All Clinical Trials

A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. IPN10200 is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: * The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of IPN10200 to inject at each point, * The total amount (dose) of IPN10200 that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks. Read Less

Background: Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents. Objective: To monitor the effects of HRT on adolescents with POI. Eligibility: Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed. Design: All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include: Blood and urine tests. A test of their heart function. A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates. A test of their grip strength. Participants will squeeze a handheld device as hard as they can. Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner. A test to measure skin pigmentation. Participants skin will be touched lightly with a device. An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush. Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills. Read Less

The purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA), with the current standard of care of patient-directed auditory training in improving common measures of speech recognition and cochlear implant (CI) specific quality-of-life in new adult CI recipients in their first year post-activation. Read Less

Background: People who will participate in research studies need to undergo proper screening, evaluation, and assessment (SEA). SEA helps keep those who participate in studies safe. It also helps ensure accurate study results. The National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) wants to screen people with alcohol and/or substance use disorders (ASUD) as well as people without ASUD for ongoing studies at NIDA in Baltimore, MD Objective: To screen people with or without ASUD for ongoing studies at NIDA. The ultimate goals are to learn why some people (1) use drugs; (2) stop using drugs; (3) use drugs but do not get addicted; and (4) never use drugs snd to develop ASUD treatments. Eligibility: People aged 18 years and older. They may (1) currently use nicotine, alcohol, opioids, cocaine, or other drugs; (2) no longer use them; or (3) have never used them. Design: Participants will have 1 screening visit that could last up to 8 hours. The visit may be split over more than 1 day. The duration of the screening may vary for each individual based on which studies they are interested in and screened for. The tests they undergo may vary and may include the following: * Physical exam. * Blood, saliva, and urine tests. * Breath samples that test for alcohol and carbon monoxide. * Test of heart function. * Smell test that measures sense of smell. * Tests of memory, attention, and thinking. * Mental health evaluation. * Mock magnetic resonance imaging (MRI) scan. * Questionnaires about alcohol and other drug use, mental health, medical history, and life in general. Read Less

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies. Read Less

The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in healthy participants and participants with Parkinson's disease. Read Less

The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum. Fewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life. Read Less

This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives. Odevixibat is a medicine that helps patients with ALGS, a rare disease that harms their liver and causes itching. The main aim of this study is to observe the long-term, everyday effectiveness and safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment. Read Less

To demonstrate the efficacy of targeted and tailored sequential therapy in patients with AML. Read Less

The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder. Read Less

Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remove necrotic tissue from the pancreas. For this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN. Read Less

The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes: A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection. Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice. The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them. Read Less