Clinical trials

The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib. Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.

This prospective observational before-after study evaluates the impact of a Mobile Geriatric Unit (MGU) on hospitalisation rates among nursing home residents. The study includes a 12-month control phase with usual care followed by a 12-month intervention phase during which the MGU is implemented. The MGU provides advanced on-site diagnostics and telemedicine-supported specialist consultation within nursing homes.

Aim of this study is to conduct longitudinal and cross-sectional analyses about the corneal ectatic disease Keratoconus based on data obtained from Keratoconus patients in the Homburg Keratoconus Center (HKC). The Homburg Keratoconus Center (HKC) was founded in 2010 and, up to now, comprises more than 3,000 Keratoconus patients. Topographic, tomographic and biomechanic characteristics of the disease are being analyzed with the intention to elucidate how the disease begins and develops during lifetime.

Aim of this study is to reflect on the changing trends in absolute numbers, surgical techniques and indications of corneal transplantations being performed in Germany. The Section Cornea of the German Ophthalmological Society provides interim-assessments on a regular basis about the most up-to-date results of this long-term study.

The recommended treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) currently focuses on lifestyle changes, including dietary adjustments and increased physical activity. Intermittent fasting is a specific dietary approach in which food intake is restricted for certain periods. Recent scientific evidence suggests that intermittent fasting can positively influence body weight, insulin resistance, and markers of inflammation. This study will examine whether restricting energy intake to approximately 600 kcal on two days per week has beneficial effects on MASLD. The nutritional framework is based on the guidelines of the German Nutrition Society (DGE) for a healthy diet (10 rules for healthy eating). Following a two-week introduction to these DGE recommendations, participants will be randomly assigned to one of two treatment groups. In the intervention group, participants follow a 5:2 intermittent fasting regimen, eating without restrictions on five days per week and limiting intake to about one-quarter of their usual daily energy (≈600 kcal) on two non-consecutive days. In the control group, participants follow a healthy diet according to DGE guidelines without restrictions on timing or energy intake.

Prospective, open-label, randomized controlled phase III trail that aims to investigate whether Re-Radiochemotherapy (Re-RCT) and sequential immunotherapy with pembrolizumab improves overall survival compared to the standard treatment with pembrolizumab alone (± chemotherapy) in locoregionally recurrent PD-L1 positive (CPS≥1) HNSCC.

Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome Analysis and Investigation of a Possible Benefit of Probiotics.

The CORSAAR study is an observational, prospective study to investigate the natural biology of COVID-19

Background: Stroke is a leading cause for individual, family and societal harm with huge health-economic impact. Immediate and correct prehospital acute stroke pathway initiation is key for treatment success. Evidence points towards sex inequity in management pathways of acute stroke care. A complicating factor in acute stroke management is the diversity in clinical presentation among patients of different sex. This increases the challenges of correct prehospital identification. Most of the currently available data on male and female differences in acute stroke management come from patients with hospital-confirmed stroke. Little to no information is available about sex-related management differences of patients with prehospital suspected stroke, often missed by stroke quality databases. Objectives: To identify sex differences in EMS-delivered prehospital diagnostic accuracy and management of patients with suspected or confirmed acute stroke. Methods: International project collaboration to conduct a cross-regional cohort analysis of patients with a prehospital working diagnosis of stroke and/or hospital-confirmed stroke diagnosis. Relevance: More information and details about the reasons for a potential prehospital treatment inequity are a necessary next step for any improvement and subsequent development of structured training programmes for emergency medical service personnel. This project is the first large-scaled international collaboration addressing sex differences in prehospital stroke care. With this approach the project will not only lead to more urgently needed information, but will also serve as a lighthouse project for raising general awareness for this topic.

The rational to conduct the LOVE study builds on the lack of available data on outcomes in steatotic liver disease in well characterized patients over a time frame of several years. At current limited data on liver-specific and overall outcome in patients with MASLD, MetALD and ALD are available. Liver histology is the only accepted surrogate to reasonably likely predict outcomes in patients with non-cirrhotic liver disease and is currently used in regulatory trials. To overcome the limitations of liver biopsy and use validated non-invasive tests (NITs) to predict outcomes, the LOVE study will be conducted based on existing cohort studies in well pheno- and genotyped patients and will inform on the relevant outcomes based on baseline and ongoing biomarker assessment. The overarching goal is to qualify a NIT for patient identification and preventive measures in the regulatory context.

Every day, patients present to emergency department due to acute heart failure. There are many causes for decompensation. One possible cause is a lack of adherence to heart failure medication (prognosis-improving medications and diuretics). The aim of this study is to directly measure adherence in patients with acute heart failure (gold standard of adherence measurement using liquid chromatography coupled to high-resolution mass spectrometry= LC-HRMS/MS) at the emergency department. Questionnaires are used to investigate possible factors influencing adherence.

Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy of immunotherapy with durvalumab concomitant with radiochemotherapy, followed by durvalumab maintenance therapy in combination with stereotactic radiotherapy in extensive stage SCLC

Critically ill patients are at risk of developing a sudden decrease of kidney function which may be detected by a decrease in urine output or is diagnosed on the basis of blood tests for substances normally eliminated by the kidney, primarily creatinine. Because it takes about 24 hours for the creatinine level to rise, even if both kidneys have ceased to function, better markers are needed. This trial is investigating if the marker urinary dickkopf-3 (uDKK3) allows an early prediction of a sudden decrease of kidney function.