31 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…
The aim of this study is to determine the levels of hemostasis factors after an uncomplicated pregnancy.
(1) to establish the effect of adding amiloride to lithium- treatment on the progression of renal insufficiency in patients with lithium- nephropathy (2) to answer the question whether adding amiloride to the use of lithium has the same effect as…
The objective of this prospective randomised multi-center study is to compare the clinical outcome of the cemented and hydroxy-apatite coated uncemented hemi-arthroplasty for patients with a proximal intracapsular femoral fracture and the indication…
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.
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…
To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…
Primary objective: To determine the antitumor activity regarding objective response rate (ORR) of tipifarnib in subjects with locally advanced non-resectable or metastatic, relapsed and/or refractory, non-haematological malignancies with HRAS…