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CONNected Electronic Inhalers Asthma Control Trial 3 (*CONNECT 3*), a 24-Week Treatment, Multicenter, Open Label, Randomized, Parallel Group Comparison Study of Standard of Care Treatment Versus the Budesonide/Formoterol Digihaler Digital System, to Optimize Outcomes in Adult Patients with Asthma

The primary objective of this study is to demonstrate the effectiveness of the DS compared to the SoC group. The secondary objectives:(#1) is to describe the asthma management actions by HCPs for all patients in both groups. (#2) is to evaluate…

Evaluating the effect of different daily plant stanol ester intakes on the vaccination response to an influenza vaccine

The primary objective of this study is to demonstrate the effect of consuming different daily amounts of plant stanols (2.0, 3.0, or 4.0 gr stanols; delivered via products enriched with plant stanol esters) on the vaccination response to an…

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington*s Disease

Primary objective:x To evaluate the safety and tolerability of WVE-003 in patients with Huntington's disease (HD)Secondary objectives:x To characterize the pharmacokinetics (PK) of WVE-003 in plasma x To characterize the concentration of WVE-…

A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

This study has been transitioned to CTIS with ID 2024-517528-20-00 check the CTIS register for the current data. Primary objective:• To evaluate the anticancer efficacy of INBRX-109 in the intention-to-treat (ITT) population as measured by…

The effect of the Progressive Goal Attainment Program (PGAP) on cognitions and perceptions and workparticipation of workers with a chronic disease in the Netherlands

To study whether PGAP is effective in changing cognitions and perceptions and increasing work participation of workers with a chronic diseae in the Netherlands and to study whether implementing PGAP is feasible in the Netherlands.

A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG)

Primary objective:- To assess the clinical efficacy of efgartigimod IV 10mg/kg administered in a q2w continuous regimen compared to that administered in a cyclic regimen.Secondary objectives:- To evaluate the safety and tolerability of both…

Online nurse-assisted eye-screening in home healthcare; implementation study and economic evaluation, from an individual, healthcare and socio-political perspective [iSCREEN-study]

Cost-utility and cost-effectiveness of eye-screening in home healthcare in reducing eye complaints from a societal perspective and its health consequences will be investigated over 1 year. A cluster randomized controlled trial (RCT), including an…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of TW001 in Alzheimer Patients

Primary objective:The main objective of the present trial are:• to evaluate the effect of TW001 on oxidative stress biomarkers• to evaluate the safety of TW001 in patients with Alzheimer*s DiseaseSecondary objective:The secondary objective of the…

Evaluation of the safety, efficacy and cost-effectiveness of transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation in the Netherlands.

The primary objective is to determine to what extent T-TEER on top of SOC reduce mortality and hospitalizations for heart failure, and improve QoL at 12 months, compared to SOC alone, in patients with severe symptomatic tricuspid valve regurgitation…

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose Phase 2 Study
to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from
Nonalcoholic Steatohepatitis (NASH)

Primary objectiveTo evaluate the efficacy of BMS-986263 compared with placebo to improve liver fibrosis in participants with compensated cirrhosis due to NASHSecondary objectives1. To further assess the efficacy of BMS-986263 compared with placebo…

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Analysing the immunogenicity of additional booster vaccinations in healthcare workers.
A multicenter, randomised, controlled trial

Key objective The key objective of the study to determine whether it is necessary to boost the healthy population in autumn. Primary endpoint: The primary endpoint is to determine the fold change in antibody level at day of boost and 28 days after…

A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Primary• To evaluate the effect of CK-3773274 on exercise capacity (VO2) in patients with symptomatic oHCMSecondary• To evaluate the effect of CK-3773274 on patient health status• To evaluate the effect of CK-3773274 on New York Heart Association (…

A Randomised, Double-Blind, Placebo-controlled, 32-week, Phase IIa trial to investigate the efficacy of OM-85 versus matched placebo in reducing disease severity in children aged 3 to 24 months with early clinical diagnosis of moderate atopic dermatitis

Primary Objective Primary objective is to assess the efficacy of OM-85 versus matched placebo in children with moderate AD in reducing disease severity over the first 16 weeks and the first 24 weeks of the treatment period.Secondary Objectives…

A Phase 2/3 Study to Evaluate the Efficacy and Safety of Unesbulin in Unresectable or Metastatic, Relapsed or Refractory Leiomyosarcoma

Primary:• Progression-free survival (PFS) of unesbulin plus dacarbazine (DTIC) versus placebo plus DTICSecondary:Efficacy:• Overall survival (OS) of subjects treated with unesbulin plus DTIC versus placebo plus DTIC• Antitumor activity of unesbulin…

Feasibility study for a randomized controlled trial to evaluate the effect of hearing aids on cognitive decline in elderly individuals: Cognition and Isolation in Deafness

To assess the feasibility of an RCT assessing the effects of hearing aids on cognitive decline.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX1502 in Normal Healthy Volunteers

PrimarySAD: - To evaluate the safety and tolerability of single ascending doses of ANX1502 in healthy participants.MAD: - To evaluate the safety and tolerability of multiple ascending doses of ANX1502 in healthy participants.SecondarySAD: - To…

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2023-505749-14-00 check the CTIS register for the current data. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab…

Machine Learning for Risk Stratification in the Emergency Department: A Pilot Clinical Trial

To determine the feasibility of a full-scale randomised controlled trial evaluating the clinical effectiveness of the RISKINDEX based on experience gained from conducting this pilot RCT. ML mortality predictions will be compared with clinical…

Grip on knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for young knee osteoarthritis patients in regular care.

To determine whether KJD is non-inferior on patient reported effectiveness as compared to a KP (i.e. usual care) for relatively young patients with end-stage knee OA. For the substudy: the primary objective is to predict the benefit from knee…

Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer

This study has been transitioned to CTIS with ID 2024-517646-34-00 check the CTIS register for the current data. The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is…