This study aims to evaluate the safety and tolerability of ARQ-151 cream 0.05% in infants with mild to moderate eczema after daily application for four weeks. ARQ-151 contains the active ingredient roflumilast, which reduces the activity of the enzyme PDE-4 involved in inflammation. Since eczema is an inflammatory skin disease, ARQ-151 could potentially help treat this condition.
Eligible participants (ages 18+ whom have daily cigarette use) will attend an in-person assessment (though some aspects of the study, including consent, can be completed remotely). Participants will submit a breath sample for assessment of expired carbon monoxide. Approximately 5-7 days after completion of the in-person assessment, participants will meet with research staff. A medical clinician will meet with the participant to present a smoking cessation treatment recommendation along with resources. Participants will also complete surveys to assess their treatment preferences, motivation, and self-efficacy following receipt of the recommendation.
This is a research study to help see if a new interview for posttraumatic stress disorder (PTSD), called the Revised Clinician-Administered PTSD Scale for DSM-5, or the CAPS-5-R for short, is accurate and reliable for veterans. By doing this study, we hope to learn if the CAPS-5-R can be used in VA to diagnose PTSD. Participation will all be done remotely. Joining this study will involve (1) completing some questionnaire measures and (2) completing an interview remotely by videoconference over 2 days at most.
Participants must be Veterans, aged 18 or older in the Ralph H. Johnson VA Health Care System who have experienced trauma or at least one PTSD symptom.
This study is for adult patients with Triple Negative Breast Cancer (TNBC) who are at high risk for cardiotoxicity. The purpose of this study is to evaluate a non-anthracycline-based chemotherapy and immunotherapy regimen to determine if this approach reduces heart-related side effects. Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. Participation in this study is anticipated to last approximately 6 months with follow up over 2 years.
This study will compare the safety, tolerability, and efficacy of inhaled study drug LTI-03 to placebo in participants diagnosed with IPF within 5 years of Screening who may be receiving standard of care (SoC) antifibrotic therapy. Taking part in this research is expected to last up to 32 weeks, which includes a 4-week screening period, a 24-week treatment period, and 4-week post-treatment follow-up period. The general procedures include review of eligibility; review of medical and medication history and changes in health; completing questionnaires; undergoing physical exams and having vital signs measured; collecting blood samples; examinations such as ECG, spirometry, HRCT, and DLCO and using an inhaler to take the study drug.
The study is researching an experimental drug called REGN7544. The study is focused on adult patients (18 to 85 years old) hospitalized due to a serious infection (called "sepsis" in this form) and receiving standard-of-care medications for low blood pressure (called "vasopressors" in this form) due to sepsis. The aim of the study is to see if REGN7544 is safe, tolerable and effective when compared to placebo, by observing the effects on blood pressure and the total amount of vasopressor dose received. The general procedures include collection of information from medical records, some additional testing, such as electrocardiogram, collection of blood, and having blood pressure and heart rate measured .There will also be a screening visit, two telephone visits, and one additional in-person visit. It is expected that taking part in this research will last about 13 weeks (3 months).
This study is enrolling participants with calcific aortic valve stenosis (CAVS) which is a heart valve disease. Blood pumped out of the heart goes through the aortic valve, and in CAVS, calcium builds up causing the valve to thicken over time so it is not able to open as much or as easily and over time this restricts blood flow. This study involves an investigational medication called ataciguat which is being studied to see how well it can slow the progression of CAVS. Investigational means it has not been approved for commercial use by the Food and Drug Administration (FDA). Ataciguat is taken by mouth daily.
Participation in this study will last about 3 years and include about 14 visits. Study procedures include collection of medical data, physical exams, electrocardiogram (ECG - a recording of your heart's electrical activity), bloodwork, echocardiogram (ultrasound test of the heart), CT scan, questionnaires and home monitoring of your blood pressure and heart rhythm.
Risks related to ataciguat include headache, nausea, abdominal pain, diarrhea and dizziness. Study procedure risks include radiation risks, risks of drawing blood and loss of confidentiality.
The purpose of this study is to find out if adding a drug called ribociclib to the usual hormone therapy drugs can lower the chance of your breast cancer coming back again. This study is for patients with locoregional, recrrent, resected hormonone receptor positive HER2 negative breast cancer. Endocrine therapy has already been approved by the FDA for your type of cancer. Ribociclib has already been approved by the FDA for your type of cancer that has not been removed by surgery or has spread to other parts of the body.
Receiving ribociclib with endocrine therapy is still being studied and to yet approved by the FDA. Ribociclib is taken as a pill and endocrine therapy is taken as an injection. Participants will receive ribociclib with endocrine therapy for up to 3 years and can receive endocrine therapy alone for an additional two years after stopping ribociclib. Participants can remain on the study for up to 5 years.
The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections.Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, we use a transcranial magnetic stimulator. We hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.
This study is for patients that have been diagnosed with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC). The study is testing an investigational drug called DB-1311. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to determine the recommended phase II dose of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 by assessing the safety and tolerability. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study for 72 months.