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Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial (COVID-Compromise Study).

There have been reports of a more serious course of COVID-19 infections in patients with a reduced immune system, such as patients with congenital immune disorders, (haematological) malignancies or patients taking medications that suppress the…

Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma

Valemetostat tosylate may modify epigenetic changes, which plays an important role in the pathogenesis of PTCL. In the ongoing open-label Phase 1 study (DS3201-A-J101, 25 Dec 2019 data cut-off), valemetostat tosylate monotherapy demonstrated…

A phase II, open label, multicenter study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with treatment-naïve metastatic Merkel Cell Carcinoma - the MERKLIN 1 Study

Primary Objective: to evaluate clinical efficacy of domatinostat in combination with avelumab in treatment-naïve metastatic or distally recurrent MCC patients as determined by the Objective Response Rate (ORR) according to Response Evaluation…

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects with Amyotrophic Lateral Sclerosis

To evaluate the efficacy, safety, tolerability, in subjects with ALS following the oral administration of study drug (active or placebo capsules).

A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group,
group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for the
treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.

The overall objective of this trial is to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalized patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from Phase…

Neo-adjuvant FOLFOXIRI and chemoradiotherapy for high risk (*ugly*) locally advanced rectal cancer.

This study has been transitioned to CTIS with ID 2023-509758-74-00 check the CTIS register for the current data. The aim of this study is to assess the effectiveness of the addition of neoadjuvant induction FOLFOXIRI systemic therapy to…

Efficacy and feasibility of ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial
(Ketamine Trial for Acute suicidality, KETA)

The aim of this study is to find a directly applicable intervention for acutely suicidal patients, so that the risk of these patients committing suicide is substantially lowered, leading to fewer actual suicides. To this end we propose a randomized…

Mental Health Promotion and Intervention in Occupational Settings: A Pilot Study

The project aims to improve mental health and wellbeing in the workplace by developing, implementing and evaluating an intervention targeting both clinical (depressive, anxiety disorders) and non-clinical (stress, burnout, depressive symptoms)…

Effectiveness of Somatostatin Analogues in patients with Gastric antral
vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-trial

Primary Objective: To investigate the efficacy and safety of octreotide treatment (a somatostatin analogue) in decreasing the transfusion requirements (IV iron infusions and / or red blood cell transfusions) in patients with GI bleeding caused by…

Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia

This study has been transitioned to CTIS with ID 2024-510816-55-00 check the CTIS register for the current data. The primary objective of the study is to evaluate the efficacy and safety and rIFN-γ as adjunctive treatment in combination with…

Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients

The primary objective of this study (MAP4B-safety) is to assess the safety of the application of the therapeutic product Alkaline Phosphatase (AP) in severely burned patients admitted to the intensive care unit. Secondary objectives are to assess…

A phase Ib/II randomized double-blind placebo controlled trial evaluating the effect of Nivolumab for patients with in-transit melanoma metastases treated with isolated limb perfusion (NivoILP trial)

This study has been transitioned to CTIS with ID 2023-509265-21-00 check the CTIS register for the current data. To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further…

A Phase IIb open-label, multi-centre, extension study to explore the long-term safety and efficacy of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation who have completed the KHENERGYZE study KH176-202.

The primary objective of this study is to enable continued treatment with the study drug sonlicromanol for patients who have completed study KH176-202 and to investigate the safety and tolerability of sonlicromanol over an 12 months treatment period…

Boosting the endocannabinoid system before the treatment of anxiety symptoms

This study has been transitioned to CTIS with ID 2024-514783-78-00 check the CTIS register for the current data. The aim of this project is to investigate CBD as a new medicine to target the ECS in the reduction of anxiety symptoms. Subsidiary aims…

Resuscitation for repair of endothelial permeability in endotoxemia

The main objective of the proposed study is to investigate the effect of plasma products and albumin on markers of endothelial function in a human endotoxemia model.

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic
Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

This study has been transitioned to CTIS with ID 2023-506987-15-00 check the CTIS register for the current data. 1) Objective: To evaluate the safety and tolerability of the pembrolizumab combination therapy.2) Objective: To estimate PSA response…

A Phase 2, randomized, double-blind, placebo-controlled, multicenter proof-of-concept study evaluating efficacy and safety of rilzabrutinib (SAR444671) in adult patients with moderate-to-severe atopic dermatitis who are inadequate responders or intolerant to topical corticosteroids

Primary objective:Assess the efficacy of rilzabrutinib in participants with atopic dermatitis (AD)Secondary objectives: * Assess the efficacy of rilzabrutinib at different time points* Assess the safety of rilzabrutinib

Selective Indocyanine Green Injection of a Segmental Hepatic Artery Followed by Near-Infrared Fluorescence
Guided Anatomical Liver Resection: A Feasibility Study

Primary objective: To investigate the feasibility of using intraarterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection.Secondary Objective(s): 1. To investigate the dosage which provides sufficient…

Targeting metabolic flexibility in ALS (MetFlex); safety and tolerability of trimetazidine for the treatment of ALS;An investigator initiated and conducted, multicentre, international, open-label Phase 2a trial to determine the safety and tolerability of trimetazidine for the treatment of amyotrophic lateral sclerosis/motor neuron disease (ALS/MND)

The objectives of this study are to determine:• The safety and tolerability of trimetazidine in patients with ALS/MND• The change from baseline in oxidative stress markers in patients with ALS/MND after the initiation of trimetazidine• The change…

A Phase 2b Multicentre, Randomised, Double-Blind, Active Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin
in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2

· To evaluate the effect of zibotentan anddapagliflozin in combination and alone versusplacebo on UACR.