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.
Rationale: The construction of esophageal anastomoses is associated with considerable risk at postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially prevent anastomotic leakage. Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal anastomoses. Study design: Non-randomized, non-blinded, single-center intervention study. Study population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be enrolled. A total number of 15 patients will be included in the study. Intervention: Gastric or esophageal resection will be executed according to the common procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all enrolled participants will receive a TachoSil® patch, which will be applied on the esophageal anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy. TachoSil® will be degraded enzymatically in a period of approximately 24 weeks after application. Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by evaluation of adherence of the patch. A time-action analysis of the application of the Tachosil patch will be performed. Nature and extent of the burden associated with participation: The burden for the patient is minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative care and outpatient visits do not differ from regular protocol. TachoSil® is approved and registered for supportive treatment in surgery for improvement of haemostasis and to promote tissue sealing by the European Commission.
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).
The purpose of this study is to characterize the natural history of HPP in patients with Juvenile-onset HPP.
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.
20% of patients who undergo major abdominal surgery will have a major complication, which requires invasive treatment and is associated with increased mortality, morbidity, hospital stay and intensive care stay. A quality control algorithm after Major Abdominal Surgery (MAS) aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein as an early marker for postoperative complications, however clinical significance has yet to be determined. Here the investigators propose a randomized clinical trial in order to determine the effect of postoperative monitoring with standardized CRP measurements on postoperative morbidity and mortality, if CRP levels exceed 140 mg/L additional CT-scan imaging will be conducted.
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
The overall aims of the study are: - To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference. - To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061. - To further determine the safety and tolerability of ALX-0061. - To further evaluate the systemic (serum) immunogenicity of ALX-0061.