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IBIS: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-IminoBiotin in acute Ischemic Stroke due to large vessel occlusion

This study will be a prospective, placebo controlled, randomised phase 2 single centre study with the primary objective to evaluate the safety and tolerability of 2-IB when administered to patients with AIS due to LVO, treated with IVT and/or EVT.…

Pembrolizumab for locally advanced, irresectable, non-metastatic dMMR colorectal cancers. The PUMA study.

This study has been transitioned to CTIS with ID 2023-509707-32-00 check the CTIS register for the current data. To investigate whether the response rate of pembrolizumab exceeds the response rate of the historic control in locally advanced,…

A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with
Amyloid Light Chain (AL) Amyloidosis

This study has been transitioned to CTIS with ID 2023-507069-25-00 check the CTIS register for the current data. The primary objectives for the study are: Cohort 1, to characterize cardiac safety of different Daratumumab, cyclophosphamide,…

The immunomodulatory effect of sugammadex after total hip replacement surgery under neuraxial anaesthesia: a pilot study

The overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without…

Stereotactic Arrhythmia Radiotherapy in the Netherlands no. 2

To confirm our STARNL-1 pilot efficacy and safety data in a larger cohort and obtain insights in the mechanism of action by evaluating electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory…

A randomized, placebo-controlled, double-blind, multi-center Phase 2/3 trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease

This study has been transitioned to CTIS with ID 2023-505313-24-00 check the CTIS register for the current data. To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD)

Matched Unrelated vs. Haploidentical donor for allogeneic stem cell transplantation in patients with Acute Leukemia with identical GVHD prophylaxis - A randomized porspective European trial.

Primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anit-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 HLA…

Conversion of unresponsiveness to immunotherapy by Fecal Microbiota Transplantation in patients with metastatic melanoma and non-melanoma skin cancer: a randomized phase Ib/IIa trial

Primary objective:• To investigate the efficacy, defined as clinical benefit (stable disease (SD), partial response (PR), complete response (CR)) at 12 weeks, confirmed on a second scan after 4 weeks, of an FMT-intervention with responder and non-…

Multicenter, open*label, phase II study in patients with monoclonal
gammopathy of unknown significance (MGUS) and anti Myelin Associated
Gycoproteine (MAG) Neuropathy and Zanubrutinib Treatment * MAGNAZ trial

Main objective:To improve the functional neurological outcome of patients, as measured on the Raschbuilt Overall Disability Scale (RODS) for inflammatory neuropathies (iRODS) with Zanubrutinib in combination with standard treatment with Rituximab or…

A multicenter phase II randomized trial to evaluate systemic therapy versus systemic therapy in combination with stereotactic radiotherapy in patients with metastatic colorectal cancer

To assess the impact of SBRT in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with mCRC.

A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and
tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and
adults with macrophage activation syndrome (MAS) in Still*s disease (including systemic
juvenile idiopathic arthritis and Adult onset Still*s disease) or with MAS in Systemic lupus
erythematous

This study has been transitioned to CTIS with ID 2024-516153-52-00 check the CTIS register for the current data. Primary objective: To demonstrate efficacy of emapalumab in the treatment of patients in:• Cohort 1: Macrophage activation syndrome (MAS…

Precision Radiotherapy using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 patients

This project aims to explore the efficacy and safety of radiotherapy for asymptomatic pNET using delivery of radiotherapy by MR-linac in Multiple Endocrine Neoplasia 1 (MEN1) patients.

A MULTIPART EXPLORATORY STUDY TO EVALUATE SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS

The Galvani Splenic Neuromodulation System consists of a lead, rechargeable implantable pulse generator, external components and accessories. The system is designed to deliver electrical stimulation to the splenic NVB in patients with moderate to…

Efficacy and safety of NNC6019-0001 at two dose levels in participants with
transthyretin amyloid cardiomyopathy (ATTR CM)

This study has been transitioned to CTIS with ID 2023-506824-96-00 check the CTIS register for the current data. • safety and tolerability from baseline to week 64 in participants with hATTR or wtATTR cardiomyopathyPrimary • To compare the effect of…

A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension.

The purpose of this study is to explore the efficacy and safety of LTP001 in participants with WHO Group 1 pulmonary hypertension (PH), also referred to as Pulmonary Arterial Hypertension (PAH).This proof of concept study will be executed as the…

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson*s Disease

This study has been transitioned to CTIS with ID 2023-505645-12-00 check the CTIS register for the current data. Main objective: To evaluate the efficacy of BIIB122 225 mg compared with placebo.Secondary objective: To evaluate the efficacy, safety…

Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients with Atrial Fibrillation

The primary objective of this study is to demonstrate the superiority of etripamil NS over placebo in reducing ventricular rate in patients with AF.

Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa

Primary Objective:1. To evaluate the efficacy of sonelokimab at 2 different dose levels (120 mg, 240 mg) compared with placebo in the treatment of participants withactive moderate to severe hidradenitis suppurativa.Secondary Objectives:1. To…

Pedicled Peritoneum Vaginoplasty in feminizing genital Surgery; implementation according to IDEAL framework

Primary Objective: To assess the safety of the single flap peritoneum vaginoplasty procedure by studying adverse events and complications during, directly after and within 90 days of the operation. Secondary Objectives: - To assess short- (12 weeks…

A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)

Main Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on exercise endurance.Secondary Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by…