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Sentinel lymph node detection of cervical occult lymph node metastases in patients with parotid gland carcinoma by means of sentinel node biopsy using 68-galium-tilmanocept PET-CT.

This study has been transitioned to CTIS with ID 2024-514233-37-00 check the CTIS register for the current data. To evaluate the feasibility and prove the concept of sentinel node biopsy in patients with carcinoma of the parotid gland and scheduled…

Drug-COated Balloon Coronary Angioplasty versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion - The Co-CTO Trial.

The aim of the study is to investigate the value of DCB treatment in the residual disease of the coronary artery after successful recanalization and stenting of the actual CTO body as compared with complete stenting in a randomized fashion.

A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A

This is a so-called *lead-in study* in which patients receive their standard treatment and no study treatment. The researchers will collect dataabout the patients* bleeding episodes, FVIII containing treatments used to prevent bleeding episodes and…

A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT)

Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE plus)

This study has been transitioned to CTIS with ID 2023-506918-45-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

A phase 3 extension trial of DELTA 1 and DELTA 2 to evaluate the long-term safety of a twice-daily treatment with delgocitinib cream 20 mg/g as needed for up to 36 weeks in adult subjects with chronic hand eczema (DELTA 3)

Primary objective:To evaluate the long-term safety of an as-needed treatment with twice-daily applications of delgocitinib cream 20 mg/g.Secondary objective:To evaluate the long-term efficacy of an as-needed treatment with twice-daily applications…

A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)

This study has been transitioned to CTIS with ID 2023-507146-91-00 check the CTIS register for the current data. Primary Objective:• To evaluate the safety and tolerability of viltolarsen administered intravenously (IV) at weekly doses of 80 mg/kg…

A multi-center, randomized, double-blind, placebo controlled study of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled by H1-antihistamines

The purpose of this study is to establish efficacy and safety of ligelizumab (QGE031) versus placebo in participants with chronic inducible urticaria who remain symptomatic despite treatment with H1 antihistamine.

DAVINCY trial: optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial*

This study has been transitioned to CTIS with ID 2024-517846-32-00 check the CTIS register for the current data. To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the…

SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes

The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria.

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

The objective of this Phase 3 study is to investigate the safety and efficacy of benralizumab as a treatment for patients with eosinophilic gastritis and/or gastro-enteritis.

A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin*s Lymphoma (iNHL) - The COASTAL Study

This study aims to test the hypothesis that zandelisib in combination with rituximab has better clinical activity and risk/benefit profile compared to standard 2nd line immunochemotherapy (R-CHOP/R-B) in subjects with relapsed FL or MZL. Primary…

Physiotherapy WORKs: a randomized controlled trial on the (cost-)effectiveness of a multimodal, personalized, work-oriented physiotherapy intervention in inflammatory arthritis.

The present project aims to evaluate the effectiveness of a multi-modal, personalized, work-oriented physiotherapy intervention in optimizing work ability (primary outcome) and improving clinical outcomes (secondary outcomes), compared to usual care…

Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD)

The aim of the follow-up study is to determine the differences between early versus late treatment with GZ / SAR402671 in the effect on total kidney volume growth (total kidney volume, TKV) and in the effect on slowing down renal impairment (change…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE)

This study has been transitioned to CTIS with ID 2023-506919-18-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

An RCT on cognitive bias modification for alcohol use disorders in a religion-based rehabilitation program

The present study aims to assess the effectiveness of a religion-adapted CBM intervention compared to a standard, non-religion CBM intervention, and sham intervention based on approach bias modification (ApBM).

A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19

Primary Objective:To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo.Secondary Objectives:a. To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19, using a…

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator*s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

The purpose of this study is to demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in participants with second- or third-line (2L-3L) cervical cancer (Overall Survival-OS)

A MULTICENTER, OPEN-LABEL EXTENSION
STUDY TO EVALUATE THE LONG-TERM SAFETY
AND TOLERABILITY OF FARICIMAB IN PATIENTS
WITH NEOVASCULAR AGE-RELATED MACULAR
DEGENERATION

This study will evaluate the long-term safety and tolerability of IVT faricimab in patients with nAMD who have completed either of the Phase III (GR40306 or GR40844) studies. Additional assessments relating to efficacy, pharmacokinetics,…

Positive end-expiratory pressure levels during resuscitation of preterm infants at birth

The specific trial aim is to establish whether the use of a high, dynamic 8-12 cmH2O PEEP level strategy to support the lung during stabilisation at birth, compared with a static 5-6 cmH2O PEEP level strategy, increases the rate of survival without…