Clinical Research Directory

Anthropometric Normalization in Inter-Individual Variability of Comprehensive Isokinetic Strength Assessment

Accurate normalization of peak torque (PT) is critical for comparing muscle strength across individuals of varying body composition. While body weight (BW) is commonly used, body mass index (BMI) may provide a more stable representation of inter-individual variability. The study aims to compare the effects of BW and BMI normalization on inter-individual variability of trunk, hip, and knee muscle strength in healthy female participants.

Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants

The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.

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....

"Xuong Tan Lac Than" Exercise for Range of Motion and Muscle Endurance

The goal of this clinical trial is to learn the effects of the "Xuong tan lac than" exercise on range of motion and muscle endurance in healthy volunteers. The main questions it aims to answer are: * Does practicing the "Xuong tan lac than" exercise improve joint range of motion (cervical spine, lumbar spine, shoulder, elbow, wrist, knee, and ankle)? * Does the exercise improve muscle endurance around these joints? Participants will: * Perform the "Xuong tan lac than" exercise for 12 weeks (5 days per week, once daily). * Be trained to perform the exercise correctly before starting the intervention. * Undergo assessments of joint range of motion and muscle endurance at baseline and after 2, 4, 8, and 12 weeks.

Predicting Future Errors During Skill Performance

Background: Many tasks people do every day require a series of individual movements. Control over these movements is called motor skills. But even highly skilled people can make mistakes. Researchers have found that they can predict when a person will make a mistake 0.1 second before it happens. Now, they want to find out if they can increase that time up to 1 second-long enough to warn the person and prevent the mistake. Objective: To see if motor skill errors can be detected up to 1 second before they occur. Eligibility: Right-handed healthy adults aged 18 to 35. Design: Participants will have 2 to 5 study visits. Each visit will be 1 to 2 hours. They will have a physical and neurological exam. They will have 1 or 2 magnetic resonance imaging (MRI) scans. They will lie on a table that slides into a large cylinder. The MRI uses strong magnets to capture images of the inside of the body, including the brain. They will have another scan, called magnetoencephalography (MEG). Small metal disks attached to wires will be taped to their head. Participants will sit in a padded chair with their head inside of a helmet. The helmet will not cover their eyes or face. Participants will perform a series of typing tasks on a keyboard. They will have short breaks between each round. Their head movements will be tracked, and their eye and finger movements will be videotaped.

A Study of [14C]-LY4064809 in Healthy Participants

The purpose of this study is to determine in healthy participants the percentage of LY4064809 that enters bloodstream after oral administration. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 21 days, not including screening. Participants will remain in the clinical research center for 14 days.

Activation-Socialization Intervention Program for Seniors

Objective No. 1: Verify the short-term effectiveness of the Activation-Socialization Intervention Program on the experiences (emotionality, anxiety) and behavior (agitated behavior) of seniors in the experimental and control groups. Objective No. 2: Verify the long-term effectiveness of the Activation-Socialization Intervention Program on the experience (emotionality, anxiety) and behavior (agitated behavior) of seniors in the experimental and control groups.

A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function

This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose. The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. By comparing these groups, researchers want to understand whether liver function changes how the medicine behaves in the body. People who join the study will receive one injection of the study medicine. They will stay at the study clinic for a short time and return for follow-up visits so doctors can do blood tests, physical exams, and safety checks. This study is not expected to provide direct medical benefit to participants. The information collected will help researchers develop future treatments and understand how this medicine may be used safely in people with liver disease.

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 of the Effect of Diltiazem on the Plasma Levels of Nemtabrutinib (MK-1026-022)

The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called diltiazem.

To Evaluate the Safety, Pharmacokinetic and Pharmacodynamics of JW0061 in Healthy Volunteers

This clinical study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation clinical trial to evaluate the safety, pharmacokinetic and pharmacodynamics of JW0061 following topical application in Korean and Caucasians healthy adults.

