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Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss.

This study has been transitioned to CTIS with ID 2024-513658-31-00 check the CTIS register for the current data. The primary objective of this study is to assess the efficacy of a single intratympanic injection of AC102 compared to oral steroids in…

DESCARTES trial: De-ESCAlating RadioTherapy in patients with pathologic complete rESponse to neoadjuvant systemic therapy.

Primary aim: to assess whether local recurrence is acceptable when radiotherapy is omitted after breast conserving surgery in patients treated with NAC who achieve a pathologic complete response.Secondary aim: to assess quality of life and cancer…

The influence of sacral neuromodulation on brain areas involved in the sensation of bladder filling in patients with Overactive Bladder (OAB) using fMRI

2.1 Primary Objectives• To identify brain activation evoked by sensation in response to bladder filling in patients with an implanted sacral neurostimulator as a treatment for overactive bladder (OAB), compared to a baseline in OAB patients without…

APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

This study has been transitioned to CTIS with ID 2023-508364-29-00 check the CTIS register for the current data. To evaluate the efficacy of patisiran compared with placebo treatment on functional capacity (6 minute walk test [6-MWT]) in patients…

Autoimmune epilepsy Modulated by IVIg - effects on Cortical Excitability, the AMICE study

1. Assessing the efficacy of IVIg in autoimmune epilepsy, both clinically and serologically.2. Identifying an objective marker of therapy response in epilepsy, measuring cortical excitability by TMS-EEG/EMG, in vivo.3. Providing evidence that…

Towards optimal management of Marfan Syndrome

The aim is to investigate the value of novel MRI parameters for aortic hemodynamics and aortic motion and pressure waveforms in MFS patients as potential new biomarkers for guiding surgical and medical treatment of MFS, by analysing these parameters…

Validation of CPM#1 compressibility in healthy volunteers in rest and after exercise

The primary objective is - To clinically validate the inter-observer reliability of compressibility measurements with the CPM#1 device during rest in healthy volunteers.

Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in a prior clinical study.

This study has been transitioned to CTIS with ID 2024-512580-31-00 check the CTIS register for the current data. PrimaryTo evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.SecondaryTo…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

Main objective:The primary objective of the trial is to evaluate the efficacy of test investigational medicinal product (IMP) as compared to placebo IMP for the preventive treatment of chronic migraine (CM). Secondary objectives:To evaluate the…

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

This study has been transitioned to CTIS with ID 2023-506365-64-00 check the CTIS register for the current data. The purpose of this study is to investigate if niraparib added to a standard treatment (consisting of abiraterone acetate plus…

Safely reduce cystoscopic evaluations for microscopic Hematuria patients (SeARCH Trial).

To assess the clinical impact of implementing a molecular urine test in the diagnostic workup of patients presenting with microscopic hematuria.

Preoperative chest CT-imaging in surgical aortic valve replacement with or without CABG: a randomized controlled trial.

The purpose of this RCT is to improve the outcome of surgical treatment of severe and/or symptomatic aortic valve pathology with or without concomitant coronary artery disease by reducing morbidity (stroke) and change of operative strategy in…

A Randomised, Double-Blind, Placebo-Controlled, Single- and Multiple-, Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of VRG50635 and Food Effect in Healthy Volunteers (Phase 1a)

Part 1; Single ascending dose (main objective)• To investigate the safety and tolerability of single oral doses of VRG50635 in healthy adult subjectsPart 1; Single ascending dose (secondary objective)• To characterize the plasma and urine…

A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib.

This study has been transitioned to CTIS with ID 2023-509345-12-00 check the CTIS register for the current data. The purpose of the study is to provide efficacy, safety and tolerability data for remibrutinib to support regulatory approval worldwide…

Wireless Laser Speckle Contrast Imaging Device for the visualisation of the microcirculatory during DIEP flap breast reconstruction.

This study aims to demonstrate that the new generation of the HAPI, the Wireless Perfusion Imager (WIPI) is able to visualise the microcirculation of the abdominal flap and the newly reconstructed breast during DIEP flap breast reconstruction. The…

CLEAR SYNERGY (OASIS 9)
A 2x2 factorial randomized controlled trial of CoLchicine and spironolactonE in patients with myocARdial infarction/SYNERGY Stent Registry -
Organization to Assess Strategies for Ischemic Syndromes 9

In patients with acute MI (STEMI or Non-STEMI) who have undergone PCI, the objectives are to determine: 1. If colchicine can reduce the incidence of cardiovascular death, recurrent MI, or stroke. 2. If routine use of spironolactone can reduce the…

A randomized controlled trial on the visual function after bilateral implantation of two novel Extended Depth-of-Focus intraocular lenses.

The primary objective of this study is to compare the binocular uncorrected intermediate visual acuity (UIVA) at 66 cm under photopic conditions 3 months postoperatively, in a series of patients bilaterally implanted with the Acunex® Vario IOL…

Evaluation of ablation lesions using cardiovascular magnetic resonance imaging

Primary Objective: 1. To evaluate the ablation lesion characteristics of different ablation modalities and strategies Secondary Objectives: 2. To evaluate the ablation lesion characteristics of different ablation energy profiles; 3. To evaluate the…

COMPARISON OF CONVENTIONAL AND COOLED RADIOFREQUENCY TREATMENT OF THE GENICULAR NERVES VERSUS SHAM PROCEDURE FOR PATIENTS WITH CHRONIC KNEE PAIN: A MULTICENTRE, DOUBLE BLIND, RANDOMISED CONTROLLED TRIAL

The aim of the COGENIUS trial is to investigate the effect of the two types of RF treatment on individuals experiencing chronic knee pain that is resistant to conservative treatments. For this purpose, the efficacy and cost-effectiveness of cooled…

Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts

Dose Escalation (GEN3009 for R/R B-cell NHL Including CLL/SLL):- Determine the MTD with and/or determine the RP2D of GEN3009- Evaluate safety and tolerability of GEN3009Expansion (GEN3009 for R/R, DLBCL, FL, and CLL Cohorts):-Evaluate (preliminary)…