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A randomized, multicenter Study to evaluate the Effect of secukinumab 300 mg s.c. administered during 52 Weeks to patients suffering from new-onset moderate to severe plaque Psoriasis as early Intervention compared to standard treatment with narrow band UVB (STEPin study)

The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…

Clinical assessment of a new adhesive and HME for night-time use in laryngectomized patients: Provox Luna

The objective of this clinical investigation is to evaluate the clinical performance of Provox Luna in comparison to the usual care of the patient.

A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)

Primary:The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with…

A twenty-six week, randomized, open-label, 2-arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transition to Toujeo compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with six month extension.

To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.

A randomized, two-arm, prospective, subject blind study to assess the safety and efficacy of InSpace* device in comparison to full thickness massive rotator cuff repair in subjects scheduled for a repair surgery.

This is a post-marketing study to further assess the safety and efficacy of the InSpace* device implantation in comparison to surgical repair of full thickness MRCT . The efficacy will be assessed by comparing the pre- and post- operative shoulder…

A randomized, placebo-controlled, double blind, 4-period, cross-over trial, to study the effects of aliskiren, hydrochlorothiazide and moxonidine on endothelial dysfunction in obesity related hypertension

Primary objective: to compare changes in endothelial function in patients with obesity related hypertension after 8 weeks of treatment with aliskiren, moxonidine and HCTZ.Secondary objectives: to compare changes in the following parameters in…

Improving preconceptional glycaemic regulation using RealTime Continuous Glucose Monitoring in women with type 1 diabetes who have *acceptable but not optimal* HbA1c values: an observational study

This study is designed to investigate whether it is possible to achieve substantial improvement in HbA1c values using RT-CGMS in women with type 1 diabetes with acceptable but not optimal glycaemic control in preconceptional period (which is HbA1c…

Comparison of monocular implantation of the Acrysof Toric T2 intraocular lens with a standard monofocal intraocular lens in subjects with cataracts and low corneal astigmatism

- Analyse the effect of the toric T2 intraocular lens on quality of vision, compared to a standard monofocal intraocular lens. - Analyse the satisfaction of patients with their visual acuity with the toric T2 intraocular lens, compared to a standard…

Women*s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life

The primary objective is to evaluate health related QoL under an oral sequential treatment with natural steroid hormones: Duogestan®. The secondary objective is to evaluate the bleeding patterns over a one-year period.

Standardized versus individualized growth hormone treatment of short children born small for gestational age: Effects on short-term and long-term efficacy, long-term psychosocial development, glucose metabolism and body composition.

The primary objective of this study is to assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height and the first and five year growth response. Secondly, we want to assess the long term…

Optimizing the treatment of psoriasis with methotrexate; after 40 years the first dose-finding study.

Our aim is to optimize treatment for patients with moderate to severe psoriasis by creating evidence for the optimal dose of MTX (on short- and long-term) with the largest disease reduction and the least side effects.

Does buprenorphine 0.3 mg prolongs the analgesic effect of a blockade of the femoral nerve with ropivaciane 0.2% for patients with a total knee replacement. A prospective triple-blinded placebo-controlled RCT?

The purpose of this study is to evaluate whether there are differences in duration and intensity at a femoral nerve block with ropivacaine Klaris standard 30ml 0.2% with and without addition of buprenorphine (Temgesic ®) 0.3 mg buprenorphine…

Saliva pharmacokinetics of methylphenidate (MPH) following ingestion of immediate and sustained release formulations in children with attention- deficit hyperactivity disorder (ADHD)

Objective: Main objective of this study is to compare the area under the MPH saliva concentration versus time curve (AUC) following ingestion of immediate and sustained release formulations of MPH in children with ADHD. Secondary objectives are: 1.…

A single-arm, open-label, multicentre, non-randomised, study to assess the effect and tolerability of standardised laxative therapy (SLT) for the reversal of opioid-induced constipation (OIC) in subjects suffering from malignant or non-malignant pain that requires around-the-clock opioid therapy.

To assess the effect of SLT on the frequency of soft (stool of type 3, 4 or 5 on the Bristol Stool Form Scale (BSFS)) complete bowel movements (SCBMs) and SCBMs non-straining (NS) per week in subjects taking World Health Organisation (WHO) step II/…

Women*s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life

To evaluate health related QoL under an oral cyclic treatment with physiological steroid hormones: Duogestan®.

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…

Metformin, a weightreducing drug in the obese pediatric population?

The aim of this study is determine the efficacy and safety of Metformin as a weight reducing drug in the euglykemic, obese paediatric population.

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.

eOPTIMA Registry

The primairy objective of this study is to evaluate the safety and efficacy of the Janus OPTIMA stent in the treatment of the novo lesions in native cotronary arteries with a maximum lenght of 28 mm and a diameter of 2.5 - 4.0 mm

Intensive five day intravenous insulin treatment combined with enteral feeding in hyperglycemic ischemic stroke patients: a feasibility study

To optimize a safe five-day intensive intravenous insulin treatment post stroke and to assess glucose profiles in patients with stroke and HG on admission, receiving standard continues enteral tube feeding.