64 results
(1) To compare adenoma miss rates (AMR) between Endocuff Vision-assisted colonoscopy (EAC) and conventionalcolonoscopy (CC)(2) To compare adenoma detection rates (ADR) between EAC and CC(3) To assess whether a proposed increased ADR and reduced AMR…
We hypothesize that verapamil reduces progression from paroxysmal to persistent AF, improves rate control, exercise tolerance and quality of life and reduces costs compared to metoprolol.
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
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.
To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.
Objectives: 1) to evaluate the effectiveness of the e-CBT-i “i-Sleep” compared to a waiting list condition on sleep efficiency at 3, 6 and 12 months in ACC. 2) to assess the effects of eCBT-I on secondary outcomes: fatigue, quality of life, chronic…
IV sildenafil is superior to iNO for the treatment of pulmonary hypertension in CDH newborns and should be considered as the drug of first choice in the future
The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…
Primary objective: To determine the effect of obesity (BMI *35 kg/m2) on the pharmacokinetics, including oral bioavailability of fluconazole.Secondary objective: To develop an optimal dosing regimen for obese patients.
We plan to conduct a large, pragmatic, multicentre, randomised non-inferiority trial to determine whether the use of intraoperative dexamethasone, a widely used antiemetic in perioperative medicine, is associated with an unacceptable increased risk…
In this study, we want to demonstrate that MPP is no less effective than MPP plus XRT.
Primary Objective:The primary objective of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon IOL compared to historical SPE rates as reported in EN ISO 11979-7:2014.Secondary…
To compare the effect of radioactive Iodine or hemithyroidectomy on the symptoms and quality of life (QoL) of patients with a benign euthyroid goiter.
The aim of this study is to guide European PH-centers to become specialized centers for training in PH. This approach is in line with European PH-guidelines [12] which classified the exercise training in specialized centers with a closely monitored…
The purpose of our study is to test the augmenting effect and mechanisms of change of exercise provided directly before in total 12 CBT sessions.
Primary Objective:* To demonstrate the safety of intravenous (i.v.) iodinated iso-osmolar iodixanol (Visipaque* Injection 320 mgI/mL) usage in contrast-enhanced computed tomography (CECT) for CKD stage III/IV patients by evaluating the incidence of…
Primary Objective: To determine the subjective improvement of symptoms in women with SUI treated with PDMS (Urolastic®)Secondary Objectives: - To determine the patients* satisfaction- To determine the complications and re-intervention rate- To…
The purpose of the study is to evaluate changes in key clinical outcome measures (eg, motor, respiratory, fatigue) in adult subjects with late-onset Pompe disease (LOPD) receiving standard-of-care enzyme replacement therapy (ERT). Additionally,…
The primary objective is to establish the non-inferiority of treating a symptomatic urinary tract infection in patients with a long-term indwelling catheter for 5 days, as compared to the standard duration of 10 days of therapy. Secondary objectives…
The primary objective is to obtain post-market clinical data according to the requirements of the MEDDEV 2.21/2 in order to fulfil 18 post-market surveillance (PMS) obligations according to Section 3.1 of Annex II, 19 Section 3 of Annex IV, Section…