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 purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.
The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response ("minimal residual disease [MRD] tests") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse. The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.
With this analysis the investigators aim at discovering a difference in sexuality between transmen, cissexual women and cissexual men. A potential impact of body satisfaction will also be explored. Furthermore the investigators want to assess the gender dysphoria in transmen.
Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three months of age. Breastfeeding in the first year of life appears to be protective against obesity development. Objective: of the "Josef Ressel Centre for Early Life Metabolic Programming of Dispositions of Obesity" is to identify maternal and infant predictors of metabolic risk of obesity. The main considerations of modifiable factors are early infant nutrition, 24-hours-drinking-volume, the velocity of infant weight gain, in relation to infant fat mass and fat free mass, to biomarker and to the nutritional status of the mother. A second focus is put on maternal feeding style, infant eating behaviour and the identification of satiety cues. Multi-Study design: a monocentric prospective longitudinal cohort of 100 healthy, non-obese, non-smoking pregnant mothers and their term, normal birthweight, singleton babies. Mothers and exclusively breastfed versus exclusively formula fed children (at 16 weeks) will be examined at 36 weeks of pregnancy, 4 - 8 - 12 and 16 weeks of life, follow-up at 1 and 2 years of life. Methods: four weighing protocols between 4th and 16th week of life, feeding diary, anthropometric data measurement of mother and child, child fat mass index by air displacement plethysmograph. Macronutrient and energy content of the breast milk will be analysed by MIRIS™. Well-defined biomarkers of oxidative stress and inflammation, lipid profile, adipokines, insulin, as well as micro- und macronutrients will be analysed as meaningful indicators regarding the development of obesity and/or the metabolic syndrome in newborns. Samples, such as plasma, urine, saliva, and stool of the mothers and children will be examined with High Performance Liquid Chromatography, High Performance Gas Chromatography, Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA) and more. Also questionnaires for the evaluation of the maternal milk feeding style are used as well as the Baby and Child Eating and Behaviour Questionnaire at 16 weeks, 1 and 2 years. A semi-automatic recognition of infants' satiety cues during feeding will be performed. The recording environment includes video cameras and microphones, a pulse oximeter, etc. All signals are synchronously recorded with the aid of the hardware and software infrastructure.
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol number: CL-N-KLP-TX-III/07-AT/17 Trial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver. Intended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days). Purpose of the study The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas. Patient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study. Planned number of patients (recipients) In total N=362 including: Kidney 242 (including approx. 30 combined kidney-pancreas) Liver 120
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
The Study will evaluate the effects of VVX001, a novel vaccine for hepatitis B, to - elicit a robust protective IgG immune response in vaccine naive subjects - in subjects who failed to demonstrate seroconversion after treatment with a licensed hepatitis B vaccine and - in patients chronically infected with HBV.
There are large inter-individual differences in the bleeding pattern of patients with moderate or mild hemophilia. The major determinant of bleeding phenotype is the level of coagulant factor VIII or IX. In hemophilia A, studies addressing the association between factor VIII level and the clinical bleeding pattern yield conflicting results. In hemophilia B such studies have not yet been performed. The primary aim of this project is to analyze the association between factor VIII and factor IX levels and the bleeding phenotype. The secondary aim is to analyze potential differences in phenotype between hemophilia A and B. The project is a multicentre observational cohort study. We will include 500 patients with moderate or mild hemophilia A (FVIII 0.02-0.35 IU/mL) and 500 patients with moderate or mild hemophilia B (FIX 0.02-0.35 IU/mL) who are 12 to 55 years old. The main cohort study consists of clinical data collection, one blood sample and an online questionnaire for patients. Data will be collected on the nature and duration of all bleeding episodes, disease and treatment characteristics, physical activity level and musculoskeletal status. One blood withdrawal will be performed for centralized laboratory assays for FVIII or FIX levels (both one-stage and chromogenic assays) and genetic analysis for the most prevalent prothrombotic mutations. The online questionnaire for patients focuses on bleeds experienced in the past. A subset of 200 patients aged 24 years or older (100 with moderate or mild hemophilia A and 100 with moderate or mild hemophilia B) will be investigated in more detail by longitudinal data collection including analysis of physical joint status, MRI imaging of joints and biomarkers for joint damage. This longitudinal observation will consist of two time points that lie two years apart, allowing us to identify any changes that occur over the observed time period with respect to joint status.
The research group on adaptive image-guided radiotherapy for locally advanced cervical carcinoma completed the protocol for the EMBRACE II study in October 2018. This study will be carried out in the next few years at the University Clinic for Radiotherapy at the Medical University of Vienna and other international partner institutes. EMBRACE II builds on the findings of the current EMBRACE study. These are already implemented in everyday clinical practice in order to further improve the accuracy of the entire therapy of cervical carcinomas, using state-of-the-art techniques of tele- and brachytherapy. The aim of the EMBRACE II study is to maintain and enhance the excellent local tumor control as well as the nodal and systemic control for all tumor stages while minimizing the adverse reaction rates for all affected organs (rectum, sigmoid, urinary bladder, and vagina) to increase the quality of life of patients with cervical carcinomas.
sensiTVT is a relatively new tape. The aim of this study is to analyze the objective and subjective outcome at one year follow-up.