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The social impact of living with burn scars

The aim of this study is to examine how many persons with burns experience problems in different social areas, and which factors prospectively impact on functioning. Predictors that will be investigated in this population relate to invalidation,…

Multidisciplinary step in the prediction and primary prevention of preterm birth

The aim of this study is to study risk factors (in the field of public health and occupation as well as medical technical factors) to enable early detection of pregnant women at increased risk and to integrate these risk factors in a risk prognostic…

S-1 versus capecitabine in the first line treatment of metastatic colorectal cancer patients, the SALTO randomised phase III study of the Dutch Colorectal Cancer Group. A safety evaluation of oral fluoropyrimidines.

The primary objective is to determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. Secondary objectives include a comparison of efficacy.

Preservation of metabolic flexibility by acetylcarnitine formation

To test the hypothesis that metabolic inflexibility in pre-diabetic subjects and diabetic patients is due to a reduced capacity to form acetylcarnitines: We aim to investigate whether glucose intolerant subjects have a lower capacity to form acetyl-…

AN OPEN-LABEL, MULTICENTRE, DOSE-ESCALATION, PHASE I STUDY WITH AN EXPANSION PHASE, TO EVALUATE SAFETY, PHARMACOKINETICS AND THERAPEUTIC ACTIVITY OF RO6895882, AN IMMUNOCYTOKINE, CONSISTING OF A VARIANT OF INTERLEUKIN-2 (IL-2v) TARGETING CARCINOEMBRYONIC ANTIGEN (CEA) ADMINISTERED INTRAVENOUSLY, IN PATIENTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS.

* to describe the safety profile for qW, q2W and q3W regimens. * to determine the Maximum Tolerated Dose (MTD), if achieved (all regimens)* to describe the pharmacokinetics (PK) of single-agent RO6895882. Substudy BP28920/IMGThe study is designed to…

Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)

Effect on bone mineral density.

The effect of individualized NUTritional counselling on muscle mass and treatment outcome in patients with metastatic COLOrectal cancer undergoing chemotherapy: the COLONUT study

To study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first-line chemotherapy. Secondary, effect on total lean body mass,…

Symptomatic treatment of vascular cognitive impairment

Primary Objective: To study the change on performance on executive function and memory function (as measured on Neurocart), after an active challenge with methylphenidate (monoaminergic) and galantamine (cholinergic), compared to placebo, in…

Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to surgical treatment of peri-implantitis; a single blind randomized controlled study

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plusmetronidazole therapy in conjunction with surgical treatment of peri-implantitis. The secondary objective is toassess the…

Detection of cardiac fibrosis by LGE MRI and circulating biomarkers in patients with myocardial infarction.

The primary objective of this study is to investigate whether circulating fibrotic biomarkers are related to the amount of cardiac fibrosis as determined by MRI in patients. Secondarily, this study aims to investigate whether these biomarkers are…

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation- Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)

Primary: to evaluate the effect of everolimus with reduced exposure CNI versus MPA with standard exposure CNI on the binary composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50mL/min/1.73m2 at Month 12 post-transplantation.…

GLOBAL LEADERS: Comparative effectiveness of 1 month of ticagrelor plus aspirin followed by ticagrelor monotherapy versus a current-day intensive dual antiplatelet therapy in all-comers patients undergoing percutaneous coronary intervention with bivalirudin and BioMatrix family drug-eluting stent use.

To determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor…

Watchful waiting in patients with good and intermediate risk metastatic renal cell carcinoma; an imaging guided observational approach

ObjectivesPrimary objective: To assess the added value of FDG-PET and 89Zr-Girentuximab-PET results measured at presentation to predict time to progression under watchful waiting in patients with good or intermediate prognosis mccRCC who are…

Comparison between two surgical methods in the treatment of anterior chronic compartment syndrome: a patient blinded, randomized study.

To compare two surgical techniques in the treatment of patients with a anterior CECS.Surgical method 1: use of conventional *Due* fasciotome Surgical method 2: use of the new *Fasciomax©* in stead of the *Due*-fasciotome.

Steroid Treatment Effect in Pulmonary Sarcoidosis

Against this background, we aim to describe response to corticosteroid therapy and tapering in a cohort of newly treated pulmonary sarcoidosis patients, using a hand-held spirometer and patient reported complaints. Results of this pilot-study will…

Use of lung mechanics to identify the optimal level of positive end-expiratory pressure in mechanically ventilated children with acute lung injury: a pilot study

The primary objective is to study the level and time course of the end-expiratory lung volume during the individual incremental * decremental PEEP titration; the secondary objective is to study if there is a significant association between the end-…

Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson*s disease: a multi-center placebo-controlled trial (CHEVAL)

investigate whether early treatment with ChEI delays the progression of minor VH to major VH without insight or PDP. In addition, we will measure motor control, psychotic symptoms, cognitive impairment, mood disorders, adverse events and compliance…

A Double-Blind, Randomized, Phase III Trial of the Safety and Efficacy of CPP-1X/Sulindac Compared with CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)

The primary objective of this trial is to determine whether the combination of CPP-1X + sulindac is superior to either treatment individually, sulindac alone or CPP-1X alone, in delaying time to the first occurrence of any FAP-related event in the…

Prevent CardioKids

The aim of Prevent CardioKids is to evaluate to what extend disturbed vascular function markers are present in children of different weight categories and whether these are age dependent. Also differences * and relationships between * vascular…