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Efficacy and safety of bumetanide oral liquid formulation in children and adolescents aged from 7 to less than 18 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children and adolescents aged from 7 to less…

A non-therapeutic feasibility study to evaluate the kinetics and test-retest repeatability and reproducibility of the radioligand [11C]-UCB-J for imaging synaptic density in healthy subjects and mild-to-moderate Alzheimer*s Disease subjects

Primary objective:* Assess the test-retest repeatability and reproducibility of radioligand [11C]-UCB-J binding.Secondary objective:* Compare the precision and accuracy of PET data analysis using 60 versus 90 minutes of scan data.* Assess group…

High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS)

* Primary Objective: To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in subjects with non ST elevation acute coronary syndrome (NSTE ACS) who are taking maximally tolerated statin therapy.* Secondary Objective(s): To evaluate the…

Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures

The objectives of the study are to fine-tune the Xres5 algorithm settings (for cine and fluoroscopy) to optimize the image quality (IQ) and assess and feasibility of using the improved IQ of Xres5 processing to reduce radiation dose or contrast…

Proton pump inhibition for secondary hemochromatosis in hereditary anemia, a phase III placebo controlled randomized cross-over clinical trial.

Primary Objective to show that PPIs compared to placebo are an effective treatment of secondary hemochromatosis in a relative large number of patients with hereditary anemia and mild iron overload. Secondary Objectives: To assess the safety and side…

A randomized, double-blind, double-dummy, placebo-controlled, three-way crossover study to investigate the effects of mexiletine and lacosamide on nerve excitability and evoked pain tests in healthy subjects.

Primary Objective- To evaluate the feasibility and test-retest variability of nerve excitability threshold tracking - To investigate the sensitivity of nerve excitability measures to detect the effects of mexiletine- To investigate the sensitivity…

A Randomized Intra-Patient Controlled Trial of MagnetOsTM Granules vs. Autograft in Instrumented Posterolateral Spinal Fusion

The primary objective is to demonstrate non-inferiority of MagnetOsTM Granules compared to autograft in instrumented posterolateral spinal fusion, in terms of efficacy and safety by means of an intra-patient model.

Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: a method to probe the depression network. Replication and dose-response.

To explore whether influence on parasympathetic activity can be used as a functional outcome measure reflecting adequate targeting of the DLPFC-sgACC network and, secondary: 1) to explore the dose-response to the intensity of the TMS output and 2)…

Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

This exploratory study is designed to evaluate several depatuxizumab mafodotin-related OSE management strategies.The main objective of this trial is to estimate the percentage of subjects in each prophylactic treatment arm who require a change in…

Home-monitoring of disease activity in pediatric chronic disease.

General- To compare physical activity levels of pediatric patient subjects with healthy control subjects.- To compare mean heart rate and variation in heart rate during the day of patients and healthy controls.- To compare sleep duration of patients…

A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV)
Serotype 8 (AAV8)-Mediated Gene Transfer of Glucose-6-Phosphatase (G6Pase) in Adults with
Glycogen Storage Disease Type Ia (GSDIa)

Primary Objective: To determine the safety of single intravenous (IV) doses of DTX401 in adultswith GSDIa, including the incidence of dose-limiting toxicities (DLTs).Secondary Objective:To establish a dose of DTX401 that achieves symptom-free…

Home-monitoring of physical activity and vital parameters of pediatric patients following admission due to pneumonia, bronchiolitis or asthma.

- To determine a mean recovery period for patients admitted with pneumonia, bronchiolitis, preschool wheezing and asthma by using data obtained during admission and via home-monitoring of a two week period following admission and control period and…

Protocol for gathering data for the pediatric control groups of various CHDR trial@home studies with wearable technology and smart-phone applications.

- To determine the tolerability, feasibility and quality of the employed methods of data collection in different age groups. - To investigate inter-subject variability and normal-values regarding step count, heart rate, sleep duration, blood…

New Exploratory Tools, Technologies and Biomarkers to characterize Depression

To assess utility and accuracy of an electroencephalography (EEG) -based brain network analysis platform as potential diagnostic tool for MDD, to correlate digital biomarkers and *gold standard* psychometric questionnaires such as MADRS in MDD and…

A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…

A phase 2, randomized, vehicle and ketoconazole-controlled, evaluator-blinded, study to explore the efficacy, pharmacodynamics and safety of omiganan 1.75% topical gel BID in patients with mild to moderate facial seborrheic dermatitis.

Primary Objective* To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis Secondary Objectives* To explore skin and faecal microbiome in patients with seborrheic dermatitis * To evaluate the…

Phase I, international, multicentre, open-label, non-randomised, non-comparative study of intravenously administered S64315, a Mcl1-inhibitor, in patients with Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)

The primary study objective is to determine the safety profile and tolerability of S64315 in patients with AML and MDS and to determine the recommended phase 2 dose. Secondly, the PK profile of S64315 and potential metabolites will be determined in…

The effect of lactate administration on cerebral blood flow during hypoglycemia

To investigate the effect of intravenous lactate administration, compared to placebo, on thalamic (regional) and global CBF during euglycemia and hypoglycemia in patients with T1DM and NAH.

FAB: Functional Analysis of BRCAness

Primary: To determine whether the outcome of the RAD51 assay (HR proficient or HR deficient) correlates with objective response rate (RR) of olaparib, in patients with recurrent high grade epithelial ovarian cancer.Secondary:• Compare the…

Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The aim of the research is to determine the effect of GZ/SAR402671 on the total growth in kidney volume (total kidney volume, TKV) in patients with ADPKD. This research also looks at the effectiveness of GZ / SAR402671 in slowing down the decrease…