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.
Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.
This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy. The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected. Secondary objectives are: - To establish the feasibility and safety of the combined treatment modalities; - To study the impact of the local technique (RFA/Radiotherapy) on the results; - To investigate biomarkers to predict response to the combined treatment
So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.
The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates. The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: - Migration, measured by means of RSA. - Patient Reported Outcome Measures by means of questionnaires.
The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces
A 1-year Clinical Investigation on the On1 Concept.
OBJECTIVE: To determine the quality of life (QOL) and clinical outcome after conservative therapy, embolization (proximal versus distal) or surgery in patients with traumatic splenic injury. Secondary aims: (I) to examine therapy-related complications, (II) to establish the necessity of additional therapies, (III) the assessment of splenic function related to splenic morphology (MR imaging) after embolization and (IV) to find the prognostic factors for failure of non-operative management (NOM) in patients with splenic injuries. Finally, with the acquired data from this study a patient-oriented protocol will be provided for the management of traumatic splenic injury. HYPOTHESIS: The investigators expect that NOM is superior to surgery with regard to QOL, clinical outcome and splenic function. Embolization will need more additional therapies. Splenic morphology is related to splenic immune function. Expected prognostic factors are age above 40, ISS >25 and a splenic injury grade of 3 or higher. STUDY DESIGN: A combination of a retrospective and a prospective multicentre cohort study. This protocol involves the prospective part of the study. STUDY POPULATION/DATASET: Patients who enter the participating hospitals between March 2017 and December 2018 with splenic injury will be asked to participate. The follow-up period will be one year with regard to QOL, clinical symptoms and imaging. INTERVENTION: All patients will complete a number of questionnaires at different time points. The patients who were treated with splenic artery embolization (SAE) will undergo an MRI one month and one year after treatment. OUTCOME MEASURES: Primary outcome is QOL. Secondary outcomes are clinical symptoms and imaging. SAMPLE SIZE: Approximately 100 patients will be included per year during the inclusion phase. DATA ANALYSIS: With regard to the prospective data linear modelling will be performed. COLLABORATION/CONNECTION: Tilburg University, Erasmus Medical Center Rotterdam, Maasstad Hospital Rotterdam, Albert Schweitzer Hospital Dordrecht, Amphia hospital Breda, Leiden University Medical Center, VU University Medical Center Amsterdam, Medical Spectrum Twente, Radboud University Nijmegen, Isala Zwolle. TIME SCHEDULE: Year 1: literature search and conducting the retrospective study and analyses. Years 1-3: inclusion prospective study and follow-up of patients. Year 4: finishing follow-up data collection and analysing.
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.