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MRI study to prepare for adaptive MRI-guided radiation of prostate carcinoma.

The aim of the study is to investigate the effect of magnetic resonance (MR) based online adaptive radiotherapy (RT) for treatment of low to intermediate risk localized prostate carcinoma (PCa) on the radiotherapy dose on the prostate and organs at…

Feasibility and acceptability study of a new positive psychology intervention (*Living well with a chronic mental health disorder*) for people with chronic depression or chronic anxiety

The primary objective of the study is how patients with therapy resistant anxiety or depression evaluate a well-being intervention *living well with a chronic mental health disorder* and if they experience an increase in personal recovery and mental…

The dynamic interaction between experiential avoidance, cognitive avoidance, perceived control and social anxiety symptomology

The goal of the study is 1) showing that EA, CA and perceived control are not stable but of dynamic nature and interact in predicting social anxiety symptom severity, 2) identifying possible mechanisms of change of CBT (the exact working of which is…

A 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial

To assess cognitive impairment in participants with highly-active RMS, having participated in the CLARIFY MS trial, at 4 years afterinitial dose of cladribine tabletsTo assess health related quality of life (HRQoL) in participants with highly-…

A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors

Part 1: Dose-Escalation Stage (not in The Netherlands)Primary objective:* Safety and tolerability of HBM4003Secondary objectives:* Preliminary anti-tumor activities of HBM4003 in advanced solid tumors* Pharmacokinetics (PK) of HBM4003Other…

Efficacy of B cell-targeted therapy in autoimmune bullous diseases

To characterize the immunological read out, e.g. the immune cell compartments, and antibodies of patients with autoimmune bullous diseases during rituximab treatment and during relapses.

An explorative and feasibility study of Venetoclax combined with Tamoxifen in patients with relapsed/refractory Diffuse Large B-cell Lymphoma

Primary objectives1. To assess the safety of Tam added to Ven. Venetoclax will be dosed at 800 mg once daily. After 2 days of venetoclax, tamoxifen will be orally administrated in a ramp-up phase (2 days 10mg, 2 days 20mg, to a final dose of 40 once…

The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant

To assess the efficacy and safety of vaccination against COVID-19 in patients with CKD4/5, patients on dialysis, and kidney transplant recipients as compared to controls

Single center, open-label study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO6889450 in healthy male volunteers

In this study we will investigate how quickly and to what extent ralmitaront is absorbed, transported, and eliminated from the body (this is called pharmacokinetics). Ralmitaront is radioactively labelled with carbon 14 (14C). In this way…

Safety and Effectiveness IDE trial for Boston Scientific*s Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

Prospective, open label, single arm, First in Human (FIH) clinical study to assess Safety and efficacy of the CorNeat Keratoprosthesis for the treatment of corneal blindness

The objective of this clinical study is to prove the safety of the CorNeat KPro.

4D-CT examination to evaluate range of motion obstructions and underlying causes in scheker implants

Primary objective: To use 4D-CT to find possible relations between functional deficiencies of patients with an Aptis Scheker prosthesis and important prosthesis characteristics like implant placement and implant design.Secondary objective: To…

The TAVI PCI (optimal timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention) Trial

The primary objective of this study is to compare in a non-inferiority design the safety and efficacy of iwFR (or comparable resting diastolic indices)-guided complete revascularization after (within 1-45 days) with iwFR (or comparable resting…

The role of renal function in the pharmacokinetics and safety of remdesivir in COVID-19 patients

To determine the influence of renal function and renal replacement therapy on the pharmackinetics and safety of remdesivir in COVID-19 patients.

Omission of stent placement on ileal urinary conduit

To assess whether the omission of IOS placement in patients undergoing cystectomy and ileal urinary conduit results in a similar per patient event-free 30-day survival rate as compared to those who receive regular IOS placement.

PRospective Evaluation of complete revascularization in patients with multiveSsel disease Excluding chroNic Total occlusions

To compare OCT guided complete revascularization to the predefined objective performance goal (OPG) for all-cause death, stroke, myocardial infarction, or repeated revascularization namely 7% at 12 months. The OPG is derived from the most recent (9-…

A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A

This is a so-called *lead-in study* in which patients receive their standard treatment and no study treatment. The researchers will collect dataabout the patients* bleeding episodes, FVIII containing treatments used to prevent bleeding episodes and…

A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in participants with diffuse systemic sclerosis

Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…

A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

PART A and PART DTo assess the safety and tolerability of TAK-994 following multiple oral doses in subjects with narcolepsy with or without cataplexy (NT1 or NT2).PART B and PART C To assess the efficacy of TAK-994 on reducing excessive daytime…

A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT)

Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…