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.
This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.
Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups. Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination. Study design: prospective single center observational cohort study. Study population: - all Dutch patients on dialysis with data registered in the Dutch Dialysis registry (RENINE) - all Dutch patients after kidney transplantation with data registered in the Dutch national kidney transplant registry (NOTR). - All Dutch patients with chronic kidney disease stage G4-G5 registered in the Santeon hospitals. Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn for antibody response measurements at day 28 and month 6 after 2nd vaccination at by mailer-based finger-prick in 3400 hemodialysis patients, 600 peritoneal dialysis patients, 4000 patients after kidney transplantation and 4000 patients with chronic kidney disease stage G4-G5. Patients who will undergo a 3rd SARS-CoV-2 vaccination via the national vaccination program for immunocompromised patients will be asked to carry out the mailer-based finger-prick 28 days after the 3rd SARS-CoV-2 vaccination, instead of the antibody measurement 6 months after the 2nd SARS-CoV-2 vaccination. Main study parameters/endpoints: The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as: - the incidence of COVID-19 after vaccination. Secondary endpoints are - mortality - adverse events of specific interest according to (inter)national authorities in collaboration with LAREB - presence of HLA-antibodies in dialysis patients on the waiting list for a first kidney transplantation - acute rejection and graft failure in patients after kidney transplantation In a subset of patients additional secondary endpoints will be assessed - the antibody based immune response at 28 days after completion of SARS-CoV-2 vaccination. - the durability of antibody based immune response at 6 months compared to at 28 days after having received two subsequent SARS-CoV-2 vaccinations, in patients that have not received a 3rd SARS-CoV-2 vaccine. - the antibody based immune response at 28 days after having received the 3rd SARS-CoV-2 vaccination. The incidence of these endpoints will be compared, if applicable, to those: - in the general population who are vaccinated - in patients on dialysis or after kidney transplant who are not vaccinated Within these patient groups endpoints will be compared between recipients of different vaccines.
This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the immunogenicity-tolerability ratio 14 days following first vaccination with ABNCoV2.
ULTRACOLOR is a randomized multicentre investigator-initiated study to investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access.
This study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic COVID-19 disease
Fasting or a Fasting Mimicking diet (FMD) can lower blood concentration of glucose and IGF1. Since cancer cells rely mostly on a glucose-based metabolism, FMD renders cancer cells more vulnerable to chemotherapy, thereby enhancing therapeutic efficacy. This process is known as differential stress sensitization (DSS). Another response to nutritional stress by fasting is known as differential stress resistance (DSR). DSR is a state in which healthy cells rather focus resources on protection and internal repair, which can result in reduced chemotherapeutic toxicity. Recent preclinical studies found that fasting or FMD not only aids healthy cell protection, but also has the potential to benefit effector T-cells and could thereby improve antitumor immunity. However in most oncotherapeutic clinical trials investigating the addition of a fasting regimen, other factors such as chemotherapy, surgery and additional medication affect the immune system as well. That is why this explorative study, conducted in healthy subjects, might be more suitable to investigate the immunological alterations upon FMD more specifically. This exploratory study aims to identify immunological alterations by using extensive immunoprofiling before and after three days of FMD in healthy subjects, as well as investigate possible side effects of FMD.
Age-related chronic diseases including dementia, type II diabetes mellitus (T2DM) and cardiovascular disease (CVD) become more prevalent and of increasing societal concern. Common denominators of these co-morbidities are insulin-resistance and impaired vascular function. Animal and short-term human studies now suggest that NWT-03 - an egg-protein hydrolysate - improves insulin-sensitivity and peripheral vascular function, which are risk markers for the development of T2DM and CVD. Insulin-resistance is also associated with cognitive decline, while impaired brain vascular function is an important event preceding the development of impaired cognitive performance. The investigators have already shown in a shorter-term trial (12 weeks) beneficial effects of a daily dose of 5.0 g of NWT-03 on cognitive performance. However, underlying mechanisms have not yet been addressed, while the long-term effects remain unknown. Thus, the investigators now hypothesize that NWT-03 beneficially affects cognitive performance and brain vascular function following long-term daily intake. The primary objectives of this trial are to evaluate in overweight or obese adults (aged 60-75) with subjective cognitive decline (SCD) the effects of a 36-weeks NWT-03 intervention on (1) cognitive performance using a neurophysiological test battery, and (2) cerebral blood flow, as quantified by the current non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Secondary study objectives are to examine effects on insulin-sensitivity and peripheral vascular function. This intervention study will have a randomized, controlled, parallel design. The total study duration will be 36 weeks. Forty-four older adults (aged 60-75 years) with a Body Mass Index (BMI) between 25-35 kg/m2 (overweight or obese) and subjective cognitive decline (SCD), as assessed with the cognitive failure questionnaire, will participate. These study individuals are known to be at increased risk of cognitive impairment, allowing for improvement by the intervention. During the study, subjects will receive daily (in the morning) 5.0 g NWT-03 or placebo powders for 36 weeks.
Improving healthy physiological processes through nutritional intervention, as opposed to restoring physiology after disease occurrence, is an important new avenue for the reduction of disease burden in the population. A relatively new target for interventions is the gut microbiome. Dietary fibre is a nutritional intervention shown to alter gut microbiome and function. The present study aims to elucidate the relationship between microbiome modulation with dietary fibre and health. In order to assess health improvement, a meal challenge will be given to characterize the physiological processes and their resilience to challenge in healthy volunteers before and after microbiome modulation.
Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.
Rationale: The sacroiliac joint (SIJ) is increasingly being recognized as a potential cause of chronic low back and buttock pain. The SIJ is affected in 14-22% in patients presenting with this pain. Conservative treatment options include oral analgesic use, physical therapy, radiofrequency denervation and intraarticular steroid injections. When non-surgical treatment remains ineffective, surgical intervention is a reasonable option in the form of minimally invasive sacroiliac joint fusion (MISJF). Recent literature suggests that imbalance and sagittal sacropelvic morphology can occur in patients with SIJ dysfunction. Using motion analyses, the investigators want to evaluate full movement patterns in SIJ patients. Potentially, changes in these parameters can be observed before and after MISJF surgery. Objective: To determine spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity in patients suffering from SIJ dysfunction before and after MISJF surgery. Movement parameters will also be determined in healthy individuals to compare with patients suffering from SIJ dysfunction. Methods: This prospective cohort study will include patients enlisted for MISJF surgery because of SIJ dysfunction. Spatiotemporal parameters, pelvic obliquity, center of gravity and load capacity will be examined before and 3 months after surgery in a professional Motion Lab. Movement parameter of healthy individuals will also be evaluated at the Motion Lab. All data will be analyzed using MATLAB software.