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An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)

This study has been transitioned to CTIS with ID 2023-509276-42-00 check the CTIS register for the current data. Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term…

HEalthy Living in Inflammatory Arthritis (HELIA trial): a randomized controlled trial comparing efficacy between an interactive, online lifestyle intervention program and general nutrition recommendations

Lifestyle intervention programs reduce inflammatory activity and might, therefore, be of added value in the management of patients with an inflammatory arthritis. Therefore, the aims of this randomized controlled trial are: 1. To compare the…

Interventional, randomized, double-blind, parallel-group, placebo-controlled study of add-on eptinezumab treatment to brief educational intervention for the preventive treatment of migraine in patients with dual diagnosis of migraine and Medication Overuse Headache

This study has been transitioned to CTIS with ID 2024-510729-24-00 check the CTIS register for the current data. Primary Objective• To evaluate the efficacy of eptinezumab as add-on to BI for the prevention of migraine and treatment of MOHSecondary…

Efficacy of repetitive transcranial magnetic stimulation in patients with medication-resistant bipolar depression. A multicenter, randomized, double-blind, sham-controlled study

Objective: We want to determine the effectiveness of rTMS in patients with bipolar depression who did not respond to two or more adequately dosed medication trials, using an adequately powered pragmatic RCT. We hypothesize that active rTMS, compared…

Encorafenib/binimetiib master protocol: an open-label continuation study for participants continuing from encorafenib/binimetinib clinical studies. ;Sub-study 1:
An open-label study for continued treatment access for participants from the C4211001 (Array CMEK162X2201) and the C4211003 (Array-162-311, MILO) Binimetinib studies.;Sub-study 2:
An open-label study for continued treatment access for participants from the C4221004 (Array CMEK162B2301, Columbus) Encorafenib and Binimetinib study;Sub-s

This study has been transitioned to CTIS with ID 2023-509408-13-00 check the CTIS register for the current data. - To monitor the safety and tolerability of binimetinib- To monitor the safety and tolerability of encorafenib

Assessing long-term outcomes of dupixent treatment in patients with chronic rhinosinusitis with nasal polyposis

As part of your treatment, you will receive DUPIXENT. We would like to learn what the experiences of patients are with this medical product and if you notice any changes. The aim of the study is to better understand the characteristics of patients…

Corcym Mitral, Aortic aNd Tricuspid post-maRket Study in a reAl-world setting

Monitor ongoing safety and performance of the CORCYM heart valve devices and accessories for aortic, mitral and tricuspid valvular diseases in a real-world setting.

Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients

This study has been transitioned to CTIS with ID 2023-504360-42-00 check the CTIS register for the current data. The Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients (LEGACY) trial will investigate…

Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation.

This study has been transitioned to CTIS with ID 2024-511585-36-00 check the CTIS register for the current data. The key objective is to personalize tacrolimus treatment for children with a renal transplant by using dosing algorithms to calculate…

Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study

This study has been transitioned to CTIS with ID 2024-517502-28-01 check the CTIS register for the current data. Our explorative pilot study wants to observe whether TDM can attribute to an efficient dose de-escalation strategy of SC vedolizumab in…

Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO): a prospective, multicentre, single-arm study

Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.

The effect of extra hydration on kidney function during carboplatin-pemetrexed-pembrolizumab in patients with advanced non-small cell lung cancer.;*Hydration to prevent nephrotoxicity due to pemetrexed (HydraPem Study)*

To investigate the effect of fluid infusion to prevent deterioration of kidney function due to pemetrexed, during treatment with carboplatin, pemetrexed and pembrolizumab in patients with non-squamous NSCLC. The primary objective is to reduce the…

Standard dose alectinib versus Therapeutic Drug Monitoring guided alectinib dosing

This study has been transitioned to CTIS with ID 2023-506886-76-00 check the CTIS register for the current data. The primary objective will be a prolonged mPFS for the TDM-guided dosing cohort versus the standard fixed dosing cohort in the group of…

Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis: a randomized controlled trial

With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity (clinically and radiologically) compared to the standard (fixed 24 week interval) treatment.

Gag Therapy for Recurrent urine tract infection Assessing Comparability to International Nitrofurantoin Gold standard study.

The main objective of the study is to compare efficacy between GAG therapy and gold standard treatment (AB prophylaxis) in the prevention of rUTI. Primary questionIs GAG therapy as efficacy as antibiotic prophylaxis in the prevention of rUTI?…

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…

Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel

This study has been transitioned to CTIS with ID 2023-505530-10-00 check the CTIS register for the current data. The purpose of this long-term follow-up study is to monitor the health status of patients who were previously enrolled in cilta-cel…

*Prevention of opioid-induced constipation in patients with advanced cancer*

This study has been transitioned to CTIS with ID 2023-509462-38-00 check the CTIS register for the current data. Primary Objective: In patients with advanced cancer, starting with opioids for pain: • To prove non-inferiority of magnesium hydroxide…

Prospective Analysis of Pharmacokinetic Infliximab data in Paediatric Inflammatory Bowel Disease patients

This study has been transitioned to CTIS with ID 2023-507352-72-00 check the CTIS register for the current data. The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule…

What is the optimal antithrombotic strategy in patients with atrial fibrillation having acute coronary syndrome or undergoing percutaneous coronary intervention?

This study has been transitioned to CTIS with ID 2022-502140-13-00 check the CTIS register for the current data. 1. To compare bleeding risk (i.e. safety) with DAPT compared to standard therapy during the first 30 days following PCI/ACS in patients…