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172 Healthy Subjects Trials Near You
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Learn More About Power11C-JMJ-129 for Healthy Subjects
Bethesda, Maryland
Background:
PDE4D is a protein in the body that plays a role in thinking and depression. This protein may play a major role in disorders such as Alzheimer disease or major depressive disorder. To learn more about these disorders, researchers want to be able to detect levels of PDE4D in the brain. 11C-JMJ-129 is a new radiotracer (a radioactive substance that highlights parts of the body during imaging scans) that was developed to attach only to PDE4D.
Objective:
To test the new radiotracer 11C-JMJ-129 during imaging scans in healthy volunteers.
Eligibility:
Healthy people aged 18 years and older who had a screening assessment under protocol 01-M-0254.
Design:
Participants will have 2 to 4 clinic visits.
Participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function.
Participants will undergo 1 or more of these scans:
A positron emission tomography (PET) scan of the whole body. The radiotracer will be injected through a tube placed in a vein in the arm. Participants will lie on a table while a donut-shaped machine passes over them. Blood will be drawn from the arm during this scan.
A magnetic resonance imaging (MRI) scan of the brain. Participants will lie on a table that slides into a tube.
A PET scan of the brain. These participants will be injected with the radiotracer. They will lie on a table with their head in the scanner.
Participants will be called within 3 days after each PET scan for a check on their health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Axis I Diagnosis, Neurologic Illness, Seizures, HIV, Others
40 Participants Needed
Ethanol for Alcohol-Related Behaviors in Healthy Subjects
Bethesda, Maryland
Background:
Alcohol use disorder (AUD) can damage people s health, work, and family. Researchers want to know more about why some people are more vulnerable to AUD than others. The ZIP8 gene may be linked to an increased risk of AUD. Researchers want to find out how different forms of the ZIP8 gene affect how healthy people drink alcohol and how alcohol affects their brain.
Objective:
To study how genes may affect how people drink alcohol and how it affects their brain.
Eligibility:
Healthy people aged 21 to 60 years. They must not smoke, and they must have no history of AUD. They must have European ancestry and be enrolled in Natural History Protocol (14-AA-0181).
Design:
Participants will have 2 study visits.
At the first visit, participants will be given alcohol; it will be infused through a tube attached to a needle inserted into a vein. They may self-administer each dose by pressing a button. Over time, they will have to press the button an increasing number of times to receive more alcohol. The infusion period will last 2.5 hours.
Participants will have blood samples taken and breath measurments, and they will do computer tasks and complete questionnaires during and after the infusion. After the infusion, they will remain in the clinic until their breath alcohol levels drop to a safe level.
At the second visit, participants will have an imaging scan of their brain. They will do tasks and play games on a computer screen during the scan.
Some participants may have an extra visit for screening. A mid-study visit may also be needed if more than 6 months pass between the 2 study visits....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:21 - 60
Key Eligibility Criteria
Disqualifiers:Major Medical Illness, Psychiatric Disorders, Alcohol Use Disorder, Non-drinkers, Others
Must Not Be Taking:Antidepressants, Antihypertensives, Insulin, Others
50 Participants Needed
Synbiotic Supplement for Gut Health
Bethesda, Maryland
Background:
Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health.
Objective:
To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk.
Eligibility:
Healthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions).
Design:
Participants will have 2 clinic visits.
The first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study.
Eligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person.
The supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal.
The second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, Vegan, Chronic Diarrhea, Others
Must Not Be Taking:Prebiotics, Probiotics, Others
100 Participants Needed
HIV Vaccines Safety and Response in Healthy Volunteers
Bethesda, Maryland
Background:
Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious.
Objectives:
To test the safety and effects of three new HIV vaccines.
Eligibility:
Healthy adults 18-49 years old (vaccinees)
Their household and intimate contacts 18-65 years old
Design:
Vaccinees will be screened with:
Physical exam
Medical history
Blood and urine tests
Questions about HIV risk
Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study.
Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18-65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam.
All applicable participants will have a pregnancy test at every visit.
Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get:
1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits
The booster vaccine by needle in an arm at 1 visit
Nasal swabs taken at some visits
Vaccinees will note their temperature and symptoms for at least 1-4 weeks after each vaccine.
