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Adrenaline use in local infiltration analgesia during TKA;Randomized, double blind, controlled study

The goal of the pilot study is to compare LIA with or without adrenaline infiltration by means of post operative pain (VAS) scores, PONV, early mobilisation and early discharge criteria.

The effect of exenatide compared to insulin glargine on cardiac function and metabolism in type 2 diabetic patients with congestive heart failure: a randomized-controlled trial

In this study we will assess the effects of exenatide on cardiac metabolism and function in patients with T2DM and CHF. We will address the following hypothesis: exenatide improves global cardiac function in CHF patients with T2DM, by favorable…

A randomized controlled trial on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth

In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…

Morphine versus piritramide (Dipidolor??) in postoperative analgesia. Time of onset of analgesia and incidence of postoperatieve nausea and vomiting after intravenous injecttion. A comparison.

The investigation of differences between morphine and piritramide concerning the incidence of postoperative nausea and vomiting and the time of onset of adequate analgesia.

Epifysiodesis for adolescents; What is the most effective postoperative pain treatment? An RCT

What is the effectiveness of an epidural painmanagement compared with a PCA method as postoperative treatment after an epiphysiodesis for adolescents during the first 5 days after the procedure?

INCH-trial: A multicenter randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional-hernia repair.

The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life.…

Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes - the ADREM study

To examine the effect of two different degludec dose adjustments on glucose profiles and the incidence of (nocturnal) hypoglycaemia after oxidative exercise in people with DM1 at elevated risk of hypoglycaemia.

A prospective, randomized, international, multicenter, double-arm, controlled, open label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal.

The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…

Comparison of subcutaneous and intravenous retreatment with ultra-low dose rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial

The aim of this study is to investigate non-inferiority of rituximab SC 336 mg to rituximab IV 200 mg.

(Cost-)Effectiveness of local corticosteroid injection versus exercise therapy for shoulder complaints: a pragmatic randomized, 12 months comparative parallel-group trial

We will evaluate the clinical and cost-effectiveness of the two guideline recommended treatments for patients with persisting shoulder pain over a 12 month time period. Patients will be randomized to a local corticosteroid injection or referral for…

A Prospective, Randomized, Multi-center Study to Assess the SaFety of the Orsiro Mission Stent compared to the ResoLute Onyx Stent in Subjects at High Risk for Bleeding in combination With 1-month Dual Antiplatelet Therapy (DAPT).

To assess the safety of the Orsiro Mission Stent System in subjects at high bleeding risk (HBR) undergoing PCI followed by 30-days Dual Antiplatelet Therapy (DAPT).

Comparing effectiveness and safety of Left Atrial Appendage Occlusion for non-valvular Atrial Fibrillation patients at high stroke risk unable to use oral anticoagulation therapy

Study the effectiveness and safety of LAAO in non-valvular AF patients at high stroke risk unable to use OAC

An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) after Discharge in Participants with Chronic Kidney Disease treated for Hyperkalaemia

Main: To evaluate the efficacy of continuing SZC as part of the discharge medications, compared to SoC, in maintaining NK Secondary:To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC:1. in reducing the…

Migration and kinematics of the new Persona PS versus the proven NexGen LPS knee - a randomized controlled trial using radiostereometric analysis, fluoroscopy and gait

The objective of this study is to accurately assess and compare migration, kinematics, gait analysis, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent…

Monitoring the effect of oral anticoagulants during cardiac catheterisation

1) to investigate if patients on chronic NOAC treatment are sufficiently anticoagulated without additional UFH during CAG/PCI, and 2) if this sufficient anticoagulation can be confirmed pre-procedure by a point-of-care test, and3) to investigate if…

The POWER-PLUS study - Very high power ablation in patients with atrial fibrillation scheduled for a first pulmonary vein isolation

This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided PVI (35W/50W) versus very high power radiofrequency delivery (90W) in AF patients scheduled for a first PVI.

The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium
Bromide/Vilanterol in a Single Inhaler (TRELEGY ELLIPTA) when Compared
with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual
Care Setting.(study 206854)

Primary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT for the impact of COPDon wellbeing and daily life after 24 weeks* treatment. Secondary:To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT on lung…

A Randomized Clinical Trial of Andexanet Alfa in acute intracranial haemorrhage in patients receiving an oral factor Xa inhibitor

In oral FXa inhibitor-treated patients with acute intracerebral bleeding, the objectives of this study are as follows:Primary Efficacy Objective:To evaluate the effect of andexanet versus usual care on the rate of effective hemostasis.Secondary…

Prospective monitoring of immune response following COVID-19 vaccination in children with cancer

PRIMARY OBJECTIVE: -To assess the antibody response after mRNA (Pfizer, Moderna) SARS-CoV-2 vaccination in children with cancerSECONDARY OBJECTIVES:To assess in children with cancer after SARS-CoV 2 vaccination:- durability of the antibody response…

Comparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial

The main aim is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours after trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and ARDS) within 30 days (combined…