Clinical Research Directory

Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers

Background: Infections in the lower respiratory tract (lungs) are the leading cause of death from infectious disease worldwide. This was true even before the COVID-19 pandemic. Respiratory viruses are still a major health threat. Many of these viruses infect people by penetrating the thin skin that lines the nose. These viruses can also spread easily to other people when they multiply in the tissues that line the nose. Researchers want to learn more about what these viruses do inside the nose, how they get from the nose to the lungs, and how they spread from person to person. Objective: To collect cell samples from inside the noses of healthy people. These cells will be stored for use in future research on respiratory diseases. Eligibility: Healthy volunteers aged 18 years and older. Design: Most participants will have 1 visit on 1 day. They will be asked questions. Those who have a runny nose, coughing, congestion, or fever will be asked to wait up to 21 days before participating. Participants will be given a slender swab with small bristles at the end. They will rub the inside of their nose with the swab. A clinic staff member will be present to help, if needed. Participants will provide their name, age, and sex. This information will be encoded so that only certain researchers will know the participants identities. Participants will not be contacted again....

Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants

The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.

First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers

Background: PDE4D is a protein found in the brain. It helps control chemical signals that affect mood, memory, and thinking. Problems with PDE4D may play a role in depression and Alzheimer's disease. Being able to measure PDE4D levels in the body would help doctors identify and manage these diseases. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them see PDE4D in people more effectively. Objective: To test a new tracer (\[11C\]JMJ-129-d2) during imaging scans of the brain and body in healthy people. Eligibility: Healthy people aged 18 years and older. They must have been screened under protocols 01M0254 or 17M0181. Design: All participants will give samples of blood and urine. They will have a test of their heart function. A plastic tube will be inserted into a vein in their arm; the new tracer will be given through this tube. Some participants will have 1 positron emission tomography (PET)/computed tomography (CT) scan of their whole body. They will lie on a padded bed that slides into a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body. Some participants will have 1 or 2 PET/CT scans of their brain only. Their head will be supported to keep it still during the scan. They will also have a magnetic resonance imaging (MRI) scan of the brain. MRI uses magnetic fields to capture images of the inside of the body. The MRI scan may require a second visit. All participants will receive a follow-up call to check on their well-being 1 to 3 business days after their scans.

PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)

Background: About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI. Objective: To test whether medical imaging using a new radiotracer (\[18F\]PF-06445974) can measure PDE4B in the brains of people with AD or MCI. Eligibility: People aged 50 years and older with AD or MCI. Healthy volunteers are also needed. Design: Participants will have up to 5 clinic visits with 3 imaging scans of the brain. They will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory. Participants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each. Participants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....

A Study of LY3867070 in Healthy Participants

The purpose of this study is to evaluate how well LY3867070 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Great Toe Strength (GTS) is a potential clinical biomarker that has been associated with functional mobility and health; Additionally, GTS has been identified in the literature as one of the early symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The purpose of this research study is to evaluate GTS in individuals with CIPN and healthy adults using ToeScale and see how it relates to nerve issues from chemotherapy. Additionally, we aim to assess the usability of the novel GTS assessment device, ToeScale among the participants. As a part of this study visit, you will complete some questionnaires followed by GTS and balance and gait assessments.

Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration. The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.

Glutamatergic Mechanisms: Aim2

In the present study, 120 healthy volunteers (HV) will be randomized to one of three ketamine-induced pharmacoBOLD (phBOLD) arms: low, medium, and high. Within each ketamine arm, participants will be randomized to 4 days of "study drug" \[TS-134 (1st 20 participants) or XT (remaining 100 participants)\] or placebo in a 5:3 ratio (25 study drug:15 placebo per arm). During the study, each participant will undergo a Screening Period (up to 31 days), a 4-day Treatment Period, and a total of two phBOLD sessions: a first session at Baseline and a second session on Day 4 of the Treatment Period, conducted at least 7 days apart, and a follow up visit.

Pregnancy 24/7 Offspring Study

There is growing evidence that maternal health and behaviors in pregnancy, such as pre-pregnancy obesity, excessive gestational weight gain, poor diet, smoking, and adverse pregnancy outcomes, are linked to fetal programming for obesity and cardiovascular disease (CVD) risk in the offspring. Yet, there is a surprising lack of research on the role of prenatal sedentary behavior, physical activity, and sleep (conceptualized together as 24-hour behavior) on offspring obesity risk and CVD risk; this is an unfortunate research gap since there is strong physiological rationale that these behaviors in pregnancy could influence offspring health and are modifiable intervention targets in pregnancy. This multi-site observational cohort study will leverage state-of-the-art, 24-hour behavior assessment in each trimester of pregnancy, collected as part of the Pregnancy 24/7 cohort study and add additional assessments of offspring growth, adiposity, and CVD risk through 24 months to inform future primordial prevention interventions to decrease the risk of offspring obesity and CVD across the lifespan.

