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Anakinra in Cerebral haemorrhage to Target secondary Injury resulting from Neuroinflammation - a phase II clinical trial

This study has been transitioned to CTIS with ID 2024-517230-17-00 check the CTIS register for the current data. To determine the effect of anakinra on the development of perihematomal oedema, compared to standard medical management. In an…

The COllaborative Neonatal NEtwork for the first CPAM Trial, the CONNECT

The main objective is to identify the optimal management for patients with an asymptomatic CPAM, based on functional outcome measures. Furthermore, the primary objective is to stratify asymptomatic CPAM patients into a low and high risk group for…

DRAGON 2 - An international multicenter randomized controlled trial to compare combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE alone in patients with Colorectal Liver Cancer Metastases (CRLM) and a small Future Liver Remnant (FLR).

The primary objective of DRAGON 2 is to demonstrate the superiority of combined PVE/HVE over PVE alone in either the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and the 5-year…

Comprehensive Medical and Invasive Treatment strategy for patients with significant Left Anterior Descending artery disease

The primary objective of the trial is:To assess whether a non-surgical, fractional flow reserve (FFR) and optical coherence tomography (OCT)-guided treatment strategy* has a comparable outcome (MACE) with surgical revascularization of significant…

A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)

The primary objective of this study is to evaluate the effect of single daily SC administration of elamipretide for 48 weeks on the distance walked (in meters) on the 6-minute walk test.The secondary objectives of this study are:- To evaluate the…

He-move-philia, a combined lifestyle intervention program for patients with hemophilia and other congenital coagulation disorders

The aim of this exploratory study is to compare the effect of a lifestyle intervention program consisting of combined individual coaching and group sessions (CLI) with a lifestyle intervention program with individual coaching only (II).The program…

Effect of a foot muscle strengthening program in mobile older adults

To investigate the effect of adding PIFM strengthening exercises to a functional exercise program compared to a functional exercise program alone on maximum gait speed in mobile older adults. The secondary objective is to also investigate the effect…

Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers

Primary objective - to describe immunogenicity and safety in healthy volunteers of the intradermal dermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with…

A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria in Subjects with Inadequate Response to C5 Inhibitor Therapy

Part 1 - To determine the efficacy of oral BCX9930 monotherapy administered for 24 weeks, compared to continued complement component 5 (C5) inhibitor therapy, in subjects with paroxysmal nocturnal hemoglobinuria (PNH) with an inadequate response to…

A phase 3 study of PTC923 in subjects with phenylketonuria

Primary:• To evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria (PKU) as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (ie, the average of each respective…

The effect of ingesting a whey and collagen protein blend on myofibrillar and connective tissue protein synthesis rates at rest and during recovery from exercise

To assess the impact of the combined ingestion of whey and collagen protein on myofibrillar and connective tissue protein synthesis rates in muscle tissue obtained at rest and during recovery from exercise in vivo in humans.

Prospective clinical trial to evaluate the efficacy of acetazolamide for the treatment of cystoid macular edema in inherited retinal dystrophies: the CAR trial

Our study objective is to evaluate the efficacy of acetazolamide for the treatment of cystoid macula edema in inherited retinal dystrophies in anticipation of future clinical trials.

A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for up to 48 Weeks in Participants with Heart Failure With Left Ventricular Ejection Fraction > 40%

This study aims to evaluate the effect of AZD4831 on functional improvement and reduction of symptoms in participants with heart failure with left ventricular ejection fraction > 40%. Additionally, the PK and overall safety profile of AZD4831…

A randomized, double-blind, placebo-controlled, multi-center, dose-ranging Phase 2 study of rilzabrutinib followed by an open-label extension phase in patients with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment

The purpose of the study is to evaluate how effective rilzabrutinib is and how safe it is, in reducing the signs and symptoms in patients with chronic spontaneous urticaria (CSU), who continue to have symptoms despite the use of H1-antihistamines (…

A phase 1, randomized, double-blind, placebo-controlled, multiple dose platform study investigating the immunopharmacology of EDP1815 and EDP2939

Primary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (two dose levels using EC2 capsules) on the immune system.Secondary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (…

Interventional, randomized, double-blind, parallel-group, placebo-controlled study of add-on eptinezumab treatment to brief educational intervention for the preventive treatment of migraine in patients with dual diagnosis of migraine and Medication Overuse Headache

This study has been transitioned to CTIS with ID 2024-510729-24-00 check the CTIS register for the current data. Primary Objective• To evaluate the efficacy of eptinezumab as add-on to BI for the prevention of migraine and treatment of MOHSecondary…

RCT to assess In hospital 24 hour observation with telemetry of Syncope patients admitted to the Cardiac Emergency Room

1) To determine if the 24 hour admission with TM can be omitted safely in the setting of CER for patients with low- and intermediate risk syncope (non-inferiority) 2) to determine the health care cost reduction (superiority), 3) additional…

Influence of oxycodone on individuals taking an SSRI

To determine the effect of low-dose oxycodone versus placebo in individuals that either use a selective serotonin reuptake inhibitor (SSRI) such as sertraline, paroxetine, citalopram or escitalopram on ventilation at an extrapolated end-tidal carbon…

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

To assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis.

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…