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The impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males
DELPhI acquisition and analysis software, a QuantalX Neuroscience development, which is designed to measure, analyze, and display brain electrical activity of human electroencephalogram (EEG), to transcranial magnetic stimulation (TMS), will be used to evaluate different psychiatric conditions.
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®), respectively. The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30, or 60 mg of duloxetine, respectively. The purpose of this study is to verify through a single dose study, if the test formulation of duloxetine is bioequivalent to the reference formulation (Cymbalta®) when administered with the same dosage and under fed conditions in healthy male research subjects.
Predicting fluid responsiveness in critically ill patients is of paramount importance. It can help define an adequate fluid balance. Overzealous fluid administration is poorly tolerated and has been associated with poor outcomes but so has insufficient administration. Currently available predictors of fluid responsiveness rely on invasive monitors and require patients to be on mechanical ventilation. It is thus important to develop non invasive novel methods to assess fluid responsiveness to provide an accurate management for a favorable outcome. We propose a readily available non-invasive method that relies on improvement of the ventilation perfusion mismatch as recorded by end tidal CO2. Ventilation of physiologic dead space is part of a spectrum of mismatch between ventilation and perfusion of the lungs. The extent of pulmonary dead space varies depending on factors affecting pulmonary perfusion (e.g. pulmonary capillary hydrostatic pressure) and alveolar pressure (e.g. positive pressure ventilation). Compromised pulmonary capillary perfusion can lead to ventilation-perfusion mismatch in a patient with clear conductive airway and adequate alveolar oxygen pressure. Alveolar dead space results in decreased CO2 exchange that translates into lower levels of expired CO2. Stroke volume of the right ventricle is a major determinant of the pulmonary capillary perfusion. Right ventricular cardiac output can be increased by passive lower limb elevation maneuver, which ultimately results in improvement of the ventilation to perfusion ratio. This effect leads to a higher participation of perfused (and ventilated) alveolar units in gas exchange and narrowing of the gradient between arterial and expired CO2 concentration. Performing a passive leg raising (PLR) maneuver leads to stroke volume enhancement in both healthy patients and in those experiencing hemodynamic instability. Responsiveness to PLR can be assessed by different methods including echocardiography and pulse pressure variation. Left ventricular cardiac output (LVCO) can be easily measured by transthoracic echo and be used as a surrogate of right ventricular preload changes. LVCO can thus be used to assess the fluid responsiveness of PLR and the effects of on end tidal CO2 that ensue. We propose this study to test the hypothesis that expired CO2 is a reliable predictor of fluid responsiveness after performance of the PLR maneuver, based on the assumption that increasing right ventricular output causes a reduction of the ventilation to perfusion ratio, leading to increased levels of expired CO2. T
The primary objective of this trial is to investigate the safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses. A secondary objective is the exploration of the PK including dose proportionality of BI 705564 after single dosing.
There is a big change in our understanding of aging in recent years. Recent researches has revealed clock-like patterns of epigenetic change across in humans. The aging involves a timed epigenetic reprogramming. However, this biological clock which ticks in our DNA is affected by our experience, diet, stress, etc. and it could be changed by experience and life style potentially. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in ELOVL2-AS1 gene in saliva samples using a next generation sequencing.
In Brazil, duloxetine is currently available as hard gelatinous capsule with delayed release microgranules for oral administration containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine (Cymbalta®), respectively. The Sponsor has developed a hard gelatinous capsule with delayed release microgranules formulation containing enteric-coated pellets of 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 30, or 60 mg of duloxetine, respectively. The purpose of this study is to verify through a single dose study, if the test formulation of duloxetine (60 mg) is bioequivalent to the reference formulation (Cymbalta® 60 mg) when administered with the same dosage and under fasted conditions in healthy male research subjects.
This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects
The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 days prior to first dose.