2372 results
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…
From Page 14 of the C1 research protocol document:Primary Objective: To determine if changes in gravity through alterations in post-prandial body position affects protein digestion and absorptionSecondary objectives: To determine if changes in…
Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
With the proposed study we aim to gain insight into the effects of oxytocin (OT) on both parents* and grandparents* sensitive, empathic, and protective responses to their (grand)children, and in the neural origins of these responses.The primary…
The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical and conservative treatment of non-obstructive meniscal injuries in older patientsHypothesis: We assume equal improvement of physical function in both…
to investigate the effect and efficacy of pyridostigmine on muscle strength and fatiquabillity in patients with SMA.
• To evaluate the tolerability and safety of ascending single oral doses of ACT-541468 in healthy male subjects.• To investigate the single oral dose pharmacokinetic (PK) and PD of ACT-541468 in healthy male subjects.• To investigate dose…
ObjectivesPrimary:• To assess the effect of ethanol compared to placebo on a driving simulator performance tests;• To assess the effect of alprazolam compared to placebo on a driving simulator performance tests;Secondary:• To assess the effect of…
The main study parameter is the routine measurement of serum phosphate concentrations after 8 and 12 weeks. Other study parameters are compliance to phosphate binders and supplement-related complaints such as nausea, diarrhoea, flushing and itchness…
Primary objective:To compare the change in small airways obstruction (FEF75%) in patients with CF when inhaling one ampule of inhaled tobramycin with the Akita® compared to standard of treatment (twice daily nebulization of one ampule using standard…
Primary Objective: to ascertain whether tVNS affect performance (as measured by modulation of reaction times and/or error rates) in two cognitive tasks designed to examine PES and PIA, as well as specific components of pupillary response that will…
* To assess the safety and tolerability of inhaled PA101 delivered via eFlow in patients with IPF with refractory chronic cough.* To assess the efficacy potential of inhaled PA101 by measuring the changes in cough severity and the urge-to-cough as…
The first objective is to evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.Key Secondary objectiveTo evaluate the superiority of CHF…
The primary aim of the study is (i) to assess the effect of a soft brace on pain, knee stability and activity limitations. Secondary aims are (ii) to assess the difference in effect of two knee soft braces (i.e., non-tight and tight) on pain and…
To test the hypothesis that metabolic inflexibility in pre-diabetic subjects and diabetic patients is due to a reduced capacity to form acetylcarnitines: We aim to investigate whether glucose intolerant subjects have a lower capacity to form acetyl-…
- to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixeddose combination…
To elucidate in the same participants (late chronotypes with at least two hours of social jetlag) the changes in sleep timing, social jetlag and endogenous circadian phase of melatonin with more than two hours of social jetlag shielded from blue…
The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
The aim of this study is to assess the influence of alveolar tampon packing on incidence of pain, swelling, trismus, alveolar osteitis, and QoL in the week following M3 surgery.
Evaluate the performance of directional microphone systems in binaural (bimodal or bilateral) cochlear implant users