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.
In German cardiac rehabilitation clinics the number of patients with reduced ejection fraction is continuously increasing since years. Approximately 2,000 patients with cardiac diseases were treated per year per clinic and LVEF < 40% was often found in patients. The mean length of stay in the rehabilitation clinics is 21 days, which gives the chance and the necessity to optimize not only medical therapy. Here, all relevant baseline parameters (indication for rehabilitation, all clinical diagnoses, age, sex, BMI, echocardiographic parameters such as LVEF or diastolic dysfunction, laboratory parameters corresponding to the recording standard of the clinic, etc.) will be recorded in an electronic CRF. Medical treatment is recorded at the drug class level and enquires about the use of the following drug classes: betablockers (BB) (yes/no), angiotensin converting enzyme inhibitors (ACEI) (yes/no), angiotensin receptor blockers (ARB) (yes/no), aldosterone receptor antagonist (yes/no) and diuretics (yes/no). Furthermore, treatment according Guideline ESC 2016 (yes/no) will be recorded in all patients at initial presentation and follow-up as well as if recommended target dose was reached (yes/no). New York Heart Association (NYHA) quantification of heart failure symptoms will be noted. Furthermore, NT-proBNP at baseline and, if available, at discharge, Quality of Life (SF-12), anxiety and depression (HADS-D) will be determined and non-drug therapy including nutrition (minimal nutrition assessment = MNA) (5) and exercise (patient exercise diary) will be investigated during inpatient rehabilitation and follow-up period. After discharge, patients will be contacted by mail after three and twelve months. Here, general questions about drug therapy and dosages, re-hospitalizations especially in connection with HFrEF are recorded in a standardized questionnaire. If postal response cannot be achieved, a telephone contact will be carried out. Drug therapy with special regards to HFrEF will be documented by comparing drug lists at demission to the patient reported drugs, which are taken at time of follow-up. The patient will be asked whether medication has been changed and if so, why, and who changed it. The observational design of the project allows no exact calculation of sample size, however, inclusion of 500 patients is aimed (50 patients per site). Continuous variables will be described using summary statistics: mean, standard deviation, median, 25% and 75% percentiles, and minimum and maximum values. Categorical variables will be described using number and percent per category. For comparison of change from clinic entry endpoints, which are normally distributed variables, the paired sample t-test will be used. The Wilcoxon signed rank test will be used to assess skewed change variables, which do not meet the normality assumption. For categorical variables, the chi-square test will be employed. Statistical analyses were performed using SPSS® software, V24 (SPSS Inc., Chicago, Illinois).
Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.
This is a single-center, multi-ICU prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients.
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Background: Chronic fatigue (CF) is a prominent symptom in many sarcoidosis patients, affecting quality of life (QoL) and interfering with treatment. This study investigates neuropsychobiological mechanisms and markers of CF in sarcoidosis.
To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.
The main objective of this trial is to investigate the influence of moderate and severe renal impairment on the pharmacokinetics of a single dose of BI 764198 in comparison to a group of matched controls with normal renal function.
People with Parkinson's disease (PD) often show gait impairments such as, shuffling gait, short steps and gait asymmetry and irregularity. These gait problems are already apparent in the early disease stages, having an immense effect on daily life functioning. Especially Freezing of Gait (FOG), where the patients are not able to initiate or continue their movement despite their intention to do so, is a debilitating problem. It is thought that lack of gait adaptability could be an underlying cause of FOG. With a split-belt treadmill the speed of both legs can be controlled independently, which forces participants to actively adapt their gait to the new situation. In a previous study performed at our lab, it was shown that only one session of split-belt training (SBT), in which the speed of one leg was reduced, improved gait adaptability and other gait features compared to tied-belt training (TBT). Furthermore, overground turning speed improved after only one single training session and this was even retained 24 hours later, indicating training induced long-term potentiation. Since the short-term effects of SBT are promising, the objective of this study is to investigate if 4 weeks of SBT, 3 times a week, has an effect on gait deficits found in individuals with PD, compared to 4-weeks, 3 times a week, of TBT.
This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.
High salt intake is a major risk factor for cardiovascular events, including stroke, heart disease and kidney failure. Pizza is a popular salty food. In this exploratory pilot study, the effects of a pizza meal challenge on immunometabolism in healthy subjects will be tested.