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A multi-centre, double-blind, parallel-group, randomised controlled study to investigate efficacy, safety and tolerability of orally administered BI 409306 during a 12-week treatment period compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

The primary objective of this study is to assess efficacy and safety of BI 409306 at doses of 10 mg, 25 mg and 50 mg once daily, 25 mg twice daily compared to placebo over a 12-week treatment period in patients with the following criteria: mild…

Levosimendan in Acute Kidney Injury Study

The objective of this study is to investigate whether Levosimendan is able to lower creatinine levels as a measure of kidney failure and if urinary output can be increased.

Multi-center, Randomized, Open-label, Parallel-arm, Single-dose, Pharmacokinetic Study of rVIIa-FP (CSL689) in Subjects with Congenital Factor VII Deficiency

- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689

A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

To determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib and subjects not on other treatment for IPF.

A phase I trial of actively personalized peptide vaccinations plus immunomodulators in patients with newly diagnosed glioblastoma concurrent to first line temozolomide maintenance therapy

Primary objective of this study is to assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB) patients.Secondary study…

A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…

The efficacy of the walk-bike on quality of life and exercise capacity in patients with idiopathic pulmonary fibrosis: a pilot study.

Primary objective• To assess the effect of use of a walk-bike in IPF patients for 8 weeks on health-related quality of life, measured with the St. George Respiratory Questionnaire, at baseline, week 9 and week 18, in patients with IPF.Secondary…

Vitamin Deficiencies and Supplementation in Morbidly obese

The main objective is to optimize the supplementation of vitamins and minerals to prevent postoperative deficiencies after MB / RYGB or GS on the long term. We also examined whether the number of outpatient visits, blood tests, and costs can be…

A single center, randomized, open-label, cross-over exploratory study to evaluate the pharmacodynamic and pharmacokinetic response to a subcutaneous administration or oral administration of furosemide in subjects presenting with chronic fluid overload

Primary Objective • To assess the effects of 80mg of furosemide delivered by subcutaneous delivery in the abdominal area over 5 hours when compared to oral administration in patients with heart failure with chronic fluid overload. Secondary…

A two part, phase 1, randomised, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of GBR 830 in adult healthy volunteers (Part 1) and a randomised, placebo-controlled, pharmacodynamic study to evaluate the effect of single dose of GBR 830 on vaccination response in adult, healthy volunteers (Part 2)

The purpose of this study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics) and to what extent the…

A Phase 2, randomized, open-label, multicenter study to assess safety and efficacy of nab®-paclitaxel
(ABI-007) with epigenetic modifying therapy of CC-486, and nab®-paclitaxel
monotherapy as second-line treatment in subjects with advanced nonsquamous non-small cell
lung cancer (NSCLC): ABOUND.2L

To assess the efficacy of nab-paclitaxel administered intravenously (IV) on Days 8and 15 with epigenetic modifying therapy of CC-486 once daily (QD) on Days 1 to14 every 21 days, and nab-paclitaxel monotherapy administered IV on Days 1 and 8every 21…

EuroSkinGraft - Novomaix phase II
A phase 2, intra-patient randomised controlled multicentre international study to evaluate the efficacy of an acellular dermal template Novomaix for the treatment of full thickness skin defects.

To test an acellular dermal template (Novomaix) in human patients in need of full thickness skin defect coverage and to compare the results with those obtained after conventional STSG. The main goals are to study the efficacy and scar quality after…

Mindfulness training versus treatment as usual in adults with attention deficit hyperactivity disorder (ADHD)

To examine the (cost)effectiveness of mindfulness versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD).

Op Volle Kracht: An intervention to increase emotional resilience among youth in residential treatment centers

Main: 1. To investigate whether a short term CBT-based group program is more effective in reducing symptoms of depression and anxiety than treatment as usual (TAU), among adolescents aged 10-16 within residential treatment settings in the youth…

Improving CNS penetration of radiolabeled TKI PET tracers through PgP/BCRP inhibition

The primary objective of this study is to obtain clinical proof of principle that the addition of a PgP/BCRP inhibitor increases CNS concentrations of tyrosine kinase inhibitors by inhibition of drug efflux transporter function in the blood brain…

Safety and Efficacy of the Self Sizing Radiofrequency ablation balloon for eradication of Barrett's esophagus: an uncontrolled multicenter feasibility study

The aim of the study is to assess the efficacy and safety of the self-sizing RFA ballon for eradication of Barrett's mucosa with low-grade, high-grade and early neoplasia

The effect of pulse rate on temporal resolution and speech intelligibility in cochlear implant users

To determine the (in)direct effect of CI pulse rate on speech intelligibility by means of (1) a standard test for temporal resolution: amplitude modulation detection (AMD) at two different modulation frequencies, (2) speech intelligibility tests (…

A MULTICENTER, POSTMARKETING STUDY TO EVALUATE
THE CONCENTRATION OF CERTOLIZUMAB PEGOL IN THE
BREAST MILK OF MOTHERS RECEIVING TREATMENT WITH
CIMZIA® (CERTOLIZUMAB PEGOL)
PHASE 1B (CLINICAL PHARMACOLOGY)

The primary objectives of this study are to assess whether there is transfer of CZP into breastmilk of lactating mothers who are receiving an established dosing regimen of CZP by evaluatingthe concentration of CZP in mature breast milk, and to…

Efficacy of a skin barrier repair cream (Dermalex Eczema) in atopic dermatitis patients

The primary objective of this study is to compare the therapeutic effect on atopic dermatitis of a skin barrier repair cream (Dermalex eczema) in contrast to a standard used emollient (unguentum leniens FNA) and a dermatocorticoid (hydrocortisone)…

PVAI alone vs. PVAI plus ablation of complex fractionated atrial electrograms in a specific area of the left atrium in patients suffering from (longstanding) persistent atrial fibrillation.

The aim of this study is to determine if adding ablation restricted to specific areas of the left atrium to PVAI is superior to the standard care PVAI alone.