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Healthy Volunteers clinical trials

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NCT ID: NCT05801809 Recruiting - Healthy Volunteers Clinical Trials

Understanding the Effects of Transauricular Vagus Nerve Stimulationon on Neural Networks and Autonomic Nervous System

Start date: April 26, 2023
Phase: N/A
Study type: Interventional

This trial aims to perform an exploratory, mechanistic, randomized double-blind sham-control trial in healthy participants to assess the physiologic effects of a single 60 minutes session of bilateral taVNS, on neural networks and autonomic function.

NCT ID: NCT05799274 Recruiting - Healthy Volunteers Clinical Trials

Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer

Start date: November 9, 2023
Phase: Phase 1
Study type: Interventional

The objective of this clinical trial is to determine the safety of an intravenously administered radioisotope, RAD301 ([68Ga]-Trivehexin), in either health volunteers or patients with pancreatic cancer. All subjects will undergo: Screening, which entails physical examination and blood samples for standard blood testing. Subjects that successfully pass screening will undergo: Gallium-68 PET scanning procedures, which will occur during a single day (about 5-6 hours). These subjects will return to the clinic at 2 weeks for additional safety labs. All scanned subjects will also be evaluated by telephone follow up on a weekly basis for 1 month after scanning.

NCT ID: NCT05794230 Recruiting - Healthy Volunteers Clinical Trials

Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

MEQ00064
Start date: March 27, 2023
Phase: Phase 3
Study type: Interventional

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers. It will be conducted in India and the RSA in 2 cohorts: - Cohort I: Infants and toddlers 6 months to 16 months of age - Cohort II: Infants and toddlers 6 weeks to 15 months of age In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines. In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8). The primary objectives of this study are: - To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA) - To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA The secondary objectives of this study are: - To describe the antibody titers to the meningococcal serogroups A, C, Y, and W: - before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine: - in infants and toddlers 6 weeks to 15 months of age in India and the RSA. - in infants and toddlers 6 months to 16 months of age in India and the RSA. The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

NCT ID: NCT05774860 Recruiting - Healthy Volunteers Clinical Trials

Neural Bases of Social Cognitive Processing in Healthy Individuals

Start date: July 14, 2018
Phase:
Study type: Observational

The goal of this single center non-interventional fMRI and EEG study is to assess the neural bases of social cognitive processing in healthy individuals, and whether/how their responsiveness is modulated by ageing. The main questions it aims to answer are: - are there specific brain regions where individual differences in social cognitive performance reflect well-established metrics of social cogntion such as empathy and mentalizing? - is there a relationship, at the behavioral and neural levels, between ageing-related changes in social cognitive performance and empathy/mentalizing? Healthy participants will be recruited for: - a behavioral assessment including multiple tests of social cognition focused on empathy and mentalizing; - for half participants: a fMRI session to collect data concerning a) brain activity associated with action observation and social cognitive processing, b) brain structural morphometriy (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging) - for half participants: a EEG session to collect data concerning brain responsiveness to social cognitive processing with higher temporal resolution than that afforded by fMRI. Results will provide an useful baseline for investigating alterations of social cognitive processing, and of their neural bases, in pathological conditions.

NCT ID: NCT05774847 Recruiting - Healthy Volunteers Clinical Trials

Unconscious Processing in Decision-making

Start date: May 24, 2021
Phase:
Study type: Observational

This behavioral study on healthy participants aims to provide a baseline reference for assessing alterations of decision-making performance in pathological conditions. To this purpose, this single center non-interventional behavioral study will assess the extent to which decision-making performance is affected by distinct experimental manipulations, as well as by ageing effects, in 200 healthy individuals. The main questions it aims to answer are: - to what extent is decision-making performance stable, within individuals, regardless of non-economic manipulations concerning stimuli perceptual features as well as type of processing and motor response required to participants? - are these manipulations additionally influenced by participants' age? Healthy participants will be recruited for distinct behavioral studies assessing the effects of the aforementioned manipulations of distinct metrics of decision-making performance, such as loss aversion, risk aversion, and delay discounting.

NCT ID: NCT05774834 Recruiting - Healthy Volunteers Clinical Trials

Neural Bases of Decision-making in Healthy Individuals

Start date: November 10, 2018
Phase:
Study type: Observational

The goal of this single center non-interventional fMRI study is to assess the neural bases of decision-making and executive functioning in healthy individuals,and whether/how their responsiveness is modulated by ageing. The main questions it aims to answer are: 1. are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making? 2. Is there a relationship, at the behavioral and neural levels, between ageing-related changes in executive functioning and decision-making? Healthy participants will be recruited for 1. a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control; 2. a fMRI session to collect data concerning a) brain activity associated with decision-making and executive functioning, b) brain structural morphometriy (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging). Results will provide an useful baseline for investigating alterations of decision-making and executive functioning, and of their neural bases, in pathological conditions.

NCT ID: NCT05752396 Recruiting - Healthy Volunteers Clinical Trials

Overlapping Pain Trajectory Study

COPC
Start date: March 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. 2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: - quantitative sensory testing - blood draw - sleep assessment - questionnaires

NCT ID: NCT05732194 Recruiting - Healthy Volunteers Clinical Trials

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

Start date: January 18, 2023
Phase: Phase 1
Study type: Interventional

The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days.

NCT ID: NCT05729386 Recruiting - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions

Start date: February 6, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fed conditions to healthy adult volunteers.

NCT ID: NCT05724797 Recruiting - Healthy Volunteers Clinical Trials

Single Ascending Dose Study of NRS 033 in Healthy Volunteers

Start date: April 17, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, first in human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult male and female subjects 18 to 55 years of age, inclusive.