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 role of laparoscopic liver surgery with respect to clinical outcome remains unclear.
Pivotal Summary: The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System. Continued Access Summary: This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
Fractures of the shoulder, the so-called proximal humeral fractures, can be treated with locking plates that have shown good results in clinical practice, but complications can occur. In order to further improve the treatment of proximal humerus fractures and decrease the rate of fixation failures, further research is necessary. As a first step, the reasons for potential implant failures need to be understood. This study has been initiated by scientists at the AO Research Institute Davos (ARI), Switzerland, which is the research center of the AO Foundation (www.aofoundation.org), an international non-profit organization led by surgeons specialized in fractures such as these. Researchers at the ARI have been developing a computational simulation tool to predict fixation failure and demonstrated its efficiency in laboratory conditions. This clinical study has been organised to validate this tool using patient data, by comparing the risk of mechanical failure predicted by the computer simulated model with the clinically observed fixation failure. In future, this computer simulation tool is expected to help surgeons to select the best fixation for a given patient and to develop improved implants.
The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart. This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting insulin analogue or by an automated closed-loop system using faster insulin aspart in random order. Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.
The overall aim of this clinical study is to develop a general bioequivalence (BE) testing method using dermal open flow microperfusion (dOFM) for dermatological drug products. In this study BE of different lidocaine/prilocaine products will be assessed and factors that influence dOFM data variability will be evaluated.
The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). The study is open to participants with type 2 diabetes. It will last about 42 weeks for each participant.
The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.
Background: Giving birth is a critical moment for the mother and the fetus, potentially accompanied by stress, tissue damage, cell injury, placental hypoxia and sometimes multisystem vascular syndrome known as preeclampsia. Epidural analgesia with a local anesthetic is a common anesthetic approach during labor. Local anesthetics inhibit the oxidative phosphorylation and impair the synthesis of ATP, resulting in mitochondrial dysfunction and increased reactive oxygen species. Especially when the high demand of ATP during pregnancy cannot be reached, apoptosis will occur in an anaerobic environment. During apoptosis the cell membrane integrity is disturbed, releasing the cytoplasm into the blood circulation. Circulating cell-free mitochondrial DNA acts as a damage associated molecular pattern (DAMP) by activating the innate immune system leading to inflammation. These DAMPs are evolutionary conserved and have structural similarity to their bacterial ancestor. Therefore, cell-free mitochondria can act as a potent agent triggering the immune system in an autoimmune manner as well as a biomarker for cell damage and hypoxia. Objective: The aim of this study is to investigate to role of epidural analgesia during birth, quantifying the copy number of circulating cell-free mitochondrial DNA in maternal serum and the placenta compared to controls. The investigators hypothesize that epidural analgesia with a local anesthetic has an effect on cell-free mitochondrial DNA levels, promoting the pathogenesis of ERMF and early inflammation. In addition, circulating mitochondrial DNA could be a potent biomarker for cell damage, early placenta hypoxia/insufficiency or preeclampsia. Methods: For this study the investigators planned 3 groups each consisting of 15 patients. The intervention group (group 1) will be women with vaginal delivery having epidural analgesia and developing fever before delivery. The control group (group 2) will be women with vaginal delivery having an epidural analgesia without developing fever before delivery. Women with vaginal delivery without an epidural analgesia will serve as additional control (group 3). Blood will be taken at arrival at the delivery ward and immediately after delivery from a peripheral venous line. In addition, venous blood from the umbilical vein will be drawn postpartum. Axillary temperature will be measured routinely using a thermometer in a routine clinical fashion. Circulating cell-free mitochondrial DNA and other immunological markers will be quantified in maternal and umbilical cord (fetal) serum by real time quantitative PCR and statistical analysis will be performed by non-parametric tests.
Adequate perfusion is necessary for maintaining tissue function. This applies also for the eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference between mean arterial pressure (MAP) and intraocular pressure (IOP). In the latter formula, IOP substitutes for central retinal venous pressure (CRVP), which is assumed to be slightly higher than IOP to allow blood flow to exit the eye. It has, however, been found that in some patients CRVP is elevated and significantly higher than IOP, which would lead to a decrease in OPP which is not taken in account with the proposed formula. Therefore, techniques for measurement of CRVP are warranted. Recently, a new, method for measurement of this parameter without corneal contact has been introduced. Briefly, with this method, IOP is elevated until the vein collapses, which then equals CRVP. In the present study this technique will be applied in 12 healthy subjects to validate whether the values that are preset by the device correlate to measurements obtained with standard Goldmann applanation tonometry. For this purpose, IOP will be experimentally increased in steps of approximately 5mmHg until it reaches 40mmHg as measured by applanation tonometry. After a resting period of 30 minutes, IOP will be again increased stepwise to 40 mmHg while retinal vessel diameters will be monitored using dynamic vessel analyzer. During this session CRVP will be measured. After another resting period of 30 minutes IOP will be stepwise increased a third time and after each step OCT, OCT-A and OCT EDI will be performed.
Background. Brain metastases are the most common intracranial tumor and occur in 20-40% of all oncological patients. The most common primary cancer in brain metastases is lung cancer, followed by melanoma, breast cancer, renal cancer and colorectal cancer. The incidence of brain metastases has been increasing but the occurrence of brain metastases is still associated with high morbidity and poor prognosis. The main treatment methods are stereotactic radiosurgery (SRS), microsurgical resection and whole brain irradiation (WBRT). The stereotactic Gamma Knife Radiosurgery (GKRS) is a non-invasive method, applying high dose radiation into an exact defined volume within the cranium, and thereby associated with significantly decreased neurotoxicity. It is the only treatment method for multiple disseminated and thereby non-resectable brain metastases. A novel treatment method of brain metastases is the combination of GKRS and systematic immunotherapy (IT), targeted therapy (TT) or chemotherapy, which showed significant improvements in survival. Furthermore, patients with brain metastases often develop cerebral edema, which is commonly treated with glucocorticoids to relieve the symptoms and decrease the fluid accumulation, but the long-term use was shown to be unfavorable due to various side effects. One of the potentially concerning side effect of glucocorticoids is the immunosuppressive properties. This raises the question of whether glucocorticoids might influence the effect of immunotherapy. Aim. The aim of the study is to evaluate if the use of glucocorticoids before, during and after treatment with gamma knife radiosurgery and immunotherapy effect the overall survival in patients with brain metastases, in contrast to patients undergoing gamma knife radiosurgery and immunotherapy alone. In addition, the effect of glucocorticoids on progression-free survival and clinical outcome will be evaluated. For the evaluation of the modern oncological treatment, patients with gamma knife radiosurgery, receiving immunotherapy, will be compared to patients not receiving immunotherapy. Patients and methods. The investigators plan to conduct a observational prospective preliminary study including about 200 radiosurgically treated patients with brain metastases. Patients will be included to our study, if they were diagnosed with one of two most common primary cancers (lung cancer or melanoma) and were treated with at least one Gamma Knife radiosurgical treatment for at least one brain metastasis. For the outcome evaluation of the different treatment options, a comprehensive database will be established. The study participations will not interfere with any clincally indicated therapeutic decisions and the study participants will not be exposed to any additional risks.