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.
People often experience the acute phase of a myocardial infarction as a stressful and traumatic event that seems lifethreatening. Such anxiety, pain and stress can lead to the development of posttraumatic stress disorder in the long run. Previous studies suggest that there might be a relevant percentage of people developing Posttraumatic Stress Disorder (PTSD) after a myocardial infarction. Posttraumatic stress disorder is a risk factor for the development of coronary heart disease. The goal of this study is to detect the percentage of people that develop symptoms of anxiety, stress, and PTSD after an acute myocardial infarction.
Venous thromboembolism (VTE) is a common disease with an incidence of 1-2/1000 persons per year. VTE is a chronic disease with a considerable risk of recurrence. Patients with unprovoked VTE, i.e. VTE in the absence of a temporary risk factor including surgery, cancer or immobilisation, have a high recurrence risk and indefinite anticoagulation is generally recommended. The recurrence risk of patients with VTE provoked by a transient risk factor is regarded as low. Discontinuation of anticoagulation after three months is recommended because the benefit of reducing the recurrence risk further by prolonged anticoagulation is outweighed by the bleeding risk. However, the newer direct oral anticoagulants are potentially associated with a lower bleeding risk than vitamin K antagonists. Because they are also meanwhile widely available and are convenient there is a trend towards prolonging anticoagulation also in patients with a VTE after a transient provoking factor. However, the definition of transient provoking factors is imprecise and a distinct categorization according to the risk of recurrence is lacking. Preliminary evidence suggests that the recurrence risk varies considerably between the different transient provoking factors. In a prospective cohort study, the investigators will include patients with a deep vein thrombosis or pulmonary embolism provoked by a transient risk factor defined according to Guidance of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (Kearon et al., J Thromb Haemost 2016; 14: 1480-3) after discontinuation of anticoagulation. The study endpoint is recurrent symptomatic VTE.
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grfating (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
Cardiovascular magnetic resonance imaging enables comprehensive assessment of cardiovascular function, morphology and pathology. The investigators aim to evaluate the nature and clinical significance of magnetic resonance imaging parameters in patients presenting with first acute ST-elevation myocardial infarction.
Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.
The purpose of this study is to evaluate the efficacy of addition of letrozole to the standard maintenance therapy in subjects following a primary diagnosis of Estrogen-receptor (ER) positive high and low grade epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) and subsequent primary treatment surgery and chemotherapy. Half of the participants will receive to the standard maintenance treatment, letrozole, whilst the other half receives placebo. The study's primary hypothesis is that the treatment with letrozole increases progression free survival in comparison to the maintenance standard treatment (superiority trial).
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
Orthodontic treatment extends over a longer period of time. lt takes months or rather years and it is no short-term treatment. The current literature does not answer the question of patients' expectations on aligner treatment and patients' experiences during aligner therapy sufficiently. Therefore, it is clinically and ethically highly relevant to know answers to these questions. This knowledge can highly improve the orthodontic consultation and therapy as well as the patients' comfort and wellbeing during the therapy. The proposed questionnaire-based interview survey is anticipated as a two-vear study. In the first year study patients' expectations and preferences before the aligner treatment with Invisalign® aligners will be evaluated as well as preliminary changes in quality of life during the first stages of the Invisalign® aligner treatment. In the second year study it is planned to continue with the time equivalent questionnaires of the first year study and to investigate the patients' expectations, patients' experiences and levels of quality of life during and after aligner treatment. Therefore, it is planned to enroll 55 patients in this multicentre questionnaire-based interview survey. Two different questionnaires will be handed out to the patients. The first questionnaire, the aligner questionnaire, collects information from three different time points regarding the patients' expectations, preferences, experiences and views on second opinion concerning the aligner treatment. The results of those three time points, i.e. first (Ta0 before treatment begin), second (Ta6Mo, after 6 months of treatment) and third (Ta final, after finishing the treatment) will be statistically described and compared over time. We expect most questionnaires of the second (during aligner treatment) and third time points (after finishing of treatment) to be evaluated by the end of the second year (second-year study), as the average treatment duration is about two years. The aim of the second questionnaire (OHlP 14) is to find out the changes in quality of life and is scheduled be started already in the firsfyear study. This questionnaire will be handed out to the patients before the treatment begins (Tq0), at the first check-up after the beginning of the treatment (TqCo1) and semi-annually afterwards (Tq6Mo' Tq12Mo, Tq18Mo, Tq24Mo, Tq30Mo) and finally at the end of the treatment (Tq final).
Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on this, the postsurgical therapy should be considered on the basis of biologic tumor characteristics rather than nodal involvement. Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to decrease, and perhaps eliminate, surgery in patients who have a pCR. The investigators designed a clinical trial in which only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) will be included and type of surgery will be defined according to the response to NAST rather than on the classical T and N status at presentation. In the planned trial, axillary surgery will be eliminated completely (no axillary sentinel lymph node biopsy [SLNB]) for initially cN0 patients with radiologic complete remission (rCR) and a breast pCR as determined in the lumpectomy specimen. The trial design is a multicenter single-arm study with a limited number of patients (N=350) which might give practice-changing results in a short period of time, sparing the time and the costs of a randomized comparison. Patients will be recruited in European countries (Austria, Germany, Italy, and Spain) over a period of 48 months.
Despite a number of prospective studies already initiated in the past years, the current epidemiology and course of interstitial lung disease (ILD) and pulmonary hypertension (PH) in patients with connective tissue disease (CTD) is still not well defined, particularly regarding its prevalence, incidence and the management of a broad spectrum of disease presentations. Major challenges include the identification of patients with progressive disease, the appropriate time point of therapeutic intervention and the underlying driver of disease (inflammatory or pro-fibrotic stimulus or both?). To address these issues in Western Austria, a progressive registry of patients with CTD exploring routine clinical and pathophysiological characteristics of ILD and PH will be conducted. This multidisciplinary, prospective and observational registry aims to collect comprehensive clinical data on incidence, prevalence and course of disease regarding all PH and ILD presentations in a real-world setting.