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: Dupilumab has proven to be effective and safe in several large randomized controlled trials. However, study populations in RCT's represent only a small proportion of severe asthma patients treated in real life circumstances. Therefore, real-life studies provide data complementary to RCT's derived from a more diverse and heterogeneous group of patients. This study is unique in that it represents a large population of European patients that are not represented in the Global Registry. Objective: To collect and analyse efficacy and safety data in severe asthma patients treated with dupilumab in a real-life setting. Study design: Single center, retrospective cohort analysis of severe asthma patients treated with dupilumab, as decided by the treating physician. Setting: Severe Asthma Expert Center Franciscus Gasthuis & Vlietland, Rotterdam Study population: All patients that started with dupilumab from jan 2019 (early access program) until June 2020 are eligible for the study. They should be 18 years or older, with severe T2 high asthma and treated with at least one dose of dupilumab. Main study parameters/endpoints: - Primary endpoint: To assess changes in annual exacerbation rate between baseline and after 12 months treatment in severe asthma patients treated with dupilumab. - Secondary endpoints: To collect data on ACQ, OCS use, FEV1, treatment response rate, influence of co-morbidities and safety. Methods: Exacerbation history and patient characterization will be done at baseline. We aim to include patients in the analysis that had at least one administration of dupilumab (intention-to-treat). Treatment response evaluation is done at 12 months. Final evaluation of efficacy and safety is done at 12 months of treatment. We aim to enroll at least 120 patients in the study. Data collection will be done in Castor Electronic Data Capture. Of the 120 patients scheduled for inclusion, all have already started treatment and data will be collected retrospectively at the predefined time points. Patient data will be handled confidentially. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a retrospective cohort analysis there are no extra visits, interventions or procedures needed. Therefore, there is no increased burden or risk for the patients involved.
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.
A cardiopulmonary exercise test (CPET) is increasingly used for preoperative risk assessment. Oxygen uptake (VO2) at peak exercise (VO2peak) and VO2 at the ventilatory anaerobic threshold (VO2VAT) are the most commonly used preoperative CPET variables that are associated with postoperative outcomes following colorectal cancer surgery. The aim of this study is to investigate the association between preoperative submaximal and effort-independent CPET variables and postoperative outcomes in colorectal cancer surgery. Specifically, the slope of the relation between minute ventilation and carbon dioxide production (VE/VCO2-slope) and the oxygen uptake efficiency slope (OUES) will be investigated.
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Purpose: with an increased risk of complications. Improved preoperative risk stratification and earlier diagnosis of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) aims to establish a comprehensive biorepository that will facilitate research in this field. Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first 7 postoperative days (or longer as indicated), participants will be subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel EEG). In addition, we will collect blood samples as well as microbiome specimens at selected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium. Secondary outcomes include mortality as well as long-term psychopathology, cognitive dysfunction, and quality of life. PLUTO is the first perioperative biobank worldwide that includes a broad range of high-risk surgical patients, collecting prospective bedside data as well as both blood and microbiome specimens during the entire perioperative period. The data and materials collected in PLUTO will be used to develop, externally validate, and update prognostic prediction models for improved risk assessment, to test novel biomarkers for early detection of postoperative complications and to study the aetiology, attributable morbidity and mortality related to these events.
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.
The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.
This is a multi-center, randomized, sponsor open-label, participant- and investigator-blinded, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in HFrEF/HFmrEF.
This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
There is still a discrepancy between the number of liver transplant candidates and the availability of liver grafts, resulting in waiting list mortality. To increase the supply of suitable liver grafts, extended-donor criteria allografts can be used. However, in the case of donation after cardiac death this is not without a risk. Donor after cardiac death (DCD) grafts have increased risk of primary non function and biliary complications, resulting in either retransplantation, patient morbidity or patient death. Due to uncertainty of their quality DCD grafts can be discarded. However, normothermic machine perfusion (NRP) has the potential to overcome these disadvantages of DCD liver grafts. In DCD livers the physiological abdominal circulation is simulated with in vivo, normothermic, oxygenated perfusion during the first two hours after cardiac death. With this perfusion technique, early ischemia can be reversed, surgical damage due to a hasty procedure can be prevented and organs can be tested on viability. In many countries, NRP is obligatory, however this is not the current golden standard in the Netherlands. The primary objective of this study is the utilization of livers after NRP. Secondary study parameters are reasons for graft discard or rejection at proposal, patient- and graft survival, biliary complications, cost assessment of NRP and outcomes of kidney and pancreas transplants. This multicenter, observational study will be performed on adult liver transplant recipients who have been allocated a DCD liver graft (Maastricht type III and V) of a donor above fifty years old. According to current national procurement protocol, grafts procured in region west will be retrieved with NRP followed by dual hypothermic oxygenated perfusion (DHOPE). Grafts retrieved in region East/North will be retrieved using standard rapid retrieval followed by DHOPE, if the donor is aged 50-60. Grafts from donors aged above 60 will undergo controlled oxygenated rewarming normothermic machine perfusion (COR-NMP) after DHOPE.