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.
This registry will capture real-world clinical use patterns and associated clinical outcomes with the use of CytoSorb for the removal of antithrombotic agents.
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1) head and neck squamous cell carcinoma. Secondary objectives are to determine the efficacy in terms of overall survival ,objective response rate and duration of response. Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC.
The Myeloid Neoplasms Biology and Outcome Project (MyBOP) aims to establish a registry study for patients with myeloid neoplasms. It integrates clinical data, biological samples, socio-demographic information, long-term follow-up and patient reported outcomes in a structured manner for scientific purposes. The ultimate benefits are: 1. Improvement of evidence-based clinical management of patients with myeloid neoplasms through better understanding of the course of disease and prognostic and predictive parameters 2. Direct access to new and personalized treatment approaches through recruitment into clinical studies based on the myeloid neoplasms study platform 3. Quality assurance of participating centers by evaluating and comparing clinical outcomes and side effects of the MyBOP patients with published data.
The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.
An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. Therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.
The primary objective is: To evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG) The secondary objectives of the study are: - To evaluate the effect of pozelimab + cemdisiran (ie, combination) and cemdisiran monotherapy on: - Clinician-assessed signs of myasthenia gravis (MG) and muscle strength - Daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG (cemdisiran monotherapy only). - Proportion of patients with improvements in daily function that is impacted by signs and symptoms of MG - Proportion of patients that have improvements in clinician-assessed signs of MG and muscle strength - Health related quality of life - Proportion of patients with minimal MG symptoms - Patient- and clinician-reported signs and symptoms of MG - To evaluate the safety and tolerability of pozelimab + cemdisiran and cemdisiran monotherapy - To assess the concentration of total pozelimab in serum - To assess the concentrations of cemdisiran and its metabolites in plasma - To assess the immunogenicity of pozelimab - To assess the concentration of total C5 in plasma - To assess the immunogenicity of cemdisiran - To study the effect of pozelimab + cemdisiran and cemdisiran monotherapy on complement activation
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).
This study is a phase II trial of belimumab in combination with rituximab/venetoclax in patients with refractory or relapsed chronic lymphocytic leukemia (CLL). Treatment of CLL has drastically changed in the past years as new therapeutic agents have gained clinical approval. The combination rituximab/venetoclax over a course of two years is approved as second line therapy especially in patients with high risk CLL (del17p), showing high remission rates and achievement of MRD (minimal residual disease) negativity. The next goals in CLL therapy are now to increase the rate of MRD negativity and to achieve an earlier MRD negativity during the course of treatment to allow for a reduction of treatment time and therefore treatment-induced toxicities. In line with other hematologic diseases, progression free survival depends on remission status, especially MRD negativity, after last treatment as MRD positivity after therapy indicates the persistence of treatment resistant CLL cells. One mechanism of therapy resistance has been described as reduced sensitivity to rituximab-induced antibody dependent cell-mediated cytotoxicity (ADCC) by natural killer (NK) cell production of B-lymphocyte stimulator (BlyS, also called BAFF), which can be bound by belimumab, a human anti-BAFF antibody. Moreover, recombinant human (rh)BAFF can dose dependently reverse cytotoxic effects of venetoclax, which could also be restored by the application of belimumab. This led to the conceptualization of this clinical trial, in which belimumab is applied as a weekly subcutaneous injection in combination with standardrituximab/venetoclax treatment for up to 24 months in relapsed and refractory CLL patients. By removing BAFF from the CLL microenvironment we aim to increase the efficacy of rituximab/venetoclax treatment to achieve higher and earlier MRD negativity rates and allow for an abbreviated treatment.
The incidence of skin cancer has been continuously increasing over the past decades und the number of non melanoma skin cancer is well as melanoma is still going to increase. Invasive biopsy and histological examination represents the gold standard in diagnosis of benign and malignant skin tumors. However, novel technologies such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) have been introduced in dermatology. Multiple studies have shown the applicability of both technologies for diagnosis of skin tumors as well as other skin diseases and to increase the specificity of diagnosis resulting in the reduction of unnecessary biopsies. New technological developments resulted in a high resolution OCT scanner (AMO, Taiwan), which allows vertical and horizontal evaluation (3D) of the skin at cellular resolution and up to a depth of around 400 μm and thus combines the advantages of both above mentioned techniques. ApolloVue® S100 Image System is a FDA-cleared 510(k) Class II medical device. Other non-invasive imaging method (reflectance confocal microscopy and conventional optical coherence tomography) will be used to evaluate a subset of skin lesions.