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 COVID-19 pandemic leads to a greatly increased risk of substantial psychological stress worldwide. We intend to evaluate an online support program aiming at reducing stress in the context of the COVID-19 pandemic. The program consists of twelve modules that participants undergo, covering a broad range of topics related to stress in the context of the COVID-19 pandemic. It has been developed together with and is provided by Selfapy GmbH, Berlin. The aim of this randomised clinical trial with observational components is to estimate the effects of the intervention as a whole, as well as individual modules and selected chapters. Further, follow-up assessments as well as information on risks and the long-term course of COVID pandemic-related stress may help to elucidate COVID-19 pandemic stress across time and what we can do to prevent long-term negative consequences.
Hantavirus disease are zoonotic infections and remain a clinical challenge with globally increasing incidence and multiple serious outbreak situations in Europe within the last years. Hantavirus disease encompasses two clinical syndromes, hemorrhagic fever with renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome (HCPS) caused by Old World and New World hantaviruses, respectively. Depending on the causative Old World hantavirus species, clinical course of HFRS can vary from mild to moderate to severe. At present, there is no specific therapy available for hantavirus disease. As the clinical course of hantavirus disease is dependent on the causing viral pathogen and as there worrisome hints that clinical course HFRS and HCPS overlap, further studies with regard to the disease course are mandatory. Furthermore, the examination of attributable mortality and costs of hantavirus disease will need to be studied on a multinational basis and therefore HantaReg will particularly use a matched case control design.
The primary aim is to study the short-term outcome of elderly ICU patients (≥ 70 years) suffering from COVID-19 using a multicenter and multi-national approach. The secondary aim is to investigate the properties of a simple frailty scale in this cohort, and in particular if this is an instrument that can be used for outcome prediction in this group. In addition, various other parameters of potential relevance for older critically ill patients will be studied.
This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to receive optimal medical care for the prevention of CI AKI with periprocedural hydration either in combination with or without use of an Impella device during PCI. Renal function will be assessed over 6 months, potential complications (in particular bleeding and access site complications) over one month. Effects of device-assisted PCI on pathways for salt and water handling, as well as on kidney oxygenation will be detected by sequential sampling of blood and urine as well as detection of magnetic resonance imaging indicative of blood kidney oxygenation (BOLD MRI).
With this trial we aim to characterize the intraoperative signatures of the Direct-Current-Electroencephalogram (DC-EEG) of elderly patients developing a PostOperative Delirium (POD) compared to patients who do not develop a POD. We hereby intend to gain a better understanding of the electrical potential at the blood-brain-barrier (measured with DC-EEG) during general anaesthesia. Second, we want to study the effect of age on the DC-EEG by comparing a younger (18-30y) to an elderly cohort (>70). Third, we aim to couple the DC-EEG signatures to blood sample analysis in order to understand the relationship between metabolic, inflammatory and vascular reaction with the intraoperative DC-EEG.
Craniosacral Therapy (CST) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. Initial randomized trials support CST's efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders. To date, there is no trial investigating the effectiveness of CST as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer. In clinical practice, therapists also report alleviating as well as regulating effects of simple CST self-help techniques, offered to patients within a group concept. Within the recent study, a CST treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group. The first group will receive 24 units of CST treatment in a 1:1 setting with a certified craniosacral therapist over 12 weeks. The second group will receive 24 units of group training in CST self-help techniques offered by a certified craniosacral therapist over 12 weeks. They will be reassessed after 12 and 26 weeks (6 months) after randomization. The third group will wait for 26 weeks and will receive no specific study intervention. After 26 weeks patients of the third group were offered to take part in two individual CST interventions and the CST self-help training. For all groups, treatment as usual is allowed.
Treatment of depression with repetitive transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. The treatment of negative symptoms with the same protocol in schizophrenia is considered as possible effective. Theta burst stimulation is a new protocol which is characterized by shorter sessions showing first evidence that it's efficacy is comparable to the high-frequency rTMS. In this randomized placebo-controlled study the efficacy of high-frequency rTMS and TBS are evaluated.
Preclinical research has established a convincing connection between changes in the gut microbiota composition and stroke outcome. However clinical data on the gut-brain axis, and its chronic characteristics, is sparse. Additional investigations in the context of ischemic stroke regarding the relationship between dysbiosis and functional changes of the microbiome, as characterized by the metabolome, are still required. The StrokeMicroBiomics study will offer insight into these mechanisms and offer new potential targets for therapeutic interventions. The primary objective is the characterisation of gut dysbiosis in ischemic stroke patients in the acute phase after stroke and during a 3 month follow-up period. The secondary objectives include the identification of dysregulated gut microbiome metabolites and key immune cell populations in addition to the clinical progression of the study participants during the 3 month follow-up period after disease onset.
The GENOME + project will enroll patients (n = ca. 100) and their healthy parents with unclear molecular cause of the disease, suspected genetic cause of the disease and previous detailed molecular analysis like Whole Exome Sequencing (WES) did not lead to the identification of the disease causing mechanism. As well healthy parents of those affected for trio analysis (exception of one parent is not available for the study).
This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)