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Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a safety study

This study has been transitioned to CTIS with ID 2023-508143-51-01 check the CTIS register for the current data. Objective: The primary aim of the study is to demonstrate that cervical administered ITB is a safe treatment of spasticity of the UE…

Continence Achieved through Recording of Electrophysiology (CARE) Study: A Prospective Study to Evaluate the Safety and Feasibility of using the Closed Loop Medical Sacral Nerve Stimulation System in the treatment of symptoms of Overactive Bladder

Safety1) To evaluate the safety of implantation and use of the Closed Loop Medical SNS System for the duration of the device use.Performance2) Feasibility of using electrophysiological response recordings to guide targeting and stimulation delivery…

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS >=50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

This study has been transitioned to CTIS with ID 2023-507933-12-00 check the CTIS register for the current data. MAIN OBJECTIVES:- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone, as measured by…

An Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH).

Primary Objectives:• To determine the safety of ELA026 administered IV and SC to participants with sHLH.• To identify the RP3D and schedule for ELA026.Secondary Objectives:• To characterize the pharmacokinetic (PK) profile of ELA026 administered IV…

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF)

The aim of this study is to evaluate the efficacy, safety and tolerability of BI 1015550 9 mg BID and 18 mg BID compared to placebo in patients with IPF, in addition to the patient's standard of care. The primary objective of this study is to…

Trial Examining Methods for Antidepressant Discontinuation

This study has been transitioned to CTIS with ID 2024-511997-66-00 check the CTIS register for the current data. TEMPO will directly compare i) conventional 2-step reduction with ii) gradual tapering in patients with remitted MDD who use either the…

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

This study has been transitioned to CTIS with ID 2024-512785-33-00 check the CTIS register for the current data. Primary objective: To evaluate the clinical improvement of efgartigimod PH20 SC treatment compared with placebo, in addition to standard…

A controlled, open-label post-authorisation efficacy and safety study in imlifidase desensitised kidney transplant patients with positive crossmatch against a deceased donor prior to imlifidase treatment, including non-comparative registry and concurrent reference cohorts

This study has been transitioned to CTIS with ID 2024-511810-18-00 check the CTIS register for the current data. Primary objective• To determine the 1-year graft failure-free survival in highly sensitised kidney transplant patients, pre-treated with…

A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression

This study has been transitioned to CTIS with ID 2023-505455-44-00 check the CTIS register for the current data. Part 1 (phase 1b)Primary:• To observe the safety and tolerability of bemarituzumabSecondary:• To evaluate preliminary antitumor activity…

Quinidine versus verapamil in short-coupled idiopathic ventricular fibrillation: An open label, randomized crossover pilot trial.

This study has been transitioned to CTIS with ID 2024-511190-30-00 check the CTIS register for the current data. To investigate the feasibility of a definitive RCT to assess the efficacy and safety of verapamil and quinidine in patients with short-…

Improving therapeutic ratio with hypofractionated stereotactic radiotherapy for brain metastases.

To determine if the incidence of adverse local events (local failure or radionecrosis) can be reduced with more than 20% using fSRT versus SRT in one or three fractions.

Pharmacokinetic-guided dosing of emicizumab in congenital haemophilia A patients - The DosEmi study

This study has been transitioned to CTIS with ID 2024-515528-35-00 check the CTIS register for the current data. Primary objectiveTo determine whether individualized pharmacokinetic (PK)-guided dosing of emicizumab is non-inferior to conventional…

An open-label, first-in-human, dose-escalation/expansion study of SAR443579 administered as single agent by intravenous infusion in adult and pediatric participants with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), high risk-myelodysplasia (HR-MDS) or blastic plasmacytoid dendritic cell neoplasm (BPDCN)

This study has been transitioned to CTIS with ID 2023-508357-58-00 check the CTIS register for the current data. The aim of the escalation portion of this study, in which SAR443579 is administered for the first time in humans, is to establish the…

LIMited wEdge ResectIon for Colonic T1 cancer - a prospective multicenter cohort study

The aim of this study is to investigate the safety and efficacy of CAL-WR as primary and curative colon-preserving treatment for T1 colon cancer. Our primary endpoint is reduction of oncologic resections for low-risk T1 colon cancer. As secondary…

EASYII - A Post-Market Clinical Follow-up Study (PMCF) in patients with infrarenal aortic aneurysm undergoing endovascular stenting with the E-tegra Stent Graft System - imaging cohort

To assess the stent stability and durability as well as the seal of the stent graft during the cardiac cycle and over time as well as to evaluate safety and clinical performance of the Etegra Stent Graft System used in endovascular treatment of…

Aronia and Cognitive Fitness: Focus on Brain Insulin-Sensitivity and Vascular Function

The primary objectives are to investigate effects of AME intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective).

The DESyne BDS Plus RCT: A Randomized Clinical Trial to Assess the Elixir DESyne BDS Plus Drug Eluting Coronary Stent System for the Treatment of de novo Native Coronary Artery Lesions

To evaluate the safety, effectiveness and performance of the DESyne BDS Plus DECSS (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native…

A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis

This study has been transitioned to CTIS with ID 2023-508729-28-00 check the CTIS register for the current data. The purpose of the study is to look at how well the study treatment works in participants with idiopathic pulmonary fibrosis.

A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE* FL-1)

This study has been transitioned to CTIS with ID 2023-505628-67-00 check the CTIS register for the current data. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult…

Characterizing tissue protein synthesis rates of non-small cell lung carcinomas in lung cancer patients

The current study aims to recruit a greater number of lung cancer patients to measure tissue protein synthesis rates of non-small cell lung carcinomas and healthy lung tissue. The protein synthesis rates of healthy lung tissue will be compared to…