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.
This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups. This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.
The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are: - Is the group therapy feasible? - Is the group therapy accepted by stroke survivors and therapists? - Are there first indications on the efficacy of the group therapy to improve mental health? Participants will take part in 8 weekly group therapy sessions of 90 minutes each.
The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec. The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected. The study will be conducted in three parts (A, B, and C). Healthy participants in part A will receive one single dose of LY3938577 or a placebo, whereas participants in Parts B and C with T1DM will receive single doses of either LY3938577 or Insulin Degludec given via intravenous (IV) infusion. The study will last up to approximately 5.5, 10 and 13 weeks for parts A, B, and C, respectively, including screening period.
The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only. In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care.
The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.
Objectives: - Assess the extent of financial burden of patients undergoing radiotherapy - Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity - Design a structured social consultation to reduce financial burden induced by radiotherapy Inclusion criteria: 1. age ≥ 18 years of age 2. indication for radiation treatment of a malignant disease 3. Karnofsky Performance score (KPS) ≥ 70% 4. Life expectancy ≥ 3 months Exclusion criteria: 1. Inability to provide informed consent 2. Inability to attend study visits and fulfill data collection requirements 3. Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapy Secondary outcomes: - Socio-Economic factors at baseline - Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months - Depression (PHQ-9) at baseline and 3 months - Coping mechanisms to address financial burden Primary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months. Secondary Endpoints: - Changes in the COST-Score over time - Changes in PHQ-9 over time - Changes in EORTC QLQ-C30 over time This is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled. To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120
This is an observational study, in which data from people in Japan with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems. The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone. The data will come from a network of commercial electronic health records (EHRs) and national claims data in Japan. They cover the period from July 1st, 2021 until September 2023. Only already available data is collected and studied. There are no required visits or tests in this study.
This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing. Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires. The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms. Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia.