Clinical trials

This study aims to assess the current state of oral health education in nursing training programs in Germany. Good oral health is an important component of general health, yet it is often insufficiently addressed in nursing practice and education. This cross-sectional study uses self-developed standardized online questionnaires to collect data from educational leaders (such as school directors and program coordinators) as well as nursing trainees and students. The survey examines how oral health topics are integrated into curricula, which content is taught, how teaching is delivered, and how learners assess their own competence and educational needs in this area. The results of this study will provide a comprehensive overview of current practices and help identify gaps and opportunities to improve oral health education in nursing programs.

This study aims to explore how midwives in Germany perceive their professional role in the context of oral health of pregnant women and young children. A nationwide, anonymous, non-interventional online survey will be conducted to assess self-perceived role, confidence in counseling, perceived barriers, information sources, and training needs. The study is designed as an exploratory cross-sectional survey without hypothesis testing.

Tremor is a symptom that has already been described in many case reports and case series concerning patients with Charcot-Marie-Tooth (CMT) disease. However, the pathophysiology of tremor in this condition remains largely unclear. It has also not been sufficiently investigated to what extent tremor in CMT patients constitutes a relevant impairment of quality of life. This project focuses on a more detailed characterization of tremor in CMT patients using surface electromyography and accelerometer analysis, as well as the collection of individual clinical data, particularly regarding the symptom of tremor, in order to facilitate the characterization and etiological classification of the tremor. In addition, a questionnaire-based assessment will be conducted to capture the impact of tremor on activities of daily living and the associated burden in this specific patient cohort. The entire data collection process will be supported by a clinical examination, which will be video-recorded by experienced neurologists to ensure more reliable analysis. This serves both the characterization of tremor and the illustration of its functional limitations. Where available, the data will be correlated with genetic variants to allow conclusions about possible genetic predispositions or disease progression. As a control group, CMT patients who have not yet reported a tremor will be included.

Hereditary neuropathies are a phenotypically and genetically heterogeneous group of disorders. One of the most common forms is Charcot-Marie-Tooth neuropathy (CMT), which can be further divided into demyelinating (CMT1) and axonal (CMT2) neuropathies, as well as various pathogenic genetic variants. In addition to the clinically predominant motor and sensory deficits, symptoms of the autonomic nervous system have also been described in patients with CMT, often leading to significant limitations in daily functioning and quality of life. However, little is known about the prevalence and extent of autonomic dysfunction in CMT patients. In this study, patients with CMT will be assessed for the presence, severity, and characteristics of autonomic dysfunction using questionnaires and non-invasive diagnostic methods. Furthermore, diagnosis, genotype, and individual disease data-such as disease duration, severity of neurological impairment, and comorbidities-will be collected from patient records. The aim of this study is to evaluate and characterize autonomic dysfunction in patients with CMT. It seeks to determine how frequently autonomic dysfunction occurs in CMT, which areas of the autonomic nervous system are most commonly affected, whether risk factors exist, and what differences can be observed between the various CMT subtypes. The findings of this study are expected to provide new insights into the role of autonomic dysfunction in CMT, ultimately contributing to improved care and treatment for affected patients.