A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems

This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m\^2 can take part. Women can only participate if they cannot get pregnant. This study includes people with mild liver problems, people with moderate liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild and moderate liver problems affect how the body handles a medicine called zongertinib. Participants take zongertinib once as tablets. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times. This also includes an overnight stay for 6 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the study staff regularly takes blood samples.

A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005)

Researchers are looking for new weight loss medicines for people with higher body weight. The trial medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a trial medicine to participants with a health condition, researchers first do trials in healthy participants to find a safe dose level (amount) of the trial medicine. The goal of this study is to learn what happens to MK-4082 in a person's body over time. Researchers will compare what happens to levels of MK-4082 in people's blood when it is taken alone (Part 1, Period 1 and Part 2) and in combination with (Part 1, Period 2) another medicine called diltiazem. Researchers also want to learn about the safety of MK-4082 taken with and without diltiazem and if people tolerate them.

Pediatric Parenting Support in Flint

Public health disasters have disproportionate impacts on low income communities, through pathways that add to those of poverty and associated stressors, and act over extended periods. Very young children are highly vulnerable to long-term impacts on development and mental health in the context of parenting challenges following disasters, yet frequently receive the least attention and resources. This study will test the role of universal parenting support in enhancing young children's development and mental health in Flint, Michigan following the Flint Water Crisis.

Peer-Supported Clinical Orientation Training

This randomized controlled study will aim to evaluate the effect of a peer-supported video and interaction-based clinical orientation program on reality shock and adaptation during the first clinical experience. The study will be conducted with nursing students who will start their first clinical practice. Participants will be randomized into intervention and control groups. The intervention group will receive a peer-led orientation program including videos recorded in real clinical settings by senior students, interactive question-answer sessions, a structured hospital tour, and ongoing digital communication support. The control group will receive the routine clinical orientation. Data will be collected at two different time points. The first measurement will be performed at the end of the second week of clinical practice to allow students to experience the clinical adaptation process. The second measurement will be conducted four weeks after the first assessment. Reality shock and clinical adaptation levels will be evaluated using valid and reliable scales. This study is expected to provide evidence on the effectiveness of peer-supported and technology-enhanced orientation strategies in facilitating students' adaptation to clinical environments and contribute to the development of innovative practices in nursing education.

A Study to Test How Well Different Doses of BI 3821001 Are Tolerated by Healthy People

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 administrations of multiple rising doses.

A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07985631) for the possible treatment of a kidney disease called IgA nephropathy. This study is seeking participants who * are male or female between 18 and 45 years of age (55 for Japanese/Chinese/multiple dose participants) * are deemed to be healthy Participants in this study will receive PF-07985631 or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07985631 or placebo will be given as a small needle injection (in the abdomen, thigh or back of the arm) or as an IV infusion in the arm (given directly into a vein) at the study clinic. Most participants will receive PF-07985631 or placebo one time. Some participants may receive PF-07985631 or placebo once a month for 3 months. The study will compare the experiences of people receiving PF-07985631 to those of the people who do not. This will help decide if PF-07985631 is safe and effective. Participants who take PF-07985631 or placebo only 1 time will take part in this study for about 4 months. During this time, they will stay at the study clinic for 11 to 14 days and will have 8 more study visits at the study clinic. Participants who take PF-07985631 or placebo more than once will take part in this study for about 6 months. During this time, they will stay at the study clinic for about 4 days a month 3 times and will have 10 more study visits at the study clinic. During study clinic stays and study visits, blood samples will be done and safety reviews completed.

A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body

The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.

Study of New Magnetic Resonance Imaging Methods of the Brain

The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. This study will evaluate new MRI methods for monitoring blood flow to regions of the brain in response to simple tasks. The MRI machine used in this study is more powerful than those in most hospitals, permitting a higher visual resolution. Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will be screened with a medical history and questionnaire, and a neurological examination. Study participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. A lightweight circular or rectangular coil-a device that improves the quality of the images-may be placed on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and 90 minutes. During the scan, the subject may perform simple tasks, such as listening to tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons. Information from this study will be used to develop better imaging methods that will, in turn, permit a greater understanding of normal and abnormal brain behaviors. ...

