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Cost-effectiveness of a transmural integrated care program for knee arthroplasty patients in the working population

In this study we will assess the (cost)effectiveness of a transmural integrated care programme supporting return to daily activities (including work)after knee arthroplasty compared to usual care. We hypothesize our transmural integrated care…

Feasibility study of an orthosis for treatment of a Clubfoot

Primary ObjectiveThe primary objective of this study is to examine the feasibility of using the clubfoot brace. This will be done by recording the effect of the brace on the clubfoot deformity by determining the improvement of the Dimeglio and…

The BIOPSY-trial: Biopsy versus Resection in Elderly Glioblastoma Patients. A prospective cohort study.

This study is performed to investigate the optimal strategy for maintaining quality of life and improving survival in elderly patients (65 years or older) diagnosed with primary GBM. Primary endpoints of the study are: 1) Proportion of patients with…

A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma

This study has been transitioned to CTIS with ID 2023-509461-20-00 check the CTIS register for the current data. The primary objective is to investigate if IMO-2125 is capable of a) lowering the number of tumor positive SLN and b) inducing a loco-…

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen (PSMA) Half Life Extended (HLE) Bispecific T-cell Engager (BiTE) AMG 160 in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Main objective:Parts 1, 3, 4, 5 en 6: AMG 160 monotherapy• Evaluate the safety and tolerability of AMG 160 in adult subjects• Part 1 only: Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)Part 2: AMG 160 in combination…

Mindfulness versus Cognitive Behavioural Therapy in Tinnitus Patients - A Randomized Controlled, Non Inferiority Trial

Primary Objective: The primary objective is to determine whether MBCT is non inferior in the effectiveness on TFI reduction as CBT in adults with chronic tinnitus. Non inferioirty would be declared if the mean decrease in TFI score for MBCT is no…

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

* The primary objective of this study is to compare the proportion of warm antibody autoimmune hemolytic anemia (wAIHA) subjects whoachieve a durable hemoglobin response between the fostamatinib and placebo groups.* The secondary objectives of this…

Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn*s Disease that failed conventional treatment

The aim of this preliminary study is to prospectively assess the efficacy of LDN as induction therapy in CD.

A randomized, controlled study to evaluate the reliability of the Ablacon Electrographic FLOW (EGF) algorithm technology (Ablamap® Software) to identify AF sources and guide ablation therapy in patients with persistent atrial fibrillation

The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap® Software) to identify AF sources and guide ablation therapy in patients with persistent atrial fibrillation.

Gut microbiome dynamics in metastasized or irresectable colorectal cancer: initiating a prospective multicenter cohort

To analyze the gut microbiome in relation to response and toxicity in a prospective cohort of patients with newly diagnosed metastasized or irresectable colorectal carcinoma treated with standard systemic therapy.

Predicting outcome of total knee replacement surgery in patients with knee osteoarthritis: a prospective study on the role of altered central pain processing and structural, functional, metabolic, inflammatory and psychological factors.

1. To unravel which factors (altered CPP, structural, functional, metabolic, inflammatory and psychological factors measured presurgical) are predictive for an unsatisfactory outcome 1 year after a primary TKR (longitudinal).2. To unravel the…

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Primary objective (Parts A and B):To evaluate the long-term safety and tolerability of VX-445/TEZ/IVA in subjects with CF who are heterozygous for the F508del mutation and a gating (F/G) or residual function (F/RF) mutation.Secondary objectives (…

The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery: a multicenter strategy study

To study the effect of deep neuromuscular block compared to standard neuromuscular block on intra-operative adverse events during laparoscopic surgery using the CLASSIC score system.

Deciphering the functional dynamics of the immune system during (immune)therapy in children with neuroblastoma

We aim to identify immunological parameters during (immune)therapy. We will study the effect of (immune)therapy on generic immune mediators and more specifically for NK cell, T effector and Treg cell functionality. Furthermore, we will explore DNX…

A combination of pre-screening for DPD deficiency by genotyping/phenotyping methods and pharmacokinetics-guided dosing of 5-FU for precision treatment to prevent severe toxicity in gastrointestinal cancer patients.

The primary objective of this study is to investigate the clearance of 5-FU for the 4 most common DPYD gene variants compared to the clearance of 5-FU in DPYD wild-type patients. The secondary objectives of this study are to determine the toxicity…

A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study)

The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…

The effect of different radiotherapy regimen on the immune cell landscape

We want to investigate what happens to the immune cells during different types of radiotherapy (schedules). With this study, we want to take blood samples from patients during their standard radiotherapy for cancer and determine the effect on immune…

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

This study has been transitioned to CTIS with ID 2024-513513-12-00 check the CTIS register for the current data. Primary ObjectivesEvaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants…

Endobronchial ultrasound in diagnosing and staging of Lung cancer
22 G TBNB vs 22 G TBNA needles; a randomized controlled trial;EBUS Acquire** Needle Trial

To determine if EBUS / EUS-B guided nodal/lung tumor sampling with 22 Gauge (G) TBNB (Acquire**) needles results in improved tissue core sample acquisition in comparison to standard 22 G TBNA needles for the diagnosis and staging of lung cancer.

Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients with Fabry Disease

To evaluate the ongoing safety, tolerability, and efficacy parameters of pegunigalsidase alfa in adult Fabry patients who have successfully completed studies PB-102-F20 and PB-102-F30, or completed at least 48 months in study PB-102-F03.