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NCT06690294
Background: Many people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults. Objective: To explore how childhood experiences affect adult eating behaviors. Eligibility: Healthy people aged 18 to 60 years. Design: Participants will have 3 clinic visits. They will be screened with blood tests. They will answer questions about their alcohol and tobacco use. At the next visit, participants will undergo these activities: Parts of their body (such as waist, neck, and thighs) will be measured with a tape. They will have an imaging scan to find out how much body fat they have. They will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days. They will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days. They will answer questions about their education, childhood, and routines. They will receive a kit to collect a stool sample at home. At the last visit, participants will have these tests: Participants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head. Blood samples will be taken before and after participants drink a sugary drink. Participants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.
NCT07310264
This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C). Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights. Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit. Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.
NCT00090662
Increased numbers of white blood cells called eosinophils can cause disease. To investigate this disease, researchers need blood, urine, sputum, stool, cerebrospinal fluid, skin and/or bone marrow samples to compare to samples from patients with this problem. Some of the samples will be used for genetic testing or future research. This study will last for about 10 years and will include a maximum of 50 paid volunteers ages 18 to 65. ...
NCT03561545
During weightlessness, the cardiovascular system is subject to rapid changes which has been demonstrated in studies of short term (Space Shuttle) and long term missions to Skylab, MIR, and the International Space Station (Nicogossian et al., 1989; Blomquist, 1994; Platts et al., 2014). There is also evidence for changes in the blood vessel structure, the metabolism and the responses to vasodilator and constrictor substances that might have long-term health consequences resembling the effects of aging on the cardiovascular system (Hughson and Shoemaker, 2004). Cardiovascular adaptations cause an increased incidence of postflight orthostatic intolerance (fainting), decreased cardiac output and reduced exercise capacity. Besides these postflight effects, weightlessness could also have harmful consequences during the flight. For example, it has been shown that cardiac arrhythmia may occur during space missions, even in healthy individuals (Convertino, 2009). To understand the cardiovascular reactions of the human body to changing conditions of gravity is thus an important aim of space science. While non-invasive imaging of microcirculation is a very promising tool to evaluate cardiovascular condition, knowledge on the involvement of the microcirculation in cardiovascular alterations induced by weightlessness is very limited and further research in this field seems promising. Before using a non-invasive technique for imaging the microcirculation during space flights, it has to be evaluated on earth. Different proven simulation models exist for investigating the effects of weightlessness on the human body under terrestrial conditions: head down bed rest, dry and wet immersion, and parabolic flights. Among these models, only parabolic flight recreates a real state of weightlessness (see the participant document of information for a description of parabolic flights). Cardiovascular studies have often been performed during parabolic flights. Within the limitations inherent to the method (short duration of weightlessness - about 21 s - following and followed by hypergravity 20 s periods at 1.8g), some remarkable results have been published over the years. The aim of our research approach is to test feasibility of the in vivo evaluation of the microcirculation in parabolic flight in order to be able to better describe cardiovascular response mechanisms under these conditions. In this context, we expect alterations in the microcirculatory flow during the weightlessness period of parabolic flight. Our approach might help develop a diagnostic tool to more easily identify weightlessness-induced cardiovascular diseases and improve strategies for adapting astronauts to weightlessness prior to the space mission.
NCT06342713
This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.