A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting conditions.

Meditation and Yogic Breathing-driven Modulation of Neurofluid Coupling and Brain Clearance

This study will examine whether meditation and yogic breathing can alter brain fluid movement and waste clearance in healthy adults. It will also evaluate the GLYMPHOMETER, a new external forehead-worn device designed to objectively measure changes in brain fluid movement and exchange during meditation.

A Study of MK-7240 in Healthy Participants (MK-7240-009)

The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 and if people tolerate it.

Testing the Feasibility and Impact of a Whole-Food Plant-Based Diet Intervention on College Students

The goal of this pilot randomized controlled trial (RCT) was to assess the feasibility, acceptability, and impacts of a whole-food plant-based (WFPB) vegan diet intervention for undergraduate university students randomly assigned, stratifying by sex and race/ethnicity, to one of two intervention groups (each with a distinct teaching-learning design, i.e., interactive (IA) versus lecture-based (LB)) and a control group. The main questions the researchers aimed to answer were: * Were the study procedures feasible and acceptable for the overall sample and were the intervention sessions, following a WFPB vegan diet, and the prospect of continuing this diet feasible and acceptable for the intervention participants? * Were there greater improvements in diet quality, WFPB vegan diet adherence, physical and mental health, and intrapersonal factor outcomes for the intervention group engaging in interactive learning compared to the intervention group learning through traditional lecture? And were there greater improvements in these outcomes for both intervention groups compared with the control group? The researchers compared the group outcome means for the two intervention groups against one another and those for the two intervention groups against those of the control group. Study participants completed two sets of measurements over the course of 6 weeks. * All participants completed online baseline and post-intervention surveys and in-person baseline and post-intervention biometric measurements. * Only the intervention group participants attended three 75-minute consecutive weekly intervention sessions to learn about different aspects of the WFPB vegan diet between the two sets of survey and biometric measurements.

The Effect of Short-term Supplementation of OliPhenolia® on Fat Oxidation

There is current research interest in the use of fruit and plant-based food products containing high levels of natural antioxidants and their impact on exercise, which may be particularly beneficial for recreationally or low-active populations. One such product is an olive extract drink (called OliPhenolia®) produced by Fattoria La Vialla (an organic farm based in Northern Italy) and commercially available for the general public. Whilst previous research from the investigators (at Anglia Ruskin University) using this product has demonstrated potential antioxidant benefits and reduced oxygen cost during aerobic exercise, there are to date no studies investigating whether the short-term consumption of OliPhenolia® can benefit fat oxidation during exercise or whether such effects can be further enhanced employing a pre workout caffeinated beverage. Therefore the aim of this study is two-fold: i) to assess the impact of short-term supplementation (8 days) of OliPhenolia® relative to body mass on fat oxidation during aerobic cycling exercise in comparison to placebo in healthy recreationally active volunteers; and ii) whether potential benefits of OliPhenolia® on fat oxidation are enhanced with a pre-workout caffeinated beverage in comparison to placebo in healthy recreationally active volunteers.

A Study to Evaluate the Effect of Genetic Variation on Beta-cell Function During Fasting and Hyperglycemia in Nondiabetics

The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study to find out how genetic variations in GLP1R alter insulin secretion, in the fasting state and when blood sugars levels are elevated.

Deliver-EE: Evaluating Effects of Meal Delivery

This study will randomly assign 2,300 older adults on waiting lists at fourteen Meals on Wheels programs in Florida, Illinois, Maryland, Tennessee, Texas, North Carolina, South Carolina, and California into two groups who will receive: (a) daily delivery of meals, five days a week or (b) a shipment of 10 frozen meals, every two weeks. Researchers will examine participants' Medicare claims to understand if differences in healthcare utilization occur between the two groups within six months after they start receiving meals. Researchers will also ask participants questions prior to receiving meals, and again at three months, to understand how meals impact their ability to obtain food, their feelings of loneliness, and their overall quality of life. The primary study outcome will be the ratio of days spent in institutional settings (i.e., hospital, nursing home) in the six months after participants begin receiving meals. The secondary outcomes include the ratio of days spent in institutional settings in the three months after participants begin receiving meals, food insecurity, subjective isolation/loneliness, and health-related quality of life. The team will also examine differences in dietary intake between the two groups as an exploratory outcome.