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.
- Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks. - During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.
This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: - The product is approved locally for use in inoperable CTEPH patients; - Development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities - The investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine alone until disease progression or unacceptable toxic effects. Safety assessments will be conducted in 3-weekly intervals, efficacy assessments (CT or MRI) will be conducted every 9 weeks. Aim of this study is to determine whether treatment with capecitabine in combination with bendamustine is efficacious and safe.
Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500 - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance considering the increasing number of persons suffering from impaired glucose tolerance or diabetes and the unique opportunities provided by the mountainous regions of the Alps to perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude between 1500 - 3500 m. Metabolic responses to exercise may be largely mediated by interleukin 6 (IL-6), which is predominantly derived from the contracting limbs and may support the maintenance of metabolic homeostasis during exercise. In addition, IL-6 is elevated with acute and chronic altitude exposure at least partly mediated via adrenergic stimulation. Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations and differences in serum IL-6 concentrations might help to explain distinctions between responses of glucose metabolism to CE and EE at low and moderate to high altitude. 32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic condition will be a break of approximately 12 month. Measurements of glucose metabolism, IL-6 plasma concentration will be performed pre, mid (day 5) and post intervention. Moreover anthropometric, strength and exercise capacity characteristics will be performed pre and post intervention. We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in normoxia.
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks. •During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.
The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating deep sclerectomy procedure. In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open angle glaucoma and clinically significant cataract. Given that a considerable number of glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer i.o. during a combined procedure of phacoemulsification and deep sclerectomy. This is also of importance because a combined procedure avoids the need of a second operation in this group of patients. Finally, it has been shown that combined phacoemulsification - deep sclerectomy does not induce a further risk compared to deep sclerectomy alone(open phase I study). Safety will be assessed based on the occurrence of adverse events. Efficacy assessments will be performed at every visit and efficacy analysis will include: - Proportion of subjects at each study time point which will need additional IOP lowering drug therapy to achieve an IOP reduction to values < 21 mmHg. If a subject needs more than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP reduction will be recorded. - Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture to achieve an IOP reduction to values < 21 mmHg.
AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been applied during AFF008 with regard to safety as well as immunological-, radiological and clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied. Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at the occasion of 4 quarterly visits. This is offered to patients who received PD01A vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will ensure standardized and controlled management of individuals who have received PD01A as part of AFF008, the Phase I study analyzing for the first time in humans this first in class candidate.
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.
Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.