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A 24-week, multicenter, international, randomized (1:1), parallel-group, open-label, comparative study of insulin glargine versus liraglutide in insulin-naïve patients with Type 2 diabetes treated with oral agents and not adequately controlled, followed by a 24-week extension period with insulin glargine for patients not adequately controlled with liraglutide

The primary objective of this study is to demonstrate the superiority of insulin glargine over liraglutide in termsof percentage of patients reaching a HbA1c < 7% at the end of the comparative period in Type 2 diabetic patientsfailing…

A prospective patient registry for bonegraft substitutes in spinal fusion

To identify the patient profile for Actifuse and for other grafting products used to achieve bone fusion.

Long term prospective observational cohort study of the safety and efficacy of golimumab in the daily clinical practice of rheumatoid arthritis with emphasis on the lipid profile

To determinate the efficacy and safety of golimumab in rheumatoid arthritis patients in daily clinical practice during 48 months. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study.

Ventricular Tachycardia Ablation vs. ENhanced Drug Therapy In Structural Heart Disease

To compare aggressive antiarrhythmic drug therapy to catheter ablation (ablation) for ventricular tachycardia (VT) in patients who have suffered prior myocardial infarction.

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL
EVALUATING THE SAFETY AND EFFICACY OF EARLY TREATMENT WITH
EPLERENONE IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION

To assess the impact of eplerenone on cardiovascularmortality and morbidity in patients with acutemyocardial infarction (STEMI) when initiated withinthe first 24 hours of onset of symptoms (preferablyduring the first 12 hours)To investigate the…

Prospective, pharmacokinetic study for determination of the relationship between lean body weight and anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin in morbidly obese patients after bariatric surgery.

Primary objective: prospective evaluation of the relationship between lean body weight and anti-Xa activity of 5700 IU nadroparin 4 hours after subcutaneous administration in morbidly obese patients.Secundary objectives: - Correlation between other…

Treatment of resistant hypertension using a radiofrequency percutaneous transluminal angioplasty Catheter (POST MARKET APPROVAL SURVEILLANCE STUDY)

Aim of the study is to study a new therapeutic option for the treatment of hypertension

An exploratory, open label, single-arm study to evaluate the effect of Eligard® 6-month on biomarkers of disease in patients with metastatic prostate cancer

To explore the effect of Eligard® on the following prostate cancer biomarkers:• Testosterone in serum• Prostate Specific Antigen (PSA) in serum• Prostate Cancer Antigen (PCA3 score) in urine • PSA mRNA in blood/PBMC• PCA3 mRNA in blood/PBMC• TMPRSS2…

DD-study: diet or diuretics for salt-sensitivity in chronic kidney disease

Primary objective: To compare the anti-hypertensive response to dietary salt restriction with the anti-hypertensive response to the diuretics hydrochlorothiazide/amiloride in patients with CKD stages 3 or 4. Secondary objectives: * To analyze the…

Left Ventricular Thrombus Formation after Acute Myocardial Infarction - a randomized multi-center trial comparing 2 different anti-thrombotic regimens

The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation

A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF)

The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…

A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 mcg o.d.) vs tiotropium (18 mcg o.d.) + salmeterol/fluticasone propionate FDC (50/500 mcg b.i.d.) in patients with moderate to severe COPD

The purpose of this study is to determine whether the efficacy and safetyof QVA149 (110/50 *g o.d.) and triple treatment with tiotropium (18 *go.d.) + salmeterol/fluticasone propionate FDC (50/500 *g b.i.d.) arecomparable in patients with moderate…

Median Local Anaesthetic Dose (MLAD) of intrathecal Bupivacaine in primary total knee arthroplasty

The objective of this study is to find the Median Local Anaesthetic Dose (MLAD/ED50) of Bupivacaine that allow direct postoperative mobilization and will accommodate sufficient anaesthesia during surgery.Results of this study might lead to…

Markers of Efficacy of Xolair (Omalizumab) in Chronic Spontaneous Urticaria

To relate the reduction of inflammatory characteristics in skin and in peripheral blood to clinical efficacy in patients with CSU. Major focusses of this study are the (early) effects on basophils and other Fc*RI-bearing leukocytes before, during,…

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima* (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn*s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…

Multimodal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism* a randomised placebo controlled Trial

Main objective: To test the efficacy of thyroxine replacement for subclinical hypothyroidism (SCH) in older adults. Primary Objective: To determine multi-modal effects (quality of life; cognitive; musculoskeletal and cardiovascular) of levo-…

perioperative intravenous insulin, GIK and GLP-1 treatment in diabetes mellitus

This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion, insulin bolus regimen and…

Assessing and predicting functional and quality of life-related outcomes of islet and pancreatic transplantation in patients with type 1 diabetes mellitus

There are two objectives for this study: first, to find specific serum beta cell damage markers that can serve as a clinical predictive tool for beta cell allograft loss. Second, to compare quality of life and diabetes-related outcomes in patients…

Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for Treatment of In-Stent Restenosis in the Superficial Femoral Artery.

To evaluate the post-market performance of the GORE® VIABAHN® Endoprosthesis for the treatment of in-stent restenosis in the superficial femoral artery.

FDC116115: A prospective study of sexual function in sexually active men treated for BPH

Primary: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with Combodart, compared to placebo. Secondary: changes in sexual function during 1st 9 months of the study,…