or irritation around the ear. Thinking and talking about how one sees themselves in social situations may be distressful.
There are no direct benefits to participants. This study will help researchers better understand how ear stimulation can improve the strategies that can help the way that people think about themselves in social situations.
This study aims to explore how painful and non-painful stimuli are processed in people with and without nerve pain with chronic SCI. We are recruiting individuals with spinal cord injury at T11 and above, with or without neuropathic pain in the leg, and who are able to stand with or without an assistive device. Study participation involves 3 in-person visits, each of which will last 2-3 hours. Compensation and mileage reimbursement are available for all study visits.
The aim of this study is to assess the efficacy and safety of an investigational medication, Inebilizumab, in patients with autoimmune hepatitis (AIH) who inadequately respond to at least 9 months of standard-of-care (SOC) treatment, or who are intolerant to SOC within 6 months of screening.