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A Single Dose, Double-Blind, Parallel Arm, Comparative Pharmacokinetic Study of DRL_AB, US licensed Reference Abatacept (Orencia®) and EU approved Reference (Orencia®), Administered by the Intravenous Route to Male Normal Healthy Volunteers

The sponsor is developing a biological product (DRL_AB) similar to the approved medicine Orencia®. As part of medical-scientific studies to confirm the similarity of the biological products, the Sponsor wants to compare DRL_AB with EU-approved…

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…

Effect of a probiotic strain on immune response to influenza vaccination

To investigate the effect of Bifidobacterium lactis CECT 8145 BPL1® on the seroconversion rate after influenza vaccination in healthy adults, compared to placebo treatment.

Endothelial cell loss in pseudophakic patients receiving a Paul glaucoma drainage device with its tube inserted in the anterior versus posterior chamber: a randomized controlled trial

Primary: to determine the loss of corneal endothelial cells after implantation of a Paul GDD with its tube either anterior or posterior of the iris. Secondary: to compare efficacy and safety of both procedures.

A phase 1, randomised, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of Ent001 in healthy subjects

In this study we will investigate how safe the new compound Ent001 is and how well it is tolerated when it is used by healthy subjects.We also investigate how quickly and to what extent Ent001 is absorbed, transported, and eliminated from the body (…

Effectiveness of Autonomy Enhancing Therapy in hearing-impaired adults with psychosocial problems and/or mental disorders

The study aims to determine the effectiveness of the application of AET in decreasing self-reported deficits in autonomy-connectedness / self-reported symptoms of anxiety and depression in HI adults.

Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome

Comparing different ventilation strategies in focal and non-focal ARDS in invasively ventilated patients admitted to the intensive care unit.

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis

3. STUDY OBJECTIVES3.1. Primary ObjectivesThe primary objectives are:• To determine if CAEL-101 and treatment for PCD improves overall survival in Mayo stage IIIb AL amyloidosis patients who are treatment naïve compared to treatment for PCD alone•…

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…

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.

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…

A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind,
Placebo-Controlled, Parallel Group Dose-ranging Study to Assess
Efficacy, Safety, and Tolerability of the Combination of
Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy
Versus Placebo in Participants with Cirrhosis with Features of
Portal Hypertension

This study has been transitioned to CTIS with ID 2023-505405-17-00 check the CTIS register for the current data. The main objective of this Phase IIa/b study is to demonstrate the effectof zibotentan on HVPG, and that dapagliflozin can mitigate…

The impact of a preoperative very low calorie ketogenic diet (VLCKD) on body composition in patients undergoing bariatric surgery: an open trial

The main objective of the proposed study is to investigate the effect of a VLCKD on body composition in patients undergoing bariatric surgery, and to compare this with a standard VLCD.

Repetitive Transcranial Magnetic Stimulation (rTMS) versus sham rTMS in
Body Dysmorphic Disorder

The main objective of this study is to investigate whether rTMS treatment will improve clinical outcomes in body dysmorphic disorder, by reducing BDD YBOCS outcomes. Furthermore to improve localization and rTMS treatment in the dorsolateral…

Shifting the interpretation bias and attention bias with an online training in borderline personality disorder

The purpose of the current study is to test the effectiveness of both trainings (IBT and ABT) in a non-clinical and clinical sample, with the future goal of making the training available to all patients with BPS. The central objectives for this…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine - the REBUILD-1

This study has been transitioned to CTIS with ID 2023-505836-36-00 check the CTIS register for the current data. Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the…

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…

A randomized controlled trial to investigate the (cost)effectiveness of oral immunotherapy with different allergens in young children with an established food allergy.

What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care?What is the effect of early low…

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Evaluate the antitumor activity of nemvaleukin alfa (*nemvaleukin*, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancerSecondary Objectives:Evaluate the antitumor activity of…