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Safety and protective efficacy of chemoprophylaxis and sporozoite immunization with Plasmodium falciparum NF135 against homologous and heterologous challenge infection in healthy volunteers in the Netherlands

Primary Objective: To determine the safety and tolerability of NF135.C10 sporozoite immunization under chemoprophylaxisSecondary Objectives:• To determine the dose-dependent protective efficacy of NF135.C10 CPS-immunization against homologous…

Screening and patient-tailored care for Emotional and COgnitive problems in patients discharged home after ischemic stroke (ECO-stroke)

Patients with good outcome in terms of motor functioning and communication are likely to be discharged home without referral to further rehabilitation services. A substantial amount of these patients experience emotional and cognitive problems,…

A multi-centre, randomized, double-blind (sponsor open), placebocontrolled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis (study 201247)

Primary:To evaluate the safety and tolerability of repeat subcutaneous doses of GSK2330811 in participants with dcSSc.Secondary:PK. PD (serum levels of total and free OSM). Antibodies against GSK2330811.

Conditioning of insulin responses: a high rist- high gain intervention for diabetes type-2

The primary objective of this study is to investigate the effects of classical conditioning with intranasal insulin on endogenous insulin and glucose levels in diabetes type-2 patients and healthy controls. Additionally, we will examine the effects…

ILLUMINATE-A: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study with an Extended Dosing Period to Evaluate the Efficacy and Safety of Lumasiran in Children and Adults with Primary Hyperoxaluria Type 1

Primary objective- To evaluate the effect of lumasiran on percent reduction in urinary oxalate excretion Secondary objectives - To characterize the effect of lumasiran on absolute levels of urinary oxalate excretion, oxalate:creatinine ratios, and…

Dose REduction Strategy Study of TNF inhibitors in Psoriatic arthritis and axial Spondyloarthritis patients.

The aim of the study is to compare the proportion of patients (for PsA and axSpA together) having LDA at 12 months between a T2T strategy with versus without tapering attempt against a pre-set non-inferiority margin of 20%.

The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced airway obstruction

To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children.

The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium
Bromide/Vilanterol in a Single Inhaler (TRELEGY ELLIPTA) when Compared
with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual
Care Setting.(study 206854)

Primary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT for the impact of COPDon wellbeing and daily life after 24 weeks* treatment. Secondary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT on lung…

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (Triple M trial)

This study will compare sequential mifepristone and misoprostol treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands.

A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

To evaluate the effect of MEDI6012 on infarct size compared with placebo.

Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)

The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTcinterval in patients with stable CAD10 within the exposure range observed in Phase II/IIIstudies:Primary objective:* To investigate whether there is a…

A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy

The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.

A double blind (sponsor open) placebo-controlled, stratified, parallel group study to evaluate the efficacy and safety of repeat doses of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD) (207972)

Primary:To evaluate the efficacy of 3 doses of GSK3772847 (administered every 4 weeks) compared with placebo in moderate to severe asthma participants with allergic fungal airway disease (AFAD) who are currently on Standard of Care (SoC) Secondary:…

US-guided Percutaneous needle tenotomy in Patients with Lateral Elbow Tendinopathy: A multicenter Randomized Controlled Trial

To study the effect of PNT and structured exercises on function and pain of patients with lateral elbow tendinopathy.

Efficacy and safety of bumetanide oral liquid formulation in children and adolescents aged from 7 to less than 18 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children and adolescents aged from 7 to less…

Multi-center, blinded, randomized, PaRAllEl-group, Phase 3 study with aproCItentan in Subjects with Resistant HypertensiON (RHT)

The primary objective of the study is to demonstrate the BP lowering effect ofaprocitentan when added to standard-of-care in true resistant hypertension subjects.The secondary objectives of the study are• to demonstrate that the effect of…

A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…

*The PreRisk calculator in suspected or confirmed preeclampsia: A new tool to safely reduce the number of unnecessary admissions*

The objective of our study is to investigate whether application of the PreRisk calculator, based on the sFlt1/PlGF ratio,protein-to-creatinine ratio and gestational age, in patients with (suspected) PE can reduce the number and duration of…

*CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept*

This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects with Multiple Osteochondromas

Primary Objective• To evaluate the efficacy of two dosage regimens of palovarotene compared with placebo in preventing new osteochondromas (OCs) in subjects with multiple osteochondromas (MO) due to exostosin 1 (Ext1) or exostosin 2 (Ext2) mutations…