Clinical Research Directory

Effects of Different Intensities of Bilateral- and Cathodal Transcranial Direct Current Stimulation in Healthy Individuals

This study will separate study to investigate the effects of 1 mA, 1.5 mA, and 2 mA of 1) bilateral- and 2) cathodal tDCS on cortical activity and motor learning in healthy individuals

Efficacy and Safety of Acute Topical and Aromatic Essential Oil-Based Products for Cognitive Support

This study will evaluate whether the InTune product system may help support attention, memory, focus, and other thinking skills in healthy adults ages 18-64. Participants will be randomly assigned to receive either the InTune products or placebo products that look and feel the same but do not contain active ingredients. Participants will use the products throughout their participation in the study and complete a series of cognitive tests and questionnaires at the beginning and end of the study. Researchers will compare changes in memory performance, self-reported mental clarity and focus, product experiences, and any side effects between the two groups.

Efficacy and Safety of an Essential Oil-Based Product System for Immune Support

This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety and efficacy of an essential oil-based product system for immune support in healthy adolescents and adults aged 18-45 years. Participants will be randomized to receive aromatic, topical, internal, or combined use of the investigational product or matching placebo for 30 days. The aromatic intervention consists of overnight diffusion, the topical intervention consists of diluted application to specified areas prior to bedtime, and the internal intervention consists of oral capsule administration twice daily. Study visits will occur at baseline and at the end of the 30-day intervention period. Primary outcomes include changes in immune-related biomarkers, including complete blood count, comprehensive metabolic panel, salivary immunoglobulin A (IgA), and inflammatory cytokines (IL-6, TNF-α, IL-10). Epigenetic markers will also be evaluated. Secondary outcomes include validated subjective assessments of immune status and overall well-being, as well as evaluation of safety and tolerability. The study includes an adaptive design with interim analysis to assess enrollment and study continuation parameters.

Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique

Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested. Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations. Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations. The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique.

Ultrasound Imaging of the Head, Neck, and Airway

Purpose and Objectives: The main purpose is to test an ultrasound device that can assess the upper airway to create dynamic 4D imaging, which current technology cannot do. Ultrasound waves travel well within soft tissue but are unable to penetrate cartilage, bone, and air-filled structures, obscuring findings which are covered by these structures and limiting the ability of the ultrasound to adequately image posterior to the soft tissue upper airway, trachea, or behind the mandible.

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.

Reject Analysis of Periapical Radiographs of Dental Implants.

Periapical radiographs of dental implants, acquired as part of two ongoing research projects, will be retrospectively analyzed using a newly developed image quality scoring form. Following an initial classification (Excellent - Acceptable - Rejected), a detailed assessment of the various image quality criteria and any deviations from these criteria will be performed. In addition, the frequency with which radiographs had to be retaken to obtain a diagnostically acceptable image will be evaluated. The influence of anatomical factors (e.g., implant location in the mouth, maxilla or mandible, etc.) and the use of individualized radiographic holders will also be assessed. Through this retrospective analysis of an existing dataset of implant radiographs, the study aims to identify the factors that have influenced image quality, the ability to accurately assess the surrounding bone level, and the need for repeat radiographic exposures. The findings may contribute to the development of guidelines to improve the quality of periapical radiographs and potentially reduce radiation exposure for patients.

Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users

The purpose of the present study is to assess prospectively the abuse potential of gabapentin when taken with and without oxycodone compared to placebo in healthy non-drug-dependent recreational opioid drug users under fasted condition.

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....

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....

A Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of SB35 (Proposed Ixekizumab Biosimilar) to Taltz in Healthy Participants

This is a randomised, double-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of ixekizumab (SB35 and Taltz) in healthy participants.

SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy

The purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. This study will test hypotheses relating to the presence and mechanisms of aberrant brain structure at the synaptic level in living humans with virologically controlled HIV on antiretroviral therapy. To evaluate associations between PET imaging radiotracers \[11C\]UCB-J, a ligand for presynaptic vesicle protein 2A (SV2A), a vesicle membrane protein expressed in synapses, and PET \[11C\]PBR28 a measure of microglia function in the brain, the Yale PET center has developed an advanced approach of combining multiple distinct ligands in coordinated same-day PET imaging. Additionally, the study will evaluate the associations of this novel synaptic density marker with well-established clinical measures of neurocognitive performance and laboratory measures of blood and cerebrospinal fluid (CSF).

Multidimensional Determinants of Functional Health In Women Aged 45-60

The goal of this observational study is to learn about the multidimensional determinants of functional health in women aged 45 to 60 years. The study will focus on the role of muscle strength, bone mineral density, body composition, physical activity, sleep quality, depressive symptoms, and menopause-related symptoms in functional health. The main questions it aims to answer are: 1. Does muscle strength contribute to functional health in women aged 45 to 60 years? 2. Does bone mineral density contribute to functional health in women aged 45 to 60 years? 3. How are physical activity, sleep quality, depressive symptoms, body composition, and menopause-related quality of life associated with functional health? Participants will: * Undergo handgrip strength measurement * Perform a 30-second chair stand test * Undergo bone mineral density and body composition assessment * Complete questionnaires about physical activity, sleep quality, depressive symptoms, menopausal symptoms, and quality of life * Provide demographic and clinical information

A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants

The main purpose of this study is to measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Blood tests will be performed to investigate how the body processes the study drug under each condition. For each participant, the study will last about 9 weeks and will include a stay in the Clinical Research Unit (CRU) lasting almost a month.

