The purpose of this research is to assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
The purpose of this study is evaluate safety and effectiveness of an investigational drug in adults diagnosed with chronic urticaria (hives). The investigational drug is known as BLU-808 and will be taken daily orally. Participation in the study is expected to be approximately 18 weeks.
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.
This study is for adult patients with large brain metastases. The purpose of this study is to compare two different radiation therapy dose treatments: staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT). Both treatment options are currently used as standard of care. Participation in this study will include standard of care visits along with questionnaires completed for research purposes.
Deep brain stimulation (DBS) is a surgical treatment that can help improve the symptoms of Parkinson's disease (PD). However, the effectiveness of this treatment varies among patients, and physicians currently have no way to predict who will benefit the most. This study will investigate whether the types of bacteria in a person's gut can help predict their response to DBS. By analyzing patient samples, we aim to identify biomarkers that could help doctors better select candidates for this procedure, ultimately leading to more successful treatment outcomes for individuals with Parkinson's disease.
This will be a study in the home care setting to further validate the concept of Simeox 200 in a cohort of patients with bronchiectasis and overproduction of mucous as an alternative to other methods of ACT(airway clearance techniques). Bronchiectasis is a chronic lung disease where airways become permanently damaged, widened, and lose their ability to clear mucus, leading to a buildup of bacteria, recurrent infections, and symptoms like a daily cough, thick, discolored phlegm, shortness of breath, and fatigue. The device is a 510(k) FDA cleared device that works using by air and vibration to help clear mucous from the lungs. There are 4 visits and an at home usage period. The study will be running approximately a year or until the cohort is filled. The data from this study will be used to power a future randomized controlled pivotal clinical study comparing Simeox 200 against other ACTs such as High Frequency Chest Wall Oscillation (HFCWO).
This study is enrolling participants with symptomatic ATTR-CM (transthyretin amyloidosis cardiomyopathy). ATTR-CM is a rare and serious disease that occurs when a protein in the blood called transthyretin (TTR) builds up throughout the body, including in the heart and nerves. When the abnormal protein, known as amyloid, deposits in the heart, the heart muscle thickens and stiffens, causing the heart to fail. This research study is designed to test whether the medication nucresiran is safe and helps people with ATTR-CM, in comparison to the effects of placebo.
Nucresiran is considered investigational, meaning it is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of ATTR-CM. Nucresiran is a TTR silencer. It is like a "quiet button" that turns down the amount of the disease-causing protein that is made. Because there is less TTR, there may be less buildup in the heart and other organs over time.
This is a randomized study meaning once eligibility is confirmed, participants will be assigned by chance, like drawing straws, to either receive nucresiran or placebo. You will have a 2 out of 3 chance of being assigned to nucresiran and a 1 out of 3 chance of being assigned placebo. Placebo is a substance that looks like the actual medication and is given the same way but contains no active substance. The study drug, which can be either nucresiran or placebo, will be given as an injection under the skin in the abdomen (avoiding the area around the navel), thigh, or the side or back of the upper arms. Neither the participants nor the study doctor will know who is assigned to nucresiran or placebo but this information can be made available if need be.
Participation in this study is expected to last for 5-8 years, Study related procedures include physical exams, vital signs, echocardiograms (ultrasound test of the heart), electrocardiograms, (ECG, a tracing of the heart's electrical activity), blood work, urine samples and questionnaires. Participants will also take Vitamin A daily. Study related risks include risks related to the study drug including injection site reactions, abnormal liver function or an allergic reaction. There may be risks related to study procedures including loss of confidentiality. There may not be any direct benefit, but the information learned may benefit others with ATTR-CM in the future.
This study is for male subjects that have been diagnosed with metastatic prostate cancer (that has spread to other parts of the body) and progressed following standard hormonal/radiation therapy and surgery. Subjects are expected to remain in the study for a minimum of 48months or longer. There will be a total of 10 subjects locally enrolled.
In this study, we are testing whether a higher dose of a non-invasive brain stimulation technique, called transcranial direct current stimulation (tDCS), can be safely used in people with depression. Participants will come to the Brain Stimulation Lab and receive mild electrical stimulation through electrodes placed on their scalp.
The study begins with a safety run-in, where the first few participants will receive stimulation at gradually increasing levels (2, 4, and 6 milliamps) while being closely monitored. If no serious side effects are found, later participants will receive repeated 6 milliamp sessions for 5 days total. We will check skin comfort, mood, and overall tolerability after each session.
This is a prospective single-arm post-market multicenter study to evaluate
clinical outcomes of Cohealyx when used to manage full thickness wounds
post-surgical excision. Patients with a full thickness wound where autografting is clinically indicated will be considered for participation in this study. Patients will
undergo a staged surgical procedure for wound closure. In the first surgery, Cohealyx will be applied to the surgically excised wound bed within 5-days post-injury. Once Cohealyx has successfully integrated into the wound bed, the wound will be prepped and autografted per standard of care.