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 phase III trial is aimed to investigate the efficacy of an individualized, sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC. Two question are aimed to be answered by this study: 1. Is the individual chemosensitivity index (BICSI) a prognostic / predictive biomarker for chemotherapy ? 2. Is an individualized, sensitivity-directed combination chemotherapy superior to the standard regimen DTIC in terms of survival and response ?
Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a retrospective multicenter international study showing that postoperative mitotane treatment was associated with a significant reduction of the risk of relapse and death. However, these promising results need confirmation in a randomized prospective study. Caution should be adopted particularly in patients with low risk of disease relapse, in whom the benefit of therapy should be weighted against the side effects. Even if an adjuvant treatment seems justified in patients at high risk of relapse, a randomised prospective study is needed to assess whether such a treatment is efficacious in patients at low-intermediate risk. The purpose of the present study is to determine whether adjuvant mitotane treatment is effective in prolonging the disease free survival in patients with adrenocortical carcinoma at low-intermediate risk of progression who underwent radical resection
Chronic organ dysfunction after lung transplantation (BOS) is the most common cause of death in long-term survivors after lung transplantation and refractory to most interventions. Early markers will be established in this project study to overcome the problem of disease recognition when impairment of graft function is already taken place. Long-term longitudinal monitoring in stable recipients of innovative markers of airway inflammation and ventilation and new imaging techniques will define different entities of chronic organ dysfunction after LTx. A database and specimen service unit for further projects will be created. Hypothesis: This project will reveal new markers and imaging tools in recipients who develop BOS after lung transplantation. These tools will allow earlier diagnosis and more accurate monitoring of the disease process. Different patterns of the disease will be characterized.
Transvenous pulmonary vein (PV) isolation using radiofrequency energy is an effective treatment for atrial fibrillation (1-4). However, rare but potentially life threatening complications such as thromboembolism (5), PV stenosis (5-10), left atrium-oesophageal fistula (11) and inflammatory syndromes (12) have been described. In preliminary studies an alternate approach using cryoenergy induces less endothelial disruption/ thrombus formation (13), preserves the extra cellular matrix and creates lesions with well-delineated border zones (14). Therefore, cryoenergy seems to be the ideal form of energy to safely perform PV isolation. We therefore hypothesise that in the setting of PV isolation for the treatment of atrial fibrillation (AF) cryoenergy is less traumatic and therefore reduces systemic inflammatory responses compared to radiofrequency energy. 78 patients presenting with symptomatic intermittent or persistent AF will be randomised to PV isolation with either radiofrequency (26 patients open irrigated tip, 26 patients closed irrigated tip) or cryoenergy (26 patients with cryoballoon). Systemic markers of cell damage and inflammatory response (t-troponin, CK, CK-MB, vWF, PAI-1, micro particles, platelet activation/overall function, CRP, IL-6, IL-8, IL-10, TNF alpha, procalcitonin) will be monitored before, during and 48h after the procedure. Further endpoints include time to PV-isolation and procedure related complications. Six month clinical follow-up will focus on freedom from AF and cardiovascular events.
The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting Xience V stent platform regarding a composite of cardiac death, myocardial infarction or target lesion revascularisation in a real-world population.
Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling). In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.
Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure. Therefore the investigators assumed that the population of patients with implantable cardioverter-defibrillators (ICD) with impaired left ventricular function may also benefit from a cardiovascular training in terms of improved quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and therapeutic effects of exercise training are very limited or not available. This prospective randomized study examines the feasibility and benefits of exercise therapy in patients with ICD and congestive heart failure.
This Germany-wide, multi-center, epidemiologic study is designed to evaluate the incidence of post-operative/anesthesia effects of muscle relaxants (i.e. post-operative residual curarization: PORC) and their effect on patient outcome. Aside from biometric data, type of operation, use of muscle relaxants and neuromuscular monitoring, all patients will be clinically evaluated after their operation in the post-anesthesia care unit. To look at long-term effects, patients will be followed-up 28 days after their operation/anesthesia regarding post-operative/anesthesia morbidity and mortality.
While glucocorticoids and immunosuppressants ameliorate manifestations of SLE in many patients, current therapies are insufficient to control the disease in a subset of patients, and their clinical prognosis remains poor due to the development of vital organ failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy. Immunoablative chemotherapy followed by autologous hematopoietic stem cell transplantation (ASCT) has recently emerged as a promising experimental therapy for severely affected patients, providing them the potential to achieve treatment-free, long-term remission. The investigators postulate that immunoablative therapy eliminates or effectively reduces the level of autoreactive T and B lymphocytes and then regeneration of de novo immunity resets the autoreactive immune system into a self-tolerant, protective immune system resulting in prolonged and treatment-free remission.
The purpose of this study is to determine whether polymorphisms in G protein subunits, namely Galphas and Galphaq, are associated with altered cardiac performance in heart failure patients.