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.
The study trial is a open-label, single-arm, multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements
The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP) and Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing surveys (questionnaires) for the accessory medical devices by the investigators.
As part of the in vitro fertilisation treatment, ovarian stimulation is routinely performed. For this purpose, FSH preparations are used. Follitropin delta is a FSH preparation that is approved for a wide range of applications and is dosed individually according to body weight and serum anti-Müllerian hormone (AMH). Body weight is used to estimate the distribution volume of the glycoprotein FD in the patient and is thus a proxy of exposure. The AMH is used to estimate the ovarian reserve and thus the number of follicles in the ovaries that can be recruited by Follitropin delta stimulation. An algorithm is used for individual dosing. The aim of individual dosing is to reduce the probability of an under or overreaction of the ovaries to FSH therapy. In contrast to phase III registration studies, patients with severe overweight and underweight, as well as very high and very low AMH values and associated disorders of the menstrual cycle and oocyte maturation, are also found in the reality of care. The performance of the dosing algorithm and thus the results of ovarian stimulation in these subgroups of patients have so far been insufficiently investigated in the phase III registration trials. In the present study no statistical hypothesis will be tested. The study is descriptive by design and the analyses are descriptive and exploratory. NIS is chosen in order to explore how the individualized dosing regimen of REKOVELLE® performs in routine clinical practice and to investigate the effectiveness and safety of REKOVELLE® under real-world conditions. This is a monocentric, prospective, non-interventional cohort study conducted in normal care setting in a fertility clinic that will collect information from 850 women undergoing up to two cycles of IVF or ICSI treatment with controlled ovarian stimulation with REKOVELLE®.
Non-invasive transcranial brain stimulation (NTBS) techniques are well established in experimental neuroscience and have been increasingly used in the treatment of mental illnesses, especially depressive disorders, in the last years. Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert antidepressant effects. Treatment with tDCS for MDD requires sessions several times a week, which is very time-consuming and stressful for patients, as they have to come to the clinic almost every day. At the same time, the availability of non-drug therapies for MDD is limited, especially in more rural areas. The home-treatment approach with tDCS for MDD could address this problem and is of increasing interest in times of the Covid-19 pandemic, when frequent clinic visits should be avoided. There are some studies on the home-treatment approach with tDCS for different, mainly neurological disorders such as parkinson's disease, multiple sclerosis and chronic pain. For the treatment of MDD with tDCS in the home treatment setting, only one pilot study has been published so far, which shows good feasibility and good antidepressant effects. However, this study does not include a placebo condition. The study will be conducted in a double-blind, placebo-controlled, parallel-group design with 16 patients per group. Patients with MDD do a 6-weeks self-administered treatment with prefrontal tDCS (anode: F3, cathode: F4, 5 sessions/week, 30min/day, 2mA intensity) or sham tDCS (parameters correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation) as adjunctive treatment to a serotonergic medication or alone. For the continuous monitoring of the technical parameters and thus for quality control and for blinding, the same technical achievements as in the DepressionDC trial are used. As a new feature, a cap is used for easier handling in the home-treatment setting, in which electrodes are already integrated at the F3 and F4 points. This study aims to investigate the feasibility and effectiveness of 6 weeks of daily home treatment with tDCS for MDD. According to the DepressionDC trial, the primary outcome parameters are the decrease in the MADRS after 6 weeks and at the end of the follow-up phase, as well as the feasibility based on the dropout rates and the outcome in the comfort rating questionnaire. Additional baseline examinations with cMRI and e-field modelling will investigate the possible influence of the individual e-field on the outcome.
Psoriatic arthritis (PsA) is a form of inflammatory arthritis associated with the skin condition psoriasis. A variety of different treatments are used to try to control arthritis and skin psoriasis and management often involves trial and error to find the right medication for the right person. Very little is known about the decisions made to increase treatment in individual patients. Previous research in rheumatoid arthritis found that clinical measures of disease activity, patient reported outcomes and characteristics of the treating doctor all influenced the decision to change therapy in routine practice. This investigators particularly want to establish whether routine use of the psoriatic arthritis impact of disease (PsAID-12) questionnaire in the clinic setting can enable a better understanding of the impact of PsA on each individual, improve physician-patient communication and lead to appropriate interventions. The PsAID-12 questionnaire is a relatively new European developed questionnaire measuring patient impact across 12 different domains in PsA. This study will use routine implementation of the PsAID-12 questionnaire and see if this is related to treatment decisions and patient satisfaction. The investigators will also examine other factors that may influence treatment decisions including patient characteristics, physician characteristics, disease activity and quality of patient-physician interactions.
This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)
This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)
This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.
The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant