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An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

Primary Objective: To monitor long-term safety of durvalumab (allcohorts)Secondary Objectives: To assess the efficacy of durvalumab in terms of ORR and DOR in patients who undergoretreatment with durvalumab (Cohort 2 only)Secondary ObjectivesTo…

The detrimental course of acute intestinal ischemia: improvement of the diagnosis

We aim to validate a panel of plasma biomarkers and investigate volatile biomarkers that potentially allow early and accurate identification of acute intestinal ischemia in patients. Second, we aim to identify a volatile organic compound (VOC)…

A randomized, placebo-controlled, patient and investigator blinded study investigating the safety, tolerability and preliminary efficacy of 8-week treatment with intra-articular LRX712 to regenerate articular cartilage in patients with mild/moderate knee osteoarthritis

Primary objective - To assess the efficacy of q4w x3 i.a. injections of LRX712 in restoring the morphometrics of articular cartilage in the medial femoral condyleSecondary objectives- To evaluate LRX712 and metabolite MAE344 pharmacokinetics in…

Reducing fatigue in visually impaired adults with E-nergEYEze: An RCT to assess the cost-effectiveness of a blended vision-specific E-health based cognitive behavioral & self-management intervention.

The objective of the study is to develop and test a blended vision-specific E-health-based cognitive behavioral & self-management intervention (*E-nergEYEze*). Our specific goals are: (1) to further develop E-nergEYEze for visually impaired…

Effectiveness and cost-effectiveness of the Transmural Trauma Care Model (TTCM), a non randomized controlled multicenter trial

Primary objective: The primary objective of this study is to assess the effectiveness and cost-effectiveness of the Transmural Trauma Care Model (TTCM) as compared to usual care.The research question addressed is:Is the Transmural Trauma Care Model…

General Risk factors And iNflammatory Determinants in younger PAtients with copd: the GRANDPA study

To compare young and old COPD immunologically, physiologically, risk factors, patient behaviour and quality of life.

Exercise for breast cancer patients undergoing neoadjuvant chemotherapy: the BENEFIT study

The major objectives of BENEFIT are (1) to explore the effect of exercise during neoadjuvant chemotherapy on the anti-tumoral chemotherapy effect, tolerability and compliance to chemotherapy, patient-reported outcomes including fatigue, sleep…

An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients

The objectives of this study are to:• Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects• Evaluate pharmacokinetics of imlifidase• Evaluate pharmacodynamics profile of imlifidase• Evaluate…

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

This study has been transitioned to CTIS with ID 2022-502354-14-00 check the CTIS register for the current data. Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had…

A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa

Secondary objectiveTo assess the safety and tolerability of the investigational treatments in patients with moderate to severe hidradenitis suppurativa (HS) by:• Number and severity of AEs • Physical examination, vital signs, safety laboratory…

TWIN Longitudinal Investigation of FEtal discordance

The main objective is to pinpoint the biological pathways that set long-term risk of CVD and NDI when epigenetically disturbed during fetal development by (1) establishing a longitudinal cohort of MC twins, (2) defining epigenetic alterations…

Adoptive therapy with TCR gene-engineered T cells to treat patients with MAGE-C2-positive melanoma and head and neck cancer.

This study has been transitioned to CTIS with ID 2024-516922-70-00 check the CTIS register for the current data. Phase I• Primary objectives:o To study the safety and feasibility of AT with autologous MC2 TCR T cells, combined with epigenetic drug…

A cluster Randomised Controlled Trial of the effectiveness, usability and acceptability of a smart inhaler programme in asthma patients: the ACCEPTANCE study

This study aims to investigate the effectiveness of a smart inhaler based asthma self-management programme on medication adherence in adults with partially controlled or uncontrolled asthma. Secondary objectives are 1) to evaluate the effect of the…

The effect of coblation treatment on knee cartilage quality in patients with meniscal lesions and cartilage loosening of the knee

Primary Objective: To study the in vivo effect of coblation treatment on knee cartilage quality in patients with meniscal lesions and partial cartilage loosening of the knee.Secondary Objective: To study the relationship between knee cartilage…

A multicenter, randomized, double-blind, placebo-controlled study in participants with sarcoidosis-associated pulmonary hypertension (SAPH) to assess the efficacy and safety of oral selexipag.

The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

Impact of galacto-oligosaccharides on the intestinal microbial composition and -activity: a proof of concept study

We would like to investigate whether GOS benefically alters the microbiota composition and -activity of the colon (not only faeces as done previously). This has not been done before by performing colonoscopies in a physiological condition and…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis. SELECT-GCA

This study has been transitioned to CTIS with ID 2023-505476-29-00 check the CTIS register for the current data. This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week…

Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma

This study has been transitioned to CTIS with ID 2024-516125-31-02 check the CTIS register for the current data. Primary objective is to determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended…

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) (study 208467)

This study has been transitioned to CTIS with ID 2024-513032-14-00 check the CTIS register for the current data. Primary:To evaluate the efficacy of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02…

Effectiveness and cost-effectiveness of MicroShunt (MS) implantation versus standard trabeculectomy (TE)

The objective of this project is to aid in deciding on the use of the MicroShunt in glaucoma surgery by assessing its efficacy and cost-effectiveness in patients with primary open-angle glaucoma (POAG), pigment dispersion syndrome or ocular…