The most common inherited neuropathy is Charcot-Marie-Tooth disease type 1A (CMT1A), caused by a duplication of the gene expressing PMP22. CMT1A patients develop symptoms in early childhood with variable progression and there is no established therapy until now. Therapy must start in childhood, before peripheral nerves degenerate. However, the investigators lack easily obtainable biomarkers in early disease stages. In peripheral nerves from young CMT1A rats, the invstigators found changes in gene regulation that predicted the clinical disease severity later in adulthood, and gene expression from blood samples in young CMT1A rats were strong predictors of the future disease course. In blood samples from adult CMT1A patients, changes in gene expression also correlated with disease severity, demonstrating that findings can be "translated" from CMT rats to patients. Objectives: In CMT-MODs, the investigators will identify disease and prognostic biomarkers in young CMT1A patients. Strategy/ Methodology: In a translational approach, the investigators will first perform a multi-omic analysis (transcriptomic and proteomic) in sciatic nerves, blood and skin of young CMT1A rats at two timepoints in order to identify novel early markers of disease severity. In parallel, the investigators will assess a large cohort of CMT1A children, adolescents and young adults aged 10-30 years over 12 months applying the novel clinical outcome measures CMT Examination Score/CMT Neuropathy Score Version Version 2 Rasch versions (CMTES-R/CMTNSv2-R), the functional outcome measure CMT-FOM, pCMT-Qol, as well as a nerve conduction study (NCS) and quantitative MRI. Moreover, the following patient-reported outcome measures (PROMs) will also applied: VAS (pain, fatigue, cramps), WALK-12 and PGI-c. Blood (and optional skin) samples will be taken and gene expression of the most promising candidates, which the investigators originally identified in CMT rats, will be measured. Results: This unprecedented assessment of CMT patients and animal models at early disease stages will allow CMT-MODs to establish biomarkers that may serve as a standard readout for disease severity and predict the disease course. Impact: These novel diagnostic measures are urgently needed and will make clinical trials in early disease stages (children) possible in order to effectively treat and prevent CMT1A disease. Without effective biomarkers, promising preclinical therapeutic strategies cannot be translated to patients.

The systematic recording of patient-reported symptoms and health-related quality of life (patient-reported outcomes, PROs) is a central component of oncological care. Currently, however, screening for support needs in German hospitals is inconsistent and uses different assessment tools, leading to heterogeneity, redundant surveys, and limited comparability of results. This complicates standardized, patient-centered, and cross-sector care, as well as the early identification of therapy-associated side effects and support needs. The aim of the study is to investigate the acceptance and relevance of the core set of questions from the perspective of both cancer patients and professional healthcare providers. Cancer patient acceptance will be measured by the proportion of fully completed questionnaires, while cancer patient relevance will be assessed using a feedback form. The professional perspective will be gathered through guided feedback in quality circles conducted regularly in accordance with internal standards

The goal of this study is to better understand the progression of CMT1A and identify risk factors influencing disease course. CMT1A, the most common hereditary peripheral neuropathy, shows high variability in individual phenotypes despite genetic similarity. Key objectives include analyzing determinants of phenotypic expression and documenting symptom variability over five years to capture disease dynamics. Although incurable, novel CMT therapies are in development. Proving efficacy is challenging due to slow progression and limited sensitive outcome measures. This study aims to validate biomarkers (DNA/epigenetics and RNA/RT-PCR) and sensitive outcome measures from blood and skin of CMT patients over five years to support clinical therapy trials. Approximately 25 healthy volunteers will serve as controls, providing blood and skin samples for biomarker validation. Additionally, the project will build a tissue collection (skin, blood, and cultured fibroblasts) from CMT patients of various subtypes for unrestricted scientific research, especially for the German CMT-NET network (NCT03386266). Scientific partners have free access to samples and data for research (commercial use is excluded). Currently, this collection includes over 100 standardized skin biopsies from CMT1A patients and is Germany's only repository for hereditary neuropathy tissue samples.

Professional musicians are often exposed to significant physical and psychological strain. Long hours of playing, high muscle tension in the head and neck area, and performance-related stress can lead to problems such as musculoskeletal pain, jaw joint disorders, facial pain, and reduced oral health. Although these health issues are common, preventive strategies and structured health education are often insufficiently integrated into music training programs. This study aims to assess how topics related to musicians' health and performing arts medicine are currently included in the curricula of music universities in Germany, Austria, and the German-speaking part of Switzerland (D-A-CH region). Professors and lecturers responsible for musicians' health or curriculum planning at 39 music universities will be invited to complete a short questionnaire (approximately 10 minutes). The survey collects information about whether and how health-related topics are taught, including whether they are mandatory or elective, their duration, and the specific subjects covered. This is a non-interventional survey study. No medical examinations or treatments will be performed. Participation consists solely of completing the questionnaire. The results will help identify gaps in health education for professional musicians and support the future development of preventive and educational programs.