Vaccinees may choose to have:
Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm.
Small pieces of the tonsil removed
Sponsoring Institute: National Institute of Allergy and Infectious Diseases
...
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Uncontrolled Diabetes, Asthma, Others
Must Not Be Taking:Glucocorticoids, Immunosuppressives, Antivirals, Others
300 Participants Needed
Sprint Interval Training for Endurance Performance
Toronto, Ontario
Sprint interval training improves endurance performance and induces metabolic adaptations in muscle. Most research demonstrating these responses has been conducted in males, with limited studies evaluating changes to endurance performance and skeletal muscle oxidative capacity in females. Moreover, it is currently unknown if training in specific phases of the menstrual cycle influences adaptations to training. Thus, the purpose of the present study is to compare adaptations to 2 weeks of sprint interval training performed in the follicular vs. luteal phase of the menstrual cycle in healthy, eumenorrheic women.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 35
Sex:Female
Key Eligibility Criteria
Disqualifiers:PCOS, Endometriosis, Cardiovascular, Metabolic, Others
Must Not Be Taking:Oral Contraceptives, Corticosteroids, NSAIDs, Others
24 Participants Needed
Tryptophan Intake for Healthy Adults
Toronto, Ontario
Tryptophan is an essential amino acid needed for growth and bodily functions. It is used to make serotonin which is needed for the brain to develop and function properly. However, when the body is stressed, tryptophan is broken down into compounds that can cause harm to the brain. Premature babies who get nutrition through their vein \[i.e. total parenteral nutrition (TPN)\] can experience this type of stress. The amount of tryptophan in TPN solutions is much higher than what premature babies need and can produce too much harmful compounds. So, it is important to study the amount of these compounds made from tryptophan. But there are no methods available to study this. Therefore, the goal of this study is to develop a method to measure the compounds made from tryptophan breakdown in adults so that it can be used for preterm babies on TPN later.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Male
Key Eligibility Criteria
Disqualifiers:Diabetes, Cancer, Liver Disease, Others
Must Not Be Taking:Steroids, Anti-inflammatories, SSRIs, Others
6 Participants Needed
Barley Lysine Availability for Healthy Subjects
Toronto, Ontario
Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. Barley is an important cereal grain in the diet. The protein in barley is low in the essential amino acid lysine. Hence barley protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body. It is important to assess the effect of different cooking methods on the lysine availability of barley.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Male
Key Eligibility Criteria
Disqualifiers:Weight Loss, Allergy, Others
Must Not Be Taking:Steroids
7 Participants Needed
Brain Cooling with TMS for Healthy Subjects
Bethesda, Maryland
Sub-Study: Phase Triggered Paired Associative Stimulation (PAS) (actively recruiting)
Background:
-Previous research has shown that the brain s activity changes with changes in brain waves. We can study brain activity with a procedure called transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation. EEG allows for measuring ongoing brain waves. The goal of this study is to optimize TMS delivery by utilizing EEG-triggered TMS.
Objectives:
-To see if changes in brain waves change the brain and body s response to TMS.
Eligibility:
-Healthy, right-handed adults age 18-35.
Design:
* Participants will be screened under another protocol with medical history and physical exam. They may take a pregnancy test. They will have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. with:
* Participants will have up to 4 outpatient visits lasting 2-3 hours each (4 outpatient visits). The following procedures may occur at a visit:
* Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain.
* Electroencephalography (EEG): Small electrodes on the scalp record brain waves.
* Electromyography (EMG): Small sticky electrodes on the skin measure muscle activity.
* Transcranial magnetic stimulation (TMS): A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.
Main Study: Influence on Plasticity of Brain Temperature (no longer recruiting)
Background:
- Brain activity changes with changes in body temperature. Brain activity can be studied with a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the brain through the scalp using a cooling cap. They want to see if cooling changes the brain and body s response to TMS.
Objectives:
- To look at the effects of cooling on the brain.
Eligibility:
- Right-handed adults age 18-50 who can abstain from caffeine and tobacco.
Design:
* Participants will be screened with medical history and physical exam. They will be asked about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures.
* Participants will have 3 outpatient visits. The following procedures will occur at each visit.
* Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through the cap. It will feel like an ice pack in a towel. Their core temperature will be monitored. Their temperature will also be measured under their tongue and on scalp, stomach, forearm, and calf.
