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Healthy Volunteers clinical trials

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NCT ID: NCT03082768 Completed - Healthy Volunteers Clinical Trials

Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects

Start date: March 3, 2017
Phase: Early Phase 1
Study type: Interventional

The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical.

NCT ID: NCT03081468 Completed - Healthy Volunteers Clinical Trials

The PUPIL Study - Automated, Quantitative Pupil Assessment Using Binocular OCT

Start date: May 18, 2017
Phase:
Study type: Observational

In current, clinical ophthalmology, a range of specialised testing allows comprehensive evaluation of ocular health. These tests have typically evolved over many years to ensure their clinical validity. For example, the assessment of visual acuity has traditionally been measured with Snellen letter charts from a distance of six metres (20 feet), leading to the phrase "20/20 vision". Despite this, the limitations of Snellen testing are well established and more sophisticated testing is now available (e.g., logMAR testing using ETDRS (Early Treatment Diabetic Retinopathy Study) charts). Many other diagnostic tests have undergone similar cycles of refinement, often over extended time periods. Therefore, it should be incumbent on any new device to undergo detailed evaluation of its validity (how its measurements agree with other testing) and its repeatability (the variability when a further measurement is obtained in short time period, by the same operator and under the same conditions). Binocular OCT extends the application of OCT devices beyond that of simple, cross- sectional imaging to a diverse array of diagnostic tests. The binocular design also removes the need for additional personnel to perform testing (i.e., the device can be self-operated in an automated manner), and allows for novel testing to be performed that is not possible with monocular imaging. In particular, binocular OCT devices have the potential to perform automated, quantitative pupillary measurements - an entirely novel application for this imaging modality. This study will assess the validity and repeatability of pupil measurements using binocular OCT.

NCT ID: NCT03080051 Completed - Healthy Volunteers Clinical Trials

Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain

Start date: August 2016
Phase: Early Phase 1
Study type: Interventional

The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as [18F]UCB-K), a tau targeted PET radioligand.

NCT ID: NCT03078738 Completed - Healthy Volunteers Clinical Trials

Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

Start date: February 8, 2017
Phase: Phase 1
Study type: Interventional

The aim of this first-in-human study is to assess the safety, tolerability, PK and exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in healthy male subjects to support further clinical development of OMT-28 in the indication of atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide dosing for Phase II trials.

NCT ID: NCT03077763 Recruiting - Healthy Volunteers Clinical Trials

The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation

Start date: December 2016
Phase: Phase 1
Study type: Interventional

The study is a pharmacodynamic random order cross-over trial investigating the physiological effects of intra-arterial infusion of nitrite following a haemolysed autologous blood transfusion.

NCT ID: NCT03077282 Completed - Healthy Volunteers Clinical Trials

Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

Start date: April 26, 2018
Phase: Phase 1
Study type: Interventional

To investigate the safety of Prasaprohyai 95% ethanolic extract at doses of 100 mg and 200 mg for for 6 weeks. (Clinical Trial phase I)

NCT ID: NCT03072355 Completed - Healthy Volunteers Clinical Trials

Reliability and Validity of a Shoulder Fatigue Test

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Introduction: The exercise performed with elastic tools has been appearing in the current scenario as a clinical tool because it presents advantages such as easy handling, low cost and safety. However, its use as an assessment tool, specifically for localized muscular resistance, is reduced and not standardized. In addition, there are no records of the physiological / neurofunctional effects of tests that use such a tool, since it allows a differentiated degree of prescription. Objective: To determine the reliability and reproducibility of a shoulder abduction resistance test in two tools, elastic tube and isokinetic dynamometer. In addition to analyzing the metabolic profile of both comparative order and targeting subsequent training prescription. Method: The study will consist of a sample of 30 participants and will be carried out in 2 stages, 15 participants will perform step 1 and the other 15 will perform step 2. The difference between the steps is the order of the tools used to perform the test . Each stage will consist of 5 sessions (Orientation, Familiarization 1 and 2, Test and Retest). During the test and retest sessions the physiological response of the test will be analyzed. In order to observe the response, will be analyzed the lactic anaerobic parameter (lactate concentration), allelic anaerobic (post-exercise oxygen uptake analysis - EPOC), aerobic parameter (VO2 values) and electromyographic measurements. Will be used the statistical package SPSS Statistics 22.0, Pearson's correlation and their respective confidence intervals will indicate the relationship between the numerical variables and multivariate models will be constructed by means of linear regression. The significance level of 5% will be adopted.

NCT ID: NCT03071224 Completed - Healthy Volunteers Clinical Trials

Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein

Start date: June 2016
Phase: Early Phase 1
Study type: Interventional

The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.

NCT ID: NCT03070405 Active, not recruiting - Healthy Volunteers Clinical Trials

The Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.

NCT ID: NCT03065335 Recruiting - Depression Clinical Trials

Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder

Start date: May 25, 2017
Phase: Phase 1
Study type: Interventional

Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect. Objective: Main Study: To study the effects of ketamine in treating depression. Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry. To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down. Eligibility: Main Study: People ages 18-65 with major depressive disorder and healthy volunteers Ketamine Metabolites Substudy: Healthy volunteers ages 18-65 Design: Main Study: Participants will be screened in another study, with: - Medical and psychiatric history - Psychiatric and physical exam - Blood, urine, and heart tests Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks. Phase I (2-7 weeks): - Gradually stop current medications - MRI: Participants lie and perform tasks in a machine that takes pictures of the body. - Mood and thinking tests - Blood and urine tests - Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep. - Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity. - Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks. Phase I tests are repeated in Phases II and III and in the final visit. Phase II (4-5 weeks): - 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity. Phase III (optional): - 8 infusions of ketamine over 4 weeks Phase IV (optional): - Symptoms monitoring for 4 weeks - Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months. Ketamine Metabolites Substudy: Participants will be screened in another study, with: - Medical and psychiatric history - Psychiatric and physical exam - Blood, urine, and heart tests Participants will be inpatients at NIH for 4 days. Study Procedures: Mood and thinking tests Blood and urine tests 1 infusion of ketamine Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry