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SIMILAR Trial: Santeon InflixMab biosimILAr Research
A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission

The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…

BIOFLOW-V: BIOTRONIK * A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions * V

To assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent…

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an
All COmeRs PopulaTion (BIO-RESORT): Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

The aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all…

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 randomized, multicenter Study to evaluate the Effect of secukinumab 300 mg s.c. administered during 52 Weeks to patients suffering from new-onset moderate to severe plaque Psoriasis as early Intervention compared to standard treatment with narrow band UVB (STEPin study)

The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…

Closure after small skin incisions and excisions with a new closing system

compare the SoClose system with traditional skin wound closure with intracutaneous suturs of small skin excision on: cosmetics, wound healing, closing time, patient comfort and costs.

Preventing contrAst induced Nephropathy after TranscathEter aortic valve Replacement

To evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline hydration prior to TAVI in patients with CKD to prevent CIN.

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…

Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…

A randomised clinical trial evaluating the effect of remifentanil vs fentanyl
during cardiac surgery on the incidence of chronic thoracic pain.

The primary objective of this study is to determine the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic pain one year after cardiac surgery. The secondary objectives are to…

Urolastic® versus Bulkamid® in treatment of female stress incontinence: randomized controlled trial.

Subjective cure of urinary stress incontinence at 12 months after intervention and comparison of a new bulking agent Urolastic ® with Bulkamid® in the treatment of stress urinary incontinence. Our hypothesis: based on our study and literature…

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.

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…

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.…

Fixed versus variable dosing strategy of prothrombin complex concentrate for bleeding complications of vitamin K antagonists

To test whether the clinical outcome of lower fixed dose of PCC is superior to higher variable dose of PCC, for VKA related bleeding in a randomized setting. Secondary objectives include the comparison of INR after administration of PCC, time to…

Bandolera trial: The 'Banded' Gastric Bypass

To research in three groups whether there is a significant difference between RYGB and BRYGB patients.

Immunological effect of early extra MMR immunization in infants between 6 and 12 months of age in an outbreak setting

Main: To assess the effect of an early extra measles immunization between 6and 12 months of age on the development of humoral and cell-mediatedimmunity against measles following routine MMR immunization at 14months of age.Secundary:Determine effect…

The effects of hyperoxia on organ dysfunction and outcome in critically ill patients with SIRS

1. To study the short- and long-term effect of different target PaO2's on circulatory status, organ dysfunction and outcome.2. To study underlying mechanisms of hyperoxia by determining differences in oxidative stress response between the…

BIOTRONIK- *A Prospective, Randomized, Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Stent in the Treatment Of Subjects With up to two de novo Coronary Artery Lesions* - IV

To evaluate the safety and effectiveness of Orsiro for the treatment of subjects with up to 2 de novo atherosclerotic coronary artery lesions.

Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation target

To assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.