* Participants will have TMS before and after wearing the cap. A brief electrical current will pass through a wire coil held on their scalp. Electrodes that detect muscle movement will be placed on their hand. They will also have repetitive TMS, which uses repeated magnetic pulses. Their wrist will also receive a shock.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 35
Key Eligibility Criteria
Disqualifiers:Psychiatric Conditions, Neurologic Disorders, Implants, Others
Must Not Be Taking:Antidepressants, Anxiolytics, Anticonvulsants, Others
63 Participants Needed
CelluJuve Injections for Healthy Volunteers
North York, Ontario
Single-center, exploratory study assessing the safety and histological presentation of CelluJuve® injected into the brachium of healthy volunteers
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:30 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Skin Disease, Cancer, Others
Must Not Be Taking:Anticoagulants, Immunomodulating Therapy
10 Participants Needed
Suvorexant for Alcoholism
Bethesda, Maryland
Background:
Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.
Objective:
To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.
Eligibility:
People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.
Design:
Participants with AUD will stay in the clinic for at least 3 to 4 weeks for alcohol detoxification. They will receive normal treatment for AUD.
Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.
Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay.
Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.
Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies.
Imaging scans and other tests will be repeated at the end of the study.
Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.
...
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Severe Mental Illness, Severe Depression, Severe Hepatic Impairment, Others
Must Not Be Taking:Antipsychotics, Antidepressants, Opioids, Others
150 Participants Needed
Ketamine for Major Depressive Disorder
Bethesda, Maryland
Background:
Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect.
Objective:
Main Study: To study the effects of ketamine in treating depression.
Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry.
To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down.
Eligibility:
Main Study: People ages 18-65 with major depressive disorder and healthy volunteers
Ketamine Metabolites Substudy: Healthy volunteers ages 18-65
Design:
Main Study:
Participants will be screened in another study, with:
* Medical and psychiatric history
* Psychiatric and physical exam
* Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks.
Phase I (2-7 weeks):
* Gradually stop current medications
* MRI: Participants lie and perform tasks in a machine that takes pictures of the body.
* Mood and thinking tests
* Blood and urine tests
* Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep.
* Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity.
* Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks.
Phase I tests are repeated in Phases II and III and in the final visit.
Phase II (4-5 weeks):
* 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity.
Phase III (optional):
* 8 infusions of ketamine over 4 weeks
Phase IV (optional):
* Symptoms monitoring for 4 weeks
* Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months.
Ketamine Metabolites Substudy:
Participants will be screened in another study, with:
* Medical and psychiatric history
* Psychiatric and physical exam
* Blood, urine, and heart tests
Participants will be inpatients at NIH for 4 days.
Study Procedures:
Mood and thinking tests
Blood and urine tests
1 infusion of ketamine
Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Substance Abuse, Others
Must Not Be Taking:Reversible MAOIs, Opioids
150 Participants Needed
Improved Heart MRI Techniques for Heart Disease
Bethesda, Maryland
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Pacemaker, Severe COPD, Others
Must Not Be Taking:Metformin, Phosphodiesterase-5 Inhibitors
4000 Participants Needed
Sucralose for Healthy Subjects
Bethesda, Maryland
Background:
Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes.
Objective:
To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.
Eligibility:
People ages 18-60 who:
* Are black or Hispanic
* Weigh more than 110 pounds
* Have a body mass index of 25-40
* Do not have a condition that requires drug treatment
Design:
Participants will be screened with:
* Medical history
* Physical exam
* Blood, heart, and urine tests
Participants must not eat or drink anything with artificial sweeteners throughout the study.
Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.
Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:
* An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.
* A piece of fat tissue may be taken from the abdomen (biopsy).
* Participants will have a sweet drink. Blood samples will be taken over 2 hours.
Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.
Overnight Visit 2 repeats Visit 1 except the biopsy.
Then participants will take the capsules for another 2 weeks.
Overnight Visit 3 repeats Visit 1.
