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Healthy Volunteers clinical trials

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NCT ID: NCT01518985 Completed - Healthy Volunteers Clinical Trials

The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

Start date: January 2012
Phase: Phase 1
Study type: Interventional

This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.

NCT ID: NCT01517100 Completed - Healthy Volunteers Clinical Trials

The Role of Endocannabinoids in Insulin Production and Action

Start date: January 5, 2012
Phase: Phase 1
Study type: Interventional

Background: - The endocannabinoid system is involved in different body functions and processes. It helps regulate appetite and mood, and sends signals to the nervous system. It may also be involved in how the body produces insulin during digestion. Researchers want to test two drugs that work on the endocannabinoid system: nabilone and CP-945,598. These drugs may be able to affect insulin levels in the blood. This information may suggest possible new treatments for people with diabetes. Objectives: - To study how the endocannabinoid system is involved in insulin production and action. Eligibility: - Healthy men between 21 and 55 years of age. Design: - Participants will be screened with a physical exam and medical history. They will provide blood and urine samples. They will also have imaging studies to test their brain responses, especially to food-related cues. Some participants will also have a study visit to test their insulin resistance levels. - Participants will have four separate study visits 6 weeks apart. They will keep a food diary before each visit. At each visit, they will have one of the following combinations of drugs: - Double placebo - Placebo and nabilone - Placebo and low dose of CP-945,598 - Placebo and high dose of CP-945,598. - Participants will have follow-up visits 1 week after each study visit. Blood samples will be taken....

NCT ID: NCT01515358 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants

Start date: February 2012
Phase: Phase 1
Study type: Interventional

The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.

NCT ID: NCT01514968 Completed - Healthy Volunteer Clinical Trials

A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers

Start date: December 2011
Phase: Phase 1
Study type: Interventional

This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.

NCT ID: NCT01513967 Completed - Healthy Volunteers Clinical Trials

A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study will be divided into three parts: A, B, and C (NOT Performed)

NCT ID: NCT01513200 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers With and Without Bendavia

Start date: January 2012
Phase: Phase 1
Study type: Interventional

This will be a phase 1 randomized, double-blind crossover trial enrolling approximately 12 healthy volunteers to assess whether intravenous (IV) UFH and IV Bendavia administered together have any significant impact on the pharmacodynamic effects of UFH and the pharmacokinetics of Bendavia.

NCT ID: NCT01510899 Completed - Healthy Volunteer Clinical Trials

A Study on the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

Start date: October 2011
Phase: Phase 1
Study type: Interventional

This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.

NCT ID: NCT01507402 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Safety and Tolerability of Single Ascending Doses of REGN1033(SAR391786)

Start date: January 2012
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in healthy volunteers.

NCT ID: NCT01505049 Completed - Healthy Volunteers Clinical Trials

Immune Memory After Papillomavirus Vaccination

IMAP-1
Start date: January 2012
Phase: N/A
Study type: Observational

Vaccines for human papillomavirus (HPV) have been available in the United States since 2006. Early studies have shown a high rate of effectiveness of these vaccines, however it is not known how long this protection will last. The IMAP study will look at various parts of the immune system and potential markers for long lived immune responses to this vaccine.

NCT ID: NCT01498263 Completed - Clinical trials for Alzheimer's Disease and Related Dementias

Inherited Diseases, Caregiving, and Social Networks

Start date: January 9, 2012
Phase:
Study type: Observational

Approximately 66 million informal caregivers care for someone who is ill, disabled, or aged. These caregivers experience significant distress associated with caregiving, which may be particularly salient in the context of inherited conditions. Previous studies have not examined caregiving from a network perspective, nor have they considered how cognitive and emotional responses, such as caregivers worry for themselves and relatives acquiring the disease or guilt related to the genetic etiology of their child s illness, as possible stressors; the current project fills this literature gap. Caregiving processes may vary across type of illness and the life course. In illnesses that impact children, parents and grandparents may take on caregiving roles whereas in conditions that impact adults, spouses and adult children may provide care. Caregivers must adapt to the strain of caring for their affected relatives and this adaptation may differ depending on caregiver roles. The caregiver s support network may influence adaptation, impacting the health and well-being of patients, their caregivers, and other relatives. This project, comprised of 5 substudies, will examine social contexts surrounding families involved in caring for individuals with chronic inherited conditions from a relational perspective. Surveys and interviews will assess participants cognitions and emotions about the disease, caregiving burden and caregiving/support network systems. In addition, biomarkers will be considered in 2 substudies to examine how caregiving roles and expectations impact health among caregivers. As part of our current inquiry, we have developed an assessment tool aimed at understanding caregiver experiences related to dietary practices in the context of metabolic conditions. To evaluate the psychometric properties of this scale, we propose a fifth substudy under the current protocol. We aim to recruit at least 5550 participants through residential/daycare centers, advocacy groups, and the NIH Clinical Center. We will recruit formal caregivers, multiple biological and non-biological adult relatives of affected individuals and typically developing controls to construct and evaluate caregiving/support network systems. This project will use a social network framework to develop and adapt common measures of caregiving roles to evaluate burden, perceptual bias, and unmet expectations in caregiving. The psychometric properties of these new measures, characteristics of family caregiving and support networks, and how these network characteristics are associated with caregiving strain and well-being, including biomarkers of physical health, will be investigated. The moderating role of family members cognitions and emotions and disease context will be considered. Findings will guide future research to develop network-based interventions promoting positive adaptation to the presence of inherited conditions in families through improved social environments and coping skills....