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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…

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…

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 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…

A two-part, single dose, randomized, single-blinded, placebo controlled, phase I study to assess the safety and pharmacokinetics of oral MT1980 in healthy volunteers when dosed in the fasted state

In this study we will investigate how safe the new compound MT1980 is and how well it is tolerated when it is used by healthy participants. We also investigate how quickly and to what extent MT1980 is absorbed, transported, and eliminated from the…

A study of the effects of single doses of MK-1167 on neurotransmitter cycling in the brain of healthy adult participants using 13C-Magnetic Resonance Spectroscopy.

To investigate effect of a single dose of MK-1167 on glutamate levels in the brain using MRS. Glutamate is a chemical that sends signals between nerve cells in the brain. To test the safety and tolerability of single oral doses of the trial drug, MK…

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 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.

Treating Leg Symptoms in Women with X-linked Adrenoleukodystrophy: A Key to Improving Sleep and Gait Performance

This study has been transitioned to CTIS with ID 2024-518989-27-00 check the CTIS register for the current data. Objective: Primary Aim (PHASE 1):To determine the prevalence of RLS in women with ALD.Secondary Aim (PHASE 2):To determine whether in a…

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 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

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…

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.

Effectiveness of L-serine dietary supplementation in children with a GRIN2B loss-of-function mutation: n-of-1 series

Assess the potential efficay of L-serine dietary supplementation in patients children with a GRIN2B LoS mutation.

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 (…