NCT07060404
In Papua New Guinea, administration of primaquine (PQ) or tafenoquine (TQ) to breastfeeding mothers is contraindicated during the first six months postpartum, when infants are recommended to be exclusively breastfed, because of a lack of comprehensive pharmacokinetic data on PQ/TQ neonatal and infant exposure via breast milk. The therapeutic restriction of PQ/TQ use in lactating women during the first six months postpartum effectively translates into \~10% of females being excluded from radical cure in endemic areas at any time. This is because many at risk women live in remote areas, are frequently lost to follow-up, or may have conceived again before they reattend. As a result, radical cure is rarely achieved and women are exposed to recurrent infections and cumulative risk of anaemia. Relapses may occur for years, placing subsequent pregnancies at risk and perpetuating intergenerational failure of fetal growth. They also contribute to malaria transmission, thus household and community exposure to vivax malaria. The goal of the present study is to determine how much PQ/TQ is transferred to a suckling baby, if a mother receives a treatment course of PQ/TQ at time of delivery. We also want to confirm that this treatment is safe and has no major side effects for babies in Papua New Guinea. The study Interventions areas follows: Group 1 - Participants receive PNG standard of care; PQ given 6-months postpartum; Group 2 - Participants receive a 14-day treatment regimen of PQ, at the standard dose prescribed in PNG for vivax radical cure (0.5 mg/kg/day for 14 days); Group 3 - Participants receive an accelerated high-dose 7-day treatment regimen of PQ, as per current WHO recommendations (1.0 mg/kg/day for 7 days); Group 4 - Participants receive a single dose of 300mg tafenoquine. All participants will be monitored for a total duration of 6 months, with the safety, tolerability, pharmacokinetics and preliminary relapse efficacy of PQ/TQ evaluated at standardised time points over this period (Day 0, 1, 3, 6, 8, 15, 20, 28, and Month 2, 3, 4, 5 and 6). At each of these time points, participants will be asked to describe any symptoms they may be experiencing, participate in a medical examination, and provide a blood and breast milk sample for drug analysis and safety (biochemistry and haematology testing). The investigators will also collect a small blood sample (heel prick) from the infant to measure drug concentrations and safety testing.
NCT06223555
Background: Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research. Objective: To learn how fixed vs adjusted meals affect blood glucose levels in healthy people. Eligibility: Healthy people aged 18 years or older. Design: Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks. Participants will have baseline tests: Their height, weight, and waist size will be measured. They will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink. They will have a body scan. Participants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits: Resting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out. MMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....
NCT01915212
Background: \- Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine that could prevent genital herpes could improve the general health of the world s population. Researchers want to study whether a new vaccine, HSV529, which may be used in the future to prevent herpes infections, is safe. Objectives: \- To test whether a new herpes vaccine is safe. Eligibility: \- Healthy adults 18 40 years old. Design: * Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone calls over 1 year. * Each vaccination visit will last about 4 hours. * Participants will be screened with a medical history and physical exam. * Participants will have a blood sample taken. * Participants will be given the vaccine or a placebo, by injection from a needle. They will be monitored for 30 minutes to check for any allergic reaction. * Participants will be given a diary card to record any symptoms they may feel later. * At follow-up visits, participants will give a blood sample and answer health questions. * In the phone calls, participants will answer health questions.
NCT07472361
The study is designed to evaluate the relative bioavailability, safety, and tolerability of a single dose of ENX-104 administered orally as a solution fasted, a tablet fasted, or a tablet with a high fat meal in healthy participants
NCT07465731
The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.
NCT01266577
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.
NCT07463716
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy. The main questions it aims to answer are: * To assess if mask design impacts the ventilatory ratio in healthy volunteers. * To assess if mask design impacts transcutaneous CO2, respiratory rate, and tidal volume in healthy volunteers. Participants will attend five study visits: * Visit 1. Participants will be fitted to use non-invasive ventilation briefly to acclimatize them to using the therapy. * Visit 2. Participants will receive NIV with one of four masks. They will be asked to breathe through their mouth or through their nose, with a break from NIV in between the two sessions of NIV. * Visits 3-5. Participants will receive NIV with one of the other three masks, repeating Visit 2.
NCT06841315
This clinical trial is designed to determine the pharmacokinetics, safety and tolerability of varegacestat in people with impaired liver function compared to people with normal liver function.
NCT06823947
Part 1 : To evaluate the safety of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension. Part 3 : To assess the safety profile of repeated dosing of KK3910 in an additional hypertension cohort.
