There are about 25560 clinical studies being (or have been) conducted in Germany. 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 primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: - To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT - To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT - To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT - To assess cemiplimab pharmacokinetics and immunogenicity in human serum
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.
This study characterizes heart failure patients who attended the University Hospital Würzburg. The primary aim is a better understanding of the relationships and differences between the subgroups HFrEF (EF < 40%), HFmrEF (EF 40-49%), and HFpEF (EF>50%), contributing to an improved diagnosis, prognosis and therapy of patients with heart failure.
Avelumab + Paclitaxel/ Ramucirumab as second line treatment in gastro-esophageal adenocarcinoma following first-line therapy with platinum and fluoropyrimidine doublet with or without anthracycline, docetaxel or trastuzumab
As a consequence of the increasing life expectancy hospitals are seeing a growing number of elderly patients undergoing elective surgery. These patients are likely to suffer from one or more chronic illnesses, malnutrition, reduced physical strength and mobility and sensory impairment. Age related loss of resilience in combination with these conditions often results in frailty. Frailty syndrome describes a reduction in weight, mobility and strength, as well as declining cognitive capacities and reduced performance in daily life activities. This decline in constitution is accompanied by an increased risk of complications and mortality in the period after surgery. Frail patients are generally admitted to hospital for a longer period and are readmitted more often. A multitude of studies has demonstrated that these risks can be significantly reduced by offering frail patients a prevention program prior to their surgery. These prevention programs are often referred to as prehabilitation and combine strength and cardiovascular training with breathing exercises. Despite the obvious benefits, prehabilitation programs are not yet commonly applied outside of research settings as they carry considerable costs and required additional skilled personnel. In response to the unmet need for a widely applicable, cost and personnel efficient prehabilitation program a home-based prehabilitation program has been designed. This prehabilitation allows patients to safely perform an individualised set of exercises without relying on a personal trainer or a training group. Efficiency and feasibility will be evaluated in this study.
The MiDiSeq project will enroll 20 unresolved index patients with suspected mitochondrial disease prioritized for genomic analysis.
Participants with recent onset psychosis (ROP) experience delusions, hallucinations, and impairment in social, cognitive and emotional functioning. Although symptoms often improve following pharmacological intervention, the marked cognitive deficits, that often precede the onset of symptoms, continue to persist despite current treatment methods. Computerized neurocognitive interventions (NCI) are a promising therapeutic approach in participants with chronic schizophrenia and individuals at risk for psychosis. Specifically, focus has shifted to social cognitive training (SCT) as treating social cognition have been shown to provide improvements not only in general cognitive deficits but is also related to improvements in functional outcome (occupational and social). NCIs include non-invasive computerized tasks that are done on a tablet. This intervention can be conducted in a clinical setting, as well as out of the comfort of one's home. Additionally, research has shown that NCIs have the potential to elicit neuroplastic effects on the brain. The purpose of this study is to explore the efficacy of a 10-hour SCT in improving the primary outcome measure, global cognition, and secondary outcome measure, global functioning, in ROP participants. It is hypothesized that participants receiving the intervention will show gains in global cognition, as well as the subdomains of social cognition, processing speed, and working memory. Additionally, participants undergoing active intervention are expected to show gains in functional connectivity primarily between the prefrontal cortex and amygdala and other brain areas, that are engaged in social cognition. Furthermore, machine learning approach will be used(support vector classification) to investigate how the decision scores of the resting state classifier, indicating health vs. disease proneness, change in response to the training. In this randomized controlled trial, participants with a ROP receive a 4-6-week treatment with 10 hours of SCT, with 30-minute sessions 4-5 times per week or treatment as usual (TAU) control condition. Baseline and follow-up (6 weeks after the baseline assessment) assessments include clinical diagnostic and symptom assessment, standard neuropsychological testing, and structural and functional imaging. The already recruited part of the ROP sample counts 27 participants in SCT and 27 in the TAU arm. The power analysis recommends to recruit at least 6 more participants in both study arms. For the purpose of machine learning part of the analysis an independent psychosis (ROP)-healthy population (HC) classifier will be used, which takes the data from the naturalistic multi-center european study, Personalized Prognostic Tools for Early Psychosis Management, in order to be able to track the decision scores of the intervention SCT sample without risk of overfitting.
IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine. Additionally, the proportion of patients with low, intermediate and high RS in predefined clinical subgroups will be determined. To evaluate the impact of the RS on tumor cell dissemination, these subgroups also include DTC-negative versus DTC-positive patients.
This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.