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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…

Comprehensive Medical and Invasive Treatment strategy for patients with significant Left Anterior Descending artery disease

The primary objective of the trial is:To assess whether a non-surgical, fractional flow reserve (FFR) and optical coherence tomography (OCT)-guided treatment strategy* has a comparable outcome (MACE) with surgical revascularization of significant…

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…

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…

The use of direct nerve visualisation with the Evotouch/7starscope compared to the conventional fluoroscopy technique for transforaminal epidural injection.

We hypothesize that using the Evotouch/7stascope, ultrasound guided TFEI procedures are non-inferior to the golden standard with fluoroscopy, which means correct placement of the needle within the neuroforamen without intravascular positioning.

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…

Deep versus moderate neuromuscular blockade during total hip replacement surgery to improve postoperative quality of recovery and immune function: a randomized controlled study

The main objective of this study is to assess the potential effect of deep neuromuscular blockade on the quality of recovery after total hip replacement surgery under general anesthesia. Secondary aims are to establish the relationship between the…

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…

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…

Reduction of blood loss in pediatric osteotomies around the hip
- A randomized placebo-controlled trial with tranexamic acid -

This study has been transitioned to CTIS with ID 2024-516324-34-01 check the CTIS register for the current data. To evaluate (reduction of) intraoperative blood-loss with and without pre-operative TXA administration, in children undergoing a…

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…

A 26 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE FORMULATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE FORMULATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN SUBJECTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WI

Main Phase:To demonstrate the superiority of medium-dose BDP/FF/GB pMDI compared to high-dose BDP/FF pMDI in terms of the proportion of subjects exhibiting on average NPAL over 26 weeks of treatment in the study sub-population with PAL at screening…

EMECLO: the Electroconvulsive therapy vs. MEdication in patients with CLOzapine-refractory symptoms trial

The main objective of this study is to investigate the feasibility of a larger single-blind, randomized trial focused on (cost) effectiveness and safety of ECT vs. aripiprazole addition in patients with schizophrenia spectrum disorders (SSD)…

A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis

This study has been transitioned to CTIS with ID 2023-504869-23-00 check the CTIS register for the current data. 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30…

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.

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…

A randomized controlled trial on hypertonic saline inhalation in patients with nodular-bronchiectatic Mycobacterium avium complex pulmonary disease

To determine the effect of hypertonic saline inhalation and best supportive care versus best supportive care alone on clinical efficacy measures in patients with nodular-bronchiectatic M. avium complex pulmonary disease, as measured by changes in…

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…

The effect of ROSA-assisted knee arthroplasty on clinical outcomes

Primary Objective: to compare improvement in arthrosis symptoms between patients operated with ROSA-assistance and conventionally operated patients.Secondary Objective(s): to compare clinical, procedural, logistic and economic outcomes between…