Healthy Clinical Trials in Baltimore, MD

Background: - Biomarkers are substances in people s blood and tissues. They help researchers understand diseases and signs of aging. Scientists want to do more research on biomarkers to find ways to improve quality of life in old age. Objective: - To learn more about biomarkers and their relationship to aging. Eligibility: - Adults at least 20 years old who weigh at least 110 pounds and have a body mass index below 30. They must agree that their genetic samples can be collected, studied, and stored. Design: Participants will be screened with medical history, physical exam, and blood and urine tests. They will have heart tests and nurse will assess their veins. They will fill out a questionnaire. Participants will have a 2-day baseline visit. Then they will return every 2 years for up to 10 years. These follow-up visits will repeat the baseline visit: Repeat of screening procedures. Physical performance tests like balance and walking tests. Leg and grip strength tests. Health and mental state questions. Memory and problem solving tests. Cytapheresis. Blood will be removed through a needle in the vein of one arm and run through a machine. The blood will be returned through a needle in a vein of the other arm. Visits may also include: Magnetic resonance imaging scans. Participants will lie on a table that slides in and out of a machine that takes pictures. Diabetes test. After fasting, participants will drink a sweet drink and give blood. Breathing and walking tests. Wearing a device that record physical activity. Scan of the abdomen and the right leg. A small amount of muscle tissue and/or skin removed. Read Less

Background: Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction. Objectives: To learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas. Eligibility: Healthy, right-handed adults ages 18 60 who are non-drug users. Design: Participants will be screened under protocol 06-DA-N415. Participants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit. Each visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires. Participants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain. The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation. Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 2 3 weeks after their last session. Read Less

Background: The use of electronic cigarettes (vaping) has increased among adolescents over the past decade. Vaping raises many health concerns. People who vape inhale toxic chemicals. Vaping is also linked with mental health issues, such as depression and suicide risk. In one survey, 85% of young adults reported that they used both vaping and tobacco products; the primary reason they cited for using these products was stress. Objective: This natural history study will survey adolescents and their parents about their attitudes toward vaping. Eligibility: People aged 13 to 17, including those who vape; those who once vaped; and those who have never vaped. Parents of people aged 13 to 17 who are known or suspected of vaping are also needed. Design: Participants will take a survey. They will use their own smartphone, computer, or tablet to answer questions. The survey will take about 20 minutes. Their answers will be anonymous. Teenage participants will answer questions on different topics: Vaping habits, such as when and how they vape. Drug use, including nicotine, cannabis, and alcohol. Mood issues, such as depression, anxiety, and stress. Social influences on vaping, including perceived attitudes of parents and peers. Other leisure habits, including online gaming and use of social media. Parents will answer similar questions. A phone number and links will be given to participants who need help for suicidal thoughts. Other links will be given to those who want help with parenting resources or aids to quit vaping. Participants may be invited to take part in an 8-week course on mindfulness-based stress reduction. Participants who finish the survey will receive $10. ... Read Less

Background: Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover. Objective: To measure rates of protein turnover in healthy adults. Eligibility: Healthy people aged 20 years and older with a body mass index between 20 and 30. Design: Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit. Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs. Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years. Participants will have tests during study visits, including: Imaging scans of a leg. Exercise on a treadmill. Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen. Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes. Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands. D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle. Read Less

Background: As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose. Objective: To learn if UA improves levels of insulin and other hormones that help control blood glucose. Eligibility: People aged 55 years and older with a body mass index of 27 or higher. Design: Participants will have 6 clinic visits over 8 weeks. Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half 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 have tests during the study including: Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours. Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study. Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces. Imaging scans of the thigh; scans of the brain are optional.... Read Less

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called Epidermal growth factor receptor (EGFR) and Human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2 that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies on people with advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. Researchers think that BAY2927088 might affect an enzyme (called CYP3A4) that breaks down drugs in the body. This might make the effects of some drugs weaker or stronger. Midazolam is a drug that is broken down by CYP3A4. By studying the level of midazolam in the blood, researchers can understand how BAY2927088 might influence this enzyme's activity. The main purpose of this study is to find out how BAY2927088, taken as a single dose and as multiple doses, affects the level of another drug, called midazolam, in the blood of healthy participants. To achieve this goal, researchers will measure the following for midazolam when participants take it with or without BAY2927088: Area under the curve (AUC): a measure of the total amount of midazolam in participants' blood over time Maximum observed concentration (Cmax): the highest amount of midazolam in participants' blood The study will have 3 treatment periods: Period 1 (Day 1 to Day 2): On Day 1, participants will take midazolam Period 2 (Day 3 to Day 4): On Day 3, participants will take midazolam with BAY2927088 Period 3 (Day 5 to Day 15): On Days 5 to 13, participants will take BAY2927088 On Day 14, participants will take midazolam with BAY2927088 Participants will be part of the study for about 8 weeks with at least 3 visits to the study clinic. Participants will visit the study clinic: More than/at least once, within 2 to 28 days before the treatment starts Once on the day before the treatment starts and will stay in the clinic until Day 15 of the treatment Once, within 7 to 10 days after they finish treatment for a health checkup During the study, the doctors and their study team will: do physical examinations collect blood samples from the participants to measure the blood levels of midazolam and of BAY2927088 check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. Read Less

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach. The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following: Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood The study will have 4 treatment periods: - Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period. On Day 9, participants will take esomeprazole on an empty stomach. - Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088. On Day 13, participants will take esomeprazole on an empty stomach. Participants will be in this study for about 8 weeks with 3 visits to the study clinic. Participants will visit the study clinic: at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment once, 7 to 10 days after last dose of BAY2927088, for a health check-up During the study, the doctors and their study team will: do physical examinations collect blood samples from the participants to measure the levels of BAY2927088 check participants' health by performing tests, such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment. Read Less

This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants. Read Less

Background: - National Institute on Aging researchers are looking at studies that require large numbers of white blood cells for lab use. Standard blood samples do not provide enough white blood cells for these studies. Researchers want to use cytapheresis to collect white blood cells from volunteer donors. This procedure can collect larger amounts of white blood cells and reduce the amount of fluid and other cells that are lost. Objectives: - To use cytapheresis to collect white blood cells for study. Eligibility: - Healthy blood donors at least 18 years of age. Design: Participants will be screened according to the usual blood donation procedures. Participants will provide white blood cells through cytapheresis. The blood cells will be collected in a machine that separates the white blood cells from the rest of the blood. The rest of the blood will be returned to the donor. Participants may have this type of donation every 56 days (six times per year). They will be asked to become a repeat donor. A donation schedule may be set up. Once a year, participants will have blood tests to continue to be eligible as a donor. Read Less

This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of [14C]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing. Read Less

The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users. Objectives: - To collect genetic information for research on genetic aspects of addiction and substance abuse. Eligibility: Adults age 18 or older (1) healthy, non-drug-using nonsmokers, (2) healthy smokers, (3) healthy individuals dependent on other commonly abused drugs, and (4) individuals with other psychiatric disorders. Participants must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol. Design: This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant's current research protocol study visits or on the same day as those visits. Participants will provide a blood sample and complete questionnaires about mood, memory, and learning. Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen. Read Less

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. Read Less