This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).
iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.
The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.
IgAN is a progressive condition that causes chronic kidney disease. Over time, some patients develop end-stage kidney disease (ESKD) requiring dialysis or kidney transplant.
The purpose of this study is to see if an investigational medication is safe and effective in the treatment of IgA nephropathy.
If you are eligible for the study and decide to participate, you will come to MUSC for study visits for about 3 years. These visits will involve blood and urine samples, questions about your health, EKGs, and physical exams. Participants will be randomized in a 1:1 ratio to receive either a weight-based IV infusion of ravulizumab or placebo for 106 weeks. Depending on your response to initial treatment, there is a possibility of additional treatment. An exploratory, open-label cohort of approximately 20 participants with eGFR 20-29 mL/min/1.73m2 may also be enrolled to expand the evidence of ravulizumab in participants with advanced kidney impairment at high risk for ESKD progression.
There is no guarantee that being in this study will help you. There is no cost to participate and compensation is available for the study visits.
This study is asking for volunteers who have been diagnosed with acute pulmonary embolism (PE). PE is a blood clot that blocks and stops blood flow to an artery in the lung. PE usually results from a blood clot in the leg that travels to the lung. Patients with PE may have shortness of breath, chest pain and/or an irregular heartbeat. This study will use a device known as the Vertex Pulmonary Embolectomy System. The Vertex Pulmonary Embolectomy System is a medical device which is indicated for use in the pulmonary arteries for the non-surgical removal of blood clots from blood vessels. The Vertex System has not yet been approved for use by the Food and Drug Administration (FDA) but is approved for use in this study for PE removal. Your study doctor will inform you about the risks that are related to your PE procedure. The risks associated with the study include loss of confidentiality and unknown risks. There will be no benefit to you, but it is hoped the information gained will add to the understanding of treatment options for others in the future. You do not have to participate to have your condition treated. This study will take 30 days to complete.
Part A of this study will compare the effects of Clofazimine Inhalation Suspension to placebo. The purpose of this study is to find out if Clofazimine Inhalation Suspension can treat NTM lung disease by getting rid of the bacteria from the lungs and to make sure that Clofazimine Inhalation Suspension is safe for use. The participant will continue with current treatment for NTM lung disease in this study. To test if the bacteria are gone from the lungs, sputum will be tested on a regular basis (every month) to see if the culture changes from positive to negative. Participants will be randomly assigned by chance (like drawing numbers from a hat) to either Clofazimine Inhalation Suspension or placebo.
After the participant completes the study treatment in Part A, they will be eligible to receive Clofazimine Inhalation Suspension in Part B.
Approximately 234 participants will take part in the study at approximately 120 sites globally.
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large or medium vessel occlusions (LVOs and MVOs).STEP is a registry-based trial; it uses data from existing registries to record information for a subset of the trial Case Report Form (CRF). Additional registry data from non-randomized STEP patients may be used for trial screening, planning, and generalizability assessment purposes.
This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The purpose of this study is to compare BDA MDI with AS MDI on severe asthma exacerbations in adolescent participants aged 12 to < 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year. Participants will administer randomized IMP as needed as they normally would with their own prescribed rescue inhaler.
This study is enrolling subjects with high blood pressure who just received a pacemaker (an implantable device placed in the upper chest that monitors the heart rate and can send an electrical signal if needed to pace the heart to maintain a normal heart rate) or are about to undergo a pacemaker implant. This is a randomized study meaning subjects will be assigned by chance to have a new program downloaded to the pacemaker to help control blood pressure or to not receive the program. Subjects will have a 50:50 chance to receive the program. The new program is called AVIM therapy and it is investigational meaning it has not been approved by the US Food and Drug Administration. (FDA) Participation in this study will last about 36 months and include about 10 visits. Study related procedures include blood pressure monitoring including wearing a 24 hour blood pressure monitor, blood work, questionnaires, echocardiogram - an ultrasound test of the heart, pacemaker interrogation (meaning your pacemaker is checked to obtain the information stored on it) and randomization. Study related risks include risks related to the software download such as the risk that the software will not help control blood pressure, risks related to study related procedures and the risk of the loss of confidentiality.
This study is testing a new radiotracer dye called I-124 evuzamitide in patients with suspected cardiac amyloidosis. Cardiac amyloidosis occurs when proteins misfold and deposit as amyloid fibrils in the heart. The build up of these fibrils (proteins) cause the heart to enlarge due to wall thickening so the heart has to work harder. Over time, this can lead to heart failure. I-124 evuzamitide is given during a Positron Emissions Tomography/ Computed Tomography (PET/CT) scan to help diagnose cardiac amyloidosis. It is not a treatment for amyloidosis. I-124 evuzamitide is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration. (FDA). It will be given one time through an intravenous line, meaning in the vein before the PET/CT scan.
This study will last about 60 days and include 4 visits. The final study visit will take place at day 30 but medical records will be reviewed up to day 60. In addition to receiving I-124 evuzamitide, participants will also receive potassium iodide, an approved medication, by mouth to take for 3 days to protect the thyroid gland from the radiotracer I-124 evuzamitide, electrocardiogram (ECG), bloodwork and questionnaires.
This study is to evaluate an investigational study drug, itepekimab, for the treatment of bronchiectasis. The main purpose for this study is to assess the safety, efficacy, and tolerability of itepekimab in bronchiectasis in addition to the current background treatment you are receiving which may include bronchodilators, inhaled corticosteroids, mucolytics, and/or maintenance antibiotics. You will receive either the study drug or a placebo if you participate in this research. This study will include about 300 participants with bronchiectasis across approximately 20 countries worldwide.