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*A Phase 2b Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects with Mild Cognitive Impairment and Mild Dementia due to Alzheimer*s Disease.*

Primary objectives:Safety for Dose Selection• To assess the safety and tolerability of PQ912Efficacy • To evaluate the efficacy of PQ912 on working memory and attentionSecondary Objectives:Safety• To assess the safety and tolerability of long-term…

Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study has been transitioned to CTIS with ID 2023-507885-21-00 check the CTIS register for the current data. Primary objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant…

REtreatment with VEnetoclax and Acalabrutinib after venetoclax Limited duration (REVEAL)
A prospective, multicenter, phase-II trial of venetoclax plus acalabrutinib in patients who have relapsed after first line venetoclax + anti-CD20 mAb treatment for chronic lymphocytic leukemia (CLL or SLL)

This study has been transitioned to CTIS with ID 2023-505449-18-00 check the CTIS register for the current data. Primary objective• To evaluate efficacy of acalabrutinib/venetoclax (AV) in terms of undetectable minimal residual disease (uMRD)…

Combining Afatinib and concurrent chemotherapy, followed by Osimertinib and concurrent chemotherapy, in untreated EGFR positive NSCLC tumors

• to assess the efficacy of the sequential combination strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance.

PEMbrolizumab Plus Lenvatinib In Second Line And Third Line Malignant Pleural MEsotheLiomA Patients.

Primary: 1. To determine the objective response rate (ORR), defined by Modified (i)RECIST criteria for pleural mesothelioma, of the combination of pembrolizumab - lenvatinib in pre-treated patients with MPM. Secondary:1. To describe the safety of…

COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 * a randomized, double-blind, placebo controlled, clinical trial in patients with severe Covid19 disease

To test whether treatment with oral imatinib reduce disease burden and consumption of medical resources.

Diagnostic accuracy of neuroblastoma patient imaging with [18F]mFBG PET-CT compared to [123I]mIBG scanning.

The primary objective is to compare18F-MFBG PET-CT imaging for neuroblastoma patients with the current standard of imaging, 123I-MIBG SPECT, using the SIOPEN score for skeletal lesions and the number of detected soft tissue lesions as endpoints.

MICROVASCULAR RECOVERY USING CONTRAST ULTRASOUND IN ST-ELEVATION MYOCARDIAL INFARCTION - AMBULANCE PILOT STUDY

Primary objectives: 1. Safety 2. Practical feasibility Secondary objectives: 1. angiographic patency rate before PCI 2. Cumulative ST-segment resolution. 3. myocardial infarct characteristics 4. Myocardial perfusion on contrast echocardiography 5.…

An open label, randomized Phase II study of BI 754091 alone or in combination with BI 836880 in patients with chemotherapy resistant, unresectable, metastatic squamous cell carcinoma of the anal canal

The objective of this trial is to assess anti-tumour activity of BI 754091 as a monotherapy and of BI 754091 in combination with BI 836880 in patients with unresectable or metastatic squamous cell carcinoma of the anal canal who progressed on or…

Stratified Treatment to Ameliorate Diastolic left ventricular stIffness in eArly Heart Failure with preserved Ejection Fraction (STADIA-HFpEF)
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in patients with early HFpEF.

The primary objective is to assess in a 2x2 crossover design, whether compared to placebo dapagliflozin 10 mg od for 13 weeks improves LV distensibility, measured with echocardiography in patients with early HFpEF (LVEF >= 50%), defined as…

[11C]MeDAS PET: an imaging tool for quantitative assessment of changes in myelin density over time in multiple sclerosis

The objective of this study is to evaluate [11C]MeDAS PET as a quantitative method for assessment of changes in myelin density over time and thus the efficacy of [11C]MeDAS PET to image myelin degradation and repair.

A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally.

The purpose of this trial is to demonstrate proof of concept of clinical activity of BI 1015550 on the change of Forced Vital Capacity (FVC) between baseline and 12 weeks. New treatments are needed that further reduce the decline in FVC, positively…

A Phase 2a, Open-label, Multicenter Study to Evaluate Safety and Tolerability of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors; MSC-NTF cells) in Participants with Prodromal to Mild Alzheimer*s Disease

The primary objective is to determine the safety, tolerability and preliminary efficacy of repeated intrathecal administration of NurOwn® (MSC-NTF: Autologous Mesenchymal Stem Cells [MSC] Secreting Neurotrophic Factors [NTF]) given three times at…

Stress- and SmokeFree Start of Life

The effectiveness of an e-health intervention will be tested by means of a randomized controlled trial. The control condition consists of psycho-education on pregnancy, stress and smoking. The primary outcome measure is smoking (frequency of women…

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501

The primary study objective is long-term safety of RGX-501 and secondarily evaluation of the long-term effects of RGX-501 on LDL-C and other lipid parameters.

Fecal Microbiota Transplantation to Restore Residual Beta Cell Function In Patients With Long-Duration Type 1 Diabetes Mellitus

To investigate whether fecal microbial transplantation (FMT) from either allogenic (individuals with type 1 diabetes and a highly preserved beta cell fraction) or autologous (own) donor, administered every 8 weeks during 6 months through a small…

The effect of Eye Movement Desensitisation and Reprocessing (EMDR) on abdominal pain in patients with Irritable Bowel Syndrome (IBS).

Our goal is to investigate the effect of EMDR treatment on abdominal pain in patiënts with Irritable Bowel Syndrome. In addition we will investigate the effect of EMDR treatment on other IBS physical complaints and on patients' experienced…

18F-PSMA-1007 PET to detect primary prostate cancer: a comparative study with mpMRI and correlation to histopathology

This explorative study aims to investigate the added value of a 18F-PSMA PET to mpMRI in the detection of local prostate cancer lesions.

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

Progesterone for Breast Development in Trans Women; Assessment of effects and safety -a pilot trial-

To explore the effects on breast development of addition of progesterone to the treatment with estradiol in trans women after vaginoplasty or orchiectomy. Secondary objectives include safety and patient satisfaction, mood, and sleep.