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NCT ID: NCT02147392 Completed - Pharmacokinetics Clinical Trials

Assessment of [11C]ER176 to Image Translocator Protein in Brain and Whole Body of Healthy People

Start date: May 14, 2014
Phase: Early Phase 1
Study type: Interventional

Background: - A protein called translocator protein may play a role in brain inflammation. Sometimes it is present at higher levels in the lungs than in the brain. Researchers want to see if a drug called [11C]ER176 can provide an image of this protein in the brain. Objective: - To test the ability of a drug to image a protein, and test how it is distributed in the body. Eligibility: - Healthy adults over age 18. Design: - Participants will be screened with medical history, physical exam, and blood and urine tests. - Participants will have a PET scan of the brain using [11C]ER176. It will be injected through an intravenous tube into 1-2 arm veins. A tube may also be put into an artery at the wrist or elbow. Some participants will also have a lung scan. - For the PET, participants will lie on a bed that slides in and out of a doughnut-shaped scanner. A plastic mask will be molded to their face and head. They may be wrapped with restraining sheets. The scan will last about 120 minutes. Blood may be taken during the scan. - Blood and urine will be taken before and after the scan. - During another visit, participants will have an MRI scan of the brain. Participants will lie on a table that slides in and out of a metal cylinder. A strong magnetic field and radio waves will take pictures of the brain. The scanner makes loud knocking noises. Participants will be given earplugs. - Some participants will have only a whole-body PET scan using [11C]ER176.

NCT ID: NCT01939925 Completed - Adult Clinical Trials

Communicating Evidence From Systematic Reviews to the Public

PLSRCT
Start date: May 2009
Phase: N/A
Study type: Interventional

The purpose of this randomised controlled trial is to compare a new standardised summary format for presentation of synthesised evidence from systematic reviews for the public (a new plain language summary format) to the current format used in Cochrane systematic reviews. The study will evaluate if the new presentation improves understanding about the benefits and harms of an intervention, if it improves the accessibility of the information, and if it is preferred over other versions by the public over the current format.

NCT ID: NCT01915719 Completed - Adult Clinical Trials

Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.

IVNICTUS
Start date: August 2013
Phase: N/A
Study type: Interventional

Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure

NCT ID: NCT01175993 Completed - Clinical trials for Traumatic Brain Injury

Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury

Start date: August 24, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, more research is needed into different treatments for traumatic brain injury. - Exercise has been shown to improve movement and balance in people with strokes, cerebral palsy, and other conditions that affect the brain, and can improve symptoms of memory problems or depression. Bright light therapy has also been shown to improve mood in people with depression. Researchers are interested in studying problems with movement, balance, thinking, and mood in people with traumatic brain injury. By comparing the effects of exercise and bright light exposure on brain function, new treatments may be developed for acute traumatic brain injury. Objectives: - To compare the effects of exercise and bright light therapy on the brain function of individuals with traumatic brain injury. Eligibility: - Individuals between 18 and 44 years of age who either have been diagnosed with traumatic brain injury or are healthy volunteers. Design: - Individuals with traumatic brain injury will have four outpatient evaluation visits at the clinical center, a 3-month home exercise program, and a 3-month bright light exposure program at home. Healthy volunteers will have one evaluation visit at the clinical center. - At the first study visit, all participants will have a full physical examination and medical history. Individuals with traumatic brain injury will also have an eye exam to determine if it is safe for them to receive light therapy. - All participants will have the following initial tests: - Tests of walking and movement, including monitoring by a physical therapist; tests to record joint movement and evaluate muscle function; tests that combine movement, thinking, and speaking; and balance and reaction time tests. - Magnetic resonance imaging scans - Tests of thinking and mood, including questionnaires, computerized tests, and simple action tests. - Participants with traumatic brain injury will have separate 3-month sessions of exercise and bright light therapy, with additional evaluation visits between each 3-month session and at the end of the study. Between the 3-month sessions, participants will have 1 month with no intervention. - Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes for 5 days a week, and bright light therapy sessions will involve sitting in front of a light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor the effects of the therapy.

NCT ID: NCT01167075 Completed - Sepsis Clinical Trials

A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)

Intestamin
Start date: February 2006
Phase: N/A
Study type: Interventional

The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.

NCT ID: NCT01162863 Completed - Clinical trials for Irritable Bowel Syndrome

Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation

Start date: November 2010
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI tract motility. Lubiprostone, a novel drug that works by activating the colonic ClC-2 chloride channel, has been approved for use in patients with chronic idiopathic constipation and recently approved for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such as abdominal pain and constipation. However, there is limited physiologic data to explain how exactly lubiprostone improves IBS-C symptoms. The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon) transit time. The primary aim of this study is to determine the effects of lubiprostone on whole GI tract transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with differing doses of lubiprostone. The investigators hypothesize that lubiprostone will increase whole GI and colonic transit compared to placebo in patient with IBS. the investigators do not expect a change in intraluminal pH with lubiprostone compared to placebo.

NCT ID: NCT01124968 Completed - Adult Clinical Trials

eConculta: Impact of Virtual Visits in Primary Care

eConsulta
Start date: January 2009
Phase: N/A
Study type: Interventional

eConsulta is a before and after quasi-experimental study without control group and its purpose is to asses the impact of virtual visits in primary care on the frequency of attendance of the patients to the primary care centre. The use of virtual consultations should lower the number of face to face visits to primary care. It also should create satisfaction to both users: primary care professionals and patients.

NCT ID: NCT01122706 Completed - Stress Clinical Trials

Efficacy of Taiji Training as a Program for Stress Prevention

Start date: July 2010
Phase: N/A
Study type: Interventional

Background: Excessive exposure to psychosocial stress can be a potent trigger for somatic diseases and psychological disorders, a cause for missing work, and eventually lead to high economic loss. Therefore, for health and economic reasons the assessment of effectiveness of stress preventive interventions is of high relevance. According to several clinical studies, Taiji, a Chinese form of mindful and gentle movements, can significantly reduce symptoms of somatic diseases and psychological disorders. Some recently conducted Taiji-studies with healthy subjects indicate a stress protective effect. However, the stress protective impact of Taiji regarding psychosocial stress has not yet been examined. Objective: To investigate the efficacy of a 12 week Taiji training as a stress prevention program by measuring psychosocial stress reactivity in a laboratory setting, as well as the subjective perception of stress and coping-resources in daily life of 70 healthy volunteers. Hypothesis: Healthy subjects attending a 12 week Taiji course (frequency: twice a week for 1h) will show significantly reduced psychobiological reactivity, decreased stress perception and increased coping-resources on a standardized psychosocial stress test compared with healthy subject of the waiting list.

NCT ID: NCT01084018 Completed - Pain Clinical Trials

Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery

SOULAGETAVIE
Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this project is to develop and evaluate the effects of a computer-tailored intervention targeting pain barriers and catastrophizing in adults having cardiac surgery. The hypotheses are that in the experimental group, in comparison to the control group, participants will show lower levels of pain, less pain interference in their activities, less attitudinal barriers, and less pain catastrophizing. A pilot-RCT is privileged to assess the preliminary effects of the intervention on the following outcomes: pain intensity, analgesic consumption, pain interference, barriers and pain catastrophizing.

NCT ID: NCT01054300 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

Start date: February 17, 2010
Phase: Phase 1
Study type: Interventional

This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in adults with type 2 diabetes.