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 objective of the phase I part of the trial is the determination of the maximum tolerated dose (MTD) of TCP (Tranylcypromine) in combination with fixed-dose ATRA (all-trans-retinoic acid) and with fixed-dose AraC (Cytarabine) and to derive the recommended phase II dose (RP2D) in patients with non-APL AML or MDS for whom no standard treatment is available or who failed azanucleoside treatment. The objective of the phase II part of the trial is a first evaluation of the efficacy of TCP at the RP2D in combination with fixed-dose ATRA and with fixed-dose AraC as basis for further investigations of TCP
In order to estimate the effect of fluid management in regard to postoperative complications this observatory study will document every kind of fluid intervention peri- and intraoperatively.
This multi-center randomized controlled phase II trial will investigate the impact of stereotactic fractionated radiotherapy to the resection cavity of complete resected recurrent glioblastoma on progression free survival. As secondary endpoints, overall survival, safety and toxicity as well as early response criteria on MRI, quality of life and neurocognitive function will be assessed. Chemotherapy will not be part of the protocol, however, additional treatment will be possible upon investigators best choice.
Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Among others, deficient cognitive control over emotional distraction is a central characteristic of MDD (Ochsner & Gross 2005; Disner et al. 2011; Beck 2008). Hypoactivation of the dorsolateral prefrontal cortex (DLPFC) has been linked with this deficit (Dolcos & McCarthy 2006). Moreover, aberrant functional connectivity patterns have been found in MDD patients (Kaiser et al. 2015). Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has been largely investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. In addition, it is increasingly investigated as treatment for negative symptoms in schizophrenia (SCZ) (Brunelin et al. 2012). So far, prefrontal tDCS has been shown to enhance cognitive control over emotional distraction in MDD patients (Wokenstein & Plewnia 2013). Also, tDCS-induced connectivity changes found in fMRI studies comparing resting-state networks configurations before and after prefrontal tDCS may reflect a state of enhanced alertness (Keeser, Meindl, et al., 2011; Park et al., 2013). The aim of this study is to investigate the neurophysiological correlates of tDCS effects in patients with different psychiatric disorders for which tDCS is a possible intervention, in particular MDD and SCZ, as compared to healthy individuals. For this purpose, we determine the most promising protocol in from investigations in healthy volunteers and apply this protocol in the patient sample including age- and gender-matched controls. First, functional magnetic resonance imaging (fMRI) data is collected during the execution of a cognitive control task as well as during a resting-state condition together with application of real or sham tDCS inside the scanner. It is hypothesized that prefrontal tDCS as compared to sham a) reduces distractibility by compensating for deficient DLPFC activity and b) enhances functional connectivity in networks associated with externally directed attention or cognitive engagement. Second, magnetic resonance spectroscopy (MRS) is performed to measure concentrations of GABA and glutamate in target regions of tDCS. It is hypothesized that tDCS effects are mediated via modulation of the inhibitory/excitatory systems and GABA and glutamate are used as markers of these systems. In this placebo-controlled study healthy volunteers and patients with a diagnosis of MDD or SCZ receive a single treatment with prefrontal tDCS (anode over electrode position F3, cathode over F4, 20 min, 2mA intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation). We conduct resting-state and MRS measurements combined with application of tDCS in the fMRI scanner. Subsequently, participants perform the cognitive control task (in dependence of Plewnia, C., Schroeder, P. A., & Wolkenstein, L. (2015)) in the scanner. The participants are assigned to either the real or sham tDCS condition according to a randomised, double-blind parallel design.
Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally recommended under sedation and also carried out in practice here. The vital signs monitoring to avoid complications is dictated by current national guidelines. Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In patients with severe heart disease an ECG recording should be used additionally. Moreover, the guidelines require that the sedation is clinically monitored continuously to avoid an unwanted anesthetic stage. Such evaluation, however, is often difficult under clinical conditions and even counterproductive, since a constant response and tactile stimulation of the patient (to check clinically the depth level of sedation ), interrupts endoscopic complex intervention. However, clinical most relevant aspect is the avoidance of unrecognized transition of patients from the stage of deep sedation in an anesthetic stage. Current recommendations do not take into account new study results from a gender perspective, which showed that women and men need a different wake-up time using the EEG derivation means by using teh Narcotrend after total intravenous anesthesia, which may be due to different total doses of sedatives needed. However, the research group has been demonstrated in a previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective adaptation of sedation, in particular a more rapid recovery time by a lower dose of the administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde cholangiopancreatography-(ERCP). In the presented study the investigators evaluate the extent of gender differences in the wake-up time after sedation with propofol during endoscopic ultrasound when using EEG monitoring.
A direct application of jejunal tube feeding is necessary especially in patients with gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease. Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are beneficial. While in a randomized trial of Schwab et al. it could be shown that the use of Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly faster there are currently no comparative data to use the Easy-In® probe subsequently developed , which is directly introduced through the working channel of the endoscope, and thus shortening the procedure time.
The key goals of SPORTAX-NHS is to compare the phenotype of multiple system atrophy of cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) and to determine the rate of disease progression in both groups including determination of the factors that predict the development of MSA-C vs. SAOA, and at which time after onset of ataxia, a reliable distinction between both disorders is possible. The planned study will also allow to collect blood samples and other biomaterials from patients with sporadic ataxia, which will be useful for future genetic and biomarker studies.
This is a post-marketing surveillance study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.
The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries. This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.