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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.…

A single-center, double-blind, randomized, phase I/II dose escalating study to assess the safety, tolerability and immunogenicity of three doses of the therapeutic synthetic long peptide (SLP) vaccine (ISA104) in patients with chronic hepatitis B (cHBV).

This study has been transitioned to CTIS with ID 2024-518355-36-00 check the CTIS register for the current data. Primary objective:- To determine the safety and optimal dose of three doses of a novel therapeutic vaccine (ISA104) consisting of 12…

A 2-Part, Randomized, Double-blind, Double-Dummy, Placebo- and Active Comparator-controlled, Repeat Dose Study to Establish Proof-of-Concept of GRX-917 in Experimentally Induced Panic and to Further Characterize its Repeated Dose Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Part 1:Primary Objective- To investigate whether repeated dose GRX-917 reduces panic symptoms elicited by an experimental 35% CO2 -induced fear challenge administered in healthy CO2-sensitive subjects. Secondary Objectives- To investigate whether…

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 IIIa 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 IIIa AL amyloidosis patients who are treatment naïve compared to treatment for PCD alone•…

The effect of Galacto-oligosaccharides (GOS) on self-perceived stress in apparently healthy but stressed Dutch women: randomized controlled study

The main objective of this study is to assess the effect of GOS in combination with 2*-FL on perceived stress. The secondary objective is to assess the effect of GOS in combination with 2-FL on saliva cortisol levels, as well as on perceived anxiety…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine - the REBUILD-2

This study has been transitioned to CTIS with ID 2023-505835-11-00 check the CTIS register for the current data. PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17…

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study To Assess The Safety, Tolerability, Pharmacokinetics Of Two Monoclonal Antibodies In Healthy Volunteers

In this study we will investigate how safe the experimental compounds AER001 and AER002 are and how well they are tolerated when they are used in healthy subjects.We also investigate how quickly and to what extent AER002 (as a single dose) and…

Postprandial amino acid uptake kinetics of barley rice proteins

In the current study we aim to measure the postprandial amino acid uptake kinetics of barley rice protein, and compare this to pea protein. A benchmark protein (whey) will be included for comparability of amino acid uptake of different protein…

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)

The impact of milk protein glycation on protein digestion and absorption in healthy young men

To compare the appearance of dietary protein-derived amino acids in plasma after ingestion of a milk protein powder with different levels of protein glycation in healthy young men.

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-…

The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects

This current study aims to examine the effects of a 6-week colon-delivered multi-vitamin supplement intervention on cognitive performance and stress levels in military under real-life, stressful working conditions.

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…

Additional effect of hydrolysed collagen/vitamin C in exercise treatment for Patellar Tendinopathy (Jumper*s knee); a randomized controlled trial

The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 24 weeks…

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who…

Effect of dapaglifozin on serum magnesium in HNF1β patients with renal hypomagnesemia

This study has been transitioned to CTIS with ID 2024-518855-43-00 check the CTIS register for the current data. Primary objective: To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on serum magnesium in diabetic and non-diabetic…

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

To investigate the safety and tolerability of DNL919To characterize the serum PK of DNL919

Using a complex carbohydrate mixture added to a high-protein DIet to STeer fermentation to improve metabolic, gut and brain heALth

Primary Objective: The main goal of this study is to provide evidence that steering saccharolytic/proteolytic fermentation by a specific indigestible fibre mixture supplemented against the background of a high-protein diet optimizes beneficial and…

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…