4763 results
Page 18 of the protocol (v1.0, 4-Nov-2013):The primary objectives of this study are:- To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study…
The effects of intravenous TRH administration on brown adipose tissue activity in healthy, lean men.
To investigate whether BAT tissue can be activated by intravenous administration of TRH. Secondary objectives are to determine whether intravenous TRH increases the degree of cardiovascular sympathetic stimulation and the response of skin…
the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…
Primary objective• To assess the effect of use of a walk-bike in IPF patients for 8 weeks on health-related quality of life, measured with the St. George Respiratory Questionnaire, at baseline, week 9 and week 18, in patients with IPF.Secondary…
The goal of this study (mono-center study) is to study the effect of renal denervation with the EnligHTN Renal Denervation System on sympathetic nerve activity.
To define the amount of dietary protein required to optimally stimulate post-exercise muscle protein synthesis in the older population.To assess whether co-ingesting 1.5 g of free leucine (contained within 15 g dairy protein) along with 15 g protein…
Primary objective:- To demonstrate that CT-P13 is noninferior to Remicade at Week 6 (Dose 3), in terms of efficacy, asdetermined by the Crohn*s Disease Activity Index (CDAI)-70 response rate.Secondary objectives:-To evaluate long-term secondary…
With this study we will investigate the effects of lumbar sympathetic blockade on ERPF and measured GFR and relative changes in non - invasive hemodynamics measured before and after continuous lumbar sympathetic blockade or splanchnic blockade in…
Primary Objectives: To evaluate the overall bowel cleansing efficacy and the *Excellent plus Good* cleansing rate in the colon ascendens of a 1-day day before-only split-dosing regimen with NER1006 compared to a 1-day day before-only split-dosing…
The primary objective for part I of the study is the investigation of the pharmacokinetics. Although there is substantial clinical experience with all components of HTX-011, the formulation itself and the route of administration is new, which…
To assess the efficacy of rosuvastatin 20 mg on low-density lipoprotein cholesterol (LDL-C), compared to placebo, after 6 weeks of treatment in pediatric patients with HoFH.
Objectives:Primary:• To determine the absolute bioavailability of niraparib by using an intravenous (IV) niraparibmicrodose of 100 µg (containing approximately 1 µCi of [14C]-niraparib) in subjects with cancer.Secondary:• To characterize the…
Primary Objectives-To evaluate if mitochondrial dysfunction can be induced in healthy, middle aged subjects, through the use of simvastatin, and whether it can be reversed by oral ubiquinol supplementation. -To validate the techniques NIRS, PpIX-…
To determine sensitivity, specificity, positive predictive value and negative predictive value of the spectroscopic cervical imaging device in detection of high grade cervical intraepithelial neoplasia.
Primary Objectives:• Part 1: To evaluate the safety and tolerability of ruxolitinib in combination with pemetrexed/cisplatin and select a dose for further evaluation• Part 2: To evaluate and compare the overall survival of subjects with nonsquamous…
The objectives of the study are as follows:*1. To assess the effectiveness of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating chronic cough. Improvements in chronic cough will be assessed by measuring the change from…
Primary objective:Evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of multiple doses of intravenous (IV) ATYR1940 in adults 18 to 65 years of age, inclusive, with FSHDSecondary objective:Explore pharmacodynamic (PD)…
Primary objective: To estimate the MTD/RDE of LOP628 in solid tumors and AML, respectively.Secondary objectivesL:- To characterize the safety and tolerability of LOP628- To characterize the pharmacokinetic profile of LOP628- To assess emergence of…
Primary Objectives:-To characterize the safety and tolerability of ISIS 494372 in individual patients at escalating doses of 100, 200, and 300 mg/week-To characterize the efficacy of ISIS 494372 in lowering Lp(a) using a dose titration study design.…
Primary:• To prove the superiority of a 12-week add-on treatment with 3.2 g/daygastro-resistant phosphatidylcholine granules (LT-02) in at least one of twodifferent dosing regimens versus LT-02 placebo for the induction ofremission in patients with…