There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The study will apply the principles of Community Based Participatory Research to evaluate implementation strategies, designed to assist in the delivery of an evidence-based lifestyle counseling intervention for pregnant participants. The primary strategies include a technology supported strategy (low touch) in which text messaging and online videos are used for asynchronous viewing compared to a Community Health Worker-led synchronous (group and individual) strategy (high touch). Prior to implementation, one-time interview and focus groups will be conducted with clinic providers and staff. In addition, a subsample of subjects will be enrolled into a prospective cohort to complete a survey during pregnancy and a survey postpartum. The aims of the study are 1) to evaluate and compare adoption of the program delivery with text technology messaging vs. delivery by Community Health Workers (CHW), 2) to examine implementation fidelity , 3) to evaluate and compare the impact of the strategies on key clinical outcomes, 4) to examine sustainability (continued adoption) following the CHW-led strategy implementation period and conduct an economic evaluation of the two-implementation strategies.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced. The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine - Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time - Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood The study will have 2 treatment groups. In Group 1, participants will take: - BAY2927088 as a single dose on Days 1 and 8. - Itraconazole once daily on Days 5 to 11. In Group 2, participants will take: - BAY2927088 as a single dose on Days 1 and 14. - Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2. Participants will visit the study clinic: - at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study - on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2 - once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up During the study, the doctors and their study team will: - perform physical examinations - collect blood samples from the participants to measure the levels of BAY2927088 - check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.
The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are: - In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will - Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording. - Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks. - Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other.
The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice, but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain and inflammation. Given these findings, this study will examine the postprandial effects of meals with 2 levels of saturated fatty acids (SFA) on metabolic endotoxemia, inflammation and satiety, using a randomized cross-over design. The low SFA meal includes peanuts that are high in monounsaturated fatty acids (MUFA) and this will be compared to a high SFA meal. The results of this study have the potential to provide valuable insights into the role of peanuts in promoting health and preventing disease in at-risk older adults.
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts.
This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.
Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.
The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone.
The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.