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A multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

Spinal Muscular Atrophy, SMN protein and Genetics; A population based study on spinal muscular atrophy in the Netherlands to explore the prevalence of SMA type 1-4 and their severity in the Netherlands by registrating all patients in a so called SMA-database, to elucidate the genetic factors determining disease severity and to determine the value of SMN protein concentrations as a surrogate marker for clinical trials.

The main objective of this prospective population-based study of patients with proximal SMA in the Netherlands is to register SMA patients in the Netherlands in a socalled SMA-database to study prevalence and severity of SMA types 1-4, to perform…

Ammendment of protocol: Intravenous iron treatment in iron deficient patients with idiopathic pulmonary arterial hypertension. Title amendment: Skeletal muscle strength in healthy persons and patients with pulmonary hypertension

To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls

A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

Study to investigate the association between the response to a cholinergic challenge with galantamine and the clinical response to subsequent treatment with galantamine in patients with mild to moderate Alzheimer's Disease

We propose to conduct a study in patients with mild to moderate AD where a cholinergic challenge is given in a placebo-controlled, cross-over fashion, prior to onset of treatment with a CEI. Patients will be followed over a period of 6 months to…

CD4+ T cells and immune ageing; major players and predictors for disease activity in giant cell arteritis

Primary Objective: to study the differences in CD4+ T cell subsets (Th1/Th2/Th17/Tregulatory/Tsenescent) between GCA patients and healthy controls at diagnosis and during follow up and in remission. Secondary Objective(s): - To characterize the cell…

Study R-FACT
Risk factors for alloimmunization against red blood cell transfusions: a case cohort study

The aim of the project is to examine the association between clinical, environmental and genetic characteristics of the recipient of erythrocyte transfusions and the risk or resistance to immunization against erythrocyte alloantigens that he/she was…

Clinical comparison of the straight lateral approach and the anterior approach to the hip.

The objective of this project is to 1. increase accuracy and reproducibility of the most critical step in hip arthroplasty i.e. cup positioning;2. to alleviate one of the major complications of the straight lateral approach, i.e. abductor…

*Energetics in hypertrophic cardiomyopathy: translation between PET, MRI and cardiac myofilament function*

Within this project we aim to determine the energetic conditions that underlie the transition to hypertrophy of the HOCM heart. A prospective comparison will be made between results of PET, MRI and function of cardiac myofilaments (in vitro). Also,…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

Ventilator-Induced Diaphragm Dysfunction in ICU patients

PRIMARY OBJECTIVE1. To determine the contractile strength and the (ultra)structure of single diaphragm muscle fibers of mechanically ventilated patientsSECONDARY OBJECTIVE1. To determine whether diaphragm muscle fiber weakness is part of a…

Renal concentrating capacity and plasma AVP/copeptin levels during a water deprivation test in ADPKD patients versus healthy subjects and patients with chronic kidney disease.

Primary Objective: • To compare urinary concentrating capacity in ADPKD patients with healthy subjects and patient with IgA- or membranous glumerulopathy.Secondary Objectives:• To compare urinary concentrating capacity in ADPKD patients with an eGFR…

Anterograde amnesia with electroconvulsive therapy; severety and course; a prospective controled cohort study

This study aims at the questions about anterograde amnesia. How often does it occur in patients being treated with bilateral ECT for a depressive disorder, how does anterograde amnesia develop during the treatment course and how does it subside…

Muscle synergies in reaching movements of stroke patients

The aim of the current study is to identify couplings of muscle activation patterns (muscle synergies) in reaching movements in stroke patients. Insight in the motor control of stroke patients can contribute to improve the disabled arm functioning…

A single blind, randomized, cross-over placebo controlled dose finding study to investigate the pharmacokinetic profile of 3 doses of sublingual testosterone solution and their effect on physiological and subjective arousal in healthy, sexually functional premenopausal women.

Primary objectives:To establish the lowest effective dose using physiological and subjective measures of sexual arousal.To evaluate and compare the pharmacokinetics of testosterone and its metabolites following administration of three (3) doses (0.…

Visual processing in Autism-spectrum disorders

The main objective of the current study is to examine whether people with ASD have over-active inhibitory inter-connections in visual processing areas that can account for their over-sensitivity to perceptual dissimilarities.

Quantification of motor and sensory aspects of tonic dystonia

The objective of the present study is to obtain a better understanding of tonic dystonia by quantification of the motor and sensory characteristics of the condition, and to assess the relationship between both these parameters. Specifically, this…

Effort during listening: disentangling the contribution of auditory and cognitive functions to the
listening effort during speech comprehension.

This project examines their relative contribution using pupil dilatation and concentration cortisol and alpha amylase in saliva as objective measures of mental effort and questionnaires. Young and elderly normally hearing and hearing impaired…

Transfusion of fresh frozen plasma in non bleeding ICU patients

With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgoup of ICU patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs…

Effects of acute elevation of circulating fatty acids on hepatic lipid accumulation and metabolism in overweight and obese men with non-alcoholic fatty liver disease

The major research objective is:- To examine if acute exercise results in lower hepatic lipid content and further if elevation of plasma FFAs observed during recovery from exercise results in hepatic lipid accumulation.Additional research objective…