Spectral Characteristics of Memory Transformation

Sometimes, it is necessary to re-learn a previously learned movement behavior, for example, a bad posture during the golf drive or while playing the piano. Unlearning or relearning an intensively trained behavior is particularly important if the behavior is hampering recovery, for example, in chronic pain or after a stroke. With this pilot study, the brain mechanisms that control the change of pre-existing stable memories of a motor skill will be tested with electroencephalography (EEG). Non-invasive brain stimulation will be used to modulate these brain mechanisms and test if it is possible to change the pre-existing motor memory and the learning of a new motor skill.

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.

A Study in Healthy People to Test How Vicadrostat Affects the Heart

The main objective of this trial is to investigate the effect of vicadrostat on the heart compared with placebo in healthy male and female volunteers.

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 Study to Understand How a Study Medicine Called PF-07328948 is Absorbed and Processed in the Body of Healthy Male Adults

The purpose of this study is to learn how a certain amount of \[14C\] PF-07320948 is taken up into the bloodstream and removed from the body. This study is seeking participants who are: * Male between 18 to 64 years of age * Deemed to be healthy This is a 2 Part, 4 Period study where Part 1 has Periods 1 and 2 and Part 2, which is optional, has Periods 3 and 4. Part 1 * Period 1: The purpose is to see how much of the study medicine PF-07328948 gets into and leaves the body. * Period 2: The goal is to compare how much PF-07328948 is available in the body when taken by mouth versus by injection into the blood. Part 2 (Optional) * Period 3 (optional): If needed, the purpose is to see how PF-07328948 acts after taking it daily until the body reaches a steady level. * In Period 4 (optional), the goal is to check again how much PF-07328948 is absorbed and leaves the body after daily dosing. During study clinic stays and study visits, the study team will collect urine and blood samples and perform safety reviews. If only Part 1 is conducted, total time in the study (screening (start) through follow-up (end)) will be about 14 weeks. If both Part 1 and Part 2 are conducted, total time in the study will be about 22 weeks.

Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults. It also assessed the effects of magnesium on selected blood markers. The main questions it aimed to answer were: Did magnesium supplementation improve sleep quality? Did magnesium supplementation improve cognitive function? Researchers compared participants who received magnesium citrate to a control group that did not receive any intervention to evaluate its effects. Participants: Took magnesium citrate (400 mg daily) for 90 days (two capsules: one in the afternoon and one 1-2 hours before bedtime) Visited Umm Al-Qura University twice (before and after the intervention) for: Sleep quality assessment Cognitive function assessment Blood sample collection to measure serum magnesium and HbA1c The control group did not receive any supplementation during the study period.

Fermented Papaya and Driving Simulator Older Adult Study

Yes, this additional detail will refine the original template content to emphasize the study's specific aims and hypotheses. Here's an updated version: The goal of this clinical trial is to assess if Fermented Papaya Preparation (FPP) can enhance driving performance and reduce driving errors in community-dwelling older adults aged 70-80, who serve as their own controls. The main questions it aims to answer are: Does FPP reduce the total number of driving errors, particularly those related to psychomotor performance? Does FPP improve driving-related cognitive functions, such as divided attention, working memory, reaction time, and executive function? How do FPP dosage, timing, and acute effects impact driving performance in adults aged 65 and older? Participants will: Consume three doses of FPP (3 grams per dose) within 24 hours, with the final dose administered before the simulator driving test. Complete a high-fidelity driving simulation to assess the association between FPP use and driving errors that predict on-road performance. Undergo baseline and post-FPP cognitive assessments to compare psychomotor performance and cognitive functions after FPP administration.

Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women

The aim of the present clinical trial is to examine the effects of everolimus, resistance training, or their combination on bone and muscle health formation in elderly women aged 60-75 years. The main questions it aims to answer are: Can rapamycin's analog (Everolimus), resistance training, or their combination, enhance bone formation and muscle functions in elderly women compared to non-treatment controls. Participants will be randomized 1:1:1:1 to one of the following treatment regimens: * Oral everolimus 5 mg once a week. * Oral placebo once a week. * Oral everolimus 5 mg once a week plus resistance training RT 1 hour, 3 times weekly. * Oral placebo once a week plus resistance training RT 1 hour, 3 times weekly. During the study there will be a total of 5-7 visits, where the participants will undergo the following: * Blood samles * DXA-, HRpQCT- (only Odense Universitetshospital) and MRI-scans * Muscle- and bone biopsies * Quality of life questionnaires * Testing of muscle funtion * Metabolic studies of muscle and bone protein turnover using labelling with deuturated water

Selective PET Imaging of Astrocytes and Microglia in Alzheimer's Disease

Inflammation occurs in many brain diseases including Alzheimer's disease. In Alzheimer's disease, an abnormal protein called amyloid starts accumulating decades before the start of forgetfulness. However, scientists have reported that inflammation but not amyloid is linked to forgetfulness and the topography of brain inflammation and tau buildup are closely correlated in patients with mild cognitive impairment due to Alzheimer's disease. New medications are under development to help healing and prevent permanent damage in the brain. To see if inflammation is improving or getting worse with these medications, investigators can watch inside of the brain using a special camera called positron emission tomography (PET). It is currently possible to watch inflammation in the brain by taking pictures of a molecule called translocator protein (TSPO). But the problem is that by imaging TSPO, investigators can catch changes in more than one kind of cells. The information is not specific to each cell type. Such vague information is not completely useful to monitor the effect of new medications for inflammation. This proposal attempts to develop a novel method to capture changes in each of two major players in inflammation, microglia and astrocytes. To do so, investigators will take selective pictures of one cell type by using a novel imaging agent for PET. Investigators will also take PET pictures of TSPO. Investigators will process these two kinds of PET pictures using advanced mathematical methods and extract specific information on microglia and astrocytes. Our novel method will be useful to monitor new therapies to treat inflammation in the brain.

Study to Evaluate Pharmacokinetics, Relative Bioavailability, Palatability of Obefazimod Minitablet Formulation

The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of the 50mg minitablet compared to the adult obefazimod 50 mg capsule in adult healthy volunteers.

Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term Travel

This study aims to evaluate the effects of a dual Bifidobacterium longum probiotic formulation (dipro-O and dipro-X) on sleep quality, stress responses, and gut microbiota stability in healthy adults during short-term travel. Using a randomized, double-blind, placebo-controlled design, the study investigates whether probiotic supplementation can enhance sleep resilience, buffer stress, and modulate microbiome and physiological responses under travel-related environmental changes.

Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study

This study includes an open label clinical trial comparing two doses of CoQ10 for 8 weeks to improve fatigue among patients with Crohn's disease and a prospective cohort study of healthy controls taking CoQ10 for 2 weeks. Additionally, among 15 participants who do not meet the fatigue threshold for the open label trial, the investigators will measure CoQ10 levels in blood and fasting urine, as well as complete the same data collection. Hypotheses 1. Fatigue will improve with CoQ10 and there will be a dose response with greater improvement with higher dose as measured by the Patient Reported Outcomes Measurement Information Systems Fatigue PROMIS Fatigue 7a instrument. 2. Fatigue will improve when measured with other fatigue scales in a similar dose dependent manner and that general and physical fatigue will improve more than mental fatigue. 3. CoQ10 will improve quality of life as measured with the short Inflammatory Bowel Disease Questionnaire (sIBDQ).

Use of Incentives for Stressful Medical Procedures

The goal of this clinical trial is to learn about the use of incentives in pediatric patients requiring medical procedures. The main questions it aims to answer are: Are incentives effective at reducing pediatric anxiety for medical procedures? What is the best way to use incentives with pediatric populations requiring medical procedures? Participants will be provided support in preparation for their procedure and during the procedure by a child life specialist and might receive an incentive prize after their procedure. Participants distress levels during the procedure will be observed and they will be asked to rate their anxiety on a visual analog scale. Researchers will compare the anxiety of those who did or did not receive an incentive after their procedure to see if incentives reduced procedural anxiety.