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Synaptic density and tau pathology in Alzheimer's disease

This study has been transitioned to CTIS with ID 2024-517636-22-00 check the CTIS register for the current data. The main objective of the present study is to investigate the association between in vivo regional synaptic loss ([18F]SynVesT-1 PET),…

The Dutch Parkinson GBA Ambroxol trial (DUPARG-AMBROXOL):
A randomised, double-blind, placebo-controlled, single-center trial with Ambroxol in Parkinson patients with a GBA mutation

The primary objective is to compare the effectiveness of ambroxol versus placebo on the MDS-UPDRS part III motor sub-score in the *practically defined OFF-medication state* in patients with moderate PD, carrying a GBA mutation. The hypothesis is…

Treatment of severe gout patients with rasburicase

The primary outcome parameter is the Gout Activity Score (GAS)after 6 months of rasburicase treatment. Secondary outcome parameters are the serum uric acid concentration, the clinical evaluation of tophus load, patient reported outcomes: MD-HAQ, GAQ…

A randomized, placebo-controlled, double blind trial to study the effects of Etidronate on ectopic CALCIfication in FAhr*s Disease or syndrome.

This study has been transitioned to CTIS with ID 2024-512300-19-00 check the CTIS register for the current data. The objective is to determine whether etidronate can halt or attenuate disease progression in patients with Fahr*s disease or syndrome.

A Pilot, Multicenter, Randomized, Non Comparative, Double-Blind Study of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection due to Staphylococcus aureus Treated with DAIR and Antibiotic Therapy

Considering the paucity and the variability of data regarding the clinical control of infection in patients presenting a prosthesis Joint Infection (PJI) later than 1 month after the arthroplasty and treated with DAIR + suppressive antibiotics…

A Phase II, Double-Blind 2-arm study to investigate the effect on ventricular ectopy, safety, tolerability and pharmacokinetics of S48168 (ARM210) compared with Placebo in adults with Type 1 Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT1)

This is a research study. The purpose of this study is to test if the investigational medicinal product S48168 (ARM210) is safe and effective when given to patients diagnosed with CPVT1. Primairy objective:To assess the effect of S48168 (ARM210) on…

Imlifidase treatment for acute inflammation in AQP4-IgG associated neuromyelitis optica spectrum disorder

To analyse in what proportion of NMOSD patients with an episode of acute inflammation circulating pathogenic anti-AQP4 IgG antibodies are depleted below detection limits, as measured with a state-of-the-arts cell-based assay, in the timeframe within…

OPEN LABEL PHASE 2 BASKET TRIAL WITH ATEZOLIZUMAB AND TIRAGOLUMAB IN SOLID TUMORS: TIRACAN

This study has been transitioned to CTIS with ID 2024-512616-21-00 check the CTIS register for the current data. The main objective of the trial is to determine the pathological response rate in cohort 1 and the radiological response rates in cohort…

Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREEN.

To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases.

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1*POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER

Primary Objective: This study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in patients with previously untreated, locally advanced, unresectable or…

The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.

The main objectives of the study are to investigate if sleep positional therapy, using the LEFT smartwatch app, reduces nocturnal gastroesophageal reflux symptoms and can train patients to avoid sleeping in right side position.

Phase II, open label, single arm study to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the ixabepilone Drug Response Prediction (DRP) after failure of an anthracycline and a taxane

Primary:• To evaluate the clinical benefit rate (CBR) of ixabepilone Secondary:• To evaluated progression free survival (PFS)• To evaluate overall survival (OS)• To evaluate objective response rate (ORR) defined as Complete Response (CR) and Partial…

Imaging inflammation in Alzheimer*s Disease

The main objective is to quantify neuroinflammation using [11C]SMW139 PET-scans in subjects along the AD continuum and age/sex-matched cognitively unimpaired subjects.

Neo-adjuvant Pembrolizumab as an alternative treatment for MMRd uterine cancer, a phase II efficacy study

This study has been transitioned to CTIS with ID 2024-516736-10-00 check the CTIS register for the current data. Based on the success of the pilot feasibility study, we propose a follow-up efficacy study to explore neo-adjuvant ICB therapy as…

A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare

This study has been transitioned to CTIS with ID 2024-518844-20-00 check the CTIS register for the current data. Primary Objective:To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain…

The (cost-)effectiveness of an innovative, personalised intervention of therapeutic VirtuAl Reality IntEgrated within physioTherapY for a subgroup of complex chronic low back pain patients

Our primary objective is to investigate whether a personalised, physiotherapy intervention with integrated therapeutic virtual reality (VR) is (cost-)effective at 3 months and 12 months follow-up, compared to usual physiotherapy, in a subgroup of…

A Phase 1/2 Randomized, Umbrella Study to Evaluate the Safety and Efficacy of Pembrolizumab Plus Enfortumab Vedotin (EV) in Combination With Investigational Agents Versus Pembrolizumab Plus EV, as First-Line Treatment for Participants With Advanced Urothelial Carcinoma (KEYMAKER-U04): Substudy 04B

This study has been transitioned to CTIS with ID 2023-506385-30-00 check the CTIS register for the current data. Primary Part 1:-To evaluate ORR in participants treated with MK-4280A plus EV (Arm A), MK-7684A plus EV (Arm B), and pembrolizumab plus…

A randomized phase 1b/2a trial of the effectiveness of intermittent hypoxia interventions in Parkinson*s disease

To explore the safety, feasibility and net symptomatic effects of multiple intermittent hypoxia intervention sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.

First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors

This study has been transitioned to CTIS with ID 2024-512639-58-00 check the CTIS register for the current data. ____________________PRIMARY OBJECTIVESFor Parts 1 and 2: To assess the safety and tolerability of BNT142 at all dose …

An open-label extension study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension

To assess the long term safety of LTP001 in participants with pulmonary arterial hypertension (PAH).