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

The purposes of this study are to determine: * The pharmacokinetics (the amount of study drug in your blood and how long it takes the body to get rid of it) of the study drug and its metabolites (substances produced as the body breaks down the study drug) in participants with moderate or severe liver function impairment compared to participants with normal liver function (also known as a healthy volunteer). Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug. * How well the study drug is tolerated and any side effects that may occur in participants with moderate or severe liver function impairment compared to participants with normal liver function. This study is for research purposes only and is not intended to treat any medical condition.

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.

A Study to Test How BI 3034701 is Taken up and Processed by the Body in Healthy Men With Normal Weight or Overweight

The main objectives of this trial are: To assess the mass balance (total recovery of \[14C\]-radioactivity) in urine, faeces, and expired air after a single subcutaneous dose of BI 3034701 (C-14) in healthy male trial participants.

Gut Oxalate Absorption in Calcium Oxalate Stone Disease

The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will * ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time * ingest a soluble form of oxalate and sugar preparations to test gut permeability * collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test

Imaging Techniques in MRI

Background: \- Magnetic resonance imaging (MRI) scans must be performed according to specified sets of parameters that provide optimal images of each organ and each area of the body. These scanning parameters are often specific to the institution or organization at which they are employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI scanning equipment is always being updated and upgraded, researchers are interested in developing new and optimized scanning parameters for MRI scans. Objectives: \- To improve current methods and develop new techniques for magnetic resonance imaging. Eligibility: * Individuals 18 years of age and older who are either volunteers or current NIH protocol participants. * Participants must not have any medical history factors (e.g., extreme claustrophobia, history of metal implants) that would prevent them from receiving MRI scans. Design: * Participants will have at least one MRI scan that will last from 20 minutes to 2 hours (most scans will last between 45 and 90 minutes). The total time commitment for most visits will be approximately 4 hours from start to finish. * Some MRI techniques require standard monitoring equipment or specific procedures during the scanning, such as an electrocardiogram. * Participants will have blood samples taken at the time of the scan. Some MRI studies will require the use of a contrast agent that will be administered during the scan. * Volunteers may be asked to return for additional MRI scans over the course of a few years. Follow-up scans may be done on the same part of the body or on different parts of the body. No more than one MRI scan will be performed in any 4-week period for this protocol.

Pulse Revolution: Enhancing Metabolic Health Through the Power of Processed Chickpeas

The purpose of this research is to test how processing can affect how one's body uses the nutrients in that food. For this study the researchers are examining how making different food products out of chickpeas, such as hummus or pasta, changes how one's body uses those foods for energy.

A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with and without liver problems. BI 1291583 is being developed to treat people with bronchiectasis, a chronic disease of the lungs. People living with this condition often also have liver problems. Therefore, it is important to find out whether liver problems influence the amount of BI 1291583 that gets into the blood. Study participants receive a single dose of BI 1291583 as a tablet taken by mouth. Participants are divided into 4 groups based on how well their liver works: 1 group without liver problems, and 3 groups with mild, moderate, and severe liver problems. Each participant without liver problems is matched with participants from the other groups based on factors such as age, sex, smoking habits, and body weight to ensure accurate comparisons. Participants are in the study for about 3 months. They stay for 3 days at the study site and also visit the study site up to 9 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The doctors regularly check participants' health and take note of any unwanted effects.

Evaluation of radKIDS 2.0, a Multi-media Training Program for Elementary School Bullying and Abuse Prevention

The goal of this clinical trial is to evaluate an adapted version of the radKIDS® Personal Empowerment and Safety Education Program in randomly assigned 4th grade classrooms. The primary hypothesis is that students in the radKIDS study arm will have significantly higher growth in safety knowledge, safety skill self-efficacy, confidence in help-seeking and in maintaining personal safety, and self-esteem compared to classrooms in the business as usual condition. At the student level, researchers will compare 4th grade students in classrooms randomized to receive the radKIDS program to those in classrooms receiving their regular instruction. Student participants will complete two surveys a few months apart assessing safety knowledge, self-efficacy, and self-esteem. In the radKIDS2.0 arm, students will receive the radKIDS program between the two surveys. In the control arm, students will receive instruction as usual.

A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.

Smart Sock Heart Rate Monitoring in Hospitalized Newborns

The goal of this observational study is to evaluate a commercially available smart sock for heart rate monitoring in hospitalized newborn infants without known heart disease. The study aims to determine whether the smart sock provides heart rate information comparable to that obtained from the standard patient monitor used in routine neonatal care. The main questions this study aims to answer are: * Does the smart sock provide heart rate measurements comparable to those obtained from the standard patient monitor? * Does the smart sock provide comparable information on clinically relevant rhythm abnormalities? * How do parents and healthcare professionals perceive the usability and safety of the smart sock? Participants will wear the smart sock while undergoing routine monitoring on the neonatal ward. Heart rate and rhythm data from the smart sock will be compared with data from the standard patient monitor. Parents and healthcare professionals will provide feedback on the usability and perceived safety of the device.