25 results
Primary Objective(s):1. To determine whether aging associated cognitive impairment can be attenuated by roflumilast administration as assessed by cognitive battery tests.Secondary Objective(s):1. To determine whether brain electrical activity (ie,…
The objective of this study is to assess whether sitagliptin may prevent prednisolone-induced impairment of glucose metabolism and beta-cell function.
The primary objective is to examine whether roflumilast (a PDE-4 inhibitor) can improve the cognition of healthy young volunteers. Secondary, we will assess the effects of roflumilast on electrophysiological correlates of cognition.
To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.
Primary objective:To compare the clinical benifit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens, one of…
* To investigate the effect of roflumilast 500 µg tablets once daily versus placebo on exacerbation rate, and pulmonary function and major adverse cardiovascular events (MACE) in COPD patients who are concomitantly treated with a fixed combination…
To examine the difference in gene expression profiles of ASM in bronchial biopsy specimens between asthmatic patients, non-asthmatic allergic and non-asthmatic non-allergic controls.To associate the gene expression profiles with airway…
Primary objective:To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism and beta-cell function in healthy males
Primary Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.Secondary Objectives: The secondary…
Recent studies show that treatment schedules of the first episode can safely be reduced (Hahn et al., 2015; Hoyer,2015), which may reduce steroid toxicity. The hypothesis of the REducing STEroids in Relapsing Nephroticsyndrome (RESTERN) study is…
Primary objectives: This study has co-primary objectives:• To compare OS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. • To compare DFS of nivolumab versus placebo in subjects with resected EC or GEJ cancer. Secondary…
The aim of the study is to compare overall survival (OS) and Blinded Independent Central Review (BICR)-assessed progression free survival (PFS), of nivolumab, and nivolumab in combination with ipilimumab, versus placebo in subjects with ED-SCLC…
We hypothesise that treatment with nivolumab will extend disease-free survival, compared with placebo, as adjuvant therapy in all randomized patients and in patients with PD-L1 expressing tumours (membranous staining in > 1%) who are at high…
The purpose of this study is to determine the cost - effectiveness and safety of prednisolone 5 mg / day for 2 years compared with placebo , in patients 65 and older with rheumatoid arthritis .
The aim of the study is to compare the Overall Response Rate (ORR) and assess Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded…
The main objective is the measure the effect on subretinal and intraretinal fluid in severe cCSC calculated by the cumulative areas of fluid objectified on optical coherence tomography (OCT). Secondary objectives are to gain insight in the mechanism…
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…
The objective is to validate the effects of chronic roflumilast treatment on cognitive function (i.e. episodic memory) by means of behavioral tasks, in people suffering from cognitive impairments at least 1 year after stroke.
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured…
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms. In the first phase Ib part, 20 patients will be enrolled and followed for…