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 (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.
Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical entity. The most characteristic feature is the disproportionate more motor impairment of the arms and especially the hands than the legs, bladder dysfunction and sensory. Recently, it has been shown that the distinction of TCCS with an incomplete cervical spinal cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact incidence is not known. Uncertainty about the treatment exists. A good recovery has been described after conservative treatment. Conservative treatment was usually considered when a fracture or dislocation of the spine were absent. It is often seen in hyperextension trauma in the elderly with degenerative spondylotic stenotic cervical spine. However, some reports suggest a better outcome after surgical decompression. Randomized trials have not been performed. To avoid discussion about possible confounding or effect modification related to the mechanism of trauma, this study will focus on ICSCL in patients without fracture or instability of the cervical spine on radiological examination. Also the problem of crossover from the conservative group to the surgical one due to the nature of spinal instability will be reduced. Goal of the study: To compare the efficacy of early decompressive surgery to improve functional outcome in patients with ICSCL without a fracture or instability of the cervical spine compared to those receiving conservative treatment. Definition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that could indicate a fracture of the cervical spine or instability. An overt sequestrated herniated disc should not be present since this will always necessitate immediate surgery. Involvement of the cervical spinal cord should be established at physical examination (symptomatic arm or hand dysfunction is obligatory).
Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Also home-monitoring is available for continuous monitoring and information sending to the treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever arrhythmia's we hope to improve patient care. Objective of the study: To investigate the clinical efficacy in detecting clinically relevant arrhythmia's (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score >2), currently not treated with oral anticoagulation (OAC). Study design: In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class) 2-3, a CHADS2-score>2 and no indication for a implantable cardioverter-defibrillator (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward clinic visits. The number of relevant arrhythmia's detected will count for the primary endpoint. Also the number of medication changes and institution of OAC. Study population: 50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known. Primary study parameters/outcome of the study: Primary endpoints - AF burden and AF episodes detected - Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias (VT's) or bradycardias - % patients on OAC after 1 year follow-up - Number of clinically relevant patient activated events - Number of treatment policy changes based on the Reveal XT Secondary study parameters/outcome of the study - specificity of AF detection algorithm by the Reveal - Predictive value of the cardiac Compass data to predict worsening heart failure episodes.
Evidence exists that EPA (eicosapentaenoic acid or C20:5n-3) supplementation can reduce the risk for coronary heart disease. EPA can be synthesized from α-linolenic acid (ALA or C18:3n-3), but conversion is low. It has been suggested that the rate-limiting step for this conversion is the Δ6-desaturation of ALA into stearidonic acid (SDA or C18:4n-3). Thus, providing oils rich in SDA may increase the endogenous synthesis of EPA. This may subsequently lower serum triacylglycerol concentrations, an effect frequently observed after EPA supplementation, especially in people with increased triacylglycerol levels. The objective is to study the effects of echium oil, rich in SDA on serum triacylglycerol concentrations in healthy overweight and slightly obese men and women. The minor objective is to study the effects of echium oil on the omega-3 index, which is negatively related to cardiovascular risk and defined as the proportion of EPA and DHA in red blood cells.
Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed. Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human intervention studies.
This is a one-week, randomized, double blind add-on study of valaciclovir versus placebo in 24 clinical patients with Schizophrenia according to DSM IV, currently experiencing psychosis as is defined by the positive items of the Positive and Negative Syndrome Scale (PANNS) score, being five or higher on one item or four on two items of this scale. Each patient will be randomized to double blind treatment with either valaciclovir or placebo for one week. The main objective is to find a pre- and post-valaciclovir treatment difference in hippocampal inflammation, as measured with positron emission tomography. The secondary objective is to improve cognition by the supposed anti-inflammatory effect on the hippocampus of valaciclovir. This is measured by pre- and post-treatment performance on the PANSS, the attention and memory test. Both the treatment team and the patient will remain blinded during the course of the study. Following the active treatment phase, patients will receive treatment as clinically indicated.
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.