Participants may be contacted by phone within 4 weeks after they finish.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 60
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Glaucoma, Cardiac Abnormalities, Others
Must Be Taking:Digoxin, Midazolam
150 Participants Needed
Antibiotics Impact on Healthy Subjects
Bethesda, Maryland
More than 250 million courses of antibiotics are prescribed annually in the ambulatory care setting in the United States alone, including more than 40 million in children under 18 years of age. The perception that antibiotic use has minimal attendant adverse side effects contributes to the over-utilization of antibiotics in clinical circumstances when they are not strictly indicated. We have learned much about the human microbiome. The emerging view is of profound life-long bi-directional interactions between our microbiota and our cells. Perturbations in the microbiota affect metabolic, immune, and cognitive physiology in experimental animal models. When a person takes an antibiotic, the antibiotic diffuses via the blood into all body compartments, selecting for resistance. We propose to examine the effects of two commonly used antibiotics (the beta-lactam, amoxicillin and the macrolide azithromycin) on human microbial populations and on metabolic and immune physiology, studying healthy human volunteers in a randomized controlled clinical trial at the NIH Clinical Center. Our hypothesis is that in addition to acutely perturbing the human microbiome, these agents will have measurable metabolic and immunologic effects, with residual effects in the weeks that follow. To test this hypothesis, we will assess the effects of a brief therapeutic course of antibiotics on microbiome and metagenome composition. After an initial evaluation period, antibiotics will be given for 7 days or 5 days (depending on the antibiotic), and there will be a post-treatment evaluation. A control group will receive no drug intervention. Specimens will be obtained from multiple sites at each of 10 time points occurring before, during, and after antibiotic administration, and used for estimating bacterial and fungal composition and gene content. We will also assess the effects of the antibiotic course on markers of innate and adaptive immunity as well as markers of metabolic and hormonal physiology. A subgroup of subjects will be studied in the clinical center metabolic chamber to assess 24-hour energy expenditure and its components (sleeping, diet-induced, and activity energy expenditure), as well as macronutrient oxidation rates (carbohydrate, fat, and protein), during 3 of the 10 study visits. In addition to the primary data analyses, we will build a model that integrates the temporal data to begin to understand the complex intertwined physiology between microbiome and host.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 49
Key Eligibility Criteria
Disqualifiers:Obesity, Hypertension, Diabetes, Asthma, Others
Must Not Be Taking:Antibiotics, Corticosteroids, Immunosuppressants, Others
108 Participants Needed
Motion Reset for Cybersickness in Virtual Reality
Bethesda, Maryland
Background:
People use virtual reality (VR) technology to play games, socialize, work, or receive medical care. Some people have "cybersickness" after using VR. Cybersickness is similar to motion sickness. Symptoms include eye strain, nausea, dizziness, or headache. The symptoms are usually mild and go away after the person stops using VR. New software called Motion Reset is being designed to reduce symptoms of cybersickness during VR use.
Objective:
To see if Motion Reset software can reduce cybersickness in people using VR.
Eligibility:
Healthy adults aged 18 to 60 years.
Design:
Participants will have 1 clinic visit that will last about 1 hour. They will answer questions about how they are feeling. They will learn how to use the VR headset and the handheld game controllers.
The study will be broken into 2 parts. For the first part, participants will be assigned to 1 of 3 groups:
Group 1 will participate in a VR experience designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller.
Group 2 will participate in a VR experience that is not designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller.
Group 3 will have no VR experience.
Participants will complete 2 questionnaires about their experiences in the first part of the study.
For the second part, all participants will spend up to 20 minutes playing a commercial VR game called Jurassic World Aftermath. Every few minutes, they will be asked if they are experiencing discomfort.
After playing the game, participants will complete 12 questionnaires about their experience....
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Motion Sickness, Seizure Disorders, Pregnancy, Others
Must Not Be Taking:Nausea Inhibitors
150 Participants Needed
Sociocultural Influences on Pain Assessment
Bethesda, Maryland
Objective
The current proposal investigates behavioral, psychophysiological, and social processes that may help explain biases and disparate outcomes in pain. Health disparities, or health outcomes that adversely affect disadvantaged populations, are pervasive and apparent in many diseases and symptoms, including pain. Pain is the number one reason individuals seek medical treatment. Health disparities in pain encompass both differences in pain experience and treatment for pain. For instance, research indicates that Black individuals report increased pain and have reduced pain tolerance relative to White individuals, yet doctors are less likely to treat minority patients pain and underestimate their pain experience. This project aims to address this systemic discrepancy by focusing on interpersonal processes that may contribute to these disparities, including socially-relevant responses to pain (i.e. pain expression) and pain assessment (e.g. visual attention). The proposed research aims to determine whether the study of pain expressions and their assessment can yield insights on how social factors shape pain and its treatment. Further, we test the efficacy of potential interventions designed to improve accuracy and reduce biases in pain assessment. If successful, this work will form the foundation of a new research program that will link the field of pain research with the field of social neuroscience, and forge new insights on the critical problem of health disparities in pain.
