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.
Background: Calcineurin inhibitors (CNIs) are the most commonly used immunosuppressive drugs to prevent rejection after kidney transplantation. However, the efficacy of preventing rejection comes at the cost of important side-effects. Among the most common side-effects is hypertension. Hypertension after kidney transplantation is clinically relevant, because it increases the risk of cardiovascular disease and is associated with increased graft loss and recipient mortality. The mechanism of CNI-induced hypertension is incompletely understood and, therefore, the treatment is currently empiric. These and other investigators recently showed that CNIs cause salt-sensitive hypertension by activating a sodium transporter in the kidney, namely the thiazide-sensitive sodium chloride cotransporter. Hypothesis: The investigators hypothesize that thiazide diuretics are non-inferior to calcium channel blockers (CCBs) (currently usually the treatment of choice) for the treatment of CNI-induced hypertension. Objective: To compare the blood pressure response to thiazide diuretics and CCBs in patients with CNI-induced hypertension. Study design: Single-center, randomized cross-over trial. Study population: Kidney transplant recipients with a good functioning allograft (eGFR > 30 ml/min) who are hypertensive (daytime systolic blood pressure > 140 mm Hg) and who do not have proteinuria (< 1 g/day). Intervention: Patients will be randomized to receive chlorthalidone (12.5 mg once daily, if needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to 10 mg once daily). Main study parameters/endpoints: 24-hour blood pressure recording. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both drugs have long been registered for the treatment of hypertension. The side-effect profile of both drugs is considered to be equal. The burden of the study for the patients are blood pressure measurements using 30-minute automated blood pressure measurement and 24-hour ambulatory blood pressure measurement.
This study aims to prove that a strategy of first line local ablation of colorectal liver metastases with microwaves is not inferior to liver resections in terms of survival rates at three years with secondary endpoints being survival at five and ten years, interventional complication rates, length of stay, ablation precision measurements, need for further interventions and health-economic analysis. A cohort of 100 patients treated with CT guided microwave ablation of 1-5 metastases <31mm in size will be followed and compared with propensity scored matched controls from the Swedish liver surgery registry - Sweliv. The study is a multi-institutional effort by the Hepato Pancreatico Biliary (HPB) units in Stockholm Sweden, Bern Switzerland and Groningen in the Netherlands.
The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.
The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).
Small fiber neuropathy (SFN) is the most common cause of neuropathic pain in peripheral neuropathies, with a prevalence of at least 53/100.000. Patients with SFN may have excruciating pain and current anti-neuropathic and other pain drugs do not relief pain substantially. Several studies suggested an immunological basis in SFN and case studies have reported efficacy of treatment with intravenous immunoglobulin (IVIg) in patients with SFN. It is therefore conceivable that immunological mechanisms play a role in idiopathic SFN (I-SFN). However, to date no randomized controlled study with IVIg in patients with SFN has been performed. The aim of the current study is to investigate the efficacy and safety of IVIg in patients with I-SFN in a randomized, double-blind, placebo-controlled study. The objective of the study is to evaluate the efficacy of IVIg treatment (4 courses of treatment, 3 weeks apart) compared to placebo on pain alleviation.
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.
Sorafenib is an oral anticancer drug and inhibits multiple protein kinases important for tumor growth and metastases, including VEGFR, PDGFR, and RAF kinases. In daily clinical practice it is currently used at a dose of 400 mg twice daily in a continuous schedule. In this phase I study patients will be treated with a new dosing schedule of sorafenib: i.e. a high-dose, pulsatile schedule. The tolerability and safety of this new schedule is examined in exposure escalation cohorts based on a target plasma AUC0-12h (area under the curve). Exposure escalation cohorts are used instead of conventional dose escalation cohorts because the effect of a drug is dependent of its AUC levels and large differences in plasma sorafenib AUC0-12h have previously been shown between patients treated at the same dose level. Using pharmacokinetic monitoring, the sorafenib dose will be adjusted to a target plasma AUC0-12h. The escalation cohorts consist of 3-6 patients per exposure level starting with a target plasma sorafenib AUC0-12h level of 25-50 mg/L/h. After the determination of the maximum tolerated AUC0-12h, 10 additional patients will be entered into an expansion cohort. In the expansion cohort the patients will be treated with a weekly pulse of sorafenib at the maximum tolerated AUC0-12h for further assessment of safety and preliminary exploration of efficacy.
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
Intraileal infusion of nutrients results in a reduction in food intake. A previous study by our group showed that both sucrose and casein infusion resulted in an increase in satiety and release of gastrointestinal peptides and a decrease in hunger and food intake. Encapsulating both nutrients, daily ingestion of this micro encapsulate and hereby releasing them in the distal small intestine could result in a chronic ileal brake activation. The obtained reduction in food intake and caloric intake could help overweight subjects to lose weight.
A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after co-administration of single entity tablets and of the combination tablet EC905 under steady state conditions at three dose strengths.