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.
Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.
This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to < 18 years of age, with HSCT-TMA. The treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.
The study aims to induce plastic reorganization by a therapeutic protocol to increase the rate of gross total resection (GTR) and to optimize the oncological result.
The primary objective of this trial is to evaluate the seizure frequency during a course of radiotherapy for high-grade (grade III or IV) gliomas. The patients keep a seizure diary during and up to 6 weeks following radiotherapy. Every day, the patients document the number (and type) of seizures and intake of anti-epileptic medication. At the end of radiotherapy, the patients are asked to complete a questionnaire regarding their satisfaction with the seizure diary. Progression of seizure activity compared to baseline is defined as increase of frequency of seizures by more than 50%, increase of severity of seizures, or as Initiation or increase anti-epileptic medication by at least 25%. To obtain an objective assessment of seizure activity in addition to patient reported outcomes, an electroencephalography (EEG) is performed during the first and the sixth week of radiotherapy, and during the sixth week following radiotherapy. The main goal of the study is to generate objective data regarding the occurrence, frequency and severity of seizures as well as regarding the use of anti-epileptic medication during the course of radiotherapy for high-grade gliomas. These data are used to evaluate the potential effect of radiotherapy on occurrence of seizures in these patients and generate hypotheses. Therefore, statistical analyses of primary and secondary endpoints focus on descriptive methods. If statistical tests are applied, they are to be interpreted from an exploratory perspective. Thirty-two patients with documented start of radiotherapy and any documented diary data at baseline and after start of radiotherapy should be subjected to statistical analysis. Assuming that 10% of patients do not fulfil these requirements, a total of 35 patients should be enrolled to this trial. Recruitment should be completed within 12 months. With this sample size a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance if the rate of patients with progression of seizure events during the course of radiotherapy compared to baseline is 30% (rate under the alternative hypothesis) assuming a 'natural' background progression-rate of 10% without radiotherapy (null hypothesis). If the natural course of the disease would lead to a progression-rate of 5% without radiotherapy only, the power increases to 98%.
Whole-genome and transcriptome sequencing of patients with advanced solid tumors enrolled in the NCT/DKTK MASTER (Molecularly Aided Stratification for Tumor Eradication Research) program revealed genetic alterations in a substantial proportion of patients including (i) alterations that lead to aberrant activation of BRAF, ERBB2, ALK, and the PI3K-AKT and MAPK pathways and (ii) changes that predict sensitivity to immune checkpoint inhibition, such as high tumor mutational burden and specific alterations of the PD-L1 locus. Within this seven-arm basket phase II clinical trial, we aim to investigate the efficacy of targeted-therapy plus immune checkpoint inhibition in patients with advanced tumors exhibiting one of the following genetic alterations detected within the NCT/DKTK MASTER study: (i) BRAF V600E/K, (ii) ERBB2 amplification and/or overexpression or activating ERBB2 mutation, (iii) ALK rearrangement or activating ALK mutation, (iv) activating mutations or amplification of AKT, loss of PTEN, (v) activating PIK3CA mutations, (vi) abberations predicting increased RAF-MEK-ERK pathway activity; (vii) patients with high tumor mutational burden and/or specific alteration predicting sensitivity to PD-1/PD-L1 inhibition are eligible within this study for immune checkpoint inhibition. Recruitment of adequate patient numbers into these well-defined molecular subgroups is achieved in a multicenter approach including NCT Heidelberg and NCT Dresden as well as DKTK partner sites. Eligible patients will be identified by in-depth molecular characterization of tumors within the NCT/DKTK MASTER program. All study arms are based on similar biometrical assumptions, and sample size as well as power calculations are based on Simon's optimal two-stage design for each study arm separately. The overall aim is to reduce the cumulative hazard of progression-free survival observed within the study (PFS2) compared to the cumulative hazard of the progression-free time before inclusion into the study (PFS1) using a paired log-rank test. The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and 175 patients.
The aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device: The following questions will be answered: 1. What is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia? 2. Is it possible to train patients with haemophilia to perform sonography of their target joints? 3. Does a patient-based ultrasound monitoring with a handheld device work in a home setting? 4. What is the quality of the patient's self-acquired ultrasound images? 5. Will the test persons be able to distinguish normal findings from (any) pathologic findings?
Smartphone use in academic contexts (e.g., in lectures or while studying for an exam) appears to go along with negative effects on students' academic performance (i.e., concentration, perceived learning achievement, and grades) and well-being (e.g., anxiety, positive and negative affect). Despite these alarming effects, intervention studies aiming at reducing smartphone interference are generally scarce and evidential inconsistent. For instance, existing studies suggest that short separation phases from smartphones accelerate anxiety and lead to cravings and smartphone overuse after the separation period. Other studies, however, conclude that separation phases enhance individual well-being and academic performance. RESEARCH QUESTIONS. The present study aims at rigorously studying the effects of smartphone separation during exam phases on university students' performance and well-being. To do so, smartphone use reduction is incorporated into students' everyday life and encouraged through a planning intervention. The main research questions concern whether the intervention can reduce smartphone use in students, whether planning is effective in this regard, whether the intervention positively affects students' academic performance (e.g., concentration, perceived performance, grades), and whether the intervention enhances students' well-being (e.g., increased positive and decreased negative affect, lower anxiety). Furthermore, possible moderating (e.g., smartphone dependence, FoMO) and mediating variables (e.g., exam preparation-related flow, smartphone usage time, used mobile applications) are examined. METHOD. Students are to develop action plans (BCT 1.4; plans on how to reduce smartphone use during exam phases) and coping plans (BCT 1.2; plans on how to uphold reduced smartphone use during exam phases despite potential stressors or urges). The relevant variables are assessed over the course of 5 measurement points (t1-t3 take place on a weekly basis, t4 takes place after the last exam, t5 takes place 2 months after t4). Furthermore, smartphone use (smartphone use time, used mobile applications) is objectively measured via a mobile application.