17 results
Primary objectiveTo investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PHSecondary objectivesTo investigate wether Sildenafil treatment results in a…
Primary Objectives: The primary objectives of this study are to evaluate the efficacy and safety of IV sildenafil when added to iNO for the treatment of neonates with PPHN or hypoxic respiratory failure and at risk for PPHN. Secondary Objectives: *…
The relative effects of sildenafil on mortality when administered at the three doses indicated above in adults with PAH will be evaluated in this clinical study. In addition, the relative effects on clinical worsening and 6-minute walking distance (…
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
To measure in vivo biodistribution of 89Zirconium labeled GSK2849330 and characterize its dose receptor occupancy relationship in subjects with advanced HER3 positive solid malignancies.
To describe and investigate safety and tolerability of the intradermal delivery of two fractional doses of 20 µg mRNA-1273 in patients with Fibrodysplasia Ossificans Progressiva.To compare the immunogenicity of patients with FOP after intradermal…
3.2.1 Primary objectivesTo assess the efficacy in terms of Anti-SARS-COV-2 RBD antibody responses in patients diagnosed with and/or under treatment for a hematological disorder to SARS-CoV-2 vaccination.3.2.2 Secondary objectives 1. What is the…
To assess immunogenicity and safety of SARS-CoV-2 vaccination in patients with isolated antibody deficiencies, i.e. patients with immunoglobulin G (IgG) subclass deficiency and patients with selective antibody deficiency with normal immunoglobulins…
To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…
Primary objective: To demonstrate pharmacokinetic comparability of 3D-printed sildenafil tablets and the originator sildenafil tablets following a single 20 mg dose in healthy adult subjects.Secondary objectives:• To describe the plasma…
To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…
In the coming months, immunocompromised patients treated in our hospital will be requested to undergo vaccination if they comply with the National Institute for Public Health guidelines. For all subgroups, it is of utmost importance to assess the…
Primary objectives:- to describe tolerability, safety and immunogenicity in healthy adults of the intradermal delivery of one or two fractional doses of 10 µg and 20 µg mRNA-1273 LPN vaccine (Moderna).- to compare the immunogenicity in healthy…
To assess immune response and adverse events after administration of one approved vaccine against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy
To assess the efficacy of SARS-CoV-2 vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination
To investigate, in RA patients, the role of different RTX doses (200, 500 and 1000mg) and timing of RTX on risk of obtaining adequate humeral response against COVID-19 vaccines, by performing a sensitivity analysis on response, using logistic…
The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients aged…