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.
A common difficulty related to the insulin pumps are occlusions of the insulin infusion set (IIS). This study aims to evaluate the performance of a new software algorithm to detect catheter-occlusion in silico in order to refine the current automated occlusion detection algorithm of the mylife™ YpsoPump®.
Alcohol use disorder (AUD) is a chronic relapsing disorder. Alcohol craving, a hallmark symptom of AUD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound is Oxytocin (OXY), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, OXY seems to enhance effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist which is approved for AUD treatment via positive synergism on neurotransmitter levels. The proposed two-armed, 1:1 randomized, double-blind, parallel group trial seeks to test the putative synergistic effects of combined intranasal OXY spray (24 IU) + oral NTX (50mg) against Placebo spray + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AUD that suffer from high alcohol craving, within the framework of a validated alcohol cue-and stress-exposure task (i.e. a combined Trier Stress Test and alcohol cue-exposure) that was established for screening new medications in AUD and determine their effects on craving and relapse risk. Treatment effects on additional neurobiological and biochemical markers of craving that show strong associations to individual relapse risk, will serve as secondary outcomes. Collection and analysis of follow-up data (90 days) will be performed to determine whether treatment effects relate to patient outcome. The clinical trial period for an individual participant consists of a screening visit (visit 1), a baseline visit (visit 2) and two treatment visits (visits 3 and 4)(all within equal or less than ten days) followed by a 90 days (+/- 7 days) follow-up phase with two visits (visits 5 and 6) at day 30 (± 7 days) and day 90 (± 7 days). Visits 1 to 4 will be conducted while participants are undergoing standard in-patient treatment at the Department of Addictive Behavior and Addiction medicine at the Central Institute of Mental Health (CIMH) in Mannheim, Germany, for the medical condition under investigation.
This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197
In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434. NNC0385-0434 is a new potential medicine that is currently being tested for intake as a tablet. It is not yet approved and cannot be prescribed yet. Besides 40 mg of NNC0385-0434, each tablet also contains 500 mg of the absorption enhancing agent SNAC, which helps to move NNC0385-0434 from the stomach into the blood. The aim of this study is to investigate the effect of food intake on the amount of NNC0385-0434 in the blood after multiple tablet intake. For this purpose, NNC0385-0434 is given either after a high-fat breakfast or on an empty stomach. After dosing, participants must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on the group participants are assigned to. After taking the NNC0385-0434 tablets, the amount of NNC0385-0434 (and of SNAC) in the blood will be measured. The effect of food intake on the uptake of NNC0385-0434 into the body will be investigated so that correct and safe intake recommendations and medicine labels can be given. The study can last for up to approximately 14 weeks for each participant, with a total of 7 clinic visits. This includes a screening period (up to 4 weeks) and one in-house treatment period (together a total of 13 consecutive days). It also includes a follow-up period with 5 ambulatory visits at the clinic (for approximately 7 weeks [total of 50 days] after the last dosing). participants will have blood tests at every clinic visit. Participants must be healthy and have a body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive). Only men can participate in this clinical study.
Perioperative cardiac output-guided goal-directed therapy (GDT) triggers fluid, vasopressor, and inotrope administration assuming that optimizing cardiac output (i.e., global blood flow) ensures adequate oxygen delivery and microcirculatory perfusion - that are usually not directly monitored during goal-directed therapy. There is increasing evidence that perioperative cardiac output-guided goal-directed therapy may reduce postoperative complications compared to routine hemodynamic management in high-risk patients having major surgery. The effect of cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as microcirculatory perfusion, however, is unknown. The investigators aim to investigate the effect of using different cardiac output-guided goal-directed therapy algorithms on perioperative oxygen delivery and consumption as well as sublingual microcirculatory perfusion compared to routine perioperative hemodynamic management in patients having major abdominal surgery with general anesthesia.
Safety and tolerability and Pharmacokinetics of multiple doses of BV100 in healthy volunteers
Researchers are looking for a better way to treat heart failure, a condition in which the heart does not pump blood as well as it should. Heart failure can happen in both adults and children. The study treatment, vericiguat, is already available for doctors to give to adults who have heart failure. It works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. The current form of vericiguat is a tablet that releases the "active substance" immediately. The "active substance" is the part of the drug that works in the body to treat the condition. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure, but think it will be easiest for them to take a liquid treatment. Another study is planned to find out how well vericiguat works in children who have a specific type of heart failure. Before researchers can give vericiguat to children, they must first study different doses and ways of taking vericiguat in adults. In this study, the researchers will study a new liquid form of vericiguat in adults. This form is also known as the "pediatric formulation". In this study, the researchers want to find out how the new pediatric formulation of vericiguat moves into, through, and out of the body compared to the currently approved tablet form for adults. The researchers also want to find out if eating food affects the new pediatric formulation differently than the current tablet form of vericiguat. The study will include about 36 healthy white male participants aged between 18 and 45 years old. During this study, the participants will all take 4 different treatments in different orders. They will take: - a high dose of vericiguat in the new pediatric formulation, with food - a high dose of vericiguat in the new pediatric formulation, without food - a low dose of vericiguat in the new pediatric formulation, with food - a dose of the currently available tablet form, with food While taking each study treatment, the participants will stay at the study site for 4 days. There will be a break of at least 10 days between each treatment. Overall, the participants will be in this study for about 11 weeks. During the study, the participants will: - have blood and urine samples taken - have their overall health and heart health checked - answer questions about how the new pediatric formulation tastes - answer questions about any adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.
Specialised outpatient palliative care (German: Spezialisierte ambulante Palliativversorgung, abbreviation: SAPV) aims to support incurably ill or dying people spending their last lifetime at home. Furthermore, a major goal is to prevent unnecessary hospital admissions. However, they occasionally occur for various reasons. This project aims to explore predictors of readmission in terms of structural factors as well as family caregivers' psychological distress. Study Aims 1. Identification of structural predictors and caregiver reported predictors for hospital readmissions. 2. Identification of psychological liabilities of nursing relatives. 3. Developing a concept to support nursing relatives.
The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22. The secondary objectives of the study are: - To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups. - To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period. - To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.