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Healthy Volunteers clinical trials

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NCT ID: NCT04831502 Withdrawn - Healthy Volunteers Clinical Trials

Bioavailability and Food Effect Study of Two Formulations of TAK-906

Start date: April 2, 2021
Phase: Phase 1
Study type: Interventional

The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting. This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.

NCT ID: NCT04594395 Withdrawn - Healthy Volunteers Clinical Trials

Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in HealthyVolunteers

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

Background: In early 2020, many people thought Cambodia would have a serious COVID-19 outbreak due to the high number of Chinese travelers going to Cambodia. But as of June 14, 2020, only 128 cases of COVID-19 have been identified in the country. Many of these cases have been from people who had traveled in Europe. Researchers want to do antibody tests on blood from a sampling of people in Phnom Penh to learn the infection risks for people in the greater Phnom Penh area. Objective: To estimate the level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the blood of people living in Phnom Penh, Cambodia. Eligibility: Healthy males and females age 18-65 living in Phnom Penh since January 2020. Design: A mobile unit will travel to schools, shopping areas, parks, and pagodas around Phnom Penh. Participants will be screened with questions about their age and where they live. They will have blood taken via fingerstick. About 80 uL of blood will be taken. It will be tested for SARS-CoV-2. This visit will take about 30 minutes. If the test result is positive, participants will be contacted by phone. They will be asked to have a second blood draw. This time, 20 mL of blood will be taken. They can have this visit at their home or in a clinic. This visit will take about 30 minutes. If a participant has an adverse event, the mobile units and at-home units will have the tools needed to aid the participant. If needed, the participant will be sent to a nearby clinic.

NCT ID: NCT04282226 Withdrawn - Healthy Volunteer Clinical Trials

Brain Effect of Vagal Nerve Stimulation at Rest and Pain

Start date: March 16, 2020
Phase: N/A
Study type: Interventional

Pain is a ubiquitous distressing sensory experience and is the most frequent symptom in numerous gastrointestinal disorders including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). Visceral pain is especially difficult to treat with conventional medications and new treatments are needed. Recently, the relationship between autonomic nerve system (ANS) and pain has gathered attention because it could represent an effective treatment target for visceral pain. The parasympathetic nervous system (PNS), one of the two main branches of the ANS, is considered to play an important role for analgesia possibly due to vagal nerve-mediated activation of key brain areas implicated in descending analgesia of pain. Transcutaneous vagal nerve stimulation (tVNS) can non-invasively modulate vagal nerve and be expected as a new method to treat visceral pain. For example, the preliminary study showed that vagal nerve stimulation experimentally modulated cardiac vagal tone (CVT) and prevented the development of acid-induced oesophageal hyperalgesia. Disturbances in ANS function have been reported not only in IBS patients but also in fibromyalgia and chronic pelvic pain syndrome. Many of these disorders have been associated with differences in brain structure and/or function as demonstrated by the use of structural and functional magnetic resonance imaging (fMRI). Of note, the investigators have recently shown that these differences in brain structure and function may be in part attributable to the aforementioned disturbance in ANS function, adding weight to the proposition that autonomic neuromodulation may be efficacious in pain disorders. For instance, in healthy participants the investigators have recently shown, using functional connectivity analysis, that higher resting parasympathetic CVT predicts the engagement of a subcortical functional network that is implicated in descending analgesia, thereby supporting the notion that vagal-mediated analgesia is achieved via descending inhibitory pathways1,4. Thus, tVNS seems a reasonable method to treat pain. However, to date, the precise real-time effect of tVNS on brain function, including during the processing of visceral pain is unknown. Hence, the aims of this study are to investigate the real-time effect of tVNS compared to sham stimulus on brain activity whilst experiencing acute oesophageal pain, using fMRI in double-blind, randomised crossover study of tVNS vs sham stimulation in healthy subjects.

