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 clinical trial is planned as a prospective, multicentre, blinded, randomised, placebo-controlled, national clinical trial in Germany. The clinical trial is designed for testing the prophylactic and therapeutic effects of Aconite pain oil as compared to placebo in oncological patients receiving neurotoxic chemotherapy with taxanes and/or platinum derivatives.
Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction. The Melody valve (Medtronic Inc., Minneapolis, Minnesota) was the first to be used, validated in 2006 by the European Commission and in 2010 by the Food and Drug Administration (FDA). Subsequently, the Sapien valve (Edwards SAPIEN pulmonic transcatheter heart valve, Edwards Lifesciences, Irvine, California) was subsequently approved for PPVR (Europe, 2010; FDA 2016). Infective endocarditis (IE) after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3%, much higher than the rate of prosthetic left-heart IE. The Sapien valve has been introduced more recently and some cases of IE have been published. Despite the attention this issue is receiving, there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted. Recently, a multicenter study was published by the American team of McElhinney et al (J Am Coll Cardiol 2021 ; 78 :575-589). Although it was a sizeable cohort (2476 patients), there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve, in favor of Melody patients (2038 Melody patients vs. 438 Sapien patients). In this study, the estimated risk of IE was higher for patients who received a Melody valve, according to univariable analysis but not anymore after multivariate analysis. To further answer this question, we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted (Melody vs. Sapien) using a large population of patients with comparable characteristics (match-population).
MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible. The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients
This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios. Primary endpoint: - 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART Secondary endpoints: - Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes - Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score
The primary objective of this study is to assess the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the composite endpoint of all-cause mortality (ACM) and total cardiovascular (CV) clinical events.
This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks. The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.
The effectiveness of an optimized group exposure treatment is investigated in spider-fearful individuals. Participants will undergo an optimized standardized exposure treatment. After receiving information about the treatment and the phobic stimulus (spider) through a psychoeducation video, participants will observe an exposure treatment of another fearful person, either live or by watching a movie of an exposure treatment online. Subsequently, participants will undergo a live in vivo exposure treatment conducted in a group setting. The effectiveness of the treatment is measured by symptom improvement according to online behavioral avoidance tests and subjective ratings immediately after training and one week later.
This research project aims to investigate the everyday relevance of reactive hypoglycemia (hypoglycemia after a glucose load) in the oral glucose tolerance test (OGTT). Therefore, blood glucose profiles in everyday life will be examined using continuous glucose measurement (Free Style Libre PRO IQ system) over a period of 14 days in affected persons.
Alzheimer's disease (AD) is the most common form of dementia. In the brains of people with AD, certain small substances stick together. This leads to changes in thinking and behaviour. The company PRInnovation is developing a new treatment for Alzheimer's disease, called PRI-002. It is thought that PRI-002 can cut the sticked substances back into small pieces. That would reduce the effects of Alzheimer's disease. In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment (MCI) or mild dementia due to AD.
The goal of this non-interventional study is to evaluate quality of life (QoL) in adult patients with newly diagnosed IDH1 R132-mutated AML who are not eligible to receive standard induction chemotherapy and who are treated with ivosidenib in combination with azacitidine in a real-world setting in Germany. The main questions it aims to answer are: - Evaluate QoL by validated and widely used Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) questionnaire and European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire during treatment and follow-up period - Assesment of effectiveness in routine treatment (e.g. overall survival, event-free survival, overall response rate) - Assessment of drug safety (all adverse events) - Description of treatment reality in detail