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A feasibility study investigating the safety, performance and gastrointestinal transit of the DV3395 device concept in healthy participants.

We will investigate how safe the study device DV3395-C1 is when it is taken in by healthy participants. We will also look at the passage (i.e., gastrointestinal transit time) and activation of the study device. For this, we will see if the device…

ELectroanatomic substrate-guided STereotactic Ablative Radiotherapy for refractory Ventricular Tachycardia

Number of patients with >=80% reduction of VT burden, i.e., any ICD-treated or highly-symptomatic VT episodes, at one year after STAR compared to the year before (including VTs during the 8 week-blanking period). Efficacy parameters will be…

A phase 1, open-label, single-center study of absorption, metabolism and excretion and absolute bioavailability in humans of leriglitazone (MIN-102) in 2 parallel cohorts of male healthy subjects

In this study we will investigate how safe the compound leriglitazone is and how well it is tolerated when it is used by healthy participants.Apart from extensive laboratory and animal testing, leriglitazone has been used in the past both in healthy…

Adrenal vein sampling as a tool to identify biomarkers that aid the diagnosis of adrenocortical carcinoma

To detect differences between ACC patients and controls without ACC, and between the diseased and healthy adrenal gland of ACC patients, in microRNA (miRNA), circulating cell-free tumor DNA (ctDNA), circulating tumor cells (CTCs), and steroid…

Two-groups, open label, fixed-sequence study to evaluate the effect of CYP3A4/P-gp inhibition (Itraconazole) or CYP1A2/3A4 inhibition (Fluvoxamine) on the single-dose PK of MEN1611 in healthy subjects.

In this study we will look at how quickly and to what extent the study compound MEN1611 is absorbed, transported, and eliminated from the body (this is called pharmacokinetics) and how this is influenced by the approved drug itraconazole fluvoxamine…

A two-part, single dose, randomized, single-blinded, placebo controlled, phase I study to assess the safety and pharmacokinetics of oral MT1980 in healthy volunteers when dosed in the fasted state

In this study we will investigate how safe the new compound MT1980 is and how well it is tolerated when it is used by healthy participants. We also investigate how quickly and to what extent MT1980 is absorbed, transported, and eliminated from the…

A phase I, open-label trial to investigate metabolism, pharmacokinetics (following a mass balance design) and absolute bioavailability of BI 690517 (C-14) after oral and intravenous administration in healthy male subjects

The purpose of this study is to investigate how quickly and to which extent the new study compound BI 690517 is absorbed, transported,and eliminated from the body. BI 690517 is an investigational study compound which has not yet been approved for…

A study of the effects of single doses of MK-1167 on neurotransmitter cycling in the brain of healthy adult participants using 13C-Magnetic Resonance Spectroscopy.

To investigate effect of a single dose of MK-1167 on glutamate levels in the brain using MRS. Glutamate is a chemical that sends signals between nerve cells in the brain. To test the safety and tolerability of single oral doses of the trial drug, MK…

A randomized, placebo-controlled, double-blind, multi-center Phase 2/3 trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease

This study has been transitioned to CTIS with ID 2023-505313-24-00 check the CTIS register for the current data. To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD)

Clinical trial to evaluate safety and efficacy of the C2 CryoBalloon 180° Ablation System for the treatment of dysplastic Barrett*s esophagus: CBAS180 de-escalation study

Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett*s epithelium.

Matched Unrelated vs. Haploidentical donor for allogeneic stem cell transplantation in patients with Acute Leukemia with identical GVHD prophylaxis - A randomized porspective European trial.

Primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anit-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 HLA…

A Natural History Study of Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia (ALSP)

The objectives of the study are:• To understand the phenotypic heterogeneity and phenotype/genotype correlation and natural history of ALSP.• To develop and evaluate biomarkers for assessing disease progression in patients with ALSP.• To create the…

Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with brain tumors

This study has been transitioned to CTIS with ID 2024-517575-20-00 check the CTIS register for the current data. This study proposes a safety study in children in which tumors are operated on using fluorescence-guided resection which are similar to…

Preoperative functional liver assesement with primovist enhanced MRI for patients with suspected resectable perihilar cholangiocarcinoma: a proof-of-concept pilot study

To assess whether MRI Primovist could replace 99mTc-mebrofenin HBS as a preoperative functional liver assessment in addition to CT-volumetry in predicting PHLF in patients with resectable pCCA who require a major liver resection.

A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and
tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and
adults with macrophage activation syndrome (MAS) in Still*s disease (including systemic
juvenile idiopathic arthritis and Adult onset Still*s disease) or with MAS in Systemic lupus
erythematous

This study has been transitioned to CTIS with ID 2024-516153-52-00 check the CTIS register for the current data. Primary objective: To demonstrate efficacy of emapalumab in the treatment of patients in:• Cohort 1: Macrophage activation syndrome (MAS…

THE IMMUNE SYSTEM IN FOXP1 SYNDROME

Primary Objective: We aim to provide a clear phenotype of the immune system in patients with FOXP1 syndrome. Secondary Objectives:We aim to correlate the immunophenotype of patients with FOXP1 syndrome with frequency and type of infections reported…

A single-center, two-part, randomized, open-label, parallel-group, four-sequence, four-treatment, four-period crossover study to investigate the bioequivalence and the effect of food on the pharmacokinetics and safety of single oral doses of two different formulations of RO6868847 in healthy participants

In Part 1 we will investigate and compare to what extent RO6868847 is absorbed, distributed, metabolized, and eliminated from the body of 2 different types of tablet composition. This is done to see if both tablet compositions deliver the study…

Effect of dapaglifozin on serum magnesium in HNF1β patients with renal hypomagnesemia

This study has been transitioned to CTIS with ID 2024-518855-43-00 check the CTIS register for the current data. Primary objective: To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on serum magnesium in diabetic and non-diabetic…

The effects of timed-restricted eating on insulin sensitivity, de novo lipogenesis and liver fat in subjects with obesity and insulin resistance

Primary objectives: To determine the effects of combined isocaloric TRE and meal timing on insulin sensitivity.Secondary objectives: To determine the effects of combined isocaloric time-restricted eating and meal timing on hepatic fat content, de…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

Primary:- To evaluate the effect of suvratoxumab on reducing the incidence of nosocomial all-cause pneumonia.Secondary:- To evaluate the safety of a single IV dose of suvratoxumab.- To evaluate the effect of suvratoxumab on reducing the incidence of…