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.
Aim of this study is to proof the efficacy of in Jena established prophylaxis of new bone formation aside the skeleton with irradiation and compare it with the common literature. Furthermore we want to compare irradiation treatment with the alternative prophylaxis with analgetics from the NSAID type.
Understanding the mechanisms of expectation effects in the affective system is vital, given high placebo rates in antidepressants. Evidence has consistently confirmed that expectations can influence our emotional experience. Recently, a crucial role of prefrontal top-down regulation and cognitive capacity was shown in verbally instructed expectation effects within the affective system. Empirical findings systematically point to a positivity effect in emotionally healthy aging, linked to prefrontal functioning. It is unclear whether the effects and mechanisms of positive expectations on emotional processing might also change throughout the lifespan. Hence, the investigators' goal is to explore the neurobehavioral mechanisms underlying positive expectation effects in healthy aging. Healthy older adults (N=55; 50% female) will be invited to a cross-over (positive expectation vs. no expectations induced) fMRI experiment during which they will perform an emotional interference task that manipulates cognitive resources. The investigators hypothesize that older adults demonstrate a resource-dependent positivity effect and that this effect will be further enhanced through the induction of positive expectations. Additionally, it is expected that these result are related to participants' general cognitive control ability and to be reflected on the corresponding neural correlates in prefrontal-limbic networks.
The objective of this multicenter randomized controlled trial is to compare a 6-month exercise and nutrition intervention (intervention group, IG) aimed at maintaining or improving physical functioning and quality of life with usual care (control group, CG) in ovarian cancer patients. The main question it aims to answer is: • Can an exercise and nutrition program improve physical performance during and after active treatment for ovarian cancer? Participants of the IG will undergo: - Weeks 1-18: approximately 15-30 minutes of daily exercise (cardio, resistance, and balance exercises); nutritional counseling focusing on malnutrition (protein-energy malnutrition). - Weeks 19-25: More intense daily training; nutritional counseling focusing on the Mediterranean diet. The study design includes 3 survey time points: - Baseline: After surgery and before starting chemotherapy - T1: After chemotherapy (week 19) - T2: After intervention (week 26) The primary outcome is: • 6-minute walk test, 6 months after enrollment (T2)
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.
This is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe SU via percutaneous access in the bile duct. The device has a CE-approval. First feasibility and safety for application assessed in the bile duct performed ex vivo and in a patient case report study. The study will take place at 5 different sites in Germany. Recruitment is competitive. In total, 15 patients will be enrolled. Patients are screened for study inclusion at the participating hospitals. Primary objective: • Feasibility of percutaneous cryobiopsy in the bile duct Secondary objectives: - Size of biopsy (mean area (in mm2) of each biopsy technique) - Percentage of successful retrievals of biopsies by each biopsy technique - Representativeness of each biopsy sample - Quality of each biopsy sample - Grade of crash artifacts occurrence defined as crush artifact area per biopsy - Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess
The main objective of this study is to investigate whether checklist-based close telephone consultation and process surveillance for S. aureus bacteraemia (SAB) can improve adherence to our in-house SAB-guidelines (prospective quality- improvement group). In addition, the effects of telephone consultation on the clinical outcome of patients will be examined.
The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).
The goal of this non interventional study is to evaluate the use of Tyenne, a tocilizumab biosimilar, in a real world setting in Rheumatoid Arthritis (RA) patients over a period of 12 months. The main questions it aims to answer are: - What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 6 months after treatment start? - What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 12 months after treatment start? The decision of prescribing Tyenne will be done by the physician independently, prior to patient enrolment in the study. Enrolled patients will be followed for 12 months following Tyenne treatment start, or until they permanently discontinue Tyenne. There will be one baseline visit and three follow-up visits at approximately 3, 6 and 12 months after Tyenne treatment initiation. All follow-up visits will be conducted according to the physician current clinical practice and are not imposed due to this protocol.
Prospective, non-comparative, multicenter study on medical device with 12 months follow-up.
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is marketed in the European Union since 2006 (date of first authorisation is 2006, date of renewal of the authorisation is 2016) and serves as Reference product. It is the intention of this clinical trial to assess patch adhesion properties of the newly developed rotigotine patch and the marketed Reference product Neupro® 8 mg/24 h after multiple patch applications.