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DALI: Vitamin D and Lifestyle Intervention for GDM Prevention: dosing study

The overall aim of the DALI study is to identify the best available measures to prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of GDM prevention for health care systems, and to establish a pan-European cohort of mother-…

An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent (NEMO).

The aim of the trial is to obtain data on the optimal dose, feasibility and pharmacokinetics of bumetanide when given as an add-on treatment for seizures in full term babies with hypoxic ischemic encephalopathy (HIE). Bumetanide will be given in a…

DALI: Lifestyle pilot

The overall aim of the DALI study is to identify the best available measures to prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of GDM prevention for health care systems, and to establish a pan-European cohort of mother-…

Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy.

Our aim is to determine a Pharmacokinetic/Pharmacodynamic (PkPd) based dosing model for nicardipine used for treatment of severe hypertension in preeclamptic patients. The model is based upon determination of maternal, fetal and neonatal plasma…

Adult mesenchymal stromal cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stromal cells IntraNasally)

This study will investigate whether bone marrow-derived allogeneic MSCs, as administered by the nasal route, can induce the formation of neuronal tissue and restore brain function in neonates who suffered from perinatal arterial ischemic stroke (…

Remote ischemic preconditioning for pain management in labour: a randomized controlled pilot study.

Reduce the need for other analgesia after RIPC by investigating the efficacy of remote ischemic preconditioning on pain during labour.

A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and
Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe
Hemolytic Disease of the Fetus and Newborn (HDFN)

Primary Objectives: - To evaluate the safety in mother and neonate/infant of nipocalimab administered to pregnant women at high risk for EOS-HDFN. - To evaluate the efficacy of nipocalimab as measured by proportion of patients with live birth at or…

Adult mesenchymal stromal cells to regenerate the neonatal brain: the PASSIoN trial (Perinatal Arterial Stroke treated with Stromal cells IntraNasally)

This study will assess safety and feasibility of bone marrow-derived allogeneic MSCs, as administered by the nasal route, in neonates who suffered from PAIS. The ultimate goals of the present study is therefore to develop a therapy using adult human…

A Phase I/II, Open Label, Proof of Concept Study to investigate Tolerability and Safety of Treatment with Recombinant Human C1 Inhibitor (conestat alfa) in Patients with Preeclampsia.

Primary: To evaluate the tolerability and safety of the treatment with rhC1INH (conestat alfa) on top of Standard Care, for patients with pre-eclampsia.Secondary: To evaluate the efficacy of treatment with rhC1INH (conestat alfa) on top of Standard…

Validating and realising a clinically tested A-EMDR application for postpartum traumas

The main objectives are to investigate whether our product is suitable for the target group, to identify barriers to wider implementation in mainstream care, and to gather patient experience and feedback. We want to know if patients perceive the…