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.
The purpose of this study was to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
This study is designed as a single-blind RCT in 80 postmenopausal women to compare the effect of immediate administration of daily calcium supplementation (1000 mg calcium) or two daily dosages of calcium + vitamin D (1000 mg calcium + 880 IU vitamin D or 1000 mg calcium + 1760 IU vitamin D) to standard care (administration of vitamin D3 12 weeks after fracture) in terms of calculated bone strength based on analysis of cortical and trabecular bone parameters using HR-pQCT, fracture healing and functional outcome.
The purpose of this study is to assess if ACZ885 will improve lung function in association with reduction of tissue inflammation in patients with chronic sarcoidosis.
Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic headache, is seriously hampered because of common features and complex interaction of the neurological and musculoskeletal system. Current therapies are therefore not as effective and the population of patients with PRH keeps on increasing. The diagnostic as well as the therapeutic process need more structure in order to select the most effective treatment; thereby contributing to preventive measures. This goal can be achieved through fundamental research with a clinically oriented background. Our study starts from a clinical problem, with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to play an important role in PRH, the first step in the diagnostic process is to analyse postural differences between a PRH- and a control-group. In addition, the role of the dura mater in the headache-process will be examined. Patients with PRH will be classified in homogeneous groups based on these results. In a second phase individual-specific treatment programs will be composed. The general treatment-approach of postural abnormalities in the past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal problems has been proven to be successful in the past (O'Sullivan & Dankaerts, non-specific low back pain). Our study is divided in 2 phases: - phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic controls) - phase 2: interventional phase (clustered headache-groups, based on the results of phase 1
Prospective data will be collected in approximately 250 patients sustaining BCFx with or without any additional fracture(s) of the symphysis. Patients will be followed according to the standard (routine) at approximately 6 weeks and 3 months after the treatment. Data collection will include fracture details (i.e. classification, mechanism of injury), treatment details, functional and patient-reported outcomes, and anticipated or procedure-related adverse events (i.e. complications).
Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age <28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. However, a common finding is that medical and/or surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity. This might be related to the fact that a substantial portion of preterm infants are treated unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any specific intervention. An expectative approach is gaining interest, although convincing evidence is still missing. The objective of this study is to investigate whether in preterm infants <28 weeks' gestation with a PDA an expectative management is not inferior to early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.
The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Cognitive function will be assessed using a comprehensive battery of tests with an evaluation of longitudinal change of cognitive domains including memory, executive function, and attention.
Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis. A pro-drug of abiraterone, abiraterone acetate (Zytiga®), was developed to overcome its poor bio-availability and is fully converted to the active moiety abiraterone. Abiraterone acetate tablets are administered at a fixed oral dose of 1000mg QD in a fasted state in combination with 10mg prednisolon daily. Abiraterone acetate has a low solubility in aqueous media and a low permeability. The bioavailability of abiraterone acetate is significantly influenced when ingested with food. Ingesting abiraterone acetate with a low fat or a high fat meal resulted respectively in a 5- or 10-fold increase in AUC0-∞. The high and low fat FDA meals used in these food effect studies differ largely from breakfasts taken in everyday life (ca. 800-1000 cal). A continental breakfast contains 160 to 320 calories of which 25-50% is fat, is more compatible with a normal lifestyle and therefore easily sustainable in daily practice. However, the effect of a continental breakfast on the absorption of abiraterone is unknown yet. Furthermore, increasing healthcare costs are a growing concern in all developed countries. Therefore effort should be invested to keep anticancer treatment affordable. A food intervention resulting in a better absorption and enhanced exposure to abiraterone, can lead to a reduced dose, which could significantly impact health care costs for a tumor which is as prevalent as metastatic prostate cancer. Therefore the investigators want to perform a bioequivalent study to investigate what dose of abiraterone with a continental breakfast equals the dose of 1000mg taken in fasted conditions.
Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of patients with RCC. The aim of the present study is to show the impact of the Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.