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An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

The primary objective of this efficacy and safety study is to demonstrate that tight control of disease activity using stringent criteria based on CDAI, hs-CRP, fecal Calprotectin, and corticosteroid use improves the rate of mucosal healing 48 weeks…

Adrenaline use in local infiltration analgesia during TKA;Randomized, double blind, controlled study

The goal of the pilot study is to compare LIA with or without adrenaline infiltration by means of post operative pain (VAS) scores, PONV, early mobilisation and early discharge criteria.

Gastrointestinal stromal tumors: assessment of mutations in tumors and in circulating tumor DNA and measurement of TKI plasma exposure to optimize treatment

Primary objectives:• To assess whether secondary GIST mutations can be found in circulating tumor DNA of patients with progressive disease on TKI treatment (according to RECIST 1.1 on computer tomography), whereas they are NOT present in the…

A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).

Primary• To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician*s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment• To assess the effects of RVT-101 versus…

Trigeminovascular effects of propranolol in migraine treatment

To determine the mechanism of action of propranolol in the prophylactic treatment of migraine.

A Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety study of Gantenerumab in patients with Mild Alzheimer*s disease; part II: open-label extension for participating patients

The primary efficacy objective for this study was to evaluate the efficacy of gantenerumab compared with placebo administered to patients by subcutaneous (SC) injection over 100 weeks as measured by the following co-primary endpoints (final outcome…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects with Severe Sepsis and Coagulopathy.

The primary objectives of this study are:• To determine whether ART-123, when administered to subjects with infection complicated by at least one organ dysfunction and coagulopathy, can reduce mortality.• To determine the safety of ART-123 in this…

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event
International, multi-centre, randomized, double-blind placebo-controlled phase II study.

Efficacy and safety trial with S 44819 after recent ischemic cerebral Event

Neuro-cognitive effects of tyrosine supplementation in healthy older adults:
A fNIRS-EEG study

We aim to assess the effects of tyrosine supplementation on prefrontal brain activation, as measured by a combination of fNIRS and EEG, during response inhibition and working-memory performance in older adults. We will also assess whether…

Pharmacokinetic analysis of sinecathechins ointment 10% (Veregen) by means of Raman micro-spectroscopy in the skin of healthy volunteers

To gain insight in the pharmacokinetics of sinecathechins ointment 10% (Veregen) applied on healthy skin, using Raman micro-spectroscopy and chromatography of tape strips.

Feasibility of exoskeleton training for home use for patient with motor complete spinal cord injury.

In the present study, the feasibility of a training program with an exoskeleton for home use for people with motor complete SCI (ASIA A and B) will be examined. Participant will also be evaluated based on individual goal setting, patient…

Influenza vaccination in patients with Myasthenia Gravis

The main objective of this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG). The secondary objectives are to determine if vaccination…

A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION

Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…

The influence of breathing techniques and exposure to cold on inflammation during human endotoxemia, an explorative study

The primary objective of the present study is to determine the effects of the `strength ventilation` breathing technique and exposure to cold, both separately and in combination, on the inflammatory response during human endotoxemia. To this end, we…

Randomised Clinical Trial comparing cemented and hydroxy-apatite coated uncemented hemi-arthroplasty in the elderly patient with a proximal intracapsular femoral fracture.

The objective of this prospective randomised multi-center study is to compare the clinical outcome of the cemented and hydroxy-apatite coated uncemented hemi-arthroplasty for patients with a proximal intracapsular femoral fracture and the indication…

Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial.

To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.

Prednisolone Rhinosinusitis Efficacy Trial (PRET) study

To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.

Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…

Pharmacokinetics of posaconazole given as a single intravenous dose to obese subjects: Dosing Obese with Noxafil® Under a Trial (DONUT).

Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…

Families in the Frontline 1.0: An Evaluation Study of Multi-Family Therapy (MFT) for Veteran Families

1) To investigate the effectiveness of Multi-family therapy (MFT) versus individual oriented treatment as usual (TAU) on end-of-treatment family functioning of veteran families, as reported by the veteran. TAU consists of supportive counselling or…