Study population
We will accrue up to 700 total healthy volunteers to target 240 completers
Design
Our overall aim is to understand how social factors influence the assessment and management of pain, and to gain insight into psychosocial processes that may underlie health disparities in pain. We propose a series of studies designed to test these links. First, we will measure pain perception and physiological responses to painful stimuli in a diverse group of individuals to test for sociocultural and biological influences on pain and pain-related responses. In subsequent studies, new participants ("perceivers") will view images of these initial participants ("targets") and will provide estimates of 'targets' pain experience. We will measure a) whether perceivers can accurately estimate 'targets' pain experience; b) whether accuracy differs as a function of similarity between target and perceiver (ingroup vs outgroup); and c) whether individuals can improve accuracy through feedback.
Outcome measures
Primary outcome measures for all experiments will be decisions about pain (experienced by self or other) measured with visual analogue scales, reaction time, and/or categorical judgments (pain/no pain). We will also measure physiological responses (e.g., facial muscle response, skin conductance, pupil dilation) and brain responses using functional magnetic resonance imaging (fMRI) as secondary outcome measures. We will test whether pain and pain-related responses varies as a function of sociocultural/demographic factors (e.g. race, ethnicity, sex) and whether accuracy in assessing others' pain is influenced by group similarity (i.e. ingroup vs. outgroup) and training (e.g. performance-related feedback)....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Mood Disorders, Chronic Pain, Others
Must Not Be Taking:Opiates, Antidepressants, Anticonvulsants, Others
700 Participants Needed
MRI and MRS Brain Scans for Brain Mapping in Healthy Subjects
Bethesda, Maryland
Background:
- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.
Objectives:
- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.
Eligibility:
- Healthy individuals between 18 and 65 years of age.
Design:
* This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center.
* Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing.
* During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Axis 1 Diagnosis, HIV, Neurological Illness, Others
300 Participants Needed
PPD Challenge for Tuberculosis
Bethesda, Maryland
Background:
Tuberculosis (TB) is a lung disease. It is caused by inhaling a type of airborne bacterium. Tuberculin Purified Protein Derivative (PPD) is used to test for TB exposure. It is usually injected under a person s skin. In this study, it will be applied in the lung.
Objective:
To learn how the cells within the lung react (immune response) when exposed to PPD.
Eligibility:
Adults ages 18-64 who (1) have been exposed to TB but do not have active disease or symptoms or (2) have never been exposed to TB.
Design:
Participants will be screened with a medical history, physical exam, and blood tests. They will have a TB skin test. They will also have an electrocardiogram to examine heart rhythm. For this, sticky patches will be placed on their chest.
Some screening tests will be repeated at study visits.
Participants will have 3 FDG PET-CT scans. They will lie in a machine that creates pictures of the inside of their body. They will get a radioactive substance injected into their arm called 18FDG. It helps make the pictures.
Participants will have 3 bronchoscopies. Their mouth and nasal airways will be numbed. They will get drugs to relax. A tube will be inserted through their nose or mouth into a lung. Fluid will be delivered into the lung and suctioned back out to collect cells. They will get PPD during the first bronchoscopy.
Participation will last for about 30 days. Participants will visit the clinic up to 8 times. They will go home after each procedure. No hospital stays are needed....
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Not Listed
8 Participants Needed
EPA for Omega-3 Metabolism
Toronto, Ontario
The goal of this clinical study is to learn how fast EPA is converted to other molecules, including DHA, with consideration of biological sex and genetics in healthy humans.
The main questions it aims to answer are:
* How fast is EPA converted to DHA in blood, and is the conversion rate affected by sex and a specific genotype we previously identified?
