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Healthy Volunteers clinical trials

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NCT ID: NCT06258941 Not yet recruiting - Healthy Volunteers Clinical Trials

The Effects of 12-Week High-intensity Interval Training With Mindfulness-based Recovery on Executive Function, Fitness, and Mindfulness in Children

Start date: June 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 10-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities. Multiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases. During the pretest phase, participants an their parents will complete the following 1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient 2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index 3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness 4. Computerized tasks to assess EF 5. Parent-reported demographic and health information Following the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit. Following the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again. Researcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF. Further, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.

NCT ID: NCT06244472 Not yet recruiting - Healthy Volunteers Clinical Trials

A New Generation of Magnetoencephalographs for High Speed Functional Brain Imaging

DEMAGUS
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The goal is to perform a first evaluation of the capabilities of a new generation of non-invasive magnetoencephalography whole head device using optically pumped magnetometers using Helium 4 as the sensitive element (OPM He4) to record brain magnetic activities. The investigators will record 1) healthy subjects stimulated with visual, auditory, somesthesic and motor stimuli and 2) athletes who suffered a mild concussion. The main hypothesis is that the OPM magnetoencephalographs (MEG) system will be able to detect brain activity. The secondary hypothesis is that the data recorded with the OPM MEG system will allow to reconstruct maps of the brain activity. To test the main hypothesis, they will compare the signal to noise ratio of brain activities between a classical MEG system and the new OPM He4 MEG. The secondary hypothesis will be tested through a comparison of the maps of brain activity obtained thanks to the data recorded with a classical MEG system and the new OPM He4 MEG.

NCT ID: NCT06244407 Not yet recruiting - Healthy Volunteer Clinical Trials

The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions

Start date: May 23, 2024
Phase: Phase 1
Study type: Interventional

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions

NCT ID: NCT06243809 Not yet recruiting - Healthy Volunteer Clinical Trials

The Bioequivalence Study of Linagliptin 5 mg Film-coated Tablet in Healthy Thai Volunteers

Start date: April 24, 2024
Phase: Phase 1
Study type: Interventional

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Linagliptin 5 mg Film-coated Tablet (LINIPTIN) and Reference Product (Trajenta®) in Healthy Thai Volunteers under Fasting Conditions

NCT ID: NCT06236009 Not yet recruiting - Healthy Volunteers Clinical Trials

A First-In-Human Study of TAK-004 in Healthy Adults

Start date: September 4, 2024
Phase: Phase 1
Study type: Interventional

This study is the first study with TAK-004 conducted in human beings. Participants will receive either TAK-004 or placebo. The main aim of this study is to learn how safe TAK-004 is in healthy adults and how well participants tolerate one or more doses of TAK-004. Other aims are to learn about the effects of TAK-004 on the heart rate and blood pressure and if TAK-004 creates an immune response (immunogenicity). Another aim is to learn how the body of healthy adults affects TAK-004 (pharmacokinetics). Participants will receive TAK-004 or placebo via injection just under the skin (subcutaneous injection or SC injection). Depending on the groups participants are assigned to, they will either receive just one dose of TAK-004 or placebo or multiple doses of TAK-004 or placebo while they are in the study. Blood and urine samples will be taken during the study.

NCT ID: NCT06228443 Not yet recruiting - Healthy Volunteer Clinical Trials

Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product Under Fasting Conditions

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

This Study Aims to Assess the Relative Bioavailability, Including the Rate and Extent of Absorption, of 20 mg Leflunomide Tablets Compared to ARAVA® 20 mg Tablets. The Evaluation Will be Conducted Following a Single Oral Dose (1 x 20 mg Tablet) in Healthy Thai Male Volunteers Under Fasting Conditions.

NCT ID: NCT06228430 Not yet recruiting - Healthy Volunteer Clinical Trials

The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions

Start date: February 12, 2024
Phase: Phase 1
Study type: Interventional

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Acyclovir 800 mg Tablet and Reference Product (Zovirax™) in Healthy Thai Volunteers under Fasting Conditions

NCT ID: NCT06228339 Not yet recruiting - Healthy Volunteer Clinical Trials

The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions

Start date: March 9, 2024
Phase: Phase 1
Study type: Interventional

Objective: Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7 days washout period. Study Design: A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study

NCT ID: NCT06223555 Not yet recruiting - Obesity Clinical Trials

Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose

Start date: June 5, 2024
Phase: N/A
Study type: Interventional

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....

NCT ID: NCT06206031 Not yet recruiting - Healthy Volunteers Clinical Trials

Intraosseous Doppler Ultrasonography to Study Skeletal Physiology: Exploratory Study Before Use in Space Physiology

Echo-Os
Start date: January 29, 2024
Phase: N/A
Study type: Interventional

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.