NCT ID: NCT04271449 Withdrawn - Healthy Volunteers Clinical Trials

tDCS and Prismatic Adaptation: Roles of the Cerebellum and the Primary Motor Cortex in the Transfer of After-effects

TRANSTIM
Start date: January 17, 2024
Phase: N/A
Study type: Interventional

Human beings are able to produce precise and smooth movements despite varying demands thank to the nervous system plasticity. Primastic exposure is a method that allows to easily study these sensorimotor plasticity processes in a laboratory context. In a typical protocol, participants wear prismatic goggles that induce a lateral deviation of the visual field while performing a goal directed motor task (e.g. pointing). During the first trials, participants make errors in the direction of the deviation and correct them trial-by-trial. Finally, participants go back to baseline performances after a few dozen of trials. Upon goggles removal, participants make mistakes toward the direction opposition to the initial prismatic deviation. These after-effects reflect adaptive processes that occurred to counteract the perturbation. The way that these after-effects can be transferred to other situations which have not been exposed to the prismatic perturbation bring crucial information about the nature of the processes involved. Additionally, these transfer properties might be of great interest in the field of neuro rehabilitation. In fact, the purpose of therapeutic strategies is to induce compensations that can be transferred to daily life situations. In previous studies, the investigator showed that expertise on the exposed had a notable influence on transfer properties. However, these studies did not allow to identify the cerebral regions involved in transfer. The cerebellum is described as a major area implied during motor adaptation and the occurrence of after-effects, while the primary motor cortex might play a crucial role in the formation of motor memory. As such, these two regions are likely to be involved in transfer properties. The objective of this project is to identify the roles of the cerebellum and the primary motor cortex in the transfer of visuomotor compensations acquired during prism exposure to task that has not been practiced under the perturbation. To do so, the investigator will use transcranial direct current stimulation (tDCS) which is a non-painful and non-invasive functional brain stimulation method. Several groups will be constituted to test if stimulation (inhibitory and excitatory) of the cerebellum or the primary motor on the transfer of prism acquired compensations to a non-exposed task. More precisely, the investigator aim to study the influence of different stimulation modalities (cerebellum vs MA, inhibitory vs excitatory vs sham) on the error reduction during prism exposure, on the amount of after-effects and on the amount on transfer to the non-exposed task. On a fundamental level, this project will allow a better understanding of the sensorimotor plasticity processes involved to counteract a perturbation and about mechanisms underlying transfer properties. Future results would allows to shed light on the conditions necessary to give rise to transfer as well as the implied brain regions. On longer-term these results will be used to optimize rehabitation strategies in motor function recovery in order to favour the transfer of acquired compensations to daily life situations.

NCT ID: NCT04106050 Withdrawn - Healthy Volunteers Clinical Trials

Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy

Start date: September 30, 2020
Phase: Phase 1
Study type: Interventional

Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095. Part B (optional): Equivalent objectives are pursued for BIIB074.

NCT ID: NCT04082481 Withdrawn - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-988 in Healthy Participants

Start date: November 17, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of TAK-988 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly (HE) participants.

NCT ID: NCT04081597 Withdrawn - Healthy Volunteers Clinical Trials

A Study of Single Ascending Doses of STAR-101 in Healthy Participants

Start date: February 2020
Phase: Phase 1
Study type: Interventional

The study will include a single ascending dose approach to evaluate the safety, tolerability, and pharmacokinetic properties of STAR-101 after a single oral administration in healthy participants

NCT ID: NCT04032691 Withdrawn - Healthy Volunteers Clinical Trials

PET Study of a2a Agonist Effects on the Ventricular CSF Clearance of [11C]Butanol

Start date: August 27, 2019
Phase: Early Phase 1
Study type: Interventional

This investigator initiated, pilot study will assess the feasibility of characterizing the effects of an orally administered alpha-2 adrenergic (a2a) agonist, clonidine, on the clearance rates of Carbon-11 butanol from the ventricular cerebrospinal fluid (vCSF) with positron emission tomography (PET) in healthy volunteers.

NCT ID: NCT04017208 Withdrawn - Healthy Volunteers Clinical Trials

A Study to Assess ASP2713 in Healthy Subjects

Start date: July 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate safety and tolerability of ASP2713 in healthy participants. The study will also evaluate the pharmacokinetics and pharmacodynamics of ASP2713.

NCT ID: NCT03832816 Withdrawn - Healthy Volunteers Clinical Trials

Behavioral and Physiological Effects of THC and CBD

Start date: December 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.