Clinical Research Directory

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....

Effectiveness of Aquamin® in Mitigating Halitosis

The purpose of this study is to assess whether Aquamin®, a multi-mineral natural product from red marine algae, can help reduce halitosis when taken for 90 days.

Vitamin and Mineral Absorption From Milk and PBMAs

Plant-based milk alternatives (PBMAs) are a popular alternative to cow's milk. The different types of PBMAs on the market shelf include almond, oat, soy, coconut, cashew, pea, hemp, and rice. Among these, PBMA made from almonds, oats and soy are the most popular in North America. Though PBMAs are designed to mimic cow's milk in terms of color, they often have a very different nutrition profile. In order to better substitute for cow's milk, PBMAs often have added vitamins and minerals, as well as added sugars and flavorings to improve flavor. This study will test how well certain nutrients (vitamin D, calcium, potassium, and magnesium) are absorbed by the body after intake of milk and PBMAs. Nutrient absorption will be measured using blood samples after short term intake (from 1 hours to 1 week) of almond, soy, and oat milk, and compare it to cow's milk. Participants in the study will avoid all fluid dairy products and vitamin-D supplemented foods for three weeks and then be asked to consume either almond, soy, oat, or cow's milk for one week. All participants will visit the Clinical Nutrition Research Center (CNRC) four times over the course of about one month. These visits include a screening and pre-study visit (1.5 hrs), a pick-up visit (30 min), one long study day visit (\~11 hours), and two shorter follow up study day visits (1 hr).

Investigating ELSI Issues That May Facilitate or Impede Clinical Translation of Epigenetic Research. Phase 3b

Few people realize that environmental pollution and some behaviors like physical activity and tobacco smoking can affect their health by "turning on" or "turning off" certain genes through a process called "epigenetic modification." This study will develop and test strategies for communicating about epigenetics that are understandable and that do not increase ethical, legal or social issues (ELSI).

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....

Expansion of Childhood Relationship Study to Young Adult Romantic Relationships

Background: \- An earlier study on child development focused on the relationship between children and their caregivers (usually mothers). It looked at how this relationship influenced children's social and mental development. It also studied how these children related with family members and friends. Researchers are now interested in expanding the study with the same group of children. They want to look at these children, who are now young adults, and focus on their current romantic relationships. This new study will look at how child development affects the formation of stable, mature romantic relationships in young adulthood. Original child study participants and their significant others will be included in the new study. Only participants who are living together with a partner will be studied. Objectives: \- To look at romantic partnerships in a childhood study s original participants and their significant others. Eligibility: * Participants of the 88-CH-32 study who are at least 18 years of age. * Significant others of the study participants who are at least 18 years of age. * Original participants and significant others must be cohabiting (living together). Design: * No screening tests will be required for this study. No study visits will be needed. Samples will not be collected. * Original study participants will fill out four online questionnaires. They will be on a National Institute of Child Health and Human Development (NICHHD) website. They will ask personal questions about relationships with the current romantic partner and other important people. The questions will take about 25 minutes to answer. * Significant others will fill out 13 online questionnaires. They will be on a NICHHD website. They will ask personal questions about the romantic partner and other important people. The questions will take about 1.5 hours to answer. * All participants will receive a small amount of money for completing the study.

A Clinical Trial of Multiple Formulations of MK-4082 in Healthy Overweight and Obese Participants (MK-4082-007)

Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) and formulation (version) of the study medicine that can be used in future studies. The goals of this study are to learn about: The safety of different formulations of MK-4082 and if people tolerate them What happens to different formulations of MK-4082 in a person's body over time

Sodium Storage in Singaporeans

The overarching hypothesis of this study is that the kidney and the skin form an integrative network for water conservation, where Na+ storage is utilized to prevent body water loss, even at the expense of increased cardiovascular risk. The aim of this project is to characterise skin and muscle Na+ storage in a cohort designed to prospectively measure cardiovascular outcomes in Singaporeans, in order to determine whether humans with increased tissue Na+ storage have increased cardiovascular risk. To gain a better understanding of the mechanisms behind Na+ storage, the investigators will also test the hypothesis that participants with mutations of the skin protein filaggrin, who have increased water loss through the skin, will have increased skin Na+ storage and higher blood pressure levels.

A Study to Learn About the Single Dose Pharmacokinetics of Study Medicine Called Tilrekimig in Healthy Adults When Co-Mixed With rHuPH20

This study aims to learn how the body handles tilrekimig when given with another medicine called recombinant human hyaluronidase PH20 (rHuPH20). rHuPH20 is approved to help some medicines be taken up by the body when they are given together as an injection (shot) under the skin.

A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women

The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics \[PK\]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.

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.

