The purpose of this study is to test whether a mobile app, the Digital Wellness Nurse (DWN), can help families with weight problems lead healthier lifestyles. Participants in this study will receive education and tips on physical activity and healthy eating through weekly videos and online meetings with a community health worker (CHW) via the DWN app. The meetings with the CHW will take place once a week for 12 weeks. During these meetings, adolescents and their caregiver will set weekly goals and have the chance to earn incentives for meeting them. While in the study, participants will be asked to wear a Fitbit to track physical activity and to complete a monthly survey about eating and physical activity habits. At the end of the study, participants will be asked to participate in a focus group and talk about their experiences with the app and the study. Participation in this study may improve physical well-being, but that cannot be guaranteed.
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.
This registry is enrolling subjects who are indicated for renal denervation to treat high blood pressure that has remained high despite treatment. Renal denervation is a procedure where a catheter (a thin, flexible plastic tube with four electrodes near the end) is placed inside the blood vessels that go to the kidneys. Heat is delivered through the electrodes to disable the nerve activity and lower the blood pressure.
Participation in this registry will last about 1-3 years and include 3-6 visits depending on how often your doctor typically conducts follow up visits. Data will be collected including medical history, medications, blood pressure readings, labs, from the procedure and from any complications if applicable. There is a risk of loss of confidentiality and there may be risks that are not known. There may be no direct benefit but the information learned may help others in the future.
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.
Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of individuals with apathy. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, we are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. Our study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). Our study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.
This phase 2 study is screening patients who may have acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This study is a non-treatment protocol and the first step of taking part in myeloMATCH, which is a clinical trial. The main purpose of the study is to see if testing on patient's bone marrow and blood results in finding certain biomarkers that will qualify participants for the treatment study or for Standard of Care (SOC) therapies. The study will enroll approximately 5000 patients. The study has two periods, initial and post-treatment screening. It takes about four days for the study doctor to receive the screening results and the patient's first treatment assignment in myeloMATCH. Patients will complete post-treatment screening after their participation in treatment trials or SOC therapies. It will take about 11 days for the study doctor to receive these results and decide their next treatment assignment. Further testing may match patients with myeloMATCH substudies in the future. The main risk is that biomarker test results may be wrong. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
This study is looking for individuals who have resistant hypertension. This is a non-interventional research study and it does not involve a new drug or treatment. The goal of this study is to find out how many people with resistant hypertension, a type of high blood pressure that is hard to control, also have high levels of a hormone called cortisol. High cortisol levels, a condition called hypercortisolism, may make it more difficult to manage blood pressure. If you join the study, you will attend two to three clinic visits. During the first visit, you will go to the clinic for a short checkup. You will have vitals and your medical history reviewed. You will also have a blood draw and be given a pill called dexamethasone which will help us assess your cortisol levels. At your second visit you will fast and have a your blood collected to review your cortisol levels. If necessary, you will be invited for a third visit where you will get a CT scan. The risks associated with the study include bruising, dizziness, or, in rare cases, infection from blood draws, allergic reactions from taking the dexamethasone pill, and exposure to radiation from the CT scan. The study will be completed over the course of 2-3 visits in one months timeframe.
This study is enrolling participants with heart failure, a condition where the heart muscle does not pump blood efficiently, with preserved ejection fraction, meaning the heart muscle contracts (squeezes) normally but is unable to relax appropriately. The study involves implanting a pacemaker, a small device that is placed in the upper left chest, and then programming it to either standard settings or personalized settings for you based on your height and heart function. The programming is randomized, meaning assigned by chance, like flipping a coin so you do not get to choose which group you are in nor does your doctor. The study is trying to determine if using the pacemaker to control your heart rate can help you heart failure.
Your participation will last at least 18 months and may be as long as 4.5 years depending on when you join the study. The study will include about 8 visits and include the pacemaker implant procedure as well as testing such as physical exams, 6 minute walk test, echocardiograms (ultrasound test of your heart), blood work, questionnaires and pacemaker checks.
There are risks associated with the pacemaker implant procedure, risks related to study related procedures and the risk of loss of confidentiality. There may be benefit to you and to others with this condition in the future.
This phase 2 study is enrolling patients who have acute myeloid leukemia (AML) with certain biomarkers. This study is being done to see the effectiveness of different combinations of drugs to treat AML. It will involve 3 groups of patients receiving different combinations of Gilteritinib, Azacitidine and Venetoclax. Gilteritinib is an investigational drug, Azacitidine and Venetoclax are FDA approved. The main purpose of the study is to see if the amount of leukemia in the patient's body can be lowered by adding the drug Gilteritinib to the Standard of Care of treating AML with Azacitidine and Venetoclax. The study will include approximately 147 patients. The patients will be randomized into the three groups (like flipping a coin), Group 1 will receive just Azacitidine + Venetoclax, Groups 2 and 3 will also receive Gilteritinib but Group 2 will receive it for more time within a treatment cycle. Patients will complete screening after participating in this treatment trial or SOC therapies. Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that the study drugs may not be as good as the usual approach for their cancer or condition at shrinking or stabilizing their cancer. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.
The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.