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MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

The purpose of this study is to identify the first time-point the OMERACT RAMRIS score for the activity of synovitis is statistically significantly reduced compared to Baseline, in response to cerolizumab pegol (CZP) therapy. In addition, the early…

A phase II, double blind, exploratory, parallel-group, placebo-controlled clinical study to assess two dosing regimens of GSK2402968 for efficacy, safety, tolerability and pharmacokinetics in ambulant subjects with Duchenne muscular dystrophy

Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…

A multi-centre randomised double blind, placebo and active controlled parallel group study to investigate efficacy and safety of ONO-5334 in post menopausal women with osteopenia or osteoporosis.

The objective of this study is to investigate if use of ONO-5334 has a more positive effect on bone density and biochemical markers of bone turnover than Alendronate (a bisphosphonate) and placebo.

Effects of levosimendan on diaphragm contractility in healthy subjects

The primary objective of this proof of principle study is to determine the effect of levosimendan on the strength and endurance of the diaphragm in healthy subjects. The secondary objective is to gain insight in the neural activation and efficiency…

Bone augmentation with autologous adipose tissue-derived mesenchymal stem cells and calcium phosphate carriers in the human maxillary sinus floor elevation model

> Primary Objective:This is a pilot study, aiming at the clinical evaluation with respect to safety and feasibility of a one-step surgical procedure for maxillary sinus floor augmentation for the placement of dental implants, using a ceramic…

A randomised, double-blind, placebo-controlled, single ascending dose, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of PG110 (anti-NGF monoclonal antibody) in patients with pain attributed to osteoarthritis of the knee

The study has two objectives. Firstly, we will investigate the safety and tolerability of the study drug following administration of a single escalating dose of the drug. Secondly, we will investigate the rate at which the study drug is absorbed…

Exploratory trial on intra-articular etanercept treatment in inflammatory arthritis

The primary objective is to determine if intra-articular etanercept therapy reduces the clinical signs and symptoms of inflammatory arthritis and improve outcome (beneficial effect). The secondary objective is to study safety and to analyse…

A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis

Primary: To demonstrate the efficacy of each secukinumab regimen 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 TNFα inhibitor naïve.…

The effectiveness of Pulsed Electromagnetic Field in the treatment of medial tibial stress syndrome: a pilot study.

Primary Objective: - Determine the effectiveness of a treatment with pulsed electromagnetic field therapy in patients with medial tibial stress syndrome (MTSS).Secondary Objective(s): - Determine the feasibility of the study design.- Determine the…

Effectiveness and safety of parecoxib in children undergoing scoliosis surgery compared to placebo: a double-blinded randomised controlled trial

Assessing the effectiveness and safety of parecoxib compared to placebo in pain relief children undergoing scoliosis surgery

PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)

Certolizumab pegol is a PEGylated humanized Fab* fragment with specificity for humanTNF*. Certolizumab pegol has demonstrated efficacy in clinical studies of Crohn*s disease(CD), psoriasis (PSO), and RA. The objective of this study is to demonstrate…

PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ADULT ONSET ACTIVE AND PROGRESSIVE PSORIATIC ARTHRITIS (PSA)

Certolizumab pegol is a humanized Fab* conjugated to PEG with specificity for human TNF*. Certolizumab pegol has demonstrated efficacy in clinical studies of Crohn*s disease (CD), PSO, and RA. The objective of this study is to demonstrate the…

Study on the effect of pain medication on functional capacity and self reported disability in patients with chronic low back pain;
a triple blinded RCT

This study aims to investigate the effect of analgetics on a functional capacity evaluation (FCE) and self reported disability in patients with CLBP.

can the symptoms of a tmd be positively influenced by an osteopathic treatment.

As a result of the vele symptoms which can appear at these patientengroep several diagnoses to be mostly put because many occupational groups occupy themselves such as dentists, dental surgeons, chiropraktikers, osteopaten and fysiotherapeuten,…

Efficacy of post-operative pain management with intralesional ropivacaine after subacromial decompression

The researchquestions of this study are:1. What is the efficacy of treatment of postoperative pain after subacromial decompression with a subacromial catheter with ropivacaine versus placebo?2. What are the differences in costs per patient and in…

Combining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierarchical modeling. The case of Mexilitin for patients with Non-Dystrophic Myotonia.

(voor meer details zie CMO-protocol paragraaf 2: Objectives) Primary Objective: The objective of this project is to further refine N-of-1 trial methodology, and explore whether Bayesian analysis of multiple N-of-1 trials can serve as a sufficient…

PILOT
Conservative treatment of midclavicular fractures with Kinesio® clavicular tape and sling vs sling

Goal of our study is to compare conservative treatment of mid-shaft clavicle fracture with Kinesio® clavicle tape combined with sling to conservative treatment with sling. Goal of our Pilot-studie is;Investorise if the VAS-score, the DASH…

Title (English)
*Optimization of a postoperative multi modal paincare protocol after total knee replacement: comparison of the femoral nerve block with the intra-articular infiltration technique, a prospective randomized double blinded controlled trial.*

Assessment of the additional effect of a peripheral pain management technique to regular PCA controlled intravenous morphine technique. Also the two peripheral pain management techniques will be compared: femoral nerve block technique and the intra-…

ProMuscle, A protein supplementation and exercise strategy to promote muscle protein anabolism in frail elderly people

The present study is designed to investigate whether timed protein supplementation in the presence or absence of a resistance-type exercise training will increase skeletal muscle mass in frail elderly.

A phase 1 double blind, placebo controlled study of ALX-0141 single dose subcutaneous administration in healthy post-menopausal women

- to determine the maximum tolerated dose (MTD) and/or biological effective dose (BED) after single s.c. administration of ALX-0141 - to determine the safety and tolerability of escalating single doses of ALX-0141 in healthy postmenopausal women