* How do sex and the specific genotypes affect blood DHA levels and other products of DHA in response to dietary EPA?
* How fast does dietary EPA replace blood EPA and other omega-3 fatty acids, and is the rate affected by sex and genotype?
Participants will be asked to take EPA supplements for 12 weeks and provide a series of venous blood samples over the study duration.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 35
Key Eligibility Criteria
Disqualifiers:High Fish Intake, Pregnancy, Diseases, Others
Must Not Be Taking:Chronic Medications
64 Participants Needed
Neurofeedback for Alcohol Use Disorder
Bethesda, Maryland
Background:
Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person s social behavior and brain structure, but researchers don t have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem drinking.
Objectives:
To study what happens in the brains of people who drink alcohol when they look at pictures of social things and of alcohol. To learn if people can control brain activity in a magnetic resonance imaging (MRI) scanner and if this helps people with drinking.
Eligibility:
Adults ages 21 65 who have an alcohol use disorder.
Healthy volunteers ages 21 65
Design:
Participants will be screened with
Physical exam
Medical history
Blood, urine, and heart tests
Mental health interview
Questions about their alcohol drinking.
At each session, participants will have:
A urine test for drugs and pregnancy. If they test positive, they cannot participate.
A breath alcohol test and assessment for alcohol withdrawal.
Participants will complete surveys, talk to researchers about behaviors, and play games.
Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic field. They will lie on a table that slides in and out of the scanner for 1 2 hours.
Participants will do tasks in the scanner:
They will look at pictures, sometimes of alcohol.
They will try to hit a goal. Some participants will get feedback during this task. They will see how their brain activity changes or how someone else s changes.
Participants may have follow-up phone questions at least 3 times over about 6 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 65
Key Eligibility Criteria
Disqualifiers:Head Trauma, Neurological Disease, Pregnancy, Others
116 Participants Needed
Why Other Patients Applied
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
Early vs Late Dinner for Obesity
Bethesda, Maryland
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Sleep Disorders, Diabetes, Cardiovascular Disease, Others
Must Not Be Taking:Diabetes Medications, Psychiatric Medications
32 Participants Needed
Psychological Interventions for Pain Perception
Bethesda, Maryland
Background:
- Painful stimuli cause changes in a network of brain regions called the "Pain Matrix." But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision.
Objectives:
- To better understand how pain and emotions are processed and influenced by psychological factors.
Eligibility:
- Healthy volunteers ages 18-50.
Design:
* This study requires 1 to 2 clinic visits that last 1 to 3 hours.
* Participants will be screened with medical history and physical exam.
* Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs.
* Participants heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored.
* Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI.
* Participants will fill out questionnaires.
* The study will last 3 years.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Neurological, Mood Disorders, Others
Must Not Be Taking:Opiates, Antidepressants, Anticonvulsants, Others
500 Participants Needed
Diagnostic Assay for Liver Disease
Bethesda, Maryland
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.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Early Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Hepatitis C, Others
Must Not Be Taking:Anti-coagulation, Anti-platelet
400 Participants Needed
Dairy vs Carbs vs Water for Bone Health and Inflammation
Toronto, Ontario
This trial tests if drinking milk, Greek yogurt, a sugary drink, or water after exercise can improve bone health and reduce inflammation in healthy young adults. The study will measure changes in indicators related to bones and inflammation. The goal is to find out if these simple dietary changes can help keep bones strong and reduce body swelling. Milk has been shown in various studies to promote bone formation and prevent bone loss.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30
Key Eligibility Criteria
Disqualifiers:Smoking, Chronic, Inflammatory, Auto-immune, Others
Must Not Be Taking:Chronic Condition Medications
25 Participants Needed
Background:
People with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.
Objective:
To see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be compared with a non-INSTI drug, tenofovir alafenamide (TAF).
Eligibility:
Healthy people aged 18 to 55.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.
Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with a 3-week break between.
Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug for 8 days during each stay.
Participants will have tests to see how their body uses energy:
They will spend 23 continuous hours in a special room that measures how much oxygen they breathe in and how much carbon dioxide they breathe out. They will do this a total of 6 times.
They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density.
They will lie on a table. Electrodes will be placed on their hands and feet to measure body fat and lean body mass.
