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.
The main task of this study includes analyses of the BCR-ABL1 (breakpoint cluster region/Abelson) gene and mutations in the BCR-ABL1 tyrosine kinase domain within flow-sorted stem cells from the bone marrow and/or peripheral blood specimens. To assess the germline configuration of the patient, DNA from fingernail clippings will be investigated.
Patients with chronic hepatitis C that are under opiate substitution therapy are likely to have psychiatric comorbidities such as depression; hence an Interferon based therapy is contraindicated. Additionally many of these patients have a borderline compliance, which makes it impossible to treat them at specialized hepatological centers. An ideal opportunity to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be administered daily together with the opiate substitution therapy at a low threshold facility.
Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.
Background: Thrombosis may be crucial in driving the progression of fibrosis in chronic liver disease (CLD). The potential role of platelets and platelet activation in this process is unclear. Platelets participate in inflammation by secretion of pro-inflammatory mediators which may advance hepatic fibrosis. Hepatitis B virus transgenic mice, developed significantly smaller necroinflammatory foci and their serum ALT levels were 80% lower, if they were pre-treated with anti-platelet antibodies. Sinusoidal aggregation of activated platelets also occurs in chronic hepatitis C in humans. It may contribute to thrombocytopenia observed in CLD. Platelet activation is generally believed to be compromised in CLD. However, there is data suggesting that CLD may even be associated with an enhancement of platelet activation. Measurement of hepatic venous pressure gradient (HVPG) constitutes the most common method for estimation of portal venous pressure. HVPG is significantly correlated with histological indices of CLD progression. Study hypotheses: 1. HVPG as a marker for advancement of hepatic fibrosis and progression of CLD is associated with an increase in platelet activation. 2. Platelet activation and function is not generally compromised in CLD. Comparison of platelet function in CLD to a control group of healthy volunteers is intended to clarify whether CLD leads to a manifest platelet dysfunction Methods: Study design is observational. 100 patients with CLD of various origins (viral, alcoholic, cholestatic) scheduled for routine HVPG measurement will be enrolled. 30 healthy volunteers will donate blood as a control group. Platelet function and activation will be evaluated by multiple electrode aggregometry (primary outcome variable area under the curve (AUC). Plasma levels of P-selectin (ELISA), PFA (Platelet Function Analyzer) 100™ parameters (EPI-CT and ADP-CT), percentage of P-selectin, GPIIb/IIIa, thrombin receptor positive platelets after stimulation (flow-cytometry) will constitute secondary outcome parameters. Plasmatic coagulation will be evaluated by rotational thrombelastometry (ROTEM). Platelet count and routine coagulation parameters will be monitored. HVPG measurement by hepatic vein catheterization and patient blood sampling will be carried out via the internal jugular vein. Blood sampling in volunteers will be performed via the antecubital vein Study Rationale: If higher levels of platelet activation are associated with increased HVPGs, this would provide an insight into the pathogenesis of CLD. It would also point toward a possible benefit of anti-platelet therapy in CLD. Verification of platelet dysfunction in CLD is relevant to clinical practice in anaesthesiology and intensive care as procedures are often postponed in CLD-patients for fear of bleeding complications. CLD patients may also receive prophylactic platelet concentrates prior to interventions which is costly, fraught with risk of bacterial infection and may be unnecessary in the absence of platelet dysfunction.
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. The trial consists of a 26 week main trial period, followed by a 26 week extension trial period, a 104 week safety extension period, a 208 week longterm safety extension trial period and a 30 day follow up period. Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods. Two additional age groups, cohort II (age below 2 years and 26 weeks at screening) and cohort III (above 9 years (girls)/ above 10 years (boys) and equal to or below 17 years at screening) are included in the 208 week long-term safety extension trial period only.
An increasing number of clinical studies on SD-OCT of ocular pathologies and potential new clinical applications has recently been published in the peer-reviewed literature. However, the successful use of SD-OCT in routine clinical use depends upon the diagnostic sensitivity, biometric accuracy and reliability of the SD-OCT machines. This prospective, comparative, observational study aims to evaluate the imaging quality and diagnostic performance of two commercially available SD-OCT machines for both the anterior and posterior segment of the eye.
