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Open label, randomized, cross-over study to explore the pharmacokinetics of BAY 1834845 after oral and intravenous dosing, including food effect and absolute bioavailability (Part A), and to investigate the effect of BAY 1834845 on the pharmacokinetics of orally administered methotrexate (Part B) in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent BAY 1834845 is absorbed and eliminated from the body (this is called pharmacokinetics). In both study parts it will also be investigated to what extent BAY 1834845 is…

Evaluation of the LatellaTM Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

To demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain

A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis

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The effect of high-resistance muscle strength training and vitamin D supplementation in persons with knee osteoarthritis

To determine (1) whether high-resistance strength training (70-80% of one-repetition maximum (1RM)) is more effective in improving muscle strength compared to low-resistance strength training (40-50%% of 1RM) and (2) whether vitamin D…

Pilot study into the development of an effective home-based-exercise-strategy for patients after THA delvered on a Tablet-PC.

The main objective of this pilot study is the application of a home-based exercise strategy that helps patients to return faster to their functional level of before the surgery. At first, practical feasibilty of the exercise strategy delivered by…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…

Phase II trial of Linsitinib (anti-IGF-1R/IR) in patients with relapsed and/or refractory Ewing Sarcoma

Primary ObjectivesTo determine the pharmacodynamic effect of linsitinib in the tumourTo evaluate the safety and tolerability of linsitinibSecondary ObjectivesTo determine the clinical outcomeTo conduct pharmacokinetic assays with linsitinib…

Long-term results of fixated olecranon fractures; evaluation of 235 patients with a minimum 1 year follow-up

Aim of this study is to determine the functional outcome after a minimum of 1 year follow-up after fixation of the fractured olecranon with TBW or PF. Subgroup analyses will be done to investigate the assumed advantage of PF compared to TBW in…

Fixation of the posterior malleolus via the posterolateral or precutaneous "AP" approach, an analysis of radiological and functional outcome.

To compare radiological and functional outcome in 2 retrospective cohorts. We compare the results of the MILAN study with a cohort after changing our operative strategy in 2010.

Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA

Main objective: The main objective of this open-label, single arm study is to further characterize the safety, tolerability and effectiveness profile of olesoxime in SMAThe primary safety objective for this study is as follows:To evaluate the safety…

Evidence-Based Mindset & Physical Therapy for Add-on Treatment of Active Axial Spondyloarthritis: Safety and Efficacy

To investigate whether an add-on mindset & physical therapy program based on the *Wim Hof Method* can safely and efficaciously be applied in patients with active axial spondyloarthritis.

The effect of of a spinal orthosis on gait and balance in patients with symptomatic osteoporotic vertebral compression fractures (OVCFs)

The data will be used in order to evaluate statistical variability (mean, SD) in an attempt to predict an appropriate sample size prior to the RCT based on the effect size, alpha and beta. The aim of the RCT is to assess the effects of the Osteoline…

What is the most optimal treatment strategy for an adolescent with knee complaints?

What is the most optimal treatment strategy for children / adolescents with knee complaints? Our hypothesis is (based on the invasive surgical procedure) patients that will be surgical treated (index group) have a clinical relevant gain of pain…

The Effect of Intensive Urate Lowering Therapy (ULT) with Febuxostat in Comparison with Allopurinol on Cardiovascular Risk in Patients with Gout Using Surrogate Markers: a Randomized, Controlled Trial.

The primary study objective is to determine whether Febuxostat daily 80-120 mg is better than Allopurinol daily 100-600 mg in inducing positive changes in Pulse Wave Velocity (PWV) after 36 weeks of treatment.

Long-Term Multi-center Evaluation of E-Poly* and Regenerex* Cementless Acetabular Components: Clinical and Radiographic Outcomes

The purposes of this long-term mutli-center study are: - To compare the long-term (10-year) radiographic and clinical outcomes of new E-Poly* liner in primary total hip arthroplasty with the conventional ArcomXL® polyethylene liner.- To compare the…

A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long-term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis (CAIN457F2310)

Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNF*…

The WOW! Study, Weight-bearing or Non-Weight bearing. A prospective randomised multicenter comparison of three different care regimens after operatively fixed ankle fractures.

Primary Objective: Compare functional results of the three postoperative care regimens assessed with the Olerud-Molander ankle score 12 weeks after surgery.Secondary Objective(s): 1) Compare functional results and patient satisfaction of the three…

MCL-laxity in valgus knee deformity before and after closing wedge high tibial osteotomy

1. To assess the effects of a CWHTO on the MCL and LCL laxity.2. To assess the effects of a CWHTO on the patient*s experience of collateral ligament instability.

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…

Efficacy of paracetamol and diclofenac for patients with acute low back pain: a randomized placebo controlled trial (PACE plus trial)

Based on the identified gaps in the evidence underlying the clinical guidelines on non-specific low back pain of the Dutch College of GPs and the recent findings of the Australian PACE study the objectives of the present study are: 1. What is the…