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Filter by:Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI). The PI's hypothesis is that MBAT will improve performance in SMR based BCI.
RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.
Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic risk profiles and gut microbiota in subjects with high BMI Primary objectives of the trial are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile acid and fecal sterol concentrations. Secondary objectives are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of intestinal permeability in plasma; (8) inflammation Study Design Placebo-controlled, randomized, double-blind parallel trial Criteria for Enrollment Inclusion criteria: Aged 18-65 years; BMI >27 kg/m^2. Good General health. Exclusion criteria: Fasting blood glucose >300 mg/dl; triglycerides >500 mg/dl; uncontrolled hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco smoking. Methodology After a run-in phase of two weeks, participants will be randomized to receive supplementation with either wheat Aleurone-rich food (27 g Aleurone/day) or placebo for 4 weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S. di Dietetica e Nutrizione Clinica, St Chiara, Trento. Clinical tests, blood drawing, and stool and urine collection will be performed during visits at the beginning and end of each treatment period (T0 and T1) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento. A 4 day-food diary record will be collected before visits T0 and T1. Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14, LPS-binding protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal microbiota analysis. Safety Assessments. Adverse events. Statistical analyses. Post-intervention data will be compared by ANOVA using the General Linear Model with baseline as a covariate. Data with a skewed distribution will be log transformed before analyses. Simple and multiple linear regression will be used to determine relationships between variables and independent t-tests performed to evaluate differences in reported compliance between groups. Results will be expressed as mean +/- SEM and differences will be considered significant at P < 0.05.. Duration of Dosing. Subjects will make three visits during the study (start of run-in phase - visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week 6). Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is targeted.
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.
This study will be a single-center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in approximately 18 subjects. In Part C, the effects of donepezil administered in combination with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in approximately 24 subjects.
This study measures how much of the trial drug enters the body and how long it takes for the body to remove it via the feces and urine. In addition, the different breakdown products after a single oral dose of radio-active ASP3652 will be identified.
The aim of this study will be to investigate the effect of rectal distension, controlled by electronic barostat, on cognitive control ability in healthy subjects. We will use the Stroop task and an intertemporal choice task as standard instruments. Like bladder control and rectal control, both Stroop task performance and intertemporal choices - though very different tasks at the surface - are dependent on the conflict monitoring function of the anterior cingulate cortex. The Stroop task requires the naming of the print color of a series of visually presented color words, and reaction time and error rates are typically used as performance indicators. When word color and word meaning do not match, performance of the task (color naming) requires the inhibition of a (near) automatic response (word reading). The intertemporal choice task consists of a series of choices between a sooner smaller monetary reward and a larger but later reward. The choices are constructed such that they allow the estimation of a discount parameter, which is an index for the level of impulsiveness manifested by the participant at the time the choices are made. The hypothesis is that the inhibition induced by the urge generated during rectal distension will improve cognitive inhibitory performance, as has previously been shown for bladder filling.
The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects. Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in healthy young Caucasian male subjects and to assess the safety and tolerability of multiple doses of ASP3652 in healthy young Caucasian male subjects.
The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.
Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers. Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress. The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.