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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…

Therapeutic drug monitoring of asparaginase and methotrexate metabolism in childhood acute lymphoblastic leukemia.

The main objective of the study is to develop an optimal and individualized asparaginase treatment protocol. The study consist of four sub-studies. The objective of the population pharmacokinetic study is to get more insight in the pharmacokinetics…

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…

Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study)

The primary objective of the study is to assess the effect of missed doses of atomoxetine and OROS methylphenidate in ADHD patients who are stable on pharmacotherapy based on the patient*s daily behavior as assessed by the Daily Parent Report of…

Pilot study: performance of the Progensa PCA3 test in post-oxytocin urine specimens

The primary objective is to determine the yield of prostate cells in the urine specimen after oxytocin nasal spray, using a urine specimen with no manipulation as a reference method.

Endobronchial EZ-Blocker Compared to Left Sided Double-Lumen Tube for One-Lung Ventilation

The aim of the study is to compare the ease of placement, the incidence of malpositioning and the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity of damage to laryngeal, tracheal and bronchial structures…

PercutAneous Ventricular RestorAtion In Chronic Heart failure due to Ischemic HearTDiseasE-III

The primary objective is to continue to assess the long term safety of the CardioKinetix Parachute Implant System in the partitioning of the leftventricle in patients with heart failure due to ischemic heart disease.

International Second Immunoglobulin Dose in Guillain-Barre Syndrome patients with poor prognosis.

Primary objectiveTo determine whether a second IVIg dose in GBS patients with a poor prognosis improves functional outcome after 4 weeks.Secondary objectives To investigate whether: - a second IVIg dose in GBS patients with a poor prognosis improves…

Vincristine and concomitant azole therapy in pediatric acute lymphoblastic leukemia patients - a pharmacokinetic study

Primary objective:To assess vincristine pharmacokinetics during concomitant azole therapy, which is given in the context of standard treatment (hence this concerns an observational and not an intervention study)Secondary objectives:- To evaluate the…

A prospective single-centre open label study on the efficacy and safety of 4 weekly pasireotide LAR administration in combination with or without weekly pegvisomant in previously controlled acromegaly subjects with combined treatment of long-acting somatostatin analogs and weekly pegvisomant.

The primary study objective is to assess the proportion of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 24 weeks of treatment.Secondary study objectives are assessment of the…

Establish limits for fitness to drive with prolonged use of ICADTS class III medication

The aim is to determine on the basis of the results of this study whether there is measurable effect on the ability to drive after long term use of ICADTS class III drugs. To achieve this goal drugs will be tested out of the groups most commonly…

A Multicenter, Prospective, Long-term Registry of Pediatric
Patients with Crohn*s Disease and Ulcerative Colitis

The objective of this registry is to obtain long-term safety and clinical statusinformation on pediatric patients with IBD (ie, CD, UC, or IC).

How well is the efficacy of hepatitis A vaccination in elderly people?

React elderly >60 years of age just as good and quickly to hepatitis A vaccination as younger travellers?

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with Raptiva (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST).

PrimaryTo assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects trated with Raptiva® in the framework of the CLEARESTTM study:- Subjects developing adverse events (AEs) corresponding to pre-specified newly…

Effect of mild diarrhea on tacrolimus exposure

Primary objective: To assess the degree of tacrolimus over-exposure in renal transplant patients with mild diarrhea while on treatment with tacrolimus and mycophenolate mofetil.Secondary objective: To assess the intra-individual variability of…

A MULTI-CENTER, POST MARKETING SURVEILLANCE STUDYTO MONITOR THE SAFETY AND PERFORMANCEOF THE BARRICAID® ARD IN THE TREATMENT OF BACK ANDRADICULAR PAIN CAUSED BY PRIMARY LUMBAR DISCHERNIATION

Safety and performance will be based on a comparison of overall success rates of the Barricaid ARDand either a concurrent group (nonrandomized) of control patients treated by conventional surgicalmethods (e.g., noninstrumented discectomy) at select…

Coronary versus Intravenous abCiximab administration during Emergency Reperfusion Of ST-segment elevation myocardial infarction - the CICERO trial

To investigate whether IC administration of abciximab during primary PCI is superior to IV administration in improving myocardial perfusion in patients with STEMI.

The TOUCAN trial: a randomised, blind, clinical trial that compares the effects of TOUpet fundopliCAtion and Nissen fundoplication on the mechanics of the gastroesophageal junction.

To identify differences in the mechanisms leading to dysphagia after laparoscopic Toupet and Nissen fundoplication.

Relation among shoulder kinematics and kinetics during thoracohumeral elevations, performance of standardized ADL tasks, rehabilitation exercises, and clinical outcome measures in patients with a primary placed total shoulder prosthesis

The purpose of this study is to evaluate the relation among shoulder kinematics during thoracohumeral, glenohumeral and scapulairthoracic elevations, performance of standardized ADL, Activitities od Daly Life, tasks and clinical outcome measures of…

Treatment of port wine stains using Pulsed Dye Laser, Erbium Yag Laser and topical sirolimus in an open label pilot study (POLAR).

Primary: to evaluate and compare the efficacy of:1) PDL treatment followed by topical sirolimus application after Er:Yag laser ablation of the stratum corneum in PWS 2) PDL treatment followed by topical sirolimus application without Er:Yag laser…