There is a paucity of data on the histopathological response of peritoneal tumor deposits from colorectal cancer to neoadjuvant chemotherapy. Particularly, no prospective assessment of chemotherapy-associated histopathological response within the peritoneum has been performed so far. Therefore, there is an urgent need to conduct a clinical trial aimed at prospectively assessing the histopathological response within the peritoneum in patients with peritoneal metastasis from colorectal cancer. Recently, Loupakis et al. reported that the triplet regimen of 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI) in combination with bevacizumab significantly improved median progression-free survival in metastatic colorectal cancer patients from 9.7 to 12.1 months as compared with fluorouracil, leucovorin, and irinotecan (FOLFIRI) + bevacizumab. In view of these data, it is likely that FOLFOXIRI + bevacizumab will also lead to a significant improvement of the histopathological response within the peritoneum of patients with peritoneal metastasis from colorectal cancer (pcCRC) as compared with previous standard chemotherapy. The investigators hypothesize that FOLFOXIRI + bevacizumab will induce a pCR or major response in peritoneal tumor deposits in >30% of patients (taking the response rate to FOLFOX- or FOLFIRI-based neoadjuvant chemotherapy from the published literature as a reference).
Dry eye syndrome (DES) is a highly prevalent ocular condition with potential severe consequences for affected patients. DES can be either caused by decreased tear production or increased tear evaporation, both leading to an instable tear film. Despite many efforts, generally accepted methodologies to diagnose, assess the severity and monitor DES are still lacking. Moreover, widely used clinical methods such as tear break up time (BUT), fluorescein staining of the cornea or Schirmer test only poorly reflect patients´ complains. One of the main problems in the diagnosis and treatment of DES is that the most critical component - the tear film itself - is difficult to characterize. The development of new ultra-high resolution optical coherence tomography systems allows now for the direct visualization of the human tear film and for the non-invasive in-vivo measurement of tear film thickness (TFT). The investigators could recently show that this system provides excellent reproducibility and is able to assess even subtle changes in TFT induced by therapeutic interventions. However, to which extent tear film thickness is associated with other standard clinical measures of DES is currently unknown. In the present study, the investigators set out to test the hypothesis that ocular TFT is a new and good surrogate parameter for the assessment of the severity of DES. Consequently, the aim of the study presented in this protocol is to investigate whether and if so, to what extent clinical signs of DES and reported symptoms are reflected in ocular TFT. For this purpose, a cross sectional study in healthy subjects and patients with DES will be performed. This should allow the investigators to more specifically characterize the role of the tear film in DES and to assess whether measurement of TFT with OCT can be a promising surrogate parameter for the diagnosis and the follow up of DES.
Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most of these eye drops contain preservatives to allow for the use of multi-dose containers. In the recent years evidence has, however, accumulated that these preservatives may induce ocular surface disease (OSD). This is particularly true for the most widely used preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro and animal studies, evidence from clinical trials is sparse. The only randomized masked study that showed superiority is a pivotal company-sponsored study indicating improved tolerability and reduced hyperemia of unpreserved versus preserved latanoprost eye drops. The investigators have recently introduced an optical coherence tomography (OCT) technology that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the investigators were able to show that tear film thickness (TFT) is negatively correlated with symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level of resolution as also evident from studies after administration of lubricants. In the present study, the investigators hypothesize that switching glaucoma patients from preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase in TFT as measured with OCT. As a control the investigators will use preserved latanoprost and the study hypothesis will be tested in a randomized, controlled, single-masked parallel group design. TFT is chosen as main outcome variable, standard measures for signs and symptoms of OSD are selected as secondary outcomes. The present study may provide valuable information on the superiority of unpreserved versus preserved therapy.
Inhibition of SGLT2 by specific inhibitors has been shown to reduce the renal threshold for glucose excretion in patients with type 2 diabetes mellitus (T2DM) and control subjects leading to significant renal glucose loss even in the presence of normal glucose concentrations. SGLT2 inhibition with canagliflozin induces a 24h urinary glucose loss of around 70g in healthy subjects. Recent studies indicate that under fasting and postprandial conditions administration of SGLT-2 inhibitors leads to increase in endogenous (hepatic) glucose production (EGP) potentially counteracting the glucose lowering potency of these drugs. Dapagliflozin has been shown to acutely increase endogenous glucose production (EGP) and plasma glucagon concentrations under postabsorptive conditions within 2 hours after drug ingestion in patients with (T2DM). Glucagon binds to receptors in the liver and activates hepatic gluconeogenesis (GNG) and glycogenolysis, likely contributing to the observed increase in EGP. So far the likely interrelation between acute changes in hepatic glucose metabolism and energy turnover contributing to increased hepatic glucose production induced by SGLT2 inhibition has not been studied. It is known that out of the 80% of oxygen consumption coupled to ATP synthesis, 7- 10% is used by GNG. However, so far the effects of dapagliflozin on acute changes in gluconeogenesis (GNG) and ATP turnover in hepatic tissue and on the time course of hormones involved in hypoglycaemia counter regulation have not been studied.