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A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.

the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…

Efficacy of a skin barrier repair cream (Dermalex Eczema) in atopic dermatitis patients

The primary objective of this study is to compare the therapeutic effect on atopic dermatitis of a skin barrier repair cream (Dermalex eczema) in contrast to a standard used emollient (unguentum leniens FNA) and a dermatocorticoid (hydrocortisone)…

A randomized, cross-over, dose-response trial of tyrosine and its effect on working memory in healthy elderly and young people

The primary objective is to choose the dose (100, 150 or 200 mg/kg body weight) of tyrosine that shows the highest increase in plasma tyrosine concentration, based on comparison of the dose-response curves, in elderly. These dose-response curves…

Analgesic efficacy of saphenous nerve blockade for outpatient knee anterior cruciate ligament surgery

The general aim of this present study is to investigate whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of…

A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys from donors older than 50 years of age and donated after circulatory death.

To compare the effect of oxygenated versus non-oxygenated hypothermic machine perfusion of grafts of DCD category III (awaiting circulatory death - controlled), kidneys aged 50 years or older on kidney graft function.

Calcific tendinitis of the rotator cuff: a randomized controlled trial to the effects of the adjuvant application of platelet-rich plasma after needle aspiration of calcific deposits

To determine the effect of the adjuvant application of PRP after NACD on pain reduction, recovery of shoulder function, tendon recovery, resorption of calcific deposits, the percentage of patients with persistent complains and quality of life. The…

PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients - The PROBESE Randomized Controlled Trial

To compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs.We hypothesize that an intra-…

Intravenous immunoglobulin (IVIg) overtreatment in chronic inflammatory demyelinating polyneuropathy (CIDP)

The primary objective is to determine whether subjects with CIDP are overtreated with maintenance IVIg treatment and to reduce overtreatment-associated subjects* burden and health care costs.

Efficacy of Verapamil/ Verapamil-Kenacort injection versus Kenacort injection in Scar Treatment

Scar volume and POSAS score will be measured in the Verapamil group, these will be compared to the scar volume and POSAS score in the Kenacort+Verapamil group and the Kenacort group. In addition, complications/ adverse effects will be reported.

A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD.

The aim of this study is to demonstrate that once daily treatment with tiotropium + olodaterol fixed dose combination will reduce the number of exacerbations over tiotropium 5 µg monotherapy.A secondary aim of the study is an assessment of a…

A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment with the Holaira* Lung Denervation System in Patients with Moderate to Severe COPD.

Phase A: To evaluate the safety and feasibility of the Holaira System at two energy levels in order to establish the optimal energy dose.Phase 2: To compare the safety and feasibility outcomes between the Holaira System vs. a Sham-control group…

A randomized, double-blind, double-dummy, parallel group, multicenter study of once daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, twice daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and twice daily Fluticasone Propionate 250 mcg Inhalation Powder in the treatment of persistent asthma in adults and adolescents already adequately controlled on twice-daily inhaled corticosteroid and long-acting beta2 agonist (study 201378)

Primary: To demonstrate non-inferiority of RELVAR 100/25 once-daily to SERETIDE 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent asthma,adequately controlled on twice-daily ICS/LABA. Secondary: Adverse…

Protein and lifestyle intervention to preserve muscle mass in obese older type 2 diabetes patients - a 13-week randomised, controlled exploratory study with a 24-week follow-up period.

Primary: To investigate the effect on leg muscle mass in the test group compared to the control group in older obese type 2 diabetes patients after 13 weeks of interventionSecondary: - To investigate the effect on glycemic control in the test group…

Intraarticular treatment of osteoarthrits of the hip: A randomized trial of hyaluronic acid (Fermathron S) vs corticosteroids (Depomedrol).

Will the hyaluronic acid injections have impact on pain reduction and functional improvement in patients with osteoarthritis of the hip ?

Adrenaline use in local infiltration analgesia during TKA;Randomized, double blind, controlled study

The goal of the pilot study is to compare LIA with or without adrenaline infiltration by means of post operative pain (VAS) scores, PONV, early mobilisation and early discharge criteria.

"Back on Track"; Chronic low back pain rehabilitation program in primary care

Primary objective- To assess the differences in treatment effect (change of functional disability between pre- and post-treatment, and between pre-treatment and 3 months of follow up) between the new primary care intervention *Back on Track* and…

A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old men.

This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…

Effects of alpha-linolenic acid on 24h-ambulatory mean arterial pressure in untreated high-normal and stage I hypertensive subjects

To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial pressure (MAP) in men and women with high-normal blood pressure and mild hypertension compared to high oleic sunflower oil, poor in ALA.

Effect of a Platelet Rich Plasma (PRP) injection on the outcome of chronic lateral epicondylitis.
A double blinded randomized controlled clinical trial.

The effectiveness of PRP treatment in patients suffering from chronic lateral epicondylitis is still ambiguous. Therefore we study PRP treatment in a double blind randomized controlled trial in a homogeny patient population with respect to duration…

An attention bias modification training as waitlist intervention for depression:
A randomized controlled trial

Aim of the study is to evaluate the effectiveness and cost-effectiveness of a positivity training based on attention bias modification as waitlist-intervention for adult outpatients with a major depressive disorder.