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TropicALL study; Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with
Low-molecular-weight heparin: a randomized controlled trial

Main objective:To assess the efficacy of thromboprophylaxis with high prophylactic dose LMWH as compared with standard care without systemic thromboprophylaxis in children treated for primary ALL during asparaginase treatment.Secondary objectives:1…

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

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DIAN-TU-001 A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multicenter Study of Potential Disease Modifying Therapies in Individuals at Risk for and with Dominantly Inherited Alzheimer*s Disease

To assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer*s disease-causing mutation by determining if treatment with the study drug slows the rate of progression…

Effectiveness of penfluridol (oral long acting neuroleptic) as compared to second generation oral neuroleptics in psychotic disorder patients: an open label randomized controlled trial.

Primary Objective: The aim of this study is to determine the time to all-cause discontinuation of penfluridol (acemap; oral long acting neuroleptic) as compared to second-generation oral neuroleptics (olanzapine, risperidone) using an open label…

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…

TimeToStop (TTS) Trial, A randomized controlled trial of cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery

Primary Objective: To assess whether early postoperative AED withdrawal improves cognitive function compared to late withdrawal.Secondary objectives: * To confirm safety of earlier AED withdrawal; we will assess eventual seizure freedom, seizure…

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…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…

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 2 Multicenter, Investigator-blind, Subject-blind, Placebo-controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects with Moderate to Severe Hidradenitis Suppurativa

Primary objectiveThe primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe HS.Secondary objectiveThe secondary objective of this study is to assess the safety, tolerability, immunogenicity,…

A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.

Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the compositeendpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients withCHF (NYHA class II-IV) and reduced…

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…

Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients

Primary Objective To compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice over 6 months following de novo renal transplantation in a real-life setting in different European Countries.…

Effects of an afternoon stroll under different light conditions on alertness, sleep quality and -perception

To investigate whether three hours of consecutive daylight and activity can affect alertness and improve night-time objective and subjective sleep.

SUCCESS STUDY; Smoking reduction by a smoking cessation strategy in the national cervical cancer screening program

We hypothesize that a smoking cessation strategy for smoking cervical cancer screening participants will increase their motivation to quit and will lead to an increased proportion of smokers performing a serious quit attempt. Eventually this will…

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.