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.
After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation. Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa. Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space. Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers. The procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1. Samples taken are the same amount as done in the previous food associated study.
This study will assess dynamic effects of two major antigens on the duodenal mucosa by confocal laser endomicroscopy (CLE). Patients will be blinded to the antigens used (wheat, yeast). Following CLE it is planned to have a cross over exclusion diet with/without the antigens including a washout phase. Furthermore, patients will undergo a 2 week FODMAP diet to be able to compare results found of both diets and allow to understand whether our findings of food intolerance will be better and more precise than a common FODMAP diet. Post CLE food challenge patients biopsies will be taken for histology. They will then be randomized into two groups and blinded to the diet they undergo. They will be provided with a supply of custom-made bread they will have for 2 weeks (custom made by a bakery in Kiel). For one study arm bread will contain either wheat and yeast, for the other arm the bread will not contain these ingredients. The taste of the "normal" bread will be denaturised. Crossover will take place after a two-week washout phase.
The purpose of this prospective observational study is to investigate the changes in sleep architecture after a hip surgery and its potential association with postoperative delirium and postoperative cognitive dysfunctions respectively.
Development of a new MS-based biomarker for the early and sensitive diagnosis of Hurler disease from plasma. Testing for clinical robustness, specificity and long-term stability of the biomarker.
Development of a new MS-based biomarker for the early and sensitive diagnosis of Sly disease from blood (plasma)
Development of a new MS-based biomarker for the ear-ly and sensitive diagnosis of Sanfilippo Disease Type A-B-C-D from blood (plasma)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Mucolipidosis Disorder type I,II,III or IV from blood (plasma)
Development of a new MS-based biomarker for the ear-ly and sensitive diagnosis of GM1/GM2 from blood
Development of a new mass spectrometry-based biomarker for the early and sensitive diagnosis of Farber disease from the blood
In this prospective, observational study the investigators assess the perioperative course of right ventricular function in combination with the venous return in patients undergoing major non-cardiac surgery. The study aims to investigate if patients undergoing major non-cardiac surgery develop an impairment of right ventricular function and/or venous return. Furthermore, the study evaluates if an impairment of right ventricular function and/or venous return is associated to left ventricular function, arterial side of the circulation and to postoperative clinical outcome.