Cognitive-Motor Incorporated Training and Its Relations in Cerebrovascular Diseases With Cognitive and Motor Impairments

The following three-part proposal will explore the impact of applying motor-cognitive incorporated training (MCIT) in individuals with post-stroke cognitive impairment (PSCI) or Moyamoya disease (MMD), and examine the relationship between cognitive and motor impairments and brain activation patterns in these populations. Part I is a cross-sectional study designed to characterize cognitive and motor performance and their relationship with brain activation patterns in individuals with post-stroke cognitive impairment (PSCI) or Moyamoya disease (MMD), compared to age-matched healthy controls. Thirty participants will be screened for eligibility and recruited for each group (90 participants total). After collecting basic data, all participants will undergo cognitive and motor function tests. Cognitive function tests include tests of global cognition, and executive function. Motor function tests include tests of sensorimotor function, single and dual task standing, muscle strength, and ambulation ability. Functional near-infrared spectroscopy (fNIRS) will be used to evaluate the brain activation during the cognitive tests, and single and dual task standing. Results from all tests will be used to determine the motor, cognitive, and other functional performance, and will be used in the design of the training program in Part II and III. Part II and III are single-blinded randomized controlled trials that will explore the short and long-term effects of a motor-cognitive incorporated training (MCIT) on motor, and cognitive function in individuals with post-stroke cognitive impairment (PSCI) or Moyamoya disease (MMD). 60 individuals with PSCI (Part II), and 60 individuals with MMD (Part III) will be recruited. After screening for eligibility and collection of demographic data, participants will undergo a pretest assessment. In addition to the motor and cognitive tests used in Part I, stroke location, and time of onset will also be collected for each participant. Brain activation will be assessed during the cognitive tests, single and dual task standing assessments using fNIRS. Participants will be randomly allocated to one of the two groups (MCIT group and active control group) (n=30 in each group) via a sealed envelope selected by a blinded assistant. The training protocol is 30 minutes per session, 3 sessions per week for a total of 4 weeks. The control group will receive motor training only, including upper and lower extremity exercises, bed mobility, strengthening (core and extremities), and balance training, progressing from static to dynamic tasks. The MCIT group will engage in the program combines motor and cognitive training that starts with attention and short-term memory tasks, advancing to working memory and inhibitory control with increasing difficulty. A post-test will be conducted after the 4-week intervention, followed by follow-up assessments at 1, 3, and 12 months for individuals with PSCI or MMD in both the control group and the MCIT group. At the 3-month follow-up, participants who are unable to attend in person will be contacted by telephone. At the 12-month follow-up, all participants will receive a telephone interview focused on return-to-work status.

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.

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

A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants

To assess pharmacokinetics, safety, and tolerability of multiple oral doses of verducatib in healthy Chinese male and female trial participants in order to facilitate the clinical development of verducatib in China.

Endogenous Oxalate Synthesis in Idiopathic Calcium Oxalate Kidney Stone Disease

The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased production of oxalate by the body, 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 amounts of oxalate for 5 days ingest a soluble form of glycolate and vitamin C collect urine, blood, stool during the dietary and oral dosing portions of the study and also collect breath sample during the oral glycolate test

Breathwork and Stress: Investigating the Mechanisms of Action and Effectiveness of Breathing Interventions in Modulating the Psychophysiological Response to Acute Stress Test

This study investigates whether the psychophysiological benefits of breathing exercises are driven by a specific physiological rhythm (6 breaths per minute) or by the general psychological experience of performing a structured, mindful activity. Researchers aim to determine if "coherent breathing", which is hypothesized to synchronize heart and respiratory rhythms, offers unique physiological protection against stress compared to breathing at a natural pace or simple resting. The main questions it aims to answer are: * Does slow, steady breathing at 6 breaths per minute lower physical stress markers (like heart rate variability and cortisol) better than faster, but structured breathing or just sitting still? * Is the calming effect caused by the specific breathing rhythm or simply by performing a structured, relaxing activity? Researchers will compare three groups to see if the specific rhythm of "coherent breathing" offers unique benefits: 1. Group (Interventional): Coherent Breathing: Slow breathing at 6 breaths per minute. 2. Group (Sham Breathing): Regular breathing at 15 breaths per minute (matching a natural pace). 3. Spontaneous Breathing (Control Group): Natural, unguided breathing. Participants will: * Complete a one-day preparation phase to become familiar with the breathing technique. * Visit the research center for one experimental session. * Perform their assigned breathing method before and after a stress test. * Take the Maastricht Acute Stress Test (MAST), which involves putting a hand in cold water and doing mental math. * Provide saliva samples and have their heart rate variability, and mood measured multiple times.

Renal Metabolism of Glycolate to Oxalate

This study will determine the contribution of glycolate metabolism to urinary oxalate excretion in healthy subjects, using carbon 13 isotope glycolate tracer technique and a low-oxalate controlled diet.

Characterizing the Scalp Tolerability of TMS

The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters.

New Heart Imaging Techniques to Evaluate Possible Heart Disease

Background: \- Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography. Objectives: \- To compare heart MRI techniques with other tests used to diagnose heart disease. Eligibility: \- People at least 18 years of age who either have or may have heart disease, or are healthy volunteers. Design: * Participants will be screened with a physical exam, medical history, and blood tests. * They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease. * Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan. * No treatment will be provided as part of this protocol.

Impact of Heat on Dual Task Performance

This study looks at how people response performing single and dual tasks (cognitive and motor) prior to and after a rapid heat stress that increased core temperature to 39C.

A Study of HW243040 in Healthy Participants

This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants.

A Study in Healthy People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food

The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.

A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults

A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of single and multiple dose regimens of SYNT-101 in healthy and overweight adults.