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Brightline-1: A Phase II/III, randomized, openlabel, multi-center study of brigimadlin (BI
907828) compared to doxorubicin as first line treatment of patients with advanced
dedifferentiated liposarcoma.

This study has been transitioned to CTIS with ID 2024-511361-11-00 check the CTIS register for the current data. The trial will assess the efficacy and safety of brigimadlin compared to doxorubicin as first line systemic therapy for advanced or…

Exploring biological measures to facilitate the discovery and development of new treatments for social and cognitive deficits in Alzheimer*s disease, schizophrenia, and major depression: replication and generalisability of the Psychiatric Ratings using Intermediate Stratified Markers (PRISM)1 study

The overall goal of the PRISM programme of research is to develop a quantitative, transdiagnostic, neurobiological approach to the understanding of neuropsychiatric disorders in order to accelerate the discovery and development of better treatments…

Hyperbaric Oxygen Therapy for Pyoderma gangrenosum As a New Treatment Strategy

To investigate the therapeutic efficacy and feasibility of hyperbaric oxygen (HBO) in addition to standard wound care in patients with pyoderma gangrenosum wounds.

Metabolomics in Dravet syndrome

Primary Objectives: 1. To assess the metabolic profile of patients with Dravet syndrome and identify metabolic variations that contribute to the pathophysiology of seizures and developmental delaySecondary Objectives:2. To assess the association…

Diagnostic accuracy of MRI for neurodegenerative parkinsonism

The primary objective is to determine the diagnostic accuracy of the automated diagnostic software (mPDia, Heuron) using SMWI to distinguish neurodegenerative parkinsonism from patients with non-neurodegenerative parkinsonism compared with the final…

BRAINmodel: Clinical characterization and understanding of excitation/inhibition ratio homeostasis in children with genetic syndromes caused by chromatin- or synapse regulatory factors.

In this study we aim to further characterize E/I balance (at different translational levels), and its relation to metabolic- and immune processes, clinical profiles, behavior and cognition

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (PROGRESS)

This study has been transitioned to CTIS with ID 2023-504129-38-00 check the CTIS register for the current data. Primary:To determine the efficacy of INCB000928 for the prevention of new HO in participants with FOP.Key Secondary:To further evaluate…

Dynamic disease activity monitoring in Psoriatic Arthritis by novel personalized digital biomarkers*

To early identify changes in disease activity by changes in digital biomarkers. Smartphone screen time, keystroke dynamics, accelerometer & gyroscope data, emoticon use and incidental video recordings will be evaluated on occurring patterns…

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Zooming in on cerebral abnormalities in severely affected COVID-19 patients: a 3T and 7T MRI study

This study aims to relate factors of hypercoagulability, inflammation or general illness itself (all during ICU admission) to microstructural and microvascular abnormalities on follow-up brain advanced 3T and 7T MRI in COVID-19 ICU survivors. By…

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

This study has been transitioned to CTIS with ID 2022-503012-16-00 check the CTIS register for the current data. To evaluate intraoperative efficacy of PROTHROMPLEX TOTAL in comparison with standard of care (SOC) 4F-PCC, for reversal of…

Role of the central brain clock in the pathophysiology of insulin resistance

Primary Objective: to determine the activity rhythm of the SCN in humans with progressive stages of insulin resistanceSecondary Objective(s): to determine the daily rhythm of the peripheral clock in buccal cells in humans with progressive stages of…

Neurological, cardiovascular, visual and neurocognitive performance in pediatric HIV-1- infected patients as compared to healthy controls NOVICE - III a follow up study

This study is a follow-up study of the NOVICE I & NOVICE II (METC 2012_093 and METC 2016_173). The objective of the study is to both cross-sectionally and longitudinally, after an interval of 10 years, gain more insight into the presence,…

Improvement of laboratory diagnostics in hypothyroid patients using levothyroxine.

The aim of this study is to identify whether we can improve laboratory diagnostics in patients with hypothyroidism receiving thyroid hormone supplementation. We will investigate whether, in addition to the current laboratory tests of TSH and fT4,…

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery

The objective of this clinical investigation is to compare the safety and efficacy of GATT-Patch versus TachoSil in liver surgery

A First in Human trial to study safety and tolerability of single rising intravitreal doses (oPen label, non-randomized, uncontrolled) and in Addition the early biological Response of mulTiple intravitreal doses (double-masked, RandomIzed, shamcontrolleD) of BI 765128 in panretinal photocoaGulation (PRP) treated diabetic rEtinopathy (DR) patients with diabetic macular ischemia (DMI) - the PARTRIDGE Study

Diabetic Macular Ischemia (DMI) is a complication of diabetic retinopathy (DR) and can lead to vision loss. Currently, there are no approved or effective treatments to prevent either onset or progression of DMI in DR patients.As a transition from…

EvaLuating negAtive pressUre wound theRapy in brEast coNserving surgery - the LAUREN pilot study

The primary objective of this trial is to compare the number of postoperative wound complications in patients with and without negative pressure therapy after breast conserving surgery in the first three months after surgery. Wound complications…

Integrating biology and behaviour for precision stratification of mental disorders

The primary objectives of this study are to: (i) derive quantitative measures of behaviour on the basis of smartphone monitoring in a healthy cohort and a cross-diagnostic cohort of patients with mental disorders (e.g. depression, anxiety and…

A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis patients with Fused in Sarcoma mutations (FUS-ALS)

This study has been transitioned to CTIS with ID 2024-512163-31-00 check the CTIS register for the current data. Primary objective: To evaluate the clinical efficacy of ION363 in clinical functioning and survival in FUS-ALS patients. Secondary…

Uncovering Pathophysiologic Mechanisms of Treatment Resistant Depression: A comparison with non-TRD patients

To determine if dopaminergic dysfunction and neuroinflammation is increased in patients with TRD compared to patients who respond to antidepressant medication