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NCT ID: NCT02654678 Not yet recruiting - Heart Failure Clinical Trials

Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

LENA-WP10
Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12 years of age at recruitment into the preceding short-term pharmacokinetic (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as acceptability and palatability assessments in children still under enalapril Orodispersible Minitablet (ODMT) treatment.

NCT ID: NCT02652741 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease

LENA-WP09
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

NCT ID: NCT02652728 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy

LENA-WP08
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age, suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

NCT ID: NCT02578355 Not yet recruiting - Clinical trials for Coronary Artery Disease

National Plaque Registry and Database

OPeRA
Start date: September 2016
Phase: N/A
Study type: Observational [Patient Registry]

The ultimate goal of this project is to develop a risk score to identify patients with vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome. Early identification of vulnerable plaques may have an enormous impact on public health through primary and secondary prevention of acute myocardial infarction. Investigators hypothesize that a risk score that incorporates non-invasive coronary CT imaging (calcium score and/or coronary CTA) in combination with clinical characteristics (classical risk prediction models) will improve the identification of patients who are at highest risk to suffer myocardial infarction or sudden cardiac death. The overall goal of the OPeRA project is to develop, implement and validate a novel risk assessment tool based on image markers and clinical characteristics to identify patients who are at increased risk to suffer myocardial infarction or sudden cardiac death.

NCT ID: NCT02550600 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Extracorporeal Lung Assist Device in Acute Lung Impairment

EXODUS
Start date: November 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effect of interventional Lung Assist iLA activve to standard therapy in mechanically ventilated patients with severe acute lung impairment. Hypothesis: iLA(active) reduces the incidence of an increase in SOFA-Score of ≥3 points (or death) within 28 days compared to standard treatment.

NCT ID: NCT01995721 Not yet recruiting - Clinical trials for Recurrent Respiratory Papillomatosis

4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

Start date: February 2014
Phase: Phase 3
Study type: Interventional

Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process. After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.

NCT ID: NCT01258725 Not yet recruiting - Clinical trials for Severe Oligohydramnios

Alterations of the Uteroplacental and Fetal Pulmonary Circulation Following Amnioinfusion

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The aim of this study is to compare the uteroplacental and pulmonary circulation of the fetuses with severe (AFI<5cm) idiopathic oligohydramnios (with unknown origin) to those in normal controls. Further purpose of the study is to measure the changes of the uteroplacental and fetal pulmonary circulation in patients presenting with severe idiopathic oligohydramnios, managed either with single amnioinfusion or with serial amnioinfusions.