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 phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or subcutaneously at escalating dose levels in healthy, malaria naïve, adults. This study will also evaluate the pharmacokinetics of TB31F and the functional activity of mAb TB31F in the standard membrane feeding assay.
The aim with this descriptive multicenter study is to examine the quality of the ventilation given by Emergency Medical Service (EMS) personnel during cardiopulmonary resuscitation (CPR). Primary endpoint is the ventilation quality measured as ventilation frequency, tidal volume and minute ventilation. This will primarily be studied during CPR with a 30 compression/2 ventilation ratio performed by the EMS personnel where the airway is managed with a supraglottic device but also in CPR with continuous ventilation (8-10 breaths/minute) after the airway management have been replaced with an endotracheal within the emergency room. The inclusion of patients will be performed at two sites (Uppsala; Sweden and Utrecht; Holland), all out-of-hospital cardia arrest (OHCA) patients will receive care according to current CPR guidelines using mechanical chest compressions.
Stroke is a major cause of death and disability worldwide. Stenotic carotid arteries can lead to stroke if the cause of the stenosis is a vulnerable atherosclerotic plaque. Recent studies reveal that if a patient has a plaque in the carotid artery it is highly probable that he/she will develop plaques in other superficial arteries like the femoral artery. Currently, duplex ultrasound is used to determine the grade of stenosis and is the main criterion for intervention (endarterectomy) planning. However, the stability, or instability of the plaque cannot be determined non-invasively. Photoacoustics is a novel, non-invasive imaging modality that uses pulsed laser light to generate laser induced ultrasound in the absorbing region of the tissue. Photoacoustic imaging provides optical contrast of biological tissue chromophores with an acoustic resolution and imaging depth, which is promising for visualization of plaque composition. The advantage of photoacoustics is the use of multiple wavelengths, since different tissues respond differently to different wavelengths. Hence, non-invasive, in vivo, morphology assessment is a future application of this new modality that would improve diagnosis and clinical decision making. The drawback is the limited penetration depth of the laser light and the signals generated by surrounding tissue. A new, integrated photoacoustic device has been developed that meets all safety requirements and has an improved penetration depth, suitable for imaging of carotid arteries with the aim to distinguish between plaques with different morphology.
Articular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation has been established as the first advanced treatment therapy medicinal product. Although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure. 'Instant MSC Product accompanying Autologous Chondron Transplantation' (IMPACT) combines autologous recycled chondrons (chondrocytes surrounded by pericellular matrix) with MSCs for one-stage treatment of cartilage defects. IMPACT was successfully executed in a first-in-man phase I/II clinical trial in which 35 participants with cartilage defects were treated. The results showed a good safety profile, proper feasibility and good initial clinical efficacy at 18 months follow-up. Also good outcome at 24 and 36 months was shown in ongoing post study surveying of the participants. Consequently a new study with IMPACT was designed; IMPACT2. The objective of IMPACT2 is to compare clinical outcomes of 30 individual participants with cartilage defects treated with IMPACT to 30 participants treated with standard care for 9 months (consisting of optional physical therapy and pain medication). Participants should be aged 18-45 years with a symptomatic Modified Outerbridge Grade III or IV cartilage lesion of the knee ranging in size 2-8 cm^2. After enrolment, participants will be allocated (randomized) to either group A in which case they receive IMPACT-treatment, or group B that will receive standard care. Standard care consists of optional physical therapy and pain medication. After 9 months, participants in group B can receive the IMPACT-procedure as well.
To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome
The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI) when administered as an fixed dose combination (FDC) (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide [D/C/F/TAF]) compared to the co-administration as the separate commercial formulations (DRV and F/TAF and COBI), under fed conditions, in healthy participants.
SYD985.004 is a two-part phase I study with the antibody-drug conjugate SYD985 in combination with niraparib aimed at evaluating safety, pharmacokinetics and efficacy in patients with HER2-expressing locally advanced or metastatic solid tumours.
Cognitive performance is negatively related to an impaired glucose metabolism, possibly due to impairments in brain vascular function. Supported by the statement from the American Heart and Stroke Association that a healthy lifestyle is one of the most effective strategies to protect against cognitive decline, the investigators now hypothesise that healthy lifestyle intervention-induced changes in glucose metabolism cause beneficial effects on brain vascular function thereby improving cognitive performance. The primary objective of this intervention study is thus to evaluate in sedentary older men and women the effect of a 16-week aerobic-based exercise program on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to examine effects on glucose metabolism using the homeostatic model assessment for insulin resistance (HOMA-ir) and cognitive performance as assessed with a neurophysiological test battery.
The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH). The primary objective for Part B of the study is to demonstrate a reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab in pediatric (5 to 11 years of age) patients with HoFH. The secondary objective for Part A of the study is to evaluate the safety and tolerability of evinacumab administered intravenous (IV) in pediatric patients with HoFH. The secondary objectives for Part B of the study are: - To evaluate the effect of evinacumab on other lipid parameters (ie, apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a [Lp(a)]) in pediatric patients with HoFH - To evaluate the safety and tolerability of evinacumab administered IV in pediatric patients with HoFH - To assess the PK of evinacumab in pediatric patients with HoFH - To assess the immunogenicity of evinacumab in pediatric patients with HoFH over time - To evaluate patient efficacy by mutation status
The study is a randomized, cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions with a minimum of 1 week between visits. During each visit, participants will receive a carbohydrate rich test-meal with Kori-tofu (protein) or whey protein. The two meals will be given in randomized order and blood will be collected via a catheter before and up to 3 hours after consumption of the test-meal. Study participants will also wear continuous glucose meters during the trial. They will receive a standardized evening meal prior to each study day and are asked not to drink alcohol or perform heavy exercise the day before. After each test day participants are offered a meal.