62 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…
We hypothesise that glaucoma patients with non-overlapping visual field defects have poorer binocular visual performance while performing complex visual tasks than would be predicted from their visual field. Knowledge on this topic is highly…
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…
This study investigates the impact of a goal directed nutritional support protocol on sarcopenia in oncological patients undergoing an esophagectomy and secondary the incidence of anastomotic leakage and pneumonia, surgical infection and lenght of…
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…
To determine if SSA are effective in decreasing transfusion requirements and improving quality of life while being cost-effective.
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.
Primary objective: The primary objective of this non-randomized intervention trial is to investigate whether TAVR improves exercise capacity in patients with preserved LVEF and NF/LG or LF/LG severe AS reclassified based on hybrid CT/TTE-derived…
The objective of this study is to determine whether contralesional cTBS treatment modulates the interhemispheric imbalance in excitability or local or transcallosal inhibitory processes in the motor network of a population of stroke patients…
To assess the effectivity and feasibility of HCV RNA self-testing in reducing the time to diagnosis of HCV re-infection in MSM previously cured of an HCV infection, compared to the current diagnostic standard of care. To evaluate whether the uptake…
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.
Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…