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Healthy Volunteers clinical trials

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NCT ID: NCT02773446 Completed - Healthy Volunteer Clinical Trials

Human Challenge Model Refinement With Enterotoxigenic Escherichia Coli Strain B7A

Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the safe and optimal dose and regimen (fasting duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain. Additionally, an assessment of homologous protection following rechallenge with B7A will be assessed.

NCT ID: NCT02770404 Completed - Healthy Volunteers Clinical Trials

A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects

Start date: April 25, 2016
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.

NCT ID: NCT02769988 Completed - Clinical trials for Healthy Volunteers Only

Educational Impact of the NLM/National Area Health Education Center Organization (NAO) Project-SHARE Based Teen Health Information Literacy Curriculum

Start date: May 11, 2016
Phase:
Study type: Observational

Background: The Teen Health Information Literacy Project is an after-school program for high school students. It gives them skills to access valid and reliable health data. It also aims to grow young health advocates. Researchers want to find out more about the impact the program has had on students. They want to use this feedback to improve the program. Objective: To gain feedback about the Teen Health Information Literacy Project. Eligibility: Young people who participated in the Teen Health Information Literacy Project. The project was run by Area Health Education Centers (AHECs) and sponsored by the National Library of Medicine (NLM). Design: The study will be explained to students during a program session. They will take consent forms home to their parents. Participants will split into 6 focus groups. Each one will be conducted at an AHEC project site. The focus group will be a 90-minute discussion between participants and an evaluator from the NLM. The evaluator will be present either in person or by video conference. The evaluator will ask participants questions, which may include the following. What did they like and dislike about the program? Why did they decide to participate? What have they learned? Would they recommend this program to another student? How has the program affected their interest in health-related careers? The discussion will be audio-recorded. The evaluator will use an automated tool to convert recordings into text. After that, she will destroy the audio.

NCT ID: NCT02769741 Completed - Healthy Volunteers Clinical Trials

A Controlled-Feeding Study to Assess the Effect of Cashews on Fasting Lipoprotein Levels

Start date: January 2016
Phase: N/A
Study type: Interventional

This study will assess the nutritional effect of cashews on LDL-C concentrations and secondarily on other aspects of the fasting lipoprotein lipid profile in healthy men and women with moderately elevated cholesterol.

NCT ID: NCT02757755 Completed - Healthy Volunteers Clinical Trials

Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults

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

This study will examine the safety of ascending doses of AB-SA01 when topically applied to intact skin of healthy adults.

NCT ID: NCT02755870 Completed - Clinical trials for Healthy Volunteers - Male and Female

A Phase I SAD and MAD Clinical Trial of CNM-Au8 in Healthy Male and Female Volunteers

Start date: April 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1, First-Time-In-Humans, randomized, placebo-controlled, double-blind, escalating single- and multiple-dose study to evaluate the safety, tolerability, and pharmacokinetics of CNM-Au8 in healthy male and female volunteers. There will be 2 phases to this study: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD Phase will be conducted first followed by the MAD phase of the study.

NCT ID: NCT02755584 Completed - Healthy Volunteers Clinical Trials

Study of Skin Cells That Stop Replicating (Senescent) During Wound Healing

Start date: June 30, 2016
Phase:
Study type: Observational

Background: Cellular senescence is the aging of cells. It is a complex process that may be connected with aging and age-related diseases. It is unknown if these cells appear around wound sites in humans a few days after skin injury and if there are differences in young and old individuals. This study is being done to look at how cells in your body respond to small skin wounds. This information may help treat age-related diseases. Objective: To study how cells in the body respond to small skin wounds. Eligibility: Healthy adults ages 20-39 or 70+ Design: Participants will be screened with medical history, physical exam, and blood sample. They will fast before the screening visit. Women will have a urine pregnancy test. Participants will have 3 study visits over about 3 weeks. Visits 1 and 2: Participants will fast before and have blood taken. Women will have a urine test. All participants will have 2 skin biopsies. A spot on the upper arm will be numbed. Two small pieces of skin will be removed. They will keep the area covered until the next visit. Visit 3: Participants will have their vital signs taken. Their biopsy wounds will be measured and photographed.

NCT ID: NCT02754492 Completed - Healthy Volunteers Clinical Trials

Evaluation of Trima Version 7.0 Platelets in 100% Plasma

Start date: April 2016
Phase: N/A
Study type: Interventional

To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in 100% plasma meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).

NCT ID: NCT02754440 Completed - Healthy Volunteers Clinical Trials

Evaluation of Trima Version 7.0 Platelets in PAS

Start date: April 20, 2016
Phase: N/A
Study type: Interventional

To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).

NCT ID: NCT02748694 Completed - Schizophrenia Clinical Trials

Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

Start date: May 9, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2. As add-on therapy to antipsychotics in stable schizophrenia participants. 3. To determine the oral bioavailability of the TAK-041 tablet formulation compared to the oral suspension formulation in the fasted state. 4. To assess the effect of food on the PK of TAK-041 in healthy participants.