NCT06206031
Use of intraosseous Doppler ultrasonography to study skeletal physiology ("Echo-Os Study"). Exploratory study before its use in space physiology. Bones have a complex vascular network providing nutrients and oxygen to bone cells. The physiology of intraosseous blood circulation remains very little known to date, particularly in human. Human bone vascularization studying is very difficult because of a lack of simple tools for functional exploration of bone vascular perfusion. For blood flow studies, ultrasonography is best suited, allowing for dynamic non-invasive measures. Bone has until now been considered to stop ultrasound and therefore prevent any intraosseous measurements. From a physics viewpoint, bones conduct ultrasound waves well, but they are reflected differently compared to soft tissues. A specific analysis of the ultrasound returned by the bone, using specific correction factors, is therefore needed to interpret ultrasound signals, reconstruct an anatomical image, and extract physiological information. The system proposed in this study combines standard conventional low-frequency ultrasound probes with a specific analysis of ultrasound wave reflection. This system makes it possible to reconstruct an anatomical bone image and record the pulsatile signal of intraosseous vascular perfusion. The investigators will use this system to study the vascular reactivity induced by different physiological maneuvers. This protocol proposes to study the following mechanisms of blood flow regulation at the level of tibia cortical bone: flow-mediated dilation induced by endothelium (with arterial occlusion test), vasoconstriction induced by sympathetic activation (with static handgrip test), and vasoconstriction induced by veno-arteriolar reflex (with venous occlusion test). This is a pilot study in physiology performed with healthy volunteers. This study will verify whether our intraosseous ultrasound system can properly measure physiological responses expected during these maneuvers. This protocol will also establish links between perfusion and bone architecture at tibial level.
NCT06649110
A study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
NCT00084305
The etiology of pulmonary fibrosis is unknown. Analyses of blood, genomic DNA, and specimens procured by bronchoscopy, lung biopsy, lung transplantation, clinically-indicated extra-pulmonary biopsies, or post-mortem examination from individuals with this disorder may contribute to our understanding of the pathogenic mechanisms of pulmonary fibrosis. The purpose of this protocol is to procure and analyze blood, genomic DNA, and specimens by bronchoscopy, lung biopsy, lung transplantation, extra-pulmonary biopsies, or post-mortem examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA, clinically-indicated extra-pulmonary biopsies, as well as bronchoscopy and post-mortem examination specimens may be procured and analyzed from relatives of subjects with hereditary forms of pulmonary fibrosis; blood, genomic DNA, and bronchoscopy specimens may be procured from healthy research volunteers....
NCT07455994
Some physiological factors, such as physical activity, or pathological factors, such as sepsis or diabetes, are known to modulate the overall autonomic activity and the individual's intrinsic capacity to regulate their sympathetic and parasympathetic balance. These conditions can alter the physiological autonomic balance, sometimes with positive consequences on the FC-breathing control and blood pressure adjustment, depending on the individual's position and the status of blood volume, but sometimes with deleterious effects, such as poor regulation of sinus cardiac activity and respiration rate. Cardiovascular autonomic neuropathy is a major complication of type 1 diabetes. Several studies have described autonomic dysfunction in patients with type 1 diabetes, but these data are derived from cohorts of adults and adolescents or short ECG recordings at rest. Moreover, there are often confounding factors such as sedentary/physical activity, overweight, exposure to post-pubertal hormonal peaks, toxic drugs, or cardiac therapy. These factors don't greatly influence children's autonomic physiological maturation, whereas diabetes can sometimes exist for several years. In this population, the search for cardiac dysautonomia is entirely appropriate.
NCT07455318
A multicentre, open label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens (2 x 1IM regimen, 2 x 2 ID regimen, 1 x 2 ID regimen) when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming.
NCT07395024
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation. ASP3082 is thought to replace some of the abnormal proteins made from the faulty KRAS gene. If other medicines are given at the same time as ASP3082, they may affect how the body processes ASP3082. In this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and carbamazepine affect how the body processes ASP3082. These medicines may affect how the body processes ASP3082 when they are taken at the same time. This study will have 3 groups of adults. One group will be given fluconazole and ASP3082, the second group will be given carbamazepine and ASP3082, and the third group will be given itraconazole and ASP3082. ASP3082 will be given to people slowly through a tube into the vein (infusion). Fluconazole and carbamazepine will be given as a tablet and itraconazole will be given as a liquid by mouth. People will be given study treatments for about 1 month. They will then return to the clinic about 1 week after they finish study treatment for a final safety check.