There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Rationale: Rapid on-Site Evaluation (ROSE) of cytologic specimens acquired with EUS-guided fine needle aspiration (EUS-FNA) represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Cytologic interpretation, however, requires a high degree of expertise rarely found outside high volume centers and ROSE is not available in many countries. This has created a barrier to the widespread dissemination of EUS in the community and throughout the world, because the lack of cytologic expertise has resulted in a low diagnostic accuracy and, therefore, in a limited perceived utility of EUS. A device that is able to: (i) acquire histologic core biopsy samples usually easier to be interpreted; (ii) be used by most of the endosonographers and not only by the experts; (iii) have a performance at least not inferior to ROSE, will represent a major breakthrough in the field of EUS tissue acquisition. The availability of such needles will determine a shift from cytology to histology that will overcome some of the limitations of cytology and ROSE, thus strongly contributing to the diffusion of EUS throughout the world and in the community. Objectives: To compare the performance and the diagnostic accuracy of EUS-guided fine needle biopsy (EUS-FNB) coupled with ROSE with that of EUS-FNB alone using an FNB needle. Study design: International randomized multicenter trial. Study population: Patients ≥18 years old, referred for EUS-guided tissue sampling of a solid pancreatic mass. Intervention: EUS-guided tissue acquisition by means of either EUS-FNB with ROSE or EUS-FNB alone, using one of the following FNB needles: Procore 20-gauge, SharkCore 22-gauge or Acquire 22-gauge. Main study parameters/endpoints: The main endpoint is the diagnostic accuracy, measured against the gold standard diagnosis that will be surgical resection specimen or in non-operated patients the results of other diagnostic work-up (other tissue sampling techniques and imaging studies) or the clinical course of the disease. Secondary endpoints include: i) safety; ii) presence of tissue core; iii) feasibility to perform additional immunohistochemical/molecular biology analyses; iv) time of the sampling procedure.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.
The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine. The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.
The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B. This Phase 1 study is designed primarily to assess Pharmacokinetics (PK) under fed and fasted conditions, and to assess the safety, tolerability and Pharmacodynamics (PD) of single oral doses of EYP001a in subjects with chronic HBV infection.
First aim: PARIS study The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Aortic tissue will only be obtained when patients undergo conventional open repair. The other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year. Second aim: Pearl AAA biobank For future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. This biobank will be embedded within the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The Pearl AAA will be established in the extension of the PARIS study
Diagnostic study which evaluates the level of PSMA expression in patients with locally advanced, recurrent and/or metastatic ACC/SDC of ≥18 years old with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy
The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.
The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia.
The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.