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Primary:To determine the MTD and/or RP2D of BKM120 and MEK162 in combination when administered orally to adult patients with selected advanced solid tumors. Secondary:• To characterize the safety and tolerability of the oral combination of BKM120…
In this prospective study we aim to find out whether an early refeeding strategy in addition to standard care can improve maternal and neonatal outcome and reduce hospital stay.
1) Evaluating the effect and recovery of glioma surgery in eloquent areas on cognitive functioning.2) Examining the effec tof glioma surgery in eloquent areas on quality of life.3) Examining the effect of gliomas in eloquent areas on the…
Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…
The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…
Primary Objective(s): 1. To obtain preliminary data on whether (and to which extend) adjuvant chemotherapy for colon cancer results in (a) deterioration of contractile muscle properties and increased muscle fatigability, (b) increased inflammation…
Primary objectives:1. What is the effect of walking on a treadmill compared to walking in a patient-in-charge mode on kinematics in healthy subjects?2. What is the effect of walking on a treadmill compared to walking in a patient-in-charge mode on…
The present study has 1 primary and 1 secondary objective:1: The primary objective of the present study is to analyse the effects of supplementation with ITFs of different chain lengths and RSC on hepatitis B vaccination efficacy. The main parameter…
The aim of this study is to investigate whether infiltration of the upper eyelid with Citanest is less painful then infiltration of the upper eyelid with Xylocaine. If this hypothesis proves to be correct, then in the future Citanest can be used in…
Primary objective: To investigate left ventricular diastolic function in AS-patients compared with osteoarthritis patients. Secondary objectives: To assess the prevalence of valvular heart diseases and conduction disturbances. To assess left…
The incidence of wound complications in endovascular aneurysm repair (EVAR). VAS scores will be obtained to objectify the advances of a percutaneous approach. Cultures and wound biopsies will be obtained from every patient. Also cost-effectiveness…
Primary objectives:1.1 To investigate the differences between patients* and resident loved ones' perceptions of patients* health status and problematic ADLs.1.2 To study prospectively the effects of an acute COPD exacerbation on resident loved…
Primary Objective: Identification of rare variants in candidate genes and regulatory elements in pediatric IBD patients. Secondary Objective(s): To determine the functional consequences of identified genetic variants in IBD, we will correlate…
The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to…
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
Analyse costs and effects of point of care (POC) C-reactive protein (CRP) measurement in children with non-severe lower respiratory tract infection (LRTI) in primary care.
The objective of the current study is to compare three different strategies of pain management in patients presenting to an emergency department and to a general practice with acute musculoskeletal syndromes (defined as musculoskeletal complaints…
The primary study objective is to assess whether CML patients who respond to treatment with nilotinib (MMR within 12 months of treatment) differ from the non-responders in terms of adherence. Secondary objective is to evaluate whether responders and…
To evaluate whether neuromuscular ultrasound discriminates between patients with and without ICU-AW.To detect differences between patients that do and do not have ICU-AW in order to determine relevant cut-offs which can be used in future diagnostic…
The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.