There are about 6915 clinical studies being (or have been) conducted in Austria. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Subjects will be allocated to one of the 3 diet types (minus 500 kcal / d): - Yoghurt diet: 500 g low-fat yogurt / d, about 1000-1100 mg calcium / d, - Milk product diet: 500 g of low-fat milk or buttermilk / d, about 1000-1100 mg calcium / d - Standard diet: 500 g soy yogurt / d, about 500 mg calcium / d Primary endpoint is the change in fat mass (baseline vs. 12 weeks), secondary endpoints are metabolic and endocrine parameters, gut microbiome, quality of life, hunger and satiety.
Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index >6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.
This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic cancer in the lung. Patients who have consented to participate in this study (enrolled) will be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C procedure. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment. Patients will be followed for up to 12 months.
The aim of the present study is to investigate the clinical performance of the Metronom CGM system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM sensor will be tested in an inpatient setting (meal/insulin test with frequent plasma glucose monitoring) at different days of wear-time. Sensor data will be compared to gold standard reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed over time. Additionally, safety and tolerability of the sensor will be investigated by regular assessment of the insertion site.
AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection. Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients. 100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy
The Ultra Q Reflex® (Ellex) constitutes the only Nd:YAG laser approved for the treatment of vitreous floaters. No randomized controlled clinical trial has been carried out to this day in order to investigate its superiority over sham treatment. In the present study, 60 eyes will be randomized and blinded into 2 groups, one receiving up to two sessions of laser vitreolysis the other scheduled for two sessions of sham treatment. After a maximum of two (sham) treatment sessions (1 per month), patients' utility value score and BCVA will be re-assessed. A follow-up period of 12 months (with visits at month 1, 6 and 12 post-treatment) will ensue the "treatment phase" to register any late adverse events that may be associated with laser vitreolysis. As vitrectomy constitutes a highly invasive procedure, which must therefore be restricted to severe cases only, laser vitreolysis may present a valuable treatment option for patients with moderate vitreous floaters that are not eligible for vitrectomy.
Background: Conclusive evidence states that the serotonergic system mediates neuroplasticity from early embryonic development until brain maturation in adulthood. This study aims to demonstrate that selective serotonin reuptake inhibitors (SSRIs) enhance learning-dependent neuroplasticity in vivo, hereby contributing to the investigators understanding of the mechanism of action of therapy with SSRIs. Objectives: 1. To prove a positive influence of SSRIs on structural remodeling during learning, reflected by enhancements of gray and white matter microstructure, connectivity and functionality in brain regions involved in learning processes. 2. To show that this effect is topologically specific, i.e. that enhancements of plasticity markers are found in different regions depending on their involvement during the performance of specific learning tasks. Study design: Randomized, double-blind, placebo-controlled, longitudinal mono-center study. 80 healthy subjects will undergo three MRI scanning sessions: 1. baseline, at study entry, 2. after 3 weeks of facial/emotional (n=40) or Chinese character-meaning learning (n=40) and 3. after 3 weeks learning of new associations under administration of an SSRI or placebo. Methods: MRI measurements will be performed on a 3 Tesla PRISMA MAGNETOM MR scanner. Changes in gray matter microstructure will be assessed using high-resolution structural MRI and analyzed with voxel-based morphometry (VBM). Diffusion tensor imaging (DTI) enables non-invasive investigation of neuroplasticity in the human brain based on the reduction in mean diffusivity associated with swelling of astrocytes after increased synaptic activity. Resting-state functional MRI (fMRI) will allow for the measurement of changes in functional coupling between brain regions, and fMRI during tasks will assess differential activity in brain regions during learning. Relevance and implications: This study aims to provide evidence that SSRIs facilitate cytoarchitectonical restructuring. In addition to expanding the investigators current knowledge on the trophic effects of SSRIs, the results of this study will also elucidate interactions between the serotonergic system and changes to neuronal networks during learning as well as their behavioral consequences. By probing the neurobiological correlates of the antidepressant and anti-anxiety effects of SSRIs, this study will provide a rationale for targeted interventions that harness the neuroplasticity enhancing properties of SSRIs to facilitate therapeutic processes.
Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12 years of age at recruitment into the preceding short-term pharmacokinetic (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as acceptability and palatability assessments in children still under enalapril Orodispersible Minitablet (ODMT) treatment.
Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.
Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age, suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.