Clinical trials

Triple-negative breast cancer (TNBC) is considered a tumor with a high risk of recurrence and metastasis and requires aggressive systemic therapy combining immunotherapy and chemotherapy. If the therapy leads to complete remission (pCR), this is prognostically beneficial for patients. Studies demonstrating the influence of the microbiome on the development of cancer and on the efficacy and toxicity of immunotherapy and chemotherapy underscore the potential of targeted nutritional interventions. Current data from microbiome research indicate that a high-fiber, gut-healthy diet modulates the microbiota in such a way that the response to and toxicity of immunotherapy and chemotherapy could be improved. The aim of this project is to translate these findings into clinical care. The study will investigate whether an online integrative oncology group training program with mind-body elements supports and is feasible for the implementation of a high-fiber diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemotherapy. The program will be compared with a control group that receives a flyer with nutritional recommendations. If the feasibility of this complementary medicine approach can be demonstrated, a confirmatory study is planned to investigate the expected effect on the pathological complete remission of TNBC.

The idea of that project is to characterize the hemodynamic changes of a daily used clinical intervention (induction of anesthesia) in a highly controlled environment by two hemodynamic monitoring devices. The aim is an advanced hemodynamic profiling of this intervention and additionally screen for changes in flow patterns in an exploratory fashion. Both devices complement one another in their hemodynamic profiling ability. One device is a continuous monitoring with instant traceable changes and the other an intermittent point-of-care ultrasound/echocardiography device with advanced possibilities for differential diagnostics. A second purpose is to test the possibility to implement advanced echocardiography in a point-of-care approach during anaesthesia induction and evaluate the time and quality of a comprehensive analysis by a not-certified anaesthetists with an echocardiography device with features of artificial intelligence versus a certified expert.

This study is a monocentric uncontrolled observational study to evaluate a 12-14 day inpatient stay in an internal medicine clinic for integrative and complementary medicine for patients with episodic migraine and/or episodic tension headache. The aim is to investigate the extent to which a 14-day inpatient stay can influence a reduction in headache days and/or pain intensity, medication use, quality of life, anxiety, depression, perceived stress, general well-being, and a reduction in sick days/work absenteeism, and prevent the chronification of migraine and may counteract the chronification of migraine or tension-type headache. In addition, patients' previous experiences with complementary naturopathic therapies, expectations and perceived benefits in everyday life will be analysed.

Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature. The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic. In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study. In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities.

Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0/Tis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated. The present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.