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Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases: a multicenter double-blind placebo-controlled randomized study.

Aim of the studyTo study the effectiveness and toxicity of dexamethasone to prevent the occurrence of a pain flare after short schedule radiotherapy for painful bone metastases and to define the optimal schedule of dosing.Research questions:1. What…

Multi-center, randomized clinical trial to study the impact of in-hospital guidance for acutely decompensated heart failure treatment by predefined NT-proBNP targets (>30% reduction in NT-proBNP during admission) on the reduction of readmission rates and mortality

The primary objective of the present study is to demonstrate that NT-proBNP guidance during in-hospital treatment for acutely decompensated heart failure (to strive for >30% reduction) reduces readmissions and mortality and increases the…

Effect of infrapatellar nerve block on chronic anterior knee pain after tibial nailing.

To study the effect of a nerve block of the infrapatellar nerve with local infiltration with lidocaine or saline on chronic anterior knee pain after tibial nailing.Secondairy objectives:- to measure knee pain on a VAS for eight different activities…

Dexamethasone in community-acquired pneumonia.

Primary Objective: - To confirm the effect of dexamethasone on clinical outcome in patients admitted with CAP.Secondary Objectives: - To study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis…

D-dimer and Factor XIII activation peptide in cerebral venous thrombosis (CVT)

To assess the sensitivity and negative predictive values of D-dimer- and FXIII activation peptide (AP-FXIII) values in order to exclude to exclude CVT in patients with clinical suspicion of CVT.

An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA)

The primary objectives of this study are: • To determine the longterm safety and tolerability of rhHNS administered via an intrathecal (IT) route once monthly for 8 years in patients with MPS IIIA, who have received and tolerated 6 months of…

An open-label, single-arm, phase II, multicenter study to evaluate;the efficacy of vemurafenib in metastatic melanoma patients with brain metastases

The primary objective of this trial is to evaluate the efficacy of vemurafenib using BestOverall Response Rate (BORR), as assessed by an Independent Review Committee (IRC)using RECIST, v1.1 criteria in the brain of metastatic melanoma patients with…

BRCA mutations and ovarian ageing in normo-ovulatory women

Primary objective: To confirm that a BRCA-mutation is a determinant of advanced ovarian ageing by using serum-AMH as ovarian reserve test.Secondary objective: To confirm that a BRCA-mutation is a determinant of reduced reproductive health/outcome.

Proof of principle and pharmacological phase 0 crossover study with controlled release capecitabine (ModraCape001)

Primary objective is to determine the plasma pharmacokinetics of ModraCape001 and compare these to the pharmacokinetic profile of Xeloda®.Secondary objectives are:• To determine the AUC in blood plasma of capecitabine and its metabolites 5-dFCR, 5-…

Q-Kids

To estimate the risk of Q fever infection in children and adolescents in various exposure groups, estimate the true regional incidence of Q fever infections in children and adolescents, identify associated risk factors, and assess the impact of Q…

Clinical study on total hip arthroplasty patients with instrumented shoes

The first aim of this study is to investigate whether the IFS is a sufficiently sensitive instrument to show differences in mobility performance between before and after THA. The second objective is to investigate how mobility characteristics, as…

The effect of different macronutrients on the ileal brake

Hypotheses: - Ileal delivery of casein and/or sucrose induces stronger effects on satiation compared to placebo- Ileal delivery of casein induces stronger effects on satiation than ileal fat delivery- Ileal delivery of sucrose induces stronger…

Is the presence and development of microvascular disease in type 1 diabetes related to changes in brain structure and cognitive function?

Are changes in cognitive functioning related to structural changes in the brain in patients with type 1 diabetes mellitus. How are these changes related to diabetic complications like duration of chronic hypoglycaemia, disease duration and presence…

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Patients

The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…

A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)

The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.

Anamorelin HCl in the Treatment of
Non-Small Cell Lung Cancer - Cachexia (NSCLC-C):
A Randomized, Double-Blind, Placebo-Controlled,
Multicenter, Phase III Study to Evaluate the
Safety and Efficacy of Anamorelin HCl
in Patients with NSCLC-C

Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…

The Steep Ramp Test in Children and Adolescents: Norm Values in Relation to Sex and Age

Primary objective:- Collecting and setting up norm values for the Steep Ramp Test for healthy children and adolescents between 8 and 18 years (what is the maximal attained work rate (Wpeak) during the Steep Ramp Test in healthy children and…

Interventional, randomised, double-blind, sequential-group, placebo-controlled single ascending dose study investigating the safety, tolerability, and pharmacokinetic properties of Lu AF34134 in healthy young men and healthy elderly men and women, and open-label, three-period crossover, food interaction study of Lu AF34134 in healthy elderly men and women.

- to examine the safety and tolerability of the research medication- to examine how the research medication is absorbed, broken down and excreted by the body.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

Pharmacokinetic study to assess the bioavailability of phenolics from an olive leaf extract

The objective of the study is to obtain information on the bioavailability and pharmacokinetics of the phenolics present in an olive leaf extract (Bonolive®, dose 250 mg), standardized on 40% oleuropein, and to identify the composition of the…