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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…

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…

KetoEasy meal plan for Ketogenic Diet Therapy in children 2-12 years with parmacoresistant epilepsy

Primary Objective: To evaluate whether KDT application as the KetoEasy meal plan induces ketosis and leads to seizure reduction in children 2-12 years with refractory epilepsy.Secondary Objective(s): To evaluate-Feasibility: application in daily…

The feasibility of a home-based remotely supervised maintenance exercise training program
in patients with COPD

To evaluate the safety, feasibility and efficacy of an 8-week remotely supervised home-based maintenance exercise training program following pulmonary rehabilitation in patients with COPD.

THerapeutic Oncolytic Monitoring AS a tool for effective exposure to 5-FU in patients with locally advanced, resectable gastric or gastro-oesophageal junction cancer treated with perioperative FLOT

Primary Objective: - To establish the population range (24-h AUC) of high-dose infusional 5-FU in patients with locally advanced, resectable gastric or gastro-esophageal junction cancer treated with perioperative FLOT.Secondary objectives: - To…

Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe With Osteoporosis

The primary objective of the study is to evaluate the post-market safety and BMD improvement of AGN1 LOEP in patients with osteoporosis in at least one hip. The secondary objective is to evaluate the post-market functional measures of clinical…

Brain structure and neurocognitive development in sickle cell disease; a longitudinal cohort study (BRICK study)

The primary objective is to evaluate longitudinal developmental changes in brain structure in patients aged 6-18 years with SCD. The secondary objective is to analyze the longitudinal relations between biomarkers, demographic characteristics, brain…

Atellica VTLi Sample matrix study for Plasma Separation Membrane Comparison

Compare Atellica VTLi reference plasma separation membrane with at least one alternative plasma separation membrane using hs-cTnI values from capillary whole blood from fingerstick, Li-Hep whole blood and plasma from venipuncture.

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…

Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation

To determine safety and efficacy of low molecular weight dextran sulphate during islet transplantation

Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels

To observe and evaluate the efficacy, of Magic Touch SCB compared to one of the gold standard treatment for native vessel disease, (everolimus-eluting stent, EES).The main OCT subanalysis endpoints are:- Acute mean and minimum lumen cross-sectional…

Detection of tumor tissue in peritoneal metastases of colorectal origin using a VEGF targeted optical fluorescent imaging tracer during diagnostic laparoscopy: a single center phase 1 study

This study has been transitioned to CTIS with ID 2024-517718-13-00 check the CTIS register for the current data. Primary Objectives:To determine the optimal dose of the VEGF-targeting optical agent Bevacizumab-IRDye800CW for an adequate tumor-…

Magnetic resonance imaging for phenotyping and accurate Monitoring of Interstitial Lung Disease: the M-ILD study

To develop an innovative magnetic resonance imaging (MRI) protocol(M-ILD) for accurate phenotyping and sensitive monitoring of therapy in ILD patients.

The effect of extra hydration on kidney function during carboplatin-pemetrexed-pembrolizumab in patients with advanced non-small cell lung cancer.;*Hydration to prevent nephrotoxicity due to pemetrexed (HydraPem Study)*

To investigate the effect of fluid infusion to prevent deterioration of kidney function due to pemetrexed, during treatment with carboplatin, pemetrexed and pembrolizumab in patients with non-squamous NSCLC. The primary objective is to reduce the…

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)

Main objective: To determine the efficacy of pemigatinib in participants with recurrent GBM with an activating FGFR1-3 mutation or fusion/rearrangement. Secondary objectives: 1. To determine the efficacy of pemigatinib in participants with recurrent…

Grip on knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for young knee osteoarthritis patients in regular care.

To determine whether KJD is non-inferior on patient reported effectiveness as compared to a KP (i.e. usual care) for relatively young patients with end-stage knee OA. For the substudy: the primary objective is to predict the benefit from knee…

The effect of 12-week supplementation with olive leaf extract (OLE) on body composition and muscle strength, skin-aging and menopause-related quality of life in postmenopausal women (45-70 y); a randomized controlled trial.

The aim of this study is to investigate the effect of 12-week of 250 mg/day of olive leaf extract (OLE) supplementation on body composition and muscle strength, skin-aging and menopause-related quality of life in post-menopausal women (45-70 y).

The effectiveness of the serious game *Broodles* in improving psychosocial well-being of siblings (6-9 years old) of children with visual impairment and/or intellectual disability: A randomized controlled trial

The goal of this study is to evaluate the effectiveness of the serious game *Broodles* in improving the quality of life and psychosocial well-being of siblings (6-9 years) of children with VI and/or ID.

Molecular Imaging of Zirconium-89-labeled Brentuximab as a Tool to Investigate brentuximab biodistribution in CD30-positive Lymphoma

This study has been transitioned to CTIS with ID 2024-511151-18-00 check the CTIS register for the current data. • Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow assessment of the biodistribution of 89Zr-brentuximab in tumor…

COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

Primary Objective: To prove that in patients with multivessel coronary disease (MVD) (>= 2 lesions with diameter stenosis >=50%) a PCI revascularization strategy based on revascularisation of all lesions presenting a vulnerable plaques…