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Preterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold, a randomized controlled trial

Our primary objective is to test our hypothesis that lower Hb thresholds than the current ones, provided adequate cerebral oxygen saturation values are met, will lead to a better neurological outcome in preterm infants at three monts post-term. Our…

Safety and tolerability of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis: a multicenter, double-blind, placebo controlled randomized clinical trial.

The aim of this study is to assess the safety and tolerability of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis.

A multicentre, randomised, dose-confirmation, factorial phase II study to evaluate the optimal dose of 68Ga-OPS202 as a PET imaging agent in subjects with gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Primary Study Objective:*To define the optimal dose range for peptide mass and radioactivity of 68Ga-OPS202 based on detected lesions in adult subjects with somatostatin receptor 2 (sstr2) positive gastroenteropancreatic neuroendocrine tumour (GEP-…

Gastrointestinal tolerance in ICU patients after administration of an energy and protein enriched peptide formula as compared to an isocaloric standard tube feed

The objective of this study is to compare gastrointestinal tolerance in ICU patients during administration of an upgraded peptide based tube feed product to an isocaloric standard tube feed during a period of maximal two weeks.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis

The primary objective of the study is To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF.The secondary objectives of the study are:* To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF as…

A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT).

Primary Objective:Efficacy:· Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.Secondary Objectives:Safety:· Assess the safety and…

Long-term follow-up of patients previously treated with autologous T cells genetically modified with retroviral vectors.

Primary Objective:- Long-term safetySecondary Objective:- Survival- Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression- Chimeric antigen receptor (CAR) transgene persistence- Replication competent…

A Phase I, open-label, dose escalation study of LDK378 in pediatric patients with malignancies that have a genetic alteration in anaplastic lymphoma kinase (ALK)

Primary objective: Estimate the MTD and/or RDE of LDK378 as a single agent when administered orally to pediatric patients with ALK-activated tumors in the fasted and in fed stateSecondary objectives: Objective 1: Characterize the safety and…

A 24 weeks multicentre, randomized, double-blind, placebo-controlled, parallel group, study to evaluate the efficacy, safety and tolerability of intravenous IG-8801 20 mg and 40 mg in subjects with chronic low back pain

To assess, in patients with non-specific low back pain, lasting for over 3 months, the effect of two doses of olpadronate administered intravenously on low back pain as compared to placebo treatment. Assessment of safety and tolerability are also…

Follow-up Safety Trial in children with chronic heart failure therapy receiving Orodispersible Minitablets of Enalapril (WP10 Trial).

Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…

PHASE II, EXPLORATORY, MULTICENTER, NON RANDOMIZED, SINGLE AGENT COHORT STUDY TO DETERMINE BEST TUMOR RESPONSE WITH TRASTUZUMAB EMTANSINE IN HER2 OVEREXPRESSING SOLID TUMORS

A number of anti-HER2 therapies have proven efficacy, are approved and part of the Standard of Care for HER2-positive BC and GC. In contrary, there is currently no clinical data on the potential therapeutic effect of trastuzumab emtansine treatment…

A randomized pilot study on probiotics and their effect on vitamin K2 status

Objectives: To investigate the effect of a daily sachet of probiotics on vitamin K status for 12 weeks vs placebo.

Trial NL87938.000.24

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