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Top-Down Infliximab Study in Kids with Crohn's disease (TISKids)

The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD. Secondary objectives are determination of the pharmacokinetic/-dynamic profile of IFX and finding predictors of…

A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLOWED BY HIGH-DOSE CARBOPLATIN AND ETOPOSIDE (TI-CE) AS FIRST SALVAGE TREATMENT IN RELAPSED OR REFRACTORY GERM CELL TUMORS

This study has been transitioned to CTIS with ID 2024-513509-30-00 check the CTIS register for the current data. To compare the overall survival of patients with relapsed or refractory GCT treated with conventional-dose chemotherapy using the TIP…

A 52 week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy

The purpose of this Phase 3 study is to evaluate the safety and clinical efficacy of ligelizumab 240 mg and 120 mg given subcutaneously (s.c.) every 4 weeks (q4w) to ensure protection against allergic reaction by decreasing the sensitivity to oral…

A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines

The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab.

Effectiveness of customized corneal crosslinking versus standard corneal crosslinking in patients with progressive keratoconus

The objective of this project is to evaluate whether the effectiveness of customized cross-linking (cCXL) is non-inferior to the standard cross-linking protocol (sCXL).

A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITH COMPLEMENT INHIBITORS

This study has been transitioned to CTIS with ID 2023-506498-36-00 check the CTIS register for the current data. To evaluate the efficacy of crovalimab compared to eculizumab

Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene

Primary:To assess the effect of bilateral treatment with AAV5-hRKp.RPGR on functional vision as measured by vision-guided mobility assessment.Secondary:To assess changes after treatment administration in retinal function, functional vision, visual…

The TRISTARDS trial - ThRombolysIS Therapy for ARDS
A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19.

Main objective is to evaluate the efficacy and safety of two (Part 1) different dosing regimen and of one dosing regimen (Part 2) of intravenous alteplase given for up to 5 days on top of standard of care (SOC) compared with SOC alone in ARDS…

Virtual reality therapy for voice hearing: a randomized controlled trial

To investigate whether VR-VOICES is more effective than regular treatment for voicehearing in patients with auditory hallucinations.

Internet-based emotion regulation training in adolescents with depressive and anxiety disorders: a randomized controlled trial.

The primary aim of the proposed study is to test the effectiveness of CBT + ERT in reducing depressive and anxiety symptoms against CBT alone in adolescent patients (aged 13-19) with depressive or anxiety disorders in a randomized controlled trial (…

Additional effect of hydrolysed collagen/vitamin C in exercise treatment for Patellar Tendinopathy (Jumper*s knee); a randomized controlled trial

The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 24 weeks…

Clinical and cost-effectiveness of group schema therapy for
complex eating disorders: the GST-EAT study

The aim of the current project is to test the clinical and cost-effectiveness of GST for patients with an ED (i.e., anorexia nervosa, bulimia nervosa, other specified), that are not likely to benefit from CBT-E. The study will focus on those…

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…

Effect of a probiotic strain on immune response to influenza vaccination

To investigate the effect of Bifidobacterium lactis CECT 8145 BPL1® on the seroconversion rate after influenza vaccination in healthy adults, compared to placebo treatment.

A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

This study has been transitioned to CTIS with ID 2023-510160-12-00 check the CTIS register for the current data. To assess if venetoclax combined with FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine - the REBUILD-1

This study has been transitioned to CTIS with ID 2023-505836-36-00 check the CTIS register for the current data. Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the…

A Phase 3 Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients with Hereditary Angioedema (HAE)

Primary objective: The primary objective of the study is to evaluate the clinical efficacy of ISIS 721744 in patients with hereditary angioedema (HAE).Secondary objective: Evaluate the effects of ISIS 721744 on the quality and pattern of HAE attacks…

A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE)

The aim of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of enzastaurin in preventing new arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to…

A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation

To evaluate the efficacy and pharmacodynamics (PD) of ELX/TEZ/IVA

The effectiveness of blended Forensic Ambulant Systemic Treatment (FASTb): A randomized controlled trial comparing blended and regular FAST

The main goal of the current study is to investigate whether FASTb is equally effective as FASTr.