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.
B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.
The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.
This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.
Rationale: Cancer treatment is increasingly successful, resulting in a rising number of cancer survivors. A substantial number of survivors may experience long-term and late side effects from their cancer treatment. In addition, evidence is accumulating that an active lifestyle positively influences cancer treatment outcome and changes the recurrence rates of the disease. Therefore, physical activity (PA) programs are urgently needed and should be incorporated in current treatment regimens. It is noted though that cancer patients and survivors experience difficulties in remaining physically active. A 'smartphone application' (app) may be an accessible way to counteract these problems. The app 'RunKeeper', founded by Mr. Jason Jacobs, 2008, FitnessKeeper Inc. (RunKeeper) is a free, widely spread and well-known app for self-monitoring PA. Convenient features of RunKeeper are self-monitoring PA with GPS or stopwatch, recording progress, goal setting, and personal records. In this study the investigators aim to determine if the RunKeeper app use improves PA by self-monitoring and empowering PA during or after cancer treatment in comparison with usual care in a 12-week follow-up. Objective: The primary objective is to identify an improvement in PA as measured by the PASE questionnaire when using the RunKeeper app in comparison with usual care for 12 weeks during or after cancer treatment. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior. Secondary objectives are to explore the usability of the RunKeeper app. Study design: The present study is a single-centre prospective two-armed randomized controlled feasibility study. Study population: Adult patients diagnosed with cancer currently being treated or under surveillance at the department of Medical Oncology at the UMCG. Intervention: Patients who give informed consent will be randomized in one of the two study arms; 'Group A', usual care (N=15) or 'Group B', usual care + the RunKeeper app (N=15). Directly after randomization, Group B will be sent a brief user's manual for RunKeeper and requested to install the RunKeeper app. Group B will use the RunKeeper app for 12 weeks to self-monitor PA. Main study parameters/endpoints: The primary endpoint is to calculate the effect-size of the RunKeeper app use for 12 weeks on PA as compared to usual care as measured by the Physical Activity Scale for the Elderly (PASE) questionnaire. The investigators hypothesize that the RunKeeper app might assist in stimulating and improving PA behavior.
The investigators will evaluate ventricular reversed remodelling after double lung transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.
The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent system.
The primary objectives of the study are: -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）
The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.