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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…

The role of corticosteroids on coagulation and inflammation in asthma

Primary objective:- To evaluate the effects of a 10 day-course of prednisolon on coagulation and fibrinolysis parameters in patients with mild-moderate astma, patients with severe asthma, and healthy controls.Secondary objectives:- To compare the…

Study of the effectiveness of a coping self-help intervention for women in the waiting period after an embryo transfer during an IVF/ICSI treatment

To investigate if a short copingintervention reduces anxiety in patients undergoing an IVF or ICSI treatment in the UMCU during the waitingperiod after an embryotransfer.

Evaluation of an intervention to decrease the need for recovery in office employees by increasing daily physical activity and relaxation at work.

The aim of this study is to evaluate an intervention program consisting of group motivational interviewing (GMI), supported by a social media platform, and/or environmental modifications, to decrease the need for recovery in office employees by…

A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreichâ¤*s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…

The effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers

To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.

The effect of Local Infiltration Analgesia on postoperative pain in Total Knee Arthroplastia

Reduction of the postoperative pain in Total Knee Arthroplatia through the use of a peri- and intracticular injection of Local Infiltration Analgesia.

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.

The effectiveness of a microscope during apical surgery; a prospective randomized controlled blinded clinical trial.

The objective of this study is to assess whether or not apical surgery that is carried out with the help of a microscope has a higher success rate than apical surgery without the use of a microscope. No RCT is found in present literature (Del Fabbro…

Sweet and Salt preferences in children that started weaning exclusively with fruit or with vegetables.

Objective: The main objective is to test the preference for sweet and saltwater solutions in infants that started weaning exclusively with fruit or with vegetables. Acceptance of sweet and salt intensity is compared between the fruit and vegetable…

The effectiveness and evaluation of the online 'Kanker Herstel Hulp' intervention in cancer survivors.

The project primarily aims to study short (3 and 6 months) and long term (12 months) health related effects of the 'Kanker Nazorg Wijzer' on survivors' psychosocial distress and quality of life (QoL). Furthermore, process aspects of…

Effects of a nurse coordinated program of lifestyle improvement aimed at reducing the risk of recurrent cardiovascular events in patients who have suffered an acute coronary syndrome.;RESPONSE2: (Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2)

Primary Objective: To determine the effectiveness of a comprehensive lifestyle intervention program aimed at reducing the risk of recurrent cardiovascular events in patients who have suffered an acute coronary syndrome.Secondary Objective:…

MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma (MEA115575)

Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.

Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor

In this phase II study, the toxicity and treatment effects of early donor derived CD4+ lymphocyte infusion, three months after allo-SCT, will be evaluated

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Pain from Osteoarthritis of the Knee

The primary objective for this study is to compare the safety, tolerability and analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of 2 doses to placebo in subjects with pain due to osteoarthritis (OA…

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

The primary objective of this study is to compare the overall survival (OS) distributions between LY2157299 monohydrate plus lomustine therapy with lomustine plus placebo therapy (control arm), in patients who have relapsed or have progressive GB…

RAndomized comParison between the STENTYS self-aPpOSIng Sirolimus-eluting Coronary STent and a balloon-expandable stent In AcuTe MyocardIal InfarctiON

The objective of this study is to evaluate whether two different stent technologies (a self-expandable stent and a balloon-expandable stent) may be associated with different stent strut apposition and a variety of stent strut coverage with…

A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…

A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures.

To determine the efficacy and the safety of PREOB, a proprietary population of autologous bone-forming cells, in the treatment of non-infected hypotrophic non-union fractures of long bones.

Evaluation of the Origo prototype for enhancing women*s labor & delivery experience. A pilot study.

The objective of this study is to gain insights into the value of the proposition *Origo* for women and their loved ones, medical staff and care institution.