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.
Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer. Subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). The estimated duration of Part A is 21 days. Part B: The purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of GEH200520 and GEH200521 (18F) when administered to patients with cancer before and after immunotherapy treatment. Subjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ICI) treatment visits and 2 additional imaging and 1 follow-up visit . The estimated duration of Part B is approximately 64 days.
This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC alone in patients with symptomatic severe Tricuspid Regurgitation (TR) in the Netherlands.
A patient decision aid (PDA) was tested in a population of patients with superficial basal cell carcinoma. This study evaluates whether the use of a PDA improved outcomes like decisional conflict and knowledge.
In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study. Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.
To investigate feasibility of basal-ganglia regions as fMRI-neurofeedback targets in Parkinson's patients and evaluate self-regulation success
The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.
An increasing number of cancer patients are eligible to receive immunotherapy. Efficacy and tolerance have been demonstrated in multicentre randomized clinical trials with positive results. However, real-life experience differs from clinical trial results, especially regarding the management of potential adverse events. HR-QoL (Health Related Quality of Life) is one of the components of QoL (Quality of Life) in its broad acceptation and is certainly the only one usually collected in trials while little is known about QoL in cancer patients treated in the 'real-world'. QUALITOP partners intend to bring together all relevant longitudinal information present in large heterogeneous data (big data) to estimate patient QoL and find surrogate markers of QoL and its evolution. Within the QUALITOP consortium, 5 countries will collect prospective clinical and QoL data and also retrospective clinical data, and share it. This project will enable collecting, managing, sharing, modelling, processing, and exploiting big data on QoL. Furthermore, beyond the description of QoL, analytical tools (including causal inference methods and machine learning) are needed to understand the determinants of QoL and their complex relationships with irAEs (immune related Adverse Events) in a big-data context where standard statistical techniques would be limited. Artificial intelligence and causal models may be applied and developed to empower the patient, prevent adverse medical conditions, and promote QoL. The created knowledge will enable proposing guidelines for promoting better QoL. QUALITOP aims at identifying the determinants of health status regarding immunotherapy-related adverse events (IR-AEs, such as toxicities) depending on the patient's profile in a real-world context. The richness of QUALITOP is in the diversity of the experts who will collaborate in it. Clinicians involved in the care (thus the health status of the patients) will collaborate with psychologists and sociologists to understand and integrate complementary dimensions of QoL related to immunotherapy. Experts in pharmacovigilance and pharmacists will investigate the IR-AEs and their associations with patient behaviour and non-drug consumption. Epidemiologists, data scientists (including bioinformaticians and biostatisticians) and economists will extract information from the data and develop simulation models to produce knowledge. The project will take place in close relation with patient associations that will interact with experts to design the analyses, interpret their results, and proceed to their dissemination. The main objective is to collect data of patients receiving immunotherapy in order to describe its impact in their quality of life. - Create the first real-life cohort of cancer patients treated with immunotherapy within a context of multidimensional management (with data on clinical information, health-related QoL (HR-QoL), IR-AEs, drug consumption, lifestyle, and administrative data). - Accelerate knowledge directed to different stakeholders (patients, relatives, clinicians, pharmacists, health authorities, and the general public) for a better understanding of the determinants of QoL and its optimization after immunotherapy through the development of innovative analytic tools (artificial intelligence and causal models). - Produce policies and recommendations to improve patients QoL and participate in the implementation of the SDGs (Sustainable Development Goals) for 4P medicine (Predictive, Preventive, Personalized, Participative) in immunotherapy for cancer patients.
Rationale: Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS). Objective: To identify predictors for SAMS in statin users and to objectively assess physical activity levels and sedentary time between symptomatic and asymptomatic statin users.
Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. However, the consequences of such a transition on muscle mass still remains to be explored. This is of particular importance in the older population, where sarcopenia is highly prevalent. The aim of this randomized controlled cross-over study is to investigate the short-term effect of a 10-day controlled vegan diet on daily muscle fractional synthesis rates in comparison to a 10-day controlled omnivorous diet in 35 community-dwelling older adults. Participants will follow a fully controlled vegan diet, directly followed by a fully controlled omnivorous diet for 10 days, or vice versa. Researchers will compare the effect of the vegan diet to the effect of the omnivorous diet.
The cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. This study found a promising equal migration of both tibial components and a lesser migration of the femoral component of the ATTUNETM knee system after two years, although with a similar migration rate between year 1 and 2. this raises the question of whether the migration of the prostheses relative to each other will increase or remain the same in the long term. To examine this, a mid-and long-term RSA follow-up to measure migration is necessary. In addition, another new RSA measurement parameter has become known in recent years that may provide an indication of the bonding of the prosthesis to the bone at the time of measurement. This new parameter, called the Induced Displacement (ID) of a prosthesis, measures the position and orientation relative to the bone while the prosthesis is under different loading conditions (e.g., patient in supine or standing position). This means that a large measured difference between these different loading condition measurements would indicate that osseointegration of the prosthesis never occurred or is no longer present. To improve the understanding of the tendency of both prostheses to aseptic loosening after a mid- to long-term follow up, migration over time and inducible displacement analyses are necessary. The primary objective of this study is to accurately compare mid- and long-term migration of two uncemented TKR prostheses. The secondary objectives of this study are to evaluate if inducible displacement can be used as a parameter to detect loose implants, and to compare inducible displacement, clinical and radiological outcome and patient-reported outcomes (PROMS) after a follow-up of 5 and 10 years of two uncemented TKR prostheses.