114 results
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…
The aim of this study is to investigate how many patients with an early and/or chronic psychotic disorder reach personal recovery during follow-up and which determinants and processes influence personal, clinical, functional and societal recovery…
The primary objectives of the study are:For Parts A through C:1. Evaluate the safety and tolerability of multiple doses of CX-072, administered as monotherapy or in combination with ipilimumab or vemurafenib to patients with metastatic or locally…
Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…
The primary objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo. Secondary…
The primary objective of the study is to perform a set of hypothesis-driven analyses on the study data set, aiming to correlate established biomarkers (obtained clinically, from brain MRI, from CSF, from known genetic factors, and from monitoring of…
Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…
The primary objective is to investigate whether (and if so, which) type of CBT-element (cognitive restructuring (CR), behavioral activation (BA), relaxation (RE) and problem solving skills(PS)) is relevant for the positive effect of CBT-programs on…
The main objective is to investigate whether local mast cell activation correlates with an unstable phenotype of the atherosclerotic plaque.Secondary objectives are: 1. To investigate whether elevated systemic mast cell markers are correlated to…
The primary objective is to characterize the programming effects of Boston Scientific Vercise* PC System using the Deep Brain Stimulation Directional Lead for bilateral subthalamic nucleus DBS for the treatment of Parkinson*s disease in acute and…
The aim of this study is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.
(1) to create and train an algorithm to generate synthetic CT images of the craniofacial area(2) to evaluate the resulting synthetic CT images in terms of geometrical accurate visualization of the craniofacial osseous structures compared to the…
The objectives are to assess the efficacy, safety and effect on quality of life of Nintedanib compared to chemotherapy in women with relapsed, advanced or metastatic clear cell cancer of the ovary of endometrium.
Aim: To investigate the efficacy of nortriptyline in FD patients with a predicted CYP2D6 extensive metabolizer phenotype. Nortriptyline is a second generation TCA with significantly fewer anticholinergic side effects compared to the first generation…
Main study objective: to explore the compliance to nutritional test product intake after the first 3 cycles of systemic therapy in patients with metastatic colorectal cancer receiving first line of CAP-containting systemic treatment. Other study…
The primary objective of this study is to examine whether MIS is non-inferior to laparotomy in terms of disease free survival (DFS) in women with advanced stage EOC that received 3 to 4 cycles of NACT.
To investigate the pain phenotype of patients with hand OA. To investigate the prevalence of neuropathic pain symptoms and central sensitization and their determinants in patients with painful hand OA. To investigate the presence of small- and large…
The project*s overarching aim is to diminish respiratory disease burden in moderate-late preterm born infants in their first 18 months of life. We have formulated the following specific objectives: 1. Determine whether the introduction of our follow…
The primary objectives of the study are as follow:1) To assess usability and adherence to a T2T strategy implemented through a digital e-health tool website (i.e. do physicians work through all aspects of the website and take part in all the T2T…