Oral health problems such as xerostomia or oral infections are common in palliative care patients and can significantly impair quality of life. Adequate dental care may contribute substantially to symptom control and well-being; however, oral health and dental services are often insufficiently integrated into palliative care practice. In addition, little is known about the level of awareness, knowledge, and interprofessional collaboration regarding oral health among palliative care professionals. This prospective, non-interventional survey study aims to assess the relevance of oral health in palliative care by surveying both palliative care patients and healthcare professionals who are members of the German Society for Palliative Medicine. The study investigates patients' oral health status, oral health-related quality of life, and access to dental care, as well as professionals' knowledge, attitudes, and current practices related to oral health and dental care in palliative settings. The findings are intended to identify existing gaps and inform strategies for improved integration of dental expertise into palliative care.

The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM), the proposed investigational medicinal product (IMP; designated "Biological Ventricular Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. EHM are constructed from defined mixtures of induced pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.

This registry is designed to collect comprehensive information about the molecular genetic diagnoses and clinical information of individuals with CABP2-associated hearing impairment to support a natural history study.

This prospective survey study investigates knowledge, attitudes, experiences, and practices related to dental care in patients with head and neck cancer among affected patients and dentists. Participants complete an anonymous online questionnaire before and after receiving written, guideline-based information. The study aims to evaluate whether targeted educational materials improve knowledge and perceptions regarding dental care in the context of head and neck cancer treatment.

The goal of this interventional clinical trial is to evaluate the efficacy and safety of preoperative hypofractionated Stereotactic Body Radiotherapy (SBRT) in the treatment of patients undergoing surgery for spinal metastases. The main questions this study aims to answer are: * Does preoperative SBRT result in local tumor control at the involved spinal segments as assessed by MRI/CT scan at 3 and 6 months postoperatively? * What are the postoperative outcomes in terms of pain intensity, functional status and quality of life? Participants will receive hypofractionated SBRT to spinal metastases shortly before surgical intervention. Participants will undergo preoperative and follow-up assessments, including: * MRI and CT scans before and after surgery and at 3 and 6 months after surgery to measure tumor size * Pain questionnaires where patients rate their current pain, worst pain, and average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable) * A short questionnaire (Karnofsky Performance Status) to assess the patient's general ability to carry out daily activities * Several patient questionnaires to evaluate back pain, physical limitations, and overall quality of life (Oswestry Disability Index, EORTC QLQ-C30, and EORTC QLQ-BM22)

The goal of this observational study is to evaluate the orointestinal microbiome and microbial derived metabolome in patients suffering from acute pancreatitis as a biomarker for severity. The main questions it aims to answer are: * Can the orointestinal microbiome robustly predict the course of acute pancreatitis? * How does the microbiome impact the severity of an acute pancreatitis? Buccal/ rectal swabs, plasma and stool is collected from patients with acute pancreatitis within 48h after hospital admission.

In this prospective registry study, patients with low-, intermediate- and high-risk tumor entities as well as patients with high symptom burden of any tumor entity in palliative constellation with indication for radiation treatment are included. This radiation treatment can be applied either as 3D-conformal RT or IGRT. The duration of treatment can range from one day to several weeks. For the primary endpoint as well as the secondary clinical and other exploratory endpoints, the 3 groups will be compared in terms of DR, QoL, toxicities and treatment plan parameters

In this monocentric observational study the research question is to what extent data collected via Apple Watch can predict the heart failure status of decompensated HF patients. For this purpose, physiological data from the Apple Watch (such as single-lead electrocardiogram, SpO2, respiratory rate, step count, nighttime temperature, etc.) will be extracted and used as predictor variables to forecast outcomes like risk of decompensation and rehospitalization within the follow-up period. Since this is a data-driven study, additional data collected as part of guideline-compliant treatment will also be included.

The trial aims at the construction and validation of an accurate, affordable and simple prognostic tool to be used in everyday clinical practice, which allows the early and reliable identification of DLBCL patients who have a very high risk of treatment failure following R-CHOP/-like first-line therapy.

Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.

This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios. Primary endpoint: * 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART Secondary endpoints: * Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes * Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score