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A multi center, multi national, open label, extension study to evaluate the long-term efficacy and safety of BMN 044 (PRO044) in subjects with Duchenne muscular dystrophy

The aim of this study is to provide continuing access to BMN 044 treatment for subjects previously treated with the study drug. The information gained from this study is expected to further characterize the efficacy and safety of BMN 044 over a…

Gait retraining by real-time feedback in patients with knee osteoarthritis
(KneeMo Feedback Study )

A) To evaluate the use of real-time visual and audio feedback on the knee adduction moment and on kinematic patterns during gait in patients with knee osteoarthritis to decrease the biomechanical load on the knee via implicit learning and explicit…

A phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple subcutaneous doses of BMN 045 (previously known as PRO045) in subjects with Duchenne muscular dystrophy

Primary objective:To assess the efficacy of BMN 045 after 48 weeks treatment in ambulant subjects with Duchenne muscular dystrophy.Secondary objectives:To assess the safety and tolerability of BMN 045 after 48 weeks of treatment in all study…

Prospective evaluation of bone strength, physical activity, falls, subsequent fractures and mortality in patients presenting with a recent clinical fracture.

The primary objective is to assess bone structure parameters and bone strength by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical activity in relation with subsequent falls, fractures and mortality in patients with a…

A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis (CBYM338B2203)

Primary: to demonstrate that at least one dose regimen of BYM338 in sporadic inclusion body myositis patients will increase the distance traveled as measured by change from baseline at Week 52 of the 6 minute walking distance test relative to…

Treatment of osteoporosis with unfocused extracorporeal shock wave therapy: pilot study

A clinical pilot-study were we will look if one time shock wave therapy on the distal radius leads to an increased bone mass. At the same time we would like to study if shock wave therapy of the distal radius could result in complications and we…

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494

To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in RA subjects who have completed Study M13-550 or Study M13-537 Phase 2 RCT with ABT-494.

Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)

Effect on bone mineral density.

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

A Study of Respiratory Muscle Strength, including Effort-Independent Measures, in Subjects with Late-Onset Pompe Disease

The primary objective of this study is to compare respiratory muscle strength values obtained using volitional techniques with values obtained using non-volitional techniques. The secondary objective is to compare the change for these two sets of…

A Phase I/II, open-label, dose escalating with 48-week treatment study to assess the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of BMN 053 (previously knoen as PRO053) in subjects with Duchenne muscular dystrophy

Primary objective: To assess the efficacy of BMN 053 at recommended dosing regimen after 48 weeks treatment in ambulant subjects with Duchenne muscular dystrophy.Secondary objectives: - To assess the safety and tolerability of BMN 053 after single…

Cryotherapy in the recovery of bursectomy for subacromial pain syndrome. A pragmatic randomized controlled trial.

The purpose of this study is to investigate the value of postoperative cryotherapy on subjective patients-reported pain; shoulder function and quality of life in patients operated for SAPS .

Median Local Anaesthetic Dose (MLAD) of intrathecal Bupivacaine in primary total knee arthroplasty

The objective of this study is to find the Median Local Anaesthetic Dose (MLAD/ED50) of Bupivacaine that allow direct postoperative mobilization and will accommodate sufficient anaesthesia during surgery.Results of this study might lead to…

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…

Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis.

This study has been transitioned to CTIS with ID 2024-518684-35-00 check the CTIS register for the current data. The current project proposal continues on our findings of the performed prospective cohort study, aiming to develop a biomarker guided…

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…

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…

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…

A randomized, double-blind, placebo-controlled, parallel group, Phase II, 24-week study investigating the efficacy, safety and tolerability of AIN457 in patients with active overuse tendinopathy refractory to oral NSAIDs/acetaminophen, physiotherapy or corticosteroid injections

To assess the efficacy of secukinumab 300 mg s .c. vs. placebo in patients with overuse rotator cuff tendinopathy in relieving clinical symptoms at week 14