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TRICS-III: Transfusion Requirements in Cardiac Surgery. An international, multi-centre, randomized controlled trial to assess transfusion thresholds in patients undergoing cardiac surgery

A lower hemoglobin concentration for red cell transfusion (restrictive transfusion strategy) will be non-inferior to a liberal strategy in terms of vital organ function (heart, brain and kidney) and mortality.

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

Neural substrates of anticipatory food reward in healthy males and cancer survivors, investigated with fMRI.

Investigating the neural mechanisms underlying the anticipation of food reward induced by visual cues related to different foodcharacteristics in healthy males would provide 1) brain activity patterns that can be associated with the anticipation of…

A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis

Voor meer informatie verwijs ik u naar sectie 2 in het protocol

Effects of oral riboflavin supplementation on the growth of Faecalibacterium prausnitzii and the impact on the gut microbiota: A randomized, double-blind, placebo-controlled human intervention trial.

In this trial we now aim to investigate comprehensively the effect of riboflavin supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota in faeces of healthy volunteers. Additionally we will assess whether…

What is the most optimal treatment strategy for an adolescent with knee complaints?

What is the most optimal treatment strategy for children / adolescents with knee complaints? Our hypothesis is (based on the invasive surgical procedure) patients that will be surgical treated (index group) have a clinical relevant gain of pain…

RANDOMIZED PHASE 2 TRIAL COMPARING EXPERIMENTAL IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 S.C.,GM-CSF) IN RECURRENT HIGH RISK NEUROBLASTOMA PATIENTS WITH STANDARD IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 I.V., GM-CSF) IN PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED HIGH RISK NEUROBLASTOMA

Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors.

Primary Objective:To compare the efficacy of BMS-986142 versus placebo on a background of MTX as assessed by ACR20 and ACR70 response rates at week 12.Secondary Objectives:1) Assess additional efficacy outcomes of BMS-986142 at week 12 and over 12…

A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB* (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES

Primary Objectives* Phase 1b lead-in: To assess safety and tolerability of a single dose level of avelumab in combination withincreasing dose levels of other immune modulators in combination with a single doselevel of avelumab in patients with…

The role of beta (20 Hz) oscillations in learning during uncertainty:
A transcranial alternating current stimulation study

To investigate the direct role of local beta oscillatory activity in the frontal cortex during a reversal learning paradigm.

A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS

* To assess maintenance of biochemical control of octreotide capsules compared to parenteral SRLs in patients with acromegaly, who previouslydemonstrated biochemical control on both treatments.* To assess symptomatic response to octreotide capsules…

US-guided Percutaneous needle tenotomy and Physiotherapy in Patients with Lateral Epicondalgia: A single blinded Randomized Controlled Trial

Primary Objective: To study the effect of PNT and structured physiotherapy on function and pain of patients with lateral epicondylalgia.Secondary Objectives: To study the effect of PNT and structured physiotherapy on quality of life, patient…

A twenty-six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transition to Toujeo compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with six month extension.

To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.

A Phase 1 Pharmacokinetic-Pharmacodynamic Study of Avelumab (MSB00100718C) in Patients with Previously Treated Advanced Stage Classical Hodgkin*s Lymphoma

Primary Objective* To characterize the pharmacokinetics (PK) of different dosing regimens of avelumab and its relation to target occupancy (TO) in peripheral blood of patients with classical Hodgkin*s Lymphoma (cHL).Secondary Objectives* To evaluate…

Performance of bioresorbarble scaffold in primary percutaneous intervention of ST elevation myocardial infarct

Study goal is to compare the performance of the Absorb bioresorbable scaffold with a metallic drug eltuting stent in the STEMI patient.

The Nausea Care App in patients receiving chemotherapy: A Randomized Controlled Trial

Primary objective of this study is to determine whether there are differences in occurrence of nausea, vomiting, use of escape medication, and in quality of life between smartphone-owners who downloaded the App, and smartphone-owners who did not use…

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

1. To determine the efficacy of QPI-1002 to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of a donation after brain death (DBD) older donor kidney.2. To assess the safety and tolerability of QPI-…

A two-stage, controlled, open-label, dose-ascending first-in-man study to assess the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine

To evaluate the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine in healthy adults.

Low volume high-intensity resistance training in type 2 diabetes: effects on glycemic control.

Primary Objective: (1) To study the efficacy of low volume high-intensity resistance training for improving glycemic control in patients with T2DM. Secondary Objectives: (2) To study the feasibility of low volume high-intensity resistance training…

Sleeve Gastrectomy and the Influence of Concomitant Hiatal Hernia Repair

To define the exact effect of LSG with and without concomitant HH repair on the prevalence of GERD and GERD-related symptoms in obese patients who are intraoperatively diagnosed with a small HH. Furthermore, to examine the effect of LSG on the…