They will stand still on a platform for about 30 seconds. High-resolution laser cameras will scan their bodies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis, Diabetes, Cardiovascular, Others
Must Not Be Taking:Anticonvulsants, Rifamycins, St. John's Wort, Others
120 Participants Needed
PET Radioligands for Rheumatoid Arthritis
Bethesda, Maryland
Background:
Inflammation plays a significant role in various disorders that involve neurodegeneration or autoimmune reaction as one of their mechanisms. PET scans can help detect inflammation. Two new drugs may create better PET images.
Objective:
To see if the drug \[11C\]MC1 can help image inflammation.
Eligibility:
People ages 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM).
Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed.
Design:
Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181.
Participants with arthritis or IIM will have a screening visit. This will include:
Medical history
Physical exam
Blood and urine tests
Possible CT or X-ray: A machine will take pictures of the body.
Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured.
Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans.
Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:HIV, Cardiovascular Disease, Pregnancy, Others
Must Not Be Taking:NSAIDs, Willow Bark Tea, Probenecid
30 Participants Needed
iTBS for Healthy Individuals
Toronto, Ontario
The goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on brain plasticity in healthy, right-handed individuals aged 18 to 50 years. Brain plasticity is the brain's ability to change through growth or reorganization. iTBS is a form of transcranial magnetic stimulation (TMS), where magnetic pulses are applied to the scalp using a coil. These pulses pass through the scalp, and can alter brain activity in the area underneath the coil. Based on previous research conducted in animals and humans, researchers believe that iTBS can strengthen the connections between cells in the brain, leading to improved brain plasticity.
This trial will compare the effects of the compressed iTBS (iTBS-c) protocol, which is commonly used to treat depression, and the spaced iTBS (iTBS-s) protocol. Researchers want to find out which protocol is better able to produce changes in brain plasticity. Sham iTBS (iTBS-sh) will be used as a control to make the results of the study more reliable.
Participants will complete 5 study visits within the span of 3 months, including:
* Screening assessments to determine eligibility (Visit 1);
* Calibration iTBS session (Visit 2) to assess tolerability of brain stimulation;
* Three experimental iTBS sessions (iTBS-s, iTBS-c, and iTBS-sh) in a randomized order (Visits 3-5), each separated by at least 72 hours. During each session, the study team will stimulate the motor cortex and record the muscle activity of your hand to measure changes in brain plasticity.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Age, DSM-5 Diagnosis, Neurological Conditions, Others
Must Not Be Taking:Psychotropic Medications
30 Participants Needed
Negative Pressure Wound Therapy for Breast Reduction Surgery
Washington, District of Columbia
In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Smoking, Breast Cancer, Others
Must Not Be Taking:Steroids, Immune Modulators
92 Participants Needed
Injections for Healthy Volunteers
Nashville, Tennessee
This is a Phase 1, single-center, open-label, single-arm, dose-escalation positron emission tomography study to assess the safety and tolerability, immunogenicity, Pharmacokinetics, dosimetry, and biodistribution after GEH200521 (18F) Injection is co-administered with GEH200520 Injection in healthy volunteers.
The estimated study duration for each subject is approximately 28 days in part A and 34 days in part B.
The primary study objective is to evaluate the safety and tolerability of the IMPs, the selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521 (18F) Injection.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Surgery, Pregnancy, Radiation Exposure, Others
Must Not Be Taking:Prescribed Medications
24 Participants Needed
Apple Polyphenol Diet for Gut Health
College Park, Maryland
The goal of this controlled feeding trial is to learn about the metabolism of polyphenols, a common class of compounds found in plant-based foods, by the gut microbiome. It will evaluate how differences in gut bacteria across individuals influence metabolism of polyphenols from foods, which may influence health benefits that people receive from different foods.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Pregnancy, Food Allergies, Renal, Others
Must Not Be Taking:Antacids, Antibiotics
30 Participants Needed
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Frequently Asked Questions
How much do Healthy Subjects clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Healthy Subjects clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Healthy Subjects trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Healthy Subjects is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Healthy Subjects medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Healthy Subjects clinical trials?
Most recently, we added Barley Lysine Availability for Healthy Subjects, Citrate for Kidney Stones and TEA Device Usability and Safety Study to the Power online platform.
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