This study is enrolling patients with uncontrolled high blood pressure. This study will see if a medication called Zilebesiran can help lower blood pressure. Zilebesiran is an investigational medication meaning it is not approved for commercial use by the Food and Drug Administration (FDA) but it is approved for use in this study. This is a randomized study meaning if you are eligible, you will be assigned by chance, like the flip of a coin to receive Zilebesiran or placebo. Placebo will look like the study medication but will not contain any active ingredients. You and the study team will not know if you are taking Zilebesiran or placebo, both of which are given as an injection under the skin every six months. This study will last between 2.5 and 5 years and include 10-14 visits. Study related procedures include physical exams, medical history including medications, vital signs, blood and urine collection. and electrocardiogram (ECG - a recording of your heart's electrical activity)
This study is being conducted to evaluate the drug AZD0292, including how safe it is, how long it stays in the blood, and if it may help in reducing the number of exacerbations in people with Pseudomonas aeruginosa in their lungs. These patients have more frequent lung exacerbations and reduced quality of life. Pseudomonas aeruginosa is a bacteria that can make the symptoms of bronchiectasis worse. The study drug (AZD0292) works by attaching to Pseudomonas aeruginosa, thereby reducing its effects on the lungs and improving symptoms.
This study aims not only to test AZD0292 but is also being done to better understand bronchiectasis disease and its associated health problems.
Study drug (AZD0292) or placebo, will be given to participants as an intravenous (IV) infusion. The study is double-blinded.
About 435 participants with bronchiectasis 12 years of age and older, weighing at least 35kg will take part in this study. This study will be conducted globally in approximately 25 countries.
Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.
This study is for family members and informal caregivers who support an adult with mild cognitive impairment or early Alzheimer's disease. Researchers are testing a 10‑week, online program designed to help caregivers feel supported and better manage caregiving‑related stress. The program includes education about dementia and future planning, brief relaxation exercises, and opportunities to connect with other caregivers by sharing experiences in a supportive setting. Participants will be randomly assigned to receive one or more parts of the program, which helps researchers understand which types of support are most helpful. All study activities can be completed from home. Findings from this study will be used to improve and expand support programs for families impacted by dementia.
This study systematically evaluates the efficacy of a highly promising neuromodulation strategy - continuous theta burst (cTBS) transcranial magnetic stimulation - as a tool to change alcohol use behavior (Aim 1) and neurobehavioral concomitants of that behavior (Aim 2) in non-treatment seeking individuals with alcohol use disorder (AUD). In addition, we can begin to test prediction of individual treatment response based on an electrocortical signature of sign tracking (exploratory aim). This study is a double-blind, active sham-controlled study in community dwelling, non-treatment seeking individuals who meet DSM 5 criteria for AUD. Participants will be randomized to one of three groups: cTBS to ventromedial prefrontal cortex, cTBS to pre-supplementary motor area, or sham stimulation (10 sessions in one day). Participants will undergo comprehensive outcomes assessment, with measures including pre- and immediately post-cTBS clinical assessments (e.g., interview, Timeline Follow-back), alcohol craving tests, structural and fMRI, MRS, and EEG/ERP during salience- and cognitive flexibility-related tasks. To test alcohol craving and also use in alcohol-available settings, participants will complete a bar-lab session post-cTBS only (to avoid potential habituation to alcohol cues within the laboratory setting). Finally at 1-week post-treatment participants will complete craving and Timeline Follow-back measures remotely via REDCap.
The purpose of this study is to evaluate the efficacy and safety of ibuzatrelvir with and without remdesivir compared with remdesivir alone for the treatment of symptomatic COVID-19 in adult participants who are severely immunocompromised. This study is being done to learn how the study drug, called ibuzatrelvir, works in treating people with COVID-19 who have a severely compromised immune system. Ibuzatrelvir stops the virus that causes COVID-19 from multiplying in cells and spreading around the body. It may help people to get better and stay out of the hospital.
This study is recruiting pediatric patients who have been diagnosed with osteosarcoma. Osteosarcoma is the most common primary bone malignancy of childhood and adolescence. The goal of the study is to determine the feasibility of adding cabozantinib to standard MAP (high dose methotrexate, doxorubicin, and cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a resectable primary tumor and to compare the effects, good and/or bad, of cabozantinib in combination with MAP versus MAP alone on people with newly diagnosed OST to find out which is better. Common side effects of chemotherapy include nausea, vomiting, hair loss, and fatigue (tiredness). Participants will receive the medications through an IV in their arm and PO. Study participation is expected to last up to 16 months.
Feeding requires babies to coordinate sucking and swallowing, which depends on healthy brain development. Some newborns who experience brain injury or serious illness cannot safely practice feeding by mouth, which disrupts the development of these important brain circuits. As a result, many of these infants require a feeding tube placed in the stomach (called a G-tube) when they leave the hospital. Unfortunately, long-term feeding tube dependence is linked to poorer growth, delayed development, and breathing problems. Despite how common and serious these feeding difficulties are, there are currently no effective therapies for infants with the most severe swallowing problems. This study will test a non-invasive therapy called transcutaneous auricular vagus nerve stimulation (taVNS), which gently stimulates a nerve in the ear that connects to the brain. When paired with structured oral motor exercises, this approach may help strengthen the brain circuits needed for feeding. We will study 12 infants with severe feeding impairments to evaluate whether this therapy is safe, feasible, and shows early signs of benefit. This project will provide early evidence about whether a targeted brain-based therapy can improve feeding outcomes during a key window of early development.
This study is being done to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease (IBD) taking azathioprine/6MP or biologic therapy or small molecules are different from those among IBD-affected women not taking these medications. Participants will be asked to give blood samples to assess drug levels during pregnancy and after birth. They will also be asked to answer questionnaires about their and their baby's health.
The purpose of this pilot study is to refine a mobile app, based on usability data, from 15 adults living with pulmonary hypertension (PH). The app is intended to reduce symptom burden and improve health-related quality of life for adults with PH, a chronic and debilitating cardiopulmonary condition. Participants will be asked to use the app and provide their thoughts about how to make it better by completing surveys and through interview. We also aim to assess readiness for broader implementation through surveys and targeted interviews with PH providers (N=15). Optimizing barriers and facilitators to implementation and gathering clinician perspectives will inform the design of a future randomized controlled feasibility trial.